diff --git "a/sample_size_estimation/test.jsonl" "b/sample_size_estimation/test.jsonl" new file mode 100644--- /dev/null +++ "b/sample_size_estimation/test.jsonl" @@ -0,0 +1,1000 @@ +{"trial_id": "NCT04946682", "pmid": "34998377", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment\n\nIncluded conditions:\n- Encephalitis\n- Meningitis\n- Meningoencephalitis\n- Next-Generation Sequencing\n- Polymerase Chain Reaction\n\nStudy Armgroups:\n- {'label': 'Group of mNGS', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: Types of etiological diagnostic methods']}\n- {'label': 'Group of PCR', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: Types of etiological diagnostic methods']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Types of etiological diagnostic methods', 'description': 'In Group of mNGS, all patients will be tested by meta next generation sequncing on admission, while patients in Group of PCR will be tested by polymerase chain reaction in accordance with the method in the guidelines.', 'armGroupLabels': ['Group of PCR', 'Group of mNGS']}\n\nPrimary Outcomes:\n- {'measure': 'The change Modified Rankin Scale (mRS) at 1 year', 'description': \"The Modified Rankin Scale at 1 year Grade Description 0 No symptoms\\n\\n1. Minor symptoms not interfering with lifestyle\\n2. Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients' ability to look after themselves\\n3. Symptoms that restrict lifestyle and prevent totally independent living\\n4. Symptoms that clearly prevent independent living, although the patient does not need constant care and attention\\n5. Totally dependent, requiring constant help day and night\", 'timeFrame': 'mRS should be measured at 1 year'}\n\nPlease estimate the sample size based on the assumption: \n5% drop-out rate", "answer": 484, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The predicted sample size was calculated using the PASS 11 software. Assuming hazard ratio (HR)\u00e2\u0080\u0089=\u00e2\u0080\u00891.48 and \u00ce\u00b8\u00e2\u0080\u0089=\u00e2\u0080\u00891, and according to previous research, pE\u00e2\u0080\u0089=\u00e2\u0080\u00890.7, PA\u00e2\u0080\u0089=\u00e2\u0080\u00890.5, each group requires 230 samples. Assuming a 5% drop-out rate in follow-up, each group needs 230\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00891.05\u00e2\u0080\u0089=\u00e2\u0080\u0089242 people; therefore, the total sample size of the two groups combined is calculated to be 484 people.", "id": 1143, "split": "test"} +{"trial_id": "NCT04946695", "pmid": "36249182", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Efficacy of the Use of Telephysiotherapy for Improving Functional Independence and Quality of Life in Children and Young People With Lower Limb Fracture in a Low Resource Setting in Anantapur (India)\n\nIncluded conditions:\n- Lower Extremity Fracture\n\nStudy Armgroups:\n- {'label': 'Telefisio India', 'type': 'EXPERIMENTAL', 'description': 'Feasibility and efficacy of the use of Telephysiotherapy for improving functional independence and quality of life in children and young people with lower limb fracture in a low resource setting in Anantapur (India).', 'interventionNames': ['Other: Telefisio India']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Telefisio India', 'description': 'Implement telephysiotherapy programmes in low-resource areas.', 'armGroupLabels': ['Telefisio India'], 'otherNames': ['Improving functional independence and quality of life in low-income areas']}\n\nPrimary Outcomes:\n- {'measure': 'The Barthel Index (Functional Independence)', 'description': \"Independence in self-care and mobility; it assesses the patient's level of independence with respect to the performance of some basic activities of daily living (ADLs), whereby different scores are assigned. Provides information both from the global score and from each of the partial scores for each activity. This helps to gain a better understanding of the person's specific impairments and facilitates the assessment of their evolution over time. The total score is reached by adding up the scores for each measurement and predicts the time and help that the patient will require. Scores can range from zero to 100, adding up to five points per category, so that higher scores indicate a greater degree of functional independence. It is an easy to apply measure, with a high degree of reliability and validity, capable of detecting changes, easy to interpret, and is not bothersome to apply.\", 'timeFrame': 'Four weeks'}\n- {'measure': 'The functional independence measure (FIM)', 'description': 'A global ordinal scale for functional assessment (mobility and self-care) is useful in making decisions about the effectiveness of therapy. Several studies have used the FIM to investigate treatment outcome in self-care, transfers (mobility) and locomotion. The FIM uses a 7-level scale to rate functional performance. The total FIM score is obtained by summing the ratings of the 18 items included in the different levels. The scale has good reliability and its comparison with other instruments yields correlations of 0.84 with the Barthel Index.', 'timeFrame': 'Four weeks'}\n- {'measure': 'The Timed \"Up & Go\" test (TUG) Functional mobility', 'description': 'The original Get-up and Go test was intended to clinically assess dynamic balance in older people during the performance of a task involving fall-critical situations. The TUG test measures, in seconds, the time required for an individual to get up from a standard chair with armrests (approximately 46 cm high), walk 3 m, turn around, return to the chair and sit down again. The test has been widely used in clinical practice as an outcome measure to assess functional mobility, fall risk or dynamic balance in adults. The TUG test, proved to be a good tool for assessing functional mobility in the paediatric. Assessment in seconds, ranging from less than 10 seconds considered as independent mobility to more than 20 seconds considered as reduced mobility.', 'timeFrame': 'Four weeks'}\n- {'measure': 'Quality of life (SF12), 12- Item Short Form Survey', 'description': 'The SF-12 questionnaire will be used for the assessment of health-related quality of life. The SF-12 questionnaire assesses eight dimensions of health-related quality of life: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. The range of scores obtained is from 0 to 63 points. High internal consistency indices are observed both in the Spanish validation of the questionnaire 0.83 and 0.9039, as well as in several international studies.', 'timeFrame': 'Four weeks'}\n\nPlease estimate the sample size based on the assumption: \nA one-tailed test with a significance level of 0.05, power of 0.8, and an expected proportion of losses (dropout rate) of 10%.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n To date, no studies have reported on the use of digital physiotherapy practice program in children in low resource setting; so that this randomized, blinded clinical trial will provide evidence for the effect size. However, an online sample size calculator was used (https://www.ai-therapy.com/psychology-statistics/sample-size-calculator) to determine minimal sample size (accessed on 10 May 2021). Included in the calculation was a one-tailed test, we assumed a medium effect size of 0.65 based on related study on a similar topic (42\u00e2\u0080\u009344), a significance level of 0.05 and power of 0.8. As the first estimate of effect size, a sample size of 66 participants has been calculated, with an expected proportion of losses (10%), and a proportional distribution for each arm of the study (EG = 30 and CG = 30), this information is expanded in the Supplementary material.\n For the development of this research a non-probabilistic purposive sampling will be used for the convenience of the study, due to the characteristics of the subjects. Patient recruitment will ensure socio-demographic diversity with regard to social background, gender, ethnicity and education adapted to the particularities of the reference population in India and prior information on compliance with data protection laws. The homogeneity of the sample data will be checked at baseline to ensure that there are no significant differences in demographic and medical variables.", "id": 1144, "split": "test"} +{"trial_id": "NCT04948736", "pmid": "37451728", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Clinical Application of Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenic Older Adults With Metabolic Syndrome: Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Sarcopenia\n\nStudy Armgroups:\n- {'label': 'Combined exercise nutrition intervention group', 'type': 'EXPERIMENTAL', 'description': 'Customized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period.', 'interventionNames': ['Combination Product: Combined exercise and nutrition intervention']}\n- {'label': 'Conventional medial care group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional medical care service for 12weeks during intervention period.', 'interventionNames': ['Other: Conventional medial care']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Combined exercise and nutrition intervention', 'description': 'Combined exercise and nutrition intervention for 12 weeks (an introductory phase 3 weeks, an expanded phase 3 weeks, and a maintenance phase 6 weeks).\\n\\nExercise intervention (each 60-min session) includes stretching, resistance exercise, and aerobic exercise according to protocol.\\n\\nNutritional intervention includes investigating dietary habits and calculate insufficient protein intake using Mini Nutritional Aseessment (MNA) and Korean Protein Assessment Tool (KPAT) to provide customized diet and high protein drink.', 'armGroupLabels': ['Combined exercise nutrition intervention group']}\n- {'type': 'OTHER', 'name': 'Conventional medial care', 'description': 'Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. They were given a brochure about exercise and protein-rich foods at their first visit.\\n\\nThe control group patients maintain their usual amount of activity and diet during the 6-month evaluation period. usual activity and dietary habits.', 'armGroupLabels': ['Conventional medial care group']}\n\nPrimary Outcomes:\n- {'measure': '5-times chair stand test', 'description': 'Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test', 'timeFrame': 'Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)'}\n\nPlease estimate the sample size based on the assumption: \nStudy power set at 90%, alpha set at 0.05, 80% compliance, and 25% dropout rate.", "answer": 168, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on a previous study,23 the study power will be set at 90% and alpha was set at 0.05, with p<0.05 indicating statistical significance. Using PASS 2020 statistical software (NCSS Statistical Software, Kaysville, Utah, USA), we will determine that, to measure a difference of 2.5\u00e2\u0080\u0089s on the 5-repetition chair test between groups, 50 participants per group will be required. A total of 168 participants will be recruited based on an estimated 80% compliance and 25% dropout rate for the two groups.", "id": 1145, "split": "test"} +{"trial_id": "NCT04949633", "pmid": "37068892", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oxytocine Versus Prostaglandines Pour le d\u00e9clenchement du Travail Des Femmes Dont le Col Est d\u00e9favorable apr\u00e8s 24 Heures de Maturation Cervicale : Essai Multicentrique randomis\u00e9 de Non inf\u00e9riorit\u00e9\n\nIncluded conditions:\n- Cervical Ripening\n- Unfavorable Cervix\n\nStudy Armgroups:\n- {'label': 'Induction of labor', 'type': 'EXPERIMENTAL', 'description': 'women randomized in the experimental group will be admitted to the labor ward to undergo induction of labor with intra-veinous oxytocin and early amniotomy. Oxytocin will be administered according to the French guidelines for induction of labor. Maximum oxytocin used should not exceed 10 UI.', 'interventionNames': ['Drug: Oxytocin']}\n- {'label': 'Second cervical ripening', 'type': 'ACTIVE_COMPARATOR', 'description': 'women randomized in the control group will undergo a second cervical ripening lasting a maximum of 24 hours with either:\\n\\n* Vaginal slow releasing system of dinoprostone PROPESS\u00ae which is inserted in the vagina, against the cervix and left in place during 24 hours.\\n* Oral misoprostol (ANGUSTA\u00ae) 25 \u00b5g every 2 hours, 8 times (maximum dosage should not exceed 200\u00b5g). Tablets will be given one at the time by midwives.\\n* Vaginal gel of dinoprostone (2 mg PROSTINE\u00ae) every 6 hours, maximum dose of 6 mg.\\n\\nThe choice of the cervical ripening agent will depend of the local protocol of the participating maternity unit. The choice between ANGUSTA\u00ae, PROPESS\u00ae and PROSTINE\u00ae will be made by investigators of each participating unit at the beginning of the trial.\\n\\nAt the end of the second cervical ripening procedure women not in labor will be transferred to the labor ward for induction of labor with oxytocin.', 'interventionNames': ['Drug: Prostaglandins', 'Drug: Oxytocin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Prostaglandins', 'description': 'Second cervical ripening lasting a maximum of 24 hours', 'armGroupLabels': ['Second cervical ripening']}\n- {'type': 'DRUG', 'name': 'Oxytocin', 'description': 'Induction of labor with oxytocin.', 'armGroupLabels': ['Induction of labor', 'Second cervical ripening']}\n\nPrimary Outcomes:\n- {'measure': 'Cesarean delivery rate', 'description': 'The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery', 'timeFrame': 'Up to 2 days after intervention'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80% with a two-tailed type I error of 5%", "answer": 1494, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated from data obtained from a recent French prospective observational study conducted in 94 maternity units, showing that among women with an unfavourable cervix after 24 hours of cervical ripening, the caesarean delivery rate was 37%. Assuming a caesarean rate of 37% in each group and with a 7% non-inferiority margin, this individually randomised trial would require the inclusion of 1494\u00e2\u0080\u0089women to achieve a power of 80% (with a two-tailed type I error of 5%), that is, 747\u00e2\u0080\u0089women in each group.", "id": 1146, "split": "test"} +{"trial_id": "NCT04950920", "pmid": "37308251", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase III Clinical Trial of Y-2 Sublingual Tablet in the Treatment of Acute Ischemic Stroke - a Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Y-2 sublingual test group', 'type': 'EXPERIMENTAL', 'description': 'Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg.', 'interventionNames': ['Drug: Y-2 sublingual tablets']}\n- {'label': 'placebo group', 'type': 'SHAM_COMPARATOR', 'description': '60 \u03bcg d-borneol', 'interventionNames': ['Drug: d-borneol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Y-2 sublingual tablets', 'description': '30mg Edaravone+6mg d-borneo OR\uff0c Bid', 'armGroupLabels': ['Y-2 sublingual test group']}\n- {'type': 'DRUG', 'name': 'd-borneol', 'description': '60 \u03bcg d-borneol OR\uff0c Bid', 'armGroupLabels': ['placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'mRS score \u2264 1', 'description': 'Whether patients with mRS(Modified Rankin Scale) score \u2264 1. Used to calculate the proportion of patients with mRS score \u2264 1.', 'timeFrame': '90 days after treatment initiation'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided \u03b1 of 0.05, power of 80%, and a drop-out rate of 15%.", "answer": 914, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary efficacy outcome is the proportion of patients achieving an mRS\u00e2\u0089\u00a41 at 90 days. According to TASTE trial(Treatment of Acute Ischemic Stroke with Edaravone Dexborneol),18 the proportion of patients with an mRS score of \u00e2\u0089\u00a41 on day 90 is 50% in the experimental group and 40% in the control group. Taking a two-sided \u00ce\u00b1 of 0.05 and a power of 80%, the required sample size for each group is 388. Considering a drop-out rate of 15%, a total sample size of 914 are estimated with 457 patients per group.", "id": 1147, "split": "test"} +{"trial_id": "NCT04951986", "pmid": "38720383", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis\n\nIncluded conditions:\n- Disseminated Tuberculosis\n- HIV\n\nStudy Armgroups:\n- {'label': 'High dose Rifampicin plus Levofloxacin', 'type': 'EXPERIMENTAL', 'description': 'Standard TB treatment plus additional Rifampicin 35 mg/kg/day PLUS Levofloxacin for 14 days', 'interventionNames': ['Drug: Rifampin', 'Drug: Levofloxacin', 'Drug: Rifampicin, Pyrazinamide, Ethambutol and Isoniazid']}\n- {'label': 'Prednisone', 'type': 'EXPERIMENTAL', 'description': 'Prednisone 1.5 mg/kg for 14 days', 'interventionNames': ['Drug: Prednisone']}\n- {'label': 'Standard TB treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'High dose rifampicin/levofloxacin comparator', 'interventionNames': ['Drug: Rifampicin, Pyrazinamide, Ethambutol and Isoniazid']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Prednisone comparator', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rifampin', 'description': 'Rifampicin up to 35 mg/kg/day for 14 days', 'armGroupLabels': ['High dose Rifampicin plus Levofloxacin'], 'otherNames': ['rifampicin', 'Rifadin', 'Rimactane']}\n- {'type': 'DRUG', 'name': 'Levofloxacin', 'description': 'Levofloxacin 750mg daily (for weight \\\\<50kg) or 1 g daily (for weight \\\\>50 kg) daily for 14 days', 'armGroupLabels': ['High dose Rifampicin plus Levofloxacin']}\n- {'type': 'DRUG', 'name': 'Rifampicin, Pyrazinamide, Ethambutol and Isoniazid', 'description': 'Rifampicin 10 mg/kg; Isoniazid 5 mg/kg; Pyrazinamide 15 mg/kg; Ethambutol15 mg/kg in fixed dose combination administered per weight band. Standard of care control arm', 'armGroupLabels': ['High dose Rifampicin plus Levofloxacin', 'Standard TB treatment'], 'otherNames': ['Rifafour']}\n- {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Prednisone 1.5mg/kg/day for 14 days', 'armGroupLabels': ['Prednisone'], 'otherNames': ['Trolic']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo identical to Prednisone', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'All-cause mortality', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a significance level (alpha) of 0.05 and is powered at 80%. There is an assumed 5% loss to follow-up rate.", "answer": 732, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The study is designed to demonstrate superiority of each intervention separately over the standard of care with a p-value threshold of 0.05 used to determine a significant result. There is no adjustment for multiple comparisons. We assume mortality at 12 weeks to be 28% in the standard of care arm. This was based on extrapolation of mortality data from previous study amongst patients with HIV associated TB [4]. The trial is powered to demonstrate a relative reduction in mortality of 32% (reduction from 28 to 19% in absolute 12-week mortality). To have adequate power of 80% and alpha 0.05, a sample size of 347 per arm is required. Inflating this number to account for 5% loss to follow-up, we will recruit 732 participants to the trial. The factorial design of the trial may result in interaction between the interventions, and this will be evaluated as a secondary endpoint. This interaction analysis is relatively underpowered, and we would only be able to detect a large interaction.", "id": 1148, "split": "test"} +{"trial_id": "NCT04953208", "pmid": "36271928", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The DiSCoVeR Project: Examining the Synergistic Effects of a Cognitive Control Videogame and a Self-administered Non-invasive Brain Stimulation on Alleviating Depression\n\nIncluded conditions:\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'Active treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'active tDCS (using the Neuroelectrics Starstim tCS 5G kit) and cognitive and emotional control video game', 'interventionNames': ['Device: active tDCS', 'Behavioral: cognitive and emotional control video game']}\n- {'label': 'Sham treatment', 'type': 'SHAM_COMPARATOR', 'description': 'sham tDCS (using the Neuroelectrics Starstim tCS 5G kit) and non-active videogame', 'interventionNames': ['Device: sham tDCS', 'Behavioral: sham video game']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'active tDCS', 'description': 'Treatment will be applied daily 5 days/week for a period of 6 weeks, which equals a tDCS stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.', 'armGroupLabels': ['Active treatment']}\n- {'type': 'DEVICE', 'name': 'sham tDCS', 'description': 'sham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.', 'armGroupLabels': ['Sham treatment']}\n- {'type': 'BEHAVIORAL', 'name': 'cognitive and emotional control video game', 'description': 'a video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.', 'armGroupLabels': ['Active treatment']}\n- {'type': 'BEHAVIORAL', 'name': 'sham video game', 'description': 'a video game which does not target cognitive control, played for total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.', 'armGroupLabels': ['Sham treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of treatment', 'description': 'Feasibility is met if a patient will complete 20 sessions per protocol with a probability of more than 50.00%.Completion per protocol is achieved, if the patient completes 20 sessions per protocol with a probability of more than 50 percent.', 'timeFrame': 'Six weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05 (one-sided). The power for the primary hypothesis test is approximately 0.98 if the true completion rate is 0.67. For the efficacy analysis, the power is estimated to be 0.91. A drop-out rate of 20% is incorporated.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size was determined based on the feasibility analysis (primary endpoint). Our primary hypothesis that the probability of completion is larger than 0.5 will be tested using a one-sided binomial test. Assuming N\u00e2\u0080\u0089=\u00e2\u0080\u0089114 subjects, the one-sided binomial test would reject the null hypothesis (i.e., that the probability of completion is equal or less than 0.5) if the number of completers is\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008965 patients. This would constitute an effective completion rate of 57%. In terms of power, if the true completion rate is instead 2/3 (0.67), the probability of rejecting the null hypothesis would amount to approximately 0.98.\n This sample size would also adequately power the efficacy analyzes (i.e., time x treatment interaction effect for MADRS change). Power in this analysis was estimated using a Monte-Carlo simulation of 10,000 datasets. Setting the threshold for detection at a significance level of 0.05 (one-sided), the estimated power for N\u00e2\u0080\u0089=\u00e2\u0080\u0089114 subjects (38 enrolled per site) is 1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.91. A drop-out rate of 20% was incorporated, based on a comparable ongoing trial at the LMU Munich site [46]. Power measured the probability of detecting a significant time \u00c3\u0097 treatment interaction effect. Effects were estimated using a linear mixed regression model (LMM), with time \u00c3\u0097 treatment and center as fixed effects and subjects modeled as random effects. In the Monte-Carlo simulation, it was assumed that the time \u00c3\u0097 treatment interaction effect was 4 points on the MADRS scale (adapted from [85]). The random effects were set at SD\u00e2\u0080\u0089=\u00e2\u0080\u00896 points for individual change (beyond baseline variability) and a standard deviation of 2.5 points was added as a center \u00c3\u0097 treatment \u00c3\u0097 time interaction. The assumed effect size of the interaction, after controlling for baseline, was Cohen\u00e2\u0080\u0099s d of 0.41 (medium effect size).", "id": 1149, "split": "test"} +{"trial_id": "NCT04953936", "pmid": "35738656", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \u03b2-hydroxy-\u03b2-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'HMB', 'type': 'EXPERIMENTAL', 'description': 'The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)', 'interventionNames': ['Dietary Supplement: HMB-enriched Nutritional Supplements', 'Behavioral: Caloric Restrition Diet']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.', 'interventionNames': ['Dietary Supplement: Placebo', 'Behavioral: Caloric Restrition Diet']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'HMB-enriched Nutritional Supplements', 'description': 'The participants will receive oral HMB-enriched nutritional supplements (65 g, once daily), which include soybean isolate protein, flaxseed oil powder, yam powder, whey protein, oligomeric isomaltose powder, cocoa powder, medium-chain fatty acid powder, calcium beta-hydroxy-beta-methylbutyrate, sunflower seed oil powder, L-glutamine, wheat germ powder, membrane isolated casein, wheat oligopeptide, konjac flour, vitamin E, vitamin D, stevioside, edible flavors.', 'armGroupLabels': ['HMB']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'Placebo (maltodextrin 65 g once daily) with the same package as the intervention.', 'armGroupLabels': ['Placebo']}\n- {'type': 'BEHAVIORAL', 'name': 'Caloric Restrition Diet', 'description': 'Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies', 'armGroupLabels': ['HMB', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The mean change in whole-body skeletal muscle mass (SMM)', 'description': 'The whole-body skeletal muscle mass (SMM)', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05, 80% statistical power, and a 25% attrition rate.", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n To date, no studies have been done to determine whether HMB-enriched nutritional supplements are effective and safe for improving muscle mass and muscle function in obese adults during weight loss. To determine the sample size, we examined similar studies on HMB and referred to the study by Peng and Cheng that evaluated the effectiveness of HMB for improving SMM and quality in prefrail older adults.12 Using a 0.05 significance level, 80% statistical power and 25% attrition rate, a sample size of 70 has been assumed using an assumed effective size of 0.93. Moreover, to achieve a gender-balanced distribution within and between groups, a random stratification method including 36 samples per gender is proposed, adding up to 72 samples in total.", "id": 1150, "split": "test"} +{"trial_id": "NCT04955717", "pmid": "35255814", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Diagnosis and Treatment of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Pregnant Women to Prevent Adverse Neonatal Consequences.\n\nIncluded conditions:\n- Chlamydia Trachomatis Infection\n- Neonatal Infection\n- Preterm Birth\n- Gonorrhea\n\nStudy Armgroups:\n- {'label': 'Testing and treatment', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive CT and NG testing and treatment (if necessary) at their first antenatal care visit and a visit during their third trimester. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing.', 'interventionNames': ['Other: Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert']}\n- {'label': 'Standard of care', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive the standard of care for STI management, which is treatment based on signs and symptoms. Women will also receive support for partner notification. All women will receive postnatal testing and treatment. Those who test positive at the postnatal visit will be offered infant testing.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert', 'description': 'Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert', 'armGroupLabels': ['Testing and treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery', 'description': 'Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms', 'timeFrame': 'This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.'}\n\nPlease estimate the sample size based on the assumption: \n80.7% power to detect a 4.3% absolute difference using a one-sided Fisher\u2019s Exact test at a 0.05 significance level, with a 7% loss to follow-up rate.", "answer": 500, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size of 500 participants was determined to have sufficient power to detect a difference in rates of vertical transmission of CT and NG based on (1) the prevalence of CT and/or NG among pregnant women in Botswana (10%) [80], and (2) the risk for vertical transmission of CT/NG to newborn infants during parturition (50%).[44\u00e2\u0080\u009347]. Antenatal CT/NG testing and treatment is expected to reduce vertical transmission by over 85%, from 5% in the control to 0.7% in the intervention group.[44, 45] When accounting for a 7% loss to follow-up rate, 250 women per arm will yield N\u00e2\u0080\u0089=\u00e2\u0080\u0089232 evaluable subjects. With N\u00e2\u0080\u0089=\u00e2\u0080\u0089232 evaluable samples per arm, we achieve 80.7% power to detect a 4.3% absolute difference in our primary endpoint, which is the proportion of vertical transmission of CT/NG, between the two groups, using a one-sided Fisher\u00e2\u0080\u0099s Exact test, at a 0.05 significance level.", "id": 1151, "split": "test"} +{"trial_id": "NCT04955756", "pmid": "35858876", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Identification and Severity Prediction of Acute Respiratory Infectious Disease\n\nIncluded conditions:\n- Acute Respiratory Infection\n- Severe Pneumonia\n- Next Generation Sequencing\n- Multiplex PCR\n\nStudy Armgroups:\n- {'label': 'mNGS group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: mNGS']}\n- {'label': 'PCR group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: Multiplex PCR']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'mNGS', 'description': 'Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.', 'armGroupLabels': ['mNGS group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Multiplex PCR', 'description': 'Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.', 'armGroupLabels': ['PCR group']}\n\nPrimary Outcomes:\n- {'measure': 'time for targetted antibiotic treatment', 'description': 'time interval from enrollment to targetted antibiotic treatment initiation', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 = 0.05, \u00ce\u00b2 = 0.10, 10% rate of participants in Group II receiving mNGS, 10% rate of lost to follow-up", "answer": 440, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n PASS 11 software was applied to calculate the sample size. Assuming hazard ratio (HR) = 1.50, \u00ce\u00b1 = 0.05, \u00ce\u00b2 = 0.10, and a 10% rate of participants in Group II receiving mNGS additionally, each group requires 200 subjects. Considering a 10% rate of lost to follow-up, each group needs 200 \u00c3\u0097 1.1 = 220 subjects; therefore, the total sample size of the two groups combined is calculated to be 440 subjects.", "id": 1152, "split": "test"} +{"trial_id": "NCT04959279", "pmid": "38373857", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pilot Randomized Controlled Trial of ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care\n\nIncluded conditions:\n- Psychomotor Agitation\n- Behavioral Disorder\n\nStudy Armgroups:\n- {'label': 'ED-TREAT', 'type': 'EXPERIMENTAL', 'description': 'EHR-embedded clinical decision support (CDS) tool designed to overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting.', 'interventionNames': ['Other: ED-TREAT']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ED-TREAT', 'description': 'Patients will be assessed and treated based on a clinical decision support system.', 'armGroupLabels': ['ED-TREAT']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of visits adherent to protocol', 'description': 'Proportion of visits in the intervention arm that are adherent to \\\\>95% of the observational workflow checklist (primary outcome of fidelity)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size is estimated to achieve a 95% CI with a width of \u00b120%. The trial is feasible if \u226530% of visits assessed for eligibility are enrolled and \u226590% of all outcome measures are collected.", "answer": 26, "answer_type": "ESTIMATED", "explanation": "Sample size and data analysis\n As this pilot trial is not designed to test the efficacy of ED-TREAT, a power calculation is not appropriate.73 To determine the sample size for this pilot randomised trial, we will use the outcome of fidelity as measured by the proportion of visits in the intervention arm that are adherent to >80% of the observational workflow checklist. To estimate the proportion achieving this level of fidelity with a reasonable precision (95%\u00e2\u0080\u0089CI with a width of \u00c2\u00b120%), a total of at least 26 eligible subjects will be enrolled in the pilot trial. We will determine ratings from the SUS57 and calculate proportions of each clinician group with scores of >85, indicating excellent usability. We will consider ED-TREAT to be acceptable if \u00e2\u0089\u00a590% of each clinician group give ratings >85. For feasibility, we will measure the proportion of potentially eligible patient visits with successful enrolment and collection of all outcomes of interest. Based on our group\u00e2\u0080\u0099s anecdotal experience with pilot studies, we will consider a comparative effectiveness trial feasible if \u00e2\u0089\u00a530% of visits assessed for eligibility are enrolled and \u00e2\u0089\u00a590% of all outcome measures are collected. Qualitative data obtained from interviews will be analysed with Dedoose using the analytic strategy mentioned earlier for iterative refinement of the study protocol in preparation for a comparative effectiveness trial.", "id": 1153, "split": "test"} +{"trial_id": "NCT04960332", "pmid": "35717239", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall. A Randomized Controlled Trial\n\nIncluded conditions:\n- Sarcoma\n- Cancer\n- Neoplasms, Connective and Soft Tissue\n\nStudy Armgroups:\n- {'label': 'Standard treatment', 'type': 'NO_INTERVENTION', 'description': 'Group A: Standard wound closure with staples and conventional wound dressing.'}\n- {'label': 'Prevena', 'type': 'EXPERIMENTAL', 'description': 'Group B: Wound closure with staples and Negative Pressure Wound Therapy (PREVENA PLUS\u2122 Incision Management System).', 'interventionNames': ['Device: Prevena']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Prevena', 'description': 'RCT (no blinding) where the patients will be randomized to wound closure with staples and either Negative Pressure Wound Therapy (PREVENA PLUS\u2122 Incision Management System) for 7 days or a conventional wound dressing.', 'armGroupLabels': ['Prevena']}\n\nPrimary Outcomes:\n- {'measure': 'Wound complication/healing', 'description': \"A major wound complication defined as in O'Sullivan et al. \\\\[11\\\\]:\\n\\n* A secondary surgery under anesthesia for wound repairs such as debridement, operative drainage and secondary wound closure.\\n* Wound management without secondary surgery, this includes invasive procedure without anesthesia such as aspiration of seroma and readmission for wound care such as intravenous antibiotic or persistent deep packing within 4 months (120 days) after surgery.\", 'timeFrame': '120 days postoperatively'}\n\nPlease estimate the sample size based on the assumption: \n80% power to avoid type II error, 5% significance level for type I error, and allowance for few dropouts expected over a 4-month follow-up period.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Calculation of sample size\n In the study of O\u00e2\u0080\u0099Sullivan et al. [11], a major wound complication within 4\u00e2\u0080\u0089months postoperatively was identified in 16 out of 94 (17%) STS patients treated with surgery and postoperative radiation therapy. There exist no studies evaluating the effect of NPWT on wound complications after surgery for STS combined with postoperative radiation therapy. However, in retrospective studies, it was found that NPWT reduced the risk of wound complications from 47 to 8% (83% reduction) in patients with lower extremity STS treated with preoperative radiation [14] and from 27 to 7% (75% reduction) in patients undergoing hip and knee revision surgery [20].\n In a study design with an 80% risk of avoiding type II error, a 5% risk of type I error, and an 80% wound complication risk reduction in a population similar to the study by O\u00e2\u0080\u0099Sullivan et al. [11], we will need to include 154 STS patients (77 in each group) in an RCT.\n To make allowance for dropouts (since the follow-up period regarding the primary study endpoint is only 4\u00e2\u0080\u0089months\u00e2\u0080\u0089=\u00e2\u0080\u0089120\u00e2\u0080\u0089days few dropouts are expected) during the study period, we plan to include 160 patients.", "id": 1154, "split": "test"} +{"trial_id": "NCT04961723", "pmid": "36691209", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Control Trial of Home-based Hepatitis C Self-testing in Key Populations in Georgia\n\nIncluded conditions:\n- Hepatitis C\n- Diagnostic Self Evaluation\n\nStudy Armgroups:\n- {'label': 'MSM Postal delivery', 'type': 'EXPERIMENTAL', 'description': 'Participants who identify primarily as MSM will receive a home delivered HCV self-test kit in non-identifiable packaging. The kit will include the test, instructions for use (IFU), and information about additional supporting materials, such as access to live chat and a call center for questions about testing', 'interventionNames': ['Diagnostic Test: (OraQuick\u00ae HCV Self-Test']}\n- {'label': 'MSM Peer delivery', 'type': 'EXPERIMENTAL', 'description': 'Participants who identify primarily as MSM will schedule a peer delivery of the HCV self-test kit and IFU. The peer will provide basic information about the test, what to do if the test is reactive, and how to access to live chat and a call center for questions about testing', 'interventionNames': ['Diagnostic Test: (OraQuick\u00ae HCV Self-Test']}\n- {'label': 'MSM control', 'type': 'NO_INTERVENTION', 'description': 'Participants who identify primarily as MSM will receive information about standard of care HCV antibody testing available at local testing sites in their community. Participants will also have access to live chat and a call center for questions about HCV testing'}\n- {'label': 'PWID peer delivery', 'type': 'EXPERIMENTAL', 'description': 'Participants who identify primarily as PWID will schedule a peer delivery of the HCV self-test kit and IFU. The peer will provide basic information about the test, what to do if the test is reactive, and how to access to live chat and a call center for questions about testing', 'interventionNames': ['Diagnostic Test: (OraQuick\u00ae HCV Self-Test']}\n- {'label': 'PWID control', 'type': 'NO_INTERVENTION', 'description': 'Participants who identify primarily as PWID will receive information about standard of care HCV antibody testing available at local testing sites in their community. Participants will also have access to live chat and a call center for questions about HCV testing'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': '(OraQuick\u00ae HCV Self-Test', 'description': 'The OraQuick\u00ae HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick\u00ae HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick\u00ae HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.', 'armGroupLabels': ['MSM Peer delivery', 'MSM Postal delivery', 'PWID peer delivery']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM', 'description': 'The number of participants who report completing the HCV antibody testing in the intervention group vs the control group', 'timeFrame': '2 weeks to 2 months after enrollment'}\n- {'measure': 'To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM', 'description': 'To assess that the proportion of participants who report completing the HCV antibody testing in the intervention group is superior to that of the participants in the control group by a margin of 20%.', 'timeFrame': '2 weeks to 2 months after enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was calculated using a one-tailed test, 80% power, and a 5% significance level. The study assumes up to a 20% loss to follow-up rate. The study is not powered to detect statistical differences in secondary endpoints due to the estimated proportion of anti-HCV positive results being \u226410%.", "answer": 1250, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analyses\n The target sample size is a minimum of 1250 participants (250 per study arm). The sample size was calculated using G*Power V.3.1 software (University of Dusseldorf, Germany) using a one-tailed test, 80% power and a 5% significance level in order to detect a significant change in the primary outcome between the control and intervention groups. With up to a 20% loss to follow-up rate, we conservatively estimate that 250 participants in each group will be sufficient to detect differences between the control and each intervention group.\n As the estimated proportion of anti-HCV positive results among study participants is estimated to be \u00e2\u0089\u00a410%, the study is not powered to detect statistical differences between study arms in the secondary endpoints.\n Statistical analyses will be performed in the per-protocol population (all participants who fully comply with the protocol). A 20% difference between intervention and control arms for the primary endpoint will be considered as demonstrating superiority of HCVST compared with referral to standard of care. In our settings, the superiority test is a (one-sided) hypothesis test where the null hypothesis is that the outcome in the intervention arm is not better than in the control arm, so rejecting the null hypothesis will support the evidence of the anticipated superiority of the intervention arm.\n Secondary outcomes will be analysed using descriptive statistics including proportions and means, with the exception of cost of HCVST, for which a cost-effectiveness analysis will be performed.\n Building off the lessons learnt from the HIV self-testing (HIVST) pilot study, the sample size will be reached using social media to promote the study to the target population. The promotional strategies will be tailored to the clientele of each site. For Tanadgoma and Equality Movement, posts and social media advertisements will be generated using Facebook and online dating sites and mobile applications Hornet, PlanetRomeo and Tinder; advertisements will also be placed in the gay video section of pornography sites. For Imedi Batumi and Tbilisi New Way, promotions will be done through posts and advertisements on Facebook as well as flyers distributed at the harm reduction sites. Promotional materials will include digital fliers and posters (approved by the National Ethics Board), as well as online talk shows and videos which will provide basic information on hepatitis C and why testing is important and explain about the HCVST study providing information on where to enrol.", "id": 1155, "split": "test"} +{"trial_id": "NCT04961762", "pmid": "36517099", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial\n\nIncluded conditions:\n- Homeless Persons\n- Case Management\n- Primary Care\n- Hospital Readmission\n\nStudy Armgroups:\n- {'label': 'Navigator Program', 'type': 'EXPERIMENTAL', 'description': 'In addition to receiving Standard Care, participants in the intervention arm will be assigned to a Homeless Outreach Counsellor. The Homeless Outreach Counsellor will connect with the participant as soon as possible during the admission and will provide support during the hospital admission and for approximately 90 days after hospital discharge.', 'interventionNames': ['Other: Navigator Program']}\n- {'label': 'Standard Care', 'type': 'NO_INTERVENTION', 'description': 'Standard Care consists of support from Care Transition Facilitators who work with patients during their hospital stay to arrange discharge plans and make follow-up arrangements. Care Transition Facilitators do not routinely work with patients after hospital discharge. As part of the routine discharge process, the health care team provides patients with medical recommendations, appointments for follow-up care as needed, a written discharge summary, and prescriptions as needed. If the patient has an identified primary care provider, a copy of the discharge summary is sent electronically to the primary care provider.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Navigator Program', 'description': \"The main role of the Homeless Outreach Counsellor is to support continuity and comprehensiveness of care by helping participants follow their post-discharge plans and facilitating strong links with community-based health and social services. The Homeless Outreach Counsellor also helps address specific needs of participants, develop comprehensive care plans with members of patient's multidisciplinary circle of care, and facilitate the transition of clients to long-term community-based health and social services.\", 'armGroupLabels': ['Navigator Program']}\n\nPrimary Outcomes:\n- {'measure': 'Follow-Up with Primary Care Provider (PCP)', 'description': \"Occurrence of a follow-up visit with a PCP (family physician or nurse practitioner). In-person encounters (e.g., ambulatory clinics, shelter clinics, and community health centers), virtual encounters (with video), and phone calls (without video) will be considered as follow-up visits. These modes of PCP follow-up are consistent with those outlined by quality standards from Health Quality Ontario. The investigators will ascertain PCP follow-up through both participant self-report at the 30-day interview and by contact with the PCP office. Ascertainment will be based on the PCP office's report if the participant is unreachable, or by participant self-report if the PCP office is unreachable. In the event of any discrepancy, the report of the PCP office will take precedence over participant self-report.\", 'timeFrame': 'Within 14 Days of Discharge'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power of 80%, and an estimated 20% attrition rate.", "answer": 640, "answer_type": "ESTIMATED", "explanation": "Sample size\n No previous data are available to ascertain 14-day PCP follow-up rates after hospitalisation among people experiencing homelessness under usual care. However, a previous study reported that 14-day PCP follow-up rates after hospitalisation among low socioeconomic status (SES) patients was ~48%.54\u00e2\u0080\u0089An assumption was made that 14-day PCP follow-up rates after hospitalisation among people experiencing homelessness under usual care is around 2/3 that of low-SES patients (32%). This study is powered to detect an effect size of 12%, equivalent to a 37.5% increase in relative rate of follow-up with a PCP within 14 days of discharge. With an \u00ce\u00b1 of 0.05, 256 participants per study arm will result in an 80% power to test the study hypothesis. Given an estimated 20% attrition rate based on past studies in this population,55 a total of 640 participants will be recruited for this study.", "id": 1156, "split": "test"} +{"trial_id": "NCT04962646", "pmid": "37230515", "question": "Here is the design of a clinical trial:\n\nOfficial Title: CARbon Dioxide Flooding to Reduce Postoperative Neurological Injury Following Surgery for Acute Type A Aortic Dissection - A Prospective, Randomized, Blinded, Controlled Clinical Trial\n\nIncluded conditions:\n- D000784\n- D020521\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Once the thoracic cavity os opened during surgery, carbon dioxide flooding using a diffusor will be instigated with a flow of 5L/min. The flooding will be terminated once the aorta and the heart have no open contact with surrounding air.', 'interventionNames': ['Procedure: Carbon dioxide flooding']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'No intervention. No sham will be used as the staff performing the surgery would have been able to detect the lack of carbon dioxide in the surgical wound.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Carbon dioxide flooding', 'description': 'Once the thoracic cavity is opened a flow of carbon dioxide of 5L/min will be initiated into the surgical wound and proceed until there is no connection between the cardiac or aortic cavity and surrounding air.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Number of ischemic lesions on magnetic resonance imaging (MRI)', 'description': 'Number of ischemic lesions visualized using MRI', 'timeFrame': 'MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.'}\n- {'measure': 'Size of ischemic lesions on magnetic resonance imaging (MRI)', 'description': 'Size of ischemic lesions visualized using MRI', 'timeFrame': 'MRI will be performed before postoperative day 7. When not possible due to medical considerations, MRI may be performed up to 30 days after surgery.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 significance level (alpha), 5%-10% loss of follow-up due to mortality.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n To date, there are no studies to indicate the effect of carbon dioxide flooding on postoperative neurological outcomes following ATAAD surgery. However, Leshnower et al published a study showing that RCP in conjunction with aortic surgery reduces the occurrence of ischaemic lesions from 100% to 45% and the number of these lesions by 70% compared with ACP.25 Previous studies have shown that 61% of patients who underwent routine aortic valve replacement have postoperative ischaemic lesions visualised by MRI.26 We hypothesise that the beneficial effect of RCP showed by Leshnower et al is due to a reduction of air embolism and we, therefore, used this data as a basis for our power calculation. The results of Leshnower et al suggest a reduction in the number of ischaemic lesions from 4.0\u00c2\u00b13.5\u00e2\u0080\u0089to 1.2\u00c2\u00b12.1. A study sample of 25 patients in each arm would yield 80% power to detect a significant difference between the groups with a 0.05 significance level (alpha). A 50% reduction of ischaemic lesions from a baseline prevalence of 70% (as in the study by Leshnower and colleagues) would require 31 patients in each arm to achieve similar statistical power. We presume loss of follow-up due to 5%\u00e2\u0080\u009310%\u00e2\u0080\u0089mortality during or immediately after the surgical procedure, and, therefore, we aim to include 40 study patients in each arm. With an annual case load of 30 ATAAD patients at our institution, we expect an inclusion period over 3\u00e2\u0080\u0089years.", "id": 1157, "split": "test"} +{"trial_id": "NCT04965298", "pmid": "39909521", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness and Risks of Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole: a Randomised Placebo-controlled Multi-centre Clinical Trial\n\nIncluded conditions:\n- Idiopathic Pulmonary Fibrosis\n\nStudy Armgroups:\n- {'label': 'Active treatment arm', 'type': 'EXPERIMENTAL', 'description': 'Lansoprazole 30mg (as 2 x 15mg capsules) twice daily, 12 hours apart, for 12 months. IMP should be taken at least 30 minutes before food.', 'interventionNames': ['Drug: Lansoprazole']}\n- {'label': 'Matched-Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Matched placebo 2 capsules twice daily, 12 hours apart, for 12 months. Treatment should be taken at least 30 minutes before food.', 'interventionNames': ['Other: Matched placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lansoprazole', 'description': 'Lansoprazole 30mg (as 2 x 15mg capsules) twice daily, 12 hours apart, for 12 months. IMP should be taken at least 30 minutes before food.', 'armGroupLabels': ['Active treatment arm']}\n- {'type': 'OTHER', 'name': 'Matched placebo', 'description': 'Matched placebo 2 capsules twice daily, 12 hours apart, for 12 months. Treatment should be taken at least 30 minutes before food.', 'armGroupLabels': ['Matched-Placebo arm']}\n\nPrimary Outcomes:\n- {'measure': 'Absolute change in percent predicted (%) forced vital capacity (FVC)', 'description': 'Absolute change in percent predicted (%) forced vital capacity (FVC) at 12 months post-randomisation of lansoprazole versus placebo.', 'timeFrame': '12 months post-randomisation'}\n\nPlease estimate the sample size based on the assumption: \n90% power, SD of 9%, significance level of 5%, 20% loss to follow-up rate, coefficient of variation of 1, 30% loss to follow-up rate, 80% power, SD of 5.6, correlation coefficient of 0.6", "answer": 298, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size of 270 individuals, 135 per group, provides 90% power to detect a minimal important difference of 4% reduction in %FVC versus placebo assuming a SD of 9%,46 a loss to follow-up rate of 20%46 47 and a significance level of 5%. However, we will randomise 298 patients to account for 10% of patients being asymptomatic.\n A sample size of 160 patients provides 90% power to detect a ratio of geometric means of 0.6 for cough frequency, which is smaller than the published minimal important difference,48 assuming a coefficient of variation of 1 (from the PPIPF trial11) and a loss to follow-up rate of 30%.\n For the HRCT scan substudy, a sample size of 82 participants provides 80% power to detect a 3.45% difference in WRVS at a 5% significance level, assuming a SD of 5.6 and a correlation coefficient of 0.6. We will aim to recruit up to 100 participants to allow for a 20% loss to follow-up rate.", "id": 1158, "split": "test"} +{"trial_id": "NCT04966052", "pmid": "37813532", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of COPD Co-infection With Tuberculosis on Th17 Cell Differentiation and Its Significance\n\nIncluded conditions:\n- Tuberculosis Infection\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'COPD combined with TB group', 'description': 'COPD combined with pulmonary TB infection', 'interventionNames': ['Other: No intervention']}\n- {'label': 'COPD non-TB control group', 'description': 'COPD combined without pulmonary TB infection'}\n- {'label': 'TB non-COPD control group', 'description': 'pulmonary TB infection without COPD'}\n- {'label': 'Non-smoking non-TB control group', 'description': 'Non-smoking without pulmonary TB infection'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'No intervention', 'description': 'No intervention', 'armGroupLabels': ['COPD combined with TB group']}\n\nPrimary Outcomes:\n- {'measure': 'Differentiation of Th17 cells', 'description': 'Distribution of T cell subtypes, including CD4+, CD8+ T cells and Th17 cells, in blood specimens and alveolar lavage fluid by flow cytometry', 'timeFrame': 'Day 1'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power of 80%, and the proportion of smokers to non-smokers is 1:5.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n We will explore the association of different variables with the development of PTLD, including age, gender, body mass index, economic status, sputum positive/negative culture, cigarette smoking, comorbidities such as diabetes, serum albumin level, haemoglobin level and chest imaging scores. There are 10 variables in the logistic regression model. Considering the sample size requirements of multiple logistic regression, 100\u00e2\u0080\u0093150 cases are required based on the 10\u00e2\u0080\u009315 event per variable rule. Assuming the incidence of PTLD is approximately 30%\u00e2\u0080\u009350% as reported,10 18 a sample of 400 participants is required. At the same time, we will compare the difference of lung function measurements between the smoking group and the non-smoking group after the cure of pulmonary TB. According to our previous work (unpublished data), it is estimated that the prevalence rate of PTLD is 50% in the smoking group and 30% in the non-smoking group, respectively, and the proportion of smokers and non-smokers in patients with pulmonary TB was 1:5. Given an \u00ce\u00b1 level of 0.05 and a power of 80%, we calculated a required sample size of 365 using PASS software.", "id": 1159, "split": "test"} +{"trial_id": "NCT04966104", "pmid": "36691152", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ODYSSEE-vCHAT Pilot Trial: a Virtual Community Promoting Health Literacy, Self-Care, and Peer Support for Heart Failure\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'ODYSSEE-vCHAT', 'type': 'EXPERIMENTAL', 'description': \"ODYSSEE-vCHAT consisted of:\\n\\n* Automated digital counselling resources (educational pages, videos, tools, and trackers)\\n* Chatrooms available 24/7\\n* Weekly 30-minute webcasts led by a healthcare professional or patient representative\\n\\nEach aspect was informed by a rotating schedule of 7 weekly self-care themes. Webcasts were recorded and streamed to our private YouTube channel, and associated hyperlinks were shared on the program. Subjects had the option of submitting photographs depicting heart-healthy lifestyles and activities (with no identifying, sensitive, or personal information) to the Gallery Wall.\\n\\nSubjects were invited by email to access the resources available to them. They logged on to the program using password-protected personal accounts. Each participant's total number of logins and login time (with timestamps) were recorded. Assessments occurred online at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months).\", 'interventionNames': ['Behavioral: ODYSSEE-vCHAT']}\n- {'label': 'eUC', 'type': 'NO_INTERVENTION', 'description': 'eUC provided educational HF self-care resources that are available to the public on professional heart health websites (e.g., Heart Failure Society of Canada, American Heart Association, European Society of Cardiology, Health Canada). Patients were provided with unlimited access to these resources. Subjects were invited by weekly emails to partake in these resources. Self-reported assessments are administered at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ODYSSEE-vCHAT', 'description': 'Automated digital counselling program with social network support', 'armGroupLabels': ['ODYSSEE-vCHAT']}\n\nPrimary Outcomes:\n- {'measure': 'Composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization', 'description': 'The primary goal of the trial is to evaluate whether use of ODYSSEE-vCHAT versus eUC reduces the risk for a composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization. This data will be collected using the Ontario population-based databases at the Institute for the Clinical Evaluative Sciences (ICES). Data for patients will be linked to ICES databases via Ontario Health Insurance Plan (OHIP) number, first and last name, and date of birth using deterministic/probabilistic linkage (patient unique IKN number).', 'timeFrame': 'Trial completion (median = 8.5 months, range = 2 to 15 months)'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error of 5%, power of 80%, and a 14.7% adjustment for withdrawal or attrition.", "answer": 61, "answer_type": "ACTUAL", "explanation": "Sample size estimate\n The sample size estimate considers ODYSSEE-vCHAT\u00e2\u0080\u0099s usability and efficacy. In terms of usability, the CHF-CePPORT25 trial achieved moderate programme adherence over 12 months (median sessions accessed=61%), with greater logon time for digital counselling (median=381\u00e2\u0080\u0089minutes, 95%\u00e2\u0080\u0089CI 321-441) versus eUC (median=229\u00e2\u0080\u0089minutes, 95%\u00e2\u0080\u0089CI 187-270), p<0.001. The sample to detect this effect with a two-group design, a type 1 error of 5%, and power of 80% was N=114. With 14.7% adjustment for withdrawal or attrition (6.5% patients withdrew and 8.2% were lost to follow-up), our sample estimate is N=131. To account for efficacy, we considered a trial by Krum et. al,47 in which structured telehealth support reduced a composite index of all-cause mortality and hospitalisations over 12 months (50.6%) versus usual care (59.3%), p=0.01. A sample estimate of 142 was yielded. Using a 14.7% adjustment rate for withdrawal or attrition based on values obtained from CHF-CePPORT,25 our final total sample size estimate is 162, with a type 1 error of 5% and power of 80%.", "id": 1160, "split": "test"} +{"trial_id": "NCT04967573", "pmid": "35228291", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial\n\nIncluded conditions:\n- Venous Thrombosis\n\nStudy Armgroups:\n- {'label': 'Prophylactic Anticoagulation', 'type': 'EXPERIMENTAL', 'description': 'Rivaroxaban 10 mg od for 3 months', 'interventionNames': ['Drug: Rivaroxaban']}\n- {'label': 'Therapeutic Anticoagulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Rivaroxaban 20 mg od for 3 months', 'interventionNames': ['Drug: Rivaroxaban']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rivaroxaban', 'description': 'Rivaroxaban 20 mg or 10 mg for 3 months', 'armGroupLabels': ['Prophylactic Anticoagulation', 'Therapeutic Anticoagulation']}\n\nPrimary Outcomes:\n- {'measure': 'Radiographically confirmed recurrent venous thromboembolism', 'description': 'Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.', 'timeFrame': '6 months'}\n- {'measure': 'Major or clinically relevant non-major bleeding events', 'description': 'Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses 80% targeted power at the \u03b1 level of 0.05 for a two-sided test. A dropout rate of 20% is considered.", "answer": 480, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Based on a previous retrospective study and the current experience, the estimated rate of recurrent VTE was 10% and 3% in prophylactic and therapeutic anticoagulation group, respectively.13 According to statistical requirements, we used 80% targeted power at the \u00ce\u00b1 level of 0.05 for a two-sided test. Sample size of 191 in each group was thus obtained. Besides, for the primary safety outcome, a sample size of 163 in each group was developed with 80% power at a two-sided 5% level of significance, assuming that the incidence of bleeding events is 2% and 9% in prophylactic and therapeutic anticoagulation group, respectively.13 Moreover, considering the dropout rate of 20%, a total of 480 patients are required for this study eventually.\n Primary outcome analyses are performed in both intention-to-treat (ITT) and per-protocol (PP) modalities to ensure the results robust. In the ITT analysis, all enrolled patients will be analysed as for the group they are initially allocated to. However, patients with regimen violations will be excluded from the PP analysis. The rate of recurrent VTE at 6 months following randomisation and its 95%\u00e2\u0080\u0089CI will be generated and compared between the two groups using a Fisher exact test or \u00cf\u0087\u00c2\u00b2 as appropriate. For the primary safety outcome, the same statistical analysis will be applied. Moreover, sensitivity analysis will be conducted to evaluate the robustness of the primary results. All the data will be analysed with STATA software (V.15).", "id": 1161, "split": "test"} +{"trial_id": "NCT04968522", "pmid": "38631835", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Attention Management Trial for Children With FASD - a N-of-1 Control Trial of Prescribed Stimulants for ADHD in FASD\n\nIncluded conditions:\n- Fetal Alcohol Spectrum Disorders\n\nStudy Armgroups:\n- {'label': 'Placebo comparator 2', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will be allocated a randomly allocated sequence of treatment. The randomisation will be in two-week pairs - so the order of treatment (A) and placebo (P) to be randomly assigned within each two-week cycle (over 8 weeks). Placebo will be matched in dose to their stimulant dose at enrolment to the trial as determined and titrated by their primary paediatrician. This dose will remain constant for the course of the trial (8 weeks). Placebo will be orally administered, unless this is not possible for clinical reasons.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Stimulant', 'type': 'EXPERIMENTAL', 'description': 'The stimulants used in the trial are commercially available and will be used in accordance with the approved labelling. Participants must be on a stable dose of stimulant medication for at last 1 month prior to the study. The dose is individualized and titrated by treating primary paediatrician. This will represent the starting dose for the trial, and this will remain stable through the course of the 8-week trial. This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. Based on pilot data from this group, psychostimulant medications prescribed in this population may include:\\n\\n* Methylphenidate IR\\n* Methylphenidate LA\\n* Dexamphetamine\\n\\nChildren will take the required number of capsules to match the total prescribed dose (e.g. 30mg Ritalin LA is 3x10mg capsules).', 'interventionNames': ['Drug: Methylphenidate Hydrochloride', 'Drug: Methylphenidate Hydrochloride 18 MG', 'Drug: Dexamphetamine sulfate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methylphenidate Hydrochloride', 'description': \"This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin 10 will be administered at the child's prescribed dose and may include a half tablet (5mg) increment. Ritalin 10 will be encapsulated in full tablet (10mg) or half tablet (5mg) dose.\", 'armGroupLabels': ['Stimulant'], 'otherNames': ['Ritalin 10 tablets']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'The placebo is Maize Starch and Pregelatinised Maize Starch. The placebo will be encapsulated using the same capsule that is opaque so that participants cannot distinguish the two visually. Where the active mediation amount is small for the capsule, there will be additional Starcke 1500 (Maize Starch and Pregelatinised Maize Starch) added to fill the capsule so that the active drug and capsule also weigh approximately the same. The dose of placebo will be matched to the participants currently prescribed stimulant medication.', 'armGroupLabels': ['Placebo comparator 2']}\n- {'type': 'DRUG', 'name': 'Methylphenidate hydrochloride', 'description': \"This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin LA will be administered at the child's prescribed total dose. Ritalin LA will be encapsulated.\", 'armGroupLabels': ['Stimulant'], 'otherNames': ['Ritalin LA Long acting capsules']}\n- {'type': 'DRUG', 'name': 'Methylphenidate Hydrochloride 18 MG', 'description': \"This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Concerta (18mg) will be administered at the child's prescribed total dose. Concerta will be encapsulated.\", 'armGroupLabels': ['Stimulant'], 'otherNames': ['Concerta']}\n- {'type': 'DRUG', 'name': 'Dexamphetamine sulfate', 'description': \"This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Dexamphetamine (10mg) will be administered at the child's prescribed total dose. Dexamphetamine will be encapsulated.\", 'armGroupLabels': ['Stimulant'], 'otherNames': ['Aspen Dexamfetamine Tablets']}\n\nPrimary Outcomes:\n- {'measure': 'Change in ADHD symptoms - teacher report - between placebo and stimulant', 'description': \"ADHD symptoms will be measured using the Conners 3rd Edition-Teacher (Conners 3-T), for 6-18 year old's and the Conners Early Childhood teachers/childcare providers (full length) form for participants 2-6 years. Each item is rated on a Likert scale from 0 to 3 (0=never or rarely; 1=sometimes; 2=often; 3=very often). Test- retest values for the Conners scales indicate excellent temporal stability (ranging from .73 to 1.00).\\n\\nThe T-score is norm referenced, with a mean of 50. The average range falls within one standard deviation of the mean (i.e., between 40 and 59). A higher score indicates more elevated symptoms. T score Guideline 70+Very Elevated Score 65-69 Elevated Score 40-59 Average score 60-64 High average score \\\\< 40 Low score. Investigators will examine Inattentive and Hyperactivity/Impulsivity Symptom Scales. Symptoms indicated for each subscale are summed to get total.\", 'timeFrame': 'Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total)'}\n- {'measure': 'Change in ADHD symptoms - parent report - between placebo and stimulant', 'description': \"ADHD symptoms will be measured using the Conners 3rd Edition-Parent (Conners 3-P), for 6-18 year old's and the Conners Early Childhood parent (full length) form for participants 2-6 years. Each item is rated on a Likert scale from 0 to 3 (0=never or rarely; 1=sometimes; 2=often; 3=very often). Test- retest values for the Conners scales indicate excellent temporal stability (ranging from .73 to 1.00).\\n\\nThe T-score is norm referenced. The average range falls within one standard deviation of the mean (i.e., between 40 and 59). A higher score indicates more elevated symptoms. T score Guideline 70+Very Elevated Score 65-69 Elevated Score 40-59 Average score 60-64 High average score \\\\< 40 Low score. Investigators will examine Inattentive and Hyperactivity/Impulsivity Symptom Scales. Symptoms indicated for each subscale are summed to get the total.\", 'timeFrame': 'Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total)'}\n- {'measure': 'Change in spatial working memory - between placebo and stimulant', 'description': \"Spatial Working Memory (SWM) task from the Cambridge Neuropsychological Test Automated Battery. SWM is a component of cognitive executive function which is measured by SWM task of CANTAB between the errors. The ability to retain spatial information and manipulate remembered items in working memory will be measured with the SWM task of CANTAB which is self-ordered and assesses the individual's ability to strategise. Between search errors will be analysed. Scores are raw scores, with no normative data available. Higher error score indicated poorer performance. Scale does not have a maximum range.\", 'timeFrame': 'Day 3 of each trial week (8 weeks total)'}\n- {'measure': 'Change in Visual Information Processing - between placebo and stimulant', 'description': 'Rapid Visual Information Processing (SOC) from Cantab. SOC Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. The participant must move the balls in the bottom display to copy the pattern shown in the top display. The balls are moved one at a time by selecting the required ball, then selecting the position to which it should be moved. The participant is instructed to make as few moves as possible to match the two pattern.\\n\\nThe outcome measure of this subtest is the number of problems completed, regardless of whether the maximum moves limit was reached on any problem.', 'timeFrame': 'Day 3 of each trial week (8 weeks total)'}\n\nPlease estimate the sample size based on the assumption: \n80% power (\u03b2=0.20), significance level \u03b1=0.05, variance of 42.05, and accommodation for dropouts/missing data", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n The multiple N-of-1 trials will comprise a convenience sample (n=20).\n \n N-of-1 data\n Estimation of the needed number of cross-overs (ie, \u00e2\u0080\u0098sample size\u00e2\u0080\u0099 in N-of-1 studies) was based on having at least 80% power (\u00ce\u00b2=0.20) to detect a 5.9-point reduction in Conners 3 ratings at the individual level (defined as an important difference from prior studies)27 and following sample size calculations of N-of-1 trials as suggested by others.28 We set significance testing at the \u00ce\u00b1=0.05 level. Using our clinically important difference of 5.9 (variance of 42.05) with 36 observations per participant (18 placebos and 18 active medications), we achieve >80% power (one-sided hypothesis test). To accommodate dropouts and/or missing data (completely at random), we increased the trial to 40 observations per patient (20 placebos and 20 active medications).", "id": 1162, "split": "test"} +{"trial_id": "NCT04970433", "pmid": "34967368", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma\n\nIncluded conditions:\n- Major Trauma\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture (EA)', 'type': 'EXPERIMENTAL', 'description': 'Acupoint regimen: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electrical stimulation using an EA apparatus, with a pair of electrodes connecting acupoints LI4 with PC6, and another pair of electrodes connecting ST36 with SP6. EA stimulation will last for 15 min with a continuous wave of 2 Hz and a current intensity of 0.1-1 mA.', 'interventionNames': ['Procedure: Electroacupuncture (EA)']}\n- {'label': 'Laser acupuncture (LA)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants allocated to the LA group will receive LA therapy at the same acupoints used in EA group. The laser will be applied to each point for 40 seconds, which delivered 3 J of energy at each of the acupoints.', 'interventionNames': ['Procedure: Laser acupuncture (LA)']}\n- {'label': 'Sham laser acupuncture (SLA)', 'type': 'SHAM_COMPARATOR', 'description': 'Participants in the control group will receive sham LA treatment without any laser output. The acupuncture points, application duration, and total number of treatments are the same as those in the LA group.', 'interventionNames': ['Procedure: Sham laser acupuncture (SLA)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Electroacupuncture (EA)', 'description': 'Acupuncture at Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electrical stimulation with a pair of electrodes connecting on LI4/PC6 and ST36/SP6.', 'armGroupLabels': ['Electroacupuncture (EA)']}\n- {'type': 'PROCEDURE', 'name': 'Laser acupuncture (LA)', 'description': 'The laser applies to each point for 40 seconds, which delivers 3 J of energy at each of the acupoints as those in electroacupuncture group.', 'armGroupLabels': ['Laser acupuncture (LA)']}\n- {'type': 'PROCEDURE', 'name': 'Sham laser acupuncture (SLA)', 'description': 'The laser device without any laser output applies on the acupoints the same as those in the LA group.', 'armGroupLabels': ['Sham laser acupuncture (SLA)']}\n\nPrimary Outcomes:\n- {'measure': 'Length of hospital stay', 'description': 'Count the total days of hospitalization', 'timeFrame': 'up to 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAnticipating a power of 95% (1-\u03b2 = 0.95), statistical significance (\u03b1 = 0.05) of 95% and a dropout rate of 20% to 25%.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "2.4\n Sample size, blinding, and randomization\n No related studies on the effect of inflammatory mediators and clinical outcomes of acupuncture in patients with major trauma have been conducted. However, TNF-\u00ce\u00b1 is well known to play a major pro-inflammatory role in local and systemic inflammatory response, including major trauma. Thus, we determined the necessary sample size based on a previous study of the effects of acupuncture on inflammatory responses in septic patients via the change of TNF-\u00ce\u00b1.[15] The TNF-\u00ce\u00b1 levels on day 7 were 20.32\u00e2\u0080\u008a\u00c2\u00b1\u00e2\u0080\u008a11.30 in the experimental group and 32.99\u00e2\u0080\u008a\u00c2\u00b1\u00e2\u0080\u008a20.62 in the control group. Anticipating a power of 95% (1-\u00ce\u00b2\u00e2\u0080\u008a=\u00e2\u0080\u008a0.95), statistical significance (\u00ce\u00b1\u00e2\u0080\u008a=\u00e2\u0080\u008a0.05) of 95% and a dropout rate of 20% to 25%, a sample size of 60 participants was estimated for each group by G\u00e2\u0088\u0097Power analysis, for a total of 180 participants in this trial.\n Recruited patients will be randomized in a ratio of 1:1:1 into 3 parallel treatment groups of 60 participants: EA, LA, and SLA. All the participants will be told that they will receive one kind of acupuncture treatment in addition to the conventional treatment. The participants will not be notified about their group allocation or the kind of acupuncture treatment before randomization. The participants will be randomly assigned to the 3 groups after providing written informed consent. Randomization will be performed with a 1:1:1 allocation using a computer-generated sequence executed by an independent researcher, who will not be involved in the inclusion or exclusion process, treatment, or assessment procedures. Participants receiving EA will not be blinded to EA in this trial. Participants receiving LA or SLA will be blinded to the LA. The outcome assessors and data analysts will be blinded to the allocation of interventions by using labels A, B, and C for the 3 groups until the trial is completed.", "id": 1163, "split": "test"} +{"trial_id": "NCT04973670", "pmid": "37709320", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials\n\nIncluded conditions:\n- ARDS\n\nStudy Armgroups:\n- {'label': 'Sivelestat sodium', 'type': 'EXPERIMENTAL', 'description': 'Sivelestat sodium 0.2mg/kg.h', 'interventionNames': ['Drug: Sivelestat sodium']}\n- {'label': 'placebo', 'type': 'ACTIVE_COMPARATOR', 'description': 'The same amount of NS containing only sivelestat sodium excipients', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sivelestat sodium', 'description': 'Sivelestat sodium 0.2mg/kg.h for 1-7 days', 'armGroupLabels': ['Sivelestat sodium']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'The same amount of NS containing only sivelestat sodium excipients', 'armGroupLabels': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Progression to ARDS within 7 days (Berlin criteria)', 'description': 'The proportion of patients with sepsis progressing to ARDS', 'timeFrame': 'From study drug administration to days 7'}\n\nPlease estimate the sample size based on the assumption: \nThe trial aims for 80% power at a 2.5% one-sided significance level. An interim analysis will be performed at 50% recruitment, with a p-value threshold of 0.00258 for early stopping. Conditional power (CP) greater than 80% will continue the trial as planned, while CP less than 80% will trigger sample size re-estimation. The Lan-DeMets alpha spending function with an O'Brien-Fleming boundary is used to control type I error.", "answer": 238, "answer_type": "ESTIMATED", "explanation": "Sample size and interim analysis\n The project statistician calculated the sample size based on the primary outcome before starting the trial. A sample size of approximately 238 patients is required to achieve 80% power at a 2.5% one-sided \u00ce\u00b1 level. On the basis of the results observed in the publication by Fein and Calalang-Colucci25 and Li et al,8 the incidence of ARDS in the control group was 18~38%. Based on these data, it is assumed that the incidence rate of placebo in patients with sepsis is 30% and that of treatment is approximately 15%.\n The adequacy of sample size is crucial in clinical trials. Typically, the sample size is determined based on the results of one or more external pilot studies, butt appropriate sample size calculation was not possible due to the lack of available high-quality data. So, in our study, we are uncertain about the treatment effect of sivelestat sodium, which is expected to be around 15%. Given this uncertainty, sample size adjustment may be particularly important if the trial specifications have been made on preliminary and/or uncertain information. In our approach, we prospectively plan modifications to the sample size based on interim estimates of treatment effect for sivelestat sodium and placebo. An interim analysis will be performed when the recruitment rate reaches 50%. If strong evidence of effectiveness is observed with a p value<0.00258 (one-sided), the trial will be stopped early. Otherwise, if the conditional power (CP) is greater than 80%, the trial will continue as planned, and the sample size will remain unchanged. However, if the CP is less than 80%, we will re-estimate the sample size and increase it to ensure the statistical power of the trial.\n The project statistician is responsible for authorising members of the Statistical Analysis Center (SAC) to access unblinded data and prepare reports for the DSMB. Members of the SAC will not be involved in the conduct of the study, other than preparation for and attendance at DSMB meetings. The sample size re-estimation will be conducted by an independent statistician based on the actual effect size in the interim analysis. The interim analyses lead to an inflation of the type I error, and the Lan-DeMets alpha spending function with an O\u00e2\u0080\u0099Brien-Fleming boundary was used to control type I error. If no more subjects are needed, early termination will be executed with the one-side 0.00258 nominal significance level.", "id": 1164, "split": "test"} +{"trial_id": "NCT04974294", "pmid": "35798520", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase IV Double Blind Randomised Controlled Trial (DBRCT) to Investigate the Effect of PCV-13 and PPV-23 on Pneumococcal Colonisation Using the Experimental Human Pneumococcal Challenge (EHPC) Model in Healthy Adults\n\nIncluded conditions:\n- Streptococcus Pneumonia\n\nStudy Armgroups:\n- {'label': 'PPV23', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Biological: PPV23']}\n- {'label': 'PCV13', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Biological: PCV13']}\n- {'label': 'Saline placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Saline for injection']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'PPV23', 'description': 'random allocation 1:1:1 IM injection', 'armGroupLabels': ['PPV23'], 'otherNames': ['pneumovax']}\n- {'type': 'BIOLOGICAL', 'name': 'PCV13', 'description': 'random allocation 1:1:1 IM injection', 'armGroupLabels': ['PCV13'], 'otherNames': ['prevenar']}\n- {'type': 'OTHER', 'name': 'Saline for injection', 'description': 'random allocation 1:1:1 IM injection', 'armGroupLabels': ['Saline placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods', 'description': 'The rate of experimental pneumococcal colonisation with SPN3 determined by the presence of pneumococcus in nasal wash (NW) by classical culture or molecular methods at any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.', 'timeFrame': 'any time point during 23 days following experimental human pneumococcal challenge (EHPC) 1 month after vaccination in the PCV-13, PPV-23 and control groups.'}\n\nPlease estimate the sample size based on the assumption: \n96.2% power and 0.05 significance level for Part A; 81.5% power and 0.05 significance level for Part B; 20% dropout and screen failure rate; interim analysis with nominal \u03b1 of 0.0025 and final analysis \u03b1 of 0.0475.", "answer": 516, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim for 410 participants to complete part A of the study to detect a 50% relative risk reduction in experimental SPN3 colonisation acquisition rates from 30% (detected by classical microbiology) in the control arm to 15% in the intervention (PCV13) arm. Each arm (figure 1, Groups 1+2 vs Groups 4+5) will need 164 participants to complete the study. The sample size has been calculated to achieve 96.2% power and a type I error (\u00ce\u00b1) of 0.05. Up to 516 participants will be recruited to ensure 410 complete part A, allowing for a 20% dropout and screen failure rate from each group. Up to 312 participants will proceed to Part B to ensure 246 complete part A and B to detect a 50% relative risk reduction in experimental SPN6B colonisation acquisition rates (detected by classical microbiology) from 40% in the control arm to 20% in the intervention (PCV13) arm. Each arm (figure 1, 50% of Groups 1+2 vs 50% of Groups 4+5) will need 82 participants to complete the study. The sample size has been calculated to achieve 81.5% power and a type I error (\u00ce\u00b1) of 0.05.\n In calculating the sample size, we have assumed:\n \n \n SPN3 colonisation rates in unvaccinated adults aged 18\u00e2\u0080\u009350 are 30%, as determined by classical microbiology from a recent EHPC study (Establishing SPN3 Challenge Model, unpublished data).\n \n \n SPN6B colonisation rates in unvaccinated adults are 40%, as determined by classical microbiology from previous EHPC studies.41\n\n \n \n PPV23 confers no protection against colonisation, as supported by Cochrane meta-analysis.19 Therefore, we have not included this group in power calculations (figure 1, Group 3).\n \n \n PCV13 confers 50% relative risk reduction in colonisation against SPN3 as determined by microbiology compared with placebo at 1\u00e2\u0080\u0089month post-vaccination; 78% risk reduction against SPN6B colonisation seen in previous EHPC study.41\n\n \n \n A maximum of 10% screen failure rate and 10% dropout rates leading to non-completion.\n \n \n During part A, unblinded team members will monitor colonisation rates in the control arm (figure 1, Groups 4+5). If colonisation is <30%, we will recalibrate the sample size accordingly, allowing for a 50% risk reduction between control and vaccine at 80% power and 5% significance level (table 5).\n \n Table 5\n \n Sample size required per arm to detect a 50% relative risk reduction between intervention (PCV-13 SPN3 clades Ia and II) and control arms (saline SPN3 clades Ia and II) at 80% power and 5% significance level\n \n \n \n \n Experimental SPN3 colonisation rates in control arm (%)\n Sample size required per arm (50% risk reduction)\n Sample size required per arm (40% risk reduction)\n Sample size required per arm (30% risk reduction)\n \n \n \n \n 15\n 278\n 460\n 862\n \n \n 20\n 199\n 329\n 615\n \n \n 25\n 152\n 250\n 466\n \n \n 30\n 121\n 198\n 367\n \n \n 40\n 82\n 133\n 244\n \n \n 50\n 58\n 93\n 170\n \n \n 60\n 42\n 67\n 120\n \n \n \n \n \n PCV13, 13-valent pneumococcal conjugate vaccine; SPN3, Streptococcus pneumoniae serotype 3.\n \n \n \n \n Interim analysis\n After completion of planned enrolment and before the final analysis of part A of the study, we will reassess all sample size calculations inputs to determine if the sample size needs to be increased based on colonisation rates in the control arm and the risk reduction point estimate observed between control and vaccine. The sample size adjustments will be as per table 5. A nominal \u00ce\u00b1 (0.0025) will be assigned to this preliminary assessment. The remaining \u00ce\u00b1 (0.0475) will be used for the final analysis to ensure the overall hypothesis testing \u00ce\u00b1 is below the 0.05 significant level. If PCV13-associated risk reduction point estimates against SPN3 acquisition for both clades of SPN3 (combined and individual results) are <30%, additional enrolment will not be undertaken, as this is considered the limit of a meaningful outcome for the study.", "id": 1165, "split": "test"} +{"trial_id": "NCT04976179", "pmid": "36076211", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Nigerian Women (IVON): an Open Label, Randomized Controlled Trial\n\nIncluded conditions:\n- Iron Deficiency Anemia of Pregnancy\n\nStudy Armgroups:\n- {'label': 'FCM - Intravenous Ferric carboxymaltose', 'type': 'EXPERIMENTAL', 'description': 'Intravenous Ferric Carboxymatlose administered in a single dose of 20mg/Kg to a maximum of 1000mg in 200mls of infusion given over minimum of 15 - 20 minutes at enrollment.', 'interventionNames': ['Drug: Ferric carboxymaltose']}\n- {'label': 'FS -Oral Ferrous sulphate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral Ferrous Sulphate (containing 65mg of elemental iron) to be taken as one 200mg tablet 3 times a day until delivery.', 'interventionNames': ['Drug: Ferrous sulfate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ferric carboxymaltose', 'description': 'Ferric carboxymaltose to be given as an intravenous infusion', 'armGroupLabels': ['FCM - Intravenous Ferric carboxymaltose'], 'otherNames': ['Ferinject']}\n- {'type': 'DRUG', 'name': 'Ferrous sulfate', 'description': 'Ferrous sulphate tablet to be taken orally', 'armGroupLabels': ['FS -Oral Ferrous sulphate'], 'otherNames': ['Fesulf']}\n\nPrimary Outcomes:\n- {'measure': \"Prevalence of maternal anemia at 36 weeks' gestation\", 'description': 'To be collected from data source on number of women with hemoglobin concentration less than 10g/dl as determined by hemocue.', 'timeFrame': 'Measurement taken at 36 weeks gestational age'}\n- {'measure': 'Incidence of preterm delivery', 'description': 'Measured using data source. Preterm delivery is defined as all births after 28 weeks gestational age but before 37 completed weeks of gestation.', 'timeFrame': 'Data will be collected following delivery.'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 90% power, and 15% attrition rate.", "answer": 1056, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Per the multi-country FER-ASAP (FERric carboxymaltose-Assessment of SAfety and efficacy in Pregnancy) study in Europe, Asia, and Australia [40], the expected levels of anaemia correction for oral iron and FCM in pregnancy are approximately 70% and 84%, respectively. At 5% significance, 90% power and adjusting for 15% attrition [41], 1056 pregnant women (528 in each study arm) was the estimated sample size to detect a 14% difference in the correction of AIP between the control (70%) and intervention groups (84%).", "id": 1166, "split": "test"} +{"trial_id": "NCT04976881", "pmid": "37940161", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n- Electronic Health Record\n- Primary Health Care\n- Reproductive Behavior\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Usual care includes: 1) no specific materials to promote medication reconciliation, reproductive planning, or patient education on diabetes self-management within the context of preconception care, 2) variable physician preconception counseling without any EHR notifications or counseling support; and 3) no specific patient support or prompts to promote healthy behaviors post-visits.'}\n- {'label': 'PREPARED Strategy', 'type': 'ACTIVE_COMPARATOR', 'description': \"Our PREPARED strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. PREPARED will leverage electronic health record technology at clinic visits to: \\\\[1\\\\] promote medication reconciliation and safety, \\\\[2\\\\] prompt provider preconception counseling, and \\\\[3\\\\] deliver low literacy print tools to reinforce counseling and promote diabetes self-care. Post-visit, text messaging will be used to: \\\\[4\\\\] encourage healthy lifestyle behaviors.\", 'interventionNames': ['Behavioral: Medication Reconciliation (MedRec) Tool', 'Behavioral: Provider Alert and Decision Support', 'Behavioral: PREPSheet', 'Behavioral: Text Messaging']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Medication Reconciliation (MedRec) Tool', 'description': 'Patients will receive a print MedRec tool, generated via the EHR, which includes a list of medications prescribed according to the patient record. Patients are asked to review this list, to add/remove drugs to reflect actual use, to note how they are taking each medication, and to describe any concerns.', 'armGroupLabels': ['PREPARED Strategy']}\n- {'type': 'BEHAVIORAL', 'name': 'Provider Alert and Decision Support', 'description': 'During the clinic visit, an automated, EHR alert will notify the provider that the patient is a woman of reproductive age with T2DM and should receive counseling on the importance of glycemic control, the use of contraception until glycemic control is achieved, and the benefits of folic acid.', 'armGroupLabels': ['PREPARED Strategy']}\n- {'type': 'BEHAVIORAL', 'name': 'PREPSheet', 'description': 'When patients leave an encounter, they will receive a patient-friendly educational material (a.k.a. the PREPSheet) that reviews potential risks of pregnancy in the context of T2DM and highlights the importance of: 1) achieving glycemic control through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is desired, 3) discussing medication use with a provider if planning or becoming pregnant, and 4) taking folic acid daily to reduce increased risk of neural tube defects.', 'armGroupLabels': ['PREPARED Strategy']}\n- {'type': 'BEHAVIORAL', 'name': 'Text Messaging', 'description': 'Within \\\\~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.', 'armGroupLabels': ['PREPARED Strategy']}\n\nPrimary Outcomes:\n- {'measure': 'Average difference in HbA1c values between Intervention and Control Patients', 'description': 'We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.', 'timeFrame': '6 months'}\n- {'measure': 'Knowledge of reproductive risks', 'description': 'We will use a questionnaire, developed by our team and the scientific literature, to evaluate patient knowledge of reproductive risks and recommended health behaviors for women with type 2 diabetes. It includes items assessing knowledge of pregnancy planning, reproductive risks, and desired diabetes self-care behaviors. Correctly answered questions will be summed and a total knowledge score will be generated. Higher scores indicate greater knowledge.', 'timeFrame': '1 month'}\n\nPlease estimate the sample size based on the assumption: \nSignificance levels: \u03b1=2.5% for primary outcomes, \u03b1=1% for secondary outcomes; 80% power; intraclass correlation coefficient of 0.015; \u22643% pregnancy rate; at least 85% retention at 6 months; up to 25% attrition.", "answer": 840, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n We will conduct statistical tests of the impact of PREPARED on HbA1c (primary outcome) and knowledge of T2DM reproductive risks (\u00ce\u00b1=2.5%) as well as engagement in diabetes self-care activities (\u00ce\u00b1=1%). Prior data from the participating sites suggest the average HbA1c value of this population is 7.8 (SD=1.8).40 41 As this is a cluster randomised trial, we expect some modest correlation between outcomes for patients in the same clinic, and thus assume an intraclass correlation coefficient of 0.015. We further anticipate \u00e2\u0089\u00a43% pregnancy rate among participants and at least 85% retention at 6 months.\n Given these assumptions, a total sample size of 840 patients will need to be enrolled to obtain 695 across N=51 sites (N>13 per site). This would provide 80% power to detect effects of Cohen\u00e2\u0080\u0099s d=0.26 (ie, 0.43\u00e2\u0080\u00930.47%\u00e2\u0080\u0089decrease in HbA1c, 2.4\u00e2\u0080\u00932.6%\u00e2\u0080\u0089increase in knowledge of T2DM reproductive risks) for primary outcomes tested at the \u00ce\u00b1=2.5% level.42 Analyses of secondary outcomes would have 80% power to detect increases in rates of patients engaging in diabetes self-care activities of 8\u00e2\u0080\u009315% (ORs of 1.7\u00e2\u0080\u00932.8) in PREPARED versus usual care, depending on how frequently usual care patients engage in these activities (\u00ce\u00b1=1%). Note that even if attrition is as large as 25%, this sample size would ensure 80% power to detect changes in HbA1c of 0.5%.", "id": 1167, "split": "test"} +{"trial_id": "NCT04978116", "pmid": "35523502", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low-dose CT Compared to Lung Ultrasonography vs Standard of Care for the Diagnosis of Pneumonia in the Elderly: a Multicentre Randomized Controlled Study\n\nIncluded conditions:\n- Pneumonia\n- Elderly Infection\n\nStudy Armgroups:\n- {'label': 'Chest X-Ray (CXR)', 'type': 'EXPERIMENTAL', 'description': 'Only CXR (image and standardized report) will be available to the clinician in charge of the patient (standard of care). LDCT and LUS will be performed but not available (clinician will be blinded to LDCT and LUS).', 'interventionNames': ['Diagnostic Test: Chest X-Ray (CXR)', 'Diagnostic Test: Low-dose CT scan (LDCT)', 'Diagnostic Test: Lung ultrasonography (LUS)']}\n- {'label': 'Low-dose CT scan (LDCT)', 'type': 'EXPERIMENTAL', 'description': 'Only LDCT (image and standardized report) will be available to the clinician (first intervention arm). CXR and LUS will be performed but not available (clinician will be blinded to CXR and LUS).', 'interventionNames': ['Diagnostic Test: Chest X-Ray (CXR)', 'Diagnostic Test: Low-dose CT scan (LDCT)', 'Diagnostic Test: Lung ultrasonography (LUS)']}\n- {'label': 'Lung ultrasonography (LUS)', 'type': 'EXPERIMENTAL', 'description': 'Only LUS (image and standardized report) will be available to the clinician (second intervention arm). CXR and LDCT will be performed but not available (clinician will be blinded to CXR and LDCT).', 'interventionNames': ['Diagnostic Test: Chest X-Ray (CXR)', 'Diagnostic Test: Low-dose CT scan (LDCT)', 'Diagnostic Test: Lung ultrasonography (LUS)']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Chest X-Ray (CXR)', 'description': 'The 3 following imagings will be performed in the emergency room: chest X-Ray (CXR), low-dose CT scan (LDCT) and lung ultrasonography (LUS) will be performed for all included patients, but only one will be available to the clinician in charge of the patient according to the allocation arm.\\n\\nThe blinding will be maintained during the first 5 days, and hence will not influence the diagnosis and the treatment of the patient.\\n\\nThe clinician in charge will be asked to assess on a 3-level Likert scale the probability of pneumonia (high, intermediate, low level) while considering all available clinical and biological data, plus the imaging modality according to the randomization arm.', 'armGroupLabels': ['Chest X-Ray (CXR)', 'Low-dose CT scan (LDCT)', 'Lung ultrasonography (LUS)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Low-dose CT scan (LDCT)', 'description': 'See above in CXR paragraph', 'armGroupLabels': ['Chest X-Ray (CXR)', 'Low-dose CT scan (LDCT)', 'Lung ultrasonography (LUS)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Lung ultrasonography (LUS)', 'description': 'See above in CXR paragraph. LUS will be performed by another clinician than the one in charge of the patient', 'armGroupLabels': ['Chest X-Ray (CXR)', 'Low-dose CT scan (LDCT)', 'Lung ultrasonography (LUS)']}\n\nPrimary Outcomes:\n- {'measure': \"Accuracy of the clinician's diagnosis of pneumonia\", 'description': 'The probability of pneumonia will be rated by the clinician in charge, before the patient is discharged from the Emergency Room, on a 3-level Likert scale (\"low\", \"intermediate\" or \"high\").The probability of pneumonia will be rated by the panel of experts a posteriori on the same scale. For the primary outcome, a diagnosis of pneumonia will be positive if the probability is rated \"intermediate\" or \"high\" and negative if the probability is rated \"low\". The accuracy will be the proportion of patients with a clinician\\'s diagnosis (either negative or positive) matching with the panel of experts\\' diagnosis which is considered as the reference. Grouping the levels \"intermediate\" or \"high\" makes sense from a medical decision making perspective since a patient rated \"intermediate\" will be treated with antibiotics in the same way as a patient rated \"high\". In a secondary analysis, the diagnosis of pneumonia will be considered positive only if the probability is rated \"high\".', 'timeFrame': 'Before the patient is discharged from the Emergency Room (Day 0 -an average of 10 hours)'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha error of 0.05, power of 90%, and a 10% drop-out rate.", "answer": 495, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on the accuracy of diagnostic strategies for pneumonia assessed in the PneumO-LD-CT cohort (unpublished results, online supplemental file 1). In this study, the accuracy of the clinician\u00e2\u0080\u0099s diagnosis was 68% when based on CXR and 84% when based on LDCT.\n \n 10.1136/bmjopen-2021-055869.supp1\n Supplementary data\n \n\n\n \n With an expected improvement of 16% of the accuracy using LDCT instead of CXR, 150 patients will be required in each arm to demonstrate the superiority of LDCT over CXR with a two-sided alpha error of 0.05 and a power of 90%. Allowing for a 10% drop-out after randomisation, the final recruitment objective is 165 patients in each arm, for a total of 495 patients.", "id": 1168, "split": "test"} +{"trial_id": "NCT04982718", "pmid": "35413933", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial of Home-based Hepatitis C Self-testing for Key Populations in Malaysia\n\nIncluded conditions:\n- Hepatitis C\n- Diagnostic Self Evaluation\n\nStudy Armgroups:\n- {'label': 'Oral fluid-based HCV ST', 'type': 'EXPERIMENTAL', 'description': 'In the intervention group, participants will receive a HCV self-test (ST) kit delivered in non-identifiable packaging to their home or a preferred mailing address. The kit will include the test, instructions for use, and information about additional supporting materials, such as access to live chat and a call center for questions about testing. In order to evaluate two sampling methods for HCV self-testing, the first 250 participants in the intervention group will receive an oral fluid-based HCV ST.', 'interventionNames': ['Diagnostic Test: OraQuick\u00ae HCV Self-Test']}\n- {'label': 'Blood-based HCV ST', 'type': 'EXPERIMENTAL', 'description': 'In the intervention group, participants will receive a HCV self-test (ST) kit delivered in non-identifiable packaging to their home or a preferred mailing address. The kit will include the test, instructions for use, and information about additional supporting materials, such as access to live chat and a call center for questions about testing. In order to evaluate two sampling methods for HCV self-testing, the next 250 participants will receive a blood-based fingerstick HCV ST.', 'interventionNames': ['Diagnostic Test: First Response\u00ae HCV Self-Test']}\n- {'label': 'Control standard of care', 'type': 'NO_INTERVENTION', 'description': 'In the control group, participants will receive information about standard of care HCV antibody testing available at local testing sites in their community and information about additional supporting materials, such as access to live chat and a call center for questions about testing.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'OraQuick\u00ae HCV Self-Test', 'description': 'Self-testing will be performed using the OraQuick\u00ae HCV Self-Test manufactured by OraSure Technologies Inc., USA. Modified IFU developed by the manufacturer will be used to adapt the below professional use kits to a self-test: the OraQuick\u00ae HCV Rapid Antibody Test is prequalified by WHO and CE marked for professional use (sensitivity 98.1%, specificity 99.6%).\\n\\nAs it is not approved for self-test use in Malaysia, the OraQuick\u00ae HCV Self-Test kits provided to participants in the intervention group will be labelled for Research Use Only (RUO) and test results will not be used for patient management.', 'armGroupLabels': ['Oral fluid-based HCV ST']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'First Response\u00ae HCV Self-Test', 'description': 'Self-testing will be performed using the First Response\u00ae HCV Card Test (Self Test) manufactured by Premier Medical Corporation, India. Modified IFU developed by the manufacturer will be used to adapt the below professional use kits to a self-test: the First Response\u00ae HCV Card Test is CE-marked and currently under WHO review for professional use (sensitivity 100%, specificity 100%).\\n\\nAs it is not approved for self-test use in Malaysia, the First Response\u00ae HCV Self-Test kits provided to participants in the intervention group will be labelled for Research Use Only (RUO) and test results will not be used for patient management.', 'armGroupLabels': ['Blood-based HCV ST']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing', 'description': 'The number and estimate of the proportion of participants who report completing the HCV antibody testing in the intervention group vs the control group.', 'timeFrame': 'Time Frame: 2 weeks to 2 months after enrollment'}\n- {'measure': 'To assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing', 'description': 'To assess that the proportion of participants who report completing the HCV antibody testing in the intervention group is superior to that of the participants in the control group by a margin of 20%.', 'timeFrame': 'Time Frame: 2 weeks to 2 months after enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe study is based on 80% statistical power and an alpha level of 0.05. The null hypothesis is that there is no significant difference in the proportion of individuals reporting HCV test results in the intervention versus control groups.", "answer": 750, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The study will enrol a minimum of 750 participants who meet the inclusion criteria. There will be a minimum of 250 participants who receive an oral fluid-based HCV self-test, 250 participants who receive a blood-based HCV self-test and 250 participants in the control group. The study is powered to detect at least a 20% between-group difference in HCV antibody self-testing between the intervention group and the control group, based on 80% statistical power and an alpha level of 0.05. As this study is one of the first to explore the impact of an HCV self-testing distribution model, there are no references available to draw on for the expected difference in between-group uptake of antibody testing rates. The use of a 20% between-group difference in HCV antibody testing uptake is based on expert opinion, according to previous experiences with HIV self-testing and the increases in the uptake of testing seen with the use of HIV self-testing [15].\n For the primary objective, the null hypothesis is that there is no significant difference in the proportion of individuals reporting HCV test results in the intervention versus control groups. The alternative hypothesis is that home-based HCV self-testing in the intervention group will significantly increase the proportion of individuals reporting HCV test results.\n The study is not powered to detect significant differences in the secondary objectives. However, similarly to the primary objective, the null hypothesis would be no significant difference between the intervention versus control groups, with the alternative hypothesis being that home-based HCV self-testing will result in significantly higher numbers of HCV-infected individuals being diagnosed, linked to care and treated, making it a cost-effective approach to HCV case-finding and elimination.", "id": 1169, "split": "test"} +{"trial_id": "NCT04984616", "pmid": "36638112", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Statins (Atorvastatin) on Inflammation and Cardiac Function in Patients with Chronic Chagas Disease: Pathophysiological Studies in a Multicenter Proof-of-concept\n\nIncluded conditions:\n- Chronic Chagas Disease\n\nStudy Armgroups:\n- {'label': 'ATORVASTATIN 40', 'type': 'EXPERIMENTAL', 'description': '40 mg Atorvastatin/day for 120 days P.O.', 'interventionNames': ['Drug: 40 mg Atorvastatin/day for 120 days P.O.']}\n- {'label': 'ATORVASTATIN 80', 'type': 'EXPERIMENTAL', 'description': '80 mg Atorvastatin/day for 120 days P.O.', 'interventionNames': ['Drug: Atorvastatin 80']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo/day for 120 days P.O.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '40 mg Atorvastatin/day for 120 days P.O.', 'description': 'Oral administration of Atorvastatin 40 mg/daily for 120 days', 'armGroupLabels': ['ATORVASTATIN 40']}\n- {'type': 'DRUG', 'name': 'Atorvastatin 80', 'description': 'Oral administration of Atorvastatin 80 mg/daily for 120 days', 'armGroupLabels': ['ATORVASTATIN 80']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Oral administration of Placebo daily for 120 days', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients that present a change in the phase of the chronic cardiomyopathy', 'description': 'To evaluate whether the effect of atorvastatin in combination with antiparasitic therapy (NFX or BZD), more effective than antiparasitic therapy alone in preventing the onset of cardiac disorders as determined by non-progression in the phase from the A-phase according to the I Latin American Guidelines for the diagnosis and treatment of Chagas cardiomyopathy (Andrade et al, Arq Bras Cardiol 2011;97 Suppl 3:1-48.).', 'timeFrame': 'Twelve months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% significance level (2-sided), 25% drop-out rate", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size\n A sample size of 75 patients per arm is sufficient to reach a 90% power at a global 5% significance level (2-sided), assuming the proportion of patients that improve cardiac damage and function at EOT in the experimental treatment group is 0.40. The proportion in the placebo group (Pp-Placebo) is 0.20, with an odds ratio of 2.5. Considering an estimated drop-out rate of 25%, then 100 patients per group would be recruited (300 patients in total) [60]. The study will be sufficiently powered to provide evidence of superior efficacy of either dose of ATO plus antichagasic therapy relative to antichagasic treatment alone.", "id": 1170, "split": "test"} +{"trial_id": "NCT04985695", "pmid": "37221022", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block\n\nIncluded conditions:\n- Laparotomy\n\nStudy Armgroups:\n- {'label': 'Thoracic epidural anesthesia', 'type': 'ACTIVE_COMPARATOR', 'description': 'Epidural analgesia during midline laparotomy', 'interventionNames': ['Drug: Epidural analgesia', 'Procedure: Laparotomy']}\n- {'label': 'Bilateral rectus sheath block', 'type': 'EXPERIMENTAL', 'description': 'Bilateral rectus sheath block during midline laparotomy', 'interventionNames': ['Drug: Bilateral rectus sheath block', 'Procedure: Laparotomy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Epidural analgesia', 'description': 'All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.', 'armGroupLabels': ['Thoracic epidural anesthesia']}\n- {'type': 'DRUG', 'name': 'Bilateral rectus sheath block', 'description': 'Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump', 'armGroupLabels': ['Bilateral rectus sheath block']}\n- {'type': 'PROCEDURE', 'name': 'Laparotomy', 'description': 'A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy', 'armGroupLabels': ['Bilateral rectus sheath block', 'Thoracic epidural anesthesia']}\n\nPrimary Outcomes:\n- {'measure': 'Change in total QoR-15 score', 'description': 'The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0=\"none of the time\" to 10=\"all the time\"; for negative items the scoring was reversed).', 'timeFrame': 'Postoperative day 2'}\n\nPlease estimate the sample size based on the assumption: \nRisk \u03b1 set to 5%, power 1-\u03b2 set to 80%, and no losses to follow-up between randomisation and POD2.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size\n RSB and TEA patients are randomised at a 1:1 ratio. Unilateral testing for RSB superiority over TEA in terms of the primary objective (change in total QoR-15F score on POD2 relative to baseline) will require 55 patients per group (110 patients in total). This calculation was based on the following: (1) an RCT on laparoscopic colorectal cancer surgery showed that general anaesthesia combined with epidural block led to mean total QoR-15 scores of 116 (SD=4) and 123 (SD=7) on POD 3 and POD 7, respectively.54 (2) Our ongoing R\u00c3\u00a9habilitation Am\u00c3\u00a9lior\u00c3\u00a9e Apr\u00c3\u00a8s Chirurgie pour HYSterectomie programm\u00c3\u00a9e (RAACHYS) study investigating the impact of an ERAS programme on patients undergoing hysterectomy52 shows that on POD 1, the SD of the mean total QoR-15F score is 20. Therefore, for the sample size calculation, we hypothesised that the SD would be 15. (3) An 8-point difference in QoR-15 scores is clinically relevant.53 Thus, if the estimated mean total QoR-15F score of the TEA groups is 120, an 8-point improvement represents a 7% difference. Using this together with a risk \u00ce\u00b1 set to 5% and power 1-\u00ce\u00b2 set to 80%, 55 patients/group are needed to show that RSB is superior to TEA in terms of total QoR-15F score evolution. We expect no losses to follow-up between the randomisation, on the day before surgery, and POD2.", "id": 1171, "split": "test"} +{"trial_id": "NCT04985994", "pmid": "35672071", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study\n\nIncluded conditions:\n- Tuberculosis\n\nStudy Armgroups:\n- {'label': 'Tuberculosis Patients', 'description': '1. Diagnosed with pulmonary TB after detailed history collection, clinical examination, and laboratory assessment (sputum culture positive).\\n2. Aged 18 years or above.\\n3. Willing to participate in the study.'}\n- {'label': 'Healthy Volunteers', 'description': '1. Healthy subjects with no symptoms or history of pulmonary TB\\n2. Negative sputum culture\\n3. Matched for sex and age (\u00b15 years) with the TB patient group.'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Gut microbiome diversity and functional potential', 'description': 'To explore the effect of TB infection and anti-tuberculosis therapy on gut microbiome diversity, functional potential and immune response in newly diagnosed TB patients from Pakistan.', 'timeFrame': '2 Years'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power cannot be calculated accurately due to strict inclusion and exclusion criteria and absence of similar studies.", "answer": 450, "answer_type": "ACTUAL", "explanation": "Sample size\n Because of the strict inclusion and exclusion criteria, and absence of similar studies, statistical power cannot be calculated accurately. Therefore, we have followed a pragmatic approach for sample size calculation. Previously published literature suggest that for metagenomic studies, a sample size of 30 is sufficient to observe phenotypic heterogeneity at the molecular level.25 We are aiming to recruit 450 TB patients on the basis of 7% TB treatment failure rate in Pakistan,1 to achieve sufficient numbers to observe phenotypic differences in the corresponding microbiomes (treatment failure vs success). Furthermore, we will also recruit 30 healthy controls.", "id": 1172, "split": "test"} +{"trial_id": "NCT04987151", "pmid": "34535474", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Three Different Exercise Training Modalities (Aerobic, Strength, and Mixed) in Patients With Schizophrenia: Study Protocol for a Multi-centre Randomised Wait-list Controlled Trial\n\nIncluded conditions:\n- Schizophrenia\n\nStudy Armgroups:\n- {'label': 'Strength training', 'type': 'EXPERIMENTAL', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups.', 'interventionNames': ['Other: Experimental-Strength training']}\n- {'label': 'Aerobic training', 'type': 'EXPERIMENTAL', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking,', 'interventionNames': ['Other: Experimental-Aerobic training']}\n- {'label': 'Strength/Aerobic training', 'type': 'EXPERIMENTAL', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups', 'interventionNames': ['Other: Experimental-Strength/Aerobic training']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Experimental-Strength training', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups', 'armGroupLabels': ['Strength training']}\n- {'type': 'OTHER', 'name': 'Experimental-Aerobic training', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.', 'armGroupLabels': ['Aerobic training']}\n- {'type': 'OTHER', 'name': 'Experimental-Strength/Aerobic training', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.', 'armGroupLabels': ['Strength/Aerobic training']}\n\nPrimary Outcomes:\n- {'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'description': 'Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms', 'timeFrame': '16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve 90% power, with an \u00ce\u00b1 level of 0.05, and anticipating a drop-out rate of 30%.", "answer": 105, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation was conducted using G*Power software V.3.1.9.247 based on data collected from a similar study by Silva et al24 The effect size (\u00ce\u00b7p2) for the time by-group interaction in the positive symptoms of schizophrenia was 0.229. To achieve 90% power, with an \u00ce\u00b1 level of 0.05, the total sample size needed is 80. Thus, anticipating a drop-out rate of 30% according to Vancampfort et al,48 the necessary total sample size would be (n=105).", "id": 1173, "split": "test"} +{"trial_id": "NCT04990232", "pmid": "36600424", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Personalized Immunotherapy in Sepsis: a Multicentre and Multinational, Double-blind, Double-dummy Randomized Clinical Trial\n\nIncluded conditions:\n- Sepsis\n\nStudy Armgroups:\n- {'label': 'Standard of care', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will receive the standard type of treatment decided by the attending physicians. They will also receive 20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Immunotherapy', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive the standard type of treatment decided by the attending physicians. They will also receive IV anakinra 200 mg three times daily (every eight hours) or sc rhIFN\u03b3 100 \u03bcg once every other day. More precisely, patients randomized for hyper-inflammation will receive anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. Patients having immunoparalysis will receive IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFN\u03b3 every other day for 15 days. Especially for patients with creatinine clearance lower than 30 ml/min anakinra will be given half dose (i.e. 100 mg three times daily). Creatinine clearance is calculated by the Cockcroft Gault equation \\\\[(140-age in years)/ (72 x serum creatinine in mg/dl) for men; this is multiplied by 0.85 for women.', 'interventionNames': ['Drug: Anakinra or rhIFN\u03b3']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Anakinra or rhIFN\u03b3', 'description': 'In hyper-inflammation anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. In immunoparalysis IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFN\u03b3 every other day for 15 days.', 'armGroupLabels': ['Immunotherapy'], 'otherNames': ['Imukin', 'Kineret']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': '20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days', 'armGroupLabels': ['Standard of care']}\n\nPrimary Outcomes:\n- {'measure': 'Mean total Sequential Organ Failure Assessment score', 'description': 'Difference in the mean total Sequential Organ Failure Assessment score between the two arms', 'timeFrame': '9 days'}\n\nPlease estimate the sample size based on the assumption: \nPowered for 90% at the 5% level of significance, with an anticipated mean difference in the SD between the two groups of 3.2, and a drop-out rate of about 15%.", "answer": 280, "answer_type": "ACTUAL", "explanation": "Sample size\n The study is powered for the primary endpoint, that is, decrease of mean SOFA score by at least 1.4 points on day 9. In order to calculate the power of the study, the following hypotheses are made: according to data from the previous RCTs in sepsis VISEP9 and MAXSEP10 on a total of 1137 patients, there is a significant association between the mean total SOFA score at day 9 and 28-day mortality. A reduction of the primary endpoint by 1.4 points is expected to be associated with a reduction of 28-day mortality. Based on the preliminary results of the PROVIDE Study (ClinicalTrials.gov NCT0333225), 40% of the enrolled patients in each arm will be recruited with fulminant hyperinflammation and another 60% for sepsis-associated immunoparalysis. The study is powered for 90% at the 5% level of significance and the anticipated mean difference in the SD between the two groups will be 3.2. In order to detect this difference of 1.4 points in the mean SOFA score, 117 patients will be needed per trial arm. Considering a drop-out rate of about 15%, a total of 280 patients need to be randomised.", "id": 1174, "split": "test"} +{"trial_id": "NCT04992598", "pmid": "36600368", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department\n\nIncluded conditions:\n- Shoulder Dislocation\n\nStudy Armgroups:\n- {'label': 'Hypnosis group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Hypnosis session', 'Procedure: Reduction']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Procedure: Reduction']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Hypnosis session', 'description': 'Hypnosis session will precede therapeutic strategies and reduction', 'armGroupLabels': ['Hypnosis group']}\n- {'type': 'PROCEDURE', 'name': 'Reduction', 'description': 'All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.', 'armGroupLabels': ['Control group', 'Hypnosis group']}\n\nPrimary Outcomes:\n- {'measure': 'Analgesic consumption', 'description': 'Calculated as the equal dose of morphine', 'timeFrame': 'Day 1'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk set at 5%, power of 80%.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n We expect that 25% of the patients will need three or more equipotent doses of analgesics in the control group, and 5% in the hypnosis group.23 Under these conditions and with an alpha risk set at 5%, it is necessary to include 35 patients per group, or 70 patients in total, to achieve a power of 80%.", "id": 1175, "split": "test"} +{"trial_id": "NCT04993534", "pmid": "36761135", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RESPOND: Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns Resulting From the COVID-19 Pandemic. A Randomized Controlled Trial in Italy\n\nIncluded conditions:\n- Psychological Distress\n\nStudy Armgroups:\n- {'label': 'Psychological First Aid + Stepped-care intervention (DWM/PM+)', 'type': 'EXPERIMENTAL', 'description': 'All participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises.\\n\\nThe treatment group will receive the stepped-care program consisting of DWM (step 1) and Problem Management Plus (PM+).\\n\\nThe DWM program has been developed by WHO and collaborators working in the humanitarian field. DWM was designed to be relevant for large segments of adversity-affected populations: it is intended to be transdiagnostic, and easily adaptable to different cultures and languages.\\n\\nPM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques that are empirically supported.', 'interventionNames': ['Behavioral: Stepped-care DWM/PM+']}\n- {'label': 'Psychological First Aid + usual care', 'type': 'OTHER', 'description': 'All participants will be offered individual Psychological First Aid (PFA), a WHO developed support strategy that involves humane, supportive and practical help for individuals suffering from serious humanitarian crises.\\n\\nIn addition, both the groups will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.', 'interventionNames': ['Other: Psychological First Aid + usual care (CAU)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Stepped-care DWM/PM+', 'description': 'The DWM program consists of a self-help guide that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, have been adapted for use on a smartphone or other device with internet access.\\n\\nPM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support.', 'armGroupLabels': ['Psychological First Aid + Stepped-care intervention (DWM/PM+)']}\n- {'type': 'OTHER', 'name': 'Psychological First Aid + usual care (CAU)', 'description': 'All participants, both in the treatment and the comparison group, will be offered individual Psychological First Aid (PFA) through a face-to-face or teleconferencing meeting. In addition to PFA, both the treatment and the comparison group will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.', 'armGroupLabels': ['Psychological First Aid + usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Patient Health Questionnaire - Anxiety and Depression (PHQ-ADS)', 'description': 'Decrease in symptoms of depression and anxiety. The total score ranges from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.', 'timeFrame': 'Two-month follow-up after the PM+ intervention ended'}\n\nPlease estimate the sample size based on the assumption: \nPower = 0.95, alpha = 0.05, two-sided test, rho = 0.9, attrition rate of 30%.", "answer": 212, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n Based on prior studies on PM+ (32, 52), we aim to detect a small to medium Cohen's d effect size of 0.3 in the PM+ group at 2 months post-intervention based on the primary composite outcome PHQ-ADS. A power calculation for a repeated measurement design suggests a minimum sample size of N = 74 per group (power = 0.95, alpha = 0.05, two-sided, rho = 0.9) to identify an effect at the time of interest. Assuming an attrition rate of 30%, we aim to include a total number of 212 participants [106 in the stepped-care DWM/PM+ intervention group (with PFA and CAU) and 106 in the PFA and CAU comparison group].", "id": 1176, "split": "test"} +{"trial_id": "NCT04995107", "pmid": "35147087", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial\n\nIncluded conditions:\n- Hot Flashes\n- Acupuncture Therapy\n- Perimenopausal Disorder\n- Postmenopausal Symptoms\n\nStudy Armgroups:\n- {'label': 'Electro-Press Needle group', 'type': 'EXPERIMENTAL', 'description': 'Body acupoints of Yintang (GV29), Dazhui (GV14), Guanyuan (CV4), bilateral Zigong (EX-CA1), and bilateral Sanyinjiao (SP6) and auricular acupoints of Heart (CO15), Chuiqian (LO4) and Shenmen (TF4) will be selected for treatment. Auricular acupoints on right and left ear will be stimulated alternatively, one side on each time.The treatment will last 40mins for each session, 3 sessions a week (ideally every other day) for a succession of 6 weeks.', 'interventionNames': ['Device: Electro Press needle']}\n- {'label': 'Waiting-list group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the waiting-list group will receive no intervention for 6 weeks and be followed up till weeks 30.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electro Press needle', 'description': 'Body acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China). After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin. Then, the electric device (\u03c644\u00d715.8mm Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively. The electric device will be switch to the mode of \"dense intermittent wave\", and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed).', 'armGroupLabels': ['Electro-Press Needle group'], 'otherNames': ['EPN']}\n\nPrimary Outcomes:\n- {'measure': 'the proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline', 'description': 'The mean 24-hour HF score = (1 \u00d7 number of mild HF + 2 \u00d7 number of moderate HF + 3 \u00d7 number of severe HF + 4 \u00d7 number of very severe HF)/Number of days reported.', 'timeFrame': 'week 6'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on 80% power, a 2-sided significance level of 5%, and a drop-off rate of 20% in the follow-up.", "answer": 122, "answer_type": "ESTIMATED", "explanation": "2.8.3.4\n Sample size calculation\n The sample size was calculated based on the primary outcome, which is the proportion of participants with a reduction of 50% or more on their mean 24-hour HF score from baseline at week 6. The proportion of participants with at least a 50% decrease from baseline in 6\u00e2\u0080\u008aweeks was assumed to be 55% in the EPN group and 28% in the waitlist control group based on the previous research.[9,23] Therefore, a sample size of 49 in each group is estimated to detect the group difference of 27%, with 80% power and a 2-sided significance level of 5%. A total of 122 patients (61 in each group) will be recruited for the study, assuming drop-off rate of 20% in the follow-up.", "id": 1177, "split": "test"} +{"trial_id": "NCT05001126", "pmid": "35232475", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of High Intensity Functional Training on Cardiometabolic Risk Factors and Exercise Enjoyment in Men and Women With Metabolic Syndrome: a Randomized, 12-week, Dose-response Trial\n\nIncluded conditions:\n- Metabolic Syndrome\n- Atherogenic Dyslipidemia\n- Insulin Resistance\n- Endothelial Dysfunction\n\nStudy Armgroups:\n- {'label': 'HIFT 1x/week', 'type': 'EXPERIMENTAL', 'description': 'HIFT exercise performed one time per week.', 'interventionNames': ['Behavioral: HIFT 1x/week']}\n- {'label': 'HIFT 2x/week', 'type': 'EXPERIMENTAL', 'description': 'HIFT exercise performed two times per week.', 'interventionNames': ['Behavioral: HIFT 2x/week']}\n- {'label': 'HIFT 3x/week', 'type': 'EXPERIMENTAL', 'description': 'HIFT exercise performed three times per week.', 'interventionNames': ['Behavioral: HIFT 3x/week']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'HIFT 1x/week', 'description': 'HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 1x/week represents a dose of one HIFT workout per week.', 'armGroupLabels': ['HIFT 1x/week']}\n- {'type': 'BEHAVIORAL', 'name': 'HIFT 2x/week', 'description': 'HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 2x/week represents a dose of two HIFT workouts per week.', 'armGroupLabels': ['HIFT 2x/week']}\n- {'type': 'BEHAVIORAL', 'name': 'HIFT 3x/week', 'description': 'HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 3x/week represents a dose of three HIFT workouts per week.', 'armGroupLabels': ['HIFT 3x/week']}\n\nPrimary Outcomes:\n- {'measure': 'Mean change from baseline and comparison between groups in apolipoprotein B (ApoB) count after 12 weeks of training.', 'description': 'Baseline and post-training blood analysis of apolipoprotein B will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the cholesterol content of low-density lipoproteins (LDL-C).', 'description': 'Baseline and post-training blood analysis of LDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the cholesterol content of very low-density lipoproteins (VLDL-C).', 'description': 'Baseline and post-training blood analysis of VLDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the cholesterol content of high-density lipoproteins (HDL-C).', 'description': 'Baseline and post-training blood analysis of HDL-C will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the total cholesterol (TC) content of all lipoproteins.', 'description': 'Baseline and post-training blood analysis of TC will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the triglyceride content of LDL (LDL-T).', 'description': 'Baseline and post-training blood analysis of LDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the triglyceride content of VLDL (VLDL-T).', 'description': 'Baseline and post-training blood analysis of VLDL-T will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the total triglyceride content of all lipoprotein classes (TG).', 'description': 'Baseline and post-training blood analysis of TG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in blood glucose (BG).', 'description': 'Baseline and post-training blood analysis of BG will be measured via venipuncture of the anti-cubital vein and reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in blood insulin (INS).', 'description': 'Baseline and post-training blood analysis of INS will be measured via venipuncture of the anti-cubital vein and reported in units of mcIU/mL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in the Homeostatic Assessment of Insulin Resistance (HOMA-IR).', 'description': 'The baseline and post-training blood analysis of BG and INS will be used to calculate insulin resistance (IR) using the validated homeostatic model assessment (HOMA) \\\\[Sarafidis et al., 2007; Matthews et al., 1985\\\\]. HOMA-IR will be reported in units of mg/dL. Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups in glycosylated hemoglobin (HbA1c) after 12 weeks of training.', 'description': 'Baseline and post-training blood analysis of HbA1c will be measured via venipuncture of the anti-cubital vein and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group as well as for male and female subgroups within each dose group. The mean (SD) change for each variable will be compared between the three dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups of endothelial-dependent peak blood flow (PBF).', 'description': 'Baseline and post-training endothelial-dependent PBF of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography and reported in units of percent (%). Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n- {'measure': 'Mean change from baseline and comparison between groups of endothelial-dependent area under the curve (AUC) of hyperemia blood flow.', 'description': 'Baseline and post-training endothelial-dependent hyperemia AUC of the non-dominant forearm will be measured using venous occlusion strain-gauge plethysmography. Hyperemia blood flow will be measured for 5 min after a 5 min occlusion period. 30 sec AUC blood flow will be quantified reported in units of percent (%) x time. Change from baseline will be calculated and aggregated as mean (SD) for each dose group and male/female subgroups. Mean (SD) for each variable will be compared between dose groups and male and female subgroups.', 'timeFrame': 'Baseline and 48hrs post 12-week training completion'}\n\nPlease estimate the sample size based on the assumption: \nAssumptions include a power of 0.90, \u03b1 = 0.05, and a 5% dropout rate.", "answer": 25, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The sample size was projected with a change in ApoB as the main outcome variable between HIFT1 and HIFT3. Power calculations (IBM SPSS v25 Armond, NY) assumed a 1:1 equal allocation between HIFT1 and HIFT3. The baseline mean and standard deviations from a previous study [97] and pilot studies for ApoB were ~ 129 \u00c2\u00b1 25\u00e2\u0080\u0089mg/dL in sedentary adults with elevated cardiometabolic risk. Collectively, using these data, we consider a 15% reduction in ApoB to be clinically meaningful within the HIFT3 group [98]. Assuming a power of 0.90, \u00ce\u00b1 = 0.05, and an effect size of d = 0.80, a paired samples one-tailed t-test sample size calculation revealed a sample size of 60 subjects (20 per group) will establish the superiority of HIFT3 versus HIFT1 for pre- to post-differences in the primary outcome ApoB. With an estimated 5% dropout rate, we will recruit 22 subjects/group to obtain the necessary sample size of 60. Therefore, a total of 60 men and women who meet the previously stated inclusion criteria will be recruited and randomized post-baseline assessments into one of the three intervention groups. Data will be collected in cohorts of 12, randomized into intervention groups. This will continue until 20 participants per intervention group have completed the study. This will accommodate dropout within cohorts.", "id": 1178, "split": "test"} +{"trial_id": "NCT05001568", "pmid": "38324512", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis\n\nIncluded conditions:\n- Scoliosis\n- Idiopathic Scoliosis\n\nStudy Armgroups:\n- {'label': 'Optimized Providence brace', 'type': 'EXPERIMENTAL', 'description': 'The braces will be designed using optimization and finite element analysis.', 'interventionNames': ['Device: Immediate in-brace correction: Conventional Brace', 'Device: Immediate in-brace correction: Optimized Brace', 'Device: Long-term bracing: Optimized Brace']}\n- {'label': 'Conventional Providence brace', 'type': 'ACTIVE_COMPARATOR', 'description': 'The braces will be designed by an orthotist using the conventional design method.', 'interventionNames': ['Device: Immediate in-brace correction: Conventional Brace', 'Device: Immediate in-brace correction: Optimized Brace', 'Device: Long-term bracing: Conventional Brace']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Immediate in-brace correction: Conventional Brace', 'description': \"The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic (supine position) and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.\", 'armGroupLabels': ['Conventional Providence brace', 'Optimized Providence brace']}\n- {'type': 'DEVICE', 'name': 'Immediate in-brace correction: Optimized Brace', 'description': \"The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic (supine position) and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.\", 'armGroupLabels': ['Conventional Providence brace', 'Optimized Providence brace']}\n- {'type': 'DEVICE', 'name': 'Long-term bracing: Conventional Brace', 'description': \"After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.\", 'armGroupLabels': ['Conventional Providence brace']}\n- {'type': 'DEVICE', 'name': 'Long-term bracing: Optimized Brace', 'description': \"After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.\", 'armGroupLabels': ['Optimized Providence brace']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Cobb angle', 'description': 'Radiographics will be gathered and analyzed to observe changes between time points. All out-of-brace radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.', 'timeFrame': 'Baseline, 1 year, 2 years'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level of 5%, power of 80%, allocation ratio of 1, estimated 15% participant loss", "answer": 58, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size was calculated to answer our primary hypothesis. The sample size was calculated with a significance level of 5%, a power of 80%, an allocation ratio of 1 and a non-inferiority margin of 5\u00c2\u00b0. With an estimated 15% of participants loss, the sample size calculated was 29 participants per group for a total of 58. Automatic scheduling of follow-up visits and reminders will be used to reduce participants loss.", "id": 1179, "split": "test"} +{"trial_id": "NCT05002049", "pmid": "37156575", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)\n\nIncluded conditions:\n- Healthy Lifestyle\n\nStudy Armgroups:\n- {'label': 'Citizen Science Behavioral Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention group (IG) participants will receive the whole citizen science intervention of the SEEDS project, and participants will be assessed at baseline and end-of-study.', 'interventionNames': ['Behavioral: Intervention Group']}\n- {'label': 'Control Group (No intervention)', 'type': 'NO_INTERVENTION', 'description': 'The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention Group', 'description': 'Teenagers with leadership skills from intervention schools (called ambassadors) and stakeholders will participate in focus groups to gain insights on the barriers and facilitators for healthy lifestyles of teenagers, and how science could help address these. Building on the information of the focus groups, ambassadors, stakeholders and other peers will participate in a collaborative competition event where the SEEDS intervention(s) will be designed. The intervention(s) will be implemented at intervention high-schools during 6 months. Outcomes in health behaviours and science literacy will be assessed by validated questionnaires at the start and end of the project.', 'armGroupLabels': ['Citizen Science Behavioral Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Physical activity', 'description': 'Change in physical activity assessed by validated questionnaire HBSC and Physical Activity Questionnaire for Children (PAQ-C).\\n\\nHBSC: days a week physically active for a total of at least 60 minutes, frequency of exercise in free time that participants get out of breath or sweat and means of transport to go to school.\\n\\nPAQ-C: 7-day recall questionnaire that assesses participation in different physical activities, as well as activity during Physical Education, lunch break, recess, after school, in the evenings and at weekends. Each of the 9 questionnaire items is scored between 1 (low) and 5 (high physical activity), and a mean score of all items constitutes the overall PAQ score.', 'timeFrame': 'Change from Baseline to end-of-study (6-month)'}\n- {'measure': 'Snacking choices', 'description': 'Change in healthy snacking choices (inside and outside school). This outcome will be assessed by validated questionnaires HBSC (times per week consume healthy and unhealthy snacking choices) and Beverage Frequency Questionnaire ( 7-day food record of beverages). Additionally, questions for assessing the frequency of consumption (times per week and time frame of the day) of each type of snack (chocolates, fruit and vegs, cakes or cookies and chocolates and sweets).', 'timeFrame': 'Change from Baseline to end-of-study (6-month)'}\n- {'measure': 'Sedentary time', 'description': 'Change in prolonged sedentary time. This outcome will be assessed by validated questionnaire HBSC (hours/day spend watching television/ playing computer games/ on computer for purposes other than playing).', 'timeFrame': 'Change from Baseline to end-of-study (6-month)'}\n- {'measure': 'Youth interest in life science', 'description': 'Changes in life science interest. This outcome will be measure by STEM interest survey.', 'timeFrame': 'Change from Baseline to end-of-study (6-month)'}\n- {'measure': 'Science capital perception and interest', 'description': 'Changes in science capital.This outcome will be measure by Science Capital Survey, developed by Archer et al. (2015): The selection of questions includes 4 components of the total Science Capital Survey: Future science job affinity (aspirations), utility of science qualifications, valuing science and scientists, and self-efficacy in science.', 'timeFrame': 'Change from Baseline to end-of-study (6-month)'}\n- {'measure': 'Youth interest in science technology engineering and math (STEM) career.', 'description': 'Changes in STEM career. This outcome will be measure by Attitude towards STEM questionnaire.', 'timeFrame': 'Change from Baseline to end-of-study (6-month)'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, at least 80% power, mean of 4.17 days a week, and SD of 2.07 days a week.", "answer": 720, "answer_type": "ACTUAL", "explanation": "Sample size\n A statistical power analysis, using the UCSF calculator,32 was performed for the estimation of sample size for an anticipated difference in outcomes between intervention and control group, considering clustering at the school level. With 12 schools as clusters in the intervention group and accepting a type I error of 0.05 and at least 80% power, 720 subjects (360 in each group) are required for achieving an effect size of 0.35 with an intraclass correlation coefficient of 0.06 in physical activity changes. According to Cohen, 0.35 is the middle term between a small (0.2) and a moderate effect (0.5).33 34 According to the HBSC study, the mean and SD used are 4.17 and 2.07 days a week, respectively.", "id": 1180, "split": "test"} +{"trial_id": "NCT05002413", "pmid": "36410804", "question": "Here is the design of a clinical trial:\n\nOfficial Title: NANO-RAST: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis\n\nIncluded conditions:\n- Bacteremia Sepsis\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Resistell AST', 'description': 'The Resistell AST is intended for rapid antibiotic susceptibility testing of most common clinically relevant Gram-negative bacteria causing bloodstream infections (BSI) (bacteremia). In the scope of this study, the Resistell Phenotech device will be used to test the susceptibility of Gram-negative bacteria, in particular Escherichia coli and Klebsiella pneumoniae to ceftriaxone and ciprofloxacin.', 'otherNames': ['Resistell Antibiotic Susceptibility Test']}\n\nPrimary Outcomes:\n- {'measure': 'Sensitivity of Resistell AST', 'description': 'The primary endpoint will be the sensitivity of the device in detecting antibiotic susceptibility in blood samples positive for Gram-negative bacteria.', 'timeFrame': 'Approximately 30 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, significance level of 0.05 (actual 0.0377), and an anticipated 20% inflation to account for withdrawals.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical methods\n Based on the preclinical validation, the Resistell AST is expected to be at least 95% accurate.\n To this aim, a total sample size of 240 (with anticipated 209 susceptible samples) achieves 90% power to detect a change in sensitivity from 0.97 of the \u00e2\u0080\u0098gold standard\u00e2\u0080\u0099 to 0.8 of Resistell AST using a two-sided binomial test, with target significance level at 0.05. The actual significance level achieved by the sensitivity test is 0.0377. About 87% of the PBCs analysed with Gram-negative bacteria at Lausanne University Hospital are susceptible to antibiotics. Therefore, the sample size was rounded to 300 to account for withdrawals, with an inflation of about 20%. The sample size was calculated using PASS 2019, V.19.0.5 (NCSS, Kaysville, Utah, USA).", "id": 1181, "split": "test"} +{"trial_id": "NCT05005117", "pmid": "38632602", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial\n\nIncluded conditions:\n- Laparoscopic Surgery\n- Colorectal Cancer\n- Colorectal Disorders\n- Emergencies\n- Complication of Surgical Procedure\n- Long-term Effects of Cancer Treatment\n\nStudy Armgroups:\n- {'label': 'Laparoscopic operation', 'type': 'EXPERIMENTAL', 'description': 'Laparoscopic emergency colon resection', 'interventionNames': ['Procedure: Laparoscopic operation']}\n- {'label': 'Open operation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Open emergency colon resection', 'interventionNames': ['Procedure: Open operation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic operation', 'description': 'Operation', 'armGroupLabels': ['Laparoscopic operation']}\n- {'type': 'PROCEDURE', 'name': 'Open operation', 'description': 'Operation', 'armGroupLabels': ['Open operation']}\n\nPrimary Outcomes:\n- {'measure': 'postoperative morbidity', 'description': 'Postoperative morbidity evaluated by Clavien-Dindo classification', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, and a 10% patient drop-out rate during the 30-day follow-up period", "answer": 192, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations will be based on previous studies, which report 48.3% 30-day postoperative morbidity after open surgery and 27.8% after laparoscopy [22]. The aim of the study is to show that postoperative morbidity is lower after laparoscopic surgery. Assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a (?) power\u00e2\u0080\u0089=\u00e2\u0080\u008980, 87 patients are needed for both groups. The effect size is 0.54. Assuming a 10% patient drop-out rate during the 30-day follow-up period, a total of 192 patients, i.e., 96 in each group, is needed.", "id": 1182, "split": "test"} +{"trial_id": "NCT05005897", "pmid": "37080624", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vitamin B12 Status in Infancy and the Effect of Providing Vitamin B12 to Infants With Signs of Suboptimal Vitamin B12 Status - a Registry-based, Randomized Controlled Trial\n\nIncluded conditions:\n- Vitamin B 12 Deficiency\n\nStudy Armgroups:\n- {'label': 'Screening - treatment', 'type': 'EXPERIMENTAL', 'description': 'From 6 weeks of age, infants will be screened for elevated plasma total homocysteine concentrations. Those who have a concentration above the defined cut-off will be treated with cobalamin (vitamin B12).', 'interventionNames': ['Biological: Cyanocobalamin']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control-group sample will be stored and analyzed when the child is 12 months old. Those with elevated tHcy will contribute to the control group.'}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Cyanocobalamin', 'description': 'Intramuscular injection of 400 \u00b5g cobalamin to children with elevated thcy at enrollment', 'armGroupLabels': ['Screening - treatment'], 'otherNames': ['Vitamin B12']}\n\nPrimary Outcomes:\n- {'measure': 'Neurodevelopment', 'description': 'Bayley Scales of Infant Development 4th edition', 'timeFrame': '12 months of age'}\n- {'measure': 'Prevalence of vitamin B12 deficiency', 'description': 'Number of children with elevated plasma homocysteine or low cobalamin', 'timeFrame': '1-3 months of age'}\n- {'measure': 'Prevalence of other vitamin deficiencies', 'description': 'Number of infants with vitamin deficiencies other than vitamin B12 deficiency', 'timeFrame': '1-3 months of age'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 0.05, a statistical power of 80%, and a follow-up rate of 85% are assumed. The calculations were performed using Stata V.16 with the 'power twomeans' command.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n We anticipate following 85% of the enrolled participants with signs of subclinical vitamin B12 deficiency until the main outcome is assessed at 1\u00e2\u0080\u0089year. For an effect size of 0.25 SD, results from 500 infants are required to achieve a statistical power of 80%. We will therefore target 600 infants (500/(1\u00e2\u0080\u00930.15)=588). Sample sizes or different scenarios for the various effects are shown in figure 2. The power to detect differences between the study groups are larger for larger effect sizes. In our estimations we assume a two-sided significance level of 0.05. The calculations were performed using Stata V.16 using the \u00e2\u0080\u0098power twomeans\u00e2\u0080\u0099 command.\n \n Figure 2\n \n Estimated required total sample sizes for the randomised controlled trial according to different standardised mean differences.\n \n \n \n In this study we will compare cognitive development assessed at 1\u00e2\u0080\u0089year, between infants with subclinical vitamin B12 deficiency at baseline treated with hydroxocobalamin (n=300) versus infants with untreated subclinical vitamin B12 deficiency (n=300).\n Previous studies from Norway have indicated that approximately 8% of infants have vitamin B12 deficiency, and 46\u00e2\u0080\u009379% have subclinical deficiency.6 35 36 We will use the same biomarker and cut-off to define subclinical vitamin B12 deficiency, but anticipate the proportion of infants may be different in our population-based sample. To reach the goal of including 600 infants with subclinical vitamin B12 deficiency, we have chosen to target 2400 infants. This will be sufficient even if only one-third of screened infants have signs of subclinical vitamin B12 deficiency (tHcy>6.5\u00e2\u0080\u0089\u00c2\u00b5mol/L).", "id": 1183, "split": "test"} +{"trial_id": "NCT05007132", "pmid": "35897060", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine/Tipiracil Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer: FIRE-8; AIO-KRK/YMO-0519\n\nIncluded conditions:\n- Metastatic Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Trifluridine/tipiracil, 35 mg/m\u00b2 body surface area (BSA), twice daily, orally on days 1-5 and 8-12 Panitumumab at 6 mg/kg bodyweight, intravenous infusion on days 1 and 15', 'interventionNames': ['Biological: Panitumumab 20 milligram/ML', 'Drug: Trifluridine/Tipiracil Hydrochloride']}\n- {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Trifluridine/tipiracil, 35 mg/m\u00b2 body surface area, twice daily, orally on days 1-5 and 8-12 Bevacizumab at 5 mg/kg bodyweight, intravenous infusion on days 1 and 15', 'interventionNames': ['Biological: Bevacizumab', 'Drug: Trifluridine/Tipiracil Hydrochloride']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Panitumumab 20 milligram/ML', 'description': 'Participants receive Panitumumab at 6mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.', 'armGroupLabels': ['Arm A']}\n- {'type': 'BIOLOGICAL', 'name': 'Bevacizumab', 'description': 'Participants receive bevacizumab at 5 mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.', 'armGroupLabels': ['Arm B']}\n- {'type': 'DRUG', 'name': 'Trifluridine/Tipiracil Hydrochloride', 'description': 'Participants receive Trifluridine/tipiracil at 35 mg/m\u00b2 BSA, twice daily, orally on days 1-5 and 8-12', 'armGroupLabels': ['Arm A', 'Arm B'], 'otherNames': ['Lonsurf']}\n\nPrimary Outcomes:\n- {'measure': 'Objective response rate', 'description': 'Objective response rate according to RECIST 1.1', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nA Fisher's exact test with a two-sided nominal significance level of 0.05 and at least 80% power. An estimated drop-out rate of 10% is considered.", "answer": 153, "answer_type": "ESTIMATED", "explanation": "Statistical Hypothesis and Sample Size Determination\n The primary endpoint will be tested to demonstrate superiority of initial treatment with trifluridine/tipiracil plus panitumumab (arm A) versus trifluridine/tipiracil plus bevacizumab (arm B). Patients are randomized in a 1:1 ratio into arm A and arm B.\n For arm B, an objective response rate of 30% is assumed based on previous studies [4, 6, 7]. For arm A, we hypothesize an improvement in the objective response rate of 25% leading to an estimated response rate of 55% based on the results of the PANDA trial [8]. This difference corresponds to an odds ratio of 2.85.\n A Fisher\u00e2\u0080\u0099s exact test with a two-sided nominal significance level of 0.05 will have at least 80% power to detect a significant difference when the sample size amounts to 138 patients. Given an estimated drop-out rate of 10% (i.e. patients who received no treatment within the study), 153 patients need to be enrolled.\n Secondary and exploratory endpoints will be analyzed in descriptive manner. All additional p-values will be estimated exploratorily without adjustment for the level of significance using two-sided test procedures. Demographic and prognostic baseline measures will be analyzed for heterogeneity between the two treatment arms.", "id": 1184, "split": "test"} +{"trial_id": "NCT05008042", "pmid": "36997252", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia: Single-blind Randomized Controlled Trial With Three-month Follow up\n\nIncluded conditions:\n- Fibromyalgia\n\nStudy Armgroups:\n- {'label': 'Mecobalamine 5 mg/ml', 'type': 'ACTIVE_COMPARATOR', 'description': 'The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly.', 'interventionNames': ['Drug: Mecobalamin 5 MG']}\n- {'label': 'NaCl 9mg/ml', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly.', 'interventionNames': ['Other: Placebo Comparator : NaCl 9 mg/ml']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mecobalamin 5 MG', 'description': 'The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly', 'armGroupLabels': ['Mecobalamine 5 mg/ml']}\n- {'type': 'OTHER', 'name': 'Placebo Comparator : NaCl 9 mg/ml', 'description': 'Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.', 'armGroupLabels': ['NaCl 9mg/ml']}\n\nPrimary Outcomes:\n- {'measure': 'Tolerance time', 'description': 'Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided t-test for two independent groups with a power of 80% and a 5% significance level was used. To compensate for any loss, the sample size was increased.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n In order to obtain an adequate sample size, a power analysis was performed based on results from a previously published study29 in which women with fibromyalgia underwent the same stimulation procedure with the cold pressor test. Account is taken here of the SD shown and compensation for any placebo effects. Based on these results, the expected effect difference is estimated at 20\u00e2\u0080\u0089s with an SD of 20\u00e2\u0080\u0089s between the two groups after 12 weeks of treatment with mecobalamin (vitamin B12)/placebo. Using a two-sided t-test for two independent groups with a power of 80% and 5% significance level, it was calculated that each group would consist of 16 participants. In order to compensate for any loss, 20 participants per group are therefore included. The study continues until 40 participants have been included and have completed the study.", "id": 1185, "split": "test"} +{"trial_id": "NCT05009394", "pmid": "37131180", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Surgical Treatments for Postamputation Pain\n\nIncluded conditions:\n- Residual Limb Pain\n- Amputation Neuroma\n- Phantom Limb Pain\n- Pain, Neuropathic\n- Pain, Nerve\n\nStudy Armgroups:\n- {'label': 'Targeted Muscle Reinnervation (TMR)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The surgical procedure comprises three steps: preparation of the donor nerve, identification of a motor branch to the targeted muscle, and nerve coaptation. To prepare the donor nerve, the surgeon will identify the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Next, the surgeon will identify a motor branch to a nearby target muscle and will confirm muscle contraction using a hand-held nerve stimulator. The motor branch to the target muscle will be transected as close as possible to its entry point without tension. In the final step, the previous nerve stump from which the neuroma was resected will be transferred and coapted to the newly severed motor branch that innervates the target muscle and secured by 2-3 non-resorbable monofilament sutures. The surgery time is approximately 2-3 hours and it takes place in the hospital.', 'interventionNames': ['Procedure: Targeted Muscle Reinnervation (TMR)']}\n- {'label': 'Regenerative Peripheral Nerve Interface (RPNI)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The RPNI procedure involves construction of a residual peripheral nerve split into several nerve fascicles and implanted into free skeletal muscle grafts. First, the surgeon identifies the nerve with a painful neuroma and resect the neuroma up to healthy fascicles. Then, a longitudinal intraneural dissection will be performed exposing its fascicles. Next, autologous muscle grafts will be harvested from a healthy donor site, and the dissected nerve stumps will be placed parallel to the muscle fibers. The nerve stump will be secured to the muscle graft, thereafter the graft will be wrapped around the nerve stump and anchored in the folded graft, thus creating an RPNI. This will be repeated for each fascicle obtained from splitting the transected nerve. Lastly, the RPNIs will be placed in a protected area. The surgery time is approximately 2-3 hours and it takes place in the hospital.', 'interventionNames': ['Procedure: Regenerative Peripheral Nerve Interface (RPNI)']}\n- {'label': 'Standard neuroma treatment, neuroma excision, and muscle burying', 'type': 'ACTIVE_COMPARATOR', 'description': 'The standard neuroma treatment, also called neuroma transposition, includes excision of the terminal neuroma and burying the nerve into an adjacent deep muscle.The standard neuroma treatment entails the excision of the terminal neuroma and then implanting the nerve into an adjacent muscle. Firstly, the surgeon will identify the nerve with a painful neuroma and thereafter resect the neuroma up to healthy fascicles. Next, the surgeon will identify a nearby muscle which is not involved in joint motion and has limited output opportunities for the nerve. The nerve will then be channeled at least 1 cm inside the muscle without applying any tension to it and secured by 1-2 non-resorbable monofilament sutures. The identified nerve with the painful neuroma will not be treated with any additional therapy than the resection (e.g., diathermy, pharmacotherapy, crushing, etc.). The surgery time is approximately 1-2 hours and it takes place in the hospital.', 'interventionNames': ['Procedure: Standard neuroma treatment, neuroma excision, and muscle burying']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Targeted Muscle Reinnervation (TMR)', 'description': 'Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.', 'armGroupLabels': ['Targeted Muscle Reinnervation (TMR)']}\n- {'type': 'PROCEDURE', 'name': 'Regenerative Peripheral Nerve Interface (RPNI)', 'description': 'Surgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.', 'armGroupLabels': ['Regenerative Peripheral Nerve Interface (RPNI)']}\n- {'type': 'PROCEDURE', 'name': 'Standard neuroma treatment, neuroma excision, and muscle burying', 'description': 'Surgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.', 'armGroupLabels': ['Standard neuroma treatment, neuroma excision, and muscle burying']}\n\nPrimary Outcomes:\n- {'measure': 'Residual limb pain intensity', 'description': 'Difference in residual limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.', 'timeFrame': 'Baseline to 12-month post-surgery'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 10% dropout rate.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation is based on previous studies investigating the surgical treatments for neuroma pain [12, 13] and based on the limited number of available participants. To receive a minimum power of 80% from a Fisher\u00e2\u0080\u0099s non-parametric permutation test assuming a standard deviation of TMR and RPNI to be 2.2 and 3.3 for control [12] with a mean difference of 2.0 and at 5% significant level between the randomised groups in an allocation ratio of 2:1 (TMR and RPNI vs control), it is estimated that at least 84 (n\u00e2\u0080\u0089=\u00e2\u0080\u008928 per group) participants are required. With the same assumptions, but instead looking at one reconstruction technique compared to control in a ratio of 1:1 (TMR vs control, RPNI vs control), 99 participants (n\u00e2\u0080\u0089=\u00e2\u0080\u008933 per group) are needed to reach minimum power of 80% with a Fisher\u00e2\u0080\u0099s non-parametric permutation test with a mean difference of 2 NRS and at 5% significant level. The drop-out rate is expected to be around 10%; therefore, a total of 110 participants will be aimed to be randomised.", "id": 1186, "split": "test"} +{"trial_id": "NCT05009459", "pmid": "35428627", "question": "Here is the design of a clinical trial:\n\nOfficial Title: eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain Participating in Swedish Interdisciplinary Pain Rehabilitation Programs: a Registry-based Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)', 'type': 'EXPERIMENTAL', 'description': 'Participant takes part of the unit\u00b4s program with an addition of eVIS. eVIS consists of objectively measured physical activity tracking using a wrist-worn activity tracker (Fitbit Versa 2) is combined with a daily activity goal (steps/day) and daily patient reports of known important clinical outcome assessments: pain intensity and its affect on daily activities and pharmaceutical consumption. Data is collected and visualized in a purpose-developed web application, Pin And TRaining ON-line (PATRON), which can be used by the patient and the IPRP-team to follow and adjust individual physical activity levels.', 'interventionNames': ['Behavioral: eVIS']}\n- {'label': 'Treatment as usual (interdisciplinary pain rehabilitation program)', 'type': 'NO_INTERVENTION', 'description': 'Participant takes part of the unit\u00b4s program with an addition of daily self-report of pain intensity (0-10), affect of pain on daily activities (0-10), and pharmacological consumption.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'eVIS', 'description': 'To facilitate individualized physical activity levels within the Swedish IPRP setting, an eVISualisation (eVIS) of physical activity and pain intervention has been systematically developed. eVIS is designed to target facilitating mechanisms for behavior change, such as outcome expectations, self-monitoring, self-evaluation, and self-efficacy, which are theoretically framed by the Social Cognitive Theory by Bandura. In eVIS, objectively measured physical activity tracking using a wrist-worn activity tracker (Fitbit Versa 2) is combined with a daily activity goal (steps/day) and daily patient reports of known important clinical outcome assessments: pain intensity and its affect on daily activities30-34 and pharmaceutical consumption. Data is collected and visualized in a purpose-developed web application, Pin And TRaining ON-line (PATRON), which can be used by the patient and the IPRP-team to follow and adjust individual physical activity levels.', 'armGroupLabels': ['eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)']}\n\nPrimary Outcomes:\n- {'measure': 'Physical health', 'description': 'Physical health domain by RAND-36, ranging from 0 to 100, with high values indicating good health.', 'timeFrame': '12 months follow up after IPRP'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level is set to 0.05 (two-tailed), power is 80%, and a dropout rate of 20% is allowed.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size for the pilot study of at least n=30 is considered sufficient for planned feasibility analyses since it will not involve hypothesis testing and sample size calculation per se.43 66 67 For the main trial, a preliminary power calculation is based on assumptions from previous research reporting on proportions of patients who report a clinically meaningful difference of \u00e2\u0089\u00a53 points in the physical health domain in RAND-36, 12\u00e2\u0080\u0089months after completed IPRP.25 The calculation was performed in R, using a calculation method for simple randomisation and for independent observations. The preliminary power calculation allows a dropout rate of 20% and requires a total sample size of approximately n=400\u00e2\u0080\u0089to have an 80% power to detect a 15% difference (\u00e2\u0089\u00a53\u00e2\u0080\u0089p) between the groups in the outcome physical health. Physical health is measured by the RAND-36 health survey at the 12-month follow-up measurement point after the completion of the IPRP. The significance level is set to 0.05 and is two tailed. The sample size calculation may be recalculated after the pilot study is completed. In this trial, the null hypothesis is that there will be no difference between the intervention group and the control group (<15% with \u00e2\u0089\u00a53 points improvement) with regards to proportional improvement in the PCS domain of RAND-36 health survey when assessed at the 12-month follow-up after the completion of the IPRP.", "id": 1187, "split": "test"} +{"trial_id": "NCT05009979", "pmid": "36367894", "question": "Here is the design of a clinical trial:\n\nOfficial Title: 18F-DCFPyL PET/CT in Hepatocellular Carcinoma\n\nIncluded conditions:\n- Hepatocellular Carcinoma\n\nStudy Armgroups:\n- {'label': '1/Baseline and Post-treatment Imaging', 'type': 'EXPERIMENTAL', 'description': '18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment', 'interventionNames': ['Drug: F18-FDG', 'Device: MRI', 'Device: CT', 'Drug: F18-DCFPyL']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'F18-FDG', 'description': 'Within approximately 2 weeks of each 18F-DCFPyL PET/CT scan, participants will be scanned with a 18F-FDG PET/CT imaging at the NIH Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their FDG metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.', 'armGroupLabels': ['1/Baseline and Post-treatment Imaging']}\n- {'type': 'DEVICE', 'name': 'MRI', 'description': 'A standard of care CT and/or MRI will be performed within 2 months of each 18F-DCFPyL PET/CT.', 'armGroupLabels': ['1/Baseline and Post-treatment Imaging']}\n- {'type': 'DEVICE', 'name': 'CT', 'description': 'A standard of care CT and/or MRI will be performed within 2 months of each 18F-DCFPyL PET/CT.', 'armGroupLabels': ['1/Baseline and Post-treatment Imaging']}\n- {'type': 'DRUG', 'name': 'F18-DCFPyL', 'description': 'Each subject will receive a single IV dose of 18F-DCFPyL by bolus injection at a rate of approximately 1 ml/3-5 sec. The maximum amount of injected active drug will be less than 4.02 microgram. The target administered activity will be 9 mCi. The 18F-DCFPyL PET/CT imaging will consist of the 18F-DCFPyL injection, followed by a approximately 45 min dynamic CT imaging of a single bed position (including the liver lesion), and a static whole-body PET/CT imaging (top of head to mid-thighs) performed at 1 hour (+/- 10 minutes) post 18F-DCFPyL injection. Only a single injection of 18F-DCFPyL is required. The initial 45 minutes dynamic regional scan will be used to determine the kinetics of 18F-DCFPyL within the tumor as compared with normal liver and other background.', 'armGroupLabels': ['1/Baseline and Post-treatment Imaging']}\n\nPrimary Outcomes:\n- {'measure': 'Positive predictive value', 'description': 'The point estimates and 95% confidence intervals of the positive predictive value of 18F-DCFPyL PET/CT will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation.', 'timeFrame': 'Baseline, post ablation, disease progression'}\n\nPlease estimate the sample size based on the assumption: \nThe limits of the 95% confidence interval to the true lesion level positive predicted value are less than 15%. The confidence interval distance from the positive predictive value to the limits is 0.148.", "answer": 7, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size was calculated such that the limits of the 95% expected confidence interval to the true lesion level positive predicted value is less than 15%. The lesion level positive predictive value is the proportion of biopsy positive lesions. Assume 80% of the participants enrolled to the study each have 1\u00e2\u0080\u00932 lesions identified by 18F-DCFPyL-PET/CT with 0.2 modest inter-lesion correlation, and the positive predictive value is 70%. A sample size of 40 evaluable participants accrued to the study produces a two-sided 95% confidence interval with the distance from the positive predictive value to the limits equal to 0.148. An evaluable participant is defined as a participant who completes all required study procedures. To account for non-evaluable participants, the accrual ceiling will be set to 50.", "id": 1188, "split": "test"} +{"trial_id": "NCT05010148", "pmid": "35667730", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial\n\nIncluded conditions:\n- Postoperative Delirium\n- Postoperative Pain\n- Spinal Fusion\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will be administered D5 water intravenously at the same infusion rate (ml/hr) as the intervention group for 48 hours after major spinal surgery.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Intervention-Intravenous Lidocaine Infusion', 'type': 'EXPERIMENTAL', 'description': 'Will be administered intravenous lidocaine at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery.', 'interventionNames': ['Drug: Lidocaine IV']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lidocaine IV', 'description': 'Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery', 'armGroupLabels': ['Intervention-Intravenous Lidocaine Infusion'], 'otherNames': ['Lidocaine, xylocaine']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo, D5 water']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Postoperative Delirium', 'description': 'Confusion Assessment Method (CAM) will be performed once daily using a structured interview to assess for delirium incidence. Delirium cases will be validated by a second investigator. Investigators will collect preoperative and surgery related variables that may be associated with delirium.', 'timeFrame': 'From 24 hours after start of lidocaine infusion to 3 days after surgery.'}\n\nPlease estimate the sample size based on the assumption: \nIncidence of postoperative delirium is 28% in elderly spine surgery patients, 80% power, 2-sided alpha error set at 0.05, and a dropout rate of 5%.", "answer": 278, "answer_type": "ESTIMATED", "explanation": "Sample size\n There is little direct evidence about the effect of a lidocaine infusion on the incidence of postoperative delirium. There are data on other opioid sparing adjuncts that show a reduction of approximately 50% in the incidence of postoperative delirium.45 Based on our prior work showing an incidence of postoperative delirium of 28% in elderly spine surgery patients, a sample size of 132 patient/group (264 in total) will provide an 80% power to detect a significant effect on postoperative delirium (with 2-sided alpha error set at 0.05).9 Because we do not randomise patients until they are in surgery, we assume a very low dropout rate of 5% and so we need to enrol 139 patients per group (or 278 total).", "id": 1189, "split": "test"} +{"trial_id": "NCT05010733", "pmid": "34967362", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SPECT-CT Metabolic and Morphological Study of Two Types of Cemented Hip Stem Protheses in Primary Total Hip Arthroplasty Patients: A Randomized Controlled Clinical Trial (SPECT-PROTMA)\n\nIncluded conditions:\n- Arthropathy of Hip\n\nStudy Armgroups:\n- {'label': 'Thick-Layer Technique', 'type': 'EXPERIMENTAL', 'description': 'Total hip arthroplasty using the Exeter V40 cemented femoral stem \\\\[Stryker Orthopaedics, Mahwah, New Jersey\\\\].', 'interventionNames': ['Device: Total hip arthroplasty using the Exeter V40 cemented femoral stem']}\n- {'label': 'Thin-Layer Technique (French Paradox)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Total hip arthroplasty using the M\u00fcller Straight Stem \\\\[Zimmer, Winterthur, Switzerland\\\\].', 'interventionNames': ['Device: Total hip arthroplasty using the M\u00fcller Straight Stem']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Total hip arthroplasty using the Exeter V40 cemented femoral stem', 'description': \"Consists of applying a cement layer of at least 2 millimeters surrounding an undersized prosthetic stem, so that this layer of cement fits between the femoral medullary canal and the prosthetic's femoral stem.\", 'armGroupLabels': ['Thick-Layer Technique'], 'otherNames': ['Total hip arthroplasty using the Thick-Layer Technique']}\n- {'type': 'DEVICE', 'name': 'Total hip arthroplasty using the M\u00fcller Straight Stem', 'description': \"Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.\", 'armGroupLabels': ['Thin-Layer Technique (French Paradox)'], 'otherNames': ['Total hip arthroplasty using the Thin-Layer Technique (French Paradox)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of counts per image set in the SPECT study', 'description': 'Counts per image: unit of measure defined as the number of photons captured by the gamma camera, which represent the radiopharmaceutical uptake', 'timeFrame': '24 months after surgery'}\n- {'measure': 'Alignment angles in the plain radiography and in the CT scan study.', 'timeFrame': '24 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size calculation was performed. The study is exploratory in nature.", "answer": 16, "answer_type": "ESTIMATED", "explanation": "2.8\n Sample size\n This pilot clinical trial is an exploratory study by nature. To our knowledge, there are no studies comparing bone metabolism evolution in the postoperative period of these 2 types of femoral stem prostheses with SPECT-CT. We have not proceeded to a formal sample size calculation. A total of 16 patients will be randomized (8 by group) in this clinical trial. This sample size is feasible and achievable with the available budget.", "id": 1190, "split": "test"} +{"trial_id": "NCT05011149", "pmid": "39053961", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Selective Early Medical Treatment of the Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Patent Ductus Arteriosus After Premature Birth\n\nStudy Armgroups:\n- {'label': 'Selective early medical treatment (SMART) strategy', 'type': 'EXPERIMENTAL', 'description': 'Infants who are randomized to experimental group will follow the SMART treatment protocol, which includes echocardiographic screening every 72 hours to categorize PDA disease severity by combining clinical and echocardiographic features. At any evaluation if patients are found to have a \"severe PDA\" on echocardiography, irrespective of clinical symptoms, or a \"moderate PDA\" on echocardiography with at least moderate clinical illness, they will receive pharmacotherapy aimed at PDA closure (The PDA severity has been divided into mild, moderate or severe based on pre-defined clinical and echocardiographic criteria).', 'interventionNames': ['Drug: Ibuprofen']}\n- {'label': 'Early conservative management strategy', 'type': 'NO_INTERVENTION', 'description': 'Infants randomized to this arm will not undergo any further echocardiographic assessment or pharmacological treatment of the PDA regardless of the clinical signs. If the infant gets an echocardiographic assessment for a reason different than PDA assessment (such as hypotension or oxygenation failure) and a PDA is incidentally noted that fits the treatment criteria, the infant will not be initiated on pharmacotherapy. After 7 days of age, decision on PDA assessment and treatment will be at the discretion of the treating physician.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ibuprofen', 'description': 'Pharmacotherapy, when indicated (ie, for \"severe PDA\" on echocardiography, irrespective of clinical symptoms, or a \"moderate PDA\" on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg/kg followed by 2 doses of 5mg/kg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.\\n\\nFor treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent.', 'armGroupLabels': ['Selective early medical treatment (SMART) strategy']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of eligible infants recruited during the study period', 'timeFrame': '7 days postnatal age'}\n- {'measure': 'Proportion of randomized infants with no reported protocol deviations', 'timeFrame': '7 days postnatal age'}\n\nPlease estimate the sample size based on the assumption: \nThe pilot RCT will be deemed 'definitely feasible' if more than 60% of eligible infants are recruited and protocol adherence is demonstrated in more than 75% of randomised infants. It will be deemed 'may be feasible' if 40-60% of eligible infants are recruited and protocol adherence is demonstrated in 65-75% of randomised infants.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size for pilot trial\n Being a pilot study, the desired sample size was based on the sample required to reliably demonstrate feasibility. The criteria for success of the pilot study (feasibility measures) are defined in table 3.\n \n Table 3\n \n Criteria for considering feasibility\n \n \n \n \n Primary feasibility outcomes\n Success criteria\n \n \n Definitely feasible\n May be feasibility\n \n \n \n \n Proportion of eligible infants enrolled for the study\n >60%\n 40\u00e2\u0080\u009360%\n \n \n Proportion of randomised infants with no reported protocol deviations\n >75%\n 65\u00e2\u0080\u009375%\n \n \n \n \n Assuming a 70% recruitment of eligible infants and assuming a CI of 10% around this estimate to be acceptable,31 the required sample size to demonstrate feasibility (ie, the lower bound of CI >60%) will be at least 100 infants. Similarly, assuming an 85% protocol adherence of randomised infants, to demonstrate protocol adherence feasibility (ie, the lower bound of CI >75%), a minimum of 77 infants will be required. Therefore, success of the feasibility study can be reliably demonstrated with a total sample size of 100 randomised infants.\n Based on the consensus of the trial steering committee, the pilot RCT will be deemed \u00e2\u0080\u0098definitely feasible\u00e2\u0080\u0099 if we are able to recruit more than 60% of eligible infants during the study period and protocol adherence is demonstrated in more than 75% of randomised infants (table 3). The pilot RCT will be deemed \u00e2\u0080\u0098may be feasible\u00e2\u0080\u0099 if we are able to recruit 40\u00e2\u0080\u009360% of eligible infants during the study period and protocol adherence is demonstrated in 65\u00e2\u0080\u009375% of randomised infants. If the pilot RCT is deemed \u00e2\u0080\u0098definitely feasible\u00e2\u0080\u0099 or \u00e2\u0080\u0098may be feasible\u00e2\u0080\u0099 and no further protocol changes are mandated by the trial steering committee, all 100 participants may be rolled-over into the full-scale SMART-PDA trial. If a decision is made by the steering committee to modify the trial protocol in any form for the full-scale SMART-PDA trial, then data from the SMART-PDA pilot trial will be analysed as a separate standalone trial.", "id": 1191, "split": "test"} +{"trial_id": "NCT05011721", "pmid": "35509030", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Intervention with activity tracker', 'type': 'EXPERIMENTAL', 'description': 'Women allocated to the intervention arm will used an activity tracker', 'interventionNames': ['Device: Activity tracker']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Activity tracker', 'description': 'Participants will receive a Withings Steel HR activity tracker (Withings, Issy-les-Moulineaux, France), which they will be asked to wear 24 hours per day throughout the whole intervention (12 months). At baseline, the Withings Health Mate mobile phone application will be downloaded onto each participant\\'s smartphone or tablet. The clinical research assistant will instruct the participant in the use of the activity tracker. The participant will then accept and activate the sharing of the data collected with the secure server dedicated to the \"NeoFit\" study at the Institut Curie. Participants will be asked to synchronize the activity tracker regularly (ideally daily) via Bluetooth with the Withings Health Mate application, for automatic transfer of the data to the secure \"NeoFit\" space.', 'armGroupLabels': ['Intervention with activity tracker']}\n\nPrimary Outcomes:\n- {'measure': 'Describe physical activity profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy', 'description': 'The activity tracker will register step counts for each day. the investigators will plot the average daily step counts and the 95% confidence interval across the entire study period. Then will will study the change in step count trajectory during the study. Linear mixed model will be used for describing change over time', 'timeFrame': 'Month 12'}\n- {'measure': 'Describe heart rate profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy', 'description': 'The activity tracker will register heart rate at 10-minute intervals for each day. The investigators will plot the average heart rate frequency and the 95% confidence interval across the entire study period. Then will will study the change in heart rate frequency trajectory during the study. Linear mixed model will be used for describing change over time', 'timeFrame': 'Month 12'}\n- {'measure': 'Describe sleep profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy', 'description': 'The activity tracker will register sleep duration for each day. The investigators will plot the average sleep duration and the 95% confidence interval across the entire study period. Then will tudy the change in sleep duration trajectory during the study. Linear mixed model will be used for describing change over time', 'timeFrame': 'Month 12'}\n- {'measure': 'Identify digital profiles (physical activity, heart rate, sleep) in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy', 'description': 'To identify digital profiles, The investigators will combine step counts profiles, heart frequency profiles and sleep profiles using mixed models with latent classes. The use of a mixed model will make it possible to analyze repeat data for the population, and to determine an average profile or trajectory for the whole population. The optimal number of classes will be determined a posteriori, based on a set of statistical and clinical criteria. The most widely used statistical criterion is the \"Bayesian information criterion\" (BIC), which penalizes the model\\'s likelihood according to its complexity. The BIC, which is stricter than many other criteria, has been shown to have a better performance in simulations. The number of trajectories will also be based on clinical interpretation (whether it is worthwhile retaining classes containing very small numbers of subjects, etc.).', 'timeFrame': 'Month 12'}\n\nPlease estimate the sample size based on the assumption: \nThe model validation will use a training sample of 150 and a validation sample of 100. The accuracy for 150 subjects is about 8%. A 10% dropout rate is hypothesized.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size\n As the main objective of the study is descriptive, there is no need to define a minimum number of subjects. For model validation, we will divide our population into two groups: i) a training sample (n\u00e2\u0080\u0089=\u00e2\u0080\u0089150) and ii) a validation sample (n\u00e2\u0080\u0089=\u00e2\u0080\u0089100). The accuracy of the model for 150 subjects will therefore be about 8%.\\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}$$CI=2\\times \\surd \\frac{p\\times q}{n}$$\\end{document}CI=2\u00c3\u0097\u00e2\u0088\u009ap\u00c3\u0097qn\n We hypothesize that 10% of the participants may be lost to follow-up. In the context of this study, that would mean not completing the questionnaires despite reminders, or not wearing the activity trackers. The inclusion of 300 participants is therefore expected to result in the collection of at least 250 completed questionnaires and 250 activity tracker datasets.", "id": 1192, "split": "test"} +{"trial_id": "NCT05011838", "pmid": "36002215", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'A multi-component intervention to improve hypertension care and control', 'type': 'EXPERIMENTAL', 'description': 'The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.', 'interventionNames': ['Other: 1. Health Services Redesign', 'Other: 2. Clinical Staff Training', 'Other: 3. Patient and Community Engagement']}\n- {'label': 'Routine Care', 'type': 'NO_INTERVENTION', 'description': 'The Commune 6 was selected as control area, where routine care will be delivered.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': '1. Health Services Redesign', 'description': '1.1. Healthy Hearts service: a nursing station providing blood pressure measurement, cardiovascular risk assessment, preventive counselling and effective follow-up in extended opening hours.\\n\\n1.2. Hypertension screening: All adults attending health care facilities who did not have their blood pressure measured in the previous year will be referred to the Healthy Hearts Service for screening.\\n\\n1.3. Clinical management: 1.3.1. Creation of the cardiovascular risk team: a group of doctors supervising hypertension management and coordinating improvement.\\n\\n1.3.2. Guideline-based standardized diagnostic and treatment protocols: a simplified diagnostic and treatment algorithm will identify a core set of primary and secondary antihypertensive medications.\\n\\n1.3.3. Availability of antihypertensive medications: it will be assured through procurement mechanisms and its availability will be communicated to clinicians at the beginning of each week and ad hoc in case of stock-outs.', 'armGroupLabels': ['A multi-component intervention to improve hypertension care and control']}\n- {'type': 'OTHER', 'name': '2. Clinical Staff Training', 'description': '2.1. Training on good clinical management of hypertension: focused on correct blood pressure measurement, use of evidence-based guidelines, cardiovascular risk assessment, use of a standardized diagnostic and treatment algorithm, correct prescription of pharmacological and non-pharmacological treatment, patient counselling, and how to tackle clinical inertia.\\n\\n2.2. Training on communication skills and patients\\' needs assessment for all health workers involved in hypertension care. This training will be designed under the \"patient-centred medicine\" framework, aiming at equipping health providers with tools for understanding patients\\' feelings and experience of illness, and to improve their capacity to address social, psychological, and behavioural dimensions of hypertension care.', 'armGroupLabels': ['A multi-component intervention to improve hypertension care and control']}\n- {'type': 'OTHER', 'name': '3. Patient and Community Engagement', 'description': '3.1. Patient empowerment: \"expert hypertensive patients\" , under the supervision of a social worker, will provide support and transmit their know-how to other patients in need, particularly those newly diagnosed or non-adherent to treatment or presenting uncontrolled hypertension.\\n\\n3.2. Community engagement: a Community Hypertension Outreach Group will be set up, composed of existing voluntary community health workers, who will be trained and certified. This group will conduct blood pressure measurements in selected public areas of the commune, referring those with positive screening to the nearest health facility for diagnosis confirmation. It will also provide health information with emphasis on healthy lifestyles. Existing local communication channels such as the community radio and the local newspaper will be engaged.', 'armGroupLabels': ['A multi-component intervention to improve hypertension care and control']}\n\nPrimary Outcomes:\n- {'measure': 'Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.', 'description': 'Uncontrolled hypertension: an average blood pressure measurement higher than 140/90 mmHg for aware hypertensive patients between 35 and 59 years old or for diabetic patients regardless of age, and higher than 150/90 mmHg for aware hypertensive patients aged 60 years or older.', 'timeFrame': 'through the population survey completion, up to 2 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 95% confidence level, 10% non-response rate, and a design effect of 1.25.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size and sampling procedures for the surveys\n Expecting at baseline 60% non-control in the 35 years or older hypertensive population and at endline 10% difference in difference (baseline minus endline) between the intervention and control arms, a sample of 385 hypertensive individuals per arm is required for 80% power and a 95% confidence level. Given a 45% prevalence of hypertension in individuals aged 35 years or older, screening 856 individuals will allow finding the needed number of hypertensive individuals. We will increase the number screened to 1190 individuals, assuming 10% non-response and, based on previous observations, a design effect of 1.25 for our sampling scheme.\n A cluster sample will be drawn from a sampling frame consisting of the addresses of all premises provided by the municipality and using maps of Medellin detailing house blocks. Given an average of 1.5 individuals \u00e2\u0089\u00a535 years old per household, 795 households will be sampled per study arm by selecting 53 clusters of 15 households from the different neighbourhoods of the communes, with an allocation of the number of clusters proportional to neighbourhood size. A group of trained interviewers will make up to two repeat door-to-door visits to every selected household to include all identified eligible household members aged 35 years or older in the surveys.", "id": 1193, "split": "test"} +{"trial_id": "NCT05015283", "pmid": "36175102", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission (ORDER): a Multi-centric, Randomized, Open-label, Superiority Trial\n\nIncluded conditions:\n- Type2 Diabetes\n- Complication of Bariatric Procedure\n\nStudy Armgroups:\n- {'label': 'Laparoscopic One-anastomosis gastric bypass', 'type': 'EXPERIMENTAL', 'description': 'In this group, the bariatric procedure is laparoscopic one-anastomosis gastric bypass, all operations follow the same standard operating procedure.', 'interventionNames': ['Procedure: The laparoscopic One-anastomosis gastric bypass will consist of:']}\n- {'label': 'Laparoscopic Roux-en-Y gastric bypass', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this group, the bariatric procedure is laparoscopic Roux-en-Y gastric bypass, all operations follow the same standard operating procedure.', 'interventionNames': ['Procedure: The laparoscopic Roux-en-Y gastric bypass will consist of:']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'The laparoscopic One-anastomosis gastric bypass will consist of:', 'description': 'gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \\\\< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 200cm, food branches 100cm exact relationship with mesangial defect', 'armGroupLabels': ['Laparoscopic One-anastomosis gastric bypass']}\n- {'type': 'PROCEDURE', 'name': 'The laparoscopic Roux-en-Y gastric bypass will consist of:', 'description': 'the laparoscopic Roux-en-Y gastric bypass gastric sac size \\\\< 30ml gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \\\\< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 50cm, food branches 150cm exact relationship with mesangial defect', 'armGroupLabels': ['Laparoscopic Roux-en-Y gastric bypass']}\n\nPrimary Outcomes:\n- {'measure': 'One year after operation, the complete remission rate of type 2 diabetes mellitus [HbA1c < 6%, fasting plasma glucose < 5.6 mmol/L, no need to use any hypoglycemic drugs]', 'description': 'Complete remission of type 2 diabetes mellitus: the blood sugar HbA1c\\\\<6.0% and fasting plasma glucose\\\\< 5.6 mmol/L can be controlled only by changing lifestyle intervention without taking hypoglycemic agents after operation. Partial remission: blood glucose can be controlled only by changing lifestyle intervention after operation. HbA1c\\\\<6.5%, fasting plasma glucose 5.6\\\\~6.9mmol/L, and blood glucose 7.8\\\\~11.0mmol/L 2 hours after meal. Failure: blood sugar was relieved once, and then returned to the preoperative level.Unified OGTT measurement method', 'timeFrame': '1 year after surgery'}\n\nPlease estimate the sample size based on the assumption: \n20% loss to follow-up, 5% exclusion due to unpredictable factors, statistical power of 80%, and significance level (\u03b1) of 5%.", "answer": 248, "answer_type": "ESTIMATED", "explanation": "Sample size\n The Power Analysis and Sample Size software (PASS, V.15.0 by NCSS, LLC. Kaysville, Utah, USA) was used for sample size calculation, which was based on the estimate of the complete remission rate as reported by high-quality RCT studies9 17 and preliminary clinical results from the Greater China Metabolic and Bariatric Surgery Database (GC-MBD), which is a national bariatric database in China. Considering mean complete diabetes remission rates of 37.5% and 60% in the RYGB and OAGB groups at 1\u00e2\u0080\u0089year, respectively, we hypothesised that OAGB would be superior to RYGB if the difference of complete remission rate was significantly superior to the margin of 5%. We assumed a 20% loss to follow-up and another 5% exclusion due to other unpredictable factors, such as pregnancy, consent withdrawal; thus, 124 patients per group (248 in total) were required to conclude OAGB superiority with a statistical power of 80% and an \u00ce\u00b1 of 5%.", "id": 1194, "split": "test"} +{"trial_id": "NCT05015335", "pmid": "36600374", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy and Safety of Adalimumab for Inflammatory Flare Prevention in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage Compared With Methotrexate, a RCT Study\n\nIncluded conditions:\n- Uveitis, Anterior\n- Adalimumab\n\nStudy Armgroups:\n- {'label': 'Adalimumab', 'type': 'EXPERIMENTAL', 'description': 'Adalimumab administered subcutaneously at 40mg every 2 weeks', 'interventionNames': ['Drug: Adalimumab']}\n- {'label': 'Methotrexate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Methotrexate given 10mg orally once a week.', 'interventionNames': ['Drug: Methotrexate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Adalimumab', 'description': 'ADA 40mg q2w', 'armGroupLabels': ['Adalimumab'], 'otherNames': ['ADA']}\n- {'type': 'DRUG', 'name': 'Methotrexate', 'description': 'MTX 10mg qw', 'armGroupLabels': ['Methotrexate'], 'otherNames': ['MTX']}\n\nPrimary Outcomes:\n- {'measure': 'Uveitis flare', 'description': 'Uveitis flare is defined as anterior chamber cell count grading increased from 0 to 1.\\n\\nThe grading method is in accordance with SUN criteria. Anterior chamber cell count was scored according to Standardization of Uveitis Nomenclature (SUN) criteria', 'timeFrame': \"At 6 months' follow-up visit\"}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 1:1 randomisation, and a lost to follow-up rate of 5%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The null hypothesis is that adalimumab and methotrexate perform equally in preventing the inflammatory flare of uveitis in children with non-infectious anterior uveitis. To detect a relative reduction of 30% between a presumed failure risk of 10% in the adalimumab group and 45% in the methotrexate group, with 80% power at 5% significance and 1:1 randomisation, a total of 48 patients will be required. Taking the lost to follow-up rate of 5% into consideration, the sample size is increased to 50 patients.\n A pilot study was done in our centre for paediatric non-infectious uveitis with peripheral retina vascular leakage,11 in which among 20 children who had active anterior uveitis treated with adalimumab, no patients had inflammatory flare within 6 months follow-up. However, in that retrospective study, topical GCs and systemic immunomodulatory therapy were adjusted and not unified. Thus, we propose a maximum of 10% inflammatory flare rate in the adalimumab in this study. The inflammatory flare rate of 45% in the methotrexate group is estimated from an RCT published in NEJM,6 in which JIA-associated paediatric uveitis was treated with methotrexate plus placebo in the control group and had treatment failure rate of 45% at the 6\u00e2\u0080\u0089months follow-up according to its the Kaplan-Meirer curve. We estimate that lost to follow-up will be approximately less than 5% based on the severe nature of this disease potentially causing vision loss, and the clinical experience of our study centre.", "id": 1195, "split": "test"} +{"trial_id": "NCT05016388", "pmid": "39464248", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Efficacy of a Multidimensional Collaborative Model to Improve the Resolution of Depression in Primary Care Teams in the Maule Region\n\nIncluded conditions:\n- Depression\n\nStudy Armgroups:\n- {'label': 'Collaborative Multidimensional Model (CMD)', 'type': 'EXPERIMENTAL', 'description': 'The teams in the CMD group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the CMD training and the CMD will be installed in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after.', 'interventionNames': ['Other: Collaborative Multidimensional Model (CMD)']}\n- {'label': 'Standard Model (SM)', 'type': 'OTHER', 'description': 'The teams in the SM group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the SM training and the SM will be set in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after.', 'interventionNames': ['Other: Standard Model (SM)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Collaborative Multidimensional Model (CMD)', 'description': 'The teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model.', 'armGroupLabels': ['Collaborative Multidimensional Model (CMD)'], 'otherNames': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Standard Model (SM)', 'description': 'The teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM.', 'armGroupLabels': ['Standard Model (SM)'], 'otherNames': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Depressive symptoms at three months relative to baseline', 'description': 'Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9).\\n\\nThe Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile.\\n\\nThe Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview.\\n\\nTotal score ranges from 0 to 27 points and greater scores means worse symptoms.', 'timeFrame': 'Three months after admission to depression treatment'}\n- {'measure': 'Change in Depressive symptoms at six months relative to baseline', 'description': 'Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9).\\n\\nThe Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile.\\n\\nThe Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview.\\n\\nTotal score ranges from 0 to 27 points and greater scores means worse symptoms.', 'timeFrame': 'Six months after admission to depression treatment'}\n\nPlease estimate the sample size based on the assumption: \nThis calculation is based on a one-sided model with an alpha of 5%, a power of 80%, a confidence level of 95%, a maximum variance of 50%, and an intraclass correlation coefficient (ICC) of 0.0337, resulting in a design effect of 1.64 due to the involvement of 12 clinics.", "answer": 394, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size estimation account for a 20% difference, as suggested by previous studies conducted in Chile.\n\n21\n\n,\n\n22\n This calculation is based on a one-sided model with an alpha of 5%, a power of 80%, a confidence level of 95%, and a maximum variance of 50%. A total of 240 depressed individuals are required, with 120 participants in each group (intervention and control). Bases on previous data, the intraclass correlation coefficient (ICC) is estimated to be 0.0337,\n\n22\n resulting in a design effect of 1.64 due to the involvement of 12 clinics. Applying this design effect increases the sample size to 341, based on a prior study the sample size is set at 394 patients.\n\n8", "id": 1196, "split": "test"} +{"trial_id": "NCT05017363", "pmid": "35764983", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach): A Pragmatic Cluster Randomized Controlled Trial and Economic Analysis\n\nIncluded conditions:\n- Neurodevelopmental Disorders\n\nStudy Armgroups:\n- {'label': 'Intervention Group (ENGAGE)', 'type': 'EXPERIMENTAL', 'description': 'Therapists will consist of pairs within sites providing similar interventions to similar children so that treatment and child characteristics other than the goal-setting intervention will be similar within each site. Therapists will use principles-based goal-setting approaches and strategies in the goal-setting toolbox. It is anticipated that treatment block lengths will vary from 3-8 sessions over 2-8 weeks, representing typical clinical variation.', 'interventionNames': ['Procedure: ENGAGE']}\n- {'label': 'Usual Care Group (Control)', 'type': 'NO_INTERVENTION', 'description': 'The control group will comprise usual care.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'ENGAGE', 'description': 'Goal-setting approach and strategies including the Perceived Efficacy and Goal Setting Tool (PEGS), which is established goal setting tools for children aged 5-9. Administration of the Canadian Occupational Performance Measure (COPM), the most widely used goal-setting tool in paediatric rehabilitation that has been used with children as young as seven years. Introducing simple strategies to assist children in identifying goals and to ensure ongoing focus on goals using principles of motivational interviewing, strategies to assess and nurture perceived competence (self-efficacy), and child-friendly feedback strategies on goal-related performance.', 'armGroupLabels': ['Intervention Group (ENGAGE)']}\n\nPrimary Outcomes:\n- {'measure': 'Self-perceived, goal-related performance on the COPM (COPM-P)', 'description': 'Canadian Occupational Performance Measure, Performance rating, 1 (not able to do it -10 able to do it extremely well).', 'timeFrame': 'Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) = 0.05, power = 80%, intra-cluster correlation (ICC) = 0.1, minimal dropout rate (less than 5%), using a 2-sided, cluster-adjusted, t-test for the comparison of means.", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size will be 96 children (12 therapists as clusters per group and four children per therapist) recruited from the six separate sites by the study therapists (4 children/therapist). Based on our pilot work, we anticipate that child dropout from the pre-post intervention period will be minimal (i.e., less than 5%). A target change score of 2.0, a clinically significant change on the Canadian Occupational Performance Measure (goal performance rating) (COPM-P; primary outcome) [31], with a standard deviation of 2.75 [32] corresponds to an effect size of 0.723 for the comparison of means. A sample size of 96 will enable us to detect an effect size of at least 0.682 in the primary outcome (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 80% power), assuming an intra-cluster correlation (ICC) of 0.1 using a 2-sided, cluster-adjusted, t-test for the comparison of means. We selected an ICC of 0.1 based on the results of a previous cluster RCT with children with cerebral palsy (ICCs between 0.08 to 0.13) [32]. Since therapist attrition is possible over the duration of the study, a cluster size of 11 would still provide 80% power to detect an effect size of 0.716, below our target effect size. Smaller effect sizes will be detectable if the ICC is smaller than 0.1.", "id": 1197, "split": "test"} +{"trial_id": "NCT05018585", "pmid": "36316084", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd\u00ae to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype\n\nIncluded conditions:\n- Type 1 Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'Diamyd', 'type': 'EXPERIMENTAL', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections with 4\u00b5g Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)', 'interventionNames': ['Biological: Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel\u00ae', 'Dietary Supplement: Colecalciferol 2000 IU']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd (rhGAD) on Days 0, 30, and 60 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day -30 through Day 90)', 'interventionNames': ['Dietary Supplement: Colecalciferol 2000 IU', 'Biological: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel\u00ae', 'description': 'Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel\u00ae', 'armGroupLabels': ['Diamyd'], 'otherNames': ['Diamyd']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Colecalciferol 2000 IU', 'description': 'Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).', 'armGroupLabels': ['Diamyd', 'Placebo'], 'otherNames': ['Divisun 2000 IU']}\n- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'Placebo for Diamyd, Alhydrogel\u00ae only', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in stimulated C-peptide during a MMTT', 'description': 'Change from baseline to Month 24 in C-peptide AUCmean 0-120 min during a 2 hour MMTT.', 'timeFrame': 'Baseline and 24 months'}\n- {'measure': 'Change in hemoglobin A1c (HbA1c).', 'description': 'Mean difference in change from baseline to Month 24 in HbA1c (mmol/mol)', 'timeFrame': 'Baseline and 24 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 5% type I error rate controlled using a fallback procedure, with 4% alpha for the overall population and 1% alpha for the HLA DR4-DQ8-negative subgroup. 90% power, assumed CV of 0.95, and 12% drop-out rate.", "answer": 330, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n The primary efficacy analysis will be performed in the full analysis set. The primary efficacy variables will be (1) change from baseline to Month 24 in log-transformed C-peptide AUCmean 0-120 min during an MMTT and (2) change from baseline to Month 24 in mean HbA1c. The coprimary endpoints will be tested in both the overall population and in the subgroup of patients who carry the HLA DR3-DQ2 haplotype and simultaneously do not carry the DR4-DQ8 haplotype (hereafter the HLA DR4-DQ8-negative subgroup). The overall two-sided 5% type I error rate will be controlled using a fallback procedure. A two-sided 4% alpha will be assigned to the primary efficacy analysis in the overall population. The remaining 1% alpha will be assigned to the primary efficacy analysis in the HLA DR4-DQ8-negative subgroup.\n A total sample size of 288 patients is planned for a 2:1 randomisation to the rhGAD65 and placebo arms, respectively. This achieves 90% power to detect a clinically relevant difference of 40% in geometric mean ratio C-peptide (AUCmean 0-120 min) during an MMTT at month 24 between the rhGAD65 arm and placebo arm using a two-sided test at the 4% significance level. This is based on a t-test employing natural log transformation of C-peptide (AUCmean 0-120 min) during an MMTT at month 24 and assumed CV of 0.95 based on simulations of EoS (month 15) results in the placebo group of the phase 2b study DIAGNODE-2. Allowing for 12% drop-out to month 24, approximately 330 patients will be randomised.", "id": 1198, "split": "test"} +{"trial_id": "NCT05021601", "pmid": "36446460", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial\n\nIncluded conditions:\n- Persistent Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Bi-atrial ablation group', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure.', 'interventionNames': ['Procedure: Bi-atrial ablation']}\n- {'label': 'Left atrial ablation group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure.', 'interventionNames': ['Procedure: Left atrial ablation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Bi-atrial ablation', 'description': 'This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.', 'armGroupLabels': ['Bi-atrial ablation group']}\n- {'type': 'PROCEDURE', 'name': 'Left atrial ablation', 'description': 'This intervention includes mitral valve surgery concomitant with left atrial ablation alone.', 'armGroupLabels': ['Left atrial ablation group']}\n\nPrimary Outcomes:\n- {'measure': 'Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs', 'description': 'Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.', 'timeFrame': 'At 12-month after intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a one-sided Z test with pooled variance, a significance level of 0.05 (one-sided), and a power of 90% for the primary end point and 80% for the key secondary end point. A withdrawal rate of 10% is also considered.", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The calculation of the sample size is based on the primary end point and the key secondary end point according to previously published data and our own clinical experience. The primary end point of the study is the probability of freedom from any recurrence of atrial tachyarrhythmias at 12 months after operation. It is estimated that the probability of freedom from atrial tachyarrhythmias at 12 months in the LA group is 70%10 17 22 and that in the BA group is 85%.10 17 23 Therefore, a sample size of 131 patients (per group) is needed to provide 90% power based on a one-sided Z test with pooled variance and a significance level of 0.05 (one-sided).\n The key secondary end point of this study is the probability of freedom from permanent pacemaker implantation at 12 months. It is estimated that the probability of freedom from permanent pacemaker implantation at 12 months in the LA group is 97%.14 24 Considering the feasibility of clinical studies, the non-inferiority margin is determined as \u00e2\u0088\u00925%.25\u00e2\u0080\u009327 Therefore, a sample size of 144 patients (per group) is needed to provide 80% power based on a one-sided Z test with pooled variance and a significance level of 0.05 (one-sided).\n As mentioned above, both primary and key secondary end points should be considered. Therefore, 144 patients per group are required. When considering a withdrawal rate of 10%, 320 patients are required to be randomly assigned into two groups in a 1:1 allocation.", "id": 1199, "split": "test"} +{"trial_id": "NCT05021731", "pmid": "36269714", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of 3-month Once-weekly Isoniazid Plus Rifapentine, 4-month Daily Rifampicin, and 3-month Daily Isoniazid Plus Rifampicin for the Treatment Latent Tuberculosis in Patients With End-stage Kidney Disease: A Randomised Clinical Trial\n\nIncluded conditions:\n- Latent Tuberculosis\n- Kidney Failure\n\nStudy Armgroups:\n- {'label': '3-month Isoniazid plus Rifampicin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Daily isoniazid 300 mg plus rifampicin 600 mg for three months', 'interventionNames': ['Drug: Rifampicin plus Isoniazid']}\n- {'label': '3-month Isoniazid plus Rifapentine', 'type': 'EXPERIMENTAL', 'description': 'Weekly isoniazid 900 mg plus rifapentine 900 mg for 12 weeks', 'interventionNames': ['Drug: Rifapentine plus Isoniazid']}\n- {'label': '4-month Rifampicin', 'type': 'EXPERIMENTAL', 'description': 'Daily rifampicin 600 mg for four months', 'interventionNames': ['Drug: Rifampicin alone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rifampicin plus Isoniazid', 'description': 'Administration of rifampicin plus isoniazid for latent tuberculosis', 'armGroupLabels': ['3-month Isoniazid plus Rifampicin']}\n- {'type': 'DRUG', 'name': 'Rifapentine plus Isoniazid', 'description': 'Administration of rifapentine plus isoniazid for latent tuberculosis', 'armGroupLabels': ['3-month Isoniazid plus Rifapentine']}\n- {'type': 'DRUG', 'name': 'Rifampicin alone', 'description': 'Administration of rifampicin alone for latent tuberculosis', 'armGroupLabels': ['4-month Rifampicin']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment completion', 'description': 'Proportion of participants who complete the treatment assigned at randomization, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than in 2 occasions, for 3HR (control arm); 2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for 3HP (experimental arm 1), and 3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than in two occasions, for 4R (experimental arm 2).', 'timeFrame': 'From date of randomization until the date of completion of the assigned treatment, or date of lost to follow-up, or date of death, whichever came first, assessed up to 16 weeks for the 3HR arm, 14 weeks for the 3HP arm, and 20 weeks for the 4R arm.'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided \u03b1 = 0.025, \u03b2 = 0.20, and 5% expected losses.", "answer": 225, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated to demonstrate clinically significant better completion rates with the 4R or 3HP regimen, respectively (experimental arms), compared to the 3HR regimen (control arm). With an one-side \u00ce\u00b1 = 0.025, \u00ce\u00b2 = 0.20, and 5% expected losses, and assuming a 0.75 proportion of treatment completion in the control arm (3HR) according to our prior experience [7], 225 subjects (75 per arm) will be needed to demonstrate, if it exists, an increase in treatment completion rates of 0.16 in the respective experimental arms (4R or 3HP). The size of the sample was calculated with GIGAcalculator [14].\n The 0.16 increase in compliance (from 0.75 to 0.93) was set according to the previous experience at the TB clinics of the coordinating centre. The rationale is that in our cohort of 534 ESKD patients treated in the last 9 years, central nervous system toxicity related to isoniazid occurred in more than 10% of patients, and it was the main reason for discontinuation of treatment. Therefore, assuming that such adverse event is avoided by using either once a week isoniazid (3HP regimen) or rifampicin alone (4R), together with the presumable reduction in liver toxicity with these two regimens, a compliance 0.93 is reasonable and achievable.", "id": 1200, "split": "test"} +{"trial_id": "NCT05022823", "pmid": "35379618", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial\n\nIncluded conditions:\n- Breast Cancer Related Lymphedema\n\nStudy Armgroups:\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)', 'interventionNames': ['Device: Compression sleeve, daytime wear', 'Behavioral: Home exercise program']}\n- {'label': 'DPRE + compression sleeve during exercise', 'type': 'EXPERIMENTAL', 'description': 'Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)', 'interventionNames': ['Device: Compression sleeve, worn during exercise', 'Device: Compression sleeve, daytime wear', 'Behavioral: Decongestive Progressive Resistance Exercise program']}\n- {'label': 'DPRE + AC garment during exercise', 'type': 'EXPERIMENTAL', 'description': 'Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).', 'interventionNames': ['Device: Adjustable Compression (AC) garment, worn during exercise', 'Device: Compression sleeve, daytime wear', 'Behavioral: Decongestive Progressive Resistance Exercise program']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Compression sleeve, worn during exercise', 'description': 'Participants wear their daytime compression sleeve during the DPRE program.', 'armGroupLabels': ['DPRE + compression sleeve during exercise']}\n- {'type': 'DEVICE', 'name': 'Adjustable Compression (AC) garment, worn during exercise', 'description': 'Participants wear an Adjustable Compression (AC) garment during the DPRE program. Participants will be fitted for an Adjustable Compression garment and instructed in its application by a physical therapist.', 'armGroupLabels': ['DPRE + AC garment during exercise']}\n- {'type': 'DEVICE', 'name': 'Compression sleeve, daytime wear', 'description': 'Compression sleeve worn for at least 12 hours per day, seven days a week.', 'armGroupLabels': ['DPRE + AC garment during exercise', 'DPRE + compression sleeve during exercise', 'Standard of Care']}\n- {'type': 'BEHAVIORAL', 'name': 'Decongestive Progressive Resistance Exercise program', 'description': 'Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.\\n\\nAfter the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually.', 'armGroupLabels': ['DPRE + AC garment during exercise', 'DPRE + compression sleeve during exercise'], 'otherNames': ['DPRE']}\n- {'type': 'BEHAVIORAL', 'name': 'Home exercise program', 'description': 'Participants are provided with a home exercise program that follows the decongestive exercise sequence and instructed to perform the exercise sequence once daily for a 10-15 minute period.', 'armGroupLabels': ['Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Lymphedema Arm Volume', 'description': 'Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).', 'timeFrame': 'Up to 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 0.01, Power: 86%, Missing/dropout rate: 10%", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size for the study was based on the findings of the pilot vanguard trial phase. Using the point estimates and measures of variability derived for LRV of the 12 week post intervention, we estimated a mean reduction of 18% in lymphoedema (SD: 16%) in favour of the combined data from the intervention groups. As a result of the interim analyses, an alpha adjustment was required to preserve the overall type I error rate. Thus, the value for the level of significance for this study was revised from 0.05 to 0.01. The estimated sample size of 51 participants or 17 per group achieves about 86% power (significance level: p=0.01). Considering a 10% loss to follow-up/ withdrawal, and one level of stratification, an additional nine participants will be added for a total sample size of 60 including the 20 participants from the pilot study. Thus, 40 more participants will be recruited to the trial.", "id": 1201, "split": "test"} +{"trial_id": "NCT05025826", "pmid": "36670495", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Double-blind, Multicenter Placebo-controlled Study Evaluating Neurotoxicity in Patients with Metastatic Gastro Intestinal Cancer Taking Phycocare\u00ae or Placebo During Oxaliplatin Based Chemotherapy\n\nIncluded conditions:\n- Metastatic Gastric Cancer\n\nStudy Armgroups:\n- {'label': 'Phycocare', 'type': 'EXPERIMENTAL', 'description': 'PHYCOCARE during 12 cycles of 14 days from day -3 before oxaliplatin based chemotherapy until cycle 3 months after the last dose of oxaliplatin (18 cycles, about 9 months) From D-3 to D14 before cycle 1 chemotherapy: patient will take Phycocare From D1 to D14 of cycle 2 chemotherapy and further chemotherapy cycles : patient will take Phycocare On days of chemotherapy the patient does not take Phycocare', 'interventionNames': ['Other: Phycocare']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo during 12 cycles of 13 days from day -3 before cycle 1 of oxaliplatin based chemotherapy until 3 months after the last dose of oxaliplatin (9 months).\\n\\nFrom D-3 to D13 before cycle 1 chemotherapy: patient will take Placebo From D1 to D13 of cycle 2 chemotherapy and further chemotherapy cycles : patient will take Placebo.\\n\\nOn days of chemotherapy the patient does not take Placebo', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Phycocare', 'description': 'Phycocare every day during 9 months (except days of chemotherapy: no Phycocare)', 'armGroupLabels': ['Phycocare']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo every day during 9 months (except days of chemotherapy = no Placebo)', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Demonstrate a 50% decrease of the grade> or = 2 neurotoxicity at 4 months after oxaliplatin-based chemotherapy start in the PHYCOCARE arm', 'description': 'neurotoxicity according to NCI (National Cancer Institute) criteria in both arms', 'timeFrame': '4 months after oxaliplatin-based chemotherapy start'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate of 0.05, power of 0.90, and a lost-to-follow-up rate at 4 months of 20%.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Simon\u00e2\u0080\u0099s two-stage design [15] will be used. The null hypothesis that the true response rate is 0.60, the proportion of neurotoxicity targeted, will be tested against a one-sided alternative. In the first stage, 31 patients will be accrued. If there are 18 patients or fewer with grade 1 neurotoxicity among these 31 patients in the SLPC arm, the study will be halted. Otherwise, 24 additional patients will be accrued, making a total of 55. The null hypothesis will be rejected if 38 or more responses are observed in 55 of the SLPC arm patients. With a type I error rate of 0.05 and a power of 0.90, 55 patients will be enrolled in each arm, that is to say, 110 patients.\n All the previous hypotheses account for a lost-to-follow-up rate at 4 months of 20%.", "id": 1202, "split": "test"} +{"trial_id": "NCT05028088", "pmid": "35105573", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diaphragm Ultrasound to Evaluate the Antagonistic Effect of Sugammadex on Rocuronium After Liver Surgery in Patients With Different Liver Child-Pugh Grades\n\nIncluded conditions:\n- Diaphragm Ultrasonography\n- Liver Dysfunction\n- Sugammadex\n- Rocuronium\n\nStudy Armgroups:\n- {'label': 'Child-Pugh A', 'type': 'EXPERIMENTAL', 'description': '1. Diaphragm ultrasound scan before induction of anesthesia.\\n2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5\u03bcg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 \u03bcg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.\\n3. When the TOF value was \u22652%, patients in each group will be given SUG (2mg/kg).\\n4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation.', 'interventionNames': ['Drug: sugammadex']}\n- {'label': 'Child-Pugh B', 'type': 'EXPERIMENTAL', 'description': '1. Diaphragm ultrasound scan before induction of anesthesia.\\n2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5\u03bcg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 \u03bcg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.\\n3. When the TOF value was \u22652%, patients in each group will be given SUG (2mg/kg).\\n4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation.', 'interventionNames': ['Drug: sugammadex']}\n- {'label': 'Child-Pugh C', 'type': 'EXPERIMENTAL', 'description': '1. Diaphragm ultrasound scan before induction of anesthesia.\\n2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5\u03bcg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 \u03bcg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.\\n3. When the TOF value was \u22652%, patients in each group will be given SUG (2mg/kg).\\n4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation.', 'interventionNames': ['Drug: sugammadex']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'sugammadex', 'description': 'This study is a prospective, double-blind, low-intervention, non-randomized controlled clinical trial involving 99 patients with American Society of Anesthesiologists \u2160-\u2162, body mass index 18.5-24.9 kg/m2, who will undergo laparoscopic radical resection of liver cancer under general anesthesia in the Wuhan Union Hospital. Ultrasonography will be applied to monitor the change rate of diaphragm thickness at different time after extubation to evaluate the recovery rate of muscle relaxant, which indirectly reflects the dose-effect relationship of SUG antagonizing against rocuronium in patients with different liver Child-Pugh grades preoperatively.', 'armGroupLabels': ['Child-Pugh A', 'Child-Pugh B', 'Child-Pugh C'], 'otherNames': ['diaphragm ultrasonography']}\n\nPrimary Outcomes:\n- {'measure': 'the recovery rate of muscle relaxation', 'description': \"the incidence of residual muscle relaxation at different time points after the operation and the baseline recovery rate of the diaphragm\uff08immediately after extubation, 10minutes, 30minutes and 2hours\uff09\\n\\nWhen the patients' consciousness and spontaneous breathing are restored, participants can open their eyes according to the doctor's instructions, shake hands firmly, and at the same time, participants can complete the movement of raising their head continuously for more than 5 seconds to remove the tracheal tube.\", 'timeFrame': '2 hours'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) is 0.05, power (1-\u03b2) is 0.80, and a 10% dropout rate is considered.", "answer": 99, "answer_type": "ESTIMATED", "explanation": "Statistical analyses and sample size calculation\n SPSS V.26.0 software will be used for statistical analysis. In the statistical data, the counting data are expressed by the rate, while the measurement data are expressed by the mean\u00c2\u00b1SD. If the variance of the measurement data is uniform, the measured values of each observation index among the groups are compared by analysis of variance, otherwise, the rank sum test is used. SNK-Q test was used for pairwise comparison of the measured values within the group. Count data comparison adopts row-list \u00cf\u00872 test or the Fisher\u00e2\u0080\u0099s exact test, as appropriate. For all comparisons, the p<0.05 is considered statistically significant.\n The main variable measured by outcome is the incidence of residual muscle relaxation after tracheal extubation for 10\u00e2\u0080\u0089min, and significant level \u00ce\u00b1 is equal to 0.05, a power of the test will be calculated with 1-\u00ce\u00b2=0.80. According to our preobservation results, 10\u00e2\u0080\u0089min after SUG antagonises rocuronium, the incidence of residual muscle relaxation under diaphragmatic ultrasound in patients with different liver Child-Pugh grades (Child A, Child B and Child C) before surgery is 4%, 16% and 40%, respectively. Cases will be allocated according to 1:1:1 into the three groups, considering that 10% of the samples probably fall off, and each group should contain 33 valid cases after calculation by the Power Analysis and Sample Size software, thus, a total of 99 cases will be included in this observation.", "id": 1203, "split": "test"} +{"trial_id": "NCT05028153", "pmid": "35418427", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study\n\nIncluded conditions:\n- Childhood Asthma With Acute Exacerbation\n\nStudy Armgroups:\n- {'label': 'Antibiotics', 'type': 'ACTIVE_COMPARATOR', 'description': 'Azithromycin (10mg/kg) administered via oral suspension for 3 consecutive days', 'interventionNames': ['Drug: Azithromycin Oral Liquid Product']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo with no active substance administered via oral suspension for 3 consecutive days', 'interventionNames': ['Other: Placebo mixture']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Azithromycin Oral Liquid Product', 'description': '10 mg/kg for 3 consecutive days', 'armGroupLabels': ['Antibiotics']}\n- {'type': 'OTHER', 'name': 'Placebo mixture', 'description': 'Placebo mixture containing no active substance', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Duration in days of the asthma-like episode from the start of randomization.', 'description': 'Number of days based on a diary.', 'timeFrame': '1-30 days'}\n\nPlease estimate the sample size based on the assumption: \nFor both study arms, a power of 80% and a two-tailed alpha (\u03b1) of 5% are assumed. A 10% dropout rate is also expected.", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size\n The main outcome in the azithromycin study arm is the duration of the episode with asthma-like symptoms in days; that is non-normally distributed. Due to some observations of zero days duration, we will add a pseudocount of 1\u00e2\u0080\u0089day duration for transformation of all durations: log(duration+1) = \u00ce\u00b20+R*\u00ce\u00b21+error, where R is the intervention. Based on the COPSAC2010 RCT duration of symptoms,12 we expect a SD of log(duration+1)=1.04. With a power of 80% and a two-tailed alpha (\u00ce\u00b1) of 5%, a delta (\u00ce\u00bb) in geometric mean ratio of 1.5, corresponding to a 50% reduction in symptoms duration, we need a sample size of n=230 children randomised in two groups on a 1:1 and expecting a drop out of 10%. To increase power, we aim to recruit 250 children (125/arm).\n The main outcome in the vitamin D study arm is the number of episodes with asthma-like symptoms requiring OCS and/or ED visit and/or hospitalisation over a 12-month period (\u00ce\u00bb), which is estimated at 0.94/child in the placebo arm based on previous RCTs with ICS.39 A sample size of 145 children per arm will provide 80% power with a two-tailed \u00ce\u00b1 of 5% to detect a 35% relative reduction in the mean number of events (ie, \u00ce\u00bb=0.94\u00e2\u0080\u0089in the placebo vs \u00ce\u00bb=0.611\u00e2\u0080\u0089in the intervention group), based on a previous observed rate ratio of 0.64 for exacerbations requiring OCS in a meta-analysis.19 We expect a 10% drop-out and therefore aim to recruit 320 children (160/arm).", "id": 1204, "split": "test"} +{"trial_id": "NCT05029050", "pmid": "35725264", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Alpha 2 Adrenergic Receptor Agonists for the Prevention of Delirium and Cognitive Decline After Open Heart Surgery (ALPHA2PREVENT): Randomised Controlled Trial.\n\nIncluded conditions:\n- Delirium\n- Cognitive Decline\n- Frailty\n\nStudy Armgroups:\n- {'label': 'Dexmedetomidine (D)', 'type': 'EXPERIMENTAL', 'description': 'Continuous intravenous infusion of dexmedetomidine 0.4 \u03bcg/kg/hour from the start of cardiopulmonary bypass and during surgery, followed by 0.2 \u03bcg/kg/hour until discharge from the ICU or 24 hours postoperatively, whichever happens first.', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Clonidine (C)', 'type': 'EXPERIMENTAL', 'description': 'Continuous intravenous infusion of clonidine 0.4 \u03bcg/kg/hour from the start of cardiopulmonary bypass and during surgery, followed by 0.2 \u03bcg/kg/hour until discharge from the ICU or 24 hours postoperatively, whichever happens first.', 'interventionNames': ['Drug: Clonidine']}\n- {'label': 'Placebo (P)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Continuous intravenous infusion of saline 0.4 \u03bcg/kg/hour from the start of cardiopulmonary bypass and during surgery, followed by 0.2 \u03bcg/kg/hour until discharge from the ICU or 24 hours postoperatively, whichever happens first.', 'interventionNames': ['Drug: Natriumchlorid']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Continous intravenous infusion', 'armGroupLabels': ['Dexmedetomidine (D)'], 'otherNames': ['Dexdor', 'Precedex', 'N05C M18']}\n- {'type': 'DRUG', 'name': 'Clonidine', 'description': 'Continous intravenous infusion', 'armGroupLabels': ['Clonidine (C)'], 'otherNames': ['Catapresan', 'Catapressan', 'N02C X02']}\n- {'type': 'DRUG', 'name': 'Natriumchlorid', 'description': 'Continous intravenous infusion NaCl', 'armGroupLabels': ['Placebo (P)'], 'otherNames': ['Saline', 'NaCl 9mg/ml']}\n\nPrimary Outcomes:\n- {'measure': 'Postoperative delirium', 'description': 'Cumulative incidence of postoperative delirium, as diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria', 'timeFrame': 'Up to 7 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered to detect a difference with a power of 80% and a significance level of 5%. The initial sample size calculation was conservative, considering a higher drop-out rate and the use of a time-to-delirium analysis strategy.", "answer": 900, "answer_type": "ESTIMATED", "explanation": "Current sample size justification\n The proportion of patients experiencing postoperative delirium after open heart surgery for all ages has been reported to be 24%,3 and higher in older adults.4 Since the lower age limit in our trial is 70 years, we estimate that the proportion in the control group will be at least 30%. The most recent meta-analysis of the effect of dexmedetomidine estimates the delirium risk to be reduced to approximately half of the untreated group (ie, 15%).25 We anticipate that the effect of clonidine may be weaker, but still clinically relevant. We have thus powered the study based on an estimated delirium incidence of 20% in the clonidine group. An initial, conservative sample size calculation based on comparison of two proportions indicated that a sample size of 290 in each group (870 altogether) will give a power of 80% with a significance level of 5% to detect such a difference between the clonidine and the placebo group in the proportion developing delirium within 7 days postoperatively. To account for dropouts, we aim at including 900 patients. This sample size calculation approach was conservative considering the use of time-to-delirium analysis strategy, accommodating for both a higher drop-out rate and that this trial has three arms. We have further confirmed the adequacy of this sample size estimate for the logrank test with differing rates of drop-out and considering the three arms (online supplemental figure S1).\n \n 10.1136/bmjopen-2021-057460.supp1\n Supplementary data", "id": 1205, "split": "test"} +{"trial_id": "NCT05029115", "pmid": "36652465", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus\n\nIncluded conditions:\n- SGLT-2 Inhibitor\n- Atrial Fibrillation\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'SGLT-2 inhibitor administration group', 'description': 'The group who administrated SGLT-2 inhibitor for hypoglycemic medication', 'interventionNames': ['Drug: SGLT2 inhibitor']}\n- {'label': 'control', 'description': 'The group who are not administrated SGLT-2 inhibitor'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'SGLT2 inhibitor', 'description': 'Dapagliflozin, Empagliflozin', 'armGroupLabels': ['SGLT-2 inhibitor administration group']}\n\nPrimary Outcomes:\n- {'measure': 'recurrence rate of AF within a year in all participants', 'description': 'Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.', 'timeFrame': 'during 1 year'}\n- {'measure': 'recurrence rate of AF within a year in ablated participants', 'description': 'Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nAssuming 10% follow-up loss, the sample size is expected to achieve 80% power and an alpha-level of 5%. The study will use the Chi square method for primary analysis, with additional analyses using Chi square test, student t-test, Kaplan-Meier method, and Cox regression analysis. Missing data will be controlled using multiple imputation.", "answer": 716, "answer_type": "ESTIMATED", "explanation": "Statistical plan, sample size, and power determination\n In this study, 716 patients will be enrolled from 7 tertiary medical centers. The sample size was determined based on the primary outcome, i.e., the SGLT-2 inhibitors should show 40% reduction in AF after a year of treatment [32] and 50% of AAD users should step up to the ablation therapy [33,34]. Assuming 10% follow-up loss, the sample size of 716 patients (358 in each group) is expected to achieve 80% power and an alpha-level of 5% to detect the difference. The study is powered to demonstrate the superior additive effect of SGLT-2 inhibitors over other hypoglycemic agents using the Chi square method. AF recurrence rate and ratio of sinus rhythm on 24-h holter EKG will be analyzed using Chi square test, and left atrial size, NT-pro BNP and quality of life (AFEQT) score on 12-month final follow-up will be analyzed by student t-test. Disease-free survival and overall survival during the follow-up period will be calculated using Kaplan-Meier method. Mono-variable and multi-variable cox regression analysis will be used to calculate hazard ratio of SGLT-2 group.\n To reduce the selection bias, all subjects will be randomized to allocate the hypoglycemic agents according to random number table. Missing data is planned to be controlled using multiple imputation.", "id": 1206, "split": "test"} +{"trial_id": "NCT05033210", "pmid": "37978577", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic: a Randomized Controlled Trial\n\nIncluded conditions:\n- Psychological Distress\n- Quality of Life\n- Psychosocial Intervention\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'OTHER', 'description': 'The control group will receive Psychological First Aid (PFA) and Care as Usual (CAU)', 'interventionNames': ['Behavioral: Psychological First Aid (PFA)', 'Behavioral: Care as Usual (CAU)']}\n- {'label': 'Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'The treatment group will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2), in addition to Psychological First Aid (PFA) and care as usual (CAU). Step 2 will only be provided if the participant still has elevated levels of psychological distress (K10 \\\\> 15.9) at 2 weeks after DWM, i.e. during the second quantitative assessment at 2 weeks after DWM.', 'interventionNames': ['Behavioral: Psychological First Aid (PFA)', 'Behavioral: Care as Usual (CAU)', 'Behavioral: Doing What Matters in Times of Stress (DWM)', 'Behavioral: Problem Management Plus (PM+)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Psychological First Aid (PFA)', 'description': 'PFA is a WHO developed support strategy that involves humane, supportive and practical help for individuals living in a serious humanitarian crisis. PFA does not necessarily involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to promote in the aftermath of crises, i.e. a sense of safety, calm, self- and community efficacy, connectedness, and hope (Hobfoll et al., 2007). It consists of a conversation (approximately 30-45 minutes) that a helper has with a participant which can be provided remotely (e.g. videoconferencing or telephone). It has various themes; the helper provides non-intruding practical care and support, listen to needs and concerns, helps people to address basic needs (e.g. information), listens to people without pressuring them to talk, comforts people and helps them to feel calm, helps people to connect to information, services, and social support, and protects people from further harm (WHO, 2011).', 'armGroupLabels': ['Control Group', 'Treatment Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Care as Usual (CAU)', 'description': 'In addition to PFA, both arms will be allowed to receive any usual care (CAU). CAU ranges from community care to specialised psychological treatments.', 'armGroupLabels': ['Control Group', 'Treatment Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Doing What Matters in Times of Stress (DWM)', 'description': 'DWM is based on the acceptance and commitment therapy (ACT), a form of cognitive-behavioural therapy, with distinct features (Hayes, Levin, Plumb-Vilardaga, Villatte \\\\& Pistorello, 2013). ACT is based on the concept that ongoing attempts to suppress unwanted thoughts and feelings can make these problems worse, so instead it emphasises on learning new ways to accommodate these thoughts and feelings without letting them dominate. ACT has been shown to be useful for a range of mental health issues (Tjak et al., 2015) and has been used successfully in a guided self-help format (Hayes et al., 2013). DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, will be adapted for use on a smartphone or other device with internet access.', 'armGroupLabels': ['Treatment Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Problem Management Plus (PM+)', 'description': 'PM+ is a brief, psychological intervention program based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011). The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. In these 90-minute sessions participants may talk to trained non-professional helpers (who are supervised by registered (clinical) psychologists). PM+ has four core features: it is brief (five sessions); delivered by non-specialist helpers; transdiagnostic thereby addressing depression, anxiety, PTSD, stress and problems as defined by people themselves; and originally designed for people in low-income country communities but easily adaptable to different (vulnerable) populations, cultures and languages.', 'armGroupLabels': ['Treatment Group']}\n\nPrimary Outcomes:\n- {'measure': 'PHQ-ADS', 'description': \"The PHQ-ADS is the sum of the PHQ-9 and GAD-7 scores (details of both instruments summarised below) and thus can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology. Two validation studies of the PHQ-ADS in trial data-sets of patients with chronic (musculoskeletal) pain and oncological diseases have been published (Kroenke et al., 2016; Kroenke et al., 2019). Evidence shows high internal reliability (Cronbach's alpha of 0.8 to 0.9), strong convergent and construct validity, sufficient uni-dimensionality and evidence for sensitivity to change (i.e. differentiating between individuals classified as worse, stable, or improved by a reference measure at three months post-intervention).\", 'timeFrame': 'Week 2, Week 8, Week 14, Week 22'}\n\nPlease estimate the sample size based on the assumption: \npower = 0.80, alpha = 0.05, bilateral, rho = 0.9, attrition rate = 30%", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Sample size\n Overall, 210 participants will be included. Based on previous studies of PM+ [30, 31], we aim to detect a small to medium effect size corresponding to a Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.4 in the intervention group at 2 months, as measured with the PHQ-ADS and as compared to the control group. A calculation of statistical power for a repeated measures study design (mixed regression model), given incomplete participation in each of the planned assessments, suggests a minimum sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008973 per group (power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890, 05, bilateral, rho\u00e2\u0080\u0089=\u00e2\u0080\u00890.9). Considering an attrition rate of 30%, estimated based on a prior pilot study and past evaluations of PM+, we calculated a total number of 210 participants needed (105 in each group). If needed, missing data on study covariates will be handled using standard multiple imputation techniques.", "id": 1207, "split": "test"} +{"trial_id": "NCT05033314", "pmid": "38171625", "question": "Here is the design of a clinical trial:\n\nOfficial Title: THromboprophylaxis in Sickle Cell Disease with Central Venous Catheters (THIS): a Pilot Study\n\nIncluded conditions:\n- Sickle Cell Disease\n- Central Venous Catheter Thrombosis\n- Venous Thromboembolism\n\nStudy Armgroups:\n- {'label': 'Rivaroxaban thromboprophylaxis', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Rivaroxaban 10 MG']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rivaroxaban 10 MG', 'description': 'Rivaroxaban 10mg PO daily as thromboprophylaxis', 'armGroupLabels': ['Rivaroxaban thromboprophylaxis'], 'otherNames': ['Xarelto 10mg']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'matching placebo daily', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of eligible patients who will enroll into a trial of thromboprophylaxis', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe calculations assume an alpha of 0.05, 80% power, and a 3.5% loss to follow-up per year. The baseline rate will be revised based on new data, including blinded pilot data.", "answer": 4, "answer_type": "ACTUAL", "explanation": "Sample size and power calculations\n The aim is to enrol 50 patients in the pilot trial. The expected number of patients that will need to be assessed to identify 50 patients ranges from 63 to 84 across participation percentages of 60%\u00e2\u0080\u009380%. The resulting percentage of participants can be estimated with a 95% CI of approximately \u00c2\u00b110%. The estimate from the pilot will be applied to patient counts at potential future study sites to (a) assess feasibility of randomisation of approximately 200 patients across all sites and (b) calculate the number of sites and duration of accrual needed for the full trial.\n In a meta-analysis of studies by Jeng et al,2 Abdul-Rauf et al,30 Phillips et al31 and Shah et al,32 the estimated pooled rate of VTE events is 0.21 per year (corresponding to a median time to thrombosis without prophylaxis of 3.3 years33). Combining 50 patients from the pilot (with a maximum of 1 year of follow-up) with an additional 160 patients in the full trial (with 3 years of accrual and 2 years of follow-up) gives 80% power to detect a HR for treatment of 0.5, using an alpha of 0.05 and an assumed 3.5% loss to follow-up per year. The estimated baseline rate will be revised based on any new data available before the full trial commences, in particular the estimated baseline rate from the pilot, calculated from the blinded pilot data. The assumed drop-out rate will also be updated with pilot trial data.", "id": 1208, "split": "test"} +{"trial_id": "NCT05035316", "pmid": "39557557", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT)\n\nIncluded conditions:\n- Bipolar Disorder\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '125 BD participants will receive placebo. Patients, clinicians and researchers will be blinded for the intervention', 'interventionNames': ['Drug: Calcium']}\n- {'label': 'Active', 'type': 'ACTIVE_COMPARATOR', 'description': '125 BD participants will receive active treatment. Patients, clinicians and researchers will be blinded for the intervention', 'interventionNames': ['Drug: acetylsalicylic acid']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'acetylsalicylic acid', 'description': 'Oral tablet: acetylsalicylic acid,150 mg, 1 tablet/day', 'armGroupLabels': ['Active'], 'otherNames': ['Aspirin']}\n- {'type': 'DRUG', 'name': 'Calcium', 'description': 'Oral tablet: calcium, 1 tablet/day', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Daily self-reported mood instability', 'description': 'Daily self-reported mood instability collected via the Monsenso system', 'timeFrame': '6 months (12 months for a subgroup of participants)'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 0.05, attrition rate of 10%", "answer": 250, "answer_type": "ACTUAL", "explanation": "Sample size and power\n According to prior analyses,95 MI varies on a scale from close to 0\u00e2\u0080\u009310 with an average MI of 4.1 (SD=2.6). To detect a clinically relevant decrease of 0.7 in MI with treatment compared with placebo with a power of 80% and a significance level of 0.05, a total of 217 patients needs to be randomised. To further accommodate an attrition rate of 10%, we will include 250 patients in the study.", "id": 1209, "split": "test"} +{"trial_id": "NCT05038657", "pmid": "37726695", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Atezolizumab in Patients With Urinary Tract Squamous Cell Carcinoma: a Single Arm, Open Label, Multicentre, Phase II Clinical Trial\n\nIncluded conditions:\n- Squamous Cell Carcinoma\n- Urinary Tract Cancer\n\nStudy Armgroups:\n- {'label': 'Atezolizumab', 'type': 'EXPERIMENTAL', 'description': 'Treatment will consist of atezolizumab, by IV infusion, at a fixed dose of 1680 mg, every 28 days (day 1 of each cycle, +/- 3 days), for up to one year. Each participant will receive up to 13 doses in total.', 'interventionNames': ['Drug: Atezolizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Treatment will consist of atezolizumab, by IV infusion, at a fixed dose of 1680 mg, every 28 days (day 1 of each cycle, +/- 3 days), for up to one year. Each participant will receive up to 13 doses in total.', 'armGroupLabels': ['Atezolizumab'], 'otherNames': ['Treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Response to', 'description': 'To determine the clinical activity of atezolizumab in patients with incurable histologically confirmed, immunotherapy na\u00efve UTSCC\\n\\nTo determine the clinical activity of atezolizumab in patients with incurable histologically confirmed, immunotherapy na\u00efve UTSCC', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided Type I error rate of 0.1, 90% power, p1=15%, p2=35%, and accounting for dropout.", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n This study uses a modified Simon\u00e2\u0080\u0099s 2-Stage optimal design with best Overall Response Rate (ORR; % with confirmed partial or complete response by RECIST v1.1) at a minimum of 12\u00c2\u00a0weeks from commencing treatment as the primary endpoint. We propose that an ORR of\u00e2\u0080\u0089<\u00e2\u0080\u008915% would not warrant further investigation, and an ORR\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008935% would warrant further investigation in a randomised trial. With a one-sided Type I error rate of 0.1, 90% power, p1\u00e2\u0080\u0089=\u00e2\u0080\u008915% and p2\u00e2\u0080\u0089=\u00e2\u0080\u008935%, up to 19 patients will be recruited into Stage 1. If 4 or more patients out of the 19 in Stage 1 (with a minimum of 12\u00c2\u00a0weeks from commencing treatment) have an objective response (confirmed partial response (PR) or complete response (CR) by RECIST v1.1) then the trial will continue with ongoing recruitment to Stage 2 recruiting a maximum of 14 further patients or 33 patients overall. There is no pause in recruitment whilst the Stage 1 analysis is undertaken. Otherwise, accrual will close. If 8 or more patients overall have a best objective response by RECIST (confirmed PR or CR) then this intervention will be considered to have clinical activity that warrants further investigation. To account for drop out, prior to commencing treatment, up to an additional 3 patients may be recruited, making a possible final sample size of 36 patients.\n The trial will aim to open sites with a good geographical spread across the UK and encourage cross-referrals between hospitals to minimise the challenges of recruiting in rare disease groups.", "id": 1210, "split": "test"} +{"trial_id": "NCT05042180", "pmid": "36990475", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence: A Randomized Controlled Trial (CRAVR)\n\nIncluded conditions:\n- Alcohol Dependence, in Remission\n- Addiction, Alcohol\n\nStudy Armgroups:\n- {'label': 'Virtual Reality Cognitive Behavioral Therapy (VRCBT)', 'type': 'EXPERIMENTAL', 'description': 'The VR exposure is performed to induce alcohol craving and high-risk induced reactions during the therapy session, in order to trigger a lifelike response to alcohol, while the therapist is present and able to train the participant in applying CBT-based coping strategies to deal with the alcohol cravings.', 'interventionNames': ['Behavioral: Virtual Reality Cognitive Behavioral Therapy (CRAVR)']}\n- {'label': 'Cognitive Behavioral Therapy (CBT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'CBT is made up of the following elements: i) recognition (ii) avoiding and (iii) overcoming drinking cravings in high-risk situations with the aim of preventing relapse.', 'interventionNames': ['Behavioral: CBT']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Virtual Reality Cognitive Behavioral Therapy (CRAVR)', 'description': 'Participants in the intervention group will scheduled for 14 treatment sessions based on manualized cognitive behavioral therapy assisted with alcohol-related high risk situations in virtual reality. VR-assisted gradual exposure therapy is integrated as a part of CBT. I.e. VR scenes are used in CBT to induce craving for coping strategy skill training and cognitive analysis.', 'armGroupLabels': ['Virtual Reality Cognitive Behavioral Therapy (VRCBT)']}\n- {'type': 'BEHAVIORAL', 'name': 'CBT', 'description': 'The active comparator receives 14 conventional cognitive behavioral therapy sessions with', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT)']}\n\nPrimary Outcomes:\n- {'measure': 'Reduction in total alcohol consumption', 'description': 'Percent change in alcohol consumption, defined as \"x\" grams of alcohol for past 30 days. This will be registered using the Timeline-Follow-Back (TLFB) method.', 'timeFrame': 'Baseline, 6 months, 9 months, 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha: 5%, Power: 90%, Estimated SD: 34.5, Dropout rate: 50%", "answer": 102, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome measure (total alcohol consumption) was used for the sample size calculation. Based on data from the study by Johnson et al, where the reduction in the percentage of consumption was 60.3% in the intervention group and 32.7% in the control group, with an alpha of 5%, a power of 90% and an estimated SD of 34.5, the estimated sample size is of 68 patients (34 in each group).39 With an estimated dropout rate of 50%, a total of 102 patients (51 in each arm) are needed. The patients will be randomised into two groups with 51 patients in each group, using the randomisation module in Research Electronic Data Capture (REDCap).", "id": 1211, "split": "test"} +{"trial_id": "NCT05042700", "pmid": "37696629", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Melatonin in Patients With Low Anterior Resection Syndrome\n\nIncluded conditions:\n- Low Anterior Resection Syndrome\n\nStudy Armgroups:\n- {'label': 'Melatonin-Placebo sequence', 'type': 'EXPERIMENTAL', 'description': '50% of the included patients will receive 4 weeks of treatment with melatonin, followed by a 4 week wash out period, and then 4 weeks of treatment with placebo. The treatments are blinded.', 'interventionNames': ['Drug: Melatonin', 'Drug: Placebo']}\n- {'label': 'Placebo-Melatonin sequence', 'type': 'EXPERIMENTAL', 'description': '50% of the included patients will receive 4 weeks of treatment with placebo, followed by a 4 week wash out period, and then 4 weeks of treatment with melatonin. The treatments are blinded.', 'interventionNames': ['Drug: Melatonin', 'Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Melatonin', 'description': 'Enema with 25 mg melatonin', 'armGroupLabels': ['Melatonin-Placebo sequence', 'Placebo-Melatonin sequence']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Enema without melatonin', 'armGroupLabels': ['Melatonin-Placebo sequence', 'Placebo-Melatonin sequence']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Low Anterior Resection Syndrome Score', 'description': 'The LARS Score questionnaire is filled out by the participants before and after each treatment period.', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculation is based on a two-sided test with a power of 0.90 and a significance level of 5% (alpha=0.05). An expected attrition rate of 20% is also considered.", "answer": 21, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation is based on data from a similar Scandinavian cohort, which showed a median LARS Score up to 12 months after surgery with early closure of an ileostomy to be 31 (IQR 22\u00e2\u0080\u009336) and with late closure of an ileostomy to be 34 (IQR 28\u00e2\u0080\u009339).46 Based on these IQRs, we have calculated the SD to be 10.5 in the population.47 We assume that the LARS Score can be reduced by 13 points, which is a clinical relevant difference as a patient with a maximum LARS Score of 42 would go from having major LARS to minor LARS. The power calculation is based on two-sided test, and with a power of 0.90 and a significance level of 5% (alpha=0.05), the required sample size is 15. Due to an expected attrition rate of 20%, the study will proceed until 18 patients have been enrolled. In addition, 3 patients will initially be included in an internal feasibility test of the study, thus a total of 21 patients will be included in the study.", "id": 1212, "split": "test"} +{"trial_id": "NCT05045040", "pmid": "36977536", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Facilitating Program Utilizing a Mobile Application for Initiating Advanced Care Planning Discussions Between Patients with Advanced Cancer and Healthcare Providers: Protocol for a Randomized Controlled Trial (J-SUPPORT 2104)\n\nIncluded conditions:\n- End of Life Care\n- Advanced Cancer\n- Recurrent Cancer\n\nStudy Armgroups:\n- {'label': 'Mobile-based empathetic communication support program group', 'type': 'EXPERIMENTAL', 'description': 'Patients are provided a mobile-based empathetic communication support program to promote ACP discussion for patients with advanced cancer and physicians. The experimental group also receives the usual care as is standard practice.', 'interventionNames': ['Behavioral: Mobile-based empathetic communication support program to promote ACP discussion']}\n- {'label': 'Usual care group', 'type': 'NO_INTERVENTION', 'description': \"Patients receive the usual care. The usual care includes routine medical treatment and care by physicians, nurses, pharmacists, and others as well as support from the palliative care team and others as per the patient's situation.\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mobile-based empathetic communication support program to promote ACP discussion', 'description': \"Patients in the intervention group are provided a mobile-based empathic communication support program-an app on a mobile phone. The app comprises a QPL (46 questions in eight categories) and questions about the patient's preferred treatment and end-of-life care based on their values and goals. Then, they proceed with the content themselves, at home or anywhere, at any time. Between app registration and the next outpatient visit, the patient is interviewed (by phone or in person) by a nurse or a clinical psychologist, who helps them prepare for the discussion with the physician and asks questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, feedback is provided to patients and their physicians based on the interview. The duration between the start of app use and the next consultation is a minimum of one week and a maximum of four weeks.\", 'armGroupLabels': ['Mobile-based empathetic communication support program group']}\n\nPrimary Outcomes:\n- {'measure': \"Oncologists' communication behaviors - RE subscale (reassurance and emotional support) from the SHARE scoring manual\", 'description': \"SHARE comprises 26 items and four subscales categorized as S: Supportive environment, H: How to deliver bad news, A: Additional information, and RE: Reassurance and Emotional support. The investigators focus on RE, which assesses oncologists' behavior in providing reassurance and their empathetic responses to participants' emotions. Patient-physician conversation is audio-recorded, and a third person's impression of the physician's communication behavior is scored on a five-point scale (0: not applicable at all, 4: strongly applicable). Higher score indicates better communication behavior.\\n\\nReferences:\\n\\nA randomized controlled trial with a cluster of oncologists evaluating of an integrated communication support program for oncologists, caregivers, and patients with rapidly progressing advanced cancer on patient-centered conversation: J-SUPPORT 1704 study. ASCO Annual Meeting; 2021. J Clin Oncol.\\n\\nFujimori M, et al. Palliat Support Care 2014;12(5):379-86.\", 'timeFrame': 'The first post-baseline visit (up to 4 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 5% with a two-tailed test, a power of 80%, and a drop-out rate of 5% are assumed.", "answer": 264, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n In a previous preliminary study, the effect size of the primary endpoint was 3.1.27 In this study, the principal investigators agree that an effect size of 2.5 would be considered clinically meaningful, given that this is an app-based intervention. Based on a significance level of 5% with a two-tailed test and a power of 80%, 250 participants are required. Previous studies on palliative care had high drop-out rates. This is mainly owing to changes in patients' physical condition over the study period. This study, however, has a short time frame of 1\u00e2\u0080\u00934 weeks to obtain a primary outcome. In a previous study conducted in the same time frame, the drop-out rate before obtaining the primary outcome was 5%.50 Additionally, in a study that adopted surprise questions in the eligibility criteria, the drop-out rate was 6%.24 Therefore, the planned enrolment is 264 patients, assuming a realistic and minimal drop-out rate of 5%.", "id": 1213, "split": "test"} +{"trial_id": "NCT05050526", "pmid": "37280584", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial\n\nIncluded conditions:\n- Pain\n- Mental Disorders\n\nStudy Armgroups:\n- {'label': 'Exercise program', 'type': 'EXPERIMENTAL', 'description': 'Participants in the experimental group will take part in a 12-week exercise program.', 'interventionNames': ['Behavioral: Real-time videoconference-based Exercise program']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will not receive any intervention.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Real-time videoconference-based Exercise program', 'description': \"12-week exercise program consisting of two weekly 45 minute group-based sessions, remotely supervised by a professional via real-time videoconference. Each session will consist of a warm-up (5-10 min), general strengthening (30 min) and cool-down (5-10 min). Warm-up will include general joint mobility and exercises focused on increasing heart rate. General strengthening will include 4 series of 6 exercises (2 for lower limb, 2 for upper limb and 2 for the trunk) performed with minimal equipment, combining body-weight and elastic-band exercises. Three difficulty levels will be set for each of the exercises, and progression will be made at weeks 5 and 9. Participants will be asked to work in a given rate of perceived exertion (between 3 and 5 in Borg's CR10 scale) and not to reach failure in any of the exercises. Cool-down will include stretching and breathing/relaxing exercises.\", 'armGroupLabels': ['Exercise program']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline average pain intensity at 12 weeks', 'description': 'Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 12-week follow-up'}\n- {'measure': 'Change from baseline average pain intensity at 48 weeks', 'description': 'Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 48-week follow-up'}\n- {'measure': 'Change from baseline highest pain intensity at 12 weeks', 'description': 'Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 12-week follow-up'}\n- {'measure': 'Change from baseline highest pain intensity at 48 weeks', 'description': 'Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 48-week follow-up'}\n- {'measure': 'Change from baseline pain frequency at 12 weeks', 'description': 'Number of days in pain during the last 7 days (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 12-week follow-up'}\n- {'measure': 'Change from baseline pain frequency at 48 weeks', 'description': 'Number of days in pain during the last 7 days (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 48-week follow-up'}\n- {'measure': 'Change from baseline pain interference at 12 weeks', 'description': 'Number of days in which pain negatively interferes with work during the last 7 days of work (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 12-week follow-up'}\n- {'measure': 'Change from baseline pain interference at 48 weeks', 'description': 'Number of days in which pain negatively interferes with work during the last 7 days of work (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.', 'timeFrame': 'At baseline and at 48-week follow-up'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha error of 0.05, a beta error of 0.20 (80% power), and a 20% expected dropout rate are assumed.", "answer": 130, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size was calculated to detect a significant change in low back pain that could be relevant in terms of absenteeism from work [54]. Taking into account the average low back pain intensity of 5.0\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00892.6 in the 0\u00e2\u0080\u009310 NRS for pain observed in previous studies carried out by our research group in eldercare workers [55] and accepting an alpha error of 0.05 and a beta error of 0.20 in a bilateral contrast, 108 participants are necessary to detect a difference equal to or greater than 1 unit. The sample size has been increased by 20% due to expected dropouts. Therefore, the required sample will be 130 participants (65 in the control group and 65 in the experimental group).", "id": 1214, "split": "test"} +{"trial_id": "NCT05051618", "pmid": "38632556", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis\n\nIncluded conditions:\n- Multiple Sclerosis\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'POWER-MS', 'type': 'EXPERIMENTAL', 'description': 'The POWER-MS condition will deliver the Guidelines for Exercise in MS (GEMS) program with a remotely coached/guided, home-based setting using telerehabilitation. GEMS recommends 30 minutes of moderate intensity aerobic activity, 3x/week AND strength training exercises for major muscle groups, 3x/week.', 'interventionNames': ['Behavioral: POWER-MS']}\n- {'label': 'FLEX-MS', 'type': 'ACTIVE_COMPARATOR', 'description': 'The FLEX-MS condition will primarily focus on flexibility as the applicable exercise modality. As such, the program will emphasize that flexibility is an important component of fitness. The goal would be for each participant to enhance their flexibility by engaging in a titrated exercise prescription where the number of sets and time to hold per set will increase throughout the 16-week program.', 'interventionNames': ['Behavioral: FLEX-MS']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'POWER-MS', 'description': 'The POWER-MS intervention includes both aerobic exercise and resistance exercise:\\n\\nAerobic Exercise:\\n\\nThe goal of the aerobic exercise training is for participants to achieve three moderate-intensity walking sessions of 30+ minutes per session by the end of the 16-week intervention.\\n\\nResistance Exercise:\\n\\nParticipants will complete resistance exercise training that consists of 1-2 sets (10-15 repetitions) of 5-10 exercises targeting the lower body, upper body, and core muscle groups performed three days per week, with the sets, repetitions and number of exercises increasing based on an individualized difficulty level.', 'armGroupLabels': ['POWER-MS']}\n- {'type': 'BEHAVIORAL', 'name': 'FLEX-MS', 'description': 'The FLEX-MS intervention is specifically a stretching exercise prescription. All exercise movements are consistent throughout the program. At the beginning of the program, the stretching exercise sessions will take five minutes (1 set) three days per week (15 minutes per week). By the end of the 16-week program, the sessions will take about 30 minutes (2 sets) to be performed three days per week (1.5 hours per week).', 'armGroupLabels': ['FLEX-MS']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Depression Severity (self-report)', 'description': 'Patient Health Questionnaire (PHQ-9); scores range between 0 (min) and 27 (max), higher scores indicate greater depression severity.', 'timeFrame': 'baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)'}\n- {'measure': 'Change in Depression Severity (observer-rated)', 'description': 'Hamilton Depression Rating Scale (HDRS-17); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of depressive symptoms.', 'timeFrame': 'baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)'}\n\nPlease estimate the sample size based on the assumption: \nThe power analysis included assumptions of reliability for the within-subjects factor of ICC = 0.50, two-tailed \u03b1 = 0.025, and \u03b2 = 0.05 (i.e., 95% power). The \u03b1 = 0.025 was selected based on two primary outcomes.", "answer": 146, "answer_type": "ESTIMATED", "explanation": "Power analysis and sample size\n The power analysis was conducted in G*Power, Version 3.1 using F test for Test family and ANOVA: Repeated measures, within-between interaction for Statistical test. We estimated the sample necessary for detecting a Condition (2 levels of between-subjects factor: Intervention vs. Control)\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089Time (2 levels of within-subjects factor: 0 and 4\u00c2\u00a0months) interaction on the primary outcomes of depression severity (i.e., 9-item Patient Health Questionnaire (PHQ-9; [36]) and Hamilton Depression Rating Scale (HDRS-17; [37]). We did not include 3 time-points as this assumes linear change across all 3 time points in G*Power 3.1, and we expected change between 0 and 4\u00c2\u00a0months for the intervention condition, followed by stability between 4 and 8\u00c2\u00a0months. The effect size (Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.18) was from our previous meta-analyses [15] regarding the effect of exercise training on depressive symptoms in persons with MS. The power analysis included assumptions of reliability for the within-subjects factor of ICC\u00e2\u0080\u0089=\u00e2\u0080\u00890.50, two-tailed \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025, and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (i.e., 95% power); the \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025 was selected based on two primary outcomes. The power analysis indicated the minimal total sample size for testing the Time\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089Condition interaction of 122 participants (61 per group), and we anticipate a dropout rate of\u00e2\u0080\u0089~\u00e2\u0080\u008920% resulting in a projected recruitment of 146 participants.", "id": 1215, "split": "test"} +{"trial_id": "NCT05051774", "pmid": "35788765", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of a Motivated, Action-based Intervention on Improving Physical Activity Level, Exercise Self-efficacy and Cardiovascular Risk Factors of Coronary Heart Disease Patients: A Randomized Controlled Trial\n\nIncluded conditions:\n- Coronary Heart Disease\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'In addition to usual care, the intervention group will receive the 12 weeks intervention consists of three monthly group education and center-based group exercise followed by 20 minutes of individualized telephone follow-up at weeks 3, 7, and 11.', 'interventionNames': ['Behavioral: 1. Education', 'Behavioral: 2. Exercise', 'Behavioral: 3. Telephone follow-up']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive the usual care provided in the study hospital included an unstructured health education conducted by a nurse on healthy lifestyle and health assessment and brief unstructured health education on their conditions, focusing on the risk factors management and stress management by the cardiologist.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': '1. Education', 'description': 'Three monthly face-to-face group education with 8 to10 participants using a validated educational booklet will be provided by the researcher at the study hospital.', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'BEHAVIORAL', 'name': '2. Exercise', 'description': 'The exercise intervention comprised of two elements as follows:\\n\\n1. Three monthly hospital-based supervised group exercise consists of 8 to 10 participants. First two sessions: warm-up exercise-5 minutes, brisk walking-20 minutes at low intensity with music, and cool-down exercise-5 minutes. Third session: brisk walking for 30 minutes at moderate intensity with music.\\n2. Twelve-weeks home-based exercise: The participants will be asked to continue the exercise performed in the previous week at the hospital with music at least five times per week.', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'BEHAVIORAL', 'name': '3. Telephone follow-up', 'description': 'A 20-minutes telephone follow-up at weeks 3, 7, and 11 for strengthening the volition of the participant to perform the exercise and follow the healthy diet at home.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in physical activity level', 'description': 'The validated Tamil version of International Physical Activity Questionnaire Short Form (IPAQ-SF) will be used to assess the self-reported time spent in walking, moderate and vigorous-intensity activities, and sitting in this study', 'timeFrame': 'Change from baseline physical activity level at 3 months.'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8, a significance level of 0.05 (two-sided), and a 14% attrition rate are assumed.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n The sample size estimation is based on the primary outcomes of the study, namely, the physical activity level. Referring to the findings of the literature review, the effect size on improving physical activity is from 0.5 [25] to 0.8 [26]. Therefore, the smallest effect size of 0.5 [25] will be considered in calculating the sample size for this study. To achieve a power of 1-\u00ce\u00b2 = 0.8 with a significance level of 0.05 (two sides) and account for 14% of the attrition rate [27] of the previous study, a total of 150 participants will be recruited in this study.", "id": 1216, "split": "test"} +{"trial_id": "NCT05053568", "pmid": "34697125", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Live visualised, fluoroscopy-fused, image-guided, left ventricular lead placement on the basis of avoiding scar and targeting late mechanically activated segments.', 'interventionNames': ['Device: CARTBox']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Empirical standard-of-care left ventricular lead placement, in line with current CRT implantation guidelines with electrical guiding on the basis of Q-LV sense.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CARTBox', 'description': 'CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Differences in % of patients with succesfull LV lead location', 'description': 'Lead location, defined as being within, adjacent, or remote from the pre-defined target.', 'timeFrame': 'Direct post-CRT'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided Fisher exact test with 80% power and alpha=0.05. Expected SD below 25% for LV reverse remodelling. Accounting for a 10% rate of failed implantations, loss to follow-up, and incomplete data.", "answer": 130, "answer_type": "ESTIMATED", "explanation": "Sample size\n When comparing image-guided and contemporary implantation of CRT, the proportional difference in within-target LVLP ranges between 6% and 30%, and thus varies considerably.8 In contrast, ADVISE target segments approximately half the size of areas used in previous studies, rendering the chance of fortuitously successful in-target implantation in either study group much smaller.\n We therefore hypothesised that image-guidance will result in a proportional difference in within-target LVLP of at least 27% when compared with empirical lead placement. In order to demonstrate this proportional difference using a two-sided Fisher exact test with 80% power and alpha=0.05, a total of 114 successfully implanted patients are needed.\n Concerning the secondary endpoint of LV reverse remodelling, given an expected SD below 25%, a significant difference in LVESVi reduction between both groups of at least 13% can be detected in 116 patients. Accounting for failed implantations, loss to follow-up and incomplete (echocardiographic) data in about 10% of cases, total sample size necessary was set at 130 patients.", "id": 1217, "split": "test"} +{"trial_id": "NCT05054985", "pmid": "35321900", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)\n\nIncluded conditions:\n- Thoracoabdominal Aortic Aneurysms\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Patients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form.', 'interventionNames': ['Device: Multi-Branched Thoracoabdominal Stent Graft System']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Multi-Branched Thoracoabdominal Stent Graft System', 'description': \"Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .\", 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.', 'description': 'Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.', 'timeFrame': 'Within 30 days after procedure'}\n- {'measure': 'Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.', 'description': 'Successful treatment of thoracoabdominal aortic aneurysm is a composite index that needs to meet the following indicators at the same time: Immediate technical success (immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body and no type I/III endoleak), no secondary surgical intervention related to thoracoabdominal aortic aneurysms 12 months after procedure (due to aneurysm rupture, continuous enlargement, stent displacement, type I/III endoleak, branch stenosis/ Second surgery caused by occlusion) .', 'timeFrame': '12 months after procedure.'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for at least 80% power with a one-sided significance level of 0.25% (alpha). A dropout rate of 20% is assumed.", "answer": 73, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n As the end point of the GUARANTEE study differs from that of the t-Branch studies, the expected end point incidences were obtained based on data extracted from previous studies.6 11 12 We hypothesised that the performance of this multibranched stent graft system will not be inferior to that of the t-Branch stent graft; in this setting, the expected 30-day major adverse event rate and 12-month successful TAAA treatment rate were determined to be 6.3% and 85.7%, respectively. Currently, no guiding principle exists regarding objective performance criteria (OPC) for a multibranched stent graft system in China. After thorough deliberation by a panel composed of clinical and statistical experts, the OPC of the 30-day adverse event rate and 12-month successful TAAA treatment rate were set as 20% and 70%, respectively.\n The minimum study sample size required to obtain at least 80% power with a one-sided significance level of 0.25% (alpha), thereby detecting a difference between the expected technical success rate of 85.7% and the OPC of 70% is 58 patients; assuming a dropout rate of 20%, the required enrolled sample size is 73 patients. To detect a difference between the expected adverse event rate of 6.3% and the OPC of 20% with a power of 80% and one-sided significant level of 0.25%, a sample size of 53 patients is required; assuming a dropout rate of 20%, the required enrolled sample size is 67 patients. Therefore, the aim is to enrol a total of 73 patients in the clinical trial.", "id": 1218, "split": "test"} +{"trial_id": "NCT05055544", "pmid": "35750460", "question": "Here is the design of a clinical trial:\n\nOfficial Title: BeaRberry in the Treatment of Acute UncoMplIcated Cystitis (BRUMI)- Protocol of a Multicentre, Randomized Double-Blind Clinical Trial\n\nIncluded conditions:\n- Cystitis\n\nStudy Armgroups:\n- {'label': 'Fosfomycin', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A)', 'interventionNames': ['Drug: Fosfomycin']}\n- {'label': 'Bearberry', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).', 'interventionNames': ['Drug: Bearberry']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fosfomycin', 'description': 'a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A),', 'armGroupLabels': ['Fosfomycin']}\n- {'type': 'DRUG', 'name': 'Bearberry', 'description': 'a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).', 'armGroupLabels': ['Bearberry']}\n\nPrimary Outcomes:\n- {'measure': 'Change of symptom severity', 'description': 'the change of symptom severity of uncomplicated cystitis after 7 days of treatment. The improvement of symptoms will be determined by using the validated Hungarian version of the Acute Cystitis Symptom Score on day 0 and day 7 according to predefined thresholds', 'timeFrame': 'The 2 time points at which the measurement is assessed is the time of enrollment, after 7 days of treatment.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 0.0294 (type-I error probability). Power: 80%. Drop-out rate: 15%. Descriptive statistics: mean, median, SD, quartiles, relative frequency. Relative risk for the primary endpoint. OR calculation for the primary endpoint. Interim analysis at 50% of planned sample size with adjusted p value of 0.0294.", "answer": 504, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size calculation\n \n Sample size estimation\n Sample size calculation suggests that 504 patients (1:1) will need to be enrolled to confirm or reject the hypothesis for the primary endpoint, that is, improvement of symptoms of uncomplicated cystitis based on the ACSS score at day 7 (80% vs 77%; non-inferiority margin: 14%) with a 15% drop-out, and power 80%. For this calculation we considered the clinical cure rates of different antibiotic treatments in UTI (79%\u00e2\u0080\u009392%).28 Sample size calculation was performed for the dichotomous primary endpoint by using Stata V.16 (StataCorp).\n \n \n Statistical analysis\n Descriptive statistics\u00e2\u0080\u0094mean, median, SD, quartiles and relative frequency\u00e2\u0080\u0094relative risk (dichotomous variables) for the primary endpoint. Statistical analyses will be performed with an error probability of 0.0294 (type-I error probability). A safety analysis will be performed after reaching 10% of the planned sample size. OR will be calculated for the primary endpoint. Statistical analysis will be performed by using R Core Team (2022; R Foundation for Statistical Computing, Vienna, Austria).\n \n \n Interim analysis\n A predefined interim analysis will be performed after reaching 50% of the planned sample size. We will calculate statistical power for the primary endpoint which will decide whether additional subjects should be enrolled or not. If 80% statistical power is reached, no more subjects will be needed, and early stopping will be applied. We will test our hypotheses first in an interim analysis, and at the end of the study, in the final analysis. For this reason, the p value should be adjusted to diminish the probability of type I error; therefore, the corrected level of significance (p value) will be 0.0294.", "id": 1219, "split": "test"} +{"trial_id": "NCT05055544", "pmid": "35750460", "question": "Here is the design of a clinical trial:\n\nOfficial Title: BeaRberry in the Treatment of Acute UncoMplIcated Cystitis (BRUMI)- Protocol of a Multicentre, Randomized Double-Blind Clinical Trial\n\nIncluded conditions:\n- Cystitis\n\nStudy Armgroups:\n- {'label': 'Fosfomycin', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A)', 'interventionNames': ['Drug: Fosfomycin']}\n- {'label': 'Bearberry', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).', 'interventionNames': ['Drug: Bearberry']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fosfomycin', 'description': 'a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A),', 'armGroupLabels': ['Fosfomycin']}\n- {'type': 'DRUG', 'name': 'Bearberry', 'description': 'a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).', 'armGroupLabels': ['Bearberry']}\n\nPrimary Outcomes:\n- {'measure': 'Change of symptom severity', 'description': 'the change of symptom severity of uncomplicated cystitis after 7 days of treatment. The improvement of symptoms will be determined by using the validated Hungarian version of the Acute Cystitis Symptom Score on day 0 and day 7 according to predefined thresholds', 'timeFrame': 'The 2 time points at which the measurement is assessed is the time of enrollment, after 7 days of treatment.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 0.0294 (type-I error probability). Power: 80%. Drop-out rate: 15%. Descriptive statistics: mean, median, SD, quartiles, relative frequency. Relative risk for the primary endpoint. OR calculation for the primary endpoint. Interim analysis at 50% of planned sample size with adjusted p value of 0.0294.", "answer": 504, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Sample size calculation suggests that 504 patients (1:1) will need to be enrolled to confirm or reject the hypothesis for the primary endpoint, that is, improvement of symptoms of uncomplicated cystitis based on the ACSS score at day 7 (80% vs 77%; non-inferiority margin: 14%) with a 15% drop-out, and power 80%. For this calculation we considered the clinical cure rates of different antibiotic treatments in UTI (79%\u00e2\u0080\u009392%).28 Sample size calculation was performed for the dichotomous primary endpoint by using Stata V.16 (StataCorp).", "id": 1220, "split": "test"} +{"trial_id": "NCT05056376", "pmid": "38755706", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs\n\nIncluded conditions:\n- PreDiabetes\n- Hyperglycemia\n- Glucose, High Blood\n- Overweight\n- Prediabetic State\n- Impaired Glucose Tolerance\n- Obesity\n- Weight Loss\n- Lifestyle, Healthy\n- Lifestyle Risk Reduction\n- Lifestyle, Sedentary\n\nStudy Armgroups:\n- {'label': 'Fully-Automated Digital Diabetes Prevention Program', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive Sweetch Digital Diabetes Prevention Program consists of a smartphone app and bluetooth-enabled digital body weight scale that syncs with the app.', 'interventionNames': ['Behavioral: Digital Diabetes Prevention Program (dDPP)']}\n- {'label': 'Human Coach-Based Diabetes Prevention Program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.', 'interventionNames': ['Behavioral: Human Coach-based Diabetes Prevention Program (hDPP)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Digital Diabetes Prevention Program (dDPP)', 'description': \"The Sweetch app is a hyper-personalized mobile digital coach that provides users with tailored recommendations to promote healthy lifestyle behaviors (150 minutes per week of physical activity, weight reduction, and healthy eating habits) to reduce the risk of type 2 diabetes.\\n\\nThe Sweetch app uses self-tracking and multiple evidence-based persuasive eCoaching strategies. The Sweetch artificial intelligence algorithm delivers just-in-time support and/or adapt recommendations based on the user's response. For example, push notifications will be sent when the algorithm detects that the user is potentially available and able to act upon the recommendation, based on various parameters including location, previous response, calendar availability, and weather, etc.\", 'armGroupLabels': ['Fully-Automated Digital Diabetes Prevention Program']}\n- {'type': 'BEHAVIORAL', 'name': 'Human Coach-based Diabetes Prevention Program (hDPP)', 'description': 'The Human Coach-Based Diabetes Prevention Program will consist of a CDC recognized lifestyle change program. Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.', 'armGroupLabels': ['Human Coach-Based Diabetes Prevention Program']}\n\nPrimary Outcomes:\n- {'measure': \"Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)\", 'description': 'The achievement is defined as attainment of one or more of the following:\\n\\n1. At least 5% weight loss at 12 months.\\n2. At least 4% weight loss at 12 months and at least 150 minutes/week of physical activity (measured using monthly serial Actigraphy and averaged over months 1-11)\\n3. At least 0.2% reduction in A1C at 12 months (for participants whose A1C result obtained at baseline study visit is between 5.7% and 6.4%).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) set at 0.05, 80% power, and a conservative attrition rate of 25% at the 12-month mark. The probability of success (\u03c0s) is likely to fall in the 30\u201340% range, but 50% was used for non-inferiority sample size calculations.", "answer": 368, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Under a 1:1 randomization design, with a significance level (alpha) set at 0.05 and 80% power, and assuming that 50% of participants achieve the primary outcome in both study arms, it is necessary to enroll 138 participants in each of the two arms, resulting in a total study sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089276.\n Considering a conservative attrition rate of 25% at the 12-month mark, the adjusted sample size is increased to 184 participants per group, totaling 368 participants. This adjustment ensures that the minimal necessary analyzable sample of 276 is retained.\n If there is indeed no difference between the h-DPP and ai-DPP, then having 276 participants allows us to be 80% confident that the upper limit of a one-sided 95% confidence interval will exclude a difference in favor of the h-DPP by more than 15%. Although it is acknowledged that the probability of success (\u00cf\u0080s) is likely to fall in the 30\u00e2\u0080\u009340% range, we used 50% in the non-inferiority sample size calculations. This choice was made because it results in the largest necessary sample size among all options for \u00cf\u0080s, making the study robust in terms of statistical power across various values for \u00cf\u0080s.", "id": 1221, "split": "test"} +{"trial_id": "NCT05057312", "pmid": "38840086", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Promoting HPV Vaccination Among Young Adults in Texas\n\nIncluded conditions:\n- Human Papillomavirus Infection\n\nStudy Armgroups:\n- {'label': 'Group I (standard CDC information)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants receive standard CDC information about HPV vaccination.', 'interventionNames': ['Other: Informational Intervention', 'Other: Interview', 'Other: Questionnaire Administration']}\n- {'label': 'Group II (video narratives)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive video narratives about HPV vaccination.', 'interventionNames': ['Other: Informational Intervention', 'Other: Interview', 'Other: Questionnaire Administration']}\n- {'label': 'Group III (written narratives)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive written narratives about HPV vaccination.', 'interventionNames': ['Other: Informational Intervention', 'Other: Interview', 'Other: Questionnaire Administration']}\n- {'label': 'Group IV (enhanced access to vaccine, CDC information)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.', 'interventionNames': ['Other: Enhancing Accessibility to Health Care', 'Other: Informational Intervention', 'Other: Interview', 'Other: Questionnaire Administration']}\n- {'label': 'Group V (enhanced access to vaccine, video narratives)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive enhanced access to vaccination and video narratives about HPV vaccination.', 'interventionNames': ['Other: Enhancing Accessibility to Health Care', 'Other: Informational Intervention', 'Other: Interview', 'Other: Questionnaire Administration']}\n- {'label': 'Group VI (enhanced access to vaccine, written narratives)', 'type': 'EXPERIMENTAL', 'description': 'Participants receive enhanced access to vaccination and written narratives about HPV vaccination.', 'interventionNames': ['Other: Enhancing Accessibility to Health Care', 'Other: Informational Intervention', 'Other: Interview', 'Other: Questionnaire Administration']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Enhancing Accessibility to Health Care', 'description': 'Receive enhanced access to vaccination', 'armGroupLabels': ['Group IV (enhanced access to vaccine, CDC information)', 'Group V (enhanced access to vaccine, video narratives)', 'Group VI (enhanced access to vaccine, written narratives)']}\n- {'type': 'OTHER', 'name': 'Informational Intervention', 'description': 'Receive standard CDC information', 'armGroupLabels': ['Group I (standard CDC information)', 'Group IV (enhanced access to vaccine, CDC information)']}\n- {'type': 'OTHER', 'name': 'Informational Intervention', 'description': 'Receive video narratives', 'armGroupLabels': ['Group II (video narratives)', 'Group V (enhanced access to vaccine, video narratives)']}\n- {'type': 'OTHER', 'name': 'Informational Intervention', 'description': 'Receive written narratives', 'armGroupLabels': ['Group III (written narratives)', 'Group VI (enhanced access to vaccine, written narratives)']}\n- {'type': 'OTHER', 'name': 'Interview', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (standard CDC information)', 'Group II (video narratives)', 'Group III (written narratives)', 'Group IV (enhanced access to vaccine, CDC information)', 'Group V (enhanced access to vaccine, video narratives)', 'Group VI (enhanced access to vaccine, written narratives)']}\n- {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (standard CDC information)', 'Group II (video narratives)', 'Group III (written narratives)', 'Group IV (enhanced access to vaccine, CDC information)', 'Group V (enhanced access to vaccine, video narratives)', 'Group VI (enhanced access to vaccine, written narratives)']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of human papillomavirus (HPV) vaccination initiation', 'timeFrame': 'At 3 months'}\n- {'measure': 'Rate of HPV vaccination completion', 'timeFrame': 'At 9 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided alpha of 0.005 (with a Bonferroni adjustment) is used for each test. The study assumes 15% attrition at 3-month follow-up and 20% attrition at 9-month follow-up. The power analysis indicates excellent power (82%~99%) to detect group differences.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Our sample size calculations are mainly based on hypothesis testing for both vaccination initiation and vaccination completion in Aim 1, with a two-sided alpha of 0.005 (=\u00e2\u0080\u00890.05/10) (with a Bonferroni adjustment) for each test. This adjustment is used because Aim 1 has 10 tests in total, including five comparisons specified in hypotheses for each of the two HPV vaccination outcomes. The five comparisons are for two simple effects (i.e., written/video narrative\u00e2\u0080\u0089+\u00e2\u0080\u0089access vs. control), two marginal effects (i.e., written/video narrative vs. no narrative), and a main effect (access vs. no access). The assumed HPV vaccination rates for these comparison groups are calculated based on the expected vaccination rates inferred from the literature [20, 21, 33, 34] for the six groups (i.e., control, written narratives, video narratives, access only, access\u00e2\u0080\u0089+\u00e2\u0080\u0089written, and access\u00e2\u0080\u0089+\u00e2\u0080\u0089video): 12%, 20%, 22%, 20%, 40%, and 42% at 3-month follow-up for initiation, and 4%, 10%, 11%, 15%, 30%, and 32% at 9-month follow-up for completion, respectively. Post-attrition sample sizes used for power analysis represent the worst-case scenario and thus provide conservative estimates. Assuming 15% and 20% attrition at 3- and 9-month follow-ups, a total sample size of 1200 at baseline yields 1020 for analysis of vaccination initiation (1200*85%=1020) and 960 for completion (1200*80%=960), respectively. Sample sizes available per group for each comparison/test (written/video narratives\u00e2\u0080\u0089+\u00e2\u0080\u0089access vs. control, written/video narrative vs. no narratives, access vs. no access) are 170, 340, and 510 for HPV vaccination initiation and 160, 320, and 480 for HPV vaccination completion, respectively. Power analysis using nQuery 7.0 [35] shows that these sample sizes will have excellent power (82%~99%) to detect group differences in each of the 10 tests.", "id": 1222, "split": "test"} +{"trial_id": "NCT05057819", "pmid": "36123073", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Double-blind, Placebo-controlled Crossover Trial Assessing the Impact of the SGLT2 Inhibitor Empagliflozin on Postprandial Hypoglycaemia After Gastric Bypass\n\nIncluded conditions:\n- Dumping Syndrome\n- Hypoglycemia, Reactive\n\nStudy Armgroups:\n- {'label': 'Empagliflozin first, Placebo second', 'type': 'EXPERIMENTAL', 'description': 'Oral empagliflozin 25 mg daily in the morning for 20 days, followed by oral placebo (daily in the morning) for 20 days after a wash-out period of 2-6 weeks', 'interventionNames': ['Drug: Empagliflozin 25 MG', 'Drug: Placebo']}\n- {'label': 'Placebo first, Empagliflozin second', 'type': 'PLACEBO_COMPARATOR', 'description': 'Oral placebo (daily in the morning) for 20 days, followed by oral empagliflozin 25 mg daily in the morning for 20 days after a wash-out period of 2-6 weeks', 'interventionNames': ['Drug: Empagliflozin 25 MG', 'Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Empagliflozin 25 MG', 'description': 'Treatment naive patients with bariatric bypass surgery will be given oral empagliflozin 25mg once daily for 20 days', 'armGroupLabels': ['Empagliflozin first, Placebo second', 'Placebo first, Empagliflozin second']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Treatment naive patients with bariatric bypass surgery will be given oral placebo once daily for 20 days', 'armGroupLabels': ['Empagliflozin first, Placebo second', 'Placebo first, Empagliflozin second']}\n\nPrimary Outcomes:\n- {'measure': 'Amplitude of change in plasma glucose (difference between peak and nadir plasma glucose concentration in mmol/L) during the mixed meal test.', 'description': 'On day 20 of the intake of either empagliflozin or placebo, participants undergo a mixed meal test. During the test, the amplitude of plasma glucose (difference between peak and nadir plasma glucose concentration in mmol/L) will be measured.', 'timeFrame': 'The outcome will be assessed during the mixed-meal test on the day of the experimental visit at the end of each study period (day 20-24 of the respective study period).'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with a power of 90% at a 5% alpha-level using a two-tailed test. A 20% dropout rate is also assumed.", "answer": 22, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was calculated based on the primary outcome. In a preliminary study involving a sample of 12 patients with PBH, the mean paired-difference (empagliflozin\u00e2\u0088\u0092placebo) of the decrease in plasma glucose following a mixed meal test was \u00e2\u0088\u00921.46\u00e2\u0080\u0089mmol/L (SD 0.31\u00e2\u0080\u0089mmol/L). With a sample size of 17 participants, the study would detect a mean paired-difference of 0.3\u00e2\u0080\u0089mmol/L (this corresponds to an effect size of 0.75 with the assumption of a within participant SD of 0.35\u00e2\u0080\u0089mmol/L) with a power of 90% at a 5% alpha-level using a two-tailed test. To allow for 20% dropouts, a sample size of 22 will be recruited. The power calculation was carried out using G*Power (V.3.1).", "id": 1223, "split": "test"} +{"trial_id": "NCT05058092", "pmid": "36064731", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial\n\nIncluded conditions:\n- Fibromyalgia\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The Remedee Solution consists of:\\n\\n* a wristband designed to deliver millimeter wave\\n* a mobile application that allows the patient to follow his treatment sessions\\n* a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment\\n\\nThe use of the Remedee Solution start at the randomization day (D0)', 'interventionNames': ['Device: Immediate Remedee Solution']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'The Remedee Solution consists of:\\n\\n* a wristband designed to deliver millimeter wave\\n* a mobile application that allows the patient to follow his treatment sessions\\n* a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment\\n\\nThe use of the Remedee Solution start at three months (M3) after randomization day', 'interventionNames': ['Device: Delayed Remedee Solution']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Immediate Remedee Solution', 'description': '* D0 to M3: Remedee Solution + medical care\\n* M3 to M6: Remedee Solution without personalized support + medical care\\n* M6 to M9: medical care only', 'armGroupLabels': ['Intervention']}\n- {'type': 'DEVICE', 'name': 'Delayed Remedee Solution', 'description': '* D0 to M3: medical care only\\n* M3 to M6: Remedee Solution + medical care\\n* M6 to M9: Remedee Solution without personalized support + medical care', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of patients who significantly improve their fibromyalgia-specific quality of life on the FIQ questionnaire between the inclusion visit at D0 and the 3-month visit (M3).', 'description': 'A decrease in FIQ score \u2265 14% is considered clinically meaningful (Bennett et al., 2009)', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, beta risk of 10%, and a 10% risk of loss to follow-up.", "answer": 170, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Considering an alpha risk of 5% and a beta risk of 10%, and assumptions of a rate of patients with a clinically relevant decrease in FIQ of 50% in the Immediate solution group, versus 25% in the Delayed solution group, the number of subjects needed for a comparison of proportions is 77 per group (154 in total). Considering a 10% risk of loss to follow-up, the number of 85 patients per group will be retained (170 patients in total). The clinically relevant decline retained is 14% on the FIQ scale [29].", "id": 1224, "split": "test"} +{"trial_id": "NCT05058547", "pmid": "35470201", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Evidence-based Digital Support for One Year to Facilitate a Sustainable Return to Work for Persons With Chronic Musculoskeletal Pain and Their Employers: Study Protocol for a Registry-based Multicentre Randomized Controlled Trial.\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'SWEPPE', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive the smartphone application SWEPPE.', 'interventionNames': ['Device: SWEPPE']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants randomized to the control group will not receive any active intervention for return to work after completing an Interdisciplinary Pain Rehabilitation Program .'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SWEPPE', 'description': 'In the smartphone application SWEPPE the individual can create an action plan, perform daily registrations of health aspects, self-monitoring of health aspects and goals, have access to a library with evidence-based facts and a coach, and possibility to share information with the employer.', 'armGroupLabels': ['SWEPPE']}\n\nPrimary Outcomes:\n- {'measure': 'Sick leave', 'description': 'Number of gross and net days with sickness cash benefit', 'timeFrame': '12 months follow up after IPRP'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a significance level of 0.05, and an allowance for 20% of participants lost to follow-up.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n The null hypothesis in this trial is that there will be no difference between the intervention group and the control group concerning the primary outcome sick leave. Since there is no established minimal clinical important difference regarding sick leave, the sample size calculation was inspired by previous research regarding patterns of sick leave after IPRP.49 50 It has been shown that the distribution of sick leave among persons with chronic pain change over time from full-time to partial sick leave after IPRP49 and sick leave are reduced with approximately 16 net days from 1\u00e2\u0080\u0089year before to 2\u00e2\u0080\u0089years after IPRP.50 Therefore, an estimated difference between the groups of 20 net days with an SD of 60 and an effect-size of 0.333 was set for rejection of the null hypothesis. To detect this difference with a power of 80% and a significance level of 0.05\u00e2\u0080\u0089a total sample size of approximately 300 participants (150/group) are needed. With an allowance for 20% of participants lost to follow-up we aim to recruit a total sample size of 360 participants (n=180 intervention, n=180 control). To reach the target sample size, participants will be recruited from multiple special and primary care level healthcare providing IPRP for patients with chronic pain.", "id": 1225, "split": "test"} +{"trial_id": "NCT05059379", "pmid": "38195438", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery\n\nIncluded conditions:\n- Breast Cancer\n- Radiotherapy; Complications\n- Effect of Radiation Therapy\n\nStudy Armgroups:\n- {'label': 'Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and medial supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.', 'interventionNames': ['Radiation: Medial supraclavicular lymph node radiotherapy']}\n- {'label': 'Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)', 'type': 'EXPERIMENTAL', 'description': 'Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular node. Treatment will be given by normfractionated or hypofractionated radiotherapy (50Gy/25Fx/5w or 42.5Gy/16Fx/3.5w). IMRT and VMAT technique are recommended.', 'interventionNames': ['Radiation: Entire supraclavicular lymph node radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Entire supraclavicular lymph node radiotherapy', 'description': 'Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.', 'armGroupLabels': ['Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)']}\n- {'type': 'RADIATION', 'name': 'Medial supraclavicular lymph node radiotherapy', 'description': 'Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.', 'armGroupLabels': ['Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)']}\n\nPrimary Outcomes:\n- {'measure': 'Disease free survival (DFS )', 'description': 'defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer', 'timeFrame': 'Up to 5 years after completion of radiation therapy'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a two-sided significance level (\u00ce\u00b1) of 0.05 and 80% power. A 10% dropout rate is also considered.", "answer": 1650, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n The primary endpoint is DFS. According to data from a Chinese prospective study, the 5-year DFS for high-risk patients after breast-conserving surgery or mastectomy is 73% [19] (control group). We assume a clinically meaningful difference in 5-year DFS of 5% between groups. The hypothesis of the current study is that the 5-year DFS will be superior in the E-SCLI group (experiment group) compared to the M-SCLI group (control group), with a 5-year DFS increase from 73% in the M-SCLI group to 78% in the E-SCLI group. Sample size calculation for comparing DFS was performed with a two-sided \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 80% power. Hazard ratio is 0.79. This yields to a total sample size of 1500 patients. Accounting for a 10% dropout rate, the total sample size is increased to 1650 patients (825 per group). Based on these assumptions, it is estimated that 510 events will be required for the final analysis. Statistical analysis will be performed based on the intent-to-treat principle, with all patients analyzed as randomized, regardless of eligibility or protocol compliance.", "id": 1226, "split": "test"} +{"trial_id": "NCT05059873", "pmid": "37247957", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels\n\nIncluded conditions:\n- Acute Exacerbation of COPD\n- Corticosteroid\n- Morality\n- Lung Diseases, Obstructive\n- Blood Eosinophil Count\n- COPD\n- Pulmonary Disease, Chronic Obstructive\n\nStudy Armgroups:\n- {'label': 'Systemic corticosteroid group', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization.', 'interventionNames': ['Drug: Prednisone']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Oral prednisone 40mg/day for five consecutive days', 'armGroupLabels': ['Systemic corticosteroid group']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Oral placebo of 40mg/day for five consecutive days', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment failure rates', 'description': 'Collect during index hospitalization and within 30 days after discharge. Treatment failure is defined as either one of events: a) requiring or receiving invasive or non-invasive MV during the index hospitalization; b) requiring or transferring to ICU during the index hospitalization; c) length of index hospitalization longer than 14 days; d) death during the index hospitalization or within 30 days after discharge; e) readmission with acute exacerbations of COPD within 30 days after discharge.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 80% power with a type I error rate of 5%. A dropout rate of 10% is assumed.", "answer": 11, "answer_type": "ACTUAL", "explanation": "Sample size\n The aim of this trial was to establish whether oral systematic corticosteroid therapy was superior to placebo in terms of clinical outcome (treatment failure rates). Based on a Cochrane meta-analysis on administration of systematic corticosteroids compared with placebo,11 the treatment failure rate of the corticosteroid treatment group was approximately 50% lower than that of the placebo control group. The failure rate of the intervention group and control group is assumed to be 13% and 25%, respectively. A margin of superiority of 12% is considered to be a minimally clinically relevant difference in patients with AECOPD.11 There will be 205 patients in each group, 410 in total, in order to have 80% power, assuming that the type I error rate is 5%. The final study population is comprised of 456 patients assuming a dropout rate of 10%.", "id": 1227, "split": "test"} +{"trial_id": "NCT05060731", "pmid": "36918236", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous Ferric Carboxymaltose Versus Oral Ferrous Sulfate Replacement in Anaemia Due to Acute Nonvariceal Gastrointestinal Bleeding (FIERCE): Protocol of a Multicentre Randomised Controlled Trial\n\nIncluded conditions:\n- GastroIntestinal Bleeding\n- Anemia\n\nStudy Armgroups:\n- {'label': 'Oral iron supplementation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to receive oral ferrous sulfate, ca. 200-300 mg every day for 3 months.', 'interventionNames': ['Drug: Oral iron supplementation']}\n- {'label': 'Intravenous iron supplementation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to receive one dose of 1000 mg intravenous ferric carboxymaltose.', 'interventionNames': ['Drug: Intravenous iron supplementation']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oral iron supplementation', 'description': 'Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.', 'armGroupLabels': ['Oral iron supplementation']}\n- {'type': 'DRUG', 'name': 'Intravenous iron supplementation', 'description': 'One dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization.', 'armGroupLabels': ['Intravenous iron supplementation']}\n\nPrimary Outcomes:\n- {'measure': 'Composite outcome', 'description': 'The composite endpoint includes all-cause mortality, unplanned emergency visit (general practitioner or emergency outpatient clinic), and unplanned hospital admission for any reason. The investigators will calculate the proportion of the outcome in each arm.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n30% dropout rate, 80% power, 5% significance level (two-sided \u03c72 test).", "answer": 570, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Available data in the literature regarding the differences in the investigated endpoints and elderly patients are scarce. Therefore, we performed a sample size calculation using data from the Hungarian Gastrointestinal Bleeding Registry collected between 2020 December and 2022. August.31 Post-hoc analysis of all patients who fit our current inclusion criteria and received oral iron at discharge (20 patients) resulted in a 20% occurrence for our primary outcome within 3 months. Reasons for mortality (20/3) and readmission (20/1) were related to ischaemic events. The assessed effect size is similar to already published data. A cohort analysis with elderly patients (>65 years) showed a 4.5% mortality rate for the whole population and a 32% 30-day readmission rate with anaemia. Considering that 28% of that cohort had malignancy and authors assessed all causes of readmission, a 15%\u00e2\u0080\u009320%\u00e2\u0080\u0089lower rate for unplanned rehospitalisation due to anaemia could be imagined if the iron stores are not replenished fast enough.32 Also, another study showed that when elderly patients are discharged with moderate or severe microcytic anaemia, the 3-month mortality rate can reach 8% (without excluding patients with cancer\u00e2\u0080\u009422% of the cases).33\n Based on the RCT of Bager et al, participants receiving intravenous iron had normalised Hb levels after 1\u00e2\u0080\u0089month. Data are lacking about the effect of intravenous iron on the investigated outcomes. However, results from other study populations found a 5% rate of anaemia-related events leading to hospitalisation only with intravenous iron34 35 and 0% mortality (two studies with small sample sizes).8 10 Due to unlimited data, we assumed that intravenous iron could result in at least a 50% risk decrease (to 10%) after non-variceal GIB since it could result in a quicker heamatopoiesis, preventing ischaemic events.10\n With a 30% dropout rate,10 using a power of 80% and a significance level of 5% (two-sided \u00cf\u00872 test) to measure the treatment effect, we calculated a sample size of 570.", "id": 1228, "split": "test"} +{"trial_id": "NCT05062837", "pmid": "37770273", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma\n\nIncluded conditions:\n- Hepatocellular Carcinoma\n\nStudy Armgroups:\n- {'label': 'Hepatectomy Combined With Camrelizumab and Apatinib', 'type': 'EXPERIMENTAL', 'description': 'Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.', 'interventionNames': ['Drug: Hepatectomy Combined With Camrelizumab and Apatinib']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Hepatectomy Combined With Camrelizumab and Apatinib', 'description': 'Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.', 'armGroupLabels': ['Hepatectomy Combined With Camrelizumab and Apatinib']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'OS is defined as the time from the hepatectomy to death from any cause.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nFalse-positive error (significance level) is 0.05, false-negative error (power) is 0.1, and the lost-to-follow-up rate is 15%.", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n The 2-year OS rate for advanced HCC patients with Child-Pugh grade A liver function in the RESCUE trial that underwent first-line treatment with camrelizumab and apatinib was 43.3%.28 Among patients with HCC involving macrovascular invasion, hepatectomy improved about 20% OS than TACE (1\u00e2\u0080\u0089year, 81% vs 68%; 3 years, 46% vs 22%; 5 years, 20% vs 5%). TACE or camrelizumab plus apatinib are palliative treatments for HCC. Given that the progression of intrahepatic lesions is the primary cause of mortality in individuals with advanced HCC, hepatectomy-mediated removal of intrahepatic lesions is expected to improve OS by a minimum of 20% to 63.3% at 2 years. Given the established 24-month enrolment and 24-month follow-up periods, the false-positive and false-negative error values for this trial were respectively set to 0.05 and 0.1, with 15% lost-to-follow-up, resulting in a calculated sample size of 62 patients.", "id": 1229, "split": "test"} +{"trial_id": "NCT05063240", "pmid": "37794523", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health and Survival Outcomes, a Group Sequential Randomised Standard of Care Controlled Trial\n\nIncluded conditions:\n- Breastfeeding, Exclusive\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'Mobile phone text messaging plus prospective motivational interviewing', 'type': 'EXPERIMENTAL', 'description': \"Experimental: Text messaging-motivational interviewing. Every Monday morning, a text message (SMS) will be sent to participants in the intervention group encouraging participants to continue breastfeeding, and inquire if participants have any problems breastfeeding the infants. Participants will be asked to respond within 48 hours, indicating no problem or a problem with breastfeeding that requires help. In addition to text messaging, participants will have motivational interviews post-delivery at weeks 2, 6, and 10. Motivational interviews will explore and support the participant's commitment to continue breastfeeding.\", 'interventionNames': ['Behavioral: Mobile phone text messaging plus prospective motivational interviewing', 'Behavioral: Standard infant feeding counselling']}\n- {'label': 'Standard infant feeding counselling', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard infant feeding counselling as part of routine primary healthcare practice', 'interventionNames': ['Behavioral: Standard infant feeding counselling']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mobile phone text messaging plus prospective motivational interviewing', 'description': 'Interactive weekly mobile phone text messaging plus prospective motivational interviewing at study follow up visits', 'armGroupLabels': ['Mobile phone text messaging plus prospective motivational interviewing']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard infant feeding counselling', 'description': 'Standard infant feeding counselling as part of routine practice at primary healthcare facility', 'armGroupLabels': ['Mobile phone text messaging plus prospective motivational interviewing', 'Standard infant feeding counselling']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants who are exclusively breastfeeding', 'description': 'Number of participants who report giving only breast milk and no other liquid or solid based foods to infants as assessed by the infant feeding questionnaire', 'timeFrame': 'from birth to 6 month of child age'}\n- {'measure': 'Number of participants who are practicing any form of breastfeeding', 'description': 'Number of participants who report giving breast milk and other liquid or solid based foods to infants as assessed by the infant feeding questionnaire', 'timeFrame': 'from birth to 6 months of child age'}\n\nPlease estimate the sample size based on the assumption: \nUsing O'Brien-Fleming boundaries at the 0.05 significance level and 80% power, with an inflation factor of 1.01 for two planned analyses. The sample size is further inflated by 33% to account for a 30% loss to follow-up and 3% of infants testing HIV positive.", "answer": 275, "answer_type": "ESTIMATED", "explanation": "Sample size, power, and detectable differences\n We expect an exclusive breastfeeding rate of 8% at age 6\u00c2\u00a0months in the usual care group [17]. We want to detect a difference of 15% between the intervention and usual care groups (i.e., 23% vs 8%). The traditional fixed sample size computations using WinPepi give a sample size of 182 for a two-sided test. Using inflation factor 1.01 for two planned analyses of O\u00e2\u0080\u0099Brien-Fleming boundaries at the 0.05 significance level and 80% power, we compute the maximum sample size of 182\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00891.01\u00e2\u0080\u0089=\u00e2\u0080\u0089184. The sample size is inflated by 33% to 275, to account for loss to follow-up (30%) and infants who test HIV positive (3%) who are included in the analysis ignoring infant HIV status and repeat the analysis excluding HIV-infected infants. The study is not powered for the co-primary endpoint (i.e., any form of breastfeeding rate at 6\u00c2\u00a0months of age) and secondary endpoints. The co-primary and secondary endpoint analyses are considered exploratory and may only be supportive of the primary analysis of exclusive breastfeeding endpoint. No adjustment to the significance level for testing of multiple co-primary endpoints is made since all the co-primary endpoint analyses are considered exploratory.", "id": 1230, "split": "test"} +{"trial_id": "NCT05064176", "pmid": "38729754", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled Trial\n\nIncluded conditions:\n- Lymphoedema of Leg\n- Lymphedema Arm\n- Lymphedema\n\nStudy Armgroups:\n- {'label': 'Reconstructive lymphatic surgery', 'type': 'EXPERIMENTAL', 'description': 'The intervention treatment is reconstructive lymphatic surgery and consists of the application of lymphovenous anastomosis (LVA), lymph node transfer (LNT) or a combination of both. The choice of reconstructive technique(s) is determined by the surgeon and is based on the algorithm for reconstructive lymphatic surgery of lymphoedema.\\n\\nAdditionally, all patients receive usual care (i.e. maintenance decongestive lymphatic therapy)', 'interventionNames': ['Other: Usual care', 'Procedure: Reconstructive lymphatic surgery']}\n- {'label': 'No surgery', 'type': 'ACTIVE_COMPARATOR', 'description': 'All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Home physical therapist performs usual care and educates the patient to perform self-management\\n\\nUsual care:\\n\\nM1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist):\\n\\n* week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group)\\n* week 3-4: start physical therapy, 2 days/ week: exercises, skin care \\\\& manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care \\\\& MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions)\\n\\nM7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist:\\n\\n- 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up', 'armGroupLabels': ['No surgery', 'Reconstructive lymphatic surgery']}\n- {'type': 'PROCEDURE', 'name': 'Reconstructive lymphatic surgery', 'description': 'For the procedure of LVA:\\n\\n- Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly\\n\\nFor the procedure of LNT:\\n\\n- Aim:\\n\\n1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network;\\n2. Placed lymph nodes induce lymphangiogenesis', 'armGroupLabels': ['Reconstructive lymphatic surgery']}\n\nPrimary Outcomes:\n- {'measure': 'Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)', 'description': 'evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema', 'timeFrame': 'at 18 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, significance level (alpha) of 0.05, drop-out rates of 5%, 10%, 15%, and 20% at various follow-up points, SD of lymphoedema-specific QoL equal to 20, and correlation between baseline and follow-up measurements equal to 0.50.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is calculated to have at least 90% power to detect a difference between the intervention group receiving reconstructive surgery and the control group without surgery, on lymphoedema-specific QoL at 18 months, separately within patients with upper limb lymphoedema and within patients with lower limb lymphoedema. Both comparisons are considered as separate trials and therefore alpha has been set equal to 0.05.\n The planned analysis to compare the groups is a constrained longitudinal data analysis (cLDA),22 using the baseline measurement and the follow-up measurements after 1, 3, 6, 12 and 18\u00e2\u0080\u0089months as outcome. The primary analysis refers to the comparison after 18\u00e2\u0080\u0089months (based on a two-sided test with alpha=0.05). The approach is similar in spirit as an analysis of covariance but does not exclude subjects with one or more missing measurements. The calculation of the required sample size is based on an approach presented by Stroup.23 Information with respect to variability of the lymphoedema-specific QoL score and the correlation between the time points was obtained from two retrospective series (130\u00e2\u0080\u0089patients with arm oedema and 83\u00e2\u0080\u0089patients with leg oedema).\n The following assumptions have been made for the comparison of the lymphoedema-specific QoL:\n \n \n SD of the lymphoedema-specific QOL equal to 20.\n \n \n Correlation between the baseline and each of the follow-up measurements equal to 0.50.\n \n \n Drop-out of 5%, 10%, 15% and 20% after 1 and 3\u00e2\u0080\u0089months, 6\u00e2\u0080\u0089months, 12\u00e2\u0080\u0089months and 18, 24 and 36\u00e2\u0080\u0089months, respectively\n \n \n To detect a difference of 15 points, which is a clinically important difference,13 20 36 subjects are required per group (2\u00c3\u00972\u00c3\u009736=144 subjects in total for the two trials) to have at least 90% power. If the number of subjects is reached before the end of the planned recruitment period of 24 months, recruitment will continue up to 45 subjects per group (180 subjects for the whole study) to obtain more precise information, especially on the set of secondary outcomes. If the number is not attained, the recruitment period will be prolonged.\n The sample size estimation heavily depends on estimates of the variability of the lymphoedema-specific QoL and the correlation with the baseline measurement. Therefore, after inclusion of 40\u00e2\u0080\u0089subjects per group the already available information will be used to verify if the assumptions were plausible (note however that there will be no information yet at the moment of the primary endpoint). If the observed SD and correlations deviate from the assumed values such that the desired power level of 90% is not guaranteed anymore, an increase of the planned sample size will be considered (if feasible). At the moment of this blinded interim analysis for sample size reestimation, the assumed drop-out rates will also be verified. No interim analyses are planned to stop the study earlier for efficacy or futility, this is to avoid loss of information on the secondary endpoints.", "id": 1231, "split": "test"} +{"trial_id": "NCT05064670", "pmid": "36800978", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer\n\nIncluded conditions:\n- Prostate Cancer\n- Breast Cancer\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will, in addition to routine clinical care according to (inter-) national guidelines, receive an exercise program of resistance and aerobic exercise delivered live online by an upskilled exercise professional in group exercise classes twice weekly for 3 months', 'interventionNames': ['Behavioral: Exercise']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive routine clinical care according to (inter-) national guidelines'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': 'A twice weekly, 3-month supervised exercise program of whole body resistance training using body weight and a resistance band, and moderate to high intensity aerobic activities, consisting of a consecutive series of timed exercises performed one after the other (14-18 on the Borg scale). Classes are conducted live in groups through Microsoft Teams. Participants will not receive any contact or exercise support in the 3-month follow-up period following the initial 3-month intervention', 'armGroupLabels': ['Exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Health-related quality of life', 'description': 'Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).', 'timeFrame': 'Baseline, 3 months'}\n- {'measure': 'Health-related quality of life', 'description': 'Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha of 5% (two-tailed), and a 20% attrition rate.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n We aim to include 200 participants in this trial. Sample size calculations have been based on having sufficient power to detect a medium effect size (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5) for the primary endpoint, overall patient-reported HRQoL post-intervention. We regard an improvement in HRQoL in the intervention arm from baseline to three months post-baseline relative to the control arm to be of relevance. With a power of 80% and an alpha of 5% (two tailed) from pre- to post-intervention, a total of 160 participants needs to be included; 80 in each arm.\n To ensure sufficient participant numbers at the completion of the trial, sample size calculations account for a 20% attrition rate, leading to a total sample size of 200 participants.", "id": 1232, "split": "test"} +{"trial_id": "NCT05068713", "pmid": "37712725", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation\n\nIncluded conditions:\n- Liver Transplant; Complications\n\nStudy Armgroups:\n- {'label': 'Hihg Target Mean Arterial Pressure', 'type': 'EXPERIMENTAL', 'description': 'Target of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant.', 'interventionNames': ['Other: Usual Care + High Target of Mean Arterial Pressure']}\n- {'label': 'Low Target Mean Arterial Pressure', 'type': 'ACTIVE_COMPARATOR', 'description': 'Target of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant.', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual Care + High Target of Mean Arterial Pressure', 'description': 'Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.', 'armGroupLabels': ['Hihg Target Mean Arterial Pressure']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.', 'armGroupLabels': ['Low Target Mean Arterial Pressure']}\n\nPrimary Outcomes:\n- {'measure': 'incidence of Acute Kidney Disfunction', 'description': 'Incidence of acute kidney Disfunction according to kdigo criteria.', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nPrimary outcome incidence of 73.7%, power statistic of 80%, alpha of 5%, and incidence of AKI based on an increase in serum creatinine by 1.5 times the baseline value.", "answer": 174, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on the primary outcome incidence of 73.7% (acute renal dysfunction within 7\ndays) obtained from a database of the same population and location, 174 patients\nwill be required to demonstrate an absolute reduction of 20% in the primary\noutcome, with a power statistic of 80% and alpha of 5%. The data used for this\ncalculation were obtained by calculating the incidence of AKI based on an\nincrease in serum creatinine by 1.5 times the baseline value. The criterion used\nto choose the effect (20% absolute reduction in the AKI outcome) was chosen\nbased on the principle of clinical relevance. All patients selected for\ntransplantation will be evaluated regarding the inclusion and exclusion criteria\nand will be informed of the study in a standardized way if able to\nparticipate.", "id": 1233, "split": "test"} +{"trial_id": "NCT05068830", "pmid": "36538409", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease: The ExPlas Study\n\nIncluded conditions:\n- Alzheimer Disease\n\nStudy Armgroups:\n- {'label': 'Exercised plasma (ExPlas)', 'type': 'EXPERIMENTAL', 'description': 'Dosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 ExPlas transfusions during the time span of one year (weekly transfusions in 3 four-week periods)', 'interventionNames': ['Drug: ExPlas']}\n- {'label': 'Octaplasma', 'type': 'ACTIVE_COMPARATOR', 'description': 'Dosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 Octaplasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods)', 'interventionNames': ['Drug: Octaplasma']}\n- {'label': 'Saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'Dosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 saline infusions during the time span of one year (weekly transfusions in 3 four-week periods)', 'interventionNames': ['Drug: Saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'ExPlas', 'description': 'ExPlas (plasma from fit donors) is a Investigational Medicinal Product. ExPlas is plasma drawn by plasmapheresis once a month for 4 months, from a total of 30 donors (aged 18-40, BMI \u226427 kg/m2 and VO2max \\\\>50 mL/kg/min) at the Blood Bank at St. Olavs Hospital. All unites will be virus inactivated by the Intercept method (Cerus corporation, US) in accordance with the procedures at Blood Bank at St. Olavs Hospital.\\n\\nThe transfusion volume will be 200 mL at every time point.\\n\\nThe main study consists of 6 rounds of examinations in addition to 12 plasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline.', 'armGroupLabels': ['Exercised plasma (ExPlas)']}\n- {'type': 'DRUG', 'name': 'Octaplasma', 'description': 'Octaplasma is defined as a Investigational Medicinal Product. Octaplasma is human pooled plasma produced by Octapharma (Lachen, Switzerland). The transfusion volume will be 200 mL at every time point .\\n\\nThe main study consists of 6 rounds of examinations in addition to 12 plasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline.', 'armGroupLabels': ['Octaplasma']}\n- {'type': 'DRUG', 'name': 'Saline', 'description': 'Saline is provided by the hospital pharmacies in Central Norway. The infusion volume will be 200 mL at every time point.\\n\\nThe main study consists of 6 rounds of examinations in addition to 12 saline infusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline.', 'armGroupLabels': ['Saline']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients with adverse events', 'description': 'as a measure for safety and tolerability of the treatment', 'timeFrame': '1 year'}\n- {'measure': 'Number of subjects who comply with the research protocol', 'description': 'as a measure for feasibility', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level is set at 0.05, power at 0.8, and an expected dropout rate leading to the inclusion of 20 participants per group. The average MMSE-NR-3 score is expected to be around 24 with a standard deviation of approximately 3.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size and statistics\n We do not expect that ExPlas will cause more adverse effects than Octaplasma, but have made the following considerations about power calculations related to safety. The most common reaction to transfusion of Octaplasma is allergy and occurs in up to 1% of the elderly. If we consider that ExPlas would cause a dramatic increase in allergic reactions, of for example, 35% versus 1% after Octaplasma treatment, 19 participants will be needed in each group to show significant differences (with alpha 0.05 and power of 0.8). There are substantial uncertainties in the assumptions for this power calculation. However, considering that another study found that transfusing plasma from young donors to patients (n=18) with MCI or early AD was safe with no adverse events,39 we find it likely that 20 patients in each group will be enough to test safety in ExPlas.\n The magnitude of a possible treatment effect of ExPlas is currently not established. The following information has been established: (i) a difference of 2 points on the MMSE score primarily between those receiving ExPlas versus Octaplasma will be clinically relevant after 1 and 2 years; (ii) based on several clinical studies in this population, we expect an average MMSE-NR-3 of about 24 in our population, (iii) based on previous studies, we expect a SD of MMSE-NR-3 score of approximately 3. These assumptions suggest that 17 participants are needed in each group (with alpha 0.05, and power 0.8) to demonstrate a clinically relevant effect of ExPlas. Given potential dropouts, it is reasonable to include 20 in each group. The plan is therefore to include 60 patients in the study.\n For the primary endpoints, counts will be reported and compared using recommended methods for analysis of contingency tables.57 Secondary and other endpoints will be analysed using mixed models with the outcome variable as the dependent variable, treatment group, time and their interaction as categorical covariates, and patient as random effect. In these analyses, we will adjust for the baseline value of the outcome variable, as recommended.64 65", "id": 1234, "split": "test"} +{"trial_id": "NCT05069363", "pmid": "35768101", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Whole-Body Photobiomodulation Therapy for Chronic Pain: a Feasibility Trial\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'All participants in this feasibility trial will receive a course of whole-body photobiomodulation therapy (18 sessions over 6 weeks)', 'interventionNames': ['Device: Whole-Body Photobiomodulation Therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Whole-Body Photobiomodulation Therapy', 'description': \"* All participants entering the trial will receive a course of whole-body PBM therapy\\n* The NovoTHOR Whole-Body PBM therapy device consists of a hinged, clamshell design with light-emitting diodes (LEDs) arranged to emit near-infrared and visible red light therapy is delivered to the entire body at once.\\n* Participants will be expected to lie horizontal in the device with the lid as closed as they are comfortable with.\\n* 18 sessions is the currently recommended and widely instituted and accepted practice with the NovoTHOR device.\\n* The LED equipment delivers red and near infrared light therapy to the participant\\n* Session 1 = 6 minutes\\n* Session 2 = 12 minutes\\n* Sessions 3-18 = 20 minutes\\n* Timescale: 3 treatments/week for 6 weeks\\n* The dosage of LED light (also known as 'fluence') will be equivalent to 25J/cm2. The device will supply a dual wavelength of red and near-infrared light with a 50:50 ratio; 660nm and 850nm respectively\", 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates', 'description': 'Expressed at percentages/proportions', 'timeFrame': '6 months'}\n- {'measure': 'To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates', 'description': 'Expressed as percentages/proportions', 'timeFrame': '6 months'}\n- {'measure': 'To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions', 'description': 'Participant-reported experience questionnaire (qualitative)', 'timeFrame': '6 months'}\n- {'measure': 'To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions', 'description': 'Audio-recorded semi-structured interviews', 'timeFrame': '6 months'}\n- {'measure': 'To assess acceptability of outcome measures', 'description': 'Participant-reported experience questionnaire', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Pain: Brief Pain Inventory-Short Form\\n\\nPain severity - 4xNRS questions (0-40) Interference - 7xNRS questions (0-70)', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Pain: Widespread Pain Index/Symptom Severity Score\\n\\nWPI score 0-19, SSS 0-12. Total out of 31.', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Fatigue: Fatigue Severity Scale\\n\\n9 x Likert scale questions (1-7). Final score=mean', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Sleep disturbance: Jenkins Sleep Questionnaire\\n\\n4 x 0-5 questions (total score out of 20)', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Patient global: Patient Global Impression of Change\\n\\n1-7', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Multidimensional function: Revised Fibromyalgia Impact Questionnaire (FIQR)\\n\\n21 x NRS questions (0-100)', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Anxiety and Depression: Hospital Anxiety and Depression Score\\n\\n7x Likert scale questions (0-3). Total out of 21.', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Tenderness: dolorimeter to apply a set pressure of \\\\<4kg/cm2 to 18 tender points\\n\\nNRS for pain at each point (0-10). MTPS/FIS score total 0 - 180', 'timeFrame': '6 months'}\n- {'measure': 'Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy', 'description': 'Dyscognition: Stroop Test (to assess inhibitory control and processing speed)\\n\\nNumber of correct answers in 60 seconds. No negative marking', 'timeFrame': '6 months'}\n- {'measure': \"To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial\", 'description': 'Participant-reported experience questionnaire (qualitative)', 'timeFrame': '6 months'}\n- {'measure': \"To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial\", 'description': 'Audio-recorded semi-structured interviews', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study follows CONSORT guidelines for feasibility studies, focusing on descriptive analysis of feasibility/process outcomes. Recommendations for sample size calculations in pilot and feasibility trials by Moore et al, Lancaster and Thabane, Lewis et al, and 'rules of thumb' by Kieser and Wassmer were considered. Information power principles will guide the qualitative component, aiming for data saturation of themes.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n The trial will continue until 20 participants are recruited and complete 6 weeks of whole-body PBM therapy. CONSORT guidelines for feasibility studies require a primary evaluation that focuses on descriptive analysis of feasibility/process outcomes (eg, recruitment, adherence and treatment fidelity).36 In order to gauge our sample size, we took data from a 2019 meta-analysis on focused PBM therapy in fibromyalgia,45 as best proxy of the widespread chronic pain and included all of the symptoms under observation in this study. Our chosen sample size takes into account the study population\u00e2\u0080\u0099s number of visits at our clinics, objectives of the study and recommendations for the sample size calculations in pilot and feasibility trials by Moore et al46 Lancaster and Thabane,47 Lewis et al48 as well as the \u00e2\u0080\u0098rules of thumb\u00e2\u0080\u0099 for feasibility trials as set out by Kieser and Wassmer.49\n Sample size for the qualitative component will be guided by the concept of information power.50 Information power uses specific principles which will guide numbers including the sample specificity, the aim of the study, the use of established theory, quality of dialogue and analysis strategy. We will seek to establish data saturation of themes.51 Considering past research52 looking at experiences of an intervention, we will attempt to interview all participants.", "id": 1235, "split": "test"} +{"trial_id": "NCT05069467", "pmid": "37891531", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Acupuncture Versus Sham Acupuncture or Usual Care for Antiandrogen-Induced Hot fLashes in Prostate Cancer (AVAIL): a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Hot Flashes\n- Prostate Cancer\n- Acupuncture\n\nStudy Armgroups:\n- {'label': 'Acupuncture', 'type': 'EXPERIMENTAL', 'description': 'Licensed acupuncturists with more than 5 years of experience will be responsible for administering interventions three times per week for 6 weeks. The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling. Acupuncture was defined as targeting the 10 bilateral acupuncture points: Xinshu (BL15), Shenshu (BL23), Zhongliao (BL33), Sanyinjiao (SP6), Yinlingquan (SP9). The needle will be left in place for 30 minutes with brief manipulation at the beginning, middle, and end of therapy.', 'interventionNames': ['Device: Acupuncture']}\n- {'label': 'Sham Acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.', 'interventionNames': ['Device: Sham Acupuncture']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Patients receiving usual care received neither acupuncture nor sham acupuncture. After the 6-week assessment, patients will be offered the option to receive acupuncture treatment as the acupuncture group.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Acupuncture', 'description': \"For the active acupuncture group, the acupuncturist chose standard points depending on subjects' preferred positions. In addition, up to four acupuncture points were chosen on the basis of subjects' other presenting symptoms (such as fatigue, insomnia, or erectile dysfunction). The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling.\", 'armGroupLabels': ['Acupuncture']}\n- {'type': 'DEVICE', 'name': 'Sham Acupuncture', 'description': 'Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.', 'armGroupLabels': ['Sham Acupuncture'], 'otherNames': ['Placebo Needle', 'Non-penetrating Acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Weekly mean hot flash symptom severity score (HFSSS)', 'description': 'The HFSSS is defined as the product of \"hot frequency\" and \"hot severity\". The severity of hot flashes is assessed based on the duration of hot flashes and physical and emotional symptoms; it is scored as mild, moderate, severe, and very severe (range 1-4, from mild to very severe).', 'timeFrame': 'Baseline to week 6'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation for HFSSS reduction is 4.6. Type I error probability is 5%, and type II error probability is 10%. A 20% dropout rate is considered. A difference smaller than 50% compared with baseline is not clinically relevant.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size is estimated using data from previous clinical studies [12, 14]. We assumed that patients who receive verum acupuncture, sham acupuncture, and usual care will have a 7.5-, 5-, and 3.5-point diminishment after 6 weeks of treatment. With these data, we estimated a 2.5-point difference effect between acupuncture and sham acupuncture and 4-point difference between acupuncture treatment and usual care, with assuming the standard deviation for the HFSSS reduction would be 4.6, probabilities of 5% for type I error, and 10% for type II error. To ensure adequate power for each individual hypothesis testing, a sample size of 96 will be required, which consists of 48 subjects in the verum acupuncture group, 24 subjects in the sham acupuncture group and 24 subjects in the usual care group. Considering 20% of the participants might drop out early or be affected by surgical procedure, resulting in a final estimated sample size of 60 patients in verum acupuncture group, 30 patients in sham acupuncture, and 30 patients in usual care, for a total of 120 participants. Further, we considered a difference smaller than 50% difference compared with baseline not to be clinically relevant.", "id": 1236, "split": "test"} +{"trial_id": "NCT05070338", "pmid": "36123066", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reducing Inappropriate Prescription Opioid Prescribing at Hospital Discharge\n\nIncluded conditions:\n- Opioid Prescribing\n\nStudy Armgroups:\n- {'label': 'Guideline-Based Nudges', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Guideline-Based (Injunctive Norm) Nudges']}\n- {'label': 'Peer-Based Nudges', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Peer-Based (Social Norm) Nudges']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Guideline-Based (Injunctive Norm) Nudges', 'description': 'Surgeons in this arm will receive an email with the following content at the end of each month in which at least two of their patients are discharged with an opioid prescription that exceeds the prescribing guideline for the procedure performed.\\n\\nDear Dr. \\\\[Name\\\\],\\n\\nIn \\\\[month\\\\], at least XX of your patients were discharged with opioid prescriptions exceeding the amounts recommended by safety guidelines for these procedures.\\n\\nFor patient safety, Sutter Health recommends prescribing within the ranges below for these procedures. Doing so will also meet best-practice safety guidelines for post-operative opioid prescribing.\\n\\nWe will continue to send you opioid prescribing safety reports.\\n\\nSincerely, \\\\[Signature\\\\]\\n\\n\\\\[Table displaying recommended ranges of 5mg oxycodone tablets for each procedure\\\\]', 'armGroupLabels': ['Guideline-Based Nudges']}\n- {'type': 'BEHAVIORAL', 'name': 'Peer-Based (Social Norm) Nudges', 'description': 'Surgeons in this arm will receive an email with the following content at the end of each month in which at least two of their patients are discharged with an opioid prescription that exceeds the prescribing guideline for the procedure performed.\\n\\nDear Dr. \\\\[Name\\\\],\\n\\nIn \\\\[month\\\\], at least XX of your patients were discharged with opioid prescriptions exceeding the amount prescribed by YY% of your peers for these procedures.\\n\\nYY% of \\\\[specialty\\\\] surgeons at Sutter Health prescribe within the ranges below for these procedures.\\n\\nWe will continue to send you opioid prescribing safety reports.\\n\\nSincerely, \\\\[Signature\\\\]\\n\\n\\\\[Table displaying recommended ranges of 5mg oxycodone tablets for each procedure\\\\]\\n\\nThe ranges of 5mg oxycodone tablets displayed will be the same as the ranges stipulated by the prescribing guidelines, but this nudge will not mention guidelines.', 'armGroupLabels': ['Peer-Based Nudges']}\n\nPrimary Outcomes:\n- {'measure': 'Share of discharge opioid prescriptions above prescribing guidelines', 'description': 'Prescriptions will be compared to prescribing guidelines via morphine milligram equivalents (MMEs) and coded as within or above guidelines. If no opioid is prescribed at discharge, this will be coded as within guidelines.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study does not explicitly mention assumptions on general statistical parameters such as significance level, power, or missing/dropout rate.", "answer": 778, "answer_type": "ACTUAL", "explanation": "Sample size and characteristics\n Our study intervention targets 778 surgeons (table 2). Though discharge medication orders are sometimes written by a clinician other than the surgeon, such as a hospitalist or nurse practitioner, we posit that the surgeon is still ultimately responsible for all medication orders written for their patients. If surgeons cannot influence medication orders written by other clinicians for their patients, the effect of the intervention will be attenuated.\n \n Table 2\n \n Characteristics of eligible study site surgeons\n \n \n \n \n \n Per cent of surgeons\n \n \n Total (n=778)\n General surgery (n=187)\n Orthopaedic surgery (n=244)\n Obstetric/gynaecological surgery (n=347)\n \n \n \n \n Year of medical degree\n \n \n \u00e2\u0080\u00831960\u00e2\u0080\u00931969\n 0.7\n \u00e2\u0080\u0093\n 0.4\n 1.3\n \n \n \u00e2\u0080\u00831970\u00e2\u0080\u00931979\n 7.3\n 7.9\n 7.4\n 7.0\n \n \n \u00e2\u0080\u00831980\u00e2\u0080\u00931989\n 21.3\n 20.8\n 23.4\n 20.0\n \n \n \u00e2\u0080\u00831990\u00e2\u0080\u00931999\n 28.5\n 30.3\n 23.4\n 31.1\n \n \n \u00e2\u0080\u00832000\u00e2\u0080\u00932009\n 26.2\n 28.7\n 31.6\n 21.0\n \n \n \u00e2\u0080\u00832010\u00e2\u0080\u00932019\n 16.0\n 12.4\n 13.9\n 19.7\n \n \n Sex\n \n \n \n \n \n \n \u00e2\u0080\u0083Female\n 39.9\n 28.2\n 5.0\n 71.7\n \n \n \u00e2\u0080\u0083Male\n 60.1\n 71.8\n 95.0\n 28.3\n \n \n \n \n A total of 778 surgeons targeted by our study intervention operate at a total of 23 physical hospitals. One set of three physical hospitals and another set of two physical hospitals are located together, each set functioning as a hospital campus. A third set of two hospitals essentially share the same surgical staff. We treat each of these three sets as a single hospital for the purposes of this study, both to capture the organisation structure and to minimise the potential for spillover effects, resulting in 19 hospital units. For brevity and clarity, we refer to these 19 hospital units simply as \u00e2\u0080\u0098hospitals\u00e2\u0080\u0099 throughout.", "id": 1237, "split": "test"} +{"trial_id": "NCT05071573", "pmid": "34930182", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimised Electronic Patient Records to Improve Clinical Monitoring of HIV-positive Patients in Rural South Africa (MONART Trial)\n\nIncluded conditions:\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Quality improvement package Identification of a viral load champion whose role will include tracing and recalling patients who need further assessments of their VL or switch to second-line regimen.\\n\\nQIP to address process and clinic impediments to VLM as well as training in antiretroviral treatment monitoring guidelines Training in the use of enhanced TIER.Net technology developed as part of the trial and how to access reports on the dashboard system.\\n\\nAugmentation of TIER.Net with a dashboard system VL results will be imported into TIER.Net daily from the National Health Laboratory Service which will be linked to patients in TIER.Net based on multiple exclusive and linked deterministic rules using a combination of variables such as name, surname, sex, date of birth, date of visit, NHLS lab number, facility and folder number. The information contained in TIER.Net will be used to develop a dashboard which summarises viral load data at individual and clinic level.', 'interventionNames': ['Other: Optimised electronic patient records']}\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': \"Viral load results are manually captured on to the TIER.Net system with filing of the paper results in patients' clinical notes for nurses' review during routine appointments. This is used to produce a monthly enrolment and quarterly cohort reports for the central monitoring of the ART programme.\"}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Optimised electronic patient records', 'description': 'Viral load champions trained in the monitoring of patient on antiretroviral therapy to aid prompt identification of virological failure and institution of appropriate clinical management', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of all patients who have a VL measurement and are virally suppressed (composite outcome) after 12 months of follow up.', 'description': 'Viral suppression defined as VL \\\\< 50 c/mL', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 80% power, design effect of 2 or 3, coefficient of variation (k) of 0.20, and a 3-month recruitment phase.", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n \n Health system gaps\n The precision with which the prevalence of each outcome can be estimated will depends on the prevalence itself and the amount of correlation within clinics (the \u00e2\u0080\u0098design effect\u00e2\u0080\u0099). For a prevalence of 30%, a sample size of 800 patients will allow us to estimate it with a precision of\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00894.5 or\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00895.5% with 95% confidence if the design effect is 2 or 3, respectively. For a prevalence of 60%, the corresponding figures are\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00894.8 and\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00895.9%. This sample size will also allow us to determine the association of factors with a missing VL measurement. For example, if the design effect is 2, assuming the prevalence of missing VL is between 30 and 60%, we would have\u00e2\u0080\u0089>\u00e2\u0080\u008980% power to detect an OR of 2.25 or more for factors associated with missing VL, if the prevalence of the risk factor among those with non-missing VL is between 15 and 70%. This would allow us to identify any strong predictors of missing VL.\n \n \n Evaluation of the intervention\n We estimate that during the 3\u00c2\u00a0month recruitment phase, an average of 150 patients who have been on ART for\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008912\u00c2\u00a0months will attend each clinic. Based on our previous work, we expect that around 50% of patients in the control arm will have a VL measurement and be virally suppressed at the end of follow-up. With 5 clinics per arm, assuming a coefficient of variation, k, of 0.20, and a sample size of 150 patients per clinic, we would have 80% power to detect an increase in the proportion of patients who have a VL measurement and are virally suppressed from 50% in the control arm to 77% in the intervention arm (Table 1).Table 1Numbers needed to demonstrate an improvement in viral load monitoring, for different assumptions regarding clinic size and effect sizesNumber of clinics per armNumber of patients per clinic1Coefficient of variation (k)% with VL suppressed in control% with VL suppressed in interventionPower (%)51000.2045677151000.2045708051000.2050747151000.2050778051000.2055807051000.2055848051500.2045667051500.2045698051500.2050737051500.2050778051500.2055807051500.205584801Harmonic mean to account for varying facility size", "id": 1238, "split": "test"} +{"trial_id": "NCT05078047", "pmid": "37131154", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO\n\nIncluded conditions:\n- Lung Cancer Metastatic\n- Renal Cell Carcinoma\n- Head and Neck Cancer\n- Triple Negative Breast Cancer\n- Merkel Cell Carcinoma\n- Hepatocellular Carcinoma\n- Melanoma\n- Urothelial Carcinoma\n- Colorectal Carcinoma With Microsatellite Instability\n- Esophageal Squamous Cell Carcinoma\n- Endometrial Carcinoma\n- Cervical Cancer\n- Gastric/Gastro-esophageal Junction/Esophageal Adenocarcinoma\n- Basal Cell Carcinoma\n- Squamous Skin Carcinoma\n\nStudy Armgroups:\n- {'label': 'Experimental arm', 'type': 'EXPERIMENTAL', 'description': \"Reduced dose intensity of IO:\\n\\nIO will be administered every 3 months (at the same dose levels) until disease progression, unacceptable toxicity, death or patient's choice or investigator's decision\", 'interventionNames': ['Drug: Reduced dose intensity of IO']}\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': \"Standard IO:\\n\\nContinuation of IO at the same dose levels and rhythmicity until disease progression, unacceptable toxicity, death or patient's choice.\"}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Reduced dose intensity of IO', 'description': \"After 6 months of treatment with standard IO, IO will be administered every 3 months (at the same dose levels) until disease progression, unacceptable toxicity, death or patient's choice or investigator's decision\", 'armGroupLabels': ['Experimental arm']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival (PFS)', 'description': 'The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.', 'timeFrame': 'From randomization to disease progression or death, up to 3 years'}\n\nPlease estimate the sample size based on the assumption: \n5% level of significance, 90% power, 5% lost to follow-up rate", "answer": 646, "answer_type": "ESTIMATED", "explanation": "Sample Size calculation\n Given a HR of 1.3 as the non-inferiority margin, 498 progressions or deaths are necessary to establish the non-inferiority in PFS of the experimental arm versus the control with 5% level of significance and 90% power assuming no difference between arms (HR\u00e2\u0080\u0089=\u00e2\u0080\u00891).\n Assuming 22-month median PFS in both arms, 36-month accrual period, 72-month study duration and a 5% lost to follow-up rate, a total of 646 patients is planned.\n The final analysis is scheduled 3\u00c2\u00a0years after the last patient randomization.", "id": 1239, "split": "test"} +{"trial_id": "NCT05079828", "pmid": "35853017", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 for the Detection of Recurrent Prostate Cancer in PSMA-ligand PET/CT\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Arm 1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive first a PET/CT with 68Ga-PSMA-11 and a second PET/CT with 18F-PSMA-1007', 'interventionNames': ['Diagnostic Test: 18F-PSMA-1007', 'Diagnostic Test: 68Ga-PSMA-11']}\n- {'label': 'Arm 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive first a PET/CT with 18F-PSMA-1007 and a second with 68Ga-PSMA-11', 'interventionNames': ['Diagnostic Test: 18F-PSMA-1007', 'Diagnostic Test: 68Ga-PSMA-11']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': '18F-PSMA-1007', 'description': 'PET/CT scan using 18F-PSMA-1007', 'armGroupLabels': ['Arm 1', 'Arm 2']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': '68Ga-PSMA-11', 'description': 'PET/CT scan using 68Ga-PSMA-11', 'armGroupLabels': ['Arm 1', 'Arm 2']}\n\nPrimary Outcomes:\n- {'measure': 'Patient-level detection rate', 'description': 'The primary endpoint is the proportion of patients with a pathological PSMA-positive finding (= patient-based sensitivity) at one time-point (2h) with the existing standard-of-care (68Ga-PSMA-11) compared to the new tracer (18F-PSMA-1007).', 'timeFrame': '3-6 months following final scan'}\n\nPlease estimate the sample size based on the assumption: \nNon-inferiority design with a one-sided alpha of 2.5%. Power of 85%. Lower limit of a two-sided 95% confidence interval for the difference in the proportion of radiopharmaceutical-positive patients. Assumed correlation of paired measurements is 75%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size determination\n Power was determined using Monte Carlo simulations with 1000 repetitions and the following assumptions:\n \n \n Marginal probabilities: 80% of the patients are positive for radiopharmaceutical A and 80% are positive for radiopharmaceutical B\n \n \n Both radiopharmaceuticals are applied to each patient\n \n \n Non-inferiority design with a one-sided alpha of 2.5%\n \n \n Non-inferiority margin of -10% (clinically acceptable margin in detection rate, balanced against the requirements for clinically realistic number of patients). We justify this margin as being less than 50% of the margin reported for superiority (22%) in a prospective trial published for [68Ga]Ga-PSMA-11 versus the first-generation radiopharmaceutical [18F]-Choline [17].\n \n \n Non-inferiority is concluded if the lower limit of a two-sided 95% confidence interval (Wald with Bonett\u00e2\u0080\u0093Price Laplace adjustment) for the difference in the proportion of radiopharmaceutical-positive patients (new radiopharmaceutical\u00e2\u0080\u0094old radiopharmaceutical) is larger than the non-inferiority margin\n \n \n A pragmatic assumption is made regarding the correlation of the paired measurements. Limited data are available for this, given the dearth of comparative studies. Neither retrospective analyses [21] nor limited pilot studies [22, 23] have demonstrated any difference in detection rate. We take a worst-case scenario, and assume that both radiopharmaceuticals are positive for 75% of the patients.\n \n \n Data was simulated using function rmvbin from R package bindata [24]. With 100 patients this study will have a power of 85% to detect non-inferiority.\n For the exploratory analysis of radiopharmaceutical kinetics (secondary endpoint), N = 10 patients is justified on the previous dosimetry paper for the established PET radiopharmaceutical [68Ga]Ga-PSMA-11 [25].\n \n Strategies to ensure target recruitment\n All patients referred for PSMA-PET/CT in rPC will be screened. We recognise that not all patients will meet our inclusion criteria or will be prepared to participate in this study, and the target sample size represents one fifth of all patients examined at our centre with PSMA-radiotracers yearly.", "id": 1240, "split": "test"} +{"trial_id": "NCT05079841", "pmid": "39207839", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial\n\nIncluded conditions:\n- Oxytocin\n- Labor Pain\n- Induction of Labor Affected Fetus / Newborn\n- Physiologic Effects of Drugs\n\nStudy Armgroups:\n- {'label': 'Intrapartum nipple stimulation', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.', 'interventionNames': ['Device: Electric breast pump']}\n- {'label': 'Exogenous oxytocin intravenous infusion', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.', 'interventionNames': ['Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electric breast pump', 'description': 'Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours', 'armGroupLabels': ['Intrapartum nipple stimulation']}\n- {'type': 'DRUG', 'name': 'Exogenous oxytocin intravenous infusion without nipple stimulation.', 'description': 'Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care', 'armGroupLabels': ['Exogenous oxytocin intravenous infusion'], 'otherNames': ['Pitocin intravenous infusion']}\n\nPrimary Outcomes:\n- {'measure': 'Spontaneous vaginal delivery', 'description': 'Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean', 'timeFrame': 'At delivery'}\n- {'measure': 'Breastfeeding as the sole source of nutrition (BSSN)', 'description': 'Number of participants using breastfeeding as the sole source of nutrition (BSSN) at time of maternal discharge or 72 hours of life (whichever is sooner)', 'timeFrame': 'up to 72 hours following delivery'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses 2-tailed tests with a significance level (\u03b1) of 0.05 and 90% power. An attrition rate of 5% is accounted for. For cost-effectiveness analysis, a 15% attrition rate at 2 weeks postpartum is assumed, with 90% power to detect a standardized effect size of 0.224.", "answer": 988, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power\n The sample size for the trial is based on the primary outcome of spontaneous vaginal delivery for aim 1 (Table 2). All sample size and power estimates are based on 2-tailed tests. This is important because we will be powered to detect both increases and decreases in outcomes with intrapartum nipple stimulation therapy (intervention) versus immediate synthetic oxytocin infusion without nipple stimulation (comparator). The expected rate of spontaneous vaginal delivery in the setting of immediate synthetic oxytocin infusion without nipple stimulation used for the sample size estimation is based on averaged institutional data from the 3 study sites: (62%+66%+70%)/3=66%. Accounting for a 5% attrition rate, we estimate that a total of 988 participants (494 in the nipple stimulation therapy group and 494 in the immediate synthetic oxytocin infusion without nipple stimulation group) will be sufficient to detect a minimum of 9.8% absolute difference (estimated 75.8% with nipple stimulation therapy vs 66% in the comparator group) in spontaneous vaginal delivery with 90% power (2-sided \u00ce\u00b1=.05). Of note, 80% statistical power would be needed to detect a minimum absolute difference of 8.6% (74.6% vs 66%).\n \n Table 2\n \n Sample size estimation for primary outcome.\n \n \n \n \n \n \n \n Detectable absolute difference (%)\n Anticipated with nipple stimulation therapy (%)\n Total sample size across 2 study groups for 90% power, N\n \n \n \n \n 9.4\n 79\n 988\n \n \n 9.6\n 78\n 988\n \n \n 9.7\n 77\n 988\n \n \n 9.8\n 76\n 988\n \n \n 9.9\n 75\n 988\n \n \n 10.0\n 74\n 988\n \n \n 10.1\n 73\n 988\n \n \n 10.1\n 72\n 988\n \n \n \n \n At first glance, the anticipated minimum of approximately 10% absolute increase in the spontaneous vaginal delivery rate in our proposed trial appears modest. On the contrary, because the potential public health impact is large, this effect size is significant. It is estimated that 40% of the 1 million women who undergo inpatient labor induction each year in the United States are nulliparas. Therefore, a minimum of approximately 10% increase in spontaneous vaginal delivery corresponds to 40,000 more spontaneous vaginal deliveries and 40,000 fewer operative and cesarean deliveries each year. Avoiding 40,000 operative or cesarean deliveries each year will have a substantial impact on overall morbidity and health care resource use in the United States and can have broad implications beyond the United States.\n The sample size of 988 for the primary outcome will be sufficient to detect a 9.4% or 10.8% absolute difference in BSSN at the time of delivery and hospitalization postpartum discharge with 80% power and 90% power, respectively (2-sided test, \u00ce\u00b1=.05). This represents the difference between an expected BSSN rate of 45.5% in the setting of synthetic oxytocin infusion without nipple stimulation (average rate at the 3 study sites based on institutional data: 44%+50%+42.5%/3=45.5%) and 54.9% (with 80% power) or 56.3% (with 90% power) with nipple stimulation therapy.\n Assuming a 15% attrition rate at 2 weeks post partum (the time frame for our primary cost-effectiveness analysis in aim 3), the sample size of 988 will have 90% power for detecting a standardized effect size of 0.224 (0.194 for 80% power) for the between-group difference in cost and difference in quality-adjusted life year (QALY; 2-sided test, \u00ce\u00b1=.05). This is considered a small effect size based on conventional criteria; hence, if we observe an even larger effect size, we should be sufficiently powered [68].", "id": 1241, "split": "test"} +{"trial_id": "NCT05080556", "pmid": "39806715", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer\n\nIncluded conditions:\n- Ovarian Cancer\n- Relapsed Ovarian Cancer\n- Fallopian Tube Cancer\n- Peritoneal Cancer\n- Endometrioid Carcinoma\n- High Grade Serous Carcinoma\n- Ovary Cancer\n\nStudy Armgroups:\n- {'label': 'Arm 1 (control) - standard dosing carboplatin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Arm 1 (Standard Dosing): Carboplatin AUC5 based on nuclear medicine renal clearance.', 'interventionNames': ['Drug: Carboplatin']}\n- {'label': 'Arm 2 (experimental) - adaptive therapy carboplatin according to CA125', 'type': 'EXPERIMENTAL', 'description': 'Arm 2 (Adaptive Therapy): Carboplatin dose will be calculated according to the CA125 value.', 'interventionNames': ['Drug: Carboplatin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Treatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2.', 'armGroupLabels': ['Arm 1 (control) - standard dosing carboplatin', 'Arm 2 (experimental) - adaptive therapy carboplatin according to CA125']}\n\nPrimary Outcomes:\n- {'measure': 'Modified Progression Free Survival (mPFS)', 'description': 'Measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) but comparing CT scans to the baseline CT rather than the radiological nadir), clinical progression or death from any cause (in the absence of progression)', 'timeFrame': 'From the date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.'}\n\nPlease estimate the sample size based on the assumption: \n80% power at the one-sided 20% significance level, 3-year recruitment period, 1 year of additional follow-up, and a dropout rate of up to 10% per year.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n A total sample size of N=80 is required to detect an improvement in median mPFS from 5 months in the control arm to 7.5 months with AT, representing an HR (hazard ratio) of 0.667, with 80% power at the one-sided 20% significance level. This assumes a 3-year recruitment period, 1 year of additional follow-up from the last patient randomised and a dropout rate of up to 10% per year. Eligible patients will be randomised equally between the two trial arms using minimisation and stratified by the number of prior lines of chemotherapy (1, 2 or \u00e2\u0089\u00a53), length of platinum\u00e2\u0080\u0090free interval (6\u00e2\u0080\u009312 months or >12 months) and BRCA (Breast Cancer gene) status (positive (pathological mutation only), wild type (including variants of unknown significance) or unknown).", "id": 1242, "split": "test"} +{"trial_id": "NCT05082961", "pmid": "39369231", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Circulating Immunes Cells, Cytokines and Brain Radiotherapy\n\nIncluded conditions:\n- Head and Neck Cancer\n\nStudy Armgroups:\n- {'label': 'X-ray photon therapy + biological samples', 'type': 'OTHER', 'interventionNames': ['Other: Collection of blood samples']}\n- {'label': 'Protontherapy + biological samples', 'type': 'OTHER', 'interventionNames': ['Other: Collection of blood samples']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Collection of blood samples', 'description': 'Samples to evaluate the circulating CD8+ T cell count.', 'armGroupLabels': ['Protontherapy + biological samples', 'X-ray photon therapy + biological samples']}\n\nPrimary Outcomes:\n- {'measure': 'CD8+ T-cell count.', 'timeFrame': 'up to 3 months'}\n\nPlease estimate the sample size based on the assumption: \nNo power calculation was performed. Statistical analysis will be mainly descriptive, using both quantitative and qualitative methods.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n The main criterion is the variation of circulating CD8+ T-cell counts between inclusion prior to radiotherapy and completion of radiotherapy by photons or protons. No power calculation was performed to determine the sample size. The study will be conducted with 40 patients, in 2 groups of 20 patients per modality of radiotherapy (proton therapy and photon therapy). Statistical analysis will be mainly descriptive, based on both quantitative and qualitative methods. In particular, the levels of various circulating biomarkers of immunity, and their evolution before, during and after radiotherapy will be described.", "id": 1243, "split": "test"} +{"trial_id": "NCT05083247", "pmid": "37735634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)\n\nIncluded conditions:\n- Pancreatic Neoplasm\n- Pancreatic Adenocarcinoma\n- Borderline Resectable Pancreatic Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'ACTIVE_COMPARATOR', 'description': 'mFOLFIRINOX (oxaliplatin: 85 mg/m2, CPT-11: 165-180 mg/m2, folinic acid: 400mg/m2 and 5FU 2000-2400 mg/m2/46 h) regimen for 8 cycles every 2 weeks; or\\\\*Gemcitabine-Nab-P: gem: 1000 mg/m2 weekly 3 w/4; nab-P: 125 mg/m2 3 w/4 for 4 cycles in case of unfit for mFFX).', 'interventionNames': ['Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel', 'Procedure: Surgery']}\n- {'label': 'Arm B', 'type': 'EXPERIMENTAL', 'description': 'mFOLFIRINOX for 6 cycles (or for 3 cycles Gemcitabine-Nab-P: gem: 1000 mg/m2 weekly 3 w/4; nab-P: 125 mg/m2 3 w/4 in case of unfit for mFFX) +Isotoxic high-dose SBRT: 5 x 7Gy with Simultaneous Integrated Boost (SIB) up to maximum 55Gy (= 1 week; starting ideally 2 weeks and maximum within 4 weeks after the end of chemotherapy)', 'interventionNames': ['Drug: mFOLFIRINOX or Gemcitabine nab-paclitaxel', 'Radiation: Isotoxic High-Dose (iHD)-SBRT', 'Procedure: Surgery']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'mFOLFIRINOX or Gemcitabine nab-paclitaxel', 'description': 'oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel', 'armGroupLabels': ['Arm A', 'Arm B'], 'otherNames': ['mFFX or Gem/Nab-p']}\n- {'type': 'RADIATION', 'name': 'Isotoxic High-Dose (iHD)-SBRT', 'description': 'Radiation therapy', 'armGroupLabels': ['Arm B']}\n- {'type': 'PROCEDURE', 'name': 'Surgery', 'description': 'Surgery', 'armGroupLabels': ['Arm A', 'Arm B']}\n\nPrimary Outcomes:\n- {'measure': 'Disease free survival', 'description': 'Defined as time from randomisation to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) discovery of hepatic or peritoneal carcinomatosis during surgical exploration, 3) recurrent disease following R0-R1 surgery, or 4) death due to any cause.', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks'}\n- {'measure': 'R0 Resection rate', 'description': 'Defined as the proportion of eligible randomised patients in whom a R0 resection was achieved during surgery after neoadjuvant treatment with FOLFIRINOX +/- iHD-SBRT. R0 resection indicates a microscopically margin-negative resection (\\\\>1 mm) from the inked margins (pancreatic transection, vascular and posterior circumferential resection margins).', 'timeFrame': 'up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided \u03b1-error of 0.025 and \u03b2-error of 0.20, yielding a power of 80%. A 10% inevaluability rate is considered. Interim analysis for futility will be performed after 80 events. B\u00eata spending Lan-Demets functions will be used to control for multiplicity. The study duration is estimated to be 111 months (51 months for accrual + up to 5 years of follow-up).", "answer": 256, "answer_type": "ESTIMATED", "explanation": "Sample size and statistics\n The co-primary endpoints of the study are both R0 resection and DFS after randomisation in the two treatment groups. R0 resection rate is expected to be 40% in the control arm and the difference worth to detect was an absolute increase of 20% (from 40 to 60%)\u00c2\u00a0[34]. Based on the current literature, a median DFS of 11 months post-randomisation was chosen for statistical design, and is expected to be prolonged up to 18 months (which translates into HR:0.61 with the assumption of exponential distributions) [35]. To adjust for two primary comparisons, a two sided \u00ce\u00b1-error of 0.025 and \u00ce\u00b2-error of 0.20, yielding a power of 80%, we assessed sample size separately for both objectives and chose the largest sample size.\n For R0 resection, we need a sample size of 230 evaluable patients. Taking into account a 10% inevaluability rate, 256 patients need to be included to reach the objective related to R0 resection rate.\n For DFS, 160 events will be required; with 5 patients included/ month, this number of events could be reached with the randomisation of 206 patients (both arms). An interim analysis (IA) for futility will be performed after 80 events and is expected to be feasible after the inclusion of 160 patients. B\u00c3\u00aata spending Lan-Demets functions will be used to control for multiplicity. The study could be stopped for futility if, at the IA, the HR estimate is in the interval [0.90; 1.12]).\n The study duration is then estimated to be 111 months (51 months for accrual\u00e2\u0080\u0089+\u00e2\u0080\u0089up to 5 years of follow-up).\n Safety will be assessed after the first 20 patients having received the TNT sequence and surgery. Safety analysis will then be planned every six months. The final decision to terminate the trial in case the criteria for stopping rules and futility are encountered will be done by the sponsor of the study.\n The statistical analysis of efficacy will consist for DFS on HR testing and for R0 resection on the testing of the difference between R0 resection rates. Analysis will also make use of Kaplan-Meier analysis of DFS, OS and duration of response, in the intention-to-treat population. Multivariable analysis of DFS and OS by means of Cox proportional hazards.", "id": 1244, "split": "test"} +{"trial_id": "NCT05083637", "pmid": "36178918", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Role of L-Carnitine Supplementation on Rate of Weight Gain and Biomarkers of Environmental Enteric Dysfunction (EED) in Children With Severe Acute Malnutrition\n\nIncluded conditions:\n- Malnutrition\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Children randomized to this arm will receive L- carnitine oral solution (100mg/ml) (Generic Name) with the dosage- 100 mg/kg/day, divided into 3 doses per day for 15 days.', 'interventionNames': ['Drug: L- carnitine oral solution']}\n- {'label': 'Control Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Children randomized to this arm will receive placebo in same quantity, divided into 3 doses per day for 15 days.Placebo solution will be identical in appearance, smell and taste to the active preparation (L-carnitine syrup) with no therapeutic value.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'L- carnitine oral solution', 'description': 'The L-carnitine syrup formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up', 'armGroupLabels': ['Intervention Arm'], 'otherNames': ['Levocarnitine oral solution']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'The placebo formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up', 'armGroupLabels': ['Control Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of weight gain', 'description': 'The rate of weight gain (g/kg/day) will be calculated by using the formulae below:\\n\\n\\\\[{Weight on completion of study - Weight on enrolment (or at no edema) (g)} / {Total duration (in days) \\\\* weight on enrolment in kg}\\\\]', 'timeFrame': 'Baseline to 15th day of treatment'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of the primary outcome variable is 4.3. The clinically acceptable margin is 0.1. The significance level is set at 95% (Z1-\u03b1 = 1.645). A 10% attrition rate is considered.", "answer": 98, "answer_type": "ACTUAL", "explanation": "Sample size and power\n The sample size is calculated in this study considering the primary outcome variable. The researcher has considered an interventional study by Alp. Haiden et al. as the primary objective [7]. Using the formula n = 2 \u00c3\u0097 (Z1\u00e2\u0088\u0092\u00ce\u00b1+Z1+\u00ce\u00b2\u00ce\u00b4\u00e2\u0088\u0092\u00ce\u00b4\u00e2\u0088\u0098) \u00c2\u00b2 \u00c3\u0097 S\u00c2\u00b2, where n is the sample size required in each group, S is the standard deviation of the primary outcome variable = 4.3, \u00ce\u00b4 is the size of difference of clinical importance = 2.4 (taken from an intervention study where they found that the mean difference between the rate of weight gain in malnourished children after L-carnitine supplementation was 2.4), \u00ce\u00b4\u00cb\u00b3 is the clinically acceptable margin = 0.1, Z1-\u00ce\u00b1 is the value for standard normal distribution at 95% level of significance = 1.645 (at a 5% level of significance). Therefore, the final estimated sample size is 49 participants in each group with a 10% attrition rate. And the total sample size for this study is 98. This sample size will allow us to detect significant differences between-arm in our outcomes.", "id": 1245, "split": "test"} +{"trial_id": "NCT05084898", "pmid": "38279184", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Do Far-UVC Light Devices Reduce the Incidence of Respiratory Viral Illness in Long-term Care Facilities?\n\nIncluded conditions:\n- COVID-19 Respiratory Infection\n- Respiratory Virus Infection\n- Influenza -Like Illness\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Far-UVC light as an additional method of disinfection', 'interventionNames': ['Other: Far-UVC light as an additional method of disinfection']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '\"Inactive\" fluorescent light (no additional disinfection)', 'interventionNames': ['Other: Placebo fluorescent light']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Far-UVC light as an additional method of disinfection', 'description': 'Far-UVC light is a form of ultraviolet light with an extremely short wavelength (222 nm)', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Placebo fluorescent light', 'description': '\"Inactive\" fluorescent light (no additional disinfection)', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'A diagnosis of COVID-19 or other respiratory viral infection', 'description': 'Diagnosis will be based on positive laboratory finding of SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, or other respiratory viral infections (as per available testing). Testing will be performed on nasal swabs collected from participants who are positive for any of the symptoms in the screening protocol.', 'timeFrame': 'Over 3 flu seasons, approximately 28 months'}\n\nPlease estimate the sample size based on the assumption: \nPower was set at 0.8, alpha at 0.05, and the number of clusters in both experimental and placebo groups was 3 each. The intra-class correlation coefficient (ICC) was considered but found to be unreliable due to low incidence rates.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Prior to Phase 1, sample size estimations were limited by uncertainty surrounding the\u00c2\u00a0expected incidence of SARS-CoV-2 in the study setting. The approach taken here was to include as many clusters as feasibly possible given budget and logistical constraints, and then estimate the necessary sample size 1\u00c2\u00a0year into the study.\n The sample size was determined using a log-rank test comparing two survival rates in a cluster randomized design. The intra-class correlation coefficient\u00c2\u00a0(ICC) for the neighborhoods and the survival probability for the entire sample was calculated using the data collected by year 1. The survival probability should be calculated for just the control group; however, using the entire sample enabled the primary biostatistician to remain blinded, which is the recommended practice [29\u00e2\u0080\u009331]. Theoretically, this approach would lead us to overestimate the necessary sample (if we assume the treated group had less or equal cases to the control group).\n At the time of the interim analysis, there were 178 participants in the trial (20\u00e2\u0080\u009325 per cluster), and the median time in the study was 0.98\u00c2\u00a0years (IQR: 0.49\u00e2\u0080\u00931.02). There were 30 cases resulting in an incidence rate of 0.22 (95% CI: 0.15\u00e2\u0080\u00930.31). The ICC was estimated using a random effects logistic regression model [32], but the low incidence rate meant the estimate was not reliable (ICC\u00e2\u0080\u0089=\u00e2\u0080\u00890.12, 95% CI: 0.002\u00e2\u0080\u00930.883). We believe that our incidence rate estimate of 0.22 cases per year is low and unlikely to represent the future rates of infection because of the changes in prevention strategies since the first year of data collection. We have therefore modelled several scenarios where we vary the survival probability between 0.4 and 0.7 (Additional File 1).\n The fixed parameters used were power at 0.8, alpha at 0.05, the number of clusters in the experimental and placebo groups (3 in control and 3 in the treatment), and a hazard ratio of 0.7. Analysis was completed using the Stata\u00e2\u0080\u0099s power logrank, cluster command. We attempted to include varying levels of ICC; however, our sample size estimates were very sensitive to the ICC and could not actually be estimated with our parameters specified above. Without accounting for the ICC, we would require between 470 and 968 participants if the survival probability in the control group was 0.4 or 0.7 respectively. At the time of this calculation, we anticipated recruiting a maximum of 250 participants within our timeline, which would likely leave us underpowered. Based on these results, we added an additional site (five more clusters) and extended the study by a year (i.e., Phase 2). With these modifications, we anticipate being able to recruit approximately 500 persons into the study. We will conduct another interim analysis at year 2 of the study to determine if these modifications will suffice. At that time, we anticipate being able to define our survival probability more accurately and properly account for the ICC in the sample size calculation.", "id": 1246, "split": "test"} +{"trial_id": "NCT05085288", "pmid": "38730383", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial\n\nIncluded conditions:\n- Stage 1 Pressure Ulcer\n- Stage 2 Pressure Ulcer\n\nStudy Armgroups:\n- {'label': 'Intermittent electrical stimulation system (IES) treatment Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes.', 'interventionNames': ['Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours']}\n- {'label': 'Standard of care Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard inpatient nursing practice for wound care, wound care prevention, and any other wound care or plastic surgery treatments deemed appropriate as per usual care.', 'interventionNames': ['Other: Turning population every two hours']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Intermittent electrical stimulation system (IES) treatment and turning patient every two hours', 'description': 'The investigators propose to assess whether addition of the IES system and the use of standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 and stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population.', 'armGroupLabels': ['Intermittent electrical stimulation system (IES) treatment Group']}\n- {'type': 'OTHER', 'name': 'Turning population every two hours', 'description': 'The investigators propose to assess whether current standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries.', 'armGroupLabels': ['Standard of care Group']}\n\nPrimary Outcomes:\n- {'measure': 'Efficacy of adding the IES System to standard of care', 'description': 'Investigators will assess the IES System to determine the efficacy of an IES system after being added to the standard of care on the primary outcome of sacral and ischial pressure injury score measured over time.', 'timeFrame': '24 hours of admission to the ICU or non-ICU hospital service'}\n- {'measure': 'Compare using the IES oppose to only standard care', 'description': 'Investigators will assess time to resolution of the ulcer', 'timeFrame': '24 hours of admission to the ICU or non-ICU hospital service'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to have 90% power at the 0.05 significance level. The sample size calculation incorporates the number of measurements per patient and an assumed intraclass correlation (ICC) to account for within-subject correlation. The design effect is applied to a standard 2-group comparison for independent data.", "answer": 1100, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n Sample size calculations are based on the primary outcome of pressure ulcer score (0\u00e2\u0080\u00934), measured over time within a patient and assuming a statistical model (mixed effects ordinal regression) which accounts for the within-subject correlation over the repeated measurements. We designed the study to have 90% power at the 0.05 significance level to detect a treatment effect as large or larger than the effect seen in Table\u00c2\u00a01 (A) (for the combined starting stages I and II). Sample size was estimated based on applying a design effect to a standard 2-group comparison for independent data (i.e., the Wilcoxon Rank Sum test); it incorporates the number of measurements per patient (m) and an assumed intraclass correlation (ICC) to account for within-subject correlation (i.e., multiply standard sample size calculation by 1\u00e2\u0080\u0089+\u00e2\u0080\u0089(m-1)ICC) [15].\nTable 1Minimal clinically important differences in pressure ulcer scoreA. Combined stages I and IIN\u00e2\u0080\u0089=\u00e2\u0080\u0089586 fixed, assuming single measurement per patientN\u00e2\u0080\u0089=\u00e2\u0080\u0089668 with interim analysis adjustmentPressure ulcer score\u00c2\u00a0(row percent)0IIIIIIIVIntervention82.52.512.52.50Control72.52.51555B. Patients starting at stage IN\u00e2\u0080\u0089=\u00e2\u0080\u0089548 fixed (620 with interims)0IIIIIIIVIntervention8557.52.50Control7551055C. Patients starting at stage IIN\u00e2\u0080\u0089=\u00e2\u0080\u0089616 fixed (697 with interims)0IIIIIIIVIntervention80017.52.50Control7002055Hypothetical percent in each pressure ulcer score category by treatment arm, for smallest clinically important effects: overall (A), for stage I (B), and stage II (C)\n Table 2 gives total sample size for the combined stages in Table\u00c2\u00a01 (A), varying the number of measurements per subject (10, 20, 40) and varying ICC (0.2, 0.5, 0.8). The ICC is expected to be relatively high, so the recommended minimum sample size is 548 total (274/gp) for the overall treatment effect combining stages 1 and 2. However, since sufficient power is desired for each of the 2 starting strata, stage I and stage II, roughly the same sample size (548) should be achieved for each strata (see Table\u00c2\u00a02 for stage I and stage II strata). Therefore, a total maximum (accounting for interim analyses) sample size of approximately 1100 patients was recommended for this trial.\nTable 2Sample size for varying # measurements and ICC. Data\u00e2\u0080\u0089=\u00e2\u0080\u0089N total. Starting with N\u00e2\u0080\u0089=\u00e2\u0080\u0089668 total observations (Table\u00c2\u00a01 (A)), what is the required N subjects accounting for ICC and expected number of measurements/subject?Patient sampleN measurements per patientICC.2.5.8Combined stages Table\u00c2\u00a01 (A) effect101883685482016235154240148344538Stage I start Table 1 (B) effect101743425102015032650440138318500Stage II start Table 1 (C) effect101963845722016836656440154358562N\u00e2\u0080\u0089=\u00e2\u0080\u0089668 assumed 1 measurement per patient (Table\u00c2\u00a01)ICC intraclass correlation", "id": 1247, "split": "test"} +{"trial_id": "NCT05090410", "pmid": "36869356", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate: Comparative Study With Filgotinib and Tocilizumab Examined by Clinical Index as Well as Musculoskeletal Ultrasound Assessment\n\nIncluded conditions:\n- Rheumatoid Arthritis\n- JAK Inhibitor\n- IL-6 Inhibitor\n- Musculoskeletal Ultrasound\n- Biomarker\n\nStudy Armgroups:\n- {'label': 'Filgotinib monotherapy', 'type': 'EXPERIMENTAL', 'description': 'The administration of filgotinib 200mg/day switched from MTX \u00b1 other csDMARDs throughout the study period.', 'interventionNames': ['Drug: filgotinib 200mg/day']}\n- {'label': 'Tocilizumab monotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'The administration of subcutaneous tocilizumab 162mg/biweekly switched from MTX \u00b1 other csDMARDs throughout the study period.', 'interventionNames': ['Drug: subcutaneous tocilizumab 162mg/biweekly']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'filgotinib 200mg/day', 'description': 'Patients will be randomized in a 1:1 ratio to the administration of filgotinib 200mg/day or subcutaneous tocilizumab 162mg/biweekly switched from MTX \u00b1 other csDMARDs throughout the study period.', 'armGroupLabels': ['Filgotinib monotherapy']}\n- {'type': 'DRUG', 'name': 'subcutaneous tocilizumab 162mg/biweekly', 'description': 'Patients will be randomized in a 1:1 ratio to the administration of filgotinib 200mg/day or subcutaneous tocilizumab 162mg/biweekly switched from MTX \u00b1 other csDMARDs throughout the study period.', 'armGroupLabels': ['Tocilizumab monotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'the proportion of patients who achieve an American College of Rheumatology (ACR) 50 response', 'timeFrame': 'at week 12'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical power is 0.80, with a 2-sided 95% confidence interval. A 12% dropout rate is assumed.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the following description of power analysis, the total required number of participants for randomization was estimated to be 400. First, we estimated the sample size to obtain a statistical power of 0.80 in the primary analysis using 2000 pairs of binary sequences generated from the Bernoulli process with the parameter p\u00e2\u0080\u0089=\u00e2\u0080\u00890.40 and the length of a predetermined value n. The value of p, 0.40, was decided based on a previous report [25]. Our null hypothesis is that the difference in the proportions between the 2 groups is higher than the non-inferiority margin, which is 0.15, in our primary analysis. We determined the minimum of the n with which the probability of\u00e2\u0080\u0089>\u00e2\u0080\u00890.80 in rejection of the null hypothesis by counting the number of pairs of binary sequences with which the upper limit of the 2-sided 95% confidence intervals of proportions\u00e2\u0080\u0099 difference [26]\u00e2\u0080\u0089<\u00e2\u0080\u00890.15 among 2000 pairs of binary sequences. Consequently, the minimum of n, which corresponded to the sample size to obtain a statistical power over 0.80, was estimated to be 176 participants per group. Then, we set the target number of patients to 200 participants per group, assuming that 12% of enrolled participants would be excluded from the per-protocol set. The power analysis was conducted in the R: a language and environment for statistical computing [27]. The Wilson score interval of difference was calculated via the diffscoreci (score interval for the difference of proportions) function in the PropCIs package version 0.3.0.", "id": 1248, "split": "test"} +{"trial_id": "NCT05093296", "pmid": "35410938", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder - a Randomized Double-blind Placebo-controlled Parallel-group Trial\n\nIncluded conditions:\n- Alcohol Use Disorder\n- Alcoholism\n- Alcohol Addiction\n\nStudy Armgroups:\n- {'label': 'Oxytocin + Naltrexone', 'type': 'EXPERIMENTAL', 'description': 'All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the experimental group, patients will receive a single dose of 24 I.U. oxytocin nasal spray at two study visits during in-patient treatment:\\n\\n* Visit 2 - First Application of Oxytocin 40 minutes prior to a combined stress- and alcohol cue-exposure during visit 2\\n* Visit 3 - Second Application of Oxytocin 40 minutes prior to an fMRI-based assessment of alcohol cue-reactivity', 'interventionNames': ['Drug: Oxytocin nasal spray', 'Drug: Naltrexone Pill']}\n- {'label': 'Placebo + Naltrexone', 'type': 'ACTIVE_COMPARATOR', 'description': 'All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the comparator group, patients will receive a placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin) at two study visits during in-patient treatment:\\n\\n* Visit 2 - First Application of Placebo 40 minutes prior to a combined stress- and alcohol cue-exposure during visit 2\\n* Visit 3 - Second Application of Placebo 40 minutes prior to an fMRI-based assessment of alcohol cue-reactivity', 'interventionNames': ['Drug: Naltrexone Pill', 'Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oxytocin nasal spray', 'description': '24 I.U. Oxytocin nasal Spray will be administered twice on two separate trial days.', 'armGroupLabels': ['Oxytocin + Naltrexone']}\n- {'type': 'DRUG', 'name': 'Naltrexone Pill', 'description': 'All participants will receive 50mg Naltrexone daily as oral tablet throughout the study', 'armGroupLabels': ['Oxytocin + Naltrexone', 'Placebo + Naltrexone']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin)', 'armGroupLabels': ['Placebo + Naltrexone']}\n\nPrimary Outcomes:\n- {'measure': 'Alcohol Urge Questionnaire (AUQ)', 'description': 'Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ', 'timeFrame': '60 minutes after oxytocin/placebo application and directly after the combined stress- and cue-exposure will serve as primary outcome measure at Visit 3'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.90 using Mann-Whitney U test at a two-sided significance level of \u03b1=5%. A dropout rate of 5% for the primary endpoint is assumed.", "answer": 62, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n To date, no study investigated the combined effects of OXY+NTX on craving in AD. Therefore, no firm prediction of the expected effect size can be made. However, according to previous work investigating new compounds in AD, we assume that only large effects on craving will be of clinical relevance and warrant further confirmatory trials. Hence, the current trial is designed to detect such effects using the AUQ at 60 min after OXY/PLC application (AUQ60min). The AUQ has a range between 8 and 56 and has a considerably skewed distribution; thus, methods assuming a normally distributed outcome are not applicable. Instead, non-parametric methods will be used. We assume a distribution shift of \u00ce\u00b4=4 (ie, 4 points on the AUQ craving scale) in the experimental group, corresponding to an effect that would reflect clinical significance for patients with high craving values. Under these assumptions, a sample size of n=29 patients per group yields a power of 1\u00e2\u0088\u0092\u00ce\u00b2=0.90 when using Mann-Whitney U test at a two-sided significance level of \u00ce\u00b1=5% (according to the sample size formula proposed by Zhao et al.31 The exact values for the cumulative distribution functions assumed under H1, which we used for calculating the sample size, are shown in online supplemental table S1. In order to validate this analytically computed sample size, we conducted a power analysis using PASS V.16 with 1 000 000 simulation runs. These simulations confirmed the result of the analytical sample size calculation, yielding a simulated power of 0.92 for a sample size of 29 patients per group. Based on previous trials at our clinic,21 23 we assume a dropout rate of 5% for the primary endpoint. Hence, n=62 patients (n=31 per group) have to be enrolled and randomised. Using the non-parametric sex-adjusted van Elteren test and the implementation of a predefined imputation strategy, we expected to yield an additional increase in power.\n \n 10.1136/bmjopen-2021-059672.supp1\n Supplementary data", "id": 1249, "split": "test"} +{"trial_id": "NCT05093673", "pmid": "39186573", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cerebellar Stimulation for Aphasia Rehabilitation\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Cathodal Cerebellar tDCS and SFA', 'type': 'ACTIVE_COMPARATOR', 'description': 'Cathodal cerebellar tDCS, 2 milliamp (mA) plus Semantic Feature Analysis (SFA) naming treatment for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes. SFA will be delivered by a Speech and Language Pathologist to improve naming', 'interventionNames': ['Device: Cathodal Cerebellar tDCS', 'Behavioral: Semantic Feature Analysis (SFA)']}\n- {'label': 'Sham Cerebellar tDCS and SFA', 'type': 'SHAM_COMPARATOR', 'description': 'Sham cerebellar tDCS plus SFA for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SFA will be delivered by a Speech and Language Pathologist to improve naming.', 'interventionNames': ['Behavioral: Semantic Feature Analysis (SFA)', 'Device: Sham']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Cathodal Cerebellar tDCS', 'description': '2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes.', 'armGroupLabels': ['Cathodal Cerebellar tDCS and SFA']}\n- {'type': 'BEHAVIORAL', 'name': 'Semantic Feature Analysis (SFA)', 'description': 'Semantic Feature Analysis (SFA) is a treatment technique designed to improve lexical retrieval by increasing the level of activation within a semantic network. The treatment will proceed according to a series of steps including naming aloud the target picture, generating semantic features, naming aloud the target picture again, and generating a sentence using the target word.', 'armGroupLabels': ['Cathodal Cerebellar tDCS and SFA', 'Sham Cerebellar tDCS and SFA']}\n- {'type': 'DEVICE', 'name': 'Sham', 'description': '2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.', 'armGroupLabels': ['Sham Cerebellar tDCS and SFA']}\n\nPrimary Outcomes:\n- {'measure': 'Change in accuracy of naming untrained pictures (Philadelphia Naming Test)', 'description': 'Behavioral measure of change in untrained naming. Scores ranges from 0 to 175 with higher scores meaning better naming ability.', 'timeFrame': 'Pre-treatment to one week after the end of SFA treatment'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, 0.1 level of statistical significance, 10% attrition rate", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n Sample size was determined based on the PI\u00e2\u0080\u0099s prior crossover trial data [30]. That data was used to estimate the variability of untrained naming score. Enrolling 52 participants (26 per group) will give us 80% statistical power to detect 0.7 SD difference in change in accuracy of naming untrained items at 1-week post-treatment between the study arms. This was done using Wald test for group assignment coefficient in linear regression at 0.1 level of statistical significance. The effect size (0.7SD) is a bit conservative compared to the difference observed on group comparison for 21 participants (10 in tDCS and 11 in sham) in the crossover trial data, when the tDCS was administered in Phase 1. We propose to enroll 60 participants to account for 10% attrition. However, if we have trouble meeting recruitment/retention goals, we will add Johns Hopkins Bayview Medical Center as a site.", "id": 1250, "split": "test"} +{"trial_id": "NCT05094180", "pmid": "38066614", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation, Compared to the Traditional Clinical Consultation\n\nIncluded conditions:\n- Various Clinical Conditions Commonly Followed up in a Secondary Hospital\n\nStudy Armgroups:\n- {'label': 'Face-to-face consultation', 'type': 'OTHER', 'interventionNames': ['Other: Face-to-face appointment']}\n- {'label': 'Remote consultation (telephone or video consultation mode)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Remote consultation (telephone or video consultation mode)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Face-to-face appointment', 'description': 'Participants will be scheduled with face-to-face appointments as usual (control arm). All phone calls (except reminders for scheduled visits) performed by the physician during the study will be recorded. Per protocol, participants allocated in the control arm can receive up to 25% of physician-doctor interactions by phone (that is, one phone call allowed for three face-to-face appointments).', 'armGroupLabels': ['Face-to-face consultation']}\n- {'type': 'OTHER', 'name': 'Remote consultation (telephone or video consultation mode)', 'description': \"Patients will be seen through one of the two remote consultation modalities: video consultation or telephone. Patients will receive a reminder by text or call before the appointment.\\n\\nIn the case of telephone consultation, patients will be informed of the date and time slot in which they must wait for the doctor's call. At the time of the appointment, the doctor will call the contact phone number of the patients and/or their family members, starting with the first contact number that appears in the patient's medical history, and using the rest of the contacts available if there is no response. .\\n\\nIn the case of video consultation, at the time of the appointment, patients will receive a link to the application that manages the teleconsultation. Once in the application, they will remain in the virtual waiting room until the doctor switches to the videoconference.\", 'armGroupLabels': ['Remote consultation (telephone or video consultation mode)']}\n\nPrimary Outcomes:\n- {'measure': 'Complications of the underlying disease', 'description': 'Frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nType-I error of up to 2.5%, statistical power of 80%, and 10% of participants lost to follow-up.", "answer": 2136, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n The sample size was estimated based on the primary endpoint of cumulative incidence of complications related to the baseline disease. The sample size analysis was computed with R software [24], following the approach described by Steen A. Julious for non-inferiority trials [25]. Although there is little available information regarding this outcome in the general population of chronic patients, we expect 10% of events in face-to-face consultations [26\u00e2\u0080\u009328] and 12% in the remote consultation arm (based on routine practice of the research team). Assuming a type-I error of up to 2.5% and a statistical power of 80%, 1068 subjects per arm should be analyzed to reject the non-inferiority hypothesis with a non-inferiority margin of 2% and assuming 10% of participants lost to follow-up.\n Altogether, the participating centers schedule 252,000 routine follow-up visits during a period equivalent to the study, corresponding to 121,400 different patients. Therefore, the recruitment of the estimated 2136 patients is considered within the capabilities of the participating centers.\n Owing to the scarcity and heterogeneity of available data about the primary endpoint, a blinded interim analysis will be conducted when 50% of the total sample has been recruited to revise the assumptions used to calculate the sample size, as proposed in the E9 Guide of the ICH on Statistical Principles for Clinical Trials [29].", "id": 1251, "split": "test"} +{"trial_id": "NCT05094557", "pmid": "35732390", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity (SOCRATES)\n\nIncluded conditions:\n- Obesity, Morbid\n\nStudy Armgroups:\n- {'label': 'Experimental Group 1', 'type': 'EXPERIMENTAL', 'description': \"Participants from the Experimental Group 1 will engage in a self-conversation through embodied perspective taking (body swapping), according to which they will be embodied alternately in their own virtual representation and in their counsellor's virtual body. They will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.\", 'interventionNames': ['Behavioral: Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual']}\n- {'label': 'Experimental Group 2', 'type': 'EXPERIMENTAL', 'description': 'Participants from the Experimental Group 2 will be embodied in their own body and will participate in a \"pre-established discourse\" provided by their virtual counsellor. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.', 'interventionNames': ['Behavioral: Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d\u00b4 Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.', 'interventionNames': ['Behavioral: Control Group: Psychoeducational video + Treatment As usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Experimental Group 1: Body swapping VR intervention + psychoeducational video + Treatment As usual', 'description': \"The patient will be embodied in his/her own avatar and will maintain a conversation with a counsellor's avatar of his/her choice. Once the experiment starts, the patient, embodied in his/her own body, will start describing his/her problem in terms of subjective experiences of being obese in daily life. Then, he/she will be body swapped to the counsellor's body and try to respond to the problem just manifested by the patient. The crucial aspect here is that the patient, from the counsellor's viewpoint, will see a representation of his/her real body when looking at the patient's avatar speaking and moving. Therefore, the patient will have the opportunity to see himself/herself in first person (1PP) and second person (2PP) perspectives.\", 'armGroupLabels': ['Experimental Group 1'], 'otherNames': ['EG1']}\n- {'type': 'BEHAVIORAL', 'name': 'Experimental Group 2: VR intervention without body swapping + psychoeducational video + Treatment As usual', 'description': 'Participants from the Experimental Group 2 will be embodied in their own body and will participate in \"pre-established discourse\" provided by the chosen counsellor, who will ask about the perceived barriers for engagement with a healthier lifestyle and will give practical recommendations about how to achieve a healthier and happier life, in terms of healthy eating and physical activity. No body swapping will take place for this group. Participants will also continue receiving Treatment As usual plus a Psychoeducational video with useful information about how to engage with a healthier lifestyle.', 'armGroupLabels': ['Experimental Group 2'], 'otherNames': ['EG2']}\n- {'type': 'BEHAVIORAL', 'name': 'Control Group: Psychoeducational video + Treatment As usual', 'description': 'Participants from the Control Group will receive their Treatment As Usual plus a Psychoeducational video. Treatment as usual will consist of regular medical, nutritional and/or psychiatric follow-ups with the obesity specialists of the Vall d\u00b4 Hebron University Hospital and standard routine tests. These visits aim to provide practical recommendations about how to achieve a gradual weight loss and engage more with physical exercise.', 'armGroupLabels': ['Control Group'], 'otherNames': ['CG']}\n\nPrimary Outcomes:\n- {'measure': 'Readiness to change I', 'description': 'Readiness Rulers are Visual Analogue Scales ranging from 1 to 10 that assess \"Importance\", \"Confidence\" and \"Readiness\" to change. For the present study, these 3 variables will be measured in terms of a) achieving a healthy weight and b) exercising more, while the \"Readiness\" scale will be used as critical response primary variable.', 'timeFrame': 'Baseline (week 0); Post-Experiment1 (week 3)- Baseline; Post-Experiment2 (week 4)- Baseline; Post-Experiment3 (week 5) - Baseline; Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline'}\n- {'measure': 'Readiness to change II', 'description': 'As a complementary readiness to change measure, the Spanish version of the Stages of Change in Overweight and Obese People (S-Weight) and the Processes of Change in Overweight and Obese People (P-Weight) will be used. Regarding P-Weight, lower scores on this scale reflect no use of a given process of change and higher scores reflect the full use of that process. To make scores from the different subscales comparable, these scores are transformed on a scale ranging from 0 to 100.', 'timeFrame': 'Baseline (week 0); Post-Intervention (week 6)- Baseline; 1-week follow-up (week 7)- Baseline; 4-week follow-up (week 10)- Baseline'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an alpha of 0.05 and a power of 0.80 in a two-way repeated measure analysis of variance, with a dropout rate of 20%.", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The a priori sample size calculation was based on results from a previous study with individuals with an ED, which implemented a 2-week self-compassionate letter-writing intervention using the readiness to change ruler.53 A medium between-group effect size (Cohen\u00e2\u0080\u0099 s f=0.28) is expected. The calculation was conducted using the software programme G*POWER. The primary analysis will concern the hypothesis that the average level of readiness to change (\u00e2\u0080\u0098preparation\u00e2\u0080\u0099 to eat healthier and to exercise more domains) at post intervention in the EG1, based on the RR score, will be higher compared with the EG2 and the CG. Assuming an alpha of 0.05 and a power of 0.80 (\u00ce\u00b2\u00e2\u0088\u00921) in a two-way repeated measure analysis of variance, a minimum of 27 participants would be required per study arm (three treatment conditions \u00c3\u0097 four assessment factors). Allowing for a dropout rate of 20% of study participants from baseline, taking the average score of similar previous studies evaluating VR interventions,17\u00e2\u0080\u009319 a total of 96 participants need to be recruited.", "id": 1252, "split": "test"} +{"trial_id": "NCT05095714", "pmid": "38367972", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs\n\nIncluded conditions:\n- Hepatocellular Carcinoma\n- Liver Cancer\n- Cirrhosis\n- Chronic Liver Disease\n\nStudy Armgroups:\n- {'label': 'Enhanced screening', 'type': 'EXPERIMENTAL', 'description': 'Half-yearly liver ultrasound and fast-MRI', 'interventionNames': ['Other: Liver ultrasound and fast-MRI']}\n- {'label': 'Screening recommendations', 'type': 'ACTIVE_COMPARATOR', 'description': 'Half-yearly liver ultrasound', 'interventionNames': ['Other: Liver ultrasound']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Liver ultrasound and fast-MRI', 'description': 'Half-yearly liver ultrasound and fast-MRI', 'armGroupLabels': ['Enhanced screening']}\n- {'type': 'OTHER', 'name': 'Liver ultrasound', 'description': 'Half-yearly liver ultrasound', 'armGroupLabels': ['Screening recommendations']}\n\nPrimary Outcomes:\n- {'measure': 'Incremental cost / QALY ratio', 'description': 'Medico-economic efficiency criterion will assess the quality of life using the EQ-5D5L scale and compare their variations to the total costs evaluated for each arm.', 'timeFrame': 'at 36 months'}\n\nPlease estimate the sample size based on the assumption: \nBilateral alpha risk of 5%, minimum power of 80%, 15% expected follow-up losses, expected annual HCC incidence of \u22653%, bilateral alpha risk of 2.5% for cost-utility ratio analysis.", "answer": 944, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Concerning the clinical efficacy criterion, based on published data, it is anticipated that approximately 28%\u00e2\u0080\u009330% of HCC cases will be detected at a very early stage with the usual US strategy, while an expected 60% detection rate is anticipated for the AMRI strategy. With a bilateral alpha risk of 5%, the inclusion of 944 patients with high-risk HCC (n=821+15% expected follow-up losses) followed for 3 years with an expected annual HCC incidence of \u00e2\u0089\u00a53% (n \u00e2\u0089\u00a574 expected detected HCC cases) will enable the identification of a significant difference with a minimum power of 80%.\n From a medical-economic perspective, only one study has been published13 regarding costs and quality of life expressed in QALYs associated with using liver MRI compared with US for semi-annual surveillance of patients with high-risk HCC. This study, conducted in South Korea, primarily with patients with HBV-related cirrhosis, allows us to anticipate a cost difference of approximately \u00e2\u0082\u00ac800 (\u00c2\u00b1\u00e2\u0082\u00ac150) and a QALY difference of 0.04 (\u00c2\u00b10.15) over a 3-year timeframe. Based on this, and using Glick\u00e2\u0080\u0099s formula26 assuming a maximum willingness to pay per QALY of \u00e2\u0082\u00ac100\u00e2\u0080\u0089000 (which is conservative, as an article from 2020 suggests values of \u00e2\u0082\u00ac150 000\u00e2\u0080\u0093\u00e2\u0082\u00ac200\u00e2\u0080\u0089000 for France), the most unfavourable possible correlation between cost and effect (rho=\u00e2\u0088\u00921), and a bilateral alpha risk of 2.5% (Bonferroni approach for the double medical-economic criterion analysis according to EQ5D or EORTC-QLQC30), the sample size calculation described earlier for clinical efficacy will enable the validation of the cost-utility ratio with a minimum power of 80%.\n To this aim, 944 patients will be recruited in 37 tertiary French centres during a 36-month period and will comprise a 36-month follow-up (table 2).\n \n Table 2\n \n Recruitment and timelines\n \n \n \n \n Number of anticipated patients\n 944\n \n \n Number of recruiting centres\n 37\n \n \n Inclusion period (months)\n 36\n \n \n Follow-up (months)\n 36\n \n \n Number of patients/centre\n 25.51\n \n \n Number of patients/centre/month\n 0.70\n \n \n First included patient\n October 2022\n \n \n End of trial\n October 2028", "id": 1253, "split": "test"} +{"trial_id": "NCT05106608", "pmid": "38267245", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Photobiomodulation Therapy with M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study\n\nIncluded conditions:\n- Head and Neck Cancer\n- Head and Neck Neoplasms\n- Xerostomia\n\nStudy Armgroups:\n- {'label': 'Group PBM_1', 'type': 'EXPERIMENTAL', 'description': 'Energy density 7.5 J / cm2 for group PBM_1', 'interventionNames': ['Device: Energy density photobiomodulation (7.5)']}\n- {'label': 'Group PBM_2', 'type': 'EXPERIMENTAL', 'description': 'Energy density 3 J / cm2 for group PBM_2', 'interventionNames': ['Device: Energy density photobiomodulation (3)']}\n- {'label': 'Placebo Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective glasses) using the same laser device to imitate a real irradiation; however, the device will be turned off and a recording of the emission sounds will be used to give the patient the hearing sensation of the laser therapy.', 'interventionNames': ['Device: Sham placebo']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Energy density photobiomodulation (7.5)', 'description': 'A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.', 'armGroupLabels': ['Group PBM_1']}\n- {'type': 'DEVICE', 'name': 'Energy density photobiomodulation (3)', 'description': 'A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.', 'armGroupLabels': ['Group PBM_2']}\n- {'type': 'DEVICE', 'name': 'Sham placebo', 'description': 'In addition, a mobile health application (LAXER) will be provided.', 'armGroupLabels': ['Placebo Control']}\n\nPrimary Outcomes:\n- {'measure': 'General and specific quality of life.', 'description': 'The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 comprises 30 items on 5 functional scales, 3 symptom scales, 6 single items and a global health scale measured by a 4-point Likert scale with a total score ranging from 0 to 100. Higher scores on the functional and global health scales indicate better functioning or QoL, respectively, but higher scores on the symptom scales or single items indicate a high level of symptoms. In addition, the specific head and neck module (EORTC QLQ-H\\\\&N35) will be used; this module comprises 35 items on 7 multi-item scales and 11 single items scored from 0 to 100. Higher scores indicate more symptoms.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Oral Health. Severity of xerostomia.', 'description': 'Xerostomia Inventory consists of 11 items (score range 1-5) with a total score ranging from 11 to 55 points to rate the severity of chronic xerostomia. A higher score indicates more severe xerostomia.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Oral Health. Dysphagia.', 'description': 'Eating Assessment Tool questionnaire (EAT-10) consists of 10 items related to swallowing difficulties (score range 0-4, 0=no problem, 4=severe problem), with a total score of 3 or higher indicating dysphagia.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Oral Health. Perceived xerostomia.', 'description': 'A numeric visual analog scale (VAS) will be used with with a grade ranging from 0 (no symptoms) to 10 (the worst possible symptoms).', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Oral Health. Degree of mouth opening.', 'description': 'The degree of mouth opening will be determined by the range of motion (ROM) using a sliding caliper, which will measure the maximal interincisal distance in millimeters.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Oral Health. Clinical physical findings (dryness in the mouth).', 'description': 'A total of 10 examples of clinical physical findings where each one represents a feature of dryness in the mouth will be administered through the Clinical Oral Dryness Score (CODS). A score of 2 or more indicates significant oral dryness.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Oral Health. Regional oral dryness.', 'description': 'Regional Oral Dryness Inventory (RODI) quantifies the severity of dryness at 9 different locations in the oral cavity and is represented by 9 illustrations. Patients will indicate the severity of perceived oral dryness using a 5-point Likert scale (1=none, 5=severe).', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Salivary secretion.', 'description': 'The 5-min unstimulated and 5-min stimulated salivary flow rates (SFRs) will be calculated (ml/min) and the volume of each sample will be also calculated (in microlitres). Samples from unstimulated saliva will be used to analyse salivary biomarkers, such as proteins (e.g., antibodies), calcium concentration and pH, using commercial kits.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n- {'measure': 'Salivary gland ultrasound assessment.', 'description': 'The morphology of the parotid and submandibular glands will be assessed using 2D echography (Samsung HM70A echograph) to quantify changes in size in three dimensions.', 'timeFrame': 'Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).'}\n\nPlease estimate the sample size based on the assumption: \nPower of 95%, alpha level of 0.05, three arms, and a maximum loss to follow-up of 15%.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Power and sample size considerations\n The power calculations and sample size will be determined for the primary outcome, the EORTC QLQ-H&N35 specific module,49 through one component, oral dryness (xerostomia). Assuming that the PBM therapy arms will increase QoL in terms of oral dryness with an effect size of d=0.45 (based on a previous study)70 compared with the control arm, with a power of 95% and an alpha level of \u00ce\u00b1=0.05, with three arms, 17 patients will be necessary per arm. 60 patients in total (20 per arm for three arms) will be recruited to allow for a maximum loss to follow-up of 15% (G*Power V.3.1.9.2 for Windows) (online supplemental file 1).\n \n 10.1136/bmjopen-2023-078068.supp1\n Supplementary data\n \n\n\n \n For the estimation of the annual number of eligible patients, it must be emphasised that specific statistics on HNC in Granada (Spain) are not available. Therefore, the potential success in terms of patient eligibility has been extrapolated from previous studies (both prospective and cross-sectional) that involved patients with HNC and were conducted by the research team. Notably, two of these studies indicated a high participation response rate, surpassing the required sample size.71 72 This fact, in conjunction with (1) inclusive eligibility criteria and (2) the observation that approximately 70% of irradiated patients with HNC suffer xerostomia and/or hyposalivation, increasing to 85% at 2 years after RT,3 18 73 suggests an adequate annual number of eligible patients (estimation of the prevalence in men/women in Spain 2020: 71\u00e2\u0080\u0089927 and 23 122, respectively).74 Regarding recruitment rates, past studies have demonstrated rates between 73% and 76%,9 71 75 which indicates that a similar rate might be anticipated for the current trial.\n Establishing an exact mortality rate is challenging owing to the absence of local reference data. Nonetheless, patients eligible for this trial were those who completed medical treatment and were in complete remission; these patients were categorised as disease-free survivors with HNC. Furthermore, given that the time span from the end of RT to the study varies from 1 to 36 months and considering a 5-year relative survival rate of 68% for these patients,76 it is anticipated that the majority of patients will be alive during the study period, excluding deaths due to non-cancer-related causes.", "id": 1254, "split": "test"} +{"trial_id": "NCT05108454", "pmid": "35636782", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of a Business Model of Multiple Micronutrient Supplementations (MMS) Project for Bangladeshi Pregnant Women\n\nIncluded conditions:\n- Infant, Low Birth Weight\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'description': 'Pregnant women who received MMS from the SMC program', 'interventionNames': ['Drug: Multiple micronutrient supplementation']}\n- {'label': 'Comparison', 'description': 'Pregnant women who did not receive MMS'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Multiple micronutrient supplementation', 'description': 'Multiple Micronutrient Supplements (MMS) is a nutritional supplement for use during pregnancy based on United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation following WHO specification. It contains 15 micronutrients including Iron and Folic Acid (IFA) at dosages that approximate the recommended dietary allowances for pregnancy.', 'armGroupLabels': ['Intervention group'], 'otherNames': ['MMS']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of Low birth weight babies', 'description': 'Babies born with birth weight less than 2500 grams', 'timeFrame': 'November 2021 to June 2024'}\n\nPlease estimate the sample size based on the assumption: \n5% level of significance (\u03b1), 80% power, design effect of 1.5%, and 10% attrition rate.", "answer": 4500, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Quantitative survey\n Based on national data, we assume that the proportion of LBW in the control areas will be 20%16 and, due to the intervention, the prevalence of LBW will be reduced by 5% in the intervention group. The effect size of a difference of 5% point between the groups was considered the minimum difference worthy of the intervention. Based on that with a 5% level of significance (\u00ce\u00b1), 80% power, design effect of 1.5% and 10% attrition, the minimum sample size is estimated to be 2988 with a sample size per arm of 1494. Assuming the MMS compliance of 50% among the pregnant women,17 the sample size in the intervention group has been doubled to 1494\u00c3\u00972=2988\u00e2\u0080\u0089and, therefore, the total sample size is 4482. We have rounded this to 4500 pregnant women.\n \n \n Qualitative interviews\n Trained moderators and interviewers whose native language is Bangla with purposively selected respondents will conduct the interviews. In-depth interviews (IDIs) will be conducted with pregnant women, BSP/GSP service providers and their supervisors. Key informant interviews (KIIs) will be conducted with the government and non-governmental organisation stakeholders and policymakers involved in the MMS programme implementation. The duration of each KII will be approximately 60\u00e2\u0080\u009390\u00e2\u0080\u0089min. We have developed separate open-ended guidelines for conducting KII and IDI. The number of interviews will be decided following an iterative process to achieve saturation of information; that is, we will continue interviewing until no new information emerges. For BSP/GSP observation, a checklist will be used. The interview guidelines and questioning routes have been prepared in English and translated into Bangla thereafter.", "id": 1255, "split": "test"} +{"trial_id": "NCT05110001", "pmid": "39192339", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction\n\nIncluded conditions:\n- Acanthamoeba Keratitis\n- Fungal Keratitis\n\nStudy Armgroups:\n- {'label': 'Standard Therapy', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT', 'interventionNames': ['Drug: Moxifloxacin Ophthalmic', 'Drug: Chlorhexidine Gluconate', 'Drug: Natamycin', 'Other: Placebo']}\n- {'label': 'Cross-Linking with rose Bengal (RB-PDT)', 'type': 'EXPERIMENTAL', 'description': 'Patients in this arm will receive topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT', 'interventionNames': ['Drug: Moxifloxacin Ophthalmic', 'Drug: Chlorhexidine Gluconate', 'Drug: Natamycin', 'Drug: Rose Bengal']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Moxifloxacin Ophthalmic', 'description': 'Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis.', 'armGroupLabels': ['Cross-Linking with rose Bengal (RB-PDT)', 'Standard Therapy']}\n- {'type': 'DRUG', 'name': 'Chlorhexidine Gluconate', 'description': 'Topical chlorhexidine gluconate 0.02% is an antiseptic agent, with both antibacterial and antifungal properties. This is a standard therapy for Acanthamoeba keratitis.', 'armGroupLabels': ['Cross-Linking with rose Bengal (RB-PDT)', 'Standard Therapy']}\n- {'type': 'DRUG', 'name': 'Natamycin', 'description': 'Natamycin 5% is an antifungal agent used to treat fungi that cause keratitis. This is a standard therapy for fungal keratitis.', 'armGroupLabels': ['Cross-Linking with rose Bengal (RB-PDT)', 'Standard Therapy']}\n- {'type': 'DRUG', 'name': 'Rose Bengal', 'description': 'Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 5-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure.', 'armGroupLabels': ['Cross-Linking with rose Bengal (RB-PDT)'], 'otherNames': ['Corneal Cross Linking with rose Bengal']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Study participants receive sham RB-PDT within 48 hours of randomization. Participants will receive a 30-minute loading dose of topical balanced salt solution which will be applied in 5-minute intervals to the de-epithelialized cornea. A pen light covered with a green filter will be used for 15 minutes. Repeat cornea culture will be collected 30 minutes after the sham procedure.', 'armGroupLabels': ['Standard Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Best Spectacle-Corrected Visual Acuity', 'description': 'Best Spectacle-Corrected Visual Acuity', 'timeFrame': '6 Months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, 90% power, 15% loss to follow-up, and a residual standard deviation of 0.286.", "answer": 330, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The trial\u00e2\u0080\u0099s sample size calculation was based on the primary outcome, 6-month BSCVA. We informed the calculation with measurements from the first Steroids for Corneal Ulcers Trial (SCUT), among patients enrolled with between 20/60 and 20/400 vision. The SCUT trial measured BSCVA at baseline, 3\u00c2\u00a0months, and 12\u00c2\u00a0months. We conservatively used the 12-month outcome measure for the calculations since there was no 6-month measurement. The standard deviation of BSCVA at 12\u00c2\u00a0months was 0.293 [32]. Since the primary analysis will adjust for baseline BSCVA, we used an estimate of the residual standard deviation, which is.\\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}$$SD_r=SD1-r_2\\quad\\quad\\sqrt{\\mathrm{SDr}=\\mathrm{SD}1-\\mathrm r2}$$\\end{document}SDr=SD1-r2SDr=SD1-r2where r is the correlation between the baseline measure and primary endpoint. In SCUT, the correlation between baseline and 12-month BSCVA among patients with between 20/60 and 20/400 vision at enrollment was 0.216. We thus assumed a residual standard deviation of\\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}$$0.2931-0.{216}_2\\quad\\quad\\sqrt{=0.2860.2931-0.262=0.286}$$\\end{document}0.2931-0.2162=0.2860.2931-0.262=0.286\n Assuming a significance level of 0.05, allowing for approximately 15% loss to follow-up, we estimate that we will have 90% power to detect a 1.1-line difference (logMAR 0.11) between groups with 165 study participants per arm (330 total). For the same sample size and under the same assumptions, the detectable difference at 80% power is 1.0-lines (logMAR 0.10). These calculations were based on the standard power formula for the T-test (using an estimated residual standard deviation).", "id": 1256, "split": "test"} +{"trial_id": "NCT05110924", "pmid": "36356999", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Large Pragmatic RCT Investigating Treatment Versus Non Treatment of Low-risk BCCs in Elderly\n\nIncluded conditions:\n- Basal Cell Carcinoma\n- Elderly\n\nStudy Armgroups:\n- {'label': 'Treatment arm (T-arm)', 'type': 'OTHER', 'description': \"Patients in the T-arm will receive diagnostic investigation(s) as in standard care. This includes clinical and dermoscopic examination and (in most cases) a biopsy to confirm the diagnosis of a BCC. Patients will be asked to fill out a questionnaire (Q) concerning their HrQoL. Important is the possible exclusion of patients (when the biopsy shows the lesion is not a BCC) in this step.\\n\\nPatients will receive treatment of their BCC in accordance with the standard treatment regimen. The treatment will be performed by an independent dermatologist of the investigator's department who is blinded and not aware of the patient's participation in this study. After the treatment, a new Q will be sent out to capture the HrQoL and possible patient-reported side effects. Afterwards, the patients will be followed every 6 to 12 months for 36 months with a clinical evaluation of the previously treated skin site, evaluation of possible complications and the HrQoL and complications Qs.\", 'interventionNames': ['Other: Standard of care']}\n- {'label': 'non-Treatment arm (n-T-arm)', 'type': 'OTHER', 'description': 'Patients allocated to the n-T-arm will receive diagnostic investigations by non-invasive imaging techniques to confirm the diagnosis of a BCC. Patients will be asked to fill out a Q concerning their HrQoL. Important to point out is the possible exclusion of certain patients (when the imaging shows the lesion is not a BCC) in this step.\\n\\nThe patients in this arm will be followed every 6 to 12 months for 36 months. Every study visit there will be a clinical evaluation of the tumor. At the follow-up visits of 6, 12, 24 and 36 months a new documentation of the tumor will take place with in vivo imaging. At these time-points, patients will also be asked to fill out the HrQoL Q and complications Q.\\n\\nBecause of ethical reasons, a maximum tolerable diameter of the tumor has been defined in advance: BCCs in the non-treatment arm that reach a diameter of 4cm will be excluded and will receive treatment.', 'interventionNames': ['Other: Monitoring']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard of care', 'description': 'Patients in the treatment arm will receive standard care.', 'armGroupLabels': ['Treatment arm (T-arm)']}\n- {'type': 'OTHER', 'name': 'Monitoring', 'description': 'Patients in the non-treatment arm will be closely monitored: the tumor will be evaluated using non-invasive imaging devices based on multispectral dermoscopy, reflectance confocal microscopy to determine the exact histology and high definition optical coherence tomography for imaging and volume calculation of the BCC.', 'armGroupLabels': ['non-Treatment arm (n-T-arm)']}\n\nPrimary Outcomes:\n- {'measure': 'Health-related Quality of Life', 'description': 'To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Day 0'}\n- {'measure': 'Health-related Quality of Life', 'description': 'To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Day of Treatment'}\n- {'measure': 'Health-related Quality of Life', 'description': 'To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 6'}\n- {'measure': 'Health-related Quality of Life', 'description': 'To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 12'}\n- {'measure': 'Health-related Quality of Life', 'description': 'To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 24'}\n- {'measure': 'Health-related Quality of Life', 'description': 'To determine the impact on the health-related quality of life in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 36'}\n- {'measure': 'Complication risks', 'description': 'To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Day of Treatment'}\n- {'measure': 'Complication risks', 'description': 'To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 6'}\n- {'measure': 'Complication risks', 'description': 'To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 12'}\n- {'measure': 'Complication risks', 'description': 'To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 24'}\n- {'measure': 'Complication risks', 'description': 'To determine the complication risk in elderly patients with low-risk basal cell carcinomas in the treatment versus the non-treatment arm.', 'timeFrame': 'Month 36'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 30% drop-out rate", "answer": 9, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size calculation was performed using SAS (version 9) power and sample size. A sample size of 104 per group yields 80% to detect a clinically relevant difference in HRQoL of 0.03 (health utility index), assuming a SD of 0.0768. Assuming a drop-out rate up to 30% (patients will be excluded from the RCT if they develop a high-risk BCC or another type of KC (excluding actinic keratosis) during study follow-up), 136 patients are required in each group. This means a total of 272 patients are required in this study with a 1:1 allocation.", "id": 1257, "split": "test"} +{"trial_id": "NCT05114252", "pmid": "37198558", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stereoptic Serious Games as a Visual Rehabilitation Tool for Individuals With Residual Amblyopia: A Crossover Randomized Controlled Trial - AMBlyopia and stEReoptic Games for Vision\n\nIncluded conditions:\n- Amblyopia\n- Healthy\n\nStudy Armgroups:\n- {'label': 'Participants with amblyopia in the serious games intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants with amblyopia receiving the experimental intervention consisting of serious videogames focusing on binocular function (with image modification) in a virtual reality environment.', 'interventionNames': ['Device: Vivid Vision Home']}\n- {'label': 'Participants with amblyopia in the standard care intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants with amblyopia receiving the standard care intervention consisting of wearing spectacles with individualized refractive correction.', 'interventionNames': ['Behavioral: Refractive error correction']}\n- {'label': 'Healthy participants', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants without amblyopia or other conditions receiving the experimental intervention consisting of serious videogames focusing on binocular function (without any image modification) in a virtual reality environment.', 'interventionNames': ['Device: Vivid Vision Home']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Vivid Vision Home', 'description': 'The study intervention consists of playing serious games (Vivid Vision, San Francisco, USA) embedded in a virtual reality headset in a home environment 5 days a week for 30 minutes over 8 weeks (20 h of total gaming).', 'armGroupLabels': ['Healthy participants', 'Participants with amblyopia in the serious games intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Refractive error correction', 'description': 'The control intervention will be refractive error correction that consists of wearing the lenses with the prescribed correction for 2 months.', 'armGroupLabels': ['Participants with amblyopia in the standard care intervention'], 'otherNames': ['Standard care']}\n\nPrimary Outcomes:\n- {'measure': 'Best Corrected Visual Acuity', 'description': 'Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.', 'timeFrame': 'Baseline for Treatment A'}\n- {'measure': 'Best Corrected Visual Acuity', 'description': 'Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.', 'timeFrame': 'Post-test for Treatment A (2 months)'}\n- {'measure': 'Best Corrected Visual Acuity', 'description': 'Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.', 'timeFrame': 'Follow-up for Treatment A (2 months)/Baseline for Treatment B'}\n- {'measure': 'Best Corrected Visual Acuity', 'description': 'Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.', 'timeFrame': 'Post-test for Treatment B (2 months)'}\n- {'measure': 'Best Corrected Visual Acuity', 'description': 'Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.', 'timeFrame': 'Follow-up after Treatment B (2months)'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u03b1 = 0.05), power (80%), potential dropout rate (25%)", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated the sample size necessary to obtain a significant difference (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05) between our treatment and refractive correction based on medium effect size (F\u00e2\u0080\u0099s Cohen\u00e2\u0080\u0089=\u00e2\u0080\u00890.25) with 80% power for a crossover design immediately after the intervention on our primary endpoint. This estimation resulted in a total sample of 24 individuals with residual amblyopia. To account for the potential dropout, we will increase the sample size by 25%, resulting in 30 individuals with amblyopia. We will additionally recruit 30 age-matched typically developing individuals to undergo the serious game VR-training. This sample will serve to account for the potential changes in vision, selective attention and motor control which are known to occur in healthy adults after a VR-training.", "id": 1258, "split": "test"} +{"trial_id": "NCT05115864", "pmid": "37185188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Role of Self-assessment Combined with Home-based Wearable Device Over Supervised Pelvic Floor Muscle Training for Stress or Mixed Urinary Incontinence in Postpartum Women: a Multi-center Randomized Controlled Trial\n\nIncluded conditions:\n- Stress Urinary Incontinence\n\nStudy Armgroups:\n- {'label': 'PFMT with device (intervention) group', 'type': 'EXPERIMENTAL', 'description': 'The patients in PFMT with device (intervention) group followed the practice program three months. During three months, the intervention group is commanded to complete the PFMT program with the vaginal device and assess the grade of type I and II pelvic floor muscle fiber strength once three weeks.', 'interventionNames': ['Device: PFMT with device']}\n- {'label': 'PFMT alone \uff08control\uff09 group', 'type': 'NO_INTERVENTION', 'description': 'The patients in PFMT alone (control) group are commanded to follow the same practice program three months without using the device.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PFMT with device', 'description': 'The wearable PFMT device (XFT-0010CK) is made by two parts. One part is the screen device which is able to show the real-time vaginal resting pressure and voluntary contraction pressure in units of mmHg. The other part is a vaginal air-filled probe. The two parts are combined with a thin air tube. The whole device is connected to a smartphone app by Bluetooth to record the progress of PFMT. There are two modes of the device, one is assessment mode, when it comes to the assessment mode that the device is able to assess the grade of type I and II pelvic floor muscle fiber strength by the patients themselves, the other mode is practice mode by displaying real-time visual pressure value according to the completeness of the PFMT program.', 'armGroupLabels': ['PFMT with device (intervention) group']}\n\nPrimary Outcomes:\n- {'measure': 'International Consultation on Incontinence Questionnaire [ICIQ-UI SF]', 'description': 'The ICIQ-UI SF score ranges from 0 to 21 and is the weighted sum of three items addressing urinary incontinence frequency (\"how often do you leak urine?\" 0=never to 5=all the time), leakage quantity (\"how much urine do you usually leak?\" 0=none to 6=a large amount), and interference with everyday life (0=not at all to 10=a great deal). Higher scores reflect greater severity.', 'timeFrame': 'Baseline (pre-test)'}\n- {'measure': 'Change from Baseline ICIQ-UI SF at 3 months', 'description': 'The change on the severity of SUI', 'timeFrame': 'at 3 months'}\n- {'measure': 'Change from Baseline ICIQ-UI SF at 6 months', 'description': 'The change on the severity of SUI', 'timeFrame': 'at 6 months'}\n- {'measure': 'Change from Baseline ICIQ-UI SF at 12 months', 'description': 'The change on the severity of SUI', 'timeFrame': 'at 12 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.9, two-sided significance level of 0.05, and approximately 10% loss to follow-up during the 12-month period.", "answer": 500, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome of this study is the ICIQ-UI SF score. An ICIQ-UI SF minimal clinically important difference of 2.5 points was reported by Nystr\u00c3\u00b6m E in 2015.41 We referred to two RCT studies reporting ICIQ-UI SF data as the primary outcome for women with SUI with 5-month and 6-month follow-ups indicated an assumed SD of 5.42 43 Another study determined an SD of 10 because they expected that the SD at the 24-month time point could possibly be as high as 10.33 34 According to our study design, it would be reasonable for us to expect an SD of 8.1 at the 12-month time point. On this basis, the sample-size calculation in our study is expected to be based on a significant difference of 2.5 points in ICIQ-UI SF scores (SD of 8.1) as the primary outcome between the groups. A sample size of 222 participants per group will detect this difference calculated through PASS V.15, with a power of 0.9 and a two-sided significance level of 0.05. Thus, a total of 500 women will be recruited (250 women per group), allowing for approximately 10% loss to follow-up during the 12-month period.", "id": 1259, "split": "test"} +{"trial_id": "NCT05122091", "pmid": "38341203", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Single-arm, Multicenter, Open-label Phase II Study of Fruquintinib Plus SOX as a Neoadjuvant Therapy for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma\n\nIncluded conditions:\n- Gastric Cancer\n- GastroEsophageal Cancer\n- Fruquintinib\n- SOX\n\nStudy Armgroups:\n- {'label': 'Fruquintinib group', 'type': 'EXPERIMENTAL', 'description': 'Two-four preoperative cycles of Fruquintinib plus SOX. One cycle consists of Day 1-14 Fruquintinib 5mg oral (daily), Day 1 Oxaliplatin 130mg/M2 intravenous, Day 1-14 Tegafur gimeracil oteracil potassium capsule 40-60mg bid\uff08dosage according to body surface area\uff09.\\n\\nRepeated every 21st day', 'interventionNames': ['Drug: Fruquintinib + SOX']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fruquintinib + SOX', 'description': 'Fruquintinib\uff1a5mg qd for 2 weeks on and 1 week off, q3w\uff1b SOX: Tegafur gimeracil oteracil potassium capsule: 40-60mg bid\uff08dosage according to body surface area\uff09\uff0cd1-14\uff0cq3w\uff1b Oxaliplatin\uff1a130mg/m2\uff0cintravenous (IV) \uff0cd1\uff0cq3w.', 'armGroupLabels': ['Fruquintinib group']}\n\nPrimary Outcomes:\n- {'measure': 'Pathological remission rate (PRR)', 'description': 'Rate of patients with \\\\< 2/3 residual tumor lesion (Grade 1b, 2, 3) in surgical specimen compared to baseline', 'timeFrame': 'Approximately 2 years'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided \u03b1=0.05, 1-\u03b2=0.8, registration period of 3 years, follow-up period of 3 years, and a 10% drop-out rate.", "answer": 53, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Given the absence of large phase III research data on the pRR after neoadjuvant treatment for locally advanced GC, a study using the neoadjuvant SOX scheme revealed a pRR of 50.0%.17 The null hypothesis posits that the pRR from the fruquintinib plus SOX regimen could reach 70%. With one-sided \u00ce\u00b1=0.05, 1\u00e2\u0080\u0093\u00ce\u00b2= 0.8, registration period of 3 years and follow-up period of 3 years, at least 47 patients are required for sampling. Accounting for a 10% drop-out rate, the total sample size is 53 patients.", "id": 1260, "split": "test"} +{"trial_id": "NCT05122169", "pmid": "36810189", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns\n\nIncluded conditions:\n- Vaginal Delivery\n- Surgical Site Infection\n\nStudy Armgroups:\n- {'label': 'chlorhexidine', 'type': 'EXPERIMENTAL', 'description': 'Pre-vaginal delivery skip prep using chlorhexidine-alcohol', 'interventionNames': ['Drug: Chlorhexidine']}\n- {'label': 'Povidone-iodine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pre-vaginal delivery skip prep using Povidone-iodine', 'interventionNames': ['Drug: Povidone-Iodine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Povidone-Iodine', 'description': 'Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.', 'armGroupLabels': ['Povidone-iodine'], 'otherNames': ['Povidone-iodine 10%']}\n- {'type': 'DRUG', 'name': 'Chlorhexidine', 'description': 'Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.', 'armGroupLabels': ['chlorhexidine'], 'otherNames': ['Hexitanol 2% Soln., Chlorhexidine Gluconate Solution']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participant with episiotomy site infection', 'description': 'Superficial or deep infection of episiotomy site', 'timeFrame': '21 days'}\n\nPlease estimate the sample size based on the assumption: \n80% power, a type 1 error of 0.05, and a 10% dropout rate.", "answer": 4140, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was calculated to determine how many participants would be needed to detect a risk reduction from 6% by chlorhexidine-alcohol to 4% by povidone-iodine. We estimated the perineal infection rate as 6% for povidone-iodine, according to our retrospective database. To have 80% power, a type 1 error of 0.05, and a ratio of 1:1 between chlorhexidine-alcohol and 4% by povidone-iodine, a total of 3726 subjects will need to be randomized. To accommodate a 10% dropout rate, 4140 subjects will be enrolled (2070 chlorhexidine-alcohol, 2070 povidone-iodine). The sample size was calculated (PASS 15 (NCSS Statistical Software, USA)) based on the primary endpoint of the study.", "id": 1261, "split": "test"} +{"trial_id": "NCT05122286", "pmid": "37474136", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion: A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial (ANGEL-REBOOT)\n\nIncluded conditions:\n- Acute Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'Bailout angioplasty', 'type': 'EXPERIMENTAL', 'description': 'If the patient is randomized into the bailout angioplasty arm, the choice of balloon dilation or stenting will be left to the discretion of the interventionalist.', 'interventionNames': ['Procedure: Bailout angioplasty']}\n- {'label': 'Standard therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'If the patient is randomized into the standard therapy arm, the interventionalist will decide whether to stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters.', 'interventionNames': ['Procedure: Standard therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Bailout angioplasty', 'description': 'Use balloons or stents for bailout angioplasty', 'armGroupLabels': ['Bailout angioplasty']}\n- {'type': 'PROCEDURE', 'name': 'Standard therapy', 'description': 'Stop the endovascular recanalization procedure or to perform further recanalization attempts using stent-retrievers and/or aspiration catheters', 'armGroupLabels': ['Standard therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical outcome 90 (\u00b114) days after randomization on the modified Ranking Score (mRS) as an ordinal scale (shift analysis)', 'description': 'The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with \"0\" being perfect health without symptoms to \"6\" being death.\\n\\nScore 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.\\n\\nScore 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\\n\\nScore 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\\n\\nScore 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\\n\\nScore 6: Dead', 'timeFrame': '90\u00b114 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve 80% power in detecting a difference of 15% between two groups, with a two-sided significance level (alpha) of 0.05, using a group-sequential z-test for two independent proportions. The trial will be subjected to two interim analyses, which may result in early termination due to futility or early success. A 10% patient dropout rate is assumed.", "answer": 348, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A formal sample size calculation was based on the primary outcome mRS at 90 (\u00c2\u00b114) days. Since there is no reliable data for the ordinal mRS distribution in the two groups, the sample size planning was performed for a dichotomised clinical outcome endpoint defined as good (mRS 0\u00e2\u0080\u00932) versus poor (mRS>2). For the ordinal mRS analysis, we expect a statistical power gain. Based on previous trial data, we expect a good clinical outcome in 25% of the control and 40% of the study groups.\n To achieve 80% power in detecting a difference of 15% between two groups, with a two-sided significance level (alpha) of 0.05, using a group-sequential z-test for two independent proportions, a sample size of 156 participants per group (312 participants in total) is required. These findings are contingent on conducting three sequential tests using the O\u00e2\u0080\u0099Brien-Fleming spending function to establish the test boundaries. The trial will be subjected to two interim analyses, which may result in early termination due to futility or early success. If the trial is not halted prematurely, it will proceed until it reaches a maximum of 312 patients. A total recruitment target of 348 (174 per group) should be planned to assess the primary 90-day endpoint assuming a 10% patient dropout rate.", "id": 1262, "split": "test"} +{"trial_id": "NCT05123027", "pmid": "39288373", "question": "Here is the design of a clinical trial:\n\nOfficial Title: NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)\n\nIncluded conditions:\n- Opioid Overdose\n\nStudy Armgroups:\n- {'label': 'Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer', 'Behavioral: Treatment As Usual Peer']}\n- {'label': 'Treatment As Usual Peer', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Treatment As Usual Peer']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer', 'description': 'Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.', 'armGroupLabels': ['Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer']}\n- {'type': 'BEHAVIORAL', 'name': 'Treatment As Usual Peer', 'description': 'Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.', 'armGroupLabels': ['Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer', 'Treatment As Usual Peer']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission', 'description': 'Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors.', 'timeFrame': '180 days (6 months)'}\n\nPlease estimate the sample size based on the assumption: \nOver 90% power to detect the expected treatment effect.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Power Analysis and Sample Size Estimation\n Power analyses and sample size calculation were based on the primary outcome of comparing ORBC total score differences at month 6 between PILOT and TAU participants. The self-reported overdose risk behaviors to be used for this trial are modified and expanded from a version used by Bohnert et al [26], in which the maximum score was 32, with average baseline scores of 3.3 and 3.8 in their control and intervention groups, respectively. They used a Poisson regression model to estimate the intervention effect, reported to be a 0.72 RR. For the power simulations conducted for this study, a baseline mean score of 3.55 was used, with a treatment effect of 0.72. With a mean of 3.55 at baseline and an RR of 0.72, there is over 90% power to detect the expected treatment effect with a total sample size of 150.", "id": 1263, "split": "test"} +{"trial_id": "NCT05124808", "pmid": "38423770", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial\n\nIncluded conditions:\n- Gestational Diabetes\n- Pregnancy, High Risk\n- Overweight and Obesity\n\nStudy Armgroups:\n- {'label': 'Intensive glycemic targets', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will target a fasting blood glucose of \\\\<90 mg/dL and 1 hour post-prandial blood glucose values \\\\<120 mg/dL.', 'interventionNames': ['Other: Intensive glycemic targets']}\n- {'label': 'Standard glycemic targets', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this arm will target a fasting blood glucose of \\\\<95 mg/dL and 1 hour post-prandial blood glucose values \\\\<140 mg/dL.', 'interventionNames': ['Other: Standard glycemic targets']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intensive glycemic targets', 'description': 'Fasting blood glucose \\\\<90 mg/dL, 1 hour post-prandial blood glucose \\\\<120 mg/dL', 'armGroupLabels': ['Intensive glycemic targets']}\n- {'type': 'OTHER', 'name': 'Standard glycemic targets', 'description': 'Fasting blood glucose \\\\<95 mg/dL, 1 hour post-prandial blood glucose \\\\<140 mg/dL', 'armGroupLabels': ['Standard glycemic targets']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with composite neonatal morbidity', 'description': 'Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome', 'timeFrame': 'Within 7 days of delivery'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on achieving 80% power and a type 1 error of 0.05. A 10% loss to follow-up or incomplete data is anticipated. One interim analysis is planned after 50% of participants have delivered.", "answer": 828, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The total sample size for the trial is estimated based on the primary outcome. Observational and clinical data indicated that the baseline prevalence of the composite primary outcome among individuals with GDM and overweight or obese women with GDM at the study sites ranged from 30% at Pittsburgh25 to 50% at the University of Oklahoma (unpublished data). Based on the baseline prevalence of the primary outcome and our prior dating demonstrating that lower maternal glucose values are associated with improved outcomes,25 we assume that the primary outcome would occur in 30% of the standard glycaemic target group and we anticipate a 30% reduction in the prevalence of the composite primary outcome to 21% (ie, an absolute difference of 9%) with tighter glucose control, compared with standard control. To achieve this difference with 80% power and a type 1 error of 0.05, we estimate that we need 744 participants based on a logistic regression model with a two-sided Wald test. We are enrolling 828 participants to account for a 10% loss to follow-up or incomplete data. We anticipate one interim analysis after 50% of enrolled participants have delivered (n=414).", "id": 1264, "split": "test"} +{"trial_id": "NCT05124977", "pmid": "36810173", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care\n\nIncluded conditions:\n- Ventilator Associated Pneumonia\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Antimicrobial stewardship based on daily clinical assessment of clinical cure (experimental group). Discontinuation of antibiotic therapy antibiotics if criterions of clinical cure (regression of tracheal secretions, regression of temperature, improvement of PaO2/FiO2 ratio, absence of hemodynamic failure) of confirmed VAP are met. In the intervention group, intensivists will perform clinical assessment daily in order to decide on the pursuit or discontinuation of antibiotic therapy.', 'interventionNames': ['Drug: Antimicrobial Stewardship']}\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'Standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines. In the control group, intensivists will perform clinical assessment daily, but a minimum duration of 7 days, as highly recommended of antibiotic therapy will be mandatory whatever the clinical cure.', 'interventionNames': ['Drug: Standard management']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Antimicrobial Stewardship', 'description': 'Antimicrobial stewardship based on daily clinical assessment of clinical cure. Discontinuation of appropriate antibiotic therapy antibiotics if criteria of clinical cure of confirmed pneumonia are met. Intensivists will perform clinical assessment daily in order to decide on the pursuit or discontinuation of antibiotic therapy.', 'armGroupLabels': ['Experimental group']}\n- {'type': 'DRUG', 'name': 'Standard management', 'description': 'Standard management: duration of appropriate antibiotic for confirmed pneumonia fixed for 7 days according to guidelines. In the control group, intensivists will perform clinical assessment daily, but the antibiotic will not be discontinued until 7 days whatever the clinical cure.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Investigate whether an AMS for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia', 'description': 'The primary endpoint is a composite endpoint with non-inferiority criteria including:\\n\\n1. all-cause mortality (ACM) measured at day 28 after initiation of therapy', 'timeFrame': '28 days'}\n- {'measure': 'Investigate whether an AMS for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia', 'description': 'The primary endpoint is a composite endpoint with non-inferiority criteria including:\\n\\n2. Treatment failure defined by new signs of pneumonia within 72 hours after the end antibiotic treatment at the test of cure visit', 'timeFrame': '28 days'}\n- {'measure': 'Investigate whether an AMS for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia', 'description': 'The primary endpoint is a composite endpoint with non-inferiority criteria including:\\n\\n3. New episode of microbiologically confirmed VAP from 72H after the end of antibiotic treatment to day 28 after initiation of VAP antibiotic treatment', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, type I error (alpha) of 2.5%, and a non-inferiority margin of 10%.", "answer": 590, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Assuming that 25% of the patients will encountered ACM, treatment failure or occurrence of new episode of VAP before day 28 in the control arm,19 590 subjects (295 per arm) are needed to establish non-inferiority with the absolute difference of death, treatment failure or occurrence of new episode of VAP does not exceed 10% (non-inferiority margin) between experimental and control arms with a power of 80%, a type I error (alpha) of 2.5%.\n A non-inferiority margin of 10% was chosen taking into account the methodological data applied to the randomised controlled trials dedicated to VAP. According to European medicines Agency (https://www.ema.europa.eu/en/addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-0), the suggested non-inferiority margin should not exceed\u00e2\u0080\u009412.5% for clinical outcome documented at a Test-of-Cure visit. In this recommendation, the margin of 12.5% does not include mortality.\n In a published study (ASPECT)20 designed to show non-inferiority for the primary endpoint in the intention-to-treat population, with a 10% non-inferiority margin to achieve 90% power at a one-sided significance level of 0.025 (based on regulatory agency guidance and assuming a 28-day ACM rate of 20% in both groups).", "id": 1265, "split": "test"} +{"trial_id": "NCT05125146", "pmid": "37192176", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating the Effectiveness of Electronically Delivered Cognitive Behavioural Therapy (e-CBTi) Compared to Pharmaceutical Interventions in the Treatment of Insomnia\n\nIncluded conditions:\n- Insomnia\n\nStudy Armgroups:\n- {'label': 'Pharmacotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': \"Trazodone is the treatment of choice for insomnia and participants allocated to the pharmaceutical intervention group will be prescribed trazodone as a regular treatment for the duration of the study. Participants on trazodone will also visit the psychiatrist every month to ensure their wellbeing is protected, the quality of the data is maintained, the conduct of the trial is in compliance with the approved protocol, and other regulatory requirements. Trazodone is the routine practice for insomnia and is covered through most patients' healthcare. However, if the patient does not have coverage for trazodone, they will be provided financial compensation to offset the cost.\", 'interventionNames': ['Drug: Trazodone']}\n- {'label': 'e-CBTi', 'type': 'EXPERIMENTAL', 'description': 'The e-CBTi modules will involve guiding participants to develop constructive and balanced strategies that would help to handle sleep problems. The e-CBTi program is based on the idea that insomnia is caused by thoughts and behaviours that can be changed. The modules aim to adjust negative thinking so patients can think about and adapt to the events that are happening to them, allowing them to adjust their behaviour and thoughts to be more realistic. Continuing, the modules are designed to help patients with insomnia deal with inaccurate thoughts about sleep and negative sleep behaviours, change their lifestyle practices that negatively affect their sleep, and improve relaxation skills to improve healthy sleep patterns. More specifically, the focus of the program is on addressing and exploring the concept of sleep, sleep habits, sleep hygiene, bedtime worries, negative thoughts, and thought examination.', 'interventionNames': ['Behavioral: e-CBTi']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'e-CBTi', 'description': 'See arm/group description', 'armGroupLabels': ['e-CBTi'], 'otherNames': ['Electronically-Delivered CBT']}\n- {'type': 'DRUG', 'name': 'Trazodone', 'description': 'See arm/group edescription', 'armGroupLabels': ['Pharmacotherapy'], 'otherNames': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Insomnia Severity Index (ISI) - Change in Symptoms (Quantitative)', 'description': 'Measures insomnia symptom severity; 7 questions; answer range from 0-4, 0 being best, 4 being worst', 'timeFrame': 'Baseline (week 0), mid-point (week 3-4), post-treatment (week 7)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) = 0.05, power = adequate to detect the effect, and an anticipated dropout rate of up to 25%.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n A priori power analyses using the G*Power V3.1 software indicated that a sample size of 36 participants would provide adequate power to detect a medium (f = 0.25) group x time interaction effect using repeated measures analysis of variance (ANOVA) with four sequential measurements per subject per week when the correlation among the measures was 0.3 (\u00ce\u00b1 = 0.05). Given the likelihood of participant dropout or withdrawal, participants have been purposely over-sampled to obtain meaningful and statistically significant results regarding changes in their symptoms at the end of the study. Based on previous experience with e-CBTi in similar patient populations, a dropout of up to 25% is anticipated [38]. Considering that former studies of similar nature have suggested that N = 20, 30, 24 per study arm has produced statistically significant interaction effects [39\u00e2\u0080\u009341]. A sample size of 30 participants in each arm or 60 participants in total, is planned to be recruited for this study to detect significant results with p = 0.05 after expected attrition.", "id": 1266, "split": "test"} +{"trial_id": "NCT05127057", "pmid": "39894518", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): a New Model of Care\n\nIncluded conditions:\n- Parkinsonism\n\nStudy Armgroups:\n- {'label': 'PRIME Parkinson Care', 'type': 'EXPERIMENTAL', 'description': 'PRIME Parkinson Care is a multi-component model of care comprising individual components: a) Case management b) Empowerment of patients and care givers c) Empowerment of healthcare professionals d) IT infrastructure.', 'interventionNames': ['Other: PRIME Parkinson Care', 'Other: Usual Care']}\n- {'label': 'Usual care', 'type': 'PLACEBO_COMPARATOR', 'description': 'Usual care provided by NHS', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'PRIME Parkinson Care', 'description': 'A novel model of care', 'armGroupLabels': ['PRIME Parkinson Care']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Usual NHS Care', 'armGroupLabels': ['PRIME Parkinson Care', 'Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Goal attainment', 'description': 'Measured using the Bangor Goal-Setting Interview (BGSI) - score 1-10, higher score = better outcome', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is a single-centre RCT with data collection starting in October 2022 and ending in July 2025. Both quantitative and qualitative data will be collected. A purposive sample of around 10% of the recruited participants will be used for qualitative data collection.", "answer": 214, "answer_type": "ACTUAL", "explanation": "Study design and sample size\n The design of the primary study is a single-centre RCT to determine whether PRIME-Parkinson care can improve goal attainment as well as measures across multiple domains of health-related quality of life and symptom burden compared with usual care.16 The sample size is 214 people with parkinsonism. A mixed-methods approach will be conducted for the process evaluation outlined in this protocol. Data collection in the main trial started in October 2022 and will end in July 2025. Quantitative and qualitative data will be collected alongside trial outcome data between these time points to answer the specific process evaluation research questions.\n All participants will contribute quantitative process evaluation data which will be collected prospectively throughout the study. Qualitative data for the process evaluation will be collected as part of a qualitative substudy (\u00e2\u0080\u0098PRIME-Qual\u00e2\u0080\u0099 IRAS 293614) from people with parkinsonism and caregivers enrolled in the main trial as well as members of the PRIME multidisciplinary team delivering the intervention and staff delivering \u00e2\u0080\u0098usual care\u00e2\u0080\u0099. We will recruit a purposive sample of around 10% recruited to the PRIME-UK RCT. This amounts to circa 10\u00e2\u0080\u009315 patients and 10\u00e2\u0080\u009315 caregivers from the active arm and the same from the control arm. We aim to achieve a varied sample in terms of variables which are anticipated to influence delivery and/or effectiveness of the intervention. Successful recruitment will be categorised as a sample containing:\n \n \n Both male and female participants.\n \n \n Participants from each quartile of age from the study population.\n \n \n A spread across time since diagnoses capturing those with early PD (diagnosed <2 years ago) and those living with PD for >10 years.\n \n \n Participants from across all five Hoehn and Yahr stages.\n \n \n Participants within low, medium and high risk of admission categories.\n \n \n Participants across all three local integrated care boards (ICBs).\n \n \n At least one participant from a nursing home.\n \n \n Participants who have and do not have an enrolled caregiver.\n \n \n Participants living in both rural and urban areas.\n \n \n We also aim to recruit between 10 and 15 staff to the study from those who are involved in the delivery of the new model of care and those involved in delivery of usual care.", "id": 1267, "split": "test"} +{"trial_id": "NCT05127733", "pmid": "36523236", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support\n\nIncluded conditions:\n- Substance Use Disorders\n\nStudy Armgroups:\n- {'label': 'Online Cogntivie Behavioural Therapy', 'type': 'EXPERIMENTAL', 'description': \"Breaking Free Online (BFO) is an online intervention, supporting adults struggling with substance use. It provides psychoeducation and skills building exercises in CBT and compatible approaches. The intervention strategies contained within BFO are provided via a six-domain biopsychosocial model used in CBT. Each domain of the model corresponds to a module in the BFO program which contains psychoeducation and an 'action' strategy to facilitate behaviour change. Data captured at the baseline assessment is used by the program to provide feedback to the individual on their levels of functioning across the six domains. The program then guides the user to concentrate on intervention strategies for domains with the greatest level of impairment.\\n\\nAll groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.\", 'interventionNames': ['Behavioral: Online Cognitive Behavioural Therapy']}\n- {'label': 'Online Cognitive Behavioural Therapy Plus Individual Peer Support', 'type': 'EXPERIMENTAL', 'description': \"BFO delivered with peer support will comprise BFO with at least weekly contact with a peer with lived experience. Peer support workers will receive training on how to facilitate participant engagement with and progress through the BFO program, as well as a weekly session plan. As part of this training, peer support workers will be given their own access code to use BFO and be encouraged to use the program. Session One constitutes an initial orienting to the program. Subsequent sessions review each information and action strategy in the BFO program, with a series of prompts to guide peer support of this content.\\n\\nAll groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.\", 'interventionNames': ['Behavioral: Online Cognitive Behavioural Therapy', 'Behavioral: Individual Peer Support']}\n- {'label': 'Group Peer Support', 'type': 'ACTIVE_COMPARATOR', 'description': \"The control condition will consist of group peer support facilitated by trained peers and offered through the Community Addictions Peer Support Association (CAPSA). The group meets weekly and will offer participants a space to share their experiences and receive support.\\n\\nAll groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.\", 'interventionNames': ['Behavioral: Group Peer Support']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Online Cognitive Behavioural Therapy', 'description': 'Interactive program utilizing cognitive behavioural therapy principles that guides users through its components and provides feedback, which facilitates behavior change (i.e., reduction in alcohol or substance use).', 'armGroupLabels': ['Online Cognitive Behavioural Therapy Plus Individual Peer Support', 'Online Cogntivie Behavioural Therapy'], 'otherNames': ['Breaking Free Online (BFO)']}\n- {'type': 'BEHAVIORAL', 'name': 'Individual Peer Support', 'description': \"Weekly meetings with a trained peer support worker who guides participants through the BFO platform, reviews the platform's content with them, and supports them in the creation of an action strategy based on the platform's suggestions.\", 'armGroupLabels': ['Online Cognitive Behavioural Therapy Plus Individual Peer Support'], 'otherNames': ['BFO Peer Support']}\n- {'type': 'BEHAVIORAL', 'name': 'Group Peer Support', 'description': 'Meetings with a group of peers led by a trained peer support worker/volunteer which will offer the participants an opportunity to discuss their experiences in a supportive and open environment.', 'armGroupLabels': ['Group Peer Support'], 'otherNames': ['All People All Pathways']}\n\nPrimary Outcomes:\n- {'measure': 'Timeline Follow-Back', 'description': 'Frequency (days) of substance use over the past 30 days', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \npower of 80%, alpha level of 0.05, pre-post correlation of 0.50, attrition rate of 20%", "answer": 225, "answer_type": "ESTIMATED", "explanation": "Sample size\n A power calculation for a randomised trial indicated that a sample size of n=60 participants per study condition (N=180 in total) will be required to locate a small-to-medium effect size (Cohen\u00e2\u0080\u0099s f=0.13) with a power of 80% (for main effects or interactions), an alpha level of 0.05, and assuming a pre\u00e2\u0080\u0093post correlation of 0.50. This power analysis was conducted using G*Power62 and was based on based on the power necessary to detect the interactions between pre\u00e2\u0080\u0093post changes in the primary outcome and the planned comparisons among the intervention groups (see proposed analyses below). We anticipate an attrition rate of 20%, and thus will randomise an attrition-adjusted sample size of 225 participants (75 per condition) to compensate for the impact of attrition on statistical power, although we will conduct an intent-to-treat analysis using data from all participants randomised (see below).", "id": 1268, "split": "test"} +{"trial_id": "NCT05135377", "pmid": "36316072", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Canadian Anaphylaxis Network- Predicting Recurrence After Emergency Presentation for Allergic REaction\n\nIncluded conditions:\n- Anaphylaxis\n\nStudy Armgroups:\n- {'label': 'Children with Anaphylaxis', 'description': 'Patients under 18 years of age presenting to the Emergency Department (ED) with an allergic reaction that matches diagnostic criteria for anaphylaxis.', 'interventionNames': ['Other: Observational']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Observational', 'description': 'Not applicable - observational study', 'armGroupLabels': ['Children with Anaphylaxis']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of biphasic anaphylaxis', 'description': 'The primary outcome for this prospective cohort study of children who present to ED with anaphylaxis is the development of biphasic anaphylaxis (BA) in the ED or after hospital/ED discharge. As per the published consensus definition in 2019, to be classified as BA, an anaphylactic reaction must meet 3 criteria: 1) initial anaphylactic reaction followed by resolution of all initial manifestations for \u22651 h, with no new symptoms or treatment administered in that time; 2) the second phase of new or recurrent symptoms or signs that meet the consensus definition of anaphylaxis, and 3) the new or recurrent symptoms or signs are not caused by antigen re-exposure. This definition focuses on clinically important or major biphasic reactions. Mild symptoms that involve only the skin (e.g. urticarial rash) without any other systems involvement will be captured and classified as minor biphasic responses. However, these minor responses do not meet our case definition for BA.', 'timeFrame': 'Up to 5 days post enrollment'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level and power are not explicitly mentioned. The study considers a 10% lost to follow-up rate.", "answer": 1682, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on our research,35 48 49 estimates from prospective ED studies28 44 45 80 and published data from large adult and paediatric studies,81 82 10% is a conservative estimate of the population-wide event rate of BA. Our systematic reviews of potential predictors48 and other relevant studies identified 19 potential predictive variables.83 Recent BMJ and Stat in Med articles offer practical guidance for calculating the sample size required for the development of clinical prediction models.84 85 Following these guidelines, we considered sample size from four perspectives, with the largest being selected as the sample size needed. The four calculations are based on: the approximate 95% CI for the overall outcome proportion 0.10 in the study population (calculated sample size needed n=139); the mean absolute prediction error of the average error in the model\u00e2\u0080\u0099s outcome (n=274); achievement of an expected uniform shrinkage factor of \u00e2\u0089\u00a410% (n=1529); and ensuring a small, expected optimism in the apparent proportion of overall variation explained R2 (n=719). Details of these calculations with the selection of the parameter estimates and sensitivity considerations are provided in online supplemental material A. Taking the largest sample size that meets all four criteria, we need to enrol 1529 participants with anaphylaxis. Based on previous studies by our network, we anticipate 10% lost to follow-up.86 87 Thus, our estimated sample size is 1682 participants.\n \n 10.1136/bmjopen-2022-061976.supp1\n Supplementary data", "id": 1269, "split": "test"} +{"trial_id": "NCT05136027", "pmid": "39696604", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exercise Program in Patients With Treatment-resistant Depressive Disorder Compared to Usual Practice\n\nIncluded conditions:\n- Resistant Depression, Treatment\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Intervention group: In the exercise session will carry out a combined training in four parts, low- intensity interval training in a bicycle, resistance circuit training, low- intensity interval training in a bicycle, and CORE exercises.', 'interventionNames': ['Other: Combined training']}\n- {'label': 'Attention Control', 'type': 'NO_INTERVENTION', 'description': 'Regular in-hospital treatment with occupational activity sessions with the same frequency and duration as the intervention group.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Combined training', 'description': 'Low-intensity interval training and resistance exercise', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Montgomery-Asberg Depressi\u00f3n Rating Scale (MADRS)', 'description': 'Ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.\\n\\nHigher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.\\n\\nUsual cutoff points are:\\n\\n0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \\\\>34 - severe depression', 'timeFrame': '12 weeks'}\n- {'measure': 'Cardiorespiratory fitness', 'description': 'Cardiorespiratory fitness evaluation measured by cardiopulmonary exercise test. Maximu oxygen uptake measured in mL/kg/min or L/min is the gold standard variable.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve a power of 80% and a significance level of 5%, with an assumed 10% loss rate.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n We have conducted a previous pilot study with 18 participants diagnosed with RMD in a single supervised exercise group (12\u00c2\u00a0weeks, 2\u00c2\u00a0days/week). Following the intervention (data not yet published), no significant changes (P\u00e2\u0080\u0089>\u00e2\u0080\u00890.05) were found in the body composition, main CRF physiological variables, and biochemical profile. However, regarding clinical symptoms, MADRS (\u00ce\u0094\u00e2\u0080\u0089= \u00e2\u0088\u0092\u00e2\u0080\u008927.2%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.021), CGI-S (\u00ce\u0094\u00e2\u0080\u0089= \u00e2\u0088\u0092\u00e2\u0080\u008925.3%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.006), and SDS (\u00ce\u0094\u00e2\u0080\u0089= \u00e2\u0088\u0092\u00e2\u0080\u008922%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.046) values decreased; and the domains of health-related QoL, general health (\u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u008950.5%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.017), vitality (\u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u008941.4%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.045), social functioning (\u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u008976.5%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.008), and mental component summary (\u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u008924.9%; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.024) values increased. Thus, based on this previous pilot study with the same population, to achieve a power of 80% where differences in depressive symptoms (measured by the MADRS) are detected after the exercise intervention, having a significance of 5%, a reference mean of 29.13\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008912.2 units, an experimental group mean of 22.23 units, a standard deviation between both groups of 9.61, and an expected difference of 2.5 units, 31 patients per group will be needed. If we assume a 10% loss rate, 35 patients per group will be required, with a total sample of 70 participants.", "id": 1270, "split": "test"} +{"trial_id": "NCT05138380", "pmid": "36691129", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial\n\nIncluded conditions:\n- Hip Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Foot orthoses', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Foot orthoses']}\n- {'label': 'Flat shoe insert', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Device: Flat shoe insert']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Foot orthoses', 'description': \"Manufacturer: Foot Science International.\\n\\nMaterial: High grade thermoformable closed-cell polyolefin foam (medium density)\\n\\nArch support: inbuilt.\\n\\nCovering: fabric\\n\\nProvided by: Study Practitioner: Registered physiotherapist \\\\> 2 years musculoskeletal experience will be trained to prescribe the insert according to the prescription algorithm.\\n\\nWhere: Administered via telehealth\\n\\nWhen and how much: Week 0 to 1: one telehealth session with study practitioner to fit one pair of pre-fabricated orthoses Week 1 to 2: Follow-up session for questions if required\\n\\nTailoring: Orthoses are fit to comfort. Lengths (S, S, M, L, XL, XXL) (dependent on participant's shoe size). Hardness = Medium density. Modifications: can be cut to size to assist in fit using the shoes original sock liner as a guide, by participants using standard scissors. Heat molding: optional.\\n\\nAdherence: Adherence recorded with diary/ log book (insert wear time)\", 'armGroupLabels': ['Foot orthoses'], 'otherNames': ['Foot Science International Ltd; Formthotic']}\n- {'type': 'DEVICE', 'name': 'Flat shoe insert', 'description': \"Manufacturer: Foot Science International.\\n\\nMaterial: High grade thermoformable closed-cell polyolefin foam (medium density)\\n\\nArch support: no.\\n\\nCovering: fabric\\n\\nProvided by: Study Practitioner: Registered physiotherapist \\\\> 2 years musculoskeletal experience will be trained to prescribe the insert according to the prescription algorithm.\\n\\nWhere: Administered via telehealth\\n\\nWhen and how much: Week 0 to 1: one telehealth session with study practitioner to fit one pair of pre-fabricated orthoses Week 1 to 2: Follow-up session for questions if required\\n\\nTailoring: Fit to comfort. Lengths (S, S, M, L, XL, XXL) (dependent on participant's shoe size). Hardness = Medium density. Modifications: can be cut to size to assist in fit using the shoes original sock liner as a guide, by participants using standard scissors. Heat molding: optional.\\n\\nAdherence: Adherence recorded with diary/ log book (insert wear time)\", 'armGroupLabels': ['Flat shoe insert']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility: adherence', 'description': 'Recruitment rate (average 1 participant per week); 50% log-book completion rate (daily); drop-out \\\\<20%; 35 hours per week adherence to intervention (log book)', 'timeFrame': '6 weeks'}\n\nPlease estimate the sample size based on the assumption: \n20% drop-out rate, no interim analysis.", "answer": 28, "answer_type": "ESTIMATED", "explanation": "Sample size\n The recommended sample size for feasibility and pilot studies is 12 people per group.43 Allowing for a 20% drop-out rate per group, a total of 28 participants (14 per group) will be recruited for this study. No interim analysis will be conducted as a component of this study.", "id": 1271, "split": "test"} +{"trial_id": "NCT05139433", "pmid": "36273162", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Brief Internet-delivered Cognitive-behavioral Intervention for Children and Adolescents With Anxiety and Depression Symptoms During the COVID-19 Pandemic: a Randomized Clinical Trial\n\nIncluded conditions:\n- Childhood Anxiety Disorder\n- Childhood Depression\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will receive 5 internet-delivered cognitive-behavioral intervention and will have access to 15 educational videos', 'interventionNames': ['Behavioral: Telepsychotherapy', 'Behavioral: Psychoeducational Videos']}\n- {'label': 'Active Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this arm will have access to 15 educational videos.', 'interventionNames': ['Behavioral: Psychoeducational Videos']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Telepsychotherapy', 'description': '5 weekly psychotherapy sessions that will cover the following contents: psychoeducation on stress responses, family communication, relaxation and mindful techniques, emotion recognition, management of irritability, behavioral activation and cognitive restructuring. The sessions will be implemented via the internet by a trained psychologist. Participants will also have access to the psychoeducational videos described at \"intervention 2\"', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Psychoeducational Videos', 'description': '15 educational videos to be watched by the families. There will be one video about psychoeducation on stress responses, one about family communication, four about mindfulness and relaxation techniques, two about emotion recognition, one about management of irritability, one about behavioral activation, three about healthy routines, one about cognitive restructuring, and one about management of anxiety crisis.', 'armGroupLabels': ['Active Control Group', 'Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Anxiety and depressive symptoms at T1- caregiver report', 'description': 'The first primary outcome is the change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children\\'s Anxiety and Depression Scale, parent reported, between T0 and T1. The RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale (\"never\", \"sometimes\", \"often\", and \"always\") based on personal observations from parents or legal guardians. The scale has two subscales assessing Anxiety and Depression, and an overall score. It will be completed by an independent clinician blinded to allocation based on an interview with the main caregiver (through videoconference or phone call).', 'timeFrame': 'At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group)'}\n- {'measure': 'Anxiety and depressive symptoms at T1 - child/adolescent report', 'description': 'The change in depressive and anxiety symptomatology, measured by the 25-item version of the Revised Children\\'s Anxiety and Depression Scale (RCADS), child reported, between T0 and T1. This version of RCADS is a 25-item scale that measures the frequency of anxiety and low mood symptoms using a 4-point Likert scale (\"never\", \"sometimes\", \"often\", and \"always\") based on personal observations from the child. The scale has two subscales assessing Anxiety and Depression, and an overall score.It will be completed by an independent clinician blinded to allocation based on an interview with the child/adolescent (through videoconference or phone call).', 'timeFrame': 'At entry (T0), 1-3 days after the last psychotherapeutic session (intervention group) OR 1-3 days after the last video is made available (active control group)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, power of 80%, 1:1 randomisation, and an estimated attrition rate of 30%.", "answer": 280, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n In a meta-analysis, Vigerland et al. [51] found the estimated size-effect for internet-delivered CBT in children and adolescents to be 0.62 (95% CI 0.41\u00e2\u0080\u00930.84). Given that most of the studies assessed in that meta-analysis evaluated interventions involving a greater number of sessions than that to be evaluated in our study, we decided to be conservative and expect an effect size within the lower bound of that confidence interval, that is, 0.41. Therefore, the minimum sample size would be 190 participants, with an alpha of 0.05, power of 80% and 1:1 randomisation. Assuming an estimated attrition rate of 30%, we will need a total sample of 280 participants.", "id": 1272, "split": "test"} +{"trial_id": "NCT05141513", "pmid": "36307845", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma\n\nIncluded conditions:\n- Pancreatic Cancer\n\nStudy Armgroups:\n- {'label': 'Intra Operative Radiation Therapy (IORT) Group', 'type': 'OTHER', 'description': 'The IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy.', 'interventionNames': ['Radiation: High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)', 'description': 'After the patient receives standard of care treatment, they will receive a single dose of radiation (15 Gy) at the time the tumor is surgically removed. Surgeons will then place clips along the blood vessels around the surgical area. These clips will be used to confirm (after surgery) that the expected dose of radiation was received during surgery.', 'armGroupLabels': ['Intra Operative Radiation Therapy (IORT) Group']}\n\nPrimary Outcomes:\n- {'measure': 'Acute post-operative toxicity of targeted IORT', 'description': 'To evaluate acute post-operative toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n15% of patients will not be surgically explored due to radiographic metastatic disease or too locally extensive disease after SBRT. An additional 15% will require unexpected arterial reconstruction (exclusion criteria). No interim data analysis. Data analysis will occur once the study has been completed.", "answer": 25, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size\n Descriptive statistics will be utilized to record patient demographic, disease, and treatment characteristics including age, sex, race, disease extent, chemotherapy, radiation therapy, and type of surgery. Time to event outcomes such as OS, LPFS, DMFS, and PFS will be analyzed using Kaplan\u00e2\u0080\u0093Meier method. Our institution\u00e2\u0080\u0099s data and experience suggest that 15% of patients will not be surgically explored due to development of radiographic metastatic disease or too locally extensive disease after SBRT. An additional 15% will require unexpected arterial reconstruction (exclusion criteria). Therefore, 25 patients will be enrolled with the expectation that 20/25 patients will undergo surgical exploration and IORT. A sample size of 20 patients was chosen because this will enable safety evaluation using a closely monitored Bayesian stopping rule and is also recommended by the literature [21, 22]. There will not be any interim data analysis. Data analysis will occur once the study has been completed.", "id": 1273, "split": "test"} +{"trial_id": "NCT05146245", "pmid": "36539734", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT\n\nIncluded conditions:\n- Autism Spectrum Disorder\n\nStudy Armgroups:\n- {'label': 'Therapeutic Drug Monitoring', 'type': 'EXPERIMENTAL', 'description': 'Physicians receive dosing advice based on measured blood levels of risperidone and 9-OH-risperidone.', 'interventionNames': ['Other: Therapeutic Drug Monitoring', 'Other: Risperidone plasma level']}\n- {'label': 'Care As Usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'Physician decides on possible dosing changes without receiving advice based on blood levels.', 'interventionNames': ['Other: Risperidone plasma level']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Therapeutic Drug Monitoring', 'description': 'Physician receives dosing advice based on risperidone plasma level.', 'armGroupLabels': ['Therapeutic Drug Monitoring']}\n- {'type': 'OTHER', 'name': 'Risperidone plasma level', 'description': 'Plasma levels of risperidone and 9-OH risperidone are measured in a Dried Blood Spot.', 'armGroupLabels': ['Care As Usual', 'Therapeutic Drug Monitoring']}\n\nPrimary Outcomes:\n- {'measure': 'BMI z-score', 'description': 'Difference in body mass index z-scores 6 months after start of treatment.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% and the significance level (alpha) at 0.05. A 10% dropout rate is also considered.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A 5% change in body weight is generally seen as clinically significant [29]. For children, 5% gain of bodyweight on top of their normal growth trajectory amounts to an increase in BMI z-score of about 0.5 over a 6-month period. Using a conservative power analysis for basic between groups\u00e2\u0080\u0099 differences, with a power of 80% and an alpha of 0.05, including 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008964 children allows us to detect medium clinical effects. Moreover, use of the repeated measures approach is likely to allow us to detect smaller effect sizes as well. In the SPACe study, we found an overall event rate of 40% significant increase in BMI z-score. 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008964 patients affords us enough power to detect a halving of the event rate in the active group. Allowing for 10% dropout, we aim to include a total of 140 patients.", "id": 1274, "split": "test"} +{"trial_id": "NCT05148715", "pmid": "38871657", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)-Pilot Trial\n\nIncluded conditions:\n- Organ Transplant Failure or Rejection\n- Brain Death\n- Ischemic Reperfusion Injury\n\nStudy Armgroups:\n- {'label': 'Tacrolimus', 'type': 'EXPERIMENTAL', 'description': 'Tacrolimus 0.02 mg/kg ideal body weight 4-8 hours before organ recovery', 'interventionNames': ['Drug: Tacrolimus']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '0.9% sodium chloride 4-8 hours before organ recovery', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tacrolimus', 'description': 'Single dose intravenous tacrolimus over 4 hour infusion at a dose of 0.02 mg/kg ideal body weight diluted with 0.9% sodium chloride starting 4-8 hours before scheduled organ recovery.', 'armGroupLabels': ['Tacrolimus'], 'otherNames': ['Prograf']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Single dose of intravenous 0.9% sodium chloride over 4 hour infusion, starting 4-8 hours before scheduled organ recovery.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Organ donor accrual rates', 'description': 'One primary objective of this pilot study is to determine if a national multi-centre placebo randomized controlled trial (RCT) will be feasible with respect to: organ donor accrual.', 'timeFrame': '6 to 12 months after the beginning of the trial'}\n- {'measure': 'Recipient consent rate', 'description': 'Another primary objective of this pilot study is to determine if a national multi-centre placebo controlled RCT will be feasible with respect to the consent rates of organ recipients. Recipient consent rates will be assessed during analysis, analyzing the rate and reasons for non-enrolment.', 'timeFrame': '6 to 12 months after the beginning of the trial'}\n\nPlease estimate the sample size based on the assumption: \n20% of eligible donors may be missed due to various reasons; expected accrual rate is 80% (90/112) with a 95% confidence interval of 72% to 87%.", "answer": 414, "answer_type": "ESTIMATED", "explanation": "Sample size\n The target sample size for 1 year of enrolment is 414 participants, including 90 DNC donors and their corresponding transplant recipients (approximately 324). Extrapolating from a prior national cohort study in deceased organ donation, the nine participating donation centres are expected to provide 112 eligible donors in the year of study and each donor generates, on average, 3.6 recipients. The sample size determination allows for 20% of eligible donors to be missed for various reasons including staff availability, drug availability and declined consent from donor families. Thus, we expect to accrue 80% (90/112) (95% CI 72% to 87%) of study-eligible donors.46", "id": 1275, "split": "test"} +{"trial_id": "NCT05151575", "pmid": "37759212", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Walking on Frailty, Cognitive Function and Quality of Life Among Inactive Older Adults in Saudi Arabia: A Randomized Control Trial by Comparing Supervised Group-based Intervention and Non-supervised Individual-based Intervention\n\nIncluded conditions:\n- Physical Activity\n\nStudy Armgroups:\n- {'label': \"group-based walking intervention with professional trainer's supervision\", 'type': 'EXPERIMENTAL', 'description': 'Participants will conduct the intervention in groups under the supervision of a professional fitness trainer.', 'interventionNames': ['Behavioral: supervised group-based walking and non-supervised individual-based walking interventions']}\n- {'label': 'individual-based walking intervention without professional trainer supervision', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will conduct the intervention individually, without the supervision of a professional fitness trainer', 'interventionNames': ['Behavioral: supervised group-based walking and non-supervised individual-based walking interventions']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'No intervention will be given to the control group.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'supervised group-based walking and non-supervised individual-based walking interventions', 'description': \"Group exercise interventions tended to be systematic and supervised by professionals. The current intervention is proposing to conduct a randomized control trial that is not only examining the nature of walking on older adults' well-being but also involving the elements of group-based and professional supervision intervention, aiming at comparing with the individual-based intervention without professional supervision. Qualified professional fitness trainers (1 male and 1 female separately for male and female groups, respectively) will be involved in the group-based intervention programs in order to provide appropriate guidance and supervision to the participants. Whereas, the non-supervised individual-based intervention will be conducted by a research assistant (males and females) to ensure the attendance and general safety, but without providing professional advice or supervision.\", 'armGroupLabels': [\"group-based walking intervention with professional trainer's supervision\", 'individual-based walking intervention without professional trainer supervision']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Health-related quality of life at 4 months and at 7 months', 'description': 'The Short Form-36 (SF-36) is a widely used health survey questionnaire, especially for older adults to assess the health-related quality of life (HRQoL). The higher the scores mean a higher level of quality of life.', 'timeFrame': 'Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention'}\n- {'measure': 'Change from baseline Frailty level at 4 months and at 7 months', 'description': 'Physical Performance Test (PPT) is one of the tools which is used to assess the level of frailty. For our research we will use 9 item scale that includes 9 standardized tasks such as writing a sentence, simulated eating, turning 360 degrees, putting on and removing a jacket, lifting a book and putting it on a shelf, picking up a penny from the floor, a 50-foot walk test, and climbing stairs (scored as two items) (Reuben and Siu, 1990). The score range of each task is 0-4 and for 9 items it will be 36. A higher score indicates better performance (Villareal et al., 2017).', 'timeFrame': 'Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention'}\n- {'measure': 'Change from baseline Cognitive function at 4 months and at 7 months', 'description': 'The Mini-mental state examination (MMSE) is the most commonly used method to measure the level of cognitive impairment, especially in older adults. The score of Mini-mental state examination is calculated on a scale of 0-30 where score 24 or above is usually considered as the normal cognitive status or no cognitive impairment of the individual. The overall scorings are Severe cognitive impairment (0-17), Mild cognitive impairment (18-23) and No cognitive impairment (24-30).', 'timeFrame': 'Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% probability for detecting a treatment difference at a two-sided 5% level of significance is assumed. A 20% potential dropout rate is also considered.", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n G*Power was used to determine the sample size. Based on the previous intervention studies, the most frequently reported effect size was ranged from moderate (0.25) to high (0.70) [28, 29], a moderate effect size of 0.25 will be adopted for the current study. To ensure a power of 80% probability for detecting a treatment difference at a two-sided 5% level of significance, a sample size of 35 participants per group (total 105 for 3 groups) is expected to recruit. Yet, considering a 20% of potential dropout rate, a sample size of 42 participants per group (total 126 for 3 groups) will be required in the current study for the two-way repeated measures in three-time points. It is decided a total of 126 participants will be recruited. In order to satisfy the culture of KSA that males and females should undergo walking intervention separately in the group, an equal number of males and females (63\u00c2\u00a0M and 63\u00c2\u00a0F) will be recruited and randomly and equally assigned to the two intervention groups and control group. Moreover, in order to have an approximate mean age in each intervention group, the participants will be divided into 2 groups (60\u00e2\u0080\u009364 and 65 to 70) for the randomization.", "id": 1276, "split": "test"} +{"trial_id": "NCT05156008", "pmid": "37480132", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty a Randomized Controlled Trial\n\nIncluded conditions:\n- Vascular Access Complication\n- Vascular Access Site Bruising\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'NO_INTERVENTION', 'description': 'Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by standard palpation of vein under strict aseptic measures. Application of tourniquet on upper arm, palpation of vein, disinfection of skin and insertion of cannula. After two unsuccessful punctures, UGVA operator will step in and perform insertion of cannula with ultrasound.\\n\\nMedical staff will note:\\n\\n* number of attempts\\n* time to obtain vascular access\\n* type of cannula\\n* DIVA score'}\n- {'label': 'Group B', 'type': 'OTHER', 'description': 'Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by ultrasound guided vascular access under strict aseptic measures. With or without tourniquet applied on upper arm operator will prescan vasculature of arm to choose applicable vein. After disinfection of skin optimal vein is on plain part of arm and cannula must not end in flection (elbow, wrist) of arm.\\n\\nMedical staff will note:\\n\\n* number of attempts, if 2 attempts fail, another operator will perform insertion\\n* time to obtain vascular access\\n* diameter of vein\\n* type of cannula\\n* DIVA score', 'interventionNames': ['Other: Ultrasound-guided vascular access']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Ultrasound-guided vascular access', 'description': 'Patients in this arm will have peripheral venous cannula inserted under realtime ultrasound guidance. Out of plane technique (in plane technique if too deep when tip of the needle is on vessel wall) used by experienced physicians in UGVA. Out of plane technique strictly used in step by step manner. That means moving probe with the tip of the needle to always locate its exact position, all the way into the vein. All performed insertions are carried out by skilled operators in UGVA with out of plane technique. Just before surgery in block room.', 'armGroupLabels': ['Group B']}\n\nPrimary Outcomes:\n- {'measure': 'Ultrasound guided venous access need less attempts to successful cannulation', 'description': 'Number of punctures through skin defines number of attempts. Every puncture of skin with cannula is considered as attempt. Number of attempts are recorded in protocol as whole number. Does not matter with technique is used.', 'timeFrame': 'up to 24 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a 20% risk of complications with the standard method, a 5% Type I error probability (\u03b1 < 0.05), a 90% power (\u03b2 = 0.10), and a 5% risk of first insertion failure in the USG group.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The estimate for the final sample size was based on the expected drop-out rate and the objective and design of the study. This trial assumes a comparison of the effect on outcome variables in peripheral vein insertion in the USG group and palpation-inserted peripheral venous cannula as the control group. In overall, we hypothesize that it will take fewer attempts to insert the cannula into a vein with the USG technique (USG: 1 vs. C: 1\u00e2\u0080\u00933), corresponding to a reduction in time of\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00893\u00c2\u00a0min (clinically relevant indicator) for successful cannulation in the USG group. When calculating the sample size, based on our experience and literature data, we assumed a 20% risk of complications inserting the cannula into a vein in the standard way, 5% as a probability of a Type I error (\u00ce\u00b1\u00e2\u0080\u0089<\u00e2\u0080\u00890.05), and the power of the test 90% (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.10). Theoretically, we also accepted a 5% risk failure of a first insertion of a cannula into a vein in the USG group. The sample size calculation was based on the result of the risk ratio (RR) between groups as % of complications (unsuccessful prick) with cannula insertion into the peripheral veins [9]. The adequate sample size of 162 patients was calculated as described previously [10], increased by 20% for the case unforeseeable circumstances (technical error, data loss, poor patient cooperation, etc.) and rounded\u00e2\u0080\u0089\u00e2\u0089\u0085\u00e2\u0080\u0089200.", "id": 1277, "split": "test"} +{"trial_id": "NCT05157347", "pmid": "37567748", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Overground Gait Training Using a Torgue-Assisted Exoskeletal Wearable Device on Ambulatory Function in Subacute Stroke Patients, Multi-Center, Randomized Single-blinded Controlled Prospective Pilot Study\n\nIncluded conditions:\n- Subacute Stroke\n\nStudy Armgroups:\n- {'label': 'Robot-assisted Training Group', 'type': 'EXPERIMENTAL', 'description': '- After the baseline test, the training is performed with 20 sessions in total (60 min / session); five sessions a week for four weeks. The robot-assisted training group is given 30 min conventional gait training and another 30 min (excluding robot attachment and detachment time) gait training using an exoskeletal wearable robot, while the control group is given 1 hr conventional gait training for the same time as the robot-assisted training group. In all participants in each group, no other robot-assisted rehabilitation such as Lokomat, Erigo, or Morning Walk could be performed.', 'interventionNames': ['Other: Robot-assisted Training']}\n- {'label': 'Control Group', 'type': 'OTHER', 'description': '- After the baseline test, the training is performed with 20 sessions in total (60 min / session); five sessions a week for four weeks.', 'interventionNames': ['Other: Conventional Therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Robot-assisted Training', 'description': 'The gait training in this study uses an exoskeletal wearable robot (Product name: ANGEL LEGS M20, Angel robotics, Co., Ltd.) consisting of a wearable part, a hip or knee joint gear providing the auxiliary force, and a controller backpack. This product is a powered orthopedic device for gait rehabilitation and treatment such as the lower limb muscle reconstruction and joint motion recovery in patients or handicapped individuals. The product consists of a power part, a controller part and a gear part, while the device is powered by an electric motor and the device motion induces the gait posture to support the lower limbs and allow the gait training to be performed.', 'armGroupLabels': ['Robot-assisted Training Group']}\n- {'type': 'OTHER', 'name': 'Conventional Therapy', 'description': 'The conventional gait rehabilitation has been performed as a 1:1 training session between the therapist and a stroke patient.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Functional Ambulatory Category- Pre', 'description': '- The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.', 'timeFrame': 'pre-treatment evaluation: before interventions approximately 5 days'}\n- {'measure': 'Functional Ambulatory Category- Post', 'description': '- The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.', 'timeFrame': 'post-treatment evaluation: after interventions approximately 5 days'}\n\nPlease estimate the sample size based on the assumption: \ntwo-tailed independent t-test, significance level (\u00ce\u00b1) = 0.05, power = 95%, dropout rate = 25%", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was determined a priori, which assumed a two-tailed independent t-test with \u00ce\u00b1 equal to 0.05 and power at 95%. The sample size was derived using a recent article23 that is a similar study design to this study. An estimated sample size of 150 participants was expected to detect a statistically significant difference in primary outcome with a statistical power of 95% based on effect size d=0.961 at \u00ce\u00b1=0.05 with a 25% dropout rate.", "id": 1278, "split": "test"} +{"trial_id": "NCT05160818", "pmid": "37516835", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hypofractionated Stereotactic Radiotherapy Versus Single Fraction Stereotactic Radiosurgery to the Resection Cavity of Brain Metastases After Surgical Resection - A Prospective, Randomized, Controlled, Monocentric Phase III Trial\n\nIncluded conditions:\n- Brain Metastases\n- Resection Cavity\n\nStudy Armgroups:\n- {'label': 'Arm A: HSFRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Hypofractionated stereotactic radiotherapy to the resection cavity, dose prescription: 6-7 x 5 Gy', 'interventionNames': ['Radiation: Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)']}\n- {'label': 'Arm B: SRS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Single fraction stereotactic radiotherapy to the resection cavity, dose prescription: 1 x 12-20 Gy', 'interventionNames': ['Radiation: Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)', 'description': 'intervention description see above', 'armGroupLabels': ['Arm A: HSFRT', 'Arm B: SRS']}\n\nPrimary Outcomes:\n- {'measure': 'Local control', 'description': 'Local control at the resected site(s)', 'timeFrame': '12 months after adjuvant radiotherapy'}\n\nPlease estimate the sample size based on the assumption: \nThe test significance level (\u03b1) is set to 0.05, with a power of at least 80%. A dropout rate of 10% is estimated.", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Statistical considerations and sample size calculation\n The underlying null hypothesis of this study is that there is no difference in terms of LC between HFSRT and SRS. The aim of the study is to provide evidence that allows to refute the null hypothesis with a certainty of at least 95% (95% CI), so that the alternative hypothesis can be considered valid. The alternative hypothesis is that HFSRT is superior to SRS in terms of LC. The underlying data for case number calculation are the prospective trials by Mahajan et al. [5] and Brown et al. [6] for SRS (pooled mean LC rate of 66% at 12\u00c2\u00a0months) and our own institutional retrospective data for HFSRT [13] (mean LC rate of 88% at 12\u00c2\u00a0months). The sample size calculation was performed with a two group Chi-squared test of equal proportions (odds ratio\u00e2\u0080\u0089=\u00e2\u0080\u00891). The test significance level (\u00ce\u00b1) was set to 0.05. Allocating an equal number of patients to both treatment arms, 114 patients are needed to detect a superiority of HFSRT with a power of at least 80%. We estimated a dropout rate of 10%, resulting in a total number of 126 patients, and a monthly accrual of three patients. Patients will be randomized 1:1 in the two different treatment arms. Logistic regression analysis will be used to perform predefined subgroup analyses with respect to the primary endpoint.", "id": 1279, "split": "test"} +{"trial_id": "NCT05161572", "pmid": "35764956", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Phase II Trial of Perioperative Chemoimmunotherapy Verses Perioperative Chemoimmunotherapy Plus Preoperative Chemoradiation for Locally Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma\n\nIncluded conditions:\n- Stomach Neoplasms\n- Esophagogastric Junction Disorder\n- Neoadjuvant Therapy\n- Chemoradiotherapy\n- Immunotherapy\n- Gastrectomy\n- Adenocarcinoma\n- Adjuvant Therapy\n\nStudy Armgroups:\n- {'label': 'Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapy', 'type': 'EXPERIMENTAL', 'description': 'In this arm, patients will receive preoperative chemoradiotherapy (45Gy/25Fractions), two cycles of SOX and three cycles of PD-1 antibody, followed by D2 surgery and three more cycles of SOX and PD-1 antibody. Then PD-1 antibody will be given until one year after surgery.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Tegafur-Gimeracil-Oteracil', 'Drug: Sintilimab', 'Radiation: Concurrent chemoradiation', 'Procedure: D2/R0 gastrectomy']}\n- {'label': 'Perioperative chemotherapy plus PD-1 antibody', 'type': 'EXPERIMENTAL', 'description': 'In this arm, patients will receive three cycles of SOX and PD-1 antibody, followed by D2 surgery and three more cycles of SOX and PD-1 antibody. Then PD-1 antibody will be given until one year after surgery.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Tegafur-Gimeracil-Oteracil', 'Drug: Sintilimab', 'Procedure: D2/R0 gastrectomy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'The SOX regimen consists of S-1 and oxaliplatin and is repeated every three weeks. Oxaliplatin will be administered intravenously at 130 mg/m2 on day 1.', 'armGroupLabels': ['Perioperative chemotherapy plus PD-1 antibody', 'Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapy']}\n- {'type': 'DRUG', 'name': 'Tegafur-Gimeracil-Oteracil', 'description': 'The SOX regimen consists of S-1 and oxaliplatin and is repeated every three weeks. S-1 is administered orally at 40-60 mg twice a day for 14 consecutive days. Then, the patients will have a one-week rest period. The dose of S-1 is according to the body-surface area (BSA): patients with a BSA of less than 1.25 m2 receive 80 mg daily; those with a BSA of 1.25 m2 or more but less than 1.5 m2 receive 100 mg daily; and those with a BSA of 1.5 m2 or more receive 120 mg daily.', 'armGroupLabels': ['Perioperative chemotherapy plus PD-1 antibody', 'Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapy']}\n- {'type': 'DRUG', 'name': 'Sintilimab', 'description': 'The immunotherapy includes perioperative treatment and postoperative maintenance treatment. The PD-1 mAb used will be sintilimab, and the dose is 200 mg intravenously every three weeks. Regardless of which arm, the courses of immunotherapy that will be received by the enrolled patients are the same: 3 times preoperatively, 3 times postoperatively, and then maintained until one year after surgery.', 'armGroupLabels': ['Perioperative chemotherapy plus PD-1 antibody', 'Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapy']}\n- {'type': 'RADIATION', 'name': 'Concurrent chemoradiation', 'description': 'The radiotherapy (RT) consists of 45 Gy delivered in 25 fractions every five days per week for five weeks. The dose of concurrent ChT is 60 mg/m2 S-1 orally, oral tablets twice daily, days 1-5 of each week.', 'armGroupLabels': ['Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapy']}\n- {'type': 'PROCEDURE', 'name': 'D2/R0 gastrectomy', 'description': 'Gastrectomy with standard D2 lymphadenectomy is recommended. The type of gastrectomy performed depends on the location and extent of the primary lesion. For GEJ or upper third tumors, a 3 cm esophageal margin is recommended, and a total gastrectomy or esophagogastrectomy is performed. For middle third tumors, the gastric margin is recommended to be more than 5 cm, and a total gastrectomy is performed. For lower third tumors, a 2 cm duodenal margin is recommended, and a subtotal or total gastrectomy is performed. Billroth I or Roux-en-Y gastrojejunostomy is performed for distal gastrectomy patients. Roux-en-Y esophagojejunostomy is performed for patients receiving total gastrectomy.', 'armGroupLabels': ['Perioperative chemotherapy plus PD-1 antibody', 'Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Pathological complete regression (pCR) rate', 'description': 'The primary endpoint is the pathological complete regression (pCR) rate: the proportion of patients who achieve pCR after preoperative therapy. Patients with a CY0 status at the time of enrollment should have no residual tumor cells in the primary lesion and in the dissected lymph nodes in the surgical specimens (ypT0N0M0). Patients with a CY1 status at the time of enrollment should reach both ypT0N0M0 and a CY0 status.', 'timeFrame': '6 months after the enrollment of the last subject'}\n\nPlease estimate the sample size based on the assumption: \nPatients are randomly assigned to two arms at a ratio of 1:1. A one-sided test is adopted with a type I error rate (\u03b1) of 0.05 and a power (1-\u03b2) of 80%. The dropout rate is set to 10%.", "answer": 152, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The preliminary analysis of the PREACT study (NCT03013010) showed that preoperative chemotherapy with three cycles of the SOX regimen can yield a pCR rate of 2%, and two cycles of the SOX regimen plus chemoradiation of 45\u00e2\u0080\u0089Gy/S-1 yielded a pCR rate of 17%. The preliminary analysis of a study called NeoPLANET (NCT03631615) showed that the pCR rate of CapeOX plus camrelizumab combined with chemoradiation was 26.7% (4/15). According to poster 4036 of 2021 ASCO, four cycles of mFOLFOX6 plus camrelizumab yielded a pCR rate of 10% (5/52). Thus, with the addition of PD-1 mAb, the increased range of the pCR in both the preoperative ChT group and CRT group was approximately 8 to 10%, which is a reasonable range. Based on these research data, in this study, the pCR rate of Arm A is set as P1\u00e2\u0080\u0089=\u00e2\u0080\u008926%, and the pCR rate of Arm B is set as P2\u00e2\u0080\u0089=\u00e2\u0080\u008910%. The null hypothesis (H0): the pCR rate of Arm A is not better than that of Arm B, that is, P1-P2\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00890. The alternative hypothesis (H1): the pCR rate of Arm A can be increased by 16% compared with Arm B, that is, P1-P2\u00e2\u0080\u0089=\u00e2\u0080\u008916%.\n The patients were randomly assigned to two arms at a ratio of 1:1. One side test is adopted, and if the error rate of type I (\u00ce\u00b1) is set to 0.05, then 138 patients need to be enrolled, i.e., 69 in each arm, which can ensure that the test efficiency (1-\u00ce\u00b2) reaches 80%. When the dropout rate is set to 10%, 152 patients are needed, with 76 in each group.", "id": 1280, "split": "test"} +{"trial_id": "NCT05163106", "pmid": "39073142", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Presurgical Treatment With Ribociclib and Letrozole in Patients With Locally Advanced Breast Cancer: the NEOLETRIB Study.\n\nIncluded conditions:\n- Breast Cancer\n- HER2-negative Breast Cancer\n- ER-positive Breast Cancer\n- Locally Advanced Breast Cancer\n- Luminal A Breast Cancer\n- Luminal B Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Ribociclib and Letrozole Arm', 'type': 'EXPERIMENTAL', 'description': 'Patients entered into this study will be given letrozole (FemarTM) in combination with ribociclib (KisqaliTM) for at least 6 months. Premenopausal women will also receive treatment with goserelin 3.6 mg s.c. every 4 weeks.', 'interventionNames': ['Drug: Letrozole 2.5mg oral tablet; Ribociclib 600mg oral tablet', 'Drug: Goserelin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Letrozole 2.5mg oral tablet; Ribociclib 600mg oral tablet', 'description': 'Patients will be given letrozole 2.5mg and ribociclib 600mg daily, per oral for a period of 21 days followed by 7 days of letrozole only.', 'armGroupLabels': ['Ribociclib and Letrozole Arm'], 'otherNames': ['Femara; Kisqali']}\n- {'type': 'DRUG', 'name': 'Goserelin', 'description': 'Premenopausal women will be given goserelin 3.6 mg (subcutaneous) every 4 weeks in concert with their Letrozole and Ribociclib treatment.', 'armGroupLabels': ['Ribociclib and Letrozole Arm'], 'otherNames': ['Zoladex']}\n\nPrimary Outcomes:\n- {'measure': 'To study the change in levels of direct and indirect immunologic biomarkers of targeted cancer therapy with letrozole and ribociclib given in combination for patients with locally-advanced, ER-positive, HER-2 negative, luminal A7B breast cancer', 'description': 'In order to accurately profile changes in the composition of the tumor over time and identify potentially-related biomarkers of response within the tumor, single cell RNA panels will be performed at three points during the treatment period. Samples of tumor tissue will be obtained, and the cells dissociated at the single cell level. These dissociated cells will then be subjected to RNA profiling via scRNA-seq. Genes expressed at a rate higher than the threshhold (generally 50 reads per kb per million reads) will be examined using t-Distributed Stochastic Neighbor Embedding, (tSNE) clustering, generally shown as a scatterplot, to allow the characterisation of phenotypes (clones). Using this technique, it will be evident which tumour phenotypes are eradicated by the treatment combination and which are not. This examination will also help to monitor patient response.', 'timeFrame': 'Baseline, Day 21 and at time of surgery (Day 180)'}\n\nPlease estimate the sample size based on the assumption: \nThe primary aim is to deliver basic research results rather than evaluate efficacy or compare treatments. The data is expected to yield reliable results given the main endpoints and expected data variation.", "answer": 85, "answer_type": "ACTUAL", "explanation": "2.5.\n Sample size & recruitment\n Based on the results of the CORALLEEN trial [34], treatment response (24\u00c2\u00a0weeks of treatment) based on MRI was 14% Complete Response (CR), 43% Partial Response (PR), 33% Stable Disease (SD) and 10% N/A. We propose a minimum sample size in either group to be at least >30 patients, thus an inclusion goal of 100 patients in total would be sufficient for hypothesis-generating results.\n However, the primary aim of this trial is to deliver basic research results, rather than to evaluate the efficacy or compare treatments. Given the main end points and the expected data variation, the data will be sufficient to yield reliable results.\n The study was opened for inclusion on 1 April 2021, and will remain open until 31 December 2024, or until a minimum of 100 patients have completed all study procedures. At the time of manuscript submission, 85 patients have already been enrolled in the NEOLETRIB trial.", "id": 1281, "split": "test"} +{"trial_id": "NCT05163951", "pmid": "35788072", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial\n\nIncluded conditions:\n- Primary Angle Closure Glaucoma\n\nStudy Armgroups:\n- {'label': 'Trabeculectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.', 'interventionNames': ['Procedure: Trabeculectomy']}\n- {'label': 'SPI+GSL+GT', 'type': 'EXPERIMENTAL', 'description': 'Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT).', 'interventionNames': ['Procedure: SPI+GSL+GT']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Trabeculectomy', 'description': 'trabeculectomy', 'armGroupLabels': ['Trabeculectomy']}\n- {'type': 'PROCEDURE', 'name': 'SPI+GSL+GT', 'description': 'Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)', 'armGroupLabels': ['SPI+GSL+GT']}\n\nPrimary Outcomes:\n- {'measure': 'Intraocular pressure at postoperative 12 months', 'description': 'Intraocular pressure after surgery using Goldmann or non-contact tonometer.', 'timeFrame': 'Postoperative 12 month'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve a power of 90% at a one-sided significance level (\u03b1) of 2.5%, and allowing for a 20% loss to follow-up.", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This will be a non-inferiority trial. The sample size is estimated based on the primary outcome, that is, IOP 12 months after surgical treatment. Previous studies have reported that the average IOP after trabeculectomy at 12 months is approximately 14 mm Hg.30 34 An IOP of 18 mm Hg or lower will be defined as successful surgery; therefore, the non-inferiority margin (\u00ce\u0094) will be specified as 4.0 mm Hg, which will be acceptable in clinical practice. A common SD (\u00cf\u0083) of 5 mm Hg will be employed for both treatment groups, as previously reported.30 34 To achieve a power of 90%, at a one-sided significance level (\u00ce\u00b1) of 2.5%, a sample size of 34 eyes from 34 participants per group will be required. Allowing for a 20% loss to follow-up, a sample size of 88 eyes from 88 participants will be necessary. The sample size was calculated using PASS V.16.0 (NCSS, USA).", "id": 1282, "split": "test"} +{"trial_id": "NCT05164874", "pmid": "35804417", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of a Mobile Mammography Unit. A Randomized Cluster Trial Protocol of a Population Health Intervention Research to Reduce Breast Cancer Screening Disparities in Normandy, France (Mammobile)\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Women will receive a proposition for an appointment at the MMU in complement to the current screening invitation, keeping the choice of their place of screening.\\n\\nWomen will also receive the timetable of prevention actions with the invitation to participate in screening.', 'interventionNames': ['Device: Mobile Mammography Unit']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'No change from the usual breast cancer screening organization'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Mobile Mammography Unit', 'description': 'The main intervention will be a proposition for an appointment at the MMU in complement to the current OBCS', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Aggregated breast cancer screening participation rate 3 months after the last invitation', 'description': 'Participation rate will be measure at area level and compare between intervention and control arm.', 'timeFrame': '3 months after the last invitation at the end of the two years of the intervention'}\n- {'measure': 'Individual breast cancer screening participation rate 3 months after the last invitation', 'description': 'It will also be assessed at indivdual level with multilevel logistic regression', 'timeFrame': '3 months after the last invitation at the end of the two years of the intervention'}\n- {'measure': 'Impact of the mobile unit on social inequalities in screening participation', 'description': 'Impact of the mobile mammography unit on social inequalities will be assessed by comparing intervention and control arm. Social statut is measure with an ecological deprivation index', 'timeFrame': '3 months after the last invitation at the end of the two years of the intervention'}\n- {'measure': 'Impact of the mobile unit on territorial inequalities in screening participation', 'description': 'impact of the mobile mammography unit territorial inequalities will be assessed by comparing intervention and control arm. The distance to the radiologiste center will be used as territorial mesure', 'timeFrame': '3 months after the last invitation at the end of the two years of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study population is constituted to be as distant as possible from accredited radiology centres, with an average travel time calculated for each IRIS.", "answer": 91982, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The U1086 INSERM research team has developed an algorithm in python v3.0 to constitute clusters combining some constraints in a regional scenario for the four departments. Eligible population data are available in the SMS screening database. First, it was estimated than the number of intervention days should not exceed 400 over 2\u00c2\u00a0years (considering holidays, climatic and logistical hazards). Eight hundred days were considered to constitute a control arm. Based on the experience of the Department of Orne [10], it was estimated that around a hundred women had to be invited each day in order to perform around 30 mammograms daily. We also plan that, when possible, the MMU will park on the same site for at least two consecutive days so that women will have flexibility in attending. The population study (intervention arm and control arm) has been constituted to be as distant as possible from accredited radiology centres. After calculating the average travel time of women to the nearest radiology centre in each IRIS, 96,200 women were selected (algorithm stopped at the IRIS exceeding maximum population\u00e2\u0080\u0089=\u00e2\u0080\u0089800\u00e2\u0080\u0089days of work*120 women\u00e2\u0080\u0089=\u00e2\u0080\u008996,000) in the 1131 most distant IRIS. To maximize aggregation of the IRIS according to travel time to the radiology centres, the most distant ones were selected and then merged with neighbouring IRIS, still by distance travelled, until areas of the expected population size were reached. This algorithm was applied to all IRIS according to distance rank until aggregation was no longer was possible. 91,982 women (95.6%) and 1067 IRIS (94.3%) were selected in the final population in 356 clusters (with 258 created by the algorithm). This algorithm allows geographical clusters to be constructed. The number of women is estimated on the basis of a previous screening campaign, so the real number will be known when the screening invitation has been sent. Table 2 shows the distribution of clusters between departments and arms. As it is a regional calculation according to the criterion of distance, the clusters are not equally distributed among the departments.Table 2Clusters and distribution of women in each departmentDepartmentArmWomen numberN (%)Cluster numberN (%)CalvadosControl1473026875 (29.27%)54102 (27.64%)Intervention1214548EureControl1403627801 (30.27%)58111 (30.08%)Intervention1376553MancheControl802215630 (17.02%)3062 (16.80%)Intervention760832Seine MaritimeControl991921676 (23.60%)4394 (25.47%)Intervention1175751Total91982369a (356)a13 clusters cover two departments", "id": 1283, "split": "test"} +{"trial_id": "NCT05167734", "pmid": "36460332", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial\n\nIncluded conditions:\n- Anemia\n- Critical Illness\n\nStudy Armgroups:\n- {'label': 'Control (Standard of Care) Group', 'type': 'NO_INTERVENTION', 'description': 'Subjects will receive standard clinical care for the treatment of anemia while in the ICU.'}\n- {'label': 'Anemia Treatment Bundle', 'type': 'EXPERIMENTAL', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).', 'interventionNames': ['Drug: Iron Dextran', 'Drug: Erythropoietin (EPO)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Iron Dextran', 'description': '1000 mg IV', 'armGroupLabels': ['Anemia Treatment Bundle']}\n- {'type': 'DRUG', 'name': 'Erythropoietin (EPO)', 'description': '40,000 units subcutaneous', 'armGroupLabels': ['Anemia Treatment Bundle'], 'otherNames': ['EPO']}\n\nPrimary Outcomes:\n- {'measure': 'Hemoglobin concentrations', 'description': 'Mean difference in hemoglobin concentrations', 'timeFrame': '1 month post-hospitalization'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sample unequal variances t-test, two-sided alpha of 0.05, 25% dropout rate, adjustment for pre-randomisation prognostic variables to achieve 90% power.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Power/sample size are calculated to detect a difference in haemoglobin at 1-month follow-up. Preliminary data show mean (SD) haemoglobin levels of 108 (15) g/L at 1\u00e2\u0080\u0089month among 636 patients with similar inclusion/exclusion criteria receiving standard care. A total sample size of 74 (37 per group) provides 80% power to detect 10\u00e2\u0080\u0089g/L difference using a two-sample unequal variances t-test with two-sided alpha of 0.05 to compare 1\u00e2\u0080\u0089month haemoglobin between randomised arms. Actual power is expected to be higher adjusting for pre-randomisation prognostic variables to reduce residual variation. If adjustment variables account for 25% of the variation in 1-month haemoglobin, the sample size of 37 per group provides 90% power to detect 10\u00e2\u0080\u0089g/L difference using analysis of covariance. While the analysis will employ a linear mixed-effects model (LMM), power is not appreciably different. Given expected dropout of up to 25% (death, loss to follow-up), 100 subjects will be enrolled.", "id": 1284, "split": "test"} +{"trial_id": "NCT05167929", "pmid": "35162786", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Culturally-tailored Personal Self-Determination Enhancement Intervention for People With Mild Intellectual Disabilities and Their Caregivers in Hong Kong - A Randomised Controlled Trial\n\nIncluded conditions:\n- Intellectual Disability, Mild\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Self-determination Enhancement Group']}\n- {'label': 'Intervention PLUS Group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Self-determination Enhancement Plus Group']}\n- {'label': 'Comparison Group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Leisure activity group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Self-determination Enhancement Group', 'description': 'The self-determination enhancement group - Each group has eight participants. There will be 10 sessions per group and each session will last 1.5 hours.', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Self-determination Enhancement Plus Group', 'description': 'The self-determination enhancement PLUS group - Each group has eight participants and their caregivers. There will be 10 sessions per group and each session will last 1.5 hours. Meanwhile, their caregivers will attend four sessions separately and each session will last 1.5 hours.', 'armGroupLabels': ['Intervention PLUS Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Leisure activity group', 'description': 'Leisure activity group - Leisure activity group is the comparison group. Each group will consist of eight adults with mild intellectual disability. There will be 10 sessions for the group and each session will last for 1.5 hours.', 'armGroupLabels': ['Comparison Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes of self-determination competence level', 'description': 'The AIR Self-Determination Scale: the Chinese Version (AIR SDS-C) (Wong, Wong, Zhuang \\\\& Liu, 2017) will be used. This is a 24-items, 5-point Likert-scale questionnaire to measure the self-determination of people with intellectual disability', 'timeFrame': 'Pretest (T0) - baseline; posttest (T1) - after the completion of the intervention (3 months later from the pretest); and follow-up test (T2) (3 months later from the posttest)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, an \u03b1 error of 0.05, and a test including three independent groups. An estimated drop-out rate of 15% at the six-month follow-up period.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "2.3. Sample Size\n The sample size is calculated based on a moderate effect size of 0.70 for clinical outcome research. For 80% power, an \u00ce\u00b1 error of 0.05, and a test including three independent groups, the required sample size is 105 participants, which is sufficient to conduct Hierarchical Linear Modelling (HLM). Incorporating an estimated drop-out rate of 15% at the six-month follow-up period, the target sample size is 120. Drop-out cases will include participants with ID whose attendance rate in regard to the groups is less than 70%, or those who cannot complete all questionnaires during the three phases. With 6\u00e2\u0080\u00938 participants per group, 5 SD groups, 5 SD-PLUS groups and 5 leisure groups will be conducted.", "id": 1285, "split": "test"} +{"trial_id": "NCT05168280", "pmid": "36690404", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial\n\nIncluded conditions:\n- Dexmedetomidine\n- Postoperative Delirium\n\nStudy Armgroups:\n- {'label': 'DEX group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The DEX group patients will be received dexmedetomidine intraoperatively.', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo group patients will be received 0.9% saline intraoperatively.', 'interventionNames': ['Drug: 0.9% saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.', 'armGroupLabels': ['DEX group']}\n- {'type': 'DRUG', 'name': '0.9% saline', 'description': 'The 0.9% saline is administered with the same volume at the same speed as the other group.', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence of postoperative delirium', 'description': 'Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.\\n\\nDelirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present.\\n\\nIn the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score \u2264-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.', 'timeFrame': 'postoperative 5 day'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level is set at 0.05 (two-sided), power is set at 80%, and a 5% dropout rate is considered.", "answer": 420, "answer_type": "ESTIMATED", "explanation": "Sample size estimation and statistical analysis\n The incidence of POD is about 15%\u00e2\u0080\u009320% in patients undergoing neurosurgery,1 and a number of studies have shown that age is the independent risk factors of POD in neurosurgery patients.19 Therefore, the incidence of POD might be higher in elderly neurosurgery patients. According to a previously meta-analysis, intraoperative application of DEX could reduce the incidence of POD by approximately 54%.21 We assumed a 20% incidence of POD in this study and a 50% reduction (from 20% to 10%) in DEX group. With a significance and power set at 0.05 (two sided) and 80%, respectively, the sample size required to detect the difference is 394 patients. Considering about 5% of the lost to follow-up, 420 (210 in each group) patients need to be enrolled.\n The analysis will be done by SPSS software (V.22.0). The continuous variables will be described with mean and SD or median and IQR. Categorical data will be presented with counts (percentage). The independent sample t-test will be used to compare the normally distributed continuous data, and the independent sample Mann-Whitney U test will be used to compare the non-normally distributed continuous data. The difference in cumulative incidence of POD between the DEX and control groups will be analysed by the \u00cf\u00872 test. Kaplan-Meier survival analysis will be used to analyse time-to-event data, and logarithmic rank test will be used to evaluate differences between groups. The primary outcome will be analysed in the subgroups, including delirium severity, delirium motoric subtype, gender, American Society of Anesthesiologists physical status, tumour type, study drug dose and anaesthesia duration.\n Other secondary outcomes such as cognitive score, quality of sleep, postoperative quality of recovery and intraoperative haemodynamic parameters will be analysed by t-test or Mann-Whitney U test, or repeated measurements. We will apply the intention-to-treat analysis on the primary outcome according to group allocation. In addition, missing data will be imputed by using the worst-case imputation scenarios, and will be analysed in sensitivity analysis.", "id": 1286, "split": "test"} +{"trial_id": "NCT05173740", "pmid": "38303019", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial\n\nIncluded conditions:\n- Cardiac Arrest\n- Heart Arrest\n- Cardiopulmonary Resuscitation\n- Return to Work\n- Return-to-work\n- Rehabilitation\n- Recovery of Function\n- Cardiac Rehabilitation\n\nStudy Armgroups:\n- {'label': 'Individually tailored rehabilitation intervention + usual care', 'type': 'EXPERIMENTAL', 'description': \"A comprehensive neurocognitive assessment and a thorough individual assessment of rehabilitation needs will be conducted to inform the individually tailored intervention plan. Core intervention elements are: 1) comprehensive assessment of individual rehabilitation needs including neuropsychology tests in order to make a individually tailored intervention plan coordinated with the multidisciplinary rehabilitation team, 2) providing strategies to lessen impact for the individual cognitive impairment, 3) educating survivors and relatives about the impact of a cardiac arrest and consequences on daily life, 4) work preparation, including establishment of routines and opportunities to practice work skills and 5) collaboration with the local municipality's job centre and employers to plan, support and monitor graded RTW, 6) short term therapy by psychologist dealing with thoughts and behaviour in relation to cardiac arrest.\", 'interventionNames': ['Other: Individually tailored rehabilitation intervention']}\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'description': \"All participants including those allocated to the usual care group will be seen by an occupational therapist if their MoCA screening score \u226426. Furthermore, if considered relevant by the discharging unit, survivors are referred for rehabilitation provided and delivered in the local municipality where the participant is resident. The content of the rehabilitation will typically be based on the content of the rehabilitation plan from the discharging hospital unit and an individual assessment of the survivors' expressed needs, within the local municipality where the participant is resident.\", 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Individually tailored rehabilitation intervention', 'description': 'Individually tailored rehabilitation intervention', 'armGroupLabels': ['Individually tailored rehabilitation intervention + usual care']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Usual care', 'armGroupLabels': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Labour market participation using data from the DREAM database', 'description': 'The primary outcome of the clinical trial is labour market participation, defined as a dichotomized outcome, employment vs. on social transfer payment 12 months after hospital discharge.', 'timeFrame': '12-months after hospital discharge'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a superiority margin of 10%, a power of 80%, and an expected dropout rate of 20%.", "answer": 214, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation for the present trial is based on a study by Moulaert et al. who evaluated the effectiveness of a rehabilitation intervention on health-related quality of life for OHCA survivors but reported exploratory finding for RTW after 1 year. In that study, 71% of the control group had returned to work after 1 year. We expect the intervention to increase this by 25% corresponding to a RTW rate of 88.8%. Using the formula for large-sample tests for proportions in a two-sample parallel design with a superiority margin of 10% and a power of 80%, 85 survivors are needed in each arm, 170 in total. Based on the sample size calculation and an expected 20% dropout rate, 107 OHCA survivors are needed in each study arm, 214 in total [42].", "id": 1287, "split": "test"} +{"trial_id": "NCT05174286", "pmid": "38671470", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk\n\nIncluded conditions:\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Screening, Brief Intervention, and Referral to Treatment (SBIRT)', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to this arm will receive:\\n\\n1. SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment.\\n2. Culturally-adapted Alive! Program, which is a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control.', 'interventionNames': ['Behavioral: SBIRT']}\n- {'label': 'Referral as Usual (RAU)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomized to this arm will receive Referral as Usual (RAU), which will involve distributing CRC health educational materials (e.g. NCI or Centers For Disease Control brochures that include new guidelines) and contact information for screening service providers in our target community.', 'interventionNames': ['Behavioral: Referral as Usual (RAU)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'SBIRT', 'description': 'SBIRT is an evidence-based approach originally designed for people at risk of developing mental disorders. SBIRT is composed of three components: Screening with a validated instrument, Brief Intervention, Referral to Treatment. Motivational Interviewing (MI) is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. It decreases ambivalence and increases motivation for treatment.\\n\\nThe investigators will utilize the Culturally-adapted Alive! Program - a cost-effective, lifestyle coaching web-based automated platform that includes step-by-step individualized tailoring, feedback, and weekly guidance through interactive emails focused on increasing physical activity, improving eating habits, and weight control.', 'armGroupLabels': ['Screening, Brief Intervention, and Referral to Treatment (SBIRT)'], 'otherNames': ['Culturally-adapted ALIVE! Program (CAP)']}\n- {'type': 'BEHAVIORAL', 'name': 'Referral as Usual (RAU)', 'description': 'Referral as Usual will involve distributing CRC health educational materials (e.g. NCI or CDC brochures that include new guidelines) and contact information for screening service providers in our target community.', 'armGroupLabels': ['Referral as Usual (RAU)']}\n\nPrimary Outcomes:\n- {'measure': 'CRC Screening Uptake', 'description': \"Screening uptake (clinic-based colonoscopy or home-based stool test) (Primary Outcome) is the subject's self-report of completing a CRC screening test plus the research team's verification of this completion from medical records.\", 'timeFrame': '6 months post-screening'}\n\nPlease estimate the sample size based on the assumption: \nTwo-arm, cluster RCT in 22 Black churches, screening at least 40 adult churchgoers aged 45 years and older per church for study eligibility.", "answer": 880, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We will conduct a two-arm, cluster RCT in 22 Black churches. From each of these 22 churches, we will recruit 20 subjects for a total sample size of 440 subjects. Based on our prior study in which approximately 50% of AAs above age 50\u00c2\u00a0years were not up-to-date with screening [49], we will screen at least 40 adult churchgoers aged 45\u00c2\u00a0years and older per church for study eligibility (total screening\u00e2\u0080\u0089=\u00e2\u0080\u0089880 subjects).", "id": 1288, "split": "test"} +{"trial_id": "NCT05176964", "pmid": "36927585", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial\n\nIncluded conditions:\n- Rectal Cancer\n- Radiation Oncology\n\nStudy Armgroups:\n- {'label': 'HFRT with concurrent chemotherapy and immunotherapy', 'description': 'CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT', 'interventionNames': ['Radiation: split-course HFRT', 'Drug: CAPOX chemotherapy', 'Drug: Tislelizumab']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'split-course HFRT', 'description': '7Gy/F, d7, q3w, 5 cycles', 'armGroupLabels': ['HFRT with concurrent chemotherapy and immunotherapy'], 'otherNames': ['hypofraction radiotherapy']}\n- {'type': 'DRUG', 'name': 'CAPOX chemotherapy', 'description': 'CAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m\\\\^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m\\\\^2 administered orally twice daily on day 1 to 14 of a 21-day cycle.', 'armGroupLabels': ['HFRT with concurrent chemotherapy and immunotherapy'], 'otherNames': ['oxaliplatin and capecitabine']}\n- {'type': 'DRUG', 'name': 'Tislelizumab', 'description': 'Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.', 'armGroupLabels': ['HFRT with concurrent chemotherapy and immunotherapy'], 'otherNames': ['immunotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'pathological complete response(pCR)', 'description': 'pCR is defined as no residual tumor in the surgical specimen.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) is 0.05, power (\u03b2) is 0.8, and the dropout rate is 10%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n As reported, the pCR rate of conventional chemoradiotherapy is about 14%.25 Based on estimation, the pCR rate of our study is 40%.26 Using \u00ce\u00b1=0.05 and \u00ce\u00b2=0.8, the sample size (n=45) has been calculated using PASS software (V.15). Assuming the drop-out rate of patients is 10%, the sample size will be 50.", "id": 1289, "split": "test"} +{"trial_id": "NCT05177393", "pmid": "35045815", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment Outcomes of Esophageal Cancer\n\nIncluded conditions:\n- Esophageal Cancer\n\nStudy Armgroups:\n- {'label': 'Participants with Esophageal Cancer', 'description': 'Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data.', 'interventionNames': ['Other: Assessment of patient-reported outcomes (PROs)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Assessment of patient-reported outcomes (PROs)', 'description': 'Questionnaires will be administered to participants', 'armGroupLabels': ['Participants with Esophageal Cancer'], 'otherNames': ['PROs']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites', 'description': 'Descriptive statistics will be used to describe the proportion of EC patients receiving treatment with each modality at participating AfrECC sites. The investigators will assess the associations between demographic and clinicopathologic characteristic and treatment modalities employed (chemotherapy, radiotherapy, chemo-radiation, esophageal stenting, esophagectomy, supportive care alone, or a combination of these treatments)', 'timeFrame': 'Up to 4 years'}\n- {'measure': 'Change in scores of the Modified Rosenblatt Index over time', 'description': 'The 6-item Modified Rosenblatt Index by Rosenblatt, et al. adapted for use within a resource-limited context evaluates EC related parameters scored on a Likert scale assessing presence and severity of symptoms: Odynophagia (0=no pain on swallowing to 3=severe pain); Dysphagia (0=normal, no dysphagia to 4=unable to swallow saliva); Regurgitation (0=never to 3=constant); Chest and/or Back Pain (0=no pain to 2=pain not relieved by non-narcotics or requiring opiate medication); World Health Organization (WHO) performance status/Overall Well-Being (0=\"A lot better\" to 4=\"A lot worse\"). Scores will be assessed at the following time points: Baseline, 1 month and 3 months after initiation of treatment, and every 3 months thereafter.', 'timeFrame': 'Up to 4 years'}\n- {'measure': 'Median Overall Survival', 'description': 'Survival will be defined as the time elapsed from date of diagnosis (either confirmed or date of diagnostic modality leading to presumptive clinical diagnosis) to date of death. For participants who are not deceased, censorship will be performed on the date when the participant was last known to be alive.', 'timeFrame': 'Up to 4 years'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.0167 (Bonferroni correction for 3 comparisons), power = 0.99 for stenting vs. radiotherapy with or without chemotherapy, power = 1.00 for stenting vs. chemotherapy, and power = 1.00 for radiotherapy with or without chemotherapy vs. chemotherapy.", "answer": 2476, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim to recruit all patients with ESCC based on histological confirmation or presumptive clinical diagnosis that meet the eligibility criteria at participating AfrECC sites. We forecast a total accrual of an estimated 2476 study participants across all six sites (see Table 1) over the duration of the study. This estimate is based on annual ESCC cases observed in recent case series at KCH (unpublished data), annual recruitment to a recent case-control study at KCMC [18], as well as annual accrual rates in the present study at ORCI, MNH, and Tenwek since study initiation (Tenwek Hospital, n\u00c2\u00a0=\u00e2\u0080\u0089220 study participants per year; ORCI, n\u00c2\u00a0=\u00e2\u0080\u0089130 per year; and MNH, n\u00c2\u00a0=\u00e2\u0080\u0089150 per year). Of the total study population, we estimate 1102 study participants will be treated with esophageal stenting, 145 with chemotherapy, 464 with radiotherapy, 212 with concurrent chemoradiation, 450 with supportive care alone, and 103 with esophagectomy. Based upon previous data that indicate median OS following stenting is 36\u00e2\u0080\u0089weeks [10], radiotherapy with or without chemotherapy is 27\u00e2\u0080\u0089weeks [13, 19], and chemotherapy is 14\u00e2\u0080\u0089weeks [5, 19], our primary analysis comparing OS of different palliative interventions for ESCC will have the following power to detect differences between each pairwise comparisons based upon alpha of 0.0167 (adjusting for 3 comparisons based on Bonferroni correction): stenting vs. radiotherapy with or without chemotherapy, power\u00e2\u0080\u0089=\u00e2\u0080\u00890.99; stenting vs. chemotherapy, power\u00e2\u0080\u0089=\u00e2\u0080\u00891.00; and radiotherapy with or without chemotherapy vs. chemotherapy, power\u00e2\u0080\u0089=\u00e2\u0080\u00891.00.", "id": 1290, "split": "test"} +{"trial_id": "NCT05180175", "pmid": "39089718", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile\n\nIncluded conditions:\n- Inflammatory Bowel Diseases\n- Ulcerative Colitis\n- Crohn Disease\n\nStudy Armgroups:\n- {'label': 'Access to protein profile', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Top down treatment if patient at high risk']}\n- {'label': 'No access to protein profile', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Top down treatment if patient at high risk', 'description': 'Patients with an increased risk of poor disease course (as defined by a serum protein signature at diagnosis), will be treated with a top down treatment strategy.', 'armGroupLabels': ['Access to protein profile']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical and endoscopic remission', 'description': 'Composite of proportion of subjects with both corticosteroid-free clinical remission and endoscopic remission at Week 52. Surgery because of IBD during follow-up will be defined as treatment failure.', 'timeFrame': 'Week 52'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve 85% power, using Pearson's \u03c72 two-group proportions test (two-sided, with continuity correction) at a significance level of 5%.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Power and sample size calculation\n The initial goal of the NORDTREAT study was to recruit 250 patients, focusing on those exhibiting a high-risk protein profile for IBD, based on a high-risk protein profile of 25% in the IBD Character cohort.18 However, an interim assessment in August 2023 (blinded to group allocation) suggested that the prevalence was approximately 17%. To achieve 85% power, a minimum of 26 participants is required in each high-risk group, assuming a remission rate of 0.75 in the \u00e2\u0080\u0098protein profile-driven top-down\u00e2\u0080\u0099 group and 0.35 in the clinical management step-up group at week 52. This calculation is based on Pearson\u00e2\u0080\u0099s \u00cf\u00872 two-group proportions test (two-sided, with continuity correction) at a significance level of 5%. Accordingly, 300 patients will be enrolled and divided into two groups of 150 patients each. One group will have access to protein profile information, while the other group will not. In both arms, 26 patients (17%) are expected to have a high-risk protein profile.", "id": 1291, "split": "test"} +{"trial_id": "NCT05181111", "pmid": "37316919", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways\n\nIncluded conditions:\n- Monitoring\n- Clinical Deterioration\n- Acute Disease\n\nStudy Armgroups:\n- {'label': 'Monitoring Group', 'type': 'EXPERIMENTAL', 'description': 'wearable sensor, besides usual care monitoring', 'interventionNames': ['Device: Wearable Sensor', 'Other: Usual Care']}\n- {'label': 'Usual Care group', 'type': 'OTHER', 'description': 'usual care monitoring', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Wearable Sensor', 'description': 'The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.', 'armGroupLabels': ['Monitoring Group'], 'otherNames': ['Philips Healthdot']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Usual Care Monitoring', 'armGroupLabels': ['Monitoring Group', 'Usual Care group']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of patients discharged home from acute admission ward', 'description': 'Percentage of patients discharged home from acute admission ward', 'timeFrame': 'up to 7 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (\u00ce\u00b1) of 0.05, and an assumed dropout rate of 5%.", "answer": 800, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on a preliminary internal investigation and insights of healthcare professionals working in the AAW, the proportion of the control group that is safely discharged was estimated to be 40%. As an increase to 50% was deemed to be feasible and clinically relevant, this proportion was used for the sensor group in calculating the sample size. The aim is to reject the null hypothesis stating that the proportion of patients that are discharged home safely directly after AAW stay is equal in the control and sensor groups. With a power of 80%, an \u00ce\u00b1 of 0.05, and equal group sizes, a total of 768 participants are required [19]. To achieve this number of patients with an assumed drop-out rate of 5%, the sample size is set to 800 patients, i.e., 400 in the control group and 400 in the sensor group.", "id": 1292, "split": "test"} +{"trial_id": "NCT05181657", "pmid": "36064745", "question": "Here is the design of a clinical trial:\n\nOfficial Title: LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera\n\nIncluded conditions:\n- Motivational Interviewing\n\nStudy Armgroups:\n- {'label': 'LinkUP Active intervention', 'type': 'EXPERIMENTAL', 'description': \"The counselor will present basic evidence-based COVID-19 information on SARS-CoV-2 biology and epidemiology, testing and the safety and efficacy of available COVID-19 vaccines. The counselor will also address COVID-19 misinformation (e.g., that COVID is no worse than the flu), and COVID-19 disinformation (e.g., that COVID vaccines include a tracking device).\\n\\nThe LinkUP active intervention combines education, motivational interviewing (MI), problem-solving, and ongoing support from peer counselors. Through an open discussion with one of OnPoint's peer counselors who are trained in MI, the counselor will present evidence-based COVID-19 information. Next, the counselor will attempt to identify the participant's concerns about COVID-19 and vaccination in an attempt to tip their decisional balance.\", 'interventionNames': ['Behavioral: COVID-19 education']}\n- {'label': 'LinkUP Control Condition (didactic intervention)', 'type': 'PLACEBO_COMPARATOR', 'description': 'As described above, the control condition is a one-way sharing of COVID-19 information presented by an OnPoint counselor. The counselor will be instructed to answer any questions the participant may have but will not engage in motivational interviewing counseling. The same educational materials used in the LinkUP intervention module will be used for this session and it will be completed within 45 minutes.', 'interventionNames': ['Behavioral: COVID-19 education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'COVID-19 education', 'description': 'This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.', 'armGroupLabels': ['LinkUP Active intervention', 'LinkUP Control Condition (didactic intervention)']}\n\nPrimary Outcomes:\n- {'measure': 'COVID-19 Testing', 'description': 'Number of participants who agreed to and received onsite a COVID test right after receiving the intervention (i.e., same day as the intervention)', 'timeFrame': 'Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.'}\n\nPlease estimate the sample size based on the assumption: \nThe study will use logistic regression mixed models to obtain risk ratio estimates, treating the intervention condition as the primary fixed effect and including potential covariates and a random intercept for subjects. The analysis will follow intent-to-treat principles and control for baseline covariates such as 'unvaccinated vs. partially vaccinated' for the secondary outcome.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Sample size and planned data analyses\n We anticipate enrolling 150 participants into the LinkUP pilot trial, which will provide adequate precision for effect size estimates but is not powered to assess efficacy. We will conduct an intent-to-treat (i.e., per-randomization) analysis following CONSORT guidelines [45]. We will compare socio-demographics across the two study arms and if any significant differences are found we will be controlling for potential confounders and study locations in all subsequent analyses. To obtain effect sizes and standard errors, percentages along with 95% CIs for those who (a) underwent COVID-19 testing onsite or within 6\u00c2\u00a0months of the intervention and (b) had\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00891 COVID-19 vaccine dose within 6\u00c2\u00a0months of the intervention, respectively, will be calculated for the two study arms. We decided upon a 6\u00c2\u00a0months\u00e2\u0080\u0099 time frame for assessing outcomes after discussing this issue with our CSAB members, who felt that some participants might delay their decision to be vaccinated, but still be influenced by the intervention for this period of time. In previous intervention studies, intervention effects waned after 6\u00c2\u00a0months [46, 47].\n To obtain risk ratio estimates (intervention/control), we will use logistic regression mixed models with outcomes for (a) having had a COVID-19 test onsite or within 6\u00c2\u00a0months of the intervention (primary outcome), and (b) having had\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00891 COVID-19 vaccine dose within 6\u00c2\u00a0months of the intervention. These models will treat intervention condition (active intervention vs. didactic control) as the primary fixed effect, and include potential covariates (e.g., age, gender, homelessness, income) and a random intercept for subject. In the analysis to study the effect of the intervention on COVID vaccination uptake (secondary outcome), we plan to control for \u00e2\u0080\u009cunvaccinated vs. partially vaccinated\u00e2\u0080\u009d as a baseline covariate.", "id": 1293, "split": "test"} +{"trial_id": "NCT05184296", "pmid": "38858161", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated (ECMO-RESCUE): a Prospective, Multicenter, Non-randomized Cohort Study\n\nIncluded conditions:\n- Extracorporeal Membrane Oxygenation\n- Septic Shock\n- Septic Cardiomyopathy\n- Cardiogenic Shock\n\nStudy Armgroups:\n- {'label': 'cohort 1', 'type': 'EXPERIMENTAL', 'description': 'Participants taking VA-ECMO during the period of study are referred to as cohort 1', 'interventionNames': ['Procedure: Extracorporeal Membrane Oxygenation (ECMO)']}\n- {'label': 'cohort 2', 'type': 'NO_INTERVENTION', 'description': 'Patients receiving only conventional therapy without ECMO belong to cohort 2'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Extracorporeal Membrane Oxygenation (ECMO)', 'description': \"All patients in cohort 1 will initiate ECMO as fast as possible. A maximum of 6 hours is allowed between enrollment and the actual initiation of ECMO. ECMO catheterization and management will be operated by an experienced ECMO team and carried out at the bedside. VA or VAV mode will be chosen according to the patient's condition.\", 'armGroupLabels': ['cohort 1']}\n\nPrimary Outcomes:\n- {'measure': '30-day survival', 'description': 'survival rate at day-30', 'timeFrame': 'From date of enrolled (D0) until date of death from any cause or day-30, whichever came first'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation ensures 80% power using a two-sided test with a significance level of \u03b1=0.05, and considers a projected dropout rate of 10%.", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to a retrospective study from Br\u00c3\u00a9chot et al, the survival rate of patients with severe sepsis-induced cardiomyopathy was 60% in venoarterial ECMO group and 25% in control group, elevation in survival of 35% in venoarterial ECMO group can be expected. Considering the high cost and uncertain therapeutic effect of ECMO treatment, fewer participants may choose ECMO treatment than conventional treatment, with an estimated ratio of 1:1.5. The sample size for differences between two independent proportions was calculated by the PASS V.14.0 software to ensure 80% power using a two-sided test with a significance level of \u00ce\u00b1=0.05. We need 23 participants in venoarterial ECMO treatment cohort and 35 participants in conventional treatment cohort. Considering a projected dropout rate of 10%, the sample size of venoarterial ECMO treatment cohort and conventional treatment cohort should be 25 and 39, respectively. The total sample size should be 64.", "id": 1294, "split": "test"} +{"trial_id": "NCT05186064", "pmid": "36333718", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Glioblastoma Targeted Treatment Option Maximization by Whole Genome Sequencing\n\nIncluded conditions:\n- Glioblastoma\n\nStudy Armgroups:\n- {'label': 'whole genome sequencing after standard of care resection at first relapse', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: whole genome sequencing']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'whole genome sequencing', 'description': 'whole genome sequencing will be performed on tumor material after re-resection per standard of care', 'armGroupLabels': ['whole genome sequencing after standard of care resection at first relapse']}\n\nPrimary Outcomes:\n- {'measure': 'overall survival', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \n15% dropout rate due to medical conditions or personal choices, 20% dropout rate due to insufficient quality for WGS.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The aim is to include a total of 235 patients in this study. Based on clinical expertise, around 15% of the initially included patients are expected to not be able to undergo the planned reresection because of medical conditions or personal choices, resulting in a total of 200 patients who will be included in the GLOW study. Based on previous experience, for about 20% of patients the obtained material is unfortunately not suited for WGS due to insufficient harvest of tumour cells. Collecting procedures aimed for avoiding necrotic and low tumour purity regions and prioritizing the best suited material for molecular diagnostics should minimise this rate. Over the complete project, on average a maximum of 20% of samples will be expected to drop out due to insufficient quality for WGS, mainly due too low tumour purity. This means that a WGS based patient report will be generated for a minimum of 160 patients.", "id": 1295, "split": "test"} +{"trial_id": "NCT05187013", "pmid": "37903607", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MHealth to Address Uncontrolled Hypertension Among Hypertensive Homeless Adults\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Hypertension-Specific Education', 'type': 'EXPERIMENTAL', 'description': '6 months of mHealth HTN management support via SMS texts including reminders for medication adherence, appointment attendance, and HTN-specific health education and support. Texts will be delivered to support medication adherence and lifestyle changes, and participants will receive appointment reminders before each appointments with a follow-up text and robocall if the appointment is missed.', 'interventionNames': ['Behavioral: mHealth for Hypertension in Homeless Persons']}\n- {'label': 'General Health Education', 'type': 'OTHER', 'description': '6 months of mHealth including basic healthcare and general health promotion via SMS texts. Blood pressure measurements and adherence assessments will be collected at every shelter visit.', 'interventionNames': ['Behavioral: mHealth for Hypertension in Homeless Persons']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'mHealth for Hypertension in Homeless Persons', 'description': \"SMS text messages sent to participants' mobile phones\", 'armGroupLabels': ['General Health Education', 'Hypertension-Specific Education']}\n\nPrimary Outcomes:\n- {'measure': 'Blood pressure', 'description': 'Systolic and diastolic blood pressure readings (SBP and DBP)', 'timeFrame': '6 months'}\n- {'measure': 'Medication adherence', 'description': 'Voils 3 Item DOSE-Nonadherence measure', 'timeFrame': '6 months'}\n- {'measure': 'Appointment attendance', 'description': 'Percentage of appointments attended', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a two-sample t-test, a power of 80%, a significance level of 0.05 (two-sided), and an SD of 15 mm Hg for both groups. The dropout rate is expected to be low due to the shelter system and case worker support.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n The sample size and power have been calculated based on the comparison of mean BP between the CL and INT groups at 6 months. Given the data scarcity on the effect of mHealth behavioural intervention on HTN in PEH, there is not sufficient data for power estimation. A decrease in SBP of 5\u00e2\u0080\u0089mm Hg is associated with clinically important reduction in the relative risk of stroke/CAD events.56 Based on our recent study,14 we used the SD of SBP (15\u00e2\u0080\u0089mm Hg) and DBP (13\u00e2\u0080\u0089mm Hg) to calculate sample size. Assuming a two-sample t-test, we calculated that a total of 120 (60 per each group) is sufficient to achieve a power of 80% to detect a difference of 8\u00e2\u0080\u0089mmHg assuming the SD for both groups is at 15 at the 0.05 significance level (two sided). Based on data from our site, this is a conservative power estimate for either outcome of SBP or DBP. Up to 27% of PEH have HTN6; 40% uncontrolled.14 In 2019, the PR served at least 1000 unique PEH with HTN.48 Using medical record reviews and outreach, with a conservative 50% response rate, we will be able to enrol 120 participants within 4\u00e2\u0080\u00936 months. Our previous studies with the PEH did not show a high attrition rate largely because the PEH were reachable in the shelter system, case workers helped identify barriers to retention, and PEH were eager to get their healthcare covered in the system.35 57 58 The risk of contamination will be low as weekly enrolment in each clinic is low and PEH are from different shelters.", "id": 1296, "split": "test"} +{"trial_id": "NCT05187897", "pmid": "39367450", "question": "Here is the design of a clinical trial:\n\nOfficial Title: CHV-NEO: Community-based Digital Communication to Support Neonatal Health\n\nIncluded conditions:\n- Neonatal Death\n- Perinatal Death\n\nStudy Armgroups:\n- {'label': 'Standard Care Control', 'type': 'NO_INTERVENTION', 'description': 'CHVs based at facilities in the control arm will continue to implement the standard of care.'}\n- {'label': 'CHV-NEO Intervention', 'type': 'EXPERIMENTAL', 'description': 'CHVs based at facilities in the Intervention arm will implement the integrated CHV-NEO two-way SMS messaging intervention with their clients.', 'interventionNames': ['Behavioral: CHV-NEO']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CHV-NEO', 'description': 'CHV-NEO is a two-way SMS platform that supports communication between mothers and community health volunteers between home visits. The platform engages mothers with SMS communication and brings timely information and support - asking critical questions at crucial times in order to assess the needs and health of newborns and assist in care seeking decisions. The CHV-NEO SMS intervention is integrated into the current digital community health toolkit (dCHT) to support CHV workflow.', 'armGroupLabels': ['CHV-NEO Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Neonatal Mortality', 'description': 'Death during 1st 28 days of life', 'timeFrame': '28 days postpartum'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05 for primary and secondary outcomes, Bonferroni-adjusted \u03b1 = 0.025 for multiple comparisons, two-sided tests, 10% attrition, coefficient of variation of 0.25, unequal cluster sizes, 80% power.", "answer": 2000, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Our study is powered for primary and secondary clinical outcomes. The cluster-randomized trial includes 20 facility clusters, 10 interventions, and 10 controls. For ascertainment of our primary outcome of neonatal mortality, we will abstract outcomes from eCHIS on 7200 pregnancies ending in live births across the clusters. With this sample size, assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, two-sided tests, 10% attrition, a conservative coefficient of variation of 0.25, and assuming unequal cluster sizes with an average cluster size 360, we have 80% power to detect a difference in neonatal mortality of 21.0 vs. 10.3 per 1000 live births [43]. For ascertainment of secondary outcomes, we will enroll 2000 pregnant clients in the in-depth perinatal cohort. With this sample size, assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, two-sided tests, 10% attrition, coefficient of variation of 0.25, and unequal cluster sizes (ranging between 80 and 120 per cluster), we have 80% power to detect a difference in early initiation of breastfeeding, thermal care, and cord care of 50% vs. 72%. We expect the outcomes of appropriate care-seeking and knowledge of danger signs to be correlated so we will correct these analyses for multiple comparisons. Assuming a Bonferroni-adjusted \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025, we will have 80% power to detect a difference between arms of 2.0 vs. 2.4 danger signs named and 0.5 vs. 0.9 appropriate clinic visits attended in the first 6\u00c2\u00a0weeks [6, 37, 49, 50].\n Service delivery and implementation outcomes are ascertained among the in-depth perinatal cohort as well as all CHWs and supervisors providing services over the 2-year period (estimated sample size 700 CHWs and 40 supervisors). Quantitative and qualitative analyses of implementation outcomes are intended to be exploratory; no formal hypothesis testing will be performed. We expect sample sizes for qualitative interviews will be sufficient to reach theoretical saturation of themes [51].", "id": 1297, "split": "test"} +{"trial_id": "NCT05189470", "pmid": "36123051", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers: a Parallel-group, Evaluator-blinded, Randomized Clinical Trial\n\nIncluded conditions:\n- Diabetic Foot Ulcer\n- Diabetes\n- Foot Ulcer\n- Diabetic Foot\n- Diabetes Complications\n- Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'These participants will receive the usual care of the respective outpatient clinics.', 'interventionNames': ['Other: Usual care of the respective outpatient clinics']}\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Participants that are randomized to the intervention group will receive both inforatio technique and usual care. Inforatio technique will be applied at baseline, 3, 6, 9 and 12 week- follow-up as long as the ulcers have a diameter of minimum four mms and have not developed infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis. In addition, inforatio technique will not be applied on ulcers that are covered by scab if the wound care staff assess that the scab should not be removed from the ulcer.', 'interventionNames': ['Procedure: Inforatio technique', 'Other: Usual care of the respective outpatient clinics']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Inforatio technique', 'description': 'Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools near the wound edges but without involving wound edge epithelia. Inforatio technique is applied after the wound has been surgically debrided for slough and devitalized tissue.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Usual care of the respective outpatient clinics', 'description': 'Usual care of the DFUs includes local wound care and offloading treatment.', 'armGroupLabels': ['Control group', 'Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Complete healing', 'description': \"Healing is defined as complete epithelialization without any discharge from the site of the index ulcer.\\n\\nThe primary outcome is the proportion of ulcers in each allocation group where healing is observed based on blinded assessment of digital images from the participants' last trial visit. The assessment of healing on digital images will be performed separately by two blinded assessors. Digital images where disagreement occurs are discussed between the assessors until agreement is reached. Any inconsistencies between the blinded assessment of healing on images and unblinded clinical assessment at trial visits will be reported.\\n\\nIn case of death and amputation the primary outcome is registered as non-healing.\", 'timeFrame': '20 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower set at 80%, significance level (\u03b1) at 5%, and an attrition rate of 20%.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n A healing rate of 30.9% (95% CI 26.6 to 35.1) in 20 weeks has previously been reported in a systematic review that included non-infected DFUs treated by standard wound care principles.7 To our knowledge, there are no other systematic reviews that assess healing rates for DFUs receiving standard treatment. The feasibility trial that preceded this trial suggested that 60% of ulcers will heal during a follow-up of 20 weeks when patients receive the inforatio technique.11\n A power calculation with the power set at 80% and the \u00ce\u00b1 level at 5% gives a sample size of 84 participants for comparing a control group where 30% is expected to heal with an intervention group for which we aim to show that 60% will heal. To allow an attrition of 20%, the aim is to recruit 100 participants.", "id": 1298, "split": "test"} +{"trial_id": "NCT05189678", "pmid": "38446754", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Correlation Between Modified Weakness Index and Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Single-center Prospective Observational Cohort Study\n\nIncluded conditions:\n- Frailty\n\nStudy Armgroups:\n- {'label': 'frailty group', 'description': 'Modified Frailty index score greater than or equal to 0.21', 'interventionNames': ['Other: No intervention']}\n- {'label': 'non-frailty group', 'description': 'Modified Frailty index score is less than 0.21', 'interventionNames': ['Other: No intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'No intervention', 'description': 'No intervention', 'armGroupLabels': ['frailty group', 'non-frailty group']}\n\nPrimary Outcomes:\n- {'measure': 'Postoperative Delirium', 'description': 'Incidence of postoperative delirium after noncardiac surgery.Postoperative delirium usually occurs between 24 hours and 72 hours after surgery, and this study will conduct follow-up assessments at six postoperative time points (once in the morning and afternoon on days 1 to 3 after surgery, 8:00 a.m.-10:00 a.m., 18:00-20:00 pm), as long as there was one time point to assess postoperative delirium, the patient was judged to have developed postoperative delirium.', 'timeFrame': 'Twice a day from day 1 to 3 after surgery (8:00-10:00 am and 18:00-20:00 PM).'}\n\nPlease estimate the sample size based on the assumption: \nThe ratio of samples between the experimental and control groups is 0.303, with a significance level (\u03b1) of 0.05 and power (1-\u03b2) of 0.80. A 10% dropout rate is also considered.", "answer": 1, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The main outcome will be the incidence of POD. Based on literature review and early study results, the estimated incidence of frailty in surgical patients was 23.0%, while the incidence of POD in the frailty and nonfrailty groups was 35.7% and21.7%. PASS 15.0 software was used to determine the sample size for the independent sample rate comparison of the two groups. The ratio of samples between the experimental and control groups was 0.303, and the two-sided test. Test level (\u00ce\u00b1), and inspection effectiveness (1-\u00ce\u00b2) were set at 0.05 and 0.80, respectively. This calculation yielded a sample size of 112 patients in the frailty group and 370 patients in the nonfrailty group. Considering 10% dropout rate, a total of 536 study volunteers will be required, consisting of 411 patients in the nonfailty group and 125 patients in the failty group.", "id": 1299, "split": "test"} +{"trial_id": "NCT05191277", "pmid": "37344789", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Disentangling Pharmacological and Expectation Effects in Antidepressant Discontinuation - a Randomized, Balanced Open-hidden Trial\n\nIncluded conditions:\n- Depressive Symptoms\n- Expectations\n- Antidepressants\n\nStudy Armgroups:\n- {'label': 'Open discontinuation (OD)', 'type': 'EXPERIMENTAL', 'description': 'Participants will discontinue their antidepressant medication and will be fully informed about treatment (i.e., high expectation).', 'interventionNames': [\"Drug: Treatment 'discontinuation of antidepressant medication'\", \"Behavioral: Expectation 'high'\"]}\n- {'label': 'Hidden discontinuation (HD)', 'type': 'EXPERIMENTAL', 'description': 'Participants will discontinue their antidepressant medication, but will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).', 'interventionNames': [\"Drug: Treatment 'discontinuation of antidepressant medication'\", \"Behavioral: Expectation 'moderate'\"]}\n- {'label': 'Open continuation (OC)', 'type': 'EXPERIMENTAL', 'description': 'Participants will remain on their initial antidepressant medication and will be fully informed about treatment (i.e., high expectation).', 'interventionNames': [\"Drug: Treatment 'continuation of antidepressant medication'\", \"Behavioral: Expectation 'high'\"]}\n- {'label': 'Hidden continuation (HC)', 'type': 'EXPERIMENTAL', 'description': 'Participants will remain on their initial antidepressant medication, but will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).', 'interventionNames': [\"Drug: Treatment 'continuation of antidepressant medication'\", \"Behavioral: Expectation 'moderate'\"]}\n\nInterventions:\n- {'type': 'DRUG', 'name': \"Treatment 'discontinuation of antidepressant medication'\", 'description': 'Pharmacological intervention: Participants will discontinue their antidepressant medication.', 'armGroupLabels': ['Hidden discontinuation (HD)', 'Open discontinuation (OD)']}\n- {'type': 'DRUG', 'name': \"Treatment 'continuation of antidepressant medication'\", 'description': 'Pharmacological intervention: Participants will remain on their antidepressant medication.', 'armGroupLabels': ['Hidden continuation (HC)', 'Open continuation (OC)']}\n- {'type': 'BEHAVIORAL', 'name': \"Expectation 'high'\", 'description': \"Psychological intervention: Participants' expectations will be manipulated by varying verbal instructions using the open-hidden paradigm. Within the open trial arms, participants will receive full information about their treatment (i.e., high expectation). expectation).\", 'armGroupLabels': ['Open continuation (OC)', 'Open discontinuation (OD)']}\n- {'type': 'BEHAVIORAL', 'name': \"Expectation 'moderate'\", 'description': \"Psychological intervention: Participants' expectations will be manipulated by varying verbal instructions using the open-hidden paradigm. Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).\", 'armGroupLabels': ['Hidden continuation (HC)', 'Hidden discontinuation (HD)']}\n\nPrimary Outcomes:\n- {'measure': \"Discontinuation symptom load over the course of the experimental phase from baseline T0 to primary endpoint T9 - 'Discontinuation Related Signs and Symptoms Scale' (DESS)\", 'description': 'The Discontinuation Related Signs and Symptoms Scale is a self-report questionnaire to assess discontinuation symptoms, incorporating 43 discontinuation symptoms of antidepressants with intensity ratings ranging from 0 (not present) - 3 (severe) each. Total sum score ranges from 0-129 with higher scores indicating more pronounced discontinuation symptoms.', 'timeFrame': 'Measured as area under the curve (AUC) over the following time points: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]'}\n\nPlease estimate the sample size based on the assumption: \nANOVA with main effects and interactions, between-within interaction, power of 80%, two-sided significance level of 0.05, and an anticipated dropout rate of 15%.", "answer": 196, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The target sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089168 (n\u00e2\u0080\u0089=\u00e2\u0080\u008942 in each experimental group) is based on medium to large effect sizes for expectation effects on depressive symptoms and treatment outcome [47, 50] and hypothesized small to medium interaction effects with pharmacological modulations. A medium-sized effect (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.22) for the interaction of expectation and pharmacological modulation was assumed in an ANOVA (with main effects and interactions) with a between-within interaction using a power of 80% and two-sided significance level of 0.05. Including oversampling with an anticipated dropout rate of 15%, our recruitment target is N\u00e2\u0080\u0089=\u00e2\u0080\u0089196 (with n\u00e2\u0080\u0089=\u00e2\u0080\u008949 per group). Sample size calculation was conducted using G*Power (version 3.1.9.2; [57]).", "id": 1300, "split": "test"} +{"trial_id": "NCT05197439", "pmid": "37433729", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial\n\nIncluded conditions:\n- Dexmedetomidine\n- Postoperative Delirium\n- Deep Brain Stimulation\n\nStudy Armgroups:\n- {'label': 'DEX group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do.', 'interventionNames': ['Drug: 0.9% saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'The 4.8ug/kg dexmedetomidine will be diluted into 100ml and pump 2ml/h at the beginning of the second of DBS and last for 48 hours.', 'armGroupLabels': ['DEX group']}\n- {'type': 'DRUG', 'name': '0.9% saline', 'description': 'The 0.9% saline is administered with the same volume at the same speed as the other group.', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence of postoperative delirium.', 'description': 'Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.', 'timeFrame': 'Postoperative 5 days'}\n\nPlease estimate the sample size based on the assumption: \nA power of 90% to detect a 50% difference using a two-tailed alpha of 0.05. Considering a dropout rate of 5%. A p value less than 0.05 is considered statistically significant.", "answer": 192, "answer_type": "ESTIMATED", "explanation": "Statistical plan and sample size calculation\n The incidence of postoperative delirium in patients with Parkinson\u00e2\u0080\u0099s disease who underwent DBS surgery was about 40% in the previous study.8 A meta-analysis of non-cardiac surgery patients showed that the incidence of postoperative delirium reduced by approximately half when DEX was used perioperatively.25 We estimated that 162 participants would provide a power of 90% to detect a 50% difference using a two-tailed alpha of 0.05. After continuous correction, the final sample size was 182. Considering a dropout rate of 5%, we plan to enrol 192 patients, each group with 96 participants.\n Categorical variables will be presented as numbers and percentages, and analysed by the \u00ce\u00a72 test or Fisher\u00e2\u0080\u0099s exact test. Continuous variables will be checked for normal distribution and presented as mean\u00c2\u00b1SD or median and IQR as appropriate. Comparison of continuous variables will be performed by Student\u00e2\u0080\u0099s t-test for normally distributed variables and the Mann\u00e2\u0080\u0093Whitney U test for non-normally distributed variables. Time-to-event variables will be analysed by survival analysis, with the difference between groups assessed with log-rank test. We will adjust the primary outcome by the parameter which is not comparable between groups. Confounding factors will be selected from the risk factors of delirium in patients with Parkinson\u00e2\u0080\u0099s disease, such as age, severity and medication for Parkinson\u00e2\u0080\u0099s disease, as well as baseline data that were unbalanced between the two groups and finally confirmed based on their significance in univariate analysis and evidence from previous studies. Multiple logistics regression will be applied to determine the influence of these confounding factors on the primary outcome. All analyses will be conducted according to the intention-to-treat principle. SPSS software (V.22.0) was used for statistical analysis. A p value less than 0.05 is considered statistically significant.", "id": 1301, "split": "test"} +{"trial_id": "NCT05197972", "pmid": "38086587", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (cardiac Coherence) Associated with Medical Hypnosis on Preoperative Anxiety in Oncological Surgery\n\nIncluded conditions:\n- Surgery\n- Oncology\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Classic management of the preoperative period with a cardiac coherence program coupled with hypnosis.', 'interventionNames': ['Other: cardiac coherence program coupled with hypnosis']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Classic management of the preoperative period'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'cardiac coherence program coupled with hypnosis', 'description': 'At home the patient will perform the cardiac coherence sessions between 7 days and a maximum of 15 days before the surgery through the application \"Respirelax\": 3 sessions per day, lasting 5 minutes with a breathing frequency of 6 cycles/min for a period of 7 days minimum and maximum 15 days.\\n\\nAn audio tape read in a hypnotic tone can be listened to by the patient during the cardiac coherence program or at another time of the day (see the text of the audio tape).', 'armGroupLabels': ['Experimental group']}\n\nPrimary Outcomes:\n- {'measure': 'Visual Analogue Scale (VAS) of global anxiety', 'description': 'Visual Analogue Scale (VAS) of global anxiety is a anxiety self-assessment scale that allows the patient to self-assess his or her anxiety using a cursor. The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).', 'timeFrame': 'The morning of the surgery (Day 0) upon arrival in the operating room'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level (\u03b1) of 0.05, a power (\u03b2) of 90%, and a standard deviation (SD) of 25. Additionally, it considers a 10% non-evaluable rate.", "answer": 296, "answer_type": "ESTIMATED", "explanation": "Sample size\n We hypothesised that the intervention would have a positive effect on preoperative anxiety compared with standard care, with a reduction of the Visual Analogue Scale (VAS) scores for anxiety (score ranging from 0 to 100, 0=no anxiety). Sample size was calculated based on an expected difference of at least 10 points in the mean VAS Score of preoperative anxiety between arms, according to the results of the HYPNOSEIN study and the study by Kain et al.27 28 Assuming a mean VAS-anxiety score of 40 in the control arm, this would correspond to a reduction of at least 25% in the intervention arm. With 90% power (\u00ce\u00b2=0.10), a two-sided \u00ce\u00b1 risk of 0.05 and assuming a SD of 25, 133 patients per arm are required to detect such a difference.29 Considering 10% of patients as non-evaluable, a total sample size of 296 is required (148 patients per arm). Sample size was calculated based on a comparison of mean values using the Student\u00e2\u0080\u0099s t-test and the Sample Size Tables for Clinical Studies software.30", "id": 1302, "split": "test"} +{"trial_id": "NCT05198258", "pmid": "35637458", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Implementation and Effectiveness of Neck-specific Exercise for Persistent Disability and Pain After Whiplash Injury; a Randomized Controlled Study Using a Hybrid II Design\n\nIncluded conditions:\n- Neck Pain\n- Whiplash Injuries\n- Neck Disorder\n\nStudy Armgroups:\n- {'label': 'Implementation study - experimental group', 'type': 'EXPERIMENTAL', 'description': 'Physiotherapists in the experimental group (group A) will receive on-line theoretical education including three hours of practical training by the project leaders. The standardized theoretical education includes three 45 minutes on-line lectures. The theoretical education will be followed by three hours practical training including clinical examination in patients with neck disability and instructions how to perform the neck-specific exercises.To facilitate the implementation process, group A will receive additional support; the physiotherapists can contact the project leader via e-mail, phone, online meetings and/or outreach visits', 'interventionNames': ['Other: Implementation strategy - experimental group']}\n- {'label': 'Implementation study - control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Physiotherapists in the control group (group B) will receive the same theoretical and practical training as group A but without additional support from the research group or education after the first three theoretical on-line lectures and the three hours practical education.', 'interventionNames': ['Other: Implementation - control group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Implementation strategy - experimental group', 'description': 'On-line theoretical education and three hours of practical training by the project leaders. Contact with the project team via e-mail, phone and on-line repetition of the education for remaining of the clinical examination, neck-specific program and the progression of exercises.', 'armGroupLabels': ['Implementation study - experimental group']}\n- {'type': 'OTHER', 'name': 'Implementation - control group', 'description': 'Physiotherapists in the control group will receive the same theoretical and practical training as the experimental group but without repetition of the education or support from the research team.', 'armGroupLabels': ['Implementation study - control group']}\n\nPrimary Outcomes:\n- {'measure': 'Implementation - Adoption of neck-specific exercise programmes', 'description': 'Proportion of patients with neck pain receiving neck-specific exercise', 'timeFrame': 'Baseline to 3 and 12 months (proportions of 500 patients with neck pain from 20 physiotherapy clinics)'}\n- {'measure': 'Patient Effectiveness - Neck Disability Index', 'description': 'Self-reported neck-specific function', 'timeFrame': 'Change from baseline to 3 months (after treatment) and 12 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nIntra-cluster correlation of 0.02, cluster size of 21 patients, 80% power, significance level of 0.05, correlation among repeated measures of 0.3, expected dropout rate of 20%.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size and power regarding group differences were calculated by a statistician. The aim of the study is to evaluate both implementation and effectiveness. The sample size calculation to evaluate implementation was based on the assumption that 15% more patients will receive neck-specific exercises in the intervention group (40% in the intervention group and 25% in the control group). The required sample size under individual randomization will be 150 patients in each arm. With 10 physiotherapy clinics (clusters) in each arm (a total of 20 clusters), intra-cluster correlation of 0.02 and a cluster size of 21 patients, a total of 420 patients will be recruited for 80% power and a significance level of 0.05. To ensure that enough people are in each group after dropouts, a total of 500 patients will be included, 25 patients from each cluster.\n Sample size calculation to evaluate effectiveness was based on a clinically relevant improvement of 7% in the NDI, an effect size of 0.2 (Cohen\u00e2\u0080\u0099s f) or 0.4 (Cohen\u00e2\u0080\u0099s d), a correlation among repeated measures of 0.3, and the need for a total of 56 participants for 80% power and a significance level of 0.05. With an expected dropout rate of 20%, a total of 70 participating patients will be needed. The total number of patients may be more than 70 because patients will be recruited at each clinic.\n Repeated-measure ANOVA or a linear mixed model will be used to examine changes in the patient-reported outcomes over time (i.e., at baseline and 3 and 12\u00e2\u0080\u0089months). The results will be compared with the results from the RCT studies [8, 12]. Patients who are included in both the intervention and control implementation groups and receive neck-specific exercises will be treated as one group in terms of the effect of the intervention. Analyses will be performed with parametric statistics if assumptions of normality are met, and otherwise with non-parametric statistics.", "id": 1303, "split": "test"} +{"trial_id": "NCT05199324", "pmid": "35854360", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Oral Step-down Antibiotic Therapy Versus Continuing Intravenous Therapy for Uncomplicated Gram-negative Bacteraemia (the INVEST Trial)\n\nIncluded conditions:\n- Gram-negative Bacteraemia\n\nStudy Armgroups:\n- {'label': 'Early step-down to oral antibiotic therapy', 'type': 'EXPERIMENTAL', 'description': 'The oral antibiotic options are fluoroquinolones (most commonly, ciprofloxacin) or trimethoprim-sulfamethoxazole. The recommended doses for patients with normal renal function would be ciprofloxacin 750 mg twice daily (if body weight \u226570 kg) or ciprofloxacin 500 mg twice daily (if body weight \\\\<70 kg) or trimethoprim-sulfamethoxazole 5 mg/kg (for trimethoprim component) every 12 hourly or trimethoprim-sulfamethoxazole (160 mg / 800 mg; double strength) two tablets twice daily. Doses may be adjusted in the setting of renal dysfunction. The recommended treatment duration by the study team is 7 days of active antibiotics (including empiric therapy), although treatment regimen may be longer than 7 days due to regimen extension or requirement for prolonged regimen as clinically indicated.', 'interventionNames': ['Drug: Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole']}\n- {'label': 'Continuing intravenous antibiotic therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intravenous antibiotic(s) to be administered will be determined by the treating doctor according to what would be considered standard of care in the hospital site. Commonly used intravenous antibiotics (and doses) for treatment of Gram-negative bacteraemia include ceftriaxone 2 g daily or cefazolin 2 g three times daily. The recommended treatment duration by the study team is 7 days of active antibiotics (including empiric therapy), although treatment regimen may be longer than 7 days due to regimen extension or requirement for prolonged regimen as clinically indicated.', 'interventionNames': ['Drug: Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole', 'description': 'Clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the intervention arm will be switched early to oral antibiotics (within 72 hours from index blood culture collection)', 'armGroupLabels': ['Early step-down to oral antibiotic therapy'], 'otherNames': ['Fluoroquinolones (most commonly, cipro)', 'Bactrim']}\n- {'type': 'DRUG', 'name': 'Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)', 'description': 'Clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the standard arm will continue to receive an active intravenous antibiotic therapy for at least another 24 hours post-randomisation before clinical re-assessment and decision making by the treating doctor', 'armGroupLabels': ['Continuing intravenous antibiotic therapy'], 'otherNames': ['Rocephin', 'Kefzol']}\n\nPrimary Outcomes:\n- {'measure': '30-day mortality', 'description': 'All-cause mortality at day 30 post-randomisation', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \n80% power, one-sided 0.025 significance level, 5% drop-out rate.", "answer": 720, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In an RCT comparing 7 days versus 14 days of antibiotic therapy for uncomplicated Gram-negative bacteraemia, 30-day all-cause mortality occurred in 4.9% of patients in the 7-day duration arm and 4.4% of patients in the 14-day duration arm [20]. In a retrospective multicentre study of propensity score-matched cohort with monomicrobial Enterobacterales bacteraemia, 30-day all-cause mortality was 13.1% for patients who received early oral stepdown therapy and 13.4% for those who continued to receive IV therapy [7]. Accurate estimation of mortality (for this study) is complicated by significant variability in reported mortality of past studies\u00e2\u0080\u0094likely influenced by geography and isolate resistance phenotype. We assumed 30-day mortality of 8% in the standard and intervention arms of this study\u00e2\u0080\u0094determined as the approximate mid-range from the two aforementioned studies [7, 20]. With a 6% non-inferiority margin, a total of 720 patients are needed to achieve 80% power with a one-sided 0.025 \u00ce\u00b1-level after adjustment for 5% drop-out. Based on an expected mortality of 80% under a hypothetical situation where bacteraemic patients received no antibiotic treatment [21, 22], the standard arm treatment would have reduced mortality by 72% (from 80 to 8%). The pre-specified, 6% non-inferiority margin requires a 30-day mortality of \u00e2\u0089\u00a414% in the intervention arm, which preserves more than 90% of the 72% treatment effect of standard arm treatment to conclude non-inferiority. This is in accordance with requirements by the U.S. Food and Drug Administration (FDA) on non-inferiority margin to maintain at least 50% of treatment effect of the standard treatment.", "id": 1304, "split": "test"} +{"trial_id": "NCT05200351", "pmid": "38987737", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design\n\nIncluded conditions:\n- Emotion Regulation\n- Autism Spectrum Disorder\n- Adolescent - Emotional Problem\n\nStudy Armgroups:\n- {'label': 'EAT Intervention', 'type': 'EXPERIMENTAL', 'description': '15 sessions of EAT', 'interventionNames': ['Behavioral: Equine assisted Therapy (EAT)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Equine assisted Therapy (EAT)', 'description': '15 sessions of EAT will be given. Activities will be with or in the presence of the horse. There will be no horseriding.', 'armGroupLabels': ['EAT Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention', 'description': 'The EDI-short form is a validated, change-sensitive, 13-item caregiver report measure of emotion regulation impairment for individuals who are at least 6 years of age. The scale used is Not at all=0, Mild=1, Moderate=2, Severe=3, or Very Severe=4. The EDI short form includes two scales: a 7-item Reactivity Index and a 6-item Dysphoria Index. Index raw scores will be converted into t-scores.', 'timeFrame': '3 times a week during 23 weeks from baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe type 1 error rate (alpha) is 0.05, the power is 0.83, the autocorrelation is 0.15, and the number of emerging effect measures is 3. The number of samples drawn to calculate the power is 150, and the power is simulated 5 times. The False Discovery Rate (FDR) correction is used for multiple testing.", "answer": 35, "answer_type": "ESTIMATED", "explanation": "Sample size\n The tool https://architecta.shinyapps.io/power_MBD/ was used to give an estimate of the power using the following input: the number of participants is 30, the number of measurements is 69 (three times a week for 23 weeks), the number of possible starting points is 5, the minimum number of baseline measurements is 8 (once a week; phases A\u00e2\u0080\u0089+\u00e2\u0080\u0089C), the minimum number of intervention measurements is 15 (once a week; phase B), the proportion of baseline measurements is 35%, the proportion of overlapping starting moments is 80%, the effect size is 0.6, the type 1 error rate (alpha) is 0.05, the autocorrelation is 0.15 and the number of emerging effect measures is 3. In order to be able to do the power simulations, we specified the number of samples that have to be drawn to calculate the power (150 samples) and the number of times this power has to be simulated [5]. Using the above parameters we found a power of 0.83. To account for possible drop-outs, we added another five participants, thus a total of 35 participants are included. For the secondary outcomes we will correct for multiple testing by the False Discovery Rate (FDR) [52].", "id": 1305, "split": "test"} +{"trial_id": "NCT05202704", "pmid": "37045570", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating the Hypoalgesic Effects of Spinal Manipulative Therapy Using Hidden Pain Conditioning and Positive Expectation in Chronic Low Back Pain Patients: Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Experimental: Hidden conditioning procedure + Positive Expectation', 'type': 'EXPERIMENTAL', 'description': 'Patients with chronic low back pain will receive verbal delivered positive instructions regarding manipulative therapy. Then, after the spinal manipulative therapy they will be submitted to a hidden conditioning procedure in which the pain threshold will be surreptitiously downgrade to conditioning pain decrease to manipulative therapy (G1).', 'interventionNames': ['Procedure: Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation', 'Procedure: Spinal Manipulative Therapy']}\n- {'label': 'Active Comparator: Positive expectations', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with chronic low back pain will receive verbal delivered positive instructions regarding spinal manipulative therapy (G2) before the administration of a spinal manipulative therapy approach.', 'interventionNames': ['Procedure: Procedure/Surgery: Active Comparator: Positive Expectation', 'Procedure: Spinal Manipulative Therapy']}\n- {'label': 'Active Comparator: Neutral Expectations', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with chronic low back pain will receive verbal delivered neutral instructions regarding spinal manipulative therapy (G3) before the administration of a spinal manipulative therapy approach.', 'interventionNames': ['Procedure: Procedure/Surgery: Active Comparator: Neutral Expectation', 'Procedure: Spinal Manipulative Therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Procedure/Surgery: Experimental: Hidden conditioning + Positive Expectation', 'description': 'Patients will be submitted to quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectations about the treatment by means of a workshop. Immediately after the first session of manipulative therapy, participants will be submitted again to the QST but now the heat pain threshold of the hidden conditioning group will be surreptitiously downgraded (the intense noxious stimulus will be downgraded to the moderate stimulus - individually obtained during the QST) as a mean to conditioning patients to believe that spinal manipulative therapy promoted pain relief. Patients will be invited to report the pain intensity perceived just after the QST (second test - conditioning procedure). The objective of questioning the pain intensity after the conditioning test is a procedure check to ensure that the conditioning procedure worked.', 'armGroupLabels': ['Experimental: Hidden conditioning procedure + Positive Expectation']}\n- {'type': 'PROCEDURE', 'name': 'Procedure/Surgery: Active Comparator: Positive Expectation', 'description': 'Patients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce positive expectation about the treatment by means of a workshop. Immediately after the first session of spinal manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate whether the positive instructions will show any effect.', 'armGroupLabels': ['Active Comparator: Positive expectations']}\n- {'type': 'PROCEDURE', 'name': 'Procedure/Surgery: Active Comparator: Neutral Expectation', 'description': 'Patients in this group will be submitted to a quantitative sensory testing to determine different thresholds of noxious heat pain stimulus (intense, moderate or weak). Afterward, participants will receive instructions with the aim to induce neutral expectation about the treatment by means of a workshop. Immediately after the first session of spinal manipulative therapy, participants will be submitted again to the QST (without downgrading of the intense noxious heat stimulus). Patients will be invited to report the pain intensity perceived during the QST after the intervention. The objective of questioning the pain intensity in this group is a procedure check - to investigate/confirm the effect of neutral instructions.', 'armGroupLabels': ['Active Comparator: Neutral Expectations']}\n- {'type': 'PROCEDURE', 'name': 'Spinal Manipulative Therapy', 'description': 'All the groups recruited in the study will receive five sessions of Spinal Manipulative Therapy. The intervention will be performed with the patient in the supine position. The clinician-researcher will passively lean over the patient to the side to be manipulated and ask the patient to place their hands behind their head. The researcher will then passively rotate the patient on the side to be manipulated and perform a posterior and inferior thrust on the opposite anterosuperior spine. The patients will receive 4 maneuvers (twice towards right side and twice towards left side).', 'armGroupLabels': ['Active Comparator: Neutral Expectations', 'Active Comparator: Positive expectations', 'Experimental: Hidden conditioning procedure + Positive Expectation']}\n\nPrimary Outcomes:\n- {'measure': 'Numeric pain rating scale (NPRS)', 'description': 'The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents \"no pain\" and 10 represents \"worst pain imaginable\". High scores mean worse pain intensity.', 'timeFrame': '6 weeks after randomization'}\n- {'measure': 'Global Perceived Effect (GPE)', 'description': 'The GPE of improvement used for this trial is an 11-point scale that ranges from - 5 (\"vastly worse\") through 0 (\"no change\") to + 5 (\"completely recovered\") and participants are asked: \"Compared to when this episode first started, how would you describe your orofacial pain these days?\". A higher score indicates higher perception of recovery from the condition.', 'timeFrame': '6 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 5%, a power of 80%, and a 20% dropout rate.", "answer": 264, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study was designed to identify at least a two-point difference in pain intensity assessed by the NPRS across groups, with an expected SD of 2.5 points.21 For GPE, a difference of two points on the scale, with 11 points ranging from \u00e2\u0088\u00925 to +5.40 The other specifications were an alpha of 5% and a power of 80%, with a total of 228 patients. However, assuming a 20% drop in follow-up, we will enrol 264 individuals (88 patients per group). G*Power was used to calculate sample size (G*Power V.3.0.10, University of Kiel, Germany).", "id": 1306, "split": "test"} +{"trial_id": "NCT05204849", "pmid": "36581996", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Use of ACTIVE Fluid Exchange to Treat Intraventricular Hemorrhage\n\nIncluded conditions:\n- Intraventricular Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Active irrigation and aspiration', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to IRRAflow will receive a ventricular catheter with active irrigation and aspiration.', 'interventionNames': ['Device: IRRAflow']}\n- {'label': 'Standard passive external ventricular drainage', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to passive external ventricular drainage will receive a standard EVD.', 'interventionNames': ['Procedure: Standard ventriculostomy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'IRRAflow', 'description': 'Ventriculostomy using IRRAflow with active irrigation and aspiration', 'armGroupLabels': ['Active irrigation and aspiration']}\n- {'type': 'PROCEDURE', 'name': 'Standard ventriculostomy', 'description': 'Standard passive external ventricular drainage', 'armGroupLabels': ['Standard passive external ventricular drainage']}\n\nPrimary Outcomes:\n- {'measure': 'Drain survival time', 'description': 'Time to first observed occlusion of the catheter', 'timeFrame': 'Time with ventricular catheter from placement to fist observed occlusion, an average of 11 days'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided log-rank test, significance level of 20%, power of 80%, 30% dropout rate, intention-to-treat principle, Kaplan-Meier plots, Cox regression, Bonferroni adjustment for CIs, interim analysis after 20 subjects.", "answer": 58, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical considerations\n The sample size of the study was determined based on the primary outcome. We considered a two-sided log-rank test for comparison of the time-to-catheter occlusion between the two treatment groups. Furthermore, we assumed an equal length of follow-up together with an occlusion risk of 10% and 35% in the intervention and control groups. Patient mortality was assumed to be independent of the considered time to catheter occlusion and to correspond to a 30% dropout. We used a significance level of 20% due to the exploratory nature of the study. Then, for a power of 80%, Schoenfeld\u00e2\u0080\u0099s approach resulted in a required sample size of 58 (i.e., 29 subjects with drain per treatment group).\n Data will be analyzed according to the intention-to-treat principle. For the primary outcome (time to catheter occlusion), time-to-event analysis will be used, in which drains are considered the basic experimental units. Times corresponding to drains without occlusion during follow-up will be considered censored. Especially, since catheter occlusion is independent of patient mortality, patient death is treated as a censoring event. Time to occlusion will be described by Kaplan-Meier plots and investigated by Cox regression. Estimated beneficial treatment effects with a two-sided p-value \u00e2\u0089\u00a4 20% will be considered an interesting finding worth further investigation.\n Further outcome measures (secondary/exploratory) will be used for descriptive and exploratory purposes only; no formal statistical hypotheses will be tested.\n Secondary endpoints (subject-based unless otherwise specified) will be handled as follows:\n Kaplan-Meier estimates and Cox regression will be used to describe the time to recurrence of hemorrhage and time to death (with a follow-up time of 3 months).\n Occurrence of catheter-related infections and shunt dependency will be reported as proportions, and length of stay in ICU will be reported as means. Clearance of ventricular blood will be described with the help of linear mixed effect models. Measures of functional status will be dichotomized and analyzed by baseline-adjusted logistic regression. All estimates will be reported together with corresponding confidence intervals (CIs).\n Exploratory endpoints (mainly drain-based) will be handled as follows:\n Proportions and CIs will be reported for technical success, procedure success, and necessity of revision procedures. Procedure time, duration of VC in place, and number of required flushes will be described by means and CIs.\n Reported CIs will include a Bonferroni adjustment to maintain the family-wise coverage probability at 95%.\n We expect based on our prior experiences that the proportion of missing values in this study will be very low and that missing values occur completely random. All statistical analyses will be run as complete case analyses.\n For early safety monitoring, an interim analysis is done when 20 subjects have been enrolled in the study (10 subjects per arm). The analyses will be performed in an intent-to-treat fashion.\n Monitored safety outcomes are mortality as well as the total number of adverse and serious adverse events related to catheter treatment (infections, bleedings in relation to intervention, displacements of catheters, catheter misplacement). For p-values below 20%, an early stop of the study will be considered (non-binding); otherwise, the study continues until the study end.", "id": 1307, "split": "test"} +{"trial_id": "NCT05212571", "pmid": "36991381", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Long-term Pain Modulation by Intravenous Esketamine in Complex Regional Pain Syndrome: a Non-inferiority Study\n\nIncluded conditions:\n- Complex Regional Pain Syndromes\n- CRPS (Complex Regional Pain Syndromes)\n\nStudy Armgroups:\n- {'label': 'Outpatient', 'type': 'EXPERIMENTAL', 'description': 'The experimental intervention group visits the outpatient clinic to receive intravenous esketamine in day-care setting every 2 weeks for 3 months.', 'interventionNames': ['Drug: S-ketamine infusion outpatient setting']}\n- {'label': 'Inpatient', 'type': 'ACTIVE_COMPARATOR', 'description': 'The standard treatment group receives intravenous esketamine for 6 consecutive days in hospital.', 'interventionNames': ['Drug: S-ketamine infusion inpatient setting']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'S-ketamine infusion inpatient setting', 'description': 'S-ketamine is administered intravenously for six consecutive days. The administered dose of S-ketamine is 50 mcg/kg/h and can be increased to a maximum of 200 mcg/kg/h.', 'armGroupLabels': ['Inpatient'], 'otherNames': ['ketamine', 'esketamine']}\n- {'type': 'DRUG', 'name': 'S-ketamine infusion outpatient setting', 'description': 'S-ketamine is administered intravenously for six hours. The administered dose of S-ketamine is 50 mcg/kg/h and can be increased to a maximum of 200 mcg/kg/h.', 'armGroupLabels': ['Outpatient'], 'otherNames': ['ketamine', 'esketamine']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline pain scores', 'description': 'Pain intensity measured by Numerical Rating Scale (NRS). Minimum value=0 and maximum value is 10. Higher scores mean a worse outcome.', 'timeFrame': 'Baseline (week 0), During inpatient or outpatient esketamine infusion (week 1 for inpatient protocol / week 1, 3, 5, 7, 9, 11 for outpatient protocol), During telephone consultation (week 1, 3, 5, 7, 9, 11), Follow-up (3 months), End of study (6 months)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 95% confidence interval, non-inferiority limit of -1.0.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n Three months after the inpatient treatment the investigators expect a reduction of the average NRS pain score for pain from 8.0/10 to 6.0/10 (SD 1.5) and for the outpatient group from 8.0/10 to 6.0/10 (SD 1.5). These expectations are derived from a retrospective study of the inpatient continuous esketamine treatment for CRPS patients at the Center for Pain Medicine [13]. If there is truly no difference between the continuous esketamine treatment and the intermittent outpatient esketamine treatment, then 56 patients are required to be 80% sure that the lower limit of a 95% confidence interval will be above the non-inferiority limit of \u00e2\u0088\u0092\u00e2\u0080\u00891.0. We aim to include 60 CRPS patients that will be randomized between outpatient and inpatient esketamine treatment.", "id": 1308, "split": "test"} +{"trial_id": "NCT05213689", "pmid": "36418143", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Kuwawezesha Vijana (Empowering Youth): An HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth in a Refugee Settlement in Northern Uganda\n\nIncluded conditions:\n- HIV/AIDS\n- HIV Infections\n- Knowledge, Attitudes, Practice\n\nStudy Armgroups:\n- {'label': 'HIV self-testing + educational comic book', 'type': 'EXPERIMENTAL', 'description': 'At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics. Participants will also receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together.', 'interventionNames': ['Behavioral: Educational comic book', 'Diagnostic Test: HIV Self-testing']}\n- {'label': 'HIV self-testing', 'type': 'ACTIVE_COMPARATOR', 'description': 'At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics.', 'interventionNames': ['Diagnostic Test: HIV Self-testing']}\n- {'label': 'Educational comic book', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together.', 'interventionNames': ['Behavioral: Educational comic book']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': 'PNs will provide information about HIV testing, care and support services at local clinics.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Educational comic book', 'description': 'An educational comic book was developed with qualitative data collected from an earlier study phase involving focus groups with youth from Bidi Bidi. The comic book is focused on HIV testing information and decision making as it follows the story of youth in Bidi Bidi who are seeking out HIV testing. Each youth in the appropriate arm with receive a copy of the comic book and together with 5-10 other youth will meet with a PN to read through and discuss the comic book. The comic will also include blank pages so that the youth can participate in the dialogue of the comic book. The comic will be available in English, Bari and Juba Arabic.', 'armGroupLabels': ['Educational comic book', 'HIV self-testing + educational comic book']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'HIV Self-testing', 'description': 'Participants will receive HIVST kits so that they can perform their HIV testing.', 'armGroupLabels': ['HIV self-testing', 'HIV self-testing + educational comic book']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in HIV testing frequency', 'description': 'To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).', 'timeFrame': 'Time 1 (month 0), Time 2 (month 3)'}\n- {'measure': 'HIV status knowledge', 'description': 'At the final 3-month visit, a clinician supported by trained peer navigators will offer all participants a completely voluntary rapid point-of-care HIV test (Alere Determine HIV-\u00bd) to measure HIV status knowledge. HIV status knowledge will be assessed as correct for participants that agree to take the rapid test and correctly report their HIV status before receiving the result.', 'timeFrame': 'Time 2 (month 3)'}\n\nPlease estimate the sample size based on the assumption: \npower: 0.95, number of tested predictors: 5, critical F: 2.306, attrition rate: 15%", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n We will recruit 120 refugee youth aged 16\u00e2\u0080\u009324 years living in Bidi Bidi (60 adolescent girls, 60 adolescent boys) in the cluster randomised trial. The recruited youth will come from four villages in two zones (zone 3 and zone 4 annex) within Bidi Bidi, and each village will be randomised to a study arm such that all youth living in the village are clustered to receive the same intervention. Calculated using G*Power 3.1, a sample size of 105 is sufficient for multivariable regression analyses (effect size: 0.2, power: 0.95, number of tested predictors: 5, critical F: 2.306).61 To account for 15% attrition, we have selected a sample size of 120.", "id": 1309, "split": "test"} +{"trial_id": "NCT05214859", "pmid": "37419633", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancing Mother-Child Ties and Psychosocial Wellness Through Arts: A Mixed Methods Study on Dyadic Expressive Arts-based Intervention for Children With Intellectual Disability and Their Mothers\n\nIncluded conditions:\n- Intellectual Disability\n- Mother-Child Relations\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention arm will receive Dyadic Expressive Arts Group Therapy as an intervention.', 'interventionNames': ['Behavioral: The Dyadic Expressive Arts Group Therapy']}\n- {'label': 'The Treatment-as-usual Waitlist Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will continue their routine healthcare and social services. Upon completion of the 8-month study period, participants will be invited to a similar intervention group program.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'The Dyadic Expressive Arts Group Therapy', 'description': 'This therapy utilizes different art modalities, such as visual art, music, movement, dance, drama, and writing, as therapeutic means. With multiple sensory stimulations from different art forms, the therapy facilitates communication, expression, perception, and interactions. The therapy consists of 8 weekly 90 minutes sessions, with 3-4 mother-child dyads in each therapy group. Each session will follow the basic structure of Expressive Arts Therapy, including check-in, warm-up, core art-making, sharing, and closure. The following themes related to the mother-child relationship will be included, such as communication, relationship, expression, empathy, interaction, love, gratitude, and connection.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': \"Change of Baseline Mothers' Parenting Stress level at 2 months, 5 months, and 8 months\", 'description': 'The Chinese validated version of the Parenting Stress Index Short-Form will be used to assess the level of parenting stress of the mothers. The index assesses parenting stress in three domains: (i) parental distress, (ii) parent-child dysfunctional interaction, and (iii) difficult child. Higher scores represent higher parenting stress. This index will be filled in by mothers.', 'timeFrame': 'Baseline, Month 2, Month 5, Month 8'}\n- {'measure': \"Change of Baseline Mothers' Burnout level at 2 months, 5 months, and 8 months\", 'description': 'The Chinese validated version of the client burnout subscale of the Copenhagen Burnout Inventory will be used to assess the level of burnout of the mothers. Higher scores represent higher burnout. This inventory will be filled in by mothers.', 'timeFrame': 'Baseline, Month 2, Month 5, Month 8'}\n- {'measure': \"Change of Baseline Mothers' perceive Parent-Child Relationship at 2 months, 5 months, and 8 months\", 'description': \"The subscales of parent-child communication and satisfaction with parenting from the Parent-Child Relationship Inventory will be used to assess the mother's perception of the parent-child relationship. Higher scores represent a more positive perception of certain aspects of the parent-child relationship. The research team will undertake the Chinese translation process. This inventory will be filled in by mothers.\", 'timeFrame': 'Baseline, Month 2, Month 5, Month 8'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an attrition rate of 20%, the trial aims to reach 80% statistical power and attain a moderate effect size at a 5% level of statistical significance.", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was estimated using the analysis software G*power V.3.1.45 A moderate effect size (Cohen\u00e2\u0080\u0099s d=0.5) was expected based on a previously unpublished local study conducted in 2017 (Li IMY, unpublished thesis, the effectiveness of an attachment-based expressive arts therapy parenting programme for parents with special needs children, 2017). Assuming an attrition rate of 20%, a total sample of 154 dyads will be needed (ie, 77 dyads per arm) to reach 80% statistical power and attain a moderate effect size (Cohen\u00e2\u0080\u0099s d=0.5) in the proposed two-arm randomised controlled trial with four measurement time points at a 5% level of statistical significance.", "id": 1310, "split": "test"} +{"trial_id": "NCT05214937", "pmid": "35484523", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behaviour Among Prostate Cancer Survivors\n\nIncluded conditions:\n- Sedentary Behavior\n- Cancer of Prostate\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will be provided with a FitBit Inspire 2 and assigned a movement specialist. They will be asked to monitor their daily steps over the 12-week intervention period. Participants will attend 6 remotely-delivered behaviour change sessions (4 one-on-one sessions with their movement specialist, 2 group-based webinars). Sessions will be delivered bi-weekly and last \\\\~30 minutes.', 'interventionNames': ['Behavioral: Intervention']}\n- {'label': 'Fitbit Only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living (e.g., 24-hour movement guidelines).', 'interventionNames': ['Behavioral: FitBit Only']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention', 'description': 'During the first two weeks (baseline), participants will be asked to maintain their regular movement routine to set a baseline daily average step count. Phases I-III will involve self-regulatory strategies (e.g., action planning), address reducing/interrupting sedentary time, and step counts. Participants will be encouraged to increase their steps by 1000 steps/day from the baseline phase during each subsequent phase (i.e., 3000 steps above baseline by Phase III). Phases IV-V will be a maintenance phase through which participants will be encouraged to maintain 3000 steps per day above baseline. The sessions will be grounded within the Multi-Process Action Control Framework and address perceived capability/opportunity and instrumental/affective attitudes. The 1-on-1 sessions will focus on regulation (action \\\\& coping planning, social support, goal setting) and reflexive processing (self-regulation, habit). The final one on one session will be a booster session to revisit previous topics.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'FitBit Only', 'description': 'Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living. They will receive a FitBit orientation session with a movement specialist prior to the 12-week control period.', 'armGroupLabels': ['Fitbit Only']}\n\nPrimary Outcomes:\n- {'measure': 'Change in sedentary behaviour as assessed by activPAL inclinometers', 'description': 'Objectively-assessed sedentary behaviour will be assessed with activPAL inclinometers. The activPALs will be waterproofed and participants will be asked to wear the device in the mid-line of their right thigh for 7 days (24 hours per day). Participants will complete a wear log to identify sleep and non-wear periods. Total daily minutes of sedentary behaviour will be collected from the devices.', 'timeFrame': 'Baseline, Post-Intervention (12-weeks), 6-month Follow Up'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 0.05, power of 0.80, 20% attrition rate", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample Size\n A sample size calculation was performed in G*power based on a multivariate analysis of variance with two intervention levels (i.e., intervention, control) and two dependent variables (i.e., SB and PA). Based on our pilot trial with PCS, we assumed a medium effect size of Cohen\u00e2\u0080\u0099s d = 0.50 at the end of the intervention. Based on an alpha of 0.05 and power of 0.80, a total sample size of 100 is required. To account for the expected 20% attrition, a sample of 120 PCS (intervention n = 60, control n = 60) will be recruited.", "id": 1311, "split": "test"} +{"trial_id": "NCT05217758", "pmid": "37170109", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RESET-medication: Glucocorticoid Receptor (GR) Blockade As Diseasemodifying Treatment for Depression with Childhood Trauma\n\nIncluded conditions:\n- Major Depressive Disorder\n- Childhood Trauma\n\nStudy Armgroups:\n- {'label': 'Mifepristone', 'type': 'EXPERIMENTAL', 'description': 'Glucocorticoid Receptor (GR) blockade using the generic drug mifepristone', 'interventionNames': ['Drug: Mifepristone']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mifepristone', 'description': '1200 mg/day, once daily, 7 days', 'armGroupLabels': ['Mifepristone']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo, once daily, 7 days', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Depressive symptom severity at post-treatment', 'description': 'Depressive symptom severity in patients with CT-related depression, measured with the Inventory of Depressive Symptomatology - Self Report (IDS-SR, with a total score ranging from 0 to 84, where higher scores indicate higher severity of depressive symptoms)', 'timeFrame': '6 weeks after the start of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) is set at 0.05, power is 80%, and the dropout rate is estimated at 20%. For the fMRI sub-study, the power is also 80% with a type I error rate of 0.05.", "answer": 158, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on preclinical evidence [28\u00e2\u0080\u009331] and our targeted treatment of MDD with moderate to severe CT in RESET, we hypothesize a larger effect size compared to clinical trials of psychotic depression with an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.3 [39]. Therefore, it is estimated that this targeted disease-modifying treatment in a clinically specific group may have a robust treatment effect on the primary outcome measure with a medium effect size (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.50, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, two-tailed, power 80%). This requires 63 participants per group. Previous randomized studies in psychotic depression using a 7-day mifepristone treatment (300\u00e2\u0080\u00931200\u00c2\u00a0mg/day, N\u00e2\u0080\u0089=\u00e2\u0080\u00891388) found average dropout rates of around 20% [39]. Therefore, a total sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089158 is required, with N\u00e2\u0080\u0089=\u00e2\u0080\u008979 in each treatment arm of mifepristone and placebo.\n For the (f)MRI sub-study, 40 participants will be included per treatment arm (total of N\u00e2\u0080\u0089=\u00e2\u0080\u008980). This required sample size is calculated for our primary fMRI outcome measure: dynamical resting-state connectivity in response to a Trier Social Stress Test (TSST) [41]. Here we specifically aim to detect the influence of mifepristone vs. placebo on variation in network connectivity between the acute and recovery phase of this stress response. Currently, the effect size of mifepristone on these dynamics is unknown. However, we do know that the difference in resting-state network connectivity between the acute and delayed response phase is medium in healthy individuals (Cohen's f\u00e2\u0080\u0089=\u00e2\u0080\u00890.315) [42]. We also know from work in rodents that mifepristone has a medium effect on the structural integrity of the brain (Cohen's f\u00e2\u0080\u0089=\u00e2\u0080\u00890.316) [43]. Therefore, we want to be able to detect a medium effect size in our fMRI sub study. Calculations using R-package WebPower [44] revealed that we need two equal groups of 40 individuals to detect a medium effect (Cohen's f\u00e2\u0080\u0089=\u00e2\u0080\u00890.32) in within-between subject interactions in a repeated-measures ANOVA with 2 groups (i.e. placebo and mifepristone) and 2 measures (i.e. acute and delayed phase), and obtain a power of 80 percent with type I error rate of 0.05.", "id": 1312, "split": "test"} +{"trial_id": "NCT05218369", "pmid": "36332964", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Immunomodulation With Interleukin-6 Antagonists on the Coagulation System in Critically-ill Covid-19 Patients\n\nIncluded conditions:\n- COVID-19\n- Critical Illness\n\nStudy Armgroups:\n- {'label': 'Critically ill COVID-19 patients', 'description': \"Patients in ICU due to critical COVID-19 infection, who receive early (within the first 24 hours, but no later than 48 hours after intubation) IL-6 antagonist therapy at the consultant's discretion.\", 'interventionNames': ['Drug: IL6 Antagonist']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'IL6 Antagonist', 'description': \"Patients will receive IL-6 antagonist therapy at the consultant's discretion.\", 'armGroupLabels': ['Critically ill COVID-19 patients']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the lysis time', 'description': 'Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).', 'timeFrame': '48 hours'}\n- {'measure': 'Change in the lysis onset time', 'description': 'Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).', 'timeFrame': '48 hours'}\n\nPlease estimate the sample size based on the assumption: \nPower: 80%, Type I error: 5%, Statistical significance defined as p < 0.05, Missing data will not be used for specific outcomes but will be used for other outcomes, Data analysis using R statistical software, Mixed effect model with patient ID as random effect, Spearman\u2019s rank correlation analysis, p values corrected by false discovery rate method if necessary.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Since there is insufficient data in the literature to perform pro forma sample size calculation, we decided to initially enrol 30 patients (based on Bachler et al),14 after which an interim analysis and final sample size calculation (power: 80%, type I error: 5%) for the primary endpoint (change in LT. between T2) will be performed.\n Analysis of data will be performed independently based on each specific aim using the R statistical software (R Core Team (2021). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria). The collected data will be evaluated using descriptive statistical methods. Categorical variables will be expressed as frequencies (counts) and relative frequencies (percentages) and continuous data will be expressed as minimum, maximum, mean\u00c2\u00b1SD or median with IQR (Q3\u00e2\u0088\u0092Q1). In case of missing data, the participant\u00e2\u0080\u0099s data will not be used for further analysis for the specific outcome where there is any missing data, but the other data collected from the patient will be used for other outcomes.\n We will use a mixed effect model to analyse the data where the random effect will be patient ID. To observe the correlation between the laboratory parameters, we will use Spearman\u00e2\u0080\u0099s rank correlation analysis. Statistical significance defined as p <0.05. The p values will be corrected by the false discovery rate method if necessary.", "id": 1313, "split": "test"} +{"trial_id": "NCT05218447", "pmid": "39425122", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury\n\nIncluded conditions:\n- Spinal Cord Injuries\n\nStudy Armgroups:\n- {'label': 'Low Frequency', 'type': 'EXPERIMENTAL', 'description': 'Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks', 'interventionNames': ['Device: Robotic Gait Training']}\n- {'label': 'Moderate Frequency', 'type': 'EXPERIMENTAL', 'description': 'Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks', 'interventionNames': ['Device: Robotic Gait Training']}\n- {'label': 'High Frequency', 'type': 'EXPERIMENTAL', 'description': 'Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks', 'interventionNames': ['Device: Robotic Gait Training']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects will receive usual care gait training without robotic gait training', 'interventionNames': ['Other: Usual Care (UC) Gait Training']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Robotic Gait Training', 'description': 'Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.\\n\\nSubjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.', 'armGroupLabels': ['High Frequency', 'Low Frequency', 'Moderate Frequency'], 'otherNames': ['Ekso GT\u2122 robotic exoskeleton']}\n- {'type': 'OTHER', 'name': 'Usual Care (UC) Gait Training', 'description': 'Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.\\n\\nSubjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline', 'description': 'The WISCI-II defines the physical limitation for gait secondary to impairment at the person level and indicates the ability of a person to walk after SCI. The WISC-II rank orders the ability a person to walk on a scale of 0-20 with 0 representing no ability to stand or participate in assisted walking and 20 representing an ability to walk 10 meters with no devices, no braces, and no physical assistance.', 'timeFrame': 'Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, correlation among repeated measures between 0.5 and 0.75 (midpoint 0.60), ~15% attrition rate", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size determination was performed using G*Power 3.1.9 for a global F test between the 4 groups with 5 repeated measurements in each group. Estimates used in the calculations are based on our previously collected WISCI-II scores and published results on longitudinal scores [28, 29]. We estimated the correlation among repeated measures will fall between 0.5 and 0.75. Using the approximate midpoint, 0.60, we can detect a medium effect size, f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25, with 80% power at the 5% significance level with a sample size of 124. Allowing for\u00e2\u0080\u0089~\u00e2\u0080\u008915% attrition due to unplanned medical events, acute care transfers, and patient withdrawals, we will enroll 36 participants per group (total n\u00e2\u0080\u0089=\u00e2\u0080\u0089144).\u00c2\u00a0It is important to note that the sample size calculations are based on finding an overall statistically significant difference between groups and were not adjusted for potential subsequent pairwise comparisons.", "id": 1314, "split": "test"} +{"trial_id": "NCT05220137", "pmid": "37858262", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy\n\nIncluded conditions:\n- Stress Disorders, Post-Traumatic\n\nStudy Armgroups:\n- {'label': '1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Module Choice, Final Session', 'interventionNames': [\"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings']}\n- {'label': '3', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Challenging Questions, Final Session', 'interventionNames': ['Behavioral: Challenging Questions']}\n- {'label': '4', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Challenging Questions', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '5', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Problematic Patterns, Final Session', 'interventionNames': ['Behavioral: Patterns of Problematic Thinking']}\n- {'label': '6', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Patterns of Problematic Thinking', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '7', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session', 'interventionNames': ['Behavioral: Challenging Questions', 'Behavioral: Patterns of Problematic Thinking', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '8', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Challenging Questions', 'Behavioral: Patterns of Problematic Thinking']}\n- {'label': '9', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Challenging Beliefs, Final Session', 'interventionNames': ['Behavioral: Challenging Beliefs']}\n- {'label': '10', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Challenging Beliefs', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '11', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session', 'interventionNames': ['Behavioral: Challenging Questions', 'Behavioral: Challenging Beliefs', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '12', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Challenging Questions', 'Behavioral: Challenging Beliefs']}\n- {'label': '13', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session', 'interventionNames': ['Behavioral: Patterns of Problematic Thinking', 'Behavioral: Challenging Beliefs', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n- {'label': '14', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Patterns of Problematic Thinking', 'Behavioral: Challenging Beliefs']}\n- {'label': '15', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session', 'interventionNames': ['Behavioral: Challenging Questions', 'Behavioral: Patterns of Problematic Thinking', 'Behavioral: Challenging Beliefs']}\n- {'label': '16', 'type': 'ACTIVE_COMPARATOR', 'description': 'Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session', 'interventionNames': ['Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings', 'Behavioral: Challenging Questions', 'Behavioral: Patterns of Problematic Thinking', 'Behavioral: Challenging Beliefs', \"Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\"]}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Modified A-B-C: Working with Events, Thoughts, and Feelings', 'description': 'The Modified A-B-C session teaches the Veteran how to draw connections between events, thoughts, and feelings and incorporates preliminary cognitive restructuring to help challenge stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.', 'armGroupLabels': ['10', '12', '14', '16', '2', '4', '6', '8']}\n- {'type': 'BEHAVIORAL', 'name': 'Challenging Questions', 'description': 'The Challenging Questions session teaches the Veteran to question and confront maladaptive self-statements and stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.', 'armGroupLabels': ['11', '12', '15', '16', '3', '4', '7', '8']}\n- {'type': 'BEHAVIORAL', 'name': 'Patterns of Problematic Thinking', 'description': 'The Patterns of Problematic Thinking session teaches the Veteran to identify counterproductive thinking patterns. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.', 'armGroupLabels': ['13', '14', '15', '16', '5', '6', '7', '8']}\n- {'type': 'BEHAVIORAL', 'name': 'Challenging Beliefs', 'description': 'The Challenging Beliefs session teaches the Veteran to generate alternative thoughts based on the outcome of cognitive restructuring. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.', 'armGroupLabels': ['10', '11', '12', '13', '14', '15', '16', '9']}\n- {'type': 'BEHAVIORAL', 'name': \"Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)\", 'description': 'The therapist will present the Module options to the Veteran and the Veteran will select one Module to work on. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.', 'armGroupLabels': ['1', '10', '11', '13', '16', '4', '6', '7']}\n\nPrimary Outcomes:\n- {'measure': 'The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change', 'description': 'The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview used to measure of PTSD severity. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning and improvement in symptoms since a previous CAPS administration.\\n\\nScoring An index trauma/Criterion A event At least one Criterion B symptom (questions 1-5) At least one Criterion C symptom (questions 6-7) At least two Criterion D symptoms (questions 8-14) At least two Criterion E symptoms (questions 15-20) Both criterion F and G must be met as well for a PTSD diagnosis. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.', 'timeFrame': 'Baseline, 6-week, 3-month, 6-month'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect Cohen's d = 0.25 with 0.05 significance level, assuming 10% dropout rate and within-person correlation of 0.7.", "answer": 270, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We propose to enroll 270 participants. As described above, a CPT component will be considered effective if its presence produces a statistically significant main effect or two-way interaction of Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.25. A Cohen\u00e2\u0080\u0099s d of 0.25 is equivalent to a 5-point difference on the CAPS, which is recognized as the minimum threshold for therapeutic response [37]. We will consider a component to be \u00e2\u0080\u009cpossibly effective\u00e2\u0080\u009d if its main effect is significant but between 0.15 and 0.25. The sample size of 270 was planned to provide 80% power to detect at least Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 standardized effect size with 0.05 two-sided tests for the outcome of PTSD symptom change. This assumes 10% lost to assessment at the primary endpoint of 6\u00c2\u00a0months post-randomization, and within-person correlation of 0.7. Thus, we are adequately powered to meet the primary aim, as these anticipated effect sizes are consistent with the smallest clinically meaningful difference [37].", "id": 1315, "split": "test"} +{"trial_id": "NCT05221411", "pmid": "38233878", "question": "Here is the design of a clinical trial:\n\nOfficial Title: TAILOR Study: Tacrolimus Versus Mycophenolate for Autolmmune Hepatitis Patients With incompLete Response On First Line Therapy: a Randomized Trial\n\nIncluded conditions:\n- Autoimmune Hepatitis\n\nStudy Armgroups:\n- {'label': 'Mycofenolate Mofetil', 'type': 'EXPERIMENTAL', 'description': 'Patients in the mycophenolate mofetil (MMF) arm will receive MMF for a total of 12 months (if tolerated)', 'interventionNames': ['Drug: Mycophenolate Mofetil']}\n- {'label': 'Tacrolimus (Envarsus)', 'type': 'EXPERIMENTAL', 'description': 'Patients in the tacrolimus (TAC) arm will receive treatment with meltdose TAC for a total of 12 months (if tolerated)', 'interventionNames': ['Drug: Tacrolimus']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mycophenolate Mofetil', 'description': 'Mycophenolate mofetil will be started at a dose 500mg twice daily. When tolerated and an AUC within range, patients will be titrated to 1000mg twice daily at week two.', 'armGroupLabels': ['Mycofenolate Mofetil'], 'otherNames': ['Cellcept']}\n- {'type': 'DRUG', 'name': 'Tacrolimus', 'description': 'Meltdose tacrolimus will be started at a dose of 0.07 mg/kg/day. The drug will be taken orally once-daily in the morning. Dose will be adjusted to reach target AUC and trough levels.', 'armGroupLabels': ['Tacrolimus (Envarsus)'], 'otherNames': ['Envarsus']}\n\nPrimary Outcomes:\n- {'measure': 'Complete biochemical remission', 'description': 'The proportion of patients with CR after 12 months of treatment with TAC compared to MMF in patients with AIH with an incomplete response to first-line treatment.', 'timeFrame': '52 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided \u03b1 of 0.05 significance level, power of 0.8, and a 10% loss to follow-up.", "answer": 86, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample size calculation is based on the log-rank test for comparing two groups, a follow-up of 12\u00c2\u00a0months and the assumption of exponential survival times. The expected difference between groups was formulated in terms of relative risk derived from the expected cumulative incidences in the two groups according to previous literature. Papers on MMF for insufficient response in EU and North America reported 13%, 21% and 34% CR respectively, and review of the literature on TAC in adult AIH patients was also taken into account [22, 23, 25, 36]. Assuming proportions of CR at the end of follow-up of 0.22 in the MMF group and 0.53 in the TAC group with a two-sided \u00ce\u00b1 of 0.05 significance level and power of 1\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.8 to determine the difference in proportions of 0.31, results, in N\u00e2\u0080\u0089=\u00e2\u0080\u008938 patients per group. Taking into account a 10% loss to follow-up (e.g. due to side effects), this results in N\u00e2\u0080\u0089=\u00e2\u0080\u008943 patients per group. Thus, we aim to include a total of 86 patients.", "id": 1316, "split": "test"} +{"trial_id": "NCT05221749", "pmid": "35804457", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Primary Teeth\n- Microbial Colonization\n- Caries\n- Dental Caries in Children\n\nStudy Armgroups:\n- {'label': 'Silver diamine fluoride', 'type': 'ACTIVE_COMPARATOR', 'description': 'These active caries lesions will receive silver diamine fluoride treatment', 'interventionNames': ['Drug: Silver diamine fluoride']}\n- {'label': 'Nanosilver fluoride', 'type': 'EXPERIMENTAL', 'description': 'These active caries lesions will receive nanosilver fluoride treatment', 'interventionNames': ['Drug: Nanosilver Fluoride (NSF)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nanosilver Fluoride (NSF)', 'description': 'Optimized synthesis of Nanosilver Fluoride', 'armGroupLabels': ['Nanosilver fluoride'], 'otherNames': ['Nanosilver Fluoride']}\n- {'type': 'DRUG', 'name': 'Silver diamine fluoride', 'description': 'Silver Diamine Fluoride', 'armGroupLabels': ['Silver diamine fluoride'], 'otherNames': ['Advantage Arrest by Elevate Oral care, 38% SDF']}\n\nPrimary Outcomes:\n- {'measure': 'Antibacterial Effect in Active Dental Caries Lesions', 'description': 'Measuring the percent change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected immediately before application of the intervention (baseline) and one month after the intervention application (1 month follow-up).\\n\\nThe CFU counts will be used to calculate the percentage change in bacterial prevalence which will be used for assessment and reporting results', 'timeFrame': '1 month'}\n- {'measure': 'The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions', 'description': 'A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 1 month (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.', 'timeFrame': '1 month'}\n- {'measure': 'Antibacterial Effect in Unstimulated Saliva Samples', 'description': 'Measuring the change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.', 'timeFrame': '1 months'}\n\nPlease estimate the sample size based on the assumption: \n5% alpha error, 80% study power, adjustment for lost to follow-up cases.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Sample size was estimated assuming 5% alpha error and 80% study power. According to Dos Santos et al. [3], after 5 months, the NSF group had 72.7% arrested decay. Therefore, it was estimated that 14.54% of lesions treated with NSF will be arrested after 1 month. According to Milgrom et al. [3], 51.7% of lesions treated with 38% silver diamine fluoride (SDF) have been arrested after 21 days. Based on difference between two independent proportions, the minimum sample size was calculated to be 24 patients per group, increased to 25 teeth to make up for lost to follow-up cases. Total sample size = number per group \u00c3\u0097 number of groups = 25 \u00c3\u0097 2 = 50 patients. The sample size estimation was based on Rosner\u00e2\u0080\u0099s method [20] and calculated using G*Power 3.1.9.7 [21].", "id": 1317, "split": "test"} +{"trial_id": "NCT05225961", "pmid": "38195586", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Multi-center Clinical Trial to Assess Effectiveness and Safety of Tirofiban Versus Intravenous Aspirin in Patients With Acute Ischemic Stroke Secondary to Tandem Injury, Subject to Recanalization Therapy Through Endovascular Treatment\n\nIncluded conditions:\n- Acute Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'Tirofiban', 'type': 'EXPERIMENTAL', 'description': 'An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 10 ml (500 micrograms) of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters).', 'interventionNames': ['Drug: Tirofiban']}\n- {'label': 'Acetylsalicylic acid', 'type': 'ACTIVE_COMPARATOR', 'description': \"A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA\u00ae, 500 mg) will be intravenously administered. One vial of ASPIRINA \u00ae in not more than 250 ml in 0.9% sodium chloride solution, 5% and 10% glucose solution, Ringer's solution or lactated Ringer's. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial.\", 'interventionNames': ['Drug: Acetylsalicylic acid']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tirofiban', 'description': 'An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 500 micrograms of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). Tirofiban infusion started in the neuroradiology room should be maintained until a control brain computerized tomography (CT) scan is performed at 20 hours (+/-2 hours). Once the absence of parenchymal hematoma is demonstrated in control CT, loading doses of acetylsalicylic acid and clopidogrel will be intravenously administered in the Tirofiban group, and the perfusion must be maintained simultaneously of Tirofiban and oral double antiplatelet therapy for four hours, after which the administration of the experimental drug should be discontinued.', 'armGroupLabels': ['Tirofiban']}\n- {'type': 'DRUG', 'name': 'Acetylsalicylic acid', 'description': 'A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA\u00ae, 500 mg) will be intravenously administered. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. It will not be necessary to maintain aspirin infusion. In the Acetylsalicylic acid group, a head computerized tomography scan will also be performed at 20 (+/- 2 hours) after the endovascular procedure. Once the absence of parenchymal hematoma is demonstrated, a load of clopidogrel and 100 mg of Acetylsalicylic acid will be administered. Oral antiplatelet medication can be administered orally if the patient has a good level of consciousness and is not associated with dysphagia; or by placing a nasogastric tube.', 'armGroupLabels': ['Acetylsalicylic acid']}\n\nPrimary Outcomes:\n- {'measure': 'Carotid Reocclusion', 'description': 'Outcome measure assessment will be performed using ultrasound doppler, in which carotid reocclusion is define by:\\n\\n* the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, red-blue just proximal to the occlusion.\\n* An anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes.', 'timeFrame': 'Annually (single evaluation): within the first 24 hours (+/- 12hours)'}\n- {'measure': 'Platelet aggregation phenomena', 'description': 'Outcome measure assessment will be performed using ultrasound doppler, in which carotid reocclusion is define by:\\n\\n* the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, red-blue just proximal to the occlusion.\\n* An anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes', 'timeFrame': 'Annually (single evaluation): within the first 24 hours (+/- 12hours)'}\n- {'measure': 'Symptomatic intracranial hemorrhage (sICH)', 'description': 'The sICH is defined as a new intracranial hemorrhage in brain computerized tomography within hospitalization related to an National institute of Health Stroke Scale score increase \\\\>4 points compared with stroke admission.', 'timeFrame': 'Within first 24 hours after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a power of 80%, an alpha error of 5%, and includes a 5% loss rate.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n To calculate the sample size, we must state that there is no explicit literature that has made a previous comparison between the use of aspirin or tirofiban with other comparators, against placebo or with each other to prevent in-stent reocclusion in the study population group. Recent studies [14] show carotid reocclusion rates of 22% within the first 24\u00c2\u00a0h of stent placement when using a loading dose of 900\u00c2\u00a0mg of Inyesprin (intravenous ASA) and adding at the end of the endovascular procedure the administration of the loading dose of oral clopidogrel (300\u00c2\u00a0mg). In our case, we intend to confirm our hypothesis of a lower rate of reocclusion when using tirofiban in mono antiplatelet therapy, compared to the extensive and habitual use of aspirin as the generalized drug of choice in the first 24\u00c2\u00a0h after the onset of ischemic stroke symptoms. Bearing in mind that the aforementioned bibliography uses intravenous aspirin as the antiplatelet agent of choice during thrombectomy, we intend to use their data as a starting point for calculating the sample size. For this reason, we took a 22% reocclusion rate as a reference using Inyesprin as the first choice compared to an expected reduction of at least 12% with tirofiban (10% of reocclusion) to obtain a significant reduction with clinical impact in the carotid reocclusion rate.\n To calculate the sample size, we employed the free online application Granmo sample size calculator (https://www.imim.cat/ofertadeserveis/software-public/granmo/) which uses the approximation of the ARCOSENE for paired measurements (repeated in one group). The following parameters were displayed: power 80%, alpha error 5%, estimated difference between two proportions of 22% (for the control group, ASA) and 10% (for the experimental group, tirofiban). With these considerations, and including a 5% loss, the sample size would be equal to 240 patients (120 in each group).", "id": 1318, "split": "test"} +{"trial_id": "NCT05226091", "pmid": "36397087", "question": "Here is the design of a clinical trial:\n\nOfficial Title: TRial to Assess Implementation of New Research in a Primary Care Setting (TRAINS): a Pragmatic Cluster Randomised Controlled Trial of an Educational Intervention to Promote Asthma Prescription Uptake in General Practitioner Practices\n\nIncluded conditions:\n- General Practice (GP), Primary Care Settings\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'GP practices randomised to the intervention will receive a mail and email about the result of the PLEASANT study and advising them to implement the study findings.', 'interventionNames': ['Behavioral: Letter']}\n- {'label': 'Usual care arm', 'type': 'NO_INTERVENTION', 'description': 'GP practices randomised to control will not receive either mail or email and they will continue with usual care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Letter', 'description': 'Selected GP practices currently registered with CPRD will receive correspondence by both email and mail informing them about the result of the PLEASANT study and advising them how to implement what has been learnt. Included in the mailing would be a suggested letter and SMS text.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of children with asthma who have a prescription for an asthma preventer medication from 1st August 2021 to 30th September 2021.', 'description': 'prescription uptake of asthma preventer medication for children with asthma.', 'timeFrame': '8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPrecision of estimates with a half-width of a 95% confidence interval will be 1%", "answer": 1389, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size is based on feasibility and the anticipated number of practices providing data to the CPRD. We anticipate a sample size of approximately 1389 GP practices (694 on intervention and 695 on control). Alongside this, from the previous study (PLEASANT), we also anticipate 85 school-age children having asthma per practice [14]. Assuming an expected rate of 30% of people collecting their prescription and an intraclass correlation of 0.03, it is anticipated that the precision of the estimates in the study\u00e2\u0080\u0094estimated as a half-width of a 95% confidence interval\u00e2\u0080\u0094will be 1%.", "id": 1319, "split": "test"} +{"trial_id": "NCT05227391", "pmid": "37591656", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial\n\nIncluded conditions:\n- PCOS\n\nStudy Armgroups:\n- {'label': 'Letrozole-stimulated group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Oral Letrozole']}\n- {'label': 'Hormone replacement treatment group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Oral estradiol valerate']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Oral Letrozole', 'description': 'Oral Letrozole at a dose of 2.5mg daily will be started on days 3-5 of the menstrual cycle and will be continued for 5 days.', 'armGroupLabels': ['Letrozole-stimulated group']}\n- {'type': 'PROCEDURE', 'name': 'Oral estradiol valerate', 'description': 'Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.', 'armGroupLabels': ['Hormone replacement treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Live birth rate', 'description': 'Number of women with live birth/ number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation.', 'timeFrame': '11 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha error of 0.05, and a drop-out rate of 15% between randomisation and follow-up.", "answer": 1078, "answer_type": "ESTIMATED", "explanation": "Sample size\n To date, the largest study comparing the endometrial preparation protocols in patients with PCOS is the retrospective cohort study conducted by Zhang et al,20 which analysed 2664 FET cycles of PCOS and found that the LBRs of the first FET were 50.7% in HRT cycles and 54.4% in letrozole-stimulated cycles. The LBR was significantly higher in letrozole-stimulated cycles than in HRT cycles (adjusted OR 1.33, 95% CI 1.09 to 1.61) after adjusting for possible confounding factors. Additionally, we summarised the data of CITIC-Xiangya from August 2019 to March 2020, including 493 HRT cycles and 91 letrozole-stimulated cycles, and the LBRs of the two groups were 50% and 64%, respectively, after propensity score matching.\n Based on the aforementioned results, we assumed that the HRT cycles would achieve an LBR of 50%. To detect an absolute difference in LBRs of 10% (anticipated LBR of 50% in the HRT group vs 60% in the letrozole-stimulated group), with a power of 80% and an alpha error of 0.05, 916\u00e2\u0080\u0089women will need to be included. The ratio between the groups will be 1:1. Considering a drop-out rate of 15% between randomisation and follow-up, we plan to include 1078\u00e2\u0080\u0089women.", "id": 1320, "split": "test"} +{"trial_id": "NCT05227846", "pmid": "38159943", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 1 Dose Escalation Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Decompensated Cirrhosis (MSC-DLC-1)\n\nIncluded conditions:\n- Decompensated Cirrhosis\n\nStudy Armgroups:\n- {'label': 'Human Umbilical Cord-derived Mesenchymal Stem Cells', 'type': 'EXPERIMENTAL', 'description': 'Standard of care (SOC) plus a dose-escalation with 4 cohorts with 3-6 subjects/cohort who receive doses of 5, 10\uff0c15 and 20 \u00d710E7 cells. Proceed from lower dose to next higher dose if no safety concerns for each cohort.', 'interventionNames': ['Biological: Human Umbilical Cord-derived Mesenchymal Stem Cells']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Human Umbilical Cord-derived Mesenchymal Stem Cells', 'description': 'Human Umbilical Cord-derived Mesenchymal Stem Cells will be administered intravenously.', 'armGroupLabels': ['Human Umbilical Cord-derived Mesenchymal Stem Cells']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Adverse Events Incidence of Adverse Events', 'timeFrame': 'from baseline to 28th day'}\n- {'measure': 'Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day', 'description': 'The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology.\\n\\nThe MELD score is calculated by the formula: R = 9.6 \u00d7 ln (creatinine mg/dl) + 3.8 \u00d7 ln (bilirubin mg/dl) + 11.2 \u00d7 ln (INR) + 6.4 \u00d7 etiology, and the results are taken as integers. ( 0 for cholestatic and alcoholic cirrhosis and 1 for other causes of cirrhosis such as viruses).', 'timeFrame': 'at 28th day'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the paragraph.", "answer": 12, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a proof-of-concept study. A total of 3\u00e2\u0080\u00936 patients will be recruited for each dose cohort, comprising low, medium, high and super high-dose groups, denoted as cohorts 1, 2, 3 and 4, with three patients in each cohort initially. The additional patients will be added to the cohort if DLT is presented. A total of 12\u00e2\u0080\u009324 patients will be recruited for the study.19", "id": 1321, "split": "test"} +{"trial_id": "NCT05228665", "pmid": "36410797", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Prospective cohort', 'type': 'EXPERIMENTAL', 'description': \"Participants will be shown a paced breathing programme and instructed to implement this for 10 minutes twice daily for 4 weeks. During the 10-minute breathing exercises, the participant will need to wear the Polar H10 chest strap and can remove this when finished. The breathing will ideally be a breathing pattern of a 4-second nasal inhale, and 6-second nasal exhale using the 'resonance' programme in the 'biofeedback' section of EliteHRV app. They will be advised to monitor the graph of HRV on EliteHRV which allows real-time assessment of HRV and to aim to breathe in and out deeply to raise the HRV graph reading as much as possible each time. They will be advised to perform the breathing programme lying down with minimal distractions on waking in the morning and just before bed in the evening, preferably in the same location each time.\", 'interventionNames': ['Behavioral: Heart Rate Variability Biofeedback (HRV-B)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Heart Rate Variability Biofeedback (HRV-B)', 'description': 'Breathing technique twice every day (10 min each) to increase HRV', 'armGroupLabels': ['Prospective cohort']}\n\nPrimary Outcomes:\n- {'measure': 'Modified C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)', 'description': 'The C19-YRSm will be completed by the patient every week for a total of 6 weeks. There will be a total of 7 C19-YRSm documents completed. The C19-YRSm consists of 17 items with each item rated on a 4-point numerical rating scale from 0 (no symptom) to 3 (life disturbing or affecting all aspects of daily life). The C19-YRSm is divided into four subscales (range of total score for each subscale): symptom severity score (0-30), functional disability score (0-15), other symptoms (0-25), and overall health (0-10). A higher score for the first 3 subscores represents higher severity. Conversely, a lower overall health score represents greater severity.', 'timeFrame': 'Up to 6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nNot applicable as a formal sample size calculation is not required for a feasibility study.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n A formal sample size calculation is not required for a feasibility study as it does not mimic a definitive randomised trial and aim is not to measure effect size.35 A sample size of 30 is the average sample size across feasibility studies and is accepted as reasonable size to assess the acceptability and suitability of the intervention.36", "id": 1322, "split": "test"} +{"trial_id": "NCT05229861", "pmid": "37087424", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Influence of High-Intensity Interval Training Compared to Moderate Continuous Training on Cardiorespiratory Fitness, Symptom Improvement, and Disease-specific Biomarkers in Primary Progressive Multiple Sclerosis\n\nIncluded conditions:\n- Primary Progressive Multiple Sclerosis\n- Exercise\n- Cardiorespiratory Fitness\n\nStudy Armgroups:\n- {'label': 'High-intensity Interval Training (HIIT)', 'type': 'EXPERIMENTAL', 'description': 'Participants will complete seven HR-controlled HIIT sessions within their 3-week inpatient stay, corresponding to 3 exercise bouts per week.', 'interventionNames': ['Behavioral: HIIT']}\n- {'label': 'Moderate Continuous Training (MCT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'MCT represents the standard treatment at Valens rehabilitation clinic. Participants will complete seven HR-controlled MCT sessions within their 3-week inpatient stay, corresponding to 3 exercise bouts per week.', 'interventionNames': ['Behavioral: MCT']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'HIIT', 'description': 'Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Participants will perform five high-intensity intervals (95% HRpeak) at high pedalling rates of 80-100 rpm for 90 seconds each. Intervals are interspersed by active breaks of unloaded pedalling (20W, 60-70rpm) aimed to return to 60% HRpeak (approximately 1-1.5 min). The duration of a HIIT sessions is approximately 25 minutes.', 'armGroupLabels': ['High-intensity Interval Training (HIIT)']}\n- {'type': 'BEHAVIORAL', 'name': 'MCT', 'description': 'Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Participants perform continuous bicycle ergometry at moderate intensity (60% HRpeak) and 60-70 rpm for the duration of 30 minutes.', 'armGroupLabels': ['Moderate Continuous Training (MCT)']}\n\nPrimary Outcomes:\n- {'measure': 'Cardiorespiratory fitness (peak oxygen consumption, VO2peak)', 'description': 'Cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test (CPET). Higher values indicate better cardiorespiratory fitness.', 'timeFrame': 'Three weeks (day 0 to day 21)'}\n\nPlease estimate the sample size based on the assumption: \nPower: 80%, Significance level (alpha): 0.05, Dropout rate: 15%, Correlation among repeated measures: 0.6", "answer": 61, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculation for the estimated effect of HIIT or MCT on the primary outcome V\u00cc\u0087O2peak was performed using G*Power software (Version 3.1.9.7, Heinrich Heine Universit\u00c3\u00a4t, D\u00c3\u00bcsseldorf, Germany) [20]. Estimating a drop-out of 15%, a total of 61 participants (HIIT: n=\u00c2\u00a030,\u00c2\u00a0MCT: n=\u00c2\u00a031) was found to be sufficient to identify a small to moderate effect (ES\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.15) in ANOVA analysis on 2 group (HIIT vs. MCT) * 2 time (T0 vs. T4) interaction. Power was set at 80% and alpha at 0.05. Correlation among repeated measures was set at 0.6.", "id": 1323, "split": "test"} +{"trial_id": "NCT05231200", "pmid": "37130608", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Alberta (AB) Collaborative Quality Improvement Strategies to Improve Outcomes of Preterm Infants 32 - 36 Weeks' Gestation: a Stepped-Wedge Cluster Randomized Trial\n\nIncluded conditions:\n- Length of Stay\n\nStudy Armgroups:\n- {'label': 'Control Arm- Current management', 'type': 'ACTIVE_COMPARATOR', 'description': 'NICUs in the control arm can continue conducting QI activities relevant to current practice and current standard of care, but without receiving the interventions until they transition to the intervention arm.', 'interventionNames': ['Other: Current practice- standard of care']}\n- {'label': 'Intervention Arm- Collaborative Quality implementation Strategies', 'type': 'EXPERIMENTAL', 'description': 'The study intervention is a constellation of collaborative QI strategies: 1) QI Team Building; 2) QI Education; 3) Implementation of 2 standardized practice care bundles (Respiratory Care, and Nutritional Care); 4) QI mentoring; and 5) Collaborative networking.', 'interventionNames': ['Behavioral: QI Team Building', 'Behavioral: QI education', 'Other: Standardized care bundle- respiratory care', 'Other: Standardized care bundle- nutritional care', 'Behavioral: QI mentoring', 'Behavioral: Collaborative networking']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'QI Team Building', 'description': 'Each NICU will create a core QI team composed of 6-8 multidisciplinary members including a parent advisor, when feasible. This team will lead the QI activities and education, and champion the culture and practice change in the unit.', 'armGroupLabels': ['Intervention Arm- Collaborative Quality implementation Strategies']}\n- {'type': 'BEHAVIORAL', 'name': 'QI education', 'description': \"Each NICU QI team will receive standardized QI education using the 6-hour EPIQ Workshop which involves hands-on approach to enable teams to successfully implement QI projects together. EPIQ 10 Steps and QI Tools will be used to build the team's understanding of QI using realistic improvement opportunities based on the standardized care bundles identified in the trial.\", 'armGroupLabels': ['Intervention Arm- Collaborative Quality implementation Strategies']}\n- {'type': 'OTHER', 'name': 'Standardized care bundle- respiratory care', 'description': 'A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for stabilization and respiratory care in moderate and late preterm infants (MLPIs) including\\n\\n1. establishing effective ventilation in the delivery room\\n2. prevention of hypothermia\\n3. early diagnosis and management of respiratory distress with continuous positive airway pressure (CPAP)\\n4. standardized approach for surfactant indications and administration\\n5. standardized approach for early extubation.', 'armGroupLabels': ['Intervention Arm- Collaborative Quality implementation Strategies']}\n- {'type': 'OTHER', 'name': 'Standardized care bundle- nutritional care', 'description': \"A care bundle is a small, simple set (3-5 elements) of evidence-based practices that, when performed collectively and reliably, will result in improved patient outcomes. This bundle will aim to implement best practices for nutritional support in MLPIs including\\n\\n1. early initiation of enteral or parenteral nutrition;\\n2. standardized tables for feeding initiation and progression\\n3. optimizing breastfeeding and use of mother's own milk\\n4. standardized approach for a transition from enteral nutrition via tube feeds to oral feeds.\", 'armGroupLabels': ['Intervention Arm- Collaborative Quality implementation Strategies']}\n- {'type': 'BEHAVIORAL', 'name': 'QI mentoring', 'description': 'Each NICU in the intervention arm will have one or more assigned members of the study team who are experienced in collaborative QI and EPIQ methods. The mentors will help local QI teams to engage frontline staff in QI and navigate the unit-specific challenges.', 'armGroupLabels': ['Intervention Arm- Collaborative Quality implementation Strategies']}\n- {'type': 'BEHAVIORAL', 'name': 'Collaborative networking', 'description': \"The study team will conduct virtual meetings every 2 months for the NICUs in intervention arm allowing local QI teams to discuss progress, and share data. The investigators will arrange annual in-person or virtual meetings for the NICUs in the intervention arm to present projects, successes, and lessons learned. These NICUs will have continuing access to the data and will receive quarterly reports using statistical process control charts outlining the unit's performance compared to other units and to the group average.\", 'armGroupLabels': ['Intervention Arm- Collaborative Quality implementation Strategies']}\n- {'type': 'OTHER', 'name': 'Current practice- standard of care', 'description': 'All participating NICUs will be in the control arm during the first year prior to randomization to create a baseline of the current practices and between-units variation. NICUs in the control arm can continue conducting QI activities relevant to current practice, but without receiving the interventions outlined above until they transition to the intervention arm. The investigators will capture these activities and account for them in the analysis.', 'armGroupLabels': ['Control Arm- Current management']}\n\nPrimary Outcomes:\n- {'measure': 'Length of Stay', 'description': 'The duration of hospitalization until final discharge.', 'timeFrame': 'Birth until discharge home or death, whichever came first, assessed until the participant reaches a corrected age of 6 months (6 months after their birth due date).'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1 level of 0.05; power greater than 99% for length of stay reduction; 80% power for binary outcomes; intracluster correlation coefficient of 0.034; design effect of 3.41; accounting for multiple births and unequal cluster sizes.", "answer": 9500, "answer_type": "ESTIMATED", "explanation": "Sample sizeThe anticipated sample size is 9500 neonates over 4 years. Power calculations account for the design effect that is determined by the number of sites and steps, the size of the clusters within each period and the intracluster correlation coefficient. 35\u00e2\u0080\u009338 Calculations account for the relative efficiency imposed by unequal cluster sizes.39 Using historic length of stay data from 2018 and 2019, we obtained an observed intracluster correlation coefficient of 0.034 from a negative binomial model with random intercepts for sites with a corresponding design effect of 3.41. At an \u00ce\u00b1 level of 0.05, this provides power of greater than 99% to detect a 1-day reduction in length of stay (historic mean length of stay = 14 d). In the historic data, 81% of neonates were singletons. Sample size calculations accounting for multiple births resulted in similar power. Our sample size will ensure we have adequate power for assessments of some of the secondary outcomes that are in common with the Alberta FICare trial.10 Anticipated rates of intravenous fluid use and respiratory support will be similar to those of neonates with a gestational age of 34 weeks in the Alberta FICare data (both about 50%). Applying the same methods to power calculations for binary outcomes, we will have 80% power to detect a 10.2% relative reduction in event rates if the baseline rate is 50%, and 80% power to detect a relative reduction of 19.7% if the baseline event rate is 20%. Calculations are for a cross-sectional stepped-wedge design and were programmed using R 4.0.2, and lme4 function for generalized linear mixed effect models.40", "id": 1324, "split": "test"} +{"trial_id": "NCT05233150", "pmid": "36823526", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children\n\nIncluded conditions:\n- Parent-Child Relations\n- Child Maltreatment\n\nStudy Armgroups:\n- {'label': 'PriCARE/CARI\u00d1O plus Usual Care', 'type': 'EXPERIMENTAL', 'description': 'Caregiver-child dyads assigned to the PriCARE/CARI\u00d1O plus usual care group will receive the PriCARE/CARI\u00d1O intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions.', 'interventionNames': ['Behavioral: PriCARE/CARI\u00d1O']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PriCARE/CARI\u00d1O', 'description': \"PriCARE/CARI\u00d1O is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE/CARI\u00d1O uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. PriCARE/CARI\u00d1O includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. CARI\u00d1O is the culturally adapted version of PriCARE for Spanish speaking participants.\", 'armGroupLabels': ['PriCARE/CARI\u00d1O plus Usual Care'], 'otherNames': ['Child Adult Relationship Enhancement in Primary Care', 'Criando Ni\u00f1os con CARI\u00d1O']}\n\nPrimary Outcomes:\n- {'measure': 'Child Protective Services Investigations from time 3 to time 5', 'description': \"The primary outcome variable is a binary indicator of whether or not the child experienced at least one investigation from Child Protective Services (CPS) during follow-up. Beginning 4 months after randomization, each child will be followed for a period of 12 to 48 months to document all CPS investigations of suspected child maltreatment. The length of the follow-up interval will depend on the dyad's time of enrollment in the study.\", 'timeFrame': '4 month after baseline (time 3) up to 52 months after baseline (time 5)'}\n- {'measure': 'Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4', 'description': 'Change in BCAP scores from time 1 to time 4 will be measured. BCAP, a 34-item survey, measures traits and parenting styles typical of known physical child abusers. Each item has a unweighted value based on if agree vs. disagree is chosen and then the values are summed. Child abuse risk scores range from 0-24 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse.', 'timeFrame': 'Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)'}\n\nPlease estimate the sample size based on the assumption: \nGeneralized logistic regression models will be used with clinical site as a categorical random effect and fixed effects for follow-up length, treatment regimen, and language. The study assumes a significance level (alpha) of 0.05, power of 80%, and a 10% loss to follow-up at the 6-month interview. Intraclass correlation due to dyad clustering is assumed to be small (\u03c1 \u2264 0.15).", "answer": 1932, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The study to be conducted in 10\u00e2\u0080\u009315 clinics will enroll 1932 eligible caregiver-child dyads drawn from the target population of low-income children 2\u00e2\u0080\u00936 years of age. We anticipate that about 15% of the caregivers will be Spanish speakers. We anticipate that about 200\u00e2\u0080\u0093300 of the 1932 enrolled dyads will experience CPS investigation during the study after 1:1 randomization stratified by clinical site and language. In designing the study and choosing the target sample size, considerations included (1) information from previous studies; (2) the availability of eligible dyads, clinics, and clinic personnel; (3) costs and time requirements; (4) anticipated frequencies of drop-out, missing data values, and nonadherence to protocol; (5) the statistical analysis strategies and methods specified for each of the five objectives; (6) anticipated levels of precision of estimators of key population parameters (estimands); and (7) anticipated levels of power of a hypothesis test procedure concerning the effectiveness of the intervention.\n \n Objective 1 considerations\n Considerations for Objective 1 were informed by the following published reports: during a 43-month study of 250 children in Baltimore (92% Medicaid), 19% had at least one CPS investigation\u00c2\u00a0[87]. In a state-wide prospective observational study in California, 21% of children with Medicaid at birth had at least one CPS investigation over 5 years\u00c2\u00a0[58]. In Cleveland, from birth to age 10, 31% of children were investigated by CPS\u00c2\u00a0[88]. An estimated 37% of all US children will have been investigated by CPS by the time they reach age 18 years [1]. These reports suggested that if our target population receives usual clinical care only and each child is followed for 12 to 48 months thereafter, then about 20% of the children would experience at least one CPS investigation during follow-up.\n Assumptions: The statistical analyses will rely on generalized logistic regression models with clinical site treated as a categorical random effect, and with fixed effects representing length of follow-up (log10 months), treatment regimen, and language (Spanish-speaking). Additionally, variations on the model will be used to explore additional fixed effects; e.g., demographic characteristics, caregiver scores (PHQ9, GAD7, ACEs) at enrollment, and terms representing interactions among the fixed-effects.\n To avoid model overfitting bias, we require at least 20 cases (20 dyads experiencing CPS investigation) per fixed-effect regression coefficient included in the model; e.g., if 200 cases occur, the models can support up to 10 coefficients in the regression equation. We anticipate that the chosen sample size is sufficient and appropriate for supporting objective 1.\n For considerations of precision and power, simplifying assumptions and conjectures were made:the proportion (\u00cf\u00801) experiencing CPS investigation is 20% in the target population when receiving only usual care, the proportion (\u00cf\u00802) is 13% when the target population receives usual care plus the PriCARE/CARI\u00c3\u0091O intervention, the follow-up interval is the same for all the small groups, and that intraclass correlation due to dyad clustering of dyads is small (\u00cf\u0081 \u00e2\u0089\u00a4 0.15). In regard to precision, discussed in terms of the widths of 95% confidence intervals (CI): if the observed proportion of cases for the control regimen happens to be 20%, then the observed 95% CI for \u00cf\u00801 would be {20.0% \u00c2\u00b1 4.0%}; if the observed proportion for the intervention regimen is 13%, then the observed 95% CI for \u00cf\u00802 would be {13.0% \u00c2\u00b1 3.3%}; and the observed 95% CI for the difference (\u00cf\u00801 \u00e2\u0088\u0092 \u00cf\u00802) would be {7.0% \u00c2\u00b1 4.5%}, approximately. In regard to power for the test of Ho \u00e2\u0080\u009cthe treatment effect (\u00cf\u00801 \u00e2\u0088\u0092 \u00cf\u00802) is exactly zero in the target population,\u00e2\u0080\u009d if (\u00cf\u00801 \u00e2\u0088\u0092 \u00cf\u00802) = 7.0% then there is an 80% chance that a sample of dyads will be drawn from the target population such that a small p-value (< \u00ce\u00b1=0.05) will be observed. If Ho is true then the power level is 5%.\n \n \n Objective 2 considerations\n We conjecture that the intervention improves proximal outcome scores: CM risk, child behavior problems, caregiver-child interactions (n=120), caregiver stress, harsh parenting by the caregiver, and dysfunctional parenting by the caregiver all measured prior to randomization and 6\u00e2\u0080\u00938 months later. Based on prior studies we anticipate a 10% loss to follow-up at the 6-month interview.\n \n \n Objective 3 considerations\n The investigation of mediation effects will focus on model-building, estimation of effects, and qualitative analysis for purposes of hypothesis generation/refinement. We anticipate that the study design and target sample size will be adequate for these exploratory analyses.\n \n \n Objective 4 considerations\n A sample of 6 clinics will be selected, including 3 high- and 3 low-implementing clinics as identified by their clinic referral rate, enrollment rate, and mean attendance. Samples of participants will be drawn from each of the 6 clinics. To ensure that the data reflect the diversity of roles and experiences, we will use purposive sampling to include caregivers, clinicians, and PriCARE/CARI\u00c3\u0091O facilitators. Caregiver sampling will be balanced by language and number of sessions attended (<3 or >3). Clinician sampling will be balanced to include those with high and low referral rates. Altogether, we anticipate interviewing 3\u00e2\u0080\u00935 caregivers per site (18\u00e2\u0080\u009330 total), 2\u00e2\u0080\u00933 clinicians per site (12\u00e2\u0080\u009318 total), and 10 PriCARE/CARI\u00c3\u0091O facilitators. We anticipate this will provide sufficient data to achieve saturation relative to our primary objectives of identifying factors that may be implementation determinants (objective 4) and contextualizing the quantitative analyses of mechanisms of change (objective 3)\u00c2\u00a0[89].\n \n \n Objective 5 considerations\n Pre- and post-intervention ECBI scores for 483 enrolled dyads (randomized 1:1) studied during a time of virtual delivery of the PriCARE/CARI\u00c3\u0091O intervention will be compared to historical scores from 444 dyads (randomized 1:1) previously studied in three trials during in-person delivery. The observational cohort-comparison study may be subject to confounding biases. The analyses will be descriptive with a focus on point and interval estimates of means, mean changes, differences, and variance components. In terms of the ECBI pre- vs post-intervention change score, a 10-unit difference between the two regimens will be considered clinically important.", "id": 1325, "split": "test"} +{"trial_id": "NCT05233800", "pmid": "35729605", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors\n\nIncluded conditions:\n- Breast Cancer Survivor\n- Insomnia\n\nStudy Armgroups:\n- {'label': 'Voice-Activated Smart Speaker Program', 'type': 'EXPERIMENTAL', 'description': 'Faster Asleep', 'interventionNames': ['Behavioral: Faster Asleep Smart Speaker Program']}\n- {'label': 'Website', 'type': 'ACTIVE_COMPARATOR', 'description': 'Faster Asleep Website', 'interventionNames': ['Behavioral: Faster Asleep Website']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Faster Asleep Smart Speaker Program', 'description': 'Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.', 'armGroupLabels': ['Voice-Activated Smart Speaker Program']}\n- {'type': 'BEHAVIORAL', 'name': 'Faster Asleep Website', 'description': 'Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.', 'armGroupLabels': ['Website']}\n\nPrimary Outcomes:\n- {'measure': 'Insomnia Symptoms', 'description': \"Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-threshold or better scores (\u226414) among \\\\>80% of the intervention participants\", 'timeFrame': '6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nDesired power of 80%, significance level (alpha) of 0.05 (2-sided test), pre-post correlation of 0.5, and allowance for up to 30% dropout rate.", "answer": 76, "answer_type": "ACTUAL", "explanation": "Sample size\n Power calculations were based on the null hypothesis of no significant mean adjusted difference between groups post-intervention on a continuous total ISI score, after controlling for baseline score using Analysis of Covariance (ANCOVA). A systematic review and meta-analysis published in 2016 showed a large effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.77 (95% CI 0.60\u00e2\u0080\u00930.93) at post-treatment across seven randomized controlled trials [27]. A recent study of internet-based CBT-I among BCS found an effect size of 1.17 where the outcome was the ISI [28]. A series of required sample sizes were calculated in SAS 9.4 with covariate-outcome correlations with a desired power of 80% to detect effect sizes between 0.50 and 0.80 (medium to large). Alpha was set at 0.05 (2-sided test). Estimating a conservative effect size of 0.65 and a pre-post correlation of 0.5, 58 participants, with 29 in each arm would be required. We will aim to recruit N\u00e2\u0080\u0089=\u00e2\u0080\u008976 total (n\u00e2\u0080\u0089=\u00e2\u0080\u008938 per arm) to allow for drop out of up to 30%.", "id": 1326, "split": "test"} +{"trial_id": "NCT05233904", "pmid": "36482335", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy\n\nIncluded conditions:\n- Advanced Cancer Requiring Palliative Radiation\n\nStudy Armgroups:\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients will be booked for CT simulation and treatment as per the local institution's standard practice.\", 'interventionNames': ['Diagnostic Test: Standard of Care']}\n- {'label': 'Experimental Treatment Workflow', 'type': 'EXPERIMENTAL', 'description': 'Patients do not require a CT simulation appointment. A radiation treatment appointment will be scheduled on an optical surface guidance-equipped treatment unit as soon as available, but a minimum of 24 hours is required between EBAF processing and fraction 1.', 'interventionNames': ['Diagnostic Test: Diagnostic-CT-enabled Planning']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Diagnostic-CT-enabled Planning', 'description': 'Diagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease', 'armGroupLabels': ['Experimental Treatment Workflow']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Standard of Care', 'description': \"Patients will be booked for CT simulation and treatment as per the local institution's standard practice\", 'armGroupLabels': ['Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Time in Centre (TIC) on Treatment Day', 'description': 'This is defined as the total time in hours spent at the cancer centre from the scheduled CT simulation (Arrm 1) or treatment delivery (Arm 2) appointment until beam delivery completion.', 'timeFrame': '1 Treatment Day'}\n\nPlease estimate the sample size based on the assumption: \nUsing a two-sided, two-sample t-test, with a 1:2 randomization, alpha of 0.05, power of 80%, and adjusting for a 10% dropout rate.", "answer": 33, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on a review of recent same-day treatments at the London Regional Cancer Program (LRCP), the estimated TIC in the standard arm of this trial will be 4.8\u00e2\u0080\u0089hours, with a standard deviation of 2. We hypothesize that in the experimental arm, the estimated TIC will be 2.5\u00e2\u0080\u0089hours, with the same standard deviation. Using a two-sided, two-sample t-test, with a 1:2 randomization, alpha of 0.05 and power of 80%, adjusting for 10% dropout, 33 patients are required, 11 in the standard arm and 22 in the experimental arm.", "id": 1327, "split": "test"} +{"trial_id": "NCT05235152", "pmid": "35436907", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Group-based Exercise Training Programs for Military Members Presenting Musculoskeletal Disorders - A Pragmatic Randomized Controlled Trial\n\nIncluded conditions:\n- Musculoskeletal Pain\n- Low Back Pain\n- Rotator Cuff Tendinitis\n- Patellofemoral Pain Syndrome\n- Ankle Sprains\n\nStudy Armgroups:\n- {'label': 'Usual individual physiotherapy care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received usual/individual physiotherapy care over a period of 12-weeks for the treatment of their musculoskeletal conditions if randomized in this group.', 'interventionNames': ['Other: Usual individual physiotherapy care']}\n- {'label': 'Group-supervised physiotherapy training programs', 'type': 'EXPERIMENTAL', 'description': 'Participants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received group-supervised physiotherapy training programs over a period of 12-weeks for the treatment of their musculoskeletal condition if randomized in this group.', 'interventionNames': ['Other: Group-supervised physiotherapy training programs']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual individual physiotherapy care', 'description': 'Usual and individual physiotherapy care guidelines were developed through a round-table discussion involving experts in musculoskeletal health. From the round-table discussion, the consensus as reflecting best-practices for the rehabilitation of musculoskeletal rehabilitation supported an active exercise rehabilitation approach which includes strengthening and neuromuscular training exercises. Furthermore, the following treatments are considered in addition to active exercises:\\n\\n* Range of motion: active, active-assisted, passive, repeated movements (Mulligan or McKenzie);\\n* Stretching / manual therapy: mobilizations, manipulation, neural mobility, active release therapy;\\n* Individual proprioceptive training.', 'armGroupLabels': ['Usual individual physiotherapy care']}\n- {'type': 'OTHER', 'name': 'Group-supervised physiotherapy training programs', 'description': \"Three group-supervised physiotherapy training programs (The lumbar, the upper extremity and the lower extremity training programs) were developed for military members with musculoskeletal conditions. They are composed of stations that each include several exercises of varying levels of difficulty. Group size will vary between 5 to 20 participants for one physiotherapist, and each military member performs his/her own exercises. During a typical session, the participant and therapist will choose one exercise to perform per station according to two main criteria: severity of the condition and the ability to perform the exercises optimally. The level of supervision is adapted to the participant's needs and performance. Progression in the programs leads to the execution of exercises that simulate functional and occupational tasks.\", 'armGroupLabels': ['Group-supervised physiotherapy training programs']}\n\nPrimary Outcomes:\n- {'measure': 'Functional limitations', 'description': 'Pain-related functional limitations will be measured with the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Interference subscale is recommended for assessment of pain-related functional limitations and includes seven items that measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.', 'timeFrame': 'Week 26'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (1-\u03b2) = 0.95, Expected lost at follow-up = 15%", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on our sample size calculation, calculated for our primary outcome (Pain Interference subscale of the Brief Pain Inventory) using data from a pilot study on military members with MSKd [33], 15 participants per diagnosis will be required per group for a total of 120 participants (60 participants/group) (G*Power 3.1.7; \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, 1-\u00ce\u00b2\u00c2\u00a0=\u00e2\u0080\u00890.95, Baseline mean: 2.9+/\u00e2\u0088\u0092\u00e2\u0080\u00891.5 points, Follow-up mean: 0.8+/\u00e2\u0088\u0092\u00e2\u0080\u00891.2 points, expected lost at follow-up\u00e2\u0080\u0089=\u00e2\u0080\u008915% [based on past experiences with this population]. This number will enable us to determine the effects of the interventions for each of the four conditions.", "id": 1328, "split": "test"} +{"trial_id": "NCT05237089", "pmid": "38458786", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Electroacupuncture on Weight Loss in Obese Patients With Prediabetes: a Randomized Controlled Trial\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'EA group\uff1aElectroacupuncture+health education', 'type': 'ACTIVE_COMPARATOR', 'description': 'Acupuncture is the most popular adjuvant and alternative therapy in China, and it has been used to treat various diseases for thousands of years. Electroacupuncture is an innovation of traditional Chinese acupuncture, which improves the clinical effect by transmitting electrical pulses to the needles and then enhances the stimulation at the acupoints to receive better effects. Studies show that EA has been used as an alternative therapy for obesity in clinical practice.', 'interventionNames': ['Other: Electroacupuncture', 'Other: Health education']}\n- {'label': 'Sham acupuncture group\uff1ashallow acupuncture+health education', 'type': 'SHAM_COMPARATOR', 'description': 'Sham acupuncture method in this study is set as the superficial acupuncture manipulated at the same main acupoints with the thinner and shorter needles. The aim of the sham acupuncture is to eliminate the possible placebo effect of EA treatment.', 'interventionNames': ['Other: Sham acupuncture', 'Other: Health education']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Electroacupuncture', 'description': \"Regular acupuncture will be applied at the main and the additional acupoints with 0.25mm\\\\*40mm or 0.30mm\\\\*75mm needles. The main acupoints include Shangwan (CV13), Zhongwan (CV12), Jianli (CV11), Xiawan (CV10), bilateral Quchi (LI11), Hegu (LI4), Liangmen (ST21), Tianshu (ST25), Daheng (SP15), Fujie (SP14), Shuidao (ST28), Zusanli (ST36), Fenglong (ST40), Wailing (ST26), Guilai (ST29). Additional acupoints include bilateral Shangjuxu (ST37) and Neiting (ST44), bilateral Yinlingquan (SP9) and Shuifen (CV9), Qihai (CV6) and Guanyuan (CV4). Acupuncturists will use all main acupoints and choose the combined acupoints based on the patients' patterns during each treatment session. The EA apparatus will be connected to the needles at the bilateral ST21, ST25, SP15, using continuous wave type, frequency at 3 Hz, and intensity of 4-5 mA based on the endurance of each patient. Needles will be retained for 30 minutes before removal.\", 'armGroupLabels': ['EA group\uff1aElectroacupuncture+health education']}\n- {'type': 'OTHER', 'name': 'Sham acupuncture', 'description': 'Patients will receive superficial acupuncture treatment at the same main acupoints as EA group with 0.22\\\\*0.25mm needles. The electroacupuncture apparatus will connected to the needles at the bilateral Liangmen (ST21), Tianshu (ST25), Daheng (SP15) without current output. Needles will be retained for 30 minutes before removal. The treatment will be given 3 times a week in week 1-12, 2 times a week in week 13-20, and once a week in week 21-24, totaling 56 sessions of real or sham acupuncture.', 'armGroupLabels': ['Sham acupuncture group\uff1ashallow acupuncture+health education']}\n- {'type': 'OTHER', 'name': 'Health education', 'description': 'The health management brochure will be distributed to all patients in the trial after enrollment, and health education will be arranged online or offline at week 4, 8, 12, 16, 20 and 24 for about 60 minutes, including lifestyle, diet and physical activity. According to the specific situation of each patient, healthier individual lifestyle and behavior will be recommended to all patients, but there will be no strict restrictions on the diet or physical activity.', 'armGroupLabels': ['EA group\uff1aElectroacupuncture+health education', 'Sham acupuncture group\uff1ashallow acupuncture+health education']}\n\nPrimary Outcomes:\n- {'measure': 'The Percentage of patients who lost 10% of their body weight', 'description': 'We will calculate the proportion of people in each group who lost 10% or more of their baseline body weight at the end of the intervention period.', 'timeFrame': 'week 24'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate of 0.025 (one-sided), power of 80%, and a dropout rate of 20%.", "answer": 256, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation for this study was based on the proportion of patients achieving weight loss of 10% or more of their body weight, with the assumption that EA treatment would be more effective than SA treatment. Previous research conducted in this area has shown that the proportion of patients achieving this level of weight loss is 26% in the EA group and 11% in the SA group, as shown in a previous RCT.16 Sample size calculations were performed using PASS V.15.0 software (NCSS LLC, Utah, USA) which revealed that each group would require 102 cases to achieve a type I error rate of 0.025 (one-sided) and a power of 80% to reach. With a dropout rate of 20%, a total of 256 cases were required, with 128 cases allocated to each group.", "id": 1329, "split": "test"} +{"trial_id": "NCT05237219", "pmid": "35820741", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of HEAT Therapy on patiEnts With Type 2 Diabetes Mellitus (HEATED): Protocol of a Randomized, Two-arm Controlled Trial\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n- Insulin Resistance\n\nStudy Armgroups:\n- {'label': 'Passive heating', 'type': 'EXPERIMENTAL', 'description': 'Patients will be randomized to receive whole-body passive heating via 38\u00b0C natural thermal mineral water baths.', 'interventionNames': ['Procedure: Passive heating']}\n- {'label': 'Thermoneutral', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to the comparator group will dip in thermoneutral natural thermal mineral water (30-32\u00b0C).', 'interventionNames': ['Procedure: Thermoneutral']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Passive heating', 'description': 'Patients will perform baths in 38\u00b0C natural thermal mineral water a maximum of five times per week, over a 12-week period. This will result in a maximum of 60 visits. Each visit will take a maximum of 30 minutes with a physical check-up before and after the bath.', 'armGroupLabels': ['Passive heating']}\n- {'type': 'PROCEDURE', 'name': 'Thermoneutral', 'description': 'Patients will perform baths in 30-32\u00b0C natural thermal mineral water a maximum of five times per week, over a 12-week period. This will result in a maximum of 60 visits. Each visit will take a maximum of 30 minutes with a physical check-up before and after the bath.', 'armGroupLabels': ['Thermoneutral']}\n\nPrimary Outcomes:\n- {'measure': 'Change in hemoglobin A1c level', 'description': 'The absolut changes in the hemoglobin A1c from baseline to 12-weeks between the two groups will be compared.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nDropout rate of 20%, 80% power, and 95% significance level.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size and interim analysis\n The IDMB and the biostatistical specialist calculated the sample size before starting the trial. Based on the systematic literature search, we have chosen the eligible trial articles dealing with heat therapy in patients with T2DM as a reference. Olah et al,16 in a randomised trial on 20 patients with T2DM, found a mean HbA1c change of 1.1% (SD 0.61) in the intervention group and 0.98% (SD 0.52) in the control group after a 3-week follow-up period. On the other hand, based on the study of Hirst et al,35 12 weeks after the intervention, we can assume a 2.54 times higher change in the HbA1c level in both groups.\n Based on this set-up with a dropout rate of 20%, 80% power, and 95% significance level, we calculated a sample size of 65 for both groups. An interim analysis will be performed at 50% of the estimated sample size for the primary outcome. For the reassessment of the intervention duration, the analysis for the primary outcome will be carried out for the 4-week and 8-week HbA1c changes.\n A safety analysis will be performed at 10% of the required sample size.", "id": 1330, "split": "test"} +{"trial_id": "NCT05237583", "pmid": "38925705", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does a Multimodal Prehabilitation Program Improve Markers of Frailty in Patients With Cirrhosis Undergoing Liver Transplantation? A Feasibility Trial\n\nIncluded conditions:\n- Cirrhosis, Liver\n- Liver Transplantation\n- Frailty\n\nStudy Armgroups:\n- {'label': 'Prehabilitation', 'type': 'EXPERIMENTAL', 'description': 'Multimodal prehabilitation program', 'interventionNames': ['Behavioral: Prehabilitation']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prehabilitation', 'description': 'All participants will be offered a multimodal prehabilitation program. This program will include an individualized and supervised aerobic and resistance exercise training program, nutritional optimization, and psychological support. The program will last 6 months or until liver transplantation, whichever comes first.', 'armGroupLabels': ['Prehabilitation']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of the intervention', 'description': 'Proportion of participants that adhere to the intervention protocol', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated; the focus is on feasibility with potential unforeseen obstacles.", "answer": 25, "answer_type": "ESTIMATED", "explanation": "Sample size and timeline\n Due to the feasibility nature of the proposed trial, we propose a convenient sample size of 25 participants using currently available literature.15 23 30 As this is a feasibility study with potential unforeseen obstacles, we expect 30 months to finalise recruitment and completion of the study visits.", "id": 1331, "split": "test"} +{"trial_id": "NCT05237635", "pmid": "35273045", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Defining Decision Thresholds for Judgments on Health Benefits and Harms Using the GRADE Evidence to Decision (EtD) Frameworks: Protocol for a Randomized Methodological Study (GRADE-THRESHOLD)\n\nIncluded conditions:\n- Decision Support Techniques\n- GRADE Approach\n\nStudy Armgroups:\n- {'label': 'Threshold estimates', 'type': 'EXPERIMENTAL', 'description': 'Descriptive case-scenarios', 'interventionNames': ['Other: descriptive case-scenarios']}\n- {'label': 'Alternative threshold estimates', 'type': 'ACTIVE_COMPARATOR', 'description': 'Descriptive case-scenarios', 'interventionNames': ['Other: descriptive case-scenarios']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'descriptive case-scenarios', 'description': \"Each case-scenario will include: (1) a GRADE Summary of Finding (SoF) table providing information about the Population, Intervention, Comparator, Outcome (PICO), the relative and absolute anticipated effects of the intervention, and the certainty in the evidence; (2) a Health Outcome Descriptor describing key attributes of the outcome under consideration including symptoms, time horizon, testing and treatment, and consequences; a measure of the impact on health of the outcome (also known as 'value' of the outcome or 'health utility' in health economics).\", 'armGroupLabels': ['Alternative threshold estimates', 'Threshold estimates']}\n\nPrimary Outcomes:\n- {'measure': 'Small effect of an intervention', 'description': \"Questionnaire: Participants will be asked to indicate which decision threshold for discriminating between EtD judgments of 'Trivial or None' and 'Small' they felt appropriate at the time of participation in the survey.\", 'timeFrame': 'immediate after completion of study'}\n- {'measure': 'Moderate effect of an intervention', 'description': \"Questionnaire:Participants will be asked to indicate which decision threshold for discriminating between EtD judgments of 'Small' and 'Moderate' they felt appropriate at the time of participation in the survey.\", 'timeFrame': 'immediate after completion of study'}\n- {'measure': 'Large effect of an intervention', 'description': \"Questionnaire:Participants will be asked to indicate which decision threshold for discriminating between EtD judgments of 'Moderate' and Large' they felt appropriate at the time of participation in the survey.\", 'timeFrame': 'immediate after completion of study'}\n\nPlease estimate the sample size based on the assumption: \nBased on pilot testing data (n=15 participants)", "answer": 1406, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We based our sample size calculation on the data collected during pilot testing (n=15 participants). Based on this data, we computed the mean thresholds T1, T2 and T3 for each outcome separately and estimated that we need to recruit 1406 survey respondents to demonstrate a difference of 15% of the mean with non-overlapping 95% CIs. These computations were done using Winpepi.16", "id": 1332, "split": "test"} +{"trial_id": "NCT05237999", "pmid": "36765312", "question": "Here is the design of a clinical trial:\n\nOfficial Title: KopOpOuders-PTSD: Randomized Controlled Trial of A Preventive Blended Care Parenting Intervention for Parents With PTSD\n\nIncluded conditions:\n- Post-traumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'Intervention: KopOpOuders-PTSD', 'type': 'EXPERIMENTAL', 'description': \"KopOpOuders-PTSD is a blended care (i.e., partially online and partially in person) intervention that addresses the enhancing of protective factors within the family setting (reducing negative parental self-perceptions; parent-child interaction quality, social support, child adaptive functioning/coping, and child understanding of the parent's illness) from a combination of transdiagnostic and PTSD-specific perspectives. It consists of 8 sessions (5 online self-help modules, 3 in-person sessions with a professional) to be completed in a maximum period of 9 weeks.\", 'interventionNames': ['Behavioral: KopOpOuders-PTSD']}\n- {'label': 'Control: No intervention', 'type': 'NO_INTERVENTION', 'description': 'The control group receives no parenting intervention during their participation.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'KopOpOuders-PTSD', 'description': 'See arm description', 'armGroupLabels': ['Intervention: KopOpOuders-PTSD'], 'otherNames': ['KopOpOuders for PTSD']}\n\nPrimary Outcomes:\n- {'measure': 'Alabama Parenting Questionnaire (APQ)', 'description': \"Parenting skills are measured using the caregiver-report version of the Alabama Parenting Questionnaire (APQ; Frick, 1991). The APQ is a 42-item questionnaire with five subscales: positive involvement with children, supervision/monitoring, use of positive discipline techniques, consistency in discipline techniques, and use of corporal punishment. Responses are scored on a five-point Likert scale ranging from 'never' (1) to 'always' (5). APQ total scores range from 42 to 210. We will recode items so that higher scores reflect more positive parenting. The total score will be used for the main analysis and we will perform additional analyses on the separate subscales. We will use the Dutch translation of the APQ (Van Lier \\\\& Crijnen, 1999).\", 'timeFrame': '2 months'}\n- {'measure': 'Short Parenting Scale for EMA (SPS-EMA)', 'description': \"Parenting behavior is assessed three times a day during two weeks (at baseline and posttest) with an app for ecological momentary assessment (EMA) using eight adapted items from the Parenting Behavior Inventory (PBI; Lovejoy et al., 1999). For this study, we have selected eight items from the PBI, of which four from each subscale (hostile/coercive and supportive/engaged). The wording of these items has been changed slightly to fit with the EMA format (e.g., 'I say mean things to my child that could make him/her feel bad' becomes 'Since the last notification... I have said mean things to my child that could make him/her feel bad'). We have also changed the response scale from seven- to three-point Likert scale: 'Not true' (1), 'Somewhat true' (2), 'Certainly true' (3). We will analyze the total score of the two subscales combined which ranges from 8-24. For this study, we will call this questionnaire the 'Short Parenting Scale for EMA' (SPS-EMA).\", 'timeFrame': '5 hours'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of p = .05, power of 0.80, and 20-25% dropout rate for macro-level outcome. For micro-level outcome, 70% response rate to EMA prompts, autocorrelation of r = 0.30.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Sample size\n We assumed a medium effect size for the primary macro-level outcome (parenting behavior: Alabama Parenting Questionnaire), d\u00e2\u0080\u0089=\u00e2\u0080\u00890.55, based on RCTs with similar designs, interventions and populations as the current study, and with the same primary outcome [21, 82]. With a power of 0.80 and significance level of p\u00e2\u0080\u0089=\u00e2\u0080\u0089.05, the minimum n is 53 per condition. From previous experience with intervention studies in adults with PTSD, we expect 20\u00e2\u0080\u009325% dropout. We therefore corrected with 25% oversampling, resulting in 53/0.75\u00e2\u0080\u0089=\u00e2\u0080\u0089n\u00e2\u0080\u0089=\u00e2\u0080\u008971 per condition, total N\u00c2\u00a0=\u00c2\u00a0142.\n For the primary micro-level outcome (parenting behavior: Short Parenting Scale for EMA), power was calculated using PowerAnalysisIL [83] using our best estimation of relevant parameters. Based on existing EMA literature [84], we assume participants will respond to 70% of the 42 EMA prompts, resulting in 29 complete data points per participant. Assuming an autocorrelation between measurement occasions of r\u00e2\u0080\u0089=\u00c2\u00a00.30 and a medium effect size, minimum sufficient power to detect intervention effects would be reached if n\u00e2\u0080\u0089=\u00c2\u00a032 (16 per condition) agreed to take part in the EMA component of the study.", "id": 1333, "split": "test"} +{"trial_id": "NCT05241951", "pmid": "39740951", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities Using a Pharmacy Integrated Transitional Team\n\nIncluded conditions:\n- Care Transition\n\nStudy Armgroups:\n- {'label': 'Clinical Pharmacist in Transition of Care', 'type': 'EXPERIMENTAL', 'description': 'A clinical pharmacist will be provided as a patient discharges from one of four University of Washington (UW) medical centers to one of 14 post acute skilled nursing facilities randomized to the intervention arm. The coordinating transitional pharmacist will conduct (1) a comprehensive medication review including medication reconciliation, adjustment, and monitoring during the transitional period from hospital to SNF, 2) a structured handoff between clinical teams at the hospital and SNF.', 'interventionNames': ['Other: Structured hand-off', 'Other: Medication reconciliation during transitional period', 'Other: Transitional medication monitoring', 'Other: Teleconsultation']}\n- {'label': 'Patient transitions from hospital to post-acute care', 'type': 'NO_INTERVENTION', 'description': 'Patient will transition from one of four University of Washington (UW) medical centers to one of 14 post-acute skilled nursing facilities randomized to the control arm. Patients will receive the standard discharge process.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Structured hand-off', 'description': 'Use of standardized checklist to provide synchronous or asynchronous handoff that conveys medication recommendations to the SNF clinical teams', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care'], 'otherNames': ['Standardized Checklist']}\n- {'type': 'OTHER', 'name': 'Medication reconciliation during transitional period', 'description': 'Comprehensive medication reconciliation conducted during transitional period between hospital and SNF, focused on SNF-specific requirements for medication delivery (e.g., stop dates, titration instructions)', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}\n- {'type': 'OTHER', 'name': 'Transitional medication monitoring', 'description': 'Review of medication orders during first 7 days of SNF admittance to address barriers to translation of medication orders and appropriate medication delivery', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}\n- {'type': 'OTHER', 'name': 'Teleconsultation', 'description': 'Ad hoc consultation to provide additional clarification to SNF clinical teams', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Medication Related Problems', 'description': 'Number of medication related problems experienced by patients within 30 days post hospital discharge.', 'timeFrame': '30 days post hospital discharge'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for at least 80% statistical power. The intraclass correlation coefficient (ICC) is estimated to be 0.0125 for readmission and less than 0.00001 to 0.027 for death or a composite of unplanned readmission and/or death. The correlation in outcomes between periods ranges from 0 to 0.4.", "answer": 5760, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n Cluster-randomised trials require a larger sample size than trials that randomise individual patients due to a parameter called the intraclass correlation coefficient (ICC). The ICC is a measure of within-cluster variation and expresses the degree to which subjects within a group are related to one another. Data-driven estimates of the ICC in a heart failure study are available for readmission (ICC=0.0125) and death (ICC<0.00001; ICC=0.027 for a composite of unplanned readmission and/or death).33 Readmission is often a direct outcome of MRPs. Since SNFs have patients with a wide range of conditions and comorbidities,34 we expect the ICC in this study to be comparable to, or potentially lower than, what has been observed in prior research focusing on heart failure. We anticipate that 5760 patients will be discharged from 4 hospitals to the 14 participating SNFs during the 3-year intervention period. Based on data from preliminary pilot work, we estimate the baseline rate of the study\u00e2\u0080\u0099s primary outcome (MRP) to be 40%. Given the baseline rates of MRPs in the literature and estimates from prior trials estimating the impact of a pharmacist in improving transitions of care, we anticipate observing a 30% relative reduction in the proportion of MRPs in the intervention arm.1317 18 3336 We used the cpa.did.binary function in the R package \u00e2\u0080\u0098clusterPower\u00e2\u0080\u0099 to estimate the required sample size for various effect sizes. This function estimates the minimum sample size required for a given combination of ICC, number of clusters, and desired statistical power in order to determine a specific difference in difference for binary outcomes37 (table 2). Based on table 2, we aim to enrol at least 1022 patients; 511 in the first period of the study and 511 in the second period to achieve at least 80% statistical power.\n \n Table 2\n \n Sample size requirements to detect effect sizes of a 30% reduction in the MRP rate, assuming a 40% control rate, by ICC range and correlation in MRP rates between the first and second periods of the study (power fixed at 0.80)\n \n \n \n \n Correlation in outcomes between periods\n 0.4\n n=476\n n=532\n n=588\n n=672\n n=784\n n=938\n \n \n \n n=476\n n=532\n n=602\n n=700\n n=826\n n=1036\n \n \n 0.3\n n=476\n n=532\n n=616\n n=728\n n=882\n n=1134\n \n \n \n n=476\n n=546\n n=630\n n=756\n n=952\n n=1274\n \n \n 0.2\n n=476\n n=546\n n=644\n n=784\n n=1022\n n=1442\n \n \n \n n=476\n n=546\n n=658\n n=826\n n=1092\n n=1652\n \n \n 0.1\n n=476\n n=560\n n=672\n n=868\n n=1190\n n=1946\n \n \n \n n=476\n n=560\n n=686\n n=910\n n=1302\n n=2366\n \n \n 0\n n=476\n n=574\n n=714\n n=952\n n=1442\n n=3024\n \n \n \n 0\n 0.01\n 0.01\n 0.02\n 0.02\n 0.03\n \n \n \n \n \n ICCintraclass correlation coefficientMRPmedication-related problem\n \n \n \n \n \nPatientsampling for the primary and secondary outcomes during the first and second periods of the study\n\n At SNFs assigned to the intervention, patients who received all components of the intervention are included in this modified intention-to-treat analysis. The first four patients seen each month at each SNF are included in the analytic sample. If the monthly quota is not met, the remainder is rolled over to the next month. For patients with multiple admissions, the first admission that meets the sampling criteria is included. Should the intervention end earlier than 12 months due to reaching the target sample size, we redistribute the remaining patients (4 \u00c3\u0097 number of months we ended early) at each SNF to previous months as evenly as possible. For the control arm, we sample from the pool of patients seen at the SNF on the same days that the intervention is administered at the SNFs receiving the intervention (ie, only days that the pharmacist is available). Similar to the intervention arm, the first four patients meeting the above criteria each month are selected for analysis, with rollover and first admissions only. With this sampling strategy, we expect to sample 100% of patients from sites with low volume (annual patient discharges <50). Medium-volume sites (50\u00e2\u0080\u0093280 discharges) are expected to have sampling rates ranging from 17% to 98%. Large-volume sites (287\u00e2\u0080\u0093312 discharges) are expected to have sampling rates ranging from 15% to 17%. Due to the cluster-randomised design, sampling additional patients from high-volume sites results in small gains in statistical power.", "id": 1334, "split": "test"} +{"trial_id": "NCT05242614", "pmid": "35854347", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of a Hybrid Face-To-Face and Online Mode of Delivering a Mindfulness-Based Dementia Caregiving Programme for Family Caregivers of Persons With Dementia: A Randomized Controlled Trial\n\nIncluded conditions:\n- Caregiver Burden\n\nStudy Armgroups:\n- {'label': 'A hybrid Mindfulness-based Dementia Caregiving Program (MBDCP)', 'type': 'EXPERIMENTAL', 'description': 'Participants from the experimental group will receive a hybrid Mindfulness-based Dementia Caregiving Program (MBDCP). It is a 6-week program. In the 1st, 2nd and 6th session, it is delivered through face to face, while in the 3rd, 4th and 5th sessions, it will be delivered via online approach.', 'interventionNames': ['Behavioral: The Hybrid Mindfulness-based Dementia caregiving program (MBDCP)']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The family caregivers in the control group will receive 6 week education programme on dementia. It is a control for the social effects of the MBDCP. In the 1st, 2nd and 6th session, it is delivered through face to face, while in the 3rd, 4th and 5th sessions, it will be delivered via online approach.', 'interventionNames': ['Behavioral: Psychoeducation educational program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'The Hybrid Mindfulness-based Dementia caregiving program (MBDCP)', 'description': \"The hybrid MBDCP includes 6 weekly 90-minute group-based sessions delivered through a face-to-face (1st, 2nd, and 6th sessions) and online approach (3rd, 4th, and 5th sessions). The online session is designed for self-directed learning. The MBDCP includes different mindfulness practices (e.g., mindful eating, body scanning, and mindful walking), psychoeducation on caregiving, and group sharing, aimed at helping caregivers to develop mindfulness skills through the formal and informal practice of mindfulness, and to integrate these skills into their everyday life. The duration of each session is 90 minutes. Th MBDCP will be delivered by a qualified mindfulness therapist. In the MBDCP's online sessions, the caregivers will watch a teaching video (e.g., a video demonstrating mindfulness practices) through a website.\", 'armGroupLabels': ['A hybrid Mindfulness-based Dementia Caregiving Program (MBDCP)']}\n- {'type': 'BEHAVIORAL', 'name': 'Psychoeducation educational program', 'description': 'This program serves as a control for the social effects of the MBDCP. The brief education program consists of 6 weekly 90-minutes group sessions in which the sessions (1st, 2nd, and 6th) and (3rd 4th 5th) will be delivered through the face-to-face and online approach respectively, with the similar group size of the MBDCP. The education contents include caregiving skills, education on mood, and group sharing. The program will be led by a nurse.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in perceived Stress scale of caregivers', 'description': 'The change in stress will be measured by the Chinese version of perceived stress scale (Cohen et al., 1983) . The PSS contains 10 items. It is a 5 point Likert scale (1= never, 5=Very often). The total score is ranged from 10 to 50. A higher score indicating higher level of perceived stress', 'timeFrame': 'baseline, immediately after the intervention, 6 month- after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 20% attrition rate at 6 months, 80% power, and a 5% significance level (two-sided).", "answer": 290, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is estimated based on the primary outcome of our study (perceived stress). This proposed study will adopt a simplified version of mindfulness training that differs from the protocol in our prior RCT [25]. Therefore, after considering the effect size of 0.36 in the prior meta-analysis on cognitive behavioural interventions for reducing stress in family caregivers of PWD [29], we adopted a conservative medium effect size of 0.40, which is similar to the effect size of psychological and behavioural interventions suggested by Cohen, to detect the mean difference in stress reduction between the intervention and control groups [30]. Considering the 20% attrition rate at 6\u00c2\u00a0months that we found in our prior study, a sample size of 290 family caregivers (145 per group) is needed to achieve 80% power at 5% significance level (Two-sided). 20 caregivers from the intervention group will be purposively sampled to join in a focus group with a group size of 4 to 5 dyads per group one week after the intervention. After the intervention, equal proportions of participants with different levels (e.g., high, moderate, and low) of stress reduction will be selected.", "id": 1335, "split": "test"} +{"trial_id": "NCT05242692", "pmid": "35914911", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery: a Protocol for Randomized, Double-blinded, placebo-and Positive-controlled, Non-inferiority Trial\n\nIncluded conditions:\n- Postoperative Delirium\n- Elderly Patients\n\nStudy Armgroups:\n- {'label': 'S-ketamine', 'type': 'EXPERIMENTAL', 'description': 'S-ketamine (50 mg, 2 ml) is diluted to 50 ml (1 mg/ml) with 48 ml normal saline;', 'interventionNames': ['Drug: S-ketamine']}\n- {'label': 'Dexmedetomidine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Dexmedetomidine (200 ug, 2 ml) is diluted to 100 ml (2 ug/ml) with 98 ml normal saline;', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Normal saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'Control group only contains 50 ml normal saline in light of blindness', 'interventionNames': ['Drug: Normal saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'S-ketamine', 'description': 'Loading dose: 0.25mg/kg in 10 minutes Maintenance dose: 0.1mg/kg/h', 'armGroupLabels': ['S-ketamine']}\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Loading dose: 0.2 ug/kg in 10 minutes Maintenance dose: 0.2 ug/kg/h', 'armGroupLabels': ['Dexmedetomidine']}\n- {'type': 'DRUG', 'name': 'Normal saline', 'description': 'Refer to either S-ketamine or Dexmedetomidine', 'armGroupLabels': ['Normal saline']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Patients With Post-operative Delirium in 4 Days After Surgery', 'description': '3-minute Diagnostic Confusion Assessment Method (3D-CAM)', 'timeFrame': 'Within 4 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided type I error of 5%, 80% power, and a 5% dropout rate.", "answer": 780, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated for the main outcome, the incidence of POD, using PASS software V.11.0. Based on previous studies and our recently completed data, we estimated that the incidence of POD in elderly patients undergoing non-cardiac thoracic surgery was 40%.12 42\u00e2\u0080\u009346 Assuming that dexmedetomidine is associated with a 40% relative reduction in the incidence of POD, the non-inferiority margin rate ratio (RR) of S-ketamine versus dexmedetomidine will be set at 1.5.15 27 47 48 To achieve a two-sided type I error of 5% and 80% power, 729 participants (243 patients per arm) will be recruited. To accommodate a 5% dropout rate, the final sample size will be 780 (260 patients per arm).", "id": 1336, "split": "test"} +{"trial_id": "NCT05244512", "pmid": "37580090", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Online Training to Improve Evidence-based Leadership Competencies Among Nurse Leaders in Finland: Study Protocol for a Randomised Feasibility Trial (EVILED-FI)\n\nIncluded conditions:\n- Leadership\n\nStudy Armgroups:\n- {'label': 'Evidence-based leadership training', 'type': 'EXPERIMENTAL', 'description': \"The training course will take 6 months. It is divided into seven online modules. Participants join the course based on pre-structured schedule. The progress of the training course will follow specific steps to improve participants' evidence-based leadership competencies. First, each participant identifies one leadership problem on daily practice. Second, organisational data will be collected and analysed to increase the understanding of the key problem. Third, scientific literature will be searched, identified and critically appraised to find solutions. Fourth, the views of stakeholders (patients, clinicians, family members, etc.) are considered together with ethical implications. And last, all sources of information are critically appraised, new solution will be designed and implemented into the practice, and evaluated in real world context. Each module includes specific learning material. Trained tutors are responsible for mentoring each module.\", 'interventionNames': ['Other: Evidence-based leadership training']}\n- {'label': 'Conventional training', 'type': 'ACTIVE_COMPARATOR', 'description': 'The participants will join a training course with the same structure, topics, and timing as the experimental group. However, training in this group is based on independent learning methods. The participants have access to the separate learning platform, which includes reading material to be read independently. No group discussions with peers, self-reflection, assignments, or support from tutors will be offered.', 'interventionNames': ['Other: Conventional training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Evidence-based leadership training', 'description': \"7-modules online training over six months mentored by tutors. Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback.\", 'armGroupLabels': ['Evidence-based leadership training']}\n- {'type': 'OTHER', 'name': 'Conventional training', 'description': '7-modules online training over six months. Independent reading only.', 'armGroupLabels': ['Conventional training']}\n\nPrimary Outcomes:\n- {'measure': 'Acceptability of the intervention', 'description': 'The degree of execution (success and failure of execution) of the intervention protocol by calculating the number of logins for each module and all participants', 'timeFrame': '6 months'}\n- {'measure': 'Adherence in the course', 'description': 'Adherence in the course by calculating the number of returned course tasks out of all possible tasks', 'timeFrame': '6 months'}\n- {'measure': 'Adherence in the course tasks', 'description': 'Adherence in the course by calculating the number of returned course tasks by each participant', 'timeFrame': '6 months'}\n- {'measure': 'Drop-out rate', 'description': 'The drop-out rate calculated by the number of participants who left the study early (no follow-up data)', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha level of 0.05, a test power of 90%, and a significance level of 5%.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n As this will be a feasibility study, a formal sample size calculation will not be performed for the feasibility outcomes. We will invite 140 nurse leaders in Finland and 160 in China, observe the success of the recruitment with these numbers.\n For the future purposes, the study would be powered for the leadership skills. We systematically searched for but have been unable to find any directly relevant published work. Gafni Lachter and Ruland53 evaluated the effects of peer-mentoring to promote professional and leadership skills using the Multifactor Leadership Questionnaire (MLQ, 45 items). Their study showed that improvement in leadership skills was found pre\u00e2\u0080\u0093post assessment, before and after the intervention (MLQ pre-test mean 2.51 (SD 0.32), post-test mean 2.70 (SD 0.26), F 15.394, p<001). Based on their study, a sample size of 76 was suggested with a 90% power at a 5% significant level (Software PASS V.11). For our possible intervention effect as a full trial, based on the sample size calculation, assuming an effect size of 0.50 for the primary outcome, an alpha level of 0.05 and a test power of 90%, a total sample size of 140 randomised participants might be needed (Software PASS V.11). Some indirect measures from previous studies described above suggest that, if successful in recruitment, our sample of 140 collected separately in both countries might be large enough to show the effectiveness of the intervention. If not successful, the results of our feasibility study can still be used as groundwork of the power calculation for the main study.", "id": 1337, "split": "test"} +{"trial_id": "NCT05245474", "pmid": "37699634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)\n\nIncluded conditions:\n- Locally Advanced Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'CRT+concurrent PD-1 inhibition (Experiment Arm 1)', 'type': 'EXPERIMENTAL', 'description': 'Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n- {'label': 'CRT+sequential PD-1 inhibition (Experiment Arm 2)', 'type': 'EXPERIMENTAL', 'description': 'Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n- {'label': 'CRT without PD-1 inhibition (Control Arm)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)', 'description': 'Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3', 'armGroupLabels': ['CRT without PD-1 inhibition (Control Arm)', 'CRT+concurrent PD-1 inhibition (Experiment Arm 1)', 'CRT+sequential PD-1 inhibition (Experiment Arm 2)']}\n\nPrimary Outcomes:\n- {'measure': 'pCR rate', 'description': 'pathological complete response rate', 'timeFrame': 'within 10 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1=0.05 (two-sided significance level), \u03b2=0.2 (power), Drop-out rate=0.15", "answer": 186, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Calculation of sample size\n As a parallel group, superiority trial, sample size calculation is performed with the TEST FOR TWO PROPORTION function of PASS software (V.21.0.3), with the parameters set as follows:\n \n \n p1=0.4 (assuming the pCR rate of both experiment arms to be 40%, considering current evidences).\n \n \n p2=0.16 (assuming the pCR rate of control arms to be 16%, considering the actual pCR rates of participating centres).\n \n \n \u00ce\u00b1=0.05 (two-sided).\n \n \n \u00ce\u00b2=0.2.\n \n \n Drop-out rate=0.15.\n \n \n On calculation, each arm requires 62 patients, totalling 186 patients.", "id": 1338, "split": "test"} +{"trial_id": "NCT05245474", "pmid": "37699634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)\n\nIncluded conditions:\n- Locally Advanced Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'CRT+concurrent PD-1 inhibition (Experiment Arm 1)', 'type': 'EXPERIMENTAL', 'description': 'Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n- {'label': 'CRT+sequential PD-1 inhibition (Experiment Arm 2)', 'type': 'EXPERIMENTAL', 'description': 'Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n- {'label': 'CRT without PD-1 inhibition (Control Arm)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)', 'description': 'Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3', 'armGroupLabels': ['CRT without PD-1 inhibition (Control Arm)', 'CRT+concurrent PD-1 inhibition (Experiment Arm 1)', 'CRT+sequential PD-1 inhibition (Experiment Arm 2)']}\n\nPrimary Outcomes:\n- {'measure': 'pCR rate', 'description': 'pathological complete response rate', 'timeFrame': 'within 10 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1=0.05 (two-sided significance level), \u03b2=0.2 (power), Drop-out rate=0.15", "answer": 186, "answer_type": "ESTIMATED", "explanation": "Calculation of sample size\n As a parallel group, superiority trial, sample size calculation is performed with the TEST FOR TWO PROPORTION function of PASS software (V.21.0.3), with the parameters set as follows:\n \n \n p1=0.4 (assuming the pCR rate of both experiment arms to be 40%, considering current evidences).\n \n \n p2=0.16 (assuming the pCR rate of control arms to be 16%, considering the actual pCR rates of participating centres).\n \n \n \u00ce\u00b1=0.05 (two-sided).\n \n \n \u00ce\u00b2=0.2.\n \n \n Drop-out rate=0.15.\n \n \n On calculation, each arm requires 62 patients, totalling 186 patients.", "id": 1339, "split": "test"} +{"trial_id": "NCT05245474", "pmid": "37699634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)\n\nIncluded conditions:\n- Locally Advanced Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'CRT+concurrent PD-1 inhibition (Experiment Arm 1)', 'type': 'EXPERIMENTAL', 'description': 'Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n- {'label': 'CRT+sequential PD-1 inhibition (Experiment Arm 2)', 'type': 'EXPERIMENTAL', 'description': 'Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n- {'label': 'CRT without PD-1 inhibition (Control Arm)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6\\\\~12 weeks after completion of radiation.', 'interventionNames': ['Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)', 'description': 'Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3', 'armGroupLabels': ['CRT without PD-1 inhibition (Control Arm)', 'CRT+concurrent PD-1 inhibition (Experiment Arm 1)', 'CRT+sequential PD-1 inhibition (Experiment Arm 2)']}\n\nPrimary Outcomes:\n- {'measure': 'pCR rate', 'description': 'pathological complete response rate', 'timeFrame': 'within 10 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1=0.05 (two-sided significance level), \u03b2=0.2 (power), Drop-out rate=0.15", "answer": 186, "answer_type": "ESTIMATED", "explanation": "Reasons for mid-way sample size expansion\n In our initial sample size calculation, we assumed p2 to be 0.10 based on the regular pCR rate of chemoradiation in the primary centre (Beijing Friendship Hospital). However, after the first routine multicentre investigator meeting, where the regular pCR rate of the control group was discussed, consensus was reached that 0.16 is more representative as the pCR rate of the control group.21 Therefore, we revised the protocol and changed p2 from 0.10 to 0.16.\n Along with p2, we also revised the value of \u00ce\u00b1, \u00ce\u00b2 and drop-out rate: \u00ce\u00b1 was revised from 0.05 (one-sided) to 0.05 (two-sided) to reduce false positive rate; \u00ce\u00b2 was revised from 0.1 to 0.2 for the fact that setting power to 0.8 was a common practice, and a power of 0.9 was unnecessary; drop-out rate was revised from 0.20 to 0.15 for the fact that the primary endpoint of this study (pCR rate) is a short-term endpoint, a drop-out rate of 0.20 (as in those studies with 3-year or 5-year endpoints) was considered highly unlikely.\n After recalculation, sample size was expanded from 120 to 186. Revision of study protocol and update of online registry information are completed on 10 May 2023, while enrolment is still ongoing.", "id": 1340, "split": "test"} +{"trial_id": "NCT05249088", "pmid": "36854601", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial\n\nIncluded conditions:\n- Shock, Septic\n\nStudy Armgroups:\n- {'label': 'Protocolised reduction of non-resuscitation fluids', 'type': 'EXPERIMENTAL', 'description': 'Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days.', 'interventionNames': ['Other: Protocolised reduction of non-resuscitation fluids']}\n- {'label': 'Usual Care', 'type': 'OTHER', 'description': 'Participants receive non-resuscitation fluids according to local routines.', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Protocolised reduction of non-resuscitation fluids', 'description': '* Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated\\n* Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances\\n* Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice\\n* Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this\\n* Parenteral nutrition is administered according to local protocol\\n* Intravenous medications are concentrated according to a predefined protocol\\n* Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that total dose of fluids covers the daily need of water (about 1ml/kg/h)', 'armGroupLabels': ['Protocolised reduction of non-resuscitation fluids']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Participants receive non-resuscitation fluids according to local routines, with the following stipulations:\\n\\n* Maintenance fluids (crystalloids and/or glucose and/or enteral water) are given at a dose of 1 ml/kg/h unless local protocol states otherwise\\n* Glucose is used at maximal concentration of 10% unless local protocol states otherwise.\\n* Medications are concentrated according to local protocol', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in fluid administration', 'description': 'Total difference in litres of administered fluids between groups', 'timeFrame': 'Within the first three days after inclusion (days 0-3)'}\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 90%. To account for non-normal data distribution, 15% more participants than the calculated sample size will be included. The trial will have a power of 11%-29% to detect relevant treatment effects on primary exploratory clinical outcomes.", "answer": 98, "answer_type": "ACTUAL", "explanation": "Sample size and feasibility thresholds\n Data from our previous study suggest that total volume of fluids may be reduced by a median of 3.12 (IQR: 1.50\u00e2\u0080\u00934.95) L in the first 3\u00e2\u0080\u0089days after ICU admission by restrictive administration of non-resuscitation fluids in Swedish ICUs (see online supplemental appendix D for further details on the modelling).16 We believe that a median reduction in total volume of fluids in the first 3\u00e2\u0080\u0089days of ICU admission above 2 L may have an impact on outcome. To detect a difference of 2 L with an SD of 2.8 L, with an alpha of 0.05, and a power of 90% we need 42 participants in each arm. To account for data not being normally distributed, we aim to include 15% more participants than the calculated sample size using a conventional rule-of-thumb.26 Thus, we aim to include 49 participants in each arm resulting in a total sample size of 98 participants. We will encourage all participating centres to randomise at least 10 participants.\n Feasibility thresholds for the secondary feasibility outcomes will be as follows:\n \n \n The proportion of participants with outcome data on all-cause mortality, days alive without mechanical ventilation, acute kidney injury and ischaemic events in the ICU within 90 days of inclusion, should be more than 95% corresponding to a CI of 89%\u00e2\u0080\u009398% (1-sample proportions test).\n \n \n The proportion of surviving participants who were assessed by EQ-5D-5L and MoCA should be more than 85% of survivors based on a predicted all-cause mortality of 45%1\u00e2\u0080\u00935 corresponding to a CI of 73%\u00e2\u0080\u009392%.\n \n \n The proportion of eligible patients who were randomised and consented should be more than 75% corresponding to a CI of 67%\u00e2\u0080\u009381%.\n \n \n The proportion of participants experiencing at least one protocol violation should be less than 10% corresponding to a CI of 6%\u00e2\u0080\u009318%.\n \n \n Each feasibility outcome will be investigated for possible optimisation for a future pragmatic trial, especially if the feasibility threshold is not reached in this trial.\n This trial will have a power of 11%\u00e2\u0080\u009329% to detect relevant treatment effects on the primary exploratory clinical outcomes. Analysis results including effect estimates will be interpreted with caution and as hypothesis generating only.", "id": 1341, "split": "test"} +{"trial_id": "NCT05249192", "pmid": "36414969", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial\n\nIncluded conditions:\n- Surgical Complication\n- Colonic Disease\n- Postoperative Complications\n- Urinary Retention Postoperative\n- Urinary Tract Infections\n\nStudy Armgroups:\n- {'label': 'Immediate UC removal', 'type': 'EXPERIMENTAL', 'description': 'Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.', 'interventionNames': ['Device: Immediate urinary catheter removal']}\n- {'label': 'Early UC removal', 'type': 'ACTIVE_COMPARATOR', 'description': 'Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol', 'interventionNames': ['Device: Early urinary catheter removal']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Immediate urinary catheter removal', 'description': 'Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.', 'armGroupLabels': ['Immediate UC removal']}\n- {'type': 'DEVICE', 'name': 'Early urinary catheter removal', 'description': 'urinary catheter removal on the first postoperative day (6 a.m)', 'armGroupLabels': ['Early UC removal']}\n\nPrimary Outcomes:\n- {'measure': 'Acute urinary retention rate', 'description': 'Occurrence of urinary retention after removal of urinary catheter', 'timeFrame': '3 days postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes 80% power, a 5% significance level, and an 8% dropout rate.", "answer": 216, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The null hypothesis is that the immediate UC removal is significantly inferior to the 24-h UC removal. Based on the current literature, in order to test the alternative hypothesis of non-inferiority of immediate UC removal vs. 24-h UC removal, the sample size is calculated using the incidence of AUR. Available data show that the AUR rate can be estimated as high as 3% after MICR [14\u00e2\u0080\u009316].\n Sample size was calculated based on the following data. Considering an expected AUR rate of 3% (p1) for the 24-h UC removal group, we choose the non-inferiority limit of \u00ce\u00b4 = 6% with \u00ce\u00b4 = p2-p1, considering acceptable a p2 of 9% for the immediate UC removal group. We calculated that 200 patients are required in each group to give 80% power at a 5% significance level. Considering 8% dropout, the total number of patients to be enrolled is 216, 108 per group (Non-Inferiority Tests for the Difference Between Two Proportions, PASS 14)", "id": 1342, "split": "test"} +{"trial_id": "NCT05253651", "pmid": "39723627", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer\n\nIncluded conditions:\n- Colorectal Neoplasms\n\nStudy Armgroups:\n- {'label': 'Tucatinib Arm', 'type': 'EXPERIMENTAL', 'description': 'Tucatinib + trastuzumab + mFOLFOX6', 'interventionNames': ['Drug: tucatinib', 'Drug: trastuzumab', 'Drug: oxaliplatin', 'Drug: leucovorin', 'Drug: levoleucovorin', 'Drug: fluorouracil']}\n- {'label': 'Standard of Care Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab', 'interventionNames': ['Drug: bevacizumab', 'Drug: cetuximab', 'Drug: oxaliplatin', 'Drug: leucovorin', 'Drug: levoleucovorin', 'Drug: fluorouracil']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'tucatinib', 'description': '300mg given by mouth (orally) twice daily', 'armGroupLabels': ['Tucatinib Arm'], 'otherNames': ['TUKYSA, ONT-380, ARRY-380, PF-07265792']}\n- {'type': 'DRUG', 'name': 'trastuzumab', 'description': '8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.', 'armGroupLabels': ['Tucatinib Arm'], 'otherNames': ['Herceptin']}\n- {'type': 'DRUG', 'name': 'bevacizumab', 'description': '5mg/kg given by IV every 2 weeks', 'armGroupLabels': ['Standard of Care Arm'], 'otherNames': ['Avastin']}\n- {'type': 'DRUG', 'name': 'cetuximab', 'description': '400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly', 'armGroupLabels': ['Standard of Care Arm'], 'otherNames': ['Erbitux']}\n- {'type': 'DRUG', 'name': 'oxaliplatin', 'description': '85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.', 'armGroupLabels': ['Standard of Care Arm', 'Tucatinib Arm']}\n- {'type': 'DRUG', 'name': 'leucovorin', 'description': '400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.', 'armGroupLabels': ['Standard of Care Arm', 'Tucatinib Arm']}\n- {'type': 'DRUG', 'name': 'levoleucovorin', 'description': '200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.', 'armGroupLabels': ['Standard of Care Arm', 'Tucatinib Arm']}\n- {'type': 'DRUG', 'name': 'fluorouracil', 'description': '400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.', 'armGroupLabels': ['Standard of Care Arm', 'Tucatinib Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)', 'description': 'The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause', 'timeFrame': 'Up to approximately 3 years'}\n\nPlease estimate the sample size based on the assumption: \nexponential distribution of PFS, 28 months of patient accrual, 5% annual dropout rate", "answer": 400, "answer_type": "ESTIMATED", "explanation": "3.4.\n Sample size determination\n This study is designed to detect a tucatinib treatment effect of at least a 33% reduction in the risk of progression or death. Approximately 400 patients will be randomized 1:1 to either treatment arm. After approximately 40\u00e2\u0080\u0089months, the total number of events observed is expected to be sufficient to determine a tucatinib treatment effect, assuming exponential distribution of PFS, 28\u00e2\u0080\u0089months of patient accrual, and a 5% annual dropout rate.", "id": 1343, "split": "test"} +{"trial_id": "NCT05253716", "pmid": "37041057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer\n\nIncluded conditions:\n- Stage III Gastric Cancer\n\nStudy Armgroups:\n- {'label': 'immune nutrition support', 'type': 'EXPERIMENTAL', 'description': 'In the immune nutrition support group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil after discharge lasted for 6 months.', 'interventionNames': ['Other: ONS']}\n- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'In the control group, patients will receive nutrition counseling in addition to diet.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ONS', 'description': 'Immunonutritional supplement', 'armGroupLabels': ['immune nutrition support'], 'otherNames': ['fish oil']}\n\nPrimary Outcomes:\n- {'measure': '3-year disease free survival after discharge', 'description': 'from date of randomization to disease recurrence or death', 'timeFrame': 'up to 3 years'}\n\nPlease estimate the sample size based on the assumption: \nStudy power of 80%, alpha error level at two tails of 5%, and a dropout rate of 5%.", "answer": 696, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated according to the primary endpoint using PASS V.15.0 software (NCSS, Kaysville, Utah, USA). Based on relevant data available in the previous literature, the 3-year DFS after total gastrectomy for stage III GC was 36.2%.36 Assuming this type of patient received only nutritional counselling in the control group, the 3-year DFS was similar, that is, 36%. Taking into account a study power of 80%, an alpha error level at two tails of 5%, and an expected 3-year DFS of 46% in the INS group, 696 patients (348 in each group) will have to be enrolled to allow for a dropout rate of 5% or withdrawal.", "id": 1344, "split": "test"} +{"trial_id": "NCT05255250", "pmid": "36549741", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PLAYshop: A Parent-focused Physical Literacy Intervention for Early Childhood\n\nIncluded conditions:\n- Motor Activity\n- Parent-Child Relations\n- Child Development\n\nStudy Armgroups:\n- {'label': 'PLAYshop Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a 60 minute virtual physical literacy workshop, an equipment goody-bag with basic play equipment and printed resources, and access to a digital app with an online toolkit and four bi-weekly boosters lessons.', 'interventionNames': ['Behavioral: PLAYshop']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive the 60 minute virtual physical literacy workshop, equipment goody-bag, and access to the digital app after completing 2-month follow-up measures.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PLAYshop', 'description': 'The intervention includes: 1. Educational Training - the 60 min virtual workshop will be delivered by a trained facilitator. Parents will be introduced to physical literacy via education, group discussion, and active participation in fundamental movement skills (FMS) based activities with their child. 2. Distribution of Education Resources- Parents will be sent physical literacy and physical activity printed resources. 3. Material resources -parents will also be provided a bag of inexpensive active play equipment (e.g., ball, bean bag, balloons). 4. Provide Follow-up Support- After the workshop, participants will gain access to an app with an online toolkit including new active play ideas, tips, and equipment they can make at home for active play. Additionally, participants will receive four bi-weekly booster lessons that include key workshop messages, support and encouragement for parents, reflection and check-in questions, and new activities to try with their child.', 'armGroupLabels': ['PLAYshop Intervention']}\n\nPrimary Outcomes:\n- {'measure': \"Change in children's physical literacy (fundamental movement skills)\", 'description': \"Children's fundamental movement skills, including two manipulative skills (i.e., overhand throw, underhand throw), two locomotor skills (i.e., horizontal jump, hop), and one balance/stability skill (i.e., one leg balance), will be assessed in a recorded virtual meeting. The skills are from the Test of Gross Motor Development (TGMD) and the Movement Assessment Battery for Children-Second Edition (MABC-2).\", 'timeFrame': 'Baseline and 2 month follow-up'}\n- {'measure': \"Change in children's physical literacy (motivation and enjoyment; parental report)\", 'description': \"Children's motivation and enjoyment will be assessed via a parental questionnaire that includes items from the Preschool Physical Literacy Assessment (Pre PLAy). This scale includes 4 items with values of 1-5; higher values mean more motivation and enjoyment. Citation: Cairney et al. (2018)\", 'timeFrame': 'Baseline and 2 month follow-up'}\n- {'measure': \"Change in children's physical literacy (enjoyment; child report)\", 'description': \"Children's enjoyment will also be assessed via self-report using an adapted Five Degrees of Happiness Likert scale for children. This scale includes 1 item with a value of 1-5; a higher value means more enjoyment. Citation: Hall et al. (2016)\", 'timeFrame': 'Baseline and 2 month follow-up'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of 0.05, and 30% lost to follow-up/missing data.", "answer": 130, "answer_type": "ACTUAL", "explanation": "Statistical analyses and sample size calculation\n Using established procedures, missing outcome data will be evaluated for pattern of missingness (eg, missing at random, missing completely at random) and the corresponding strategy will be used to address it.40 41 Intention-to-treat analyses will be performed in addition to sensitivity analyses. Cronbach\u00e2\u0080\u0099s alphas (\u00ce\u00b1) will be calculated for outcome variables with multiple items. Descriptive statistics will be used to describe the study sample. Additional analyses will be conducted to compare: (1) adherers to the study versus drop-outs and (2) baseline variables between intervention and control groups. For the primary outcomes, which have two time points (ie, baseline and 2-month follow-up), the efficacy of the intervention will be tested with a doubly multivariate analysis of covariance (MANCOVA) repeated measures test, covarying for baseline values or covariates if needed. If the omnibus test is significant, a series of analysis of covariance (ANCOVA) repeated measures tests will be conducted for each primary outcome, covarying for baseline values or covariates if needed. For the secondary outcomes, which have two time points (ie, baseline and 2-month follow-up), specifically children\u00e2\u0080\u0099s physical activity and parent\u00e2\u0080\u0093child coparticipation in physical activity, the efficacy of the intervention will be tested using a series of ANCOVA repeated measures tests, covarying for baseline values or covariates if needed. Separate testes will be conducted for each outcome variable. For tertiary outcomes that have three time points (ie, baseline, 1\u00e2\u0080\u00932\u00e2\u0080\u0089weeks follow-up, 2 week follow-up), specifically parental capability, opportunity and motivation to support preschool-aged children\u00e2\u0080\u0099s physical literacy development, the efficacy of the intervention will be tested using a series of ANCOVA repeated measures tests, covarying for baseline values or covariates if needed. Separate testes will be conducted for each outcome variable. Tests will be accompanied by effect size estimations for use in future proposals. Additionally, descriptive analyses will be conducted for parental satisfaction and perceived usefulness as well as app data on dose.\n With a sample size of 130 participants (65 intervention, 65 control), we will have 80% power to detect a medium effect size f=0.31 (approximately d=0.60) at a probability of 0.05, for an MANCOVA interaction.42 43This effect size is estimated from a previous childcare physical activity intervention in preschoolers that included fundamental movement skills as a secondary outcome.44 Sample size calculations account for 30% lost to follow-up/missing data based on our previous work, including a parent\u00e2\u0080\u0093child accelerometer study.15 45\n Each semistructured interview will be digitally recorded and verified by the family within 1\u00e2\u0080\u0089week of the interview, then it will be uploaded into NVivo for analysis. Data will be inductively analysed following the process recommended for multidisciplinary health research.46 47 First, the research coordinator will work through the complete data set and generate preliminary codes and categories via independent, open coding of each interview.47 Second, a team member will review a partial data set to assist in finalising the working analytical framework.46 Each interview will be coded twice and categories and text units will be reviewed to explore subcategories. The research team will discuss and reach negotiated consensus regarding any controversial categorisations. Where possible, data will be charted into a matrix in NVivo to support interpretation of causes, consequences and relationships.47 Lastly, final themes and interpretive concepts will be generated to describe or explain the data.", "id": 1345, "split": "test"} +{"trial_id": "NCT05257876", "pmid": "36517097", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Pain\n- Breast Neoplasms\n- Cancer Survivors\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.', 'interventionNames': ['Other: Breathing exercise']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will receive pain information booklet and usual care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Breathing exercise', 'description': 'Participants will receive breathing exercise training, and a 4-week self exercise', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility: Time taken to recruit planned sample', 'description': 'The time that was taken to recruit the planned sample size of participants', 'timeFrame': 'Immediately after the allocation of the last subject'}\n- {'measure': 'Feasibility: Referral rate', 'description': 'The number of referrals made by clinicians in different departments divided by all referrals', 'timeFrame': 'Immediately after the referral of the last subject'}\n- {'measure': 'Feasibility: Recruitment rate', 'description': 'Proportion of subjects who participated in the study from all subjects eligible for participation', 'timeFrame': 'Immediately after the recruitment of the last subject'}\n- {'measure': 'Feasibility: Retention rate', 'description': 'Proportion of participants who completed the whole study divided by all subjects who enrolled in the study', 'timeFrame': 'At the follow-up assessment 4 weeks after the intervention completion (T3)'}\n- {'measure': 'Feasibility: Dropout rate', 'description': 'The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study', 'timeFrame': 'At the follow-up assessment 4 weeks after the intervention completion (T3)'}\n- {'measure': 'Reasons for dropping out', 'description': 'Feedback from the dropout subjects to identify their reasons for dropping out', 'timeFrame': 'Immediately once a dropout occurs'}\n- {'measure': 'Feasibility of the questionnaires', 'description': 'The percentage of missing values for each item of the scales used, including the Brief Pain Inventory (BPI), Quality of life Cancer Survivors Version (QOL-CSV), Functional Assessment Cancer Therapy-Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'At baseline (T1), immediately after the completion of the 4-week intervention (T2), and the follow-up assessment at 4 weeks after the intervention completion (T3)'}\n- {'measure': 'Feasibility: Adherence rates', 'description': 'the percentage of BE sessions performed by participants divided by the total number of BE sessions required', 'timeFrame': 'Immediately after completion of the 4-week intervention (T2)'}\n- {'measure': \"Participants' feedback\", 'description': \"Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form\", 'timeFrame': 'Immediately after completion of the 4-week intervention (T2)'}\n- {'measure': 'Adverse events associated with the intervention', 'description': \"Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact\", 'timeFrame': 'Immediately once an adverse event occurs'}\n\nPlease estimate the sample size based on the assumption: \nA potential dropout rate of 20% is considered.", "answer": 72, "answer_type": "ACTUAL", "explanation": "Participants and sample size\n Potential participants need to meet the inclusion criteria to be recruited: (1) female patients \u00e2\u0089\u00a518 years age; (2) has a confirmed diagnosis of breast cancer from stage I to IIIa; (3) has been experiencing pain since cancer diagnosis constantly or intermittently for \u00e2\u0089\u00a53 months, with the average pain intensity in the last 7 days on a numerical scale \u00e2\u0089\u00a54/10 (\u00e2\u0080\u00980\u00e2\u0080\u0099 means no pain and \u00e2\u0080\u009810\u00e2\u0080\u0099 means the worst pain); (4) has completed active anticancer treatment (such as surgery, chemotherapy, radiotherapy) for at least 3 months; (5) agrees to participate in the study and are willing to sign the informed consent and (6) can read and understand Mandarin Chinese.\n Potential participants who meet any of the following exclusion criteria will be excluded: (1) extremely weak and unable to perform the BE; (2) mentally incapable (ie, unable to follow the study instructions); (3) has scheduled treatment plan which may affect the pain experience, such as having a procedure or an operation; (4) receiving other non-pharmacological pain relief treatments, such as acupuncture, yoga, qigong, exercise programme and so on and (5) has any pre-existing chronic pain conditions prior to cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, complex regional pain syndrome, endometriosis and so on. If the participants are unable to provide a detailed medical history, the information will be collected from their hospital medical records after they have signed the study consent form.\n As the primary focus of this study is to assess the feasibility and acceptability of the RCT\u00e2\u0080\u0099s methodological procedures, intervention protocol and questionnaires, a power-based sample size estimation was deemed unnecessary.51 Having 30 participants per study group is considered reasonable and sufficient for estimation of between-group comparison and effect size in a pilot study.52 Thus, the study aims to recruit 30 participants in each group. Considering a potential dropout rate of 20% during the pilot trial process,53 therefore, the total sample size for this study will be 72, with 36 subjects in each group.", "id": 1346, "split": "test"} +{"trial_id": "NCT05258578", "pmid": "36109026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients to Manage COVID-19 Pandemic Related Mental Health and Distress (TELE-BARICARE): A Randomized Controlled Trial to Determine Effectiveness and Adaptation for Marginalized Populations\n\nIncluded conditions:\n- Obesity\n- Bariatric Surgery Candidate\n- Mental Health Disorder\n- Eating Disorders\n\nStudy Armgroups:\n- {'label': 'Tele-CBT Group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 6 weekly Tele-CBT sessions and 1 final \"booster\" session 1 month later, all approximately 55-minutes in duration. Briefly, the Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets). Five clinical psychology graduate students will work as study therapists under the supervision of Drs. Cassin and Sockalingam and will have biweekly case supervision meetings.', 'interventionNames': ['Behavioral: Tele-CBT']}\n- {'label': 'Self-Help Resources Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation. Participants in the control arm will receive weekly check-in/reminder emails for the duration of the intervention period.', 'interventionNames': ['Other: Self-Help Resources']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Tele-CBT', 'description': 'The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets).', 'armGroupLabels': ['Tele-CBT Group']}\n- {'type': 'OTHER', 'name': 'Self-Help Resources', 'description': 'Participants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation.', 'armGroupLabels': ['Self-Help Resources Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Binge Eating Scale', 'description': 'The investigators will assess change in Binge Eating Scale (BES) scores at post-intervention and at 3-month follow-up compared to baseline. The BES is a 16-item self-report measure designed specifically for use with individuals with obesity and assesses the presence of binge eating characteristics indicative of an eating disorder. Scores on the BES range from 0 to 46 with moderate and severe levels of binge eating corresponding to cut-off scores of 18 and 27, respectively.', 'timeFrame': 'Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)'}\n- {'measure': 'Change in Patient Health Questionnaire-9 Item Scale', 'description': 'The investigators will assess change in Patient Health Questionnaire-9 Item Scale (PHQ-9) scores at post-intervention and at 3-month follow-up compared to baseline. The PHQ-9 consists of 9-items assessing depressive symptoms on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the PHQ-9 range from 0 to 27 with mild, moderate, moderately severe and severe levels of depressive symptoms corresponding to cut-off scores of 5, 10, 15 and 20, respectively.', 'timeFrame': 'Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed to achieve at least 80% power for each primary endpoint, with a significance level (\u03b1) of 0.025 per endpoint to account for multiple testing. An attrition rate of ~15% is assumed based on prior RCT data.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size and power considerations\n The trial is powered to achieve at least 80% power to test each of the multiple primary endpoints (BES and PHQ-9). To account for ~15% patient attrition (as observed in our prior RCT), a total of N=140 participants (N=70 per arm) will be enrolled and randomised to ensure we have complete data on N=118 participants. The significance level (\u00ce\u00b1) is set at 0.025 per multiple primary endpoint to account for two statistical tests. A total of N=118 participants (N=59 per arm) will achieve 80.0% power to detect a difference of mean changes of \u00e2\u0088\u00923.1 between arms for BES, with a SD of 7.5 at preintervention and postintervention, and a correlation between measurement pairs of \u00cf\u0081=0.744. This sample size will achieve 96.2% power to detect a difference of mean changes of \u00e2\u0088\u00923.4 between arms for PHQ-9, with SD=5.0\u00e2\u0080\u0089and \u00cf\u0081=0.597. The proposed effect sizes, SD and correlation between measurement pairs were estimated from the preliminary results in our current RCT.22 While the trial is powered to detect differences in the multiple primary endpoints, a sample size of N=118 participants will achieve \u00e2\u0089\u00a590% power to detect differences in each of the secondary endpoints. Assuming an expected accrual rate of 11\u00e2\u0080\u009312 participants per month across 4 sites, participant accrual is expected to complete in 12 months.", "id": 1347, "split": "test"} +{"trial_id": "NCT05259046", "pmid": "37208133", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Novel Health Effects of Vitamin K: a Placebo-controlled Randomized Trial in the General Population (InterVitaminK)\n\nIncluded conditions:\n- Coronary Artery Calcification\n- Arterial Stiffness\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Intervention treatment . Dietary supplementation with Menaquinone-7 (MK-7) tablet (333 \u00b5g/day). MK-7 (K2VITAL\u00aeDELTA) tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.', 'interventionNames': ['Dietary Supplement: Menaquinone-7 (MK-7) tablet (333 \u00b5g)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo tablet (no active treatment). The placebo tablets will match the intervention treatment in both taste and appearance. Placebo tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.', 'interventionNames': ['Dietary Supplement: Placebo tablet']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Menaquinone-7 (MK-7) tablet (333 \u00b5g)', 'description': 'One MK-7 tablet containing 333 \u00b5g MK-7 per day', 'armGroupLabels': ['Intervention']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo tablet', 'description': 'One placebo tablet per day', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Total coronary artery calcification', 'description': 'Total coronary artery calcification score (unit: Agatston score) in the coronary arteries, assessed by non-contrast Cardiac CT scans. A high score reflects higher degree of calcification in the coronary arteries and increased risk of coronary artery disease. The outcome will be evaluated by randomization group (active versus placebo).', 'timeFrame': 'Baseline to three years of follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 25% drop-out rate before the 3-year follow-up visits, 89% power to detect an effect of at least 15%, and a significance level (alpha) of 0.05.", "answer": 450, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n Sample size calculations are based on the primary endpoint (3-year progression in CAC (unit: Agatston score)). In a previous trial of vitamin K supplementation in healthy participants aged 60\u00e2\u0080\u009380 years, the geometric mean progression in CAC over 3 years was 2.82, (SE: 0.06; SD: 0.57).18 In a Danish cohort study (DANCAVAS),36 the geometric mean progression in CAC over 5 years for participants with baseline CAC values >0 and <1000 was 4.58, (SE: 0.05; SD: 1.31). Based on this, we assume that our control group\u00e2\u0080\u0099s geometric mean 3-year progression in CAC will be 3.0 with an SD of 1.3. We hypothesise that vitamin K supplementation can reduce the 3-year progression in CAC by 15% in the MK-7 group compared with the placebo group. With 25% drop-out before the 3-year follow-up visits, and 450 participants (225 participants in each group) included at baseline, we will have 89% power to detect an effect of at least 15% (alpha 0.05).", "id": 1348, "split": "test"} +{"trial_id": "NCT05259566", "pmid": "38475757", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers\n\nIncluded conditions:\n- Tobacco Smoking\n\nStudy Armgroups:\n- {'label': 'no menthol ban', 'type': 'NO_INTERVENTION', 'description': 'usual menthol cigarettes and menthol flavored e-cigarette available'}\n- {'label': 'menthol ban in cigarettes only', 'type': 'EXPERIMENTAL', 'description': 'non-menthol cigarettes and menthol flavored e-cigarette available', 'interventionNames': ['Behavioral: menthol ban in cigarettes only']}\n- {'label': 'menthol ban in both cigarettes and e-cigarettes', 'type': 'EXPERIMENTAL', 'description': 'non-menthol cigarettes and tobacco flavored e-cigarette available,', 'interventionNames': ['Behavioral: total menthol ban']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'menthol ban in cigarettes only', 'description': 'menthol ban in cigarettes only, menthol available in e-cigarette', 'armGroupLabels': ['menthol ban in cigarettes only']}\n- {'type': 'BEHAVIORAL', 'name': 'total menthol ban', 'description': 'menthol ban in both cigarettes and e-cigarettes', 'armGroupLabels': ['menthol ban in both cigarettes and e-cigarettes']}\n\nPrimary Outcomes:\n- {'measure': 'Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior', 'description': 'Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change.', 'timeFrame': 'From Week 0 to week 8'}\n\nPlease estimate the sample size based on the assumption: \n80% power at two-sided alpha level of 0.05; 20% attrition rate (expected to be lower, around 13%).", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n Power was calculated using PASS software based on effect size estimates from pilot data where we detected an average change of 2.2 cigarettes, Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.68 [19]. To be sufficiently powered to detect a similar or smaller effect in the proposed study, we need N\u00e2\u0080\u0089=\u00e2\u0080\u008940 per group to achieve 80% power at two-sided alpha level of 0.05. Therefore, we will recruit 50 individuals per group for a total of 150 to allow up to 20% attrition and still achieve the specified power and required sample size of 40 per group. Due to our retention efforts, we expect our attrition rate may be even lower, as attrition in the initial study was less than the estimated 20% (i.e., attrition was 13%). For Aim 1, we will have sufficient power to detect a medium-to-large effect size (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.64, Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.32). This corresponds to the ability to detect a difference of at least 2 cigarettes per day (SD\u00e2\u0080\u0089=\u00e2\u0080\u00893) or at least a 13% difference in percent days smoke-free (SD\u00e2\u0080\u0089=\u00e2\u0080\u008920%), consistent with effect size estimates from our work and other studies [19, 33]. For Aim 2, data from our initial work indicated differences across racial groups with a large effect size estimate (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00891.21) [19]. With the proposed sample size, we will have sufficient power to detect a similar or smaller effect in the range of medium-to-large effect sizes (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.64, Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.32) with 80% power at two-sided alpha level of 0.05 for the interactions of interest.", "id": 1349, "split": "test"} +{"trial_id": "NCT05262855", "pmid": "38011131", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients with Resectable or Borderline Resectable Pancreatic Ductal Carcinoma\n\nIncluded conditions:\n- PDAC - Pancreatic Ductal Adenocarcinoma\n- FAP\n\nStudy Armgroups:\n- {'label': '68Ga-FAPI-46 PET/CT', 'type': 'EXPERIMENTAL', 'description': 'Patients receive \\\\[68Ga\\\\]FAPI-46 intravenously followed by PET/CT 15-25 minutes later', 'interventionNames': ['Drug: [68Ga]FAPI-46']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '[68Ga]FAPI-46', 'description': '\\\\[68Ga\\\\]-FAPI-46 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma (PDAC).', 'armGroupLabels': ['68Ga-FAPI-46 PET/CT']}\n\nPrimary Outcomes:\n- {'measure': 'Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.', 'timeFrame': 'Through study completion, 2 years'}\n\nPlease estimate the sample size based on the assumption: \nOne-sample binomial proportion test with a normal approximation, upper one-sided significance level of 0.05, 92.7% power", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and justification of sample size\n The study population for all analyses will be defined as all patients enrolled in the study who receive at least one dose of [68Ga]FAPI-46. Patients who exit the study prior to receiving study medication may be replaced. For this study, the primary efficacy endpoints are sensitivity and specificity, each of which will be evaluated with a hypothesis test:\n \n \n H0: Sensitivity (Specificity) \u00e2\u0089\u00a4 Performance Goal (PG)\n \n \n H1: Sensitivity (Specificity) > Performance Goal (PG)\n \n \n Success is defined as rejecting the null hypothesis for the sensitivity hypothesis tests. The specificity test will have lower power given the lower number of samples that are likely to be negative from the histopathology sample. The minimum sample size necessary to achieve desired power for sensitivity was computed for the hypothesis test above utilizing a one-sample binomial proportion test with a normal approximation, an upper one-sided significance level of 0.05, and the following parametric assumptions:\n \n \n Performance Goal (PG) = 0.75 for sensitivity and 0.70 for specificity\n \n \n True Sensitivity and Specificity = 0.90\n \n \n Given the above parametric assumptions, 60 subjects will yield 92.7% power to demonstrate that the true sensitivity and specificity is greater than 0.75.\n \n Safety analysis\n All patients who receive any amount of [68Ga]FAPI-46 will be included in the final summaries and listings of safety data. Frequencies of patients experiencing at least one AE will be displayed by body system and preferred term according to MedDRA terminology. Intensity (severity) of the AEs will be graded according to the CTCAE v4.0.\n Summary tables will present the number of patients observed with AEs and corresponding percentages. The denominator used to calculate incidence percentages will consist of patients receiving at least one dose of study medication. Within each table, the AEs will be categorized by MedDRA body system and preferred term. Additional subcategories will be based on event intensity and relationship to study drug. Deaths and other SAEs will be tabulated. Vital signs will be summarized using descriptive statistics. Summary tables will be prepared to examine the distribution of laboratory measures over time.\n \n \n Efficacy analysis\n Primary efficacy analyses. The primary efficacy endpoints will compare the results from [68Ga]FAPI-46 PET and histopathology. The primary analysis of sensitivity and specificity will be summarized using frequency counts and percentages as well as 95% asymptotic normal confidence intervals. Inference for the primary hypotheses will be conducted utilizing a one-sample binomial proportion test with a normal approximation, a one-sided upper significance level of 0.05, and assumed null proportions/performance goals of 0.75 for sensitivity. Success for the primary efficacy analyses will be defined as sensitivity that is statistically significantly greater than the performance goal. Accuracy of [68Ga]FAPI-46 PET for the detection of FAP expressing cells compared to histopathology will be presented with a 95% confidence interval.\n Secondary efficacy analyses. Association between SUVmax from [68Ga]FAPI-46 PET on cross sectional imaging and FAP expression from IHC will be summarized by correlation coefficients.\n \n \n Access to data and materials\n The lead academic investigator and other site leads will have full access to all interim and final data results of the study. All data generated and/or analyzed during this study will be available in a future publication.\n \n \n Dissemination of results\n The results of this trial will be submitted for publication in national or international peer-reviewed journals with all collaborators acknowledged. Results will also be disseminated through conference presentations. It is expected that several publications will originate from this protocol, addressing the aims as mentioned above.", "id": 1350, "split": "test"} +{"trial_id": "NCT05268640", "pmid": "37286317", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of the Efficacy of Emergency Double-level and Single Cervical Cerclage in Cervical Insufficiency in the Second Trimester of Pregnancy - Multicenter Prospective Randomized Trial\n\nIncluded conditions:\n- Cervical Incompetence\n\nStudy Armgroups:\n- {'label': 'Double-level cerclage', 'type': 'EXPERIMENTAL', 'description': 'double-level cervical cerclage placement with one suture above the other approximately 1 cm higher. Suture will be placed analogous to McDonald technique', 'interventionNames': ['Procedure: Double-level cervical cerclage']}\n- {'label': 'Single-level cerclage', 'type': 'ACTIVE_COMPARATOR', 'description': 'single-level cervical cerclage of McDonald technique', 'interventionNames': ['Procedure: Single-level cervical cerclage']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Double-level cervical cerclage', 'description': 'two cervical sutures + regimen of antibiotics + indomethacin + progesterone', 'armGroupLabels': ['Double-level cerclage']}\n- {'type': 'PROCEDURE', 'name': 'Single-level cervical cerclage', 'description': 'single cervical suture + regimen of antibiotics + indomethacin + progesterone', 'armGroupLabels': ['Single-level cerclage']}\n\nPrimary Outcomes:\n- {'measure': 'deliveries below 34+0 weeks of gestation', 'description': 'number and rate of deliveries below 34+0 weeks of gestation', 'timeFrame': 'observation after intervention for 26 weeks of until birth'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (two-sided \u03b1) = 0.05, Power = 90%, Missing/dropout rate = 10%.", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Sample size\n The only published randomised trial evaluating the effectiveness of emergency cerclage in comparison with conservative management and bed rest showed that the rate of deliveries before 34 weeks of gestation was 53%.4 A total sample size of 78\u00e2\u0080\u0089women will provide 90% power to detect a reduction in preterm deliveries before 34 weeks from 53% to 29% in women in whom double-level cerclage was applied (two-sided \u00ce\u00b1=0.05). Assuming 10% of women excluded or lost to follow-up it will be necessary to approach 86 patients diagnosed with cervical insufficiency.\n Xu et al performed a retrospective comparison of a single-level and double-level emergency cerclage. According to their results 92.3% of women with single-level cerclage and 46.2% of women with double-level cerclage delivered before 34 weeks of gestation.13 A total sample size of 48\u00e2\u0080\u0089women would provide 90% power to detect a reduction in preterm deliveries before 34 weeks from 92% to 46% in women in whom double-level cerclage was applied (two-sided \u00ce\u00b1=0.05). To minimalise the bias and risk of not receiving significant results we decided to include 86\u00e2\u0080\u0089women to the study.", "id": 1351, "split": "test"} +{"trial_id": "NCT05269212", "pmid": "36471349", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II: a Randomized Controlled Trial.\n\nIncluded conditions:\n- Failed Back Surgery Syndrome\n- Spinal Cord Stimulation\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Usual Care trajectory']}\n- {'label': 'Personalized biopsychosocial rehabilitation program', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: A biopsychosocial rehabilitation program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual Care trajectory', 'description': 'Usual care after Spinal Cord Stimulation implantation', 'armGroupLabels': ['Usual care']}\n- {'type': 'OTHER', 'name': 'A biopsychosocial rehabilitation program', 'description': 'A personalized biopsychosocial rehabilitation program specifically targeting return to work.', 'armGroupLabels': ['Personalized biopsychosocial rehabilitation program']}\n\nPrimary Outcomes:\n- {'measure': 'Work ability', 'description': 'Work ability, evaluated with the Work Ability Index', 'timeFrame': 'The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed testing (alpha=0.05) with 85% power, 20% loss to follow-up, 11.3% trial failure rate, allocation ratio (N2/N1) of 1", "answer": 112, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation was performed using G*Power version 3.1.9.2 for evaluating differences in work ability between both interventions (the control and experimental intervention). Based on the least favourable design (two treatment arms, in which patients are measured three times) with a small effect size (\u00ce\u00b72=0.069; d=0.28) [66], a sample size of 112 patients is needed to reach a significant between-subject effect. This sample size calculation accounts for a 20% loss to follow-up after 1 year and for a SCS trial failure rate of 11.3%, according to Belgian reimbursement rules [5]. Calculations were based on two-tailed testing (alpha=0.05) with 85% power. Allocation ratio (N2/N1) was defined as 1, resulting in 110.3 patients (56 patients in the experimental group and 56 in the control group (N=112)).", "id": 1352, "split": "test"} +{"trial_id": "NCT05269303", "pmid": "38134126", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing the Health-related Functions of a Wearable Monitoring Device in the Daily Life of Community-dwelling Older Adults: A Randomized Pilot Study\n\nIncluded conditions:\n- Device Ineffective\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a 3-month Live With Wearable Monitoring Device program.', 'interventionNames': ['Device: Live With Wearable Monitoring Device program']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Usual care. As with the participants in the intervention group, those in the control group can utilize the features in the Wearable Monitoring Device.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Live With Wearable Monitoring Device program', 'description': 'The participants in the intervention group will receive a home visit by a Community Healthcare Worker in the first month, and biweekly motivational messages via Whats App in the second and third months.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'The change of use intention of wearable monitoring device', 'description': 'It will be measured using a 4-item, 5-point Likert scale adopted from Bhattacherjee (2001) and Windasari et al. (2021). The five-point scale ranges from 1 = not at all satisfied to 5 = very certain, with higher scores representing a higher chance of continuing to use the WMD.', 'timeFrame': 'Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value of 0.05, power of 80%, and a 10% drop-out rate.", "answer": 72, "answer_type": "ACTUAL", "explanation": "Sample size\n A power analysis was used to calculate the sample size for this study. We adopted usability as our primary outcome measure. To determine the effect size for our study, we referred to the Overall Acceptability Score [34], where the intervention group scored 45.2 (2.9) and the control group scored 40.4 (1.3). To account for potential differences in our local sample, which may consist of older individuals with lower mobile device literacy, we used a conservative approach and discounted the effect size by one-third for sample size calculation (which was 0.72). This was done to ensure an adequate sample size.\n Assuming an alpha value of 0.05, a power of 80%, and an effect size of 0.72 [33], the sample size for each group should be 32. Accounting for a 10% drop-out rate, the total sample size in this study will be 70 (i.e., 35 per group).", "id": 1353, "split": "test"} +{"trial_id": "NCT05271266", "pmid": "36889826", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China\n\nIncluded conditions:\n- Hyperkalaemia\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Safety laboratory tests associated with AEs, SAEs and DAEs, specifically AEs', 'description': 'Serum electrolytes values\uff08mmol/L\uff09, serum BUN\uff08mmol/L\uff09, serum bicarbonate\uff08mmol/L\uff09, and others', 'timeFrame': 'From enrollment to the 6th month after Enrollment'}\n- {'measure': 'The percentage of signs and symptoms associated with AEs, SAEs and DAEs, specifically AEs', 'description': 'The percentage of edema, constipation and others', 'timeFrame': 'From enrollment to the 6th month after Enrollment'}\n\nPlease estimate the sample size based on the assumption: \nA longitudinal mixed model will be used for 95% CI estimation. The CIs will be determined using normal approximation with a log transformation of the hazard rate, assuming the hazard rate is constant and the follow-up duration is the same for all patients, between 0.5 and 1.5 months.", "answer": 1000, "answer_type": "ACTUAL", "explanation": "Sample size\n The overall sample size planned is 1000 with an estimated 500 patients in the new user group and the remaining patients will be in the ongoing user group. Using the large sample normal approximation method, a sample size of 500 patients in the new user group could provide a 95% CI estimation interval as (7.4%, 12.6%) for the FAS-P1 based on previously published data that indicated 1%\u00e2\u0080\u009310% of subjects had DAEs, SAEs and overall AEs. A longitudinal mixed model will be used for 95% CI estimation as reported in the previous studies.17 The corresponding CIs will be determined using normal approximation with a log transformation of the hazard rate as per exponential distribution, with assumption of hazard rate being constant and same fixed/predefined follow-up duration for all patients. The follow-up period is assumed to be between 0.5 and 1.5 months.", "id": 1354, "split": "test"} +{"trial_id": "NCT05273736", "pmid": "37573428", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of a Multi-Component Behavior Change Technique Intervention on Medication Adherence Among Individuals on Primary Prevention Statin Therapy: A Dose-Finding Pilot Study\n\nIncluded conditions:\n- Medication Adherence\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Dose-finding study with 14 groups of 3 participants each. To identify the minimum effective dose (MED) to increase medication adherence by 20% between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined by the modified Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous subjects.', 'interventionNames': ['Behavioral: 5 Behavioral Change Techniques']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': '5 Behavioral Change Techniques', 'description': '1. Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal to take your medication as prescribed tomorrow.\\n2. Action planning: prompt detailed planning of performance of behavior (must include a setting, frequency, duration, and intensity). Example: Develop a plan for taking your medication.\\n3. Self-Monitoring of behavior: establish a method for person to monitor and record their behavior. Example: Did you take your statin medication today?\\n4. Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You did not take your statin medication as prescribed yesterday.\\n5. Prompts/Cues: introduce or define environmental or social stimulus with the purpose of prompting or cueing the behavior. The prompt or cue would normally occur at the time or place of performance. Example: Please remember to take your medication soon.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Success or failure for change in Medication Adherence.', 'description': 'Participant medication adherence increase will be assessed between run-in and follow-up periods using the smart pill bottle. A successful adherence increase is defined as average daily adherence to statin medications in the 2-week follow-up period being higher by 20% or more than in the 2-week run-in period. The minimum effective dose (MED) will be defined as the smallest BCT dose duration associated with 80% of participants receiving that dose having a successful statin adherence increase between the run-in and the follow-up periods.', 'timeFrame': 'Medication adherence will be assessed continuously via the smart pill bottle and adherence will be calculated daily. The change in proportion of days adherent will be compared between the run-in and follow-up periods (5-14 weeks from run-in).'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size is determined to achieve a 60% probability of correct selection (PCS).", "answer": 42, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size of 42 participants (randomized to complete all study procedures) was chosen to have a sufficient number of participants to obtain a preliminary assessment of the MED for the 5-component behavioral change intervention to increase statin adherence between baseline and follow-up periods. Data will be reported transparently so that individual-level heterogeneity can be assessed.\n The dose-efficacy model is calibrated such that the modified TiTE-CRM will eventually select a BCT duration associated with 75% to 85% successful statin adherence success, i.e., within 5 percentage points of our target [52]. The sample size (n = 42) is determined to achieve 60% probability of correct selection (PCS) under logistic dose\u00e2\u0080\u0093efficacy curves with slope = 0.69 (i.e., an odds ratio [OR] = 2) [53]. As this is small-scale study, power and sample size will be calculated solely for the primary aim.", "id": 1355, "split": "test"} +{"trial_id": "NCT05275972", "pmid": "39353677", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Descemet Endothelial Thickness Comparison Trials (DETECT I & II)\n\nIncluded conditions:\n- Fuchs\n- Fuchs Dystrophy\n- Fuchs' Endothelial Dystrophy\n\nStudy Armgroups:\n- {'label': 'DMEK plus topical placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'DSO plus topical ripasudil 0.4%', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Ripasudil']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ripasudil', 'description': 'Topical Ripasudil 0.4%', 'armGroupLabels': ['DSO plus topical ripasudil 0.4%']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Topical Placebo', 'armGroupLabels': ['DMEK plus topical placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Best spectacle-corrected visual acuity (BSCVA)', 'description': 'Best spectacle-corrected visual acuity (BSCVA)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nOutcome SD of 0.106, two-sided alpha of 0.05, 90% power, 10% loss to follow-up", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n With 30 patients per group (60 total), we estimate that we will have at least 90% power to detect a difference in logMAR of 0.1, assuming an outcome SD of 0.106, a two-sided alpha of 0.05 and 10% loss to follow-up. The SD was estimated from the DETECT pilot study and was adjusted for correlation between baseline and 12-month measurements (outcome SD=0.121, correlation=0.475, adjusted SD=0.106).", "id": 1356, "split": "test"} +{"trial_id": "NCT05276596", "pmid": "38684243", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction\n\nIncluded conditions:\n- Norepinephrine\n- Hypotension\n- Anesthesiology\n- Major Abdominal Surgery\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.', 'interventionNames': ['Drug: Ephedrine']}\n- {'label': 'Test group', 'type': 'EXPERIMENTAL', 'description': 'Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.', 'interventionNames': ['Drug: Norepinephrine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ephedrine', 'description': 'The control group will be taken care of according to the protocols in force. The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.', 'armGroupLabels': ['Control group']}\n- {'type': 'DRUG', 'name': 'Norepinephrine', 'description': 'Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.', 'armGroupLabels': ['Test group']}\n\nPrimary Outcomes:\n- {'measure': 'Variation of the of the Clavien Dindo surgical score between both groups', 'description': 'The Clavien-Dindo Classification\\n\\nThe therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner.\\n\\nIt consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.\\n\\nComplications that have the potential for long-lasting disability after patient\\'s discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix (\"d\" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life', 'timeFrame': 'one month'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a two-sided first-species risk (significance level) of 5%, a power of 80%, and an expected loss to follow-up rate of 5%.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Statistical method and sample size calculation\n The medico-surgical complication rate found in the literature is between 25% and 30%.22\n\n Thus, if we set the rate of medical and surgical complications (defined by a Clavien\u00e2\u0080\u0093Dindo score of \u00e2\u0089\u00a51) to 25% in the control group, the inclusion of 500 patients (250 in each arm) would show a 10% difference between the two groups, with a two-sided first-species risk of 5% and a power of 80%, and an expected loss to follow-up of 5%.\n The main objective of this randomised controlled trial is to demonstrate the efficacy of the preventive use of norepinephrine in major abdominal surgery on the occurrence of postoperative medico-surgical complications. Patients are randomised into two groups, with stratification based on the anaesthetic induction drug (etomidate or propofol): control group or immediate norepinephrine perfusion.\n All statistical analysis will be performed on an intention-to-treat basis using SAS software version 9.4.", "id": 1357, "split": "test"} +{"trial_id": "NCT05279430", "pmid": "35790316", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Inspiratory Muscle Training on Maximal Functional Capacity in Patients With Chronic COVID After Hospital Discharge\n\nIncluded conditions:\n- COVID-19 Pneumonia\n\nStudy Armgroups:\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Patients allocated to the control arm will not receive inspiratory muscle training. They will be checked each week by a physiotherapist responsible for training intervention who will measure their maximal inspiratory pressure'}\n- {'label': 'Inspiratory muscle training', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured.', 'interventionNames': ['Behavioral: Inspiratory muscle training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Inspiratory muscle training', 'description': 'Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured.', 'armGroupLabels': ['Inspiratory muscle training']}\n\nPrimary Outcomes:\n- {'measure': 'Peak oxygen consumption', 'description': 'Maximal functional capacity will be evaluated with incremental and symptom-limited cardiopulmonary exercise testing. Peak oxygen consumption (peakVO2) will be considered the highest value of VO2 during the last 20 seconds of exercise.', 'timeFrame': '12-week'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided testing at the 0.05 significance alpha level, 80% power, and 15% withdrawals or lost to follow-up.", "answer": 26, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The study\u00e2\u0080\u0099s null hypothesis is that there are no differences between all study-group means for the primary endpoint. This study\u00e2\u0080\u0099s sample size determination assumes two-sided testing at the 0.05 significance alpha level. The effect size for the primary endpoint is based on data from two randomised control studies that evaluated the effects of 12\u00e2\u0080\u0089week IMT programmes on (1) middle-aged diabetic patients with peripheral neuropathy with obstructive sleep apnoea14 and (2) patients with heart failure and preserved ejection fraction.15 Based on these previous studies, IMT was associated with a significant increase of at least a mean of peakVO2 of 3\u00e2\u0080\u0089mL/kg/min, with an SD of \u00c2\u00b12.5.\n Assuming an allocation ratio of 1:1, 26 patients (13 patients per group) would provide 80% of power at a significance alpha level <0.05. In addition, we assume 15% of withdrawals or lost to follow-up. Thus, 13 patients per arm (26 patients) will be enrolled. The software used for sample size calculation was GRANMO.", "id": 1358, "split": "test"} +{"trial_id": "NCT05282485", "pmid": "36585139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides\n\nIncluded conditions:\n- HIV\n- Infant Morbidity\n- Breast Feeding\n\nStudy Armgroups:\n- {'label': 'Synbiotic Group', 'type': 'EXPERIMENTAL', 'description': \"A synbiotic combining 2'-Fucosyllactose (2'-FL) human milk oligosaccharides (HMO) with B.infantis (probiotic) will be administered to infants from 4 to 24 weeks of age.\", 'interventionNames': ['Dietary Supplement: Synbiotic']}\n- {'label': 'Placebo Group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Maltodextrin will be administered to infants from 4 to 24 weeks of age.', 'interventionNames': ['Dietary Supplement: Maltodextrin']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Synbiotic', 'description': \"Synbiotic (2'-FL HMO + B. infantis probiotics)\", 'armGroupLabels': ['Synbiotic Group']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Maltodextrin', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo Group']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of infants with infectious morbidity from 4-24 weeks', 'description': 'Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms', 'timeFrame': '4-24 weeks of age'}\n- {'measure': 'Infant length for age Z scores (LAZ) from 4-24 weeks', 'description': 'Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms', 'timeFrame': '4-24 weeks of age'}\n- {'measure': 'Proportion of infants with infectious morbidity from 4-48 weeks', 'description': 'Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms', 'timeFrame': '4-48 weeks of age'}\n- {'measure': 'Infant length for age Z scores (LAZ) from 4-48 weeks', 'description': 'Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms', 'timeFrame': '4-48 weeks of age'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a significance level of 0.10 and aims for 83% and 88% power to reject the null hypothesis at 24 and 48 weeks, respectively, for infectious morbidity. For continuous measures, it aims for 80% power to reject the null hypothesis at a 0.10 significance level, assuming an SD of 1 for LAZ (or WLZ/WAZ/MAZ) and within-subject correlation of 0.5\u20130.7. The study also accounts for a 10% lost to follow-up rate.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size\n This proof-of-concept futility study is designed to investigate whether the synbiotic has promise as an intervention to ameliorate common infant adverse outcomes and to investigate its effects on the hypothesised pathways of action including microbiota composition, maturity and function as well as inflammation. We propose a study of 184 mother-infant pairs (144 HEU and 40 HUU).\n Based on data from our study population, we estimate that infants HEU on placebo will have a 50% probability of any infectious morbidity through 24 weeks, and 70% probability through 48 weeks. With a sample size of 63 in each group (ie, after accounting for 10% lost to follow-up and excluding around 4 infants HIV-exposed who are anticipated to acquire HIV), we have 83% and 88% power to reject the null hypothesis of superiority (ie, the probability of infectious morbidity is 20%\u00e2\u0080\u0089points lower in the intervention group) at 0.10 significance level at 24 weeks and 48 weeks, respectively, and declare that the intervention is deemed futile (ie, not promising) if there exists no difference on infectious morbidity between the two groups in truth. This margin of superiority of 20% point difference is determined in line with previous effects of 2\u00e2\u0080\u0099FL on infectious morbidity through 24 weeks of age.17 We set type I error at 0.10 as is conventional in proof-of-concept trials19\n For differences in continuous measures of anthropometrics (LAZ and weight-for-length z-scores (WLZ)), we will be able to detect a difference in the mean LAZ (or mean WLZ) of intervention and placebo groups of \u00c2\u00b10.25\u00e2\u0080\u00930.27 (assuming within-subject correlation 0.5\u00e2\u0080\u00930.7) in LAZ/WLZ/weight-for-age z-scores (WAZ)/microbiota-for-age z-scores (MAZ) over 24 weeks or 48 weeks (a clinically significant difference,20 with an 80% power to reject the null hypothesis at 0.10 significance level, assuming an SD of 1 LAZ (or WLZ/WAZ/MAZ). For differences at each cross-sectional time point, we will be able to detect a difference in the mean LAZ (or mean WLZ) of intervention and placebo groups of \u00c2\u00b10.31.", "id": 1359, "split": "test"} +{"trial_id": "NCT05283512", "pmid": "37699636", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease (ENRICH): A Randomized Controlled Trial\n\nIncluded conditions:\n- Contrast-induced Nephropathy\n- Kidney Injury\n- Kidney Failure, Chronic\n- Risk Reduction\n\nStudy Armgroups:\n- {'label': 'IV-hydration group (standard of care according to international guidelines)', 'type': 'OTHER', 'description': 'The IV-hydration with isotonic 0.9% NaCl will be initiated three hours prior to the IV CECT and completed four hours after IV CECT (infusion rate of 1-3 mL/kg/hour). Patients are prescribed a fixed volume of 1000 mL, which is equally distributed before and after IV CECT (500 mL before and 500 mL after).\\n\\nPatients with heart failure (LVEF \u2264 40%) are prescribed a reduced volume of 500 mL, which is also equally distributed before and after IV CECT (250 mL before and 250 mL after).', 'interventionNames': ['Other: Preventive treatment with IV-hydration']}\n- {'label': 'Oral hydration group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The oral hydration regimen will be initiated one-two hours prior to IV CECT and completed within four hours after IV CECT. Patients are prescribed a fixed volume of 1000 mL, which is distributed equally before and after IV CECT (500 mL before and 500 mL after).\\n\\nPatients with heart failure (LVEF \u2264 40%) are prescribed a reduced volume of 500 mL, which is equally distributed before and after IV CECT (250 mL before and 250 mL after).', 'interventionNames': ['Other: Preventive treatment with oral hydration']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Preventive treatment with IV-hydration', 'description': 'IV hydration with isotonic 0.9% NaCl', 'armGroupLabels': ['IV-hydration group (standard of care according to international guidelines)']}\n- {'type': 'OTHER', 'name': 'Preventive treatment with oral hydration', 'description': 'Oral hydration with regular bottled water', 'armGroupLabels': ['Oral hydration group']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of PC-AKI', 'description': 'The incidence of PC-AKI within the two arms', 'timeFrame': '2-5 days after IV CECT'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a power of 80%, a one-sided alpha level of 5%, and aims to detect an absolute difference in PC-AKI between the two groups of more than 12.5%. The non-inferiority limit is set at 12.5%, based on the clinical assumption that a higher incidence of PC-AKI may not result in an increase in major adverse events.", "answer": 254, "answer_type": "ESTIMATED", "explanation": "Sample size\n Limited RCT data exist comparing different hydration protocols for their ability to prevent PC-AKI in patients exposed to intravenous CM.48 49 51 54 Data from meta-analyses on RCTs, which compare oral hydration to intravenous hydration for prevention of PC-AKI in outpatients, have reported incidences of PC-AKI around 7.7%\u00e2\u0080\u00939.5%.48 49 However, these incidences cannot easily be extrapolated to our study population due to low inclusion of high-risk patients. Data on the incidence of PC-AKI after intravenous CECT among outpatients with severe CKD has been reported as 12.1%\u00e2\u0080\u009320.5%.29 55 56 However, no RCTs have evaluated the efficacy of oral hydration versus intravenous hydration for the incidence of PC-AKI after intravenous CECT in the setting of high-risk patients. This trial will evaluate whether oral hydration is non-inferior to intravenous hydration to prevent PC-AKI among high-risk patients under the assumption that both hydration methods will prevent PC-AKI successfully in approximately 80% cases equivalent to an incidence of 20% in each arm. Based on the expected incidences in each arm, a sample size of 254 patients will have a power of 80% with a one-sided alpha level of 5% aiming to detect an absolute difference in PC-AKI between the two groups of more than 12.5%. A non-inferiority limit of 12.5% may seem high, but this is for the primary outcome, which is based on changes in SCr and not dialysis or mortality. The chosen non-inferiority limit is based on the clinical assumption that a higher incidence of PC-AKI may not result in an increase of major adverse events (ie, dialysis, renal adverse events, hospitalisation or all-cause mortality). PC-AKI often resolves within few days weeks and major adverse clinical events have been reported to be <1%.18 24 57 Thus, it is expected that the high incidence of PC-AKI among high-risk patients will not lead to increased incidence of major adverse events. Taking this clinical assumption into consideration, an absolute difference <12.5% between the two arms is reasoned to be acceptable in the absence of an increase in major adverse events between the two arms.", "id": 1360, "split": "test"} +{"trial_id": "NCT05285761", "pmid": "39334106", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ECR Visant \u00e0 \u00e9valuer l'Effet d'Une Intervention Sur la Diffusion d'Informations (Conduite de la Diversification Alimentaire) Sur le Comportement de Nourrissage Des Parents, le Comportement Alimentaire et le Statut pond\u00e9ral de l'Enfant\n\nIncluded conditions:\n- Healthy Volunteers\n\nStudy Armgroups:\n- {'label': 'paper brochure + smartphone application', 'type': 'EXPERIMENTAL', 'description': 'Parents will receive the paper brochure (new communication support developed by Sant\u00e9 publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. They will also receive the new recommendations relating to complementary feeding through an educational device in the form of a smartphone application. This app will deliver information and very short videos illustrating various aspects of responsive feeding during CF and taking up the themes of the paper brochure. These 106 messages will be delivered regularly from the 3rd month until the 36th month of the child. Parents will also receive generic information (48 messages) contained in the health record and in connection with the general development.', 'interventionNames': ['Behavioral: Provision of extended information on the conduct of complementary feeding']}\n- {'label': 'paper brochure', 'type': 'ACTIVE_COMPARATOR', 'description': 'Parents will receive the paper brochure (new communication support developed by Sant\u00e9 publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will also receive generic information (48 messages) contained in the health record and in connection with the general development.', 'interventionNames': ['Behavioral: Provision of current official information on complementary feeding']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Provision of extended information on the conduct of complementary feeding', 'description': 'Parents will receive the paper brochure (new communication support developed by Sant\u00e9 publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will receive generic information contained in the health record and in connection with the general development. These 48 messages will be delivered regularly by a smartphone application from the 3rd months until the 36th months of the child.\\n\\nIn addition to the paper brochure and the generic information, parents in the intervention group will also receive the new recommendations relating to CF through an educational device (in the form of a smartphone application). This app will deliver information and very short videos illustrating various aspects of responsive feeding during CF and taking up the themes of the paper brochure. These 106 messages will be delivered regularly from the 3rd months until the 36th months of the child.', 'armGroupLabels': ['paper brochure + smartphone application']}\n- {'type': 'BEHAVIORAL', 'name': 'Provision of current official information on complementary feeding', 'description': 'Parents will receive the paper brochure (new communication support developed by Sant\u00e9 publique France (the French Public Health Agency)), which is the current official information on complementary feeding (CF) in France. Parents will also receive generic information contained in the health record and in connection with the general development. These 48 messages will be delivered regularly by a smartphone application from the 3rd months until the 36th months of the child.', 'armGroupLabels': ['paper brochure']}\n\nPrimary Outcomes:\n- {'measure': 'Body mass index z-score at the age of 36 months', 'description': \"Z-score of the body mass index (BMI, kg / m\u00b2) at the age of 36 months of the child of the parents included in the study, calculated from measurements of the child's weight and height at the age of 36 months (carried out in the laboratory) and according to the WHO references.\", 'timeFrame': 'End of intervention (at the age of 36 months)'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power, 5% type I error rate (one tail), and a 20% attrition rate. For behavioural assessments, the same power and error rate are assumed.", "answer": 330, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We aim at enrolling 330 participants. The first 30 participants are enrolled with the objective of stabilising potential bugs in the app. The study is powered to detect a 0.28 difference in BMI z-score (WHO reference) at 36 mo (which has a clinical significance since the French BMI z-score at 36 mo in France is 0.28\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.86 (EDEN cohort, personal communication)) between intervention and control arms (80% power, 5% type I error rate, one tail, 20% attrition). We hypothesise that children in the intervention group will have a lower BMI z-score than those in the control group. The power calculation involves recruiting 118 parents in each group. We considered a potential attrition during the trial of approximately 20%, which corresponds to the attrition observed in previous cohorts [76, 77]. We expect to enrol 330 participants within 3\u00c2\u00a0years. With a primary endpoint at 36\u00c2\u00a0months of age and a follow-up one-year later, the study may last 7\u00c2\u00a0years.\n Among the whole study population, 130 participants (65 participants in each arm) are included in behavioural assessments. This number was calculated to detect a difference of 56% in caloric compensation score (%) at the age of 11\u00c2\u00a0months between the intervention and control arms, with a power of 80%, and an error rate of 5% type I (unilateral test) based on available data [9, 14]. The power calculation involves recruiting 57 parents in each group, topping it to 65 allows to mitigate risk if some data are not usable (i.e., if the child does not want to eat anything).\n Regarding the qualitative evaluation, we plan to select the first participants in the intervention group using the so-called \u00e2\u0080\u009cmaximum variation\u00e2\u0080\u009d technique, which makes it possible to count common response patterns (called \u00e2\u0080\u009cinvariants\u00e2\u0080\u009d). Conducting interviews will be stopped when the saturation threshold will be reached. This technique is traditionally used in qualitative analysis.", "id": 1361, "split": "test"} +{"trial_id": "NCT05285969", "pmid": "35513777", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.\n\nIncluded conditions:\n- Myocardial Infarction, Acute\n\nStudy Armgroups:\n- {'label': 'Motivational interview', 'type': 'EXPERIMENTAL', 'description': 'Motivation Interview program with standard care', 'interventionNames': ['Behavioral: Motivational interview']}\n- {'label': 'Standard care group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard care', 'interventionNames': ['Behavioral: Active Comparator: Standard care group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Motivational interview', 'description': 'The new CR program with MI will be structured in 4 sessions and an optional fifth during the six months after discharge. The methodology of the MI sessions will follow the four phases logical sequence of MI proposed by Rollnick and Millner. 1) engage in a collaborative relationship, 2) focus on a particular change, 3) evoke intrinsic motivations for change, and 4) plan an immediate step for change', 'armGroupLabels': ['Motivational interview']}\n- {'type': 'BEHAVIORAL', 'name': 'Active Comparator: Standard care group', 'description': 'All patients in the control group will receive a kit with informative material with the actions and procedures to follow (diet, physical activity, smoking cessation, and other recommendations about secondary prevention).', 'armGroupLabels': ['Standard care group']}\n\nPrimary Outcomes:\n- {'measure': 'Physical functional capacity', 'description': 'Improvement in aerobic capacity and resistance, measured by a physical effort test', 'timeFrame': '1st month'}\n- {'measure': 'Physical functional capacity', 'description': 'Improvement in aerobic capacity and resistance, measured by a physical effort test', 'timeFrame': '6th month'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.2, standard deviation of 80 m, and a power of 80%.", "answer": 284, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The six-minute walk test is sensitive and specific in measuring changes in functional capacity. Evidence shows the minimum clinically-relevant difference is 30\u00c2\u00a0m [31, 32]. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, with a standard deviation of 80\u00c2\u00a0m in the six-minute walk test, 284 participants (142 in the intervention group and 142 in the control group) will be required to detect differences of\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008930\u00c2\u00a0m. To achieve adequate participant enrollment and reach the minimum sample size, we analyzed the incidence of new AMI in the six PHC areas and foresee that three years will be sufficient to reach the minimum sample size.", "id": 1362, "split": "test"} +{"trial_id": "NCT05286619", "pmid": "39627139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)\n\nIncluded conditions:\n- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'Pembrolizumab plus Platinum and Gemcitabine', 'type': 'EXPERIMENTAL', 'description': 'Pembrolizumab 200 mg will be administered as 30-minute IV infusion Day 1 of every 3 weeks. Pembrolizumab will be administered first followed by the platinum and gemcitabine infusions. Cisplatin will be administered on Day 1 and 8 of each 3-weeks treatment cycle with a dose of 35 mg/m2 for 60 minutes. Carboplatin will be administered on Day 1 of each 3-weeks treatment cycle given as a dose of AUC 5 for 60 minutes. Gemcitabine will be administered on Day 1 and 8 of each 3-weeks treatment given as a dose of 1250 mg/m2 for 30 minutes. AEs associated with pembrolizumab exposure, including coadministration with additional compounds, may represent an immunologic aetiology. If one or all of the chemotherapy components is discontinued, subjects can continue with pembrolizumab up to the full 35 cycles.', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Gemcitabine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab 200mg will be administered on Day 1 every 3 weeks for up to 24months', 'armGroupLabels': ['Pembrolizumab plus Platinum and Gemcitabine']}\n- {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin at 35 mg/m2 IV using a split dose regimen on Day 1 and Day 8 of each 3-week cycle, up to 6 cycles.', 'armGroupLabels': ['Pembrolizumab plus Platinum and Gemcitabine']}\n- {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'Carboplatin at AUC 5 IV on Day 1 of each 3-week cycle, up to 6 cycles.', 'armGroupLabels': ['Pembrolizumab plus Platinum and Gemcitabine']}\n- {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine 1250mg/m2 IV on Day 1 and Day 8 of each 3-week cycle, up to 6 cycles', 'armGroupLabels': ['Pembrolizumab plus Platinum and Gemcitabine']}\n\nPrimary Outcomes:\n- {'measure': 'Objective Response Rate (ORR)', 'description': 'To determine Objective Response Rate (ORR) per RECIST 1.1 to treatment of pembrolizumab plus platinum and gemcitabine in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming power of 0.80 and Type 1 error rate (\u03b1, one-sided) of 0.10. An estimated 10% attrition rate is also considered.", "answer": 63, "answer_type": "ESTIMATED", "explanation": "Sample size, the two-staged procedures\n The study will be conducted using the Optional Simon optimal 2-stage design.14 We hypothesised that the response rate to pembrolizumab in combination with platinum and gemcitabine in R/M HNSCC patients will be 36%. The null hypothesis and alternative hypothesis of the Simon 2-stage design is 23% and 36%, respectively. Assuming power of 0.80 and Type 1 error rate (\u00ce\u00b1, one-sided) of 0.10, 26 evaluable patients will be accrued in stage 1. An interim analysis will be performed and if six or fewer patients out of the 26 evaluable patients achieve CR/PR, the study will be stopped early for futility. Otherwise, 37 additional patients will be accrued for a total of 63 patients. Considering an estimated 10% attrition rate, we plan to enrol up to 69 patients to have 63 patients with evaluable response. The null hypothesis will be rejected if there are 19 or more responses observed in 63 evaluable patients, which would be sufficiently interesting to warrant further investigation in later trials.", "id": 1363, "split": "test"} +{"trial_id": "NCT05287542", "pmid": "38167204", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Releasing Residual Cognitive Capacity After Acquired Brain Injury: A Randomized Controlled Trial Using Hypnotic Suggestion in Rehabilitation of Working Memory\n\nIncluded conditions:\n- Cognitive Rehabilitation\n- Brain Injuries\n- Cognitive Impairment\n- Working Memory\n\nStudy Armgroups:\n- {'label': 'Hypnotic suggestion', 'type': 'EXPERIMENTAL', 'description': 'During the first phase of the study, two groups will receive identical hypnotic inductions followed by targeted suggestion for one group and non-targeted suggestion for the other. The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity.', 'interventionNames': ['Other: Hypnotic suggestion']}\n- {'label': 'Mindfulness', 'type': 'ACTIVE_COMPARATOR', 'description': 'The targeted procedure consists of suggestions about enhancing WM functions through the instantiation of preinjury WM ability in the present using age regression and visualizations of brain plasticity.', 'interventionNames': ['Other: Mindfulness']}\n- {'label': 'No treatment', 'type': 'NO_INTERVENTION', 'description': 'The passive control group receives no intervention'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Hypnotic suggestion', 'description': 'The intervention group will receive four weekly 60 min. sessions with hypnosis treatment including induction followed by hypnotic suggestion.', 'armGroupLabels': ['Hypnotic suggestion']}\n- {'type': 'OTHER', 'name': 'Mindfulness', 'description': 'The active control group will receive four weekly 60 min. sessions of induction and mindfulness-based instructions.', 'armGroupLabels': ['Mindfulness']}\n\nPrimary Outcomes:\n- {'measure': 'Change in WM on neuropsychological tests', 'description': 'Measured by the WM Index WAIS IV', 'timeFrame': 'Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)'}\n- {'measure': 'Change in WM-related symptoms in everyday life', 'description': 'Assessed with the WM subscale from the Behavior Rating Inventory of Executive functioning Adult version (BRIEF-A) on a 3-point scale: Never a problem, sometimes a problem or often a problem. Higher scaled score indicates higher level of problems with WM.', 'timeFrame': 'Change from Baseline (T1) to immediately after the intervention period (T2) and 8 months after Baseline (T3)'}\n\nPlease estimate the sample size based on the assumption: \n1% significance level, 90% power, 20-25% dropout rate.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n Although Lindel\u00c3\u00b8v et al. [4] found large treatment effects, their novel and unreplicated nature causes us to design a study that will also be informative with medium effect sizes. We set a sample size so that we can detect clinically meaningful changes of 0.5 SD on the primary outcome measures, i.e., the WAIS-IV Working Memory Index and BRIEF-A Working Memory Scale. Computed in G*Power, the group \u00c3\u0097 time within-between interaction effect would require 22 completers in each group for a medium-sized effect (\u00ce\u00b7p2 = 0.07), 1% significance level (due to corrections for multiple testing), and a power of 90%. Allowing for a 20\u00e2\u0080\u009325% drop-out rate brings the required sample to 30 participants per group, i.e., a total of n = 90. The success criterion in this study is thus defined as medium effect sizes (\u00ce\u00b7p2 = 0.07).", "id": 1364, "split": "test"} +{"trial_id": "NCT05289258", "pmid": "36175973", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial\n\nIncluded conditions:\n- Cancer, Breast\n\nStudy Armgroups:\n- {'label': 'Neuropsychological treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'Combination of different neuropsychological rehabilitation programs', 'interventionNames': ['Behavioral: Neuropsychological treatment']}\n- {'label': 'Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).', 'type': 'EXPERIMENTAL', 'description': 'This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED).', 'interventionNames': ['Behavioral: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).']}\n- {'label': 'Waitlist group', 'type': 'OTHER', 'description': 'The control group will receive the Adapted Mnesic Cognitive Training (ACTIVE) (Jobe, et al., 2001), as well as the Insight (Posit Science) program (Mahncke et al., 2006) once the interventions in groups 1 and 2 have been completed.', 'interventionNames': ['Behavioral: Waitlist group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Neuropsychological treatment', 'description': 'combination of the programs tested by (Von Ah et al. 2012). These programs are, on the one hand, a cognitive training adapted from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) (Jobe et al., 2001) and, on the other, a processing speed training using the Insight program (from Posit Science) (Mahncke et al., 2006). The first consists of teaching patients memorization techniques, and the second consists of a series of exercises on information processing of varying difficulty. These exercises automatically adjust your difficulty to maintain an 85% rate of return. Treatment is carried out in groups of 10 cancer survivors. It consists of 10 weekly sessions of 2 hours each (the first hour for memory training and the second for processing speed exercises). In order to improve the adherence to treatment of the participants, emails and telephone text messages will be sent with reminders of appointments and tasks to be performed.', 'armGroupLabels': ['Neuropsychological treatment']}\n- {'type': 'BEHAVIORAL', 'name': 'Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).', 'description': \"This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED). Therefore, it focuses on the adaptive value of emotions and promotes tolerance to intense emotions as well as the identification and modification of dysfunctional emotional regulation strategies. Patients receive 10 group therapy sessions (3-5 cancer survivors per group) with all PU modules (Barlow et al., 2011). The Spanish version of the therapist's guide and the patient's workbook are used (Barlow et al., 2015). All patients receive the workbook to help them read the contents of each session, do the recommended exercises between sessions, and to help them once the treatment is finished. The treatment lasts 10 weeks (one session a week). As in the previous intervention group, emails and telephone text messages will be used with reminders of appointments and tasks to be carried out.\", 'armGroupLabels': ['Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).']}\n- {'type': 'BEHAVIORAL', 'name': 'Waitlist group', 'description': 'The control group will receive the Adapted Mnesic Cognitive Training (ACTIVE) (Jobe, et al., 2001), as well as the Insight (Posit Science) program (Mahncke et al., 2006) once the interventions in groups 1 and 2 have been completed.', 'armGroupLabels': ['Waitlist group']}\n\nPrimary Outcomes:\n- {'measure': 'Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog).', 'description': 'This is an instrument developed to assess chemotherapy-induced cognitive problems in cancer patients. It includes four different subscales: Perceived Cognitive Impairments (score range from 0-72), Impact of Perceived Cognitive Impairments on QoL (score range from 0-16), Comments from Others (score range from 0-16), and Perceived Cognitive Abilities (scores range from 0-28) that are scored using a Likert scale of five points from 0 (never) to 4 (several times a day). The higher the score, the better the cognitive function', 'timeFrame': 'Change of mean scores from baseline to immediately after intervention'}\n- {'measure': 'Memory Failures Everyday (MFE-30).', 'description': 'It is a unifactorial questionnaire that measures a single construct: \"cognitive complaints\". It is made up of 30 items that are answered on a 5-point Likert scale from 1 (never) to 4 (always or almost always) with higher scores indicate poorer memory function. Scores are from 1 to with higher scores indicating higher memory impairments', 'timeFrame': 'Change of mean scores from baseline to immediately after intervention'}\n- {'measure': 'Hopkins Verbal Learning Test-Revised (HVLT-R).', 'description': 'This test measures primary and secondary memory, the rate of verbal learning throughout three trials, as well as three forms of mnesic organization: serial ordering, semantic grouping, and subjective organization. The test consists of a list of 12 words that are presented orally at a speed of one word for every two seconds. a higher number of words is interpreted as better recall and recognition', 'timeFrame': 'Change of mean scores from baseline to immediately after intervention'}\n- {'measure': 'Trail Making Test (TMT).', 'description': 'The TMT consists of two parts: Part A measures attention, processing speed, visual search, and working memory; on the other hand, part B is used to measure attention, executive function (cognitive flexibility, ability to change tasks, coordination of categories), working memory, visual-motor skills and processing speed. A greater time to complete the tasks is interpreted as a greater deterioration', 'timeFrame': 'Change of mean scores from baseline to immediately after intervention'}\n- {'measure': 'Controlled Oral Word Association Test (COWAT).', 'description': 'The COWAT is a test that measures verbal fluency and is a recognized and sensitive indicator of cognitive functioning. the participant has to say as many words as possible in one minute, and a greater number of words is associated with greater verbal fluency.', 'timeFrame': 'Change of mean scores from baseline to immediately after intervention'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 0.80, alpha level of 0.05, correlation between repeated measures of 0.5, and a participant withdrawal rate of 13%.", "answer": 123, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size has been estimated based on data obtained in a similar randomized trial with cancer patients of different types [12]. This study examined the effect of a cognitive rehabilitation program on cognitive impairment compared to a control group. The results showed a moderate effect size of 0.49 at post-treatment. Given these results, a medium effect size of 0.5 (d index) has been assumed to detect differences between the interventions and the waitlist group. Because no software was available to determine the sample size for linear mixed model analyses, we used the f index of G*Power. Therefore, an effect size of 0.25 (f index) is assumed, equivalent to d = 0.5. Thus, with a statistical power of 0.80, an alpha level of 0.05, a correlation between repeated measures of 0.5 and three groups, a total sample of 108 participants (36 participants in each group) is required. Previous studies have reported a participant withdrawal rate of around 13% [12]. Therefore, assuming this withdrawal rate, the total sample would be 123 participants, 41 per group.", "id": 1365, "split": "test"} +{"trial_id": "NCT05290285", "pmid": "36759873", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Tolerability of a Specific Blend of Amino Acids in Patients With Anorexia Nervosa Treated in a Hospital Setting. Double-blind Randomized Study Versus Placebo\n\nIncluded conditions:\n- Anorexia Nervosa\n\nStudy Armgroups:\n- {'label': 'EAA supplementation', 'type': 'EXPERIMENTAL', 'description': 'The EAA blend consists of a complex blend of essential amino acids, including some precursors of neurotransmitters that are important for regulating mood. In particular, phenylalanine, a precursor of tyrosine (non-essential amino acid) is involved in the biosynthesis of catecholamines (noradrenaline, adrenaline, dopamine) and tryptophan is the precursor of serotonin. Furthermore, the amino acids present in the mixture and the precursors of the Krebs cycle (citrate, malate, succinate) are able to stimulate mitochondrial bioenergetics by improving metabolism and muscle function.\\n\\nThe EAA blend will be administered orally at 4.5 g twice daily (two sachets of Amino-Ther Pro per day).', 'interventionNames': ['Dietary Supplement: Amino-Ther Pro']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo is an isocaloric product containing maltodextrins instead of amino acids (Acquilani et al., 2011). The placebo will be administered orally 4.5 g twice daily.', 'interventionNames': ['Dietary Supplement: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Amino-Ther Pro', 'description': 'Food supplements', 'armGroupLabels': ['EAA supplementation']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Lean body mass', 'description': \"Percentage change in patient's lean body mass with weight gain at the end of hospital treatment, measured using the DXA (Prodigy Primo Lunar, A223040501, General Electric Company, Madison. WI 53707-7550, USA-EnCORE TM 2009 (v13.31) software)\", 'timeFrame': 'From baseline (admission to inpatient) to end of hospitalization (after 13 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level, power, and other statistical parameters are not explicitly mentioned. The intervention interruption rate is set at 15%.", "answer": 92, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Since this is an efficacy study, the primary data evaluation will be the analysis of completers. The primary outcome of interest is the percentage increase in the patient\u00e2\u0080\u0099s LBM with weight recovery at the end of the intensive treatment. The sample size was determined based on the difference between the intervention group and the control group on the change in LBM between baseline and end of treatment. We hypothesized, referring to the data of our previous study [27], that the control group could have an 8.8% increase in LBM, while the intervention group could have a further 2% increase in LBM [48, 49] to reach a variation of LBM of 10.8%. The standard deviation assumed for the sample size calculation is 3.2%.\n Based on these premises, will be necessary to have a group of completers of 80 patients at the end of the treatment (i.e., 40 patients per treatment condition). To calculate the initial sample needed to generate 80 patients at the end of treatment, we considered the intervention interruption rate (set at 15%). This calculation results from an initial sample of 92 patients (46 per treatment condition).", "id": 1366, "split": "test"} +{"trial_id": "NCT05290532", "pmid": "39232792", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline, in Elderly Patients Undergoing Urgent Abdominal Surgery: A Randomized Clinical Trial\n\nIncluded conditions:\n- Surgery--Complications\n\nStudy Armgroups:\n- {'label': 'Individualized exercise training', 'type': 'OTHER', 'description': 'Exercise training. Individual program training 2 days per week during 4 week, after one week of discharge', 'interventionNames': ['Other: Individualized exercise training']}\n- {'label': 'No Intervention: Control', 'type': 'NO_INTERVENTION', 'description': 'Usual care including rehabilitation when necessary'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Individualized exercise training', 'description': 'The intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. This training period consist on 2 training sessions of 40 minutes (Warm up 5\u00b4+ aerobic exercise 15\u00b4+ anaerobic exercise 15\u00b4+ stretching 5\u00b4)per week during 4 weeks after one week of discharge', 'armGroupLabels': ['Individualized exercise training']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in functional capacity of patients', 'description': 'The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB), which evaluates, balance, gait ability, and leg strength using a single tool. The total score will range from 0 (worst) to 12 points (best).', 'timeFrame': '1, 3 and 6 months after hospitalization discharge'}\n- {'measure': 'Changes in Cognitive capacity of patients', 'description': 'The cognitive-affective status will be measured in the follow up using the Mini Mental State Examination.nThis examination is composed of seven categories designed to assess specific cognitive functions: orientation to time (5 points), orientation to place (5 points), registration of three words (3 points), attention and calculation (5 points), recalling the three words (3 points), language (8 points) and constructive visual capacity (1 point). The MMSE score ranges from zero to 30 points, and lower values indicate possible cognitive deficit', 'timeFrame': '1, 3 and 6 months after hospitalization discharge'}\n- {'measure': 'Changes in Quality of life', 'description': 'Changes in Quality of life will be evaluated by European Quality of Life-5 Dimensions (EuroQol- 5D).\\n\\nEuropean Quality of Life-5 Dimensions: comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels, the score will range from 5 (wort) to 15 (best).', 'timeFrame': '1, 3 and 6 months after hospitalization discharge'}\n- {'measure': 'Changes in Visual Analogue Scale', 'description': \"Changes in Visual Analogue Scale (VAS). The 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' (100 points) and 'The worst health you can imagine'(0 points).\", 'timeFrame': '1, 3 and 6 months after hospitalization discharge'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, power of 90%, correlation between pre and post-intervention values of 0.6, standard deviation for the SPPB of 2.5, and a 20% dropout rate.", "answer": 218, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Assuming a type I error of 0.05, a correlation between pre and post-intervention values of the Short Physical Performance Battery (SPPB) of r\u00e2\u0080\u0089=\u00e2\u0080\u00890.6 and a standard deviation for the SPPB of 2.5, the required sample size to detect with a power of 90% a minimum difference of 1 point between groups in the change of SPPB score is 87 patients per group [27]. Assuming losses of 20%, the final objective of the size of each group is 109 patients, and, consequently, a total sample size will be 218 subjects. For the estimation, an ANCOVA method for the analysis of the differences has been considered. The outcome variables will be analyzed using mixed models, without missing data imputation. If the proportions of missing data are very large (more than 40%) on important variables, then trial results will be considered as hypothesis-generating results.\n Baseline values will be compared by group using descriptive statistics as mean and standard deviation or median and interquartile range for quantitative variables and frequencies and percentages for categorical ones. To determine the efficacy of the intervention in the quantitative variables, such as the SPPB, we will use ANCOVA models, using post-intervention value as dependent variable, group study as the principal effect and pre-intervention value as covariate. If relevant group differences were observed at baseline, we would adjust for these variables in the model. In the case of qualitative or categorized variables (such as whether an improvement of a given magnitude between pre and post-intervention has been achieved or not), comparisons between groups will be conducted with the chi-square test or Fisher\u00e2\u0080\u0099s test, and complemented with logistic regression if additional adjustment is needed.\n The level of statistical significance will be 0.05. Data will be analyzed using an intention-to-treat approach and using SPSS and R statistical software.", "id": 1367, "split": "test"} +{"trial_id": "NCT05293041", "pmid": "37620260", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Influence of Argipressin on Blood Loss During Hepatic Resection; a Double-blinded, Randomized Placebo-controlled Trial (ARG-01)\n\nIncluded conditions:\n- Colon Cancer Liver Metastasis\n- Inflammatory Response\n- Vasopressin Causing Adverse Effects in Therapeutic Use\n\nStudy Armgroups:\n- {'label': 'Argipressin', 'type': 'EXPERIMENTAL', 'description': 'Patients will be treated with Empressin\u00ae 0.8 U/ml, 0.056 ml/kg/h during surgery.', 'interventionNames': ['Drug: Argipressin']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will receive normal saline 0.056 ml/kg/h during surgery.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Argipressin', 'description': 'Infusion of Argipressin 0.8 U/ml, 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the treatment arm.', 'armGroupLabels': ['Argipressin'], 'otherNames': ['Arg']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Infusion of Normal Saline 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the placebo arm.', 'armGroupLabels': ['Placebo'], 'otherNames': ['control']}\n\nPrimary Outcomes:\n- {'measure': 'Blood loss', 'description': \"Blood loss at the end of surgery, measured according to the investigator's instructions, by visual assessment of suction devises and gauze, and subtraction of ascites and irrigation fluids.\", 'timeFrame': 'through surgery, an average of 8 hours'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 80%, and a dropout rate of 5%.", "answer": 248, "answer_type": "ACTUAL", "explanation": "Sample size\n Calculation of sample size was performed based on data from open and laparoscopic liver resections performed at Sahlgrenska University Hospital during the period January 2019 to October 2020. Log-transformation of the blood volume variable normal distribution was applied. The sample size calculation was performed using a two-sided t-test on the log-transformed variable that will correspond to the selected method for the primary analysis, that is, generalised linear model with lognormal distribution. To be able to find at least 35% reduction in the mean blood loss in the treatment arm compared with the placebo arm (962\u00e2\u0080\u0089mL vs 625\u00e2\u0080\u0089mL, respectively), that is, a difference of at least 0.43 in the log-scale assuming SD of 1.17, with a level of significance of 5%, and a power of 80%, 118 patients are needed to be included in each arm. Assuming a dropout rate of 5%, 248 patients in total will need to be included, 124 patients in each arm. A limited number of patients will be discovered fulfilling the exclusion criteria after randomisation and after start of surgery. Since the investigational product is given from the start of surgery these patients will be part of the safety population and their outcome regarding survival will be collected at the end of the study (30 days). In these cases, surgery will be immediately stopped, and they will be excluded from the study and the modified intention-to-treat (mITT) population, that is, all efficacy analyses. To account for these dropouts 248 mITT evaluable patients will be included, but not more than 272 randomised patients in total.\n For the subgroup analysis 44 patients in the argipressin and placebo arm, respectively, will be included (total n=88). The number of patients selected for extended inflammatory testing is based on a pilot study performed by Wis\u00c3\u00a9n et al (\u00e2\u0080\u0098Myocardial, renal and intestinal injury in liver resection surgery-A prospective observational pilot study\u00e2\u0080\u0099; data regarding inflammatory response was generated, but not published), performed at Sahlgrenska University Hospital.17", "id": 1368, "split": "test"} +{"trial_id": "NCT05294081", "pmid": "38468293", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EFFECT-BACK: Tackling Back Pain - Effects of Exposure Therapy and Cognitive Behavioural Therapy for Chronic Back Pain\n\nIncluded conditions:\n- Chronic Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Exposure (EXP)', 'type': 'EXPERIMENTAL', 'description': 'Exposure in vivo for fear avoidant chronic low back pain patients. This treatment means that the individual is exposed to movements and tasks that have been avoided due to fear of (re)injury. The treatment begins after three educational lessons including the rational and developing a fear hierarchy. Exposure phase includes 10 exposures sessions which are highly individualized. Behavioral experiments can be included to correct catastrophic misinterpretations. The main purpose of this intervention type is to reduce pain related disability via diminishing fear avoidance.', 'interventionNames': ['Behavioral: Exposure therapy']}\n- {'label': 'Cognitive Behavioural Therapy (CBT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Cognitive behavioural psychotherapy for fear avoidant chronic low back patients. The therapy is modularized in three main parts. The educational lesson is followed by the module graded activity which represents the behavioral part of the program. The second module comprises relaxation. And the last part contains cognitive interventions. Cognitive behavioural intervention techniques are employed to support the patient in the process of coping with chronic pain: i.e. reduction of disability and improving functional ability.', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exposure therapy', 'description': '10 sessions based on an individualized pain hierarchy', 'armGroupLabels': ['Exposure (EXP)']}\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive behavioral therapy', 'description': '10 sessions with graded activity, relaxations techniques and cognitive interventions', 'armGroupLabels': ['Cognitive Behavioural Therapy (CBT)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in pain related disability', 'description': 'Clinically significant change in pain-related impairment at the end of therapy and at 6-months and 2-years follow-up compared to baseline.\\n\\nQuebec Back Pain Disability Scale (QBPDS). Each item is scored from 0 to 5 (0 = not difficult at all, 5 = unable to do). Higher total scores reflect higher disability.', 'timeFrame': 'from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months after Posttest and 2 years after Posttest)'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided chi-square test will be used with a significance level of 0.05 and a power of 80%. A dropout rate of 20% is expected based on comparable studies and the pilot study.", "answer": 380, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on the results of the pilot study, 44% of the subjects in CBT and 65% of the subjects in the short EXP condition showed a clinically significant change in pain-related impairment [19], researchers suppose a conservative response rate of 60% in the EXP condition. Using a two-sided chi-square test to detect this effect at a significance level of 0.05 and a power of 80%, 152 patients per group are required. The use of a mixed logistic model that includes baseline QBPDS, HADS, BAT-BACK, and PHODA scores as fixed effects and the study center as a random effect in addition to the treatment group is expected to increase the power of the analysis. Based on comparable studies [16, 21] in this research area and the pilot study [19], a dropout rate of 20% is expected. To account for these expected dropouts, 380 participants (190 per group) will be randomized. The sample size calculations were performed with PASS 14.0.8 [45].", "id": 1369, "split": "test"} +{"trial_id": "NCT05294796", "pmid": "37216357", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Different Antimicrobial Durations for the Treatment of Infections Associated With Osteosynthesis Material Implanted After Long Bone Fractures (DURATIOM). Phase 3 Pragmatic Multicenter Open Labelled Randomized Trial.\n\nIncluded conditions:\n- Infections\n\nStudy Armgroups:\n- {'label': 'Short course of antibiotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients enrolled in this arm, will receive 8 weeks of antibiotherapy in case of early infection (\\\\< 2 week), and 12 weeks of antibiotherapy in case of delayed infection (2-10 weeks)', 'interventionNames': ['Combination Product: Short course of antibiotherapy']}\n- {'label': 'Long course of antibiotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients enrolled in this arm, will receive 12 weeks of antibiotherapy in case of early infection (\\\\< 2 week), and until fracture healing of antibiotherapy in case of delayed infection', 'interventionNames': ['Combination Product: Long course of antibiotherapy']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Short course of antibiotherapy', 'description': 'Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material', 'armGroupLabels': ['Short course of antibiotherapy']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Long course of antibiotherapy', 'description': 'Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material', 'armGroupLabels': ['Long course of antibiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with clinical cure in the test of cure', 'description': 'A success at the test of cure is the resolution of infection symptoms, the absence of clinical signs and symptoms of infection (persistence of symptoms of infection, relapse of infection after a period without symptoms, or superinfection by a different microorganism) without antibiotic therapy and with C-reactive protein \\\\<10 mg/L (unless another cause justifies a higher C-reactive protein value); If the patient dies, when the death was not related to the infection; and no need for chronic suppressive antibiotic therapy to \"control\" of the infection.', 'timeFrame': '12 months after completion of antimicrobial treatment'}\n- {'measure': 'Radiological healing in the test of cure', 'description': 'Radiological healing is defined as the presence of radiological signs of fracture consolidation (plain radiographic or CT) of the infected bone. Non-union or absence of consolidation of a fractured bone is defined when it has not completely healed within 9 months after osteosynthesis surgery or when it has not shown progression towards fracture callus formation in 3 consecutive months on serial radiographs.\\n\\nThe REBORNE fracture healing scale will be used for a more accurate assessment of fracture healing on radiographs, or CT if necessary.', 'timeFrame': '12 months after completion of antimicrobial treatment'}\n- {'measure': 'Definitive soft tissue coverage at test of cure', 'description': 'Number of patients who present definitive soft tissue coverage at test of cure', 'timeFrame': '12 months after completion of antimicrobial treatment'}\n\nPlease estimate the sample size based on the assumption: \n5% level of significance (\u03b1 value), 80% power, and 15% loss rate.", "answer": 364, "answer_type": "ESTIMATED", "explanation": "Sample size\n To our knowledge, no previous trials on IOM treatment had been performed; a meta-analysis of observational studies found a clinical cure of IOM when DAIR was performed (regardless antimicrobial therapy duration) of 86\u00e2\u0080\u0093100% in early IOM, and 82\u00e2\u0080\u009389% in delayed IOM. Although our primary outcome is a composite outcome including clinical cure, radiological healing and soft tissue coverage which might reduce the cure rate, but the fact that in this randomized trial we will only include patients in whom a debridement is performed, we estimated that 85% of patients in both arms will reach that primary outcome. With a 10% non-inferiority margin, a 5% level of significance (\u00ce\u00b1 value) set at 5%, 80% power, and 15% loss rate, we would need to recruit 182 patients per arm (364 in total). Subgroups analyses for the primary outcome as defined above will be exploratory, as demonstration of non-inferiority in each of them is unfeasible.\n Interim analysis will be conducted when 75 patients have been included to assess the frequency of the event rate and inclusion rate to adjust the intended size of the study population.", "id": 1370, "split": "test"} +{"trial_id": "NCT05295108", "pmid": "36400737", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Caring Connections: a Program to Alleviate Social Isolation and Loneliness in Individuals Living with Spinal Cord Injury\n\nIncluded conditions:\n- Spinal Cord Injuries and Disorders (SCI/D)\n\nStudy Armgroups:\n- {'label': 'Caring Connections intervention', 'type': 'EXPERIMENTAL', 'description': 'The Caring Connections intervention will consist of non-demanding, messages of care and concern delivered to individuals with SCI/D who had moderate to high social isolation and/or loneliness scores on the baseline survey. The caring messages will be in the form of structured, yet personalized mailed letters from one consistent peer with SCI/D, providing long-term and steady contact. Intervention participants will receive a letter every month over a 6-month period. Following a standardized set of principles, letters will contain cheerful expressions of care and micro-moments of positivity. The PI/Co-Is will provide a brief training and work with volunteer peers with SCI/D to write the letters.', 'interventionNames': ['Other: Caring Connections']}\n- {'label': 'Attention control', 'type': 'ACTIVE_COMPARATOR', 'description': 'We will mail informational materials to individuals with SCI/D in our control group at the same timepoints over 6 months as our intervention letter mailings. The informational materials will discuss life domains that are important to a good quality of life. Topics include community living, physical/healthy living, safety and security, social/spirituality, advocacy/engagement, and employment/volunteering. We will draw information for each topic from the Knowledge Translation Center SCI Factsheets (MSKTC 2021) and the LifeCourse Nexus library (2021).', 'interventionNames': ['Other: Attention control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Caring Connections', 'description': 'peer-based letter writing social connectedness intervention to improve social health outcomes', 'armGroupLabels': ['Caring Connections intervention']}\n- {'type': 'OTHER', 'name': 'Attention control', 'description': 'informational materials provided to educate on life domains that are important to social health', 'armGroupLabels': ['Attention control']}\n\nPrimary Outcomes:\n- {'measure': 'loneliness', 'description': 'UCLA 3-item Loneliness Scale', 'timeFrame': 'change from baseline to post-RCT (6 months)'}\n\nPlease estimate the sample size based on the assumption: \ncommon SD of 0.6, significance level not explicitly stated, power \u2265 0.80", "answer": 62, "answer_type": "ACTUAL", "explanation": "Sample size determination for RCT\n We based our sample size determination on the range of minimum effect sizes reported in a meta-analysis of loneliness interventions.42 We conservatively estimated that there will be a 4.63% reduction in the primary outcome, the loneliness score, of the intervention arm compared with the attention control arm. The sample size of 62 will satisfy the hypothesis that will be tested using loneliness score reduction over 6 months. We varied our effect size from 0.2 to 0.5, as reported by Masi et al42 for loneliness intervention trials and assumed a common SD between the different arms to be 0.6. Assuming an effect size of 0.3 and a common SD of 0.6, a sample size of 62 will provide adequate power (\u00e2\u0089\u00a50.80) for the RCT.", "id": 1371, "split": "test"} +{"trial_id": "NCT05295173", "pmid": "38286482", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase III, Multicenter, Randomized, Blind Endpoint and Positive Drug Control Study of Recombinant Human Tissue Plasminogen Kinase Derivatives for Injection in the Treatment of Patients With Acute Ischemic Stroke\n\nIncluded conditions:\n- Acute Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'experimental group', 'type': 'EXPERIMENTAL', 'description': 'Recombinant human tissue plasminogen kinase derivatives(r-PA) for injection: the first intravenous bolus injection of 18mg, after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time. Subjects were closely monitored during the treatment period and within 24 hours after administration.', 'interventionNames': ['Drug: Injection of recombinant human tissue plasminogen kinase derivatives']}\n- {'label': 'comparative group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Recombinant human tissue plasminogen activator (rt-PA) for injection: 0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h. Subjects should be closely monitored during the treatment period and within 24 hours after administration.', 'interventionNames': ['Drug: Recombinant human tissue plasminogen activator']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Injection of recombinant human tissue plasminogen kinase derivatives', 'description': '18mg/10ml/stick, provided by Angde Biotech', 'armGroupLabels': ['experimental group'], 'otherNames': ['Reteplase', 'brand name: Ruitongli', 'r-PA']}\n- {'type': 'DRUG', 'name': 'Recombinant human tissue plasminogen activator', 'description': '20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.', 'armGroupLabels': ['comparative group'], 'otherNames': ['Alteplase', 'brand name: Actilyse', 'rt-PA']}\n\nPrimary Outcomes:\n- {'measure': 'Functional handicap', 'description': 'Proportion of patients achieving a Modified Rankin Scale score of 0 to 1 on the 90th day after treatment.\\n\\nThe Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0-5. A separate category of 6 is usually added for patients who expire. The higher the score, the more severe the stroke.', 'timeFrame': 'on the 90th day after treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumed a 62.5% proportion of the primary outcome for alteplase, 80% power, a 3% dropout rate at 90 days, and a significance level implied by the 95% CI.", "answer": 1412, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n The sample size was calculated based on the primary efficacy outcomes and non-inferiority research design. In the RAISE study, the non-inferiority criterion was set to preserve at least 50% of the alteplase efficacy effect, which was a somewhat conservative estimate. Since the lower limit of 95%\u00e2\u0080\u0089CI of rt-PA relative ratio (RR) was 1.15 compared with placebo,4 5 the non-inferiority margin of r-PA to rt-PA was set to be 0.93 (calculated as \u00e2\u0080\u00931/(exp(Log(1.15))/2)). With the assumed 62.5% proportion of the primary outcome for alteplase, the determined sample size of 1412 (706 in each treatment group) would provide 80% power, allowing for a 3% dropout rate at 90 days. The probability of at least one death or symptomatic intracranial haemorrhage occurrence was estimated to be >99% among 1412 patients based on the incidence of symptomatic intracranial haemorrhage and death among patients with acute ischaemic stroke (1% incidence for symptomatic intracranial haemorrhage20 and 5% for death.23", "id": 1372, "split": "test"} +{"trial_id": "NCT05300776", "pmid": "37612723", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-center Prospective Clinical Study of M-ROSE Combined With mNGS to Guide the Individualized Anti-infection Treatment, Prevention and Control of Drug-resistant Bacteria in Severe Hospital-acquired Pneumonia\n\nIncluded conditions:\n- Pneumonia\n\nStudy Armgroups:\n- {'label': 'M-ROSE combined with mNGS group', 'type': 'EXPERIMENTAL', 'description': 'The bronchoalveolar lavage fluid (BALF) of patients undergoes M-ROSE analysis and decide whether the samples are qualified, whether they indicate bacterial infection and identify pathogens, and the qualified samples are sent for mNGS analysis. The individualized anti-infection treatment is comprehensively guided according to the results of M-ROSE, mNGS and clinical examinations.', 'interventionNames': ['Diagnostic Test: M-ROSE analysis']}\n- {'label': 'mNGS group', 'type': 'NO_INTERVENTION', 'description': 'BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'M-ROSE analysis', 'description': 'The M-ROSE analysis process consists of 3 procudures.\\n\\n1. Specimen quality assessment. The BALF undergoes the process of smear, diff-quik stain, gram stain and are analyzed by experts to report the cytoloy and pathogen patterns to determine whether the sample is qualified according to the cell proportions. The qualified BALF samples are: squamous epithelial cell proportion\\\\<1%, columnar epithelial cell proportion \\\\<5% .\\n2. Distinguish infection and colonization. According to the cytoloy pattern, the proportion of neutrophils \\\\> 50% often strongly suggests pulmonary bacterial infection; Neutrophil phagocytosis proportion\\\\> 5% indicates infection, and phagocytosis of bacteria is the pathogen. Besides, fungal and hyphae can be found under the microscope.\\n3. Preliminary identification of infectious pathogens. Identify the infected bacteria and fungi, and the results are gram-positive cocci, gram-positive bacilli, gram-negative cocci, gram-negative bacilli, yeasts and molds.', 'armGroupLabels': ['M-ROSE combined with mNGS group']}\n\nPrimary Outcomes:\n- {'measure': 'mortality', 'description': 'Alive or Dead.', 'timeFrame': 'During the intervention.'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 = 0.05 (two-sided test), \u00ce\u00b2 = 0.20, and an attrition rate of 10%.", "answer": 166, "answer_type": "ESTIMATED", "explanation": "Sample size\n In this study, a randomized controlled trial design is used to evaluate the treatment effect of M-ROSE in patients with severe hospital-acquired pneumonia. The primary outcome is ICU hospitalization clinical outcome (mortality). We assumed that \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-sided test), \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.20, and 28-day mortalities among the mNGS group and M-ROSE plus mNGS group will be 70% and 48%, respectively, according to the results of relevant research [23] and our previous study [24]. Seventy-five patients should be recruited in each group. Considering an attrition rate of 10%, the eligible participants in each group should be 83. Therefore, we determined that the sample size should be 83 in each group (n\u00e2\u0080\u0089=\u00e2\u0080\u0089166 in total).", "id": 1373, "split": "test"} +{"trial_id": "NCT05301023", "pmid": "37295836", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection\n\nIncluded conditions:\n- Febrile Urinary Tract Infection\n\nStudy Armgroups:\n- {'label': 'Individual group', 'type': 'EXPERIMENTAL', 'description': 'In the individual group, the participants receive individualized antibiotic therapy.', 'interventionNames': ['Other: Individualized antibiotic therapy']}\n- {'label': 'Standard group', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the standard group, the participants receive standard antibiotic therapy as defined by the national guideline.', 'interventionNames': ['Other: Standard antibiotic therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Individualized antibiotic therapy', 'description': 'Individualized antibiotic therapy is based on the duration of illness after treatment initiation, as the antibiotic therapy can be stopped three days after the participant has become healthy. The participant is classified as healthy if he/she is afebrile (\\\\<38.0 \u00b0C), has experienced significant clinical improvement, and have no flank pains or dysuria.', 'armGroupLabels': ['Individual group']}\n- {'type': 'OTHER', 'name': 'Standard antibiotic therapy', 'description': 'Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.', 'armGroupLabels': ['Standard group']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause', 'timeFrame': 'within 28 days after end of treatment'}\n- {'measure': 'Number of days with antibiotic therapy', 'timeFrame': 'within 28 days after treatment initiation'}\n\nPlease estimate the sample size based on the assumption: \nThe test will be conducted as a one-sided test with alpha of 2.5%. A total of 408 participants are needed to obtain a power of 80% to reject inferiority. We have accounted for a drop-out rate of 5%. A sample size recalculation will be conducted if the overall observed event proportion is higher than 7.5% when follow-up is available for the first 204 participants to achieve a power of at least 80%.", "answer": 408, "answer_type": "ACTUAL", "explanation": "Sample size determination\n We have determined our needed sample size by assessing our first co-primary outcome (ie, recurrent UTI or death of any cause) based on a non-inferiority design. We anticipate the event proportion in the control group (ie, standard duration of antibiotic therapy) to be 7.5% based on a single-centre retrospective study (non-published data by Sethi et al). We assume no difference between the randomised groups. Our non-inferiority limit corresponds to a 7.5\u00e2\u0080\u0089percentage points higher proportion in the intervention group compared with the control group. The test will be conducted as a one-sided test with alpha of 2.5%. A total of 408 participants are needed to obtain a power of 80% to reject inferiority. We have accounted for a drop-out rate of 5%.\n A sample size recalculation will be conducted if the overall observed event proportion is higher than 7.5% when follow-up is available for the first 204 participants to be able to achieve a power of at least 80%. The sample size recalculation will be blinded according to a United States Food & Drug Administration (FDA) rapport38 and Friede et al.39 The DSMC will oversee this analysis, and any changes will only be done after approval from both the DSMC and the ethics committee.", "id": 1374, "split": "test"} +{"trial_id": "NCT05302089", "pmid": "36253041", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Rehabilitation Following Non-surgical Management of Displaced Proximal Humerus Fractures: a Randomized Clinical Trial\n\nIncluded conditions:\n- Shoulder Fractures\n\nStudy Armgroups:\n- {'label': 'One-time physiotherapy instruction', 'type': 'EXPERIMENTAL', 'description': 'One-time physiotherapy instruction and no usual rehabilitation care', 'interventionNames': ['Other: Pain management and shoulder bandage', 'Other: One-time physiotherapy instruction']}\n- {'label': 'Usual rehabilitation care', 'type': 'ACTIVE_COMPARATOR', 'description': 'One-time physiotherapy instruction and usual rehabilitation care', 'interventionNames': ['Other: Pain management and shoulder bandage', 'Other: One-time physiotherapy instruction', 'Other: Usual rehabilitation care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pain management and shoulder bandage', 'description': 'All Patients receive standard pain management according to the local guidelines and a sling and swathe on the day of injury. After 10 to 14 days, all patients will receive a sling for optional use for one to two weeks and be randomized after oral and written informed consent.', 'armGroupLabels': ['One-time physiotherapy instruction', 'Usual rehabilitation care']}\n- {'type': 'OTHER', 'name': 'One-time physiotherapy instruction', 'description': 'Patients are offered a one-time physiotherapy instruction about the course of pain and suggestions for quick and safe return to activities of daily living within the first three months post-injury.', 'armGroupLabels': ['One-time physiotherapy instruction', 'Usual rehabilitation care']}\n- {'type': 'OTHER', 'name': 'Usual rehabilitation care', 'description': 'At the visit 10-14 days after the injury, the orthopaedic consultant (senior author SB) will refer the patient to usual rehabilitation care with a physiotherapist in a municipality close to the patient\u00b4s home. The physiotherapist then schedules the start date, typically three weeks after the injury. The rehabilitation content and duration is planned according to the choice of the local treating physiotherapist in consultation with the patient.', 'armGroupLabels': ['Usual rehabilitation care']}\n\nPrimary Outcomes:\n- {'measure': 'Oxford Shoulder Score (OSS)', 'description': 'Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nPower set at 80%, alpha at 5%, and a 20% lost to follow-up and conversion to surgery rate.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n The SD value of 12 for the primary outcome (OSS) was derived from Handoll 2009.12 The MCID for the OSS is in the range of 5\u00e2\u0080\u00936.9.13 In the absence of a patient-derived MCID for PHF, an MCID of 10 (corresponding to approx. 20% larger improvement on 0\u00e2\u0080\u009348 scale in the intervention group than in the control group) was taken to represent the presumptive MCID. The calculation was expected to power the study for the primary outcome measure of the OSS score. Power was set at 80%, alpha 5% and the estimated required sample size was 24 per group. A recruitment target of 60 participants (30 per group) was selected to allow a 20% lost to follow-up (three patients in each group) and conversion to surgery (three patients in each group).", "id": 1375, "split": "test"} +{"trial_id": "NCT05305508", "pmid": "38719313", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Placebo-controlled, Double-blind, Monocenter, Phase II Trial to Assess the Efficacy of Calcium Dobesilate (CaD) vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.\n\nIncluded conditions:\n- COVID-19 Virus Disease\n\nStudy Armgroups:\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.', 'interventionNames': ['Drug: Mannitol']}\n- {'label': 'Calcium Dobesilate', 'type': 'EXPERIMENTAL', 'description': 'The CaD (Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.', 'interventionNames': ['Drug: Calcium Dobesilate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Calcium Dobesilate', 'description': 'The treatment (CaD, Calcium Dobesilate 500 mg) will be administered orally twice a day for 7 days.', 'armGroupLabels': ['Calcium Dobesilate'], 'otherNames': ['DOXIUM 500, OM Pharma']}\n- {'type': 'DRUG', 'name': 'Mannitol', 'description': 'The comparator (placebo, Mannitol 500 mg) will be administered orally twice a day for 7 days.', 'armGroupLabels': ['placebo'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Primary Outcome', 'description': 'Reduction from baseline of RT-PCR SARS-CoV-2 viral load at day 4, defined by Polymerase Chain Reaction (PCR) threshold cycles. PCR reaction happens in cycles of amplification. Inclusion criteria to enter in the study is a RT-PCR positive for SARS-CoV-2, which correspond to 25 cycles (or lower) of the RT-PCR test. The participant will be tested at day 4 after treatment to evaluate if the viral load has decreased. To do that, another RT-PCR SARS-CoV-2 will be performed. A higher value of RT-PCR cycles compared to the one obtained when the participat was diagnosed COVID-19 positive, is considered a reduction from baseline.', 'timeFrame': 'baseline and day 4'}\n\nPlease estimate the sample size based on the assumption: \n80% power, a one-sided significance level of 2.5%, and patients for whom the main outcome will not be completed (VL at day 4) will be replaced", "answer": 74, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n To detect a difference of 1 log (or three cycle thresholds (CT)) in the mean reduction of SARS-CoV-2 VL determined by RT-PCR at day 4, with a 80% power, a one-sided significance level of 2.5% and assuming an SD of 1.5 log (difference to detect of 0.67 SD), calculated sample size is 37 in each arm, total of 74 patients. Patients for whom the main outcome will not be completed (VL at day 4) will be replaced.", "id": 1376, "split": "test"} +{"trial_id": "NCT05306145", "pmid": "39788775", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia\n\nIncluded conditions:\n- Benign Prostatic Hyperplasia\n\nStudy Armgroups:\n- {'label': 'High Freqnence Irreversible Electroporation', 'type': 'EXPERIMENTAL', 'description': 'Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia', 'interventionNames': ['Procedure: High freqnence Irreversible electroporation']}\n- {'label': 'Trans Urethral Resection Prostate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia', 'interventionNames': ['Procedure: Trans Urethral Resection Prostate']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'High freqnence Irreversible electroporation', 'description': 'High freqnence Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with benign prostatic hyperplasia', 'armGroupLabels': ['High Freqnence Irreversible Electroporation']}\n- {'type': 'PROCEDURE', 'name': 'Trans Urethral Resection Prostate', 'description': 'Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic', 'armGroupLabels': ['Trans Urethral Resection Prostate']}\n\nPrimary Outcomes:\n- {'measure': 'maximum urinary flow rate(Qmax)', 'description': 'the change from baseline in maximum urinary flow rate(Qmax)', 'timeFrame': '1 and 3 months after surgical treatment'}\n- {'measure': 'urination function(evaluated by International prostate symptom score, IPSS)', 'description': 'the change from baseline in IPSS (International prostate symptom score)', 'timeFrame': '1 and 3 months after surgical treatment'}\n\nPlease estimate the sample size based on the assumption: \nEqual changes in both treatment groups, SDs of 6.0 mL/s for Qmax and 4.5 points for IPSS, 1:1 randomization, 90% power, one-sided type I error rate of 2.5%, and 20% withdrawal/loss rate.", "answer": 118, "answer_type": "ESTIMATED", "explanation": "Sample size\n We will calculate the sample size based on the change in both Qmax and IPSS as co-primary outcomes and ultimately use the maximum of the two calculated sample sizes. Literature showed the minimally clinically important differences were 4 mL/s for Qmax and 2.5\u00e2\u0080\u00933 points for IPSS.18 19\n \n \n Sample size calculation based on change in Qmax (larger is better).\n \n \n Under the non-inferiority hypothesis, a margin of \u00e2\u0088\u00924 mL/s is set for change in Qmax. It is assumed that changes in Qmax are equal for both treatment groups (H-FIRE and TURP), and the SDs for the two groups are 6.0 mL/s. Patients were randomised to H-FIRE and TURP in a 1:1 ratio. With a target power of 90% and a one-sided type I error rate of 2.5%, the sample size calculation dictates 49 participants per group. Accounting for a 20% withdrawal/loss rate, the total sample size is adjusted to 118 participants.\n \n \n Sample size calculation based on change in IPSS (smaller is better).\n \n \n Under the non-inferiority hypothesis, a margin of 3 points is set for change in Qmax. Assuming equal changes in IPSS between the H-FIRE and TURP groups and equal SDs of 4.5 points, patients are randomised in a 1:1 ratio. With the same target power and type I error rate, 49 participants per group are required. Adjusting for the same withdrawal/loss rate, the total sample size is also 118 participants.\n The final sample size is determined as a total of 118 participants (59 participants in the H-FIRE group and 59 participants in the TURP group).", "id": 1377, "split": "test"} +{"trial_id": "NCT05306223", "pmid": "38561815", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China\n\nIncluded conditions:\n- Tuberculosis, Multidrug-Resistant\n\nStudy Armgroups:\n- {'label': 'Bedaquiline-containing Short-course Regimen (SCR)', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive an oral dose of bedaquiline 400 milligrams (mg) once daily for first 2 weeks followed by bedaquiline 200 mg thrice a week for 22 weeks (with at least 48 hours between doses) in combination with oral doses of levofloxacin (LFX) up to 1000 mg (weight-based), cycloserine (CS) up to 750 mg (weight-based), clofazimine (CFZ) 100 mg daily for 40 weeks and linezolid \\\\[LZD\\\\] 600 mg daily for at least 24 weeks . If a participant is still sputum culture-positive for Mycobacterium tuberculosis by Week 16, bedaquiline treatment will be extended from Week 24 to Week 40.', 'interventionNames': ['Drug: Bedaquiline', 'Drug: Levofloxacin', 'Drug: Linezolid', 'Drug: Cycloserine', 'Drug: Clofazimine']}\n- {'label': 'Non-bedaquiline-containing Short-course Regimen (SCR)', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive oral doses of LFX up to 1000 mg (weight-based), CS up to 750 mg (weight-based), CFZ 100 mg, Pyrazinamide (PZA) up to 2000 mg (weight-based), Protionamide (PTO) up to 800 mg (weight-based) daily for first 16 weeks and LZD 600 mg daily for at least 24 weeks.', 'interventionNames': ['Drug: Levofloxacin', 'Drug: Linezolid', 'Drug: Cycloserine', 'Drug: Clofazimine', 'Drug: Pyrazinamide', 'Drug: Protionamide']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Bedaquiline', 'description': 'Bedaquiline uncoated tablets will be administered orally.', 'armGroupLabels': ['Bedaquiline-containing Short-course Regimen (SCR)'], 'otherNames': ['SIRTURO']}\n- {'type': 'DRUG', 'name': 'Levofloxacin', 'description': 'Levofloxacin filmcoated will be administered orally', 'armGroupLabels': ['Bedaquiline-containing Short-course Regimen (SCR)', 'Non-bedaquiline-containing Short-course Regimen (SCR)']}\n- {'type': 'DRUG', 'name': 'Linezolid', 'description': 'Linezolid tablets will be administered orally', 'armGroupLabels': ['Bedaquiline-containing Short-course Regimen (SCR)', 'Non-bedaquiline-containing Short-course Regimen (SCR)']}\n- {'type': 'DRUG', 'name': 'Cycloserine', 'description': 'Cycloserine capsules will be administered orally.', 'armGroupLabels': ['Bedaquiline-containing Short-course Regimen (SCR)', 'Non-bedaquiline-containing Short-course Regimen (SCR)']}\n- {'type': 'DRUG', 'name': 'Clofazimine', 'description': 'Clofazimine capsules will be administered orally.', 'armGroupLabels': ['Bedaquiline-containing Short-course Regimen (SCR)', 'Non-bedaquiline-containing Short-course Regimen (SCR)']}\n- {'type': 'DRUG', 'name': 'Pyrazinamide', 'description': 'Pyrazinamide tablets will be administered orally.', 'armGroupLabels': ['Non-bedaquiline-containing Short-course Regimen (SCR)']}\n- {'type': 'DRUG', 'name': 'Protionamide', 'description': 'Protionamide enteric-coated tablets will be administered orally.', 'armGroupLabels': ['Non-bedaquiline-containing Short-course Regimen (SCR)']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment', 'description': \"Percentage of participants with a favorable treatment outcome at the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.\", 'timeFrame': 'At the end of treatment (Week 40)'}\n\nPlease estimate the sample size based on the assumption: \nA 2.5% one-sided significance level, 80% power, and a 10% dropout rate are assumed.", "answer": 212, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The primary study null hypothesis posits that the all-oral, BDQ-containing SCR is inferior to that of the all-oral SCR without BDQ. Conversely, the primary study alternative hypothesis posits that the all-oral, BDQ-containing SCR is non-inferior to that of the all-oral SCR without BDQ. Both hypotheses will be tested by measuring the intergroup difference in the proportion of patients achieving favorable treatment outcomes at treatment completion, with results of analysis interpreted using a 15% non-inferiority margin and a 2.5% one-sided significance level.\n Under the null hypothesis of inferiority, the favorable treatment outcome rate at treatment completion is assumed to be 85% for the control SCR and 70% for the BDQ-containing regimen. To achieve 80% power in demonstrating the non-inferiority of the BDQ-containing SCR as compared to the control SCR using the abovementioned non-inferiority margin and significance level cutoffs, a sample size of 95 evaluable patients per regimen is required.\n Assuming that 10% of randomized patients would not be evaluable for the primary treatment outcome analysis, a total of 212 randomized patients (106/regimen) would be needed.", "id": 1378, "split": "test"} +{"trial_id": "NCT05307913", "pmid": "38307528", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial\n\nIncluded conditions:\n- ARDS, Human\n\nStudy Armgroups:\n- {'label': 'EIT-guided PEEP', 'type': 'EXPERIMENTAL', 'description': 'PEEP titration by EIT', 'interventionNames': ['Other: EIT-guided PEEP']}\n- {'label': 'Table-guided PEEP', 'type': 'ACTIVE_COMPARATOR', 'description': 'PEEP selection by the lower PEEP/FiO2 table', 'interventionNames': ['Other: Table-guided PEEP']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'EIT-guided PEEP', 'description': 'PEEP setting according to EIT', 'armGroupLabels': ['EIT-guided PEEP']}\n- {'type': 'OTHER', 'name': 'Table-guided PEEP', 'description': 'PEEP setting according to the lower PEEP/FiO2 table', 'armGroupLabels': ['Table-guided PEEP']}\n\nPrimary Outcomes:\n- {'measure': 'Survival in 28 days', 'description': 'Survival within 28 days from randomization', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nThe test level \u00ce\u00b1 is defined as 0.05, the type II error probability \u00ce\u00b2 is defined as 0.2, and a 10% drop-out rate is assumed.", "answer": 680, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is estimated using the sample size calculation formula for two-sample rates comparison.\n The test level \u00ce\u00b1 is defined as 0.05, the type II error probability \u00ce\u00b2 is defined as 0.2. The ARDS mortality rate of the control group is estimated to be 45% according to a reported literature.33 The ARDS mortality rate of the intervention group is estimated to be reduced to 34% (HR=0.75).13 The sample size ratio of the intervention group and the control group is assumed to be 1:1, the required sample size calculated according to PASS V.15 software (PASS V.15.0.13, NCSS) is 614 subjects. Assuming a 10% drop-out rate, the final sample size of this study is 680, with 340 in each of the intervention group and the control group.", "id": 1379, "split": "test"} +{"trial_id": "NCT05309278", "pmid": "37599360", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Remote Physical Training Program Combined With Cognitive Training in Older Adults at Increased Risk of Clinical-functional Vulnerability: a Randomized Clinical Trial\n\nIncluded conditions:\n- Aging\n- Functional Status\n\nStudy Armgroups:\n- {'label': 'Physical and cognitive exercise group', 'type': 'EXPERIMENTAL', 'description': 'Participants will be randomized to receive physical and cognitive training for a period of 12 weeks.', 'interventionNames': ['Behavioral: Physical training', 'Behavioral: Cognitive training']}\n- {'label': 'Physical exercise only group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be randomized to receive only physical training for a period of 12 weeks.', 'interventionNames': ['Behavioral: Physical training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical training', 'description': 'Older adults assigned to this group will undergo two weekly sessions of remote and supervised physical training at home for 1 hour on non-consecutive days. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures', 'armGroupLabels': ['Physical and cognitive exercise group', 'Physical exercise only group']}\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive training', 'description': 'These participants will also perform a weekly remote and supervised cognitive training session with neurobic exercises for 1 hour. In addition to the supervised cognitive training session, participants will also be prescribed asynchronous neurobic exercises to be performed on the remaining days of the week (without supervision). The intervention will last for 12 weeks, and all asynchronous neurobic exercises will be recorded in the following synchronous sessions by the supervisor. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures', 'armGroupLabels': ['Physical and cognitive exercise group']}\n\nPrimary Outcomes:\n- {'measure': 'Timed Up and Go (TUG) performance', 'description': 'The TUG test will be used to measure possible modifications in the dynamic balance of older adults during the performance of the task.', 'timeFrame': 'Baseline (weeks 0) to Post-training (week 13)'}\n- {'measure': 'Dual-task performance', 'description': \"The TUG test will also be applied with a dual task, in which participants' functional capacity will be assessed while simultaneously performing a verbal task. Specifically, the participants will perform the same procedures explained in the TUG test session, while also pronouncing the maximal number of animal names as possible.\", 'timeFrame': 'Baseline (weeks 0) to Post-training (week 13)'}\n- {'measure': 'Mini-Mental State Examination (MMSE) score', 'description': \"The MMSE will be used to assess participants' cognitive function, which will be classified based on the education-adjusted cut-off scores.\", 'timeFrame': 'Baseline (weeks 0) to Post-training (week 13)'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level: \u03b1 = 0.05; power: 80%; dropout rate: ~20%", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was performed using the GPower v. 3.1 software, adopting a significance level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a power of 80%. Data used in the determination of the effect size f for each primary outcome (cognitive capacity: f\u00e2\u0080\u0089=\u00e2\u0080\u00890.35; dynamic balance: f\u00e2\u0080\u0089=\u00e2\u0080\u00890.22; dual-task performance: f\u00e2\u0080\u0089=\u00e2\u0080\u00890.20) were extracted from [16, 29], resulting in a total sample size of 52 participants. To account for possible losses during the study procedures, ten additional participants (i.e.,\u00e2\u0080\u0089~\u00e2\u0080\u008920%) are to be recruited for the study, totaling 62 participants randomized between the two groups.", "id": 1380, "split": "test"} +{"trial_id": "NCT05310968", "pmid": "37220998", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction: A Randomized, Double-blinded, Placebo-controlled, Multi-center Trial\n\nIncluded conditions:\n- Branch Atheromatous Disease\n\nStudy Armgroups:\n- {'label': 'Tirofiban group', 'type': 'EXPERIMENTAL', 'description': 'This group will receive tirofiban and aspirin. Day 1: Tirofiban injected intravenously for 24 hours and aspirin of 100-300 mg. Tirofiban will be injected at 4 ug/kg/ min for the first 30 minutes and 0.1 ug/kg/min for the next 24 hours.\\n\\nDay 2-90: Aspirin 100mg per day.', 'interventionNames': ['Drug: Tirofiban hydrochloride sodium chloride injection', 'Drug: Aspirin']}\n- {'label': 'Tirofiban placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'This group will receive tirofiban placebo and aspirin. Day 1: Tirofiban placebo injected intravenously for 24 hours and aspirin of 100-300 mg. The placebo will be injected at the same rate with Tirofiban group.\\n\\nDay 2-90: Aspirin 100mg per day.', 'interventionNames': ['Drug: Tirofiban hydrochloride sodium chloride injection placebo', 'Drug: Aspirin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tirofiban hydrochloride sodium chloride injection', 'description': 'Day 1: Tirofiban will be given by bolus injection at 0.4ug/kg/min for the first 30 minutes, followed by a continuous infusion at 0.1ug/kg/min for the next 24 hours.', 'armGroupLabels': ['Tirofiban group']}\n- {'type': 'DRUG', 'name': 'Tirofiban hydrochloride sodium chloride injection placebo', 'description': 'Day 1: Tirofiban placebo will be injected at the same rate with experimental group.', 'armGroupLabels': ['Tirofiban placebo group']}\n- {'type': 'DRUG', 'name': 'Aspirin', 'description': 'Day 1: Aspirin 100-300mg per day Day 2-90: Aspirin 100mg per day', 'armGroupLabels': ['Tirofiban group', 'Tirofiban placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with new stroke', 'description': 'Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord, or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke.', 'timeFrame': '90 days after randomization'}\n- {'measure': 'Number of participants with early progression of stroke', 'description': 'NIHSS score increasing by \u2265 2 points, or the score of hemiplegia increasing by\u22651 point, or the score of conscious disturbance increasing by \u2265 1 point compared with baseline within 7 days of onset, and intracranial hemorrhage is excepted by CT or MRI. Exacerbations not attributable to stroke are also excluded such as cardiac failure, liver and renal failure, etc.', 'timeFrame': '7 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nTesting power is set at 80%, significance level at 5%, and a 5% dropout rate is considered.", "answer": 970, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We assumed the incidence of the primary endpoint rate to be 20% and 13.3% in the control group7 21 and tirofiban group,22\u00e2\u0080\u009324 respectively, which implied a 30% reduction in relative risk. Considering a testing power of 80% and a significance level of 5 %, 970 patients (485 in each group) will be required, allowing for a 5% dropout rate. We used Power Analysis and Sample Size software V.11.0 (NCSS, Kaysville, Utah, USA) to calculate.", "id": 1381, "split": "test"} +{"trial_id": "NCT05312385", "pmid": "39461861", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)\n\nIncluded conditions:\n- Sedation\n\nStudy Armgroups:\n- {'label': 'Isoflurane', 'type': 'EXPERIMENTAL', 'description': 'Inhaled isoflurane administered via Sedaconda ACD-S', 'interventionNames': ['Drug: Isoflurane']}\n- {'label': 'Propofol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Propofol administered as intravenous infusion', 'interventionNames': ['Drug: Propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Isoflurane', 'description': 'Inhaled isoflurane administered by Sedaconda ACD-S', 'armGroupLabels': ['Isoflurane']}\n- {'type': 'DRUG', 'name': 'Propofol', 'description': 'Intravenous infusion of propofol', 'armGroupLabels': ['Propofol']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of time adequate sedation depth', 'description': 'To compare the percentage of time sedation depth is maintained within the target range, in absence of rescue sedation, as assessed according to the RASS scale, in isoflurane- vs propofol-treated patients', 'timeFrame': 'During study treatment up to 48 (\u00b16) hours'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an attrition rate of 5%, the trial is powered to provide 95% power for a non-inferiority test with a one-sided alpha of 0.025.", "answer": 235, "answer_type": "ACTUAL", "explanation": "Timeline, sample size and recruitment\n \n Study timeline and flow\n The study timeline and participant flow are summarised in figure 2.\n \n Figure 2\n \n Trial scheme for patient progression. Patients are screened between days \u00e2\u0088\u009230 and 0\u00e2\u0080\u0089hours prior to initiation of study drug administration to determine trial eligibility. Baseline values are obtained during the baseline phase. At randomisation, ongoing sedation and opioid infusions are reduced to half. Initiating study drug treatment is performed as close to randomisation as possible, no later than 6\u00e2\u0080\u0089hours after randomisation. Study drug titration is performed by the clinical team to reach targeted sedation depth. Blinded RASS assessments occur every 2\u00e2\u0080\u0089hours with pain levels assessed in parallel with CPOT assessments. Study drug treatment is stopped when patient is planned for extubation or reaches maximum treatment duration of 48 (\u00c2\u00b16) hours, whichever occurs first. Patients are monitored until 24 hours after end of treatment, followed-up until day 7 and day 30, and receive long-term assessments at 3 and 6\u00e2\u0080\u0089months. COPT, Critical Care Pain Observation Tool; RASS, Richmond Agitation Sedation Scale.\n \n \n \n \n \n Sample size\n The trial is powered to evaluate the non-inferiority of inhaled isoflurane via the Sedaconda ACD-S compared with intravenous propofol in maintaining the depth of sedation within the target RASS range of \u00e2\u0088\u00921 to \u00e2\u0088\u00924. Based on previous studies and accounting for lack of familiarity in the USA with inhaled sedation in the ICU, anticipated time spent in the target RASS range is on average 70% with isoflurane and 75% with propofol with an SD of approximately 20%.32 40 Assuming an attrition rate of 5%, a total of 235 randomised patients will provide 95% power for a non-inferiority test with a one-sided alpha of 0.025.\n \n \n Recruitment\n Recruitment started 28 April 2022 with completion of recruitment expected in 2024. Queries to investigators, data cleaning and closure of the database will follow. Data analysis, manuscript preparation and submission for publication are anticipated to occur in 2025.", "id": 1382, "split": "test"} +{"trial_id": "NCT05312385", "pmid": "39461861", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)\n\nIncluded conditions:\n- Sedation\n\nStudy Armgroups:\n- {'label': 'Isoflurane', 'type': 'EXPERIMENTAL', 'description': 'Inhaled isoflurane administered via Sedaconda ACD-S', 'interventionNames': ['Drug: Isoflurane']}\n- {'label': 'Propofol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Propofol administered as intravenous infusion', 'interventionNames': ['Drug: Propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Isoflurane', 'description': 'Inhaled isoflurane administered by Sedaconda ACD-S', 'armGroupLabels': ['Isoflurane']}\n- {'type': 'DRUG', 'name': 'Propofol', 'description': 'Intravenous infusion of propofol', 'armGroupLabels': ['Propofol']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of time adequate sedation depth', 'description': 'To compare the percentage of time sedation depth is maintained within the target range, in absence of rescue sedation, as assessed according to the RASS scale, in isoflurane- vs propofol-treated patients', 'timeFrame': 'During study treatment up to 48 (\u00b16) hours'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an attrition rate of 5%, the trial is powered to provide 95% power for a non-inferiority test with a one-sided alpha of 0.025.", "answer": 235, "answer_type": "ACTUAL", "explanation": "Sample size\n The trial is powered to evaluate the non-inferiority of inhaled isoflurane via the Sedaconda ACD-S compared with intravenous propofol in maintaining the depth of sedation within the target RASS range of \u00e2\u0088\u00921 to \u00e2\u0088\u00924. Based on previous studies and accounting for lack of familiarity in the USA with inhaled sedation in the ICU, anticipated time spent in the target RASS range is on average 70% with isoflurane and 75% with propofol with an SD of approximately 20%.32 40 Assuming an attrition rate of 5%, a total of 235 randomised patients will provide 95% power for a non-inferiority test with a one-sided alpha of 0.025.", "id": 1383, "split": "test"} +{"trial_id": "NCT05314920", "pmid": "36928238", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Emotional Disorder\n\nStudy Armgroups:\n- {'label': 'transdiagnostic cognitive-behavioural therapy (TD-CBT)', 'type': 'EXPERIMENTAL', 'description': 'Transdiagnostic cognitive-behavioral group therapy: The psychological interventions will be manualized. Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12-week period.', 'interventionNames': ['Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT)']}\n- {'label': 'relaxation therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. Patients will receive 7 sessions (1.5 hr/session) in groups of 8-10 individuals over a 12-week period.', 'interventionNames': ['Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Transdiagnostic cognitive-behavioral therapy (TD-CBT)', 'description': 'Transdiagnostic cognitive-behavioral therapy (TD-CBT)', 'armGroupLabels': ['transdiagnostic cognitive-behavioural therapy (TD-CBT)']}\n- {'type': 'BEHAVIORAL', 'name': 'Bernstein and Borkovec progressive muscle relaxation (PMR)', 'description': 'Bernstein and Borkovec progressive muscle relaxation (PMR)', 'armGroupLabels': ['relaxation therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Change in cost-effectiveness data', 'description': \"Cost-effectiveness results will be calculated by the ICER, defined as the difference in mean costs between interventions divided by the difference in their effectiveness according to the symptom questionnaires' mean scores.\\n\\nThe healthcare data collected will be used for cost calculations. To calculate healthcare-related costs, an ad hoc questionnaire will be used to collect emotional disorder-related healthcare data (public and private healthcare consultations, accidents, medical tests, and sick leaves in the past 3 months; psychotropic drugs or other medication, and their posology).\", 'timeFrame': 'Baseline, immediately after the intervention, and 12-month follow-up'}\n- {'measure': 'Change in cost-utility data', 'description': 'Cost-utility will be measured through the healthcare data collected above and the European Quality of Life Scale (EuroQoL, EQ) (The EuroQol Group, 1990), calculating the QALYS and the ICURs, defined as the difference in mean cost divided by the difference in mean QALYs. The Spanish version of the 5-domain, 5-level EuroQol (EQ-5D-5L) (Badia et al., 1999; van Reenen et al., 2019) will be used to assess health status in five dimensions (mobility, self-care, daily activities, pain/unease, and anxiety/depression) with five levels of severity (no problems, slight problems, moderate problems, severe problems, and either extreme problems or unable to perform activity).', 'timeFrame': 'Baseline, immediately after the intervention, and 12 month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nExpected losses after randomization are as high as 30%.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study will recruit a total of 300 participants (150 in each arm) to compensate for expected losses after randomization. Based on previous RCTs conducted in primary care settings, we expect losses to be as high as 30% [52]. Over a 30-month period (February 2020 to June 2023), we will form 10 paired groups (experimental and control) in the four health centres, with a mean of 10 participants in each group. Fifteen GPs will collaborate in the study and each is expected to refer a mean of 10\u00e2\u0080\u009315 participants for participation, which should provide a sufficient sample size considering that a proportion of these patients will not meet eligibility criteria. We do not foresee any difficulties in recruiting sufficient patients given that each GP conducts an average of 30 patient visits per day (> 7000 visits/year).", "id": 1384, "split": "test"} +{"trial_id": "NCT05317754", "pmid": "36805694", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction: An Exploratory Randomized Controlled Trial\n\nIncluded conditions:\n- Mental Health Wellness\n\nStudy Armgroups:\n- {'label': 'Mindful breathing', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Mindful breathing']}\n- {'label': 'Prostrations, according to Tibetan Buddhist tradition', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Prostrations, according to Tibetan Buddhist tradition']}\n- {'label': 'The Koan Mu, according to Zen Buddhist tradition', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: The Koan Mu, according to Zen Buddhist tradition']}\n- {'label': 'The mirror exercise, according to Toltec tradition', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: The mirror exercise, according to Toltec tradition']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindful breathing', 'description': \"* Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.\\n* There is no limit to the number of times informal practice can be performed during the day.\\n* Use of a diary is necessary to record the time and duration of all formal and informal practices.\\n* The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.\", 'armGroupLabels': ['Mindful breathing']}\n- {'type': 'BEHAVIORAL', 'name': 'Prostrations, according to Tibetan Buddhist tradition', 'description': \"* Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.\\n* There is no limit to the number of times informal practice can be performed during the day.\\n* Use of a diary is necessary to record the time and duration of all formal and informal practices.\\n* The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.\", 'armGroupLabels': ['Prostrations, according to Tibetan Buddhist tradition']}\n- {'type': 'BEHAVIORAL', 'name': 'The Koan Mu, according to Zen Buddhist tradition', 'description': \"* Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.\\n* There is no limit to the number of times informal practice can be performed during the day.\\n* Use of a diary is necessary to record the time and duration of all formal and informal practices.\\n* The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.\", 'armGroupLabels': ['The Koan Mu, according to Zen Buddhist tradition']}\n- {'type': 'BEHAVIORAL', 'name': 'The mirror exercise, according to Toltec tradition', 'description': \"* Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night.\\n* There is no limit to the number of times informal practice can be performed during the day.\\n* Use of a diary is necessary to record the time and duration of all formal and informal practices.\\n* The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.\", 'armGroupLabels': ['The mirror exercise, according to Toltec tradition']}\n\nPrimary Outcomes:\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Post-treatment 60 days from baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Three-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Six-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Post-treatment 60 days from baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Three-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Six-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Post-treatment 60 days from baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Three-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Six-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Post-treatment 60 days from baseline'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Three-months follow-up'}\n- {'measure': 'The Nondual Embodiment Thematic Inventory (NETI)', 'description': 'In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness', 'timeFrame': 'Six-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nWe assumed a 5% significance level, 80% statistical power, and used the Hotelling-Lawley Trace approach for the general linear model.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size estimation was based on testing whether the trend in the pre-to-post change would be different between the intervention groups. Firstly, we assumed that mindfulness practice would be able to present small pre-post effects on deconstruction of the ego, according to the previous studies on this subject [21]. For this reason, we assumed a common mean (SD) at baseline of 65 in the Nondual Embodiment Thematic Inventory [22], and a mean at post-test of 69 and 75 in the mindfulness group and the other deconstructive practices, respectively. This assumes a pre-post standardized difference in the mindfulness group of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.3, a pre-post standardized difference in any of the other deconstructive practices of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.8, and a post-test standardized difference between the mindfulness group and any of the other arms of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5, which corresponds to the average effect in some exploratory studies conducted by our group [23] and is aligned with the 0.5 standard deviation criterion considered clinically relevant [22]. Using a 1:1:1:1 ratio, assuming a 5% significance level and a statistical power of 80%, and applying the Hotelling-Lawley Trace approach for the general linear model, which supports the inclusion of baseline covariates and coincides with the Wald test for the general linear mixed model [24], we will need a total of 240 participants, and thus 60 subjects in each group.", "id": 1385, "split": "test"} +{"trial_id": "NCT05317832", "pmid": "38941145", "question": "Here is the design of a clinical trial:\n\nOfficial Title: mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury\n\nIncluded conditions:\n- Spinal Cord Injuries\n\nStudy Armgroups:\n- {'label': 'Web-based physical activity intervention (WI) program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).', 'interventionNames': ['Behavioral: WI program', 'Behavioral: WI Program Reminder', 'Other: Weekly PA Information']}\n- {'label': 'Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)', 'type': 'EXPERIMENTAL', 'description': 'Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.', 'interventionNames': ['Behavioral: WI program', 'Behavioral: WI Program Reminder', 'Behavioral: JITAI Goal Setting', 'Behavioral: JITAI physical activity message', 'Other: Notification EMA', 'Other: End of day EMA', 'Other: Wake up time EMA', 'Other: Weekly PA Information', 'Other: Daily PA Information']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'WI program', 'description': 'This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program', 'Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'BEHAVIORAL', 'name': 'WI Program Reminder', 'description': 'Participants will be provided with reminders to use the WI program', 'armGroupLabels': ['Web-based physical activity intervention (WI) program', 'Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'BEHAVIORAL', 'name': 'JITAI Goal Setting', 'description': 'Participants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'BEHAVIORAL', 'name': 'JITAI physical activity message', 'description': 'Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'OTHER', 'name': 'Notification EMA', 'description': 'Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'OTHER', 'name': 'End of day EMA', 'description': 'Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'OTHER', 'name': 'Wake up time EMA', 'description': 'Participants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'OTHER', 'name': 'Weekly PA Information', 'description': 'Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program', 'Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n- {'type': 'OTHER', 'name': 'Daily PA Information', 'description': 'Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.', 'armGroupLabels': ['Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in moderate-intensity (or higher) physical activity', 'description': 'The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and WI program.', 'timeFrame': 'Baseline (week 2) and WI Program (week 16)'}\n- {'measure': 'Change in moderate-intensity (or higher) physical activity', 'description': 'The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and physical activity sustainability.', 'timeFrame': 'Baseline (week 2) and physical activity sustainability (week 24)'}\n- {'measure': 'Self-reported change in moderate-intensity (or higher) physical activity', 'description': 'The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and WI program.', 'timeFrame': 'Baseline (week 2) and WI Program (week 16)'}\n- {'measure': 'Self-reported change in moderate-intensity (or higher) physical activity', 'description': 'The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and physical activity sustainability.', 'timeFrame': 'Baseline (week 2) and physical activity sustainability (week 24)'}\n- {'measure': 'Self-reported change in moderate-intensity (or higher) leisure time physical activity', 'description': 'The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and WI program.', 'timeFrame': 'Baseline (week 2) and WI program (week 16)'}\n- {'measure': 'Self-reported change in moderate-intensity (or higher) leisure time physical activity', 'description': 'The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and physical activity sustainability.', 'timeFrame': 'Baseline (week 2) and physical activity sustainability (week 24)'}\n- {'measure': 'Change in proximal physical activity', 'description': 'The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the WI program among those who are available at the previous randomization decision point.', 'timeFrame': 'WI Program (week 2) and WI Program (week 16)'}\n- {'measure': 'Change in proximal physical activity', 'description': 'The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the physical activity sustainability among those who are available at the previous randomization decision point.', 'timeFrame': 'Physical activity sustainability (week 17) and Physical activity sustainability (week 24)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) of .05, power of 80%, and a 20% dropout rate.", "answer": 196, "answer_type": "ESTIMATED", "explanation": "Sample Size Determination\n Sample size calculation for the primary aim (a 2-arm randomized controlled trial) indicated that 82 participants are needed per group to detect at least a standardized mean difference of 0.44 [48] (considered small to moderate) in the primary outcome, with 80% power (assuming a 2-sided test with an \u00ce\u00b1 level of .05). On the basis of prior research [49,50] and our pilot study [24], we anticipate a 20% dropout rate. Thus, we plan to recruit a total of 196 participants with SCI (98 participants per group). In addition, power analysis for the secondary aim (an MRT) based on 2 randomizations per day indicated that a sample size of 69 is needed to detect a difference between JITAI message and no message on the proximal PA achieved for the WI+JITAI arm [30,51]. We assumed an average proximal treatment effect for message versus no message of 0.10 (considered small) that starts with 0.12 (ie, a small effect) and decreases linearly for the 16 weeks, an \u00ce\u00b1 level of .05, and 80% power [30]. We will have sufficient power for the MRT given we plan to recruit 98 individuals for the WI+JITAI arm to ensure that the primary aim is powered.", "id": 1386, "split": "test"} +{"trial_id": "NCT05318612", "pmid": "37612610", "question": "Here is the design of a clinical trial:\n\nOfficial Title: (Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)\n\nIncluded conditions:\n- Primary Glioblastoma\n\nStudy Armgroups:\n- {'label': 'Control group (biopsy group)', 'type': 'OTHER', 'description': 'Standard of care: biopsy + adjuvant treatment', 'interventionNames': ['Procedure: Biopsy']}\n- {'label': 'Intervention group (LITT group)', 'type': 'EXPERIMENTAL', 'description': 'Biopsy + LITT + adjuvant treatment', 'interventionNames': ['Procedure: Laser Interstitial Thermal Therapy (LITT)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laser Interstitial Thermal Therapy (LITT)', 'description': 'LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.', 'armGroupLabels': ['Intervention group (LITT group)']}\n- {'type': 'PROCEDURE', 'name': 'Biopsy', 'description': 'A sample of tissue from the tumor is obtained to confirm the diagnosis.', 'armGroupLabels': ['Control group (biopsy group)']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'Percentage of patients still alive for a given period of time after randomization.', 'timeFrame': 'Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).'}\n- {'measure': 'Health Related Quality of Life (HR-QoL)', 'description': 'QoL measured with the QLQ-C30BN20 at 5 months after randomization.', 'timeFrame': 'At 5 months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nFor overall survival, a two-sided Cox proportional hazards model with alpha=0.05 and power=90% was used. For quality-of-life, a one-sided significance level of 0.05 and 80% power was used. Assumptions include a 5% post-randomization exclusion rate, 5% dropout rate prior to intervention, and 10% loss to follow-up.", "answer": 238, "answer_type": "ESTIMATED", "explanation": "Sample size\n We hypothesize that LITT will improve the overall survival without substantially compromising the health-related quality-of-life. The two co-primary outcomes were used to calculate the required sample size.\n \n Overall survival\n Recent analysis of the Dutch Quality Registry Neurosurgery data showed a median survival of patients with primary irresectable glioblastoma in the Netherlands of 5.1 months [9]. Current available literature states that LITT in newly diagnosed, irresectable glioblastoma may improve the median survival to 10.2 months [12]. A doubling of current survival to 10.2 months (median survival benefit of 5.1 months) is considered relevant, based on input from experts, the Dutch Society for Neuro-Oncology, and the Dutch patient organization.\n A Cox proportional hazards model (two-sided; alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; power\u00e2\u0080\u0089=\u00e2\u0080\u008990%) was used for sample size calculations. A hazard ratio of 0.5 was assumed for overall survival (equivalent to an improvement in median overall survival from 5.1 to 10.2 months). The null hypothesis assumed a hazard ratio of 1. The allocation ratio will be 1:1. With 46 months of accrual and 18 months of follow-up, after an average follow-up of 41 months we will have reached 96% of events (overall probability of event, pE\u00e2\u0080\u0089=\u00e2\u0080\u00890.96). The calculated sample size therefore is 91. To account for a 5% post-randomization exclusion rate due to non-glioma diagnosis on histopathology, a 5% drop-out ratio prior to intervention and 10% loss to follow-up, 114 patients (57 per arm) need to be included.\n \n \n Quality-of-life\n HR-QoL will be evaluated as non-inferiority of EORTC QLQ-C30\u00e2\u0080\u0089+\u00e2\u0080\u0089BN20 score after 5 months in those patients still alive at that time. This time point will reflect the estimated median survival in the control group, leaving at least 50% of patients to be analysed. In addition, at this timepoint a short-term treatment effect is expected to be mitigated, while a lasting effect could still affect QoL. Non-inferiority of HR-QoL is considered at a maximum decline of 10 points (5% instrument scale). This decline is in range with the reported MCID, which is generally accepted as the limit between \u00e2\u0080\u009cminimal change\u00e2\u0080\u009d and \u00e2\u0080\u009cmoderate change\u00e2\u0080\u009d [20\u00e2\u0080\u009322]. Also, the Dutch Society for Neuro-Oncology and the patient association confirm this as a relevant and clinically acceptable lower limit. Based on literature a standard deviation of 22 is assumed [20].\n Since the expected effect (either positive due to prolonged survival or negative due to treatment-related morbidity) of LITT on HR-QoL is unclear, expected mean values are assumed the same between both groups. Assuming an estimated median survival time (MST) of 5.1 months in the control group vs. 10.2 months in the treatment group, the surviving proportion at 5 months after randomization (~\u00e2\u0080\u00894.5 months after intervention) is calculated by e^(-ln[2]/MST) *4.5 months. This yields a relative survival of 54.2% in the control arm and 73.6% in the treatment group. The sampling ratio (Ntreatment/Ncontrol) will then be 1.36 (0.73/0.54). To detect non-inferiority with 80% power at 0.05 one-sided significance level, we require a sample size of 52 in the control group at 5 months after randomization. Given the relative survival, we require 96 patients to be randomised to each group prior to treatment. Considering a 5% post-randomization exclusion, 5% drop-out prior to intervention and 10% loss to follow-up, 238 patients in total (119 per arm) need to be included.\n \n \n Final sample size\n The total sample size will be 238 patients (119 per arm) as this will enable us to study both survival and quality of life.", "id": 1387, "split": "test"} +{"trial_id": "NCT05318612", "pmid": "37612610", "question": "Here is the design of a clinical trial:\n\nOfficial Title: (Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)\n\nIncluded conditions:\n- Primary Glioblastoma\n\nStudy Armgroups:\n- {'label': 'Control group (biopsy group)', 'type': 'OTHER', 'description': 'Standard of care: biopsy + adjuvant treatment', 'interventionNames': ['Procedure: Biopsy']}\n- {'label': 'Intervention group (LITT group)', 'type': 'EXPERIMENTAL', 'description': 'Biopsy + LITT + adjuvant treatment', 'interventionNames': ['Procedure: Laser Interstitial Thermal Therapy (LITT)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laser Interstitial Thermal Therapy (LITT)', 'description': 'LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.', 'armGroupLabels': ['Intervention group (LITT group)']}\n- {'type': 'PROCEDURE', 'name': 'Biopsy', 'description': 'A sample of tissue from the tumor is obtained to confirm the diagnosis.', 'armGroupLabels': ['Control group (biopsy group)']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'Percentage of patients still alive for a given period of time after randomization.', 'timeFrame': 'Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).'}\n- {'measure': 'Health Related Quality of Life (HR-QoL)', 'description': 'QoL measured with the QLQ-C30BN20 at 5 months after randomization.', 'timeFrame': 'At 5 months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nFor overall survival, a two-sided Cox proportional hazards model with alpha=0.05 and power=90% was used. For quality-of-life, a one-sided significance level of 0.05 and 80% power was used. Assumptions include a 5% post-randomization exclusion rate, 5% dropout rate prior to intervention, and 10% loss to follow-up.", "answer": 238, "answer_type": "ESTIMATED", "explanation": "Final sample size\n The total sample size will be 238 patients (119 per arm) as this will enable us to study both survival and quality of life.", "id": 1388, "split": "test"} +{"trial_id": "NCT05319717", "pmid": "38000818", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition\n\nIncluded conditions:\n- Severe Acute Malnutrition\n\nStudy Armgroups:\n- {'label': 'Ready-to-use therapeutic food, no rice bran (control/comparator)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Randomized participants will receive a locally produced ready-to-use therapeutic food to be consumed daily.', 'interventionNames': ['Dietary Supplement: Ready-to-use therapeutic food (no rice bran)']}\n- {'label': 'Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental)', 'type': 'EXPERIMENTAL', 'description': 'Randomized participants will receive a locally produced ready-to-use therapeutic food with 5% heat stabilized rice bran to be consumed daily.', 'interventionNames': ['Dietary Supplement: Ready-to-use therapeutic food with heat stabilized rice bran']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Ready-to-use therapeutic food with heat stabilized rice bran', 'description': 'Children assigned to the experimental group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food that contains 5% heat stabilized rice bran.', 'armGroupLabels': ['Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental)']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Ready-to-use therapeutic food (no rice bran)', 'description': 'Children assigned to the active comparator group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food (no rice bran).', 'armGroupLabels': ['Ready-to-use therapeutic food, no rice bran (control/comparator)']}\n\nPrimary Outcomes:\n- {'measure': 'Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by child weight.', 'description': 'This will be assessed by measures of:\\n\\n- Weight', 'timeFrame': 'Baseline, week 4, week 8, and week 16'}\n- {'measure': 'Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by mid-upper arm circumference.', 'description': 'This will be assessed by measures of:\\n\\n-Mid-upper arm circumference', 'timeFrame': 'Changes between baseline, week 4, week 8, and week 16'}\n- {'measure': 'Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by morbidity.', 'description': 'This will be assessed by measures of:\\n\\n- Morbidity (diarrhea, fever, vomiting, upper or lower respiratory infection)', 'timeFrame': 'Changes between baseline, week 4, week 8, and week 16'}\n\nPlease estimate the sample size based on the assumption: \nSD of 1.5 g/kg BW, significance level of 0.05, power of 0.80, and a 15% dropout rate.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n We aim to recruit 100 children per group (or 200 children in total) to ensure sufficient statistical power. If the Indonesian RUTFs meet the WHO requirement for an average increase in weight gain of 5\u00e2\u0080\u0089g/kg BW/day, 46 49 a total sample size of 112 children (56 per group) would allow the detection of a 20% difference between control and intervention arms. This calculation considers an SD of 1.5\u00e2\u0080\u0089g/kg BW, a significance of 0.05 and a power of 0.80. If 15% of children drop out during the intervention, a total sample size of 132 children would be required (66 children per group). If children fail to reach this 5\u00e2\u0080\u0089g/kg BW target and only gain 2\u00e2\u0080\u0089g/kg BW/day, the previous study on the efficacy of this locally produced RUTF that was assessed in Bogor, Jakarta, Indonesia will be used as reference.38 This study calculated a sample size of 75 children per group which allowed for detection of a 30% difference between the control product and the local product. Furthermore, additional power calculations for secondary outcomes returned lower numbers of required children per group.33", "id": 1389, "split": "test"} +{"trial_id": "NCT05321056", "pmid": "36854596", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exposure Measurements and Interventions for Aerosol Produced by Gastrointestinal Endoscopy\n\nIncluded conditions:\n- Droplet Transmission\n\nStudy Armgroups:\n- {'label': 'Intervention group: Mask on model face', 'type': 'EXPERIMENTAL', 'description': \"The mask (surgical mask, respirator) will be worn on the face of the in vitro bionic model.\\n\\nVitamin B2 saline solution of the same dose will be dripped into each patient's mouth before EGD examination, as a fluorescent tracer.\", 'interventionNames': ['Device: masks (surgical mask, respirator)']}\n- {'label': 'Control group: No mask on model face', 'type': 'NO_INTERVENTION', 'description': \"No mask (surgical mask, respirator) will be worn on the face of the in vitro bionic model.\\n\\nVitamin B2 saline solution of the same dose will be dripped into each patient's mouth before EGD examination, as a fluorescent tracer.\"}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'masks (surgical mask, respirator)', 'description': 'The mask (surgical mask, respirator) will be worn on the face of the in vitro bionic model in the procedure room for measuring droplet exposure.', 'armGroupLabels': ['Intervention group: Mask on model face']}\n\nPrimary Outcomes:\n- {'measure': \"Dosage of in vitro model airway inhalation of patient's exhaled droplets\", 'description': 'After EGD examination, the dosage of airway inhalation of the in vitro model is quantified as a cumulative droplet mass (\u03bcg) over all the exposure time. The deposited droplets are collected by wiping method, and the inhaled droplets are sampled by a solution-based sampler (SKC, U.S.A.). The dosage is detected by the Fluoro Max-4\u00ae fluorophotometer (HORIBA, Japan).', 'timeFrame': 'one year'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided confidence level of 95%, a power of 80%, an allocation ratio of 1:1, and a dropout rate of 10%.", "answer": 130, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Fifteen patients who had provided written informed consent were recruited from 1 July 2022 to 29 July 2022, for preliminary experiments, at which time ethical approval had been obtained and registration of the RCT had been completed. Preliminary experiments were performed with nine of these participants to explore and refine the experimental parameters. In particular, two of these nine participants were treated in accordance with the examination procedure but with 1.5\u00e2\u0080\u0089mL of the saline solution instead of 1.5\u00e2\u0080\u0089mL of a solution of VB2 in saline. This enabled the elimination of environmental interferences, such as those from participants\u00e2\u0080\u0099 saliva, environmental particles and solvents from OGD procedures, as well as the determination of the limit of detection (LOD) of fluorescent signals. Preliminary experiments involving the remaining six participants were used to guide sample size calculations.\n As mentioned, given the realistic morphological structure of the anthropomorphic model, the model\u00e2\u0080\u0099s airway dosage of infectious particles exhaled by the participants comprises the dosage on the oral cavity, nasal cavity, oropharynx and small airway with/without a surgical mask (filtration efficiency=63.31% based on the results of the preliminary experiments with fifteen patients), and the model\u00e2\u0080\u0099s surgical mask-uncovered facial mucosa dosage comprises the dosage on the eyes. These exposures were measured separately, and the highest fluorescent intensity was 567 counts per second (cps). The fluorescent intensities of buffer solutions that will be used in this RCT are less than 100 cps, and, thus, these solutions will not interfere with the fluorescence of VB2. Accordingly, given the experimental error (comprising a 20% individual difference error, a 2% measurement error and a 10% manual sampling random error), the LOD was determined to be 800 cps, which means that fluorescent intensities of less than 800 cps will be considered as negative and not included in further analyses.\n Given that the primary outcome of this trial was concentrated at infectious particles exposure through the airway, represented by the oral cavity, nasal cavity or oropharynx or small airway, the average dosages of the intervention group\u00e2\u0080\u0099s and control group\u00e2\u0080\u0099s anthropomorphic model in the above niches were referred to calculate the sample size.\n In terms of details, there were two patients in the control group without a surgical mask, one of whom was positive for the oral cavity, nasal cavity and oropharynx with a total of 1.47\u00c3\u009710-1\u00ce\u00bcg, while another one was of - 10%) compared to the findings at baseline and / or\\n* recurrent cSDH which requires surgery', 'timeFrame': 'Within three months of follow-up'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, total alpha of 5%, and a drop-out and lost-to-follow-up rate of 10%. Adaptive design with one planned interim analysis.", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Because of the potential of notable morbidity, recurrent cSDH is considered both a clinically relevant and methodologically reliable, objective primary trial endpoint.\n In one of the largest studies to date, Ban et al. compared a prospective series of 72 patients with cSDH undergoing MMA embolization with a historic standard-of-care group of 469 subjects. The overall risk difference (irrespective of hematoma evacuation) was estimated at 26% (95% CI 21 to 31%) in favor of endovascular management. There is much variability in reported cSDH recurrence risks with either treatment option, and unclarity about the realistic benefit of combined surgical and interventional therapy.\n In view of the results of published studies (in particular Ban et al.), we conservatively presume recurrence rates of 30% in the control and 10% in the experimental arm during an observation period of 3 months.\n Since our assumptions are subject to uncertainty, we will employ an adaptive design according to O\u00e2\u0080\u0099Brien-Fleming with one planned interim analysis to decide about the further trial progress, and to modify the target sample size if necessary and/or reasonable. For a power of 80% and a total alpha of 5%, data from 138 patients (i.e., 69 per group) are needed to detect a risk difference of 20% by a z-test for independent samples. Assuming a drop-out and lost-to-follow-up rate of 10%, we plan to enroll 154 patients (i.e., 77 per treatment arm) unless the interim look prompts any adjustment.", "id": 1395, "split": "test"} +{"trial_id": "NCT05328180", "pmid": "37723109", "question": "Here is the design of a clinical trial:\n\nOfficial Title: aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial\n\nIncluded conditions:\n- Carpal Tunnel Syndrome\n\nStudy Armgroups:\n- {'label': 'Non-buffered local anaesthetic', 'type': 'OTHER', 'description': 'The investigators allocate 58 patients in this arm. It serves as the control group, who receives currently used local anaesthetic solution.', 'interventionNames': ['Other: Control arm']}\n- {'label': 'Buffered local anaesthetic', 'type': 'EXPERIMENTAL', 'description': 'The investigators allocate 58 patients in this arm. It serves as the experimental group, who receives currently used anaesthetic solution that has been buffered.', 'interventionNames': ['Other: Sodium bicarbonate']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Sodium bicarbonate', 'description': 'A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5% is buffered with 7.5% sodium bicarbonate in 1:10.', 'armGroupLabels': ['Buffered local anaesthetic']}\n- {'type': 'OTHER', 'name': 'Control arm', 'description': 'A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%.', 'armGroupLabels': ['Non-buffered local anaesthetic']}\n\nPrimary Outcomes:\n- {'measure': 'Total pain level with visual analogic scale (VAS)', 'description': 'The investigators evaluate the total pain with 0-100 mm visual analogue scale (VAS). In VAS higher number means more pain and is therefore worse. The investigators calculate the mean VAS level for each group and compare the results to find statistically and clinically relevant difference. Clinically relevant difference is evaluated by comparing the VAS difference to MCID.', 'timeFrame': 'VAS is recorded immediately after the injection of local anaesthetic.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, significance level of 5%, no expected dropout or missing data.", "answer": 116, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size is calculated by the power of 90% and the risk for type 1 error is assumed to be 5%. A group difference of 15\u00e2\u0080\u0089mm is assumed, which is the smallest difference that is preferred to be detected. Minimal clinically important difference for Visual Analogue Scale (VAS) has been defined to be 13\u00e2\u0080\u0089mm on a 100\u00e2\u0080\u0089mm scale.21 22 A common SD of 25 is assumed. With these values the sample size is 58 patients per group. All the patients are expected to remain in the trial, because there is no need for long follow-up. Hence, the final total sample size is 116 patients.", "id": 1396, "split": "test"} +{"trial_id": "NCT05328206", "pmid": "38688666", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study\n\nIncluded conditions:\n- Respiratory Distress\n- Upper Airway Obstruction\n\nStudy Armgroups:\n- {'label': 'Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)', 'interventionNames': ['Other: Standard of care for intubated children']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard of care for intubated children', 'description': 'Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation', 'armGroupLabels': ['Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)']}\n\nPrimary Outcomes:\n- {'measure': 'Respiratory distress by post-extubation upper airway obstruction (UAO)', 'description': 'The respiratory distress will be assessed using the Westley score. The Westley score evaluates the severity of respiratory function by assessing five factors: level of consciousness, cyanosis, stridor, air entry, and retractions. A specific point values are given for each factor, and the final score sum has a range from 0 to 17. The greater the respiratory distress the more imminent the respiratory distress. Respiratory distress will be defined by a Westley score greater than or equal to 4 with a minimum of 1 for the \"stridor\" item, at the initiation of at least one of the following treatments (IVC, LNHD, NIV (CPAP, BiPAP or any other mode with two pressure levels), MV(reintubation or tracheotomy)).', 'timeFrame': 'within 48 hours'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided 95.0% CI of <0.10 for AUROC values greater than 0.75 is assumed. For a cut-off having 90% specificity, an exact two-sided 95% CI of 0.044 is assumed. The smallest expected ROC curve width for AUROC values greater than 0.75 is 0.199 (0.141 for an AUROC of 0.90) within each age subgroup. The cut-off having 90% specificity will have an exact two-sided 95% CI of 0.09 within the same age subgroup.", "answer": 900, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Based on the literature, the expected proportion of patients with severe UAO-PERD is 15%.14 17 20 21 Therefore, 900 patients (135 with vs 765 without UAO-PERD) are needed to estimate the qtCLT AUROC with a two-sided 95.0% CI of <0.10 for AUROC values greater than 0.75 (eg, 95% CI of 0.071 if the AUROC equals 0.90). Recruiting 765 patients without PERD will allow the identification of a cut-off having 90% specificity, with an exact two-sided 95% CI of 0.044.\n The analyses will be repeated in the following age subgroups: (2\u00e2\u0080\u0089days\u00e2\u0080\u00932 years), (2 years\u00e2\u0080\u00938 years) and (8 years\u00e2\u0080\u009317 years). The smallest expected ROC curve width for AUROC values greater than 0.75 is 0.199 (0.141 for an AUROC of 0.90) within each age subgroup. The cut-off having 90% specificity will have an exact two-sided 95% CI of 0.09 within the same age subgroup.\n Based on data recorded in each of the 19 participating PICUs during the year preceding study initiation, 18 months will be required to recruit 900 patients meeting all the study inclusion criteria and none of the study exclusion criteria.", "id": 1397, "split": "test"} +{"trial_id": "NCT05329376", "pmid": "38515201", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n- Depression, Anxiety\n- Mental Health Disorder\n- Old Age; Debility\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': '12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo\u00ae).', 'interventionNames': ['Device: Smart Speaker Echo Dot']}\n- {'label': 'Group B', 'type': 'OTHER', 'description': '12 weeks of maintenance of usual care.', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Smart Speaker Echo Dot', 'description': 'Participants will receive the Smart Speaker EchoDot 3rd Gen (Amazon Echo\u00ae) device (i.e., Alexa) for home use, installed during a home visit following the study enrollment. In addition to the usual functionality of the system, the device will be programmed using a standard model developed by the research team, applied to each patient. The proposed model involves automatic interactions between the device and the patient, comprising:\\n\\n1. Medication reminders\\n2. Glucose test reminders:\\n3. Educational health tips\\n4. Weekly educational podcasts\\n5. Good morning and good night routine', 'armGroupLabels': ['Group A']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment', 'armGroupLabels': ['Group B']}\n\nPrimary Outcomes:\n- {'measure': 'Screening for depression, anxiety and common mental health disorders in elderly', 'description': 'For mental health screening, the Self Report Questionnaire (SRQ 20) will be used, translated into Portuguese and validated for the Brazilian population. It is a questionnaire with 20 questions specially developed for the screening of depression, anxiety em common mental health disorders in the elderly. Higher scores indicating more mental distress.', 'timeFrame': 'Change from baseline to 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, power of 90%, and a 20% dropout rate.", "answer": 112, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size calculations were performed using the Statistics and Sample Size Pro software [14]. With an alpha level of 0.05, a power of 90%, and an effect size of 0.68 (Cohen\u00e2\u0080\u0099s d), it was estimated that 94 subjects (47 per group) would be required to assess mean differences in the primary outcome. Assuming a 20% dropout rate, we plan to include 112 subjects (56 per group) in the study. The effect size of 0.68 was based on the randomized controlled trial published by Fulmer R et al. [15], which evaluated the efficacy of using psychological artificial intelligence software to reduce self-identified symptoms of depression and anxiety. In the referenced trial, the main outcome was assessed using the Patient Health Questionnaire-9 (PHQ-9), which was shown to be equivalent to the Self-Reporting Questionnaire (SRQ-20) used in our trial [16].", "id": 1398, "split": "test"} +{"trial_id": "NCT05330247", "pmid": "39142677", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes Mellitus - The Meal Box Study\n\nIncluded conditions:\n- Diabetes Mellitus Type 2\n- Overweight and Obesity\n\nStudy Armgroups:\n- {'label': 'Therapeutic Diet: CRHP Diet', 'type': 'EXPERIMENTAL', 'description': 'Carbohydrate-reduced high-protein (CRHP) dietary intervention. Intervention: Therapeutic Diet: CRHP Diet.', 'interventionNames': ['Other: Carbohydrate-reduced high-protein (CRHP) Diet']}\n- {'label': 'Therapeutic Diet: CD Diet', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional diabetes (CD) dietary intervention. Intervention: Therapeutic Diet: CD Diet.', 'interventionNames': ['Other: Conventional diabetes (CD) Diet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Carbohydrate-reduced high-protein (CRHP) Diet', 'description': 'Macronutrient intake of 30 percentage of energy from carbohydrate, 30 percentage of energy from protein and 40 percentage of energy from fat.', 'armGroupLabels': ['Therapeutic Diet: CRHP Diet']}\n- {'type': 'OTHER', 'name': 'Conventional diabetes (CD) Diet', 'description': 'Macronutrient intake of 50 percentage of energy from carbohydrate, 17 percentage of energy from protein and 33 percentage of energy from fat.', 'armGroupLabels': ['Therapeutic Diet: CD Diet']}\n\nPrimary Outcomes:\n- {'measure': 'Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet', 'description': 'HbA1c will be measured in fasting blood samples at baseline, 3, 6, 9 and 12 months. HbA1c will be expressed in mmol/mol.', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided \u03b1-level of 0.05, 20% dropout rate", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Sample size is calculated in relation to HbA1c as the study\u00e2\u0080\u0099s primary outcome. Based on previous nutrition intervention trials of similar experimental diets,33 we assumed an SD of 10\u00e2\u0080\u0089mmol/mol in change in HbA1c during 1 year, thereby calculating a need of 37 completing participants in each group in order to detect a difference in HbA1c of 7\u00e2\u0080\u0089mmol/mol with 80% power and a two-sided \u00ce\u00b1-level of 0.05. This difference in HbA1c is considered clinically relevant. To account for a drop-out rate of 20%, found in similar studies,33 and for a possibly smaller effect size, we decided to include 100 participants in the study.", "id": 1399, "split": "test"} +{"trial_id": "NCT05336500", "pmid": "36670384", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates Exercises in Patients With Primary Chronic Low Back Pain: a Randomised Controlled Trial\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Pilates method exercises associated with education to keep the abdomen relaxed', 'type': 'EXPERIMENTAL', 'description': 'The group will receive guidance to perform the exercises in a relaxed and smooth way', 'interventionNames': ['Other: Pilates method exercises']}\n- {'label': 'Pilates method exercises associated with education to keep the abdomen contracted', 'type': 'ACTIVE_COMPARATOR', 'description': 'The group will receive guidance on the specific activation of the center of strength (the powerhouse)', 'interventionNames': ['Other: Pilates method exercises']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pilates method exercises', 'description': 'Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks (twice a week for 60 minutes). The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way.', 'armGroupLabels': ['Pilates method exercises associated with education to keep the abdomen contracted', 'Pilates method exercises associated with education to keep the abdomen relaxed']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity', 'description': 'Pain intensity will be obtained through self-report by the Brazilian version of the 11-point Numerical Pain Scale (NPS) (Costa et al., 2008; Vigotsky et al., 2021), which varies between 0 and 10 points, where 0 is \"no pain\" and 10 is \"the worst pain imaginable\" where individuals should report pain intensity based on the last 7 days.', 'timeFrame': '12 weeks post randomisation'}\n- {'measure': 'Disability related', 'description': 'Disability will be obtained through self-report by the Brazilian version of the Roland-Morris Disability Questionnaire (RMDQ) (Nusbaum et al., 2001), which has 24 statements involving activities and pain situations, to which the patient is instructed to answer \"yes\" only to those described in the assessment day, and each answer corresponds to one point.', 'timeFrame': '12 weeks post randomisation'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 5%, power of 80%, and a possible loss to follow-up of 15%.", "answer": 152, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n The sample size required for this study will be 152 (76 per group) to detect a mean difference of 4.0 points for disability measured by RMDQ and 1.0 for pain intensity measured by NPRS between the two intervention arms, assuming a standard deviation of 4.9 for disability and 2.0 for pain, with an alpha of 5%, power of 80% and a possible loss to follow-up of 15 % [35\u00e2\u0080\u009337].", "id": 1400, "split": "test"} +{"trial_id": "NCT05336916", "pmid": "36698197", "question": "Here is the design of a clinical trial:\n\nOfficial Title: (Cost)Effectiveness of Blended and UnguideD DeliverY of Mindfulness-based Cognitive Therapy Versus Care as Usual for Cancer Patients: BUDDY Project\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Blended MBCT', 'type': 'EXPERIMENTAL', 'description': 'The blended MBCT consists of four 2,5 hour group sessions through videoconference (session 1, 3, 5 and 8), taught by experienced mindfulness trainers. The other sessions (2, 4, 6 and 7) are delivered online and are individual. Mindfulness trainers will provide online feedback to participants for these sessions. The sessions include meditation exercises, psycho-education, and group discussion. In addition to the sessions, participants are instructed to do daily home practice 45 minutes a day. The regular MBCT program was adapted to fit the needs of the target group and, for instance includes psycho-education about grief and cancer-related fatigue.\\n\\nOnline sessions were built around a specific theme. Participants are provided with information, audio files of meditations, and recording assignments around the theme of the session through a personal, secure webpage. The sessions look appealing and persuasive technologies such as reminders and videos are used.', 'interventionNames': ['Behavioral: Buddy']}\n- {'label': 'Unguided online MBCT', 'type': 'EXPERIMENTAL', 'description': \"Participants in the unguided online arm receive access to the 8 online mindfulness sessions (same intervention as blended MBCT arm), but no mindfulness trainer will be involved.\\n\\nEach online session was built around a specific theme, for instance automatic pilot, communication or self-care. Participants are provided with information, audio files of meditations, and recording assignments around the theme of the session through a personal, secure webpage. Participants are encouraged to read the information and do the assigned meditations and recording assignments within one week. The sessions will look appealing and persuasive technologies such as reminders and video's will be used.\", 'interventionNames': ['Behavioral: Buddy']}\n- {'label': 'Treatment As Usual', 'type': 'NO_INTERVENTION', 'description': 'Not offered the mindfulness program, treatment as usual'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Buddy', 'description': 'Mindfulness-based Cognitive Behavioural Therapy', 'armGroupLabels': ['Blended MBCT', 'Unguided online MBCT']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU', 'description': 'The HADS is a 14-item questionnaire measuring distress. Items are scored on a 0-3 scale that are summed to obtain a distress total score (range 0-42). Higher scores represent more distress.', 'timeFrame': '1 week post-treatment'}\n\nPlease estimate the sample size based on the assumption: \nAlpha is set at 0.05, Pearson correlation between T0 and T1 at 0.50, and power of 0.80 for pairwise comparison eMBCT vs CAU. The power of the three-group ANCOVA is 0.95, with 0.92 for eMBCT vs CAU and 0.82 for blended eMBCT vs CAU. Dropout rates are anticipated to be 20% for blended eMBCT, 40% for unguided eMBCT, and 0% for CAU, later adjusted to 28% for all groups.", "answer": 254, "answer_type": "ESTIMATED", "explanation": "Power calculation and sample size\n Power analysis is based on a three-group ANCOVA, with psychological distress post-treatment as primary endpoint, corrected for baseline psychological distress. We will use a close testing procedure for pairwise comparisons between blended eMBCT vs. CAU, and unguided eMBCT vs. CAU. In our previous study, we found that the effect size of group MBCT was d\u00e2\u0080\u0089=\u00e2\u0080\u00890.45 and that of therapist-assisted eMBCT was d\u00e2\u0080\u0089=\u00e2\u0080\u00890.71 [8]. So, we expect the effect size of blended eMBCT to be d\u00e2\u0080\u0089=\u00e2\u0080\u00890.58 (the mean of the effect sizes of the group and therapist-assisted eMBCT in our previous trial). We estimate the effect size of the unguided eMBCT vs CAU to be d\u00e2\u0080\u0089=\u00e2\u0080\u00890.45 (the smallest effect found in our previous study). Alpha is set at 0.05 and the Pearson correlation between T0 and T1 at 0.50 (based on our previous study). To ensure a power of 0.80 in the pairwise comparison eMBCT vs CAU, a minimal group of 65 for CAU is required. This results in a power of 0.95 of the three-group ANCOVA, and a power of 0.92 for the comparison eMBCT vs CAU and 0.82 for the comparison blended eMBCT vs CAU.\n Based on our previous study, we anticipate 20% dropout in blended eMBCT, 40% dropout in unguided eMBCT, and 0% in CAU, which rendered a target sample size of at least 254 participants: 81 in blended eMBCT, 108 in unguided eMBCT, and 65 in CAU. However, after inclusion of the first 80 participants, drop-out appeared to be similar across the three conditions (28%). We therefore adjusted our target to include at least 86 participants in each arm.", "id": 1401, "split": "test"} +{"trial_id": "NCT05337033", "pmid": "39302982", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial\n\nIncluded conditions:\n- Chronic Migraine\n\nStudy Armgroups:\n- {'label': 'Cannabidiol-enriched Cannabis Herbal Extract', 'type': 'EXPERIMENTAL', 'description': 'CBD50 plus', 'interventionNames': ['Drug: MPL-001']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'MPL-001', 'description': 'CBD50 plus is a medical cannabis oil with flavouring agent produced under Good Manufacturing Practice by MediPharm Labs and purchased for this study. Each ml of oil contains 2 mg/ml of delta-9-THC and 50 mg/ml of CBD.\\n\\nParticipants will receive escalating doses from 0.2-0.4 mg/kg/day of CBD to 0.8-1 mg/kg of CBD per day for four months, with dose increases monthly in 0.2mg/kg increments. Participants will following a weekly weaning protocol.', 'armGroupLabels': ['Cannabidiol-enriched Cannabis Herbal Extract'], 'otherNames': ['medical cannabis oil']}\n\nPrimary Outcomes:\n- {'measure': 'Cannabis-related adverse events', 'description': 'The frequency of adverse events will be measured and characterized using standard CTCAE coding', 'timeFrame': 'Reported daily through study completion, an average of 6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a within-participant design and aims to characterize the pattern of adverse event frequency and severity.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n CAN-CHA is a tolerability study, designed to evaluate the safety of escalating doses of a cannabidiol-enriched CHE. Given the within-participant study design, a sample size of 20 study participants (common for early phase trials) should provide a reasonable characterization of the pattern of adverse event frequency and severity as dosing increases. To provide more generalizable data we will recruit these participants across three pediatric chronic pain/headache programs in Halifax, Vancouver, and Toronto, Canada.", "id": 1402, "split": "test"} +{"trial_id": "NCT05338151", "pmid": "37726823", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.\n\nIncluded conditions:\n- Alcohol Use Disorder\n\nStudy Armgroups:\n- {'label': 'Brief Negotiated Interview (with referral and telephone booster) alone', 'type': 'OTHER', 'description': \"All participants will receive BNI with referral and a 15-20 minute telephone booster delivered by a trained Health Promotion Advocate (HPA) at 2 weeks. The purpose of the BNI is to assist patients in recognizing and changing levels of alcohol consumption that pose health risks. The main goals of the BNI are to: 1) lessen ambivalence about reducing alcohol use; and 2) negotiate strategies for change. During BNI, the HPA will: 1) Raise the subject of alcohol; 2) Provide feedback: review the patient's alcohol consumption, make a connection to the patient's medical condition and reason for hospitalization; review guidelines for lower risk alcohol use; 3) Enhance motivation: have the patient identify on a readiness change ruler and develop discrepancy; and 4) Negotiate and Advise: negotiate goal, give advice, have patient complete drinking agreement; summarize and arrange follow-up.\", 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)']}\n- {'label': 'BNI+MAUD', 'type': 'ACTIVE_COMPARATOR', 'description': 'For either BNI+facilitated provision of MAUD or BNI+facilitated provision of MAUD+CBT4CBT, the HPA will provide education and counseling regarding MAUD as part of the BNI to the participant and communicate to the primary medical team that MAUD is indicated. The specific MAUD chosen will be made at the discretion of the patient and the primary medical team with recommendations from the study physicians, with a goal of prioritizing FDA approved medications. Participants will be encouraged to initiate (or receive as in the case of injectable naltrexone) MAUD prior to discharge and will be provided a prescription for a 30-day supply. Medications will be obtained through regular means and not provided directly through the study. During the BNI telephone booster, the HPA will inquire about and address any barriers to MAUD and encourage continued adherence.', 'interventionNames': ['Behavioral: BNI+facilitated provision of MAUD']}\n- {'label': 'BNI+MAUD+CBT4CBT', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to BNI+facilitated provision of MAUD+CBT4CBT will be given a username and password to access the web-based program and be encouraged to begin accessing the program during their hospitalization. The HPA will assist each participant with login during the first session and be available to answer any questions. Participants will be asked to complete no more than two modules per week, with an expectation of completing all seven modules by the end of the 34-day post-discharge. The program tracks, for each participant, time logged onto the program, modules accessed, progress through the program from session to session, completion of homework assignments, and learning of CBT principles through brief quizzes. Participants will be allowed to repeat modules as desired. During the BNI telephone booster, the HPA will inquire about engagement with CBT4CBT, address any questions and problems with the program, and encourage practice of coping activities (i.e., homework).', 'interventionNames': ['Behavioral: Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Brief Negotiated Interview (BNI)', 'description': 'Brief Negotiated Interview (with referral and telephone booster) alone', 'armGroupLabels': ['Brief Negotiated Interview (with referral and telephone booster) alone']}\n- {'type': 'BEHAVIORAL', 'name': 'BNI+facilitated provision of MAUD', 'description': 'Brief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD)', 'armGroupLabels': ['BNI+MAUD']}\n- {'type': 'BEHAVIORAL', 'name': 'Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT', 'description': 'Brief Negotiated Interview (BNI)+Medication for Alcohol Use Disorder (MAUD)+Computer Based Treatment for Cognitive Behavioral Treatment (CBT4CBT)', 'armGroupLabels': ['BNI+MAUD+CBT4CBT']}\n\nPrimary Outcomes:\n- {'measure': 'The primary outcome will be the percentage of participants engaged in AUD Treatment at the 34-day post hospital discharge timepoint, defined as any self-reported AUD treatment service assessed on the AUD Treatment Assessment.', 'description': 'AUD Treatment Engagement Assessment is a self-report used to assess if participants have participated in different types of treatment engagement for alcohol use over 34 days. That data is verified by an outside source.', 'timeFrame': 'Day 34 post hospital diacharge'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 0.025 (Bonferroni correction for multiple comparisons), power > 80%, and a 20% loss of data at follow-up.", "answer": 450, "answer_type": "ESTIMATED", "explanation": "Justification of sample size\n Power for the three-arm trial was estimated based on an alpha of 0.025, which is a Bonferroni correction for multiple comparisons, given three treatment conditions with two planned contrasts. We assumed a 40% base rate in engagement in AUD treatment at 34-days post-discharge (primary outcome) following BNI based on our YAMCS post-discharge data and published reports from other hospital-based addiction medicine consult services [13]. A sample size of 450 (150 per condition) will provide adequate power (>\u00e2\u0080\u008980%) to detect a 15% increase in engagement from the comparator treatment (BNI\u00e2\u0080\u0089+\u00e2\u0080\u0089MAUD or BNI\u00e2\u0080\u0089+\u00e2\u0080\u0089MAUD\u00e2\u0080\u0089+\u00e2\u0080\u0089CBT4CBT) at 34-days, consistent with a small to medium effect (delta\u00e2\u0080\u0089=\u00e2\u0080\u00890.34). With a sample size of 360 participants (120 per condition), we would have >\u00e2\u0080\u008980% power to detect a 20% increase in engagement, consistent with a medium effect (delta\u00e2\u0080\u0089=\u00e2\u0080\u00890.46). Thus, with a randomized sample of 450, we will have adequate power to detect a medium effect on AUD treatment engagement, assuming a 20% loss of data at follow-up. This is based on experiences with similar populations at YNHH [65], as well as those in our prior outpatient treatment studies [34, 74, 76].", "id": 1403, "split": "test"} +{"trial_id": "NCT05338450", "pmid": "38296293", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple Sclerosis\n\nIncluded conditions:\n- Multiple Sclerosis\n- Internuclear Ophthalmoplegia\n\nStudy Armgroups:\n- {'label': 'Clemastine Fumarate', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Clemastine Fumarate']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Clemastine Fumarate', 'description': '4 mg of Clemastine Fumarate twice daily (8mg/day) orally for 6 months (180 days)', 'armGroupLabels': ['Clemastine Fumarate'], 'otherNames': ['clemastine', 'Tavegyl']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo equivalent to experimental arm', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (6 months)', 'description': 'Our main study parameter is the versional dysconjugacy index (VDI) measured by infrared oculography. The relative change in VDI from baseline will be compared between the treatment and control group at the end of treatment (6 months). The VDI of Area Under the Curve (AUC) will be our primary study parameter. This describes the area under the saccadic trajectory of the horizontal eye position.', 'timeFrame': '6 months'}\n- {'measure': 'Versional Dysconjugacy Index (VDI) - Area Under the Curve (VDI-AUC) (36 months)', 'description': 'The relative change in VDI from baseline will be compared between the treatment and control group at the end of follow-up (36 months).', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation was based on a two-sided t-test for 80% power (\u00ce\u00b2=0.2) at a significance level of 95% (\u00ce\u00b1=0.05). An anticipated dropout rate of 20% was also considered.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Group size was calculated using a two-sided t-test for 80% power (\u00ce\u00b2=0.2) at a significance level of 95% (\u00ce\u00b1=0.05). An earlier study showed that fampridine could temporarily reduce VDI by 12.5\u00e2\u0080\u009317.4%, depending on the type of VDI measure used (VDI offirst-pass amplitude (FPA) and peak velocity (pV), respectively).19 The effect of clemastine on VDI measures is expected to be similar in order to be regarded as clinically relevant. Since the current study will use a different primary VDI measure (VDI-AUC) and may include more patients with less severe INO, a clinically relevant effect of clemastine is defined at 12% reduction in VDI for the current study. This is well above the within-subject variability on retesting, which was found to have a coefficient of variation of 1.1% for VDI-AUC of 15\u00c2\u00b0 saccades.14 VDI-AUC measurement in patients with MS with INO in the Amsterdam MS cohort showed an average VDI-AUC of 1.32 with a SD of 0.21. A clinically relevant effect of \u00e2\u0088\u009212% would therefore yield a reduction in VDI of 0.16.\n Using this information group size calculates to 30 participants per group. The anticipated dropout is 20% over the entire trial period, requiring a minimum of 38 participants per group. The final group size was set to 40 participants per group, which resulted in a requirement of 80 study participants in total.", "id": 1404, "split": "test"} +{"trial_id": "NCT05338827", "pmid": "36517088", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM Video Laryngeal Mask Airway: a Randomized Controlled Study\n\nIncluded conditions:\n- Laparoscopic Surgery\n\nStudy Armgroups:\n- {'label': 'Polyvinyl Chloride Tube group', 'type': 'EXPERIMENTAL', 'description': 'The PVC tube used is a stiff tube with an anterior curvature of approximately 130\u00b0, which retains the additional curvature imposed by its passage through the ventilation conduit of the ILMA. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.', 'interventionNames': ['Procedure: Polyvinyl Chloride Tube group']}\n- {'label': 'Wire-Reinforced Tube group', 'type': 'EXPERIMENTAL', 'description': 'In contrast to the PVC tube, the WR tube is flexible with a slightly anterior curvature. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.', 'interventionNames': ['Procedure: Wire-Reinforced Tube group']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Polyvinyl Chloride Tube group', 'description': 'The anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.', 'armGroupLabels': ['Polyvinyl Chloride Tube group']}\n- {'type': 'PROCEDURE', 'name': 'Wire-Reinforced Tube group', 'description': 'The anaesthesiologist will perform a visual screen for the SaCoVLM glottic exposure grade after the SaCoVLM is successfully inserted. The SaCoVLM glottic exposure grade was referred to the endoscopic view grading system. If the SaCoVLM glottic exposure grade is 1 or 2, a lubricated tracheal tube will be inserted in a conventional manner with the curvature of the tracheal tube aligned along the intrinsic curvature of the SaCoVLM. The passage of the tracheal tube into the glottis will be visualised. If there is a discrepancy in the alignment of the tracheal tube exiting from the SaCoVLM and the glottis that will prevent the passage of the tracheal tube into the glottis, the tracheal tube will be withdrawn and manipulations (rotation of the tracheal tube or up/down manoeuvre) will be performed in an attempt to align the glottis and tracheal tube tip to facilitate intubation. Such manoeuvres, if performed, will be recorded.', 'armGroupLabels': ['Wire-Reinforced Tube group']}\n\nPrimary Outcomes:\n- {'measure': 'The total success rate of tracheal intubation', 'description': 'defined as the cumulative third-attempt intubation success rate', 'timeFrame': 'From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to half hour or 1 hour.'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size ratio was set at 1:1, with 90% power and an alpha value of 0.025. A 10% dropout rate was anticipated.", "answer": 104, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated based on the total intubation success rate. According to previous reports, the success rates of the PVC and WR groups were expected to be 57% and 86%, respectively.8 Using PASS software (V.15.0; NCSS, Kaysville, Utah, USA) to compare the sample size of the two groups, the sample size ratio was set at 1:1, and a sample size of 46 in each group was needed to achieve 90% power with an alpha value of 0.025. Anticipating a 10% dropout rate, we plan to enrol 52 patients per group. A minimum of 104 subjects will be included in the study.", "id": 1405, "split": "test"} +{"trial_id": "NCT05342701", "pmid": "35964114", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The CHAMP Afterschool Program: Promoting Physical Activity & Health in Children\n\nIncluded conditions:\n- Physical Inactivity\n\nStudy Armgroups:\n- {'label': 'CHAMP-ASP', 'type': 'EXPERIMENTAL', 'description': \"CHAMP, is a mastery climate motor skills intervention, that provides children the opportunity to establish behaviors that reinforce decision-making while participating in a motor activity tasks. Children will participate in CHAMP for 35 minutes/day 3-4 days per week for 19 weeks.\\n\\nEach 35-min session consists of three parts:\\n\\n1. 3-5 min of motor skill introductory activity that includes a group motor activity, the teaching of the lesson that includes a demonstration and understanding of developmentally appropriate learning clues;\\n2. 25 min of motor skill instruction and practice (i.e., 'active motor engagement'), participants will be encouraged to move through 3-4 motor activity stations that align with the TARGET structure; and\\n3. 3 -5 min motor skill closure activity that involves a review of the lesson and critical elements.\", 'interventionNames': ['Behavioral: Motor Skills Intervention']}\n- {'label': 'Control - Standard of Practice', 'type': 'NO_INTERVENTION', 'description': 'The Control (standard of practice) condition will be the school typical ASP and will be implemented according to the existing procedures.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Motor Skills Intervention', 'description': 'The behavioral motor skill intervention (CHAMP) is an intervention strategy that uniquely address differences in children\\'s development. CHAMP does not equate to a \"one size fits all\" approach. Children will be in an environment that promotes opportunities for them to development improvement in motor skills based on their specific individual needs and choices. The CHAMP intervention promotes a mastery climate that allows each individual child to be successful and learn while promoting intrinsic motivation and autonomy. CHAMP consists of 35 minutes/day X 3-4 days/week for 19 weeks (dose of 1995 - 2240 minutes). Each session will consist of three parts: (a) 3-5 min of motor skill introductory activity, (b) 25 min of motor skill instruction and practice, and (c) 3-5 min motor skill closure activity.', 'armGroupLabels': ['CHAMP-ASP']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Motor Competence - process measures', 'description': 'Process scores will be assessed with the Test of Gross Motor Development (TGMD, 3rd edition); scores from the two subscales (locomotor and ball skills) will be reported as raw scores for each skills and an overall score (total MC score). The project will assess changes overtime for this measure', 'timeFrame': 'baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up'}\n- {'measure': 'Changes in Motor Competence - product measures', 'description': 'Product scores will use throwing speed, kicking speed, jump distance, running speed, and hopping speed. Product score will vary for each participant (i.e., kick, run, hopping, and throw velocity along with jumping distance - faster scores and greater distance are indicators of better MC).', 'timeFrame': 'baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up'}\n- {'measure': 'Changes in Physical Activity', 'description': 'Actigraph GTX3+ tri-axial accelerometer will be used to measure the frequency, intensity, and duration of PA among children during the ASP and in free-living settings. Participants will be asked to wear the same accelerometer for 7 full days (5 week and 2 weekend days). Data will be set to collect data in raw mode (30 Hz), and will be processed using ActiLife software or other, more advanced techniques, such as machine learning approaches.', 'timeFrame': 'baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up'}\n- {'measure': 'Changes in Health-related fitness - Cardiorespiratory endurance', 'description': 'Cardiorespiratory endurance will be assessed with a 6-min walk test. For the 6-min walk test, the children walk as fast as possible around two cones for 6 minutes.', 'timeFrame': 'baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up'}\n- {'measure': 'Changes in Health-related fitness - Muscular Strength', 'description': 'Muscular strength will be assessed with test of handgrip strength. Upper body strength will be assessed using a hand grip strength with a dynamometer, which has been deemed reliable and valid in 6-12-year-olds \\\\[62\\\\]. Grip will be appropriately adjusted for size, and two trials on the right and left sides (elbow extended) will be assessed (muscular strength). The sum of maximum score (kg) of two trials for each hand will be used in analyses.', 'timeFrame': 'baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up'}\n- {'measure': 'Changes in Health-related fitness - Body Composition', 'description': 'Body composition (i.e., body fat) will be assessed with bioelectrical impedance. Body fat percentage will be the average of two measurements assessed (to the nearest 0.1%, respectively) with a bioelectric impedance analysis scale (Tanita). The assessment will be completed in a designated, private area', 'timeFrame': 'baseline, post-intervention (i.e., 24 weeks post baseline), and 1 year post-intervention follow-up'}\n\nPlease estimate the sample size based on the assumption: \n90% power, alpha level of 0.05, intracluster correlation coefficient (ICC) of 0.05, and a 20% loss to follow-up.", "answer": 264, "answer_type": "ESTIMATED", "explanation": "Sample size, power analysis and sample attrition\n The sample size was calculated based on our primary endpoint, the change in PA between baseline and post-intervention. According to previous literature, we anticipate the changes in the primary endpoint PA for the intervention group after completing the CHAMP-ASP will be higher than that of the comparison group by 12\u00e2\u0080\u0089min of MVPA (whole day), with an estimate of the standard deviation (SD) as 26 [59, 60]. Literature shows that such a change is accepted as a clinically meaningful change in improving PA among lower-elementary-school children [59, 60]. Since we will enroll study subjects from multiple ASPs in Ann Arbor/Ypsilanti and East Lansing/Lansing, we accounted for the intracluster correlations in the following calculations. Based on our previous studies, the intracluster correlation coefficient (ICC) ranges from 0.02 to 0.05. We assumed a conservative ICC as 0.05 in power and sample size considerations. With 90% power at an alpha level of 0.05, we will need a total of 216 subjects (assuming 18 subjects per ASP, 12 ASPs with 6 randomized to be CHAMP-ASP and 6 comparison groups - 108 subjects per intervention arm) to detect the above group difference. To account for 20% loss to follow-up, we will recruit 264 subjects at baseline (assuming 22 students per ASP, 132 subjects per intervention arm). We will take steps to minimize loss to follow-up, and this extra recruitment will also help us to maintain the statistical power at 90%, with unexpected smaller detectable differences in change of PA scores, and for the secondary endpoint analysis [61].", "id": 1406, "split": "test"} +{"trial_id": "NCT05343611", "pmid": "38135320", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Combining Vitamin E-functionalized CHOcolate With Physical Exercise to Reduce the risK Of Protein Energy Malnutrition in Pre-dementia AGEd People\n\nIncluded conditions:\n- Dementia\n- Dementia, Mild\n- Dementia Moderate\n- Dementia Senile\n- Malnutrition\n- Deficiency Nutritional\n- Deficiency Diseases\n\nStudy Armgroups:\n- {'label': 'Group A (Controls: HPro diet and HIT)', 'type': 'ACTIVE_COMPARATOR', 'description': \"Subjects included in this group will serve as controls and will maintain the HPro Diet + HIT program prescribed to all the participants included in the randomization step of the study. The subjects' diet will be adjusted to receive the same overall intake of calories (+ 180 kcal) and macronutrients (+ 3 g of proteins, 4 g of carbohydrates, +11 g of fat, + 4 g of fibers) that the chocolate products will provide to groups B and C.\", 'interventionNames': ['Behavioral: Combination of High Protein Diet and Physical Exercise protocol']}\n- {'label': 'Group B (Case 1: HPP Choko)', 'type': 'SHAM_COMPARATOR', 'description': 'Individuals included in this group will undergo the same diet and physical exercise as Group A and additionally they will add to their diet 30g of 85% dark chocolate high in PP (HPP \u2265 500 mg of PP and corresponding to \u2265 60 mg of epicatechin).', 'interventionNames': ['Behavioral: Combination of High Protein Diet and Physical Exercise protocol', 'Dietary Supplement: HPP Choko']}\n- {'label': 'Group C (Case 2: HPP/VE Chocolate)', 'type': 'EXPERIMENTAL', 'description': 'Individuals included in this group will undergo the same diet and physical exercise as Group A and additionally they will add to their diet 30 grams of 85% dark HPP chocolate functionalized with 100 mg Vitamin E per day.', 'interventionNames': ['Behavioral: Combination of High Protein Diet and Physical Exercise protocol', 'Dietary Supplement: HPP/VE Choko']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Combination of High Protein Diet and Physical Exercise protocol', 'description': 'A high Protein Diet (HPro) will be provided to maintain individual caloric endpoint and to adjust protein intake to 0.9-1.0 g/Kg ideal body weight. Each participant will receive a tailored diet (taking into account personal preference) which will follow common general guidelines. Servings of food high in polyphenols will be limited to one per day.\\n\\nPhysical exercise will be undertaken three times each week for about 50 minutes per session. The intervention will consist of both aerobic and strength training exercises. Aerobic exercise will consist of walking on a treadmill with 4 x 4 minutes at (85-95% of HRmax), interrupted by 3-minute active recovery periods (60-70% of HRmax). Strength exercise consists of maximal strength training, using a seated leg press with 4 sets of 4 repetitions at \\\\~90% of maximal strength (1RM). Rest periods between the sets will be 3-4 min.', 'armGroupLabels': ['Group A (Controls: HPro diet and HIT)', 'Group B (Case 1: HPP Choko)', 'Group C (Case 2: HPP/VE Chocolate)']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'HPP Choko', 'description': 'Participants add to their diet with 30 g/day of 85% dark chocolate high in polyphenols', 'armGroupLabels': ['Group B (Case 1: HPP Choko)']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'HPP/VE Choko', 'description': 'Participants add to their diet 30 grams of 85% dark chocolate high in polyphenols, functionalized with 100 mg of Vitamin E per day.', 'armGroupLabels': ['Group C (Case 2: HPP/VE Chocolate)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in free-fat soft tissue mass (g)', 'description': 'Change in free-fat soft tissue mass, (FFSTM, g), will be assessed by means of a whole-body scan on a dual-energy X-ray absorptiometry scanner. Values at the regional level (upper limbs, lower limbs and trunk) will be also considered.', 'timeFrame': 'Baseline (T00), Pre-intervention (T0) after 2-4 weeks, Mid-intervention (T1) after 3 months, Post-intervention (T2) after 3 months and Follow-up (T3) after 3 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha=0.05, power=0.8, 20% estimated dropout rate, correlation between repeated measures is 0.5, variance explained by the between-subjects effect is 6.25, and error variance is 65.", "answer": 102, "answer_type": "ESTIMATED", "explanation": "Sample size\n Considering an alpha=0.05, a power=0.8\u00e2\u0080\u0089and the 20% of estimated drop out, we aim to recruit 102 subjects (34 in each group). The main outcome is \u00e2\u0080\u0098muscle mass\u00e2\u0080\u0099, and for all the groups treatment duration will be 6 months. In 6 months in the target population, the loss of muscle mass is assumed to be 1.0%\u00e2\u0080\u00931.5% (\u00c2\u00b10.5%).36 In control group (group A), which includes people undergoing targeted exercise, the expected increase is 2%\u00e2\u0080\u00931.5% (\u00c2\u00b10.5%). In treatment groups (groups B and C), the median average expected increase at second follow-up is 4%\u00e2\u0080\u00932% (\u00c2\u00b10.5%) and 1.5%\u00e2\u0080\u00934% (\u00c2\u00b10.5%) at 6 months.37 The rate of lost at follow-up, derived from previous studies, is 20% (\u00c2\u00b12%). The correlation between repeated measures is assumed to be 0.5, variance explained by the between-subjects effect 6.25 and error variance 65. All estimates were performed using Stata V.16.1 (StataCorp LP, College Station, Texas, USA) by \u00e2\u0080\u0098power repeated\u00e2\u0080\u0099 command.", "id": 1407, "split": "test"} +{"trial_id": "NCT05344066", "pmid": "38341207", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MIDDAS-GDM: A Two-Arm Randomised Feasibility Protocol Trial of an Intermittent Low-Energy Diet (ILED) in Women With Gestational Diabetes and Obesity in Greater Manchester\n\nIncluded conditions:\n- Gestational Diabetes\n- Gestational Diabetes Mellitus in Pregnancy\n- Intermittent Fasting\n- Pregnancy Related\n- Diabetes\n- Diabetes in Pregnancy\n\nStudy Armgroups:\n- {'label': 'Best NHS Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Best National Health Service (NHS) Care', 'interventionNames': ['Other: Best NHS Care']}\n- {'label': 'Intermittent Low Energy Diet', 'type': 'EXPERIMENTAL', 'description': 'Intermittent Low Energy Diet', 'interventionNames': ['Other: Intermittent Low Energy Diet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Best NHS Care', 'description': 'Personalised advice and support from a diabetes dietician to follow NICE healthy eating diet and physical activity recommendations for GDM.', 'armGroupLabels': ['Best NHS Care']}\n- {'type': 'OTHER', 'name': 'Intermittent Low Energy Diet', 'description': 'Two non-consecutive days of a food based 1000 kcal diet and five days of the NICE healthy eating diet and physical activity recommendations for the best NHS care group.', 'armGroupLabels': ['Intermittent Low Energy Diet']}\n\nPrimary Outcomes:\n- {'measure': 'Trial recruitment rate', 'description': 'Uptake to trial will be measured as a percentage of eligible participants who consent to participate in the trial per month.', 'timeFrame': 'Duration of trial (68 weeks)'}\n- {'measure': 'Retention to the trial', 'description': 'Retention rate will be measured as the percentage of participants who complete all scheduled 8 visits.', 'timeFrame': 'Duration of trial (68 weeks)'}\n- {'measure': 'Trial uptake', 'description': 'Trial uptake will be measured as the percentage of eligible participants who consent to participate in the trial.', 'timeFrame': 'Duration of trial (68 weeks)'}\n- {'measure': 'Adherence to the interventional intermittent low-calorie diet over course of study', 'description': 'Self-reported adherence to the two potential low-calorie days per week expressed as a percentage of the potential low-calorie days in the intermittent low energy diet group.', 'timeFrame': \"From randomisation (at 24-30 weeks' gestation) to delivery.\"}\n- {'measure': 'Adherence to capillary glucose and ketone measurements over course of study', 'description': 'The number of self-assessed glucose (4 times a day) and ketone (3 times a day on two days of the week) measurements in both groups over the course of the study.', 'timeFrame': \"From randomisation (at 24-30 weeks' gestation) to delivery\"}\n- {'measure': 'Episodes of hypoglycaemia requiring intervention', 'description': 'The percentage of women with self-reported hypoglycaemia (capillary blood glucose of \\\\<3.0 mmol/l) will be measured and compared between groups.', 'timeFrame': \"From 24-30 weeks' gestation until delivery.\"}\n- {'measure': 'Episodes of ketonaemia requiring intervention', 'description': 'The percentage of women with self-reported significant ketonaemia (capillary ketones \\\\>1 mmol/l) will be measured and compared between groups.', 'timeFrame': \"From 24-30 weeks' gestation until delivery.\"}\n- {'measure': 'Rates of neonatal hyperbilirubinaemia/jaundice', 'description': 'Percentage of neonatal hyperbilirubinaemia/jaundice (defined as a total serum bilirubin level above 86 \u03bcmol/l) episodes will be recorded in both groups.', 'timeFrame': \"From delivery until final visit at 12-13 weeks' postpartum\"}\n- {'measure': 'Rates of neonatal hypoglycaemia', 'description': 'Percentage of neonatal hypoglycaemic episodes requiring intervention (blood glucose checked 2-hours post delivery and 2-hours thereafter for 12 hours) will be recorded in both groups.', 'timeFrame': 'From delivery until 12 hours post-delivery'}\n- {'measure': 'Neonatal birthweight', 'description': 'Neonatal birth weight will be measured in kilograms and recorded in both groups.', 'timeFrame': 'At delivery'}\n- {'measure': 'Neonatal gestational age at delivery', 'description': 'Gestational age at delivery will be measured in weeks and recorded in both groups.', 'timeFrame': 'At delivery'}\n- {'measure': 'Gestational age at delivery', 'description': 'Gestational age at delivery in weeks will be recorded in both groups.', 'timeFrame': 'At delivery'}\n- {'measure': 'Rates of admission to special care baby unit or neonatal intensive care', 'description': 'Rates of admission to Special Care Baby Unit or Neonatal Intensive Care will be recorded in both groups.', 'timeFrame': \"From delivery until final visit at 12-13 weeks' postpartum\"}\n- {'measure': 'Number of stillbirths', 'description': 'Number of stillbirths will be recorded in both groups.', 'timeFrame': 'At delivery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level and power are not explicitly stated. An estimated attrition rate of 15% is considered. Recruitment rates are estimated with an error of \u00b113.42%, and retention rates with an error of \u00b111.07%.", "answer": 26, "answer_type": "ACTUAL", "explanation": "Sample size\n We plan to recruit 24 participants per study arm (n=48) which, when considering an estimated attrition rate of 15%, will provide complete outcome data on 40 participants.24\u00e2\u0080\u009326 It has been estimated that 24 participants per group will be sufficient to determine study outcomes, in line with sample size recommendations for feasibility studies.27\u00e2\u0080\u009329\n\n This number will allow us to enable estimation of recruitment/retention parameters with sufficient precision. For example, based on 40 completed participants, it will enable recruitment rates in the region of 25% to be estimated with an error of \u00c2\u00b113.42% at most; retention of 85% will be estimated with error of \u00c2\u00b111.07% at most. It is also sufficient for estimation of variability (eg, SD) in gestational weight gain and capillary glucose concentrations (proposed outcomes for the future definitive trial) with negligible bias.30", "id": 1408, "split": "test"} +{"trial_id": "NCT05347719", "pmid": "38888958", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Virtual Mindfulness Training for Adults With History of Depression\n\nIncluded conditions:\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'MBCT Intervention', 'type': 'EXPERIMENTAL', 'description': 'Eight weekly two-hour mindful MBCT intervention sessions led by a trained healthcare provider. Post-intervention, the experimental group will receive treatment as usual.', 'interventionNames': ['Behavioral: MBCT Intervention']}\n- {'label': 'Wait List Control', 'type': 'NO_INTERVENTION', 'description': 'Participants will engage in treatment as usual during the baseline period. After the experimental group completes the MBCT intervention, the wait list control group will complete the MBCT intervention.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'MBCT Intervention', 'description': 'Eight weekly two-hour mindful MBCT intervention sessions involving training in mindfulness meditation and cognitive-behavioral methods. Sessions will be designed to increase participant awareness of internal reactions that trigger relapse in MDD and to provide participants with techniques to detach from dysfunctional cognitive processes and redirect their attention to experiences. Outside of the sessions, participants will be assigned daily homework exercises and provided with handouts and audio recordings of mindfulness exercises to use in their practice.', 'armGroupLabels': ['MBCT Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Depression Severity', 'description': 'Depression severity will be assessed with the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer \\\\& Williams 2001). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe, and severe depression.', 'timeFrame': 'Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)'}\n- {'measure': 'Change in Psychiatric Distress', 'description': 'Psychiatric distress will be measured using the depression and anxiety subscales of the Brief Symptom Inventory (BSI; Derogatis \\\\& Melisaratos,1983). Items, such as \"your feelings being easily hurt,\" are ranked on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Higher scores represent higher intensity of distress during the past week.', 'timeFrame': 'Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)'}\n\nPlease estimate the sample size based on the assumption: \nThe level of significance (\u03b1 error probability) was set as 0.05 based on Ronald A. Fisher's suggestion. The expected power of the study (1-\u03b2 error probability) was set as 0.8 based on Cohen's theory. The allocation ratio (N2/N1) was expected to be 1:1, with an equal number of participants in the treatment and control groups.", "answer": 28, "answer_type": "ACTUAL", "explanation": "Sample Size\n The total sample size of our trial is expected to be 128 individuals with 64 participants placed into each group. This was estimated by a 2-tailed t test using GPower 3.1 (Informer Technologies, Inc) software. Our calculation of sample size depended on (1) the level of significance (\u00ce\u00b1 error probability), which was set as .05 based on Ronald A Fisher\u00e2\u0080\u0099s suggestion [55]; (2) the expected effect size, which was set as d=0.5, according to Cohen classification that \u00e2\u0080\u009ca medium effect of .5 is visible to the naked eye of a careful observer\u00e2\u0080\u009d [56]; (3) the expected power of this study (1\u00e2\u0080\u0093\u00ce\u00b2 error probability), which was set as 0.8 based on Cohen theory [57] because we failed to obtain support from previous similar studies; and (4) the allocation ratio (N2/N1), for which we expect number of participant in treatment group and control group to be the same.", "id": 1409, "split": "test"} +{"trial_id": "NCT05348538", "pmid": "37847695", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility Study of the Medication Review With Follow up Service for Patients With Polypharmacy in Swiss Community Pharmacies\n\nIncluded conditions:\n- Chronic Disease\n\nStudy Armgroups:\n- {'label': 'Medication review with follow up or MaJ? for the acronym in french', 'type': 'EXPERIMENTAL', 'description': 'All the pharmacists accepting to participate in the study will perform the intervention.', 'interventionNames': ['Other: Medication review with follow up or MaJ? for the acronym in french']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Medication review with follow up or MaJ? for the acronym in french', 'description': 'MaJ? service will involve a pharmacist-patient face-to-face consultation with a 6-months interval during the study, it includes:\\n\\n1. Educational training: pharmacists will attend a half a day course. They will inform pharmacy technicians of their tasks. They will also have available an online version of the training about the service and data collection.\\n2. Service provision: before the pharmacist-patient consultation (pharmacy technicians review the medication to identify the prescribed medication included in the treatment plan and to remove expired or medications non taken by the patient), during (pharmacist assess potential drug related problem) and after the consultation (to send a medication management plan to patients and doctors).\\n3. Practice change facilitation to support pharmacists: pharmacists will be follow-up by the research team during the study (1st, 2nd, 3rd, 6th, 12th and 15th months of the study) to support them through the delivery of the service.', 'armGroupLabels': ['Medication review with follow up or MaJ? for the acronym in french'], 'otherNames': ['Medication review']}\n\nPrimary Outcomes:\n- {'measure': 'Change in number of drug related problems (DRPs)', 'description': 'Number of DRPs detected by the pharmacist during the pharmacist-patient consultation. Pharmacists will complete the management plan and PharmDISC tool at all consultations with the patient (three consultations with a 6-months interval). It will be assessed by comparing the differences between the first and second consultations and the first and third consultations. Total number of DRP and mean per patient will be calculated.', 'timeFrame': 'At three points during the study: 1. First pharmacist-patient consultation, 2. Second consultation (6 months after the first one) and 3. Third consultation (12 months after the first one).'}\n- {'measure': 'Change in DRPs', 'description': 'Pharmacists will complete the PharmDISC tool which includes:\\n\\n1. Therapy choice: no concordance with guidelines, contraindication, interaction, drug not indicated, duplication, adverse effect, incomplete patient documentation.\\n2. Drug choice: inappropriate dosage form.\\n3. Dose choice: underdose/overdose, inappropriate monitoring, dose not adjusted to organ function.\\n4. Drug use: inappropriate timing of frequency of administration, inappropriate use method.\\n5. Therapy duration: inappropriate therapy duration.\\n6. Logistics: prescribed drug not available, error in medication process.\\n7. Patient: insufficient adherence, insufficient knowledge, burden due to therapy.\\n8. Other PharmDISC tool has also classification related to health problems: treatment effectiveness, untreated indication, safety of treatment, treatment costs, dissatisfaction/problems of the patient.\\n\\nPharmDISC tool has also classification related to type of problem: manifest, potential.', 'timeFrame': 'At three points during the study: 1. First pharmacist-patient consultation, 2. Second pharmacist-patient consultation (6 months after the first one) and 3. Third pharmacist-patient consultation (12 months after the first one)'}\n\nPlease estimate the sample size based on the assumption: \nThe calculation assumes a power of \u22650.8, a type I error rate of 5%, an intra-cluster correlation of 0.02, and a 15% dropout rate.", "answer": 162, "answer_type": "ESTIMATED", "explanation": "Sample size\n Primary objective of the study aims to measure the difference in DRPs per patient observed between consultations. Sample size calculation was based on this primary study outcome to detect a difference of 0.5 DRP per patient at the end of the study (using a one-tailed test because the hypothesis is that patients will have a decrease of DRPs at the end of the study). The calculation was based on a pilot study carried out on 20 patients at Unisant\u00c3\u00a9 CP. Sample size was calculated with \u00e2\u0089\u00a50.8 power, type I error rate of 5%, assuming an intra-cluster correlation of 0.02. Allowing for 15% dropout, the overall sample size is 162 patients, with 19 to 35 pharmacies (5\u00e2\u0080\u009310 patients per CP).", "id": 1410, "split": "test"} +{"trial_id": "NCT05348694", "pmid": "39683612", "question": "Here is the design of a clinical trial:\n\nOfficial Title: OsteoPreP: The Effect of Probiotic Supplementation on Bone, Muscle, and Glucose Metabolism in Postmenopausal Women: A Randomised Placebo-controlled Trial\n\nIncluded conditions:\n- Postmenopausal Osteopenia\n- Bone Loss, Age Related\n- Age-Related Sarcopenia\n- Glucose Metabolism Disorders\n- Age-related Cognitive Decline\n\nStudy Armgroups:\n- {'label': 'Pendulum WBF-038', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pendulum WBF-038, a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plus chicory inulin and magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months.', 'interventionNames': ['Dietary Supplement: Pendulum WBF-038']}\n- {'label': 'Pendulum Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Pendulum Placebo containing Magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months.', 'interventionNames': ['Dietary Supplement: Pendulum Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Pendulum WBF-038', 'description': \"All bacteria contained in Pendulum WBF-038 are commensal organisms that have been repeatedly documented to inhabit the human gastrointestinal tract under normal circumstances. Pendulum's WBF-038 is a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plus chicory inulin and magnesium stearate. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS).\\n\\nThe product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4\u2103.\", 'armGroupLabels': ['Pendulum WBF-038']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Pendulum Placebo', 'description': 'Pendulum placebo capsules containing magnesium stearate', 'armGroupLabels': ['Pendulum Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Total volumetric bone mineral density of the distal tibia', 'description': 'Percentage change in total volumetric bone density measured using high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal tibia.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 0.05 and >80% power. A 20-30% dropout rate is considered.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "2.8. Sample Size\n The sample size calculation was based on data from a previous probiotic intervention study in older women, which demonstrated a significant effect on bone health outcomes. For this study, additional metabolic outcomes are included, and effect sizes for these outcomes were estimated based on prior research using similar synbiotic interventions in comparable populations.\n Permitting for possible participant attrition, the total sample size for the trial will be 160 (80 per arm), taking a 20\u00e2\u0080\u009330% drop-out rate into account. Statistical power analysis will be performed in relation to the primary outcome of the relative twelve-month change (%) in total BMD using HR-pQCT at the distal tibia. On the basis of a similar probiotic intervention in older women [100], the expected decrease in tibia BMD is 1.85% in the placebo arm and 0.9% decline at most in the treatment arm, with a standard deviation (SD) of 1.6% and an alpha of 0.05; 46 participants are needed in each arm to achieve >80% power. To be able to detect smaller groups to group differences and to account for an attrition rate of 20\u00e2\u0080\u009330% and due to many secondary outcomes, we will recruit a minimum of 80 participants into each arm.", "id": 1411, "split": "test"} +{"trial_id": "NCT05348863", "pmid": "40032379", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control\n\nIncluded conditions:\n- Gestational Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'SPARK app', 'type': 'EXPERIMENTAL', 'description': 'Access to the SPARK app which will provide support for a healthier diet and increased physical activity as well as daily monitoring of blood glucose levels.', 'interventionNames': ['Behavioral: SPARK']}\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Standard care i.e., the routine treatment program for GDM delivered by the care provider.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'SPARK', 'description': 'The SPARK digital platform provides support to the patient (shown as an app) as well as provides the possibility for the health care provider to review and give feedback on blood glucose levels through the care giver interface of the platform.', 'armGroupLabels': ['SPARK app']}\n\nPrimary Outcomes:\n- {'measure': 'Glucose control', 'description': 'Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring', 'timeFrame': 'At the end of the intervention in gestational weeks 36-37'}\n- {'measure': 'HbA1c', 'description': 'Glycosylated hemoglobulin', 'timeFrame': 'At the end of the intervention in gestational weeks 36-37'}\n\nPlease estimate the sample size based on the assumption: \nAiming for a power of 0.8 at the 0.05 significance level. Expected dropout rate of 10%-15%. Analyses follow a Bayesian paradigm, so null-hypothesis testing is not the basis for scientific inference.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n We conducted a Monte Carlo study to estimate the number of participants we need to recruit. We simulated scenarios where the difference in TIR between groups at follow-up was five percentage points, which is of clinical relevance in diabetic women to lower the risk of adverse pregnancy outcomes.66 The differences between groups that we simulated started from 70% TIR in the control group and 75% in the intervention group to 90% TIR in the control group and 95% in the intervention group. We used an SD of 12\u00e2\u0080\u0089percentage points in both groups in all simulations. Aiming for a power of 0.8 at the 0.05 significance level, we found that with 360\u00e2\u0080\u0089women completing follow-up we will have enough power to detect a statistically significant effect in all the scenarios simulated. Based on our previous interventions,22 we expect a dropout rate of 10%\u00e2\u0080\u009315%\u00e2\u0080\u0089and will therefore recruit 412 participants. It should be noted that our analyses follow a Bayesian paradigm where null-hypothesis testing is not the basis for scientific inference; thus, a predetermined sample size to protect against type I and II errors is not required. Therefore, the function of our power calculation is only to give a target for recruitment.", "id": 1412, "split": "test"} +{"trial_id": "NCT05350085", "pmid": "37185197", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth\n\nIncluded conditions:\n- Dental Anxiety\n- Sedation Complication\n- Anterograde Amnesia\n\nStudy Armgroups:\n- {'label': 'Remimazolam Group', 'type': 'EXPERIMENTAL', 'description': 'Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.', 'interventionNames': ['Drug: Remimazolam besylate']}\n- {'label': 'Midazolam Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.', 'interventionNames': ['Drug: Midazolam']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Remimazolam besylate', 'description': '\u2460 initial dose: use a micro injection pump to pump remimazolam at the rate of 50mg/h, and observe for 4 \\\\~ 8 minutes until Ramsay Sedation grade III\uff0cthen start dental operation ; \u2461 Maintenance dose: maintain the pump speed at 5 \\\\~ 10mg/h\uff0cadjust the pump dose to maintain the patient at Ramsay Sedation grade III. \u2462 Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. \u2463 After the operation, stop the microinjection pump.', 'armGroupLabels': ['Remimazolam Group']}\n- {'type': 'DRUG', 'name': 'Midazolam', 'description': '\u2460 initial dose: use a micro injection pump to pump remazolam at the rate of 30mg/h, and observe for 4 \\\\~ 8 minutes until Ramsay Sedation grade III\uff0cthen start dental operation; \u2461 Maintenance dose: maintain the pump speed at 3 \\\\~ 6mg/h\uff0cadjust the pump dose to maintain the patient at Ramsay Sedation grade III. \u2462 Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. \u2463 After the operation, stop the microinjection pump.', 'armGroupLabels': ['Midazolam Group']}\n\nPrimary Outcomes:\n- {'measure': 'Recovery time of complete alertness', 'description': \"Calculated from the cessation of sedative injection with micro injection pump, the patients were scored with the modified observer's assessment of alertness/sedation scale (MOAA/S) every 1 minute, and the first minute with MOAA/S score = 5 for 3 consecutive times. MOAA/S score: Range from 5(Awake) to 1(Unresponsive).\", 'timeFrame': 'During treatment in hospital, an expected average of 2 hours'}\n\nPlease estimate the sample size based on the assumption: \nBilateral \u03b1=0.05, \u03b2=0.2, 10% shedding rate", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is an RCT with the main outcome being recovery time until complete alertness. The statistical method selected for the data analysis is the Z-test. Previous studies have reported a recovery time to complete alertness of 7.35\u00c2\u00b15.78\u00e2\u0080\u0089min in patients administered remimazolam and 15.84\u00c2\u00b111.57\u00e2\u0080\u0089min for midazolam (mean\u00c2\u00b1SD).28 According to bilateral \u00ce\u00b1=0.05, \u00ce\u00b2=0.2, the required sample size of each group is 19 cases, and the sample size of each group is 21 cases according to the 10% shedding rate. In the actual study, 50 patients are to be included in each study centre, with 150 patients in total.", "id": 1413, "split": "test"} +{"trial_id": "NCT05350592", "pmid": "39501388", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low-dose Dobutamine Infusion and Single-dose Tocilizumab in Acute Myocardial Infarction Patients With High Risk of Cardiogenic Shock Development - a 2x2 Multifactorial, Double-blinded, Randomized, Placebo Controlled Trial\n\nIncluded conditions:\n- Acute Myocardial Infarction\n- Cardiogenic Shock\n\nStudy Armgroups:\n- {'label': 'Tocilizumab + Dobutamine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tocilizumab IV 280 mg (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours)', 'interventionNames': ['Drug: Tocilizumab', 'Drug: Dobutamine']}\n- {'label': 'Tocilizumab + Placebo', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tocilizumab IV 280 mg (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours)', 'interventionNames': ['Drug: Tocilizumab', 'Drug: NaCl 0.9%']}\n- {'label': 'Placebo + Dobutamine', 'type': 'ACTIVE_COMPARATOR', 'description': 'NaCl 0,9% IV (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours)', 'interventionNames': ['Drug: Dobutamine', 'Drug: NaCl 0.9%']}\n- {'label': 'Placebo + Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'NaCl 0,9% IV (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours)', 'interventionNames': ['Drug: NaCl 0.9%']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tocilizumab', 'description': 'Single bolus', 'armGroupLabels': ['Tocilizumab + Dobutamine', 'Tocilizumab + Placebo'], 'otherNames': ['RoActemra (Actemra)']}\n- {'type': 'DRUG', 'name': 'Dobutamine', 'description': 'Continous weight-adjusted infusion', 'armGroupLabels': ['Placebo + Dobutamine', 'Tocilizumab + Dobutamine'], 'otherNames': ['Dobutrex']}\n- {'type': 'DRUG', 'name': 'NaCl 0.9%', 'description': 'Placebo comparator and diluent', 'armGroupLabels': ['Placebo + Dobutamine', 'Placebo + Placebo', 'Tocilizumab + Placebo'], 'otherNames': ['Saline isotonic']}\n\nPrimary Outcomes:\n- {'measure': 'ProBNP', 'description': 'ProBNP plasma concentration being assessed at multiple time points (including the primary endpoint) will be analyzed by application of a linear mixed model of covariance. As the biomarker will be measured prior to initiation of the study drug, the models will be baseline corrected (i.e., constrained linear mixed models, CLMM). The main result of these analyses will be the treatment-by-time interaction as a marker of whether the proBNP levels change differently over time in the treatment versus the placebo arm.', 'timeFrame': '48 hours'}\n\nPlease estimate the sample size based on the assumption: \nlog-normal distribution with a variation coefficient of 0.59, alpha level of 0.05, power of 0.86, accounting for potential dropouts and missing data", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation is based on recent, unpublished data on atrial natriuretic peptide (ANP) levels in STEMI patients [16]. Assuming a log-normal distribution with a variation coefficient of 0.59 for proBNP levels (similar to ANP), an alpha level of 0.05, and a power of 0.86, a total of 88 patients would be needed to detect a 30% reduction in proBNP from a baseline of 1338\u00c2\u00a0ng/L to 937\u00c2\u00a0ng/L [17]. To account for potential dropouts and missing data, total of 100 participants will be enrolled in the trial.", "id": 1414, "split": "test"} +{"trial_id": "NCT05351281", "pmid": "38172930", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Appropriate Medication USE in Dutch Terminal Care: AMUSE Trial\n\nIncluded conditions:\n- Palliative Care\n- Terminal Care\n- Medication Therapy Management\n- Clinical Decision Support System (CDSS)\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Standard of care', 'type': 'NO_INTERVENTION', 'description': 'Patients in the standard of care arm will receive the usual treatment'}\n- {'label': 'CDSS-OPTIMED', 'type': 'EXPERIMENTAL', 'description': \"In the experimental arm, attending physicians will receive weekly medication alerts from the Clinical Decision Support System (CDSS) within 1 week after inclusion of the patient. The CDSS-OPTIMED will send a medication advice on a weekly basis, based on a weekly analysis of patient's medication. The medication alerts will be sent to the physician's email address. The physician is free to follow or ignore the advice in the alerts. If the physicians thinks these alerts are relevant for the patient, the physician will discuss these alerts with the patient and/or relatives. After this conversation, the physician will prescribe or deprescribe medications based on the alerts.\", 'interventionNames': ['Device: CDSS-OPTIMED']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CDSS-OPTIMED', 'description': 'The CDSS-OPTIMED is a software program that provides the physician with a personalized alert on whether to consider stopping or starting medication for a specific patient with a life expectancy of less than 3 months.', 'armGroupLabels': ['CDSS-OPTIMED']}\n\nPrimary Outcomes:\n- {'measure': \"Patients' quality of life\", 'description': 'Measured by the quality of life question of the European Organization for Research and Treatment of Cancer Quality of Life Group 15 item core questionnaire for palliative care ( = EORTC QLQ-C15-PAL questionnaire)\\n\\nScale 1 to 7. Scale minimum 1 (very poor). Scale maximum 7 (excellent).\\n\\nScore will be rescaled to a scale from 0 to 100, in which 100 is an excellent outcome', 'timeFrame': 'Two weeks after baseline assessment'}\n\nPlease estimate the sample size based on the assumption: \nThe desired power level is 80%, the significance level (alpha) is 5%, and the intra-cluster correlation (ICC) is 0.05.", "answer": 250, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The primary endpoint on which the sample size calculation is based is patients\u00e2\u0080\u0099 quality of life two weeks after baseline assessment as measured by the EORTC QLQ-C15 PAL questionnaire, quality of life question. The calculation needs to take into account both the clustered nature as well as the stepped wedge design of the study. Since 7 clusters will be included and will switch from control to intervention one-by-one, 7 steps will be present in the design, resulting in 8 observation periods. The intra-cluster correlation (ICC) is assumed to be 0.05. Based on unpublished own research, it is assumed that the standard deviation of quality of life measured by the EORTC QLQ-C15-PAL questionnaire is 23 (score will be rescaled to a scale from 0 to 100) and the difference to be detected should lie between 10 and 15 points. The desired power level is 80% and a two-sided alpha of 5% is used. Given expected numbers of available patients per cluster per month, the average number of patients that will be recruited per observation period per cluster will be 4.5. If the average number is 4, a total number of 224 patients will be included, whereas a total of 280 patients will be included when the average number is 5. Given these sample sizes, differences can be shown with 80% power if they are at least 13.03 points and 11.84 points, respectively [37, 38]. Since the average number of patients per cluster per observation period lies in between 4 and 5, it is expected that a total of 250 patients will be included and a clinically relevant effect can be shown.", "id": 1415, "split": "test"} +{"trial_id": "NCT05351359", "pmid": "36997936", "question": "Here is the design of a clinical trial:\n\nOfficial Title: mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With Prediabetes and Type 2 Diabetes\n\nIncluded conditions:\n- Type 2 Diabetes\n- PreDiabetes\n\nStudy Armgroups:\n- {'label': 'Active control', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients from the active control group will receive brief physical activity advice from their general practitioners at baseline, and they will also receive the Fitbit tracker to self-monitor their daily steps.', 'interventionNames': ['Behavioral: Fitbit tracker', 'Behavioral: brief advice']}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months.', 'interventionNames': ['Behavioral: mHealth', 'Behavioral: phone counselling', 'Behavioral: Fitbit tracker', 'Behavioral: brief advice']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'mHealth', 'description': 'A mHealth-enabled just-in-time adaptive intervention that is based on the HealthReact system developed by the participating centre at the Faculty of Science of the University of Hradec Kralove. The HealthReact system consists of a server-side application that is connected to the Fitbit server. As such, the system allows for just-in-time text messages triggered by pre-defined context as recorded by the Fitbit wearable monitor. For example, a prompt to take a break from sedentary behaviour can be triggered after 30 sedentary minutes, a suggestion to increase walking cadence can be triggered when continuous, but slow walking is detected, or a motivational message with a specific goal to take more steps to reach their usual daily step count can be triggered when the total daily steps are too low. The mHealth component will be delivered for the entire duration of the study (i.e., 12 months).', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'phone counselling', 'description': 'Regular monthly phone calls by trained counsellors support participants in their effort to increase physical activity and reduce sedentary behaviours. The counsellors will use various behaviour change techniques, such as goal-setting, feedback, action planning, etc. The phone counselling will be provided during the first six months, i.e. 6 phone calls will be delivered.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Fitbit tracker', 'description': 'Fitbit Inspire 2 will be provided by the general practitioner to study participants at the start of the study to enable objective self-monitoring of physical activity.', 'armGroupLabels': ['Active control', 'Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'brief advice', 'description': 'A brief advice will be provided by the general practitioner at the start of the study.', 'armGroupLabels': ['Active control', 'Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'step count', 'description': 'change in daily step count', 'timeFrame': 'from baseline to 12-month assessment'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, 2-sided 0.05 significance level (alpha), standard deviation of 3000 steps/day, and an expected attrition rate of approximately 15%.", "answer": 340, "answer_type": "ESTIMATED", "explanation": "Sample size\n To detect a difference of 1000 steps/day at 12\u00c2\u00a0months between arms, with a power of 80%, using a 2-sided 0.05 significance level (alpha), and anticipating the standard deviation of 3000 steps/day [21, 40, 46], 143 subjects per arm (286 in total) will be needed. To account for an expected attrition rate of approximately 15% [21, 40, 46], we plan to recruit 340 patients for the trial. The increase of 1000 steps/day is equivalent to about 10\u00c2\u00a0min/day of brisk walking [61] and equates to around a 4% decrease in the risk of cardiovascular morbidity and mortality in individuals at high cardiovascular risk with impaired glucose tolerance [62].", "id": 1416, "split": "test"} +{"trial_id": "NCT05352802", "pmid": "37816552", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)\n\nIncluded conditions:\n- Stomach Neoplasms\n- Frail Elderly\n\nStudy Armgroups:\n- {'label': 'Prehabilitation group', 'type': 'EXPERIMENTAL', 'description': 'The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.', 'interventionNames': ['Behavioral: Multimodal prehabilitation program', 'Behavioral: ERAS protocol']}\n- {'label': 'ERAS group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The ERAS group patients were treated according to the ERAS pathway.', 'interventionNames': ['Behavioral: ERAS protocol']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Multimodal prehabilitation program', 'description': 'Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.', 'armGroupLabels': ['Prehabilitation group']}\n- {'type': 'BEHAVIORAL', 'name': 'ERAS protocol', 'description': 'The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.', 'armGroupLabels': ['ERAS group', 'Prehabilitation group']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence and severity of postoperative complications', 'description': 'Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.', 'timeFrame': 'Postoperative (\u226430 days after surgery)'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 2.5% (one-sided), the power is 80%, and the superiority margin is 20%.", "answer": 368, "answer_type": "ACTUAL", "explanation": "Sample size computation\n Due to the nature of the prehabilitation and ERAS programmes, the study was designed as a superiority study. According to the results of a previous study by our team and several previous retrospective studies of prehabilitaion for colorectal cancer and major abdominal surgery, preoperative nutritional supplementation and physical and respiratory training could reduce the incidence of postoperative complications by approximately 8%.24 25 We assumed that the rate of postoperative complications would be 20% in the prehabilitation group and 28.5% in the ERAS group, with a significance level of \u00ce\u00b1=2.5% (one-sided), a power of (1\u00e2\u0088\u0092\u00ce\u00b2)=80%\u00e2\u0080\u0089and a superiority margin of 20%.17 26 Therefore, we calculated that 368 patients would be enrolled in this study, including 184 patients in the experimental group and 184 patients in the control group. From each clinical participating centre 25\u00e2\u0080\u009330 eligible patients will be enrolled in the study.", "id": 1417, "split": "test"} +{"trial_id": "NCT05353062", "pmid": "37322511", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bipolar Hemostatic Forceps Versus Standard Therapy by Hemoclip and or Epinephrin Injection as Initial Endoscopic Treatment in Acute Non-variceal Upper GI Bleeding: a Prospective, Randomized Multicenter Study\n\nIncluded conditions:\n- Gastrointestinal Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Standard therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Endoscopic therapy with hemoclip +/- injection of epinephrine solution', 'interventionNames': ['Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution']}\n- {'label': 'Bipolar hemostatic forceps', 'type': 'EXPERIMENTAL', 'description': 'Endoscopic therapy with bipolar hemostatic forceps', 'interventionNames': ['Procedure: Hemostatic therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Hemostatic therapy', 'description': 'Bipolar hemostatic forceps', 'armGroupLabels': ['Bipolar hemostatic forceps']}\n- {'type': 'PROCEDURE', 'name': 'Endoscopic therapy with hemoclip +/- injection of epinephrine solution', 'description': 'Endoscopic therapy with hemoclip +/- injection of epinephrine solution', 'armGroupLabels': ['Standard therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Successful primary hemostasis', 'description': 'Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy', 'timeFrame': '15 minutes'}\n- {'measure': 'Rebleeding', 'description': 'Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe power analysis assumes a significance level of 0.05, a power of 80%, and a maximum dropout rate of 10%.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The study hypothesis is that experimental therapy is superior to standard therapy in terms of clinical success, defined as successful haemostasis and no (signs of) rebleeding within 30\u00c2\u00a0days. In one study, the rates of successful haemostasis and rebleeding in the experimental group were 92.3% and 0%, respectively [9]. However, this nonrandomized trial also included nonactive nonvariceal bleeding. Therefore, the rate of successful haemostasis could be lower and the rate of rebleeding higher when only active nonvariceal bleeding is present. Therefore, a success rate of 90% for primary haemostasis and a rebleeding rate of 5% were assumed, giving a combined clinical success rate of 85.5%. In a recently published study comparing the Over-the-Scope Clip (OTSC) with the haemoclip in high-risk patients with acute nonvariceal upper gastrointestinal bleeding, the rates of successful haemostasis and rebleeding in the standard of care arm (haemoclip only) were 73.1% and 15.4%, respectively [12]. However, this randomized trial also included nonactive, nonvariceal bleeding. Therefore, the rate of successful haemostasis could be lower and the rate of rebleeding higher if only active nonvariceal bleeding is present. Therefore, a success rate of 72% for primary haemostasis and a rebleeding rate of 16% were assumed, resulting in a combined clinical success rate of 60.1%. Power analysis of the combined primary endpoint revealed that 45 patients per treatment arm are required to demonstrate an absolute difference of 25.4 percentage points (85.5\u00e2\u0080\u009360.1%) with a power of 80% and a significance level of 0.05. Here, a simulation-based line calculation assuming the above absolute differences was performed using the SimEngine package version 1.1.0, implemented in R version 3.3.0. Overall, a dropout rate of a maximum of 10% is assumed, as the follow-up period is only 30\u00c2\u00a0days. A decision on the recruitment of follow-up patients will be made when 90 patients have been included as planned and the follow-up observations are available.", "id": 1418, "split": "test"} +{"trial_id": "NCT05353452", "pmid": "39535875", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy\n\nIncluded conditions:\n- Epilepsy, Post-Traumatic\n\nStudy Armgroups:\n- {'label': 'Collaborative Care', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will receive 24 weeks of neurology based collaborative care.', 'interventionNames': ['Behavioral: Neurology Based Collaborative Care']}\n- {'label': 'Standard of Care (SOC)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.', 'interventionNames': ['Behavioral: SOC Neurological care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Neurology Based Collaborative Care', 'description': \"Twenty-four week, evidence-based remote collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager, psychiatrist, and psychologist/social worker who interact with the patient participant and the patient's neurologist.\", 'armGroupLabels': ['Collaborative Care']}\n- {'type': 'BEHAVIORAL', 'name': 'SOC Neurological care', 'description': 'Usual neurology care means ongoing, epilepsy provider-recommended clinic visits, prescriptions, testing and referrals from their epilepsy provider. Mental health referrals or prescribing of antidepressants may potentially occur in this group; these types of interventions will be tracked at outcome assessments.', 'armGroupLabels': ['Standard of Care (SOC)']}\n\nPrimary Outcomes:\n- {'measure': 'Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)', 'description': 'This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life', 'timeFrame': 'Baseline through Month 6'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, 13% dropout rate, common SD of 24 units, 2-sample 2-tailed t test, \u03b1=.05 for primary outcome. 80% statistical power, \u03b1=.10, one-sided testing for secondary outcome.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power\n Given the emphasis on effectiveness in our trial, we estimated the total sample size using the primary effectiveness outcome, that is, change in emotional quality of life from baseline to 6 months. With a total sample size of 60, we will have 80% statistical power to detect a moderate clinically important difference in mean change equal to 20 units [26] in the collaborative care group, compared to usual care, assuming a dropout rate as high as 13% at 6 months in the intervention group and a common SD of 24 units [24] (2-sample 2-tailed t test, \u00ce\u00b1=.05). For our secondary outcome overall (primary implementation outcome), we will have 80% statistical power to detect a true proportion of participants of 0.8 who attend a majority of the collaborative care management calls in the first 12 weeks, assuming a sample size of 30 in the intervention group (exact binomial test, \u00ce\u00b1=.10, one-sided testing vs the null proportion of 0.6) [64].", "id": 1419, "split": "test"} +{"trial_id": "NCT05353491", "pmid": "37626428", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Technology-assisted Cognitive-behaviour Therapy Delivered by Peers Versus Standard Cognitive Behaviour Therapy Delivered by Community Health Workers for Perinatal Depression: A Cluster Randomised Controlled Non-inferiority Trial\n\nIncluded conditions:\n- Perinatal Depression\n- Depression, Postpartum\n\nStudy Armgroups:\n- {'label': 'Technology assisted Thinking Healthy Program delivered by peers', 'type': 'EXPERIMENTAL', 'description': 'A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app. The bespoke android app leverages human-centered design and makes use of 2-d videos demonstrating narrative scripts delivered by culturally appropriate animated avatars representing depressed mothers, families, peers and mental health experts.\\n\\nIt is designed as a low intensity psychosocial multicomponent intervention based on cognitive behavioral approaches. The THP improves depression through psychoeducation, behavior activation, thought challenging, improving problem solving skills and by activating social support networks.\\n\\nThe intervention program comprises of 8 sessions delivered by trained peers.', 'interventionNames': ['Behavioral: Technology assisted Thinking Healthy Program (THP-TA)']}\n- {'label': 'Standard Thinking Healthy Program delivered by community health workers', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Thinking Healthy Programme (THP) is a CBT-based manualised paper version of the intervention targeting women with perinatal depression in low socioeconomic settings.\\n\\nThe CBT techniques include guided discovery using illustrated brief vignettes, behavioural activation, and problem solving. Non-specific techniques include empathic listening and promoting social support from key family members for the mother in negotiating challenges during the perinatal period. This intervention programme is paper based utilizing reference manual, health calendar and job aid as tools for delivering content.\\n\\nThe intervention employs these techniques to improve outcomes in three areas: maternal well-being, mother-infant interaction and relationship with significant others. The intervention consists of 8 core sessions starting in the second or third trimester of pregnancy and continuing to 3 months postnatal.', 'interventionNames': ['Behavioral: Standard Thinking Healthy Program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Technology assisted Thinking Healthy Program (THP-TA)', 'description': 'A technology adapted version of the Thinking Healthy Program (THP) delivered by peers using multimedia android based app.', 'armGroupLabels': ['Technology assisted Thinking Healthy Program delivered by peers']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard Thinking Healthy Program', 'description': 'This intervention paper-based manual delivered by lady health workers ie government employed community health workers with health training background.', 'armGroupLabels': ['Standard Thinking Healthy Program delivered by community health workers']}\n\nPrimary Outcomes:\n- {'measure': 'Remission rates of perinatal depression', 'description': 'Remission rates from perinatal depression among the trial participants will be based on clinical diagnostic criteria based on the Structured Clinical Interview for the DSM-IV Axis (SCID) module. The SCID will be employed at baseline and 3 months postnatal.', 'timeFrame': '3 months postnatal'}\n\nPlease estimate the sample size based on the assumption: \nIntracluster correlation (ICC) of 0.005, alpha of 0.025 (one-sided 97.5% CI or two-sided 95% CI), 20% loss to follow-up, and power of 87.2%.", "answer": 980, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analysis\n Sample size estimation is based on the primary outcome measure, remission from a major depressive episode elicited by the Structured Clinical Interview for DSM-IV. In our initial randomized trial of THP [9], there was a 75% remission rate in the intervention arm. For non-inferiority trials, it is vital to select a relevant limit for the possible difference between arms that will lead to rejection of the hypothesis of non-inferiority [43]. In this trial, as both arms involve active treatment based on THP, we assume 75% remission rates in both arms at 3\u00c2\u00a0months postnatal and set the limit to\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008910%, which would still be considered to be of public health significance [44]. As this is a cluster randomized trial, we set an intracluster correlation (ICC) of 0.005 to allow for between-village cluster correlation. Alpha is set to 0.025, resulting in a one-sided 97.5% confidence interval or two-sided 95% confidence interval for of the assessment of non-inferiority. Allowing for 70 village clusters randomized with a 1:1 allocation ratio and 14 depressed participants per village cluster, and 20% loss to follow-up, a total of 980 participants will be required to detect non-inferiority for the primary outcome at 3\u00c2\u00a0months postnatal with a power of 87.2%.\n Primary outcome will be analyzed using a generalized linear mixed model (GLIMM). It will be based on the intention-to-treat population. Non-inferiority will be declared if the lower limit of one-sided 97.5%CI is larger than the non-inferiority margin of\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008910%. The model will have a binomial distribution and identity link function with the treatment (intervention vs control) as a fixed effect, baseline measurement of SCID score as covariate, and cluster as random effect. In addition, adjusted GLIMM model analysis will be performed with the pre-specified covariates measured at baseline being added into the above GLIMM model, which will be identified and listed in the statistical analysis plan. The unadjusted and adjusted risk differences between intervention and control group in the primary outcome together with its 95% confidence intervals (CIs) will be derived from the GLIMM models. The main conclusion will be drawn from the unadjusted analysis. In addition, subgroup analysis of primary outcome will be performed on the above pre-specified covariates.\n Analysis of secondary binary outcomes with repeated follow-up measurements will be analyzed using GLMMIX models. The model will have a binomial distribution and logit link function with the treatment (intervention vs control), visit (3 and 6\u00c2\u00a0months), interaction between treatment and visit as fixed effects, baseline measurement of outcome as covariate, and cluster and subject as random effects. The odds ratios between intervention and control group together with its 95% CIs at each visit will be derived from the GLIMM models. Analysis of secondary continuous outcomes with repeated follow-up measurements will be performed using GLMMIX models with normal distribution and identity link function. The models will have the treatment (intervention vs control), visit (3 and 6\u00c2\u00a0months), interaction between treatment and visit as fixed effects, baseline measurement of the outcome variable as covariate, and cluster and subject as random effects. The mean differences with 95%CIs between intervention and control at each visit will be derived from the GLMMIX model. Other statistical analyses may be performed if deemed necessary.\n Primary data analyses will be based on the intention-to-treat principle. The per-protocol analyses will also be performed as supplemental analysis. All analyses will be detailed in the statistical analysis plan which will be finalized before the un-blinding of the study. All statistical analyses will be performed using SAS 9.4. The trial results will be reported following the CONSORT guidelines for cluster-randomized trials.\n Exploratory mediation analyses will be conducted in a multilevel structural equation modeling framework using the MPlus software. For this, we will test a 2\u00e2\u0080\u00931-1 mediation model, where mediation is hypothesized at the level of clusters. This model is found to be appropriate because the intervention condition is randomized at the level of clusters rather than individuals. The mediator variables and PHQ-9 scores available at the level of individuals will be transformed into cluster level mean scores to model higher level variance and then group mean centered scores for lower-level variance.", "id": 1420, "split": "test"} +{"trial_id": "NCT05354258", "pmid": "35922819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population\n\nIncluded conditions:\n- Malaria\n- Soil Transmitted Helminths\n- Schistosomiasis\n- Integrated Control\n- Seasonal Malaria Chemoprevention\n- Mass Drug Administration With Anthelminthic Drugs\n\nStudy Armgroups:\n- {'label': 'Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Amodiaquine', 'Drug: Sulfadoxine pyrimethamine']}\n- {'label': 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Praziquantel', 'Drug: Amodiaquine', 'Drug: Sulfadoxine pyrimethamine']}\n- {'label': 'Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Albendazole', 'Drug: Praziquantel', 'Drug: Amodiaquine', 'Drug: Sulfadoxine pyrimethamine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Albendazole', 'description': 'Anthelminthic drugs for the treatment of soil-transmitted helminths', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3']}\n- {'type': 'DRUG', 'name': 'Praziquantel', 'description': 'Anthelminthic drugs for the treatment of schistosomiasis', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3']}\n- {'type': 'DRUG', 'name': 'Amodiaquine', 'description': 'SMC partner drug', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3', 'Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3']}\n- {'type': 'DRUG', 'name': 'Sulfadoxine pyrimethamine', 'description': 'SMC partner drug', 'armGroupLabels': ['Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3', 'Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3', 'Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'description': 'Incidence of Treatment-Emergent Adverse Events will be measured by collecting solicited and unsolicited adverse events and adverse drug reactions for causal relationships to the study drugs.', 'timeFrame': 'For six consecutive days after start of the drug administration'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 95% level of statistical significance, 10% loss to follow-up, 5% level of precision.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Haemoglobin (Hb) concentration was used to calculate the sample size. Given that the mean Hb concentration in the SMC alone group in a previous study [18] in the same population was 10.5 g/dl, we assumed a mean Hb concentration of 11.0 g/dl in the SMC + anthelminth arm and a SD of the Hb concentration of 1.5 g/dl. To detect a mean difference between the treatment arms of 0.5 g/dl with 90% power at a 95% level of statistical significance, a minimum of 189 children per treatment arm will be needed. Allowing for 10% loss to follow-up, approximately 200 children will be enrolled into each treatment arm.\n Based on a recent survey conducted in the study site (unpublished data), we assumed that the prevalence of any malaria or helminth infection in the SMC group will be 30%, the prevalence of any malaria or helminth infection in the SMC + anthelminth arms will be 16% and the relative risk will be 0.53 (that is, 47% reduction in the SMC + anthelminth arms compared to the SMC alone group). A minimum sample size of 188 children was considered sufficient to give 90% power at 95% confidence interval and 5% level of precision. Adding 10% loss to follow-up, approximately 200 children will be needed for each treatment arm. Therefore, a total of 600 children aged 1\u00e2\u0080\u009314 years will be enrolled and randomly assigned at a ratio of 1:1:1 into the control and the two intervention arms.", "id": 1421, "split": "test"} +{"trial_id": "NCT05355389", "pmid": "36104820", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive-motor Telerehabilitation in Multiple Sclerosis\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'Cognitive-motor training group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: Motor training']}\n- {'label': 'Cognitive training group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Cognitive training']}\n- {'label': 'Motor training group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Motor training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive training', 'description': 'For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.', 'armGroupLabels': ['Cognitive training group', 'Cognitive-motor training group'], 'otherNames': ['BrainStim']}\n- {'type': 'BEHAVIORAL', 'name': 'Motor training', 'description': \"For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.\", 'armGroupLabels': ['Cognitive-motor training group', 'Motor training group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Digit span backwards', 'description': 'Measure of working memory', 'timeFrame': '0 weeks, 12 weeks, 24 weeks, 64 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 95%, alpha error rate of 5%", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated the minimal sample size with G*Power [61], using an ANOVA design (repeated measures, within-between interaction) with a power of 95% and an alpha error rate of 5%. Under the assumption of a large effect size (f = 0.40, based on the change in digit span backwards score after cognitive training [62]) and moderate correlation between the pre- and post-training measurements (r = 0.50), the required sample size is 30. Under the less favourable assumption of a medium effect size (f = 0.25) and a small correlation among repeated measurements (r = 0.30), the required total sample size is 90. In this study, we chose a total sample size of 90, with 30 subjects in each group.", "id": 1422, "split": "test"} +{"trial_id": "NCT05356962", "pmid": "36258223", "question": "Here is the design of a clinical trial:\n\nOfficial Title: STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room\n\nIncluded conditions:\n- Communication Research\n- Communication, Multidisciplinary\n\nStudy Armgroups:\n- {'label': 'Interventional group', 'type': 'EXPERIMENTAL', 'description': 'The surgeons will undergo a multi-module training on how to use the StOP?-protocol and perform the StOP?-protocol during all their operations during a 4-month period.', 'interventionNames': ['Behavioral: StOP?-protocol']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'StOP?-protocol', 'description': 'The StOP?-protocol is an intra-operative briefing initiated by the responsible surgeon. When performing a StOP?-protocol, the surgeons inform the team present in the operating room about the Status (St) of the operation, the Objectives (O) of the operations, the potential problems (P) they may meet and encourage the team to ask questions or voice concerns (?). The responsible surgeon announces at the team timeout when they plan to perform the StOP-protocol(s).', 'armGroupLabels': ['Interventional group']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality within 30 days after the operation', 'description': 'Mortality within 30 days after the operation in the intervention arm compared to the control arm', 'timeFrame': '30 days after the index operation'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05 (two-sided) with a power of 84%. The intracluster correlation coefficient (ICC) is assumed to be 0.024. The coefficient of variation for cluster size is 0.5. Sensitivity analyses account for variations in cluster size, ICC, and enrollment issues. Missing data for the primary outcome are expected to be minimal and will be imputed using chained equations.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Statistical analysis plan and sample size calculation\n \n Sample size calculation\n Sample size calculations were based on the primary objective, i.e., whether patients in the StOP? intervention group have a lower risk of mortality compared to patients in the standard of care group. The primary effect measure will be odds ratio as the primary analysis will be based on a logistic regression (see below). Based on the data from the first StOP? study, we calculated an intracluster correlation coefficient (ICC) of 0.024 from a mixed-effects logistic model. Also, we estimated 30-day mortality from the before phase of the StOP? study and use this number (1.8%) for the event rate in the control group. The target treatment effect that we do not want to miss is an odds ratio of 0.5, i.e., we aim to reduce mortality in the StOP? intervention group to 0.9%. Sample size calculations were done in Stata (release 16.1) using the power twoproportions command with the cluster option. The command calculates power based on a z-test with standard error adjusted by the intracluster correlation and varying cluster size. With 400 clusters overall (with 1:1 allocation, i.e., 2 \u00c3\u0097 200), an average size of 24 patients per cluster, and a coefficient of variation of 0.5, we will achieve 84% power at a significance level of 0.05 (two-sided).\n We assume that some patients will be operated by two disparate surgeons (i.e., two surgeons randomized to different trial arms are performing one operation jointly). To accommodate this, we fixed the target average cluster size at 30 patients. This sample size allows for varying cluster sizes to accommodate differences in operation volume across clusters (coefficient of variation of 0.5, i.e., cluster size is allowed to range between 10 and 50 patients). A minimum of 12,000 patients will be required. Based on the experience of the StOP? I study, we expect that some surgeons perform many more operations than the assumed upper cluster size. Therefore, we expect that 14,000 patients will be enrolled overall. Given the relatively low number of events, we performed simulation studies to check the robustness of the assumption of an asymptotically normally distributed test statistic. Using a random-effects logistic regression in 1000 simulated trials with the same assumptions as described above, we calculated a power of more than 90%.\n We also performed several sensitivity analyses to account for the uncertainty of our assumptions, e.g., (1) allowing for a larger variation in cluster size (coefficient of variation of 0.7) results in 82% power; (2) allowing for the unlikely case of higher intracluster correlation (ICC of 0.03) results in 80% power; and (3) allowing for enrolment problems i.e., 370 clusters but similar cluster size results in 80.9% power or a similar number of clusters but smaller average cluster size (21 patients) results in 80.6% power.\n \n \n Statistical method for primary and secondary outcomes\n The primary analysis will follow the intention-to-treat (ITT) principle. We will assess outcomes at the patient level, accounting for the correlated nature of data within surgeon and hospital by using multilevel mixed-effects models. The primary outcome (30-day mortality) will be presented as a number and proportion for each group. We will incorporate random intercepts for surgeons and units in the multilevel models and adjust for variables related to the site, surgeon characteristics, and type of operation. The odds ratio of death for the intervention vs. the control group will be presented with a two-tailed 95% confidence interval (CI) and accompanying p-value. The primary null hypothesis of no difference in mortality between the two groups will be rejected if the two-tailed p-value is < 0.05.\n Binary secondary outcomes (unplanned reoperation and readmission) will be analyzed with the same model approach as used for the primary outcome. For the time-to-event outcome length of stay, we will use a multilevel mixed-effects parametric survival model parameterized as an accelerated failure time model. Random and fixed factors will be used as described above. The results will be presented as the difference in days with 95% CIs. Length of stay will be censored at the time of death or transfer to another hospital. Depending on the number of in-hospital deaths, we will consider a competing risk regression as the primary analysis approach for this outcome. Differences between the groups will be evaluated using multilevel mixed-effects linear regression, adjusting for random and fixed factors as described above. The results will be presented as the mean difference with 95% CI.\n We will report results in accordance with the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement extension to cluster-randomized trials [41].\n \n \n Statistical methods for additional analyses\n As a secondary analysis, we will perform a per-protocol analysis, excluding operations where the surgeon in the intervention group did not adhere to the protocol and where surgeons in the control group actually performed a StOP?. However, it is now well known that a na\u00c3\u00afve per-protocol analysis is problematic as it does not properly take confounding/selection bias into account [42]. Direct and indirect adjustment methods are described to estimate the per-protocol effect of a point intervention such as the StOP?-protocol [43]. We will explore the possibility to directly adjust for confounders by using inverse probability weighting [43].\n Because cluster randomization may lack the optimal balancing in characteristics between the groups seen in individual-level randomization, we will adjust each model for additional pre-defined patient-level, surgeon-level, and hospital-level variables to account for case-mix differences between the groups in a sensitivity analysis. Moreover, we will qualitatively assess the imbalances of hospital, surgeon, and patient characteristics between the groups. If we observe relevant imbalances in covariates not considered in the primary and sensitivity analyses, we will perform additional adjustments and consider propensity score-based approaches to assess the robustness of our results.\n In exploratory analyses, we will assess the adherence and study the influence of the number of StOP?-protocols on outcomes. Such analyses include the assessment of the impact of surgeons\u00e2\u0080\u0099 gender or patients\u00e2\u0080\u0099 gender on primary or secondary endpoints.\n We plan exploratory analyses based on the collected data. One such analysis concerns predictors of adherence to the protocol, based on adherence data. We also plan to investigate the changes in outcomes based on surgeon experience with the StOP?-protocol (number of operations with StOP?. Further exploratory analyses will assess the impact of surgeon and patient gender on adherence and on endpoints.\n Interaction between the treatment and the control group: An important aspect is that surgeons in the control group may be operating together with surgeons in the intervention group within a surgical department. Three different combinations are expected: (i) both surgeons are from the intervention group (25% of interactions), (ii) both surgeons are from the control group (25% of interactions), and (iii) one surgeon is from the intervention group and the other from the control group (50% of interactions). The observations from the StOP? I study showed that collaborations between board-certified surgeons are much more common in university (90% of the procedures) and large teaching (30% of procedures) hospitals, and less frequent in rural hospitals (5% of the procedures). We take this into account for the sample size calculation and the data analyses.\n We will conduct exploratory analyses for operations jointly performed by surgeons that are assigned to different treatment groups with a special emphasis on the influence of hierarchical status on adherence to the StOP?-protocol.\n \n \n Analysis of population and missing data\n The main analysis will be based on the intention-to-treat analysis set where all operations of a randomized surgeon done during the enrolment period are analyzed in the randomized arm, regardless of adherence. The per-protocol analysis set consists of all operations where the surgeon was adherent, i.e., if a surgeon in the control group performs a StOP?-protocol during an operation, such operations will be excluded and, if a surgeon in the intervention group does not perform a StOP?-protocol, such operations will be excluded.\n We do expect only few missing data with respect to the primary outcome (30-day mortality). We will impute missing outcome data based on all available baseline characteristics of hospitals, surgeons, and patients using chained equations. Analyses will be conducted as described above using Rubin\u00e2\u0080\u0099s rules to combine measures across multiple data sets [44]. This will be done for the analyses of the primary endpoint and the three key secondary endpoints.\n \n \n Reproducibility\n We will deposit the final protocol in a preprint repository (medRxiv.org) and submit it to a peer-reviewed journal. At publication of the primary results, the full protocol, the data management plan including the codebook of the trial database, and information on how to get access to the primary trial data will be published in the repository of the University of Bern which fulfills the FAIR criteria (Bern Open Repository and Information System (boris.unibe.ch)). A 12-month grace period after publication of the primary results is currently foreseen to allow all collaborators to complete additional, pre-planned analyses and projects.\n \n \n Interim analyses\n We will conduct one interim analysis after endpoint data were completely collected for 200 clusters. We will reassess the ICC based on the data collected to adjust the sample size if needed. To calculate the ICC, we will use multilevel mixed-effects logistic regression. If the ICC is > 0.024, we will perform new power calculations using the same assumptions as in the original sample size calculation. Based on these calculations, we will increase the number of clusters and/or the number of patients per cluster except if the required increase would be too large to be feasible. Because the type I error is not affected by the recalculation of the ICC, we will not adjust the significance level.\n Moreover, an interim analysis of the primary outcome will be performed to examine the trial for potential futility: The conditional power for a statistically significant difference between the intervention and control groups at the end of the study will be estimated based on data collected at the time of the interim analysis. If the conditional power is < 20%, it is recommended to terminate the trial for futility. Implications for type I and II errors are minimal, so no adjustment is needed for this type of interim analysis [45].\n Given that no interim analysis for safety or efficacy will be done, no independent Data Monitoring Board (iDMC) is established, and possible sample size adaptations or trial termination for futility will be decided by the Steering Committee.\n \n \n Blinding\n This is an open-label trial as the intervention cannot be blinded. Given the nature of the primary endpoint, the risk for ascertainment bias is considered negligible. Follow-up data collection is centralized and will be done by blinded personnel.\n \n \n Schedule\n The schedule and timelines are presented in Tables 1 and 2.Table 1Timeline related to the clusters wit\u00c2\u00a0hin one participating unitTimeline Cluster (Surgeon)Time points are related to start of StOP? implementation per clusterbefore interventionup to -4 week to start of interventionup to 2 weeks to interventionfirst 2 weeks of interventionduring intervention, for each operation1 mo after start of intervention2 mo after start of intervention3 mo after start of intervention4 mo after start of interventionAll surgeons\u00c2\u00a0Surgeon recruitmentXEligibility screeningXInformed consentXAllocation to intervention or control groupXDemographic data collectionXHospital and surgical unit characteristicsXXMeasuring adherence with StOP? Protocol / if StOP?s were performed (questionnaires filled out by the scrub nurses)XSurgeons in the intervention groupStOP? training and on-site feedbackXXFeedback and refresher trainingXXXEnd of intervention reportXTable 2Timeline related to the collection of operation and patient-related dataTimeline of aquisition of patient and operation related dataDuring intervention, for each operationEnd of every week of intervention1 month after start of intervention2 month after start of intervention3 month after start of intervention4 month after start of intervention5+ month after start of interventionMeasuring adherenceMeasuring adherence with StOP? Protocol (questionnaires filled out by the scrub nurses)XBasic characteristics of operationsXGeneration of patient keyXMeasuring patient characteristics and outcomesPatient and operation characteristics and outcome dataXXXXX\n \n \n Study schedule\n Figure 2 shows the timeline related to the participating units. Note that units are grouped according to their geographic location, because the intervention requires a high level of presence of the researchers in participating units. The study is performed in 40 centers that include university and tertiary centers in Switzerland, Germany, and Austria. Recruitment of centers is ongoing. Currently, letters of commitment are available from 28 centers.Fig. 2Timeline for the participating surgical units", "id": 1423, "split": "test"} +{"trial_id": "NCT05356962", "pmid": "36258223", "question": "Here is the design of a clinical trial:\n\nOfficial Title: STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room\n\nIncluded conditions:\n- Communication Research\n- Communication, Multidisciplinary\n\nStudy Armgroups:\n- {'label': 'Interventional group', 'type': 'EXPERIMENTAL', 'description': 'The surgeons will undergo a multi-module training on how to use the StOP?-protocol and perform the StOP?-protocol during all their operations during a 4-month period.', 'interventionNames': ['Behavioral: StOP?-protocol']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'StOP?-protocol', 'description': 'The StOP?-protocol is an intra-operative briefing initiated by the responsible surgeon. When performing a StOP?-protocol, the surgeons inform the team present in the operating room about the Status (St) of the operation, the Objectives (O) of the operations, the potential problems (P) they may meet and encourage the team to ask questions or voice concerns (?). The responsible surgeon announces at the team timeout when they plan to perform the StOP-protocol(s).', 'armGroupLabels': ['Interventional group']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality within 30 days after the operation', 'description': 'Mortality within 30 days after the operation in the intervention arm compared to the control arm', 'timeFrame': '30 days after the index operation'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05 (two-sided) with a power of 84%. The intracluster correlation coefficient (ICC) is assumed to be 0.024. The coefficient of variation for cluster size is 0.5. Sensitivity analyses account for variations in cluster size, ICC, and enrollment issues. Missing data for the primary outcome are expected to be minimal and will be imputed using chained equations.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculations were based on the primary objective, i.e., whether patients in the StOP? intervention group have a lower risk of mortality compared to patients in the standard of care group. The primary effect measure will be odds ratio as the primary analysis will be based on a logistic regression (see below). Based on the data from the first StOP? study, we calculated an intracluster correlation coefficient (ICC) of 0.024 from a mixed-effects logistic model. Also, we estimated 30-day mortality from the before phase of the StOP? study and use this number (1.8%) for the event rate in the control group. The target treatment effect that we do not want to miss is an odds ratio of 0.5, i.e., we aim to reduce mortality in the StOP? intervention group to 0.9%. Sample size calculations were done in Stata (release 16.1) using the power twoproportions command with the cluster option. The command calculates power based on a z-test with standard error adjusted by the intracluster correlation and varying cluster size. With 400 clusters overall (with 1:1 allocation, i.e., 2 \u00c3\u0097 200), an average size of 24 patients per cluster, and a coefficient of variation of 0.5, we will achieve 84% power at a significance level of 0.05 (two-sided).\n We assume that some patients will be operated by two disparate surgeons (i.e., two surgeons randomized to different trial arms are performing one operation jointly). To accommodate this, we fixed the target average cluster size at 30 patients. This sample size allows for varying cluster sizes to accommodate differences in operation volume across clusters (coefficient of variation of 0.5, i.e., cluster size is allowed to range between 10 and 50 patients). A minimum of 12,000 patients will be required. Based on the experience of the StOP? I study, we expect that some surgeons perform many more operations than the assumed upper cluster size. Therefore, we expect that 14,000 patients will be enrolled overall. Given the relatively low number of events, we performed simulation studies to check the robustness of the assumption of an asymptotically normally distributed test statistic. Using a random-effects logistic regression in 1000 simulated trials with the same assumptions as described above, we calculated a power of more than 90%.\n We also performed several sensitivity analyses to account for the uncertainty of our assumptions, e.g., (1) allowing for a larger variation in cluster size (coefficient of variation of 0.7) results in 82% power; (2) allowing for the unlikely case of higher intracluster correlation (ICC of 0.03) results in 80% power; and (3) allowing for enrolment problems i.e., 370 clusters but similar cluster size results in 80.9% power or a similar number of clusters but smaller average cluster size (21 patients) results in 80.6% power.", "id": 1424, "split": "test"} +{"trial_id": "NCT05358158", "pmid": "38382951", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection\n\nIncluded conditions:\n- Lung Neoplasms\n- Lung Surgery\n- Enhanced Recovery After Surgery\n- Fast-track Surgery\n- Pain\n- Opioid Use\n- Remission\n\nStudy Armgroups:\n- {'label': 'Drain-free group', 'type': 'EXPERIMENTAL', 'description': 'Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.', 'interventionNames': ['Procedure: Intraoperative air leak test', 'Procedure: Intraoperative chest drain removal']}\n- {'label': 'Chest drain group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.', 'interventionNames': ['Procedure: Intraoperative air leak test', 'Procedure: Standard chest drain placement']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Intraoperative air leak test', 'description': 'A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.', 'armGroupLabels': ['Chest drain group', 'Drain-free group']}\n- {'type': 'PROCEDURE', 'name': 'Intraoperative chest drain removal', 'description': 'Chest drain is removed intraoperatively.', 'armGroupLabels': ['Drain-free group']}\n- {'type': 'PROCEDURE', 'name': 'Standard chest drain placement', 'description': 'Chest drain is left in pleura.', 'armGroupLabels': ['Chest drain group']}\n\nPrimary Outcomes:\n- {'measure': 'Acute Pain', 'description': 'Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m', 'timeFrame': 'Up to postoperative day 1'}\n- {'measure': 'Rescue analgesics', 'description': 'The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry', 'timeFrame': 'Up to postoperative day 1'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes 80% power, a significance level of 5%, and a 15% drop-out rate.", "answer": 94, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size is based on a previous observational study of 48 patients treated with multimodal, non-opioid analgesia with intercostal catheter after thoracoscopic lobectomy,7 with no data on local pain following prior thoracoscopic wedge resections. Patients who undergo VATS wedge resection are operated using the same surgical approach originally developed for lobectomies.24 Patients in the study had a mean pain score at rest of 3.2 (SD 1.6) on POD 1. A difference of 30% corresponding to 1 point on the NRS scale is set as the minimal relevant clinical difference. The sample size calculation is performed only for POD 1 during only one of the planned activities, as correlations between the 12 measurements are unknown. This approach ensures the power calculation is conservative. In other words, the actual study, as described above, will have a higher power although it cannot be estimated by how much.\n With 80% power and a significance level of 5 %, 82 patients are required to show a difference from mean pain score of 3.2 in the control group to 2.2 in the intervention group. To account for a possible 15% drop-out rate or other loss of data a total of 94 patients are planned to be included in this trial.", "id": 1425, "split": "test"} +{"trial_id": "NCT05360797", "pmid": "37380212", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis\n\nIncluded conditions:\n- Acute Pancreatitis\n- Home Care\n\nStudy Armgroups:\n- {'label': 'Outpatient', 'type': 'EXPERIMENTAL', 'description': 'The Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.', 'interventionNames': ['Other: Outpatient']}\n- {'label': 'Medical home care', 'type': 'EXPERIMENTAL', 'description': 'The mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.', 'interventionNames': ['Other: Medical home care']}\n- {'label': 'Hospitalization', 'type': 'ACTIVE_COMPARATOR', 'description': 'The mild AP patient is hospitalized', 'interventionNames': ['Other: Hospitalization']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Outpatient', 'description': 'After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.', 'armGroupLabels': ['Outpatient']}\n- {'type': 'OTHER', 'name': 'Medical home care', 'description': 'After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.', 'armGroupLabels': ['Medical home care']}\n- {'type': 'OTHER', 'name': 'Hospitalization', 'description': 'After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI_1) in each center.', 'armGroupLabels': ['Hospitalization']}\n\nPrimary Outcomes:\n- {'measure': 'The treatment failure rate', 'description': 'Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, and 10% inferiority limit.", "answer": 225, "answer_type": "ESTIMATED", "explanation": "Sample size\n Only two studies with a similar objective have ever been reported,10 11 and a treatment failure rate of 4%\u00e2\u0080\u009312% was observed in the home monitoring (outpatient/home care) group. Using calculations for a non-inferiority study with an estimated 95% success rate, 80% power, 5% significance level and 10% inferiority limit, a sample size of 75 patients per study group was calculated (total=225 patients).", "id": 1426, "split": "test"} +{"trial_id": "NCT05360914", "pmid": "38697766", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving and Evaluation of a New Cross-sectoral Hospital at Home Model for Elderly Acute Ill Patients\n\nIncluded conditions:\n- Cystitis\n- Erysipelas\n- Pneumonia\n\nStudy Armgroups:\n- {'label': 'Hospital at Home (HaH) treatment', 'type': 'EXPERIMENTAL', 'description': 'The patients in this arm will receive the intervention.', 'interventionNames': ['Other: Hospital at Home (HaH) treatment']}\n- {'label': 'Standard hospital admission', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients in this arm are the control group and will receive the standard hospital treatment.', 'interventionNames': ['Other: Standard hospital admission']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Hospital at Home (HaH) treatment', 'description': 'The intervention is a new pathway of providing acut treatment for elderly acute ill patients in their own home. If the patient is randomized to the intervention group, the municipalities acute teams start the treatment. The acute team can take venous blood tests, ECG and bladder scan at home. The acute team handles the treatment at home and follows the patient closely. During the treatment course, the acute team and the ED specialist discuss the treatment process either over the phone or virtually on an iPad, where the patient is also involved. If the specialist would like to see the patient for assessment or send the patient for an X-ray, the specialist informs the acute team that the patient must go to a short check-up in the ED. Here, the specialist examines the patient himself and assesses whether the patient can continue to be treated at home, or whether the patient must be admitted to the hospital due to deterioration of the condition.', 'armGroupLabels': ['Hospital at Home (HaH) treatment']}\n- {'type': 'OTHER', 'name': 'Standard hospital admission', 'description': 'The active comparator is the standard hospital admission for elderly acute ill patients.', 'armGroupLabels': ['Standard hospital admission']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of 30-days re-admission', 'description': 'Rate of 30-days re-admission after discharge', 'timeFrame': '30 days period after discharge'}\n- {'measure': 'Health Related Quality of Life', 'description': 'Estimating quality of life by using EuroQoL-5 Dimensions. We will use EuroQoL-5 Dimensions to measure Health Related Quality of Life. The five dimensions include mobility, self-care, usual activity, pain/discomfort and anexiety/depression.This tool will provide us with health states (11111 being the best health state and 55555 the worse health state). We will use the Danish weight to give weights to different health states obtained from EuroQoL-5 Dimensions.', 'timeFrame': 'From inclusion to 3 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, 80% power, and a 1:2 ratio between control and intervention groups.", "answer": 849, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome of the project is the rate of 30-day acute readmission after discharge, which is the outcome parameter used for the power calculation for the project. Levine et al show that the proportion of 30-day acute readmission for patients who have been treated in their own home is 0.07, while for patients in the hospital, it is 0.13.4 In order to show a difference in the proportion of acute readmissions with a significance level of 5% and 80% power and a ratio of 1:2, there must be 283 patients in the control group and 566 patients in the intervention group. Therefore, a total of 849 patients living in Viborg, Skive and Silkeborg municipalities will be included in the study.", "id": 1427, "split": "test"} +{"trial_id": "NCT05362292", "pmid": "37085880", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence\n\nIncluded conditions:\n- Urinary Incontinence, Urge\n- Urinary Incontinence\n- Overactive Bladder\n- Incontinence, Urge\n- Incontinence, Urinary\n- Incontinence\n\nStudy Armgroups:\n- {'label': 'Anticholinergic bladder medication plus behavioral self-management education', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.', 'interventionNames': ['Drug: Tolterodine Tartrate ER']}\n- {'label': 'Beta-3-adrenergic agonist medication plus behavioral self-management education', 'type': 'ACTIVE_COMPARATOR', 'description': 'Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.', 'interventionNames': ['Drug: Mirabegron']}\n- {'label': 'Placebo medication plus behavioral self-management education', 'type': 'PLACEBO_COMPARATOR', 'description': 'Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tolterodine Tartrate ER', 'description': 'Anticholinergic', 'armGroupLabels': ['Anticholinergic bladder medication plus behavioral self-management education']}\n- {'type': 'DRUG', 'name': 'Mirabegron', 'description': 'Beta-3-adrenergic agonist', 'armGroupLabels': ['Beta-3-adrenergic agonist medication plus behavioral self-management education']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'matching placebo pill', 'armGroupLabels': ['Placebo medication plus behavioral self-management education']}\n\nPrimary Outcomes:\n- {'measure': 'Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.', 'description': \"The composite cognitive score will be calculated as the average of Z-scores from the following individual cognitive tests: a) Auditory Verbal Learning Test (AVLT); b) Oral Trail Making Test (OTMT) part A; c) OTMT part B; d) Digit Span Test; and e) Digit Symbol Substitution Test (DSST). The normative mean of each cognitive test will be subtracted from each participant's component test score, and this difference will be divided by the standard deviation for the appropriate normative sample. After scores from individual tests are transformed to Z scores as a common metric based on normative data, the average Z score from all available tests will be calculated to provide a composite Z score.\", 'timeFrame': 'Baseline to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nMore than 80% power in 2-sided tests with an experiment-wise type 1 error rate of 5%, corrected for two comparisons, an intraclass correlation of 0.75 among repeated cognitive outcomes, and a cumulative loss to follow-up level of 15% by 6 months of treatment.", "answer": 270, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample size of 270 participants, randomized in equal proportions to the three arms, has been chosen to provide\u00e2\u0080\u0089>\u00e2\u0080\u008980% power in 2-sided tests with an experiment-wise type 1 error rate of 5%, corrected for two comparisons (anticholinergic therapy to beta-3-adrenergic agonist therapy; anticholinergic therapy to placebo) [48] to detect an average treatment effect of 0.25 standard deviation\u00e2\u0080\u0099s difference in the composite cognitive function outcome over 6\u00c2\u00a0months, assuming an intraclass correlation of 0.75 among repeated cognitive outcomes, and cumulative loss to follow-up level of 15% by 6\u00c2\u00a0months of treatment.", "id": 1428, "split": "test"} +{"trial_id": "NCT05362305", "pmid": "39636672", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania\n\nIncluded conditions:\n- Parenting Self Efficacy\n- Postpartum Depression\n- Postpartum Anxiety\n- Breastfeeding Self-Efficacy\n- Newborn Knowledge\n\nStudy Armgroups:\n- {'label': 'Essential Coaching for Every Mother', 'type': 'EXPERIMENTAL', 'description': 'Mothers in the intervention group will receive in-hospital education by a non-study nurse midwife while on the postnatal ward prior to discharge as per standard protocol on the unit. On the third day after birth, mothers will receive daily text messages to 6 weeks postpartum. The messages will be sent automatically each day based on the date of birth of the infant.', 'interventionNames': ['Behavioral: Essential Coaching for Every Mother']}\n- {'label': 'Standard Care', 'type': 'NO_INTERVENTION', 'description': 'Mothers will receive in-person education provided by a non-study nurse midwife while on the postnatal ward prior to discharge as per current standard protocol on the unit. Mothers in this group will not receive any further text messages from the program.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Essential Coaching for Every Mother', 'description': 'Daily text messages for the first six-weeks postpartum.', 'armGroupLabels': ['Essential Coaching for Every Mother']}\n\nPrimary Outcomes:\n- {'measure': 'Newborn Care Knowledge', 'description': 'Knowledge will be assessed using a modified questionnaire developed by McConnell and colleagues. Questions will determine whether mothers can identify danger signs, hand washing practices, cord care, newborn thermal care, and breastfeeding. A summative score will be created with a maximum of five points and a minimum of zero, where each point represents knowledge on the above postnatal health topics.', 'timeFrame': 'Baseline (enrolment), and six-weeks postpartum (follow-up)'}\n\nPlease estimate the sample size based on the assumption: \nUsing a power of 80%, \u00ce\u00b1 of .05 (2-tailed).", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Sample Size\n The sample size was calculated based on the outcome of newborn care knowledge. While previous studies on postnatal education knowledge are significantly varied and no studies to date have reported on maternal postnatal education knowledge in Tanzania, we considered a binary summative score of 100% as the goal at 6 weeks post partum. Using a power of 80%, \u00ce\u00b1 of .05 (2-tailed), and assuming 90% of the intervention group and 70% of the control group will score 100% at 6 weeks, a total sample size of 124 is required. This is in line with our implementation sample size approach: recruiting across two hospitals to determine the feasibility of recruitment at these sites. We will aim for approximately similar numbers of participants at each site, recruiting for six weeks. Assuming two research assistants are recruiting five days per week at each hospital and each research assistant can recruit a minimum of 2 participants per day, this would be approximately 20 participants per week. Over six weeks, this would be 120 participants we anticipate recruiting. If recruitment is higher than anticipated, it will be limited to a maximum of 200 across both sites.", "id": 1429, "split": "test"} +{"trial_id": "NCT05362916", "pmid": "36690406", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Influence of a 3-month Letermovir Treatment on Gut Inflammation in ART-treated HIV-infected Persons in an Open Labelled Controlled Randomized Study\n\nIncluded conditions:\n- People Living with HIV\n\nStudy Armgroups:\n- {'label': 'Letermovir', 'type': 'EXPERIMENTAL', 'description': '40 patients with CMV infection will be treated with Letermovir', 'interventionNames': ['Drug: Letermovir']}\n- {'label': 'Controls', 'type': 'NO_INTERVENTION', 'description': '20 patients with CMV infection will not be given Letermovir'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Letermovir', 'description': 'Participants in the treatment arm will take either 1 tablet of 480mg PO once daily or 2 tablets of 240mg PO once daily.', 'armGroupLabels': ['Letermovir'], 'otherNames': ['PREVYMIS']}\n\nPrimary Outcomes:\n- {'measure': 'Gut Inflammation', 'description': 'To assess the influence of CMV replication inhibition with letermovir on gut translocation markers (LPS) in blood of PLWH.', 'timeFrame': '28 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA minimum sample size of 30 participants (15 per arm) would allow the detection of changes before/after PREVYMIS therapy, as compared with the control (no PREVYMIS) group with a power estimated at 0.8.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Study design, settings, sample size and recruitment strategy\n Trial CTN PT047, referred as the CIAO (\u00e2\u0080\u0098CMV Inhibition with letermovir in ART-treated people living with HIV: an Open-label, randomized, controlled trial\u00e2\u0080\u0099) study is a multi-centre, open-label, randomised, controlled clinical trial to assess the influence of letermovir on gut translocation (LPS and BDG markers) in blood in ART-treated CMV-seropositive adult PLWH; protocol version # 2.1; 27 July 2022. The study sponsor is Dr. Jean-Pierre Routy and the study support are the CIHR Canadian HIV Trials Network (CTN) and Merck Sharp & Dohme Corp (study drug supply in-kind). The study protocol fulfils the requirements of the 2013 Standard Protocol Items: Recommendations for Interventional Trials guidelines.24 25\n The study will explore the influence of letermovir treatment on gut damage, with no intention for label change. Participants (n=60) should have a CD4 count greater than 400\u00e2\u0080\u0089cells/\u00c2\u00b5L and an undetectable viral load. Forty participants will be randomised to receive letermovir (PREVYMIS 480\u00e2\u0080\u0089mg or 2\u00c3\u0097240\u00e2\u0080\u0089mg orally) daily in addition to their usual ART, and 20 participants will receive standard of care alone (ART only) for 14 weeks. Study visits will include screening, two baseline visits to assess intraparticipant variability in all parameters, followed by follow-up visits at 2, 4 and 14 weeks after starting treatment, as well as 12 weeks after ending the letermovir treatment to assess a possible carry-over effect.\n In an optional substudy, colonoscopies and colon biopsies will be performed before and after letermovir treatment or standard of care alone to assess gut mucosa inflammation.\n Assessment of outcomes will be made through various measures at baseline and throughout the study period (figure 1 and table 1).\n \n Table 1\n \n Schedule of events\n \n \n \n \n Visit type\n Screening\n Study visits\n \n \n Baseline 1\n Baseline 2\n Treatment\n Post-treatment\n \n \n Visit windowprocedures\n Week \u00e2\u0088\u00924 to \u00e2\u0088\u00921(\u00c2\u00b17\u00e2\u0080\u0089days)\n Week \u00e2\u0088\u00922 (\u00c2\u00b17\u00e2\u0080\u0089days)\n Week 0(day 0)\n Week 2(\u00c2\u00b13\u00e2\u0080\u0089days)\n Week 4(\u00c2\u00b13\u00e2\u0080\u0089days)\n Week 14(\u00c2\u00b17\u00e2\u0080\u0089days)\n Week 26(\u00c2\u00b17\u00e2\u0080\u0089days)\n \n \n \n \n \nVisit No.\n\n \n1\n\n \n2\n\n \n3\n\n \n4\n\n \n5\n\n \n6\n\n \n7\n\n \n \n Informed consent\n X\n \n \n \n \n \n \n \n \n Oral re-consent\n \n X\n \n \n \n \n \n \n \n Eligibility assessment\n X\n X\n X\n \n \n \n \n \n \n Concomitant medication\n X\n X\n X\n X\n X\n X\n X\n \n \n Medical history\n X\n \n \n \n \n \n \n \n \n Complete physical examination and vital signs\n X\n \n \n \n \n \n \n \n \n Targeted physical examination and vital signs\n \n X\n X\n X\n X\n X\n X\n \n \n Adverse event assessment\n \n X\n X\n X\n X\n X\n X\n \n \n Serum pregnancy test\n X\n X\n X\n X\n X\n X\n X\n \n \n Haematology*\n X\n X\u00e2\u0080\u00a0\n X\n X\n X\n X\n X\n \n \n Serum chemistry\u00e2\u0080\u00a1\n X\n X\u00e2\u0080\u00a0\n X\n X\n X\n X\n X\n \n \n Serology\u00e2\u0080\u00a1*\n X\n \n X\n \n \n \n \n \n \n Serology\u00e2\u0080\u0094HIV-1 viral load*\u00e2\u0080\u00a1*\n X\n X\u00e2\u0080\u00a0\n X\n X\n X\n X\n X\n \n \n Markers of gut barrier integrity, inflammation and microbial translocation\u00c2\u00a7\n \n X\n X\n X\n X\n X\n X\n \n \n Immune activation markers/cytokines (ELISA)*\u00e2\u0080\u00a1*\n \n X\n X\n X\n X\n X\n X\n \n \n Monocyte and T cell activation markers+\n \n X\n X\n X\n X\n X\n X\n \n \n Anti-CMV IgG and IgM in serum, anti-CMV CD4 and CD8 T-cells in PBMC, CMV DNA in plasma and PBMC\n \n X\n X\n X\n X\n X\n X\n \n \n Size of HIV reservoir in latently infected CD4 T cells\u00c2\u00b6\n \n X\n X\n X\n X\n X\n X\n \n \n Stool sample collection and microbiota composition**\n \n X\n X\n X\n X\n X\n X\n \n \n Alcohol use (AUDIT-Full), online supplemental appendix 1\n X\n \n \n \n \n \n \n \n \n Alcohol use (AUDIT-C), online supplemental appendix 2\n \n X\n X\n X\n X\n X\n X\n \n \n Bristol score questionnaire, online supplemental appendix 5\n X\n X\n X\n X\n X\n X\n X\n \n \n Study product dispensation\u00e2\u0080\u00a0\u00e2\u0080\u00a0\n \n \n X\n X\n X\n \n \n \n \n Dispense dosing diary\u00e2\u0080\u00a0\u00e2\u0080\u00a0\n \n \n X\n \n \n \n \n \n \n Collect dosing diary\u00e2\u0080\u00a0\u00e2\u0080\u00a0\n \n \n \n X\n X\n X\n \n \n \n Study product adherence\u00e2\u0080\u00a0\u00e2\u0080\u00a0\n \n \n \n X\n X\n X\n \n \n \n Colon mucosal biopsies\n \n \n X\n \n \n X\n \n \n \n \n \n \n *CBC, CD4 and CD8 T cell counts, erythrocyte sedimentation rate.\n \n \n \u00e2\u0080\u00a0Not required when the same tests have been performed at the screening visit within the past 14 days, with the exception of CBC, CD4, CD8 (and serum pregnancy test).\n \n \n \u00e2\u0080\u00a1Alkaline phosphatase, ALT, amylase, AST, bilirubin (total), creatine kinase, creatinine, d-dimer, fasting blood glucose, HbA1c, high sensitivity C reactive protein, lipase, lipid profile (total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides), serum phosphate, urea.\n \n \n \u00c2\u00a7Markers of gut barrier integrity, microbial translocation and inflammation: lipopolysaccharide (LPS), beta-D-glucan, LPS binding protein, soluble CD14 (sCD14), intestinal-fatty acid binding protein, Reg3a (measured in plasma by ELISA).\n \n \n \u00c2\u00b6Monocyte and T-cell activation markers include: HLA-DR and CD38. T-cell exhaustion marker: PD-1. Measured by staining and flow cytometry.\n \n \n \u00c2\u00b6PBMCs will be isolated and then latent CD4 T-cells will be isolated by flow cytometry. HIV viral reservoir in the latent CD4 T-cell population will be measured by nested qPCR. More specific tat/rev limiting dilution assay analysis will be performed on baseline week 0 and end-treatment week 14 samples to assess the HIV viral reservoir (exploratory analysis).\n \n \n **qPCR of Akkermansia muciniphila, 16S and 18S rDNA sequencing for other members of the microbiota.\n \n \n \u00e2\u0080\u00a0\u00e2\u0080\u00a0Treatment arm only.\n \n \n Optional substudy procedure.\n \n \n Serology measurements include: cytomegalovirus (CMV), hepatitis B virus (HBV), HCV and HIV viral load. Since HIV viral load will be measured at each visit, it was put as a separate line item.\n \n \n Immune activation markers/cytokines include: soluble CD14, pro-inflammatory cytokines (interleukin (IL) 1\u00ce\u00b2, IL-6, IL-8, TNF-\u00ce\u00b1, soluble TNF receptor-1) and anti-inflammatory cytokine IL-10. Measured in plasma by ELISA.\n \n \n \n \n 10.1136/bmjopen-2022-067640.supp1\n Supplementary data\n \n\n\n \n \n Figure 1\n \n Study flow chart. Visit 1, the screening visit, will take place 1\u00e2\u0080\u00934\u00e2\u0080\u0089weeks prior to the second baseline visit (week 0, visit 3) and informed consent document will be explained to the participant and will be signed. Two baseline visits will be conducted, the second one being at week 0 and all visits after that will be relative to this baseline week 0 visit. Data collected at these two baseline visits will be directly compared with determine intrapatient variability. For the treated arm, treatment will be a 1\u00c3\u0097480\u00e2\u0080\u0089mg or 2\u00c3\u0097240\u00e2\u0080\u0089mg of PREVYMIS taken with a meal, at the same time each day for 14 weeks. The control arm will receive standard of care alone (only ART). See schedule of events (table 1) for more details on tests and visits. The substudy is only available to participants at the Montreal site. ART, antiretroviral therapy; CMV, cytomegalovirus; PLWH, people living with HIV.\n \n \n \n A total of 60 ART-treated participants living with HIV will be enrolled in four clincal centres: (1) at the Chronic Viral Illness Service at the McGill University Health Centre (MUHC), Montreal, QC; (2) Centre de recherche du CHU de Qu\u00c3\u00a9bec, Universit\u00c3\u00a9 Laval; (3) Clinique d\u00e2\u0080\u0099infectiologie virale chronique, Centre Hospitalier de l\u00e2\u0080\u0099Universit\u00c3\u00a9 de Montr\u00c3\u00a9al, Montr\u00c3\u00a9al and (4) Clinique m\u00c3\u00a9dicale l\u00e2\u0080\u0099Actuel, Montr\u00c3\u00a9al, all in Quebec, Canada.\n Comparison of CMV seropositive and seronegative ART-treated PLWH showed an average of 1.7-fold difference of plasma levels of gut I-FABP, LPS or IL-6. As such, a minimum sample size of 30 participants (15 per arm) would allow the detection of changes before/after PREVYMIS therapy, as compared with the control (no PREVYMIS) group with a power estimated at 0.8. However, we chose a larger sample size of 60 (40 in the treated arm, 20 in the control arm) to ensure sufficient power to detect significant variation greater than the standard deviation (SD) of those markers after PREVYMIS treatment. Statistical analysis for sample size determination was performed by Dr C Richard (Universit\u00c3\u00a9 de Montr\u00c3\u00a9al, Qc). Results of this randomised study will be descriptive.\n Participants will be recruited at the four above-mentioned centres in Canada. Altogether, these participating medical centres provide care to more than 6000 PLWH. Teleconferences and face-to-face meetings will be organised between the Qualified Investigators and study staff to help promote participant recruitment and follow-up during the study.\n At screening, a medical history and medication history will be recorded by study staff through chart review and/or patient interview. Date of diagnosis, date of ART initiation, nadir CD4 count, mode of HIV acquisition and previous AIDS defining illnesses will be extracted from medical charts and records. Previous use of ART drugs and other medication will also be documented at each visit, including detailed information on ART adherence, given the known association between low ART adherence and inflammation. If the participant meets eligibility criteria, randomisation to the control or treated arm will be performed. The Investigator or study staff will perform a simple web-based randomisation process, using a. randomisation tool designed by the CTN/CIHR. Eligible participants will be assigned to one of two treatment groups in a 2:1 ratio (letermovir:standard of care). Investigators will maintain detailed records on all study participants. Data for this study will be recorded in the participant\u00e2\u0080\u0099s chart and applicable data entered into a study specific Electronic Case Report Form. All study records will be maintained according to the ICH-GCP and applicable regulatory requirements. Records will be retained for 15 years, in accordance with applicable regulatory requirements. All participant-related information including Case Report Forms, laboratory specimens, evaluation forms, reports, etc will be kept strictly confidential. All records will be kept in a secure, locked location and only accessible to research staff. Electronic files will be password-protected and hosted on secured hospital networks. Participants will be identified only by means of a coded number specific to each participant\n Recruitment started in September 2022 and is expected to end by December 2023.", "id": 1430, "split": "test"} +{"trial_id": "NCT05364203", "pmid": "37903608", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity\n\nIncluded conditions:\n- Central Neurogical Impairment\n\nStudy Armgroups:\n- {'label': 'no intervention', 'type': 'NO_INTERVENTION', 'description': 'Injections were done as usual without mask.'}\n- {'label': 'Comparator', 'type': 'ACTIVE_COMPARATOR', 'description': 'Injections are made as in standard practice. The virtual reality headset is added to the patient. In this case, there is no image or sound. The mask is off.', 'interventionNames': ['Device: DEEPSEN virtual reality mask']}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Injections are made as in standard practice. We add the virtual reality mask with the image and the sound.', 'interventionNames': ['Device: DEEPSEN virtual reality mask']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'DEEPSEN virtual reality mask', 'description': 'DEEPSEN virtual reality mask with 360 \u00b0 vision. The audio-visual content will be chosen by the patient.', 'armGroupLabels': ['Comparator', 'Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Heart rate variability (HRV) before injection and during the injections', 'description': 'The stress measurement is carried out using a watch and a belt (heart rate monitor) which, thanks to several parameters, will allow us to carry out an HRV analysis on the KUBIOS software.', 'timeFrame': 'during the procedure'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided type 1 error of 5%, statistical power greater than 80%, intraclass correlation coefficient fixed at 0.25, negligible lost to follow-up rate", "answer": 42, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n In order to evaluate the effect of virtual reality on stress during botulinum toxin injections, the HRV will be compared between groups, virtual reality versus control group (virtual reality headset without sound and image). Using the log low frequency/high frequency (LF/HF) as primary endpoint, 24 patients will be required to highlight a clinically relevant difference of 0.2 for an SD equals 0.3, a two-sided type 1 error of 5% and a statistical power greater than 80%, according to the results reported by Dutheil et al.18 19\n Due to the design with sequential permutations, 42 patients will be included to take into account between and within-patient variability measured by intraclass correlation coefficient fixed at 0.25. The rate of lost to follow-up should be negligible, as this is a conventional care pathway.", "id": 1431, "split": "test"} +{"trial_id": "NCT05365269", "pmid": "36123081", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Proactive Automatized Lifestyle Intervention for Cancer Prevention\n\nIncluded conditions:\n- Health Risk Behaviors\n\nStudy Armgroups:\n- {'label': 'Computer-generated feedback on health risk behaviors', 'type': 'EXPERIMENTAL', 'description': 'Proactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months', 'interventionNames': ['Behavioral: Proactive Automatized Lifestyle intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Proactive Automatized Lifestyle intervention', 'description': 'Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.', 'armGroupLabels': ['Computer-generated feedback on health risk behaviors']}\n\nPrimary Outcomes:\n- {'measure': 'Intervention reach', 'description': 'Proportion of participants among all eligible patients', 'timeFrame': 'Month 0'}\n- {'measure': 'Intervention retention', 'description': 'Proportion of participants who continue participation 1 month after hospitalization', 'timeFrame': 'Month 1'}\n- {'measure': 'Intervention retention', 'description': 'Proportion of participants who continue participation 3 months after hospitalization', 'timeFrame': 'Month 3'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u00ce\u00b1=0.05, two-tailed), power (80%), expected participation rate (90%), expected intervention participation rate (80%)", "answer": 175, "answer_type": "ACTUAL", "explanation": "Sample size determination\n The longitudinal sample to be recruited is 175 participants irrespective of HRB profile and reason of hospital admission. The sample is expected to be large enough to investigate the acceptance of the PAL intervention in terms of reach, retention and satisfaction, to provide a sufficient number of cases for latent growth modelling, and to have sufficient power (80%, \u00ce\u00b1=0.05, two tailed) to detect small-sized to medium-sized effects (Cohen\u00e2\u0080\u0099s d=0.38) in mean differences between two independent groups, for example, participants versus non-participants. Expecting 90% of the eligible patients participating in the survey, and 80% of these to participate in the intervention study as achieved in own previous studies,32 we expect to approach about 243\u00e2\u0080\u0089patients over 2\u00e2\u0080\u0089months.", "id": 1432, "split": "test"} +{"trial_id": "NCT05365776", "pmid": "38950993", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion\n\nIncluded conditions:\n- Mild Traumatic Brain Injury\n\nStudy Armgroups:\n- {'label': 'Arm 1: Graded Exposure Therapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Graded Exposure Therapy']}\n- {'label': 'Arm 2: Prescribed Aerobic Exercise', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Prescribed aerobic exercise']}\n- {'label': 'Arm 3: Enhanced usual care', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Enhanced usual care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Graded Exposure Therapy', 'description': 'Graded exposure therapy is delivered by a psychologist over 12 individual (1:1) secure videoconference sessions. The core active ingredient is graded situational exposure to foster habituation and challenge beliefs that the avoided activities are dangerous. Homework exercises involve planned exposure exercises in the home and community to support generalization.', 'armGroupLabels': ['Arm 1: Graded Exposure Therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'Prescribed aerobic exercise', 'description': 'Participants will be asked to complete 30 minutes of aerobic exercise on 5 days/week for a 12-week period. Participants select the mode (e.g., swimming, jogging, bicycling) and location of exercise (e.g., outdoors, a gym or community centre, at home). The initial exercise intensity target will be based on the Buffalo Concussion Bike Test. The target progression will be 3-5 beats per minute every two weeks.', 'armGroupLabels': ['Arm 2: Prescribed Aerobic Exercise']}\n- {'type': 'OTHER', 'name': 'Enhanced usual care', 'description': 'Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through email message support.', 'armGroupLabels': ['Arm 3: Enhanced usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change', 'description': 'Score of 0-64, with a higher score indicates worse symptoms.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n15% attrition, alpha=0.05 (two-sided), 99% power for GET vs usual care, 83% power for treatment effect modification, 80% power for prescribed aerobic exercise vs usual care", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical power\n The target recruitment is 220 patients. With a randomisation ratio of 1:2:2, this will yield 44 participants assigned to usual care and 88 each to GET and prescribed aerobic exercise. Based on simulating 1000 replications of the trial, assuming 15% attrition and alpha=0.05 (two-sided) for all comparisons, we will have 99% power to detect a difference of \u00e2\u0089\u00a54 points on the primary outcome between GET and usual care (Aim 1) and 83% power to detect the hypothesised treatment effect modification by baseline fear avoidance behaviour (Aim 2). We will also have 80% power to detect a difference between the prescribed aerobic exercise versus usual care groups.", "id": 1433, "split": "test"} +{"trial_id": "NCT05367089", "pmid": "37640455", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis\n\nIncluded conditions:\n- Candidiasis, Vulvovaginal\n- Recurrent Candidiasis of Vagina\n\nStudy Armgroups:\n- {'label': 'Fluconazole', 'type': 'ACTIVE_COMPARATOR', 'description': 'Way of administration: oral capsules. One capsule at the same day of the week.\\n\\nDosage:\\n\\nAs treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole.\\n\\nAs prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.', 'interventionNames': ['Drug: Fluconazole']}\n- {'label': 'L-Mesitran', 'type': 'EXPERIMENTAL', 'description': 'Way of administration: intra-vaginal application using an applicator.\\n\\nDosage:\\n\\nAs treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.', 'interventionNames': ['Device: L-Mesitran']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fluconazole', 'description': 'Way of administration: oral capsules. One capsule at the same day of the week.\\n\\nDosage:\\n\\nAs treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole.\\n\\nAs prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.', 'armGroupLabels': ['Fluconazole'], 'otherNames': ['diflucan']}\n- {'type': 'DEVICE', 'name': 'L-Mesitran', 'description': 'Way of administration: intra-vaginal application using an applicator.\\n\\nDosage:\\n\\nAs treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.', 'armGroupLabels': ['L-Mesitran']}\n\nPrimary Outcomes:\n- {'measure': 'vaginal swab', 'description': 'The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. The vaginal swab will be analyzed in the laboratory to determine the presence or absence of microorganisms and thus the mycological cure rate.', 'timeFrame': '1 month'}\n- {'measure': 'vaginal swab', 'description': 'The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).', 'timeFrame': '6 months'}\n- {'measure': 'vaginal swab', 'description': 'The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, and a dropout rate of up to 25%.", "answer": 252, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based on a similar study in which the effect of honey was investigated for the treatment of VVC.12 They reported a clinical cure rate of 86.6% in the honey group and 40% in the fluconazole group. Since the mycological cure rate was 76.6% in the honey group and 43.4% in the control group, we decided to use the mycological cure from the control group in our calculation. We think that a smaller difference than previously observed, that is, an absolute difference of 20% between groups instead of over 30%, can be considered clinically meaningful. To be able to have 80% power to detect a difference of 20% assuming the success rate in the control group is 43.4%, we need to include at least 94 patients per group when using an alpha of 5% for testing. To compensate for a dropout rate of up to 25% we need to include 126 patients per group or 252 in total. The calculation has been performed in R using the formula for the difference in proportions from Chow et al34", "id": 1434, "split": "test"} +{"trial_id": "NCT05367817", "pmid": "37784197", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Neuromuscular Joint Protective Exercise Therapy Program for Treatment of Wrist Osteoarthritis: a Randomized Controlled Trial\n\nIncluded conditions:\n- Osteoarthritis Wrist\n\nStudy Armgroups:\n- {'label': 'Exercise therapy', 'type': 'EXPERIMENTAL', 'description': 'The program consists of two parts. The first part of the program contains unloaded active ROM exercises for the wrist in flexion/extension, radial-/ulnardeviation and pronation/supination. The second part of the program consists of three neuromuscular exercises that focus on coordination, wrist stability and strength. The participants will perform the program twice a day for 12 weeks.', 'interventionNames': ['Other: Neuromuscular exercise therapy']}\n- {'label': 'Training program', 'type': 'ACTIVE_COMPARATOR', 'description': 'The training program for the control group will consist of ROM exercises only that will be also be performed twice a day for 12 weeks.', 'interventionNames': ['Other: Training program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Neuromuscular exercise therapy', 'description': 'Participants perform specific neuromuscular exercises aimed at enhancing the sensorimotor control of the wrist.', 'armGroupLabels': ['Exercise therapy']}\n- {'type': 'OTHER', 'name': 'Training program', 'description': 'Participants perform range of motion exercises for the wrist.', 'armGroupLabels': ['Training program']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in pain and function on the Patient-Rated Wrist Evaluation (PRWE) at 3, 6 and 12 months.', 'description': 'The PRWE is a self-reported questionnaire that includes 15 questions, divided into two subscales assessing pain (5 items) and function (10 items, 6 concerning specific tasks and 4 the ability to perform daily activities) over the past week. The questions are scored on a 10-point ordered categorical scale, ranging from no pain or no difficulty (0 points), to worst pain or unable to do (10 points). The total score of the subscales pain (sum of 5 items) and function (sum of 10 items divided by 2) ranges from 0 to 50. The maximum total score of PRWE is 100 and represents the worst disability, whereas 0 represents no disability.', 'timeFrame': 'Baseline, 3, 6 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of 14, power of 0.8, significance level of 0.05, and a dropout rate of 20%", "answer": 48, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size estimate of this RCT is based on relevant previous studies that have shown minimal clinically important differences (MCIDs) for the PRWE between 11.5 and 14 [20, 21]. An MCID of 11.5 has been found in patients with distal radius fractures [20], while an MCID of 14 was found in patients with various atraumatic upper extremity disorders, including patients with wrist OA [21]. We have calculated our sample size of an MCID in between these two studies (MCID 12.5). Using a standard deviation (SD) of 14, power (1-beta) at 0.8, and a significance level (alpha) at 0.05, we will need to recruit a sample of 40 patients, 20 in each group. Accounting for a drop-out rate of 20%, we will ultimately need to include a total of 48 patients in the trial (Fig.\u00c2\u00a01). We will continue to recruit participants until we have reached our estimated sample size. If a participant withdraws from the trial before completing the 12-week allocated treatment program, we will recruit a new participant. Participants that withdraw from the trial between the 3- and 12-month follow-ups will not be replaced.", "id": 1435, "split": "test"} +{"trial_id": "NCT05369195", "pmid": "37996955", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation\n\nIncluded conditions:\n- Atrial Fibrillation\n- Silent Stroke\n- Cognitive Impairment\n- Depression\n\nStudy Armgroups:\n- {'label': 'LAAC with neuroprotection', 'type': 'EXPERIMENTAL', 'description': 'Arm in which is used a transcatheter system to protect the cerebral circulation during the left atrial appendage closure procedures.', 'interventionNames': ['Procedure: LAAC procedure with the use of transcatheter cerebral protection system']}\n- {'label': 'LAAC without neuroprotection', 'type': 'PLACEBO_COMPARATOR', 'description': 'Arm in which the left atrial appendage closure procedures are performed without transcatheter cerebral protection.', 'interventionNames': ['Procedure: LAAC procedure without the use of transcatheter cerebral protection system']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'LAAC procedure with the use of transcatheter cerebral protection system', 'description': 'After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.', 'armGroupLabels': ['LAAC with neuroprotection']}\n- {'type': 'PROCEDURE', 'name': 'LAAC procedure without the use of transcatheter cerebral protection system', 'description': 'Only the aortography through radial access will be done before accessing the left atrium.', 'armGroupLabels': ['LAAC without neuroprotection']}\n\nPrimary Outcomes:\n- {'measure': 'Change in number of silent cerebral ischemia (SBI) foci', 'description': 'number of SBI foci in DW MRI of the brain', 'timeFrame': 'change in the period up to 24 months'}\n- {'measure': 'Change in volume of silent cerebral ischemia (SBI) foci', 'description': 'volume SBI foci in DW MRI of the brain', 'timeFrame': 'change in the period up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 2% withdrawal or invalidation ratio.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on the assumptions that cerebral protection during LAAC would result in a favorable response in 85% of patients and that the absence of new SBI on DW MRI in the control group would affect 70% of patients, the minimum group size was estimated to be 118 individuals per group. This estimation ensured 80% power to detect the anticipated difference at a significance level of 5%. Considering a withdrawal or invalidation ratio of 2%, a total of 120 individuals will be enrolled in each group, resulting in a sample size of 240 patients for the study. This sample size is necessary to provide sufficient statistical power and enable meaningful comparisons between the study and control groups.", "id": 1436, "split": "test"} +{"trial_id": "NCT05369637", "pmid": "37117001", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Back to Normal - Multiple Non-pharmacological Interventions to Accelerate the Return to the Pre-event Level of Functioning After a Transient Ischemic Attack and Minor Stroke - a Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Transient Ischemic Attack\n- Minor Stroke\n\nStudy Armgroups:\n- {'label': 'Non-pharmacological Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will receive a multidomain non-pharmacological program, including cognitive training, physical exercise, nutrition education, psychoeducation, and diagnosis and correction of hearing impairment.', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: Physical exercise', 'Behavioral: Behavioral: Nutrition education', 'Behavioral: Psychoeducation', 'Other: Diagnosis and correction of hearing impairment']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Control group will receive the usual standard of care provided to these clinical diseases.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive training', 'description': 'This component will comprise the following activities:\\n\\ni. In-person group training (monthly): 60-minute sessions, supervised by a psychologist; ii. Home individual training (\u22655 times per week): unsupervised 30-minutes remote sessions, using the COGWEB\u00ae online platform or paper/pencil exercises (for those participants without computer/internet or who do not use one autonomously).', 'armGroupLabels': ['Non-pharmacological Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Physical exercise', 'description': 'This component will be based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher:\\n\\ni. In-person group training (monthly); ii. In-person group training or remote synchronous training or provision of education booklets with photos and exercise instructions to be performed individually (twice weekly), depending on the evolution of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic.', 'armGroupLabels': ['Non-pharmacological Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Behavioral: Nutrition education', 'description': 'This component will be based on the following activities:\\n\\ni. In-person group 120-minute sessions (monthly), guided by a nutritionist, comprising: presentation and discussion of healthy and easy to cook recipes by the nutritionist and preparation of healthy meals by the participants; ii. In-person individual appointment with a nutritionist (monthly).', 'armGroupLabels': ['Non-pharmacological Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Psychoeducation', 'description': 'This component will be based on in-person group sessions (monthly; 60-minute) supervised by a psychologist, aiming to promote the acquisition of important knowledge about secondary prevention and support people understanding, exploring, and self-managing their emotions and impairments.', 'armGroupLabels': ['Non-pharmacological Intervention']}\n- {'type': 'OTHER', 'name': 'Diagnosis and correction of hearing impairment', 'description': 'This component will be based on a evaluation session conducted by otolaryngologists and audiologists, who will evaluate previous hearing problems and use of hearing aids, and include an otoscopy and an audiogram.', 'armGroupLabels': ['Non-pharmacological Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Time to recovery in each instrumental activity of daily living', 'description': 'Time to recovery in each instrumental activity of daily living measured by an adapted version of the Frenchay Activities Index.', 'timeFrame': '3 months'}\n- {'measure': 'Recruitment timeframe', 'description': 'Proportion of participants recruited within the seven days post-onset of symptoms will be calculated as the number of participants recruited within the time frame divided by the total number of participants.', 'timeFrame': '3 months'}\n- {'measure': 'Adherence to each component of the intervention', 'description': 'Proportion of adherence to each component of the intervention and to different intervention modalities (remote/in person), calculated as the number of sessions attended divided by the total number of sessions implemented. For remote cognitive training the outcome will be the absolute number of sessions.', 'timeFrame': '3 months'}\n- {'measure': 'Dropout', 'description': 'Proportion of participants who dropped out of the study, calculated as the number of participants who dropped out after attending at least one session divided by the total number of participants who attended at least one session.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a statistical power of 80% and a significance level of 5%. A dropout rate of 10% from baseline to the first follow-up is expected.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Data analysis and sample size\n The associations between the social and clinical characteristics and feasibility (eg, recruitment time frame, adherence, dropouts) and lifestyle outcomes will be quantified through linear or logistic regression models, as applicable. Time in days from the onset of symptoms to complete or partial recovery in each instrumental ADLs will be estimated and illustrated by Kaplan-Meier survival curves. The time comparison between intervention and control groups will be made through the log-rank test. To estimate the association between the intervention and the recovery time, HRs will be estimated, through the computation of univariate and multivariate Cox regression models.\n Training of the interviewers and use of standardised procedures for data collection is expected to contribute to a low proportion of missing data, and no imputation is being planned.\n To the best of our knowledge, there is no previous information regarding effect sizes and SDs regarding the primary outcome related with the recovery of functionality after a TIA or a minor stroke. Nevertheless, a sample size of at least 70 participants (35 per arm) is commonly recommended for a pilot study when estimating the pooled SD.25 Nevertheless, taking into account the results of a previous RCT evaluating a cardiac model of rehabilitation for reducing risk factors post-TIA and stroke,26 this sample size will allow to detect mean differences of 5.5 and 6.0 in the changes observed in the Hospital Anxiety and Depression Scale\u00e2\u0080\u0094anxiety and depression scores, respectively, between intervention and control groups (assuming a statistical power of 80% and a level of significance of 5%).\n To achieve the sample size needed to accomplish the proposed objectives, we expect to invite approximately 100 individuals, since a participation of 70% was previously observed in the EPIPorto cohort.27 We also expect a dropout of 10% from baseline to the first follow-up; nevertheless, and in order to minimise refusals and losses to follow-up, all activities will take place near participants\u00e2\u0080\u0099 residence and be scheduled for their convenience.", "id": 1437, "split": "test"} +{"trial_id": "NCT05370417", "pmid": "37316315", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial.\n\nIncluded conditions:\n- Hypomineralization Molar Incisor\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'SHAM_COMPARATOR', 'description': 'Participants in this group received toothpaste with fluoride concentration \u2265 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser.', 'interventionNames': ['Other: Use of fluoride toothpaste', 'Procedure: Simulated Laser Therapy', 'Procedure: Sealant application']}\n- {'label': 'Study Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group received toothpaste with fluoride concentration \u2265 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser.', 'interventionNames': ['Other: Use of fluoride toothpaste', 'Radiation: Photobiomodulation', 'Procedure: Sealant application']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Use of fluoride toothpaste', 'description': \"The participants received oral hygiene instructions - routine brushing twice per day with toothpaste containing 1000 ppm of fluoride. All participants received a toothbrush and toothpaste to ensure standardization. The aim of this intervention was to assess whether the participants' brushing technique would improve with desensitization.\", 'armGroupLabels': ['Control Group', 'Study Group']}\n- {'type': 'RADIATION', 'name': 'Photobiomodulation', 'description': 'For laser application, the following dosimetric parameters will be used:\\n\\nLow level laser diode (infra red) wavelength 808nm with a power of 100mW. Three sessions: initial session, after 48 hours and after one month. LLL was applied to three perpendicular points in contact with the surface on the mesial vestibular and distal cervical faces and in the center of the occlusal face. An energy of 1 J was applied for 10 seconds at each point.', 'armGroupLabels': ['Study Group']}\n- {'type': 'PROCEDURE', 'name': 'Simulated Laser Therapy', 'description': 'The same application described in the laser therapy group will be simulated, with the device turned off.', 'armGroupLabels': ['Control Group']}\n- {'type': 'PROCEDURE', 'name': 'Sealant application', 'description': 'A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.', 'armGroupLabels': ['Control Group', 'Study Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in pain - Visual analog scale (VAS)', 'description': 'The perception of pain in children was assessed using the Wong-Baker Faces Pain Rating Scale. This scale facilitates communication, allowing for a more accurate assessment of the pain reported by the child.', 'timeFrame': 'Baseline, 48 hours after the procedures and 1 month after.'}\n- {'measure': 'Changes in the Schiff Cold Air Sensitivity Scale (SCASS)', 'description': 'The (SCASS) will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus).', 'timeFrame': 'Baseline, 48 hours after the procedures and 1 month after.'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 90% power, 10% dropout rate. Shapiro Wilk test for normality, SD and 95% CI calculation. Parametric data: t-test for independent and dependent samples. Non-parametric data: Mann-Whitney test for intergroup and Wilcoxon test for intragroup comparisons.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Calculation of sample size\n This is a non-inferiority trial. The sample size was calculated using the G* Power software programme (V.3.1.9.2) based on the study conducted by Muniz et al. Considering an effect size of 0.80 for the primary outcome (sensitivity score) and assuming a possible 10% dropout rate, a total of 50 patients (25 in each group) will be needed to ensure a 5% significance level and 90% power. The Shapiro Wilk test will be performed to determine the normality of the data, the SD and 95% CI will be calculated.11 If the data are parametric, the t-test for independent samples will be used for comparison between groups, and the comparison between times in the same group will be done with the t-test for dependent samples. If the data are non-parametric, the Mann-Whitney test will be used intergroups and the intragroups comparison between times will be done with the Wilcoxon test.", "id": 1438, "split": "test"} +{"trial_id": "NCT05370781", "pmid": "36862648", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Michigan Men's Diabetes Project 2\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Peer led diabetes self-management support (PLDSMS)', 'type': 'EXPERIMENTAL', 'description': 'Participants in the PLDSMS arm will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. This group will then transition into monthly 90-minute diabetes self-management support (DSMS) with trained peer leaders for 6 months. After the DSMS sessions, the group will transition into 6 months of ongoing support and will be encouraged to continue DSMS through initiatives that are important to them.', 'interventionNames': ['Behavioral: Peer Led Diabetes Self-Management Support', 'Behavioral: Diabetes Self-Management Education']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist.', 'interventionNames': ['Behavioral: Diabetes Self-Management Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Peer Led 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 led diabetes self-management support (PLDSMS)']}\n- {'type': 'BEHAVIORAL', 'name': '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 platform.', 'armGroupLabels': ['Control Group', 'Peer led diabetes self-management support (PLDSMS)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Hemoglobin A1c', 'description': 'Anthropometric/clinical data', 'timeFrame': 'baseline, 3-months, 9-months, 15-months'}\n- {'measure': 'Change in Regimen Adherence', 'description': 'Survey data', 'timeFrame': 'baseline, 3-months, 9-months, 15-months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power of 0.8, 20% attrition rate, correlations of 0.25 between successive measurements of A1C.", "answer": 48, "answer_type": "ACTUAL", "explanation": "Sample size\n \n Power analysis\n While we plan to recruit 64 Black men to be our participants for this study, we expect a final sample size of 48 participants (excluding the four participants who will serve as peer leaders), assuming a 20% attrition rate. There will be 12 participants per group, with 2 groups in the control arm and 2 groups in the PLDSMS arm. Assuming correlations of 0.25 between successive measurements of A1C, this sample size will yield a power of 0.8 to detect a difference of 0.6 standard deviations between average values of A1C in the treatment and control groups.", "id": 1439, "split": "test"} +{"trial_id": "NCT05371158", "pmid": "35945582", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Patient-centered Development and Effectiveness of Online Acceptance and Commitment Therapy for Pain Interference in Cancer Survivors With Persistent Painful Chemotherapy-induced Neuropathy\n\nIncluded conditions:\n- Chemotherapy-induced Peripheral Neuropathy\n- Cancer Survivors\n\nStudy Armgroups:\n- {'label': 'Online intervention', 'type': 'EXPERIMENTAL', 'description': \"The experimental condition includes an online psychological intervention with therapist email guidance based on Acceptance \\\\& Commitment Therapy (ACT). ACT is a form of Cognitive Behavioral Therapy, which focuses on acceptance of chronic pain in order to be able to perform valuable activities, instead of attempts of avoidance and controlling (Hayes et al., 2012). The main goal of ACT is increasing psychological flexibility, which includes the ability to act effectively according to personal values, with pain. ACT can thereby play a role in creating more realistic expectations regarding expectations of future pain relief. The intervention can be worked through in the participant's own living environment. It consists of 6 modules which can be worked through in 8 weeks.\", 'interventionNames': ['Behavioral: Online intervention']}\n- {'label': 'Control condition', 'type': 'NO_INTERVENTION', 'description': 'The control condition includes a waiting list group that can receive treatment-as-usual. Participants are placed on a waiting list and receive the online psychological ACT intervention without email guidance directly after the first follow-up measurement. Participants placed on the waiting list will not receive the ACT intervention immediately. Participants do have the opportunity to access treatment as usual (TAU). Directly after the first, 3-month follow-up measurement these participants receive the opportunity to follow the intervention without email guidance by a therapist.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Online intervention', 'description': 'The first module includes psychoeducation on neuropathic pain and CIPN (Table 1). Participants acquaintance themselves with intervention goals and mindfulness exercises central to ACT. In subsequent modules, participants learn about the aversive effects of pain avoidance, gain insight into their personal values, and work on pain acceptance. Participants exercise to recognize unhelpful thoughts about their pain and learn the difference between the subjective (judging) and objective self, and think about concrete actions to prevent relapse. The intervention primarily consists of text and experiential exercises, complemented with illustrations, metaphors and audio (mp3) files. Additional functionalities may be an outline of experiences by other CIPN patients and/or the ability to keep a diary. Participants in the experimental condition will receive therapist guidance.', 'armGroupLabels': ['Online intervention'], 'otherNames': ['Embrace Pain']}\n\nPrimary Outcomes:\n- {'measure': 'Pain interference', 'description': 'Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.', 'timeFrame': 'T0b (0 months)'}\n- {'measure': 'Pain interference', 'description': 'Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.', 'timeFrame': 'T1 (3 weeks)'}\n- {'measure': 'Pain interference', 'description': 'Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.', 'timeFrame': 'T2 (6 weeks)'}\n- {'measure': 'Pain interference', 'description': 'Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.', 'timeFrame': 'T3 (2 months)'}\n- {'measure': 'Pain interference', 'description': 'Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.', 'timeFrame': 'T4 (5 months)'}\n- {'measure': 'Pain interference', 'description': 'Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.', 'timeFrame': 'T5 (8 months)'}\n\nPlease estimate the sample size based on the assumption: \nPower (p = 1-beta = .80), significance level (alpha = .05), and a drop-out rate of 30%.", "answer": 146, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Per group, 51 participants during follow-up measurements are necessary to detect minimal effect sizes of interest (d = .50) on the primary outcome. This is based on earlier findings on effectiveness of online and face-to-face ACT intervention for chronic pain [33, 34]. The power will be high enough (p = 1-beta = .80) to find significant effects in a two-sided test at alpha = .05. As found in previous online ACT interventions, a drop-out rate of 30% needs to be considered. G*Power calculations revealed that 73 participants per group are needed at baseline, which means that 146 participants are needed in total.", "id": 1440, "split": "test"} +{"trial_id": "NCT05371548", "pmid": "39581737", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Effectiveness of the Smart About Meds (SAM) Medication Management Mobile Application: A Randomized Controlled Trial\n\nIncluded conditions:\n- Medication Adherence\n\nStudy Armgroups:\n- {'label': 'Intervention (SAM app)', 'type': 'EXPERIMENTAL', 'description': \"Patients will receive training in and access to the SAM app at discharge. SAM uses prescribed and dispensed medication data to display a continuously updated drug list and provides patients and caregivers with tools to address barriers to adherence.\\n\\nDrug information: Provides patient-friendly drug monographs. Interaction checker: Generates drug-drug interactions between the patient's medications and other OTC drugs.\\n\\nAdherence alerts: Uses decision algorithms to alert users to adherence problems with the new regimen.\\n\\nSide effect checker: Displays possible side effects for each medication and frequency of occurrence.\\n\\nPIMs alerts: Alerts patients to potentially inappropriate medications in their list.\\n\\nPharmacist connect: Connects users with pharmacists through a secured messaging service.\\n\\nSocial connect: Allows users to share medication experiences. Caregiver connect: Allows patients to enroll caregivers who can use the app. Weekly medication schedule \\\\& pill reminders\", 'interventionNames': ['Device: SAM mobile application']}\n- {'label': 'Control (usual care)', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive usual care at discharge. On study units, medication reconciliation is conducted for all patients. Patients have their community medication list obtained via fax from their community pharmacy. The list is validated by the unit pharmacist who then reconciles it with admission orders, and recommends changes as needed to the attending physician. At discharge, the community drug list is reconciled with medications administered in hospital and the discharge prescription is generated by the attending physician or resident, classifying each medication as new medication, dose modification, discontinued therapy, or continued community medication. The discharge prescription is provided to the patient. Patients fill their discharge prescription at their community pharmacy. If there are questions about changes to the community drug list, the pharmacist will ask the patient, and if not clear will contact the discharging physician.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SAM mobile application', 'description': 'See description of intervention group', 'armGroupLabels': ['Intervention (SAM app)']}\n\nPrimary Outcomes:\n- {'measure': 'ED visits, hospital readmissions, and deaths (composite)', 'description': 'This is a composite, binary outcome of having experienced an ED visit, hospital readmission, or death in the 90 days post-discharge. In Quebec, physicians must record the location of the services they provide to be remunerated on a fee-for-service basis. These medical services claims data are timely and accurate in measuring hospitalization occurrence and length of stay. The hospitalization database, which records admission and discharge diagnoses and procedures for all acute care hospitalizations in Quebec, will be used to collect additional descriptive information on the reasons for hospitalization and to re-validate the medical services data. Patients will be classified as having an ED visit or hospital readmission if they received a service whose location is recorded as an ED or inpatient hospital unit, respectively. Post-discharge deaths will be retrieved from the RAMQ beneficiary database.', 'timeFrame': '90 days post-discharge'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error of 5%, type II error of 20%, two-sided test, and an overall 4% loss to follow-up rate.", "answer": 3250, "answer_type": "ESTIMATED", "explanation": "Sample size\n In our recent RCT on medication reconciliation of 3491 patients, 48% of patients in the control group experienced an ED visit, hospital readmission or death in 90 days postdischarge.6 Assuming a similar proportion will experience this outcome in the control group of the SAM RCT, to detect the smallest clinically relevant reduction of 5% (from 48% to 43%), with a type 1 error of 5% and a type II error of 20%, using a two-sided test, 1556 patients will be required per treatment group, yielding a sample size of 3112.\n Since over 99% of participants are expected to remain in the province during follow-up, we expect less than 1% loss to follow-up resulting from loss of access to medical services claims data used to measure this outcome. In addition, based on our SAM pilot RCT, we expect 3% of patients to withdraw consent following randomisation.95 For the purposes of sample size calculation, we have assumed an overall 4% loss to follow-up rate. To account for this, we need to enrol 3250 patients. This sample size would provide >80% power to detect an absolute reduction of 5% in the secondary outcome of non-adherence to medication changes, which was experienced by 44% of patients in our recent study of 2655 patients.810", "id": 1441, "split": "test"} +{"trial_id": "NCT05372068", "pmid": "40032381", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh\n\nIncluded conditions:\n- Ascaris Lumbricoides Infection\n- Necator Americanus Infection\n- Trichuris Trichiura; Infection\n- Diarrhea\n\nStudy Armgroups:\n- {'label': 'Concrete household floor', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Concrete household floor']}\n- {'label': 'Non-intervention', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Concrete household floor', 'description': 'Household soil floors will be replaced with concrete floors', 'armGroupLabels': ['Concrete household floor']}\n\nPrimary Outcomes:\n- {'measure': 'Child prevalence of any soil-transmitted helminth infection', 'description': 'Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up', 'timeFrame': 'Up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error is set at 0.05, Type II error at 0.20, and intraclass correlation at 0.066. A 15% loss to follow-up rate is assumed.", "answer": 800, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The overall trial sample size was determined based on the primary outcome of prevalence of any STH at any follow-up (ages 6, 12, 18 or 24 months). We estimated the required sample size using the standard formula for comparisons of two groups with repeated measures of a binary outcome.55 From 2017 to 2020 in Sirajganj District, the prevalence of Ascaris lumbricoides was 25.1%, and the prevalence of Trichuris trichiura was<10%.53 To be conservative, we assumed the prevalence of any STH in the control group over four follow-up rounds would be 20%. In our prior analyses of the association between concrete floors and any STH, the unadjusted prevalence ratio was 0.40 (95% CI 0.28, 0.56),56 and the adjusted prevalence ratio was 0.73 (95% CI 0.52, 1.01).57 We set the null hypothesis at a prevalence ratio of 1 (no difference between groups at any follow-up (ages 6, 12, 18 or 24 months)) and assumed a minimum detectable prevalence ratio of 0.70. We assumed intraclass correlation=0.066 for repeated measurements of STH prevalence among children<2 years.58 Assuming a Type I error=0.05\u00e2\u0080\u0089and Type II error=0.20, for a two-sided hypothesis test, the required number of households per arm is 336. Inflating this to account for 15% loss to follow-up and 10 households per randomisation block, the total required sample size across both arms is 800. 15% loss to follow-up was assumed based on the findings from the prior trial carried out by our team in rural Bangladesh,59 in which 6.5% of pregnant women miscarried or had stillbirths, 3.5% of children died by 12-month follow-up and<1% died between 12 and 24 months follow-up.", "id": 1442, "split": "test"} +{"trial_id": "NCT05375474", "pmid": "37989381", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR\n\nIncluded conditions:\n- Transcatheter Aortic Valve Replacement\n- Antithrombotic Therapy\n- Bioprosthetic Valve Thrombosis\n\nStudy Armgroups:\n- {'label': 'Oral anticoagulation therapy group', 'type': 'EXPERIMENTAL', 'description': 'Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5', 'interventionNames': ['Drug: Oral anticoagulation therapy']}\n- {'label': 'Single antiplatelet therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Aspirin, 75-100mg', 'interventionNames': ['Drug: Single antiplatelet therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oral anticoagulation therapy', 'description': 'Vitamin-K antagonists (warfarin)', 'armGroupLabels': ['Oral anticoagulation therapy group']}\n- {'type': 'DRUG', 'name': 'Single antiplatelet therapy', 'description': 'Aspirin', 'armGroupLabels': ['Single antiplatelet therapy group']}\n\nPrimary Outcomes:\n- {'measure': 'A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)', 'description': 'A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)', 'timeFrame': '1 year'}\n- {'measure': 'Rates of bioprosthetic valve thrombosis detected by 4D-CT', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation was set at alpha=0.05 (two-sided) and 90% power, with a preset loss rate of 10%.", "answer": 650, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This trial is a superior, randomised controlled trial with the SAPT group as the control group and the OAC group as the intervention group (1:1 allocation ratio). The calculation of the sample size was based on the assumption that OAC was superior to SAPT in terms of net clinical benefit endpoint and BPVT endpoints in TAVR patients. To date, there have been no \u00e2\u0080\u0098head-to-head\u00e2\u0080\u0099 randomised controlled studies directly comparing SAPT and OAC in TAVR patients without anticoagulant indications. According to previous studies, the incidence of net clinical benefit endpoint of patients undergoing TAVR treated with SAPT was about 28%, while the incidence was 16.9% for OAC.18 35 44\u00e2\u0080\u009347 PASS software (V.15, NCSS, LLC; Cassville, Utah, USA) was used to calculate the sample size set at alpha=0.05 (two-sided) and 90% power. With a preset loss rate of 10%, the total sample size was calculated to be 650 cases, that is, 325 cases in each group. Previous studies showed the incidence of SLT for APT treatment 1\u00e2\u0080\u0089year after TAVR was 15%, while that of OAC treatment was 4%.7 In accordance with the above conditions, the calculated sample size was 286 cases, 143 cases in each group. In summary, the total sample size was finally determined to be 650 cases, with 325 cases in each group.", "id": 1443, "split": "test"} +{"trial_id": "NCT05377151", "pmid": "37989361", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Dietitian-led Cluster Randomised Controlled Trial on the Effectiveness of mHealth Education on Health Outcomes Among Pregnant Women\n\nIncluded conditions:\n- Pregnant Women\n\nStudy Armgroups:\n- {'label': 'mobile application (mHealth) intervention only', 'type': 'EXPERIMENTAL', 'description': '- the subjects will receive mobile application (mHealth) intervention only', 'interventionNames': ['Other: Mobile application']}\n- {'label': 'mobile application (mHealth) intervention and dietitian consultation', 'type': 'EXPERIMENTAL', 'description': '- the subjects will receive the information from both mobile application (mHealth) and dietitian consultation', 'interventionNames': ['Other: Mobile application']}\n- {'label': 'standard usual care- dietitian consultation', 'type': 'NO_INTERVENTION', 'description': '- the subjects will receive all the related information from the standard usual care- dietitian consultation'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Mobile application', 'description': 'Nutrition intervention using either mHealth interventions or conventional methods will be carried out among pregnant women).\\n\\nSubjects will be allocated into three groups, namely, two interventions group which are:\\n\\nGroup 1: mHealth intervention group (98 subjects)\\n\\nGroup 2: mHealth intervention group + dietitian consultation (98 subjects)\\n\\nGroup 3: control group (98 subjects)', 'armGroupLabels': ['mobile application (mHealth) intervention and dietitian consultation', 'mobile application (mHealth) intervention only']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Gestational Weight Gain', 'description': 'Weight gain (kg)', 'timeFrame': '3 points time (Baseline, 6th month, 9th month/ delivery)'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence interval, significance level Z1\u2212\u03b1= 1.96, power of 80%, Z1\u2212\u03b2 = 0.84, and a 20% dropout rate.", "answer": 294, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study done by Weeks et al,99 among pregnant mothers and health care providers found that the mean (SD) for the intervention group baseline (n=50) was 11.19 (22.04) and mean (SD) for intervention group post intervention (n=50) was 22.66 (29.39). The sample size was calculated by using the formula difference between groups or between the sample of the population100 by using 95% interval, Z1\u00e2\u0088\u0092\u00ce\u00b1= 1.96\u00e2\u0080\u0089and power of 80%, Z 1\u00e2\u0088\u0092\u00ce\u00b2 = 0.84. To consider the possibility of drop off, a 20% is added which gives a total of 294 participants, with 98 participants needed in control, mHealth intervention alone and mHealth intervention group+personal medical nutrition therapy group, respectively.", "id": 1444, "split": "test"} +{"trial_id": "NCT05378607", "pmid": "37559069", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Goals for Adherence with Low-cost Incentives\n\nIncluded conditions:\n- ART\n- HIV\n\nStudy Armgroups:\n- {'label': 'Externally assigned sub-goals', 'type': 'EXPERIMENTAL', 'description': \"Participants will be eligible for prize drawings every three months based on meeting externally chosen subgoals in year 1 and maintaining 90% or more adherence in Year 2 as measured using a Wisepill device. In addition, there will be a larger prize drawing conditional on showing 90% adherence at the end of year 1 and viral suppression at the end of Year 2.\\n\\nThis arm will receive the intervention 'Incentivization based on gradually increasing externally chosen adherence goals ', 'Annual adherence prize drawing', 'SMS motivational messages + reminder of prize drawing', 'Year 2 re-allocation based on year 1 performance' and the intervention 'End of Year 2 viral suppression prize drawing.'\", 'interventionNames': ['Behavioral: Incentivization based on gradually increasing, externally chosen adherence goals', 'Behavioral: End of year 1 adherence prize drawing', 'Behavioral: SMS motivational messages + reminder of prize drawing', 'Behavioral: Year 2 re-allocation based on year 1 performance', 'Behavioral: End of Year 2 viral suppression prize drawing']}\n- {'label': 'Participatory sub-goals', 'type': 'EXPERIMENTAL', 'description': \"Participants will be eligible for prize drawings every three months based on meeting self-chosen subgoals in year 1 and maintaining 90% or more adherence in Year 2 as measured using a Wisepill device. In addition, there will be a larger prize drawing at the end of Years 1 and 2 that is conditional on showing 90% adherence and viral suppression, respectively.\\n\\nThis arm will receive the intervention ' Incentivization based on gradually increasing self-chosen adherence goals ', 'Annual adherence prize drawing', 'SMS motivational messages + reminder of prize drawing', 'Year 2 re-allocation based on year 1 performance' and the intervention 'End of Year 2 viral suppression prize drawing.'\", 'interventionNames': ['Behavioral: End of year 1 adherence prize drawing', 'Behavioral: SMS motivational messages + reminder of prize drawing', 'Behavioral: Year 2 re-allocation based on year 1 performance', 'Behavioral: End of Year 2 viral suppression prize drawing', 'Behavioral: Incentivization based on gradually increasing self-chosen adherence goals']}\n- {'label': 'Fixed goal', 'type': 'EXPERIMENTAL', 'description': \"Participants will be eligible for prize drawings every three months based on meeting a fixed adherence goal of 90% in year 1 and maintaining this adherence level in Year 2 as measured using a Wisepill device. In addition, there will be a larger prize drawing at the end of Years 1 and 2 that is conditional on showing 90% adherence and viral suppression, respectively.\\n\\nThis arm will receive the intervention ' Incentivization based on a fixed adherence goal', 'Annual adherence prize drawing', 'SMS motivational messages + reminder of prize drawing', 'Year 2 re-allocation based on year 1 performance' and the intervention 'End of Year 2 viral suppression prize drawing.'\", 'interventionNames': ['Behavioral: End of year 1 adherence prize drawing', 'Behavioral: SMS motivational messages + reminder of prize drawing', 'Behavioral: Year 2 re-allocation based on year 1 performance', 'Behavioral: End of Year 2 viral suppression prize drawing', 'Behavioral: Incentivization based on a fixed adherence goal']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': \"This arm will be provided with Mildmay's usual standard of care. Participants will not receive a prize drawing incentive based on adherence, but they will also be asked to use the Wisepill device and receive weekly motivational messages.\\n\\nThis arm will receive the intervention ' SMS motivational messages '\", 'interventionNames': ['Behavioral: SMS motivational messages']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Incentivization based on gradually increasing, externally chosen adherence goals', 'description': \"Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000, or 10,000 Ugandan Shillings if adherence matches or exceeds the subgoal chosen by the study coordinator. Subgoals will gradually increase from the participant's baseline adherence up to 90%. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.\", 'armGroupLabels': ['Externally assigned sub-goals']}\n- {'type': 'BEHAVIORAL', 'name': 'End of year 1 adherence prize drawing', 'description': 'Participants will have a chance to participate in a prize drawing at the end of year 1 with larger prize amounts of up to 20,000 Ugandan Shillings (approximately $6), where eligibility is based on reaching 90% in the three months preceding the end of year 1.', 'armGroupLabels': ['Externally assigned sub-goals', 'Fixed goal', 'Participatory sub-goals']}\n- {'type': 'BEHAVIORAL', 'name': 'SMS motivational messages + reminder of prize drawing', 'description': 'Participants will receive weekly motivational messages with a reminder of their upcoming prize drawing throughout year 1 of the study.', 'armGroupLabels': ['Externally assigned sub-goals', 'Fixed goal', 'Participatory sub-goals']}\n- {'type': 'BEHAVIORAL', 'name': 'Year 2 re-allocation based on year 1 performance', 'description': 'In Year 2 of the study, participants who have reached 90% by the end of year 1 will no longer be given sub-goals and instead will be eligible for prize drawings if they maintain the fixed level of 90% or higher. Those who have not reached 90% by the end of year 1 will be allocated to the intervention group that showed the highest effectiveness in year 1.', 'armGroupLabels': ['Externally assigned sub-goals', 'Fixed goal', 'Participatory sub-goals']}\n- {'type': 'BEHAVIORAL', 'name': 'End of Year 2 viral suppression prize drawing', 'description': 'Participants will have a chance to participate in a prize drawing at the end of Year 2 with larger prize amounts of up to 20,000 Ugandan Shillings (approximately $6), where eligibility is based on achieving viral suppression by the end of Year 2.', 'armGroupLabels': ['Externally assigned sub-goals', 'Fixed goal', 'Participatory sub-goals']}\n- {'type': 'BEHAVIORAL', 'name': 'Incentivization based on gradually increasing self-chosen adherence goals', 'description': 'Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000, or 10,000 Ugandan Shillings if adherence matches or exceeds the self-chosen subgoal. While self-chosen, subgoals are subject to a minimum threshold determined by baseline adherence working towards 90% adherence. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.', 'armGroupLabels': ['Participatory sub-goals']}\n- {'type': 'BEHAVIORAL', 'name': 'Incentivization based on a fixed adherence goal', 'description': 'Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000 or 10,000 Ugandan Shillings if adherence matches or exceeds the fixed adherence goal of 90%. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.', 'armGroupLabels': ['Fixed goal']}\n- {'type': 'BEHAVIORAL', 'name': 'SMS motivational messages', 'description': 'The control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Mean adherence to ART in previous 12 months', 'description': 'Wisepill devices monitor the date and time of all device openings to retrieve ART medication, allowing ART adherence to be tracked continuously on the Wisepill server. This will be coded as the number of ART doses taken / number of doses prescribed.', 'timeFrame': 'Measured at 12 months'}\n- {'measure': 'Mean adherence to ART in previous 12 months', 'description': 'Wisepill devices monitor the date and time of all device openings to retrieve ART medication, allowing ART adherence to be tracked continuously on the Wisepill server. This will be coded as the number of ART doses taken / number of doses prescribed.', 'timeFrame': 'Measured at 24 months'}\n- {'measure': 'The fraction of clients with adherence of 90% or more', 'description': 'Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication allowing adherence to be tracked continuously through the Wisepill server. The fraction of clients with 90% adherence or more from the total number of clients will be monitored.', 'timeFrame': 'Measured at 12 months'}\n- {'measure': 'The fraction of clients with adherence of 90% or more', 'description': 'Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication allowing adherence to be tracked continuously through the Wisepill server. The fraction of clients with 90% adherence or more from the total number of clients will be monitored.', 'timeFrame': 'Measured at 24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power (2-tailed test), 10% attrition rate per year, mean control group adherence of 62%, and about 70% of clients in the control group showing viral suppression.", "answer": 560, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n We have calculated the size of effects that our sample will be able to detect with 80% power (2-tailed test) with regard to outcomes at months 12 and 24, and assuming 10% attrition every year (we observed 8% attrition for our pilot study, so this is a conservative estimate). For the primary outcome of adherence, a sample size of 140 participants in each arm (n\u00e2\u0080\u0089=\u00e2\u0080\u0089560 total) will be able to detect an 8-percentage point (pp) difference in mean adherence between each treatment arm and control, and compared to each other. The corresponding difference at month 24 is 9\u00c2\u00a0pp. This assumes mean control group adherence of 62%, based on our pilot data. For the secondary outcome of viral suppression, we use a conservative estimate of about 70% of clients in the control group showing suppression based on discussions with the Mildmay team. Our sample size of 140 participants in each of the three arms will be able to detect about a 10\u00c2\u00a0pp difference at month 12, and 11\u00c2\u00a0pp at month 24. These represent conservative estimates of minimum detectable effect size that do not account for stratified randomization that we will perform to increase power, and to achieve better balance compared to a simple random draw [39].", "id": 1445, "split": "test"} +{"trial_id": "NCT05378815", "pmid": "39615889", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'PRP group', 'type': 'EXPERIMENTAL', 'description': \"PRP will be prepared with A-CP-T-20 kit provided by the RegenLab laboratory. This is a 2B medical device with the CE mark. 5mL will be injected in knee under ultrasound guidance.\\n\\nThe PRP extracted using this kit is poor in leukocytes, has a platelet concentration multiplied by 1.6 on average compared to circulating blood and is not activated (P2Bbeta according to the PAW classification; 3B according to the Mishra's classification).\", 'interventionNames': ['Procedure: PRP injection']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': '5 mL of NaCl will be injected in knee under ultrasound guidance.', 'interventionNames': ['Procedure: Placebo injection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'PRP injection', 'description': '3 weekly intra-articular injections of 5mL PRP under ultrasound guidance', 'armGroupLabels': ['PRP group']}\n- {'type': 'PROCEDURE', 'name': 'Placebo injection', 'description': '3 weekly intra-articular injections of 5mL NaCL under ultrasound guidance', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in global pain intensity in the target knee over the past 48 hours as assessed by Numeric Rating Scale (NRS) between week 0 and week 14', 'timeFrame': 'between week 0 and week 14'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided alpha risk of 5%, and 5% dropout rate.", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n From the available data,38 39 we postulate a mean change in VAS score of 20 points (SD=25) between W0 and W14 in the saline placebo arm. The analysis of 99 participants per arm will allow to show, with a power of 80% and a two-sided alpha risk of 5%, a minimal difference of 10 points in change in VAS score between the two groups between W0 and W14 (ie, change in VAS score of 30 points (SD=25) in the PRP arm). Considering 5% dropouts, we aim to include 210 patients.", "id": 1446, "split": "test"} +{"trial_id": "NCT05381155", "pmid": "37247964", "question": "Here is the design of a clinical trial:\n\nOfficial Title: tAckling intruSive Traumatic memoRies After chiLdbirth (ASTRAL): A Single-blind Waitlist Randomized Controlled Trial\n\nIncluded conditions:\n- Posttraumatic Stress Disorder\n- Intrusive Traumatic Memories\n\nStudy Armgroups:\n- {'label': 'Immediate Treatment', 'type': 'EXPERIMENTAL', 'description': 'Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.', 'interventionNames': ['Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay']}\n- {'label': 'Waitlist', 'type': 'OTHER', 'description': 'Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.', 'interventionNames': ['Behavioral: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay', 'description': 'The intervention is composed of two tasks:\\n\\n1. The childbirth narration task (8-10 min.): To trigger the malleability of the traumatic childbirth memory through memory reactivation, a psychologist will ask the participants to briefly narrate their childbirth and the moment associated with their most frequent or distressing CB-ITM. This intervention part will take place on the maternity ward to use this context as a reactivation cue.\\n2. The visuospatial task (3 min. practice + 20 min. gameplay): Participants will be instructed to engage in a Tetris gameplay for 20 minutes on a handheld gaming device (Nintendo 3DS), which is assumed to disrupt memory reconsolidation. This part of the intervention will take place in a neutral room.', 'armGroupLabels': ['Immediate Treatment', 'Waitlist']}\n\nPrimary Outcomes:\n- {'measure': 'The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention', 'description': 'The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre- and post-intervention', 'timeFrame': 'During the 2 weeks pre- and post-intervention'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level (\u03b1) = 0.05, 30% drop-out and exclusion rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A sample size calculation was conducted for our primary and secondary outcomes based on the results obtained from the pilot study,27 assessing the efficacy of the same intervention using a single-group pre\u00e2\u0080\u0093post design, and from laboratory studies using RCT designs to assess the efficacy of a similar BI-VT.23 24 A sample size of 90 participants (45 allocated in each group) is estimated to be necessary to detect the effect of the intervention on our primary and secondary outcomes with an 80% power (\u00ce\u00b1 = 0.05). Based on our experience with this study population,11 27 a conservative estimate of a 30% drop-out and exclusion was assumed. We therefore plan to recruit 120 participants in total.", "id": 1447, "split": "test"} +{"trial_id": "NCT05382481", "pmid": "37880168", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Anti Xa Monitoring Low Molecular Weight Heparin (LMWH) on Prevention of Venous Thromboembolism in Critically Ill Patients\uff1aA Randomized Controlled Trial\n\nIncluded conditions:\n- Venous Thromboembolism\n\nStudy Armgroups:\n- {'label': 'Peak value anti-Xa group (Group A)', 'type': 'EXPERIMENTAL', 'description': 'The peak value of anti-Xa level of this group should be remain 0.3\uff5e0.5IU/mL. This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the peak level of anti-Xa after 4 to 6 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the peak value of anti Xa.', 'interventionNames': ['Diagnostic Test: Peak value anti-Xa']}\n- {'label': 'Trough value anti-Xa group (Group B)', 'type': 'EXPERIMENTAL', 'description': 'The trough value of anti-Xa level of this group should be remain 0.1\uff5e0.2IU/mL. This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the trough level of anti-Xa after 12 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the trough value of anti Xa.', 'interventionNames': ['Diagnostic Test: Trough value anti-Xa']}\n- {'label': 'Control group \uff08Group C\uff09', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will not detect the value of anti Xa and not adjust the dose of LMWH.\\n\\nThis group will receive fixed dose of low molecular weight heparins (LMWH) 40mg, once a day.', 'interventionNames': ['Diagnostic Test: Control Group']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Peak value anti-Xa', 'description': 'This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the peak level of anti-Xa after 4 to 6 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the peak value of anti Xa.', 'armGroupLabels': ['Peak value anti-Xa group (Group A)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Trough value anti-Xa', 'description': 'This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the trough level of anti-Xa after 12 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the trough value of anti Xa.', 'armGroupLabels': ['Trough value anti-Xa group (Group B)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Control Group', 'description': 'This group will receive fixed dose of low molecular weight heparins (LMWH) 40mg, once a day. And will not detect the level of anti-Xa', 'armGroupLabels': ['Control group \uff08Group C\uff09']}\n\nPrimary Outcomes:\n- {'measure': 'number of VTE', 'description': 'VTE include symptomatic VTE or asymptomatic VTE at day 14', 'timeFrame': '14 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nA 5% loss to follow-up rate, 80% power, and a two-sided significance level of 0.05.", "answer": 858, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated using the NCSS-PASS software, V.11. Data in a previous meta-analysis study showed that the incidence of VTE in the aFXa trough level monitoring guidance group and the fixed-dose LMWH control group without aFXa monitoring was 5.4% (27 of 502) and 12.2% (78 of 637) among trauma patients, respectively.25 Therefore, we expect that the incidence of VTE will be 5.4% in the trough aFXa level monitoring group, 5.4% in the peak aFXa level monitoring group and 12.2% in the control group without aFXa monitoring at a fixed dose of LMWH. With these assumptions, assuming a 5% loss to follow-up rate, enrolment of 858 participants in three arms (at 1:1:1 ratio, 286 participants in each group) is required to provide 80% power, with a two-sided significance level of 0.05.", "id": 1448, "split": "test"} +{"trial_id": "NCT05384808", "pmid": "38183121", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of the Inclusion of a Dog in Psychotherapy on Children's Alliance and Treatment Motivation\n\nIncluded conditions:\n- Motivation\n- Alliance, Therapeutic\n\nStudy Armgroups:\n- {'label': 'No dog present', 'type': 'EXPERIMENTAL', 'description': 'Conventional psychotherapy with no dog being present.', 'interventionNames': ['Behavioral: Standard Psychotherapy']}\n- {'label': 'Dog present and active part of therapeutic narrative.', 'type': 'EXPERIMENTAL', 'description': 'The dog is actively integrated into the therapeutic narrative.', 'interventionNames': ['Behavioral: Canine-assisted psychotherapy with dog actively integrated.']}\n- {'label': 'Dog present but not active part of therapeutic narrative.', 'type': 'EXPERIMENTAL', 'description': 'The dog is present but not actively integrated into the therapeutic narrative.', 'interventionNames': ['Behavioral: Canine-assisted psychotherapy with dog passively integrated.']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Standard Psychotherapy', 'description': 'Participants receive a standard psychotherapy session with no dog being present.', 'armGroupLabels': ['No dog present']}\n- {'type': 'BEHAVIORAL', 'name': 'Canine-assisted psychotherapy with dog actively integrated.', 'description': 'A dog is present and actively integrated into the therapeutic narrative.', 'armGroupLabels': ['Dog present and active part of therapeutic narrative.']}\n- {'type': 'BEHAVIORAL', 'name': 'Canine-assisted psychotherapy with dog passively integrated.', 'description': 'A dog is present but not actively integrated into the therapeutic narrative.', 'armGroupLabels': ['Dog present but not active part of therapeutic narrative.']}\n\nPrimary Outcomes:\n- {'measure': 'Therapeutic alliance of patients', 'description': 'Patient\\'s reported therapeutic alliance is measured after the first, the third and the fifth therapy session of a newly began psychotherapy using the german adaptation of the \"Therapeutic Alliance Scales for Children\" (TASC)\". The TASC consists of 12 items, answered with a 4 point likert scale. The questionnaire assesses the therapeutic alliance from the perception of the child. Four weeks after the fifth therapy session children will be asked to fill in the questionnaire again as follow-up measurement.', 'timeFrame': '9 weeks'}\n- {'measure': 'Motivation of patients', 'description': 'Patient\\'s reported motivation is measured after the first, the third and the fifth therapy session of a newly began psychotherapy using the \"Situational Motivation Scale for children (SMS-15)\". The SMS-15 consists of 15 items answered with a 7 point likert scale. Four weeks after the fifth therapy session, children will be asked to fill in the questionnaire again as follow-up measurement.', 'timeFrame': '9 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80% at a 95% significance level. Participants who complete less than three therapy sessions will remain in the intention-to-treat population, but additional participants will be recruited until the anticipated sample size is achieved.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on the results published by Klebanoff, Rosenau, and Wood [22] and Stefanini et al. [23], we assume a coefficient of variation of 0.2 and a true difference between the groups of at least 10%. We estimate that a total of 95 participants in the dog-present and dog-active groups combined and 48 participants in the control group are required to detect a difference in the primary analysis with a power of 80% at a 95% significance level. In order to have a balanced sample, we rounded up the anticipated total sample size to 150.\n In the determination of the sample size (\\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}$$n$$\\end{document}n\n1) for this study, the following formula for difference in means was employed:\\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}$${n}_{1}=\\frac{(r+1)}{r} \\cdot \\frac{{\\sigma }^{2}{\\left({Z}_{power}+ {Z}_{a/2}\\right)}^{2}}{{{\\text{difference}}}^{2}}$$\\end{document}n1=(r+1)r\u00c2\u00b7\u00cf\u00832Zpower+Za/22difference2where:\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}$$n$$\\end{document}n\n1\u00e2\u0080\u0089=\u00e2\u0080\u0089size of smaller group.\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}$$r$$\\end{document}r = ratio of larger group to smaller group.\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}$$\\sigma$$\\end{document}\u00cf\u0083 = standard deviation of the characteristic.\n difference\u00e2\u0080\u0089=\u00e2\u0080\u0089clinically meaningful difference in means of the outcome.\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}$${Z}_{power}$$\\end{document}Zpower = corresponds to power (0.84\u00e2\u0080\u0089=\u00e2\u0080\u008980% power).\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}$${Z}_{a/2}$$\\end{document}Za/2 = corresponds to two-tailed significance level (1.96 for a\u00e2\u0080\u0089=\u00e2\u0080\u00890.05).\n Participants who complete less than three therapy sessions will remain in the intention-to-treat population, but additional participants will be recruited until the anticipated sample size of 150 for the available case population is achieved.", "id": 1449, "split": "test"} +{"trial_id": "NCT05385484", "pmid": "36527120", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors\n\nIncluded conditions:\n- Human Immunodeficiency Virus\n- STI\n- Alcohol Consumption\n- Incentives\n- Behavior\n\nStudy Armgroups:\n- {'label': 'Mobile banking account with incentives to save', 'type': 'EXPERIMENTAL', 'description': 'Participants in the savings intervention group will be provided with basic information on the importance of saving for the future, as well as (a) lottery-based incentives to save, (b) opportunities to develop savings goals, and (c) periodic reminders about the savings incentives and goals. Participants will receive assistance in opening and using a mobile savings account and will receive an education session that emphasizes the importance of saving for the future. Participants will be told about lottery-based incentives for saving money in their account.', 'interventionNames': ['Behavioral: Receives mobile banking account with incentives to save']}\n- {'label': 'Basic health and financial education', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will be given basic information on the importance of saving for the future. In addition, health education curriculum developed by Impact Research \\\\& Development Organization (IRDO) will be provided to participants with standard health education on places to seek services for HIV and STI prevention and treatment, including information on alcohol and transactional sex as risk factors for HIV transmission.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Receives mobile banking account with incentives to save', 'description': 'Participants will receive assistance in opening and using a mobile savings account, will be given education emphasizing saving practices and will be told about lottery-based incentives opportunities.', 'armGroupLabels': ['Mobile banking account with incentives to save']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of HIV and other STIs', 'description': 'Composite incidence of at least one of HIV or other STIs (herpes simplex virus type 2 (HSV-2), Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT)) over 24 months. The investigators will combine all STIs (including HIV) into a composite variable, with each participant counting once. For participants who are HIV-positive at baseline or HSV-2-positive, the outcome will be defined over all STIs other than HIV.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect a relative reduction of 21-25% in composite HIV/STI incidence over 24 months. 20% attrition rate over 24 months. Calculations based on a two-group chi-squared test of proportions with a two-sided alpha of 0.05.", "answer": 1500, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Power calculations assumed that composite HIV/STI incidence will be 15\u00e2\u0080\u009320% per year, with contributions from each STI as follows. HSV-2: data from Kenyan men show annual HSV-2 incidence among all men (adjusting for ~40% HSV-2 baseline prevalence) of 6\u00e2\u0080\u009310% [22]. HSV-2 incidence has been even higher among young men and higher-risk men (e.g., recent data for 18\u00e2\u0080\u009335-year-old men from the Afya Jozi Afya Jamii study). CT/NG: composite CT/NG annual incidence was 7\u00e2\u0080\u00938% in studies among Kenyan men [23], though some studies have reported higher incidence [24]. HIV: annual incidence of <1% is assumed from recent studies, and our anticipated incidence adjusts for baseline prevalence [18]. Accounting for co-infection with multiple STIs and baseline prevalence of HIV and HSV-2 (20% and 40%), our anticipated composite HIV/STI incidence is conservative.\n To have adequate statistical power to detect a meaningful reduction in composite HIV/STI incidence over 24 months, we will enroll a total of 1500 participants (750 per study arm). Table 2 shows that under difference assumptions of annual composite incidence in the control group, the study will have 80% power to detect a relative reduction of 21\u00e2\u0080\u009325%. We included a conservative assumption of 20% attrition over 24 months (expected to be lower given our prior studies). Calculations are based on a two-group chi-squared test of proportions.Table 2Detectable reduction in composite HIV/STI incidence over 24 months (N=1500, 80% power, 20% attrition, two-sided \u00ce\u00b1=.05)ScenarioComposite HIV/STI incidence rate in the control group (per 12 months)15%17%20%Composite HIV/STI incidence rate in the control group (per 24 months)28%31%36%Detectable relative reduction in composite incidence (relative to control)a0.250.230.21a1 \u00e2\u0088\u0092 (rate in the intervention group)/(rate in the control group)\n For the qualitative portion of this study, we will use structured and theoretical sampling approaches to compose a cohort of ~25 men from the overall study population. First, a structured sample of around n=15 participants will be randomly selected from the study sample, with over-sampling from the intervention arm given that the main objective of this study component is to understand how the intervention influences behavior. Control arm participants will be included to gain further insight on socio-ecological factors as well as health and economic decision-making. Second, using 12-month outcome data, we will systematically select around 10 additional men from the intervention arm to ensure the sample includes men who have high savings (>median) and low or no savings ( 50 mmHg), requiring treatment\\n\\nGrade 3:Pleural effusion, resulting in thoracentesis.Pneumonia.Pneumothorax.Noninvasive ventilation, strictly applied to those with all of the following: a) oxygen saturation(SpO2)lower than 92% under supplemental oxygen; b) need of supplemental oxygen \\\\>5 L/min; and RR \u2265 30 bpm .Re-intubation postoperative or intubation, period of ventilator dependence (non-invasive or invasive ventilation) \u2264 48 hours\\n\\nGrade 4:Ventilatory failure: postoperative ventilator dependence exceeding 48 hours, or reintubation with subsequent period of ventilator dependence exceeding 48 hours\\n\\nGrade 5:Death before hospital discharge', 'timeFrame': '7 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nConfidence level is set at 0.95, and a drop-out rate of 10% is considered.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome of the study is to evaluate the incidence of PPCs in paediatric patients undergoing VATS. According to a recent paediatric OLV study, the incidence of PPCs in the treatment group and the control group was 25.5% and 9.1%, respectively, with a 95% CI of 0.10 to 0.88. The OR was calculated to be 0.29.21 The sample size was determined using PASS software (V.15.0.5, NCSS) with the \u00e2\u0080\u0098CIs for the OR of two proportions\u00e2\u0080\u0099 procedure, setting the OR at 0.29. This calculation indicated that 26 participants would be required in each group, with a confidence level of 0.95. Factoring in a drop-out rate of 10%, the final predicted sample size is 60 (N1=N2=30).", "id": 1452, "split": "test"} +{"trial_id": "NCT05389189", "pmid": "37803467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis: Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Rheumatoid Arthritis\n\nStudy Armgroups:\n- {'label': 'CBT Care', 'type': 'ACTIVE_COMPARATOR', 'description': \"Intervention content\\n\\nThe MITIG.RA program incorporates the following key topics during the 8 weeks of intervention (1st phase):\\n\\n(i) Psychoeducation on RA, sleep hygiene, exercise, and general nutritional recommendations (promote behavioural change and self-care, boost the sense of self-worth and self-efficacy) (ii) Activity engagement and pacing (iii) The functioning of the mind and its problematic patterns (iv) Focusing on the 'here and now' (mindfulness) (v) Learning new ways of self-relating - self-compassion (vi) Making room for suffering (acceptance); and (vii) Moving towards what matters (identification of valued life directions and promotion of consistent values and goals-directed behaviour).\\n\\nBooster sessions, at 4 and 12 weeks after completion of the first phase\", 'interventionNames': ['Behavioral: Intervention Arm']}\n- {'label': 'TAU Care', 'type': 'NO_INTERVENTION', 'description': 'Usual Care respecting international recommendations for the management of RA.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention Arm', 'description': \"The MITIG.RA program incorporates the following key topics during the 8 weeks of intervention (1st phase):\\n\\n(i) Psychoeducation on RA, sleep hygiene, exercise, and general nutritional recommendations (promote behavioural change and self-care, boost the sense of self-worth and self-efficacy) (ii) Activity engagement and pacing (iii) The functioning of the mind and its problematic patterns (iv) Focusing on the 'here and now' (mindfulness) (v) Learning new ways of self-relating - self-compassion (vi) Making room for suffering (acceptance); and (vii) Moving towards what matters (identification of valued life directions and promotion of consistent values and goals-directed behaviour).\", 'armGroupLabels': ['CBT Care']}\n\nPrimary Outcomes:\n- {'measure': 'Fatigue', 'description': 'Fatigue levels will be assessed by the 0-10 numerical rating scale assessing fatigue as part of the RAID.7.Higher Scores indicate higher levels of fatigue', 'timeFrame': 'Week 32'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, 90% statistical power, 30% attrition rate", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The primary outcome of the study will be the difference in fatigue scores between the two intervention groups at week 32, controlling for baseline values. Based on the minimum clinical improvement established for RAID score and on our previous study assessing the responsiveness of RAID.7i, we expect a minimum difference in fatigue scores between the two groups of at least 3 points [54, 71, 72].\n A sample size of 91 was indicated by G*Power for analysis of covariance (ANCOVA) [\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, 90% statistical power, effect size of 0.50]. Assuming a 30% attrition rate and rounding up for convenience, we plan to recruit a total of 120 participants (60 participants per arm).", "id": 1453, "split": "test"} +{"trial_id": "NCT05389774", "pmid": "38176863", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes\n\nIncluded conditions:\n- AI (Artificial Intelligence)\n- Pulmonary Nodule, Solitary\n- Pulmonary Nodule, Multiple\n- Lung Cancer\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Determine the potential effect of the LCP on discharge', 'description': 'Measured difference between standard care, LCP and LCP-guided care for:\\n\\n* Percentage of cancer patients discharged (straight after assessment of the baseline scan)\\n* Percentage of benign-nodule patients discharged (straight after assessment of the baseline scan)', 'timeFrame': 'up to 1 year.'}\n\nPlease estimate the sample size based on the assumption: \nFor cancer patients, McNemar's test with 90% power and a significance level of 0.05. For benign-nodule patients, McNemar's test with 80% power and a significance level not explicitly stated.", "answer": 2000, "answer_type": "ESTIMATED", "explanation": "Sample size\n For calculations relating to the primary objectives of a measured difference between standard care and LCP for:\n \n \n Number and percentage of cancer patients discharged: results from thresholds defined for discharge in a previous study are used.7 Based on previous data within the cancer group, assuming for the discordant pairs that the Brock model threshold (representing the standard of care) identified 0.4% of cancers for which the LCP threshold would have recommended discharge, and the LCP threshold correctly identified 2.6% of cancers for which the Brock model threshold would have recommended discharge, then using McNemar\u00e2\u0080\u0099s test with 90% power and a significance level of 0.05, 659 participants would be needed. However, with a sample size of 2000, there is 90% power to detect a difference between the methods if the percentages were as small as 1.0% and 2.3%, respectively.\n \n \n Number and percentage of benign-nodule patients discharged: again, results from thresholds defined for discharge in a previous study are used.7 Based on previous data within the benign group, assuming for the discordant pairs that 17.0% of benign nodules are recommended for discharge by the LCP threshold but not by the Brock model threshold. In comparison, 13.5% are recommended for discharge by the Brock model threshold but not by the LCP threshold; there is 80% power to detect a significant difference between the two tests with 2026 individuals using McNemar\u00e2\u0080\u0099s test. This equates to an OR of 1.26\n \n \n Sample size calculations were performed using R statistical software (V.4.1.2; R Foundation for Statistical Computing, Vienna, Austria).", "id": 1454, "split": "test"} +{"trial_id": "NCT05391230", "pmid": "37104305", "question": "Here is the design of a clinical trial:\n\nOfficial Title: IGHID 12128 - Getting Malaria \"Off the Backs\" of Women and Children in Western Uganda\n\nIncluded conditions:\n- Malaria\n- P. Falciparum\n\nStudy Armgroups:\n- {'label': 'Intervention Arm : Arm that received permethrin-treated lesu', 'type': 'EXPERIMENTAL', 'description': 'Intervention Arm is the group that receives permethrin-treated lesu for use. The lesus of participants in the intervention group will be treated and subsequently retreated each month with 0.5% permethrin (Sawyer Products, Safety Harbor, FL).', 'interventionNames': ['Other: Permethrin-treated lesu']}\n- {'label': 'Control Arm: Arm that received none permethrin-treated lesu', 'type': 'SHAM_COMPARATOR', 'description': 'The lesus of participants in the control group will undergo sham treatment and re-treatment in which the cloth is soaked in water for a period of time similar to that of the intervention group. Participants and clinical staff (but not administrative staff) will be blinded to group assignments.', 'interventionNames': ['Other: Untreated lesu']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Permethrin-treated lesu', 'description': '0.5% permethrin soaked baby wraps (lesus)', 'armGroupLabels': ['Intervention Arm : Arm that received permethrin-treated lesu']}\n- {'type': 'OTHER', 'name': 'Untreated lesu', 'description': 'Water soaked baby wraps (lesus)', 'armGroupLabels': ['Control Arm: Arm that received none permethrin-treated lesu']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of clinical malaria in child', 'description': 'The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria Rapid Diagnostic Test (RDT) during observation', 'timeFrame': '7 days after onset of symptoms'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, significance level of 0.05, no interim analyses, and replacement of participants who drop out before 12 weeks.", "answer": 400, "answer_type": "ACTUAL", "explanation": "Sample size considerations\n The sample size for the study was selected to provide sufficient power to evaluate the primary study hypothesis. Assuming a baseline risk of approximately 3.0 cases per 100 person-weeks as estimated from our pilot study, the trial will have a power of at least 0.80 to detect a 30% relative reduction in the incidence rate of malaria between intervention and control groups over the proposed study period of 24 weeks with a type I error rate of 0.05. Calculations were conducted using nQuery software and are based on previously described methods [61]. No interim analyses are proposed, so no adjustments were made to these calculations to account for interim testing. We plan to recruit and enroll 400 mother-infant pairs. Additional participants will be enrolled in the study to replace those who drop out before 12 weeks. Those who drop out after 12 weeks will not be replaced. All participants who attend any clinic visits post randomization will be included in the modified intention-to-treat (ITT) analysis.", "id": 1455, "split": "test"} +{"trial_id": "NCT05391412", "pmid": "37236666", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery: A Randomized Pilot Study\n\nIncluded conditions:\n- Fibrinogen\n- Spine Deformity\n- Coagulopathy, Consumption\n- Bleeding\n\nStudy Armgroups:\n- {'label': 'Fibrinogen group', 'type': 'EXPERIMENTAL', 'description': 'The fibrinogen concentrate (20-30mg/kg, max 2g) will be administered in 100ml (Aqua pro injection) intravenously to the patient.', 'interventionNames': ['Drug: Fibrinogen Concentrate Human']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients in the control group will not receive any additional medication than standard of care.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fibrinogen Concentrate Human', 'description': 'Patients in the intervention group will receive single administration of fibrinogen concentrate intravenously at a dose of 20-30 mg/kg (depending on body weight and clinical condition, according to SmPC). The medicinal product will be diluted in a 100 ml infusion bag and administered after induction of anaesthesia prior beginning of surgery. The infusion rate should not exceed approximately 5 ml per minute.', 'armGroupLabels': ['Fibrinogen group'], 'otherNames': ['HAEMOCOMPLETTAN P']}\n\nPrimary Outcomes:\n- {'measure': 'Adverse event', 'description': 'The following primary endpoint will be monitored to evaluate the primary objective:\\n\\nAdverse event - Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.', 'timeFrame': 'through study completion, an average of 6 months'}\n- {'measure': 'Adverse drug reaction', 'description': 'The following primary endpoint will be monitored to evaluate the primary objective:\\n\\nAdverse drug reaction - All untoward and unintended responses to an investigational medicinal product related to any dose administered', 'timeFrame': 'through study completion, an average of 6 months'}\n- {'measure': 'Serious adverse event and reaction', 'description': 'The following primary endpoint will be monitored to evaluate the primary objective:\\n\\nSerious adverse event and reaction - A serious adverse event/reaction is any untoward medical occurrence or effect that at any dose:\\n\\n* Results in death;\\n* Is life-threatening;\\n* Requires hospitalization or extension of existing hospitalization;\\n* Results in persistent or significant disability or incapacity;\\n* Is a congenital anomaly or birth defect', 'timeFrame': 'through study completion, an average of 6 months'}\n- {'measure': 'Unexpected adverse reaction', 'description': 'The following primary endpoint will be monitored to evaluate the primary objective:\\n\\nUnexpected adverse reaction - Adverse reaction, the nature, severity, or outcome of which', 'timeFrame': 'through study completion, an average of 6 months'}\n- {'measure': 'Suspected unexpected serious adverse reaction', 'description': 'The following primary endpoint will be monitored to evaluate the primary objective:\\n\\nSuspected unexpected serious adverse reaction - Any suspected adverse reaction related to the study treatment that is both serious and unexpected.', 'timeFrame': 'through study completion, an average of 6 months'}\n\nPlease estimate the sample size based on the assumption: \n5% dropout rate.", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size\n Since this is a pilot study, a power calculation to determine sample size is not required. The sample size was defined in consensus by the State Institute of Drug Control of the Czech Republic, statisticians and investigators. Thirty participants (15 in both arms) were defined as a sample size according to standard guidelines for pilot studies and recommendation of good practice.26\u00e2\u0080\u009328 Considering a 5% dropout rate, 32 participants will be recruited.", "id": 1456, "split": "test"} +{"trial_id": "NCT05391763", "pmid": "36806067", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bilateral Prophylactic Mastectomy; Should we Preserve the Pectoral Fascia?: Protocol of a Dutch Double Blinded, Prospective, Randomized Controlled Pilot Study With a Within-subject Design\n\nIncluded conditions:\n- BRCA1/2 Mutation\n- Bilateral Prophylactic Mastectomy\n- Seroma\n- Pectoral Fascia\n\nStudy Armgroups:\n- {'label': 'Right: removal of fascia pectoralis, left: preservation of fascia pectoralis', 'type': 'OTHER', 'interventionNames': ['Procedure: Fascia pectoralis preservation']}\n- {'label': 'Left: removal of fascia pectoralis, right: preservation of fascia pectoralis', 'type': 'OTHER', 'interventionNames': ['Procedure: Fascia pectoralis preservation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Fascia pectoralis preservation', 'description': 'A total mastectomy will be performed in the control breast: a procedure which includes removal of the breast glandular tissue including the PF and subcutaneously excision of the nipple-areolar complex, while the pectoralis muscle will be spared. As much of the healthy skin envelope will be preserved to enable the performance of an effective breast reconstruction afterwards. When a nipple-sparing mastectomy is performed, the skin envelope together with the nipple-areolar complex will be spared. The investigational part of the operation is preservation of the PF. Dissection of cutaneous flaps and the breast with or without the PF will be performed with electrocautery.', 'armGroupLabels': ['Left: removal of fascia pectoralis, right: preservation of fascia pectoralis', 'Right: removal of fascia pectoralis, left: preservation of fascia pectoralis']}\n\nPrimary Outcomes:\n- {'measure': 'Drainproduction in milliliters', 'description': 'The total drainage volume of the left and right breast in milliliters', 'timeFrame': 'Until drain removal, maximum 1 week'}\n- {'measure': 'Time to drain removal in days', 'description': 'Number of days until drain removed', 'timeFrame': 'Until drain removal, maximum 1 week'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-tailed alpha of 0.025, SD of 165 mL for the control group and 135 mL for the intervention group.", "answer": 21, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a pilot study assessing the effect of removal versus preservation of the PF on seroma formation, and, thus, postoperative drain policy. There is no previous data of fascia preservation on drain volume in prophylactic bilateral mastectomies. According to the literature, a mean total drainage volume of approximately 545\u00e2\u0080\u0089mL is reported following mastectomy. In our institute, the total drainage volume in prophylactic mastectomies is lower because no axillary dissection is performed. It is expected that fascia preservation will lower the drainage fluid with 100\u00e2\u0080\u0093150\u00e2\u0080\u0089mL of the total volume to be clinically relevant. In order to have sufficient statistic power to detect a difference of 100\u00e2\u0080\u0093150\u00e2\u0080\u0089mL in drainage volume between the intervention and control breast, with a power of 80% and a two-tailed alpha (error of 0.025), a number of 12\u00e2\u0080\u009321 pairs is required. An SD of 165\u00e2\u0080\u0089mL for the control group and 135\u00e2\u0080\u0089mL for the intervention group was used. This means we aim to include 21 patients in this pilot study. This allows for using the results of this preliminary pilot study for an adequate power calculation of a full scale study.", "id": 1457, "split": "test"} +{"trial_id": "NCT05393362", "pmid": "37950216", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Cardiac Rehabilitation Program on Biomechanical, Imaging, and Physiological Biomarkers in Elderly Patients With Heart Failure.\n\nIncluded conditions:\n- Heart Failure With Preserved Ejection Fraction\n- Sarcopenia\n- Frail Elderly Syndrome\n- Comorbidities and Coexisting Conditions\n\nStudy Armgroups:\n- {'label': 'Cardiac Rehabilitation Program (CR)', 'type': 'EXPERIMENTAL', 'description': 'The CR program will consist of aerobic exercise sessions and strength exercise sessions. The exercises will be individualized after assessing short effort capacities (strength exercise) and long efforts (aerobic exercise). It will be done four days a week, with a minimum of 48 hours between sessions of the same type of exercise. To make progress will be taking a clinical criterion into account, determined by the absence of symptoms derived from HF at the current intensity, and a temporary criterion where provided that the clinical criterion is met, the intensity will be increased every two-three weeks.', 'interventionNames': ['Procedure: Cardiac Rehabilitation Program (CR)']}\n- {'label': 'Control Group (CG)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will receive two education sessions per week for twelve weeks on the complications derived from Heart Failure (HF), functional deterioration, and healthy lifestyle habits.', 'interventionNames': ['Behavioral: Control Group (CG)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Cardiac Rehabilitation Program (CR)', 'description': 'Strength exercises: strengthe exercise will be performed twice a week for 12 weeks, 4-6 series at 60% RM at the beginning of the program, with a progression towards 85% RM in each functional movement at the end of the intervention. The patients will rest for 90 seconds between series and 3 minutes between exercises. Each session has an estimated duration of between 45-60 min.\\n\\nAerobic exercise: aerobic exercise it will be performed twice a week for twelve weeks, between 45-60 min each session of aerobic exercise. It will be developed on a treadmill or cycle ergometer at 50% of HR max at the beginning of the program with a progression towards 80% of HR max at the end, continuously or internally. The Borg scale will prevail over the objective data to adjust the intensity of each patient, Borg = 10/20 or mBorg = 5/10 at the beginning, with progression to Borg = 14/20 or mBorg = 8/10 at the end.', 'armGroupLabels': ['Cardiac Rehabilitation Program (CR)'], 'otherNames': ['Exercise Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Control Group (CG)', 'description': 'The control group will receive two education sessions per week for twelve weeks on the complications derived from Heart Failure (HF), functional deterioration, and healthy lifestyle habits.', 'armGroupLabels': ['Control Group (CG)'], 'otherNames': ['Health education group']}\n\nPrimary Outcomes:\n- {'measure': 'Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)', 'description': 'Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \\\\[VO2,(ml/kg/min)\\\\]', 'timeFrame': 'Baseline'}\n- {'measure': 'Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)', 'description': 'Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \\\\[VO2,(ml/kg/min)\\\\]', 'timeFrame': 'Post intervention_difference (12 weeks after baseline)'}\n- {'measure': 'Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2)', 'description': 'Instruments: Cardiopulmonary Exercise Testing at Ciclo-ergometer Measure: the maximum volume of oxygen intake \\\\[VO2,(ml/kg/min)\\\\]', 'timeFrame': 'Follow up (12 weeks after post-intervention)'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, alpha error of 0.05, and a loss rate of 15%.", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated using G Power 3.1.9.2 software (University of D\u00c3\u00bcsseldorf, Germany). Based on an expected difference in VO2max increase of 3.0/ml/kg/min in the intervention group and 0.6\u00c2\u00a0ml/kg/min in the control group (based on the result of the EUCaRE Study, Prescott et al. 2020 PMID 32102550 [48]). Assuming a statistical power of 80% and an alpha error of 0.05, the required sample size is 55 patients per arm and carries a loss rate of 15%, and this would make a total of 126 (63 per arm).", "id": 1458, "split": "test"} +{"trial_id": "NCT05394298", "pmid": "37673453", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Non-inferiority Clinical Trial to Evaluate the Effectiveness and Security of Therapy for Non Complicated Enterococcal Bacteremia.\n\nIncluded conditions:\n- Enterococcal Bacteremia\n\nStudy Armgroups:\n- {'label': 'Short-treatment of any active antibiotic regimen', 'type': 'EXPERIMENTAL', 'description': '7 days from the initiation of an appropriate antimicrobial therapy and documented resolution of bacteremia (negative control blood cultures performed on day 2 or 3)', 'interventionNames': ['Drug: Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.']}\n- {'label': 'Long-treatment of any active antibiotic regimen', 'type': 'ACTIVE_COMPARATOR', 'description': '14 days of any active antibiotic treatment from the date of the last positive blood culture and documented resolution of bacteremia (negative control blood cultures performed on day 2 or 3)', 'interventionNames': ['Drug: Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Short-treatment of any active antibiotic regimen 7 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.', 'description': 'Any active antibiotic with treatment with proven in vitro activity from a pre-stablished list of antibiotics included', 'armGroupLabels': ['Short-treatment of any active antibiotic regimen'], 'otherNames': ['7 days of active antibiotics']}\n- {'type': 'DRUG', 'name': 'Long-treatment of any active antibiotic regimen 14 days of any active antibiotic treatment for uncomplicated enterococcal bacteremia.', 'description': 'Any active antibiotic with treatment with proven in vitro activity a pre-stablished list of antibiotics included', 'armGroupLabels': ['Long-treatment of any active antibiotic regimen'], 'otherNames': ['14 days of active antibiotics']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical success', 'description': 'Clinical success , composite endpoint defined as all the following: (a) survival at TOC; (b) absence of enterococcal bacteremia relapse or infective endocarditis diagnosis at TOC; (c) no need to prolong therapy beyond the pre-established duration, or restart drugs against enterococci for any reason within 30 days.', 'timeFrame': 'TOC (Test of cure) visit (performed at day 28-32 after the end of suitable antibiotic treatment) or if drainage occurs after day 7 of treatment, TOC is to be done 7 days after that day.'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 5%, 80% power, and a withdrawal rate of 5% were assumed.", "answer": 284, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was estimated for non-inferiority end-point using Ene V.3.0 software. Because there are no previous randomised trials on the treatment duration for enterococcal bacteraemia, we used data from the PROBAC cohort for our estimations.19 20 In this cohort, the rate of death or relapse in patients with 7 vs 14 days of treatment was 13.2% and 17.7%, respectively. For a significance level of 5% and 80% power to reject the null hypothesis for one-sided proportions, and assuming the outcome proportions in the control and experimental groups, for a non-inferiority margin of 6%, it will be necessary to include 134 patients per group in a 1:1 ratio, with a total of 268 patients. A withdrawal rate of 5% is expected; therefore, 284 patients (142 in each group) will be needed. For the choice of the absolute non-inferiority margin, we considered the 10% used in previous trials on the duration of treatment for BSI due to gram negative bacteria23 24; however, in the absence of previous trials in bacteraemia due to Enterococcus spp, we opted for a more demanding margin because the risk of relapse may be higher with these micro-organisms.", "id": 1459, "split": "test"} +{"trial_id": "NCT05394987", "pmid": "38950991", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Spectacle Correction for the Treatment of Amblyopia\n\nIncluded conditions:\n- Amblyopia\n\nStudy Armgroups:\n- {'label': 'Optical correction', 'type': 'EXPERIMENTAL', 'description': 'Prescription of spectacles for full-time wear to correct refractive error', 'interventionNames': ['Device: Spectacles']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Spectacles', 'description': 'Prescription of refractive error correction in spectacles. Refractive error to be determined as part of standard optometric eye exam (performed by registered optometrist).\\n\\nGuidelines for optical correction for the prescription of the study spectacles (based on Pediatric Eye Disease Investigator Group \\\\[PEDIG\\\\] amblyopia clinical trial protocols): Hypermetropia: not undercorrected by \\\\>+1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. Anisometropia: full correction of the anisometropic difference. Astigmatism: cylinder power in each eye should be within \u2264\u00b10.50D of fully correcting the astigmatism for each eye. If cylinder power is \u22651.00D, the prescribed axis in both eyes should be within \u2264\u00b16 deg of the cycloplegic refraction axis.\\n\\nAppropriate refractive error correction will be prescribed. Participants will be instructed to wear the optical correction full-time (i.e., \\\\>50% of waking hours) for the duration of the study.', 'armGroupLabels': ['Optical correction']}\n\nPrimary Outcomes:\n- {'measure': 'Best corrected visual acuity of the amblyopic eye pre-intervention', 'description': 'The size of the smallest line of letters read accurately on an ETDRS chart.', 'timeFrame': 'Approx. 5 mins, baseline (day 1 of spectacle wear)'}\n- {'measure': 'Best corrected visual acuity of the amblyopic eye post-intervention', 'description': 'The size of the smallest line of letters read accurately on an ETDRS chart.', 'timeFrame': 'Approx. 5 mins, on completion of study (week 24)'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u03b1) of 0.05, attrition rate of approximately 10%", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Sample size\n The target number of participants for this study is 36, which will allow for the detection of any within-subject differences at an \u00ce\u00b1 of 0.05. This is based on the BRAVO study20 observing a mean improvement in amblyopic eye distance VA of 0.05 (\u00c2\u00b1 0.08) logMAR following spectacle correction in teenagers and adults with amblyopia. Recruitment will cease when the target number is achieved; an attrition rate of approximately 10% is expected.", "id": 1460, "split": "test"} +{"trial_id": "NCT05396092", "pmid": "36153623", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial\n\nIncluded conditions:\n- Elderly\n- Sleep\n- Mindfulness\n- Tai Chi Chuan\n\nStudy Armgroups:\n- {'label': 'Integrated mindfulness-based Tai Chi Chuan', 'type': 'EXPERIMENTAL', 'description': 'MBTCC', 'interventionNames': ['Behavioral: Integrated mindfulness-based Tai Chi Chuan']}\n- {'label': 'Mindfulness-based intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'MBI', 'interventionNames': ['Behavioral: Mindfulness-based intervention']}\n- {'label': 'Tai Chi Chuan', 'type': 'ACTIVE_COMPARATOR', 'description': 'TCC', 'interventionNames': ['Behavioral: Tai Chi Chuan']}\n- {'label': 'Sleep Hygiene Education', 'type': 'ACTIVE_COMPARATOR', 'description': 'SHE', 'interventionNames': ['Behavioral: Sleep Hygiene Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Integrated mindfulness-based Tai Chi Chuan', 'description': 'MBTCC will integrate components from both the MBI and TCC groups. The entire intervention consists of eight weekly sessions of two-and-a-half to three hours each.', 'armGroupLabels': ['Integrated mindfulness-based Tai Chi Chuan'], 'otherNames': ['MBTCC']}\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness-based intervention', 'description': 'The MBI group is mainly based on the basic theory and research of the foundational mindfulness-based stress reduction program. The intervention consists of eight weekly sessions of two to two-and-a-half hours each.', 'armGroupLabels': ['Mindfulness-based intervention'], 'otherNames': ['MBI']}\n- {'type': 'BEHAVIORAL', 'name': 'Tai Chi Chuan', 'description': 'TCC is mainly based on a nine-form Yang-style form of TCC, which is a brief and modified version of 64-form Yang-style TCC. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.', 'armGroupLabels': ['Tai Chi Chuan'], 'otherNames': ['TCC']}\n- {'type': 'BEHAVIORAL', 'name': 'Sleep Hygiene Education', 'description': 'SHE is based on principles used in stimulus control and sleep hygiene education, which has previously been used as the control group in sleep-related research. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.', 'armGroupLabels': ['Sleep Hygiene Education'], 'otherNames': ['SHE']}\n\nPrimary Outcomes:\n- {'measure': 'the Insomnia Severity Index', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.', 'timeFrame': 'at baseline (T1)'}\n- {'measure': 'the Insomnia Severity Index', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.', 'timeFrame': 'In the 8th week from baseline (T2)'}\n- {'measure': 'the Insomnia Severity Index', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.', 'timeFrame': 'six months after T2 (T3)'}\n- {'measure': 'the Insomnia Severity Index', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.', 'timeFrame': 'one year after T2 (T4)'}\n\nPlease estimate the sample size based on the assumption: \nThe alpha level is .05, the power level is .86 for the main effect and .97 for the interaction effect, and the attrition rate is assumed to be 30%.", "answer": 256, "answer_type": "ESTIMATED", "explanation": "Sample size\n A four-armed randomized controlled pilot trial was recently conducted by the authors. A total of 76 community-dwelling older adults with symptoms of sleep disturbance took part in the pilot trial, with an attrition rate of 30%. They were randomly assigned to four different groups, including a MBI group, a TCC group, a MBTCC group, and a SHE group. The results of this pilot study are summarized in Table 1. Although the pilot study yielded moderate to large effect sizes (between .42 and .78), this variation implies that the effect sizes might be sample-dependent or context-dependent. In the current study, a larger sample size is therefore considered to be more desirable because it could pave the way for the identification of a small and hidden effect. Hence, in this power analysis, the effect size is set to .25 and the alpha level is .05. It is suggested that, to obtain the power level of .86 for the main effect and .97 for the interaction effect, at least 180 total participants are needed. Given that this study is longitudinal in nature and attrition (assuming the rate is 30%) is likely, an additional 76 participants will be recruited, resulting in a total of 256 participants (64 per arm).Table 1Comparison between four study arms in a pilot studyVariableMBI group (n = 22)TCC group (n = 23)MBTCC group (n = 10)SHE group (n = 21)Effect size (MBI vs SHE), Cohen\u00e2\u0080\u0099s dEffect size (TCC vs SHE), Cohen\u00e2\u0080\u0099s dEffect size (MBTCC vs SHE), Cohen\u00e2\u0080\u0099s dEffect Size (MBI vs TCC), Cohen\u00e2\u0080\u0099s dPre, mean (SD)Post, mean (SD)Pre, mean (SD)Post, mean (SD)Pre, mean (SD)Post, mean (SD)Pre, mean (SD)Post, mean (SD)ISI17.27 (3.69)15.64 (3.44)17.22 (3.59)15.70 (3.21)17.10 (3.35)14.40 (3.10)16.95 (3.28)16.90 (3.55)\u00e2\u0088\u0092\u00e2\u0080\u00890.44\u00e2\u0088\u0092\u00e2\u0080\u00890.42\u00e2\u0088\u0092\u00e2\u0080\u00890.78\u00e2\u0088\u0092\u00e2\u0080\u00890.03SF12 (Phy)11.05 (2.75)11.55 (2.06)11.48 (2.88)12.91 (2.91)11.90 (2.60)13.90 (2.23)12.76 (3.39)12.52 (3.27)0.240.520.69\u00e2\u0088\u0092\u00e2\u0080\u00890.32SF12 (Men)16.18 (3.66)18.05 (3.75)16.09 (3.40)16.96 (3.05)17.40 (3.20)19.50 (3.21)17.67 (3.90)17.95 (3.50)0.410.160.480.28RRQ3.06 (.79)2.61 (.77)2.89 (.88)2.79 (.78)3.23 (1.03)2.68 (.84)3.13 (.83)3.10 (.66)\u00e2\u0088\u0092\u00e2\u0080\u00890.51\u00e2\u0088\u0092\u00e2\u0080\u00890.08\u00e2\u0088\u0092\u00e2\u0080\u00890.57\u00e2\u0088\u0092\u00e2\u0080\u00890.41HS62.23 (6.75)57.59 (6.29)61.39 (6.89)53.52 (6.90)64.00 (5.94)54.70 (6.93)63.29 (5.88)61.48 (6.77)\u00e2\u0088\u0092\u00e2\u0080\u00890.44\u00e2\u0088\u0092\u00e2\u0080\u00890.93\u00e2\u0088\u0092\u00e2\u0080\u00891.240.47MBI mindfulness-based intervention, TCC Tai Chi Chuan, MBTCC mindfulness-based Tai Chi Chuan, SHE sleep hygiene education, ISI Insomnia Severity Index, SF12 (Phy) Chinese (HK) Short Form 12 \u00e2\u0080\u0093 Physical health, SF12 (Men) Chinese (HK) Short Form 12 \u00e2\u0080\u0093 Mental health, RRQ Rumination-Reflection Questionnaire, HS hyperarousal scale", "id": 1461, "split": "test"} +{"trial_id": "NCT05396469", "pmid": "36564119", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Using Thoracic Ultrasound in a Rheumatological Setting to Detect Interstitial Lung Disease in Patients With Rheumatoid Arthritis: Protocol for a Cross-Sectional Diagnostic Test Accuracy Study. AURORA.\n\nIncluded conditions:\n- Rheumatoid Arthritis and Associated Conditions\n- Lung Diseases, Interstitial\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'National guideline treatment', 'description': 'All discovered diseases will recieve national guideline treatment and follow up'}\n\nPrimary Outcomes:\n- {'measure': 'RA-ILD', 'description': 'Estimates of diagnostic accuracy and precision: The diagnostic accuracy of the TUS (index) test for interstitial lung disease in rheumatoid arthritis in comparison to the chest HRCT.', 'timeFrame': '31.01.2024'}\n\nPlease estimate the sample size based on the assumption: \nPositive LR of 3.33 with a 95% CI of 1.81 to 6.13, posterior probability of 67% with a 95% CI of 52% to 79%, negative LR of 0.42 with a 95% CI of 0.25 to 0.70, posterior probability of 20% with a 95% CI of 13% to 30%", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n The study is designed to be able to evaluate the diagnostic test characteristics (sensitivity, specificity, LRs) and determine the post-test probability of disease given the pretest probability and test characteristics.62 Given the sample size n=80 (and guestimated proportionate distributions), the following will be enabled:\n Corresponding to disease prevalence, test sensitivity, and test specificity (based on the suggested sample size): given a prevalence of 0.375, a sensitivity of 0.667, a specificity of 0.800 in a sample size of 80, the prior probability (odds) is 38% (0.6). The positive LR is 3.33 with a 95% CI of 1.81 to 6.13\u00e2\u0080\u0094the posterior probability (odds) is 67% (2.0) with a 95% CI of 52% to 79%, meaning two out of three with a positive TUS have ILD on HRCT. The negative LR is 0.42 with a 95% CI of 0.25 to 0.70. The posterior probability (odds) is 20% (0.3) with a 95% CI of 13% to 30%, meaning 10 of 13 with a negative TUS to not have ILD on HRCT. Odds=probability/(1\u00e2\u0088\u0092probability). Positive likelihood ratio (LR+) = sensitivity/(1\u00e2\u0088\u0092specificity). Negative likelihood ratio (LR\u00e2\u0088\u0092) = (1\u00e2\u0088\u0092sensitivity)/specificity). Posterior odds=prior odds \u00c3\u0097 LR.", "id": 1462, "split": "test"} +{"trial_id": "NCT05396755", "pmid": "37004078", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis - a Multicenter, Randomized Controlled, Parallel Group Trial\n\nIncluded conditions:\n- Secondary Sclerosing Cholangitis\n\nStudy Armgroups:\n- {'label': 'interventional', 'type': 'EXPERIMENTAL', 'description': 'The intervention group undergoes scheduled invasive evaluation of the biliary tract with endoscopic retrograde cholangiography (ERC) with biliary interventions (i.e. therapeutic ERC) every 8 weeks for 6 months.', 'interventionNames': ['Procedure: Endoscopic retrograde cholangiography (ERC)']}\n- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'The control group receives non-interventional standard of care.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Endoscopic retrograde cholangiography (ERC)', 'description': 'invasive evaluation of the biliary tract with ERC and endoscopic interventions every 8 weeks until 6 months (24 weeks)', 'armGroupLabels': ['interventional']}\n\nPrimary Outcomes:\n- {'measure': 'occurrence of death', 'description': 'The primary endpoint is the failure rate defined as a composite endpoint consisting of\\n\\n* occurrence of death or\\n* necessity of liver transplantation or\\n* occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.', 'timeFrame': 'up to week 48'}\n- {'measure': 'necessity of liver transplantation', 'description': 'The primary endpoint is the failure rate defined as a composite endpoint consisting of\\n\\n* occurrence of death or\\n* necessity of liver transplantation or\\n* occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.', 'timeFrame': 'up to week 48'}\n- {'measure': 'occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.', 'description': 'The primary endpoint is the failure rate defined as a composite endpoint consisting of\\n\\n* occurrence of death or\\n* necessity of liver transplantation or\\n* occurrence of cholangiosepsis (defined by SEPSIS-3 criteria and diagnosis of acute cholangitis according to the Tokyo Guidelines), whatever occurs first.', 'timeFrame': 'up to week 48'}\n\nPlease estimate the sample size based on the assumption: \nType I error set to 5% (two-sided), power of 80%, and an expected drop-out rate of 5%.", "answer": 1, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary aim of the study is to demonstrate superiority of the experimental group compared to the control group in patients with SSC\u00e2\u0080\u0093CIP. The primary endpoint is a failure rate defined as a composite endpoint including liver transplantation, death, or cholangiosepsis after 6\u00c2\u00a0months. Sample size calculation was conducted using a two-group continuity corrected chi-square test in nQuery Advisor 7.0. The type I error is set to 5% (two-sided) and the study aims for a power of 80%. In the present trial, a rate of 70% regarding the composite endpoint is expected in the control group. This assumption is based on the following observations: prognosis of SSC\u00e2\u0080\u0093CIP is dismal with an estimated survival of less than 50% of patients who develop SSC\u00e2\u0080\u0093CIP within 3\u00e2\u0080\u00936\u00c2\u00a0months [2, 4, 7]. The transplant-free survival of SSC\u00e2\u0080\u0093CIP differs between publications. However, in our large cohort, transplant-free survival was 38.9% at 6\u00c2\u00a0months [9, 16]. Additionally, biliary complications in SSC\u00e2\u0080\u0093CIP are numerous affecting up to 90% of patients [6]. Cholangiosepsis accounts for 20\u00e2\u0080\u009333% of these biliary complications [6]. A total reduction of 30% is assumed for sample size calculation. This number is estimated from clinical observation and experience of patients with SSC\u00e2\u0080\u0093CIP and PSC [11]. To demonstrate a reduction of the rate from 70 to 40% in the experimental group, a sample size of 49 patients per group is needed leading to n\u00e2\u0080\u0089=\u00e2\u0080\u008998 in total. The expected drop-out rate is assumed to be 5% (estimation from clinical practice), which leads to a sample size of 52 patients per study arm and 104 patients in total.", "id": 1463, "split": "test"} +{"trial_id": "NCT05398185", "pmid": "38233908", "question": "Here is the design of a clinical trial:\n\nOfficial Title: WiseApp for Spanish-Speaking Latino Persons Living with HIV (PLWH) in the United States (US) and the Dominican Republic (DR)\n\nIncluded conditions:\n- HIV Infections\n- Acquired Immune Deficiency Syndrome\n- Sexually Transmitted Diseases, Viral\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control includes standard health services offered at each site (e.g., mental health services, case-management, referral to clinical care) and a brief adherence educational session.'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp.', 'interventionNames': ['Device: CleverCap']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CleverCap', 'description': 'The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in self-reported ART adherence', 'description': 'Self-reported ART adherence is a single-item self-report measure on a linear scale of 0-100 with zero indicating lowest adherence and 100 indicating highest adherence.', 'timeFrame': 'Baseline, 3 month follow up, 6 month follow up, and 12 month follow up'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided tests for generalized linear mixed model, 10% attrition at 3 months, 20% attrition at 6 and 12 months.", "answer": 248, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A\u00c2\u00a0power analysis was calculated to ensure that the sample size detects at least a medium effect size of the difference in adherence to ART at 3, 6, and 12 months between study arms. We estimated statistical power based on a previous mHealth study where results showed that adherence to ART was higher in the intervention compared to the control arm (0.565 vs. 0.460, that is in the small effect size range) and a Pearson correlation coefficient of adherence of 0.6 between consecutive\u00c2\u00a0study times [30]. Using two-sided tests for generalized linear mixed model, we have at least 80% power to test for such differences by site based on these assumptions: (1) target enrollment is 248 participants across sites randomized to each study arm; (2) outcomes are measured at each follow-up visit; and (3) an overestimate of 10% attrition at 3 months and 20% at 6 and 12 months. The sample size at each site does not have enough statistical power to detect a small effect size of difference between the two arms at each follow-up time, but it is enough to test for a medium effect size of difference or greater between the two arms at 3, 6, and 12 months, separately, or to test for a small effect size of difference during entire follow-up period with >\u00e2\u0080\u008980% statistical power.", "id": 1464, "split": "test"} +{"trial_id": "NCT05401071", "pmid": "37158831", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China\n\nIncluded conditions:\n- Tuberculosis, Pulmonary\n\nStudy Armgroups:\n- {'label': 'Short Regimen with Rifapentine 10mg/kg', 'type': 'EXPERIMENTAL', 'description': 'Intervention: Short Regimen with Rifapentine 10mg/kg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).', 'interventionNames': ['Other: Short Regimen with Rifapentine 10mg/kg']}\n- {'label': 'Short Regimen with Rifapentine 15mg/kg', 'type': 'EXPERIMENTAL', 'description': 'Intervention: Short Regimen with Rifapentine 15mg/kg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).', 'interventionNames': ['Other: Short Regimen with Rifapentine 15mg/kg']}\n- {'label': 'Standardized Regimen', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention\uff1aWorld Health Organization (WHO) Standardized Regimen group consists of 26 weeks with two phases of treatment. The first is an intensive phase of 8 weeks, and included rifampicin, isoniazid, pyrazinamide, and ethambutol. This is followed by a continuation phase of 18 weeks with the following agents: rifampicin and isoniazid.', 'interventionNames': ['Combination Product: Standardized Regimen']}\n- {'label': 'Short Regimen with Rifapentine 20mg/kg', 'type': 'EXPERIMENTAL', 'description': 'Intervention: Short Regimen with Rifapentine 20mg/kg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).', 'interventionNames': ['Other: Short Regimen with Rifapentine 20mg/kg']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Short Regimen with Rifapentine 10mg/kg', 'description': 'rifapentine 10mg/kg daily; isoniazid 300mg daily; pyrazinamide \u226450kg 1000mg daily, 50-71kg 1200mg daily, \\\\>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.', 'armGroupLabels': ['Short Regimen with Rifapentine 10mg/kg']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Standardized Regimen', 'description': 'During the intensive phase, rifampicin \u226455kg 450mg daily, 55-71kg 600mg daily, \\\\>71kg 750mg daily; isoniazid \u226455kg 225mg daily, 55-71kg 300mg daily, \\\\>71kg 375mg daily; pyrazinamide \u226455kg 900mg daily, 55-71kg 1200mg daily, \\\\>71kg 1600mg daily; ethambutol \u226455kg 825mg daily, 55-71kg 1100mg daily, \\\\>71kg 1375mg daily; All treatment is taken orally.\\n\\nDuring the continuation phase, rifampicin \u226450kg 450mg daily, \\\\>50kg 600mg daily; isoniazid 300mg daily; All treatment is taken orally.', 'armGroupLabels': ['Standardized Regimen']}\n- {'type': 'OTHER', 'name': 'Short Regimen with Rifapentine 15mg/kg', 'description': 'rifapentine 15mg/kg daily; isoniazid 300mg daily; pyrazinamide \u226450kg 1000mg daily, 50-71kg 1200mg daily, \\\\>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.', 'armGroupLabels': ['Short Regimen with Rifapentine 15mg/kg']}\n- {'type': 'OTHER', 'name': 'Short Regimen with Rifapentine 20mg/kg', 'description': 'rifapentine 20mg/kg daily; isoniazid 300mg daily; pyrazinamide \u226450kg 1000mg daily, 50-71kg 1200mg daily, \\\\>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.', 'armGroupLabels': ['Short Regimen with Rifapentine 20mg/kg']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment success rate of the short regimen during drug treatment and follow-up.', 'description': 'To compare the treatment success rate without relapse between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group.', 'timeFrame': '108 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nFor stage 1, \u03b1 = 0.1 and \u03b2 = 0.2 with a 4% lost follow-up rate. For stage 2, \u03b1 = 0.05 and \u03b2 = 0.2 with a 12% dropout rate. If stage 2 includes three arms, Bonferroni correction is applied with \u03b11 = 0.025.", "answer": 2442, "answer_type": "ESTIMATED", "explanation": "Sample size assumptions\n According to previous studies, the percentage of participants with regimen discontinuation at 8\u00c2\u00a0weeks after the first dose is estimated to be 20%. Using the PASS 15 system (NCSS, Version: 15.0.5), we assumed \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.1 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2 and calculated that a sample size of 96 cases in each group was required for safety assessment in stage 1. Considering a 4% lost follow-up rate, the number of cases per arm to show safety was calculated as 100 (400 in total).\n This sample size of stage 2 was also calculated using the PASS 15 system. Assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, according to previous studies, the success rate of the control group was 85.4%, and the success rate of the test group was 84.5%, \u00cf\u0083\u00e2\u0080\u0089=\u00e2\u0080\u00896.6%. If stage 2 included three arms for research, according to Bonferroni correction \u00ce\u00b11\u00e2\u0080\u0089=\u00e2\u0080\u0089\u00ce\u00b1/2\u00e2\u0080\u0089=\u00e2\u0080\u00890.025, according to PASS 15 non-inferiority test system, 618 samples were required for each arm. In consideration of 12% of patients not satisfying the criteria for microbiological eligibility and 12% of patients not being assessed, 814 patients were required for each arm, so the total sample size of the two arms was considered to be 2442. If stage 2 was divided into two arms for the study, the significance level was set as \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 with no correction required. According to the PASS15 non-inferiority test system, 487 samples per arm were required. Considering that 12% of patients did not meet the microbiological eligibility criteria and 12% of patients could not be evaluated, thus the total number was considered to be 1282 with 641 samples needed per group.", "id": 1465, "split": "test"} +{"trial_id": "NCT05401409", "pmid": "37507763", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-Blind, Randomised Placebo-Controlled Study to Determine the Effect of Beetroot Juice on Reducing Blood Pressure in Hypertensive Adults With Autosomal Dominant Polycystic Kidney Disease\n\nIncluded conditions:\n- Autosomal Dominant Polycystic Kidney\n- Hypertension\n- Endothelial Dysfunction\n\nStudy Armgroups:\n- {'label': 'Nitrate-rich beetroot juice', 'type': 'EXPERIMENTAL', 'description': 'Beetroot juice containing naturally occurring nitrate (400mg total nitrate)', 'interventionNames': ['Dietary Supplement: Beetroot juice']}\n- {'label': 'Nitrate-depleted beetroot juice', 'type': 'PLACEBO_COMPARATOR', 'description': 'Beetroot juice with nitrate removed', 'interventionNames': ['Dietary Supplement: Nitrate-depleted beetroot juice']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Beetroot juice', 'description': '70mls beetroot juice (400mg nitrate) given daily for 4 weeks', 'armGroupLabels': ['Nitrate-rich beetroot juice'], 'otherNames': ['Beet It Sport Shot']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Nitrate-depleted beetroot juice', 'description': '70mls beetroot juice (nitrate-depleted) given daily for 4 weeks', 'armGroupLabels': ['Nitrate-depleted beetroot juice']}\n\nPrimary Outcomes:\n- {'measure': 'Change in clinic systolic and diastolic blood pressure from baseline until end of study', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power of 0.80, and an allowance for drop-out.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Determination of sample size\n In a previous study of daily BRJ (400\u00c2\u00a0mg nitrate) supplementation in hypertensive patients (n\u00e2\u0080\u0089=\u00e2\u0080\u008968) for 4\u00c2\u00a0weeks, systolic BP was significantly reduced by 7.7\u00c2\u00a0mmHg (3.6\u00e2\u0080\u009311\u00e2\u0080\u00938\u00c2\u00a0mmHg, p\u00e2\u0080\u0089<\u00e2\u0080\u00890.001) at the end of the intervention [16]. The average baseline BP of the two groups were 148\u00c2\u00a0mmHg and 149\u00c2\u00a0mmHg, with standard deviations of the two populations being 10 and 11. We expected to have a similar hypertensive population and a test for differences in two independent means was implemented in Stata SE Version 14.2 (StataCorp, TX, U.S.A) to calculate sample size. To detect this difference in systolic BP with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power of 0.80, 28 participants are required in each treatment group. To account for drop-out, the sample size was increased to 30 participants per treatment group (total n\u00e2\u0080\u0089=\u00e2\u0080\u008960). Participants will be referred from the Western Renal Service which provides a catchment of 1.2 million people and 400 potential participants with ADPKD, and therefore a single-centre study with multiple referral centres was considered adequate for this study.", "id": 1466, "split": "test"} +{"trial_id": "NCT05402891", "pmid": "35962368", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Chemopreventive Effect of Lithium on Adenoma Development in Patients With Familial Adenomatous Polyposis (FAP); a Pilot Study\n\nIncluded conditions:\n- Familial Adenomatous Polyposis\n\nStudy Armgroups:\n- {'label': 'Study population', 'type': 'EXPERIMENTAL', 'description': 'Every patient will receive treatment: Lithiumcarbonate 300mg daily in oral tablet for six months. There will no control group included since patient represent their own control in the nontreatment-phase.', 'interventionNames': ['Drug: Lithium Carbonate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lithium Carbonate', 'description': 'Patients will be administered lithiumcarbonate by an oral tablet of 300mg once a day for a duration of 6 months. Starting dose is 200mg for the first 5 days, dosage will be then increased to 300mg. To limit adverse events and side-effects, the lowest effective dose will be administered. The target serum level of lithium is 0.20 - 0.40 mmol/L and this will be maintained by regular lithium level testing.', 'armGroupLabels': ['Study population']}\n\nPrimary Outcomes:\n- {'measure': 'Change in clone size distribution positive for NOTUM.', 'description': 'For each patient crypts will be retrieved form normal tissue biopsies through colonoscopy. APC mutant stem cell dynamics will be determined by tracing the spread of the APC mutant cells using specific expression of NOTUM by RNAscope (in situ hybridization). Clone sizes will be quantified as proportions of the crypt circumference positive for NOTUM (in parts of eight, 1:8 to 8:8). When a whole crypt is positive for NOTUM (8:8), this crypt is fixed (crypt fixation) (12). This will result in an average clone size distribution for each patient per time point, as well as the proportion of fixed crypts. By analyzing the differences in clone size distribution before, during and after Lithiumcarbonate treatment we aim to observe a relative reduction in average clone size of 50% during the lithiumcarbonate treatment, as well as a reduction in crypt fixation of 50%.', 'timeFrame': 'Month 0, Month 6, Month 12, Month 18'}\n\nPlease estimate the sample size based on the assumption: \npower 80%, significance level 0.05", "answer": 12, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Simulations of clonal expansion in the intestine indicate that in order to detect a reduction of 50% (power stat. 80%, p\u00e2\u0080\u0089=\u00e2\u0080\u00890.05) in fitness of APC-mutant cells, we need to analyze sizes of APC mutant clones within 11 partially populated crypts at 4 time points in 12 individuals. To ensure sufficient material we need 840 crypts per patient per time point. A typical biopsy yields 100\u00e2\u0080\u0093250 crypts, therefore we will perform 12 biopsies in total (2 biopsies per segment, 6 segments) per patient per time point. In that way, sufficient data will be obtained to confirm or refute the study hypothesis.", "id": 1467, "split": "test"} +{"trial_id": "NCT05404035", "pmid": "36998024", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Family Connections\" an Intervention for Caregivers of People With Eating Disorders and Personality Disorders: Study Protocol for a Randomized Controlled Trial.\n\nIncluded conditions:\n- Relatives\n\nStudy Armgroups:\n- {'label': 'Family Connections for relatives of people with eating disorders and personality disorders', 'type': 'EXPERIMENTAL', 'description': 'The intervention lasts 3 months and includes 14 two-hour sessions with a group format on a weekly basis. The FC program is divided into 7 modules: 2 of Psychoeducation (ED and PD criteria, explanatory theories, available treatments, comorbidity with PD, etc.) and 5 modules of Dialectical Behavioral Therapy skills training (Relationship mindfulness, effective communication, aceptation, validation, problem management and meaning of life).', 'interventionNames': ['Behavioral: Family Connections for relatives of people with eating disorders and personality disorders']}\n- {'label': 'Optimized Treatment As Usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'Family members with this condition will continue to receive the usual treatment provided by their referral care center. In addition, we will optimize the treatment, with 3 two-hour psychoeducation sessions in group format each week (ED and PD, explanatory theories, available treatments, comorbidity with PD).', 'interventionNames': ['Behavioral: Optimized Treatment As Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Family Connections for relatives of people with eating disorders and personality disorders', 'description': 'The FC program (Fruzzetti and Hoffman, 2005) is divided into 7 modules:\\n\\n1. Introduction to the intervention program. Program objectives, guidelines, criteria, and symptoms of ED and PD.\\n2. Psychoeducation on the development of ED and PD, explanatory theories, available treatments, comorbidity with PD.\\n3. Emotional regulation skills and awareness, and to decrease emotional reactivity.\\n4. Skills to improve the quality of relationships in family interactions (letting go of guilt and anger, acceptance skills in relationships).\\n5. Communication skills and effective self-expression, such as validation.\\n6. Problem management and making safe plans for crisis management.\\n7. Making new sense of my relationship with my family member, an opportunity to grow together.\\n\\nAll the modules include practice exercises, video viewing, and homework assignment.', 'armGroupLabels': ['Family Connections for relatives of people with eating disorders and personality disorders']}\n- {'type': 'BEHAVIORAL', 'name': 'Optimized Treatment As Usual', 'description': \"Family members with this condition will continue to receive the usual treatment provided by their referral care center. In addition, we will optimize the treatment, following the recommendations of the international guidelines for the treatment of ED (NICE, 2017). There will be 3 two-hour session in group format each week, with the following components: Up-to-date information and research on ED and PD; Psychoeducation on the development of ED and PD; Explanatory theories; Available treatments and comorbidity.\\n\\nIn both conditions, after each face-to-face session, the participant will be asked to review the contents addressed during the session as homework (independently of the homework corresponding to the specific module being addressed). All interventions carried out with family members will be performed by clinical psychologists or general health psychologists with at least a master's degree or a doctoral degree and previous training in the application of the programs.\", 'armGroupLabels': ['Optimized Treatment As Usual']}\n\nPrimary Outcomes:\n- {'measure': 'Record of critical family-patient incidents', 'description': 'Number of Binge eating and vomiting episodes (purging) in the past 3 months, Number of serious arguments between patient and caregivers in the past 3 months, Number of days of self-injury in the past 3 months, Number of episodes of verbal/physical violence with caregivers in the past 3 months; Number of visits to psychiatric emergency department in the past 3 months, Number of unscheduled therapy sessions held in the past 3 months (face-to-face, phone calls, etc.).', 'timeFrame': 'Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up'}\n- {'measure': 'Burden Assessment Scale (BAS)', 'description': \"It is a 19-item scale that assesses the caregiver's objective and subjective burden due to the illness of his/her loved one within the past six months using a 4-point Likert scale ranging from 1 (nothing) to 4 (a lot). Total scores indicate that higher values mean stronger burden. The scale shows adequate validity and reliability (Cronbach's alpha ranges from .89 to .91) (Reinhard, Gubman, Horwitz \\\\& Minsky, 1994).\", 'timeFrame': 'Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, statistical power of 0.80, two-tailed t-test, and a dropout rate of 30%.", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Sample size\n To calculate the sample size, effect sizes found in previous studies on the topic have been considered. Grenyer et al. [30] tested a group psychoeducation protocol for caregivers of people with BPD in a controlled study that reports medium to large effect sizes (dyadic adjustment, d\u00e2\u0080\u0089=\u00e2\u0080\u00890.78; family empowerment, d\u00e2\u0080\u0089=\u00e2\u0080\u00891.4). Moreover, Grenyer obtained significant improvements on measures of illness burden between post-assessment and 12-month follow-up, with medium effects (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.45). These effects are in line with the literature on psychological treatments for relatives of people with ED (Positive Caregiver Experience, g\u00e2\u0080\u0089=\u00e2\u0080\u0089-0.80) [14]. Given these data, an effect size of 0.50 is expected in the present study, adopting a conservative approach. Because our design includes two experimental conditions, t-tests are assumed for the statistical analyses. Considering an alpha of 0.05 and a statistical power of 0.80 in a two-tailed t-test, the total sample size needed to reach an effect size of 0.60 in loading is 90 participants (45 participants per experimental condition). To control for the maximum possible loss of subjects during treatment, based on the literature on previous programs for family members of BPD or ED patients, a dropout rate of 30% is expected [34\u00e2\u0080\u009336]. Therefore, the required sample size should contain 124 participants in all (62 participants per group), as Fig.\u00c2\u00a01 shows. These calculations were carried out using the software program G*Power 3.1 [44].Fig. 1Flow Chart", "id": 1468, "split": "test"} +{"trial_id": "NCT05404230", "pmid": "38308227", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial\n\nIncluded conditions:\n- Peripheral Neuropathy\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Fish oil', 'type': 'ACTIVE_COMPARATOR', 'description': '4 capsules containing n-3 poly unsaturated fatty acids (EPA and DHA) with a total concentration of 3 g per day.\\n\\n4 capsules per day for 8 months', 'interventionNames': ['Dietary Supplement: Fish oil']}\n- {'label': 'Corn oil', 'type': 'PLACEBO_COMPARATOR', 'description': '4 capsules containing n-6 poly unsaturated fatty acids in a total concentration of 2 g per day.\\n\\n4 capsules per day for 8 months.\\n\\nCorn oil is regularly used in the kitchen and the daily dose in the study is the equivalent of adding an extra spoon of food oil when cooking. It has no known effect on the parameters we want to examine.', 'interventionNames': ['Dietary Supplement: Corn oil']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Fish oil', 'description': 'Fish oil containing poly unsaturated fatty acids.', 'armGroupLabels': ['Fish oil']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Corn oil', 'description': 'Corn oil', 'armGroupLabels': ['Corn oil']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of chemotherapy induced peripheral neuropathy (CIPN) 8 months after start of adjuvant chemotherapy', 'description': 'Number of patients who meet the criteria for CIPN: relevant symptoms evaluated by a medical doctor, incl one of the following: abnormal vibration test or, abnormal nerve conduction test by DPN check device or, abnormal pinprick test or, abnormal skin biopsy.', 'timeFrame': '8 months after start of adjuvant chemotherapy'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses 80% power and a 5% risk of type I error. To account for dropouts, the project will include 120 patients. P-values <0.05 will be considered statistically significant. Analyses will be performed as intention-to-treat (ITT) and per-protocol analyses will be performed as sensitivity analyses in case of non-compliance. Missing data will be explored and appropriate imputation methods will be applied if necessary.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size\n The present study will compare the treatment outcomes of patients in the two arms.\n Based on previous studies we expect an OIPN prevalence of 50% in the control group and estimate a prevalence in the fish oil group to be 23%, which is a clinically meaningful difference [6, 39, 63]. Using 80% power and 5% risk of type I error, the sample size estimate is 49+49 patients for the primary objective. To account for dropouts, the project will include 120 patients, with 60 patients in each group.\n Patient demographics and baseline characteristics will be described using descriptive statistics. Continuous variables will be summarized according to their distribution with medians and interquartile range (IQR) or means and standard deviations (sd). Categorical variables will be summarized with frequencies and percentages.\n The primary endpoint (OIPN) is a dichotomous endpoint defined by the developed definition of OIPN. The two independent proportions of OIPN in the two randomization arms will be compared using the chi2 test and reported as frequencies and percentages with corresponding p-values. P-values <0.05 will be considered statistically significant. All analyses will be performed as intention-to-treat (ITT). In case of cross-over between study arms due to non-compliance, per protocol analyses will be performed as sensitivity analyses to explore the potential bias from the non-compliance. In per-protocol analyses, non-compliance will be defined using an 80% percent cut-off or a significant lack of DHA and EPA rise in compliance blood samples.\n The proportion and patterns of missing data will be explored, and in the case of <5% missing data, analyses will be performed as complete case. If the amount of missing data is comprehensive (>5%) or suggestive of biased estimates, appropriate methods of imputation will be applied depending on the patterns of missingness.\n A complete statistical analysis plan covering each outcome will be developed together with statistical consultant Signe Timm M.Sc., PhD. Statistical analyses will be performed using STATA version 18 (STATA Corp., Texas, USA) and all steps of data management, coding and analyses will be logged.", "id": 1469, "split": "test"} +{"trial_id": "NCT05406414", "pmid": "38229181", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems\n\nIncluded conditions:\n- Depression\n- Bipolar Affective Disorder\n- Attention Deficit Disorder\n\nStudy Armgroups:\n- {'label': 'Transdiagnostic sleep and circadian treatment', 'type': 'EXPERIMENTAL', 'description': 'The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks.', 'interventionNames': ['Behavioral: Transdiagnostic sleep and circadian treatment']}\n- {'label': 'Active waitlist control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group receives sleep hygiene education', 'interventionNames': ['Behavioral: Active waitlist control group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Transdiagnostic sleep and circadian treatment', 'description': 'The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. The sessions are delivered individually and have the following content:\\n\\n1. Assessment and introduction to the sleep diary\\n2. Review of sleep diary - agreements on behavior changes and goals.\\n3. Information on normal sleep, sleep problems and circadian rhythm\\n4. Cognitive techniques\\n5. Introduction to relaxation training\\n6. Follow-up on goals and plan for prevention relapse of sleep problems', 'armGroupLabels': ['Transdiagnostic sleep and circadian treatment']}\n- {'type': 'BEHAVIORAL', 'name': 'Active waitlist control group', 'description': 'The control group receives sleep hygiene education consisting of a single session in which 10 points of sleep advice are presented. They receive a booklet on how to promote good sleep practice and must work on their own for the next 6 weeks to implement this while waiting for the intervention.', 'armGroupLabels': ['Active waitlist control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the severity of the sleep problem', 'description': \"Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.\", 'timeFrame': 'Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)'}\n- {'measure': 'Change in sleep quality.', 'description': 'Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, \"0\" indicating no difficulty and \"21\" indicating severe difficulties.', 'timeFrame': 'Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.80, a significance level of 0.05, and a 25% dropout rate based on former experiences from a pilot project.", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A power calculation was performed based on the results of a similar study [28] with PSQI as a secondary outcome using an average effect size of 0.67. Assuming a power of 0.80, a significance level of 0.05, and an expected power magnitude of 0.67, a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008944 is obtained for each group. The expected 25% dropout rate is based on former experiences from a pilot project (n\u00e2\u0080\u0089=\u00e2\u0080\u008955). A total of 88 patients will be included in the study.", "id": 1470, "split": "test"} +{"trial_id": "NCT05406830", "pmid": "37900149", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Efficacy of Acupuncture for Patients With Asymptomatic Hyperuricemia (HUA): A Multicenter Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Asymptomatic Hyperuricemia\n\nStudy Armgroups:\n- {'label': 'Verum acupuncture (VA)', 'type': 'EXPERIMENTAL', 'description': 'Participants will be treated by real manual acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.', 'interventionNames': ['Device: verum acupuncture', 'Behavioral: health education']}\n- {'label': 'Sham acupuncture (SA)', 'type': 'SHAM_COMPARATOR', 'description': 'Participants will be treated by non-penetrating sham acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.', 'interventionNames': ['Behavioral: health education', 'Device: sham acupuncture']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'verum acupuncture', 'description': 'The special type of acupuncture needles will be inserted into the skin of standard 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 (VA)']}\n- {'type': 'BEHAVIORAL', 'name': 'health education', 'description': 'According to the Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia related Diseases in China and the 2012 Guidelines of the American College of Rheumatology, health education should be given as basic prevention. These include weight control, regular exercise, limiting alcohol and high-purine and high-fructose diets, encouraging dairy and fresh vegetables and drinking moderate amounts of water, and not recommending or limiting soy products.', 'armGroupLabels': ['Sham acupuncture (SA)', 'Verum acupuncture (VA)']}\n- {'type': 'DEVICE', 'name': 'sham acupuncture', 'description': \"We will use a non-insertive sham control. Sham points are located at 5 cun lateral to the seventh, eighth, ninth, tenth, eleven and twelve thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun.\", 'armGroupLabels': ['Sham acupuncture (SA)']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in the mean level of serum uric acid from baseline.', 'description': 'The changes in the mean level of serum uric acid at 8 weeks after randomization compared to baseline', 'timeFrame': 'At baseline, and at 8 weeks after randomization.'}\n\nPlease estimate the sample size based on the assumption: \n85% power, alpha level of 0.025 (one-sided), 20% attrition rate.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary efficacy end point of this trial is the reduction in SUA from baseline at 8 weeks after randomization. The sample size of this study is driven by the superiority test of the primary efficacy endpoint, aiming to demonstrate a greater reduction in SUA concentration in the verum acupuncture group compared to the sham acupuncture group. Based on the pilot study and a previous clinical trial (33), we anticipate that SUA concentration will be reduced by an average of 0.58 mg/dL \u00c2\u00b1 1.15 mg/dL more in the verum acupuncture group than in the sham acupuncture group. Therefore, a sample size of 142 participants (71 patients in each group) is required to detect the difference between study groups with 85% power at an alpha level of 0.025 (one-sided). Considering an expected attrition rate of 20%, we plan to enroll at least 180 participants into this study.", "id": 1471, "split": "test"} +{"trial_id": "NCT05407194", "pmid": "38017500", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Additional Effect of Collagen/Vitamin C in Exercise Treatment for Patellar Tendinopathy (Jumper's Knee); a Randomized Controlled Trial\n\nIncluded conditions:\n- Patellar Tendinopathy\n\nStudy Armgroups:\n- {'label': 'Supplement + progressive tendon loading therapy', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting of maltodextrin. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement.', 'interventionNames': ['Dietary Supplement: Collagen + vitamin C']}\n- {'label': 'Placebo + progressive tendon loading therapy', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo consists of maltodextrin. In comparison the intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement.', 'interventionNames': ['Dietary Supplement: Collagen + vitamin C']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Collagen + vitamin C', 'description': 'Participants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises.', 'armGroupLabels': ['Placebo + progressive tendon loading therapy', 'Supplement + progressive tendon loading therapy']}\n\nPrimary Outcomes:\n- {'measure': 'VISA-P Score', 'description': 'The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports \\\\[1\\\\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up', 'timeFrame': 'after 6 weeks follow-up'}\n- {'measure': 'VISA-P Score', 'description': 'The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports \\\\[1\\\\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up', 'timeFrame': 'after 12 weeks follow-up'}\n- {'measure': 'VISA-P Score', 'description': 'The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports \\\\[1\\\\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up', 'timeFrame': 'after 18 weeks follow-up'}\n- {'measure': 'VISA-P Score', 'description': 'The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports \\\\[1\\\\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up', 'timeFrame': 'after 24 weeks follow-up'}\n- {'measure': 'VISA-P Score', 'description': 'The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports \\\\[1\\\\]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up', 'timeFrame': 'after 52 weeks follow-up'}\n\nPlease estimate the sample size based on the assumption: \nPower is estimated to be 80% and the significance level is 0.05. An expected loss to follow-up of 9% is considered.", "answer": 76, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The mean difference of change in VISA-P score over time between the intervention and placebo group is estimated to be 13 points higher in the intervention group compared to the placebo group. The standard deviation of the difference in VISA-P score is estimated to be 19 [15]. With a power estimated to be 80% and a significance level of 0.05, the sample size calculation (performed in G*Power 3.1.9.7) led to a total sample size of 70 participants. As we will compensate for an expected loss to follow-up of 9%, 76 participants will be included in total, i.e., 38 participants per treatment arm.", "id": 1472, "split": "test"} +{"trial_id": "NCT05407610", "pmid": "37532482", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Conventional and Cooled Radiofrequency Treatment of the Genicular Nerves Versus Sham Procedure for Patients With Chronic Knee Pain: a Multicentre, Double Blind, Randomised Controlled Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n- Persistent Postsurgical Pain\n- Chronic Knee Pain\n\nStudy Armgroups:\n- {'label': 'Conventional Radiofrequency of the genicular nerves', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the conventional radiofrequency group a intervention of 80\u00b0C at the tip is applied during 90 seconds at each nerve (superolateral, superomedial and inferomedial genicular nerves). The probe stays in place for 150 seconds at each nerve so that the time needed for each procedure is similar.', 'interventionNames': ['Procedure: Conventional Radiofrequency ablation of the genicular nerves']}\n- {'label': 'Cooled Radiofrequency of the genicular nerves', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the cooled radiofrequency group a intervention of 60\u00b0C measured at the tip and on average 80\u00b0C in the targeted tissue is applied for 150 seconds using the Cooled RF system at each nerve (superolateral, superomedial and inferomedial genicular nerves).', 'interventionNames': ['Procedure: Cooled Radiofrequency ablation of the genicular nerves']}\n- {'label': 'Sham procedure', 'type': 'SHAM_COMPARATOR', 'description': 'In the sham group a 18 gauge introducer and probe will be placed but no RF intervention will be applied. The generator will be turned on without connection to the probe for 150 seconds and the sound of the generator will be mimicked with a recording. The position of the needle will not be checked by fluoroscopy; however, the intervention team will position the fluoroscopy arm and mention the acquisition of the fluoroscopic image to the patient. This way no unnecessary radiation is used.', 'interventionNames': ['Procedure: Sham procedure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Conventional Radiofrequency ablation of the genicular nerves', 'description': 'Conventional Radiofrequency treatment of the genicular nerves of the knee blocks the transmission of painful stimuli from the sensory genicular nerves of the knee to the central nervous system by means of a thermal lesion created using RF current.', 'armGroupLabels': ['Conventional Radiofrequency of the genicular nerves'], 'otherNames': ['Conventional Radiofrequency ablation']}\n- {'type': 'PROCEDURE', 'name': 'Cooled Radiofrequency ablation of the genicular nerves', 'description': 'Cooled RF treatment causes a larger lesion size compared to conventional RF by means of internal cooling of the probe.', 'armGroupLabels': ['Cooled Radiofrequency of the genicular nerves'], 'otherNames': ['Cooled Radiofrequency ablation']}\n- {'type': 'PROCEDURE', 'name': 'Sham procedure', 'description': 'Sham procedure with placing of needles subcutaneously.', 'armGroupLabels': ['Sham procedure']}\n\nPrimary Outcomes:\n- {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention', 'description': 'The primary endpoint is the WOMAC score (range 0-96) at 6 months post-intervention.\\n\\nThe WOMAC score is derived from a self-administered osteoarthritis-specific validated questionnaire on pain, stiffness, and physical functioning of the knee joint.The lower the score, the lower the osteoarthritis-specific symptoms are.', 'timeFrame': '6 months post-intervention.'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, Bonferroni corrected alpha of 0.017 for multiple testing, 2:2:1 randomisation ratio, and up to 10% drop-out rate.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated to have 80% statistical power to detect a 10-point difference in the total WOMAC score between the compared groups with an estimated SD of 15 at 6 months after intervention. Ten points is reported to be the minimally clinically relevant difference in the total WOMAC score. As we plan three comparisons (cooled RF vs sham, conventional RF vs sham and cooled RF vs conventional RF), the Bonferroni correction for multiple testing was used to adjust the alpha used for testing (0.05/3=0.017) the superiority hypotheses.48 For each knee pain aetiology (OA and PPSP separately), given the 2:2:1 randomisation ratio and after adjustment for a drop-out rate of up to 10%, we plan to include 80 patients in the conventional RF group, 80 in the cooled RF group and 40 in the sham group adding up to 400 patients in total. To compute the sample size, we used the formula for computing sample sizes to detect a between-group difference on a continuous outcome.49 To do the computation, we used R V.4.0.2 with the package Trial Size V.1.3.", "id": 1473, "split": "test"} +{"trial_id": "NCT05407844", "pmid": "37718442", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Community Health Worker Based Intervention to Improve Palliative Care\n\nIncluded conditions:\n- Cancer\n- End Stage Cancer\n- Malignancy\n- Advanced Cancer\n\nStudy Armgroups:\n- {'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Standard cancer care'}\n- {'label': 'Standard care + DeCIDE PC intervention', 'type': 'EXPERIMENTAL', 'description': 'Community health worker support and standard cancer care', 'interventionNames': ['Other: Community Health Worker (CHW) based palliative care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Community Health Worker (CHW) based palliative care', 'description': 'Those in the intervention group will receive support from a dedicated CHW trained in motivational interviewing, components of palliative care communication, and social determinants of health.', 'armGroupLabels': ['Standard care + DeCIDE PC intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants who completed Advance Directives', 'description': 'Advanced care planning', 'timeFrame': '6 months after enrollment'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 0.05, power of 90% for ACP; alpha of 0.05, power of 80% for QOL; 20% attrition rate", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated our sample size to ensure sufficient power to detect a clinically meaningful difference in both our primary outcome (ACP) and our principal secondary outcome (QOL) between the study arms. With an alpha of 0.05 and power of 90%, we estimate a sample size of 56 participant per study arm to detect a 30 percentage point difference in ACP at 6\u00c2\u00a0months, based on effect sizes from previous studies and conservatively assuming that 30% of patients in the enhanced standard care arm will have ACP [26, 36]. After accounting for a 20% attrition rate over the study period, the adjusted final sample size based on our primary outcome is 70 participants per study arm (140 participants total). The sample size calculation based on our principal secondary outcome of QOL, measured by FACIT-Pal, is based on a recent study, which found that palliative care was associated with a standardized mean difference (SMD) in QOL of 0.46 (95% CI 0.08\u00e2\u0080\u00930.83) [28]. With an alpha of 0.05 and power of 80%, and after accounting for a 20% attrition rate, we estimate a sample size of 80 participants per study arm (160 participants total) to detect a SMD in QOL of 0.5. To ensure adequate power for both outcomes, we will plan to enroll 160 participants. We will seek to recruit a caregiver alongside each patient as a patient-caregiver dyad, but a lack of caregiver participation will not preclude a patient's enrollment. Our total potential sample size for the trial is therefore 320 participants, including 160 patients and 160 caregivers.", "id": 1474, "split": "test"} +{"trial_id": "NCT05408377", "pmid": "36401325", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Acupuncture for Cyclical Mastalgia \uff08CM\uff09\n\nIncluded conditions:\n- Mastalgia\n\nStudy Armgroups:\n- {'label': 'MA group', 'type': 'EXPERIMENTAL', 'description': 'Manual Acupuncture', 'interventionNames': ['Other: MA group']}\n- {'label': 'SA group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sham acupuncture', 'interventionNames': ['Other: SA group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'MA group', 'description': 'We will select Ashi points (the most obvious local pain over the breast), Tanzhong(CV17), bilateral Wuyi (ST15), Rugen (ST18), Tianzong(SI11), Geshu (BL17), Ganshu(BL18), Hegu(LI4), Sanyinjiao (SP6) and Taichong (LR3)in this trial.After insertion, all needles will be manually manipulated (equal manipulations of twirling, lifting, and thrusting)to achieve De qi sensation.', 'armGroupLabels': ['MA group']}\n- {'type': 'OTHER', 'name': 'SA group', 'description': 'The SA group will use a special needle in which the tip is blunt and the pedestal is opaque. There is an adhesive pad below the base to ensure that the whole pedestal can adhere to the points. Participants will receive superficial touch at bilateral sham GV8(Jinsuo), sham GV7(Zhongshu), sham GV6(Jizhong), sham GV5(Xuanshu), sham GV4(Mingmen), sham BL37(Yinmen), and sham BL57(Chengshan), the needles will touch the skin and not be inserted into the skin, then lift and twist each point evenly for 3 times, make the subject feel the similar sensation of deqi.', 'armGroupLabels': ['SA group']}\n\nPrimary Outcomes:\n- {'measure': 'Breast Pain Visual Analog Scale score', 'description': 'the change in the average ofBreast Pain Visual Analog Scale( VAS-BP )scores in the first 2 weeks of menstruation\uff0cThe VAS-BP will be measured using a 10cm linear VAS with 0 representing no pain and 10 the worst imaginable pain, a higher score denotes more severe pain', 'timeFrame': 'from baseline at weeks 4, 8, 12,24,and36'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of \u03b1 = 0.05, power (1-\u03b2) of 0.90, two-tailed test, and a 20% drop-out rate.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size estimation was based on changes in the breast pain VAS (VAS-BP) score. According to pre-trial results, the VAS-BP score significantly decreased by 2.98\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.95 points in the MA group compared to 2.35\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.97 in the SM group after treatment with respect to baseline. For the current trial, we assumed a significance level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a power (1-\u00ce\u00b2) of 0.90. For a two-sided outcome, at least 42 participants will be required for each group as calculated using PASS version 11.0 (NCSS, LLC, Kaysville, UT, USA). We assumed a two-tailed test with a 20% drop-out rate, and thus a total of 108 patients (54 in each group) will be recruited.", "id": 1475, "split": "test"} +{"trial_id": "NCT05411159", "pmid": "38124084", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study\n\nIncluded conditions:\n- Postoperative Nausea and Vomiting\n- Opioid Use\n- Thoracic Diseases\n\nStudy Armgroups:\n- {'label': 'Opioid-Free Anesthesia (OFA froup)', 'type': 'EXPERIMENTAL', 'description': 'Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.', 'interventionNames': ['Procedure: Opioid-Free Anesthesia (OFA)']}\n- {'label': 'Standard general anesthesia (OA)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.', 'interventionNames': ['Procedure: Standard general anesthesia (OA)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free general anesthesia protocol:\\n\\nAfter entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.), dexmedetomidine (0.5ug/kg i.v. in 15min), and ultrasound-guided T4-5 paravertebral nerve block (0.5% Ropivacaine 20ml).\\n\\nInduction of anesthesia with lidocaine (1.5mg/kg i.v.), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v.).\\n\\nIntraoperative anesthesia was maintained by desflurane (0.5-1MAC), continuous intravenous infusion of dexmedetomidine (0.5ug/kg/h), and lidocaine (1.5mg/kg/h).\\n\\nFlurbiprofen (50 mg i.v.) given at the time of skin suture.', 'armGroupLabels': ['Opioid-Free Anesthesia (OFA froup)'], 'otherNames': ['Non-Opioid anesthesia (NOA)']}\n- {'type': 'PROCEDURE', 'name': 'Standard general anesthesia (OA)', 'description': 'Standard general anesthesia protocol:\\n\\nAfter entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.).\\n\\nInduction of anesthesia with lidocaine (1.5mg/kg i.v.), sufentanil (0.3-0.4ug/kg), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v. ).\\n\\nIntraoperative anesthesia was maintained by desflurane (0.5-1MAC) and continuous intravenous infusion of remifentanil (0.1-0.2ug/kg/min).\\n\\nFlurbiprofen (50 mg i.v.) given at the time of skin suture.', 'armGroupLabels': ['Standard general anesthesia (OA)'], 'otherNames': ['Opioid-based general anesthesia']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of postoperative nausea and vomiting', 'description': \"Assessed using Myles's simplified postoperative nausea and vomiting impact scale.\\n\\nThe scale on the scale is a composite of the following 2 parts:\\n\\n(1) vomited or had dry-retching (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe).\\n\\nThe score\\\\>0 is regarded as PONV occurred.\", 'timeFrame': '24 hours after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a two-sided significance level (\u00ce\u00b1) of 0.05, and a dropout rate of 5% are assumed.", "answer": 168, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size calculation is based on the primary outcome. We assume that the cumulative incidence of PONV after VATs will be 40% according to that reported in previous publications (ranged from 28.6 to 41.7% in adults during the first day after VATs [4, 8, 24]). Assuming a 50% reduction of the cumulative incidence of PONV in the OFA group compared to the OA group [16], a sample size of 84 for each group (168 in total) will be required to achieve a power of 80% to detect the difference at a two-side \u00ce\u00b1 level of 0.05 with a dropout rate of 5%.", "id": 1476, "split": "test"} +{"trial_id": "NCT05416229", "pmid": "36241352", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.\n\nIncluded conditions:\n- Alcohol Use Disorder\n\nStudy Armgroups:\n- {'label': 'Psilocybin-assisted therapy', 'type': 'EXPERIMENTAL', 'description': '45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing.', 'interventionNames': ['Drug: Psilocybin']}\n- {'label': 'Placebo-assisted therapy', 'type': 'PLACEBO_COMPARATOR', 'description': '45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing.', 'interventionNames': ['Drug: Maltodextrin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Psilocybin', 'description': 'Psilocybin-assisted therapy', 'armGroupLabels': ['Psilocybin-assisted therapy']}\n- {'type': 'DRUG', 'name': 'Maltodextrin', 'description': 'Placebo-assisted therapy', 'armGroupLabels': ['Placebo-assisted therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Change in percentage of heavy drinking days', 'description': 'Heavy drinking is defined as days with five drinks/60 grams of alcohol or more for men, four drinks/48 grams of alcohol or more for women. Data will be collected using the Timeline Followback Method (TLFB) which is a widely used, calendar-based retrospective measure of self-reported use of alcohol. The number of days drinking assessed is 28 days.', 'timeFrame': 'Baseline to week 12'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, alpha of 5%, and an estimated drop-out rate of 40%", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is based on percentage of heavy drinking days (the primary outcome) from a recent proof-of-concept study.25 The authors report a mean difference in heavy drinking days of 18.2\u00e2\u0080\u0089percentage points with an SD of 20\u00e2\u0080\u0089percentage points. With a power of 90% and an alpha of 5%, we will need 27 patients in each group, that is, 54 patients. However, since drop-out is frequent in AUD trials,97 we aim to include 90 patients, estimating a drop-out rate of 40%. Should the drop-out rate be higher, we will continue to include patients until 54 have completed the 12-week trial.", "id": 1477, "split": "test"} +{"trial_id": "NCT05416944", "pmid": "36397173", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Personalized Perioperative Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Having Major Abdominal Surgery: a Multicenter Prospective Randomized Controlled Interventional Clinical Trial\n\nIncluded conditions:\n- Blood Pressure\n- Intraoperative Hypotension\n- Postoperative Complications\n- Surgery\n- Anesthesia\n\nStudy Armgroups:\n- {'label': 'Routine management (control) group', 'type': 'NO_INTERVENTION', 'description': 'Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients assigned to the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring.'}\n- {'label': 'Personalized management (intervention) group', 'type': 'EXPERIMENTAL', 'description': 'In patients randomized to the personalized management group, intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg. The perioperative trial intervention period starts with the beginning of the induction of general anesthesia and ends two hours after surgery ends.', 'interventionNames': ['Other: Personalized blood pressure management']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Personalized blood pressure management', 'description': 'Personalized blood pressure management: Intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg.', 'armGroupLabels': ['Personalized management (intervention) group']}\n\nPrimary Outcomes:\n- {'measure': 'Composite outcome of major postoperative complications', 'description': 'Collapsed composite (\"any event versus none\") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 7 days after surgery', 'timeFrame': 'Postoperative Day 7'}\n\nPlease estimate the sample size based on the assumption: \nThe study will use a group sequential design with one unblinded interim analysis using the O'Brien-Fleming spending function. The total sample size will provide 90% power to detect a difference of 8% at a significance level of 0.05 using a two-sided test of proportions with continuity correction. A total drop-out rate of 10% is assumed.", "answer": 1272, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was estimated from the anticipated incidence of the composite primary outcome of at least one severe complication or death within 7\u00c2\u00a0days after surgery. We expected an incidence of 25% in the routine management group (adapted from own data and literature [2, 25, 26]) and 17% in the personalized management group. The assumed absolute risk reduction of 8% is a conservative estimate based on a previous trial investigating the effect of individualized blood pressure management compared to routine blood pressure management on postoperative organ failure [13].\n We will use a group sequential-design with one unblinded interim analysis using the O\u00e2\u0080\u0099Brien-Fleming spending function [27]. A total sample size of 1144, i.e., 572 patients per group will provide 90% power to detect a difference of 8% between the groups at a significance level of 0.05 using a two-sided test of proportions with continuity correction including an unblinded interim analysis after 50% of patients are recruited. Allowing a total drop-out rate of 10% (assuming an 8% drop-out rate before randomization and 2% after randomization), we plan to recruit 1272 patients. We assume that all patients will remain in their allocated treatment group throughout the observation period. PASS version 16.0.3 was used for the sample size calculation.", "id": 1478, "split": "test"} +{"trial_id": "NCT05417009", "pmid": "38134136", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vagal Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy.\n\nIncluded conditions:\n- Ischemic Stroke\n- Thrombotic Stroke\n- Autonomic Dysfunction\n- Autonomic Imbalance\n\nStudy Armgroups:\n- {'label': 'Stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.', 'interventionNames': ['Device: trans-cutaneous auricular sensory stimulation']}\n- {'label': 'Electrode attachment only.', 'type': 'SHAM_COMPARATOR', 'description': 'Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off \\\\[blinded to operator\\\\].', 'interventionNames': ['Device: trans-cutaneous auricular sensory stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'trans-cutaneous auricular sensory stimulation', 'description': 'Transcutaneous auricular sensory stimulation', 'armGroupLabels': ['Electrode attachment only.', 'Stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Blood pressure variability', 'description': 'Coefficient of variation of systolic blood pressure', 'timeFrame': '0-24h after mechanical thrombectomy'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% significance level, 5% non-compliance rate in each group", "answer": 36, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n We estimated the sample size from data reported from the secondary analysis of the BEST study, which examined blood pressure variability and neurologic outcome after endovascular thrombectomy [6]. An adjusted sample size of 36 patients is required to have a 90% chance of detecting, as significant at the 5% level, a decrease in the coefficient of variation in systolic blood pressure from 15\u00c2\u00b14mmHg in the sham group to 10\u00c2\u00b14mmHg in the VAN group [assuming 5% non-compliance rate in each group].", "id": 1479, "split": "test"} +{"trial_id": "NCT05419947", "pmid": "36868593", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Clinical Trial for the Optimization of Indocyanine Green Administration in Near-infrared Fluorescent Cholangiography During Laparoscopic Cholecystectomy.\n\nIncluded conditions:\n- Laparoscopic Cholecystectomy\n\nStudy Armgroups:\n- {'label': 'Fixed dose 3 hours', 'type': 'EXPERIMENTAL', 'description': 'Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.', 'interventionNames': ['Drug: VERDYE powder for solution for injection 25 mg']}\n- {'label': 'Fixed dose 30 min', 'type': 'EXPERIMENTAL', 'description': 'Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).', 'interventionNames': ['Drug: VERDYE powder for solution for injection 25 mg']}\n- {'label': 'Weight-adjusted dose 3 hour', 'type': 'EXPERIMENTAL', 'description': 'Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.', 'interventionNames': ['Drug: VERDYE powder for solution for injection 25 mg']}\n- {'label': 'Weight-adjusted dose 30 min', 'type': 'EXPERIMENTAL', 'description': 'Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).', 'interventionNames': ['Drug: VERDYE powder for solution for injection 25 mg']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'VERDYE powder for solution for injection 25 mg', 'description': 'Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.', 'armGroupLabels': ['Fixed dose 3 hours', 'Fixed dose 30 min', 'Weight-adjusted dose 3 hour', 'Weight-adjusted dose 30 min'], 'otherNames': ['Indocyanine green (ICG)']}\n\nPrimary Outcomes:\n- {'measure': 'Identification of biliary structures prior to dissection of the hepatocystic triangle.', 'description': 'Identification of biliary structures prior to dissection of the hepatocystic triangle.\\n\\n\"yes\" or \"no\" will be used to determine whether to display:\\n\\n1. Identification of the cystic duct prior to dissection\\n2. Identification of the common bile duct prior to dissection\\n3. Identification of the junction of the cystic duct with the common bile duct prior to dissection\\n4. Identification of the union of the cystic duct with the gallbladder prior to dissection\\n5. Identification of the common hepatic duct prior to dissection\\n6. Identification of biliary anatomical variables prior to dissection 6.1. High implantation cystic duct 6.2. short cystic duct 6.3. Anterior spiral cystic duct, with mouth on the left side of the bile duct 6.4. Posterior spiral cystic duct, with mouth on the left side of the bile duct 6.5. Aberrant right hepatic duct, with drainage into the cystic duct 6.6. Others', 'timeFrame': 'At the time of the surgical procedure'}\n- {'measure': 'Identification of biliary structures after dissection of the hepatocystic triangle.', 'description': 'Identification of biliary structures after dissection of the hepatocystic triangle.\\n\\n\"yes\" or \"no\" will be used to determine whether to display:\\n\\n1. Identification of the cystic duct prior to dissection\\n2. Identification of the common bile duct prior to dissection\\n3. Identification of the junction of the cystic duct with the common bile duct prior to dissection\\n4. Identification of the union of the cystic duct with the gallbladder prior to dissection\\n5. Identification of the common hepatic duct prior to dissection\\n6. Identification of biliary anatomical variables prior to dissection 6.1. High implantation cystic duct 6.2. short cystic duct 6.3. Anterior spiral cystic duct, with mouth on the left side of the bile duct 6.4. Posterior spiral cystic duct, with mouth on the left side of the bile duct 6.5. Aberrant right hepatic duct, with drainage into the cystic duct 6.6. Others', 'timeFrame': 'At the time of the surgical procedure'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 0.95 and a significance level of \u22640.05. The recruitment rate is assumed to be a minimum of 50%, with a duration of 12 months and potential patient loss considered.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n In order to estimate the sample size, an annual average of 300 LC was estimated. Assuming a minimum recruitment rate of 50%, a duration of 12 months and the potential loss of patients, we estimated a sample size of 200 patients. Since the primary endpoint is to analyse whether there are differences between doses and administration intervals in the four arms in which categorical variables are measured, the effect of the chosen sample size (n=200) on the statistical contrasts in this type of variables is w=0.25, with a power of \u00c2\u00ae=0.95\u00e2\u0080\u0089and a cut-off point of significance for the rejection of the null hypothesis of \u00e2\u0089\u00a40.05.", "id": 1480, "split": "test"} +{"trial_id": "NCT05421650", "pmid": "38330380", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Cervical Cancer\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Concurrent chemoradiation therapy (CCRT)', 'interventionNames': ['Radiation: CCRT']}\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Surgical debulking of bulky or multiple lymph node followed by CCRT', 'interventionNames': ['Procedure: Surgical debulking of bulky or multiple lymph nodes', 'Radiation: CCRT']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'CCRT', 'description': '1. Radiation: Extended field-external beam radiation therapy (EF-EBRT) + brachytherapy + lymph node boost.\\n2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.\\n3. Radiation and chemotherapy are administered concurrently.', 'armGroupLabels': ['Control group']}\n- {'type': 'PROCEDURE', 'name': 'Surgical debulking of bulky or multiple lymph nodes', 'description': '1. Open/minimally invasive method.\\n2. Surgical debulking of bulky or multiple lymph nodes.\\n3. Postoperative imaging evaluation to determine whether the lymph node has been successfully removed.', 'armGroupLabels': ['Experimental group']}\n- {'type': 'RADIATION', 'name': 'CCRT', 'description': '1. Radiation: EBRT/EF-EBRT + brachytherapy + lymph node boost.\\n2. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles.\\n3. Radiation and chemotherapy are administered concurrently.', 'armGroupLabels': ['Experimental group']}\n\nPrimary Outcomes:\n- {'measure': 'PFS', 'description': 'Progression-free survival', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is 0.05, the test power is 80%, and the dropout rate is 13%.", "answer": 234, "answer_type": "ESTIMATED", "explanation": "5. Sample size\n The comparative indicator in this phase III randomized study will be the 3-year PFS rate. The predictive value of the 3-year PFS rate is 40%\u00e2\u0080\u009375% when CCRT alone (control group) is performed in patients with cervical cancer IIIC (LN metastasis). According to the outcomes reported by the Korean cancer centers, considering that the 3-year PFS rate of IIIC1 (pelvic LN metastasis) is approximately 70%\u00e2\u0080\u009375% and the 3-year PFS rate of IIIC2 (para-aortic LN metastasis) is approximately 40%\u00e2\u0080\u009350% [23], the 3-year PFS rate of the comparative indicator to be used in this study can be approximately 60%. However, no studies have investigated the 3-year PFS rate in patients receiving CCRT after LN debulking surgery. Lim et al. [24] only reported a 3-year PFS rate of approximately 75%\u00e2\u0080\u009380% after surgical staging of localized cervical cancer in a Korean study. Based on this, the expected difference in the 3-year PFS rates between the control and experimental groups was estimated to be 15%. The participant recruitment and follow-up periods are 4 and 3 years, respectively; when the significance level is 0.05 and the test power is 80%, the sample size required is 204 patients. Considering a dropout rate of 13%, the study requires 234 cases. The sample size is 117 participants in both the control and experimental groups.", "id": 1481, "split": "test"} +{"trial_id": "NCT05422209", "pmid": "39358750", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. Randomized Controlled Study.\n\nIncluded conditions:\n- Pelvic Organ Prolapse\n\nStudy Armgroups:\n- {'label': 'Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.']}\n- {'label': 'Mesh-augmented sacrospinal fixation with posterior colporrhaphy.', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Mesh-augmented sacrospinal fixation with posterior colporrhaphy.']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.', 'description': 'Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.', 'armGroupLabels': ['Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.']}\n- {'type': 'PROCEDURE', 'name': 'Mesh-augmented sacrospinal fixation with posterior colporrhaphy.', 'description': 'Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy.', 'armGroupLabels': ['Mesh-augmented sacrospinal fixation with posterior colporrhaphy.']}\n\nPrimary Outcomes:\n- {'measure': 'Objective cure rate', 'description': 'The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)', 'timeFrame': '24 months (2 years)'}\n\nPlease estimate the sample size based on the assumption: \nStudy power 80%, significance level 5%, data loss compensation 10%", "answer": 310, "answer_type": "ACTUAL", "explanation": "Sample size and {14}\n Taking into account the available data on the recurrence rate of unilateral sacrospinous fixation using this technology (7.4%) [11], as well as clinical observations on the recurrence rate of three-level reconstruction (1%), study power 80%, and significance level 5%, 282 patients are needed to confirm the expected difference in recurrence rate. To compensate for data loss, the estimated sample size is increased by 10%. As a result, the total sample size is 310 patients.", "id": 1482, "split": "test"} +{"trial_id": "NCT05423587", "pmid": "37337060", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Genicular artEry embolisatioN in patiEnts With oSteoarthrItiS of the Knee II\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'GAE Treatment', 'type': 'EXPERIMENTAL', 'description': 'The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiogram imaging. Through groin access and puncture of the femoral artery through a small sheath tiny microspheres (Embozene(TM)) will be injected into this area and reduce blood flow in order to reduce pain.', 'interventionNames': ['Procedure: Genicular Artery Embolisation']}\n- {'label': 'Sham Procedure', 'type': 'SHAM_COMPARATOR', 'description': 'In the control (sham) arm patients will not undergo the embolisation procedure with microspheres, instead they will have 2ml of saline injected into their knee artery supplying the abnormal area of the knee. The remainder of the procedure is otherwise identical between the two groups.', 'interventionNames': ['Procedure: Genicular Artery Injection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Genicular Artery Embolisation', 'description': 'Transarterial catheter directed embolisation of hypervascularity in patients with mild to moderate knee osteoarthritis', 'armGroupLabels': ['GAE Treatment'], 'otherNames': ['Embozene Microspheres', 'Embozene']}\n- {'type': 'PROCEDURE', 'name': 'Genicular Artery Injection', 'description': 'Transarterial catheter directed injection of normal (0.9%) saline in patients with mild to moderate knee osteoarthritis', 'armGroupLabels': ['Sham Procedure']}\n\nPrimary Outcomes:\n- {'measure': 'Determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee OA compared to Sham treatment', 'description': 'Change from baseline to 6 months post randomisation in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, activities of daily living, and quality of life (KOOS4); scores range from 0 (worst) to 100 (best)', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha error of 2-sided 0.05, a power of 0.85, and a participant dropout rate of 20%.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample Size\n Alongside a sham surgery placebo arm, a high-quality systematic review of surgical RCTs was used as a suitable benchmark to inform the sample size and power calculation [16, 17]. With a 0\u00e2\u0080\u0093100 scale for the primary endpoint of KOOS4, assuming a 1:1 randomisation, a mean difference of 6.4 (i.e. effect size) between GAE and sham treatments, a common standard deviation of 10 (a Cohen\u00e2\u0080\u0099s D of 0.64), an alpha error of 2-sided 0.05, and a power of 0.85, the 2-arm total sample size requirement is 88 subjects (44 each arm) by Normal approximation. Allowing for a participant dropout rate of 20%, the enrolment goal is 110 participants, approximately 55 in each study arm. Study activities (Table 2) will take place at a single academic centre in the UK.", "id": 1483, "split": "test"} +{"trial_id": "NCT05425147", "pmid": "36717143", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Correlation Between Perioperative Autonomic Function and Adverse Events Such as Post-induction Hypotension in Elderly Patients\n\nIncluded conditions:\n- Intraoperative Hypotension\n\nStudy Armgroups:\n- {'label': 'Post-induction hypotension group', 'description': 'Post-induction hypotension is defined as systolic blood pressure (SBP) \\\\<90 mmHg, mean arterial pressure (MAP) \\\\<65 mmHg, or a decrease of more than 30% of baseline within 20 minutes after induction or before incision.', 'interventionNames': ['Other: Perioperative autonomic function assessment']}\n- {'label': 'Stable blood pressure group', 'description': 'All enrolled elderly patients will undergo surgery under general anesthesia after preoperative monitoring. Those patients whose blood pressure is relatively stable after induction and does not meet the PIH criteria is classified as the stable blood pressure group.', 'interventionNames': ['Other: Perioperative autonomic function assessment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Perioperative autonomic function assessment', 'description': 'Patients will have BRS and HRV measurements taken for approximately 20 minutes, one day before surgery and on the day of surgery. We use LiDCO rapid to conduct non-invasive pulse and beat-to-beat blood pressure monitoring.', 'armGroupLabels': ['Post-induction hypotension group', 'Stable blood pressure group']}\n\nPrimary Outcomes:\n- {'measure': 'Post-induction hypotension', 'description': 'Systolic blood pressure (SBP) \\\\<90 mmHg, mean arterial pressure (MAP) \\\\<65 mmHg, or a decrease of more than 30% of baseline', 'timeFrame': 'within 20 minutes after induction or before incision'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a 95% power and a significance level of 5%, with a 10% dropout rate considered in the sample size calculation. The statistical power of various HRV metrics ranges from 0.84 to 1.00.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size consideration\n To investigate the association between BRS, HRV and outcomes, we used the HRV results in the literature to estimate the sample size, considering few previous studies have explored the correlation between BRS and PIH.23 Our preliminary study suggested that around 33% of elderly patients in our centre developed PIH.40 Based on the study by Padley and Ben-Menachem23 and considering the need for a multivariable analysis according to the induction strategy in our study, to achieve a 95% power and a significance level of 5%, 180 patients will be required (60 with PIH and 120 with stable blood pressure). A drop-out rate of 10% is assumed in sample size calculation. The statistical power of various HRV metrics is shown in table 2.\n \n Table 2\n \n Power calculation according to a previous study on HRV\n \n \n \n \n \n Power\n \n \n \n \n Time domain analysis\n \n \n \n \u00e2\u0080\u0083Mean RR (ms)\n 0.84\n \n \n \u00e2\u0080\u0083SDNN (ms)\n 1.00\n \n \n \u00e2\u0080\u0083RMSSD (ms)\n 1.00\n \n \n Frequency domain analysis\n \n \n \n \u00e2\u0080\u0083LF (ms2)\n 1.00\n \n \n \u00e2\u0080\u0083HF (ms2)\n 1.00\n \n \n \u00e2\u0080\u0083Total power (ms2)\n 1.00\n \n \n \u00e2\u0080\u0083LF/HF ratio\n 0.99\n \n \n \n \n \n HF, high frequency; HRV, heart rate variability; LF, low frequency; RMSSD, square root of mean squared differences of normal-to-normal intervals; SDNN, SD of the normal-to-normal intervals.\n \n \n \n Previous studies have shown that elderly women had lower BRS compared with elderly men.41 To reduce the impact of differences in sex distribution on measures and outcomes, we included patients in a specific sex ratio. From 2014 to 2022, 41.1% of the elderly patients who received elective non-cardiac surgery under general anaesthesia in our centre were female. We will include patients in a ratio of 6:4 male to female (108 male and 72 female).", "id": 1484, "split": "test"} +{"trial_id": "NCT05427344", "pmid": "38308248", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Cancer Patients' Aquatic Exercise Program for Cancer-related Fatigue, Cancer-related Neuropathy, Activity and Participation, Quality of Life and Return to Work: A Randomized Controlled Trial\n\nIncluded conditions:\n- Colon Cancer\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Water exercise group', 'type': 'EXPERIMENTAL', 'description': 'Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi', 'interventionNames': ['Other: Water exercise group']}\n- {'label': 'Land exercise group', 'type': 'EXPERIMENTAL', 'description': 'Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land', 'interventionNames': ['Other: Land exercise group']}\n- {'label': 'Control group', 'type': 'EXPERIMENTAL', 'description': 'Control group who will not perform additional physical activity or receive any extra treatments', 'interventionNames': ['Other: Control group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Water exercise group', 'description': 'Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi.', 'armGroupLabels': ['Water exercise group']}\n- {'type': 'OTHER', 'name': 'Land exercise group', 'description': 'Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land.', 'armGroupLabels': ['Land exercise group']}\n- {'type': 'OTHER', 'name': 'Control group', 'description': 'Control group who will not perform additional physical activity or receive any extra treatments.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in degree of activity and participation before the start of the intervention (at baseline) and 8 weeks of intervention', 'description': \"WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society.\\n\\nThe average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains\", 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention'}\n- {'measure': 'Changes in degree of activity and participation before the start of the intervention (at baseline) and 3 months from the end of the intervention.', 'description': \"WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society.\\n\\nThe average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains\", 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention'}\n- {'measure': 'Changes in degree of activity and participation, before the start of the intervention (at baseline), and 12 months from the end of the intervention.', 'description': \"WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society.\\n\\nThe average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains\", 'timeFrame': 'Data will be collected before the start of the intervention (at baseline), and 12, months from the end of the intervention.'}\n- {'measure': 'Changes in degree of activity and participation before the start of the intervention (at baseline) and 24 months from the end of the intervention.', 'description': \"WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society.\\n\\nThe average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains\", 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention.'}\n- {'measure': 'Changes in Quality of life before the start of the intervention (at baseline) and 8 weeks of intervention', 'description': 'The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) \"not at all\", 2) \"a little\" 3) \"quite a bit\" 4) \"very much\" except for the global health-status/quality of life scale, which has response options ranging from 1) \"very poor\" to 7) \"excellent\".', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention'}\n- {'measure': 'Changes in Quality of life before the start of the intervention (at baseline) and 3 months from the end of the intervention', 'description': 'The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) \"not at all\", 2) \"a little\" 3) \"quite a bit\" 4) \"very much\" except for the global health-status/quality of life scale, which has response options ranging from 1) \"very poor\" to 7) \"excellent\".', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention'}\n- {'measure': 'Changes in Quality of life before the start of the intervention (at baseline) and 12 months from the end of the intervention', 'description': 'The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) \"not at all\", 2) \"a little\" 3) \"quite a bit\" 4) \"very much\" except for the global health-status/quality of life scale, which has response options ranging from 1) \"very poor\" to 7) \"excellent\".', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline), and 12 months from the end of the intervention.'}\n- {'measure': 'Changes in Quality of life before the start of the intervention (at baseline) and 24 months from the end of the intervention', 'description': 'The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) \"not at all\", 2) \"a little\" 3) \"quite a bit\" 4) \"very much\" except for the global health-status/quality of life scale, which has response options ranging from 1) \"very poor\" to 7) \"excellent\".', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline), and 24 months from the end of the intervention.'}\n- {'measure': 'Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 8 weeks of intervention', 'description': 'Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention'}\n- {'measure': 'Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 3 months from the end of the intervention.', 'description': 'Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention'}\n- {'measure': 'Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 12 months from the end of the intervention.', 'description': 'Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention'}\n- {'measure': 'Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 24 months from the end of the intervention.', 'description': 'Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention'}\n- {'measure': 'Changes in Employment before the start of the intervention (at baseline) and 8 weeks of intervention', 'description': 'Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention'}\n- {'measure': 'Changes in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.', 'description': 'Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention'}\n- {'measure': 'Changes in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.', 'description': 'Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention'}\n- {'measure': 'Changes in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.', 'description': 'Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention'}\n- {'measure': 'Changes in Neuropathy before the start of the intervention (at baseline) and 8 weeks of intervention', 'description': 'Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being \"not at all\" and 4 being \"very much\"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention'}\n- {'measure': 'Changes in Neuropathy before the start of the intervention (at baseline) and 3 months from the end of the intervention.', 'description': 'Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being \"not at all\" and 4 being \"very much\"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention'}\n- {'measure': 'Changes in Neuropathy before the start of the intervention (at baseline) and 12 months from the end of the intervention.', 'description': 'Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being \"not at all\" and 4 being \"very much\"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention'}\n- {'measure': 'Changes in Neuropathy before the start of the intervention (at baseline) and 24 months from the end of the intervention.', 'description': 'Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being \"not at all\" and 4 being \"very much\"). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet.', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention'}\n- {'measure': 'Changes in duration of working hours before the start of the intervention (at baseline) and 8 weeks of intervention', 'description': 'Duration of working hours - self-report by the study participants', 'timeFrame': 'Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention'}\n- {'measure': 'Changes in duration of working hours before the start of the intervention (at baseline) and 3 months from the end of the intervention.', 'description': 'Duration of working hours - self-report by the study participants', 'timeFrame': 'Chang in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.'}\n- {'measure': 'Changes in duration of working hours before the start of the intervention (at baseline) and 12 months from the end of the intervention.', 'description': 'Duration of working hours - self-report by the study participants', 'timeFrame': 'Chang in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.'}\n- {'measure': 'Changes in duration of working hours before the start of the intervention (at baseline) and 24 months from the end of the intervention.', 'description': 'Duration of working hours - self-report by the study participants', 'timeFrame': 'Chang in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.'}\n\nPlease estimate the sample size based on the assumption: \nThe sample calculation includes a type 1 error of alpha equal to 0.05 with a power of 80%.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n One hundred and fifty cancer patients aged 18\u00e2\u0080\u009365 years (stage III colon cancer patients and breast cancer patients with lymph node involvement) will be recruited via advertisements in Hadassah Medical Center and Tal Aviv University. The sample size is based on data from the WHO Disability Assessment Schedule (WHODAS 2.0), which has been used internationally to assess function and disability among a healthy population versus an unhealthy population [26]. The expected difference in the questionnaire scores between the two groups is 15 points and the average standard deviation is 15.08. The sample calculation includes a type 1 error of alpha equal to 0.05 with a power of 80%. According to this calculation, 16 participants are needed in each of the three study groups. Because we anticipate the withdrawal of some of the participants and because of the clinical condition of all participants, a number of 50 participants per group was selected.", "id": 1485, "split": "test"} +{"trial_id": "NCT05429099", "pmid": "40016641", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Oral Cavity Cancer\n- Oral Cancer\n\nStudy Armgroups:\n- {'label': 'Free-Hand Surgery (FHS)', 'type': 'ACTIVE_COMPARATOR', 'description': 'In FHS, the site surgeon will proceed with the surgery as per their routine practice.', 'interventionNames': ['Procedure: Free-Hand Surgery']}\n- {'label': 'Virtual Surgical Planning (VSP)', 'type': 'EXPERIMENTAL', 'description': 'The trial research engineer (RE), located at Vancouver General Hospital (VGH), will segment the CT data to create a 3D model for surgical planning. During the teleconference between site surgeon (SS) and RE, the RE will load the CT data and the segmented 3D model into the virtual planning environment. With the RE navigating the software, which was created in-house at VGH and used in a previous case series, the SS will determine the extent of disease and define the resection planes. After the cutting planes are created, the RE will use the software to create the reconstruction plan with either the patient-specific fibula or scapula. Once the surgeon is satisfied with the plan, the teleconference will end and the RE will create and 3D print the surgical guides for the mandible, for the fibula or scapula, as well as the 3D computed reconstruction.', 'interventionNames': ['Procedure: Virtual Surgical Planning (VSP)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Virtual Surgical Planning (VSP)', 'description': 'The 3D reconstruction model, not requiring sterilization, will be sent directly to the SS. Prior to surgery, the SS will prebend a titanium fixation plate to the reconstruction model. Both the surgical cutting guides and titanium plate will be sterilized prior to use in surgery. If the planned resection cannot proceed (possibly due to tumour growth), the surgical team will note the reason for abandonment and conduct a standard FHS. Intraoperatively, the SS will apply the mandibular cutting guide to make the resection, remove the resected component and apply the pre-bent plate. Next, either the fibular or scapular cutting guide is applied to harvest the transplant which is then secured to the plate. The flap is re-vascularized by joining it to blood vessels in the neck.', 'armGroupLabels': ['Virtual Surgical Planning (VSP)']}\n- {'type': 'PROCEDURE', 'name': 'Free-Hand Surgery', 'description': \"The SS will adopt their standard procedure for the mandibular resection and reconstruction. This typically involves bending a titanium fixation plate, harvesting of the bony flap, and shaping of the segments all intraoperatively based on the SS's judgement.\", 'armGroupLabels': ['Free-Hand Surgery (FHS)']}\n\nPrimary Outcomes:\n- {'measure': 'Bony Union', 'description': 'The primary outcome is nonunion as assessed by two independent radiologists at Vancouver General Hospital, blinded to the intervention, based on the 12-month postoperative CT scan. Each apposition (between native bone-flap or between flap segments) will be assessed as nonunion, partial union, and complete union. Cases where there is disagreement between reviewers will undergo consensus review, any persisting disagreements will be reviewed by a third radiologist and classification will be based on the majority vote.', 'timeFrame': 'Assessed on CT scans 12 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \n15% mortality before 1 year, 5% loss to follow up before 1 year, beta = 0.20 and alpha = 0.05 (2-sided)", "answer": 420, "answer_type": "ESTIMATED", "explanation": "Statistics and sample size calculation\n The primary estimand of interest is the between-group difference in the proportion of trial patients who have a nonunion at 1 year. Point and interval estimates for the between-group difference at 1 year will be determined using the Fine-Grey competing risk regression model with treatment group as a covariate and a robust standard error to account for within-centre homogeneity of the outcome. Participants will be analyzed according to their treatment allocation regardless of treatment received (treatment policy perspective). In the primary analysis we assume that losses to follow-up (censoring) are unrelated to outcome.\n Assuming 20% (FHS) vs. 10% (VSP) nonunion at 1 year, 15% mortality before 1 year, 5% loss to follow up before 1 year, beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.20 and alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (2-sided) yields a total of 420 randomized patients (210/arm). This sample size was determined based on 10,000 simulations incorporating the proposed analytic strategy. Across 7 participating centres and accounting for estimated loss to follow-up and mortality rates, we anticipate recruiting approximately 140 patients per year thus target recruitment should be met within 3 years.", "id": 1486, "split": "test"} +{"trial_id": "NCT05430152", "pmid": "38740499", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double Blind Randomized Trial of Low-dose Naltrexone for Post-COVID Fatigue Syndrome\n\nIncluded conditions:\n- Post-Viral Fatigue Syndrome\n\nStudy Armgroups:\n- {'label': 'Low-Dose Naltrexone', 'type': 'EXPERIMENTAL', 'description': 'The Low-Dose Naltrexone (LDN) will be provided as a compounded capsule starting at a strength of 1mg/day of naltrexone and increasing up to a maximum of 4.5 mg/day. The compounding pharmacy will compound the needed doses in Capsugel\u00ae empty gelatin based capsules using Naltrexone Hydrochloride Tablets and CELLULOSE.', 'interventionNames': ['Drug: Low-Dose Naltrexone']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Matching placebo capsule will be created by compounding pharmacy to look exactly like the LDN doses. The compounding pharmacy will compound the placebo in Capsugel\u00ae empty gelatin based capsules using CELLULOSE.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Low-Dose Naltrexone', 'description': 'Study drug dosing schedule (LDN):\\n\\n* Week 1: 1 mg/day (1 mg cap)\\n* Week 2: 2 mg/day (two 1 mg caps)\\n* Week 3: 3 mg/day (three 1mg caps)\\n* Weeks 4-6: 4.5 mg/day (three 1 mg caps, plus one 1.5 mg cap = 4.5 mg/day)\\n* Weeks 7-16: 4.5 mg/day (one 4.5 mg cap) OR based on self-titration dosage (one 1mg, 2mg, or 3mg cap)', 'armGroupLabels': ['Low-Dose Naltrexone'], 'otherNames': ['LDN']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Study drug dosing schedule (Placebo; capsules made to match LDN doses):\\n\\n* Week 1: 1 mg/day (1 mg cap)\\n* Week 2: 2 mg/day (two 1 mg caps)\\n* Week 3: 3 mg/day (three 1mg caps)\\n* Weeks 4-6: 4.5 mg/day (three 1 mg caps, plus one 1.5 mg cap = 4.5 mg/day)\\n* Weeks 7-16: 4.5 mg/day (one 4.5 mg cap) OR based on self-titration dosage (one 1mg, 2mg, or 3mg cap)', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Fatigue Intensity', 'description': 'Change in the Fatigue Severity Scale (FSS) total score by 4.7 points or over', 'timeFrame': '16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAssuming 80% power, 5% significance level, a pooled SD of 9.4, and a 20% loss to follow-up rate.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated based on the primary hypothesis of reduction in fatigue severity with treatment. To detect a 4.7-point difference (effect size (d)=0.5) in the Fatigue Severity Scale (FSS) (9\u00e2\u0080\u009363) between arms, we estimate a sample size of 64 participants per arm assuming 80% power, 5% significance and a pooled SD of 9.4 (estimated from the CCDP Data Registry).83 To account for possible loss to follow-up of 20%, we estimate a final sample size of 80 per arm, for a total target sample size of 160 participants. We chose this method for sample size estimation (as opposed to the use of a minimal clinically important difference (MCID)) because we believed this to be a realistic treatment effect and there were no published MCID values available for the FSS in ME/CFS or PCC.103 104 In a sensitivity analysis, we calculated sample size using a published MCID for systemic lupus erythematosus and this yielded a similar estimate (online supplemental appendix 2).105\n\n \n Recruitment and screening\n New PC-ICCN patients will be contacted regarding study participation, and the PC-ICCN directory will be used to identify other candidate PCC patients to contact. Additionally, the trial will be accessible to individuals through REACH BC, a provincial online platform that facilitates connections between research studies and participants. All potential participants will be asked to complete an online pre-screening questionnaire, and those potentially eligible will meet with research staff to provide consent. Consented participants will complete baseline questionnaires and be assessed by a physician to confirm eligibility. Baseline laboratory studies for all participants will be done prior to initiation of the study drug and abnormal results will be reviewed by a study physician.", "id": 1487, "split": "test"} +{"trial_id": "NCT05430269", "pmid": "39729440", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Faecal Bacteriotherapy for Antibiotic-Associated Diarrhoea in Patients In Intensive Care - Randomised Controlled Trial\n\nIncluded conditions:\n- Diarrhea Caused by Drug\n- Clostridium Difficile Infections\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'ICU patients who developed diarhea after a course of antibiotic therapy treated with Faecal bacteriotherapy (FBT) delivered as enema', 'interventionNames': ['Other: Faecal bacteriotherapy (FBT)']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'ICU patients who developed diarhea after a course of antibiotic therapy treated standard-of-care protocolised treatment of postantibiotic diarhea', 'interventionNames': ['Other: standard-of-care protocolised treatment of postantibiotic diarhea']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Faecal bacteriotherapy (FBT)', 'description': 'Enema of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'standard-of-care protocolised treatment of postantibiotic diarhea', 'description': 'standard-of-care protocolised treatment of postantibiotic diarhea', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment failure', 'description': 'Difference of proportion of patients between intervention and control groups in whom the treatment failed. Failure is defined as treatment has either not been delivered or has not been effective to cure diarrhoea as per WHO definition', 'timeFrame': '7 days after randomisation'}\n\nPlease estimate the sample size based on the assumption: \n80% power, one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval).", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n There is no outcome data in critically ill adults with AAD. However, in two trials in non-critically ill patients, the success of FMT in primary Clostridioides infection was 69% (22 out of 32) or 56% (5 out of 9) as compared to 45% cured by oral metronidazole [38, 39]. Assuming that clinically significant difference between the two methods is 20% and the FMT will have identical efficacy in stopping the AAD in ICU patients, 36 patients are required to have 80% chance 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 of more than 20%.", "id": 1488, "split": "test"} +{"trial_id": "NCT05433077", "pmid": "39881247", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Real Life Pacthe : Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment\n\nIncluded conditions:\n- Non-Metastatic Breast Carcinoma\n- Remission\n- Quality of Life\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Quality of life SF-36', 'description': 'Global score of the short-form 36 (SF-36) quality of life questionnaire. The score goes from 0 to 100. Higher is the score, better is the quality of life.', 'timeFrame': '6 months after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, 95% power, and an estimated 15-20% drop-out rate.", "answer": 400, "answer_type": "ACTUAL", "explanation": "Sample size\n The main analysis consists in comparing the change in SF-36 global score at 6 months from baseline to the value obtained in the PACThe study control group (historical comparator). In the randomized PACThe study, the difference in SF-36 global score between the experimental and control groups was 2.2 points at baseline (p\u00e2\u0080\u0089=.3), and 9.5 points at 6 months (effect size\u00e2\u0080\u0089=\u00e2\u0080\u00890.63, p\u00e2\u0080\u0089<.001), with a difference between 6 months and baseline of 11.9 points in the experimental group, and 4.6 in the control group, and a standard deviation between 15 and 16.\n To determine the number of subjects required, it is assumed that the variation between 6 months and inclusion in this study will be slightly lower than in the PACThe study: expected value of 10 points. It is also estimated that the variability of the scores obtained will be greater than that observed in the PACThe study. Thus, a sample size of 400 should allow us to show a reasonable effect size of 0.2 (alpha risk equal to 5% and 95% power, for a one-sample Student\u00e2\u0080\u0099s t-test), and compensate for an estimated 15\u00e2\u0080\u009320% drop-out rate.", "id": 1489, "split": "test"} +{"trial_id": "NCT05434273", "pmid": "37224162", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of an Integrated Exercise and Cardiovascular Health Education Programme on Community-dwelling Older Adults at Risk of Atherosclerotic Cardiovascular Diseases: A Randomised Controlled Trial\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Healthy Lifestyle\n- Health Education\n\nStudy Armgroups:\n- {'label': 'Experimental Arm: Integrated Intervention', 'type': 'EXPERIMENTAL', 'description': 'Receive an integrated exercise and cardiovascular health education programme (HE programme)', 'interventionNames': ['Behavioral: HE programme']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'description': 'Receive usual care', 'interventionNames': ['Behavioral: Usual care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'HE programme', 'description': 'Participants will receive a 12-week integrated exercise and cardiovascular health education programme (HE programme) which is constructed based on self-efficacy theory. A booster intervention in the form of SMS messaging will be given from Week 1 to Week 12.', 'armGroupLabels': ['Experimental Arm: Integrated Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual care', 'description': 'Participants will receive usual care which primarily includes an education talk on basic health issues. A governmental health education leaflet and a lecture video will be provided for reference.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Physical activity level (total score) at Week 24', 'description': 'The physical activity level will be measured by the Chinese Version of Physical Activity Scale for the Elderly (PASE-C). The total score (from zero to 400 or above) is quantified based on frequency values and weights for these activities. The higher the score, the higher the level of physical activity.', 'timeFrame': 'At Week 24'}\n- {'measure': 'Physical activity level (classification of physical activity level) at Week 24', 'description': 'The physical activity level will be measured by the Chinese version of International Physical Activity Questionnaire-short form (IPAQ-C-short form). Participants are classified into \"inactive\", \"minimally active\" or \"health enhancing physical activity (HEPA) active\" based on their physical activity levels.', 'timeFrame': 'At Week 24'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test, desired statistical power of 0.80, significance level of 0.05, and an assumed attrition rate of 20%.", "answer": 190, "answer_type": "ESTIMATED", "explanation": "Sample size\n Taking PA level as the primary outcome, with reference to a meta-analysis by Conn et al. [37], the overall mean weighted effect size of patient education on PA level among 17147 patients with chronically diseases is 0.45. The sample size of the proposed study is calculated via G*Power calculator [38]. For a two-tailed test, with the desired statistical power of 0.80 and significance level of 0.05, the estimated sample size is 158. Although the attrition rates of five related studies were less than 20% [11, 12, 14, 15, 17], for conservative reason, an attrition rate of 20% is assumed. Hence, a total of 190 participants (95 participants per group) will be recruited in the study.", "id": 1490, "split": "test"} +{"trial_id": "NCT05435118", "pmid": "37419632", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) Associated With Audiovisuals During Peripheral Venous Access Insertion of Children Between 2-5 Years Old Children\n\nIncluded conditions:\n- Pain, Acute\n- Child, Only\n- Nurse's Role\n- Nitrous Oxide\n\nStudy Armgroups:\n- {'label': 'EMONO (usual care administered to all the children undergoing painful procedures)', 'type': 'NO_INTERVENTION', 'description': 'Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask. In the hospital EMONO is administered to all the children for procedure pain control.'}\n- {'label': 'EMONO + audiovisuals tool', 'type': 'EXPERIMENTAL', 'description': 'Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask and vision of audiovisual toll with smartphone or tablet. The intervention is represented by the audiovisual tool.', 'interventionNames': ['Other: EMONO + audiovisuals tool']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'EMONO + audiovisuals tool', 'description': 'EMONO + use of audiovisuals tool on smartphone or tablet', 'armGroupLabels': ['EMONO + audiovisuals tool']}\n\nPrimary Outcomes:\n- {'measure': 'collaboration', 'description': 'children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)', 'timeFrame': '30 minutes'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) of 0.05, power of 80%, and a dropout rate of about 20%.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Power and sample size\n The primary outcomes are perceived pain and cooperation detected during peripheral venous access placement as measured according to the corresponding score. A sample size of 48 subjects allows detection of an effect size on cooperation W of 0.5 (large) using a \u00cf\u00872 test with 4 df (df=(5\u00e2\u0088\u00921) times (2\u00e2\u0088\u00921)=4) 80% power and a significance level (alpha) of 0.05. If the effect size W is 0.3 (medium level), 133 subjects guarantee 80% power in a 4 df \u00cf\u00872 test with a significance level (alpha) of 0.05.\n The effect size (W) was used by Cohen (1988) because it does not depend on the sample size, with the suggestion of the effect size cut-offs of 0.1 (small), 0.3 (medium) and 0.5 (large) as rough guidelines to help calculate sample sizes in studies. For this study, a total of120 subjects will allow for an effect size between medium and large with a drop-out of about 20% and the usual assumptions of alpha=0.05\u00e2\u0080\u0089and power=0.80.", "id": 1491, "split": "test"} +{"trial_id": "NCT05436665", "pmid": "37714670", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)\n\nIncluded conditions:\n- Corneal Edema\n- Corneal Endothelial Disorder\n- Fuchs' Endothelial Dystrophy\n- Bullous Keratopathy\n- Pseudophakic Bullous Keratopathy\n\nStudy Armgroups:\n- {'label': 'Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)', 'type': 'ACTIVE_COMPARATOR', 'description': \"Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) refers to the use of a corneal endothelial/Descemet graft with a thin layer of stroma (\\\\<110um) attached.\\n\\nThe cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty.\\n\\nIn the DSAEK technique, a piece of the donor's endothelium is transplanted with a supporting layer of donor stroma.\", 'interventionNames': ['Procedure: UT-DSAEK']}\n- {'label': 'Descemet membrane endothelial keratoplasty (DMEK)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial/Descemet graft with no layer of associated stroma (15-20um thick).\\n\\nThe cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty.\\n\\nIn the DMEK technique only a piece of donor endothelium layer is together with its supporting membrane (the Descemet membrane), is transplanted.', 'interventionNames': ['Procedure: DMEK']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'UT-DSAEK', 'description': \"The main incision (3.5-5mm) is created at the corneal limbus or via a cornea-scleral tunnel with 2-3 smaller (approx. 1mm) paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber, according to the surgeon's preference. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. Once the anterior chamber is prepared, OVD or air has been removed, then the eye is ready for the new corneal graft.\\n\\nThe pre-cut corneal tissue delivered by the bank is then gently rinsed and may be stained with 0.06% trypan blue if required. The tissue is loaded into a glide or injector, and pulled into the anterior chamber using a smooth-tipped micro-forceps (e.g., Busin forceps). Once the graft enters the eye, it is lifted to the posterior cornea. The graft is further centred using air (or SF6 Gas) in the anterior chamber.\", 'armGroupLabels': ['Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)'], 'otherNames': ['Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty']}\n- {'type': 'PROCEDURE', 'name': 'DMEK', 'description': 'The main incision (2.8-3mm) is created superior or temporally at the corneal limbus and is accompanied by 2-3 smaller paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed.\\n\\nThe DMEK roll is poured into a basin and rinsed. The graft is then stained with 0.06% trypan blue to aid in graft visualization. The graft is loaded into an injector and introduced into the anterior chamber. The graft is unrolled using external manoeuvres and once unrolled, it is lifted to the back of the cornea. The eye is then pressurised with a full air fill from 10 to 120 minutes. The pressure is then reduced and the case is completed by suturing any incisions required.', 'armGroupLabels': ['Descemet membrane endothelial keratoplasty (DMEK)'], 'otherNames': ['Descemet Membrane Endothelial Keratoplasty']}\n\nPrimary Outcomes:\n- {'measure': 'BCVA 12m', 'description': 'Best-corrected visual acuity expressed in LogMAR', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSD of 0.25, 80% power, two-sided significance level of 0.05, and a conservative dropout rate of 5%.", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome is the change in BCVA at 12 months, compared with baseline measured in basic decimal Snellen and recorded in LogMAR units. Dunker et al reported an improvement of 0.16 logMAR with UT-DSAEK and 0.29 in DMEK, with a variability of 0.20.28 Given that we are using a pragmatic approach of including all endothelial decompensations, we expect to have a more heterogeneous population and testing centres, we anticipate a larger variability and, therefore, we assume a SD of 0.25. According to Rosser et al, a difference of 0.1 logMAR or 1 line is considered clinically relevant.29 Therefore, we have powered the study around the difference of 0.1 LogMAR. Sample size calculation in PASS 11 for an independent t-test, revealed that we need to include at least 105 participants per group in order to have 80% power to detect a difference of 0.1 with an SD of 0.25 (effect size 0.4) at a two-sided significance level of 0.05. Anticipating a conservative dropout rate of 5%, 110 patients per arm, or 220 patients in total, will be included. As no drop-outs were reported in the previous trials, we expect less than 5% drop-out.16 28", "id": 1492, "split": "test"} +{"trial_id": "NCT05439005", "pmid": "39961716", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'OFA group', 'type': 'EXPERIMENTAL', 'description': 'OFA (Opioid Free Anaesthesia) group:', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'CA control group', 'type': 'NO_INTERVENTION', 'description': 'CA (Conventional Anaesthesia) control group:'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Dexmedetomidine+Lidocaine', 'armGroupLabels': ['OFA group']}\n\nPrimary Outcomes:\n- {'measure': 'comparison of Morphine consumption in the two groups', 'timeFrame': 'during the first 48 hours postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 5% and a power of 80% are assumed. In case of missing data, multiple imputations by chained equation (MICE) will be used. An additional 5% of subjects are included to account for potential missing data.", "answer": 158, "answer_type": "ESTIMATED", "explanation": "Sample size\n Assumptions for the calculation of the number of subjects are based on an analysis of institutional data on patients who received \u00e2\u0080\u0098conventional\u00e2\u0080\u0099 anaesthesia: the mean and SD observed in morphine consumption over the first 48 postoperative hours were 18 mg and 11.7\u00e2\u0080\u0089mg, respectively. The minimal clinically interesting difference is a 30% decrease in morphine consumption (mean: 12.6\u00e2\u0080\u0089mg, SD assumed identical in both groups). For a first-species risk of 5%, the inclusion of 150 patients will give the study a power of 80%. In case of missing data for the primary endpoint (morphine consumption over the first 48 postoperative hours), the analysis will be performed after multiple imputations by chained equation (MICE). Although the loss of power associated with the procedure is minimal, it is planned to include an additional 5% of subjects or 158 patients (allocated in a 1:1 ratio).", "id": 1493, "split": "test"} +{"trial_id": "NCT05440149", "pmid": "36384573", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial\n\nIncluded conditions:\n- Radiotherapy\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'The Control group', 'type': 'ACTIVE_COMPARATOR', 'description': '* If patients received mastectomy, post-mastectomy radiation therapy (PMRT) should be performed.\\n* If patients received breast conserving surgery (BCS), whole breast irradiation (WBI) + Regional radiotherapy (RT) should be performed.', 'interventionNames': ['Radiation: PMRT for mastectomy / WBI + Regional RT for BCS']}\n- {'label': 'The Experimental group', 'type': 'EXPERIMENTAL', 'description': '* If patients received mastectomy, No PMRT should be performed.\\n* If patients received BCS, WBI alone should be performed.', 'interventionNames': ['Radiation: No PMRT for mastectomy / No regional RT for BCS']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'No PMRT for mastectomy / No regional RT for BCS', 'description': '* Regional RT includes high-tangent field, and can include undissected axilla.\\n* The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II.\\n* Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.', 'armGroupLabels': ['The Experimental group']}\n- {'type': 'RADIATION', 'name': 'PMRT for mastectomy / WBI + Regional RT for BCS', 'description': '* Regional RT includes high-tangent field, and can include undissected axilla.\\n* The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II.\\n* Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.', 'armGroupLabels': ['The Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Disease-Free Survival', 'description': 'Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.', 'timeFrame': '7-Year'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate is 5%. The power is 80%. The dropout rate is 5%. The recruitment period is 4 years with a 7-year follow-up. The time to progression follows an exponential distribution.", "answer": 1106, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The PORT-N1 trial was designed to determine whether the omission of RNI from BCS and PMRT in patients undergoing a mastectomy reduced treatment efficacy. The expected 7-year DFS of the control group in this trial is 90%, based on a previous multicenter retrospective studies conducted by the KROG. The rate of recurrence at 7\u00e2\u0080\u0089years was 12% for the no-PMRT group in KROG 14-23 [20]; the recurrence rate is expected to be lower in the PORT-N1 trial because more than a decade has passed since the previous study. The KROG 14-18 study analyzed pN1 breast cancer patients who underwent anthracycline and taxane chemotherapy, and reported a 5-year DFS of 92.4%, with no difference seen between BCS plus PORT and mastectomy alone groups [21]. Another analysis of KROG 14-18 data compared WBI alone and WBI plus SCL irradiation, and obtained 5-year DFS rates of 94.4 and 92.6%, respectively [19]. The sample size calculation for the PORT-N1 trial assumes a non-inferiority margin of 5%, type I error rate of 5%, 4-year recruitment period, 7-year follow-up, and exponential distribution for time to progression; 134 DFS events are expected, and 525 patients are required for each group for a power of 80%. Assuming a dropout rate of 5%, the final number of patients to be randomized is 1106 (553 for each group).", "id": 1494, "split": "test"} +{"trial_id": "NCT05440955", "pmid": "36829240", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Auditory Biomarker Analysis of Fronto-Temporal Transcranial Direct Current Stimulation (tDCS) in Targeting Cognitive Impairment Associated With Recent-onset Schizophrenia: A Randomized Double-blind Sham-controlled Trial\n\nIncluded conditions:\n- Schizophrenia\n- Psychotic Disorder\n\nStudy Armgroups:\n- {'label': 'active tDCS', 'type': 'EXPERIMENTAL', 'description': 'tDCS (transcranial Direct Current Stimulation subjects) is a noninvasive brain stimulation technique that involves the passage of a small electric current through the scalp and skull to modulate brain activity \\\\[10\\\\]. The study intervention consists of ten 20-minutes sessions of active or sham tDCS. Sessions will be delivered twice daily and separated by at least 2 hours for 5 consecutive weekdays. The electric current will be generated by an electric stimulator (class IIa medical device).', 'interventionNames': ['Device: left fronto-temporal transcranial Direct Current Stimulation (tDCS)']}\n- {'label': 'sham tDCS', 'type': 'SHAM_COMPARATOR', 'description': 'The sham procedure is developed by the tDCS device manufacturer, which allows using the same tDCS device and the same procedure (i.e., 10 sessions delivered during five consecutive days) for both the active and sham procedures. In the sham condition, the electrodes will be placed in the same positions as in the active group; however, the stimulator will be only active for initial and final ramp up/ramp down periods, in order to mimic the sensation of active stimulation. In addition, brief pulses of 110 \u03bcA will be administered every 550 ms in order to control impedance and keep the manipulator blinded to the active or sham condition.', 'interventionNames': ['Device: left fronto-temporal transcranial Direct Current Stimulation (tDCS)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'left fronto-temporal transcranial Direct Current Stimulation (tDCS)', 'description': 'The study intervention consists of ten 20-minutes sessions of active or sham tDCS. Sessions will be delivered twice daily and separated by at least 2 hours for 5 consecutive weekdays. The electric current will be generated by an electric stimulator (class IIa medical device). During the entire tDCS session, the subject is at \"rest\", comfortably seated in a chair in a quiet room. A clinician will be present for the entire session duration. The current will be applied via a pair of rubber electrodes (35 cm\u00b2) placed on the surface of the scalp. The anode will be placed over the left dorsolateral prefrontal cortex. The cathode will be placed over the left auditory cortex. The stimulation parameters will be set at 2-mA for 20 minutes, with a progressive increase during the first 30-sec and a progressive decrease during the last 30-sec of each session. The impedance of the applied current is monitored by the stimulator during each session.', 'armGroupLabels': ['active tDCS', 'sham tDCS']}\n\nPrimary Outcomes:\n- {'measure': 'Cognitive response', 'description': 'Number of responders at 1-month after tDCS, defined as the proportion of patients demonstrating a cognitive improvement greater than or equal to Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score (MCCB). The MCCB is a gold-standard standardized test battery to assess cognitive functions in patients with schizophrenia. This criterion has been used and validated in both antipsychotic and cognitive remediation trials in schizophrenia.', 'timeFrame': 'at 1-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80% and significance level (p) of 0.05.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on previous tDCS studies in patients with schizophrenia (rev. in [17], we assume that a third (33%) of participants in the active tDCS group and 5% of participants in the sham tDCS group will be responders (improvement greater than or equal to Z=0.5 from baseline on the MCCB total score). Based on this estimated difference, we calculated that 60 patients are required to demonstrate a difference between the two groups with a power of 80% (p = 0.05).", "id": 1495, "split": "test"} +{"trial_id": "NCT05443295", "pmid": "39695629", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improvement of Fatigue in Unstable Shoulder Through a Therapeutic Exercise Program in Physiotherapy\n\nIncluded conditions:\n- Instability, Joint\n- Shoulder Dislocation\n- Fatigue\n- Therapeutic Alliance\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will carry out the MoveUS Program.', 'interventionNames': ['Other: MoveUS Program']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will be subjected to the conventional guidelines in the approach to shoulder instability.', 'interventionNames': ['Other: Control intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'MoveUS Program', 'description': 'The MoveUS Program have 5 stages: 1 (approach stage), based on analytical movements, isometric peak contractions and learning/motor control; 2 (structural stage), based on muscular strength or resistance training through a cumulative work of short efforts, following with the analytical work of pushing or lifting/pulling; and ending in a closed kinetic chain; 3 (neural stage), that has two stage: 3A, based on a structural work that serves as a continuation of stage 2 and the work is focused on the training of increase cross-sectional muscular area; and 3B, based on a neural work focursed in an intra neuromuscular system highlighted motoneuron unit workout. Finally, stage 4 (functional stage), based on a functional readaptation to sports activity and/or work activity; or, failing that, to the activity of daily life with the highest demand.', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'OTHER', 'name': 'Control intervention', 'description': 'The control intervention is based on following the conventional treatment guidelines for glenohumeral instability, where immobilization, taking non-steroidal anti-inflammatory drugs, cryotherapy, passive kinesitherapy and self-assisted, pendular exercises stand out and education.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of life (WOSI)', 'description': \"Quality of life is the set of factors that contribute to a person's well-being. It will be assessed through the Western Ontario Shoulder Instability Index\", 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nStatistical significance level of 5%, statistical power of 80%, and a 20% addition for possible losses during follow-up.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size\n Version 3.1 G-Power was used to estimate the sample size. Taking a level of statistical significance of 5% and a statistical power of 80% to be able to detect the possible differences in the hypothesis contrast proposed; based on previous studies with which the population, intervention, and main outcome variable are shared, which have shown an effect size of 0.6 (95% CI 0.0\u00e2\u0080\u00931.3) [18], and adding 20% to alleviate possible losses during follow-up, that is, we will recruit a minimum of 108 patients, 54 for each group.", "id": 1496, "split": "test"} +{"trial_id": "NCT05444101", "pmid": "36948567", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study\n\nIncluded conditions:\n- Pain, Chronic\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Waitlist control', 'type': 'NO_INTERVENTION', 'description': 'Participants randomized to condition 1 are not offered any treatment components immediately upon enrollment, but will be offered a treatment component of own choice at the end of the study. Total number of sessions: 2 (2 contact hours) following study completion.'}\n- {'label': 'Mindful attention', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).', 'interventionNames': ['Behavioral: Mindful attention']}\n- {'label': 'Decentering', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours).', 'interventionNames': ['Behavioral: Decentering']}\n- {'label': 'Values and committed action', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours).', 'interventionNames': ['Behavioral: Values and committed action']}\n- {'label': 'Mindful attention + Decentering', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 5 will receive the Mindful attention treatment component and the Decentering treatment component in different orders. Total number of sessions: 4 (4 contact hours).', 'interventionNames': ['Behavioral: Mindful attention', 'Behavioral: Decentering']}\n- {'label': 'Mindful attention + Values and committed action', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 6 will receive the Mindful attention treatment component and the Values and committed action treatment component in different orders. Total number of sessions: 4 (4 contact hours).', 'interventionNames': ['Behavioral: Mindful attention', 'Behavioral: Values and committed action']}\n- {'label': 'Decentering + Values and committed action', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 7 will receive the Decentering treatment component and the Values and committed action treatment component in different orders. Total number of sessions: 4 (4 contact hours).', 'interventionNames': ['Behavioral: Decentering', 'Behavioral: Values and committed action']}\n- {'label': 'Mindful attention + Decentering + Values and committed action', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to condition 8 will receive the Mindful attention treatment component, the Decentering treatment component, and the Values and committed action treatment component in different orders. Total number of sessions: 6 (6 contact hours).', 'interventionNames': ['Behavioral: Mindful attention', 'Behavioral: Decentering', 'Behavioral: Values and committed action']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindful attention', 'description': 'The Mindful attention treatment component consists of a breathing exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.', 'armGroupLabels': ['Mindful attention', 'Mindful attention + Decentering', 'Mindful attention + Decentering + Values and committed action', 'Mindful attention + Values and committed action']}\n- {'type': 'BEHAVIORAL', 'name': 'Decentering', 'description': 'The Decentering treatment component consists of a guided imagery exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.', 'armGroupLabels': ['Decentering', 'Decentering + Values and committed action', 'Mindful attention + Decentering', 'Mindful attention + Decentering + Values and committed action']}\n- {'type': 'BEHAVIORAL', 'name': 'Values and committed action', 'description': 'The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.', 'armGroupLabels': ['Decentering + Values and committed action', 'Mindful attention + Decentering + Values and committed action', 'Mindful attention + Values and committed action', 'Values and committed action']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity (11-point Numeric Rating Scale, NRS)', 'description': 'The NRS is a validated, self-report instrument assessing pain intensity during the last week. Answer format range: 0 (no pain) to 10 (worst possible pain); total score range: 0-10. A higher score yields more pain.', 'timeFrame': 'Baseline (T1) to 1 week after last session (Post-intervention, T2)'}\n- {'measure': 'Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)', 'description': 'The BPI is a validated, self-report instrument assessing clinical pain. The BPI pain interference subscale assesses pain interference during the last week across 7 domains, i.e., general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Answer format range: 0 (no interference) to 10 (maximal interference); total score range: 0-10. A higher score yields more pain.', 'timeFrame': 'Baseline (T1) to 1 week after last session (Post-intervention, T2)'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 0.90, significance level adjusted for three primary tests, and an anticipated dropout rate of 20%.", "answer": 185, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size\n The criteria for a treatment component to be considered efficacious are (1) a statistically significant (p<0.017) effect (ie, time\u00c3\u0097group) on at least one of the two primary outcomes, (2) corresponding to an effect size of d\u00e2\u0089\u00a50.30, cf. previous effect sizes found in meta-analyses.25 30 31 The online software G*power115 116 was used to calculate statistical power. To reach a statistical power of 0.90 to detect an effect (ie, time\u00c3\u0097group), with an effect size of d=0.30\u00e2\u0080\u0089and adjusting the \u00ce\u00b1 level for three primary tests (ie, multiple comparisons; one test per treatment component), the number needed to include is 185 (including an anticipated dropout rate of 20%). With reference to the eight conditions, cf. figure 2, we thus aim to include 192 participants, corresponding to 24 per condition.", "id": 1497, "split": "test"} +{"trial_id": "NCT05444192", "pmid": "38569685", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing the Effectiveness of Computer-aided-design Computer-aided-manufacture (CAD/CAM) Insoles Manufactured From Foam-box Cast vs Direct Scan on Patient Reported Outcome Measures: A Double-blinded, Randomised Controlled Trial\n\nIncluded conditions:\n- Foot Injury\n- Foot Deformity\n- Foot Sprain\n- Feet, Flat\n- Foot Ankle Injuries\n\nStudy Armgroups:\n- {'label': 'insoles manufactured from foam-box cast', 'type': 'ACTIVE_COMPARATOR', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.', 'interventionNames': ['Device: CAD/CAM insoles']}\n- {'label': 'insoles manufactured from direct 3D scan', 'type': 'ACTIVE_COMPARATOR', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.', 'interventionNames': ['Device: CAD/CAM insoles']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CAD/CAM insoles', 'description': 'computer-aided-design computer-aided-manufacture (CAD/CAM) insoles', 'armGroupLabels': ['insoles manufactured from direct 3D scan', 'insoles manufactured from foam-box cast']}\n\nPrimary Outcomes:\n- {'measure': 'Foot Health Status Questionnaire (FHSQ) - Pain sub-domain', 'description': 'To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention'}\n\nPlease estimate the sample size based on the assumption: \n5% dropout rate.", "answer": 114, "answer_type": "ACTUAL", "explanation": "Sample size\n A sample size power calculation, based on data from Landorf et al\n36 regarding FHSQ, was used to detect a clinically important difference between groups of 13 (SD=26.9) points in FHSQ scores using the pain subdomain as the primary outcome. Giving a required minimum sample size of 54 participants in each group and including a 5% dropout rate, 57 participants will be recruited into each group, thus requiring a total sample size of n=114.", "id": 1498, "split": "test"} +{"trial_id": "NCT05445141", "pmid": "36907876", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Little ACF: A Randomized Controlled Trial on Effects of Universal Parental Group Support Regarding Infants Aged 12-24 Months\n\nIncluded conditions:\n- Parental Support\n- Emotion Regulation\n- Coping Behavior\n- Stress, Emotional\n- Coparenting\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Parents included in the intervention group will be offered to participate in four meetings that are taking place during four weeks time. The focus of the meetings is on how to promote parent-infant relationship. The theoretical base is positive developmental psychology including research on attachment, parenting and co-parenting, emotional regulation, and observational learning/role models. Roleplays, video-clips, discussions, and individual reflections are used to empower families during the sessions. Parents are encouraged to try the content with their child between the sessions and will be provided a printed material.', 'interventionNames': ['Behavioral: Little ACF [in Swedish: Lilla ABC]']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'description': 'Parents in the control group will via a web-based portal be able to view four pre-recorded lectures during four weeks. The lectures will be around 10 minutes long and have a content similar to the group meetings that are offered to the intervention group but more superficial and without printed material and reflection practices.', 'interventionNames': ['Behavioral: Lectures']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Little ACF [in Swedish: Lilla ABC]', 'description': 'Little ACF is a modified version of the program called All Children in Focus \\\\[in Swedish: Alla Barn i Centrum (ABC)\\\\] that originally is developed for parents with children 3-12 years of age. The content is based on positive developmental psychology and involves role plays, discussions and exercises to try at home with the child. Printed material will be provided to the parents at each meeting/session. Little ACF is offered once a week during four weeks. Each session is 60 minutes, thereafter the parents can stay in the facility for 30 minutes to continue discussing with each other.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Lectures', 'description': 'The lectures are pre-recorded and available during four weeks. Each lecture is 10 minutes and the content is similar to, but more superficial than, the content in Little ACF.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Change in parental self-efficacy from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.', 'description': 'Will be measured with the \"Tool to Measure Parenting Self-Efficacy\" - TOPSE (Bloomfield \\\\& Kendall, 2012), with 48 statements that are to be answered to on a 11 point scale, from 0=not agree to 10=fully agree', 'timeFrame': \"At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))\"}\n- {'measure': 'Change in parent emotion regulation from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.', 'description': 'Will be measured with the \"Parent Emotion Regulation Scale\" - PERS (Pereira et al., 2017). The scale has 20 statements that should be rated on a 5-point scale, from 1=never or almost never to 5=always or almost always.', 'timeFrame': \"At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))\"}\n- {'measure': 'Change in coping with the negative emotions of the child from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.', 'description': 'Will be measured using \"Coping with Toddlers\\' Negative Emotion Scale\" - CTNES (Spinrad et al, 2007), the scale has 12 scenarios with 7 options each on how a parent would react that to that specific scenario (Distress reactions, Punitive reactions, Expressive encouragement, Emotion-focused reactions, Problem-focused reactions, Minimization reactions and Granting wish reactions), the parent are asked to rate how likely s/he is to react in that specific manner from 1 = very unlikely to 7 = very likely, the higher the score the more likely to use that coping mechanism.', 'timeFrame': \"At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))\"}\n- {'measure': 'Change in parental stress from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.', 'description': 'Will be measured using the scales (1) incompetence, (2) social isolation and (3) role restriction from the \"Swedish Parenting Stress Questionnaire\" - SPSQ (\u00d6stberg, Hagekull \\\\& Wettergren, 1997), the scale is from 1 to 5 indicating \\'Strongly disagree\\' to \\'Strongly agree\\', the total possible score is 170 and higher scores indicate higher stress.', 'timeFrame': \"At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))\"}\n- {'measure': 'Change in coparenting relationship from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.', 'description': 'Will be measured using 5 items from \"The Coparenting Relationship Scale\" (Feinberg et al., 2012), to be answered with a 5 point scale from 1=not agree to 5=fully agree', 'timeFrame': \"At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))\"}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 95% (p-value 0.05), power of 80%, and a dropout rate of 25%.", "answer": 670, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n \n Power calculation\n A previous RCT of the program ACF for parents of children 3\u00e2\u0080\u009312\u00c2\u00a0years of age showed an effect size (Cohen\u00e2\u0080\u0099s d) of 0.30 for parental self-efficacy [16]. We expect a slightly smaller effect (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.25) because this study compares Little ACF with lectures while the previous study had a waitlist control group. A total of 251 participants in each group are therefore needed with a significance level of 95% (p-value 0.05) and a power of 80%. A drop-out of 25% is expected resulting in the need to include 670 families in total. Each group consists of parents to 5\u00e2\u0080\u00938 children so about 60\u00e2\u0080\u009370 groups are needed. Each group leader is expected to lead at least three groups which means that about 25 group leader pairs are needed in total.", "id": 1499, "split": "test"} +{"trial_id": "NCT05445778", "pmid": "39082675", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FR\u03b1-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)\n\nIncluded conditions:\n- Ovarian Cancer\n- Peritoneal Cancer\n- Fallopian Tube Cancer\n\nStudy Armgroups:\n- {'label': 'Arm 1', 'type': 'EXPERIMENTAL', 'description': 'Mirvetuximab Soravtansine (MIRV) plus Bevacizumab', 'interventionNames': ['Drug: Mirvetuximab soravtansine plus Bevacizumab']}\n- {'label': 'Arm 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Bevacizumab monotherapy', 'interventionNames': ['Drug: Bevacizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mirvetuximab soravtansine plus Bevacizumab', 'description': 'Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks', 'armGroupLabels': ['Arm 1'], 'otherNames': ['MIRV']}\n- {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Participants will receive Bevacizumab 15mg/kg every 3 weeks', 'armGroupLabels': ['Arm 2']}\n\nPrimary Outcomes:\n- {'measure': 'Assess Progression-free survival (PFS)', 'description': 'Progression-free survival defined as the time from date of randomization until investigator-assessed progressive disease (PD) or death, whichever occurs first.', 'timeFrame': 'Up to 4 years'}\n\nPlease estimate the sample size based on the assumption: \n90% power, overall attrition rate of approximately 13%, uniform enrollment over 36 months, 24 months follow-up duration", "answer": 418, "answer_type": "ESTIMATED", "explanation": "2.5.\n Sample size\n The GLORIOSA trial will enroll approximately 418 participants into the maintenance portion of the trial (~209 participants in each arm) over a period of roughly 3\u00c2\u00a0years and have 90% power to detect an HR of 0.7. Sample size and power were determined using R-Project package gsDesign version 2 with the following assumptions: median PFS in arm 2 (bevacizumab alone) is 9\u00c2\u00a0months, median PFS in arm 1 (MIRV plus bevacizumab) is 12.9\u00c2\u00a0months, there is exponential distribution for the event process, the overall attrition rate in both arms is approximately 13%, enrollment is uniform over a 36-month period, and duration of follow-up is 24\u00c2\u00a0months.", "id": 1500, "split": "test"} +{"trial_id": "NCT05446272", "pmid": "38509583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial\n\nIncluded conditions:\n- Extubation Failure\n- Bronchopulmonary Dysplasia\n- Death\n\nStudy Armgroups:\n- {'label': 'NIV-NAVA', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: NIV-NAVA']}\n- {'label': 'NS- NIPPV', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: NS-NIPPV']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'NIV-NAVA', 'description': 'Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.', 'armGroupLabels': ['NIV-NAVA'], 'otherNames': ['Non-invasive Neurally Adjusted Ventilatory Assist']}\n- {'type': 'DEVICE', 'name': 'NS-NIPPV', 'description': 'Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.', 'armGroupLabels': ['NS- NIPPV'], 'otherNames': ['Non-synchronized Non-invasive Positive Pressure Ventilation']}\n\nPrimary Outcomes:\n- {'measure': 'Extubation failure', 'description': 'Extubation failure is defined when an infant is on the allocated mode of respiratory support and meets any of the following 4 criteria: (1) Rise in FiO2 at least 20% from pre-extubation value for \\\\>2 hours to maintain local SpO2 targets, (2) pH \u22647.20 or pCO2 \u226570mm Hg; (3) \\\\>1 apneic event requiring positive pressure ventilation (PPV) within 6 hours or \u2265 6 apneic events requiring stimulation within 6 hours (4) emergent intubation by the clinical team for cardiovascular instability or surgery.', 'timeFrame': 'within the first 5 days (120 hours) post extubation'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes 90% power, a two-sided test with a family-wise error rate of 0.05, a group sequential design with 2 interim analyses, and a 2% dropout rate. The multiple birth design effect is 1.15, assuming an intraclass correlation coefficient of 0.6.", "answer": 478, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The calculated study sample size accounts for 478 infants in the randomization phase. Very little published data exists for reintubation rates using NIV-NAVA or NS-NIPPV in our study population. In a recent pilot RCT of more mature preterm infants (median 27\u00c2\u00a0weeks\u00e2\u0080\u0099 gestation), 9% of infants managed with NIV-NAVA were reintubated within 5\u00c2\u00a0days [30]. Our preliminary data indicates a higher failure rate in our more immature study population (Table\u00c2\u00a01). Sample size estimates were based on having 90% power to detect a 15% absolute risk reduction in extubation failure among infants treated with NIV-NAVA, compared with non-synchronized NIPPV, assuming a two-sided test, family-wise error rate of 0.05 and a group sequential design with 2 interim analyses. The interim analyses were set after 50% and 75% of the infants have completed the primary outcome and used Len-DeMets spending functions of the O\u00e2\u0080\u0099Brien-Fleming type. Simulation studies were used to determine that interim analyses prior to 50% completion of the primary outcome were highly unlikely to result in any clinically meaningful differences in the primary efficacy and safety outcomes while reducing power for the final analysis.\n Preliminary data from the DIVA trial sites informed sample size calculations: following extubation, 40% of infants treated with NS-NIPPV were reintubated within 5\u00c2\u00a0days, and 19% of infants treated with NIV-NAVA were reintubated within 5\u00c2\u00a0days (Table\u00c2\u00a01). This reintubation rate for NS-NIPPV is consistent with the reintubation rate of 37% among infants treated with NIPPV in the largest trial of NIPPV vs. CPAP (n\u00e2\u0080\u0089=\u00e2\u0080\u00891009) [19].\n Thus, we conservatively anticipate a 5-day extubation failure rate of 35% in the NS-NIPPV group. We assume 90% power and a two-sided proportions test. To detect a 15% absolute reduction in the rate of extubation failure rate in the NIV-NAVA group would require 406 infants. We expect 25% of enrolled infants to be from a multiple birth (based on the PIs\u00e2\u0080\u0099 previous trials and published papers). The multiple birth design effect is 1.15, assuming an intraclass correlation coefficient of 0.6. Inflating the required sample size for the design effect and conservatively allowing for 2% drop-out prior to the primary outcome results in 478 randomized infants (Table\u00c2\u00a04).\nTable\u00c2\u00a04Sample size requirements for the primary outcomePowerFailure rate in non-synchronized NIPPV armFailure rate in NIV-NAVA armGSD sample sizeICCDesign effectSample size (total infants randomized)90%30%15%3580.41.104020.61.1542220%8440.41.109480.61.1599235%15%2220.41.102500.61.1526220%4060.41.104560.61.1547840%15%1540.41.101740.61.1518220%2460.41.102780.61.15290\n Only infants in the randomization phase will be included in the analysis of NIV-NAVA vs. NS-NIPPV for specified outcomes; infants from the run-in phase do not contribute to the analysis. We anticipate enrolling (consenting) up to two infants for every infant who meets all eligibility criteria and is allocated to treatment, as not all consented subjects will be eligible for the trial at the time of extubation. Thus, we expect to enroll (consent) up to 1080 infants to obtain 540 eligible subjects allocated to study treatment across both phases.", "id": 1501, "split": "test"} +{"trial_id": "NCT05448664", "pmid": "36384815", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial\n\nIncluded conditions:\n- Oral Health\n\nStudy Armgroups:\n- {'label': 'Families HBM- mobile messaging', 'type': 'EXPERIMENTAL', 'description': 'Family- and HBM-based behavioral intervention using mobile messaging', 'interventionNames': ['Behavioral: Family HBM- mobile messaging']}\n- {'label': 'Adolescents HBM- mobile messaging', 'type': 'ACTIVE_COMPARATOR', 'description': 'Student- and HBM-based behavioral intervention using mobile messaging', 'interventionNames': ['Behavioral: Adolescent HBM- mobile messaging']}\n- {'label': 'Adolescents e-pamphlets', 'type': 'PLACEBO_COMPARATOR', 'description': 'Prevailing oral health education by e-version of pamphlets through mobile messaging', 'interventionNames': ['Behavioral: Adolescent e-pamphlets']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Family HBM- mobile messaging', 'description': 'The intervention will consist of two blocks of text messaging based on HBM model, the messages will be sent to the students and their parents in the following 24 weeks.', 'armGroupLabels': ['Families HBM- mobile messaging']}\n- {'type': 'BEHAVIORAL', 'name': 'Adolescent HBM- mobile messaging', 'description': 'The intervention will consist of two blocks of text messaging based on HBM model, the messages will be sent to the students in the following 24 weeks.', 'armGroupLabels': ['Adolescents HBM- mobile messaging']}\n- {'type': 'BEHAVIORAL', 'name': 'Adolescent e-pamphlets', 'description': 'The contents of e-version of three pamphlets, published by Department of Health (http://www.toothclub.gov.hk/en/en_index.html) will be distributed in an electronic form and sent via a mobile message.', 'armGroupLabels': ['Adolescents e-pamphlets']}\n\nPrimary Outcomes:\n- {'measure': 'Caries increment', 'description': 'Dental caries increment (by tooth level) from baseline to 2 years follow up', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, targeted statistical power of 80%, typical ICC value of 0.03, and a dropout rate of 10%.", "answer": 900, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size has been calculated using G*Power software. Our previous study showed that motivational interviewing was more effective than prevailing OHE in preventing dental caries among adolescents [17]. In this proposed study, the sample size is calculated based on mean and standard deviations of the primary outcome measure \u00e2\u0080\u0094 the number of new carious teeth (\u00e2\u0088\u0086DMFT). From the pre-existing study, an effect size of 0.21 was obtained for tooth status over 24-month evaluation (\u00e2\u0088\u0086DMFT: test group=0.12 vs. control group=0.34; SD ~ 0.50) [18], which could be considered a moderate size convention for 1-way ANOVA and clinically significant for the primary outcome [19]. Based on a significance level of 5% and a targeted statistical power of 80%, 74 participants in each group will be required. Considering a typical value of ICC = 0.03 in a cluster randomized clinical trial setting [20] and if 75 children are to be recruited from each school, the design effect will be 3.22 [21]. Assuming a similar dropout rate as our previous study in secondary school at the 2-year follow-up (dropout rate: 10%) [17], the sample size will be increased to 300 in each group, thus 900 altogether. Then 4 schools in each group, a total of 12 schools will be recruited.", "id": 1502, "split": "test"} +{"trial_id": "NCT05451953", "pmid": "37055198", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU\n\nIncluded conditions:\n- Neonatal Respiratory Failure\n- Tracheal Intubation Morbidity\n\nStudy Armgroups:\n- {'label': 'Apneic Oxygenation', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Apneic Oxygenation']}\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Standard of Care']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Apneic Oxygenation', 'description': 'Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)', 'armGroupLabels': ['Apneic Oxygenation']}\n- {'type': 'PROCEDURE', 'name': 'Standard of Care', 'description': 'No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)', 'armGroupLabels': ['Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)', 'description': 'Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.', 'timeFrame': 'During intubation procedure'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) is 0.05, power is 80%, and the analysis uses a two-sided two-sample t-test with common SD.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size\n Using preliminary available data from the study sites, we estimate the mean absolute decline in SpO2 during tracheal intubations in the control arm will be 26% with an SD of 25%. To have 80% power to detect an effect size of 0.54 (or 13.5% difference in mean decline of SpO2) with an alpha of 0.05, we will need 110 randomised infants (table 2). The effect size is the (absolute) difference in mean decline in SpO2 between the two arms divided by the SD of declines: 13.5\u00c3\u00b725=0.54. We will enrol 120 infants, 10 in the run-in phase and 110 in the randomisation phase.\n \n Table 2\n \n Sample size calculation\n \n \n \n \n Power\n N1\n N2\n N\n Effect size\n Alpha\n \n \n \n \n 0.80\n 50\n 50\n 100\n 0.57\n 0.05\n \n \n \n0.80\n\n \n55\n\n \n55\n\n \n110\n\n \n0.54\n\n \n0.05\n\n \n \n 0.80\n 60\n 60\n 120\n 0.52\n 0.05\n \n \n 0.80\n 65\n 65\n 130\n 0.50\n 0.05\n \n \n \n \n \n The detectable effect size based on application of a two-sided two-sample t-test with common SD, assuming group sizes N1 and N2 (N=N1+N2) and type-one error (alpha) of 0.05.\n \n \n The bolded row represents the selected sample size.", "id": 1503, "split": "test"} +{"trial_id": "NCT05452655", "pmid": "39441873", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Intensive Multidisciplinary Rehabilitation and Identification of New Biomarkers in Response to an Integrated Motor-Cognitive and Aerobic Exercises Approaches in People With Parkinson's Disease\n\nIncluded conditions:\n- Parkinson Disease\n- Biomarkers\n- Rehabilitation Outcome\n- Gait Disorders, Neurologic\n- Parkinsonian Disorders\n- Basal Ganglia Diseases\n- Central Nervous System Diseases\n- Movement Disorders\n- Synucleinopathies\n- Neurodegenerative Diseases\n- Cognitive Impairment\n- Gait Analysis\n- Pathologic Processes\n- Magnetic Resonance Imaging\n- Physiotherapy\n\nStudy Armgroups:\n- {'label': 'Intensive Outpatient Integrated Motor-Cognitive and Aerobic Exercises Rehabilitation Program', 'type': 'EXPERIMENTAL', 'description': 'Intervention of highly challenging motor and cognitive training for 6 consecutive weeks.', 'interventionNames': ['Behavioral: Multidisciplinary Intensive Rehabilitation']}\n- {'label': 'Home-Based Stretching Exercises', 'type': 'ACTIVE_COMPARATOR', 'description': \"Home-based self-treatment program for 40 '/ day for 6 consecutive weeks\", 'interventionNames': ['Behavioral: Muscle-stretching and active mobilization exercises']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Multidisciplinary Intensive Rehabilitation', 'description': 'The rehabilitation program will last for 6 consecutive weeks and involves the execution of 30 sessions, 5 days a week lasting 160 \\'/ day each (80\\' motor; 40 \\'cognitive and 40\\' speech therapy rehabilitation) for 3 days a week and 180\\'/ day (80 \\'motor; 60\\' cognitive and 40 \\'speech therapy rehabilitation) for 2 days a week. The EXP group will receive 18 sessions (3 times a week) of treadmill (20 min), balance exercises and functional reinforcement (20 min). The remaining motor sessions will be defined based on the patient\\'s therapeutic needs.\\n\\nThe cognitive treatment will be proposed both in traditional mode (3 times a week) and through the support of semi-immersive \"Virtual Reality Rehabilitation System\" (VRRS) (2 times/week). The VRRS treatment is structured in 2 sessions per week (60 min) for 6 consecutive weeks.\\n\\nThe speech therapy program will include clinical and instrumental evaluations and innovative techniques will be used for the treatment (biofeedback with Vitalstim).', 'armGroupLabels': ['Intensive Outpatient Integrated Motor-Cognitive and Aerobic Exercises Rehabilitation Program']}\n- {'type': 'BEHAVIORAL', 'name': 'Muscle-stretching and active mobilization exercises', 'description': \"The control group subjects will undergo a home-based self-treatment program for 40 '/ day for 6 consecutive weeks consisting of muscle-stretching and active mobilization exercises.\", 'armGroupLabels': ['Home-Based Stretching Exercises']}\n\nPrimary Outcomes:\n- {'measure': 'Serum biomarkers in neuron derived extracellular vesicles (NDEVs)', 'description': 'Oligomeric \u03b1-synuclein (\u03b1-syn) ng/ml; SNARE complex: Syntaxyn-1(STX-1A) (ng/ml), VAMP-2 (ng/ml) and SNAP-25 (ng/ml); Brain-Derived Neurotrophic Factor (BDNF) (ng/ml), pro-BDNF (ng/ml), Glial cell line-derived Neurotrophic factor (GDNF) (ng/ml) Cerebral dopamine neurotrophic factor (CDNF) (ng/ml)', 'timeFrame': '18 weeks'}\n- {'measure': 'Blood Biomarkers', 'description': 'Pro- \\\\[IL-1\u03b2 (pg/ml), Tumour Necrosis Factor alpha (TNF\u03b1) (pg/ml), Interferon gamma (IFN-\u03b3) (pg/ml), IL-6 (pg/ml), IL-18 (pg/ml)\\\\], Anti-inflammatory (IL-10) (pg/ml) cytokines.', 'timeFrame': '18 weeks'}\n\nPlease estimate the sample size based on the assumption: \n2 degrees of freedom, 80% power, 0.05 alpha, and a 20% drop-out rate.", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size\n There are currently no clinical studies examining the effectiveness of rehabilitation treatment on our primary outcomes. Therefore, the sample size was determined based on the preliminary results of a recent cross-sectional study by Agliardi and colleagues [36]. In Agliardi\u00e2\u0080\u0099s study a total of 32 PD patients were consecutively recruited and screened and a total of 40 healthy subjects were included as controls using frequency matching for age and gender. The main objective of this study was to identify differences in NDEs derived oligomeric \u00ce\u00b1-Synuclein concentration between PD and healthy controls subjects. Hence, considering 2 degrees of freedom with 80% power; 0,05 alpha and a drop-out percentage of 20%, we planned a sample size of N = 72 (N for each group = 36) that will be more than adequate to control for a potential participants\u00e2\u0080\u0099 drop out.", "id": 1504, "split": "test"} +{"trial_id": "NCT05455450", "pmid": "37270188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Feasibility Study of Eye Movement Desensitisation and Reprocessing Therapy (EMDR) for Functional Neurological Disorder (FND)\n\nIncluded conditions:\n- Functional Neurological Symptom Disorder\n\nStudy Armgroups:\n- {'label': 'EMDR + NPC', 'type': 'EXPERIMENTAL', 'description': '8-16 eye movement desensitisation and reprocessing therapy (EMDR) sessions, plus 1 month follow up session after the therapy has ended. Participants will also attend neuropsychiatric follow-up appointments as part of standard medical care.', 'interventionNames': ['Other: Eye movement desensitisation and reprocessing therapy', 'Other: Neuropsychiatric care']}\n- {'label': 'Neuropsychiatric Care (NPC)', 'type': 'OTHER', 'description': 'Standard medical care', 'interventionNames': ['Other: Neuropsychiatric care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Eye movement desensitisation and reprocessing therapy', 'description': 'Up to 16 EMDR sessions (minimum of 8 sessions), and 1-month follow-up session, as well as attending neuropsychiatric appointments (NPC). Participants will be given the choice of attending EMDR physically face-to-face or virtually via a video-consultation platform. Sessions will normally be attended weekly, with treatment completed within 6 months. Sessions will be 60-90 minutes long. EMDR will follow the standard 8-phase protocol, with additions so that it is tailored for FND presentations. The FND-specific EMDR therapy protocol has been developed for the trial by the chief investigator.', 'armGroupLabels': ['EMDR + NPC'], 'otherNames': ['EMDR']}\n- {'type': 'OTHER', 'name': 'Neuropsychiatric care', 'description': 'Standard medical care consisting of 1-3 30 minute appointments with neuropsychiatrist over the course of the 9-month trial period.', 'armGroupLabels': ['EMDR + NPC', 'Neuropsychiatric Care (NPC)']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rate', 'description': 'Percentage of potentially eligible participants attending screening interview', 'timeFrame': '12 months (recruitment stage)'}\n- {'measure': 'Intervention adherence', 'description': 'Percentage of participants randomised to EMDR+NPC who complete therapy', 'timeFrame': '18 months (intervention stage)'}\n- {'measure': 'Outcome measures completion', 'description': 'Percentage of participants who complete outcome measures at all 4 time points', 'timeFrame': '12 months (9-month follow-up stage)'}\n\nPlease estimate the sample size based on the assumption: \nPower calculation is neither possible nor necessary. The focus is on providing reliable estimates of feasibility outcomes such as recruitment, adherence, and attrition rates.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size\n This is a feasibility trial; as such, a power calculation is neither possible nor necessary. Rather, the sample size is pragmatic. Target recruitment is 50\u00e2\u0080\u0089patients in total (25 in each arm), which is consistent with those recommended for pilot and feasibility studies to provide sufficiently reliable estimates of feasibility outcomes, for example, recruitment, adherence and attrition rates and adequate precision of means and variances to inform a fully powered RCT.39\u00e2\u0080\u009341", "id": 1505, "split": "test"} +{"trial_id": "NCT05458323", "pmid": "40156032", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Level Enhancement Through Vision Exams and Refraction: a Randomized Controlled Trial to Assess Impact of Near and Distance Spectacles on Reducing Rates of Cognitive Decline With Aging in Community Dwelling Older People in India\n\nIncluded conditions:\n- Refractive Errors\n\nStudy Armgroups:\n- {'label': 'Free near and distance glasses', 'type': 'EXPERIMENTAL', 'description': 'All participants randomised to the intervention group will be provided with free near and/or distance spectacles based on the results of refraction. Glasses will be provided at the time of enrolment into the study. The participants will be asked to choose from an assortment of 20 frames. Participants will be asked to report to the study team member in case of any issue with spectacles or if spectacles are lost or broken. Replacement glasses will be provided in case of broken or lost spectacles whenever required. Participants will undergo annual eye exams and refraction, and change of glasses will be prescribed as needed.', 'interventionNames': ['Device: Free near and Distance Vision glasses']}\n- {'label': 'Control-No treatment', 'type': 'NO_INTERVENTION', 'description': 'All participants randomised to the control group will receive a prescription for spectacles and given free near and/or distance glasses as needed at study close out.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Free near and Distance Vision glasses', 'description': 'Intervention Description: All participants randomised to the intervention group will be provided with free near and/or distance spectacles based on the results of refraction.Glasses will be provided at the time of enrolment in the study.', 'armGroupLabels': ['Free near and distance glasses']}\n\nPrimary Outcomes:\n- {'measure': 'Change in cognitive score', 'description': 'The metric or method of measurement to be used: LASI-DAD global cognitive score. The best possible score is 360 and the worst possible score is 0.', 'timeFrame': 'Time point(s) of primary interest: 36 months collected at 12, 24 and 36 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, significance level of 0.05 (two-tailed), 13% annual follow-up loss, 10% eligibility rate", "answer": 760, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the three-year, un-intervened decline in LASI-DAD (Longitudinal Aging Study in India\u00e2\u0080\u0093Diagnostic Assessment of Dementia) global cognitive score from a cross-sectional study of similarly aged persons in India [23, 24], with 90% power at p\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-tailed) using a two-sample t-test and estimated annual follow-up loss of 13% based on our other studies in this demographic group in the region, 760 participants across the two study groups are sufficient to detect a 29% effect size. Using a conservative estimate that 10% of screened persons will be eligible, an estimated 7600 will need to be screened to recruit 760 participants.", "id": 1506, "split": "test"} +{"trial_id": "NCT05459298", "pmid": "38943179", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight\n\nIncluded conditions:\n- Vitamin D Deficiency\n\nStudy Armgroups:\n- {'label': 'Usual care plus placebo', 'type': 'ACTIVE_COMPARATOR', 'description': 'Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.', 'interventionNames': ['Dietary Supplement: Placebo', 'Other: Usual Care']}\n- {'label': 'Usual care plus vitamin D supplementation', 'type': 'EXPERIMENTAL', 'description': 'Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.', 'interventionNames': ['Dietary Supplement: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth', 'Other: Usual Care']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.', 'armGroupLabels': ['Usual care plus placebo'], 'otherNames': ['Normal saline']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': '800 IU/day vitamin D supplementation with feedings in the first 28 days after birth', 'description': '800 IU/day Vitamin D supplementation until 400 IU/day are provided as part of usual care (started when infants receive full feedings of about 120-160 mL/kg/day). At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.', 'armGroupLabels': ['Usual care plus vitamin D supplementation'], 'otherNames': ['Cholecalciferol']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.', 'armGroupLabels': ['Usual care plus placebo', 'Usual care plus vitamin D supplementation']}\n\nPrimary Outcomes:\n- {'measure': '25-hydroxyvitamin D (25[OH]D) level', 'timeFrame': 'about 28 days after birth'}\n\nPlease estimate the sample size based on the assumption: \nMean 25-OH-D3 = 25 ng/ml, SD = 12 ng/ml, \u226590% Bayesian power with >95% posterior probability for serum 25-OH-D3 increase, 80% power for >80% posterior probability for reducing respiratory support, 90% power for 25% RR decrease, consent rate of 60%.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Assuming a mean 25-OH-D3 = 25 (standard deviation [SD] =12 ) ng/ml based on the data of a recent study [14] with a similar population and vitamin D supplementation to our routine care, 74 infants (37 in each group) affords \u00e2\u0089\u00a590% Bayesian power (with a >95% posterior probability) to identify an increase in serum 25-OH-D3 in the intervention group, assuming a true increase of 33%. We will assess the largest sample size feasible during the study period of 3 years (\u00e2\u0089\u00a5180 infants) to maximize precision in the estimate of effect and power for other outcomes based on our annual admission rate of infants that will qualify for the study, assuming a consent rate of 60%. Using a neutral Bayesian prior probability (RR = 1.0; 95% CrI, 0.3\u00e2\u0080\u00933.3), 180 total patients afford 80% power to identify a >80% posterior probability (intervention arm) of reducing respiratory support (based on the described ordinal outcome) assuming a true RR decrease of 20% (RR = 0.80) and 90% power if the true RR decrease is 25%.", "id": 1507, "split": "test"} +{"trial_id": "NCT05459987", "pmid": "37848307", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Impact of an Intensive Team-based Intervention on Prediabetes Remission in Patients With Coronary Heart Disease\n\nIncluded conditions:\n- Prediabetic State\n- Coronary Heart Disease\n- Healthy Lifestyle\n- Remission\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet with intermittent fasting 16:8 (5 times/week for 12 weeks).\\n\\nPersonalized exercise prescription and training (3 times per week)\\n\\nPersonalized education and motivational interviewing', 'interventionNames': ['Behavioral: Lifestyle changes']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Lifestyle changes', 'description': 'Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet with intermittent fasting 16:8 (5 times/week for 12 weeks).\\n\\nPersonalized exercise prescription and training (3 times per week)\\n\\nPersonalized education and motivational interviewing', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of an intensive multidisciplinary program based on lifestyle changes in coronary heart disease patients recently diagnosed with prediabetes that are referred to the Centre EPIC.', 'description': 'Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention', 'timeFrame': 'at 3 months after the start of the intervention'}\n- {'measure': 'Feasibility of an intensive multidisciplinary program based on lifestyle changes in coronary heart disease patients recently diagnosed with prediabetes that are referred to the Centre EPIC.', 'description': 'Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention', 'timeFrame': 'at 6 months after the start of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 95% CI, 30% loss rate to follow-up, statistical significance defined as p value <0.05, descriptive statistical analysis with 95% CIs, mean and SD for continuous variables, frequencies and percentages for categorical variables, one-way repeated-measures ANOVA, univariable and multivariable logistic regression models.", "answer": 36, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Primary outcome measures for this study are feasibility criteria to inform any future randomised controlled trial powered to detect an intervention effect. Therefore, a sample size for this study was calculated to allow the estimation of a completion and compliance rate with reasonable precision. Assuming that the completion rate will be around 70%, a sample size of 25 would allow estimating this rate with an accuracy of \u00c2\u00b118.0% using a two-sided 95% CI. For a compliance rate of around 80%, a sample size of 30 participants would assure a precision of \u00c2\u00b115.7% for estimating this rate. Assuming a 30% loss rate to follow-up, approximately 36 patients will be recruited.\n Statistical analysis will be mainly descriptive with, when appropriate, the presentation of 95% CIs. They will be computed for baseline characteristics and follow-up assessments at 3 and 6\u00e2\u0080\u0089months. They will be presented as mean and SD for continuous variables and frequencies and percentages for categorical variables.\n The number of participants that can be recruited monthly and the number of participants screened will be summarised. The total recruitment and monthly rates will be presented with a 95% CI. The number of participants that complete the intervention at 3\u00e2\u0080\u0089months, the number of participants that attend their 6-month follow-up appointment, and the total number of appointments attended (nutritional intervention (up to 6), exercise training intervention (up to 36) and educational intervention (up to 3) will be summarised. Completion/retention rate at 3 and 6 months and compliance rate will be presented with a 95% CI.\n For illustrative purposes (because this pilot study is not powered to detect statistically significant findings), all analyses of this pilot study, including both secondary and tertiary endpoints, will be the assessments that could be considered as efficacy parameters in the large, full-scale study. For the analysis of change in continuous secondary and tertiary endpoints, that is, anthropometric measures, exercise-derived measurements, blood analysis measures and scores from questionnaires, a one-way repeated-measures analysis of variance model will be used to compare differences between intervention (pre, per, post) periods, with mean differences and 95% CIs and with effect sizes (Cohen\u00e2\u0080\u0099s d) when appropriate. The assumptions underlying the planned models will be checked, and if they are not tenable, data transformation or non-parametric analyses may be used if necessary.\n The adjusted impact of the different factors associated with remission of pre-diabetes (eg, mass loss, fat mass loss, visceral fat loss) will be evaluated. For this analysis, univariable and multivariable logistic regression models will be created for the categorical outcome of remission of pre-diabetes: yes/no, according to the definition previously mentioned. Covariates will be selected a priori based on their described association with remission (clinical plausibility) or as a potential confounding effect according to the rules proposed by Kleinbaum and colleagues using the user-written Stata command \u00e2\u0080\u0098confound\u00e2\u0080\u0099.12 The practical and clinical interpretation will be presented with measures of association (OR). Statistical significance will be defined as a p value <0.05. Statistical analyses will be performed using STATA (StataCorp, 2017, Stata Statistical Software: Release 15, College Station, TX: StataCorp LLC).", "id": 1508, "split": "test"} +{"trial_id": "NCT05460689", "pmid": "37231477", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial to Evaluate the Effectiveness of a mHealth Application as a Family Educational and Supportive Tool in Children Tonsillectomy and/or Adenoidectomy Perioperative Process Compared to Standard Care\n\nIncluded conditions:\n- TONSILLECTOMY\n\nStudy Armgroups:\n- {'label': 'Smartphone Application', 'type': 'EXPERIMENTAL', 'description': 'mHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy', 'interventionNames': ['Other: M-HEALTH APP']}\n- {'label': 'standard support', 'type': 'SHAM_COMPARATOR', 'description': 'Information provided by nurses and physician orally or through printed booklets.', 'interventionNames': ['Other: Standard Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'M-HEALTH APP', 'description': 'The intervention group will have in use a mHealth App for education and support of caregivers of children undergoing tonsillectomy and/or adenoidectomy in the perioperative process. An out-patient nurse will be in charge of instructing intervention group participants to mHealth App use and content options. The mHealth App will be available for intervention group families from the day of pre-admission visits to the 7th day post surgery or follow up visit.', 'armGroupLabels': ['Smartphone Application']}\n- {'type': 'OTHER', 'name': 'Standard Care', 'description': 'The control group will receive information and education provided by nurses and physician in the preoperative visits and during hospitalization. Information and education will be provided orally or through printed booklets.', 'armGroupLabels': ['standard support']}\n\nPrimary Outcomes:\n- {'measure': 'Between groups difference in preoperative primary child caregiver state anxiety (T2)', 'description': 'Differences between intervention and control groups in preoperative primary child caregiver state anxiety, measured through the State-Trait Anxiety Inventory form Y questionnaire (T2). The questionnaire consists of two self-report scales for measuring state anxiety and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how the respondent feels \"now, at this moment,\" on a 4 items Likert scale, from \"not at all\" to \"very much\"; the T-Anxiety scale (STAI Form Y-2) consists of twenty statements that evaluate how the respondent feels \"generally\" on a 4-point Likert scale from \"almost never\" to \"almost always\". Total scores range from 20 to 80 points with lower scores indicate higher trait and state anxiety.', 'timeFrame': '5 minutes before heading to the operating theatre'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value of 0.05 and beta value of 0.20", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Assuming a mean score of preoperative anxiety (main outcome of the study) of 50 for the control group, with a standard deviation (SD) of 13 [21], and a mean of 45 for the intervention group, with SD of 10 (effect size\u00e2\u0080\u0089=\u00e2\u0080\u00890.43), an alpha value of 0.05 and a beta value of 0.20, 180 subjects (90 per group) are needed to conduct the study (G*power, Wilcoxon-Mann\u00e2\u0080\u0093Whitney test, two groups).", "id": 1509, "split": "test"} +{"trial_id": "NCT05461313", "pmid": "36934286", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fully Constrained Acetabular Liner Versus Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip - A Randomized, Open-Label, Two-Arm, Non-Inferiority Study Evaluating the Post-Operative Hip Dislocation Rate\n\nIncluded conditions:\n- Metastatic Cancer to the Hip\n\nStudy Armgroups:\n- {'label': 'Constrained Liner', 'type': 'OTHER', 'interventionNames': ['Other: Constrained Liner']}\n- {'label': 'Dual Mobility Cup', 'type': 'OTHER', 'interventionNames': ['Other: Dual Mobility']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Constrained Liner', 'description': 'Subjects in this arm will receive a constrained liner with one of the following implants: Freedom Constrained Acetabular Liner (Zimmer Biomet), G7 Freedom Constrained Acetabular Liner (Zimmer Biomet) or Lubinus Acetabular Cup with a safety ring (LINK)', 'armGroupLabels': ['Constrained Liner']}\n- {'type': 'OTHER', 'name': 'Dual Mobility', 'description': 'Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet)', 'armGroupLabels': ['Dual Mobility Cup']}\n\nPrimary Outcomes:\n- {'measure': 'Post-operative joint dislocation risk', 'description': 'The 6-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner for the surgical treatment of MBD', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nPower at 80% for a one-sided 95% confidence interval.", "answer": 146, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The trial is designed with regards to the primary outcome. The sample size calculation is based on a pilot study performed at our department that included 18 patients with constrained Lubinus cups (anti-dislocation ring) and 174 patients with uncontrained Lubinus cups [25]. All patients received a THA due to a pathologic fracture or an impending pathologic fracture because of MBD. The patients with a constrained Lubinus cup had a 1-year dislocation rate at 0%, while those with an unconstrained Lubinus cup had a 7% 1-year dislocation rate. Based on this, we decided on a non-inferiority margin with a 6% absolute risk-difference, as dislocation rate outside of this margin would place DM in the same range as unconstrained THA, which is considered inferior to CL and DM. We expect that the probability of avoiding hip dislocation within 6\u00c2\u00a0months is 99% for CL and 98% for DM. With power at 80% for a one-sided 95% confidence interval, we calculate that a minimum of 73 patients is required in each treatment group for a binary-outcome non-inferiority trial. We will therefore enroll a minimum of 73 patients in each treatment arm amounting to minimum of 146 patients in total.", "id": 1510, "split": "test"} +{"trial_id": "NCT05462262", "pmid": "37277217", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Intensive Lipid-lowering on Coronary Atherosclerotic Plaque Phenotype and Major Adverse Cardiovascular Events in Adults with Low to Intermediate 10-year ASCVD Risk: a Prospective, Randomized, Open-label, Blinded Endpoint Analysis(PROBE)\n\nIncluded conditions:\n- Coronary Artery Disease Progression\n\nStudy Armgroups:\n- {'label': 'intensive lipid-lowering group', 'type': 'EXPERIMENTAL', 'description': 'Goal for LDL-C \\\\<1.8 mmol/L or \u226550% reduction from baseline.', 'interventionNames': ['Drug: Intensive lipid-lowering control']}\n- {'label': 'moderate-intensity lipid-lowering group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Goal for LDL-C \\\\<2.6 mmol/L or 30%-50% reduction from baseline.', 'interventionNames': ['Drug: Moderate-intensity lipid-lowering control']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Intensive lipid-lowering control', 'description': 'The initial recommended therapy is 10-20mg atorvastatin plus Ezetimibe, and the type and dosage of drugs can be adjusted according to the situation.', 'armGroupLabels': ['intensive lipid-lowering group'], 'otherNames': ['Lower goal for reducing LDL-C']}\n- {'type': 'DRUG', 'name': 'Moderate-intensity lipid-lowering control', 'description': 'The initial recommended therapy is 10-20mg atorvastatin, and the type and dosage of drugs can be adjusted according to the situation.', 'armGroupLabels': ['moderate-intensity lipid-lowering group'], 'otherNames': ['Standard goal for reducing LDL-C']}\n\nPrimary Outcomes:\n- {'measure': 'Major Adverse Cardiovascular Events (MACE)', 'description': 'Composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina', 'timeFrame': 'Within 3 years after the enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe two-sided statistical significance level is 0.05, the confidence level is 80%, and a 20% loss during follow-up is accounted for.", "answer": 2900, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n All the statistical analyses will be performed using SPSS V.22.0 for Windows (SPSS) by an expert in medical statistics. For descriptive analysis, continuous variables will be represented as the mean\u00c2\u00b1SD, and categorical variables will be presented as percentages. Categorical variables will be compared using \u00cf\u00872 statistics and continuous variables will be compared using a t-test. We will test the interobserver agreement of CCTA variables by k-statistic. Cumulative event rates as stratified by intervention and the control group will be estimated using the product limit (Kaplan-Meier) methods and the log-rank test. A two-sided p<0.05\u00e2\u0080\u0089will be considered to indicate statistical significance.\n According to 2012 literature,14 the incidence of 3-year MACE events in outpatients with non-obstructive coronary heart disease was 3.7%. It is expected that enhanced lipid-lowering will reduce the 3-year MACE events to 1.8%, which is a clinically acceptable positive cut-off value. The two-sided statistical significance level is 0.05, and the confidence level is 80%. The sample size (N1) in the intensive intervention group=the sample size (N2) in the control group=1160. It is increased to 1450 in each group to account for a 20% loss during follow-up. A total sample size of 2900 patients is required.", "id": 1511, "split": "test"} +{"trial_id": "NCT05463341", "pmid": "39232778", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties\n\nIncluded conditions:\n- Opiate Overdose\n- Fentanyl Overdose\n- Harm Reduction\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'EXPERIMENTAL', 'description': 'Each participant in the intervention arm will receive one-on-one education on the purpose, benefits, and limitations of fentanyl test strip (FTS) testing and undergo a brief 20-minute FTS educational intervention (including a 2-3-minute video and hands-on demonstrations on how to use FTS). They will also receive a supply of 10 FTS upon enrollment and continued supply upon request throughout the 2-year follow up period.', 'interventionNames': ['Behavioral: Fentanyl Test Strips']}\n- {'label': 'Non-Intervention Arm', 'type': 'NO_INTERVENTION', 'description': 'Fentanyl test strip (FTS) education and a supply of FTS will be offered to participants in the non-intervention arm of the study during the final quarter of year 5.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Fentanyl Test Strips', 'description': 'A brief fentanyl test strip (FTS) education intervention will be given to participants at Project DAWN sites in the intervention arm after enrollment and collecting baseline data. It will be offered one-on-one with participants and will include the purpose, benefits, and limitations of FTS testing, and information on how to use FTS, interpret the results, what to do if the FTS is positive, and how to use FTS for different drug delivery methods. Participants will practice and demonstrate use of the FTS, and the short video on how to interpret the FTS will include an on-camera statement on the importance of testing for fentanyl. The video will be accessible to participants after study enrollment. Participants will be advised of the possibility of both false positive/negative results, and that the drugs may be mixed with other substances not detectable with FTS. Participants will be encouraged to practice other harm reduction strategies.', 'armGroupLabels': ['Intervention Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.', 'description': 'Key informant interviews with all site personnel and peer recovery mentors.\\n\\nQuantitative Data/Process Measures:\\n\\n* # interested Project DAWN sites\\n* # Project DAWN sites enrolled\\n* # potential participants who request to enroll\\n* # participants successfully enrolled\\n* # people who receive FTS education and testing materials at baseline\\n* # replacement FTS requested/distributed\\n* total # FTS distributed\\n* proportion of participants in the intervention arm who complete the biweekly surveys\\n* proportion of participants who complete the 6-month follow-up questionnaire', 'timeFrame': 'Quarter 2 of Year 1'}\n- {'measure': 'Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.', 'description': 'Follow up with intervention arm site personnel to gauge satisfaction with the program and identify any concerns.\\n\\nQuantitative Data/Process Measures:\\n\\n* # interested Project DAWN sites\\n* # Project DAWN sites enrolled\\n* # potential participants who request to enroll\\n* # participants successfully enrolled\\n* # people who receive FTS education and testing materials at baseline\\n* # replacement FTS requested/distributed\\n* total # FTS distributed\\n* proportion of participants in the intervention arm who complete the biweekly surveys\\n* proportion of participants who complete the 6-month follow-up questionnaire', 'timeFrame': 'Quarter 3 of Year 5'}\n- {'measure': 'Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.', 'description': 'Interview intervention arm site personnel to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites.\\n\\nQuantitative Data/Process Measures:\\n\\n* # interested Project DAWN sites\\n* # Project DAWN sites enrolled\\n* # potential participants who request to enroll\\n* # participants successfully enrolled\\n* # people who receive FTS education and testing materials at baseline\\n* # replacement FTS requested/distributed\\n* total # FTS distributed\\n* proportion of participants in the intervention arm who complete the biweekly surveys\\n* proportion of participants who complete the 6-month follow-up questionnaire', 'timeFrame': 'Quarter 2 of Year 5'}\n- {'measure': 'Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.', 'description': 'Interview intervention arm sites about the acceptability of the program.\\n\\nQuantitative Data/Process Measures:\\n\\n* # interested Project DAWN sites\\n* # Project DAWN sites enrolled\\n* # potential participants who request to enroll\\n* # participants successfully enrolled\\n* # people who receive FTS education and testing materials at baseline\\n* # replacement FTS requested/distributed\\n* total # FTS distributed\\n* proportion of participants in the intervention arm who complete the biweekly surveys\\n* proportion of participants who complete the 6-month follow-up questionnaire', 'timeFrame': '6-month follow-up'}\n- {'measure': 'Test the hypothesis that PWUD who receive FTS education and testing materials as part of an OEND program will have improved knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for lowering their risk of an opioid overdose.', 'description': \"All participants (in both the intervention and non-intervention arms) will complete a questionnaire at enrollment (for the intervention group, prior to the intervention) and again at 6 months. Both questionnaires (baseline and 6 months) will include the same questions about the participant's knowledge of and self-efficacy in reducing their risk of an opioid overdose by using FTS (Appendix). Participants will be compensated for their time with gift cards for completing the questionnaires.\", 'timeFrame': '6-month follow-up'}\n- {'measure': 'Test the hypothesis that individuals who receive FTS education and testing materials as part of an OEND program will have a lower opioid overdose rate than individuals who receive OEND only (\"usual practice\").', 'description': 'Participants in the intervention arm will be contacted biweekly for 2 years and asked if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Intervention arm participants will be asked to notify the study team when they receive a positive FTS result. Participants in the non-intervention arm will be contacted biweekly up to a maximum of 2 years after enrollment to ask if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Fatal overdoses among participants in the intervention and non-intervention arms of the study will be identified by reviewing death certificates issued by the Ohio Department of Health quarterly starting in Year 2. Participating Project DAWN sites will be asked to advise the study team if they become aware of any fatal overdoses among clients who are enrolled in the study.', 'timeFrame': 'Quarter 3 of Year 5'}\n\nPlease estimate the sample size based on the assumption: \nEnrollment rate of 65% of eligible participants, 30% attrition rate, one Project DAWN site per county.", "answer": 2400, "answer_type": "ESTIMATED", "explanation": "Sample size\n We expect an enrollment rate of 65% of eligible participants and 30% attrition, a conservative estimate based on research with similar populations [13]. For the power calculations, we conservatively assumed one Project DAWN site per county. We also assumed that non-fatal overdose rates in the non-intervention and intervention groups are 20% and 10%, respectively, and the annual fatal overdose rate in the non-intervention group is 0.65% [14]. Based on our sample size calculations, we will enroll 1200 participants in each study arm for a total of 2400 participants. Assuming a 30% attrition rate, 840 participants in each arm will complete 2 years of follow-up, for a total of 1680 participants. This will permit detection of an effect size range of 0.3\u00e2\u0080\u00930.4 for specific aim #2 and rate differences of 0.1 and 0.14, respectively, for non-fatal and fatal rates for specific aim #3, given the assumptions identified above.", "id": 1512, "split": "test"} +{"trial_id": "NCT05464238", "pmid": "37072812", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementation, Safety, Tolerability and Effect of Exercise and Respiratory Training on 6-minute Walking Distance in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF): a Randomized Controlled Multicenter Trial in European Countries.\n\nIncluded conditions:\n- Pulmonary Hypertension Due to Left Heart Disease\n- Heart Failure With Preserved Ejection Fraction\n\nStudy Armgroups:\n- {'label': 'Exercise training', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Exercise rehabilitation']}\n- {'label': 'Standard treatment (waiting group)', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Standard treatment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise rehabilitation', 'description': 'The initial phase of exercise training will be closely monitored and will be based on a three-weeks in-hospital stay to adjust and teach the exercise training which will be continued at home for 12 more weeks. In-hospital stays will be arranged country specific and hospitalization time may range. The rehabilitation program comprises of interval ergometer training (20 minutes 5 days per week), dumbbell training (30 minutes 5 days per week), respiratory therapy (30 minutes 5 days per week), mental training and guided walks for 2-5 times/week.', 'armGroupLabels': ['Exercise training']}\n- {'type': 'OTHER', 'name': 'Standard treatment', 'description': 'Standard treatment during study duration', 'armGroupLabels': ['Standard treatment (waiting group)']}\n\nPrimary Outcomes:\n- {'measure': '6-minute walking distance', 'timeFrame': 'baseline to 15 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided Student\u2019s t-test, alpha level of 0.05, power of 85%, 15% dropout rate.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n To estimate the effect of exercise training on 6-MWD, 90 patients are expected to be enrolled, who either receive exercise training or continue their daily lifestyle for 15\u00c2\u00a0weeks. The sample size was calculated by the G*Power 3.1 program according to the results of previous studies on 6-MWD. Based on previous data and the inclusion criteria, we expect a clinically significant mean increase of 35\u00c2\u00a0m with a standard deviation of the difference of 50\u00c2\u00a0m. If the true treatment effect is a difference of at least 35\u00c2\u00a0m with an equal standard deviation of the difference of 50\u00c2\u00a0m, the two-sided Student\u00e2\u0080\u0099s t-test at an alpha level of 0.05 has a power of 85%, if 38 patients for each group are included. To account for a possible 15% dropout rate, we will include 45 patients in each group\u00e2\u0080\u009490 patients in total.", "id": 1513, "split": "test"} +{"trial_id": "NCT05464264", "pmid": "39116153", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm\n\nIncluded conditions:\n- Treatment-resistant Depression (TRD)\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ketamine', 'description': \"Participants suffering from TRD will receive their ketamine treatment intravenously twice weekly for two weeks (4 treatments in total). A dose of 0.5 mg/kg is infused over 40 minutes, with dose adjustments made at the psychiatrist's discretion.\"}\n\nPrimary Outcomes:\n- {'measure': 'Clinical remission', 'description': 'Remission, defined as MADRS \\\\<10, and suicide risk reduction is defined as a \u2265 50% reduction in the suicidal ideation item of the MADRS scale from baseline', 'timeFrame': '4 weeks following the baseline visit'}\n\nPlease estimate the sample size based on the assumption: \n15% dropout rate.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n We expect that at least 60% of TRD patients will respond to ketamine within the first 24 hours [35]. Furthermore, power analyses under the assumption of a medium-large effect size (i.e., Cohen\u00e2\u0080\u0099s f = 0.4) based on previous studies [32, 36, 37] and a 15% dropout rate indicate that N = 30 participants in total will be sufficient to test our hypotheses.", "id": 1514, "split": "test"} +{"trial_id": "NCT05464394", "pmid": "38719323", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial\n\nIncluded conditions:\n- Hemorrhage\n- Bleeding\n\nStudy Armgroups:\n- {'label': 'Tranexamic acid', 'type': 'EXPERIMENTAL', 'description': '1500mg Tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid Injection [Cyklokapron]']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'sodium chloride', 'interventionNames': ['Drug: Sodium chloride 0.9%']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tranexamic Acid Injection [Cyklokapron]', 'description': 'A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.', 'armGroupLabels': ['Tranexamic acid']}\n- {'type': 'DRUG', 'name': 'Sodium chloride 0.9%', 'description': '100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 're-intervention rate', 'description': 'To compare the re-intervention rate due to haemorrhage within 30 days postoperative, after peroperative administration of TXA versus placebo in patients receiving a RYGB or OAGB', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nPower: 80%, Significance level (alpha): 5% two-sided, Dropout rate: 10%", "answer": 1524, "answer_type": "ESTIMATED", "explanation": "Sample size\n The power analysis (power, 80%; alpha, 5% two-sided) resulted in a required sample size of 2\u00c3\u0097685=1370 patients. We anticipated a dropout rate of 10%, leading to a total sample size of 1524 patients to be included. This is based on the hypothesis that 3.9% of patients require intervention (administration of packed red blood cells or surgical, radiological or endoscopic intervention) due to postoperative haemorrhage.11 14\u00e2\u0080\u009317 19 Based on previous studies and our published trial, we expect a decrease in postoperative intervention for haemorrhage to 1.4% (a decrease of 2.5%) in patients who receive TXA peroperatively.10 20", "id": 1515, "split": "test"} +{"trial_id": "NCT05465330", "pmid": "38840210", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study\n\nIncluded conditions:\n- Visual Evoked Potentials\n\nStudy Armgroups:\n- {'label': 'Desflurane Inhalational group (DR group)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Desflurane']}\n- {'label': 'Desflurane propofol balanced anesthesia group (DPR group)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Desflurane, Propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Desflurane', 'description': 'After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and remifentanil 0.05-0.2 \u03bcg/kg/min', 'armGroupLabels': ['Desflurane Inhalational group (DR group)']}\n- {'type': 'DRUG', 'name': 'Desflurane, Propofol', 'description': 'After induction, anesthesia will be maintained with 0.5 MAC desflurane, propofol 1.5-2.5 \u03bcg/ml and remifentanil 0.05-0.2 \u03bcg/kg/min', 'armGroupLabels': ['Desflurane propofol balanced anesthesia group (DPR group)']}\n\nPrimary Outcomes:\n- {'measure': 'N75-p100 amplitude value', 'description': 'Wave amplitude difference between N75-P100 peak and trough', 'timeFrame': '60 minutes after anesthesia induction'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.025, Power (\u03b2) = 0.2, Dropout rate = 10% (based on actual 1.7% in previous study).", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We used PASS 15 to calculate the sample size for this study. According to the pre-experiment results, at 60 min after induction of anesthesia, the amplitudes of the LD group and HD group were 3.43\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.78 \u00ce\u00bcV and 2.37\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.80 \u00ce\u00bcV, respectively. According to the results of other studies, the superiority margin was defined as 20% of the N75-P100 amplitude in the HD group [6]. According to \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, a sample size of 63 cases can provide a superiority margin of 20% higher amplitude in the LD group than in the HD group. We conservatively set the dropout rate at 10% on the basis of actual 1.7% in our previous study, the sample size should be a total of 70 persons will be enrolled, and 35 patients in each group.", "id": 1516, "split": "test"} +{"trial_id": "NCT05466487", "pmid": "36324088", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcranial Alternating Stimulation in Rehabilitation: a Randomized Controlled Trial in Chronic Stroke Patients With Visuospatial Neglect\n\nIncluded conditions:\n- Spatial Neglect\n\nStudy Armgroups:\n- {'label': 'Active tACS', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Transcranial Alternating Current Stimulation (tACS)', 'Behavioral: Visual Scanning Training (VST)']}\n- {'label': 'Sham tACS', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Device: Transcranial Alternating Current Stimulation (tACS)', 'Behavioral: Visual Scanning Training (VST)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcranial Alternating Current Stimulation (tACS)', 'description': 'Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off.', 'armGroupLabels': ['Active tACS', 'Sham tACS']}\n- {'type': 'BEHAVIORAL', 'name': 'Visual Scanning Training (VST)', 'description': 'The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, \\\\& Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side.', 'armGroupLabels': ['Active tACS', 'Sham tACS']}\n\nPrimary Outcomes:\n- {'measure': 'Star Cancellation Task', 'description': 'Quality of search score', 'timeFrame': 'Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training.'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a significance level (alpha) of 0.05, a power of 0.80, and accounts for a dropout rate of 25%. The sample size calculation is based on a repeated measures ANOVA with a 2\u00d72 design.", "answer": 22, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n To our knowledge, we are the first to combine an oscillatory-based transcranial brain stimulation protocol (10-Hz tACS) with conventional neglect treatment (VST). Other forms of NIBS (repetitive transcranial magnetic stimulation; rTMS, theta burst stimulation; TBS, transcranial direct current stimulation; tDCS) have indeed been used in combination with neglect treatment previously, but there, however, the rationale was to improve neglect based on conventional theoretical models, which prescribe \u00e2\u0080\u0098re-balancing\u00e2\u0080\u0099 activity between the hemispheres, via excitatory stimulation of the under-active injured hemisphere, or inhibition of the hyperactive intact hemisphere, or a combination of both. Since the current study is a conceptually novel approach, we estimated the necessary sample size based on the results of previous neglect studies that combined neglect treatment with NIBS that aimed at such \u00e2\u0080\u0098re-balancing\u00e2\u0080\u0099 in repeated sessions. The review of Van Lieshout and colleagues [52] reports four such RCT\u00e2\u0080\u0099s for which effect sizes are known or could be calculated. Cohen\u00e2\u0080\u0099s d ranged from 1.07-5.27 in two rTMS studies [53, 54], 1.48-7.14 in two TBS studies [54, 55], and 1.50-2.35 in one tDCS study [56]. In summary, all of the studies showed large effect sizes. Since these previous studies all took place in (sub-)acute patients, in which spontaneous neurological recovery can still occur [57], we choose an effect size of 0.8, which is lower than the previously reported range of effect sizes, but which is still commonly considered as a large effect size.\n In our study, we will compare the CVDT test score before and after the six-week training period. To calculate the required sample size of our study population, we made use of G*Power (version 3.1) [58]. To find an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u0089.80 (Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u0089.40), we calculated parameters for a repeated measures ANOVA with a 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892 design (within-between interaction, 2 groups, and 2 testing sessions), a power of 0.80 and an alpha of .05, which yielded a total required sample size of 16 patients (8 per group). This is a conservative estimate, as mixed linear modeling, the method we will use to analyze our data, is more powerful than repeated measures ANOVA [59]. We choose to set this to 22 patients (11 per group) because patients may dropout due to the relatively long training period of 6 weeks (dropout estimated at 25%). The abovementioned RCT\u00e2\u0080\u0099s included a comparable number of patients per group (approximately 10 per group) and reported significant effects and large effect sizes, so we too expect that our design will have sufficient power, which we confirm with our a priori sample size calculation.", "id": 1517, "split": "test"} +{"trial_id": "NCT05466955", "pmid": "39695859", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Slashing Two-wheeled Accidents by Leveraging Eyecare: a Stepped-wedge Cluster Randomised Controlled Trial to Assess Impact of Spectacles on Reducing Crash and Near-crash Events Among Myopic Motorcycle Drivers in Ho Chi Minh City Vietnam\n\nIncluded conditions:\n- Myopia\n\nStudy Armgroups:\n- {'label': 'Free eye glasses for un or under-corrected myopia', 'type': 'EXPERIMENTAL', 'description': 'Free eyeglasses for the correction of uncorrected myopia will be provided to participants at the time of enrolment into the intervention group.', 'interventionNames': ['Device: Free eye glasses for un or under-corrected myopia']}\n- {'label': 'Control-No treatment', 'type': 'NO_INTERVENTION', 'description': \"Participants in the control period will not have glasses but the SW-CRT design means that all trial participants with uncorrected myopia will receive free glasses by the trials' completion, and no participant will have glasses withheld after being diagnosed with un- or under-corrected myopia.\"}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Free eye glasses for un or under-corrected myopia', 'description': 'All participants randomised to the intervention group will be provided with free eye glasses', 'armGroupLabels': ['Free eye glasses for un or under-corrected myopia']}\n\nPrimary Outcomes:\n- {'measure': 'Crash and near-crash (CNC) events per 1,000 km driven', 'description': 'CNC events as measured by Global Positioning System (GPS) and a gyroscopic sensor-video data-acquisition system (DAS) mounted to the motorcycles of trial participants.', 'timeFrame': 'up to18 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, intraclass correlation (ICC) = 0.02 (0.01\u20130.05), coefficient of variation of cluster sizes = 3, Individual Auto Correlation (IAC) = 0, 30% dropout rate.", "answer": 625, "answer_type": "ESTIMATED", "explanation": "Sample size\n Unpublished data from Dynamic Vision, an organisation currently collecting CNC events from motorcycle drivers in Vietnam, were used to inform the power calculation. Results showed an estimated mean event rate of 1.67 CNC events per 1000\u00c2\u00a0km driven (standard deviation [SD]\u00e2\u0080\u0089=\u00e2\u0080\u00890.556). For a postulated, clinically meaningful 10% reduction in CNC events, a stepped-wedge cohort design comprising six sequences of seven myopic participants per cluster (a 28% prevalence, below the 40% figure observed during pilot testing with the WHOeyes app), a coefficient of variation of cluster sizes of 3, and five clusters per sequence with Individual Auto Correlation (IAC) of zero, confer 90% power (mean difference\u00e2\u0080\u0089=\u00e2\u0080\u00890.167, SD\u00e2\u0080\u0089=\u00e2\u0080\u00890.556; intraclass correlation [ICC]\u00e2\u0080\u0089=\u00e2\u0080\u00890.02 [0.01\u00e2\u0080\u00930.05]) [23]. This would be achieved by collecting DAS data from 175 students over the course of 72\u00c2\u00a0weeks. To achieve this, 5200 students will be invited to self-assess their vision using WHOeyes. Pilot data indicate that approximately 12%, or 625 students, will fail that assessment and be eligible to join the preliminary phase of the study, with placement of DAS units on their motorcycles. An estimated 250 (40% of those failing the WHOeyes self-assessment) will have eligible, uncorrected/under-corrected myopia detected on their subsequent eye examination by an optometrist. They will then be assigned to the intervention condition and given free spectacles. With a 30% dropout rate, this will result in complete datasets for 175 participants over the course of the trial.", "id": 1518, "split": "test"} +{"trial_id": "NCT05467306", "pmid": "38890744", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform\n\nIncluded conditions:\n- Hiv\n\nStudy Armgroups:\n- {'label': 'Nurse-Navigator Enhanced PrEP Support', 'type': 'EXPERIMENTAL', 'description': \"Pharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits.\", 'interventionNames': ['Behavioral: Nurse-Navigator Enhanced PrEP Support']}\n- {'label': 'Standard PrEP services', 'type': 'NO_INTERVENTION', 'description': 'Standard PrEP services'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Nurse-Navigator Enhanced PrEP Support', 'description': \"Pharmacies randomized to the nurse-navigator model will receive tailored support counseling, in addition to receipt of standard PrEP services. Support counseling by nurse-navigators will provide educational messaging tailored to AGYW and actionable advice targeting PrEP persistence and adherence and/or FP topics, and will address participants' questions related to the content. Counseling will include adherence encouragement (IMB domain: motivation), PrEP efficacy and safety (IMB domain: information), self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications, IMB domain: behavioral skills) and strategies for remembering PrEP refill schedules. During enrollment, the nurse-navigator will explain that support counseling is voluntary and that the nurse will also be available at the pharmacy to address concerns or questions whenever they arise outside of scheduled visits.\", 'armGroupLabels': ['Nurse-Navigator Enhanced PrEP Support']}\n\nPrimary Outcomes:\n- {'measure': 'PrEP initiation', 'description': 'Binary endpoint (Yes/No) based on self-reported use of daily oral PrEP pills or the DPV-VR at 1-month follow-up after acceptance at enrollment. Self-reported PrEP use will be considered initiation. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance, the participant will be considered non-initiated', 'timeFrame': 'At enrollment'}\n- {'measure': 'PrEP persistence', 'description': 'Binary endpoint (Yes/No) based on self-reported persistent use of daily oral PrEP pills or the DPV-VR at 10-month follow-up after initiation at 1-month follow-up. Self-reported PrEP use will be considered persistence. If a participant declined PrEP at enrollment or reported not using PrEP after acceptance or discontinued PrEP before 10 months, the participant will be considered non-persistent', 'timeFrame': 'at 10 months'}\n- {'measure': 'PrEP adherence', 'description': 'Binary endpoint (Yes/No) based on hair samples from 10-month visits. Detectable TFV levels in hair \\\\>0.038 ng/mg or DPV levels \\\\>0.0248 n/mg will be considered adherent. If a participant stopped PrEP use or exited the study before 10 months (ie no hair sample collected), the participant will be considered non-adherent', 'timeFrame': 'at 10 months'}\n\nPlease estimate the sample size based on the assumption: \nCoefficient of variation (k) of 0.05, 90% power, significance level (\u03b1) of 0.05, and 15% attrition rate.", "answer": 1900, "answer_type": "ESTIMATED", "explanation": "Sample size \n To account for between-cluster variability, sample size calculations incorporated the coefficient of variation between pharmacies (k) [25, 26]. Assuming each cluster enrolls 95 (accounting for 15% attrition) AGYW and that 30% of participants achieve the primary outcome of PrEP persistence at 10\u00c2\u00a0months (31) in the standard pharmacy PrEP model arm (control arm) arm with a coefficient of variation between clinics (k) of 0.05, 10 clusters per arm will give 90% power to detect a 15% absolute difference in proportions and a two-sided test with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05. Typical (k) values are 0.15 to 0.5 for rare binary outcomes and 0 to 0.05 for non-rare outcomes [25, 26]. Assuming 15% attrition, will enroll a final sample of 1900 ANC attendees at 20 sites (95 women per site; 950 women per arm).", "id": 1519, "split": "test"} +{"trial_id": "NCT05468034", "pmid": "39267010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exercise in Metastatic Breast Cancer: EMBody\n\nIncluded conditions:\n- Breast Cancer\n- Indolent Metastatic Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Exercise Intervention', 'type': 'EXPERIMENTAL', 'description': \"Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.\", 'interventionNames': ['Behavioral: Exercise Intervention']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise Intervention', 'description': \"Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.\", 'armGroupLabels': ['Exercise Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in cardiorespiratory fitness', 'description': 'Measured by minutes on the treadmill', 'timeFrame': 'baseline, 16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nUsing Wilcoxon rank sum test with a two-sided alpha of 0.1, 81% power, and assuming variability of 1.8 min based on preliminary data, with a 15% attrition rate between baseline and 16 weeks.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n An increase of 1.0 MET (metabolic equivalent task) in exercise capacity is associated with improved survival in cancer patients and in the general population, and is a clinically meaningful change [11, 59]. An increase in 1.0\u00c2\u00a0min on the Modified Bruce treadmill protocol correlates with an increase in over 1.0 MET. Using Wilcoxon rank sum test with two-sided alpha of 0.1, to have 81% power to detect a 1.0\u00c2\u00a0min difference between the exercise and usual care arms, we would need 43 patients per arm (86 total), assuming variability of 1.8\u00c2\u00a0min based on preliminary data [60]. Assuming 15% attrition between baseline and 16 weeks, a total of 100 participants will be recruited (50 in each arm).", "id": 1520, "split": "test"} +{"trial_id": "NCT05468840", "pmid": "38969374", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double Blinded, Randomized, Placebo Controlled, Parallel Arm Pilot Trial of Intravenous Ketamine for Emergency Department Treatment of Suicidal Ideation in a Pediatric Population\n\nIncluded conditions:\n- Suicidal Ideation\n\nStudy Armgroups:\n- {'label': 'Intravenous ketamine infusion', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will receive 0.5mg/kg of 1mg/mL intravenous ketamine (50 mg maximum) over 40 minutes.', 'interventionNames': ['Drug: Ketamine Hydrochloride']}\n- {'label': 'Intravenous normal saline infusion', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants in the control group will receive 0.5mL/kg intravenous normal saline (50 ml maximum) over 40 minutes.', 'interventionNames': ['Drug: Normal saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ketamine Hydrochloride', 'description': 'see study arm description', 'armGroupLabels': ['Intravenous ketamine infusion'], 'otherNames': ['ketamine']}\n- {'type': 'DRUG', 'name': 'Normal saline', 'description': 'see study arm description', 'armGroupLabels': ['Intravenous normal saline infusion']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of the study as measured by the percentage of eligible of patients able to complete the study protocol.', 'description': 'Data analysis for feasibility will be descriptive in nature and there will be no formal hypothesis testing. The percentage of eligible patients who complete the study will be reported.', 'timeFrame': 'Baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe trial aims to provide information on feasibility outcomes and estimates of distribution of SI severity tools.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim to enrol 20 patients in this feasibility trial. Although this trial is not designed with adequate power to detect a clinical efficacy of ketamine therapy, enrolling 10 patients per group will provide information on our feasibility outcomes as well as estimates of distribution of our SI severity tools.", "id": 1521, "split": "test"} +{"trial_id": "NCT05469945", "pmid": "39486824", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?\n\nIncluded conditions:\n- Lymphedema\n- Genital Neoplasm\n\nStudy Armgroups:\n- {'label': 'Control arm: no compressive garments', 'type': 'NO_INTERVENTION', 'description': 'Patients detected with early stage LLL (0-1 ISL stadia) start with education and preventive measures.'}\n- {'label': 'Interventional arm: start of CC2 compressive garments', 'type': 'EXPERIMENTAL', 'description': 'Patients in the experimental arm and detected with early stage LLL (0-1 ISL stadia) start with CC2 compressive garments in addition to education and preventive measures.', 'interventionNames': ['Device: Compressive garments class II']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Compressive garments class II', 'description': 'Daily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.', 'armGroupLabels': ['Interventional arm: start of CC2 compressive garments'], 'otherNames': ['Flat knit Medi Cosy compression class II stockings and/or bermuda']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence rate of LLL', 'description': 'Number of patients with transition (evolution) to stage 0-3 LLL (ISL criteria) in the first two years after treatment for gynecologic cancer.\\n\\nWe defined three potential transitions:\\n\\n* T1: from no LLL to reversible stage 0-1 LLL\\n* T2: from no LLL to irreversible stage 2-3 LLL\\n* T3: from stage 0-1 LLL to stage 2-3 LLL', 'timeFrame': 'From diagnosis until 2 years after last oncologic treatment'}\n- {'measure': 'Incidence rate of transition from stage 0-1 LLL to stage 2-3 LLL in randomized subgroup', 'description': 'Number of patients diagnosed with stage 0-1 LLL within one year after treatment for gynecologic cancer and that evolve from stage 0-1 LLL to stage 2-3 LLL', 'timeFrame': 'From transition to stage 0-1 LLL until 1 year after'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha has been set equal to 0.05. The study aims for at least 80% power to detect a difference between the compression group and the control group. The anticipated dropout rate is 10% after 12 months. An interim analysis is planned using the O'Brien Fleming adjustment scenario for the statistical significance level, with an early stopping rule at 0.0052% significance level and final analysis at 4.92% significance level.", "answer": 218, "answer_type": "ESTIMATED", "explanation": "Sample size\n The Biostatistics Unit of the Faculty of Medicine and Health Sciences of Ghent University performed the sample size calculation. The sample size is calculated for the interventional subcohort, to have at least 80% power to detect a difference between the compression group and the control group for progression of lymphoedema. An alpha has been set equal to 0.05. Sample size calculation is based on evaluation at year 1. No longitudinal analysis is foreseen as primary analysis, but this could be included as a secondary analysis using a generalised estimating equation analysis. Baseline measurement (no lymphoedema) is performed before start of any oncologic treatment or within 14 days.\n Patients enter the interventional subcohort at \u00e2\u0080\u0098T1\u00e2\u0080\u0099 (=development of early-stage lymphoedema or ISL stage 0\u00e2\u0080\u00931). Patients may enter T1 between the day of inclusion in the observational cohort and M12 (12 months after D0=last\u00e2\u0080\u0089day of oncological treatment).\n Spontaneous in-between measuring moments are possible, in case of patient-reported changes.\n The primary analysis refers to the comparison within the interventional subcohort between control and compression at M12. The calculation of the required sample size is based on articles about lymphoedema after therapy of gynaecological tumours.1416\n The following assumptions have been made for calculating the two subgroups: assumption of transition of 75% from observational group to interventional group and drop-out of 10% after 12 months.\n To detect a difference, in the interventional subcohort 109 subjects are required per group (2\u00c3\u0097109=218 subjects in total for the two groups) to have at least 80% power. If 66% of the patients in the observational cohort will meet the inclusion criteria for the interventional randomised trial, at least 330 (=218/0.66) patients should be included in the observational cohort.14 To correct for drop out we planned to include 400 patients. The anticipated dropout rate is based on our own assumptions rather than prior literature. This assumption has been made after careful consideration of the specific context of our study and the characteristics of the participant population. If the number of subjects would be reached before the end of the planned recruitment period, recruitment will be stopped at 400 patients. If the number is not attained, the recruitment period will be prolonged. If the number of 218 subjects is reached in the interventional subcohort, randomisation will be stopped, and analysis starts. However, the observational cohort will continue accrual until 400 subjects are reached.\n We assume a difference in true transition rates (T1 to T3) in both study arms, with 0.4 in the interventional group versus 0.75 in the control group. The recruitment of 109 patients in each treatment arm would allow the assessment of benefit of the intervention with 80% power, based on the 95% two-sided CI approach for the differences in two independent proportions.\n An interim analysis is planned, using the O\u00e2\u0080\u0099Brien Fleming adjustment scenario for the statistical significance level. The interim analysis will be conducted when 56 patients in each group reached their follow-up period. This will allow the detection of an obvious treatment benefit of 35%, with 80% power at the 0.0052% significance level and will be applied as an early stopping rule for the trial. If the trial continues, the final analysis on the accumulating data will be performed at the 4.92% statistical significance level, to maintain an overall significance level of 5%.\n Sample size calculations were performed using SAS Power and Sample Size (SAS Institute, Cary, NC, USA). Stratification was performed per centre, aiming for an equal distribution of the number of patients per centre. Enrolment and randomisation will be done in REDCap.\n If 66% of the patients in the cohort meet the inclusion criteria for the randomised trial, a minimum of 330 (=218/0.66) patients should be included in the cohort.\n To account for potential dropouts and uncertainties in the incidence rate of LLL, the sample size for this study has been increased to 400 patients. Power analysis indicates that with this sample size, the minimum transition rate required to achieve 80% statistical power is 55%. Should the observed transition rate be as low as 35%, the statistical power would decrease to 59%. Consequently, it is proposed to continuously monitor the transition rate throughout the study. Adjustments to the target sample size will be made as necessary and feasible. To ensure a reliable estimate, the transition rate will be evaluated once 300 patients have reached the 12-month follow-up point.", "id": 1522, "split": "test"} +{"trial_id": "NCT05472766", "pmid": "39438108", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma (ATTAACH)\n\nIncluded conditions:\n- Subdural Hematoma\n- Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Early resumption of anticoagulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'The standard of care DOAC at appropriate standard dose assigned by the MRP will start at day 30 +/- 7 after diagnosis of acute or chronic subdural hematoma.', 'interventionNames': ['Drug: Direct Acting Oral Anticoagulant starting at Day 30']}\n- {'label': 'Delayed resumption of anticoagulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'The standard of care DOAC at appropriate standard dose assigned by the MRP will start at day 90 +/- 14 after diagnosis of acute or chronic subdural hematoma.', 'interventionNames': ['Drug: Direct Acting Oral Anticoagulant starting at Day 90']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Direct Acting Oral Anticoagulant starting at Day 30', 'description': 'Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP', 'armGroupLabels': ['Early resumption of anticoagulation']}\n- {'type': 'DRUG', 'name': 'Direct Acting Oral Anticoagulant starting at Day 90', 'description': 'Dabigatran, Rivaroxaban, Apixaban or Edoxaban at standard dose as recommended by the MRP', 'armGroupLabels': ['Delayed resumption of anticoagulation']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rate', 'description': 'The number of participants enrolled for each participating institution, measured as the rate of consent for patients meeting eligibility criteria in one year per institution. Reasons for non-enrollment of eligible patients will be recorded', 'timeFrame': '1 year'}\n- {'measure': 'Implementation of study protocol', 'description': 'The proportion of enrolled participants who have completed follow-up measures at 90 days with complete recording of the functional outcome degree of disability', 'timeFrame': 'Study completion ~2.5 years'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence interval, 70% consent rate, 12 patients recruited per centre per year, 2.5-year funding period, 1.5 years of active recruitment, seven sites.", "answer": 1, "answer_type": "ACTUAL", "explanation": "Sample size\n We plan to enrol 120 patients to estimate an adherence rate of 90% with a margin of error of \u00c2\u00b15%. A sample of 120 will produce a 95% CI with bounds of 83%\u00e2\u0080\u009395% around the hypothesised target of 90%. Based on local experience with a similar patient population (NCT03559114), we assume that about 70% of eligible patients will consent to participation in the trial. We, therefore, expect that 170 eligible patients will need to be screened to achieve a randomised sample of 120 patients, representing about 10% of the final sample size that we anticipate requiring for the full RCT in keeping with recommendations for pilot trials.36 We designed this pilot study with a conservative assumption that at least 12 patients can be recruited per centre per year. This number should be feasible to accrue within a 2.5-year funding period (1.5 years of active recruitment considering some staggered activation of centres) based on the expected number of recruitments at seven sites. All seven proposed pilot trial sites are academic tertiary care centres with about 50\u00e2\u0080\u009370 cSDH admissions per year of which 40% are typically on anticoagulation.4 5", "id": 1523, "split": "test"} +{"trial_id": "NCT05472987", "pmid": "40035894", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Robotic Versus Open Ventral Hernia Repair: a Randomized Controlled Trial\n\nIncluded conditions:\n- Ventral Hernia\n\nStudy Armgroups:\n- {'label': 'Open Ventral Hernia Repair', 'type': 'ACTIVE_COMPARATOR', 'description': 'These patients will undergo open retromuscular ventral hernia repairs', 'interventionNames': ['Procedure: Ventral Hernia Repair']}\n- {'label': 'Robotic Ventral Hernia Repair', 'type': 'ACTIVE_COMPARATOR', 'description': 'These patients will undergo robotic retromuscular ventral hernia repairs.', 'interventionNames': ['Procedure: Ventral Hernia Repair']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Ventral Hernia Repair', 'description': 'Patients will undergo retromuscular ventral hernia repair', 'armGroupLabels': ['Open Ventral Hernia Repair', 'Robotic Ventral Hernia Repair']}\n\nPrimary Outcomes:\n- {'measure': 'Length of Stay', 'description': 'Time in the hospital after the surgery', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 0.05, power of 0.90, 10% attrition at 30 days", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n Using an alpha of 0.05, a power of 0.90, and determining a 24-h difference in length of stay, the necessary sample size is 86 patients in each arm, yielding a total of 172 patients. Estimating 10% attrition at 30\u00c2\u00a0days, 200 patients would be needed, 100 patients enrolled in each arm.", "id": 1524, "split": "test"} +{"trial_id": "NCT05478382", "pmid": "37349841", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery\n\nIncluded conditions:\n- Postoperative Pain\n- Pregabalin\n- Spine Surgery\n- Adverse Reaction to Pregabalin\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Pregabalin 25mg', 'type': 'EXPERIMENTAL', 'description': '1 capsule of Kabalin 25mg Cap and 2 pills of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours', 'interventionNames': ['Drug: Pregabalin 25 MG', 'Drug: Placebo']}\n- {'label': 'Pregabalin 50mg', 'type': 'EXPERIMENTAL', 'description': '2 capsules of Kabalin 25mg Cap and 1 pill of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours', 'interventionNames': ['Drug: Pregabalin 25 MG', 'Drug: Placebo']}\n- {'label': 'Pregabalin 75mg', 'type': 'EXPERIMENTAL', 'description': '3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours', 'interventionNames': ['Drug: Pregabalin 25 MG']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pregabalin 25 MG', 'description': 'Patients are given 0 to 3 capsules per administration according to their allocated group.', 'armGroupLabels': ['Pregabalin 25mg', 'Pregabalin 50mg', 'Pregabalin 75mg']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Patients are given 0 to 3 capsules per administration according to their allocated group.', 'armGroupLabels': ['Placebo', 'Pregabalin 25mg', 'Pregabalin 50mg']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity', 'description': 'Change of Visual analogue scale (VAS) pain score', 'timeFrame': 'Arrival at the general ward'}\n- {'measure': 'Pain intensity', 'description': 'Change of Visual analogue scale (VAS) pain score', 'timeFrame': '6hours after surgery'}\n- {'measure': 'Pain intensity', 'description': 'Change of Visual analogue scale (VAS) pain score', 'timeFrame': '24hours after surgery'}\n- {'measure': 'Pain intensity', 'description': 'Change of Visual analogue scale (VAS) pain score', 'timeFrame': '48hours after surgery'}\n- {'measure': 'Pain intensity', 'description': 'Change of Visual analogue scale (VAS) pain score', 'timeFrame': '72hours after surgery'}\n- {'measure': 'IV PCA usage', 'description': 'amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)', 'timeFrame': 'Arrival at the general ward'}\n- {'measure': 'IV PCA usage', 'description': 'amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)', 'timeFrame': '6hours after surgery'}\n- {'measure': 'IV PCA usage', 'description': 'amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)', 'timeFrame': '24hours after surgery'}\n- {'measure': 'IV PCA usage', 'description': 'amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)', 'timeFrame': '48hours after surgery'}\n- {'measure': 'IV PCA usage', 'description': 'amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)', 'timeFrame': '72hours after surgery'}\n- {'measure': 'Rescue analgesic usage', 'description': 'Frequency of rescue analgesic administered', 'timeFrame': 'Arrival at the general ward'}\n- {'measure': 'Rescue analgesic usage', 'description': 'Frequency of rescue analgesic administered', 'timeFrame': '6hours after surgery'}\n- {'measure': 'Rescue analgesic usage', 'description': 'Frequency of rescue analgesic administered', 'timeFrame': '24hours after surgery'}\n- {'measure': 'Rescue analgesic usage', 'description': 'Frequency of rescue analgesic administered', 'timeFrame': '48hours after surgery'}\n- {'measure': 'Rescue analgesic usage', 'description': 'Frequency of rescue analgesic administered', 'timeFrame': '72hours after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical power was set at 0.95, the alpha level at 0.0167 (adjusted for Bonferroni's test), and a follow-up loss of approximately 15% was considered.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Sample size\n The prior calculation of the sample size indicated that at least 28 subjects were required for each group. For calculation, the software G*Power 3.1.9.7 was used with a statistical power of 0.95 at an effect size of 0.448 with an alpha level of 0.0167. The effect size was determined based on a previous study [18]. In this study, three groups\u00e2\u0080\u0094those treated with placebo, pregabalin 75\u00c2\u00a0mg, and pregabalin 150\u00c2\u00a0mg\u00e2\u0080\u0094each comprised 28 participants. The groups were compared based on their PCA usage, with mean values of 95.3, 96.6, and 105.2 respectively, and an approximate standard deviation of 10. For the purposes of this study, which involves four instead of three groups, a fourth hypothetical group was considered with the mean value of 96.6, which is the median value of the three established groups. Based on this data, Cohen\u00e2\u0080\u0099s f was calculated, resulting in an effect size of 0.448. To compare the four groups through Bonferroni\u00e2\u0080\u0099s test, the alpha level was set at 0.05 divided by 4, which is 0.0167. When calculated based on these parameters, the total sample size needed is found to be 112, and the number of participants needed per group is 28. Considering a follow-up loss of approximately 15%, 33 participants per group would be required, resulting in a total of 132 participants needed for the study.", "id": 1525, "split": "test"} +{"trial_id": "NCT05478434", "pmid": "38129910", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke\n\nIncluded conditions:\n- Stroke\n- Stroke, Ischemic\n\nStudy Armgroups:\n- {'label': 'Robot and stimulation PPC-M1', 'type': 'EXPERIMENTAL', 'description': 'Combined paired pulse stimulation (PAS) with robot-assisted therapy', 'interventionNames': ['Device: Cortico-cortical stimulation plus robot-assisted therapy']}\n- {'label': 'Robot and sham stimulation PPC-M1', 'type': 'SHAM_COMPARATOR', 'description': 'Combined sham PAS with robot-assisted therapy', 'interventionNames': ['Device: Sham cortico-cortical stimulation plus robot-assisted therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Cortico-cortical stimulation plus robot-assisted therapy', 'description': '15 sessions of cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Paired-pulse stimulation (PAS) technique, with 5ms inter-stimulus time between the two areas (PPC to M1), will be done through two high-power Magstim 200 machines (Magstim\u00ae Rapid\u00b2). To stimulate the M1 area, the coil will be placed tangentially to the scalp at a 45\u00b0 angle to the midline, to stimulate the PPC area the center of the coil will be positioned over P4 (10-20 EEG system) tangentially to the skull with the handle pointing downward and slightly medial (10\u00b0). Robot-assisted therapy will be performed with an Armeo\u00ae Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy.', 'armGroupLabels': ['Robot and stimulation PPC-M1']}\n- {'type': 'DEVICE', 'name': 'Sham cortico-cortical stimulation plus robot-assisted therapy', 'description': '15 sessions of sham cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Sham paired-pulse stimulation (PAS) will be done through two high-power Magstim 200 machines (Magstim\u00ae Rapid\u00b2). To simulate the real stimulation, the coils will placed in the same sites with different inclination respect to the scalp (90\u00b0). Robot-assisted therapy will be performed with an Armeo\u00ae Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy.', 'armGroupLabels': ['Robot and sham stimulation PPC-M1']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)', 'description': 'Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.', 'timeFrame': 'baseline; 3weeks (end of treatment); 7weeks (follow-up)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 95% confidence interval.", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n According to an a priori Power analysis, considering 80% power and a 95% CI, 32 patients would be needed for necessary sample size, based on previously published work on cortical plastic changes induced by neurostimulation via TMS [14].", "id": 1526, "split": "test"} +{"trial_id": "NCT05478902", "pmid": "38176875", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)\n\nIncluded conditions:\n- Rotator Cuff Tendinosis\n- Rotator Cuff Injuries\n- Shoulder Tendinitis\n- Calcific Shoulder Tendinitis\n- Calcification Tendon\n- Calcific Tendinitis\n- Shoulder Pain\n\nStudy Armgroups:\n- {'label': 'Exercise Therapy', 'type': 'EXPERIMENTAL', 'description': 'This group will receive the Shape Up My Shoulders (SUMS) protocol and it will be led by a physiotherapist trained in therapeutic exercise. It will last 12 weeks and it will be divided in 3 stages.\\n\\nStage I- Early-stage rehabilitation exercises (i.e., breathing and relaxation exercises, ball rolling exercises, hand gripping exercises, mental imagery and contralateral side exercises) and Shoulder Symptom Modification Procedure (SSMP). This stage typically lasts 1 to 2 weeks.\\n\\nStage II - Isometric, eccentric and heavy slow resistance exercises. The final part of Stage II is a progression from eccentric only to eccentric and concentric contractions.\\n\\nStage III - Functional program. This stage starts in week 5 or 6 and progressed to week 12. Involves pushing, pulling, throwing, lifting, carrying, and precision (sensory-motor control) exercises.', 'interventionNames': ['Procedure: Exercise Therapy']}\n- {'label': 'Extracorporeal Shockwave Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': \"This group will receive high energy Extracorporeal Shockwave Therapy (ESWT) applied by an experienced physiotherapist. ESWT will be applied on the most tender point of the shoulder, located by palpation. The dose will be 1500 impulses per session without anaesthesia and an intensity between 0.15 and 0.30 mJ/mm2 depending on patient tolerance. A total of 4 treatment sessions (1 session per week) with 1 week of rest between sessions will be implemented. Patient's position during the treatment will be seated in supine position with shoulder hyperextension and internal rotation with the hand placed below the contralateral glute with the palm touching the table.\", 'interventionNames': ['Procedure: Extracorporeal Shockwave Therapy']}\n- {'label': 'Ultrasound-Guided Percutaneous Irrigation', 'type': 'ACTIVE_COMPARATOR', 'description': 'This intervention will be performed by an experienced interventionist radiologist in two sessions. The shoulder position will be with hyperextension and internal rotation with the hand behind the back. One 20 mL syringe with saline solution, one with an anaesthetic with 20 mg/mL of mepivacaine 2% and another syringe with a corticoid injection with 40 mg/mL of triamcinolone acetonide will be prepared before the intervention. Firstly, the anaesthetic will be injected directed to the calcification. Then, the procedure will consist of injecting saline solution and aspiring the calcific deposits until it is neither possible to aspire more inside the syringe nor to detect any calcifications with ultrasound imaging. After that, a corticoid will be injected to the bursa to prevent the appearance of subacromial bursitis. Finally, an anaesthetic will be injected during the extraction of the needle.', 'interventionNames': ['Procedure: Ultrasound-Guided Percutaneous Irrigation']}\n- {'label': 'Wait and Watch group', 'type': 'NO_INTERVENTION', 'description': 'The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of RCCT. If one treatment proves to be more effective then participants in the other groups will be offered that treatment after 12 months, or before, if the investigation finishes early due to an obvious group difference and a need to break randomisation codes.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Exercise Therapy', 'description': 'Exercise protocol for rotator cuff related shoulder pain', 'armGroupLabels': ['Exercise Therapy'], 'otherNames': ['Shape Up My Shoulders Protocol']}\n- {'type': 'PROCEDURE', 'name': 'Extracorporeal Shockwave Therapy', 'description': 'High Energy Extracorporeal Shockwave Therapy', 'armGroupLabels': ['Extracorporeal Shockwave Therapy']}\n- {'type': 'PROCEDURE', 'name': 'Ultrasound-Guided Percutaneous Irrigation', 'description': 'Two sessions of Ultrasound-Guided Percutaneous Irrigation', 'armGroupLabels': ['Ultrasound-Guided Percutaneous Irrigation'], 'otherNames': ['Lavage']}\n\nPrimary Outcomes:\n- {'measure': 'Shoulder Pain And Disability Index (SPADI)', 'description': 'Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).', 'timeFrame': 'Baseline'}\n- {'measure': 'Shoulder Pain And Disability Index (SPADI)', 'description': 'Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).', 'timeFrame': '2 weeks'}\n- {'measure': 'Shoulder Pain And Disability Index (SPADI)', 'description': 'Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).', 'timeFrame': '4 months'}\n- {'measure': 'Shoulder Pain And Disability Index (SPADI)', 'description': 'Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).', 'timeFrame': '6 months'}\n- {'measure': 'Shoulder Pain And Disability Index (SPADI)', 'description': 'Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation was based on the 95% CI width of the adjusted between-group mean difference at 1-year follow-up. A 95% CI width of 20 was considered acceptable. A 20% dropout rate at 1-year follow-up was assumed.", "answer": 116, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated based on the 95% CI width of the adjusted between-group mean difference at 1-year follow-up, from an analysis of covariance (ANCOVA) including baseline measurement as the covariate.45 The SPADI was selected as the primary outcome measure. We assumed an equal SD of 20 at 1-year follow-up,46 and a correlation of 0.50 between baseline and 1-year measurement.47 The adjusted mean difference was assumed to be 18 which is the value some authors have established as the minimum detectable change in SPADI.27 It was considered that a 95%\u00e2\u0080\u0089CI width of 20 was acceptable because the lower bound is set at 8, which is the smallest value established in research as the minimum clinically important difference in SPADI.27 48 We transformed the CI width of non-adjusted difference to the ANCOVA adjusted one, using the formula proposed by previous authors,48\n(1-\u00cf\u00812), where r is the correlation between baseline and post-treatment measurement.48 The estimated sample size was 23 subjects per group (92 subjects in total). Assuming a 20% dropout rate at 1-year follow-up, the final sample size was composed of 29 subjects per group (116 subjects in total).", "id": 1527, "split": "test"} +{"trial_id": "NCT05479006", "pmid": "38195605", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Determine the Effect of Targeted High-definition TDCS on Reducing Post-stroke Upper Limb Motor Impairments\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Anodal stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere, sham on the contralesional hemisphere.', 'interventionNames': ['Device: Transcranial direct current stimulation (high- definition)']}\n- {'label': 'Cathodal stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere, sham on the lesioned hemisphere.', 'interventionNames': ['Device: Transcranial direct current stimulation (high- definition)']}\n- {'label': 'Bilateral Stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Anodal stimulation targets the primary motor cortex (arm area) in the lesioned hemisphere and cathodal stimulation targets the dorsal premotor cortex (arm area) in the contralesional hemisphere at the same time.', 'interventionNames': ['Device: Transcranial direct current stimulation (high- definition)']}\n- {'label': 'Sham stimulation', 'type': 'SHAM_COMPARATOR', 'description': 'Sham stimulation to both hemisphere of the brain', 'interventionNames': ['Device: Transcranial direct current stimulation (high- definition)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcranial direct current stimulation (high- definition)', 'description': '20 minutes, 2 mA stimulation.', 'armGroupLabels': ['Anodal stimulation', 'Bilateral Stimulation', 'Cathodal stimulation', 'Sham stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle', 'description': 'This is a neurophysiological measure that determines the use of the ipsilesional corticospinal tract.', 'timeFrame': 'Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention'}\n- {'measure': 'Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 2: Contralesional stimulation in the brain and ipsilateral response in the muscle', 'description': 'This is a neurophysiological measure that determines the use of the contralesional cortico-reticulospinal tract.', 'timeFrame': 'Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 80% power at a 5% significance level, with an assumed attrition rate of 15%.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Study personnel aim to enroll up to 30 participants (15 female) in the event of a potential attrition rate of 15%. Based on our preliminary data [24], we estimated that the targeted effect size for our study is 0.42 (SD: 0.13). The power analysis was performed by using GLMMPSE Sample Size Software (https://samplesizeshop.org/) [25]. Based on our preliminary data from a pilot trial (ClinicalTrials.gov Identifier: NCT05174949) [24] and the proposed basic statistical analysis on the primary and secondary outcomes (see the \u00e2\u0080\u009cStatistical methods\u00e2\u0080\u009d section), we determined the sample size of 26 will give 80% power at the 5% significance level for the targeted effect size. We will include a total of 30 stroke participants (15 female) for this clinical trial study to account for an attrition rate of 15% based on our previous experience in similar multiple-visit brain stimulation research.", "id": 1528, "split": "test"} +{"trial_id": "NCT05480735", "pmid": "36882246", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial\n\nIncluded conditions:\n- Bladder Carcinoma\n\nStudy Armgroups:\n- {'label': 'Prehabilitation group', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke.\\n\\nPatients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation.', 'interventionNames': ['Behavioral: Prehabilitation']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prehabilitation', 'description': 'Multimodal prehabilitation program', 'armGroupLabels': ['Prehabilitation group']}\n\nPrimary Outcomes:\n- {'measure': 'Complications', 'description': 'The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records', 'timeFrame': '0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided Fisher\u2019s exact test with a power of 80% and an alpha of 0.05, with an additional 10% dropout rate.", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Previous studies in diverse types of cancer reported a reduction of postoperative complications in the intervention group compared with the control group, with ORs ranging from 0.11 to 0.88.45\u00e2\u0080\u009351 This study aims to reduce the number of patients with any grade \u00e2\u0089\u00a52 perioperative complication within 90 days from 60%52 53 to 35% (relative risk 0.58, OR 0.36).54 55 Assuming a two-sided Fisher\u00e2\u0080\u0099s exact test with a power of 80% and an alpha of 0.05, in total 140 patients will be needed. To account for 10% dropout, including dropout due to cancelling of the planned surgery, 154 patients will be included. Approximately 380 patients with bladder cancer undergo RC in the eight participating hospitals annually. This implies that it is feasible to complete inclusion within two and a half years, if recruitment rate is at least 17%.", "id": 1529, "split": "test"} +{"trial_id": "NCT05481866", "pmid": "37845612", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum: Protocol for a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Gut Microbiota\n- Metabolites\n\nStudy Armgroups:\n- {'label': 'The intervention group will be given colostrum for oropharyngeal administration', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days.', 'interventionNames': ['Other: Oropharyngeal administration of colostrum']}\n- {'label': 'The control group will be given sterile water for oropharyngeal administration', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above.', 'interventionNames': ['Other: Oropharyngeal administration of sterile water']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Oropharyngeal administration of colostrum', 'description': 'The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours.', 'armGroupLabels': ['The intervention group will be given colostrum for oropharyngeal administration']}\n- {'type': 'OTHER', 'name': 'Oropharyngeal administration of sterile water', 'description': 'The control group will be given 0.2ml sterile water for oropharyngeal administration every 3 hours.', 'armGroupLabels': ['The control group will be given sterile water for oropharyngeal administration']}\n\nPrimary Outcomes:\n- {'measure': 'A between-group difference in gut microbial alpha diversity will be measured by Shannon diversity index at the 7th day.', 'description': 'Shannon diversity Index explains species richness and evenness, which is one of the alpha diversity indexes and less affected by rare species.', 'timeFrame': '1 year'}\n- {'measure': 'Between-group differences in the concentration of fecal metabolites (short chain fatty acids) will be quantitatively measured by non targeted liquid chromatography-mass spectrometry (LC-MS) at the 7th day.', 'description': 'Non-targeted LC-MS will be used to evaluate short chain fatty acids and other organic acids and alcohols. The relative and absolute quantitative results of metabolites will be calculated by fold change (FC) value, and the difference of metabolite expression between the two groups will be explored.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nA statistical power of 80% with a 2-sided type I error of 0.05. A loss to follow-up rate of 10-12% is assumed.", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size\n The purpose of this study is to detect the alpha diversity of gut microbiota in preterm infants (Shannon index is a better indicator of species richness and evenness) and group differences in short chain fatty acids of interest. At present, no study has reported the effect of OAC on the difference in alpha diversity of gut microbiota and metabolites between preterm infants receiving oropharyngeal administration of colostrum and those receiving sterile water. Therefore, it is difficult to estimate the expected change. However, clinically relevant differences in the Shannon index have been determined based on previous studies on the effect of different feeding types on the Shannon index of preterm infants at the 7th day of age [46\u00e2\u0080\u009349]. According to these studies, the mean between-group difference in Shannon index ranged from 0.2 to 0.6 with a standard deviation of 0.2 to 0.8 and a mode of 0.6 [46\u00e2\u0080\u009349]. In a study of the effect of OAC on oral microbiota, the mean between-group difference in Shannon index ranged from 0.2 to 0.5 [50]. Combined with these basic data, the mean difference in Shannon index is assumed to be 0.2, with a standard deviation of 0.6. We conducted sample size estimation using PASS 15.0 (NCSS, Kaysville, Utah, United States). To achieve a statistical power of 80% (2-sided type 1 error of 0.05), the calculated sample size of 143 patients for each group (286 in total) with a ratio of 1:1 will be used. In addition, the relevant difference in short chain fatty acids is based on the previous difference of acetic acid, the main metabolite of preterm infants at the 7th day of life with different feeding types. The mean value of the difference between groups of acetic acid is about 0.025\u00c2\u00a0\u00c2\u00b5mol/g, with a standard deviation of 0.02\u00e2\u0080\u00930.1 for each group [51, 52]. Therefore, a sample of 92 infants in each group (184 in total) will provide 80% power to detect a difference in short chain fatty acids of at least 0.025, assuming a standard deviation of 0.06 and a 2-sided type I error of 0.05. In combination with these two sample sizes, we will use a relatively larger sample (143 cases). Assuming a loss of 10\u00e2\u0080\u009312% to follow-up, we will need to include 160 infants in each group, resulting in a total sample size of 320. The sample size will be adjusted based on the results of interim analysis.", "id": 1530, "split": "test"} +{"trial_id": "NCT05481996", "pmid": "38041180", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of an Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain: a Randomized Clinical Trial\n\nIncluded conditions:\n- Chronic Low-back Pain\n- Telerehabilitation\n\nStudy Armgroups:\n- {'label': 'App-Based Pain Education and Exercise', 'type': 'EXPERIMENTAL', 'description': \"Patients allocated to the experimental group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include three components: 1) a physical exercise program of 8 weeks; 2) weekly messages; and 3) an online booklet. The exercise component will include 8 weeks of training, with two sessions per week of core strengthening exercises. The app will provide illustrations, with animated images (GIFs), descriptions and audios of how to perform each exercise. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises.\", 'interventionNames': ['Other: App-Based Pain Education and Exercise']}\n- {'label': 'Online Booklet', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients allocated to the control group will receive a login and password for individual access to the smartphone app designed for the study. The app's content for this group will include two components: 1) an online booklet; and 2) weekly messages. The online booklet will contain general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. The message component will provide eight messages (one per week), which will have their contents taken from the online booklet. Messages will include information about the benefits of exercise, motivation, and positive messages about coping with pain.\", 'interventionNames': ['Other: Online booklet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'App-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 smartphone application created especially for the study that will contain a program of progressive physical exercises with images and descriptions, educational messages and an online booklet for the study subjects, totaling 8 weeks of training and pain education.', 'armGroupLabels': ['App-Based Pain Education and Exercise'], 'otherNames': ['Telerehabilitation']}\n- {'type': 'OTHER', 'name': 'Online booklet', 'description': 'An online booklet containing information about chronic low back pain and weekly messages about low back pain causes, 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- {'measure': 'Disability at post-treatment follow-up', 'description': 'The primary outcome will be disability measured using the Roland Morris Disability Questionnaire, a 24-item questionnaire that assesses normal activities of daily living, where a higher score indicating a higher level of disability.', 'timeFrame': 'Post-treatment follow-up (8 weeks)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha error (two-tailed) of 5%, and a loss to follow-up rate of up to 15%.", "answer": 66, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Sample size estimation was performed a priori through G-Power\u00e2\u0080\u0099s statistical software (version 3) [53]. A sample size calculation determined that a minimum of 66 individuals would be required in the present study. Data used included 80% power to detect a between-group difference of 1.5 points in a 0 to 10 Pain NRS [54, 55], with an estimated standard deviation (SD) of 2.0 points [56], and a between-group difference of 4.0 points in a 1 to 24 points RMDQ [57], with an estimated SD of 4.9 points [58] and alpha error (two-tailed) of 5%. The estimated sample size would also allow for a loss to follow-up rate of up to 15% observed in studies involving similar populations (firefighters and military) and forms of intervention provision (i.e., app) [56, 59].", "id": 1531, "split": "test"} +{"trial_id": "NCT05482191", "pmid": "38504343", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': 'Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.', 'interventionNames': ['Behavioral: Lifestyle intervention']}\n- {'label': 'Usual practice group', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Lifestyle intervention', 'description': 'This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the treatment group will receive the following interventions:\\n\\n* Develop and implement school policies related to weight loss\\n* Distribute health education materials on diet and exercise to students\\n* Carry out student health education courses\\n* Diet and exercise instruction by professional nutritionist using internet applet\\n* Take part in sports activities that are organized by the sports health teacher during school hours.', 'armGroupLabels': ['Treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'change in body mass index (BMI)', 'description': '* weight and height will be combined to report BMI in kg/m\\\\^2\\n* caculated by terminal value minus baseline value', 'timeFrame': '3 months\uff0c9 months , 24 months and 36 months'}\n- {'measure': 'change in controlled attenuation parameters (CAP)', 'description': '* CAP will be detected by Fibroscan\\n* caculated by terminal value minus baseline value', 'timeFrame': '3 months\uff0c9 months , 24 months and 36 months'}\n- {'measure': 'Change in liver stiffness measurement (LSM)', 'description': '* LSM will be detected by Fibroscan\\n* caculated by terminal value minus baseline value', 'timeFrame': '3 months\uff0c9 months , 24 months and 36 months'}\n\nPlease estimate the sample size based on the assumption: \nThe intracluster correlation coefficient (ICC) was 0.05, and the rate of attribution was 10%. The significance level (\u03b1) was set at 0.05, and the power was aimed to be 89.1%, 87.6%, and 88.0% for detecting the effect sizes of the change in BMI, CAP, and LSM, respectively.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome measures in our study included change in BMI, change in CAP, and changes in LSM. According to previous studies, the difference between the two groups in the change of BMI (effect size) was assumed to be 0.87\u00c2\u00a0kg/m2 [15], with a standard deviation (SD) of 0.9\u00c2\u00a0kg/m2; meanwhile, the changes in CAP and LSM were assumed to be 72\u00c2\u00a0dB/m (with an SD of 75\u00c2\u00a0dB/m) and 0.30\u00c2\u00a0kPa (with an SD of 0.31\u00c2\u00a0kPa) [25], respectively. The intracluster correlation coefficient (ICC) was 0.05, and the rate of attribution was 10% in our study. We aimed to recruit 300 students in total from 6 schools with an average of 50 students in each school. This sample size will provide power of 89.1%, 87.6%, and 88.0% with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 to detect the set effect size of the change in BMI, CAP, and LSM. All power calculations were carried out in PASS 15.0.5 using the cluster-randomized function.", "id": 1532, "split": "test"} +{"trial_id": "NCT05482620", "pmid": "36893205", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Parallel-group, Randomized Controlled Trial to Test the Effectiveness of a Nordic Walking Program in Patients With Asthma\n\nIncluded conditions:\n- Asthma\n\nStudy Armgroups:\n- {'label': 'Study Group', 'type': 'EXPERIMENTAL', 'description': 'Study group following Nordic walking program and educational sessions and usual care (medical visits, medication, etc).', 'interventionNames': ['Procedure: Nordic walking program', 'Procedure: Educational sessions and usual care']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Group that will only receive educational sessions and usual care (medical visits, medication, etc).', 'interventionNames': ['Procedure: Educational sessions and usual care']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Nordic walking program', 'description': 'Nordic walking program will consist of three training sessions per week, during eight weeks. Each session will last approximately 60 minutes, including warm-up, the intervention itself and cool-down. Intervention will consist in a 30 minutes Nordic walking, working at 70-85% of maximal heart rate, measured with a Polar pulsometer. Intervention will be delivered in groups (six patients per group as maximum), in designed circuits placed in A Coru\u00f1a city.', 'armGroupLabels': ['Study Group']}\n- {'type': 'PROCEDURE', 'name': 'Educational sessions and usual care', 'description': \"Educational sessions will consist in three classes, about 60 minutes each. In these classes, participants will learn about their pulmonary system, asthma disease, asthma diagnosis, asthma classification, asthma exacerbations and triggers, types of medications, how to take inhalers, how to measure PEF (peak expiratory flow), how to control the environment in order to prevent exacerbations, healthy-lifestyle recommendations and the importance of an active lifestyle, what to do in case of asthma emergency, and how to do required data from patients to note in their Patient's Diary (one of the evaluation tools). Usual care implies following the current therapeutic plan and revisions planned by their specialist/GP.\", 'armGroupLabels': ['Control Group', 'Study Group']}\n\nPrimary Outcomes:\n- {'measure': 'Six-minute walk test (6MWT) distance', 'description': 'Change in the 6MWT distance. The 6MWT will be performed according to the American Thoracic Society / European Respiratory Society recommendations (ATS/ERS).', 'timeFrame': 'At baseline, and at two (post-intervention), three and six months.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha level of 0.05, and a dropout rate of 15%.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size\n To estimate the sample size needed, we used the tool created by the Clinic Epidemiologic and Biostatistics service from A Coru\u00c3\u00b1a University Hospital Complex (CHUAC) (http://bitly.ws/sDIp). This calculation was based on the 6MWT minimum clinically important difference in patients with asthma, which is set at 26 meters [33]. Using a standard deviation (SD) of 45.49 meters, obtained from a previous pilot study [34], and considering a power of 80%, an alpha level of 0.05, and a dropout rate of 15%, a total sample size of 114 is estimated (57 in each group).", "id": 1533, "split": "test"} +{"trial_id": "NCT05486390", "pmid": "38408067", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Nudge, health coaching and shared decision-making']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Nudge, health coaching and shared decision-making', 'description': 'The EMPOWER app aims to nudge the participant towards successful self-management of their diabetes condition by encouraging and reinforcing positive lifestyle behaviors in 3 main aspects - diet, physical activity, medication adherence. Notifications included content based on behavioural change technique including feedback on performance, positive reinforcement, and prompts to self-monitor. Each notification focused on a single behaviour (physical activity, medication adherence or diet).\\n\\nThe participants in the intervention group will also interact with health coach throughout the study duration. In this study, the health coach will be responsible for the following roles :\\n\\n1. Goal setting and action plan\\n2. After-visit summary\\n\\nA report card summarizing the lifestyle behaviour, goals will be made available to facilitate shared decision making.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'HbA1c', 'description': 'HbA1c over 9 months', 'timeFrame': '9 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect the hypothesised difference at a two-sided alpha of 5%, with a 20% attrition rate.", "answer": 320, "answer_type": "ACTUAL", "explanation": "Sample size and recruitment\n We calculated the sample size based on our primary outcome of HbA1c which is evaluated at baseline, 3 months, 6 months and 9 months. We assume a mean difference of 0.36%, a standard deviation of 1.5% [29], and an auto-correlation of 0.375 [30] between the repeated HbA1c measurements. The standard deviation of 1.5% was derived from data from the SingHealth Diabetes Registry, which showed the standard deviation of HbA1c for patients from polyclinics, hospitals and national specialty centres ranging from 1.4\u00e2\u0080\u00931.5 from 2013\u00e2\u0080\u00932019 [29]. Conservatively, we postulated that effect size of a complex intervention involving health coach and mobile app would result in a mean difference of 0.36% in HbA1c levels between the intervention and control groups. A meta-analysis has shown that the mean reduction in HbA1c is 0.41% for high quality studies involving mobile applications for Type 2 diabetes [31]. The auto-correlation of 0.375 between the repeated HbA1c measurements was assumed as it provided the most conservative (i.e. maximum) estimate of the sample size based on a repeated measurement study design with one-pre and three-post intervention measurements [30].\n Based on a repeated measures study design [30] with one pre- and three post-intervention measurements, a minimum sample size of 125 per group, or 250 in total would have an 80% power to detect the hypothesised difference at a two-sided alpha of 5%. A total of 320 participants will be required after accounting for 20% attrition.\n We will be advertising the study through posters and banners placed at polyclinic sites to ensure adequate enrolment to reach the target sample size of 320.", "id": 1534, "split": "test"} +{"trial_id": "NCT05487417", "pmid": "39806586", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy\n\nIncluded conditions:\n- Ischemic Stroke, Acute\n\nStudy Armgroups:\n- {'label': 'Minocycline treatment group', 'type': 'EXPERIMENTAL', 'description': 'Patients were given minocycline 200mg/d orally from the day of admission for 5 days. At the same time, the patient received mechanical thrombectomy and other standard treatments for acute ischemic stroke.', 'interventionNames': ['Drug: Minocycline']}\n- {'label': 'Routine treatment group', 'type': 'NO_INTERVENTION', 'description': 'Patients were given mechanical thrombectomy and other standard treatment for acute ischemic stroke, without minocycline treatment.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Minocycline', 'description': 'Minocycline is a tetracycline antibiotic. Previous studies have confirmed that its application in stroke patients has good efficacy and safety, suggesting that it could become a synergistic treatment of mechanical thrombectomy.', 'armGroupLabels': ['Minocycline treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in infarct volume from baseline to day 5', 'description': 'Baseline infarct volume is measured by diffusion-weighted imaging (DWI), day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR), Images are processed by imSTROKE software.', 'timeFrame': 'Day 5 after onset'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level (\u03b1) of 0.05, power (1\u2212\u03b2) of 0.8, and a 10% loss to follow-up rate.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Based on the basic experiments with minocycline, which have shown that minocycline can reduce the infarct volume by 41%\u00e2\u0080\u009345% within 2\u00e2\u0080\u009328\u00e2\u0080\u0089days postcerebral infarction10 12 and in light of previous literature,25 the steering committee has designed the study with sufficient statistical power to detect a mean logarithmic reduction in the relative growth of infarct volume from baseline of 0.40 (one-third decrease in relative growth) with an SD of 0.9,25 as surrogate threshold effect. The preliminary estimation of the sample size is determined with an alpha level (\u00ce\u00b1) of 0.05 and a power of 1\u00e2\u0088\u0092\u00ce\u00b2 (beta) of 0.8. Accounting for a 10% loss to follow-up rate, the final sample size is calculated to be 180 cases.", "id": 1535, "split": "test"} +{"trial_id": "NCT05487534", "pmid": "36401237", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Glycemic Variability on Cognitive Impairment, Disordered Eating Behavior, and Self-management Skills in Patients Living with Type 1 Diabetes\n\nIncluded conditions:\n- Type 1 Diabetes\n\nStudy Armgroups:\n- {'label': 'Sugar Swing +', 'description': 'Patients with type 1 diabetes with a high glucose variability (i.e., a coefficient of variation \\\\> 36% over a 10-day continuous glucose monitoring)', 'interventionNames': ['Other: Observational']}\n- {'label': 'Sugar Swing -', 'description': 'Patients with type 1 diabetes with low glucose variability (i.e., a coefficient of variation \\\\< 36% over a 10-day continuous glucose monitoring)', 'interventionNames': ['Other: Observational']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Observational', 'description': 'The same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention.', 'armGroupLabels': ['Sugar Swing +', 'Sugar Swing -']}\n\nPrimary Outcomes:\n- {'measure': 'Eating Disorder examination (EDE-Q)', 'description': 'To assess eating behaviors according to their glycemic variability.', 'timeFrame': 'Day 1 (+/- 2 days)'}\n- {'measure': 'Glucose variability and insulin resistance (CGMS - 10 days)', 'description': 'CGMS will be performed over a 10-day period using a DEXCOM G6 to separate participants into groups based on glycemic variation (i.e., a coefficient of variation \\\\[CV\\\\] \\\\>36% over a 10-day CGMS) versus those with a low glucose variability (i.e., CV \\\\<36%).', 'timeFrame': 'Start at inclusion (Day 1 to Day 10)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, increased sample size by 20% due to potential failure per protocol, n > 100 recommended for LASSO regression", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size has been estimated based on the cognitive flexibility (one of the most relevant cognitive functions for both disordered eating and self-management skills) effect size computed by Brands et al. [52] in their meta-analysis (d\u00e2\u0080\u0089=\u00e2\u0080\u0089-0.54, SD\u00e2\u0080\u0089=\u00e2\u0080\u00891.07; \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05). Given the potential failure per protocol observed in a similar study design [53], we increased the estimated sample size by 20%. The total number of participants to recruit is established at 150 (75 per group). As an n\u00e2\u0080\u0089>\u00e2\u0080\u0089100 is minimally recommended for Least Absolute Shrinkage and Selection Operator, (LASSO) regression, this sample size will also fit for more complex statistical procedures.", "id": 1536, "split": "test"} +{"trial_id": "NCT05489068", "pmid": "37865777", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adapting Intake Procedures to Improve Treatment Delivery in Addiction Treatment\n\nIncluded conditions:\n- Substance-Related Disorders\n- Treatment Adherence\n\nStudy Armgroups:\n- {'label': 'Motivational Interviewing at Intake (MII)', 'type': 'EXPERIMENTAL', 'description': 'Clients allocated to the MII condition will receive a 90-minute pure Motivational Interviewing (MI) session.', 'interventionNames': ['Behavioral: Motivational Interviewing at Intake (MII)']}\n- {'label': 'Intake as Usual (IAU)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Clients allocated to the IAU condition will receive the 90-minute standard assessment that is delivered to all clients entering intensive outpatient program (IOP)/outpatient program (OP).', 'interventionNames': ['Behavioral: Intake as Usual (IAU)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Motivational Interviewing at Intake (MII)', 'description': \"The MII will involve a goal-oriented and collaborative conversation about why the client wants treatment now, and how treatment might fit with his/her most important values. The provider will use open questions, reflective listening and autonomy support in a flexible, non-authoritative manner. Rather than asking specific questions in different life domains, the provider will explore with the client their desires, abilities, reasons, and needs for treatment, how treatment fits with their values, and what successful treatment looks like to them. The client's language about change will be strategically reinforced to increase its frequency and strength across the session.\", 'armGroupLabels': ['Motivational Interviewing at Intake (MII)']}\n- {'type': 'BEHAVIORAL', 'name': 'Intake as Usual (IAU)', 'description': \"In line with the American Society of Addiction Medicine (ASAM) guidelines, the IAU condition involves a semi-structured interview of the client's psychosocial history and clients answer a series of questions in the following domains: support system, living situation, educational, occupational, family, and medical history.\", 'armGroupLabels': ['Intake as Usual (IAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants who attended the first outpatient treatment program session based on electronic medical record review', 'description': 'Treatment entry is determined by review of electronic medical record of whether clients attended their first scheduled treatment session', 'timeFrame': 'up to 36 weeks'}\n- {'measure': 'Number of treatment sessions attended during the three-month outpatient treatment program based on electronic medical record review', 'description': 'Number of treatment sessions that clients attend is determined by review of electronic medical record and calculating number of treatment sessions attended.', 'timeFrame': 'up to 36 weeks'}\n- {'measure': 'Number of participants who completed the three-month outpatient treatment program based on electronic medical record review', 'description': 'Completion of the three-month outpatient treatment program is determined by review of electronic medical record', 'timeFrame': 'up to 36 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power = 0.80, no attrition accounted for", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size and power analysis\n An intent to treat approach will be employed such that participant data will be analyzed based on the randomization assignment status, regardless of levels of engagement in the treatment program. Target enrollment of client participants is 150, with approximately 75 in the MII condition and 75 in the IAU condition. Power analyses based on a meta-analysis of 42 studies that evaluated client engagement following an MI intervention suggest that 75 participants per condition will provide sufficient power (0.80) to detect a medium effect size (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.24 [CI 0.17, 0.31]) [34]. Given that client participant consent, baseline, follow-up assessments, and assigned intake condition will occur within a single visit, and that primary outcomes are based on electronic medical record review, we did not account for potential attrition.", "id": 1537, "split": "test"} +{"trial_id": "NCT05489432", "pmid": "37500274", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PREhabilitation of CAndidates for REnal Transplantation: a Hybrid Study\n\nIncluded conditions:\n- Prehabilitation\n- Kidney Transplant Candidates\n- Frailty\n\nStudy Armgroups:\n- {'label': 'prehabilitation group', 'type': 'EXPERIMENTAL', 'description': 'care as usual and pre habilitation intervention', 'interventionNames': ['Behavioral: Exercise']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'care as usual'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': 'A twelve-week prehabilitation program consisting of physical exercises, nutritional measures and psychosocial interventions based on the KTCs personal needs as indicated by an assessment consisting of questionnaires and physical tests. The prehabilitation program will be followed by a twelve-week consolidation program, in which the intensity and frequency of the interventions will be lower, in order to enhance the incorporation of the interventions into the daily life of the KTC. During the intervention period, participants will receive counseling by a lifestyle coach.', 'armGroupLabels': ['prehabilitation group'], 'otherNames': ['nutritional measures', 'stress reduction']}\n\nPrimary Outcomes:\n- {'measure': 'Change in frailty status', 'description': 'Frailty will be measured with the Tilburg Frailty Index, which measures the physical, psychological and social domain of frailty with 15 items. The total score ranges from 0-15, in which higher a score indicates a higher level of frailty', 'timeFrame': 'Baseline-week 13'}\n- {'measure': 'Change in frailty status', 'description': 'Frailty will be measured with the Tilburg Frailty Index, which measures the physical, psychological and social domain of frailty with 15 items. The total score ranges from 0-15, in which higher a score indicates a higher level of frailty', 'timeFrame': 'week 13- week 26'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value of 0.05 (two-sided), power of 0.80, dropout rate of 15%, and an initial exclusion of 10% of the target population.", "answer": 128, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n An a priori sample size calculation was performed based on an effect size of 0.5, which is generally found across outcomes and across populations as indicative of a minimal clinically important difference. To find a statistically significant difference between the control and intervention groups in the change of frailty at the end of the prehabilitation programme (T1) with a medium effect size (0.5), alpha value of 0.05 (two-sided) and a power of 0.80 at least 128 participants are needed in the study, n=64 in each group. Based on a dropout rate of 15%, 148 KTCs will be needed for randomisation. Given the estimated exclusion after the assessment of participants with no problems of 15%, 176 KTCs need to be included for assessment.\n Based on a conservative estimation of 50% regarding response rate to the invitation to participate in the study, and an initial exclusion of 10% of the target population (eg, because of a language barrier), a total of 388 KTCs (2\u00c3\u0097176 needed for assessment+10% exclusion) will be needed as potential eligible participants.", "id": 1538, "split": "test"} +{"trial_id": "NCT05490550", "pmid": "37803393", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing Insomnia Care As Usual to Digital Augmentation\n\nIncluded conditions:\n- Chronic Insomnia\n\nStudy Armgroups:\n- {'label': 'COAST-enhanced CBTI', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients randomized to COAST will receive CBTI via the COAST platform, with the assistance of a licensed clinician via NOCTEM's digital sleep hub. Participants will utilize the COAST patient app on their smartphone for engagement in insomnia treatment and receipt of clinician's recommendations. COAST clinicians will utilize the COAST web-based portal for adherence monitoring, progress review, and for providing personalized insomnia treatment recommendations.\", 'interventionNames': ['Behavioral: COAST-enhanced CBTI']}\n- {'label': 'Military Treatment Facility Insomnia Care As Usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to the ICAU arm will receive insomnia care as usual by a certified clinician at their respective site, according to current referral and treatment practices.', 'interventionNames': ['Behavioral: Military Treatment Facility Insomnia Care As Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'COAST-enhanced CBTI', 'description': \"Participants will receive CBTI delivered through the COAST platform by one of NOCTEM's certified and licensed COAST clinician. Communication between the participant and licensed clinician will occur primarily through COAST's HIPAA-compliant text messaging, but clinicians and patients may elect to connect via telephone calls or HIPAA-compliant secure videoconference if needed.\", 'armGroupLabels': ['COAST-enhanced CBTI']}\n- {'type': 'BEHAVIORAL', 'name': 'Military Treatment Facility Insomnia Care As Usual', 'description': 'Participants will receive the insomnia care offered at their site following current delivery practices (i.e., face-to-face or virtual; individual or group format). During the treatment phase, participants randomized to ICAU will be instructed to communicate with their clinicians as needed, according to standard procedures in place.', 'armGroupLabels': ['Military Treatment Facility Insomnia Care As Usual']}\n\nPrimary Outcomes:\n- {'measure': 'Insomnia Severity', 'description': 'Insomnia Severity Index (ISI)', 'timeFrame': 'baseline'}\n- {'measure': 'Insomnia Severity', 'description': 'Insomnia Severity Index (ISI)', 'timeFrame': '6-8 week check-in'}\n- {'measure': 'Insomnia Severity', 'description': 'Insomnia Severity Index (ISI)', 'timeFrame': '3-month follow up'}\n- {'measure': 'Symptoms of Depression', 'description': 'Patient Health Questionnaire-2 (PHQ-2)', 'timeFrame': 'baseline'}\n- {'measure': 'Symptoms of Depression', 'description': 'Patient Health Questionnaire-2 (PHQ-2)', 'timeFrame': '6-8 week check-in'}\n- {'measure': 'Symptoms of Depression', 'description': 'Patient Health Questionnaire-2 (PHQ-2)', 'timeFrame': '3-month follow up'}\n- {'measure': 'Symptoms of Anxiety', 'description': 'Generalized Anxiety Disorder 2-item (GAD-2)', 'timeFrame': 'baseline'}\n- {'measure': 'Symptoms of Anxiety', 'description': 'Generalized Anxiety Disorder 2-item (GAD-2)', 'timeFrame': '6-8 week check-in'}\n- {'measure': 'Symptoms of Anxiety', 'description': 'Generalized Anxiety Disorder 2-item (GAD-2)', 'timeFrame': '3-month follow up'}\n- {'measure': 'Acceptability of Insomnia Care', 'description': 'An adapted version of the Insomnia Treatment Acceptability Scale (ITAS) with ratings of perceived acceptability and treatment preference for both COAST-enhanced CBTI and insomnia care as usual (ICAU).', 'timeFrame': '6-8 week check-in'}\n- {'measure': 'Satisfaction with Insomnia Care', 'description': 'Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.', 'timeFrame': '6-8 week check in'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided type I error rate of \u03b1 = 0.025 was set, adjusted to \u03b1* = 0.0125 for two a priori t-tests. Power calculations aimed for 88% power with a full sample and 80% power with an attrition rate of 25%.", "answer": 188, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Power calculations and sample size were based on a conservative estimate of the non-inferiority margin (NIM) based on our preliminary data and prior studies [53\u00e2\u0080\u009355] and effect sizes reported in the literature on the effects of CBTI on insomnia severity [56\u00e2\u0080\u009360], as well as estimates of recruitment feasibility based on patient volume at the participating sites. Specifically, effect sizes in the moderate to very large range (0.50 to 2.15) have been reported for insomnia, depression, and anxiety in military and civilian samples. Thus, we conservatively estimated a NIM of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 for each outcome of interest for this trial. The NIM of |d|=\u00e2\u0080\u00890.5 set to determine non-inferiority is stringent as it represents 50% of the effect size reported in recent meta-analyses [61\u00e2\u0080\u009363]. For non-inferiority tests, we set an allowable one-sided type I error rate of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025. Conservatively adjusting for our two a priori t-tests (post-treatment and a 3-month follow-up), we use \u00ce\u00b1*\u00e2\u0080\u0089=\u00e2\u0080\u00890.0125 to determine power. Based on the current patient volume and clinical workflows at the three participating sites, we estimated that a total of 188 patients could be enrolled in this clinical trial over the period of performance. Power calculations using PASS version 23.0.2. [64] yielded 88% power with a full sample of 94 participants per group (our primary strategy and 80% power with a final sample of 140 completers assuming an attrition rate of 25% (N\u00e2\u0080\u0089=\u00e2\u0080\u008970 completers per group).", "id": 1539, "split": "test"} +{"trial_id": "NCT05490875", "pmid": "39230469", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy\n\nIncluded conditions:\n- Head and Neck Cancer\n- Carotid Artery Stenosis\n- Cardiovascular Complication\n\nStudy Armgroups:\n- {'label': 'Carotid Ultrasound Group', 'description': 'Head and neck cancer survivors treated with radiotherapy, at least 2 years since end of radiotherapy with no evidence of disease will receive a carotid ultrasound to measure carotid velocities and intima-media thickness of the carotid arteries.', 'interventionNames': ['Procedure: Carotid ultrasound', 'Other: Blood draw', 'Other: Survey']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Carotid ultrasound', 'description': 'Carotid ultrasound will be done to both sides of the neck to look at the carotid arteries.', 'armGroupLabels': ['Carotid Ultrasound Group']}\n- {'type': 'OTHER', 'name': 'Blood draw', 'description': 'This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.', 'armGroupLabels': ['Carotid Ultrasound Group']}\n- {'type': 'OTHER', 'name': 'Survey', 'description': 'Participants will complete a 15-minute survey about how acceptable participants find the ultrasound procedure, whether participants would be open to it in the future if a doctor thought it was necessary, whether participants would be open to getting treatment for artery problems, and how participants feel about their own risk of stroke.', 'armGroupLabels': ['Carotid Ultrasound Group']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants with 50% Stenosis Identified', 'description': 'This will be defined as having a peak systolic flow velocity of 150 cm/s or higher on Doppler ultrasonography will be estimated and reported along with an exact 95% confidence interval.', 'timeFrame': 'At study completion, up to 1 approximately year'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) = 0.1, power = 75%, confidence interval = 95%, method = exact Clopper-Pearson.", "answer": 60, "answer_type": "ACTUAL", "explanation": "3.1.\n Planned sample size\n The expected sample size is 60 patients. We anticipate that the rate of clinically significant CAS will be 20\u00e2\u0080\u009325% in this patient population. If the rate is 25%, with a sample size of 60, the proportion with clinically significant CAS will be estimated to be within +/- 11.6% based on an exact 95% binomial confidence interval. The maximum half-width of an exact 95% confidence interval is 13.2%, so even if the rate of clinically significant CAS is as high as 50%, the proportion can still be estimated within +/- 13.2% with a sample size of 60. While the study is not formally powered to detect a difference in the proportion with clinically significant CAS between subgroups, there is moderate power to detect some clinically relevant differences with a sample size of 60. For example, there is at least 75% power to detect a difference between a subgroup with a 10% rate and one with a 35% rate when there are 30 patients in each group using a test with alpha\u00c2\u00a0=\u00c2\u00a00.1. The precision estimates for a sample size of 60 were calculated using PASS 16 and calculated for a two-sided confidence interval for one proportion using exact Clopper-Pearson method (PASS 16 Power Analysis and Sample Size Software, NCSS, LLC., Kaysville, Utah).", "id": 1540, "split": "test"} +{"trial_id": "NCT05491213", "pmid": "39425032", "question": "Here is the design of a clinical trial:\n\nOfficial Title: TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary CarE (TELESCOPE)\n\nIncluded conditions:\n- Lung Neoplasms\n\nStudy Armgroups:\n- {'label': 'TELESCOPE intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators.', 'interventionNames': ['Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention']}\n- {'label': 'Enhanced usual care (EUC)', 'type': 'NO_INTERVENTION', 'description': 'Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'TELESCOPE, Remote Decision Coaching with Navigation Intervention', 'description': 'The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed', 'armGroupLabels': ['TELESCOPE intervention']}\n\nPrimary Outcomes:\n- {'measure': 'To assess shared decision making', 'description': 'Semi-structured interviews (qualitative data)', 'timeFrame': 'The change in baseline, three months and five years'}\n\nPlease estimate the sample size based on the assumption: \nType I error is set at 5%, with 80% power. An intraclass correlation coefficient (ICC) of 0.20 for the primary outcome and 0.04 for the secondary outcome is assumed. A 10% attrition rate by the 1-week follow-up survey is also considered.", "answer": 420, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n Our goal is to randomize approximately 120 primary care clinicians from over 40 primary care practice sites into either the TELESCOPE intervention arm or the EUC arm. We anticipated that it would be feasible to recruit on average 3\u00e2\u0080\u00934 patients from each of the 120 clinicians, resulting in 420 patients in total (210 patients per arm). We evaluated statistical power and effect sizes based on these assumptions for the quality of the SDM process\u00c2\u00a0(SDMP_4), our primary outcome, in a\u00c2\u00a0two-sample t-test with adjustment for the intraclass correlation coefficient (ICC) within a practice site and within a clinician [56\u00e2\u0080\u009358]. Assuming 10% attrition by the 1-week follow-up survey, when SDMP_4 is measured, we would have 189 patients per arm (378 total). Even with the most conservative ICC at 0.20 and Type I error set at 5%, we would have 80% power for a minimal detectable effect size of 0.38 [59]. Power will be greater for smaller ICCs. Published studies of the SDMP_4 measure have found effects sizes ranging between 0.30 and 0.60 [60, 61]. Hence, a sample of 378 patients by 1-week follow-up provides sufficient power for our primary outcome. We aim to recruit 25% Black and 15% Hispanic patients to ensure the inclusion of these underserved minority populations.\n We also evaluated statistical power and effect sizes for LCS uptake at 6\u00c2\u00a0months, our key secondary outcome, in chi-square tests with adjustment for the ICC within a practice site and within\u00c2\u00a0a clinician. LCS uptake at 6\u00c2\u00a0months is assessed from EHR data; we will use an intention-to-screen analysis to determine the proportion of participants in each arm who completed screening. Assuming an ICC (clinician and practice) of 0.04 and setting the Type I error at 5%, 210 patients per arm yields 80% power to detect a difference in LCS uptake of 14% in the EUC arm compared to 25.5% in the TELESCOPE arm. We will monitor the ICC during data collection and adjust the sample size (i.e., patients) or recruit additional clinicians if the ICC is higher than anticipated.\n Power calculations are not needed for the evaluation of TELESCOPE\u00e2\u0080\u0099s implementation potential (Aim 2) as this is primarily descriptive and qualitative in nature. Our target sample size for the surveys is up to\u00c2\u00a0131, including primary care clinicians, practice administrators, and patient and nurse navigators. We will conduct up to\u00c2\u00a034 interviews with selected individuals from these stakeholders across both study arms. We expect that data saturation will be achieved with this amount of interviews [62].", "id": 1541, "split": "test"} +{"trial_id": "NCT05491239", "pmid": "36058900", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimal Postoperative Pain Management After Lung Surgery (OPtriAL): Multi-centre Randomised Trial\n\nIncluded conditions:\n- Lung Cancer\n- Pain, Postoperative\n- VATS\n- Locoregional Anaesthesia\n- Thoracic Epidural\n\nStudy Armgroups:\n- {'label': 'Thoracic epidural analgesia', 'type': 'ACTIVE_COMPARATOR', 'description': 'See intervention description', 'interventionNames': ['Procedure: Thoracic epidural analgesia']}\n- {'label': 'Continuous regional paravertebral block', 'type': 'EXPERIMENTAL', 'description': 'See intervention description', 'interventionNames': ['Procedure: Continuous regional paravertebral block']}\n- {'label': 'Single shot intercostal nerve block', 'type': 'EXPERIMENTAL', 'description': 'See intervention description', 'interventionNames': ['Procedure: Single shot intercostal nerve block']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Thoracic epidural analgesia', 'description': 'After correct placement of the epidural catheter, a local anaesthetic (ropivacaine, levobupivacaine or bupivacaine) will be started and, according to in house protocols, an opioid will be added to the epidural solution. A provisional stop of the administration of the epidural infusion is planned after 48 hours (on the second postoperative day).', 'armGroupLabels': ['Thoracic epidural analgesia']}\n- {'type': 'PROCEDURE', 'name': 'Continuous regional paravertebral block', 'description': 'The PVB catheter is placed under general anaesthesia at the beginning of the VATS procedure under direct thoracoscopic vision. The level of the PVB catheter placement is chosen at the intercostal space of the largest incision (mostly thoracic level 4 or 5). Under direct thoracoscopic vision, the surgeon inserts a Touhy needle. The tip of the needle is observed beneath the pleural surface thoracoscopically. Injection of about 2 mL ropivacaine 7.5mg/mL will create subpleural hydrodissection to reach the adequate paravertebral plane for placement of the catheter. The PVB catheter is subsequently placed under direct thoracoscopic vision and left next to the sympathetic chain in the paravertebral space. Next, a bolus of ropivacaine (total amount 20 mL including the given amount for hydrodissection) is given through the catheter.\\n\\nPostoperatively, a ropivacaine 2 mg/mL pump for continuous infusion is given with an infusion rate of 8-14 ml/hour.', 'armGroupLabels': ['Continuous regional paravertebral block']}\n- {'type': 'PROCEDURE', 'name': 'Single shot intercostal nerve block', 'description': 'At the end of the surgery a single shot ICNB will be placed at 9 levels (thoracic level 2 to 10) with 2-3mL local anaesthetics per intercostal space under direct thoracoscopic vision. The injection site will be chosen just lateral from the sympathetic trunk. This group will have no analgesic catheters for continuous analgesia. No mobility restrictions are instructed in this group.', 'armGroupLabels': ['Single shot intercostal nerve block']}\n\nPrimary Outcomes:\n- {'measure': 'Pain scores', 'description': 'Proportion of pain scores \u22654 as assessed by the numerical rating scale (NRS) (measured from 0 until 10; lowest value signifying no pain and highest value signifying worst pain)', 'timeFrame': 'Postoperative day 0-2'}\n- {'measure': 'Quality of Recovery (QoR)', 'description': 'QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)', 'timeFrame': 'Postoperative day 1-2'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 90%, a one-sided Type 1 error of 0.0135 for non-inferiority, and a two-sided Type 1 error of 0.027 for superiority. A 12.6% dropout rate is also assumed. Non-parametric testing (Mann\u2013Whitney U-test) is used due to skewed data distribution.", "answer": 450, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A previous pilot study performed by our group [25], comparing TEA (n\u00e2\u0080\u0089=\u00e2\u0080\u008923) with subpleural continuous analgesia (n\u00e2\u0080\u0089=\u00e2\u0080\u008923), as a unilateral regional continuous analgesic technique, showed that 17.57% (SD 19.57) and 21.21% (SD 23.33) of the moments at which pain was measured postoperatively, patients had an NRS\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00894 at rest respectively. As research group, we consider the point estimators 17.57% and 21.21% as both low and find it clinically acceptable to set the non-inferiority upper margin regarding moments of pain at a difference of 17.5%, given the counterbalancing potential gain in QoR. Only if the upper limit of the 95% two-sided confidence interval (CI) of the difference in percentages of NRS measurements\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00894 between PVB and TEA remains below the 17.5% margin in the (modified) intention-to-treat analysis as well as the per-protocol analysis, we will reject the null hypothesis that PVB is worse than TEA in managing pain. For the distinct comparison between single shot ICBN versus TEA the same reasoning holds.\n The estimated values used for the sample size regarding percentage of NRS moments in which NRS\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00894, are based on a single small pilot study of limited reliability. In addition, data from this pilot study showed a skewed distribution requiring non-parametric testing. Based on the Mann\u00e2\u0080\u0093Whitney U-test assuming that the actual distribution is normal and applying Dunnett\u00e2\u0080\u0099s correction to control the familywise error rate, while comparing two independent experimental groups with the same control group [26] we calculated that 64 patients were needed per group to achieve a power of 90% with a one-sided Type 1 error of 0.0135 to demonstrate non-inferiority of unilateral regional techniques. Based on an assumed 12.6% drop-out rate due to conversion of VATS/RATS to thoracotomy (Dutch Lung Cancer Audit data), we would need to include a total of 222 patients (74 per group).\n We also calculated the needed sample size to demonstrate superiority of the unilateral regional techniques regarding QoR-15 (second primary outcome). QoR-15 is well reported in the literature and a difference of 8.0 points with a standard deviation of 18 points shows a clinically relevant difference [27]. Using this cut-off value for sample size calculation with a two-sample t-test, we initially need 125 patients per randomization group to achieve 90% power with a two-sided Type 1-error of 0.027 to control the family-wise error rate [26] in order to demonstrate superiority of the unilateral regional techniques. To account for possible non-normally distributed data and achieve 90% power with a Mann\u00e2\u0080\u0093Whitney U-test (with an asymptotic relative efficiency of 0.955 compared with the t-test) and assuming the abovementioned 12.6% drop-out rate, we aim to include 150 patients per group, or 450 patients in total. This sample size is sufficient to provide evidence for non-inferiority on pain as well, if our estimated values on percentage of NRS\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00894 are correct. A Data Safety Monitoring Board (DSMB) will be installed (1) to evaluate the point estimator and distribution of the control group (TEA) regarding the proportion of NRS\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00894 when 50% of observations in the control group are completed and (2) advise if further adjustment of the sample size is needed.", "id": 1542, "split": "test"} +{"trial_id": "NCT05492344", "pmid": "38715118", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome\n\nIncluded conditions:\n- ARDS, Human\n- Lung Ultrasound\n- Mechanical Ventilation\n\nStudy Armgroups:\n- {'label': 'Personalized ventilation', 'type': 'EXPERIMENTAL', 'description': 'If a patient is assigned to the intervention group, ventilator settings will be adjusted based on the lung morphology (focal or non focal) results of the lung ultrasound.', 'interventionNames': ['Other: Personalized ventilation']}\n- {'label': 'Standard care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients assigned to the control group will be ventilated according to the current standard of care.', 'interventionNames': ['Other: Standard care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Personalized ventilation', 'description': 'Patients who are randomized for personalized ventilation with FOCAL ARDS will receive the following ventilator settings:\\n\\n* Positive end-expiratory pressure (PEEP) \u2264 9 cm water (H2O)\\n* Tidal volume: 6 to 8 mL/kg predicted body weight (PBW)\\n* Daily prone positioning\\n\\nLUS will be repeated every 48-72 hours in supine position for the focal ARDS patients to assess whether they have developed non-focal ARDS during admission. In that case, patients will from then on be treated according non-focal personalized treatment protocol.\\n\\nPatients who are randomized for personalized ventilation with Non-FOCAL ARDS will receive the following ventilator settings:\\n\\n* PEEP \u2265 15 cm H2O\\n* Tidal volume: 4 to 6 mL/kg PBW\\n* Daily recruitment maneuver', 'armGroupLabels': ['Personalized ventilation']}\n- {'type': 'OTHER', 'name': 'Standard care', 'description': 'Patient who are randomized in the control group will receive standard care\\n\\n* Tidal volume: 6 mL/kg PBW\\n* PEEP and FiO2 according to the low PEEP and high fraction of inspired oxygen (FiO2) table of the AlVEOLI study\\n* Prone positioning if the Partial Pressure of Oxygen (PaO2) /FiO2 ratio is \\\\< 150 mmHg', 'armGroupLabels': ['Standard care']}\n\nPrimary Outcomes:\n- {'measure': 'All-cause mortality', 'description': 'Any death during ICU- or hospital-stay at day 90', 'timeFrame': '90 days after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80% at a two-tailed significance level of 0.047, interim analysis after 269 patients with a p-value of 0.003, and an interobserver agreement among experts of \u03ba: 0.85 with a clinically relevant decrease towards 0.7 for a power of 80% at a one-sided \u03b1 level of 0.05.", "answer": 538, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample of 538 patients (269 per group) is needed to detect an absolute between-group difference in 90-day mortality of 10% in favor of the intervention group, assuming a 27% mortality in the standard care, with a power of 80% at a two-tailed significance level of 0.047 [8]. In the sample size calculation, an interim analysis of the primary endpoint after the recruitment of 269 patients (using a p-value of 0.003) with alpha spending has been considered.\n The first 80 included patients will be used for the pilot phase of the trial. At least 20 patients in each personalized group are necessary to assess clinical feasibility and protocol adherence. As the expected ratio between \u00e2\u0080\u009cfocal\u00e2\u0080\u009d and \u00e2\u0080\u009cnon-focal\u00e2\u0080\u009d and the ratio between the intervention and standard care is 1:1, we would need a sample size of 80 patients for this pilot study. We expect an interobserver agreement among experts of \u00ce\u00ba: 0.85 [16]. To be able to detect a clinically relevant decrease of \u00ce\u00ba towards 0.7 between experts and bedside clinicians, a total of 77 patients is needed for a power of 80% at a one-sided \u00ce\u00b1 level of 0.05. The primary endpoint will not be evaluated in the analysis of the pilot phase.", "id": 1543, "split": "test"} +{"trial_id": "NCT05492916", "pmid": "39560984", "question": "Here is the design of a clinical trial:\n\nOfficial Title: INCLUDE: INtegrating CuLtUral Aspects Into Diabetes Education\n\nIncluded conditions:\n- PreDiabetes\n\nStudy Armgroups:\n- {'label': 'INCLUDE', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive one Diabetes Prevention Program (DPP) video per week for 24 weeks. Additionally, community health workers (CHWs) will help participants to join the community-supported agriculture (CSA) program and assess and address other social determinants of health (SDOH) barriers.', 'interventionNames': ['Behavioral: Diabetes Prevention Program (DPP)', 'Behavioral: Community-Supported Agriculture (CSA)']}\n- {'label': 'CONTROL', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive the standard of usual care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Diabetes Prevention Program (DPP)', 'description': 'Video-based intervention to prevent or delay Type 2 Diabetes. Includes both educational and social cognitive theory (SCT)-based behavioral content. Each video lasts about 5 minutes in duration.', 'armGroupLabels': ['INCLUDE']}\n- {'type': 'BEHAVIORAL', 'name': 'Community-Supported Agriculture (CSA)', 'description': 'Provides weekly and culturally appropriate fresh produce and in-language education on nutrition, healthy cooking demonstrations, and culturally tailored recipes for participants. Enables participants to socialize with other Chinese immigrants in the program as a way to enhance social cohesion and support.', 'armGroupLabels': ['INCLUDE']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage Change in Body Weight', 'description': 'Weight measured in pounds (lbs) via Bluetooth-enabled smart-scale.', 'timeFrame': 'Baseline, Month 3'}\n- {'measure': 'Percentage Change in Body Weight', 'description': 'Weight measured in pounds (lbs) via Bluetooth-enabled smart-scale.', 'timeFrame': 'Month 3, Month 6'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a type I error of 0.05, and a conservative retention rate of 85%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample Size Justification\n In our single-group, pre-post test, feasibility study of the diabetes management video intervention [20], we observed a significant 6.37% (95% CI 2.16%-10.58%; P=.005) weight loss at 6 months compared with baseline, and the SD of percent weight loss at 6 months was 10.64%. Based on these pilot data, we conservatively estimate a group difference of 5% in weight loss between the control and INCLUDE groups at 6 months; this degree of weight loss is considered clinically significant [28]. Using the observed SD of 10% in our preliminary study, based on a 2-sample, 2-sided t test, 64 per group will be required to detect a minimum group difference of 5% in percent weight loss with a power of 80% and a type I error of 0.05. Our prior studies have achieved ~85% to 97% retention. With a conservative retention rate of 85%, we will recruit 150 (75 per group) participants to yield a final sample of at least 128 (64 per group).", "id": 1544, "split": "test"} +{"trial_id": "NCT05493254", "pmid": "38030991", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care\n\nIncluded conditions:\n- Smoking Cessation\n\nStudy Armgroups:\n- {'label': 'Smoking cessation electronic visit (e-visit)', 'type': 'EXPERIMENTAL', 'description': 'This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.', 'interventionNames': ['Behavioral: Smoking cessation e-visit']}\n- {'label': 'Treatment as usual (TAU)', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.', 'interventionNames': ['Behavioral: Treatment As Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Smoking cessation e-visit', 'description': 'electronic visits (e-visits) for smoking cessation', 'armGroupLabels': ['Smoking cessation electronic visit (e-visit)']}\n- {'type': 'BEHAVIORAL', 'name': 'Treatment As Usual', 'description': \"Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking.\", 'armGroupLabels': ['Treatment as usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants who utilized smoking cessation treatment', 'description': 'Number of participants who utilized smoking cessation treatment since last assessment.', 'timeFrame': 'Month 1'}\n- {'measure': 'Number of participants who utilized smoking cessation treatment', 'description': 'Number of participants who utilized smoking cessation treatment since last assessment.', 'timeFrame': 'Month 3'}\n- {'measure': 'Number of participants who utilized smoking cessation treatment', 'description': 'Number of participants who utilized smoking cessation treatment since last assessment.', 'timeFrame': 'Month 6'}\n- {'measure': 'Cigarettes smoking', 'description': 'Cigarettes per day reduction greater than 50%', 'timeFrame': 'Month 1'}\n- {'measure': 'Cigarettes smoking', 'description': 'Cigarettes per day reduction greater than 50%', 'timeFrame': 'Month 3'}\n- {'measure': 'Cigarettes smoking', 'description': 'Cigarettes per day reduction greater than 50%', 'timeFrame': 'Month 6'}\n- {'measure': 'Quit attempts', 'description': 'Quit attempts since last contact', 'timeFrame': 'Month 1'}\n- {'measure': 'Quit attempts', 'description': 'Quit attempts since last contact', 'timeFrame': 'Month 3'}\n- {'measure': 'Quit attempts', 'description': 'Quit attempts since last contact', 'timeFrame': 'Month 6'}\n- {'measure': 'Seven-day point prevalence abstinence', 'description': 'Participant has not had a cigarette in the past 7 days', 'timeFrame': 'Month 1'}\n- {'measure': 'Seven-day point prevalence abstinence', 'description': 'Participant has not had a cigarette in the past 7 days', 'timeFrame': 'Month 3'}\n- {'measure': 'Seven-day point prevalence abstinence', 'description': 'Participant has not had a cigarette in the past 7 days', 'timeFrame': 'Month 6'}\n- {'measure': 'E-visit Acceptability', 'description': 'The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.', 'timeFrame': 'Month 1'}\n- {'measure': 'E-visit Acceptability', 'description': 'The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.', 'timeFrame': 'Month 3'}\n- {'measure': 'E-visit Acceptability', 'description': 'The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.', 'timeFrame': 'Month 6'}\n- {'measure': 'E-visit Adoption', 'description': 'Patients prescribed a medication who obtain their medication', 'timeFrame': 'Month 1'}\n- {'measure': 'E-visit Adoption', 'description': 'Patients prescribed a medication who obtain their medication', 'timeFrame': 'Month 3'}\n- {'measure': 'E-visit Adoption', 'description': 'Patients prescribed a medication who obtain their medication', 'timeFrame': 'Month 6'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is set at 0.05, with a power of >80%. The attrition rate is estimated at 25%, and it is assumed that 67% of PCPs (103 PCPs) will have enrolled patients.", "answer": 672, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Our primary effectiveness outcome is cessation, defined as 7-day CO-verified PPA at six-months. Preliminary data from our pilot trial [26] demonstrated 7-day self-reported PPA rates at three-months of 21.7% and 6.3% for e-visit and TAU groups, respectively. Although we expect similar group differences in abstinence, we expect that 7-day PPA rates will be somewhat lower at six-months for both groups and conservatively estimate these rates to be 18% (e-visit) and 4% (TAU). In addition, we expect some degree of intra-clinic and intra-provider correlation (i.e., intraclass correlation [ICC]), where patients who \u00e2\u0080\u009csee\u00e2\u0080\u009d the same provider at the same clinic are correlated. We estimate this at 0.013 for providers, based on previous site-randomized primary care studies [49, 50]. We expect that not every MUSC PCP will have a patient enrolled in the trial and estimate that 67% of PCPs (103 PCPs) will have enrolled patients. Based on our pilot trial, we plan for attrition of 25% [26]. Using an ICC of 0.013 and an a priori significance (alpha) level of 0.05, (assuming 103 PCPs will have participating patients and inflating by 25% for attrition), a total sample of 672 (448 e-visit, 224 TAU) would have sufficient power (>\u00e2\u0080\u008980%) to detect differences of 18% vs. 4% respectively, in 7-day PPA at six months.\n Other trial outcomes include cessation treatment utilization and reduction in cigarettes per day by at least 50%. In our pilot trial, treatment utilization rates at three-months were higher in the e-visit group compared to TAU (60.9% vs. 25%, respectively); similarly, reduction in cigarettes per day was higher in the e-visit group (65.2% vs. 31.3%, respectively) [26]. With sample sizes of n\u00e2\u0080\u0089=\u00e2\u0080\u0089448 in the e-visit group and n\u00e2\u0080\u0089=\u00e2\u0080\u0089224 in the TAU group, we will have more than sufficient power to see similar differences, and in fact, smaller differences, even after accounting for potentially lower rates in the e-visit group at six months than seen at three months.", "id": 1545, "split": "test"} +{"trial_id": "NCT05494424", "pmid": "36208718", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Goal Management Training (GMT)', 'type': 'EXPERIMENTAL', 'description': 'Internet-delivered group-based GMT to groups of six participants in six two-hour sessions delivered weekly (five weeks). Manualized intervention.', 'interventionNames': ['Behavioral: Goal Management Training (GMT)']}\n- {'label': 'Wait list', 'type': 'NO_INTERVENTION', 'description': 'Wait list control condition'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Goal Management Training (GMT)', 'description': 'Goal Management Training is a cognitive rehabilitation intervention that relies on metacognitive strategies to reengage top-down attention processes, in addition to teaching problem-solving techniques, attempting to address executive dysfunctions.', 'armGroupLabels': ['Goal Management Training (GMT)'], 'otherNames': ['GMT']}\n\nPrimary Outcomes:\n- {'measure': 'The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)', 'description': 'Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction.', 'timeFrame': 'Change from baseline up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 1%, power of 90%, and a dropout rate of about 20%.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "2.9\n Sample size justification and power calculations\n The lack of previous studies on GMT in post-COVID-19 condition represents a challenge in estimating the required sample size for documenting moderate effects on our primary outcome measure. However, due to the somewhat comparable EF profile between post-COVID-19 condition and depression [56], we anticipated a change of seven points in BRIEF-A MI raw score in the intervention group and a change of at most two points in the control group, based on our previous research in a depression sample [31]. We further assumed a common standard deviation of nine points. To adjust for multiple testing, we lowered the predefined significant level to 1%, and used a power of 90% (\u00ce\u00b2\u00c2\u00a0=\u00c2\u00a00.1). Based on the above, we would need 99 individuals in each group, but to allow for a dropout rate of about 20%, we aim to include 120 participants in each group, totaling 240.", "id": 1546, "split": "test"} +{"trial_id": "NCT05497830", "pmid": "38263188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Machine Learning for Risk Stratification in the Emergency Department: a Pilot Clinical Trial\n\nIncluded conditions:\n- Acute Pain\n- Emergencies\n\nStudy Armgroups:\n- {'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Routine clinical care. Physicians will actively be asked to self-report their clinical impression of each included patient and policy will be monitored.'}\n- {'label': 'RISKINDEX', 'type': 'EXPERIMENTAL', 'description': \"Routine clinical care. Physicians will actively be asked to self-report their clinical impression of each included patient and policy will be monitored. In the intervention group, physicians will be presented with the RISKINDEX. Subsequently, self-report will again be initiated to evaluate the physicians' response to the ML score and possible policy changes due to the intervention.\", 'interventionNames': ['Other: RISK-INDEX']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'RISK-INDEX', 'description': 'Presentation of RISKINDEX to the physician after approximately 2 hours. The ML RISKINDEX is a prediction model based on laboratory data from the ED. It is based on date of birth, sex and at least four laboratory data which are sampled within the first two hours of the ED visit. Laboratory data that are used as input include samples that are commonly drawn in patients that require treatment from an internal medicine physician, such as urea, albumin, C-reactive protein (CRP), lactate and bilirubin.', 'armGroupLabels': ['RISKINDEX']}\n\nPrimary Outcomes:\n- {'measure': 'RISK-INDEX performance', 'description': 'Discriminatory performance of ML risk score to predict 31-day mortality. This will be calculated using an area under the receiver operating characteristic curves (AUC).', 'timeFrame': '31 days'}\n- {'measure': 'Policy changes', 'description': 'Policy changes after presentation of RISK-INDEX. This will be assessed by a filled out questionnaire by the physician where they state whether a policy change has been made as a result of the RISK-INDEX outcome.', 'timeFrame': 'As soon as RISK-INDEX score is presented'}\n\nPlease estimate the sample size based on the assumption: \npower of 0.8", "answer": 1300, "answer_type": "ACTUAL", "explanation": "Sample size\n This pilot trial has an explorative aim, providing future trials with estimates of effect sizes and potential clinical impact of the RISKINDEX. This study aims to provide robust estimates for the likely recruitment and retention rates and give an indication of the potential variability in the proposed outcome measures, which will in turn be used to inform the power calculation for a future definitive randomized controlled trial (RCT). We calculated a required sample size of 784 patients to detect a 2% difference in the number of changes in medical treatment after presentation of the RISKINDEX between the control group and the intervention group with a power of 0.8.\n Yearly, approximately 5,500 patients are treated by an internal medicine specialist at the ED of MUMC+. Considering fluctuations in the number of patients presenting to the ED and moments of crowding, there may be moments where there will not be enough time to include patients and/or to complete the questionnaires. Therefore, we expect a total sample size of 1300 patients during the inclusion period.", "id": 1547, "split": "test"} +{"trial_id": "NCT05500443", "pmid": "37451735", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Menaquinone-7 Supplementation in Patients With Severe Coronary Calcifications\n\nIncluded conditions:\n- Coronary Artery Disease\n\nStudy Armgroups:\n- {'label': 'Active treatment', 'type': 'EXPERIMENTAL', 'description': 'Tablets with vitamin k2 (Menaquinone-7 (MK-7)) 720 \u03bcg/day', 'interventionNames': ['Dietary Supplement: Vitamin K2 (Menaquinone-7)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Tablets with placebo', 'interventionNames': ['Dietary Supplement: Vitamin K2 (Menaquinone-7)']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Vitamin K2 (Menaquinone-7)', 'description': 'Oral supplementation with vitamin K2 (Menaquinone-7 (MK-7)) 720 \u00b5g/day and D 25 \u00b5g/day', 'armGroupLabels': ['Active treatment', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Coronary artery calcium (CAC) score, all participants', 'description': 'Change in CAC score', 'timeFrame': 'From baseline to 24-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of 0.05 (two-sided), a power of 0.8, and a dropout rate of 10%.", "answer": 400, "answer_type": "ACTUAL", "explanation": "Sample size\n We are planning a study of a continuous response variable from independent control and experimental subjects with one control per experimental subject. In the AVADEC trial, the mean (SD) 2\u00e2\u0080\u0089year CAC progression among 182 men with CAC score\u00e2\u0089\u00a5400 was 380 AU (330 AU) in the placebo group and 288 AU (280 AU) in the intervention group. The joint SD was 311 AU. If this is true in a population of men and women, inclusion of 180 experimental subjects and 180 control subjects are needed to be able to reject the null hypothesis (H0). The H0 of this study is that the progression means of the experimental and control groups are equal, with probability (power) 0.8. The type I error probability associated with this H0 test is 0.05 (two-sided). Accordingly, 360 subjects are needed. However, to comply with the uncertainty and to account for drop-out of 10%, 400 patients will be included. The sample size is based on 2\u00e2\u0080\u0089years of treatment and was assessed with Stata/MP V.17 (StataCorp, College Station, Texas, USA).", "id": 1548, "split": "test"} +{"trial_id": "NCT05500742", "pmid": "37915546", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The proBNPage Reduction (PBAR) Randomized Trial: a Pilot Study to Define the Characteristics of Future Randomized Trials Aimed at Evaluating the Effects of Anti-aging Treatments on a Surrogate of Biological Age in Healthy Older Adults\n\nIncluded conditions:\n- Aging\n\nStudy Armgroups:\n- {'label': 'Coenzyme Q10 + Selenium', 'type': 'ACTIVE_COMPARATOR', 'description': 'Coenzyme Q10 100 mg bid + Selenium 100 mcg with the evening meal', 'interventionNames': ['Dietary Supplement: Coenzyme Q10', 'Dietary Supplement: Selenium']}\n- {'label': 'Resveratrol + TA-65', 'type': 'ACTIVE_COMPARATOR', 'description': 'Resveratrol 350 mg bid + TA-65 MD 100 U with the evening meal', 'interventionNames': ['Dietary Supplement: Resveratrol', 'Dietary Supplement: TA-65 MD']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo-1 bid + Placebo-2 with the evening meal', 'interventionNames': ['Other: Placebo-1', 'Other: Placebo-2']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Coenzyme Q10', 'description': 'Soft 100 mg capsules containing coenzyme Q10 in vegetable oil provided by Pharma Nord', 'armGroupLabels': ['Coenzyme Q10 + Selenium'], 'otherNames': ['Q10 Gold']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Selenium', 'description': '100 mcg tablets provided by Pharma Nord', 'armGroupLabels': ['Coenzyme Q10 + Selenium'], 'otherNames': ['SelenoPrecise']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Resveratrol', 'description': '350 mg capsules provided by NOW Foods', 'armGroupLabels': ['Resveratrol + TA-65'], 'otherNames': ['Extra Strength Resveratrol']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'TA-65 MD', 'description': '100 unit capsules provided by TA Sciences', 'armGroupLabels': ['Resveratrol + TA-65']}\n- {'type': 'OTHER', 'name': 'Placebo-1', 'description': 'Soft capsules containing vegetable oil, externally identical to coenzyme Q10 capsules, provided by Pharma Nord', 'armGroupLabels': ['Placebo']}\n- {'type': 'OTHER', 'name': 'Placebo-2', 'description': 'Tablets containing excipients, externally identical to selenium tablets, provided by Pharma Nord', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline ProBNPage at 6 months', 'description': 'Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes', 'timeFrame': '6 months'}\n- {'measure': 'Change from baseline ProBNPage at 12 months', 'description': 'Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes', 'timeFrame': '12 months'}\n- {'measure': 'Change from baseline ProBNPage at 18 months', 'description': 'Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes', 'timeFrame': '18 months'}\n- {'measure': 'Change from baseline ProBNPage at 24 months', 'description': 'Change of surrogate, in years, of biological age, derived from mathematical transformation of NT-proBNP blood concentration with separate formulas for the two sexes', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level was set at <0.05 and the power at 0.80. The study duration was set at 2 years to avoid erroneous conclusions due to casual reductions in proBNPage. The sample size calculation was based on analysis of variance for repeated measures.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample Size and Study Duration Determination\n To establish the minimum sample size, so that results may be obtained with a probability of first type error <0.05 and a power of 0.80, a few preliminary parameters are needed: standard deviation of the studied variable (proBNPage) in the population, standard deviation of the predicted effect in a longitudinal study, and correlation coefficient \u00e2\u0080\u009cr\u00e2\u0080\u009d between baseline values and post-treatment values. So far, no longitudinal study on proBNPage has been performed. Thus, this information is not available, and has been approximated using the data collected by us in a previous cross-sectional study12 (Table 1).\nTable 1Mean Course of proBNPage in Relation to Chronological AgeAge (Years)NproBNPage (Years)\u00e2\u0088\u0086 1 Year\u00e2\u0088\u0086 2 YearsMean \u00c2\u00b1 SD\u00e2\u0089\u00a565 <663565.6 \u00c2\u00b1 12.9\u00e2\u0080\u0093\u00e2\u0080\u0093\u00e2\u0089\u00a566 <678864.8 \u00c2\u00b1 13.8\u00e2\u0088\u00920.8\u00e2\u0080\u0093\u00e2\u0089\u00a567 <6810368.0 \u00c2\u00b1 13.4+3.2+2.4\u00e2\u0089\u00a568 <699069.0 \u00c2\u00b1 15.9+1.0+4.2\u00e2\u0089\u00a569 <709568.4 \u00c2\u00b1 14.8\u00e2\u0088\u00920.6+0.4\u00e2\u0089\u00a570 <717770.6 \u00c2\u00b1 12.4+2.2+1.6\u00e2\u0089\u00a571 <728574.6 \u00c2\u00b1 12.7+4.0+6.2\u00e2\u0089\u00a572 <736471.6 \u00c2\u00b1 15.0\u00e2\u0088\u00923.0+1.0\u00e2\u0089\u00a573 <746775.3 \u00c2\u00b1 16.2+3.7+0.7\u00e2\u0089\u00a574 <755874.9 \u00c2\u00b1 13.9\u00e2\u0088\u00920.4+3.3\u00e2\u0089\u00a575 <764374.4 \u00c2\u00b1 14.4\u00e2\u0088\u00920.5\u00e2\u0088\u00920.9\u00e2\u0089\u00a576 <774474.9 \u00c2\u00b1 19.1+0.50\u00e2\u0089\u00a577 <784576.5 \u00c2\u00b1 15.7+1.6+2.1\u00e2\u0089\u00a578 <792875.5 \u00c2\u00b1 13.6\u00e2\u0088\u00921.0+0.6\u00e2\u0089\u00a579 <803278.8 \u00c2\u00b1 18.3+3.3+2.3\u00e2\u0089\u00a580 <811985.4 \u00c2\u00b1 22.0+6.6+9.9\u00e2\u0089\u00a565 <8197371.6 \u00c2\u00b1 15.31.3 \u00c2\u00b1 2.52.4 \u00c2\u00b1 2.8Notes: Values obtained from the database of our previous cross-sectional study.12 \u00e2\u0088\u00861 year = Variations of proBNPage between a group of subjects with the same age compared to a group of subjects 1 year younger. \u00e2\u0088\u0086 2 years = Variations of proBNPage between a group of subjects with the same age compared to a group of subjects 2 years younger.\n Considering the variations of proBNPage between a group of subjects with the same age and a group of subjects 1 year older, in some cases, reductions were obtained (instead of the expected increases). Thus, if treatments were administered for 1 year only, casual reductions of proBNPage might occur, leading to erroneous conclusions of favorable effects of the treatments. Considering instead the variations of proBNPage between each age group and the group 2 years older, only in 1 case over 14 a decrease in proBNPage occurred. From this observation, we decided to prolong the study for 2 years. However, it is possible that during the proposed longitudinal study we could even conclude that shorter intervals are sufficient.\n The mean effect, ie the mean increase in proBNPage every two years of chronological age, was 2.4 \u00c2\u00b1 2.8 years. In addition, the 14 proBNPage mean values were related to the 14 proBNPage mean values obtained after 2 years of age, and the correlation coefficient of these two series was 0.791. In this way, the starting parameters necessary for sample size calculation were obtained.\n Sample size calculation was set on the basis of analysis of variance for repeated measures, using WebPower software.32 For 3 study groups (1 placebo + 2 groups with food supplements) and 2 time assessments (each time vs baseline), the sample size of each group depends on the main interest of the study: changes due to time (\u00e2\u0080\u009cwithin\u00e2\u0080\u009d groups), differences between treatments and placebo (\u00e2\u0080\u009cbetween\u00e2\u0080\u009d groups), or both assessments together (\u00e2\u0080\u009cbetween-within interaction\u00e2\u0080\u009d).\n Within: N = 8; Between: N = 50; Between-Within interaction: N = 9.\n The main interests of our study concern the \u00e2\u0080\u009cwithin\u00e2\u0080\u009d and \u00e2\u0080\u009cbetween-within\u00e2\u0080\u009d assessments, which would allow a minimum sample of 9 \u00c3\u0097 3 = 27 subjects. To account for probable dropouts and possible greater variability than expected and to allow possible subgroup analysis, we decided to multiply this estimate by 4, thus reaching a sample size of 40 \u00c3\u0097 3 = 120 subjects.", "id": 1549, "split": "test"} +{"trial_id": "NCT05500976", "pmid": "38302990", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Metabolomics INItiative: Effects of a MEDiterranean-amplified vs Habitual Western Diet on Biomarker Signatures, Cardiometabolic Health, and the Microbiome\n\nIncluded conditions:\n- Dietary Habits\n\nStudy Armgroups:\n- {'label': 'mini-Med', 'type': 'EXPERIMENTAL', 'description': 'Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon).', 'interventionNames': ['Other: Semi-controlled dietary intervention - MiniMed']}\n- {'label': 'Western', 'type': 'ACTIVE_COMPARATOR', 'description': 'Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert).', 'interventionNames': ['Other: Semi-controlled dietary intervention - Western']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Semi-controlled dietary intervention - Western', 'description': 'Participants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Western diet foods (eg, beef, potatoes, bread, sour cream) provided during each intervention and will be repeated twice.', 'armGroupLabels': ['Western']}\n- {'type': 'OTHER', 'name': 'Semi-controlled dietary intervention - MiniMed', 'description': 'Participants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Mediterranean foods (eg, oatmeal, salmon, nuts, basil, olive oil, fruits) provided during each intervention and will be repeated twice.', 'armGroupLabels': ['mini-Med']}\n\nPrimary Outcomes:\n- {'measure': 'Foodomics', 'description': 'Change in the number of unique to food compounds (i.e., putative biomarkers of intake) from baseline to end of each diet intervention period in participant serum samples.', 'timeFrame': 'Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period'}\n\nPlease estimate the sample size based on the assumption: \nA paired t-test is used after consuming the food. The significance level is adjusted using Bonferroni correction for multiple testing (21 compounds: p=0.0024, 355 compounds: p=0.00014). The power is set at 80%, and a 10% loss to follow-up is assumed.", "answer": 22, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Most of our planned analyses use each individual as their own control by looking at the change over each dietary intervention period. This reduces between subject variability compared to a cross-sectional analysis and increases the statistical power at a given sample size. To obtain a reasonable minimum expected effect size for the mean difference divided by the standard deviation of the difference (i.e., Cohen\u00e2\u0080\u0099s d effect size), we used our analysis of salmon FSCs [13]. The minimum salmon FSC effect size that passed an FDR adjustment was 0.45. Using a paired t-test after consuming the food, a sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u008920 was needed to achieve 80% power for this effect size of 0.45 and a Bonferroni multiple testing adjustment for the number of compounds that increased in the preliminary MED data (Ncompounds\u00e2\u0080\u0089=\u00e2\u0080\u008921; p-valueadjusted\u00e2\u0080\u0089=\u00e2\u0080\u00890.05/21\u00e2\u0080\u0089=\u00e2\u0080\u00890.0024). We assume a 10% loss to follow-up based on our experience in similar dietary intervention trials and therefore enroll n\u00e2\u0080\u0089=\u00e2\u0080\u008922 eligible individuals to have n\u00e2\u0080\u0089=\u00e2\u0080\u008920 individuals complete the trial.\n We also evaluated the power of N\u00e2\u0080\u0089=\u00e2\u0080\u008920 sample size further using the Bonferroni adjustment for the 21 compounds that increased after consumption of the preliminary Mediterranean diet foods (padj\u00e2\u0080\u0089=\u00e2\u0080\u00890.0024) and a stricter adjustment using all 355 compounds that were detected in the MED foods and plasma (padj\u00e2\u0080\u0089=\u00e2\u0080\u00890.05/355\u00e2\u0080\u0089=\u00e2\u0080\u00890.00014). For both significance thresholds, we achieve power across a range of relevant effect sizes (Fig.\u00c2\u00a02) including nearly 100% power to detect an effect size of 0.75 (the median effect size for the salmon FSCs that passed the FDR threshold).Fig.\u00c2\u00a02Power calculation for mini-MED clinical trial. Power (y-axis) for N\u00e2\u0080\u0089=\u00e2\u0080\u008920 for a paired t-test of the difference between post- and pre-consumption of a food. Power was evaluated over various effect sizes (x-axis, mean difference/SD of difference) for three significance thresholds: nominal threshold of 0.05 (yellow), Bonferroni corrected threshold for 21 compounds that increased after consumption in the initial study (p\u00e2\u0080\u0089=\u00e2\u0080\u00892.4e\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00893), and Bonferroni corrected threshold for 355 compounds that were detected in MED foods and plasma (p\u00e2\u0080\u0089=\u00e2\u0080\u00891.4e\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00894)", "id": 1550, "split": "test"} +{"trial_id": "NCT05502198", "pmid": "38129794", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal Hypertension and Hepatocellular Carcinoma in End-Stage Liver Disease\n\nIncluded conditions:\n- Liver Cirrhosis\n- Hepatocellular Carcinoma\n- Sarcopenia\n- Portal Hypertension\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': 'Baseline'}\n- {'measure': 'Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': '6 months'}\n- {'measure': 'Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': '1 year'}\n- {'measure': 'Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': '18 months'}\n- {'measure': 'Change from baseline Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': '6 months'}\n- {'measure': 'Change from 6 months Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': '1 year'}\n- {'measure': 'Change from 1 year Body composition (FFMVvcg)', 'description': 'FFMVvcg is the thigh fat-free muscle volume in the context of virtual controls which effectively measures the deviation from expected thigh fat-free muscle volume normalized to height squared using sex and BMI matched virtual control groups.', 'timeFrame': '18 months'}\n- {'measure': 'Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': 'Baseline'}\n- {'measure': 'Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': '6 months'}\n- {'measure': 'Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': '1 year'}\n- {'measure': 'Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': '18 months'}\n- {'measure': 'Change from baseline Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': '6 months'}\n- {'measure': 'Change from 6 months Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': '1 year'}\n- {'measure': 'Change from 1 year Muscle fat infiltration (%) [MFI]', 'description': 'MFI is a measure, using MR, of percentage of fat infiltration in the muscles (%).', 'timeFrame': '18 months'}\n- {'measure': 'Presence of previous decompensation', 'description': 'If the patient previously has had ascites, bleeding esophageal varices, or encephalopathy.', 'timeFrame': 'Baseline'}\n- {'measure': 'New episode of decompensation since baseline', 'description': 'If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.', 'timeFrame': '6 months'}\n- {'measure': 'New episode of decompensation since 6 months', 'description': 'If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.', 'timeFrame': '1 year'}\n- {'measure': 'New episode of decompensation since 1 year', 'description': 'If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.', 'timeFrame': '18 months'}\n- {'measure': 'New episode of decompensation since 18 months', 'description': 'If the patient has had an episode of ascites, bleeding esophageal varices, or encephalopathy.', 'timeFrame': '2 years'}\n- {'measure': 'Hepatocellular carcinoma', 'description': 'Detection of HCC by AMRI', 'timeFrame': 'Baseline'}\n- {'measure': 'Significant liver lesion', 'description': 'LI-RADS 3-5', 'timeFrame': 'Baseline'}\n- {'measure': 'Significant liver lesion', 'description': 'LI-RADS 3-5', 'timeFrame': '6 months'}\n- {'measure': 'Significant liver lesion', 'description': 'LI-RADS 3-5', 'timeFrame': '1 year'}\n- {'measure': 'Significant liver lesion', 'description': 'LI-RADS 3-5', 'timeFrame': '18 months'}\n- {'measure': 'Hepatocellular carcinoma', 'description': 'Detection of HCC by AMRI', 'timeFrame': '6 months'}\n- {'measure': 'Hepatocellular carcinoma', 'description': 'Detection of HCC by AMRI', 'timeFrame': '1 year'}\n- {'measure': 'Hepatocellular carcinoma', 'description': 'Detection of HCC by AMRI', 'timeFrame': '18 months'}\n- {'measure': 'Hepatocellular carcinoma', 'description': 'Chart review', 'timeFrame': '2 years'}\n- {'measure': 'Hand grip strength (kg)', 'description': 'Measured at each visit with a hand-grip dynamometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Hand grip strength (kg)', 'description': 'Measured at each visit with a hand-grip dynamometer', 'timeFrame': '6 months'}\n- {'measure': 'Hand grip strength (kg)', 'description': 'Measured at each visit with a hand-grip dynamometer', 'timeFrame': '1 year'}\n- {'measure': 'Hand grip strength (kg)', 'description': 'Measured at each visit with a hand-grip dynamometer', 'timeFrame': '18 months'}\n- {'measure': 'Muscle function', 'description': 'Measured using the validated Short Physical Performance Battery.', 'timeFrame': 'Baseline'}\n- {'measure': 'Muscle function', 'description': 'Measured using the validated Short Physical Performance Battery.', 'timeFrame': '6 months'}\n- {'measure': 'Muscle function', 'description': 'Measured using the validated Short Physical Performance Battery.', 'timeFrame': '1 year'}\n- {'measure': 'Muscle function', 'description': 'Measured using the validated Short Physical Performance Battery.', 'timeFrame': '18 months'}\n- {'measure': 'Child-Pugh score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy', 'timeFrame': 'Baseline'}\n- {'measure': 'Child-Pugh score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy', 'timeFrame': '6 months'}\n- {'measure': 'Child-Pugh score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy', 'timeFrame': '1 year'}\n- {'measure': 'Child-Pugh score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy', 'timeFrame': '18 months'}\n- {'measure': 'Child-Pugh score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Albumin, Bilirubin, INR, Ascites, and Encephalopathy', 'timeFrame': '2 year'}\n- {'measure': 'MELD-score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium', 'timeFrame': 'Baseline'}\n- {'measure': 'MELD-score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium', 'timeFrame': '6 months'}\n- {'measure': 'MELD-score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium', 'timeFrame': '1 year'}\n- {'measure': 'MELD-score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium', 'timeFrame': '18 months'}\n- {'measure': 'MELD-score', 'description': 'A validated score to assess prognosis in liver cirrhosis. Includes: Creatinine, INR, Bilirubin, and Sodium', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is set at 5%, and the statistical power (1-\u03b2) is set at 90%. A dropout/missing data rate is considered, assuming 60% of the population will suffer from muscle loss.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Estimation of sample size and power calculation\n One of the main objectives of the study concerns sarcopenia in patients with cirrhosis, and sarcopenia is therefore the basis for our power calculations. Previous imaging-based studies on muscle mass and composition in patients with cirrhosis have found sarcopenia to be prevalent in a range of 30 to 70% of patients [19].\n At the time of the study design, there were limited numbers of studies with longitudinal follow-up of muscle loss in a somewhat comparable way. One of these studies has shown that an annual loss of muscle volume of \u00e2\u0088\u0092\u00e2\u0080\u00893.1% (measured by computer tomography) is significantly associated with a high risk of mortality in this patient group [20]. We have previously shown that we can measure muscle volume with a precision of 0.8\u00e2\u0080\u00931.5% (coefficient of variation) [21, 22].\n To detect a change of \u00e2\u0088\u0092\u00e2\u0080\u00893.1% in a year with a precision of 1.5% (assuming upper limit for safety) and a risk of incorrectly rejecting our hypothesis (\u00ce\u00b1) of 5% and a statistical power (1-\u00ce\u00b2) of 90%, would require a population size of 47. We should reach this population size, with margin, with a total population of 150 people, if about 60% will suffer from muscle loss and we take heed for loss due to e.g., technical errors, study persons who choose to refrain from continued participation, and other unpredictable events that may affect data collection and its quality. A frequently used statistical power of 80% requires 35 people, and we can then assume that if our population is in the low 30% that will suffer from muscle loss, we can still expect to see differences/effects.", "id": 1551, "split": "test"} +{"trial_id": "NCT05503719", "pmid": "38626975", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Skin Closure With a Fast Absorbable Braided Suture Versus a Non-absorbable Monofilament Suture in Open Carpal Tunnel Release, a Randomized Controlled Trial\n\nIncluded conditions:\n- Carpal Tunnel Syndrome\n- Median Nerve Entrapment\n\nStudy Armgroups:\n- {'label': 'Absorbable Suture', 'type': 'EXPERIMENTAL', 'description': 'Surgical wounds of this arm will be closed with an absorbable suture.', 'interventionNames': ['Procedure: Surgical wound closed with an absorbable suture']}\n- {'label': 'Non-absorbable suture', 'type': 'ACTIVE_COMPARATOR', 'description': 'Surgical wounds of this arm will be closed with a non-absorbable suture.', 'interventionNames': ['Procedure: Surgical wound closed with a non-absorbable suture']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Surgical wound closed with an absorbable suture', 'description': 'Patients undergoing median nerve release surgery will get their surgical wound closed with an absorbable suture according to their respective study group.', 'armGroupLabels': ['Absorbable Suture']}\n- {'type': 'PROCEDURE', 'name': 'Surgical wound closed with a non-absorbable suture', 'description': 'Patients undergoing median nerve release surgery will get their surgical wound closed with a non-absorbable suture according to their respective study group.', 'armGroupLabels': ['Non-absorbable suture']}\n\nPrimary Outcomes:\n- {'measure': 'Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient', 'description': 'The subjective aesthetics of the scar evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from \"the ugliest scar possible\" to \"the most beautiful scar possible\". The proportion of ugly and nice scars will be reported. Outcome will be collected at one year time point.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 80% confidence that the lower limit of a one-sided 95% confidence interval (CI) will be above the non-inferiority margin of -10 points, accounting for a 15% attrition rate.", "answer": 116, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on an assessment of clinical wound evaluation scales, a VAS cosmesis scale should be able to detect the minimal clinically important difference (MCID) of 15 points on a 100\u00e2\u0080\u0089mm VAS.23 The non-inferiority margin was set to 10 points considering the MCID and by using clinical judgement. Assuming a common SD of 20 points, a sample size of 50 patients per group is required to have 80% confidence that the lower limit of a one-sided 95% CI will be above the non-inferiority margin of \u00e2\u0088\u009210 points.24 To account for a 15% attrition rate, the group size is increased to a final size of 58 patients. Thus, the total sample size is 116 patients.", "id": 1552, "split": "test"} +{"trial_id": "NCT05506904", "pmid": "40107679", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial\n\nIncluded conditions:\n- Airway Extubation\n\nStudy Armgroups:\n- {'label': 'Extubation Advisor', 'type': 'EXPERIMENTAL', 'description': \"Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.\", 'interventionNames': ['Device: Extubation Advisor']}\n- {'label': 'Standard of Care Arm', 'type': 'NO_INTERVENTION', 'description': 'Participants will undergo SBTs as directed by clinicians. The EA device will not be used.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Extubation Advisor', 'description': 'Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. The clinical outcome case report form will be completed at the time of hospital discharge.', 'armGroupLabels': ['Extubation Advisor']}\n\nPrimary Outcomes:\n- {'measure': 'Evaluate the feasibility of enrolling 1-2 patients per centre per month', 'description': 'Feasibility of patient enrolment will be evaluated by determining if 1-2 patients are enrolled per centre per month.', 'timeFrame': 'Upon study completion, 12 months after study initiation'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 95% confidence interval for detecting adherence rates. No specific assumptions on significance level, power, or missing/dropout rate are mentioned.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n We will recruit 100 patients at approximately 10 participating centres over an approximate 12-month recruitment period. With 10 participating centres, personnel at each participating centre (approx. 10 patients/centre) would obtain sufficient experience in implementing the EA tool with 1:1 randomisation (approx. 5 patients in the EA arm). We estimate that 100 patients (approximately 50 in each arm) will be required to ascertain the feasibility endpoints that are the focus of the pilot trial. A sample of 100 patients will enable us to detect achievement of 80% overall protocol adherence with 95% CI (71.1% to 86.7%). Similarly, with 50 patients per arm, we will be able to detect 80% adherence in each arm with 95%\u00e2\u0080\u0089CI (67.0% to 88.8%). The lower limit of the 95%\u00e2\u0080\u0089CI is the minimum protocol adherence rate that would be considered acceptable for the larger trial. To ensure that all centres gain experience with the protocols, we will set a maximum site enrolment of 33 patients.", "id": 1553, "split": "test"} +{"trial_id": "NCT05506943", "pmid": "38861293", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen\n\nIncluded conditions:\n- Biliary Tract Cancer\n- Cholangiocarcinoma\n- Gall Bladder Cancer\n- Ampullary Cancer\n\nStudy Armgroups:\n- {'label': 'CTX-009 plus Paclitaxel', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: CTX-009', 'Drug: Paclitaxel']}\n- {'label': 'Paclitaxel', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1.', 'interventionNames': ['Drug: Paclitaxel']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'CTX-009', 'description': 'IV infusion on day 1 and 14 of every 28 day cycle', 'armGroupLabels': ['CTX-009 plus Paclitaxel']}\n- {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'IV infusion on day 1, 8, and 15 of every 28 day cycle', 'armGroupLabels': ['CTX-009 plus Paclitaxel', 'Paclitaxel']}\n\nPrimary Outcomes:\n- {'measure': 'Best Overall Response', 'description': 'Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1', 'timeFrame': 'From randomization to treatment discontinuation for any reason, average 6 months'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 150, "answer_type": "ESTIMATED", "explanation": "3.4.\n Sample size\n The planned sample size is approximately 150 patients. This is a multicenter study with 32 study sites.", "id": 1554, "split": "test"} +{"trial_id": "NCT05507645", "pmid": "38296588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Recombinant Human Prourokinase\uff08rhPro-UK\uff09for Injection Versus Standard Medical Treatment for Acute Mild Ischemic Stroke (NIHSS\u22645) Within 4.5 Hours After Symptom Onset\n\nIncluded conditions:\n- Ischemic Stroke\n- Mild\n- Thrombosis\n\nStudy Armgroups:\n- {'label': 'rhPro-UK (35mg)', 'type': 'EXPERIMENTAL', 'description': 'rhPro-UK: 35 mg (5 mg per vial, 7 vials in total) Dissolve 15mg (3 vials) of rhPro-UK in 10ml of saline and intravenous bolus within 3 minutes, and dissolve the remaining 20mg (4 vials) in 90ml of saline and intravenous drip within 30 minutes. (Note: after adding saline, overturn it gently once to twice, do not shake vigorously, so as to avoid foaming of the rhPro-UK solution and reduce the efficacy).', 'interventionNames': ['Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)']}\n- {'label': 'standard medical treatment', 'type': 'ACTIVE_COMPARATOR', 'description': \"Standard antiplatelet or anticoagulant treatment at the discretion of local investigators according to the 'Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018'.\", 'interventionNames': ['Drug: standard medical treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Recombinant Human Prourokinase for Injection (rhPro-UK)', 'description': '15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.', 'armGroupLabels': ['rhPro-UK (35mg)'], 'otherNames': ['Puyouke']}\n- {'type': 'DRUG', 'name': 'standard medical treatment', 'description': 'Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.', 'armGroupLabels': ['standard medical treatment'], 'otherNames': ['Aspirin, clopidogrel, anticoagulant']}\n\nPrimary Outcomes:\n- {'measure': 'The modified Rankin Scale score (mRS) \u2264 1 at 90 days', 'description': 'The proportion of the modified Rankin Scale score (mRS) \u2264 1 at 90 days.', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided test with \u03b1 = 0.025, power of 1-\u03b2 = 0.8, and a 5% attrition rate.", "answer": 1446, "answer_type": "ACTUAL", "explanation": "Sample sizes and statistical analysis\n \n Sample size\n There are two arms, rhPro-UK 35\u00e2\u0080\u0089mg arm, and the standard medical treatment arm, with a group allocation ratio of 1:1. The primary efficacy outcome is mRS score \u00e2\u0089\u00a4 1 at 90 days. According to the CNSR-III (the Third China National Stroke Registry) cohort study, the rate of mRS score of 0\u00e2\u0080\u00931 at 90 days in patients who had a mild stroke (NIHSS \u00e2\u0089\u00a4 5) without thrombolysis was 83%.18 In the combined analysis of the Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events trial and Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke trial, the rate of mRS \u00e2\u0089\u00a4 1 at 90 days in patients who had a mild stroke was 90%.19 Therefore, we assume that the rate of mRS \u00e2\u0089\u00a4 1 at 90 days in the standard medical treatment group in this clinical trial will be 85%, and the absolute rate difference in the rhPro-UK group is 5%. Based on these assumptions, with the one-sided test \u00ce\u00b1 = 0.025, the power of 1-\u00ce\u00b2 = 0.8, the minimum sample size required for this clinical trial is 1372 using PASS 16.0 software (NCSS, LLC, USA). Assuming a 5% attrition rate, we set the final calculated sample size as 1446.\n \n \n Statistical analysis\n The efficacy assessment will be carried out on both the full analysis set and per protocol set. Multiple imputations will be used to fill in the missing efficacy data. Safety outcomes will be evaluated in the safety set with no imputation performed for missing safety data. The primary efficacy outcome will be analysed by using the Cochran-Mantel-Haenszel test, adjusted for centre effects, with a calculation of relative risk or risk difference and 95%\u00e2\u0080\u0089CI. Subgroup analyses for primary efficacy outcome will also be conducted based on age (< 75\u00e2\u0080\u0089vs \u00e2\u0089\u00a5 75 years and <80\u00e2\u0080\u0089vs \u00e2\u0089\u00a5 80 years), stroke severity at baseline NIHSS score < 3\u00e2\u0080\u0089and 3\u00e2\u0080\u00935 (both inclusive), time from onset to treatment 0\u00e2\u0080\u00933.0\u00e2\u0080\u0089hours (inclusive), 3.0\u00e2\u0080\u00934.5\u00e2\u0080\u0089hours (inclusive), diabetes and hypertension. Secondary outcomes will be analysed using similar methods as the primary outcome. Regarding the safety outcomes between groups, the number of cases, frequencies and rates of AEs in each group will also be analysed statistically, and a detailed list of AE descriptions will be provided. \u00cf\u00872 or Fisher\u00e2\u0080\u0099s exact tests will be used to compare differences in safety outcomes between groups. All statistical analyses will be processed by SAS V.9.4 or higher version (SAS Viya, USA).", "id": 1555, "split": "test"} +{"trial_id": "NCT05507645", "pmid": "38296588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Recombinant Human Prourokinase\uff08rhPro-UK\uff09for Injection Versus Standard Medical Treatment for Acute Mild Ischemic Stroke (NIHSS\u22645) Within 4.5 Hours After Symptom Onset\n\nIncluded conditions:\n- Ischemic Stroke\n- Mild\n- Thrombosis\n\nStudy Armgroups:\n- {'label': 'rhPro-UK (35mg)', 'type': 'EXPERIMENTAL', 'description': 'rhPro-UK: 35 mg (5 mg per vial, 7 vials in total) Dissolve 15mg (3 vials) of rhPro-UK in 10ml of saline and intravenous bolus within 3 minutes, and dissolve the remaining 20mg (4 vials) in 90ml of saline and intravenous drip within 30 minutes. (Note: after adding saline, overturn it gently once to twice, do not shake vigorously, so as to avoid foaming of the rhPro-UK solution and reduce the efficacy).', 'interventionNames': ['Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)']}\n- {'label': 'standard medical treatment', 'type': 'ACTIVE_COMPARATOR', 'description': \"Standard antiplatelet or anticoagulant treatment at the discretion of local investigators according to the 'Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018'.\", 'interventionNames': ['Drug: standard medical treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Recombinant Human Prourokinase for Injection (rhPro-UK)', 'description': '15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.', 'armGroupLabels': ['rhPro-UK (35mg)'], 'otherNames': ['Puyouke']}\n- {'type': 'DRUG', 'name': 'standard medical treatment', 'description': 'Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.', 'armGroupLabels': ['standard medical treatment'], 'otherNames': ['Aspirin, clopidogrel, anticoagulant']}\n\nPrimary Outcomes:\n- {'measure': 'The modified Rankin Scale score (mRS) \u2264 1 at 90 days', 'description': 'The proportion of the modified Rankin Scale score (mRS) \u2264 1 at 90 days.', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided test with \u03b1 = 0.025, power of 1-\u03b2 = 0.8, and a 5% attrition rate.", "answer": 1446, "answer_type": "ACTUAL", "explanation": "Sample size\n There are two arms, rhPro-UK 35\u00e2\u0080\u0089mg arm, and the standard medical treatment arm, with a group allocation ratio of 1:1. The primary efficacy outcome is mRS score \u00e2\u0089\u00a4 1 at 90 days. According to the CNSR-III (the Third China National Stroke Registry) cohort study, the rate of mRS score of 0\u00e2\u0080\u00931 at 90 days in patients who had a mild stroke (NIHSS \u00e2\u0089\u00a4 5) without thrombolysis was 83%.18 In the combined analysis of the Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events trial and Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke trial, the rate of mRS \u00e2\u0089\u00a4 1 at 90 days in patients who had a mild stroke was 90%.19 Therefore, we assume that the rate of mRS \u00e2\u0089\u00a4 1 at 90 days in the standard medical treatment group in this clinical trial will be 85%, and the absolute rate difference in the rhPro-UK group is 5%. Based on these assumptions, with the one-sided test \u00ce\u00b1 = 0.025, the power of 1-\u00ce\u00b2 = 0.8, the minimum sample size required for this clinical trial is 1372 using PASS 16.0 software (NCSS, LLC, USA). Assuming a 5% attrition rate, we set the final calculated sample size as 1446.", "id": 1556, "split": "test"} +{"trial_id": "NCT05508815", "pmid": "38238175", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis\n\nIncluded conditions:\n- Arthritis, Rheumatoid\n\nStudy Armgroups:\n- {'label': 'Modified Zhiwang Decoction Combined with Methotrexate', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Modified Zhiwang Decoction Combined with methotrexate']}\n- {'label': 'Methotrexate', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Methotrexate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Modified Zhiwang Decoction Combined with methotrexate', 'description': 'Modified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.', 'armGroupLabels': ['Modified Zhiwang Decoction Combined with Methotrexate']}\n- {'type': 'DRUG', 'name': 'Methotrexate', 'description': 'Methotrexate(7.5-15mg, once a week) for 12 weeks.', 'armGroupLabels': ['Methotrexate']}\n\nPrimary Outcomes:\n- {'measure': 'DAS28 based on erythrocyte sedimentation rate scores', 'description': \"DAS28 is widely accepted to evaluate RA disease activity and consists of number of tender joints out of 28, number of swollen joints out of 28, ESR and the patient's global assessment of disease activity.\", 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided test with significance level (\u03b1) of 0.05, power (\u03b2) of 0.2, and a dropout rate of 10%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n A superiority design approach was used in this study. The primary outcome of this study is the evaluation of DAS28 between treatment and control groups. Data on DAS28 from a previous study were used to calculate sample size.18 After 12 weeks, DAS28 of the treatment group was decreased by 3.48\u00c2\u00b11.06, while that of the control group was decreased by 2.77\u00c2\u00b11.20. In this study, the sample size of treatment and control groups was matched to 1:1. A two-sided test was chosen (\u00ce\u00b1=0.05, \u00ce\u00b2=0.2\u00e2\u0080\u0089and \u00ce\u00b4=0.5). The calculated sample size of each group is 68. Considering the dropout rate of 10%, 75 patients in each group will be selected, with 150 as the final sample size.", "id": 1557, "split": "test"} +{"trial_id": "NCT05511285", "pmid": "37024247", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving Sleep and Learning in Rehabilitation After Stroke, Part 2\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Behavioural: Digital cognitive behavioural therapy for insomnia', 'type': 'EXPERIMENTAL', 'description': '6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.', 'interventionNames': ['Behavioral: Digital Cognitive Behavioural Therapy for Insomnia']}\n- {'label': 'Treatment as usual', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive treatment as usual.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Digital Cognitive Behavioural Therapy for Insomnia', 'description': '6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.', 'armGroupLabels': ['Behavioural: Digital cognitive behavioural therapy for insomnia'], 'otherNames': ['Sleepio']}\n\nPrimary Outcomes:\n- {'measure': 'Sleep Condition Indicator', 'description': 'Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia', 'timeFrame': '10 weeks after randomisation'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1=0.05, power=80%, 2:1 random allocation ratio dCBT:control, two-tailed independent samples t-test, 25% dropout rate", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size distribution\n Based on prior work in our lab comparing dCBT with sleep hygiene information in stroke survivors36 and other studies involving dCBT in people who suffer from insomnia, we estimate a medium between group effect size of d=0.7. In order to achieve this, a sample size of n=76\u00e2\u0080\u0089will be required (\u00ce\u00b1=0.05, power=80%, 2:1 random allocation ratio dCBT:control, two-tailed independent samples t-test). A sample size of n=100 was selected to accommodate an approximate 25% dropout rate (determined from previous research experience). As the at-home motor training component of the trial is optional, we expect the resultant sample size to be reduced.", "id": 1558, "split": "test"} +{"trial_id": "NCT05511961", "pmid": "36434580", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ameliorating Child Poverty Through Connecting Economic Services With Child Health Services (ACCESS): A Randomised Controlled Trial of the Healthier Wealthier Families Model in Sweden\n\nIncluded conditions:\n- Material and Social Deprivation: An Enforced Lack of Necessary and Desirable Items to Lead an Adequate Life\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': \"Immediate referral to local budget and debt counselling service and a copy of 'Your child, your money', a financial guidance book for new parents\", 'interventionNames': ['Behavioral: Healthier Wealthier Families']}\n- {'label': 'Waitlist-control arm', 'type': 'ACTIVE_COMPARATOR', 'description': \"Immediately given a copy of 'Your child, your money' book, and referral to local budget and debt counselling service after a period of 3 months\", 'interventionNames': ['Behavioral: Healthier Wealthier Families']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Healthier Wealthier Families', 'description': \"Budget and debt counselling will involve at least one meeting with a counsellor. Examples of assistance the counsellors can offer include: suggestions on ways to improve a participant's financial situation; checking eligibility and helping to apply for social welfare support; helping to organise finances and develop a budget; and assistance with debt management, threatening letters or harassment by debt collectors, or imminent house eviction. The municipal budget and debt counselling services involved in the trial will receive guidance on how to work preventatively with families, which will align with the content of the 'Your child, your money'. The book covers topics such as planning finances, consumer rights, private insurance, family law, parental leave, pensions, saving, and budgeting.\", 'armGroupLabels': ['Intervention arm', 'Waitlist-control arm']}\n\nPrimary Outcomes:\n- {'measure': 'Child material and social deprivation (MSD)', 'description': 'The European Union (EU) measure of child MSD contains 17 items; 13 child-specific items. Parents are asked to indicate whether or not they have the item. If not, they are asked if it is because they cannot afford it (enforced lack) or for another reason (simple lack). Data are collected at the household level; if one child does not have an item it is assumed that all the children in the household lack that item.', 'timeFrame': '3 months after randomisation'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05, power at 80%, and the loss to follow-up rate is projected at 50%.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary analysis for the RCT will be a comparison of the unweighted mean number of child material and social deprivation (MSD) items lacked (T2). The target sample size has been calculated based on this primary analysis. The power calculation has been informed by child MSD data for Sweden collected via the European Union Statistics on Income and Living Conditions (EU-SILC) survey, which reports an unweighted mean of 4.5 items lacked among the materially-deprived population. Using a significance level of 0.05 and 80% power, a total of 142 families (71 per group) will be required to detect a 1-item group difference in the unweighted mean number of child MSD items lacked, assuming a standard deviation of 3. As the trial will be conducted in areas with high rates of socioeconomic disadvantage, we estimate that up to 30% of families will experience financial hardship and be eligible for inclusion. The estimated rate of uptake is 50% among eligible families, based on a pilot in the Sandviken municipality, Sweden. Loss to follow-up is projected at 50%. See Fig.\u00c2\u00a02 for the participant timeline with projected numbers.", "id": 1559, "split": "test"} +{"trial_id": "NCT05512156", "pmid": "39097315", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Toothbrushing Program in Saudi Arabia \"TOPS\"- A Cluster Randomized Controlled Trial in Kindergartens, Riyadh\n\nIncluded conditions:\n- Dental Caries in Children\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'All children in the intervention arm of the study will be receiving daily supervised toothbrushing in kindergartens for two years. All children are exposed to background water fluoridation.', 'interventionNames': ['Other: Supervised Toothbrushing']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'All children in the control arm of the study will be receiving TAU which is awareness sessions in the school about importance of the daily brushing, healthy diet and demonstrating how to brush correctly and efficiently. All children are exposed to background water fluoridation.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Supervised Toothbrushing', 'description': '* Recruitment, consent, and Questionnaires (Behaviors, Quality of Live, Cost Analysis) distribution.\\n* Inclusion \\\\& Exclusion Criteria Applied\\n* Baseline Dental examination\\n* Toothbrushes \\\\& Toothpastes Home and school use packs delivery-Colgate (six pack per child a year- child soft toothbrush with a1450ppm fluoridated toothpaste))\\n* Supervised teachers training\\n* Three months intervals monitoring visits\\n* \"12months\" Follow up and Questionnaires (Behaviours) distribution\\n* Endpoint dental Examination and Questionnaires (Behaviours, Quality of Live, Cost Analysis) distribution', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['toothbrushing']}\n\nPrimary Outcomes:\n- {'measure': 'Prevalence of Dental caries using dmft score dental inspection', 'description': 'worsening of decay will be tabulated and analysed by odds-ratios, with the attendant 95% confidence interval and p-value.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha level of 5%, design effect (DE) of 1.019, intraclass correlation (ICC) of 0.001, average class size of 15 children, and a loss to follow-up rate of 20%.", "answer": 306, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on the primary endpoint which is \u00e2\u0080\u0098worsening of decay\u00e2\u0080\u0099. This calculation used a power of 80% and an alpha level of 5%. As this is a cluster randomised trial, the usual sample size is slightly inflated by the design effect (DE) of DE=1 + (N\u00e2\u0088\u00921) *ICC. N is the average class size, which is assumed to be 15 children being successfully inspected and partly based on pilot data and partly based on the traditionally weak intraclass correlations (ICC) in public health that have been assumed to be 0.001, which produces a DE of 1.019. To detect a difference of 15% worsening in the toothbrushing group versus 30% in the TAU group,122 children in each group with evaluable endpoints will be required, providing a total sample size of 244 children. Note that to contribute an evaluable endpoint, a child will need valid dental inspections at both the baseline and the end of the study. However, in practice, not all of the children will complete the study. If a loss to follow-up rate of 20% is assumed, inflation of the number of children that are required to be randomised is 153 in each group, and 306 children in total. This corresponds to approximately 20 schools.\n In summary:\n \n \n Randomise 153+153 = 306, from 10+10 schools.\n \n \n The sample size requires 122+122 = 244 evaluable endpoints.", "id": 1560, "split": "test"} +{"trial_id": "NCT05512286", "pmid": "39832996", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Patient-Reported Outcome and Safety Outcomes Between Preoperative and Postmastectomy Radiotherapy in Breast Cancer Patients with Reconstruction of DIEP Flap: a Multicenter\uff0cProspective\uff0cOpen-label\uff0cRandomized Controlled Trial\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Preoperative radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Radiotherapy followed by mastectomy and DIEP flap reconstruction', 'interventionNames': ['Radiation: Preoperative radiotherapy']}\n- {'label': 'Postmastectomy radiotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Radiotherapy after mastectomy and DIEP flap reconstruction', 'interventionNames': ['Radiation: Postmastectomy radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Preoperative radiotherapy', 'description': 'Radiotherapy followed by mastectomy and DIEP flap reconstruction', 'armGroupLabels': ['Preoperative radiotherapy']}\n- {'type': 'RADIATION', 'name': 'Postmastectomy radiotherapy', 'description': 'Radiotherapy after mastectomy and DIEP flap reconstruction', 'armGroupLabels': ['Postmastectomy radiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Patient satisfaction with breasts questionnaire Patient satisfaction of breast', 'description': 'Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.', 'timeFrame': '24 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided alpha level of 0.025 will be used for statistical significance. The study is designed to have a statistical power of 0.93. Participants will be allocated at a 1:1 ratio between the two groups.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size calculation\n Descriptive statistics will be used to summarise baseline characteristics. Proportional differences between groups will be tested using Pearson\u00e2\u0080\u0099s \u00cf\u00872 test. T-test will be used to compare continuous outcomes between two groups, and a one-way analysis of variance will be used to compare outcomes across groups. Univariate and multivariate logistic regression analyses will be carried out to examine associations between independent variables and outcomes. All available independent variables will be considered in the univariate regression model, and only significant variables (p<0.1) will be included for further multivariate logistic regression analyses. All tests will be two-sided, and a p value of less than or equal to 0.05 will be considered significant.\n \n Sample size calculation\n The study has been designed as a randomised, controlled superiority trial with participants allocated at a 1:1 ratio between the preoperative radiotherapy and PMRT groups. According to previous studies, the mean score of the breast domain of the BREAST-Q at 2 years postoperatively was 64\u00c2\u00b116.9 in the PMRT group.29 The average score in the breast domain of the BREAST-Q at 2 years in the preoperative radiotherapy group is estimated to reach 77 on average. We assume that the breast satisfaction score will be better in the preoperative radiotherapy group than in the PMRT group. A one-sided alpha level of 0.025 will be used for statistical significance. Thus, a sample size of 40 patients per group (80 patients in total) can provide a statistical power of 0.93 to detect significant differences between the groups, assuming equal variance in both groups. PASS 15 Power Analysis and Sample Size Software (2017) (NCSS, LLC, Kaysville, Utah, USA) was used to calculate the sample size", "id": 1561, "split": "test"} +{"trial_id": "NCT05512286", "pmid": "39832996", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Patient-Reported Outcome and Safety Outcomes Between Preoperative and Postmastectomy Radiotherapy in Breast Cancer Patients with Reconstruction of DIEP Flap: a Multicenter\uff0cProspective\uff0cOpen-label\uff0cRandomized Controlled Trial\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Preoperative radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Radiotherapy followed by mastectomy and DIEP flap reconstruction', 'interventionNames': ['Radiation: Preoperative radiotherapy']}\n- {'label': 'Postmastectomy radiotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Radiotherapy after mastectomy and DIEP flap reconstruction', 'interventionNames': ['Radiation: Postmastectomy radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Preoperative radiotherapy', 'description': 'Radiotherapy followed by mastectomy and DIEP flap reconstruction', 'armGroupLabels': ['Preoperative radiotherapy']}\n- {'type': 'RADIATION', 'name': 'Postmastectomy radiotherapy', 'description': 'Radiotherapy after mastectomy and DIEP flap reconstruction', 'armGroupLabels': ['Postmastectomy radiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Patient satisfaction with breasts questionnaire Patient satisfaction of breast', 'description': 'Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.', 'timeFrame': '24 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided alpha level of 0.025 will be used for statistical significance. The study is designed to have a statistical power of 0.93. Participants will be allocated at a 1:1 ratio between the two groups.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study has been designed as a randomised, controlled superiority trial with participants allocated at a 1:1 ratio between the preoperative radiotherapy and PMRT groups. According to previous studies, the mean score of the breast domain of the BREAST-Q at 2 years postoperatively was 64\u00c2\u00b116.9 in the PMRT group.29 The average score in the breast domain of the BREAST-Q at 2 years in the preoperative radiotherapy group is estimated to reach 77 on average. We assume that the breast satisfaction score will be better in the preoperative radiotherapy group than in the PMRT group. A one-sided alpha level of 0.025 will be used for statistical significance. Thus, a sample size of 40 patients per group (80 patients in total) can provide a statistical power of 0.93 to detect significant differences between the groups, assuming equal variance in both groups. PASS 15 Power Analysis and Sample Size Software (2017) (NCSS, LLC, Kaysville, Utah, USA) was used to calculate the sample size", "id": 1562, "split": "test"} +{"trial_id": "NCT05514210", "pmid": "37989362", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Coronary Artery Disease\n- Multidisciplinary Communication\n\nStudy Armgroups:\n- {'label': 'real-time heart team group', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process', 'interventionNames': ['Behavioral: heart team meeting and discussion']}\n- {'label': 'conventional heart team group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process', 'interventionNames': ['Behavioral: heart team meeting and discussion']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'heart team meeting and discussion', 'description': \"When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.\", 'armGroupLabels': ['conventional heart team group', 'real-time heart team group']}\n\nPrimary Outcomes:\n- {'measure': '1-year major adverse cardiovascular and cerebrovascular events', 'description': 'a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission.', 'timeFrame': 'At 1 year after the coronary angiography'}\n\nPlease estimate the sample size based on the assumption: \nA 2.5% level of one-sided significance and a power level of 80% were used. A 5% drop-out rate was considered.", "answer": 490, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary aim of this study is to compare the 1-year composite adverse events between two heart team groups. We hypothesised that 1-year composite adverse events in the real-time heart team are not inferior to those in the conventional heart team. In our previous study, the incidence of composite adverse events in patients with surgical consultation within 1\u00e2\u0080\u0089year was 11.9%.23 According to previous literature,12 24 the incidence of composite adverse events in patients discussed by the heart team within 1\u00e2\u0080\u0089year ranged from 22.0% (15.2\u00e2\u0080\u009328.8%). After conducting a meta-analysis, the non-inferiority margin was set at 8.43% based on clinical experience and feasibility. Using a 2.5% level of one-sided significance and a power level of 80%, the estimated sample size of each group was at least 232 cases, requiring a total of 464 cases. Taking into account the 5% drop-out during the trial, a total number of 490 cases were needed.\n The primary secondary endpoint of the study is the time interval (days) between the completion of the angiography and final treatment. According to the results in our previous work (unpublished data), the mean interval between angiography and final treatment for patients with complex CAD who underwent traditional elective surgical consultation was 6.55 (SD 5.16) days. We hypothesised the real-time heart team approach mainly decreases the consultation waiting time. After subtracting consultation waiting time, the mean time between angiography and final treatment was 4.16 (SD 5.05) days and was set as the time interval of patients discussed by the real-time heart team. Under the difference test with the conservative estimation of the joint SD of 5.16\u00e2\u0080\u0089days and using a 2.5% level of one-sided significance and a confidence level of 80%, the estimated sample size of each group was at least 74 with the total sample size of 148. When 5% drop-out was considered, the total sample size was 156. In summary, considering the sample size of the primary endpoint and the primary secondary endpoint, a sample size of 490 patients was eventually determined with 245 patients in each group.", "id": 1563, "split": "test"} +{"trial_id": "NCT05519254", "pmid": "39122384", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae\n\nIncluded conditions:\n- Diarrhea\n- Wasting\n- Malnutrition, Child\n\nStudy Armgroups:\n- {'label': 'Lactoferrin Arm', 'type': 'EXPERIMENTAL', 'description': '16-week course of lactoferrin', 'interventionNames': ['Dietary Supplement: Lactoferrin']}\n- {'label': 'Lysozyme Arm', 'type': 'EXPERIMENTAL', 'description': '16-week course of lysozyme', 'interventionNames': ['Dietary Supplement: Lysozyme']}\n- {'label': 'Combination Arm (Lactoferrin + Lysozyme)', 'type': 'EXPERIMENTAL', 'description': '16-week course of lactoferrin and lysozyme', 'interventionNames': ['Combination Product: Lactoferrin + Lysozyme']}\n- {'label': 'Placebo Arm', 'type': 'PLACEBO_COMPARATOR', 'description': '16-week course of taste/appearance-matched placebo', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Lactoferrin', 'description': 'Caregivers of children will be instructed to provide 1.5g of lactoferrin with 40g of unmodified rice powder daily mixed with 125 mL of porridge or other complimentary food.', 'armGroupLabels': ['Lactoferrin Arm']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Lysozyme', 'description': 'Caregivers of children will be instructed to provide 41.5g of Lysosure daily mixed with 125 mL of porridge or other complimentary food.', 'armGroupLabels': ['Lysozyme Arm']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Lactoferrin + Lysozyme', 'description': 'Caregivers of children will be instructed to provide 40g of Lysosure with 1.5 grams of lactoferrin daily mixed with 125 mL of porridge or other complimentary food.', 'armGroupLabels': ['Combination Arm (Lactoferrin + Lysozyme)']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Caregivers of children will be instructed to provide 41.5 grams of unmodified rice powder daily mixed with 125 mL of porridge or other complimentary food.', 'armGroupLabels': ['Placebo Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of moderate-to-severe diarrhea', 'description': 'Defined as total number of new diarrhea episodes (\\\\> 48 hours after a diarrhea-free period) deemed moderate-to-severe, divided by the child-time at risk during the 6-month follow-up period. Moderate-to-severe diarrhea will be defined as \u2265 3 using the CODA (Community DiarrhoeA) diarrhea severity score or dysentery (evidence or reported visible blood in stool).', 'timeFrame': '6 months'}\n- {'measure': 'Time to nutritional recovery', 'description': 'Defined as the number of days since enrollment to the date of the second of two consecutive MUAC measurements \u2265 12.5 cm.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses an alpha of 0.05 and 80% power for most calculations. It assumes a 2% mortality rate and a 10% loss-to-follow-up rate. For haemoglobin assessment, it assumes 82% power, and for linear growth, it assumes 90% power. For enteric dysfunction markers, it assumes 80% power with a sample size of 50 per treatment group.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size\n To determine whether a 16-week course of lactoferrin, lysozyme or a combination of both shortens time to WHO-defined recovery from wasting (MUAC \u00e2\u0089\u00a512.5\u00e2\u0080\u0089cm) and reduces the incidence of moderate-to-severe diarrhoea during the subsequent 6\u00e2\u0080\u0089months following presentation to a health facility with diarrhoea among children with moderate/severe childhood wasting: the total sample size required (600 children, 150 per arm) was calculated based on the comparison of moderate-to-severe diarrhoea incidence between any single intervention arm (lactoferrin, lysozyme or combined therapy) to the control arm (placebo-treated children). We assumed the incidence of moderate-to-severe diarrhoea in the placebo-arm to be approximately 100 episodes/100 child years based on the Global Burden Disease 2019 estimates of under 5 diarrhoea incidence of 167/100 child years51 and assuming 60% of these episodes would meet the moderate-to-severe definition based on previous data.50 We assumed a 35% reduction in this incidence in any of the interventional arms based on previous data.25 31 Using an alpha of 0.05 and assuming 80% power, we will require, at minimum, 134 children per intervention arm. Assuming 2% of children die during follow-up, based on estimates of mortality during convalescence from moderate-to-severe diarrhoea in Kenya,50 and a 10% loss-to-follow-up, we will enrol an additional 16 children per treatment arm, recruiting 600 children in total (150 per arm). With 134 surviving children in each treatment arm with complete follow-up, we determined the minimum detectable difference in time to nutritional recovery between each intervention arm and the placebo arm assuming an alpha of 0.05 and 80% power. This conservative estimate is based on not being able to include data prior to censoring so represents the minimal detectable times. Data from CMAM programmes suggest that approximately 70%\u00e2\u0080\u009385% of children in CMAM programmes recover to a MUAC \u00e2\u0089\u00a512.5\u00e2\u0080\u0089cm, with recovery taking between 4 and 8\u00e2\u0080\u0089weeks with SD ranging from 0.2 to 3.2 weeks, based on frequency of anthropometric assessments (studies with less-frequent assessments result in larger SD of time to recovery).5256 Based on these assumptions, we will be powered to detect a difference of between 1\u00e2\u0080\u0089day (assuming a 0.2 SD) and 1\u00e2\u0080\u0089week (assuming a 3.2 SD) difference in time to nutritional recovery, respectively.\n To explore whether a 16-week course of lactoferrin, lysozyme or combination therapy improves secondary clinical, nutritional, enteric pathogen and enteric function outcomes: assuming 2% of children die during follow-up based on estimates of mortality during convalescence from moderate-to-severe diarrhoea in Kenya and 10% are hospitalised after diarrhoea copresentation with wasting, we will have 80% power to detect an HR of 0.3 or greater (in magnitude) of any two-way comparison of an intervention arm to placebo. Because this analysis will be underpowered, we will focus interpretation on the measure of effect as opposed to p values. Haemoglobin assessment and linear growth power calculations are based on the mean difference likely to be observed over 6 months. Data from the Childhood Acute Illness & Nutrition (CHAIN) cohort suggests that the mean of haemoglobin of children with acute malnutrition and diarrhoea is 10\u00e2\u0080\u0089mg/dL with an SD of 3\u00e2\u0080\u0089mg/dL.57 Data from previous clinical trials suggest that a prolonged course of lactoferrin may lead to a 1\u00e2\u0080\u0089mg/dL increase and we will have 82% power to detect that difference.29 The linear growth outcome will be assessed as change in LAZ between baseline and day 180. Over this time frame, we expect children of this age recovering from an acute illness to have a decline in delta LAZ of 0.25 with a SD of 0.1. Assuming a sample size of 134 children per arm with growth data, and an alpha of 0.05, this study would have 90% power to detect change in delta LAZ of 0.05. For the markers of enteric dysfunction, concentration and SD of myeloperoxidase are included in the power calculation as previous evidence suggests that this marker has the greatest variance. Assuming a mean log concentration of 8.9\u00e2\u0080\u0089ng/mL and SD of 1.26\u00e2\u0080\u0089ng/mL, 110 with 0.05 alpha and 50 per treatment group, we will have 80% power to detect a difference of 0.7\u00e2\u0080\u0089mg/L (8%) between two groups at any timepoint, a difference considered clinically meaningful. Anticipating a mean L:R ratio of 0.75 (SD 5.4) in the placebo group as observed in previous work in Kenya, and using data from the recent lactoferrin and lysozyme study in Malawi where there was a 30% improvement in lactulose detection (SD 9% to 14%), we determined that we will be able to detect a difference in L:R ratios of at least 4% and 6%, respectively. We expect that placebo-treated children will have prevalences of EAEC, Campylobacter and Shigella of 51%, 28% and 15%, respectively. With all children other than those who died or were lost to follow-up having a week 4 sample (134 children per arm), we will be able to detect a 25%, 37% and 50% reduction in EAEC, Campylobacter and Shigella prevalence, respectively, between intervention arms. In the subset of ~50 children per arm who will have enteric pathogen data at weeks 16 and 24, we will be able to detect prevalence reductions ranging from 35% to 62%.\n To evaluate acceptability, adherence and cost-effectiveness of lactoferrin and/or lysozyme in Kenya: the sample size for the qualitative data collection is based on the ability to reach data saturation by the re-emergence of key themes across data sources, time and resources. If during qualitative data collection, we are not able to reach data saturation using the prespecified FGD sample sizes as detailed above, an additional two FGDs will be conducted with caregivers and health workers, respectively, to ensure comprehensiveness and representativeness of the qualitative data.", "id": 1564, "split": "test"} +{"trial_id": "NCT05520515", "pmid": "39138559", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Water and Land-based Aerobic Training on Health-related Outcomes in Breast Cancer Survivors: a Randomized Clinical Trial\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Aquatic training plus health education group', 'type': 'EXPERIMENTAL', 'description': 'Aerobic exercise training program in the aquatic environment twice a week plus health education program once a week', 'interventionNames': ['Other: Aquatic Training Plus Health Education']}\n- {'label': 'Land training plus health education group', 'type': 'EXPERIMENTAL', 'description': 'Aerobic exercise training program in the land environment twice a week plus health education program once a week', 'interventionNames': ['Other: Land Training Plus Health Education']}\n- {'label': 'Health education group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Health education program once a week', 'interventionNames': ['Other: Health Education']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Aquatic Training Plus Health Education', 'description': 'Participants perform a 12-week training program with two weekly exercise sessions on non-consecutive days. Sessions last 45 min (5 min of warm-up, 35 min of exercise, and 5 min of stretching) throughout the intervention period. The intervention is performed at the thermal pool sector of Clube Brilhante in Pelotas city. The pool water temperature is maintained between 30-32\u00b0C, with participants immersed in the depth level between the xiphoid process and shoulders. The aquatic training group performs the following water aerobics exercises: stationary running, frontal kick, cross-country skiing, and butt kick during the stimulus and jumping jacks during the active recovery. The training session is collective, with 3 to 6 participants, supervised by two experienced instructors, one outside and one inside the pool. The group also receives the booklet and the offer of weekly meetings of an educational program (30 min before one of the training sessions) with the same interactive lectures.', 'armGroupLabels': ['Aquatic training plus health education group']}\n- {'type': 'OTHER', 'name': 'Land Training Plus Health Education', 'description': 'Participants perform a 12-week training program with two weekly exercise sessions on non-consecutive days. Sessions last 45 min (5 min of warm-up, 35 min of exercise, and 5 min of stretching) throughout the intervention period. The intervention occurs at the School of Physical Education, Federal University of Pelotas. Depending on weather conditions, the land training group will perform aerobic training with walking/running exercises in a flat outdoor environment or inside a multi-sport gym. The training session will be collective, with 3 to 6 participants, supervised by two experienced instructors, one at the starting point and the other following the movement of the participants. In addition, the group receives the booklet and the offer of weekly meetings of an educational program (30 min before one of the training sessions) with the same interactive lectures.', 'armGroupLabels': ['Land training plus health education group']}\n- {'type': 'OTHER', 'name': 'Health Education', 'description': 'The intervention occurs at the School of Physical Education, Federal University of Pelotas. The intervention consists of an educational program with weekly lectures of approximately 30 min. The lectures are led by a qualified health professional, using expository and interactive approaches on topics that cover basic knowledge related to breast cancer and complementary therapies. Additionally, each participant receives a self-care booklet containing information about the topics addressed during the meetings. Qualified professionals give lectures on the following topics: 1) fatigue and quality of life; 2) anxiety and depressive symptoms; 3) body image and sexual function; 4) self-esteem; 5) self-care; 6) sleep; 7) cognitive function; 8) symptoms in the arm and breast; 9) pain and arthralgia; 10) body composition and bone health; 11) eating habits; 12) physical activity.', 'armGroupLabels': ['Health education group']}\n\nPrimary Outcomes:\n- {'measure': 'Cancer-related fatigue', 'description': 'Cancer-related fatigue is measured with the Portuguese Piper Fatigue Scale (PFS) version. The Brazilian version of the PFS is a valid and reliable instrument for assessing fatigue in cancer patients in Brazil (Mota et al., 2009). The PFS consists of 22 numerical items assessing fatigue experienced by the patients (Piper et al., 1998), using a 0-10 numeric scale. The PFS measures four dimensions of subjective fatigue are: behavioral/severity, affective meaning, sensory, and cognitive/mood. The total fatigue score is calculated by adding the four subscale scores and dividing this sum by four.', 'timeFrame': 'Baseline (week 0) to post-training (week 13)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, 90% power, and approximately 20% dropout rate.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample calculation was conducted using the GPower version 3.1 program, adopting a significance level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 90% power. Data for the calculation were derived from the study results by Kessels et al. [12] for the primary outcome of cancer-related fatigue (effect size 0.605). It resulted in a total sample size of 39 subjects. Additionally, nine individuals (approximately 20%) will be included in the study to account for potential sample losses, totaling 48 participants randomized into the three groups.", "id": 1565, "split": "test"} +{"trial_id": "NCT05520671", "pmid": "37380211", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating TESLA-G, a Gamified, Telegram-delivered, Quizzing Platform for Surgical Education in Medical Students: a Protocol for a Pilot Randomised Controlled Trial\n\nIncluded conditions:\n- Surgical Education in Medical Students\n\nStudy Armgroups:\n- {'label': 'TESLA-G', 'type': 'EXPERIMENTAL', 'description': 'Participants will be randomised into the two arms with a 1:1 allocation ratio stratified by year of study. There will be 25 participants in this arm.', 'interventionNames': ['Other: Gamified online quizzing platform']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be randomised into the two arms with a 1:1 allocation ratio stratified by year of study. There will be 25 participants in this arm.', 'interventionNames': ['Other: Conventional quizzing platform']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Gamified online quizzing platform', 'description': \"TESLA-G is a novel gamified quizzing platform designed based on Bloom's taxonomy of learning domains. Questions will be created in blocks, where each block will test a specific topic within a specialty (endocrine surgery has been selected for this study). Each block has 5 questions, and each question corresponds to each level of Bloom's taxonomy and each level in game.\\n\\nFor this study, we aim to create 56 blocks of 5 questions, totalling 280 questions. All questions will be created by two board-certified general surgeons and one endocrinologist, and validated by the research team.\\n\\nThe aim of the game is for players to get as many points as they can before the timer runs out. Gamification elements include levels, countdown timer, lives, a point multiplier system, leaderboard rankings and a personalised dashboard.\\n\\nParticipants in the intervention group will be provided with a link to access TESLA-G, sent from an automated Telegram bot; this access will be provided for 14 days.\", 'armGroupLabels': ['TESLA-G']}\n- {'type': 'OTHER', 'name': 'Conventional quizzing platform', 'description': \"The conventional quizzing platform will be a modified version of TESLA-G with all gamification elements removed. The same set of questions as the gamified version will be used. Upon entering the quiz, a question stem and five choices will be shown. When an option is selected, the right answer along with its explanation will be indicated. The next question will then be sent, and this process repeats until the participant leaves the platform or has answered every question.\\n\\nQuestions will be queued in blocks, with each block corresponding to a particular topic in endocrine surgery. Unlike the gamified version, questions within each block will be randomised, regardless of their level on the Bloom's taxonomy. Participants will also not be informed of the level of Bloom's taxonomy for individual questions. The access link to the platform will be sent to participants from an automated Telegram bot, and this access will last for 14 days.\", 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of intervention', 'description': 'The feasibility of the intervention will be evaluated quantitatively. These are the objectives:\\n\\n1. Enrollment of 50 participants\\n2. Retention of at least 75% of the enrolled participants\\n3. Individual quiz completion rate of 80%\\n\\nAchieving all of these goals will prove that it is feasible to conduct a full-scale randomised controlled trial (RCT), while achieving two out of three goals will indicate that it is probably feasible. Achieving less than two goals will suggest that a full-scale RCT is not feasible with the current procedure.', 'timeFrame': '14 days'}\n- {'measure': 'Acceptability of intervention', 'description': 'Acceptability of the intervention is measured quantitatively via a post-intervention learner satisfaction survey and qualitatively via semi-structured interviews.', 'timeFrame': 'Post-intervention (14 days)'}\n\nPlease estimate the sample size based on the assumption: \n90% power", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n Fifty participants (n=50) will be recruited, that is, 25 participants per arm. This was based on a study by Whitehead et al (2015) which suggested that 25 participants for each arm is optimum for studies with small effect size (between 0.1 and 0.3) for 90% power.46 Additionally, a purposive sample of at least 10 medical students (n=10) will be invited to share their views of the intervention via semi-structured interviews. This is based on consideration of the resources available.\n Our study advertisement will be disseminated to all medical students from a medical school in Singapore via the respective Telegram group channels for each cohort. We will also advertise through advertisement posters and recruitment calls during regular lectures/seminars as well as through personal contacts. The study advertisement has a link to a secure registration form hosted by the research IT department. Every participant will be expected to fill in this registration form. This registration form will collect the name and email address of each participant. A letter of informed consent will be emailed to each participant, and he/she will be expected to provide consent in order to be considered as recruited for the study.", "id": 1566, "split": "test"} +{"trial_id": "NCT05523388", "pmid": "37889898", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RoLSSroice - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis: A Translational Approach Combining Clinical and Radiological Parameters, in Vivo Biomechanical Experiments and Advanced in Silico Musculoskeletal Modeling\n\nIncluded conditions:\n- Lumbar Spinal Stenosis\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Collection of health-related data', 'description': 'A multimodal set of data including experimental, clinical, functional, radiological and biomechanical data is compiled before and after routine surgical intervention at baseline and at one-year follow-up.'}\n\nPrimary Outcomes:\n- {'measure': 'Change in Oswestry disability index (ODI)', 'description': \"Disability related to sLSS will be assessed with the ODI, which is considered the gold standard of low back functional outcome tools. The ODI is a questionnaire comprising 10 self-administered items that quantify a patient's perceived level of functional disability. Each of the items relates to a different area of functional impairment and consists of six statements, which are scored from zero to five points.\", 'timeFrame': 'At baseline and at one-year follow-up'}\n- {'measure': 'Change in Dynamic compensation', 'description': 'Dynamic compensation is defined as the difference between static and dynamic sagittal spinal alignment. Six possible gait events are available to choose from for the definition of dynamic sagittal spinal balance (left and right; heel-strike, toe-off, midstance). Dynamic sagittal spinal balance may be defined as sagittal spinal balance during left/right midstance, left/right heel strike and/or left/right toe off. The most appropriate gait event to calculate dynamic sagittal spinal balance will be used.', 'timeFrame': 'At baseline and at one-year follow-up'}\n\nPlease estimate the sample size based on the assumption: \nTo detect a correlation of 0.3 at 80% power and 5% significance level. Considering a 10% drop-out rate.", "answer": 122, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We expect that about half of our patients will present with segmental instability. To assess the correlation between PROMS and continuous covariates, a sample size of 83 is required to detect a correlation of 0.3 at 80% power and 5% significance level. To assess the correlation between PROMS and categorical covariates with 3 levels of the covariate a sample size of 111 (37 within each level) is required to detect a correlation of 0.3 at 80% power and 5% significance level. We hypothesize that the postoperative change in the mean of PROMS at the 12-month follow-up with other covariates is 20%. Between PROMS and continuous covariates a sample size of 34 will be required to detect the difference in mean of 20% with a standard deviation of 40% (effect size = 0.5) and a power of 80% at 5% significance level. Between PROMS and categorical covariates a sample size of 107 will be required to detect the difference in mean of 20% with a standard deviation of 40% (effect size = 0.5) and a power of 80% at 5% significance level. By considering the highest number needed for the study hypothesis, we need 111 patients in this study. Considering a 10% drop-out rate, 122 subjects will be enrolled in the study.", "id": 1567, "split": "test"} +{"trial_id": "NCT05523778", "pmid": "38569703", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct\n\nIncluded conditions:\n- Insulinoma\n\nStudy Armgroups:\n- {'label': 'Stented EN', 'type': 'EXPERIMENTAL', 'description': 'Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.', 'interventionNames': ['Procedure: placement of pancreatic duct stents before enucleation surgery']}\n- {'label': 'Direct EN', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive enucleation surgery directly following normal procedure', 'interventionNames': ['Procedure: Direct enucleation surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'placement of pancreatic duct stents before enucleation surgery', 'description': 'Advance placement of pancreatic stents endoscopically', 'armGroupLabels': ['Stented EN']}\n- {'type': 'PROCEDURE', 'name': 'Direct enucleation surgery', 'description': 'Patients will receive direct enucleation surgery', 'armGroupLabels': ['Direct EN']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of POPF within 3 months after EN.', 'description': 'Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)', 'timeFrame': '3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion'}\n\nPlease estimate the sample size based on the assumption: \n85% power, one-sided significance level of 0.05, considering possible dropout", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In our previous retrospective study, a total of 44 patients with insulinoma in proximity to the MPD who underwent EN were included, of which 16 had stent placement and 28 had no stent placement, and the number of patients with POPF was 6 (37.5%) and 20 (71.4%), respectively. According to the above-mentioned POPF rate in two conditions, 38 evaluable patients per group will provide 85% power to reject the null hypothesis in a Z test (unpooled) for superiority at a one-sided significance level of 0.05 considering the POPF rate difference of at least 5% to represent a clinically relevant difference. Therefore, 78 patients in total are to be recruited in the study considering possible dropout.", "id": 1568, "split": "test"} +{"trial_id": "NCT05524909", "pmid": "39632119", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Combined Effects of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies on Objectively Measured Behavioral Outcomes in Overweight or Obese East Asian Individuals.\n\nIncluded conditions:\n- Fitness Trackers\n- Physical Activity\n- Exercise\n- Genetic Predisposition to Disease\n- Type 2 Diabetes\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive a Fitbit device'}\n- {'label': 'Intervention Group - Genetic Risk Estimate', 'type': 'EXPERIMENTAL', 'description': 'This intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .', 'interventionNames': ['Genetic: Genetic Risk Estimate']}\n- {'label': 'Intervention Group - Genetic Risk Estimate + Fitbit Functions', 'type': 'EXPERIMENTAL', 'description': 'This intervention group will receive a Fitbit device, but have a Fitbit step goal set 10% higher than their baseline step count, and use its prompt functions, in addition to the genetic risk estimate and e-leaflet.', 'interventionNames': ['Device: Genetic Risk Estimate + Fitbit Functions']}\n\nInterventions:\n- {'type': 'GENETIC', 'name': 'Genetic Risk Estimate', 'description': \"The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).\", 'armGroupLabels': ['Intervention Group - Genetic Risk Estimate']}\n- {'type': 'DEVICE', 'name': 'Genetic Risk Estimate + Fitbit Functions', 'description': \"The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).\\n\\nThe two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate.\", 'armGroupLabels': ['Intervention Group - Genetic Risk Estimate + Fitbit Functions']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Moderate to Vigorous Physical Activity Minutes between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up', 'description': 'Moderate to Vigorous Physical Activity Minutes (per day) will be objectively measured by the Fitbit tracker.', 'timeFrame': 'Baseline, 12-month post-intervention, 6-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on an alpha level of 5%, a power level of 80%, and a correlation of 0.70 among three repeated measures. An expected attrition rate of 20% and an expected Fitbit data-missing rate of 10% are also considered.", "answer": 355, "answer_type": "ACTUAL", "explanation": "Sample size\n We recruit a total of 355 overweight or obese East Asians (figure 2). We employ an over-sampling strategy to ensure sufficient statistical power in a subgroup analysis of overweight or obese East Asians with high genetic susceptibility to T2D (n=87; about 35% of the full sample, according to an estimated potential proportion of overweight or obese individuals with high genetic risk for T2D within a given population28) as well as in the full sample analysis (n=248; 87/35%). Specifically, the number of participants (n=87) needed for the subsample analysis was determined based on a desired medium effect size F of 0.3086,29 calculated from a three-group comparison where average wearable device-measured MVPA time would be 80 min/day (along with an SD of 35\u00e2\u0080\u0089min/day per group)30 in the control group, 85\u00e2\u0080\u0089min/day (ie, minimal changes) in the intervention group receiving genetic risk information alone and 105\u00e2\u0080\u0089min/day (ie, about 23% difference ((105\u00e2\u0088\u009285)/85\u00c3\u0097100%) corresponding to a 23% MVPA difference in previous intervention using Fitbit functions31 in the other intervention group receiving genetic risk information combined with the wearable functions. The sample size calculation is based on an alpha level of 5%, a power level of 80% and a correlation of 0.70 among three repeated measures. A total of 355 participants are recruited to ensure inclusion of an analysis sample of 248 (ie, 248=355\u00e2\u0080\u0093107), taking into account an expected attrition rate of 20% (n=71; 355\u00c3\u009720%) and an expected Fitbit data-missing rate of 10% (n=36; 355\u00c3\u009710%; eg, data lost due to insufficient battery life, device lost, device not worn regularly).", "id": 1569, "split": "test"} +{"trial_id": "NCT05524987", "pmid": "39516847", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Addressing HyperteNsion and Diabetes Through Community-Engaged Systems in Puno, Peru (ANDES Study)\n\nIncluded conditions:\n- Hypertension\n- Diabetes\n\nStudy Armgroups:\n- {'label': 'INTERVENTION', 'type': 'EXPERIMENTAL', 'description': 'Participants in the ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months. Implementation package delivery will end after month 12, at which time intervention participants will be advised to obtain standard care from their local healthcare facility. ANDES is an adaptation of the World Health Organization (WHO) HEARTS package and consists of the following components:\\n\\nA. Health agent-managed home care\\n\\n* BP monitoring\\n* Health coaching\\n* Health system navigation\\n* Medication adherence support B. Text message-based health coaching Specifically, the ANDES strategy is aligned with four WHO HEARTS technical package components.', 'interventionNames': ['Behavioral: ANDES INTERVENTION']}\n- {'label': 'CONTROL', 'type': 'NO_INTERVENTION', 'description': 'Participants in the usual care group will be referred to their local healthcare facility for evaluation and/or to receive medical therapy per typical standard of care and at the discretion of the treating physician for the entirety of the ANDES study.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ANDES INTERVENTION', 'description': 'ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months', 'armGroupLabels': ['INTERVENTION']}\n\nPrimary Outcomes:\n- {'measure': 'Effectiveness outcome: Systolic Blood Pressure', 'description': 'Systolic blood pressure (SBP) (mmHg) at 12 months after randomization.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 90% power, and a 10% loss-to-follow-up rate at 12 months.", "answer": 1068, "answer_type": "ESTIMATED", "explanation": "Sample size\n To detect a between-group difference in a mean change in systolic blood pressure of 2.5 mmHg between intervention and control arms with 95% confidence, 90% power, and a standard deviation of 12 mmHg, and assuming a conservative loss-to-follow-up of 10% at 12 months, we will randomize 1068 participants (534 participants per arm). We selected a target mean change of 2.5 mmHg as a minimal clinically important difference (MCID) based on prior research showing that even a 2.0 mmHg reduction in SBP can significantly reduce cardiovascular disease incidence and mortality [26, 27]. A recent CHW hypertension control trial in Argentina also demonstrated a 4 mmHg difference between groups, suggesting a potential for larger effects [12]. Our chosen MCID of 2.5 mmHg lies between the well-evidenced lower bound of 2 mmHg for clinically meaningful reductions in SBP and the 4 mmHg change in SBP observed in the Argentina trial, reflecting our decision to favor a more conservative effect size. The standard deviation of 12 mmHg was based on data from low-income participants in a household air pollution intervention trial conducted in the\u00c2\u00a0ANDES study area in Puno [28].\n All patient effectiveness outcomes will be assessed using an intention-to-treat analysis.", "id": 1570, "split": "test"} +{"trial_id": "NCT05525039", "pmid": "38176874", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dissecting the Therapeutic Mechanism of an Effective Combination Treatment Targeting Neuromuscular Junction Dengeneration and Myosteatosis to Combat Sarcopenia\n\nIncluded conditions:\n- Sarcopenia\n- Connective Tissue Diseases in Old Age\n- Musculoskeletal Abnormalities\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months.', 'interventionNames': ['Dietary Supplement: Protein supplement']}\n- {'label': 'HMB only Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months.', 'interventionNames': ['Dietary Supplement: \u03b2-hydroxy \u03b2-methylbutyrate (HMB) supplement', 'Dietary Supplement: Protein supplement']}\n- {'label': 'VT only Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months', 'interventionNames': ['Device: Low-magnitude High-frequency Vibration', 'Dietary Supplement: Protein supplement']}\n- {'label': 'HMB + VT Group', 'type': 'EXPERIMENTAL', 'description': 'Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months.', 'interventionNames': ['Device: Low-magnitude High-frequency Vibration', 'Dietary Supplement: \u03b2-hydroxy \u03b2-methylbutyrate (HMB) supplement', 'Dietary Supplement: Protein supplement']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Low-magnitude High-frequency Vibration', 'description': '0.3g, 35Hz, 20mins/day, at least 3 times/week', 'armGroupLabels': ['HMB + VT Group', 'VT only Group'], 'otherNames': ['Vibration Treatment']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': '\u03b2-hydroxy \u03b2-methylbutyrate (HMB) supplement', 'description': 'Oral nutritional HMB supplement at 3g/day', 'armGroupLabels': ['HMB + VT Group', 'HMB only Group']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Protein supplement', 'description': 'Daily protein supplement intake', 'armGroupLabels': ['Control Group', 'HMB + VT Group', 'HMB only Group', 'VT only Group']}\n\nPrimary Outcomes:\n- {'measure': 'Muscle strength-handgrip', 'description': 'Handgrip strength will be measured by a dynamometer on each hand of the subject.', 'timeFrame': '6 months'}\n- {'measure': 'Muscle performance-gait speed', 'description': 'Gait speed will be assessed by a 6-meter-walk test.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nA sample size of 41 per group will have 80% power to detect a significant difference using two-way repeated-measures ANOVA with a 0.05 significance level. Assuming a dropout rate of 15%, n=48 per group is required.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The sample size is estimated based on our preclinical animal data11 and a recent similar study with combination treatment to treat sarcopenia.18 The maximum grip strength in patients with sarcopenia with or without exercise were 16.21\u00c2\u00b15.01\u00e2\u0080\u0089kg and 19.37\u00c2\u00b17.11\u00e2\u0080\u0089kg, respectively, from which the calculated effect size is 0.248. A sample size of 41 per group will have 80% power to detect a significant difference using two-way repeated-measures analysis of variance (ANOVA) with 0.05 significance level (PASS, NCSS, USA). Assuming dropout rate of 15%, n=48 per group is required for the study. By rounding to n=50 per group, a total sample size of n=200 is finalised.", "id": 1571, "split": "test"} +{"trial_id": "NCT05526300", "pmid": "38086588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System\n\nIncluded conditions:\n- To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients\n\nStudy Armgroups:\n- {'label': 'The standard care group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: The standard care']}\n- {'label': 'Intelligent intervention group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Intelligent Hypertension Management System']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Intelligent Hypertension Management System', 'description': 'The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients', 'armGroupLabels': ['Intelligent intervention group']}\n- {'type': 'OTHER', 'name': 'The standard care', 'description': 'The standard care', 'armGroupLabels': ['The standard care group']}\n\nPrimary Outcomes:\n- {'measure': 'Net change in systolic blood pressure from baseline to 3 months follow-up', 'timeFrame': 'one and three months after study'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is 0.05 and the power of the test is 90%. A 10% dropout rate is assumed.", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the literature reporting that the intervention group had an average reduction in blood pressure of approximately 5 mm Hg from baseline,13 19\n21 we expected the intervention group to have a benefit of approximately 5 mm Hg in lowering mean arterial pressure in patients compared with the control group and 10 mm Hg compared with baseline. The SD of blood pressure in patients with hypertension is 15 mm Hg, based on reports in the literature. Thus, 145 patients should be enrolled in each group under the condition that the significance level (\u00ce\u00b1) is 0.05\u00e2\u0080\u0089and the power of test is 90%, and 160 patients would need to be enrolled in each arm given the 10% dropout rate. Therefore, 320 subjects will be needed for the whole trial.", "id": 1572, "split": "test"} +{"trial_id": "NCT05528302", "pmid": "37340492", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial\n\nIncluded conditions:\n- Dementia\n- Cognitive Impairment\n- Anxiety\n\nStudy Armgroups:\n- {'label': 'Tech-CBT intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants allocated to the Tech-CBT intervention group will attend six telehealth videoconferencing sessions - 1 session per week over 6 weeks. Each session will last between 60 to 90 minutes and will be facilitated by a trained therapist. During each session, the participant will learn and practice different psychotherapy techniques. The participant will be encouraged to practice these skills between sessions with the technology provided, either on their own or with the help of their support person.', 'interventionNames': ['Other: Tech-CBT intervention']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants allocated to the Control group will receive usual care (i.e., no treatment for anxiety) and a mid-point check-in phone call/video call/email (depending on their preference) from the study team approximately 3 weeks after completing the initial questionnaires. This mid-point check-in is to identify whether there have been any changes to their usual care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Tech-CBT intervention', 'description': 'The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.', 'armGroupLabels': ['Tech-CBT intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in anxiety', 'description': 'Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).', 'timeFrame': 'Post assessment - week 8 (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes).'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided 5% significance level, and 30% attrition rate.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The study aims to have a sample of 48 (24 in each arm) people living with MCI or dementia with complete data at T1 and T2 (primary time point) providing 80% power to detect a 5-point between-group difference in primary outcome changes (RAID) using a t-test assuming (conservative) SD of 6 points based on previous CBT study in dementia using RAID [33], and a two-sided 5% significance level. Anticipating 30% attrition based on maximum attrition rates observed in prior studies, the study aims to enrol 70 people. Care partners will also be included where possible; however, people living with MCI or dementia may participate without a care partner.", "id": 1573, "split": "test"} +{"trial_id": "NCT05530382", "pmid": "37666557", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing Self-guided Learning (Video and hands-on Simulation) With Traditional Instructor-led Learning for Medical Device Training: a Randomized-controlled Trial\n\nIncluded conditions:\n- Professional Role\n- Interprofessional Education\n- Simulation Training\n- Learning Problem\n\nStudy Armgroups:\n- {'label': 'self-guided learning (video and hands-on simulation)', 'type': 'EXPERIMENTAL', 'description': 'video-based self-directed learning', 'interventionNames': ['Other: self-guided learning']}\n- {'label': 'traditional instructor-led learning', 'type': 'NO_INTERVENTION', 'description': 'traditional instructor-led learning in face-to-face workshop'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'self-guided learning', 'description': 'video-based self-directed learning for medical device training', 'armGroupLabels': ['self-guided learning (video and hands-on simulation)']}\n\nPrimary Outcomes:\n- {'measure': 'Application skills achieved in the context of an objective structured clinical examination (OSCE) test station per participant (yes or no)', 'description': 'Achieved or not achieved based on defined practical assignments and oral questioning using a defined catalogue of questions. The testing is carried out by an expert trained as a key user. The test is rated as successful if 60% or more of the questions are answered successfully.\\n\\nThe following four criteria are checked:\\n\\n* Working principle\\n* Security aspect\\n* Handling and operation\\n* Theory-practice transfer\\n\\nEach criterion is assessed with 0-3 points 0 = does not apply\\n\\n1. = rather does not apply\\n2. = applies\\n3. = applies very well\\n\\nThe final evaluation of the device test is based on the following granulated scale:\\n\\nA - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F \\\\<60% (unsatisfactory)', 'timeFrame': '10 minutes'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 80%, and consideration of personnel fluctuation and dropout replacement", "answer": 224, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Assuming a significance level of \u00ce\u00b1=0.05, a final-exam success rate (\u00e2\u0080\u0098passed\u00e2\u0080\u0099) in both groups (ie, traditional instructor-led learning and self-directed learning) of 90% and a non-inferiority margin of \u00e2\u0088\u0086=10%, a sample size of 224 participants was calculated as necessary to establish the non-inferiority of the self-directed learning with an integrated learning video group with a power of 80%. This sample size is similar to previous studies.14\u00e2\u0080\u009316 Due to high levels of personnel fluctuation in the department, block randomisation was performed in two stages. First, all clinical staff members able to participate in the study (n=260) were randomised. Then, to ensure block size consistency, new employees replaced the previously randomised drop-outs with the same profession to maintain an appropriate sample size. Due to organisational issues, the teachers were recruited after their initial randomisation and thus were excluded.", "id": 1574, "split": "test"} +{"trial_id": "NCT05534243", "pmid": "38001507", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Awareness with Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial\n\nIncluded conditions:\n- Awareness\n- Mechanical Ventilation\n- Intubation Complication\n- PTSD\n\nStudy Armgroups:\n- {'label': 'Before group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Mechanically ventilated emergency department patients receiving standard neuromuscular blockers prior to an educational initiative on the importance of ED-based targeted shorter acting neuromuscular blocker.', 'interventionNames': ['Other: Standard neuromuscular blocker practices']}\n- {'label': 'After group', 'type': 'EXPERIMENTAL', 'description': 'Mechanically ventilated emergency department patients receiving neuromuscular blockers after an educational initiative aimed at improving use of shorter acting neuromuscular blocker practices in the ED.', 'interventionNames': ['Behavioral: Education']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard neuromuscular blocker practices', 'description': 'Usual care neuromuscular blocker in the ED', 'armGroupLabels': ['Before group']}\n- {'type': 'BEHAVIORAL', 'name': 'Education', 'description': \"Nurses and physicians will be engaged regarding the clinical outcome data on the importance of shorter acting neuromuscular blockers, and the objectives of the research. Education will include in-services and lectures focused on the importance of neuromuscular blocker protocols on patient outcome. The use of neuromuscular blokers will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based neuromuscular blocker protocols.\", 'armGroupLabels': ['After group']}\n\nPrimary Outcomes:\n- {'measure': 'The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.', 'description': 'The modified Brice questionnaire will be used in this trial.', 'timeFrame': 'up to 30 days'}\n\nPlease estimate the sample size based on the assumption: \nIntraclass correlation coefficient (ICC) of 0.001, significance level (\u03b1) of 0.05, power of 80%, and accounting for possible non-adherence and missing data.", "answer": 3090, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Our sample size is designed to detect a difference in the proportion of patients experiencing AWP in the control versus the intervention phase. The sample size must be inflated by estimating the design effect, to account for the intraclass correlation coefficient (ICC). More common outcomes are associated with higher design effects, whereas lower prevalence outcomes, such as AWP, have smaller ICCs [94]. Based on our data, and extensive supporting analyses from more than 100 ICC values obtained from research studies and population health outcomes analyses (n\u00e2\u0080\u0089>\u00e2\u0080\u00891,000,000 patients) which show a strong linear association between the ICC and outcome prevalence in clustered binary data, we conservatively estimate an ICC of 0.001 [94]. From our preliminary multicenter data, due to a reduction in rocuronium use, it is reasonable to estimate a reduction in the proportion of patients experiencing AWP from 4.0% in the control phase to 0.2% in the intervention phase (data from the operating room), which would require a total sample size of 1650 patients [95]. To err on the side of conservative assumptions, and to account for possible non-adherence during the study, we will assume a prevalence of AWP of 3.3% in the control phase and 0.6% in the intervention phase. These conservative estimates are based on our prior work (control phase), and the intervention phase event rate is similar to that seen in operating room patients managed with total intravenous anesthesia and when longer-acting NMB is limited [10, 19, 96]. Thus, these calculations are both clinically important (would prevent\u00e2\u0080\u0089~\u00e2\u0080\u008910,000 AWP cases annually in the USA) and plausible from supporting preliminary work. Considering there are 5 sites and 6 time periods, for 80% power with \u00ce\u00b1 of 0.05, we will need a total sample size 3090 patients.\n With respect to PTSD, if we estimate that PTSD occurs in 45% of those with AWP [5, 6, 9] and 20% of the rest of the cohort [25\u00e2\u0080\u009327], assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, using two-sided Z-test with pooled variance, a sample size of 1192 patients will be required for the multivariable model above. With respect to perceived threat, even if correlation between perceived threat and PTSD symptoms is smaller than our prior work (0.3) then a minimum of 412 patients is estimated to detect the mediated effect of perceived threat between clinician compassion and PTSD symptoms [38, 97, 98].", "id": 1575, "split": "test"} +{"trial_id": "NCT05534568", "pmid": "38627843", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma\n\nIncluded conditions:\n- Substance Use Disorders\n- Pregnancy Related\n- Alcohol Use Disorder (AUD)\n- Alcohol Use Complicating Pregnancy, First Trimester\n- Alcohol Use Complicating Pregnancy, Second Trimester\n- Alcohol Use Complicating Pregnancy, Third Trimester\n- Alcohol Use Complicating Pregnancy, Unspecified Trimester\n- Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium\n- Fetal Alcohol Spectrum Disorders\n- Fetal Alcohol Syndrome\n- Drug Use Disorders\n- Drug Use Complicating Pregnancy, First Trimester\n- Drug Use Complicating Pregnancy, Second Trimester\n- Drug Use Complicating Pregnancy, Third Trimester\n- Drug Use Complicating Pregnancy, Unspecified Trimester\n- Drug Use Complicating Pregnancy, Childbirth, and the Puerperium\n- Maternal Drugs Affecting Fetus\n\nStudy Armgroups:\n- {'label': 'Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'The treatment group consists of women who have used alcohol, opioids, or other drugs during pregnancy and their children. Mothers who are randomly assigned to the treatment group will receive PCAP services through the work of highly trained, closely supervised case managers.', 'interventionNames': ['Other: Parent-Child Assistance Program']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The control group consists of women who have used alcohol, opioids, or other drugs during pregnancy and their children. Women in the control group will be provided with a service resource list and receive services as usual, but they will not be enrolled in PCAP.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Parent-Child Assistance Program', 'description': 'Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources.', 'armGroupLabels': ['Treatment Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in using a reliable method(s) of birth control', 'description': 'The mother is on a reliable method(s) of birth control.', 'timeFrame': 'Measured every six months up to 4 years'}\n- {'measure': 'Change in abstinence', 'description': 'The mother is abstinent from alcohol and drugs for at least six months.', 'timeFrame': 'Measured every six months up to 4 years'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of .05, power of .80, and a dropout rate of 33%", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n The sample size of 200 participants will provide power of .80 to detect at least small-to-medium effects (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u0089.40) using two-tailed, between-groups, planned comparisons with an error probability of .05, reflecting the ceiling of statistical power. Given the nature of SUDs and their potential impact on the stability of participants\u00e2\u0080\u0099 lives, we conservatively estimate that 33% will attrit from the study before the primary endpoint of 36\u00c2\u00a0months. This is more conservative than what has been observed in Washington State, where 72% of participants who enrolled in PCAP remained in the program for 36\u00c2\u00a0months. A sample size of 132 participants will provide power of .80 to detect at least medium effects (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u0089.50), reflecting the anticipated floor of statistical power.", "id": 1576, "split": "test"} +{"trial_id": "NCT05535400", "pmid": "36940214", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Physical-Psychological Integrative (PPI) Intervention on Physical Inactivity, Depression and Chronic Pain for Community-Dwelling Spinal Cord Injury Survivors: a Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Spinal Cord Injuries\n- Physical Inactivity\n- Depression\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'The Physical-Psychological Integrative (PPI) intervention group', 'type': 'EXPERIMENTAL', 'description': \"The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program, followed by on-line group psychological intervention\", 'interventionNames': ['Behavioral: Physical-Psychological Integrative Intervention']}\n- {'label': 'The brief online didactic education control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.', 'interventionNames': ['Device: Brief online didactic education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical-Psychological Integrative Intervention', 'description': \"The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program. And the content of the intervention includes eight different sessions, including Session 1- Orientation and engagement, Session 2- Awareness and Acceptance; Session 3- Non-judgement; Session 4- Stay present and let go; Session 5- Our thoughts are not real \\\\& Response without reacting; Session 6- Empowerment of self-management and discuss pain management; Session 7- Seek out pleasant things and social support and Session 8- Review the intervention and end the programme.\", 'armGroupLabels': ['The Physical-Psychological Integrative (PPI) intervention group']}\n- {'type': 'DEVICE', 'name': 'Brief online didactic education', 'description': 'Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.', 'armGroupLabels': ['The brief online didactic education control group']}\n\nPrimary Outcomes:\n- {'measure': 'Leisure-time Physical Activity', 'description': \"Participants' leisure-time moderated-to-rigorous physical activity (MVPA) will be assessed by using the Fitbug Orb (Chicago, IL) which is a wearable, display, triaxial accelerometer that pairs with Bluetooth with compatible smartphones.\", 'timeFrame': 'Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.'}\n- {'measure': 'Depression at post-test', 'description': \"The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.\", 'timeFrame': 'Depression will be assessed at post-intervention, an average of two months.'}\n- {'measure': 'Depression at three months follow-up', 'description': \"The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.\", 'timeFrame': 'Depression will be assessed after three months follow-up.'}\n- {'measure': 'Chronic pain at post test', 'description': 'An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain.', 'timeFrame': 'Chronic pain will be assessed at post-intervention, an average of two months.'}\n- {'measure': 'Chronic pain at three months follow-up', 'description': 'An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain.', 'timeFrame': 'Chronic pain will be assessed after three months follow-up.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided 5% significance level, and a 20% attrition rate", "answer": 72, "answer_type": "ACTUAL", "explanation": "Participants and sample size\n \n Participants\n Study participants will be recruited from the Hong Kong Direction Association for the Handicapped and other community centers in Hong Kong, where groups of people with physical impairments can be reached. Emails/phone call invitations will be sent to potential participants and advertising posters will also be used to encourage them to participate.\n People with SCI will be included if they are: (1) at least 18 years old; (2) currently living in the community and having SCI for more than 6 months; (3) complete injury at the C6 or below or incomplete injury at any level; (4) having a computer/smartphone with audio-speaking function and Zoom software, and internet access in a secure place; (5) using a wheelchair for at least 2 hours a day and having approval from their physicians to perform exercises; and (7) able to communicate in Cantonese and to provide informed consent.\n People with SCI will be excluded if they are: (1) presenting with any significant cognitive impairment or brain injury; (2) having problems in hearing, verbal communication and vision; (3) engaged in ongoing psychotherapy or any other physiotherapy/exercise/relaxation interventions; (4) physically active for more than 150 minutes per week; and (5) experiencing significant psychotic symptoms, substance misuse or medically unfit for the exercise and psychological programme as diagnosed by their physicians.\n \n \n Sample size\n The central limit theorem indicates a minimum sample of 30\u00e2\u0080\u009340 that is sufficient to estimate the mean (M), standard deviations (SD), and 95% Confidence Intervals [35]. As this proposed study is to develop and evaluate the feasibility, acceptability, and preliminary effectiveness of the PPI intervention, a widely acceptable sample size for a preliminary analysis will be adopted to examine intervention feasibility and to estimate a between-group effect (i.e., 30 participants in each study group for a small standardized effect size of 0.25 with 80% power and two-sided 5% significance) [36]. Considering a potential 20% attrition rate, 36 people with SCI per study group (i.e., 72 people in total) will be recruited. A purposive sampling by key informants (containing both participants who completed all the intervention sessions and those who withdrew from the intervention) will be conducted for focus-group interviews (i.e., 4\u00e2\u0080\u00935 participants per group), until saturation of the information was reached as no relevant new codes will be found in data [37].", "id": 1577, "split": "test"} +{"trial_id": "NCT05535400", "pmid": "36940214", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Physical-Psychological Integrative (PPI) Intervention on Physical Inactivity, Depression and Chronic Pain for Community-Dwelling Spinal Cord Injury Survivors: a Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Spinal Cord Injuries\n- Physical Inactivity\n- Depression\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'The Physical-Psychological Integrative (PPI) intervention group', 'type': 'EXPERIMENTAL', 'description': \"The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program, followed by on-line group psychological intervention\", 'interventionNames': ['Behavioral: Physical-Psychological Integrative Intervention']}\n- {'label': 'The brief online didactic education control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.', 'interventionNames': ['Device: Brief online didactic education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical-Psychological Integrative Intervention', 'description': \"The PPI intervention will include eight weekly online group sessions (with each session lasts for 60-90 minutes). At the beginning of each online group meeting, the intervention provider will use motivational interviewing techniques to promote participants' adherence to the physical activity program. And the content of the intervention includes eight different sessions, including Session 1- Orientation and engagement, Session 2- Awareness and Acceptance; Session 3- Non-judgement; Session 4- Stay present and let go; Session 5- Our thoughts are not real \\\\& Response without reacting; Session 6- Empowerment of self-management and discuss pain management; Session 7- Seek out pleasant things and social support and Session 8- Review the intervention and end the programme.\", 'armGroupLabels': ['The Physical-Psychological Integrative (PPI) intervention group']}\n- {'type': 'DEVICE', 'name': 'Brief online didactic education', 'description': 'Participants in the control group will receive a short video call (approximately 20 minutes each week for eight weeks) from the trained research assistant, i.e., RA 2 to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.', 'armGroupLabels': ['The brief online didactic education control group']}\n\nPrimary Outcomes:\n- {'measure': 'Leisure-time Physical Activity', 'description': \"Participants' leisure-time moderated-to-rigorous physical activity (MVPA) will be assessed by using the Fitbug Orb (Chicago, IL) which is a wearable, display, triaxial accelerometer that pairs with Bluetooth with compatible smartphones.\", 'timeFrame': 'Leisure-time Physical Activity will be assessed throughout the study period, an average of two months.'}\n- {'measure': 'Depression at post-test', 'description': \"The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.\", 'timeFrame': 'Depression will be assessed at post-intervention, an average of two months.'}\n- {'measure': 'Depression at three months follow-up', 'description': \"The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure the participants' depression level.\", 'timeFrame': 'Depression will be assessed after three months follow-up.'}\n- {'measure': 'Chronic pain at post test', 'description': 'An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain.', 'timeFrame': 'Chronic pain will be assessed at post-intervention, an average of two months.'}\n- {'measure': 'Chronic pain at three months follow-up', 'description': 'An 11-point numerical pain rating scale (NPRS) will be used to measure pain intensity and pain unpleasantness (in the past week), where zero means no pain and 10 means the worst imaginable pain.', 'timeFrame': 'Chronic pain will be assessed after three months follow-up.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided 5% significance level, and a 20% attrition rate", "answer": 72, "answer_type": "ACTUAL", "explanation": "Sample size\n The central limit theorem indicates a minimum sample of 30\u00e2\u0080\u009340 that is sufficient to estimate the mean (M), standard deviations (SD), and 95% Confidence Intervals [35]. As this proposed study is to develop and evaluate the feasibility, acceptability, and preliminary effectiveness of the PPI intervention, a widely acceptable sample size for a preliminary analysis will be adopted to examine intervention feasibility and to estimate a between-group effect (i.e., 30 participants in each study group for a small standardized effect size of 0.25 with 80% power and two-sided 5% significance) [36]. Considering a potential 20% attrition rate, 36 people with SCI per study group (i.e., 72 people in total) will be recruited. A purposive sampling by key informants (containing both participants who completed all the intervention sessions and those who withdrew from the intervention) will be conducted for focus-group interviews (i.e., 4\u00e2\u0080\u00935 participants per group), until saturation of the information was reached as no relevant new codes will be found in data [37].", "id": 1578, "split": "test"} +{"trial_id": "NCT05537389", "pmid": "38971756", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Central Lines Filtration in Newborns: a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Newborn Complication\n- Catheter Complications\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Patients with central venous access (central umbilical venous catheter or epicutaneous cava catheter)'}\n- {'label': 'Filter', 'type': 'EXPERIMENTAL', 'description': 'Patients with central venous access and in-line filters (central umbilical venous catheter or epicutaneous cava catheter)', 'interventionNames': ['Device: In-line filter']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'In-line filter', 'description': 'All infusions, with the exception of some solutions (eg blood products), will be subjected to filtration. The aqueous solutions (parenteral therapy and drugs) will be administered through 0.2 \u03bcm filters which will be replaced every 96 h; the lipid emulsions will be administered through 1.2 \u03bcm filters which will be replaced every 24 h.\\n\\nIn case of emergency, life-saving drugs will be administered with bolus modality though the infusion line closer to the patient without the need for filtration.\\n\\nIn case of drugs/solutions not supported by filtration (eg blood products), they will be administered through a dedicated unfiltered access, which will be removed as soon as the drug is no longer needed.', 'armGroupLabels': ['Filter']}\n\nPrimary Outcomes:\n- {'measure': 'Frequency of patients with at least one inflammatory episode sepsis-like.', 'description': 'Frequency of patients with at least one inflammatory episode sepsis-like, defined by alteration of the biomarkers of inflammation in a negative-culture contest.', 'timeFrame': 'From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, power of 0.80, 1:1 group allocation, and a 5% dropout rate.", "answer": 736, "answer_type": "ESTIMATED", "explanation": "Sample size\n The baseline risk of inflammatory states in the target population remains undetermined. However, we hypothesize a range between 30 and 35%. Consequently, a median risk of 32.5% was assumed for the control group. With the application of filters, a plausible 30% risk reduction is anticipated, resulting in an estimated risk of 22.75% in the intervention arm. Utilizing Fisher\u00e2\u0080\u0099s exact test to compare two independent proportions, with an alpha of 0.05, a power of 0.80, and a 1:1 group allocation, the calculated minimum sample size required for significance is 349 infants for each arm, leading to a total of N\u00e2\u0080\u0089=\u00e2\u0080\u0089698 infants. Accounting for an estimated 5% dropout rate during follow-up, the adjusted minimum sample size becomes N\u00e2\u0080\u0089=\u00e2\u0080\u0089736 infants.", "id": 1579, "split": "test"} +{"trial_id": "NCT05538689", "pmid": "38954680", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial.\n\nIncluded conditions:\n- Metrorrhagia\n- Pelvic Pain\n- Menorrhagia\n- Leiomyoma\n\nStudy Armgroups:\n- {'label': 'Study drug Myfembree', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to take a once-daily tablet of Myfembree ( relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for 24 months.', 'interventionNames': ['Drug: Myfembree Oral Product']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': \"The standard of care will depend on the participant's type of surgery, health history, and clinical symptoms. It often includes pain management, bleeding management, physical exams, pelvic ultrasound, birth control, and Surgical reintervention.\"}\n- {'label': 'Parallel group for participants who opt not to be randomized', 'type': 'OTHER', 'description': 'patients who do not consent to randomization or opt to be in a specific group will be included in a parallel observational study and be administered their preferred treatment.', 'interventionNames': ['Drug: Myfembree Oral Product']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Myfembree Oral Product', 'description': 'The study drug Myfembree will be taken orally with water, once daily, at approximately the same time, with or without food. Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg.', 'armGroupLabels': ['Parallel group for participants who opt not to be randomized', 'Study drug Myfembree']}\n\nPrimary Outcomes:\n- {'measure': 'Fibroid recurrence on ultrasound after myomectomy.', 'description': 'Fibroid recurrence when compared to the post-myomectomy baseline pelvic ultrasound (transvaginal and/or transabdominal), defined as a new fibroid identified on ultrasound with a volume \\\\>1 cm3.', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nA Chi-square test will be used to compare the rate of occurrence of the primary endpoint in the two treatment arms. The sample size calculation assumes 80% power to detect the difference at a two-sided alpha level of 0.05. A 30% dropout rate is also assumed.", "answer": 136, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Data analysis and statistical support is obtained through the Biostatistics Laboratory (located within the Department of Public Health Sciences) at the University of Chicago. The primary endpoint of this study will be a composite endpoint defined as the occurrence of any of the following three component endpoints over a 24 month follow up period.\n Endpoint 1 (Fibroid Recurrence)\n Endpoint 2 (Symptom Recurrence)\n Endpoint 3 (Need for Re-intervention)\n A Chi-square test will be used to compare the rate of occurrence of the primary endpoint in the two treatment arms.\n Assumptions regarding the frequency of endpoint 1 are based on ref [8]. That study observed 23% recurrences in the abdominal group and 27% in the laparoscopic group over 40 months. 84% of these recurrences were seen within 24 months. Therefore, we assume the recurrence rate among patients with laparoscopic or abdominal surgery over 24-month follow-up time in the control arm will be (23%+27%)/2*0.84 = 21%. We assume a recurrence rate of 5% in the treatment group (i.e., effect size of 16% absolute reduction). For endpoint 2, a symptom recurrence rate of 7.6% in the control group [16], and 1.5% in the treatment group are assumed. For endpoint 3, a reintervention rate of 14.4% [16] in the control group and 3% in the treatment group are assumed. Assuming endpoint 1 is independent of endpoints 2 and 3, and a correlation of 0.5 between the endpoints 2 and 3, leads to a rate of 33.8% for our primary composite endpoint in the control arm vs. 8.25% in the treatment group. A sample size of 94 patients (47 per arm) will provide 80% power to detect a difference of this magnitude at a two-sided alpha level of 0.05 (PASS, Kaysville, Utah) utilizing the chi-square test as the statistical testing method. To allow for a 30% dropout rate, the sample size will be increased to 136 patients. It is expected that the 136 patients will be accrued during the first year of the trial (10\u00e2\u0080\u009312 per month) with two years of follow-up after the last patient is enrolled. The number needed to treat (NNT) will be calculated as the reciprocal of the difference in observed event rates along with a 95% confidence interval. While the sample size has been increased to allow for a 30% dropout rate, every effort will be made to retain subjects in the trial and to obtain outcome data. Sensitivity analyses will be performed to examine the effects of dropouts on the results.\n As secondary endpoints, we will analyze the three components of the primary endpoint (recurrence, symptoms, and re-intervention) separately using Chi-square or Fisher\u00e2\u0080\u0099s exact tests. Adverse event (AE) rates will be summarized by type, grade, and attribution and monitored periodically by the investigative team and compared between groups using Chi-square or Fisher\u00e2\u0080\u0099s exact tests. All categorical data will be summarized as frequencies and percentages. Pain scores and quality of life (QOL) measures over time will be summarized as means and standard deviations or medians and interquartile ranges depending on the shape of the distribution. Comparisons between groups will be performed using mixed effects models for longitudinal data [14]. Empirical semi-variograms will be constructed to assess the underlying covariance structure together with information criteria (AIC). If a suitable parametric form (for example, AR(1)) cannot be identified we will utilize an unstructured variance-covariance structure. Finally, Kaplan-Meier curves will be generated for time-to-event outcomes; logrank tests will be performed for group comparisons. REDCap will be used for data capture and data management while SAS (Raleigh, NC) and STATA (College Station, TX) will be the principal software employed for data analysis.", "id": 1580, "split": "test"} +{"trial_id": "NCT05540067", "pmid": "37146874", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic\n\nIncluded conditions:\n- Anxiety\n- Depression\n\nStudy Armgroups:\n- {'label': 'Acceptance-Based Behavior Therapy (ABBT)', 'type': 'EXPERIMENTAL', 'description': 'The 2-session ABBT will be delivered remotely or in-person, depending on preference.', 'interventionNames': ['Behavioral: Acceptance-Based Behavior Therapy (ABBT)']}\n- {'label': 'Treatment-as-Usual (TAU)', 'type': 'OTHER', 'description': 'Control participants will receive the currently recommended best practices of care at the recruitment site.', 'interventionNames': ['Other: Treatment-as-Usual (TAU)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Acceptance-Based Behavior Therapy (ABBT)', 'description': 'In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified challenges related to the COVID-19 pandemic, mental health, and social support. Interventionists will help participants identify potential challenges to acceptance. At the second session, participants will practice acceptance-based coping skills and a social support behavioral plan will be developed. These discussions will help the participant clarify how best to align their values with decisions on how to manage their mental health and social support in the context of the COVID-19 pandemic.', 'armGroupLabels': ['Acceptance-Based Behavior Therapy (ABBT)']}\n- {'type': 'OTHER', 'name': 'Treatment-as-Usual (TAU)', 'description': 'TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.', 'armGroupLabels': ['Treatment-as-Usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Hamilton Anxiety Rating Scale (HAM-A)', 'description': 'The interviewer-rated HAM-A is a measure of anxiety symptom severity.', 'timeFrame': '39 weeks'}\n- {'measure': 'Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)', 'description': 'The interviewer-rated QIDS-C is a measure of depressive symptom severity.', 'timeFrame': '39 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered (>80%) to detect small effects in the treatment by time interaction. An attrition rate of 10-15% is anticipated, leaving about 210 study completers. With 210 participants, the study is powered to detect effects as low as f = 0.08, corresponding to Cohen's d = 0.16.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "2.3\n Participants and sample size\n Based on reported efficacy of acceptance-based treatments for anxiety and depression in a large systematic review and meta-analysis [20], the feasibility of recruitment at our site, as well as statistical power considerations, we plan to enroll a sample of 240 participants. \u00c3\u0096st [20] reports meta-analytic effect size estimates for ABBT relative to TAU in the medium range (i.e., Hedge's g\u00c2\u00a0=\u00c2\u00a00.55 for posttreatment effects and g\u00c2\u00a0=\u00c2\u00a00.48 for follow-up effects). Based on power calculations for a repeated measures analysis of variance, we are well powered (>80%) to detect small effects in the treatment by time interaction across a range of samples sizes. We anticipate a 10\u00e2\u0080\u009315% attrition rate, leaving us with about 210 study completers. With a final sample of 210, we are powered to detect effects as low as f\u00c2\u00a0=\u00c2\u00a00.08, which corresponds to a Cohen's d\u00c2\u00a0=\u00c2\u00a00.16, far below those observed in prior meta-analyses.\n To increase external validity, we set a minimal inclusion threshold of \u00e2\u0080\u009cmild\u00e2\u0080\u009d anxiety and/or depressive symptoms to capture individuals who would likely benefit from our intervention. Inclusion criteria are: (a) receive services at the recruitment site; (b) identify as LGBTQ+; (c) self-reported\u00c2\u00a0\u00e2\u0089\u00a5\u00c2\u00a0mild anxiety and/or depressive symptoms, based on the Generalized Anxiety Disorder-7 (GAD-7 [28];) and/or the Patient Health Questionnaire-9 (PHQ-9 [29];); (d) 18\u00c2\u00a0years or older; (e) ability to speak and read English; and, (f) have telephone access. This study does not have any exclusion criteria, beyond not meeting the above criteria. Although receipt of external mental health treatment (e.g., outpatient psychotherapy) could impact effects, we decided to measure external treatment without making it an exclusion criterion; however, we will account for it in analyses. Because our brief ABBT is not a traditional mental health intervention, we suggest that it can be complementary to other treatment approaches.", "id": 1581, "split": "test"} +{"trial_id": "NCT05541601", "pmid": "39353693", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective Cohort for Early Detection of Liver Cancer\n\nIncluded conditions:\n- Cirrhosis\n- Hepatocellular Carcinoma\n\nStudy Armgroups:\n- {'label': 'Pearl Cohort', 'description': 'All 3000 patients recruited to the Pearl study', 'interventionNames': ['Other: Blood and Urine samples']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Blood and Urine samples', 'description': 'The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.', 'armGroupLabels': ['Pearl Cohort']}\n\nPrimary Outcomes:\n- {'measure': 'Sensitivity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches.', 'description': 'Diagnostic approaches to be tested will include:\\n\\n1. detection of epigenetic (e.g. methylation profiling) and genetic mutations, and copy number variations in circulating tumour DNA;\\n2. multiparametric MRI liver imaging including MR biomarkers of inflammation, fibrosis, fat and iron content;\\n3. host genetic makeup (relevant variants identified through Genome Wide Association Studies);\\n4. detection of autoantibodies to tumour associated antigens;\\n5. epitope mapping of circulating antibody repertoire using random peptide libraries;\\n6. protein biomarkers including the L3 isoform of alphafetoprotein, and des-gammacarboxy- prothrombin;\\n7. proteomic and metabolomic profiling, including steroid metabolic signatures in urine.', 'timeFrame': 'When 50 cases of HCC have accumulated through to study completion; up to 5 years'}\n- {'measure': 'Specificity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches.', 'description': 'Diagnostic approaches to be tested will include:\\n\\n1. detection of epigenetic (e.g. methylation profiling) and genetic mutations, and copy number variations in circulating tumour DNA;\\n2. multiparametric MRI liver imaging including MR biomarkers of inflammation, fibrosis, fat and iron content;\\n3. host genetic makeup (relevant variants identified through Genome Wide Association Studies);\\n4. detection of autoantibodies to tumour associated antigens;\\n5. epitope mapping of circulating antibody repertoire using random peptide libraries;\\n6. protein biomarkers including the L3 isoform of alphafetoprotein, and des-gammacarboxy- prothrombin;\\n7. proteomic and metabolomic profiling, including steroid metabolic signatures in urine.', 'timeFrame': 'When 50 cases of HCC have accumulated through to study completion; up to 5 years'}\n- {'measure': 'Positive/Negative predictive values of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches.', 'description': 'Diagnostic approaches to be tested will include:\\n\\n1. detection of epigenetic (e.g. methylation profiling) and genetic mutations, and copy number variations in circulating tumour DNA;\\n2. multiparametric MRI liver imaging including MR biomarkers of inflammation, fibrosis, fat and iron content;\\n3. host genetic makeup (relevant variants identified through Genome Wide Association Studies);\\n4. detection of autoantibodies to tumour associated antigens;\\n5. epitope mapping of circulating antibody repertoire using random peptide libraries;\\n6. protein biomarkers including the L3 isoform of alphafetoprotein, and des-gammacarboxy- prothrombin;\\n7. proteomic and metabolomic profiling, including steroid metabolic signatures in urine.', 'timeFrame': 'When 50 cases of HCC have accumulated through to study completion; up to 5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 10% drop-out rate, leaving a final cohort size of 2700 patients. The rule-of-thumb of 10 events per variable is used to estimate the number of prediction parameters. All-cause mortality is estimated at 5% per year.", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study will aim to recruit 3000 patients with cirrhosis over 30 months of specified aetiologies. There is an expected ~10% drop-out rate, leaving a final cohort size of 2700. There are currently more than 60\u00e2\u0080\u0089000 people living with cirrhosis9 and many of the recruiting centres have several hundred patients under annual surveillance. The study has received 23 letters of support from these centres which demonstrate the national interest in this study and demonstrate that the recruitment target is realistic. It is anticipated that this cohort will yield ~90\u00e2\u0080\u0093180 incident HCC cases over, for example, a 5-year time frame, depending on the HCC incidence rate observed (figure 4). Based on the rule-of-thumb of 10 events per variable, this would provide scope to include ~10\u00e2\u0080\u009320 prediction parameters in our model, for this time horizon. Many of the parameters to be evaluated as part of the model will be selected depending on data generated from exploratory laboratory assays. The study has been adopted onto the NIHR CRN portfolio facilitating national recruitment.\n \n Figure 4\n \n Number of patients expected to develop HCC in the Pearl cohort, according to time since enrolment and HCC incidence rate (N.B. These estimates assume an overall sample size of 3000 patients with 10% attrition. All-cause mortality is estimated at 5% per year). HCC, hepatocellular carcinoma.", "id": 1582, "split": "test"} +{"trial_id": "NCT05543239", "pmid": "37730386", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancers: A Multi-center, Randomized, Double-Blind, Sham-Controlled Trial\n\nIncluded conditions:\n- Neuropathic Pain\n- Radiotherapy Side Effect\n\nStudy Armgroups:\n- {'label': 'TaVNS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive TaVNS stimulation for 30 minutes, twice a day (between 9:00 to 10:00 and 15:00 to 16:00), for 7 consecutive days. Stimulation pulses (30 Hz frequency, 300 \u03bcs pulse width) were generated by a commercial transcutaneous auricular vagus nerve stimulation unit (tVNS 501\uff0cJiangsu, China), and the amplitude was increased to the maximum amount tolerated by the subject without pain, then stimulate for 30 min. All subjects were told that they may or may not feel any sensation from the stimulation, and the unit is packed in an opaque bag throughout the treatment.', 'interventionNames': ['Device: Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)']}\n- {'label': 'Sham TaVNS', 'type': 'SHAM_COMPARATOR', 'description': 'Patients will receive sham TaVNS stimulation for 30 minutes, twice a day (between 9:00 to 10:00 and 15:00 to 16:00), for 7 consecutive days. Stimulation unit was active for the first 30s, stimulation pulses (30 Hz frequency, 300 \u03bcs pulse width) were generated by a commercial transcutaneous auricular vagus nerve stimulation unit (tVNS 501\uff0cJiangsu, China).Then dropped to zero stimulation during 15s and shut down. All subjects were told that they may or may not feel any sensation from the stimulation, and the unit is packed in an opaque bag throughout the treatment.', 'interventionNames': ['Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)', 'description': 'Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) works by stimulating the auricular branches of the vagus nerve (mainly distributed in the concha cavity and conchae) through electrical impulses.Electrodes were placed on the concha of the left ear after cleaning the skin of the concha with a small disposable alcohol pad. Stimulation pulses (frequency 30 Hz, pulse width 300 us) were generated by TaVNS device, the amplitude was increased within 30 seconds to the subject produced a tingling sensation, and then descend within 15 seconds to the maximum tolerable amount without pain. Inform the subject that \"target stimulus has been reached\", then stimulate for 30 minutes.', 'armGroupLabels': ['TaVNS']}\n- {'type': 'DEVICE', 'name': 'Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)', 'description': 'Place electrodes on the concha of the left ear after cleaning the skin of the concha with a small disposable alcohol pad. The same stimulation pulses (30 Hz frequency, 300 us pulse width) were generated by the same device, the amplitude was increased within 30 seconds to the subject produced a tingling sensation, and then ramps down to zero stimulus over 15 seconds. The subjects were told that \"the target stimulus has been reached\". Patients receive sham stimulation for 30minutes.', 'armGroupLabels': ['Sham TaVNS']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline to day 7 with respect to pain intensity based on the NRS.', 'description': 'The primary outcome of this trial is to evaluate the change from baseline to Day 7 with respect to pain intensity based on the NRS, which evaluates the average pain in the last 24 hours from \"0\" indicating \"No Pain\" to \"10\" indicating \"Pain as bad as you can imagine\".', 'timeFrame': 'Day 7'}\n\nPlease estimate the sample size based on the assumption: \n90% power, one-sided type I error rate of 2.5%, 10% dropout rate", "answer": 116, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation was based on the primary outcome: the change of score in pain at day 7 assessed by an 11-point NRS. According to our preliminary study of taVNS for RRNP and the previous trial12 of pregabalin for the treatment of RRNP in patients with head and neck cancers, 52 participants per group will be recruited to have 90% power to detect a between-group difference of 0.9 in the change of score in pain, SD of 1.4 and a one-sided type I error rate of 2.5%. Taking into account an estimated 10% dropout rate, this trial plans to include 116 participants, with 58 participants in each group.", "id": 1583, "split": "test"} +{"trial_id": "NCT05544201", "pmid": "37540692", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Gamma-band High-definition Transcranial Alternating Current Stimulation (HD-tACS) for Sleep Disturbances in Mild Neurocognitive Disorders Due to Alzheimer's Disease\n\nIncluded conditions:\n- Brain Stimulation\n- Alzheimer Disease\n- tACS\n- Sleep Disturbance\n- Aging\n- Cognitive Impairment, Mild\n\nStudy Armgroups:\n- {'label': '40 Hz HD-tACS', 'type': 'EXPERIMENTAL', 'description': 'The stimulation parameters of HD-tACS include: 20 minutes at 40 Hz, 2 milliamps.', 'interventionNames': ['Device: High-definition transcranial current stimulation']}\n- {'label': 'HD-tDCS', 'type': 'ACTIVE_COMPARATOR', 'description': 'The stimulation parameters of HD-tDCS include: 20 minutes at 2 milliamps, 20 seconds fade-in and 20 seconds fade-out.', 'interventionNames': ['Device: High-definition transcranial current stimulation']}\n- {'label': 'Sham HD-tCS', 'type': 'SHAM_COMPARATOR', 'description': 'In sham condition, the stimulation only last for 30 seconds with the electrodes left in place for a further 20 minutes. This procedure mimics the transient skin sensation of tingling induced by active HD-tACS and HD-tDCS without producing any sustainable effects.', 'interventionNames': ['Device: High-definition transcranial current stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'High-definition transcranial current stimulation', 'description': 'High-definition transcranial current stimulation (HD-tCS) is delivered by a battery driven direct current stimulator (DC-Stimulator Plus, NeuroConn, Ilmenau, Germany) through a central anodal electrode surrounded by four return cathodal electrodes.', 'armGroupLabels': ['40 Hz HD-tACS', 'HD-tDCS', 'Sham HD-tCS']}\n\nPrimary Outcomes:\n- {'measure': 'Pittsburg Sleep Quality Index (PSQI)', 'description': \"The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction (Buysse et al., 1988). Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%)(Buysse et al., 1988). Greater score of PSQI indicates worse sleep quality.\", 'timeFrame': '24 weeks'}\n- {'measure': 'Delayed recall of words', 'description': 'Word-list learning test (WLLT), consisting of sixteen semantically non-associated words, is presented consecutively over three free trials of immediate recall, a 20-min delayed recall (to prevent recency effects) (Lu et al., 2018). The raw numbers of words recalled are used to assess the memory function.', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nConfidence level is set at 0.95, desired power (1-\u03b2) is 0.8, and an estimated dropout rate of 15%.", "answer": 99, "answer_type": "ACTUAL", "explanation": "Sample size and power analysis\n Until up to date no RCTs have been conducted in mild NCD-AD with sleep disturbances, therefore our calculation will be based on published data in similar population and our unpublished clinical data. Stemming from our aims, measurements would be evaluated comparing the total score of Pittsburgh Sleep Quality Index (PSQI) across time and intervention groups. The potential effect size of enhanced subjective sleep quality of tDCS is estimated from out previous findings of tDCS intervention conducted in mild neurocognitive disorder patients [25]. After 12 weeks, a 4-week course tDCS intervention demonstrated significant positive effects on the mean PSQI total score (5.364\u00c2\u00b11.5) than the other two groups (5.625\u00c2\u00b11.13; 6.2\u00c2\u00b11.3) (S1 Appendix).\n Sample size is estimated using G*POWER (https://stats.idre.ucla.edu/other/gpower/). We set the confidence level as 0.95 and the desired power (1-\u00ce\u00b2) as 0.8. Based on the proposed statistical analysis of the fixed effects of interventions on the mean PSQI total score, 28 participants in each group will be required to achieve a power of 0.8 in detecting enhancement with intervention. Accounting for an estimating of dropout rate of 15%, 33 participants for each group, a total of 99 participants, will be recruited to detect the significant treatment difference in this study.", "id": 1584, "split": "test"} +{"trial_id": "NCT05545787", "pmid": "37217262", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Randomized, Non-inferiority Study to Compare Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection and Hot Snare Endoscopic Mucosal Resection in Treatment for 10-19 mm Non-pedunculated Colorectal Polyps\n\nIncluded conditions:\n- Colorectal Polyp\n\nStudy Armgroups:\n- {'label': 'Cold snare endoscopic mucosal resection (CS-EMR)', 'type': 'EXPERIMENTAL', 'description': 'Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR', 'interventionNames': ['Procedure: Cold snare endoscopic mucosal resection']}\n- {'label': 'Hot snare endoscopic mucosal resection (HS-EMR)', 'type': 'EXPERIMENTAL', 'description': 'Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR', 'interventionNames': ['Procedure: Hot snare endoscopic mucosal resection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Cold snare endoscopic mucosal resection', 'description': 'During CS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The polyp and 1-2mm of surrounding mucosa will then be closely snared and transected mechanically.', 'armGroupLabels': ['Cold snare endoscopic mucosal resection (CS-EMR)']}\n- {'type': 'PROCEDURE', 'name': 'Hot snare endoscopic mucosal resection', 'description': 'During HS-EMR, methylene blue-tinted epinephrine saline will be injected into the submucosal space around the lesion to lift the lesion. The snare will be placed around the lesion, and then cautery will be applied using the electrosurgical generator.', 'armGroupLabels': ['Hot snare endoscopic mucosal resection (HS-EMR)']}\n\nPrimary Outcomes:\n- {'measure': 'Complete resection rate', 'description': 'The resection is considered histologically complete if the lateral margins of the resected polyps are surrounded by normal tissue and the vertical margin is free of neoplasia tissue. If en-bloc resection is not achieved, 5 biopsies (4 biopsies obtained in a 4-quadrant fashion from the polypectomy site margins; 1 biopsy from the base) are applied to evaluate histological completeness of resection.', 'timeFrame': 'Within 14 days'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided \u03b1 value of 0.025, power of 80%.", "answer": 232, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to a previous study, the complete resection rate of 10\u00e2\u0080\u009319\u00e2\u0080\u0089mm sessile polyps by EMR was 92.2%.14 We hypothesise that HS-EMR of 10\u00e2\u0080\u009319\u00e2\u0080\u0089mm colorectal polyps will yield a complete resection rate of at least 92%. We assume that CS-EMR will not be inferior with a non-inferiority margin of \u00e2\u0088\u009210%. With a one-sided \u00ce\u00b1 value of 0.025 and a power of 80%, the estimated sample size is 232 polyps (116 per group).", "id": 1585, "split": "test"} +{"trial_id": "NCT05546073", "pmid": "38365595", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Advanced Use of Point-of-care Technology Versus Usual Care During In-home-assessment by Acute Community Nurses in Older Adults for Reducing Acute Hospital Admissions\n\nIncluded conditions:\n- Acute Respiratory Disease\n- Acute Illness\n\nStudy Armgroups:\n- {'label': 'Control - Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control-arm will undergo usual care. This covers clinical inspection, vital parameters (respiratory rate(breaths/min), saturation (%), blood pressure (mmHg), heart rate (beats/min), body temperature (celsius), and Glasgow Coma Scale) , and point-of-care blood-test for CRP and haemoglobin'}\n- {'label': 'Intervention - Advanced point-of-care technology', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention-arm will undergo usual care as well as advanced point-of-care technology.', 'interventionNames': ['Other: Advanced point-of-care technology']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Advanced point-of-care technology', 'description': 'The intervention consists of:\\n\\n* focused lung ultrasound scan(FLUS)\\n* venous blood samples for leucocytes with 5-part differential count, creatinin, sodium, potassium, urea', 'armGroupLabels': ['Intervention - Advanced point-of-care technology']}\n\nPrimary Outcomes:\n- {'measure': 'Admission \u2264 30-days', 'description': 'Proportion of Admissions during 30 days follow-up', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 0.80, and a 5% dropout rate.", "answer": 632, "answer_type": "ACTUAL", "explanation": "Sample size and statistical power\n A parallel group design with a 1:1 allocation ratio and a superiority design was chosen for this trial. To our knowledge, the number of patients acutely admitted after a visit from ACNs are unknown. Preliminary results from a pilot-study of the intervention (not yet published) showed that 21% of included participants were acutely admitted after a visit from ACNs. We aimed to detect a clinically significant absolute reduction in acute hospital admission of 10%. Therefore, based on data from the unpublished pilot-study, we aimed in detecting a reduction from 31 to 21% at a significance level 0.05 with a power of 0.80, requiring a total of 602 participants (301 in each arm). Allowing for a 5% dropout after randomisation, 316 in each arm are required (a total of 632 participants).", "id": 1586, "split": "test"} +{"trial_id": "NCT05547048", "pmid": "39825419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrated eHealth for HIV and Substance Use Disorders in Justice Involved Women\n\nIncluded conditions:\n- HIV\n- Opioid Use Disorder\n- eHealth\n\nStudy Armgroups:\n- {'label': 'Athena Strategy', 'type': 'EXPERIMENTAL', 'description': 'Virtual care model that includes direct synchronous videoconferencing with a provider, telephone/ texting communication, electronic health records, e-prescribing for the purposes of delivering PrEP and medications for opioid use disorder. This is combined with a decision aid for PrEP', 'interventionNames': ['Combination Product: Athena strategy']}\n- {'label': 'Decision Aid', 'type': 'ACTIVE_COMPARATOR', 'description': 'Decision aid for PrEP tailored for justice-involved women with opioid use disorder', 'interventionNames': ['Behavioral: Decision Aid']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Decision Aid', 'description': 'Decision aid for PrEP tailored for justice-involved women with opioid use disorder', 'armGroupLabels': ['Decision Aid']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Athena strategy', 'description': 'eHealth for integrated PrEP/medications for opioid use disorder + decision aid', 'armGroupLabels': ['Athena Strategy']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants who initiate PrEP', 'description': 'PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)', 'timeFrame': 'up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to achieve 90% power to detect a 20% absolute difference between the two arms. The significance level is not explicitly stated, but the sample size will be inflated by 15% to account for attrition. Plans for handling missing data include intention-to-treat and per protocol analyses, as well as multiple imputation sensitivity analyses if appropriate.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study is powered on the primary outcome, PrEP initiation. The null hypothesis (H0) is that the proportion of participants initiating PrEP in the Athena arm will be the same as in the decision aid-only arm, whereas the alternative hypothesis (H1) is that the proportion of participants initiating PrEP in the Athena arm will be higher than those in the decision aid-only arm. Based on our clinical trial of a decision aid [33], we anticipate\u00e2\u0080\u0089~\u00e2\u0080\u008920% of decision aid-only participants will achieve the primary outcome. Based on our demonstration project of eHealth for PrEP for WICL [36], we anticipate 40\u00e2\u0080\u009350% of Athena participants will achieve the primary outcome. A total sample size of 212 (106 in each group) would achieve 90% power to detect a 20% absolute difference between the two arms. The proportion in the Athena arm is assumed to be 20% under the null hypothesis and 40% under the alternative hypothesis. The proportion in the decision aid-only arm is <\u00e2\u0080\u008930%. We will inflate the sample size by 15% to account for attrition and will plan to enroll 250 participants total across 2 sites, which is highly feasible. Though we attempt to minimize missing data by having an objectively measured outcome, we have considered additional plans for missing data that include performing both intention-to-treat and per protocol analyses and performing multiple imputation sensitivity analyses if appropriate.", "id": 1587, "split": "test"} +{"trial_id": "NCT05550714", "pmid": "37253497", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION)\uff1aA Randomized Controlled, Non-Inferiority Study\n\nIncluded conditions:\n- PD - Parkinson's Disease\n- Dexmedetomidine\n- Desflurane\n- Deep Brain Stimulation\n\nStudy Armgroups:\n- {'label': 'General anesthesia', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: general anesthesia']}\n- {'label': 'Conscious sedation', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Conscious sedation']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'general anesthesia', 'description': 'The patients did not use any preoperative sedative drugs and were given sufentanil citrate 0.1-0.2 \u00b5g/kg, cisatracurium 0.2 mg/kg and propofol 1.5-2.0 mg/kg during anesthesia induction. After the patients were unconscious, oral endotracheal intubation was performed. Anesthesiologists should continuously monitor PetCO2 and maintain PetCO2 at 30-35 mmHg. During the operation, patients are treated with remifentanil, cisatracurium, and desflurane inhalation at 0.5-1.0 minimum alveolar concentration (MAC). In the MER process, the desflurane concentration is adjusted to maintain 0.5-0.6 MAC. If the desflurane concentration needs to be adjusted to less than 0.5 MAC during MER for various reasons, remedial measures will be implemented.', 'armGroupLabels': ['General anesthesia']}\n- {'type': 'DRUG', 'name': 'Conscious sedation', 'description': 'A loading dose of DEX 0.5 \u00b5g/kg was infused intravenously at a constant speed within 15 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.2-0.5 \u00b5g/kg/h until the end of the first stage (deep-brain stimulation implantation) of the operation. Maintain the BIS value at 60-80.', 'armGroupLabels': ['Conscious sedation'], 'otherNames': ['asleep-awake-asleep anesthesia']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of high-normalized root mean square (high-NRMS) recorded by the MER signal (with the average NRMS recorded by MER after entering the STN greater than 2.0).', 'description': \"We will use the root mean square (RMS) value of the MER sampled signal as the main parameter for evaluating electrode position. RMS values change with the electrode properties and other external drives related to the operating room; therefore, it is crucial to normalize the RMS to comparable values. Thus, each session's RMS in a trajectory is divided by the mean RMS of the first five stable sessions in the same trajectory. This normalized RMS (NRMS) is found to be a good measure as it reflects the relative change in the total power of the signal, which elevates dramatically entering the STN.\", 'timeFrame': '1 day (during MER recording)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level \u03b1=0.025 (one-tailed), and a drop-out rate of 5%.", "answer": 188, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to the preresearch results of our centre, the proportion of high NRMS in the CS group was 0.94, and the non-inferiority margin was \u00e2\u0088\u00920.1 (meaning a <10% absolute difference). The sample size of 178 patients will provide 80% power to show the difference \u00ce\u00b1=0.025 (one tailed) between the GA group and the CS group with a ratio of 1:1. Assuming a drop-out rate of 5%, the total sample size of this study is planned to be 188.", "id": 1588, "split": "test"} +{"trial_id": "NCT05551377", "pmid": "38166676", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Heads-Up Trial: Sleeping in a Head-Up Tilt Position to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease\n\nIncluded conditions:\n- Parkinson Disease\n- Parkinsonism\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'At T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6\u00b0, 12\u00b0 and 18\u00b0. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls.', 'interventionNames': ['Other: Head-up tilt sleeping']}\n- {'label': 'Delayed intervention group', 'type': 'OTHER', 'description': 'Follows the same structure as the intervention group, but starts with a HUTS placebo angle of 1\u00b0 for two weeks, followed by two intervention angles of 6\u00b0 and 12\u00b0 for two weeks each. The 1\u00b0-angle serves as the control intervention.', 'interventionNames': ['Other: Head-up tilt sleeping']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Head-up tilt sleeping', 'description': 'Whole-body head-up tilt sleeping (HUTS) will be carried out in three different angles, each for the duration of two weeks. Prior to the first angle the participant will sleep in a horizontal position for 1 week. The different angles will be installed using a wedge between the mattress and bed frame.', 'armGroupLabels': ['Delayed intervention group', 'Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Average overnight supine blood pressure', 'description': 'Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)', 'timeFrame': 'Measured four times: in week 1, 3, 5 and 7'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size calculation was performed as this is a phase II clinical trial.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Since this is a phase II clinical trial, no formal sample size was calculated. We aim to study the effect of HUTS on clinical outcomes to power a future phase III RCT. We expect a large effect of the intervention on the main study parameters, meaning that 50 participants will be sufficient for this RCT [38].", "id": 1589, "split": "test"} +{"trial_id": "NCT05551468", "pmid": "36521888", "question": "Here is the design of a clinical trial:\n\nOfficial Title: StayFine: a Personalized Monitoring and Intervention App to Prevent Relapse of Anxiety and Mood Disorders in Youth and Young Adults\n\nIncluded conditions:\n- Depressive Disorder\n- Anxiety Disorders\n\nStudy Armgroups:\n- {'label': 'Monitoring + Intervention modules', 'type': 'EXPERIMENTAL', 'description': 'Monitoring: Ecological Momentary Assessment (EMA) of affect, thoughts and social company. Optionally with a wearable to measure activity level. Six times per day for two weeks.\\n\\nTimepoints: T0-T4.\\n\\nIntervention modules: StayFine guided app-based personalised intervention modules. Each individual receives six of eight modules of which three are mandatory and three others are selected based on a personalization procedure.\\n\\nTime point: after T0 over the course of three months.', 'interventionNames': ['Behavioral: StayFine guided app-based personalised intervention modules', 'Behavioral: StayFine app-based monitoring']}\n- {'label': 'Monitoring', 'type': 'ACTIVE_COMPARATOR', 'description': 'Monitoring:Ecological Momentary Assessment (EMA) of affect, thoughts and social company. Optionally with a wearable to measure activity level. Six times per day for two weeks.\\n\\nTimepoints: T0-T4.', 'interventionNames': ['Behavioral: StayFine app-based monitoring']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'StayFine guided app-based personalised intervention modules', 'description': 'Participants work on guided app-based personalised intervention modules in the StayFine app over the course of three months. The modules are selected by the participant based on shared decision making and a personalized advice. The intervention is based on Preventive Cognitive Therapy (PCT) with elements of Cognitive Behavioral Therapy (CBT) and Positive Psychology. Modules are: psycho education (mandatory), cognitive restructuring (mandatory), positive affect, behavioral activation, exposure, wellness, sleep and a relapse prevention plan (mandatory).', 'armGroupLabels': ['Monitoring + Intervention modules']}\n- {'type': 'BEHAVIORAL', 'name': 'StayFine app-based monitoring', 'description': 'Monitoring six times per day for two weeks in the StayFine app.', 'armGroupLabels': ['Monitoring', 'Monitoring + Intervention modules']}\n\nPrimary Outcomes:\n- {'measure': 'Time to anxiety and/or depressive relapse', 'description': 'Time to anxiety and/or depressive relapse over 36 months as assessed by a semi-structured interview: the Kiddie Schedule for Affective Disorders and Schizophrenia - lifetime version (K-SADS-PL DSM-5).', 'timeFrame': 'up to 36 months (planned: 0, 4, 12, 24, 36 months)'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power, a two-sided 5% alpha level, a 60% relapse rate over 3 years, and a 20% attrition rate.", "answer": 254, "answer_type": "ESTIMATED", "explanation": "Sample size\n The current study was powered to detect a difference in relative risk-reduction (HR=0.60) of 40% between randomisation groups, with 80% power and a two-sided 5% alpha level, assuming the relapse rate for depressive and anxiety disorders is 60% (50%\u00e2\u0080\u009370%) over 3 years. Taking into account a 20% attrition rate, this resulted in a required total sample size of 254 (with 80%*254=203.2, thus resulting in 101 participants per condition) to detect a clinically relevant effect between randomisation groups to reduce the relative risk on relapse/recurrence of 40% in favour of the intervention group during the follow-up period, based on previous studies in adolescents19 20 98\u00e2\u0080\u0093100 and adults37 101 comparing similar groups.", "id": 1590, "split": "test"} +{"trial_id": "NCT05551533", "pmid": "38913625", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Design and Pilot-test of an Innovative Mobile-based Intervention to Promote Mental Health of Informal Dementia Caregivers Through User-Centered Design\n\nIncluded conditions:\n- Caregiver Burden\n- Dementia\n- Digital Health\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'To use the mobile app developed by the study team for one month. The app has a few key features including a positive reflection journal, online peer support, knowledge sharing, self-assessment, and locally available resources. Participants in the intervention group will be required to complete at least two positive reflection journal entries per week, and will be encouraged to use other features of the app during the one month period.', 'interventionNames': ['Other: Kampung Care App']}\n- {'label': 'Wait list', 'type': 'NO_INTERVENTION', 'description': 'Participants in this group will be put on a wait-list for one month before they can use the app.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Kampung Care App', 'description': 'Please refer to the previous session', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Baseline depressive symptom', 'description': 'Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom', 'timeFrame': 'baseline - before the intervention'}\n- {'measure': 'Post-intervention depressive symptom', 'description': 'Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom', 'timeFrame': 'within 2 weeks after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe main study is designed with 90% power and a two-sided 5% significance level. An initial high attrition rate was assumed, but later found to be low.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n Given that this is a pilot RCT with the primary aim of assessing the feasibility and potential effectiveness of the \u00e2\u0080\u0099Kampung Care\u00e2\u0080\u0099 mobile intervention, we followed the recommendation from a methodological study that a sample size of 25 per intervention arm is required if the main study is designed with 90% power and two-sided 5% significance for an intervention with a small effect size [39]. No formula or software was used in the calculation. With a 1:1 allocation ratio, the required sample size was determined to be 50. As mobile-based intervention studies tend to have high attrition rates, we doubled our preliminary sample size to 100 to ensure there will be a sufficient sample for analysis. However, following the initial recruitment, we found the attrition rate among our target group to be quite low and thus adjusted our final sample to 60 \u00e2\u0080\u0093with 30 participants randomly allocated to the intervention group and waitlist control group respectively. For the in-depth interview, we intend to recruit up to 20 participants from the intervention group. This is from an experiential perspective. However, the final sample will depend on data saturation\u00e2\u0080\u0093the point at which no new information is being observed and collected to form distinct themes.", "id": 1591, "split": "test"} +{"trial_id": "NCT05552820", "pmid": "38056935", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye\n\nIncluded conditions:\n- Dry Eye\n\nStudy Armgroups:\n- {'label': 'Verum Electroacupuncture', 'type': 'EXPERIMENTAL', 'description': 'Verum electroacupuncture treatment will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.', 'interventionNames': ['Device: Verum Electroacupuncture']}\n- {'label': 'Sham Electroacupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'Sham electroacupuncture on non-acupoints plus non-penetrating plus no electrical stimulation will be given 3 times a week, at least 1 day apart , for consecutive 4 weeks with a 24-week follow-up. Each session lasts for 30 min.', 'interventionNames': ['Device: Sham Electroacupuncture']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Verum Electroacupuncture', 'description': 'Acupoints: Cuanzhu (BL2), Taiyang (EX-HN5), Sibai (ST1), Sizhukong (TE23), Baihui (GV20), Fengchi (GB20), Hegu (LI4), Zusanli (ST36), Guangming (GB23), Sanyinjiao (SP6), and Taichong (LR3). All acupoints will be taken bilaterally, except Baihui (GV20). The subject is placed in the supine position with eyes close. After routine sterilization, the sterile polyethylene cylindrical needle pad will be adhered to the acupoints. Then, the sterile acupuncture needles (0.25 mm\u00d70.40 mm, Hwato brand, China.) will be inserted into the skin through the needle pad. Twirling and lifting-thrusting manipulations will be performed on the acupoints until Deqi is reported by the subject. Two pairs of electrodes will be connected at the needle handles on BL2 and EX-HN5 with a 2 Hz, continuous-wave electro-stimulation provided by the electroacupuncture apparatus (SDZ-\u2162 type, Hwato brand, China). The pulse amplitude is about 1-2 mA.', 'armGroupLabels': ['Verum Electroacupuncture']}\n- {'type': 'DEVICE', 'name': 'Sham Electroacupuncture', 'description': 'Sham acupoints: SA1(1 cm above BL2), SA2 (1 cm above SJ23)\uff0cSA3 (1 cm above EX-HN5), SA4 (1 cm lateral to ST2), SA5 (the midpoint of the line between GV20 and right EX-HN1), SA6 (the midpoint of the line between GB20 and SJ16), SA7 (1 cm lateral to LI4), SA8 (the midpoint of the line between ST36 and GB34), SA9 (the midpoint of the line between GB37 and BL58), SA10 (1 cm backward to SP6), SA11 (the midpoint of the line between LR3 and SP4). After routine sterilization, placebo needles will be used (Streitberger, Asia-med GmbH). The tingling sensation produced when the Streitberger needle is fixed on the skin causes the subject to believe that the needle is piercing the skin, simulating a skin puncture. The electric stimulator is applied to bilateral SA1 and SA3 with no current output. The exterior appearance, indicator light, prompt tone of the sham device, and stimulation parameters are all indistinguishable from the normal one.', 'armGroupLabels': ['Sham Electroacupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)', 'description': 'The interval between a complete blink and the first breakup of tear film (indicated by a break or deformed Placido disc image on the screen) will be recorded. The measurements are carried out 3 times and the average value is considered as NIBUT.', 'timeFrame': 'Baseline, Week 4, Week 8, Week 16, Week 28'}\n\nPlease estimate the sample size based on the assumption: \nA power of 85%, a two-sided significance level of 5%, and a 20% attrition rate.", "answer": 168, "answer_type": "ESTIMATED", "explanation": "Sample size\n In the previous sham-controlled study,46 the tear break-up time (BUT) increased from 3.29\u00c2\u00b11.01\u00e2\u0080\u0089s to 4.24\u00c2\u00b11.26\u00e2\u0080\u0089s in the acupuncture group versus 3.71\u00c2\u00b11.38\u00e2\u0080\u0089s to 4.00\u00c2\u00b11.34\u00e2\u0080\u0089s in the sham acupuncture group. Based on the formulas in the Cochrane Handbook47 and the imputed correlation coefficient between the pretreatment and post-treatment values of BUT of 0.5,16 the means and SD for changes in the BUT were calculated to be 0.95\u00c2\u00b11.16\u00e2\u0080\u0089s and 0.29\u00c2\u00b11.36\u00e2\u0080\u0089s in the acupuncture group and the sham acupuncture group, respectively. Thus, we estimated a sample size of 134 (67 subjects per group) to provide a power of 85% and a two-sided significance level of 5%. Assuming a 20% attrition rate, we increased the sample size to 168 (84 subjects per group).", "id": 1592, "split": "test"} +{"trial_id": "NCT05553730", "pmid": "36750879", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Digital Buddy Programme on Older Adults' Mental Well-being: Study Protocol for a Multi-centre, Cluster Randomized Controlled Trial\n\nIncluded conditions:\n- Mental Wellbeing of Older Adults\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Older adults randomly sorted into intervention group will receive six months of intervention after registration.', 'interventionNames': ['Behavioral: Digital Buddy program']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Older adults randomly sorted into Control group will not receive six months of intervention after registration.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Digital Buddy program', 'description': 'Six months of ICT and psychoeducation delivered by youth mentors via an e-learning platform', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Five Well Being Index (WHO-5) at 6 months', 'description': 'The World Health Organization Five Well-being Index (WHO-5) will be used to measure mental well-being over the past two weeks. WHO-5 comprises five items and each item is rated by a 6-point Likert scale from 0 (at no time) to 5 (all of the time). The total score ranges from 0 to 25. A higher score indicates an increased sense of psychological well-being. The Cantonese version of WHO-5 showed good internal consistency (\u03b1=0.86) and good concurrent validity with quality of life (r=0.41-0.51).', 'timeFrame': 'Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention'}\n- {'measure': 'Change from Baseline 9-item Patient Health Questionnaire - 9 (PHQ-9) at 6months', 'description': 'The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure depressive symptoms over the past two weeks. PHQ-9 comprises nine items and each item is rated by a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. A higher score indicates greater severity of depressive symptoms. The Cantonese version of PHQ-9 showed good internal consistency (\u03b1=0.82), test-retest reliability (r=0.76), and satisfactory concurrent validity with the mental component of quality of life (r=-0.60).', 'timeFrame': 'Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention'}\n- {'measure': 'Change from Baseline 12-item Short Form survey version 2 (SF-12v2) at 6 months', 'description': 'The version 2 of the 12-item Short Form Health Survey (SF-12v2) will be used to measure health-related quality of life over the past four weeks. SF-12v2 comprises 12 items rated by scales with varying points measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The scores of eight domains are aggregated into two scores: 1) physical component summary score and 2) mental component summary score. The scores will be calculated by a standard algorithm. A higher component summary scores indicates a better health-related quality of life. The Chinese version of SF-12v2 showed good test-retest reliability (r=0.67-0.82), good construct validity with \\\\>80% of total variance explained by the two-factor model.', 'timeFrame': 'Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention'}\n- {'measure': 'Change from Baseline 10-item General Self-Efficacy Scale (GSES-10) at 6 months', 'description': 'The 10-item General Self-efficacy scale (GSES-10) will be used to measure self-efficacy. GSES-10 comprises 10 items and each item is rated by a 4-point Likert scale from 1 (not at all true) to 4 (exactly true). The total score ranges from 10 to 40. A higher score indicates better self-efficacy. The Chinese version GSES-10 showed good internal consistency (\u03b1=0.91), good criterion validity with wellbeing (r=0.56-0.63, p\\\\<0.001), self-esteem (r=0.40-0.49, p\\\\<0.001), and mental health (0.39-0.41, p\\\\<0.001).', 'timeFrame': 'Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention'}\n- {'measure': 'Change from Baseline Multidimensional Scale of Perceived Social Support (MSPSSC) at 6 months', 'description': \"The 12-item Multidimensional Scale of Perceived Social Support (MSPSS) will be used to measure perceived social support. MSPS comprises 12 items which are factored in three subscales by sources of support (i.e., family, friends, significant others). Each subscale comprises four items. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 12 to 84. A higher score indicates better social support. The Chinese version of MSPSS showed good internal consistency (Cronbach's \u03b1=0.95), good test-retest reliability (ICC=0.91), and satisfactory concurrent validity with perceived stress (r=-0.221) and caregiving rewarding feelings (r=-0.327).\", 'timeFrame': 'Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe level of significance is set at 0.05, the power at 0.8, the allocation ratio between the two groups at 1:1, and the intra-cluster correlation coefficient (ICC) is 0.01. The drop-out rate is assumed to be approximately 20%.", "answer": 292, "answer_type": "ACTUAL", "explanation": "Sample size\n We adopt a prior power analysis using the GPower employing the statistical test of the mean difference between two different groups. We set the level of significance at 0.05, the power at 0.8, and the allocation ratio between the two groups at 1:1. To estimate the effects, we refer to a similar pilot trial examining the effect of an intergenerational mentoring programme [43]. The effect size (i.e. Cohen\u00e2\u0080\u0099s d) of the study of the intervention on the primary outcome (i.e. well-being) was 0.5. A sample size of 102 participants is needed. We adopt Hemming\u00e2\u0080\u0099s method to adjust the sample size required under individual randomization for cluster RCT with fixed and equal-sized number clusters [44]. Considering that we will collect data in 6 clusters and assuming that the intra-cluster correlation coefficient (ICC) is 0.01, the estimated total sample size is 244 (i.e. 122 per arm). We assume that the drop-out rate is approximately 20%. A total sample of 292 is estimated, with 146 participants in each arm.", "id": 1593, "split": "test"} +{"trial_id": "NCT05555303", "pmid": "39053960", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis (Stake) Amendment to Study Protocol: \"All-oral Shorter Treatment Regimen for Multidrug- and Rifampicin-resistant Tuberculosis (MDR/RR-TB): Evaluating Its Effectiveness, Safety and Impact on the Quality of Life of Patients in Rwanda\" (ShORRT)\n\nIncluded conditions:\n- Tuberculosis, Multidrug-Resistant\n\nStudy Armgroups:\n- {'label': 'Amikacin', 'type': 'OTHER', 'interventionNames': ['Drug: Amikacin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Amikacin', 'description': 'In addition to the all-oral RR-TB treatment, add two intramuscular doses each consisting of 30 mg amikacin/kg, a first dose on day 1 and a second dose on day 4, all in the first week of treatment.\\n\\nThe amikacin solution will be admixed with a lidocaine solution in the syringe before administration.', 'armGroupLabels': ['Amikacin']}\n\nPrimary Outcomes:\n- {'measure': 'grade 3-4 AE likely or definitively related to amikacin', 'description': 'Assess whether less than 14% of patients treated with the amikacin-strengthened regimen will experience a grade 3-4 adverse event likely or definitively related to the use of amikacin', 'timeFrame': 'After 2 weeks of treatment'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Study design and sample size\n This is a single-arm clinical trial conducted according to protocol V.5.0 approved on 31 January 2023. Patients will be coenrolled in the ShORRT operational research study. All patients consecutively diagnosed with RR-TB in Rwanda will be assessed for eligibility and 20 patients will be enrolled in STAKE. Based on current trends, we expect about 6\u00e2\u0080\u009312 months to enrol 20 patients.", "id": 1594, "split": "test"} +{"trial_id": "NCT05555576", "pmid": "37225265", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Vitamin C on the Reduction of Opioid Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain: A Double-Blind Randomized Control Trial Protocol\n\nIncluded conditions:\n- Pain, Acute\n\nStudy Armgroups:\n- {'label': 'Vitamin C', 'type': 'EXPERIMENTAL', 'description': '1 000 mg vitamin C taken orally twice a day', 'interventionNames': ['Dietary Supplement: Vitamin C']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Matching placebo', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Vitamin C', 'description': '1000 mg vitamin C taken orally twice a day (one in the morning and one in the evening) for a 14-day period after ED discharge for the treatment arm', 'armGroupLabels': ['Vitamin C']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo taken orally twice a day (one in the morning and one in the evening) for a 14-day period after ED discharge for the treatment arm', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in the total morphine 5 mg equivalent pills consumed', 'description': 'Compare the difference in the total morphine 5 mg equivalent pills consumed after a two-week follow-up between patients receiving vitamin C versus patients receiving a placebo during these two weeks.', 'timeFrame': '14 days'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.90 and an alpha of 0.05 were used. An 18% lost to follow-up rate was anticipated.", "answer": 464, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The effect of vitamin C on 24-hour postoperative opioid consumption was used to compute treatment effect size for our primary outcome (total morphine 5\u00e2\u0080\u0089mg pills consumed after a 2-week follow-up). Two studies using oral route of vitamin C were reported, one by Kanazi et al57 and one by Tunay et al.58 To be more conservative, we used the study with the smallest treatment effect (Tunay) and calculated an effect size of d=0.32. Anticipating a similar treatment effect, 190 participants in each arm are necessary to achieve a power of 0.90 with an alpha of 0.05 (PASS, V.11.0). Given the 18% lost to follow-up rate observed during a previous study using the same diary,37 a total of 464 patients will be recruited.\n Previous studies made on the same population have shown an average recruitment rate of two participants per day at our study site.37 Therefore, an 8-month period will be necessary to enrol the initial sample. Accounting for the 3-month follow-up period and another 12 months for safety follow-up, a total of approximately 24 months will be required for recruitment and follow-up.", "id": 1595, "split": "test"} +{"trial_id": "NCT05555888", "pmid": "37802608", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer\n\nIncluded conditions:\n- Early Low Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'Treatment Arm', 'type': 'EXPERIMENTAL', 'description': 'A total of 34 patients will receive 5\\\\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.', 'interventionNames': ['Drug: PD-1 antibody', 'Drug: Capecitabine', 'Drug: Oxaliplatin', 'Radiation: Short-course radiotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'PD-1 antibody', 'description': 'PD-1 antibody (Toripalimab): 240mg d1 q3w', 'armGroupLabels': ['Treatment Arm'], 'otherNames': ['Toripalimab']}\n- {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Capecitabine: 1000mg/m2 d1-14 q3w', 'armGroupLabels': ['Treatment Arm'], 'otherNames': ['Xeloda']}\n- {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Oxaliplatin: 130mg/m2 d1 q3w', 'armGroupLabels': ['Treatment Arm']}\n- {'type': 'RADIATION', 'name': 'Short-course radiotherapy', 'description': 'Shor-course radiotherapy: 25Gy/5Fx', 'armGroupLabels': ['Treatment Arm']}\n\nPrimary Outcomes:\n- {'measure': 'complete response (CR) rate', 'description': 'Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\\\\&W strategy.', 'timeFrame': 'The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 0.8 (\u00ce\u00b2=0.2), type I error rate of 0.05 (\u00ce\u00b1=0.05), and a dropout rate of 10%. The level of significance is p<0.05.", "answer": 34, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and statistical analysis\n This study is a prospective, single-arm, phase II clinical study. The primary endpoint is the CR rate. According to the previous reports, the reference CR rate is about 45% (null hypothesis, p0) and we assumed that the CR rate in this study can be increased to 70% (alternative hypothesis, p1). With the statistical power of 0.8 (\u00ce\u00b2=0.2), the type I error rate of 0.05 (\u00ce\u00b1=0.05), approximately 30 patients will be required in this study. Considering the dropout rate of 10%, the sample size in this study will be 34 cases.\n The primary endpoint of TORCH-E study is the CR rate, including rate of pCR and cCR. The OS will be calculated from the date of randomisation to the date of death or the last follow-up. Survivals will be estimated by using the Kaplan-Meier method, including OS, DFS and LRFS. Endpoints related to the rate, including the cCR rate, pCR rate, organ preservation rate, toxicity occurrence, will be summarised with the frequency. The level of significance is p<0.05. All data analyses were performed using SPSS V.26.0.", "id": 1596, "split": "test"} +{"trial_id": "NCT05557799", "pmid": "39621728", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial\n\nIncluded conditions:\n- Postmenopausal Symptoms\n\nStudy Armgroups:\n- {'label': 'Photobiomodulation group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group will receive photobiomodulation with a vaginal diode laser and its introit.', 'interventionNames': ['Radiation: Photobiomodulation']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants in this group will receive simulated photobiomodulation, with the laser device turned off.', 'interventionNames': ['Radiation: Placebo Photobiomodulation']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Photobiomodulation', 'description': 'The treatment group will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm\u00b2, beam area of 0.2cm\u00b2, 8 sites in the external vagina, for 40s in each site, once per week for 4 weeks.', 'armGroupLabels': ['Photobiomodulation group']}\n- {'type': 'RADIATION', 'name': 'Placebo Photobiomodulation', 'description': 'The Placebo Group will receive the same four consecutive applications, but with the laser turned off.', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in the Female Sexual Function Index (FSFI)', 'description': 'The FSFI or female sexual function index is a specific and multidimensional questionnaire to assess female sexual response, accessing 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain evaluated in 19 questions about sexual activity in the last 4 weeks. In order to obtain the total score of the scale, the scores for each domain are added up, and for higher scores, better sexual function is considered, and the threshold for sexual dysfunction is a score of 2678. Based on the value of the total score, it would be possible discriminate between populations at higher and lower risk of experiencing sexual dysfunction.', 'timeFrame': 'Baseline and the 4 weeks of treatment.'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, test power of 80%, and a 10% sample loss rate.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size and participants\n Since the literature lacks studies on the effects of the photobiomodulaton on GSM, the sample size was calculated using the formula described using the estimated effect size, as described by Kadam and Bhalerao [29]. Considering a type I error of 0.05 and a test power of 80%, the calculated sample size was 60 participants, with 30 in each group (A and B). The Fig 3 shows that, for medium (0.750) and large effects (1.000\u00e2\u0080\u00931.250), a minimum of 30 patients per group is sufficient to control statistical variance, ensuring a test power greater than 0.80. Considering a 10% of sample loss, a total of 66 patients will be recruited for the study. The Fig 3 shows a plot of the test power as a function of the sample size and estimated effect size.\n \n 10.1371/journal.pone.0313324.g003\n Fig 3\n \n Test power analysis as a function of effect size and sample size.\n \n \n \n \n Recruitment\n Recruitment will be conducted through the public health system of Vargem Grande Paulista, SP, Brazil. Additionally, recruitment efforts were carried out through the municipality\u00e2\u0080\u0099s Senior Center, social media, and referrals from participants who had previously undergone the project.", "id": 1597, "split": "test"} +{"trial_id": "NCT05561010", "pmid": "37433734", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Is There a Difference in the Analgesic Response to Intra-articular Bupivacaine Injection in People With Knee Osteoarthritis Pain With or Without Central Sensitisation?: a Feasibility Randomised Controlled Trial\n\nIncluded conditions:\n- Osteoarthritis, Knee\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Intra-articular injection of bupivacaine', 'type': 'EXPERIMENTAL', 'description': '5 ml of bupivacaine (0.25% w/v)', 'interventionNames': ['Drug: Intra-articular injection of bupivacaine in the knee joint']}\n- {'label': 'Intra-articular injection of sodium chloride', 'type': 'PLACEBO_COMPARATOR', 'description': '5 ml of sodium chloride (9mg/ml, 0.9% solution for injection)', 'interventionNames': ['Drug: Intra-articular injection of placebo in the knee joint']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Intra-articular injection of bupivacaine in the knee joint', 'description': '25 participants will be allocated to the bupivacaine arm.', 'armGroupLabels': ['Intra-articular injection of bupivacaine'], 'otherNames': ['Bupivacaine hydrochloride']}\n- {'type': 'DRUG', 'name': 'Intra-articular injection of placebo in the knee joint', 'description': '25 participants will be allocated to the placebo arm.', 'armGroupLabels': ['Intra-articular injection of sodium chloride'], 'otherNames': ['Sodium chloride']}\n\nPrimary Outcomes:\n- {'measure': 'The change from baseline in pain score during the six-minute walk test', 'description': 'The change from baseline in pain score using the Visual Analogue Scale during the six-minute walk test.\\n\\n(visual analogue scale ranges from 0-100; 0 meaning no pain and 100 worst imaginable pain)', 'timeFrame': 'From baseline to approximately one hour after intra-articular injection with bupivacaine or placebo'}\n- {'measure': 'The change from baseline in pain score at rest', 'description': 'The change from baseline in pain score using the Visual Analogue Scale at rest. (visual analogue scale ranges from 0-100; 0 meaning no pain and 100 worst imaginable pain)', 'timeFrame': 'From baseline to approximately one hour after intra-articular injection with bupivacaine or placebo'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size is based on recommendations about sample size requirements for feasibility and pilot studies.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a feasibility study aiming to provide first proof of concept and descriptive statistics to power a future diagnostic trial. We aim to recruit 50 participants (25 to each group). This would be a large enough sample to assess the feasibility and inform a main trial based on statistical methodological papers providing recommendations about sample size requirements for feasibility and pilot studies.17\u00e2\u0080\u009319", "id": 1598, "split": "test"} +{"trial_id": "NCT05561413", "pmid": "37883461", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Controlled Feasibility Trial Evaluating the Effectiveness of Mindfulness Compared to Exercise and Mindfulness on Fatigue in Women With Gynaecology Cancer\n\nIncluded conditions:\n- Gynecologic Cancer\n- Uterus Cancer\n- Ovary Cancer\n- Cervical Cancer\n- Vaginal Cancer\n- Vulvar Cancer\n\nStudy Armgroups:\n- {'label': 'Mindfulness and exercise', 'type': 'EXPERIMENTAL', 'description': 'This group will undertake exercise and mindfulness for 8 weeks. The home based walking and strengthening intervention is individually tailored for each participant. All exercise demonstrations, information, reporting of activity and setting of goals will take place in the app that participants will download. Additionally this group will receive a hard copy of the goal setting diary. All mindfulness information and practices are available in the app. New content will be released each week as the participants progress through the program. Participants will be phoned weekly over the 8 weeks to monitor progress.', 'interventionNames': ['Behavioral: Mindfulness and exercise']}\n- {'label': 'Mindfulness', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will undertake mindfulness only over 8 weeks. The mindfulness program is based on mindfulness-based stress reduction (MBSR). All information, practices and logging of the mindfulness practice will be done via the app that participants will download. Participants will be phoned weekly over the 8 weeks to monitor progress. New content will be released each week as participants progress through the program.', 'interventionNames': ['Behavioral: Mindfulness']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness and exercise', 'description': 'The mindfulness and exercise group aims to gradually increase participants exercise levels so that they begin to achieve the recommended levels along with the strengthening exercises for all major muscle groups. Along side this mindfulness will be introduced and built on to help consolidate exercise uptake and help manage symptoms experienced by the participants.', 'armGroupLabels': ['Mindfulness and exercise']}\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness', 'description': 'The delivery of this practice will be through the app downloaded by participants. The practice based on mindfulness based stress reduction (MBSR). Will build on practice over the 8 weeks.', 'armGroupLabels': ['Mindfulness']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of eligibility and enrollment', 'description': 'Number of eligible participants, and the proportion of those eligible that enrolled will be assessed to evaluate the feasibility of eligibility and enrollment.', 'timeFrame': '12 months'}\n- {'measure': 'Retention rate in study as feasibility', 'description': 'Number and proportion of participants completing all assessments.', 'timeFrame': '8 weeks'}\n- {'measure': 'Feasibility as assessed by rate of attrition', 'description': 'The number of participants dropping out after start of intervention for any reason will be assessed to evaluate attrition rate.', 'timeFrame': '8 weeks'}\n- {'measure': 'Feasibility as assessed by adherence', 'description': 'Will be assessed by frequency and duration of practicing of exercise and mindfulness (recorded in a log via app).', 'timeFrame': '8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe literature indicates that feasibility studies of similar interventions and methodologies within the cancer population recruit on average 40 participants in total.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size for this study is based upon feasibility and review of similar studies. The literature indicates that feasibility studies of similar interventions and methodologies within the cancer population recruit on average 40 participants in total [60,80,81]. Therefore, it is anticipated that this study will recruit a total of 40 participants with 20 in each arm of the study.", "id": 1599, "split": "test"} +{"trial_id": "NCT05562271", "pmid": "36764712", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-center, Randomized, Single-blinded, Exploratory Clinical Trial to Evaluate Safety and Efficacy of Alleviating Symptom of Low-dose RaDiation Therapy in Patients With KNee osteoArthritis\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'sham radiation therapy', 'type': 'SHAM_COMPARATOR', 'description': 'sham radiation therapy', 'interventionNames': ['Radiation: sham radiation therapy']}\n- {'label': 'low-dose radiation therapy, 30 cGy/6 fx (experimental 1)', 'type': 'EXPERIMENTAL', 'description': 'low-dose radiation therapy, 30 cGy/6 fx', 'interventionNames': ['Radiation: low-dose radiation therapy']}\n- {'label': 'low-dose radiation therapy, 300 cGy/6 fx (experimental 2)', 'type': 'EXPERIMENTAL', 'description': 'low-dose radiation therapy, 300 cGy/6 fx', 'interventionNames': ['Radiation: low-dose radiation therapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'low-dose radiation therapy', 'description': 'low-dose radiation therapy to involved knee joint', 'armGroupLabels': ['low-dose radiation therapy, 30 cGy/6 fx (experimental 1)', 'low-dose radiation therapy, 300 cGy/6 fx (experimental 2)']}\n- {'type': 'RADIATION', 'name': 'sham radiation therapy', 'description': 'sham radiation therapy to involved knee joint', 'armGroupLabels': ['sham radiation therapy']}\n\nPrimary Outcomes:\n- {'measure': 'OMERACT-OARSI response rate', 'description': \"OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) response rate at 4 months. The OMERACT-OARSI criteria for response are (1) improvement in pain or physical function \u226550% and an absolute change \u226520 mm; or (2) improvement of \u226520% with an absolute change \u226510 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.\", 'timeFrame': '4 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses 80% power, a two-sided alpha of 0.025 with Bonferroni correction for two tests, and considers a 10% dropout rate.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n For sample size calculation, a randomised, comparative, parallel, three-arm design is used with 80% power and a two-sided alpha of 0.025 considering the comparison of the control group to each of the two types of experimental groups; a total of two tests are planned, and Bonferroni correction is performed. According to the ArthroRad trial, when doses of 0.05\u00e2\u0080\u0089Gy and 0.5\u00e2\u0080\u0089Gy per fraction (similar to this trial) were applied to degenerative arthritis of the hand and knee, the combined response rate of \u00e2\u0080\u0098markedly improved\u00e2\u0080\u0099 and \u00e2\u0080\u0098improved\u00e2\u0080\u0099 was around 60%.15 In addition, when the results of several retrospective studies were combined, clinical symptom improvement was observed in 63%\u00e2\u0080\u009390% of cases after LDRT.2 Therefore, the number of samples for this study may be determined by the following hypothesis test: assuming that the proportion of responders is 65% in the experimental groups and 30% in the control group, when the power is 80% and the alpha error is 5%, 34 patients are needed in each group. Considering a 10% dropout rate, each arm requires 38 patients. A total of 114 patients will be enrolled in this study.", "id": 1600, "split": "test"} +{"trial_id": "NCT05562999", "pmid": "37640469", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study\n\nIncluded conditions:\n- Neuromuscular Blockade\n- Innate Inflammatory Response\n- Quality of Life\n- Postoperative Complications\n\nStudy Armgroups:\n- {'label': 'Deep neuromuscular blockade', 'type': 'EXPERIMENTAL', 'description': 'Participant will receive deep neuromuscular blockade (PTC 1-2)', 'interventionNames': ['Drug: Rocuronium Bromide']}\n- {'label': 'Moderate neuromuscular blockade', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participant will receive moderate neuromuscular blockade (TOF 1-2)', 'interventionNames': ['Drug: Rocuronium Bromide']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rocuronium Bromide', 'description': 'Moderate NMB (TOF 1-2)', 'armGroupLabels': ['Moderate neuromuscular blockade'], 'otherNames': ['Bridion']}\n- {'type': 'DRUG', 'name': 'Rocuronium Bromide', 'description': 'Deep NMB (PTC 1-2)', 'armGroupLabels': ['Deep neuromuscular blockade'], 'otherNames': ['Bridion']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of Recovery 40 (QoR-40) questionnaire score', 'description': '40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)', 'timeFrame': 'Postoperative day 1'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 5%, power of 90%, and approximately 4% dropout rate.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n Regarding the primary outcome, the QoR-40 Questionnaire, Myles et al22 have reported a minimal clinically important difference of 6.3. Since this is a small difference on a 40\u00e2\u0080\u0093200 scale, we decided to use a 10-point difference instead. \u00c3\u0096zdemir-van Brunschot et al23 and Bruintjes et al24 have shown SD of 14.6 and 15.7. Therefore, an SD of 15 was used for the power calculation. A t-test was used for the sample size calculation. To detect a mean difference in the QoR-40 of 10 points on POD 1, with an SD of 15, an alpha of 5% and a power of 90% with equal allocation to two arms, 48 patients per group are required. To allow for ~4%\u00e2\u0080\u0089dropout, 100 patients will be randomised. In case of missing values regarding the primary outcome, QoR-40 on POD 1, participants will be replaced with a maximum of 4.", "id": 1601, "split": "test"} +{"trial_id": "NCT05563337", "pmid": "37775290", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Renal Denervation in Hypertensive Women Planning to Become Pregnant\n\nIncluded conditions:\n- Arterial Hypertension\n\nStudy Armgroups:\n- {'label': 'Denervation treatment', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Arteriography and renal denervation']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Procedure: Arteriography without renal denervation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Arteriography and renal denervation', 'description': 'Diagnostic renal Arteriography - Randomization - Renal denervation', 'armGroupLabels': ['Denervation treatment']}\n- {'type': 'PROCEDURE', 'name': 'Arteriography without renal denervation', 'description': 'Diagnostic renal Arteriography - Randomization', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Normalization of 24h blood pressure', 'description': 'Percentage of patients cured of their hypertension (cure defined as 24h BP\\\\<130/80 mmHg at Day 100 without treatment)', 'timeFrame': 'at Day 100'}\n\nPlease estimate the sample size based on the assumption: \n80% power, one-sided significance level (\u03b1) of 0.05.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Justification of the sample size\n This study is a pilot \u00e2\u0080\u0098proof of concept\u00e2\u0080\u0099 study to evaluate RDN in hypertensive women planning a pregnancy. In the RADIANCE-HTN SOLO trial,14 the percentage of patients who had normalisation of their 24\u00e2\u0080\u0089hours BP (<130/80\u00e2\u0080\u0089mm Hg) in the absence of antihypertensive treatment was 24% in the RDN group and 3% in the control group at 2 months post procedure. Assuming responder rates of 24% and 3%, respectively, in the treatment and control groups, a sample size of 80 subjects would provide approximately 80% power to compare responder rates on the basis of an exact binomial test with one-sided \u00ce\u00b1=0.05. A larger difference between groups would provide more power.", "id": 1602, "split": "test"} +{"trial_id": "NCT05564247", "pmid": "37752480", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of the Wheelchair Skills Training Program for Improving Wheelchair Skills and Related Rehabilitation Outcomes Among Children and Youth\n\nIncluded conditions:\n- Wheelchairs\n\nStudy Armgroups:\n- {'label': 'Experimental Group (WSTP)', 'type': 'EXPERIMENTAL', 'description': 'Participants will complete 12, 45-minute weekly sessions of WSTP delivered by clinicians with \\\\>5 years of experience working with children who use MWC. Trainers will customize each session based on the age group (child or adolescent) and training goals of each child as determined in session one. Subsequent sessions will begin with a 5-minute review of progress and socializing, followed by a 10-minute warm-up (random practice of the previously learned skills); 20 minutes of attempting new skills (training on each skill will be carried to next session until the skills are learned or until the trainer and participant mutually agree that training should be abandoned; the trainer will periodically ask the participant to practice newly learned skills to incorporate variability of practice); 10 minute cool-down, during which the participant will practice skills in a self-controlled environment. Age-appropriate considerations are incorporated into training materials', 'interventionNames': ['Behavioral: Wheelchair Skills Training Program (WSTP)']}\n- {'label': 'Control Group (Attention)', 'type': 'NO_INTERVENTION', 'description': \"Participants will be attention-matched to mimic time and contacts \\u202cof\\u202d \\u202cthe\\u202d experimental\\u202d \\u202cgroup. The control group will receive 12, 45-minute weekly sessions of 'Games and Activities' facilitated by healthcare professionals (e.g., occupational therapy/rehabilitation students) who will not be involved in the intervention or any other aspect of the study. The control group facilitator will mimic the same type of attention as the training at each site (i.e., sessions will be held at healthcare facilities and in the community (e.g., libraries, shopping centres, museums, parks). Facilitators will be equipped with current popular games and activities (according to social media and websites of popular children's stores) kits that include various board and card games, hand-eye coordination games, active games, cognitive activities, and arts and crafts suitable for children and adolescents to ensure interest and acceptability for all participants.\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Wheelchair Skills Training Program (WSTP)', 'description': 'Participants will complete customized MWC skills training based on the evidence-based wheelchair skills program. Lessons plans will be created by the clinicians, children and parents participants based on goals, age, skills and interests, and used to customize the training.', 'armGroupLabels': ['Experimental Group (WSTP)']}\n\nPrimary Outcomes:\n- {'measure': 'Wheelchair Skills Test Version 5.2.1 for MWC users', 'description': 'Change in MWC skills capacity (i.e., what a person can do in a standardized environment), and frequency of performance will be assessed using the Wheelchair Skills Test (WST).', 'timeFrame': 'Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha (\u03b1) = 0.05, 85% power, and a 10% loss to attrition.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was powered to detect a statistically significant difference of 20% between groups [24], using mean change scores from T1 to T2 in the primary outcome from Best et al., 2016, which reported a large effect size (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00891.3) for the WST and a correlation between measures (R2) of 0.6 [37]. Based on pilot work, children and adolescents have similar variability in WST capacity scores compared to adults (standard deviation varying from 8 to 20) [26, 27]. However, given the unknown variability associated with age range, a more conservative effect size informed by our pilot work (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.85) and measure correlation (0.60) was chosen. With \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, and 85% power for between-factors ANCOVA repeated measures design (F-tests) controlling for baseline score (account for function/motor development), a sample size of 18 will be required. Given site variability, each site is powered for primary analysis. G*Power v.3.1.9.2 was used for sample size calculations [38]. Adjusting for a 10% loss to attrition, a total sample size of 60 (20 per site) will be required.", "id": 1603, "split": "test"} +{"trial_id": "NCT05567016", "pmid": "38538037", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Child Health and Infection With Low Density (CHILD) Malaria, a Randomized Controlled Trial to Assess the Long-term Health and Socioeconomic Impact of Interventions Targeting Low-density Malaria Infection (LMI) Among Children in Tanzania\n\nIncluded conditions:\n- Malaria,Falciparum\n- Malaria\n\nStudy Armgroups:\n- {'label': 'Active Case Detection using molecular testing (ACDm)', 'type': 'EXPERIMENTAL', 'description': 'Per standard of care, children will receive passive case detection (PCD) using rapid diagnostic test (RDT) if they present with fever.\\n\\nChildren will receive malaria active case detection (ACD) using RDT and qPCR (quantitative polymerase chain reaction) three times yearly with treatment using artemether-lumefantrine (AL) if RDT or qPCR positive.', 'interventionNames': ['Other: Active case detection using molecular testing (ACDm)']}\n- {'label': 'Passive Case Detection using molecular testing (PCDm)', 'type': 'EXPERIMENTAL', 'description': 'Children who present with fever will receive PCD using RDT and qPCR with treatment using AL if RDT or qPCR positive.\\n\\nPer standard of care, children will not receive malaria ACD.', 'interventionNames': ['Other: Passive case detection using molecular testing (PCDm)']}\n- {'label': 'Standard passive case detection (PCD)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Per standard of care, children will receive PCD using RDT.\\n\\nPer standard of care, children will not receive malaria ACD.', 'interventionNames': ['Other: Control (standard of care)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Active case detection using molecular testing (ACDm)', 'description': 'In the ACDm arm, children will receive ACD using RDT and qPCR 3x yearly with treatment using artemether-lumefantrine (AL) if RDT or qPCR positive. With fevers, participants will receive standard PCD using RDT.', 'armGroupLabels': ['Active Case Detection using molecular testing (ACDm)']}\n- {'type': 'OTHER', 'name': 'Passive case detection using molecular testing (PCDm)', 'description': 'With fevers, participants will receive PCDm, in which qPCR will be done in RDT negatives with treatment using AL if positive.', 'armGroupLabels': ['Passive Case Detection using molecular testing (PCDm)']}\n- {'type': 'OTHER', 'name': 'Control (standard of care)', 'description': 'With fevers, participants will receive standard PCD using RDT with treatment using AL if positive.', 'armGroupLabels': ['Standard passive case detection (PCD)']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of all-cause sick visits', 'description': 'Number of sick visits to health facility per person time, excluding planned admissions for medical care, elective surgery, and trauma.', 'timeFrame': '24 months from enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of 95%, power ranging from 80% to 90%, and a 15% loss to follow-up. Additionally, a 10% refusal/ineligibility rate is assumed for recruitment.", "answer": 600, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n The estimated mean baseline incidence of all-cause sick visits in our study population is 4.3/person-year of follow-up (SD 2.9).47\u00e2\u0080\u009352 With a sample size of 200 per study arm and assuming a 15% loss to follow-up, the study is powered to detect \n\u00e2\u0089\u00a5\n20% decrease in sick visits relative to the control group (85% power, 95% significance). For the primary outcome, the sample size also provides adequate power (80%\u00e2\u0080\u009390%) across a range of standard deviations (online supplemental appendix A). To ensure 600 participants are enrolled and assuming a 10% refusal/ ineligibility, 660 households with at least one child 6 months to 10 years of age will be approached for recruitment.\n \n 10.1136/bmjopen-2023-082227.supp1\n Supplementary data\n \n\n\n \n The study is also powered for stratified analyses of primary outcome by age category. In children \n\u00e2\u0089\u00a4\n5 years and sample size 300 or 100 per arm, the study is powered to detect \n\u00e2\u0089\u00a5\n25% decrease in sick visits (90% power; 95% significance, 15% loss to follow-up) from a baseline estimate of 5.0 sicks visits/person-year (SD 2.9). In children aged 6\u00e2\u0080\u009310 years at enrolment and sample size 100 per arm, the study is powered to detect \n\u00e2\u0089\u00a5\n35% decrease in all-cause sick visits (90% power, 95% significance, 15% loss to follow-up) from a baseline estimate of 3.3 sick visits/person-year (SD 2.8). For stratified analyses of primary outcome by age, adequate power is also maintained across a range of standard deviations (online supplemental appendix A).\n The estimated baseline prevalence of the secondary outcome of anaemia (Hb<110\u00e2\u0080\u0089g/L) in the study population is 45%.27 50 53 54 With a sample size of 200 per arm the study is powered to detect \n\u00e2\u0089\u00a5\n35% decrease in the prevalence of anaemia (85% power, 95% significance (two sided), 15% loss to follow-up) from the estimated baseline prevalence. For children aged \n\u00e2\u0089\u00a4\n5 years and sample size of 300 or 100 per arm, the study is powered to detect \n\u00e2\u0089\u00a5\n40% decrease in prevalence of anaemia (80% power, 95% significance(two sided), 15% loss to follow-up) from a baseline estimate of 60%. For children aged 6\u00e2\u0080\u009310 years with an estimated baseline anaemia prevalence of 30%, the sample size of 300 does not provide adequate power to a detect difference in anaemia prevalence.", "id": 1604, "split": "test"} +{"trial_id": "NCT05567094", "pmid": "37660052", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy\n\nIncluded conditions:\n- Pancreaticoduodenectomy\n\nStudy Armgroups:\n- {'label': 'Dexamethasone', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'interventionNames': ['Drug: Dexamethasone']}\n- {'label': 'Saline placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'interventionNames': ['Drug: Saline placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'armGroupLabels': ['Dexamethasone']}\n- {'type': 'DRUG', 'name': 'Saline placebo', 'description': 'Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia', 'armGroupLabels': ['Saline placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The Comprehensive Complication Index (CCI)', 'description': 'The Comprehensive Complication Index (CCI) score within 30 days after the operation.\\n\\nThe CCI takes into account all cumulative complications and receives values between 0 and 100. The weight of complication (wC) of the CCI is based on the established Clavien-Dindo classification.', 'timeFrame': 'Within 30 days after the operation'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% (\u03b2=0.2), an \u03b1-error of 0.05, and a 20% dropout or deviation rate.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The Finland RCT reported that perioperative hydrocortisone significantly reduced postoperative complications after PD in high-risk patients (18% vs. 41%; P < 0.05; Clavien-Dindo III-IV) [14]. Based on the pancreatic transection line frozen samples, high-risk patients with >40% acini consisted of more than half of the cohort. Because 0.2 mg/kg dexamethasone has theoretically a similar anti-inflammatory effect to hydrocortisone, so we presume that the perioperative dexamethasone could reduce at least 30% of major complications in the whole PD cohort.\n For the sample size calculation, a 30% reduction in the rate of overall complications was assumed with a power of 80% (\u00ce\u00b2=0\u00c2\u00b72), and an \u00ce\u00b1-error of 0.05. This yielded an estimated group size of 128 patients. Finally, the sample size of this study is based on the primary outcome \u00e2\u0080\u0094 CCI. Because CCI is more sensitive and requires a smaller sample size compared to the Clavien-Dindo classification in RCT, 128 patients in each group are sufficient for the primary outcomes [24]. Finally, the target recruitment of the PANDEX trial will be set at 300 to account for 20% dropout or deviation of the protocol. Thus, 150 patients are required in each group.", "id": 1605, "split": "test"} +{"trial_id": "NCT05568264", "pmid": "37725613", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial\n\nIncluded conditions:\n- Motor Delay\n- Premature Birth\n- Intraventricular Hemorrhage\n- Hypoxic-Ischemic Encephalopathy\n- Bronchopulmonary Dysplasia\n\nStudy Armgroups:\n- {'label': 'Physical Therapy Intervention', 'type': 'EXPERIMENTAL', 'description': 'Infants enrolled in this arm will receive the intervention in addition to standard of care', 'interventionNames': ['Other: Physical Therapy intervention']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': 'Infants enrolled in this arm will receive standard of care'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Physical Therapy intervention', 'description': 'The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start in the NICU and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored.', 'armGroupLabels': ['Physical Therapy Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Bayley-4 motor score at 12-months corrected age', 'description': \"The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.\", 'timeFrame': 'Bayley-4 motor score assessed at 12-months CA will be the primary outcome'}\n\nPlease estimate the sample size based on the assumption: \nThe primary outcome measure is the motor subscale score of the Bayley-4 at 12 months with a mean of 100 and a standard deviation (SD) of 17.5. The significance level is not explicitly stated, but the power is 80% and the dropout rate is assumed to be 20%.", "answer": 192, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome measure, the motor subscale score of the Bayley-4 at 12 months, is a standardized score with a range of 45\u00e2\u0080\u0093155, a mean of 100 and a standard deviation (SD) of 15 but high risk children show more variable SD [99\u00e2\u0080\u0093101] and in a high risk clinic population from one study site, the SD for motor scores was 17.5 (unpublished data). For this study, we consider Bayley motor scores that are 8 points (~0.5 SD) higher in the intervention group compared to the control group at 12 months corrected age a clinically significant difference. For statistical power calculations, we used an SD of 17.5 to reflect the potential variability in Bayley-4 motor scores of infants enrolled in the trial. Given these pilot data sample size of 154 infants completing the trial (77 in each group) provides 80% power to detect an 8-point difference in the Bayley-4 motor scores at 12 months. To allow a 20% dropout rate, we will recruit up to 192 infants (96 in each group). Power calculations were completed using PASS 2020 software.", "id": 1606, "split": "test"} +{"trial_id": "NCT05568394", "pmid": "37094892", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Patients With Chronic Nonspecific Neck Pain: Study Protocol for a Randomized Controlled Trial.\n\nIncluded conditions:\n- Neck Pain\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Manual therapy and therapeutic exercise', 'interventionNames': ['Other: Manual therapy combinded with therapeutic exercise']}\n- {'label': 'Control group', 'type': 'EXPERIMENTAL', 'description': 'Routine physical therapy', 'interventionNames': ['Other: Routine physical therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Manual therapy combinded with therapeutic exercise', 'description': 'The treatment includes cervical mobilization and specific therapeutic exercises: craniocervical and cervical flexors and extensors, axioscapular muscles, and postural correction (30-40 minutes).\\n\\nThe participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Routine physical therapy', 'description': 'The treatment includes routine physical therapy (e.g., modalities, range of motion and/or gentle stretching exercise) (30-40 minutes).\\n\\nThe participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Cortical gray matter: volume and thickness', 'description': 'Cortical gray matter (volume and thickness) will be measured in pain-related areas (thalamus, prefrontal cortex (PFC), primary somatosensory cortex (S1), primary motor cortex (M1), insula, cingulate cortex, precuneus, temporal lobe and periaqueductal gray matter) using a Magnetic resonance imaging (MRI) machine', 'timeFrame': 'At baseline and post-intervention'}\n\nPlease estimate the sample size based on the assumption: \nUsing an unpaired t-test with 80% power and a 5% confidence level, and allowing for a 20% drop-out rate.", "answer": 52, "answer_type": "ACTUAL", "explanation": "Sample size\n There is no evidence for the effects of manual therapy combined with therapeutic exercise on brain structures in patients with chronic non-specific neck pain. Sample size calculation was, therefore, based on a previous study examining pretreatment to post-treatment changes in volumes for brain structures following interdisciplinary pain management programme (including physical therapy) in patients with chronic pain.13 The study showed a significant increase in total grey matter brain volume (mean percent change=0.39, p<0.001) after the programme. In addition, the study demonstrated that the average percent increase in total brain volume was greater for nonopioid users (mean percent change=0.51) compared with opioid users (mean percent change=0.21), which trended towards statistical significance (p=0.079). Assuming the SD of 0.4 for changes in brain volume13 and using an unpaired t-test with 80% power and a 5% confidence level, the optimum number of 21 participants per group is required. To allow for 20% drop-out rate, a total sample size of 52 participants (26 per group) will be recruited for this trial.", "id": 1607, "split": "test"} +{"trial_id": "NCT05571995", "pmid": "38165964", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Theory-Based Intervention Module on Occupational Safety and Health (TRIMOSH) in Improving Knowledge, Attitude, and Practice Among Food Industries Workers: Study Protocol for A Randomized Controlled Trial\n\nIncluded conditions:\n- Occupational Injuries\n- Occupational Diseases\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will receive TRIMOSH', 'interventionNames': ['Behavioral: TRIMOSH']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive no intervention.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'TRIMOSH', 'description': 'TRIMOSH will improve the knowledge, attitude and practice on occupational and health', 'armGroupLabels': ['Intervention'], 'otherNames': ['Theory-Based Intervention Module on Occupational Safety and Health']}\n\nPrimary Outcomes:\n- {'measure': 'knowledge on occupational safety and health', 'description': 'Adopted, modified and validated knowledge score questionnaire on occupational safety and health will be used to meassure the knowledge level', 'timeFrame': '3 months'}\n- {'measure': 'attitude on occupational safety and health', 'description': 'Adopted, modified and validated attitude score questionnaire on occupational safety and health will be used to meassure the attitude level', 'timeFrame': '3 months'}\n- {'measure': 'practice on occupational safety and health', 'description': 'Adopted, modified and validated practice score questionnaire on occupational safety and health will be used to meassure the practice level', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an average attrition rate of 20% at each testing time point, with three follow-up points after baseline data collection.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation in this study was based on the targeted primary outcomes, such as knowledge, attitude, and practice of safety and health. A previous power analysis specified an enrolment target of 20 clusters of six participants per condition. Provided that the average attrition rate in previous intervention studies was 20%, conservative estimation will be conducted on the attrition at 20% for each testing time point when the target sample size is designed. Given that the total time points in this study requirement are three times follow up after the baseline data collection, the required sample size comprises 20 clusters of 12 participants per group (N = 240). To encourage retention, lottery-style drawings will be carried out for participants who complete each data collection phase. Retention bonus pay will be offered for those who complete all four data collection phases.", "id": 1608, "split": "test"} +{"trial_id": "NCT05573828", "pmid": "37223015", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.\n\nIncluded conditions:\n- Iatrogenic Hypocalcemia\n\nStudy Armgroups:\n- {'label': 'Angiography group', 'type': 'EXPERIMENTAL', 'description': 'Patients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function.', 'interventionNames': ['Procedure: ICG angiography to show vascular map of parathyroid glands']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'ICG angiography to show vascular map of parathyroid glands', 'description': 'Using ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio', 'armGroupLabels': ['Angiography group']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of participants with postoperative permanent hypoparathyroidism', 'description': 'Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nAssuming 1:1 allocation, an alpha error of 5%, a statistical power of 80%, and a loss rate of approximately 5% in each group.", "answer": 394, "answer_type": "ESTIMATED", "explanation": "2.8\n Sample size and statistical analysis\n In a previous single-center study, it was found that in a prospective cohort of patients in which ICG arteriography was performed before removal of the thyroid gland, the rate of permanent hypoparathyroidism was 0% as compared with 11.9% in a cohort of historical controls (14). Based on a more conservative approach, a rate of permanent hypoparathyroidism of 2% is estimated in the ICG angiography-guided thyroidectomy and 8% in the control group. Assuming 1:1 allocation, an alpha error of 5%, a statistical power of 80%, and a loss rate of approximately 5% in each group, 197 patients per arm will be needed. Therefore, a total of 394 patients will be recruited. It is estimated that these patients will be included in the study between January 2023 and December 2024.\n Study variables will be collected by the researchers through clinical visits and results of laboratory analyses. Data will be stored in a codified electronic database specifically designed for the purpose of the study. Monitorization of study data will be performed by external personnel unaware of details of the study. To examine the benefits of identifying the vascular pattern of the parathyroid glands using an ICG angiography before thyroidectomy for preventing permanent hypoparathyroidism, a full analysis set will be performed, that is, all patients randomized who will be operated on, and followed postoperatively until permanent hypoparathyroidism will be resolved or for a maximum of 12 months after surgery. Categorical variables will be expressed as frequencies and percentages, and continuous variables as mean \u00c2\u00b1 standard deviation or median and interquartile range (IQR) (25th-75th percentile). The Shapiro-Wilks test will be used to assess the normal distribution of data and the Levene\u00e2\u0080\u0099s test to assess homoscedasticity. Categorical variables will be analyzed with the chi-square test or the Fisher\u00e2\u0080\u0099s exact test, and quantitative variables with the Student\u00e2\u0080\u0099s t test or the Mann-Whitney U test according to conditions of application. The risk ratio (RR) and the 95% confidence interval (95%) will be calculated to assess the probability of permanent hypoparathyroidism. Univariate and multivariate logistic regression models adjusted by confounding variables will be performed to identify risk factors for permanent hypoparathyroidism. P < 0.05 is set as the significance level. The Statistical Package for the Social Sciences (SPSS) version 26 for Windows will be used for data analysis.", "id": 1609, "split": "test"} +{"trial_id": "NCT05574400", "pmid": "37188468", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study\n\nIncluded conditions:\n- Postoperative Delirium\n- Postoperative Cognitive Dysfunction\n- Mild Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Prepared intravenous piggyback solution of 5 percent dextrose water at multiple postoperative time points over a 30-minute infusion period.', 'interventionNames': ['Drug: Dextrose Water']}\n- {'label': 'Low-dose Caffeine', 'type': 'EXPERIMENTAL', 'description': 'Prepared intravenous low-dose caffeine citrate (1.5 mg/kg) at multiple postoperative time points over a 30-minute infusion period.', 'interventionNames': ['Drug: Caffeine citrate']}\n- {'label': 'High-dose Caffeine', 'type': 'EXPERIMENTAL', 'description': 'Prepared intravenous high-dose caffeine citrate (3 mg/kg) at multiple postoperative time points over a 30-minute infusion period.', 'interventionNames': ['Drug: Caffeine citrate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dextrose Water', 'description': 'Dextrose 5% in water', 'armGroupLabels': ['Control']}\n- {'type': 'DRUG', 'name': 'Caffeine citrate', 'description': 'Low-dose caffeine citrate (1.5 mg/kg)', 'armGroupLabels': ['Low-dose Caffeine']}\n- {'type': 'DRUG', 'name': 'Caffeine citrate', 'description': 'High-dose Caffeine citrate (3 mg/kg)', 'armGroupLabels': ['High-dose Caffeine']}\n\nPrimary Outcomes:\n- {'measure': 'Delirium', 'description': 'Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM)', 'timeFrame': 'Day of surgery through afternoon of postoperative day three'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) set at 0.05, power between 80% and 95%, and an approximate 10% dropout rate.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n Sample size calculations were conducted via GEE Tests for Multiple Proportions in a Cluster-Randomised Design with Power Analysis and Sample Size Software (2022; NCSS).47 Significance level (\u00ce\u00b1) was set at 0.05. A postoperative delirium incidence (including the PACU time frame) of 30% was conservatively estimated based on our preliminary trial.16 A sample size of 250 participants will provide between 80% and 95%\u00e2\u0080\u0089power assuming a control group delirium incidence of 30%, 10\u00e2\u0080\u009330% in the 1.5\u00e2\u0080\u0089mg/kg group and 10%\u00e2\u0080\u009315% in the 3\u00e2\u0080\u0089mg/kg group. These effect sizes are estimated from our preliminary trial data with a similar dosing range (1.7\u00e2\u0080\u00934.5\u00e2\u0080\u0089mg/kg; median dose 2.5\u00e2\u0080\u0089mg/kg) and absolute risk reduction >20%.16 Increased potency may be expected with older patients given the reduced pharmacologic volume of distribution26 and a possible age-caffeine interaction effect with respect to cognition.25 This sample size also accounts for an approximate 10% dropout rate. Lastly, no interim analyses are planned in relation to the primary outcome.", "id": 1610, "split": "test"} +{"trial_id": "NCT05574582", "pmid": "37060040", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Arthroscopic Versus Open Cancellous Bone Grafting for Scaphoid Delayed/Non-union in Adults: Study Protocol for a Randomized Clinical Trial\n\nIncluded conditions:\n- Scaphoid Fracture\n- Scaphoid Nonunion\n\nStudy Armgroups:\n- {'label': 'Arthroscopic assisted Cancellous chips graft reconstruction', 'type': 'EXPERIMENTAL', 'description': 'The arthroscopic technique is potentially less invasive with minimal donor site morbidity and potentially faster time to union because of minimal trauma to the ligament structures, joint capsule, and the tenuous blood supply. It may also have advantageous osteogenic properties compared to a structural graft.\\n\\nCurrently, studies have reported similar union rates, patient reported outcomes score, and functional score compared to open graft technique. Results in patients with gross deformity are debated with some studies favoring conventional open structural graft and other found no difference in outcome between the techniques.', 'interventionNames': ['Procedure: Graft reconstruction and internal fixation with compression screw']}\n- {'label': 'Open cancellous graft reconstruction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Convention open technique with debridement of the nonunion side, insertion of cancellous graft from the iliac crest and osteosynthesis with compression screw is currently commonly applied in scaphoid nonunion.', 'interventionNames': ['Procedure: Graft reconstruction and internal fixation with compression screw']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Graft reconstruction and internal fixation with compression screw', 'description': 'Patients suffering from scaphoid nonunion are treated surgically by debridement, graft reconstruction and internal fixation with compression screw', 'armGroupLabels': ['Arthroscopic assisted Cancellous chips graft reconstruction', 'Open cancellous graft reconstruction']}\n\nPrimary Outcomes:\n- {'measure': 'Time to Union', 'description': 'Assessed with CT-scans. Union is proclaimed if at least 50% bone bridging is recorded together with absence of pain in the clinical examination', 'timeFrame': '6-16 weeks postoperative in 2 weeks intervals. If unions is not achieved a CT will be made 26 weeks postoperatively. If union is not achieved at that point, the patient will be presented for another treatment modality'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided alpha of 0.05, 20% dropout/loss to follow-up rate.", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was performed with an expected mean time to union of 56\u00c2\u00a0days and a SD of 30\u00c2\u00a0days in Group A and 77\u00c2\u00a0days and SD on 40\u00c2\u00a0days in group B. The sample size required in each group to provide 80% power to detect a mean 3\u00c2\u00a0weeks difference [13], with two-sided alpha on 0.05, was 36 patients in each group. Considering dropouts and loss to follow-up with a rate of 20% the final number of patients needed in total for this study is 88 patients.", "id": 1611, "split": "test"} +{"trial_id": "NCT05577481", "pmid": "39515856", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder\n\nIncluded conditions:\n- Depression\n\nStudy Armgroups:\n- {'label': 'functional MRI-guided iTBS(sham group)', 'type': 'SHAM_COMPARATOR', 'description': 'The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).', 'interventionNames': ['Combination Product: sham iTBS combined with antidepressants']}\n- {'label': 'functional MRI-guided iTBS (pgACC-DLPFC)', 'type': 'EXPERIMENTAL', 'description': 'The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).', 'interventionNames': ['Combination Product: iTBS combined with antidepressants']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'sham iTBS combined with antidepressants', 'description': 'Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.', 'armGroupLabels': ['functional MRI-guided iTBS(sham group)']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'iTBS combined with antidepressants', 'description': 'Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.', 'armGroupLabels': ['functional MRI-guided iTBS (pgACC-DLPFC)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment', 'description': 'The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.', 'timeFrame': 'baseline and 4-week post treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe test level was set at \u03b1=0.05, \u03b2=0.2, and the power was 0.8. A 20% dropout rate was considered.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to previous studies by our group and previous literature, the efficacy of the functional connectivity localisation group was about 55%19 20 while the efficacy of the sham stimulation group was about 20%.21 The test level was set at \u00ce\u00b1=0.05, \u00ce\u00b2=0.2\u00e2\u0080\u0089and the power was 0.8. The sample size was calculated using the PASS software (V.15) which required a total of 54 people to be included and 68 people were finally included, taking into account the drop-out of subjects (20%).", "id": 1612, "split": "test"} +{"trial_id": "NCT05577741", "pmid": "37173113", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of the Enriched Environment on the Risk of Relapse: Clinical Study Combining Physical Activity With Mindfulness in Virtual Reality\n\nIncluded conditions:\n- Alcoholic Relapse\n\nStudy Armgroups:\n- {'label': 'Interventional Group', 'type': 'EXPERIMENTAL', 'description': 'Patients complete a measurement session at inclusion visit (Day 1). These measures include an assessment of explicit and implicit craving, a measure of mindfulness skills and a measure of the perceived richness (in stimuli) of daily environment. After inclusion visit, patients randomized in the interventional group will have 6 sessions of enriched environment (from Day 2 to Day 9).\\n\\nThe enriched environment includes:\\n\\n* the multisensory virtual reality pod offers sessions of 20 minutes of mindfulness in immersive situations. Some immersive situations are relaxing and others trigger cues in order to improve craving management;\\n* the cognitive bike offers training sessions of 20 minutes. The patient pedals while using a touch pad with cognitive training games. This simultaneously stimulate motor skills and cognition by means of bicycle-game coupling.\\n\\nA second measurement session takes place at Day 10. Alcoholic relapse is then evaluated at two weeks, one month and 3 months.', 'interventionNames': ['Behavioral: Multisensory virtual reality pod (SENSIKS\u00a9)', 'Behavioral: Cognitive bike (V\u00e9lo-cognitif\u00ae)', 'Other: Standard treatment']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients complete a similar measurement session to the intervention arm, that include psychological tasks and questionnaires at inclusion visit (Day 1). After inclusion visit, patients randomized in the control group wil received the standard of care.\\n\\nA second measurement session takes place at Day 10. Alcoholic relapse is then evaluated at two weeks, one month and 3 months.', 'interventionNames': ['Other: Standard treatment']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Multisensory virtual reality pod (SENSIKS\u00a9)', 'description': 'Six sessions of 20 minutes of mindfulness.', 'armGroupLabels': ['Interventional Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive bike (V\u00e9lo-cognitif\u00ae)', 'description': 'Six sessions of 20 minutes of cognitive bike (pedal + cognitive games).', 'armGroupLabels': ['Interventional Group']}\n- {'type': 'OTHER', 'name': 'Standard treatment', 'description': 'Standard of care treatment', 'armGroupLabels': ['Control Group', 'Interventional Group']}\n\nPrimary Outcomes:\n- {'measure': 'Alcoholic relapse', 'description': 'Relapse at 2 weeks (after Day 10), defined by the consumption of at least 5 glasses per occasion, or by consumption at least 5 times a week, assessed by the Time Line Follow Back, a beathalyser or a significant increase in Carbohydrate Deficient Transferrin and Gamma-GT.\\n\\nWe will consider a relapse to have occurred if at least one of the three indicators points to a relapse: 1) if in the TLFB the patient indicates consumption of at least 5 times per week or at least 5 drinks per occasion; 2) if there is a significant increase in CDT and GGT since the D10 blood test, and 3) If the breathalyser is positive. We will consider patients as non-relapsers if none of these indicators (TLFB, CDT and GGT, breathalyzer) is positive.', 'timeFrame': '2 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% statistical power, a significance level of p<0.05 (two-tailed), and accounts for possible missing data by including additional participants. For secondary outcomes, the study aims for a power of 0.82 to detect a medium or larger effect size (Cohen's d>0.50).", "answer": 135, "answer_type": "ESTIMATED", "explanation": "Sample size\n The required sample size was computed to have 80% statistical power to detect a significant reduction of relapse rate of at least 25% on our primary outcome (with p<0.05, two-tailed). We considered a 25% reduction in relapse rate as the smallest effect size of interest in our study. This effect size seems realistic to us and appears to be the smallest effect size of clinical interest given the investment of material and human time in this intervention. The smallest effect size of interest is the smallest effect that (1) researchers personally care about, (2) is theoretically interesting or (3) has practical relevance.84 The relapse rate on our site is about 50% on average after 1 month.62 This is consistent with other studies in which nearly half of the patients relapsed in the weeks following hospital discharge for alcohol withdrawal.85 86 With a relapse rate of 50% after 1 month, there is significant potential to reduce the relapse rate by 25%. It is quite possible that the intervention will have a much smaller effect size. However, if the relapse rate is not reduced by at least 25%, the intervention would be considered to have no efficacy or too low to be of clinical relevance.\n The a priori power analysis for sample size indicates that the required sample size is 116 for our primary outcome. However, we will include 135 patients to compensate for possible missing data. For the secondary outcomes (craving, mindfulness skills, perceived richness of the daily environment) this sample size (N=135) provides adequate power (1-\u00c3\u009f=0.82) to detect a medium effect size or a larger effect size (Cohen\u00e2\u0080\u0099s d>0.50, with p<0.05 (two-sided).", "id": 1613, "split": "test"} +{"trial_id": "NCT05577754", "pmid": "39806603", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Double-blind Multi-center, Placebo-controlled Trial, to Assess the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients with Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)\n\nIncluded conditions:\n- Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Alpelisib (BYL719)', 'Drug: Matching placebo', 'Procedure: Optional lumbar puncture + blood sample']}\n- {'label': 'Group B', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Alpelisib (BYL719)', 'Procedure: Optional lumbar puncture + blood sample']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Alpelisib (BYL719)', 'description': 'Administration during open label and double-blind period of group B: alpelisib will be taken once a day each day over 24 mois During open label period of group A: alpelisib will be taken once a day each day over 24 months', 'armGroupLabels': ['Group A', 'Group B']}\n- {'type': 'DRUG', 'name': 'Matching placebo', 'description': 'During double-blind period of group A: matching placebo will be taken once a day each day over 6 months', 'armGroupLabels': ['Group A']}\n- {'type': 'PROCEDURE', 'name': 'Optional lumbar puncture + blood sample', 'description': 'Between 6 and 24 months of treatment with Alpelisib', 'armGroupLabels': ['Group A', 'Group B']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants with response at end of treatment assessed by the Vineland II Adaptive Behavior Scale (VABS-II)', 'description': 'Response defined by an improvement of at least 4 points in the Vineland II Adaptive Behavior Scale (VABS-II). The VABS-II consists of a form which will be filled during an interview with an adult who is familiar with the everyday activities of the patient (usually the parents). It is organized within a three-domain structure: communication, daily living skills, and socialization. In addition, VABS-II has a motor skills domain for the youngest children (younger than 6) and an optional maladaptive behavior index \\\\[Sparrow et al.,2016\\\\]. The domains (communication, daily living skills, and socialization) - standard scores have a mean of 100 and a standard deviation of 15. Adaptive levels can also be determined. A global standard score can also be computed (the Adaptive Behavior Composite standard score) and also has a mean of 100 and a standard deviation of 15.', 'timeFrame': 'At 24 months of treatment compared to baseline'}\n\nPlease estimate the sample size based on the assumption: \nAlpha=0.05, power (1-beta)=0.90, bilateral test, and accounting for possible loss of follow-up or withdrawal of consent.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The assumptions are as follows: (1) when following untreated MCAP patients 6.0% at best may have experienced the four point improvement, (2) the minimal requirement for the treatment to be considered clinically relevant by regulatory bodies is at least one-third of the treated patients (33%) experiencing the four point improvement. With alpha=0.05, 1-beta=0.90 and a bilateral test, 16 patients are needed to prove the statistical difference between the theoretical and observed proportion. We are thus planning to enrol and analyse 20 patients to take account of possible loss of follow-up or withdrawal of consent. The approach for sample size calculation is also pragmatic based on known and estimated cohorts. A cohort of about 60 patients with MCAP and PIK3CA pathogenic variants is available, two-thirds of them having ID or learning disability that could justify being enrolled in a clinical trial. If a patient is withdrawn from the study before treatment initiation, he will be replaced to be able to conduct the comparison between alpelisib and placebo groups with 10 patients in each group.", "id": 1614, "split": "test"} +{"trial_id": "NCT05578690", "pmid": "39863406", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity. A Randomized, Parallel Group, Tailored Multifactorial Lifestyle Intervention Trial Among Women With Overweight or Obesity Seeking Pregnancy - the PRE-STORK Trial\n\nIncluded conditions:\n- Overweight and Obesity\n- Pregnancy Related\n\nStudy Armgroups:\n- {'label': 'Lifestyle group', 'type': 'EXPERIMENTAL', 'description': 'A tailored multifactorial lifestyle intervention consisting of diet, exercise and mentorship in women with overweight or obesity to obtain a healthy lifestyle before and during pregnancy.', 'interventionNames': ['Behavioral: Diet', 'Behavioral: Exercise', 'Behavioral: Mentorship']}\n- {'label': 'Standard of care group', 'type': 'NO_INTERVENTION', 'description': 'The standard of care group will receive no active intervention but are encouraged to seek any possible guidance from the general practitioner for management of pre-pregnancy obesity according to current guidelines.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Diet', 'description': 'An initial 8 weeks of low-calorie diet including meal replacements (total of 800 kcal/day) will be initiated with the objective to lose at least 10% of initial body weight. From week 8 until week 12, an individual food-reintroduction plan will take place with partial meal product substitution. At week 12 and until pregnancy dieticians will ensure sustained compliance with diet aligned with the general recommendations for women seeking pregnancy (low-fat diet, rich in protein and carbohydrates and in some individuals slightly carbohydrate-reduced diet (prediabetes or family disposition to diabetes) with focus on carbohydrate quality (more fiber and whole grain). Consultations with a dietician for mapping diet and eating patterns and regular follow-up with a dietitian to maintain diet changes and modify diets if needed.', 'armGroupLabels': ['Lifestyle group']}\n- {'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': 'After an initial 8-week ramp-up phase (during the initial low-calorie diet), the women will be encouraged to attend supervised exercise sessions on the study location (combination of vigorous-intensity, interval-based indoor cycling, and circuit training) twice weekly and to perform additional moderate-to vigorous-intensity exercise to obtain at least 150 min per week of moderate-intensity or 75 min per week of vigorous-intensity physical activity or a combination. The plan will include individual exercise and/or group exercise. Exercise watches with heart-rate monitors will be worn at each exercise session to determine whether the requirement regarding weekly time spent at moderate or vigorous intensity will be met. Regular follow-up with the women to maintain exercise changes and modify the exercise plan if needed.', 'armGroupLabels': ['Lifestyle group']}\n- {'type': 'BEHAVIORAL', 'name': 'Mentorship', 'description': 'Women are offered an individualized plan to successfully fulfil the multifactorial lifestyle intervention and the women will be offered both individual and/or group sessions with a mentor. After 8 weeks of the intervention, the women will be invited to another meeting where the choice of mentor will be evaluated, and the women will be offered to join a \"pre-parents-group\". Group sessions will include conversational sessions, cooking classes and exercise classes with focus on changing lifestyle and maintaining a healthy lifestyle change. At the time of pregnancy groups will be reconsidered and the women will be offered participation in \"pregnancy-groups\".', 'armGroupLabels': ['Lifestyle group']}\n\nPrimary Outcomes:\n- {'measure': 'Neonatal adiposity', 'description': 'Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).', 'timeFrame': 'Assessed at birth or up to 72 hours postpartum.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 80%, and an anticipated 30% dropout rate. Adjustment for maternal age, BMI, and parity is expected to reduce residual SD to around 140 g.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n A Danish cohort study reported a mean neonatal fat mass of 433\u00e2\u0080\u0089g (SD 212\u00e2\u0080\u0089g) in mothers with obesity compared with 331\u00e2\u0080\u0089g (SD 163\u00e2\u0080\u0089g) in mothers with normal weight.105 Additionally the DALI study found an effect of healthy diet and physical activity counselling compared to standard of care with a difference of -63 gram (95% CI -124 gram to -2 gram, P=0.04).106 Since we will include women with a BMI of 25 to 44 kg/m\u00c2\u00b2, expected to lose 10% of their weight, we do not anticipate achieving an average pre-pregnancy BMI of 22 kg/m\u00c2\u00b2 in the intervention group. As a result, we expect a smaller reduction in neonatal fat mass of 54 grams. To detect this difference between the control and intervention group at a significance level of 5% with a power of 80%, a total of 125 newborns are needed in each group if adjustment for maternal age, BMI and parity as baseline covariates will reduce residual SD in the analysis of covariance (ANCOVA) model to around 140 g. We anticipate that approximately 30% of the randomised women will either not become pregnant or drop out of the trial. Two large Danish cohort studies examining birth rates, including 3,727 and 1,651 women respectively, found that 68% and 70% conceived after 12 cycles. Both studies excluded women with more than six cycles of attempted conception at study entry. They had no exclusion criteria related to BMI or known infertility. To our knowledge, few studies have examined pre-conception lifestyle interventions. R\u00c3\u00b6n\u00c3\u00b6 et al. assessing the effect of a pre-conception intervention aimed at preventing GDM found that 67% of women (n=72) in the intervention group and 63% (n=71) in the control group became pregnant.107 Hence, we will include a total of 360\u00e2\u0080\u0089women in the study, which will establish a birth cohort of valuable size for further follow-up.\n To our knowledge, no studies have examined the long-term effects of pre-conception lifestyle interventions on children's health. A review by Amati et al. found an association between infant adiposity and later BMI.108 Wibaek et al. showed that greater fat mass at birth, measured using PEA POD, was associated to higher cholesterol levels at age 5,109 Josefson et al. found that both newborn fat mass and birth weight were associated with childhood adiposity.110 Moore et. al. investigated the relationship between newborn adiposity and childhood obesity, measured using PEA POD. They found neonates with adiposity +1 SD above the mean had a higher BMI, with 23% being overweight or obese by ages 5-6.15 However, these findings do not allow us to predict the same long-term effects from the 54-gram difference expected in this study, which is a proof-of-concept study to assess whether pre-conception weight loss affects neonatal fat mass.\n Sample size calculations were made with SAS Enterprise guide V.7.11.", "id": 1615, "split": "test"} +{"trial_id": "NCT05580068", "pmid": "39237273", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pilot-Studie Zur Explorativen Untersuchung Und Validierung Eines Studienvorhabens Zur Digitalen Therapiesteuerung Von Patienten Mit Arterieller Hypertonie im Vergleich Der Behandlung Mit Dem Standard-of-Care - iATROS eXPLORE\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'The intervention to be carried out in the treatment group is the use of the therapy measures for the treatment of arterial hypertension, which is delivered through the iATROS medical device. The therapy by means of the medical device takes place over 90 days.', 'interventionNames': ['Device: Hypertension therapy through iATROS medical device']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'For the duration of the in-life phase, the treatment of the control group will follow the standard-of-care except for the measures necessary for the conduct of the study.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Hypertension therapy through iATROS medical device', 'description': 'The intervention to be carried out in the treatment group is the use of the therapy support provided by the iATROS medical device for the treatment of arterial hypertension.\\n\\nIn particular, patients are guided through a structured digital therapy program that enables them to better manage their disease. Patient receive reminders for taking their medication, for performing vital parameter measurements, and receive educational content for them to learn how to manage their disease better.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Exploratory testing of study-related measures and the use of iATROS.', 'description': 'Determination of subjective burden perception of the study-related measures using the Study Participant Feedback Questionnaire (SPFQ) - Questionnaire.\\n\\nThe three subscales (A-C) are administered at three discrete time points, immediately after enrolment, after half the in-live phase time has passed and at the last visit in the study center. The questions are answered on a 5-point scale with a higher level indicating a higher satisfaction with the study-related measures. Possible levels are 0 to 24 (subscale A), 0 to 39 (subscale B) and 0 to 14 (subscale C).', 'timeFrame': 'Baseline and study completion, an average of 180 days'}\n\nPlease estimate the sample size based on the assumption: \nThe primary goal was to evaluate the feasibility of the study concept, and the collected data will be used for power calculation in future larger-scaled studies.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n For the eXPLORE feasibility study, a sample size of 100 participants (n=50 intervention group vs n=50 control group) to complete the follow-up was predetermined as the primary goal was to evaluate the feasibility of the study concept. Additionally, the collected data provides information about the spread of the blood pressure data which will be considered for the power calculation of larger-scaled follow-up studies. The present investigation was not powered to detect blood pressure differences between the groups.", "id": 1616, "split": "test"} +{"trial_id": "NCT05580523", "pmid": "38631826", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial\n\nIncluded conditions:\n- Preeclampsia\n\nStudy Armgroups:\n- {'label': 'Aspirin 75 mg and placebo', 'type': 'EXPERIMENTAL', 'description': \"A capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery.\", 'interventionNames': ['Drug: 75 mg acetylsalicylic acid', 'Drug: Placebo of acetylsalicylic acid and Metformin']}\n- {'label': 'Aspirin 150 mg and placebo', 'type': 'EXPERIMENTAL', 'description': \"Two capsules of 75 mg aspirin to be taken orally once per night from enrolment until 36 weeks' gestation and metformin identical-appearing placebo capsules to be taken orally twice per day from enrolment until delivery.\", 'interventionNames': ['Drug: 150 mg acetylsalicylic acid', 'Drug: Placebo of acetylsalicylic acid and Metformin']}\n- {'label': 'Aspirin 75 mg and Metformin 1.5 g', 'type': 'EXPERIMENTAL', 'description': \"A capsule of 75 mg aspirin plus an aspirin identical-appearing capsule of placebo to be taken orally once per night from enrolment until 36 weeks' gestation and metformin capsules (up to 750 mg) to be taken twice per day from enrolment until delivery\", 'interventionNames': ['Drug: 75 mg acetylsalicylic acid', 'Drug: 1.5g Metformin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '75 mg acetylsalicylic acid', 'description': '75 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral', 'armGroupLabels': ['Aspirin 75 mg and Metformin 1.5 g', 'Aspirin 75 mg and placebo'], 'otherNames': ['75mg Aspirin']}\n- {'type': 'DRUG', 'name': '1.5g Metformin', 'description': 'up to 1.5 g metformin (C4H11N5, CAS number 657-24-9) daily, Oral Dose increases from 0.5g to 1.0g to 1.5g', 'armGroupLabels': ['Aspirin 75 mg and Metformin 1.5 g'], 'otherNames': ['1.5g Glucophage']}\n- {'type': 'DRUG', 'name': '150 mg acetylsalicylic acid', 'description': '150 mg acetylsalicylic acid (C9H8O4, CAS number 50-78-2) daily, Oral', 'armGroupLabels': ['Aspirin 150 mg and placebo'], 'otherNames': ['150mg Aspirin']}\n- {'type': 'DRUG', 'name': 'Placebo of acetylsalicylic acid and Metformin', 'description': 'Pills with shape, color and smell same with acetylsalicylic acid and metformin, daily, oral', 'armGroupLabels': ['Aspirin 150 mg and placebo', 'Aspirin 75 mg and placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of preterm preeclampsia(<37 weeks)', 'description': 'Preeclampsia will be defined as per the International Society for the Study of Hypertension in Pregnancy.The Proportions of delivery with preterm-preeclampsia between different intervention groups will be measured.', 'timeFrame': '\u226520 weeks to <37 weeks of gestation'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes 80% power, a type I error rate of 5%, and a 70% uptake rate. The detection rate of the first trimester combined test is 65%, with a 10% screen-positive rate.", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Sample size\n When using 4.3% as the incidence of preterm-PE of base-case,16 aspirin 75\u00e2\u0080\u0089mg and aspirin 150\u00e2\u0080\u0089mg are expected to reduce the incidence to 3.9%19 and 1.6%, respectively.16 19 A sample size of 790 per group is required to detect a significant difference with 80% power and type I error of 5%. In a 3-arm design, after adjusting the inflation of type I error using Bonferroni correction, a sample size of 957 per group is required so in total 3000 high-risk women are required to be randomised. Assuming a 70% uptake, 4285 high-risk women are required to be identified. The detection rate of the first trimester combined test of maternal factors, MAP and PlGF is 65% and we expect a 10% screen-positive rate, therefore, 66\u00e2\u0080\u0089000\u00e2\u0080\u0089women with singleton pregnancy will need to be screened.", "id": 1617, "split": "test"} +{"trial_id": "NCT05585099", "pmid": "37005596", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Retro Walking Exercise Using Lower Body Positive Pressure on Knee Pain and Physical Function in People With Knee Osteoarthritis\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Participants will walk in retro walking exercise on lower body positive pressure treadmill.', 'interventionNames': ['Other: Exercise']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Participants will walk in forward walking exercise on lower body positive pressure treadmill.', 'interventionNames': ['Other: Exercise']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise', 'description': 'Participants will stand on lower body positive pressure treadmill and participate in walking exercise.', 'armGroupLabels': ['Control', 'Experimental'], 'otherNames': ['Walking exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Numeric pain rating scale', 'description': 'The NPRS is an 11-point scale with \"0\" representing \"no pain\" and \"10\" representing \"most imaginable pain\" used to assess pain intensity.', 'timeFrame': 'Change from baseline pain at 6 weeks'}\n- {'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'description': 'The KOOS is a self-reported, knee-specific questionnaire that is aimed to measure knee pain, symptoms, and level of disability during the last week.', 'timeFrame': 'Change from baseline pain, symptoms, and level of disability at 6 weeks.'}\n- {'measure': 'Thigh muscle strength test', 'description': \"A Biodex isokinetic dynamometer (Model 4Pro) connected to a computer will be used to assess bilateral knee's flexor and extensor isometric muscle strength.\", 'timeFrame': 'Change from baseline thigh muscle strength at 6 weeks.'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1 level of 0.05, power of 0.80, 20% attrition rate", "answer": 26, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n G Power software analysis version 3.1.9.2 (University of Kiel, Kiel, Germany) was used to determine the sample size using pain level changes following intervention from a prior study [12]. With a small effect size of 0.29, \u00ce\u00b1 level of 0.05, and power of 0.80, the required sample size is 22 participants (11 participants per group). With a 20% attrition rate, there will be a total of 26 participants for total sample (13 participants in each group).", "id": 1618, "split": "test"} +{"trial_id": "NCT05585450", "pmid": "39032929", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial\n\nIncluded conditions:\n- Benign Prostatic Hyperplasia\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture (EA) group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the EA group will receive treatment at bilateral Bladder Meridian (BL) 32 \\\\[Ciliao\\\\], BL33 \\\\[Zhongliao\\\\], BL35 \\\\[Huiyang\\\\], and Spleen Meridian (SP) 6 \\\\[Sanyinjiao\\\\].\\n\\nBL32, in the second posterior sacral foramen; BL33, in the third posterior sacral foramen; BL35, 0.5 cun (\u224810mm) lateral to the extremity of the coccyx; SP6, posterior to the medial border of the tibia, 3 cun (\u224860mm) superior to the prominence of the medial malleolus.\\n\\nThe treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 8 weeks.', 'interventionNames': ['Device: Electroacupuncture']}\n- {'label': 'Sham Electroacupuncture (SA) group', 'type': 'SHAM_COMPARATOR', 'description': 'Participants in the SA group will receive treatment at bilateral sham BL32, BL33, BL35, and SP6.\\n\\nSham BL32, in the area of 2 cun (\u224840mm) horizontally outside BL32; Sham BL33, in the area of 2 cun (\u224840mm) horizontally outside BL33; Sham BL35, 2 cun (\u224840mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons.\\n\\nThe treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 8 weeks.', 'interventionNames': ['Device: Sham electroacupuncture']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electroacupuncture', 'description': 'BL32 and BL33 will be inserted by needles of 0.30\u00d775mm size at an angle of 45\u00b0, inward and downward, to the depth of 60-70mm. BL35 will be inserted by needles of 0.30\u00d775mm size, slightly outward and upward, to the depth of 60-70mm. SP6 will be inserted by needles of 0.30\u00d740mm to the depth of 25-30mm. The needles will be lifted, thrust, and twisted evenly three times after insertion to induce the sensation of deqi.\\n\\nThe electronic acupuncture apparatus (Yingdi KWD 808I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the four pairs of needles transversally, with a continuous wave of 5 Hertz (Hz) and an electric current of 2-6.5 milliampere (mA) for BL32, BL33 and BL35, and 0.5 mA-2mA for SP6.', 'armGroupLabels': ['Electroacupuncture (EA) group'], 'otherNames': ['EA']}\n- {'type': 'DEVICE', 'name': 'Sham electroacupuncture', 'description': 'The four pairs of acupoints will be inserted by needles of 0.30\u00d725mm or 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.\\n\\nThe electronic acupuncture apparatus (Yingdi KWD 808I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the four pairs of needles transversally, with a continuous wave of 5 Hz and a 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': 'The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline', 'description': 'The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.', 'timeFrame': 'week 8'}\n- {'measure': 'The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline', 'description': 'The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.', 'timeFrame': 'week 20'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided \u03b1 level of 0.05, 20% dropout or withdrawal rate.", "answer": 306, "answer_type": "ESTIMATED", "explanation": "Sample size\n To estimate the sample size, we will assume the proportions of participants with at least 30% reduction in the IPSS total score from baseline at week 8 to be 75% in the EA group and 55% in the SA group based on the results of our unpublished study, which showed that the primary outcome at week 8 was 77% among the group receiving EA and 55% among the SA group. The study needed 236 participants to achieve 90% power with a two-sided \u00ce\u00b1 level of 0.05. Assuming a 20% dropout or withdrawal rate, the study will need 306 participants to provide 90% power with a two-sided \u00ce\u00b1 level of 0.05.", "id": 1619, "split": "test"} +{"trial_id": "NCT05585983", "pmid": "38950997", "question": "Here is the design of a clinical trial:\n\nOfficial Title: INfluenza VaccInation To Mitigate typE 1 Diabetes (INVITED Trial)\n\nIncluded conditions:\n- Diabetes Mellitus, Type 1\n\nStudy Armgroups:\n- {'label': 'Influenza vaccination', 'type': 'EXPERIMENTAL', 'description': 'Influenza vaccine, 0.5 mL.', 'interventionNames': ['Biological: Vaxigrip Tetra Sanofi Pasteur Europe']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo, 0.5 mL saline.', 'interventionNames': ['Biological: Vaxigrip Tetra Sanofi Pasteur Europe']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Vaxigrip Tetra Sanofi Pasteur Europe', 'description': 'We will use 0.5 mL standard dose quadrivalent influenza vaccine containing 15 \u03bcg of hemagglutinin per strain consistent with WHO recommendations according to season.', 'armGroupLabels': ['Influenza vaccination', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in fasting residual \u03b2 cell (C-peptide) function.', 'description': 'Measured as the area under the concentration-time curve (AUC) for mixed-meal tolerance test-stimulated C-peptide concentration over 4 hours relative to baseline (AUC 0-4 h, C-peptide, 12 months/ AUC 0-4 h, C-peptide, baseline)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.05, statistical power of 85%, and a 10% dropout rate.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Data management, sample size calculation and statistical analysis\n All trial data from visits 1\u00e2\u0080\u00933, the 7-day side effects questionnaire and suspected unexpected serious adverse reactions will be recorded in the eCRF. Data management and statistical analyses will be performed at Aarhus University Hospital. Access to the trial database is password-protected and will be restricted to certain study team members with different levels of access assigned by the study coordinator. All participants will be assigned an identification number, recorded in the eCRF, along with baseline data and all data collected within the study.\n The study results will be analysed according to the intention-to-treat principle, with one modification. Due to the study intervention (influenza vaccine or placebo) being administered only once during the initial hospitalisation and because most protocol deviations related to the intervention are expected to be logistical (such as patients leaving the hospital before receiving the study medication), we will define the modified intention-to-treat population as all patients who were randomised to their assigned treatment and who received the study medication. A participant can withdraw from the study at any time. Participants who are lost to follow-up at 6 months will be censored on the day of the baseline visit and participants who are lost to follow-up at 12 months will be censored at the 6-month follow-up visit.\n \n Sample size calculation\n The sample size calculation is based on recommendations from an American Diabetes Association workshop report25 and a recent publication addressing the opportunity to use analysis of covariance to improve precision.28 The increase in precision is due to adjusting for both baseline C-peptide levels and age, which allows a 50% reduction in sample size relative to the unadjusted comparison. Following recommendations and calculations from Krogvold et al,17 we assumed an effect size of 50% improvement in stimulated C-peptide level at 12 months in the treatment group compared with the placebo group. This assumption is based on considerations of clinical relevance in children and adolescents with T1D. Based on the above-mentioned studies, the sample size calculation was set to estimate a 50% improvement in the primary endpoint in the treatment group with a two-sided alpha of 0.05. Accounting for 10% dropout, we will randomly assign 50 participants in each of the two groups to obtain a statistical power of 85%.\n \n \n Statistical analysis\n The primary endpoint of the relative change in mean 2-hour C-peptide area under the curve (AUC) from baseline to 12 months will be analysed using a linear mixed model for repeated measurements with adjustments for sex, age and baseline C-peptide response in the two study groups. C-peptide AUC will be fitted on a log-transformed scale. In the model, we will include measurements taken at 6 months, as these will improve precision in estimates of individual random effects, which in turn will improve the precision of effect estimates. Differences at baseline between study groups will be assessed with an unpaired t-test on the original scale or a log-transformed scale based on the evaluation of a normal distribution. Non-parametric comparisons will be applied for outcomes where it is not possible to obtain an adequate normal distribution, with or without logarithmic transformation. Ordinal variables will be assessed with the \u00cf\u00872 test for trend or the Mann-Whitney U test. To test for differences between proportions, Pearson\u00e2\u0080\u0099s \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test will be used. Missing data will be assumed to be missing at random. Multiple imputations will be used for individuals if more than 5% of the covariates are missing (m=100). Two-sided statistically significant levels of 5% will be used and estimates will be presented with 95% CIs.", "id": 1620, "split": "test"} +{"trial_id": "NCT05586724", "pmid": "39448218", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety of Oral Micronized Progesterone Versus Norethisterone Acetate in Continuous Combination With Oral Estrogen as Menopausal Hormone Therapy - a Double-blind Randomized Study- PROBES Study (Progesterone Breast Endometrial Safety Study)\n\nIncluded conditions:\n- Menopausal Symptoms\n\nStudy Armgroups:\n- {'label': 'Micronized progesterone in continuous combination with oral estrogen', 'type': 'ACTIVE_COMPARATOR', 'description': 'Capsule 100 mg mP (Utrogestan\u00ae) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem\u00ae)', 'interventionNames': ['Drug: Micronized progesterone in continuous combination with oral estrogen']}\n- {'label': 'Norethisterone acetate in continuous combination with oral estrogen', 'type': 'ACTIVE_COMPARATOR', 'description': 'Capsule 0.5 mg NETA/ 1 mg estradiol (Activelle\u00ae) orally per day (encapsulated and identical to Estrofem\u00ae and one matched placebo to Utrogestan.', 'interventionNames': ['Drug: Norethisterone acetate in continuous combination with oral estrogen']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Micronized progesterone in continuous combination with oral estrogen', 'description': 'Capsule 100 mg mP (Utrogestan\u00ae) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem\u00ae)', 'armGroupLabels': ['Micronized progesterone in continuous combination with oral estrogen']}\n- {'type': 'DRUG', 'name': 'Norethisterone acetate in continuous combination with oral estrogen', 'description': 'Capsule 0.5 mg NETA/ 1 mg estradiol (Activelle\u00ae) orally per day (encapsulated and identical to Estrofem\u00ae and one matched placebo to Utrogestan', 'armGroupLabels': ['Norethisterone acetate in continuous combination with oral estrogen']}\n\nPrimary Outcomes:\n- {'measure': 'Mammographic breast density', 'description': 'Percentage change in mammographic density', 'timeFrame': 'At baseline and 12 months treatment'}\n- {'measure': 'Endometrial pathology', 'description': 'The incidence of endometrial pathology (hyperplasia or cancer)', 'timeFrame': 'At baseline and 12 months treatment'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5% (two-sided), 80% power, and an estimated discontinuation/incomplete data rate of ~30%.", "answer": 520, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n \n Mammographic breast density: primary outcome in part 1\n Based on data from the WHI study, it was shown that an increase in mammographic density by 1% during combined MHT corresponded to a 3% increase in risk of breast cancer.42 We estimated that a difference of at least 30% in treatment response between the groups would be clinically relevant. A power analysis based on our previous results,2730 and assuming a 35% difference in treatment response, revealed that a patient material of 91\u00e2\u0080\u0089women/group would be sufficient to detect a significant difference in mammographic breast density between the groups at the 5% level (two sided) with 80% power. Considering the estimated rate of discontinuation and incomplete data (~30%), the target sample for this part of the study would be 260 patients.\n \n \n Endometrial pathology: primary outcome in part 2\n The reported 1-year background incidence rate for endometrial hyperplasia/cancer in postmenopausal women treated with authorised oestrogen/progestogen combinations is approximately 0%\u00e2\u0080\u00931%.18 19 With a sample size of 300\u00e2\u0080\u0089women in the treatment arm mP+E, two or less women with serious adverse endometrial outcomes would result in an annual incidence of 0.67% or less with an upper bound of the one-sided 95%\u00e2\u0080\u0089CI of 2.08% or less. Considering the estimated rate of discontinuation and incomplete data (~30%), the target sample for this part should be 390 patients, 130\u00e2\u0080\u0089women randomised to mP from part 1 and another 260\u00e2\u0080\u0089women from part 2.\n The total number of patients in part 1 (n=260) and part 2 (n=260) will be 520.", "id": 1621, "split": "test"} +{"trial_id": "NCT05588700", "pmid": "38225551", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A National, Multicenter, Phase III Randomized Controlled Trial to Assess the Impact of a One-year Supervised Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients\n\nIncluded conditions:\n- Metastatic Testicular Cancer\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Physical activity recommendations', 'Behavioral: Connected activity tracker']}\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Physical activity recommendations', 'Behavioral: Connected activity tracker', 'Behavioral: Physical Activity (PA) Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical activity recommendations', 'description': 'At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.', 'armGroupLabels': ['Control group', 'Intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Connected activity tracker', 'description': 'At baseline, all participants will receive a connected activity tracker to wear 24 hours a day during one year. Patients will be asked to download an application, dedicated to the study so that the physical activity data (ie. number of steps per day) will be synchronized in the application.', 'armGroupLabels': ['Control group', 'Intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Physical Activity (PA) Intervention', 'description': 'The intervention will last 1 year and will have 2 phases. Phase 1: At each cycle of chemotherapy, patients will be proposed to perform 2-4 sessions per week. This program will be individual, supervised, performed at a moderate intensity. Between cycles, patients will be asked to perform 1-2 supervised collective live online physical activity sessions per week, proposed by a partner specialized in online PA.\\n\\nPhase 2: After chemotherapy, patients will be asked to perform 2-3 PA sessions per week at a moderate intensity. Patients will be offered 2 options of PA practice: in the supervised collective live online PA session (as already performed in the phase 1), and/or in a fitness center (this practice will take place in a \"classic\" environment with a 9-month free access for patients thanks to a partnership).\\n\\nIn addition, patients will benefit from 4 individual motivational interviews, conducted by videoconference and/or by phone call with a professional.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy', 'description': 'Multidimensional aspects of fatigue will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-FA12 cancer related fatigue module. EORTC QLQ-FA12 consists of 12 items to evaluated physical, cognitive and emotional domains of cancer-related fatigue. Participants will answer to a 4-points Likert scale ranging from \"not at all\" to \"very much\". All scores will be transformed to a 0 to 100 scale and higher scores will indicate greater degree of fatigue.\\n\\nThe Primary Outcome Measure will be assessed with physical and cognitive items.', 'timeFrame': 'Year 3'}\n\nPlease estimate the sample size based on the assumption: \nBilateral alpha, type I error of 0.025 (Bonferroni adjusted p-value for two dimensions, overall risk of 5%), statistical power of 90%, 15% lost to follow-up or unavailable data.", "answer": 236, "answer_type": "ESTIMATED", "explanation": "Sample size\n In order to evaluate our primary endpoint and to detect a minimum significant difference\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008910 points in the CRF scores between the 2 groups at 3 years, with a standard deviation of 20, considering 2 dimensions of CRF (physical and cognitive fatigue) assessed by the EORTC QLQ-FA12 questionnaire, with a bilateral alpha, type I error of 0.025 (Bonferroni adjusted p-value for two targeted dimensions, overall risk of 5%), a statistical power of 90%, 200 patients with fatigue scores available at baseline and 3 years is required. Considering 15% of lost to follow-up or unavailable data and patients without fatigue scores available, 118 patients per group will be randomized (1:1), for a total of 236 patients.", "id": 1622, "split": "test"} +{"trial_id": "NCT05591625", "pmid": "38286705", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-centre, Randomised, Pilot Feasibility Study to Compare the Effectiveness of Eye-movement Desensitisation and Reprocessing Versus Usual Care in the Psychological Recovery of Intensive Care Survivors\n\nIncluded conditions:\n- Post Traumatic Stress Disorder\n- Critical Illness\n- Eye Movement Desensitisation and Reprocessing\n- Depression, Anxiety\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants who exhibit symptoms of PTSD and are randomised to the control group, will receive usual care offered by their hospital.'}\n- {'label': 'Eye Movement Desensitisation and Reprocessing', 'type': 'EXPERIMENTAL', 'description': 'Participants who exhibit symptoms of PTSD and are randomised to the intervention group, will receive EMDR plus usual care offered by their hospital. EMDR will be delivered by trained and accredited psychological therapists, employed by National Health Service community mental health teams.', 'interventionNames': ['Behavioral: Eye Movement Desensitisation and Reprocessing']}\n- {'label': 'Observation', 'type': 'NO_INTERVENTION', 'description': 'Participants who do not exhibit symptoms of PTSD will receive usual care offered by their hospital and repeat the psychological assessment at 12-months post-hospital discharge.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Eye Movement Desensitisation and Reprocessing', 'description': 'EMDR is a trauma-focussed, psychological talking therapy whereby the participant verbally relates a narrative of an emotionally disturbing memory, in brief sequential doses, while simultaneously focusing on an external stimulus, most commonly side-to-side finger movements of the psychological therapist. EMDR aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR is widely practiced, so is scalable. It is also protocolised, so can be taught and tested, and allows for fidelity assessment in controlled studies.\\n\\nThe number of sessions will depend on ongoing presence of disturbing memories. This will be determined by the psychological therapist and participant.', 'armGroupLabels': ['Eye Movement Desensitisation and Reprocessing'], 'otherNames': ['EMDR']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment, adherence, retention', 'description': 'To determine whether investigating the use of EMDR for traumatised survivors of critical care can reach predefined feasibility objectives:\\n\\n* Recruitment rate part A - we anticipate an average recruitment of 10 patients per month across the three participating sites. This is well above the median recruitment of 0.95 participants recruited per site per month, reported in a review of trials listed in the NIHR journals library (1997-2020)(31).\\n* Consent rate - number of patients recruited, expressed as a percentage of patients approached. Based on our previous work we expect this to be greater than 30%(28).\\n* Adherence will be determined by completion of \u226575% of planned EMDR sessions completed.\\n* Retention will be determined by \u226575% of participants completing the study follow-up assessment.', 'timeFrame': '12-months'}\n- {'measure': 'Acceptability', 'description': 'To explore acceptability of participating in a Randomised Controlled Trail of EMDR for critical care survivors, psychology clinicians and research staff. Reported according to the Theoretical Framework of Acceptability. This qualitative methodology, using semi-structured interviews, provides a framework for assessing conceptually different constructs of acceptability in clinical trials; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.', 'timeFrame': '12-months'}\n- {'measure': 'Number of participants with adverse events (safety and tolerability)', 'description': 'Safety will be determined by assignment of causality of serious events. 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.', 'timeFrame': '12-months'}\n\nPlease estimate the sample size based on the assumption: \nEstimated 25% mortality or loss to follow-up across all study arms.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n As this is a feasibility study, an a priori sample size calculation is not applicable. The findings will guide the sample size determination for a potential definitive RCT. Sample sizes of feasibility studies between 24 and 50 have been recommended to provide adequate estimate of SD for sample size calculation.39 40\n To achieve this, a total of 160 patients will be enrolled in part A to assess feasibility adequately. Based on an expected incidence of 20%\u00e2\u0080\u009325% post-ICU PTSD, we anticipate that around 40 patients will proceed to the part B RCT with an IES-R PTSD score\u00e2\u0089\u00a522. The remaining 120 participants will continue in the observation arm, with a 12 month reassessment. Accounting for an estimated 25% mortality or loss to follow-up across all study arms, we anticipate approximately 30 participants completing the RCT and 90 participants completing the observation arm.", "id": 1623, "split": "test"} +{"trial_id": "NCT05591820", "pmid": "38475768", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial on Brief Behavioral Parent Training Versus Care as Usual in Children With Behavioral Difficulties\n\nIncluded conditions:\n- Disruptive Behavior\n- Behavior Problems\n- Behavioral Problems\n- Problem Behaviors\n- Behavioral Symptoms\n- Behavioral Difficulties\n\nStudy Armgroups:\n- {'label': 'Brief behavioral parent training with optional booster sessions', 'type': 'EXPERIMENTAL', 'description': 'A brief, individualized, three-session parent training that exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual.', 'interventionNames': ['Behavioral: Brief behavioral parent training with optional booster sessions']}\n- {'label': 'Care as usual (CAU)', 'type': 'ACTIVE_COMPARATOR', 'description': \"The care that is usually provided by the clinical institutions to treat children's disruptive behaviors. There will be no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy.\", 'interventionNames': ['Behavioral: Care as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Brief behavioral parent training with optional booster sessions', 'description': \"A brief and individually-tailored behavioral parent training program that combines stimulus control and contingency management techniques to treat children's behavioral difficulties in three (bi)weekly sessions and optional booster sessions.\", 'armGroupLabels': ['Brief behavioral parent training with optional booster sessions'], 'otherNames': ['PAINT-P (Parent)', 'PAINT-GGZ', 'Brief parent training']}\n- {'type': 'BEHAVIORAL', 'name': 'Care as usual', 'description': \"The care that is usually provided by the clinical institutions to treat children's behavioral difficulties. There are no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy.\", 'armGroupLabels': ['Care as usual (CAU)'], 'otherNames': ['CAU']}\n\nPrimary Outcomes:\n- {'measure': 'Change in individually determined daily ratings of behavioral difficulties', 'description': \"The primary outcome is the mean severity of parents' daily ratings of four selected target behaviors in specific home situations. On the adapted version of the list of target behaviors (Van den Hoofdakker et al., 2007; Hornstra et al., 2021), parents indicate whether the 29 behaviors occur daily (yes/no). For behaviors scored as yes, parents rate the severity on a 5-point Likert scale ranging from 1 (not severe) to 5 (extremely severe). With a researcher, parents choose four daily occurring target behaviors from this list that they prefer to work on in the training. Parents also indicate in which situation these behaviors occur. For each measurement occasion, during five consecutive weekdays, short daily phone calls with parents are made to evaluate whether the four selected target behaviors occurred in the past 24 hours in the selected situation (yes/no). For each timepoint, the average score of all four behaviors on all weekdays is used as outcome measure.\", 'timeFrame': 'Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)'}\n\nPlease estimate the sample size based on the assumption: \nA power analysis was performed with an effect size of d = 0.25 (f = 0.125), two groups, three repeated measures, a between-measurement relation of r = 0.60, a power of 0.80, and a significance level (\u03b1) of 0.05. A 10% increase in sample size was applied to account for clustering.", "answer": 93, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on our previous study that found medium-sized short term effects on daily ratings of behavioral difficulties compared to waitlist (range of Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.35 to d\u00e2\u0080\u0089=\u00e2\u0080\u00890.66, [33]) and studies showing medium-sized parenting intervention effects on behavioral difficulties using parent-report rating scales [19, 20, 25, 36, 72], we estimate the effect of our brief behavioral parent training program as compared to CAU to be at least small (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.25).\n A power analysis has been performed using G*Power software [73]. Based on an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.125), two groups and three repeated measures (T0, T1, T2 for short term effectiveness), with r\u00e2\u0080\u0089=\u00e2\u0080\u00890.60 between-measurement relation, a power of 0.80 and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, we need at least 42 participants per group, resulting in a total of 84 participants. Given that the data are clustered, we increased the sample size with 10% [74], resulting in a total of 93 participants. This is in line with the number of participants in similar studies comparing behavioral treatments to CAU (e.g., [36]).", "id": 1624, "split": "test"} +{"trial_id": "NCT05593835", "pmid": "37977860", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol for a Cluster Randomised Trial of a Goal-Oriented Care Approach for Multimorbidity Patients Supported by a Digital Platform\n\nIncluded conditions:\n- Chronic Disease\n\nStudy Armgroups:\n- {'label': 'METHIS Intervention', 'type': 'EXPERIMENTAL', 'description': 'The METHIS intervention will consist of two components. The first component is a Goal-Oriented Care (GOC) Training Program for health professionals. The training program will include the concept of personalised care, methods of goal elation, implications of GOC in healthcare practice, and how METHIS platform can be used to support the application of GOC. The training will be implemented through a blended-learning, continuous education program that will be credited by Nova University of Lisbon. The second component is a GOC information system. This will be the digital platform METHIS, which will be designed to nudge clinicians to adopt a GOC and to encourage patients and caregivers to take an active role in healthcare. The investigators will adapt an existing platform that was developed for a pilot study during the COVID-19 pandemic, that promotes care coordination, optimises disease prioritisation, and patient self-management.', 'interventionNames': ['Device: METHIS Platform', 'Other: Goal-Oriented Care Training Program']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group in this trial will be the best usual care, using the standard Electronic Health Records available to the practice. Our understanding of what \"best usual care\" is for people with multimorbidity is informed by qualitative research in an earlier stage of this project. Our results suggest that healthcare professionals often provide disease-driven care. When faced with multiple healthcare problems, they prioritise based on 1) patient complaints; 2) which condition is less well controlled; or 3) which condition is more likely to adversely impact on patient Health Related-Quality of life. General practitioners and primary care nurses are often not familiar with the Goal-Oriented Care model. However, they already try to implement some of its principles such as identifying patient goals and supporting shared decision making.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'METHIS Platform', 'description': \"The METHIS platform is a digital healthcare platform, supported by three databases using PostreSQL (based in relational SQL). One of the databases allows adequate internal testing before production. Another database of production (secured with unique access codes) will be created to retrieve data from the practices' and the last database for the research data, where pseudonymised production data can be analysed for research purposes. The platform is integrated (via FCCN Scientific Computation Unit of the Portuguese Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia) with the Software Zoom\u00ae to allow encrypted teleconsultations, with a guarantee that each patient connection is unique. The digital platform is web-based, and it can be used in multiple devices.\", 'armGroupLabels': ['METHIS Intervention'], 'otherNames': ['Goal-Oriented Care Information System', 'GOC Information System']}\n- {'type': 'OTHER', 'name': 'Goal-Oriented Care Training Program', 'description': 'The training program will have three stages: initial face-to-face training, which will happen before the data collection, followed by remote, asynchronous training during a 12-month period, and a final seminar to discuss the results and inquire about the usability of the GOC model and the METHIS platform. The course will be offered to the intervention group one month before the start of patient recruitment, and for the control group at least one month after the end of data collection.', 'armGroupLabels': ['METHIS Intervention'], 'otherNames': ['GOC Training Program']}\n\nPrimary Outcomes:\n- {'measure': 'Health related quality of life', 'description': 'Participants will be asked to fill in the SF-12 questionnaire which generates a physical component score (PCS) and a mental component score (MCS). The primary outcome will be the mean difference in the variation (delta) of the PCS of SF-12 between baseline and 12 months. The SF-12 can be filled in 2-4 minutes, and it is validated for the Portuguese population. Minimum important differences validated across large populations and multiple disease categories are a change in between 2 and 3 points from the population mean of 50.', 'timeFrame': 'Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.'}\n\nPlease estimate the sample size based on the assumption: \nA conservative intracluster correlation coefficient of 0.08, an alpha of 0.05, a power of 80%, and a 10% lost to follow-up rate.", "answer": 1380, "answer_type": "ESTIMATED", "explanation": "Sample size\n To address our primary outcome, it was assumed that for the PCS of the SF-12 scale, a mean of 38.3 for the control group, a mean of 41.3 for the intervention group and a typical SD of 11.3. The mean difference of 3 points used in the sample size calculation is informed by earlier research suggesting that the minimum significant difference for SF-12 in different populations\u00e2\u0080\u0099 diseases ranges between 2 and 3 points.35 36 A conservative intracluster correlation coefficient of 0.08, an alpha of 0.05, and a power of 80% were still considered. To achieve the desired strength, approximately 600 patients will need to be enrolled in each arm, implying about 20 patients per practice, with a minimum of 30 practices in the intervention arm and 30 in the control arm. The sample size will be corrected considering the 10% lost to follow-up. This means that 1380 participants will have to be enrolled (ie, 23 participants per cluster).", "id": 1625, "split": "test"} +{"trial_id": "NCT05596292", "pmid": "38001540", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sensation of Dyspnea and Experience of Patients With Decompensated Heart Failure Undergoing an Early Mobilization Protocol With Immersive Virtual Reality: a Clinical Trial Protocol\n\nIncluded conditions:\n- Decompensated Heart Failure\n\nStudy Armgroups:\n- {'label': 'early mobilization protocol and immersive virtual reality', 'type': 'EXPERIMENTAL', 'description': \"Three days of an early mobilization protocol using immersive virtual reality glasses. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation. The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360\u00ba rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.\", 'interventionNames': ['Device: Immersive Virtual Reality glasses', 'Other: early mobilization protocol']}\n- {'label': 'early mobilization protocol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Three days of an early mobilization protocol. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation.', 'interventionNames': ['Other: early mobilization protocol']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Immersive Virtual Reality glasses', 'description': \"The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360\u00ba rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.\", 'armGroupLabels': ['early mobilization protocol and immersive virtual reality']}\n- {'type': 'OTHER', 'name': 'early mobilization protocol', 'description': 'Three days of an early mobilization protocol. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation.', 'armGroupLabels': ['early mobilization protocol', 'early mobilization protocol and immersive virtual reality']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention', 'description': 'The evaluation of dyspnea sensation using the Borg Rating Of Perceived Exertion Scale. This scale has a score ranging from zero to 10, and the higher the score the patient reports, the greater the sensation of dyspnea', 'timeFrame': 'Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 1.6-point standard deviation, and 20% possible losses and refusals.", "answer": 66, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study by Nomura et al. [19] used the Borg scale in the first 24\u00c2\u00a0h to assess the effects of medication on the sensation of dyspnea and other outcomes. In the first 24\u00c2\u00a0h, the patient\u00e2\u0080\u0099s sensation of dyspnea significantly improved, with a significant reduction in the Borg scale score [19].\n Initially, applying the Borg scale obtained an index of 7. After intervention, the index ranged from 2 to 3. This study showed that after the first 24\u00c2\u00a0h the patient tends to have less changes in the dyspnea sensation, given the use of medication [19]. Based on the literature, we believe that 1 point is a considerable change score, since the patient would probably not have a more significant change due to the compensation of the clinical condition.\n The sample size was estimated to detect differences in mean dyspnea between the intervention and control groups using the Borg scale, with a difference of 1 point being relevant for the study. For this purpose, the online version of the power and sample size (PSS) Health tool was used [20]. Considering an 80% power, a 5% significance level, and a 1.6-point standard deviation [19, 21], a total sample size of 54 participants was calculated, with 27 participants in each group. To account for 20% of possible losses and refusals, the total sample size will need to include 66 participants (33 in each group). Seeking to reach the appropriate sample number to conclude the study, a daily screening will be carried out by the research team of patients meeting the inclusion criteria admitted to the study site.", "id": 1626, "split": "test"} +{"trial_id": "NCT05598203", "pmid": "40050966", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will receive four group meetings in addition to the usual care, specifically in the form of operative groups. Participants in these groups will actively participate in the sessions and will be given tasks to complete at home. There will be four sessions, which can be held weekly, fortnightly or monthly, depending on the availability of participants. Each participant will attend each meeting only once. These sessions, lasting one hour, will take place at the Hospital de Cl\u00ednicas de Porto Alegre and approximately 20 participants will be invited to each group.\\n\\nTopics covered in these sessions will include:\\n\\n1. \"Let\\'s go shopping\" = purchasing food through NOVA classification and nutritional labeling and food labels\\n2. \"Healthy Plate\" = Diabetes Plate Method.\\n3. \"Hunger and satiety\" = signs of hunger and satiety and eating mindfully', 'interventionNames': ['Behavioral: Operative group of nutrition education']}\n- {'label': 'Control (usual treatment)', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the usual care provided, there will be a consultation with a dietitian every four months. This consultation will involve nutritional counseling, where up to five combinations of lifestyle changes will be agreed upon with the participant. The combinations will be tailored to individual needs and align with diabetes recommendations, emphasizing increased consumption of natural foods, organizing meals according to the Diabetes Plate method, and promoting a reduction in sedentary time. Subsequent visits will reassess the combinations of lifestyle changes, addressing barriers and motivations identified during the counseling process.\\n\\nPatients will not be encouraged to implement caloric restrictions, but they will be motivated to adopt healthy eating patterns in accordance with the recommendations of the American Diabetes Association and the Sociedade Brasileira de Diabetes.', 'interventionNames': ['Behavioral: Operative group of nutrition education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Operative group of nutrition education', 'description': 'The intervention will be carried out with operational nutritional education groups. Four meetings will be held, each meeting lasting one hour, weekly or fortnightly (according to the availability of the patient). The following foods proposed foods: Meeting 1 = education on classification labels and proposed foods proposed foods (education on classification labels and substitution of Brazilian foods), in this guide meeting the proposal is processed or ultra-processed by an in natura food or minimally processed; Meeting 2 = assembly of the healthy dish (food portions, food index and glycemic load, food clothes), the proposal in this meeting is the assembly of the complete dish in the meals eaten throughout the day; and Encounter 3 = hunger and satiety (aiming to increase the perception of hunger and satiety signals), encounter as a task to be accomplished; Encounter 4 = strengthening change, barriers and difficulties in maintaining habits based on the transtheoretical model of change.', 'armGroupLabels': ['Control (usual treatment)', 'Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in baseline HbA1C at 4 months', 'description': 'The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Cl\u00ednicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.', 'timeFrame': 'From baseline to 4 months'}\n- {'measure': 'Change in baseline HbA1C at 8 months', 'description': 'The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Cl\u00ednicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.', 'timeFrame': 'From baseline to 8 months'}\n- {'measure': 'Change in baseline HbA1C at 12 months', 'description': 'The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Cl\u00ednicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.', 'timeFrame': 'From baseline to 12 months'}\n- {'measure': 'Change in diabetic retinopathy and baseline diabetic kidney disease at 12 months', 'description': \"Diabetes kidney disease and diabetic retinopathy will be collected from patients' electronic medical records at baseline and at the end of the study (12 months).\", 'timeFrame': 'From baseline to 12 months'}\n\nPlease estimate the sample size based on the assumption: \ntype I error of 5%, type II error of 20%, 30% dropout rate over 12 months", "answer": 252, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation was performed using PSS Health (shinyapps.io) [16], referencing the findings from Naik et al. [17]. To detect a mean difference of 0.59 in HbA1c between participants randomized to the intervention group (patient-centered education) and those in the control group (traditional education), with a standard deviation of 1.39%, a type I error of 5%, and a type II error of 20%, a total of 88 participants per group (1:1 ratio, n\u00e2\u0080\u0089=\u00e2\u0080\u0089176) is required. Accounting for a 30% dropout rate over the 12-month study period, the inclusion of 252 participants will be necessary to maintain statistical power.", "id": 1627, "split": "test"} +{"trial_id": "NCT05600829", "pmid": "39394158", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity: The BeWEL IN CR-AF Study\n\nIncluded conditions:\n- Atrial Fibrillation\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients participate in a traditional 12-week outpatient CR program with added weekly behavioural weight loss classes.', 'interventionNames': ['Behavioral: BWLT+CR']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Patients participate in a traditional 12-week outpatient CR program.', 'interventionNames': ['Behavioral: CR-Only']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'BWLT+CR', 'description': 'Patients will attend twelve 2-hour group-based weekly sessions (over Zoom) in addition to their twice-weekly CR exercise sessions, followed by biweekly follow-up sessions alternating between individual phone-based sessions with a facilitator, and group-based sessions for an additional 12 weeks. The empirically validated ASPIRE BWLT was recently adapted for an AF population with obesity. Briefly, the BWLT was modified to incorporate education and practical strategies requested by patients, including AF risk factor management, pathophysiology, medications, and disease course; exercising with AF; and coping with difficult emotions regarding AF. Weekly treatment goals focus on nutrition and moderate calorie reduction while emphasizing adherence to an individualized CR exercise prescription. The BWLT program will be delivered by senior clinical psychology PhD students and supervised by a registered Clinical Health Psychologist.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'CR-Only', 'description': 'The CR program consists of education, medication management, risk factor modification and 12 weeks of twice-weekly supervised cardiovascular exercise sessions. Patients with AF undergo a symptom-limited graded exercise stress test at intake, 12-weeks, 24-weeks, and 1-year post-randomization, where cardiorespiratory fitness (i.e., peak metabolic equivalents \\\\[METS\\\\]) and cardiometabolic risk factors (blood pressure, blood lipid profile, BMI, waist circumference, depression and anxiety symptoms, tobacco use, and exercise volume) are assessed.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients achieving \u226510% body weight change', 'description': 'Assessed by dividing the number of kilograms at 52 weeks by the initial (T1) kg and multiplying by 100%.', 'timeFrame': 'Baseline, 52 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% alpha level, 20% loss to follow-up, and 10% drop-out rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n Assuming a 5% rate of clinically significant improvement in the control group (quality assurance data from TCR shows\u00e2\u0080\u0089<\u00e2\u0080\u00892% of patients with obesity achieve\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008910% weight loss in traditional CR; RCTs of BWLTs typically report\u00e2\u0080\u0089<\u00e2\u0080\u00895% total body weight loss among controls [54]) and a 30% rate of clinically significant improvement in the intervention group (consistent with results from weight loss trials for patients with AF and obesity [48, 54] and systematic reviews of BWLT in general [54, 55]), 78 patients (39 per group) will provide 80% power to detect a difference using a two-sided independent test of proportions with a 5% alpha level. We estimate loss to follow-up and drop-outs of 20% and 10%, respectively; therefore, 120 patients will be recruited in total (60 per group).", "id": 1628, "split": "test"} +{"trial_id": "NCT05606432", "pmid": "39814364", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users\n\nIncluded conditions:\n- Cardiometabolic Risk Factors in Adult Wheelchair Users\n\nStudy Armgroups:\n- {'label': 'Group 1', 'type': 'EXPERIMENTAL', 'description': 'Instructor-led, one-on-one M2M exercise group', 'interventionNames': ['Other: Instructor-led, one-on-one M2M exercise group']}\n- {'label': 'Group 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Self-guided control with pre-recorded standard exercise videos', 'interventionNames': ['Other: Self-guided control with pre-recorded standard exercise videos']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Instructor-led, one-on-one M2M exercise group', 'description': \"Participants will attend 3 exercise sessions per week for 24 weeks. Each session will last 15 - 40 minutes. Increasing by 5 - 10 minutes each week. Each session will last from 25 to 50 minutes by increasing 5 to 10 minutes each week. The exercise program will focus on improving cardiorespiratory fitness using a series of movement patterns accompanied by music. The program will be tailored to individuals' abilities (e.g., use of arms only vs. truck movement together; slow vs. fast tempo music). The exercise will be prescribed at a moderate intensity level (working somewhat hard with increased heart rate and breathing rate). For the follow-up phase (weeks 25-36), participants will receive the recorded M2M exercise sessions between the M2M instructors and themselves to continue to exercise for the remaining 12 weeks.\", 'armGroupLabels': ['Group 1']}\n- {'type': 'OTHER', 'name': 'Self-guided control with pre-recorded standard exercise videos', 'description': 'Participants will exercise for 36 weeks using pre-recorded exercise videos. The videos include warm-up, flexibility, muscular strength, aerobic endurance, balance, and cool-down.', 'armGroupLabels': ['Group 2']}\n\nPrimary Outcomes:\n- {'measure': 'Cardiometabolic indicators - hsCRP', 'description': 'Blood test Sphygmomanometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Cardiometabolic indicators - HbA1C', 'description': 'Blood test Sphygmomanometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Cardiometabolic indicators - fasting insulin', 'description': 'Blood test SphygmomanometerSphygmomanometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Cardiometabolic indicators - triglycerides', 'description': 'Blood test Sphygmomanometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Cardiometabolic indicators - cholesterol', 'description': 'Blood test Sphygmomanometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Cardiometabolic indicators - glucose', 'description': 'Blood test Sphygmomanometer', 'timeFrame': 'Baseline'}\n- {'measure': 'Cardiometabolic indicators - hsCRP', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '12 Weeks'}\n- {'measure': 'Cardiometabolic indicators - HbA1C', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '12 Weeks'}\n- {'measure': 'Cardiometabolic indicators - fasting insulin', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '12 Weeks'}\n- {'measure': 'Cardiometabolic indicators - triglycerides', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '12 Weeks'}\n- {'measure': 'Cardiometabolic indicators - cholesterol', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '12 Weeks'}\n- {'measure': 'Cardiometabolic indicators - glucose', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '12 Weeks'}\n- {'measure': 'Cardiometabolic indicators - hsCRP', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '24 Weeks'}\n- {'measure': 'Cardiometabolic indicators - HbA1C', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '24 Weeks'}\n- {'measure': 'Cardiometabolic indicators - fasting insulin', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '24 Weeks'}\n- {'measure': 'Cardiometabolic indicators - triglycerides', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '24 Weeks'}\n- {'measure': 'Cardiometabolic indicators - cholesterol', 'description': 'Blood test Sphygmomanometer', 'timeFrame': '24 Weeks'}\n- {'measure': 'Body composition - DEXA', 'description': 'Dual energy X-ray absorptiometry', 'timeFrame': 'Baseline'}\n- {'measure': 'Body composition - DEXA', 'description': 'Dual energy X-ray absorptiometry', 'timeFrame': '12 Weeks'}\n- {'measure': 'Body composition - DEXA', 'description': 'Dual energy X-ray absorptiometry', 'timeFrame': '24 Weeks'}\n- {'measure': 'Body composition - Waist Circumference', 'description': 'Measurement of waist size', 'timeFrame': 'Baseline'}\n- {'measure': 'Body composition - Waist Circumference', 'description': 'Measurement of waist size', 'timeFrame': '12 Weeks'}\n- {'measure': 'Body composition - Waist Circumference', 'description': 'Measurement of waist size', 'timeFrame': '24 Weeks'}\n- {'measure': 'Body composition - Weight', 'description': 'participants weight', 'timeFrame': 'baseline'}\n- {'measure': 'Body composition - Weight', 'description': 'participants weight', 'timeFrame': '12 weeks'}\n- {'measure': 'Body composition - Weight', 'description': 'participants weight', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA 2-sided 2-group t test (2-tailed) with a significance level of .05 and an expected attrition rate of 23%. The power is set at 80%.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Power Analysis and Sample Size\n We plan to recruit 132 participants into this study (66 per treatment group), with the expectation that at least 100 (50 per group) will complete this study. We anticipate an attrition rate of 23% based on the average attrition rate between the largest home-based behavioral interventions among wheelchair users (33%) [13] and our scoping review of exercise trials for people with various disabilities (13%) [14]. Due to the nature of the proposed exercise training involving one-on-one training and supervision, we believe that the role of exercise training coaches in this study will lead to lower attrition rates as it has in our past studies [26].\n Power calculations were performed using nQuery (version 8.5; Statsols). For the primary outcome of CMH, we obtained SDs of biomarkers of this outcome from our pilot study among individuals with SCI (6-wk arm crank exercise training), including SDs of 43 mg/dL for total cholesterol, 4.3% for body fat, and 22.4 mg/dL for triglycerides [27]. Assuming a final sample size of 50 participants per group, a 2-sided 2-group t test (2-tailed), and a significance level of .05, we will have at least 80% power to detect differences of 24.4 mg/dL for total cholesterol, 2.5% for body fat, and 12.7 mg/dL for triglycerides (and greater) between the intervention and control groups as being statistically significant. This is equivalent to detecting an effect size (Cohen d) of 0.566 (a moderate effect size) as statistically significant between the two groups.", "id": 1629, "split": "test"} +{"trial_id": "NCT05606770", "pmid": "38238182", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Evaluation of an Adaptive Mobile Health Physical Activity Intervention Post-stroke: a Sequential Multiple Assignment Randomised Trial\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Structured exercise', 'type': 'OTHER', 'description': 'Participants assigned to Structured Exercise will be provided with twice weekly strengthening exercise classes, delivered through the digital platform. The exercise classes will follow a circuit class style, in order to target a moderate-vigorous exercise intensity, in keeping with recent guidelines on secondary stroke prevention. Classes will include a full body warm up followed by a circuit of eight strengthening exercises completed for between one and three sets of 12 repetitions. Participants will be encouraged to exercise to fatigue on the 12th repetition of each set. This will be repeated for increasing sets and adding resistance through the use of resistance bands. During each session, participants will be reminded to reach their targeted weekly step count goals. The structured exercise component is informed by international clinical guidelines (Kleindorfer et al 2021 and Billinger et al 2021).', 'interventionNames': ['Behavioral: Structured Exercise']}\n- {'label': 'Lifestyle Physical Activity', 'type': 'OTHER', 'description': 'The Lifestyle PA component was developed using the Behaviour Change Wheel (BCW) Guide to Designing Interventions and is underpinned by the COM-B model of behavior change (Michie et al., 2014). This posits that people need capability(C), opportunity(O), and motivation(M) to perform a behavior(B). The aim of the Lifestyle PA component is to increase the capability, opportunity, and motivation of participants to reach their daily step count goals. To achieve this the 3 stages of the BCW intervention design process were followed. The first stage, understanding the behaviour, is done through a review of the literature and primary qualitative research(Cardy et al., 2022). This stage identifies the change objectives of the intervention. Stage 2 requires the selection of intervention functions and the policies that would support them. The final stage is defining the content of the intervention using behaviour change techniques (BCTs) and selecting their mode of delivery.', 'interventionNames': ['Behavioral: Lifestyle Physical Activity']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Structured Exercise', 'description': 'Participants assigned to Structured Exercise will be provided with twice weekly strengthening exercise classes, delivered through the digital platform. The exercise classes will follow a circuit class style, in order to target a moderate-vigorous exercise intensity. Classes will gradually progress in intensity throughout the program. Classes will include a full body warm up followed by a circuit of eight strengthening exercises. This will be repeated for increasing sets and adding resistance through the use of resistance bands . Exercises will involve simple full body exercises and movements for each major muscle group. This will ensure that exercises that can be completed regardless of possible unilateral weakness or physical impairment. During each session, participants will be reminded to reach their targeted weekly step count goals. The structured exercise component is informed by international clinical guidelines (Kleindorfer et al 2021 and Billinger et al 2021).', 'armGroupLabels': ['Structured exercise']}\n- {'type': 'BEHAVIORAL', 'name': 'Lifestyle Physical Activity', 'description': 'The Lifestyle PA component was developed using the Behaviour Change Wheel (BCW) Guide to Designing Interventions and is underpinned by the COM-B model of behavior change (Michie et al., 2014). This posits that people need capability(C), opportunity(O), and motivation(M) to perform a behavior(B). The aim of the Lifestyle PA component is to increase the capability, opportunity, and motivation of participants to reach their daily step count goals. To achieve this the 3 stages of the BCW intervention design process were followed. The first stage, understanding the behaviour, is done through a review of the literature and primary qualitative research(Cardy et al., 2022). This stage identifies the change objectives of the intervention. Stage 2 requires the selection of intervention functions and the policies that would support them. The final stage is defining the content of the intervention using behaviour change techniques (BCTs) and selecting their mode of delivery.', 'armGroupLabels': ['Lifestyle Physical Activity']}\n\nPrimary Outcomes:\n- {'measure': 'Physical activity- mean steps/day over 7 days', 'description': 'The primary outcome in this study is mean steps/day over 7 days measured using the Fitbit Charge 4 on the non-paretic limb.', 'timeFrame': '6 weeks post initial randomisation'}\n\nPlease estimate the sample size based on the assumption: \nProbability of 0.80 (power) of discovering the best adaptive intervention.", "answer": 117, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation relates to the primary objective of the SMART (to determine the optimum sequence of embedded treatments postintervention). This sample size calculation is based on a continuous primary outcome; mean steps/day over 7\u00e2\u0080\u0089days. Based on a standardised effect size (0.35) and a probability of 0.80 of discovering the best adaptive intervention a sample size of 117 people with stroke is required.15 This calculation assumes that the best and second best adaptive interventions differ by no smaller than an effect size of 0.35.15 To inform this sample size calculation, we have used effect size data on mean steps/day from the only available feasibility trial of a smartphone application for PA intervention among people with stroke.18 Paul et al18 demonstrated an increase of 1633 steps (SD: 2550) for the mean number of steps/day (39%) increase relative to baseline in the smartphone application PA group after a 6-week intervention in community-dwelling people poststroke.", "id": 1630, "split": "test"} +{"trial_id": "NCT05606978", "pmid": "37143003", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of Blended Forensic Ambulant Systemic Therapy (FASTb): A Randomized Controlled Trial Comparing Blended and Regular FAST\n\nIncluded conditions:\n- Conduct Disorder\n- Antisocial Behavior\n- Behavioral Disorder\n\nStudy Armgroups:\n- {'label': 'FASTb', 'type': 'EXPERIMENTAL', 'description': 'Participants receive FAST blended (FASTb): a combination of face-to-face and online therapy', 'interventionNames': ['Behavioral: FASTb']}\n- {'label': 'FASTr', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants receive FAST regular (FASTr): face-to-face therapy', 'interventionNames': ['Behavioral: FASTr']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'FASTb', 'description': 'FAST blended', 'armGroupLabels': ['FASTb']}\n- {'type': 'BEHAVIORAL', 'name': 'FASTr', 'description': 'FAST regular', 'armGroupLabels': ['FASTr']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Aggression and Delinquency assessed by the Youth Self Report (YSR)', 'description': 'The YSR is a self-reported instrument. The Externalizing scale contains 30 items assessing aggression and delinquency. Possible scores range from 0 (never) to 2 (often). For the monthly assessment, a shortened version of the YSR Externalizing scale will be administered.', 'timeFrame': 'T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention'}\n- {'measure': 'Change in Aggression and Delinquency assessed with the Child Behavior Checklist (CBCL)', 'description': 'The CBCL is a caregiver-reported instrument. The Externalizing scale contains 36 items assessing aggression and delinquency. Possible scores range from 0 (never) to 2 (often). For the monthly assessment, a shortened version of the CBCL Externalizing scale will be administered.', 'timeFrame': 'T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention'}\n- {'measure': 'Change in Delinquency assessed with the Self-Report Delinquent Behavior (ZDG)', 'description': 'The Self-report Delinquent Behavior \\\\[Zelfrapportage Delinquent Gedrag; ZDG\\\\] is a self-reported instrument, assessing how many times the juvenile has done certain (rule-breaking) things in the past year. The ZDG contains 30 items. For the monthly assessment, a shortened version of the ZDG will be administered.', 'timeFrame': 'T1 (baseline); monthly during intervention, up to 9 months; T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention'}\n- {'measure': 'Percentage of Participants with Out of Home Placement assessed using File Analysis', 'description': 'A participant is viewed as being placed out of home when they do not reside with their primary family, either temporarily or permanently, and either voluntarily or involuntarily. Out of home placement is registered by therapists during treatment as part of the standard FAST procedure.', 'timeFrame': 'T1 (baseline); T2 (post-intervention) up to 9 months'}\n- {'measure': 'Percentage of Participants with Out of Home Placement assessed using an Out of Home Placement Questionnaire', 'description': 'A participant is viewed as being placed out of home when they do not reside with their primary family, either temporarily or permanently, and either voluntarily or involuntarily. Out of home placement will be assessed using a questionnaire measuring living situation, which is filled in by juveniles and caregivers. The questionnaire contains one item assessing where the juvenile lives most days of the week.', 'timeFrame': 'T2 (post-intervention) up to 9 months; T3 (follow-up) 6 months post intervention'}\n- {'measure': 'Change in Recidivism Risk assessed with the RAF GGZ Youth', 'description': 'The RAF GGZ Youth is an extensive risk assessment instrument and includes items measuring recidivism risk. The RAF GGZ Youth is filled in by the therapist as part of the standard FAST procedure. Possible scores range from 1 (low) to 5 (high).', 'timeFrame': 'T1 (baseline); T2 (post-intervention) up to 9 months'}\n- {'measure': 'Percentage of Participants having Recidivated', 'description': 'Recidivism is defined as a conviction, which is coded from official judicial records.', 'timeFrame': 'T4 (two years post-intervention)'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, alpha of 0.05, and a dropout rate of approximately 20%", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on a MANOVA a priori power analysis, a group of n\u00e2\u0080\u0089=\u00e2\u0080\u0089120 (n\u00e2\u0080\u0089=\u00e2\u0080\u008960 per group) will allow us to identify \u00e2\u0080\u0093 with a power of 0.80, an alpha of 0.05 \u00e2\u0080\u0093 small differences (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.15) in effectiveness between FASTb and FASTr (G*power 3.1) [40]. To account for possible drop-out, which was approximately 20% in our previous comparable study [41], n\u00e2\u0080\u0089=\u00e2\u0080\u0089200 participants will be recruited. Based on the number of juveniles referred to FAST at the treatment sites participating in this project (approximately 120 juveniles yearly), and participation rates of 70\u00e2\u0080\u009390% in our earlier comparable studies [41, 42], it is considered feasible to include in total n\u00e2\u0080\u0089=\u00e2\u0080\u0089200 juveniles and their caregivers within three years.", "id": 1631, "split": "test"} +{"trial_id": "NCT05608707", "pmid": "39387205", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Innovative PlAnt Protein Fibre and Physical Activity Solutions to Address Poor AppEtite and PrevenT UndernutrITion in OldEr Adults (APPETITE)\n\nIncluded conditions:\n- Appetite Loss\n- Physical Inactivity\n- Undernutrition\n- Anorexia of Aging\n- Aging\n- Ageing Well\n\nStudy Armgroups:\n- {'label': 'Personalised diet plus physical activity intervention', 'type': 'EXPERIMENTAL', 'description': 'A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product.\\n\\nParticipants will also undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise', 'interventionNames': ['Behavioral: Physical activity intervention', 'Dietary Supplement: Personalised nutrition intervention']}\n- {'label': 'Usual diet plus physical activity', 'type': 'EXPERIMENTAL', 'description': 'Participants will consume their usual diet and undertake 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise', 'interventionNames': ['Behavioral: Physical activity intervention']}\n- {'label': 'Personalised diet plus usual physical activity', 'type': 'EXPERIMENTAL', 'description': 'A personalised diet intervention involving the incorporation of the developed plant-based protein and fibre product.', 'interventionNames': ['Dietary Supplement: Personalised nutrition intervention']}\n- {'label': 'Control (usual diet and physical activity)', 'type': 'NO_INTERVENTION', 'description': 'This arm will not be given any nutritional or physical activity support. They will be instructed to carry on with their usual activities.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical activity intervention', 'description': 'The 12 week intervention will involve 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise focused on increasing time spent walking.', 'armGroupLabels': ['Personalised diet plus physical activity intervention', 'Usual diet plus physical activity'], 'otherNames': ['Structured exercise program']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Personalised nutrition intervention', 'description': 'Two Plant-based Protein and Fibre (PPF) product products have been selected from six initially developed, with best amino acid blend, taste, and bioavailability. Participants will be provided with the PPFs to consume daily as part of a personalised diet over 12 weeks.', 'armGroupLabels': ['Personalised diet plus physical activity intervention', 'Personalised diet plus usual physical activity'], 'otherNames': ['Plant-based protein and fibre intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Ad libitum energy intake (kcal)', 'description': '12-week change in energy intake assessed at an an ad libitum lunch test meal', 'timeFrame': 'To be assessed at baseline and following a 12-week intervention or control period'}\n- {'measure': 'Changes in subjective appetite sensations', 'description': \"12-week change in appetite to be assessed by Visual Analogue Scale (VAS) during a test meal challenge. The VAS is a validated tool for assessing subjective sensations such as hunger, fullness and desire to eat. On each 100-mm line, an appetite (hunger, fullness, desire to eat) sensation was paired with the opposing sensation (for example, 'hungry' and 'not hungry').\", 'timeFrame': 'To be assessed at baseline and following a 12-week intervention or control period'}\n\nPlease estimate the sample size based on the assumption: \n20-25% dropout rate, 10% variance on a within participant standard deviation of 143 kcal for energy intake and 13 mm for VAS, 80% power, and significance level at P < 0.05.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations were conducted in G * Power (version 3.1). A 120 kcal (500 kJ) difference in ad libitum test meal energy intake and a 10 mm change in visual analogue scale (VAS) appetite ratings have previously been considered physiologically relevant differences(8,51). To allow for 20\u00e2\u0080\u009325 % dropout, a sample size of 180 participants (45 per group) is sufficient to detect these differences between groups, allowing for 10 % variance on a within participant sd of change in ad libitum test meal energy intake of 143 kcal (36,52), and for VAS of about 13 mm, observed in our unpublished data, similar to others(36), at 80 % power and significance at P < 0\u00c2\u00b705.", "id": 1632, "split": "test"} +{"trial_id": "NCT05608941", "pmid": "37682839", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of High-Intensity Respiratory Muscle Training on Respiratory Muscle Strength, Functional Outcomes and Quality of Life in Individuals with Parkinson's Disease: a Randomized Clinical Trial\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': 'Experimental Group', 'type': 'EXPERIMENTAL', 'description': 'The training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained.', 'interventionNames': ['Other: Respiratory muscle training']}\n- {'label': 'Control Group', 'type': 'SHAM_COMPARATOR', 'description': 'The control group will also perform the exercises using the Orygen Dual Valve device. A sham intervention will be implemented: the initial resistance of the device will be 0cmH2O, and will be maintained throughout the intervention period - there will be no load progression. All procedures adopted with experimental group, including the weekly home visit, will also be performed with individuals in the control group. However, there will be no real change in the training load. All devices will be wrapped with an opaque material so that the load or possible respiratory training load is not visualized.', 'interventionNames': ['Other: Control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Respiratory muscle training', 'description': 'The training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained.', 'armGroupLabels': ['Experimental Group']}\n- {'type': 'OTHER', 'name': 'Control', 'description': 'The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in Maximal inspiratory pressure (MIP)', 'description': 'Maximum inspiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.', 'timeFrame': 'At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).'}\n- {'measure': 'Change from baseline in Maximal expiratory pressure (MEP)', 'description': 'Maximum expiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.', 'timeFrame': 'At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).'}\n\nPlease estimate the sample size based on the assumption: \nA significance level (\u03b1) of 5%, a power of 0.90, and an expected dropout rate of 20% were assumed.", "answer": 34, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation was performed considering the primary outcome measures (inspiratory and expiratory muscle strength). The sample size was estimated using the G*Power Software\u00c2\u00ae (version3.1) and considering data provided by previous randomized controlled trials that investigated the effects of respiratory muscle training on respiratory muscle strength in individuals with PD [14, 15].\n The effect size (f) of 1.00 for inspiratory muscle training was derived from the study of Inzelberg et al. (2005) [14]. In that study, the MIP in the experimental group (n = 10) increased from 62\u00c2\u00b18,2 to 78\u00c2\u00b17,5, and the control group (n = 10) showed no statistically significant difference (51\u00c2\u00b18.0). Considering a significance level (\u00ce\u00b1) of 5% and a power of 0.90, a sample size of ten participants are required. The effect size (f) of 0.54 for expiratory muscle training was derived from the study of Sapienza et al. (2011) [15]. In that study, the MEP in the experimental group (n = 30) increased from 105.29\u00c2\u00b128.81 to 133.26\u00c2\u00b135.53, and the control group (n = 30) reduced from 103.65\u00c2\u00b124.82 to 99.23\u00c2\u00b127.46. Considering a significance level (\u00ce\u00b1) of 5% and a power of 0.90, fourteen participants per group are required (a total of 28 participants). For analysis of variance, the power is approximately 90% for an effect size of 0.5, considering an \u00ce\u00b1 = 0.05 and a sample size of 30 individuals [18]. This power was used aiming at a more conservative estimate since larger samples have greater statistical power [18].\n Therefore, a sample size of 28 individuals (14 in each group) was defined (largest sample size calculated). Assuming an expected dropout rate of 20%, a total sample size of 34 individuals was set (17 in each group).", "id": 1633, "split": "test"} +{"trial_id": "NCT05608993", "pmid": "37855227", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RELAX: Reducing Length of Antibiotics for Children With Ear Infections\n\nIncluded conditions:\n- Acute Otitis Media\n- Pediatric Infectious Disease\n- Ear Infection\n\nStudy Armgroups:\n- {'label': 'High Intensity', 'type': 'EXPERIMENTAL', 'description': 'Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention.', 'interventionNames': ['Other: High Intensity Intervention']}\n- {'label': 'Low Intensity', 'type': 'EXPERIMENTAL', 'description': 'Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention.', 'interventionNames': ['Other: Low Intensity Intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'High Intensity Intervention', 'description': 'The High Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields.', 'armGroupLabels': ['High Intensity']}\n- {'type': 'OTHER', 'name': 'Low Intensity Intervention', 'description': 'The Low Intensity intervention will include clinician education and EHR changes only.', 'armGroupLabels': ['Low Intensity']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of children \u2265 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.', 'description': 'Determine the effectiveness of a High and Low intensity intervention to increase prescribing of recommended antibiotic durations (short, 5 days) for AOM in children \u2265 2 years of age.', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power >99% for 25% difference with ICC=0.02-0.05, 90% power for 10% difference with ICC=0.02, and 84% power for 10% difference with ICC=0.05.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size & power\n Using feasibility data from Vanderbilt and Washington University, we estimate approximately 23,000 children will be treated for AOM during the study period (11,500 prior to the intervention, 11,500 during the intervention) at each site, or 46,000 total children. Feasibility data also indicate that the proportion of pre-intervention antibiotic prescriptions for 5\u00c2\u00a0days is approximately 2%. If the lower intensity intervention arm increases the proportion to 50%, a 25% absolute difference in the change in the primary outcome from baseline between the groups (i.e., 75% higher intensity post-intervention) can be detected with >99% power (intraclass coefficient [ICC]\u00c2\u00a0=\u00c2\u00a00.02\u00e2\u0080\u00930.05). In a more conservative estimate, a 10% absolute difference (i.e., 60% higher intensity post-intervention) can be detected with 90% power (ICC\u00c2\u00a0=\u00c2\u00a00.02) and 84% power (ICC\u00c2\u00a0=\u00c2\u00a00.05).", "id": 1634, "split": "test"} +{"trial_id": "NCT05609188", "pmid": "38026401", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Increasing Financial and Health Equity Among Low Income Black Youth and Young Adults\n\nIncluded conditions:\n- Mental Health Wellness 1\n- Health Care Utilization\n- Financial Hardship\n- Education, Professional\n\nStudy Armgroups:\n- {'label': 'Cash now', 'type': 'EXPERIMENTAL', 'description': 'Participants allocated to the \"cash now\" arm will receive a $500/month Guaranteed Income (GI) during the first twelve months of follow-up (Phase 1) and no GI in the second twelve months of follow-up (Phase 2).', 'interventionNames': ['Other: Guaranteed Income', 'Behavioral: Peer learning circles', 'Behavioral: Financial coaching']}\n- {'label': 'Cash in a year', 'type': 'OTHER', 'description': 'Participants allocated to the \"cash in a year\" arm will receive no Guaranteed Income (GI) during the first twelve months of follow-up (Phase 1) but will receive a $500/month GI in the second twelve months of follow-up (Phase 2).', 'interventionNames': ['Other: Guaranteed Income', 'Behavioral: Peer learning circles', 'Behavioral: Financial coaching']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Guaranteed Income', 'description': 'Monthly cash transfer of $500 per month for 12 months.', 'armGroupLabels': ['Cash in a year', 'Cash now']}\n- {'type': 'BEHAVIORAL', 'name': 'Peer learning circles', 'description': 'Participants can opt-in to attend peer learning circles (also called My Money Hour), which are discussion groups of 10-12 participants about financial topics co-led by a peer (Black youth) with experience in financial programming and an adult financial coach. My Money Hour sessions will be offered on-line multiple times throughout every month of the project, with rotating themes, to ensure that the 50-minute sessions are available different days of the week and times of the day.', 'armGroupLabels': ['Cash in a year', 'Cash now']}\n- {'type': 'BEHAVIORAL', 'name': 'Financial coaching', 'description': 'Participants can opt-in to receive financial coaching sessions with a trained financial mentor. Meetings will occur monthly and typically include six one hour sessions. The mentor will be responsive to individual needs, but will touch on the following priority areas: building credit (credit repair, improving credit scores, credit products); savings (emergency savings plans, savings habits and strategies, understanding savings accounts); money management (creating budgets, understanding income vs expense, assessing spending, making better financial decisions); financial products (credit building products, auto loans, credit cards); and long-term goals (home ownership, investments).', 'armGroupLabels': ['Cash in a year', 'Cash now']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of Participants with a Major or Probable Major Depressive Episode', 'description': \"Using the Center for Epidemiologic Studies Depression Scale Revised (CESDR-10), a 'major depressive episode' is defined as 1) the presence of anhedonia (inability to feel pleasure), dysphoria (generalized dissatisfaction with life), or irritability 'all the time' or 5-7 days for the past week and 2) at least 4 additional symptoms endorsed as occurring 'all the time' or 5-7 days in the past week. A 'probable major depressive episode' is defined as 1) the presence of anhedonia, dysphoria or irritability nearly every day for the past week, and 2) an additional 3 symptoms endorsed as occurring 'all the time' or 5-7 days in the past week. The analysis plan includes use of repeated measures to estimate the difference in depressive symptoms at 12 months between study arms relative to baseline proportion.\", 'timeFrame': '12 months of follow-up'}\n- {'measure': 'Proportion of Participants Reporting Investments in the future', 'description': 'Indication of enrollment in education, certification, or employment training programs. The analysis plan includes use of repeated measures to estimate the difference in investments in the future at 12 months between study arms relative to baseline proportion.', 'timeFrame': '12 months of follow-up'}\n- {'measure': 'Proportion of Participants with Unmet Mental Health Service Needs', 'description': 'Defined as the absence of receiving mental health care when needed. Unmet mental health need will be assessed by scoring 15 or above on the CESDR-10 or \u2265 10 on the brief Generalized Anxiety Disorder scale (GAD-7), and not reporting that care was utilized. Service utilization is based on self-report as stating \"no\" to having accessed any MH service from any kind of health professional. The analysis plan includes the use of repeated measures to estimate the difference in unmet mental health service needs between study arms.', 'timeFrame': '12 months of follow-up'}\n- {'measure': 'Unmet Sexual and Reproductive Health Service Needs', 'description': 'Defined as the absence of receiving sexual and reproductive health services when needed, including STI testing and family planning. This will be measured as self-reported need for SRH (having symptoms of an STI, unprotected sex, or being at risk of unwanted pregnancy) and not reporting that SRH services were utilized. Service utilization is based on self-report as stating \"no\" to having accessed any SRH service from any kind of health professional. The analysis plan includes the use of repeated measures to estimate the difference in unmet sexual and reproductive health service needs between study arms.', 'timeFrame': '12 months of follow-up'}\n\nPlease estimate the sample size based on the assumption: \nAssuming \u03b1 = 0.05 and power = 0.80, with four highly correlated post-baseline measurements (intraclass correlation (ICC) = 0.20-0.80) and a range of outcomes for waitlist control participants (change in each outcome between 5 and 40%).", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Power analyzes were generated using the equation defined by Diggle et al. (97) to compute minimum detectable effect sizes for the primary analyses to address Hypotheses 1a-1c. The study will begin with 300 participants equally allocated to two study groups. Assuming 25% attrition over 12\u00e2\u0080\u0089months, we anticipate an average of 4.3 observations from 300 participants will be available for analysis of investments in the future and mental health outcomes and an average of 5.7 observations for analysis of unmet service need outcomes. Assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, with four highly correlated post-baseline measurements [intraclass correlation (ICC)\u00e2\u0080\u0089=\u00e2\u0080\u00890.20\u00e2\u0080\u00930.80] and a range of outcomes for waitlist control participants (change in each outcome between 5 and 40%), we will have sufficient power to detect differences as low as 5.7\u00e2\u0080\u009310.7% for increase in enrollment in educational or training programs and decrease in depression, and 4.5\u00e2\u0080\u009310.6% for decrease in unmet service need, respectively, in the intervention arm compared to waitlist controls.", "id": 1635, "split": "test"} +{"trial_id": "NCT05609877", "pmid": "38200325", "question": "Here is the design of a clinical trial:\n\nOfficial Title: NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial\n\nIncluded conditions:\n- Respiratory Distress Syndrome in Premature Infant\n\nStudy Armgroups:\n- {'label': 'Fentanyl group', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients will receive 0.5-1 mcg/kg fentanyl intravenously as pre-procedure analgesia for Less Invasive Surfactant Administration (LISA).\\n\\nThe staff will perform LISA using standard pre- and post-procedure care, including non-pharmacological treatment and the use of atropine, caffeine, and naloxone at the clinician's discretion, based on local protocols and guidelines. All medications will be registered.\", 'interventionNames': ['Procedure: Less Invasive Surfactant Administration (LISA)', 'Drug: Fentanyl', 'Behavioral: Non-pharmacological standard operating procedure']}\n- {'label': 'Saline group', 'type': 'SHAM_COMPARATOR', 'description': \"Patients will receive a placebo (isotonic saline) instead of pre-procedure analgesia for Less Invasive Surfactant Administration (LISA).\\n\\nThe staff will perform LISA using standard pre- and post-procedure care, including non-pharmacological treatment and the use of atropine, caffeine, and naloxone at the clinician's discretion, based on local protocols and guidelines. All medications will be registered.\", 'interventionNames': ['Drug: Isotonic saline', 'Procedure: Less Invasive Surfactant Administration (LISA)', 'Behavioral: Non-pharmacological standard operating procedure']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Isotonic saline', 'description': 'Isotonic saline will be administered intravenously instead of pre-procedure analgesia.', 'armGroupLabels': ['Saline group']}\n- {'type': 'PROCEDURE', 'name': 'Less Invasive Surfactant Administration (LISA)', 'description': 'All infants will be treated with the Less Invasive Surfactant Administration (LISA) procedure', 'armGroupLabels': ['Fentanyl group', 'Saline group']}\n- {'type': 'DRUG', 'name': 'Fentanyl', 'description': 'Fentanyl 0.5-1.0 mcg/kg will be administered intravenously as pre-procedure analgesia', 'armGroupLabels': ['Fentanyl group']}\n- {'type': 'BEHAVIORAL', 'name': 'Non-pharmacological standard operating procedure', 'description': 'All infants will receive the same non-pharmacological standard operating procedure.', 'armGroupLabels': ['Fentanyl group', 'Saline group']}\n\nPrimary Outcomes:\n- {'measure': 'LISA failure within 24 hours.', 'description': 'The primary outcome will be LISA failure in terms of the need for endotracheal intubation and mechanical ventilation for at least 30 minutes (cumulated) within 24 hours after the procedure.', 'timeFrame': '24 hours after procedure.'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, power of 0.8, and an expected inclusion rate of 80%.", "answer": 324, "answer_type": "ESTIMATED", "explanation": "Sample size estimation and inclusion timeline\n The sample size was calculated according to the primary outcome. Previous studies on preterm infants born before 30 gestational weeks report a frequency of invasive ventilation after the LISA procedure from 33%26 and 41%27 up to 75%.28 Based on the incidence of invasive ventilation following LISA, we anticipate that the primary outcome will have an incidence of around 45% in the fentanyl group in our trial. Considering an alpha of 0.05 and a power of 0.8 to detect an anticipated incidence of about 30% for the saline group, this trial will enrol 324 infants in a 1:1 ratio. Based on an article by Wiingreen et al., ~123 infants are born before 30 gestational weeks each year in Denmark with the need for surfactant.29 The inclusion will last three to four years, considering an expected inclusion rate of 80%.", "id": 1636, "split": "test"} +{"trial_id": "NCT05610215", "pmid": "39384237", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy\n\nIncluded conditions:\n- Atrial Fibrillation\n- Cardiomyopathy, Hypertrophic\n- Radiofrequency Ablation\n\nStudy Armgroups:\n- {'label': 'hybrid ablation', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation', 'interventionNames': ['Procedure: hybrid ablation']}\n- {'label': 'catheter ablation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group will receive catheter endocardial ablation only', 'interventionNames': ['Procedure: catheter ablation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'hybrid ablation', 'description': 'simultaneous thoracoscopic epicardial and catheter endocardial ablation', 'armGroupLabels': ['hybrid ablation']}\n- {'type': 'PROCEDURE', 'name': 'catheter ablation', 'description': 'catheter endocardial ablation', 'armGroupLabels': ['catheter ablation']}\n\nPrimary Outcomes:\n- {'measure': 'Freedom from documented recurrence (off-AADs)', 'description': 'freedom from documented AF/AT episodes \\\\>30 seconds (off-AADs) by 72-hour holter monitoring', 'timeFrame': 'within 3-12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level (two-sided), 5% dropout rate", "answer": 66, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size was calculated using PASS V.11 on the basis of data derived from our estimation that percentage of freedom for AF/atrial flutter (AFL) (off AADs) at 12 months in the hybrid group of 75% versus 41% in the catheter group (rationale of the reference data for calculating sample size see in online supplemental file 1). Using these results to calculate the sample size, 31 per group will be required to detect a difference in the primary outcome with 80% power and a 5% significance level (two-sided). Taking account of a 5% dropout rate, the final sample size is 66.", "id": 1637, "split": "test"} +{"trial_id": "NCT05611931", "pmid": "38627035", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma\n\nIncluded conditions:\n- Endometrial Cancer\n\nStudy Armgroups:\n- {'label': 'Selinexor', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.', 'interventionNames': ['Drug: Selinexor']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.', 'interventionNames': ['Drug: Matching Placebo for selinexor']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Selinexor', 'description': 'Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral', 'armGroupLabels': ['Selinexor'], 'otherNames': ['KPT-330']}\n- {'type': 'DRUG', 'name': 'Matching Placebo for selinexor', 'description': 'Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Progression Free Survival (PFS) Assessed by Investigator as per RECIST v1.1', 'timeFrame': 'Time from randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample SizeA total of 220 patients will be enrolled.", "id": 1638, "split": "test"} +{"trial_id": "NCT05611931", "pmid": "38627035", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma\n\nIncluded conditions:\n- Endometrial Cancer\n\nStudy Armgroups:\n- {'label': 'Selinexor', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.', 'interventionNames': ['Drug: Selinexor']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.', 'interventionNames': ['Drug: Matching Placebo for selinexor']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Selinexor', 'description': 'Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral', 'armGroupLabels': ['Selinexor'], 'otherNames': ['KPT-330']}\n- {'type': 'DRUG', 'name': 'Matching Placebo for selinexor', 'description': 'Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Progression Free Survival (PFS) Assessed by Investigator as per RECIST v1.1', 'timeFrame': 'Time from randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample Size\n To observe up to 120 progression-free survival events (ie, progression or death due to any cause), a total of up to 220 patients will be enrolled and randomized, which provides 90% power to detect a hazard ratio (HR) with a two-sided alpha of 0.05. To compare progression-free survival of selinexor versus placebo, a two-sided stratified log-rank test adjusting for stratification factors will be performed (primary Stage IV vs recurrent disease at the time of platinum-based therapy and disease status after chemotherapy (partial response vs complete response). When approximately 36 progression-free survival events are reached throughout both treatment arms, an interim analysis (futility of progression-free survival) will be performed.", "id": 1639, "split": "test"} +{"trial_id": "NCT05612945", "pmid": "38631833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Short-duration Aerobic High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Symptomatic Patients With Peripheral Artery Disease: A Randomized Controlled Trial\n\nIncluded conditions:\n- Peripheral Arterial Disease\n\nStudy Armgroups:\n- {'label': 'High-intensity interval training group (HIIT)', 'type': 'EXPERIMENTAL', 'description': 'Exercise training sessions will consist in an alternation of brief periods (\u2264 60 s) of work performed at high intensity and brief period of passive rest.\\n\\nPatient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. This protocol will elicits moderate-to-severe claudication pain during exertion. The training intensity in the HIIT group will be set at \u226585% HRpeak recorded during the maximal cardiopulmonary exercise test.', 'interventionNames': ['Other: High-intensity interval training group (HIIT)']}\n- {'label': 'Low-to-moderate intensity training group (LowMod group)', 'type': 'EXPERIMENTAL', 'description': 'Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at \u226476% HRpeak recorded during the maximal cardiopulmonary exercise test.', 'interventionNames': ['Other: Low-to-moderate intensity training group (LowMod group)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'High-intensity interval training group (HIIT)', 'description': 'Exercise training sessions will consist in an alternation of brief periods (\u2264 60 s) of work performed at high intensity and brief period of passive rest.\\n\\nPatient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. The training intensity in the HIIT group will be set at \u226585% HRpeak recorded during the maximal cardiopulmonary exercise test.\\n\\nThe training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland).', 'armGroupLabels': ['High-intensity interval training group (HIIT)']}\n- {'type': 'OTHER', 'name': 'Low-to-moderate intensity training group (LowMod group)', 'description': 'Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at \u226476% HRpeak recorded during the maximal cardiopulmonary exercise test.\\n\\nThe training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland).', 'armGroupLabels': ['Low-to-moderate intensity training group (LowMod group)']}\n\nPrimary Outcomes:\n- {'measure': 'Maximal walking distance', 'description': 'Patients will perform an incremental treadmill test to determine the maximal walking distance (MWD). Initial walking speed will be set at 3.2 km/h, and at 0% grade. The grade will be increased by 2% each 2 min.', 'timeFrame': 'This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 5 to 14 days following the last training session.'}\n\nPlease estimate the sample size based on the assumption: \npower: 80%, significance level (\u03b1): 5%, dropout rate: 30%", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was assessed based on the results of the only study investigating the effects of exercise training intensity using longer (2\u00e2\u0080\u0089min) walking intervals in patients with PAD.51 A total of 46 patients will be needed to detect a significant mean difference in MWD on treadmill (primary outcome) of 110\u00e2\u0080\u0089m and a pooled SD of 99\u00e2\u0080\u0089m between groups (Cohen\u00e2\u0080\u0099s d value: 0.4; power: 80%; \u00ce\u00b1=5%). Considering some potential dropouts (30%), a sample size of 60 patients (30 in each group) will be recruited.", "id": 1640, "split": "test"} +{"trial_id": "NCT05613751", "pmid": "38367966", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)\n\nIncluded conditions:\n- Influenza\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Pregnant women-COVID-19 vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Pregnant women-COVID-19 vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital.'}\n- {'label': 'Pregnant women-influenza vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Pregnant women-influenza vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital.'}\n- {'label': 'Medically at risk children-COVID-19 vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Medically at risk children-COVID-19 vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital.'}\n- {'label': 'Medically at risk children-influenza vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Medically at risk children-influenza vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Nudge', 'description': 'Three text messages that are sent four weeks apart reminding to obtain the vaccines', 'armGroupLabels': ['Medically at risk children-COVID-19 vaccine RCT - intervention group', 'Medically at risk children-influenza vaccine RCT - intervention group', 'Pregnant women-COVID-19 vaccine RCT - intervention group', 'Pregnant women-influenza vaccine RCT - intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR).', 'description': 'The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one dose of influenza vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks'}\n- {'measure': 'To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR)', 'description': 'The difference in proportion of medically as risk children in the intervention versus standard care (non-intervention) group receiving at least one dose of the seasonal influenza vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'Within 3 months after randomisation'}\n- {'measure': 'To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).', 'description': 'The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one or more doses of a COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks'}\n- {'measure': 'To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of a COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR)', 'description': 'The difference in proportion of medically at risk children receiving at least one dose of a COVID-19 vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'Within 3 months after randomisation'}\n\nPlease estimate the sample size based on the assumption: \n90% power (two-sided test with alpha=0.05), intention-to-treat basis, adjustment for participating hospitals, ORs with 95% CIs, multivariable logistic regression models, cost-effectiveness analysis.", "answer": 1038, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis plan\n To detect an increase in the vaccination rate from ~50% in the control group to 60% in the intervention group, which is considered a clinically relevant impact, with 90% power (two-sided test with alpha=0.05), a sample size of n=519 per group (1038 total) is required. Should the vaccination rate in the control arm be higher than 50% or lower than 40%, this sample size will still provide at least 90% power to detect a 10% absolute increase in vaccination with the nudge intervention. We aim to enrol at least 1038 medically at-risk children to each of the two RCTs across the participating hospitals.\n Statistical analyses will be conducted on an intention-to-treat basis according to a prespecified statistical analysis plan. Baseline characteristics including age, socioeconomic status based on postcode and ethnicity will be reported for each group using percentages, means with SD or medians with ranges as appropriate. The vaccination rate will be compared between intervention and control groups using logistic regression, with adjustment only made for participating hospitals (treated as a categorical fixed effect). Intervention effects will be reported as ORs with 95% CIs. Patient characteristics associated with vaccination will be investigated using multivariable logistic regression models. Cost-effectiveness analysis of the nudge intervention will be compared with standard care from the healthcare payer perspective. The primary cost-effectiveness analysis will estimate the incremental cost per additional person vaccinated, in each of the two RCTs. Secondary analyses for the trial focused on influenza vaccination will estimate the cost per quality-adjusted life year (QALY) gained. The study results will be used to estimate the impact of the nudge intervention on health-related quality of life by calculating the QALYs gained as a result of the increased vaccine uptake. Implementation costs will be obtained from the study budget and costs related to research activities will be excluded. Estimated cost offsets to the health system associated with influenza related disease (eg, hospitalisations and emergency visits) will be derived from the literature and calculated using cost weights for Australian Refined Diagnosis Related Groups (AR-DRGs). The cost-effectiveness evaluation will follow standard reporting guidelines in the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.39", "id": 1641, "split": "test"} +{"trial_id": "NCT05613751", "pmid": "37438776", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)\n\nIncluded conditions:\n- Influenza\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Pregnant women-COVID-19 vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Pregnant women-COVID-19 vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital.'}\n- {'label': 'Pregnant women-influenza vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Pregnant women-influenza vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital.'}\n- {'label': 'Medically at risk children-COVID-19 vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Medically at risk children-COVID-19 vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital.'}\n- {'label': 'Medically at risk children-influenza vaccine RCT - intervention group', 'type': 'EXPERIMENTAL', 'description': 'Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine', 'interventionNames': ['Behavioral: Nudge']}\n- {'label': 'Medically at risk children-influenza vaccine RCT - standard care group', 'type': 'NO_INTERVENTION', 'description': 'Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Nudge', 'description': 'Three text messages that are sent four weeks apart reminding to obtain the vaccines', 'armGroupLabels': ['Medically at risk children-COVID-19 vaccine RCT - intervention group', 'Medically at risk children-influenza vaccine RCT - intervention group', 'Pregnant women-COVID-19 vaccine RCT - intervention group', 'Pregnant women-influenza vaccine RCT - intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR).', 'description': 'The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one dose of influenza vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks'}\n- {'measure': 'To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR)', 'description': 'The difference in proportion of medically as risk children in the intervention versus standard care (non-intervention) group receiving at least one dose of the seasonal influenza vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'Within 3 months after randomisation'}\n- {'measure': 'To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).', 'description': 'The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one or more doses of a COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks'}\n- {'measure': 'To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of a COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR)', 'description': 'The difference in proportion of medically at risk children receiving at least one dose of a COVID-19 vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).', 'timeFrame': 'Within 3 months after randomisation'}\n\nPlease estimate the sample size based on the assumption: \n90% power (two-sided test with alpha = 0.05), intention-to-treat basis, logistic regression with adjustment for hospital, odds ratios with 95% confidence intervals, multivariable logistic regression models.", "answer": 1038, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis plan\n All comparisons will be undertaken assuming a standard superiority hypothesis testing framework. To detect an increase in the vaccination rate from\u00e2\u0080\u0089~\u00e2\u0080\u008950% in the control arm to 60% in the intervention arm, which is considered a clinically relevant impact, with 90% power (two-sided test with alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089519 per group (1038 total) is required. Should the vaccination rate in the control arm be higher than 50% or lower than 40%, this sample size will still provide at least 90% power to detect a 10% absolute increase in vaccination with the intervention. We will enrol at least 1038 pregnant women to each of the two RCTs across the participating hospitals.\n Statistical analyses will be performed on an intention-to-treat basis according to a pre-specified statistical analysis plan. Baseline characteristics including age, socio-economic index based on post-code, ethnicity, parity, and other vaccines received during pregnancy will be reported for each group using percentages, means with standard deviations or medians with ranges as appropriate. The proportion vaccinated will be compared between randomised groups using logistic regression, with adjustment made for hospital. Treatment effects will be described as odds ratios with 95% confidence intervals. Patient characteristics associated with vaccination will be identified using multivariable logistic regression models.\n Cost-effectiveness analysis of the nudge intervention will be compared to standard care from the healthcare payer perspective. The primary cost-effectiveness analysis will estimate the incremental cost per additional person vaccinated, in each of the two trials. Secondary analysis in study population will estimate the cost per quality-adjusted life year (QALY) averted on published literature. Vaccine uptake rates will be based on the study results. Implementation costs will be obtained from the study budget and costs related to research activities will be excluded. Estimated cost offsets to the health system associated with health service use (e.g. hospitalisations and emergency visits) will be obtained from hospital records and calculated using cost weights for Australian Refined Diagnosis Related Groups (AR-DRGs). A societal perspective sensitivity analysis will be undertaken using parent-reported out-of-pocket costs and productivity losses related to influenza illness for pregnant women and medically at-risk children. Out-of-pocket costs and indirect costs will be determined based on literature review. The economic evaluation will follow standard reporting guidelines in the CHEERS statement [18].", "id": 1642, "split": "test"} +{"trial_id": "NCT05614089", "pmid": "39890140", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial\n\nIncluded conditions:\n- Diabetes Mellitus, Type 1\n- Type 1 Diabetes\n\nStudy Armgroups:\n- {'label': 'Glargine', 'type': 'EXPERIMENTAL', 'description': 'Insulin glargine (long-acting insulin analogue)', 'interventionNames': ['Drug: Insulin Glargine']}\n- {'label': 'NPH or premixed 70/30 (human insulin)', 'type': 'ACTIVE_COMPARATOR', 'description': 'NPH or premixed 70/30 (human insulin)', 'interventionNames': ['Drug: NPH or premixed 70/30 (human insulin)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Insulin Glargine', 'description': 'Formulation: Available as a clear liquid in a glass cartridge (1 cartridge =3ml=300 units).\\n\\nRoute: Reusable pen\\n\\nAmount of each dose: varies depending on baseline basal insulin needs\\n\\nDose escalation scheme: Participants randomly assigned to glargine will start with a dose that is generally equal to 80% of their total basal human insulin dose prior to the switch (per ISPAD guidelines and the switching guide developed by Life for a Child with the guidance of Dr. Ragnar Hanas and two other ISPAD members familiar with less-resourced settings).\\n\\nFrequency of dose: once per day (usually administered before bedtime)', 'armGroupLabels': ['Glargine']}\n- {'type': 'DRUG', 'name': 'NPH or premixed 70/30 (human insulin)', 'description': 'Drug: NPH or Premixed 70/30 Formulation: Available as a liquid in a glass vial or glass cartridge (10ml=1000IU).\\n\\nRoute: Bangladesh = syringes or reusable pens; Tanzania = disposable pens\\n\\nSubcutaneous injection using insulin syringe and needle Amount of each dose: varies depending on baseline basal insulin needs (per usual care or treating clinician) Frequency of dose: once or twice per day (per usual care or treating clinician)\\n\\nDuration of therapy: 12 months\\n\\nParticipants in both groups will receive the same frequency of blood glucose testing and same intensity of education and counseling (e.g. titration advice according to fasting glucose targets and strategies to avoid hypoglycemia). Participants in both groups will have equal access to test strips (sufficient to test up to 5 times per day during the active titration phase and after 3 times/day).', 'armGroupLabels': ['NPH or premixed 70/30 (human insulin)']}\n\nPrimary Outcomes:\n- {'measure': 'Time-in-serious hypoglycemia', 'description': '% spent less than 54mg/dl, averaged across all daily measures averaged across two CGM sensors', 'timeFrame': '6 months after randomization'}\n- {'measure': 'Time-in-range (TIR)', 'description': '% between 70 and 180mg/dl inclusive, averaged across two CGM sensors', 'timeFrame': '6 months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.025 for each co-primary outcome to control the overall type 1 error rate of 0.05, 78% power to detect a 33% relative reduction, over 99% power to detect a 50% relative reduction, and a 25% dropout rate.", "answer": 400, "answer_type": "ACTUAL", "explanation": "Power and sample size\n We estimated power using a bootstrap-resampling approach due to possible non-standard distribution of the primary outcome variables. Using individual participant CGM data from a pilot study of over 80 children with T1D in Uganda and Kenya (personal communication Professor Antoinette Moran, University of Minnesota), we calculated a mean per cent time <54\u00e2\u0080\u0089mg/dL of 5.8%, SD of 6.6 and maximum time <54\u00e2\u0080\u0089mg/dL of 24%.35 We assumed a clinically meaningful 33% relative reduction in per cent time-in-serious-hypoglycaemia (eg, from a median of 6% to 4%) as clinical guidelines target <15\u00e2\u0080\u0089min per day (~1%) at <54\u00e2\u0080\u0089mg/dL. In each simulated trial, the usual-care arm had an outcome from the \u00e2\u0080\u0098control\u00e2\u0080\u0099 distribution, while the glargine arm had an outcome from the control distribution multiplied by 0.67, corresponding to a 33% relative reduction in time-in-serious-hypoglycaemia.\n To estimate the study power, we simulated outcomes for the control group (human insulin) and treatment group (analogue insulin) at sample sizes ranging from 100 to 400 participants, performing planned primary analyses on simulated datasets. The power to detect a treatment benefit of glargine was computed as the percentage of simulated trials with a p value <0.025 favouring glargine on each of the co-primary outcomes to control the overall trial-wide type 1 error rate of 0.05. With an estimated 25% lost to follow-up, an analytic sample size of 300 participants (150 per arm) has 78% power to detect a 33% relative reduction in time-in-serious-hypoglycaemia. If the benefit is larger (eg, 50% relative reduction), there will be over 99% power to detect a treatment benefit.\n For the time-in-range endpoint, we used an absolute increase due to the distribution, with a mean time-in-range of 27% (SD=17) from the pilot data. A 10% absolute increase in time-in-range was considered clinically meaningful.3639 A sample size of 400 accounting for a 25% dropout rate to equal 300 provides >99% power. Our analytic strategy allows the trial to be positive if glargine benefits either the time-in-serious-hypoglycaemia or the time-in-range endpoint.", "id": 1643, "split": "test"} +{"trial_id": "NCT05614466", "pmid": "36927591", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SIMPLY-B Study - A Pilot Evaluation of a Primary Care E-support Package of Automated Case Finding, Simplified Treatment Algorithm and Decision Support to Increase Hepatitis B Treatment Uptake in Primary Care Clinics\n\nIncluded conditions:\n- Hepatitis B Virus Related Hepatocellular Carcinoma\n\nStudy Armgroups:\n- {'label': 'Patients living with hepatitis B', 'type': 'EXPERIMENTAL', 'description': 'Patients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package', 'interventionNames': ['Other: The Simply B Study']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'The Simply B Study', 'description': 'This study will be conducted in three parts:\\n\\nPart A: A prospective open label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care clinics before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package.\\n\\nPart B: A nested qualitative health services feasibility study using semi -structured interviews and thematic analysis Part C: A mathematical modelling study using a Markov model to determine cost effectiveness of Simply B for increasing hepatitis B treatment uptake compared to status quo of hospital care.', 'armGroupLabels': ['Patients living with hepatitis B']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients previously diagnosed with chronic hepatitis B within each primary care clinic study site who have attended the clinic within the 36-month period prior to implementation of the intervention', 'description': 'Number of patients previously diagnosed with chronic hepatitis B within each primary care clinic study site who have attended the clinic within the 36-month period prior to implementation of the intervention', 'timeFrame': '36 months prior to study'}\n- {'measure': 'Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP', 'description': 'Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP', 'timeFrame': '2 years'}\n- {'measure': 'Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting', 'description': 'Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting', 'timeFrame': '2 years'}\n- {'measure': 'Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care', 'description': 'Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \n80% power at alpha level 0.05", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n \n Study part A\n This is a pilot study with sample size determined by clinic caseload within the time frame of the study; however, with a sample size of 43 hepatitis B patients at baseline and 43 hepatitis B patients prospectively recruited to the study during 2022 across three high caseload primary care sites (total 86), we could detect an effect size of the intervention of 25% increase in GP-specialist comanagement) and 25% increase in treatment uptake, with 80% power at alpha level 0.05. This would translate into a 14% higher target total of 100 hepatitis B patients.\n \n \n Study part B\n For the nested qualitative study, we will aim to recruit and individually consent 30 patients with hepatitis B who are participating in study part A and 25 health workers involved in the study (GPs, clinic practice managers, nurse practitioners, hospital specialist hepatitis nurses, hospital specialists), selected to provide a broad range of stakeholder perspectives. This number has been selected given previous qualitative research experience interviewing health workers and people with hepatitis B, and interviews will continue with study participants recruited until data saturation is reached.", "id": 1644, "split": "test"} +{"trial_id": "NCT05615870", "pmid": "38504367", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters\n\nIncluded conditions:\n- Bronchiolitis\n\nStudy Armgroups:\n- {'label': 'Intervention Group (Active Filter)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child\\'s sleep space and one will be placed in another common room with both units running continuously on the \"high\" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence\\'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.', 'interventionNames': ['Other: Winix 5500-2 HEPA filtration units']}\n- {'label': 'Control Group (No Filter)', 'type': 'SHAM_COMPARATOR', 'description': 'The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.', 'interventionNames': ['Other: Winix 5500-2 HEPA filtration units']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Winix 5500-2 HEPA filtration units', 'description': 'To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.', 'armGroupLabels': ['Control Group (No Filter)', 'Intervention Group (Active Filter)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of caregiver-reported symptom-free days (SFDs)', 'description': 'An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing', 'timeFrame': '24 Weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that provides 90% power, and accounts for an anticipated attrition rate of 10% per arm.", "answer": 228, "answer_type": "ACTUAL", "explanation": "Sample size determination\n \n Sample size justification\n We plan to enroll 228 participants, or 109 participants per arm. To account for an anticipated attrition rate of 10% per arm, the power analysis is based upon a sample size of 196 participants, or 98 participants per arm. From a similar previously published study, it was found the mean of days with symptoms was 70\u00c2\u00a0days (equivalently the mean of SFDs was 98\u00c2\u00a0days out of total 24\u00c2\u00a0weeks or 168\u00c2\u00a0days of observation), and the standard deviation was 43\u00c2\u00a0days.5 The proposed sample size will provide 90% power to detect an effect size of 0.465, or a difference of 20 symptom-free days with a standard deviation of 43\u00c2\u00a0days, using a two sample t-test.\n \n \n Randomization scheme\n The randomization will be stratified by site. Within each site, participants will be randomized in a 1:1 allocation to receive active HEPA filtration (intervention group) and inactive HEPA unit (control group). Permuted block randomization will be employed.", "id": 1645, "split": "test"} +{"trial_id": "NCT05615870", "pmid": "38504367", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters\n\nIncluded conditions:\n- Bronchiolitis\n\nStudy Armgroups:\n- {'label': 'Intervention Group (Active Filter)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child\\'s sleep space and one will be placed in another common room with both units running continuously on the \"high\" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence\\'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.', 'interventionNames': ['Other: Winix 5500-2 HEPA filtration units']}\n- {'label': 'Control Group (No Filter)', 'type': 'SHAM_COMPARATOR', 'description': 'The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.', 'interventionNames': ['Other: Winix 5500-2 HEPA filtration units']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Winix 5500-2 HEPA filtration units', 'description': 'To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.', 'armGroupLabels': ['Control Group (No Filter)', 'Intervention Group (Active Filter)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of caregiver-reported symptom-free days (SFDs)', 'description': 'An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing', 'timeFrame': '24 Weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that provides 90% power, and accounts for an anticipated attrition rate of 10% per arm.", "answer": 228, "answer_type": "ACTUAL", "explanation": "Sample size justification\n We plan to enroll 228 participants, or 109 participants per arm. To account for an anticipated attrition rate of 10% per arm, the power analysis is based upon a sample size of 196 participants, or 98 participants per arm. From a similar previously published study, it was found the mean of days with symptoms was 70\u00c2\u00a0days (equivalently the mean of SFDs was 98\u00c2\u00a0days out of total 24\u00c2\u00a0weeks or 168\u00c2\u00a0days of observation), and the standard deviation was 43\u00c2\u00a0days.5 The proposed sample size will provide 90% power to detect an effect size of 0.465, or a difference of 20 symptom-free days with a standard deviation of 43\u00c2\u00a0days, using a two sample t-test.", "id": 1646, "split": "test"} +{"trial_id": "NCT05619250", "pmid": "38509514", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Cost-effectiveness of Supervised Center-based Versus Unsupervised Home-based Training Programs in Older Adults: the PRO-Training Randomized Controlled Trial\n\nIncluded conditions:\n- Physical Inactivity\n- Healthy\n- Older Adult\n\nStudy Armgroups:\n- {'label': 'Unsupervised home-based exercise group without motivational intervention (UNSUP)', 'type': 'EXPERIMENTAL', 'description': 'Participants will use a mobile application to perform a home-based training program autonomously, without the face-to-face supervision of a specialist during its execution.', 'interventionNames': ['Behavioral: Unsupervised home-based exercise group without motivational intervention (UNSUP)']}\n- {'label': 'Unsupervised home-based exercise group with motivational intervention (UNSUP+)', 'type': 'EXPERIMENTAL', 'description': 'Participants will use a mobile application to perform a home-based training program autonomously, without the face-to-face supervision of a specialist during its execution. As opposed to the \"UNSUP\" group, the \"UNSUP+\" group will receive a motivational intervention.', 'interventionNames': ['Behavioral: Unsupervised home-based exercise group with motivational intervention (UNSUP+)']}\n- {'label': 'Supervised center-based exercise group without motivational intervention (SUP)', 'type': 'EXPERIMENTAL', 'description': 'Participants will perform a center-based training program in small groups with a maximum of 8 participants per session, being supervised by an exercise professional.', 'interventionNames': ['Behavioral: Supervised center-based exercise group without motivational intervention (SUP)']}\n- {'label': 'Supervised center-based exercise group with motivational intervention (SUP+)', 'type': 'EXPERIMENTAL', 'description': 'Participants will perform a center-based training program in small groups with a maximum of 8 participants per session, being supervised by an exercise professional. As opposed to the \"SUP\" group, the \"SUP+\" group will receive a motivational intervention.', 'interventionNames': ['Behavioral: Supervised center-based exercise group with motivational intervention (SUP+)']}\n- {'label': 'Control group (CON)', 'type': 'NO_INTERVENTION', 'description': 'Participants will not perform any type of exercise program during the intervention period and will be advised to maintain their usual lifestyle.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Unsupervised home-based exercise group without motivational intervention (UNSUP)', 'description': \"UNSUP will receive a non-supervised physical exercise intervention using a mobile app at home. The UNSUP training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised groups, but is adapted to be performed at home with the use of elastic bands and the participant's own body weight. The exercise program will be divided into 3 different levels. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.\", 'armGroupLabels': ['Unsupervised home-based exercise group without motivational intervention (UNSUP)']}\n- {'type': 'BEHAVIORAL', 'name': 'Unsupervised home-based exercise group with motivational intervention (UNSUP+)', 'description': \"UNSUP+ will receive a non-supervised physical exercise intervention using a mobile app at home. The UNSUP+ training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised groups, but is adapted to be performed at home with the use of elastic bands and the participant's own body weight. The exercise program will be divided into 3 different levels. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. Further, motivational strategies will be applied based on self-determination theory.\", 'armGroupLabels': ['Unsupervised home-based exercise group with motivational intervention (UNSUP+)']}\n- {'type': 'BEHAVIORAL', 'name': 'Supervised center-based exercise group without motivational intervention (SUP)', 'description': 'SUP will attend the university facilities and will perform training in small groups, being supervised by an exercise professional. The SUP training program comprises the same exercise structure and is based on the same muscle groups and movements as the unsupervised groups, but is performed in a center using the equipment available at the facility (weight machines, free weight, stationary bikes, etc.). The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises (for upper and lower limbs), 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.', 'armGroupLabels': ['Supervised center-based exercise group without motivational intervention (SUP)']}\n- {'type': 'BEHAVIORAL', 'name': 'Supervised center-based exercise group with motivational intervention (SUP+)', 'description': 'SUP+ will attend the university facilities and will perform training in small groups, being supervised by an exercise professional. The SUP+ training program comprises the same exercise structure and is based on the same muscle groups and movements as the unsupervised groups, but is performed in a center using the equipment available at the facility (weight machines, free weight, stationary bikes, etc.). The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises (for upper and lower limbs), 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. Further, motivational strategies will be applied based on self-determination theory.', 'armGroupLabels': ['Supervised center-based exercise group with motivational intervention (SUP+)']}\n\nPrimary Outcomes:\n- {'measure': 'Lower-body muscular function', 'description': 'The force-velocity relationship and the rate of force development (RFD) will be assessed on a horizontal leg press device (Technogym, Element, Italy) instrumented with a force plate (Type 9286BA, Kistler, Switzerland) and a linear position transducer device (TForce System, Ergotech, Spain). A familiarization session will be performed in session one before the evaluation day in session number three.', 'timeFrame': 'Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).'}\n- {'measure': 'Costs', 'description': 'Researchers will calculate total costs and costs per participant for each of the intervention groups. Mean difference in quality-adjusted life-year (QALY) scores at the end of the intervention will be assessed to analyze the cost-utility. Furthermore, an incremental cost-effectiveness ratio (ICER) will be assessed. Data on health-related quality of life measured by EQ-5D will be used for the calculations.', 'timeFrame': 'Through intervention completion, that is 24 weeks.'}\n- {'measure': 'Adherence to physical training program', 'description': 'Adherence to physical training program will be recorded in the unsupervised training groups using the mobile app. Trainers will record adherence to physical training program in the supervised training groups. It will be calculated as a percentage (\\\\[sessions completed/total sessions expected\\\\] x 100), where 0 % indicates total non-adherence and 100 % indicates full adherence to the exercise prescription. During the 24-week follow-up, we will assess through an ad-hoc self-reported questionnaire whether or not participants exercised, the exercise modality performed (supervised center-based and/or unsupervised home-based), and the number of weekly exercise sessions performed. The questionnaire will be administered on a weekly basis in written form.', 'timeFrame': 'Through study completion, that is 48 weeks.'}\n- {'measure': 'Falls and adverse events', 'description': 'Participants in the unsupervised and control groups will record in a diary their falls and adverse events during and outside exercise sessions. In the supervised groups, supervisors will register the incidence of falls during exercise sessions and participants will register them outside the exercise sessions using the diary.', 'timeFrame': 'Through intervention completion, that is 24 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nThe probability of \u03b1 error was set at 0.05, 1-\u03b2 = 0.80, and 5 groups were considered. A dropout rate of 20% was also considered.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was determined by a priori power analysis using G\u00e2\u0080\u0089\u00e2\u0088\u0097\u00e2\u0080\u0089Power 3.1.9.4 software. Input parameters were entered considering repeated measures ANOVA (group by time interaction), setting the probability of \u00ce\u00b1 error at 0.05, 1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, and 5 groups. The standardized mean difference used for calculations was 0.43, based on the effect of home-based exercise on lower-body muscle power in older adults reported in a previous meta-analysis [19]. The model indicated a total sample size of 100 individuals, and considering a dropout rate of 20%, we finally decided to enroll 120 participants.", "id": 1647, "split": "test"} +{"trial_id": "NCT05619705", "pmid": "39773922", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services\n\nIncluded conditions:\n- Postpartum Weight Retention\n- Pregnancy Weight Gain\n- Overweight and Obesity\n- Behavior, Health\n\nStudy Armgroups:\n- {'label': 'Healthy for Two-Health Coaching (H42)', 'type': 'EXPERIMENTAL', 'description': \"Those assigned to the intervention group will receive the 8 to 11 month H42 health coaching intervention in addition to usual home visiting and usual prenatal and postpartum care clinical services. Intervention duration will depend on the participant's gestational age at the of enrollment. Participants can be enrolled as early in pregnancy as 20 weeks gestation and as late as 33 weeks gestation. All participants would be enrolled for 6 months postpartum. Therefore, the minimum time in the intervention would be 8 months and maximum would be 11 months.\", 'interventionNames': ['Behavioral: Healthy for Two-Health Coaching (H42)']}\n- {'label': 'Maintain Health in Pregnancy and Postpartum (mHIPP)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Those assigned to the \"usual home visiting plus\" comparison group, called maintain health in pregnancy and postpartum (mHIPP), will receive the typical, evidence-based experience in participants\\' home visiting program in addition to the participants\\' usual prenatal and postpartum care clinical services. In addition, the investigators will provide a brief (less than 5 minutes) maternal warning signs educational video that is available in English or Spanish. The video was developed for a home visiting client audience and is publicly available, https://mdmom.org/warningsigns.', 'interventionNames': ['Behavioral: Maintain Healthy in Pregnancy and Postpartum(mHIPP)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Healthy for Two-Health Coaching (H42)', 'description': 'The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.', 'armGroupLabels': ['Healthy for Two-Health Coaching (H42)']}\n- {'type': 'BEHAVIORAL', 'name': 'Maintain Healthy in Pregnancy and Postpartum(mHIPP)', 'description': 'A brief video on maternal warning signs that is available in English or Spanish.', 'armGroupLabels': ['Maintain Health in Pregnancy and Postpartum (mHIPP)'], 'otherNames': ['\"Usual Home Visiting Plus\"']}\n\nPrimary Outcomes:\n- {'measure': 'Change in postpartum weight (retention)', 'description': 'Difference between pre-pregnancy weight and weight at 6 months postpartum. Pre-pregnancy weight (baseline) will be self-reported and then confirmed by prenatal clinic medical records. 6 month postpartum weight will be obtained via BodyTrace study scales provided to all participants.', 'timeFrame': 'Baseline and 6 months postpartum'}\n\nPlease estimate the sample size based on the assumption: \nA 2-tailed type I error rate of 0.05, a type II error rate of 0.10, and \u226570% follow-up for the main outcome at 6 months. Anticipated <30% loss to follow-up for 6-month weight measurements, assuming dropout is consistent with missing at random.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power Estimates\n With 360 participants, our objective is to determine the minimum detectable difference (MDD) for the primary outcome of PPWR between the 2 study groups. Our assumptions are as follows: a 2-tailed type I error rate of 0.05, a type II error rate of 0.10, and \u00e2\u0089\u00a570% follow-up for the main outcome of PPWR at 6 months. On the basis of the past experience [33] and published literature, we anticipate <30% loss to follow-up for 6-month weight measurements, consequential to various forms of dropout (eg, lost to follow-up). With this dropout rate and the assumption that the dropout is consistent with missing at random, we expect to randomize 360 participants (n=180, 50% per arm) to retain an effective sample size of 252 participants (n=126, 50%/arm) for our primary outcome. SDs for the MDD evaluation were informed by previous studies of similar combined diet-exercise lifestyle interventions to limit weight gain in pregnancy and promote postpartum weight loss [26,41,104,105]. Under these considerations, the resulting MDDs range from 2.3 to 3.6 kg with corresponding SDs for PPWR of between 5.5 and 8.8 kg.", "id": 1648, "split": "test"} +{"trial_id": "NCT05621772", "pmid": "38709746", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MARS-PD: Meridian Activation Remedy System for Parkinson's Disease - A Single-center, Rater-blinded, Parallel Randomized Controlled Trial\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': \"Experimental group (Meridian Activation Remedy System for Parkinson's Disease)\", 'type': 'EXPERIMENTAL', 'description': \"Meridian Activation Remedy System for Parkinson's Disease (MARS-PD) treatment (16 times/8 weeks total, 2 times/week)\", 'interventionNames': [\"Other: Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)\"]}\n- {'label': 'Control group (Usual Care)', 'type': 'NO_INTERVENTION', 'description': 'Usual care (all participants will be allowed to continue their prescribed medication and treatment (except Korean Medicine therapy), and they will not receive any additional treatment or therapy in the research institute), and lifestyle advice (all participants will receive a smart band and application-based guidance about their lifestyle)'}\n\nInterventions:\n- {'type': 'OTHER', 'name': \"Meridian Activation Remedy System for Parkinson's Disease (MARS-PD)\", 'description': 'MARS-PD is a complex therapy developed by researchers to enhance the synergistic effects of acupuncture and exercise.', 'armGroupLabels': [\"Experimental group (Meridian Activation Remedy System for Parkinson's Disease)\"]}\n\nPrimary Outcomes:\n- {'measure': \"Movement Disorder Society Unified Parkinson's Disease Rating Scale Part \u2162\", 'description': 'MDS-UPDRS Part \u2162 (maximum: 132, minimum: 0; higher scores mean a worse outcome)', 'timeFrame': 'Change from baseline MDS-UPDRS Part \u2162 score at 8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power (1-\u03b2) = 90%, and a dropout rate of 20%.", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size\n The hypothesis of this clinical trial is as follows:\n \n \n H0 (null hypothesis): \u00ce\u00bct = \u00ce\u00bcc\n \n \n H1 (alternative hypothesis): \u00ce\u00bct \u00e2\u0089\u00a0 \u00ce\u00bcc\n \n \n \u00ce\u00bct denotes the average change in MDS-UDPRS Part III score from baseline to 8 weeks in the treatment group (MARS-PD treatment), and \u00ce\u00bcc denotes the average change in MDS-UDPRS Part III score from baseline to 8 weeks in the control group (usual care). The experimental and control groups will be recruited in a one-to-one ratio.\n For the determination of the sample size, we referenced a previous study that closely resembled our current investigation in terms of research design, treatment period, treatment method, number of participant visits, and outcome variables [21]. In the study conducted by Hackney and Earhart, a total of 33 patients diagnosed with PD were enrolled, with 17 participants in the exercise (Tai Chi) group and 16 in the control (no intervention) group. The treatment period lasted 10\u00e2\u0080\u009313 weeks, with a total of 20 treatment sessions. One of their outcome variables was the UPDRS motor subscale (Part III). The observed average change in UPDRS Part III scores for the treatment and control groups were -1.5 \u00c2\u00b1 6.6 and 4.3 \u00c2\u00b1 5.6, respectively. The mean difference in effect between the Tai Chi group and control group was calculated as 5.8, with a pooled standard deviation was 6.1. These parameters from the previous study served as a basis for informing the sample size calculation in our current research design.\n We used a conservative value of 5 for the mean difference of the effect and 6.5 for the standard deviation to calculate the number of test subjects to confirm the effect of the experimental group compared to the control group in this study. According to Shulman et al. [22] and S\u00c3\u00a1nchez-Ferro et al., [23] the minimal clinically important difference (MCID) for UPDRS Part III is 2.3 and 5, respectively. In the meantime, Horv\u00c3\u00a1th et al. [24] estimated that the MCID for MDS-UPDRS Part III is between 2.3 and 2.7 points. Therefore, the proposed mean difference of the effect of 5 is equal to or greater than the MCID that was previously reported by the studies. Substituting this into the calculation formula [25] results in approximately 36 people per group as shown below. Considering the dropout rate of 20%, a total of 88 clinical trial subjects, 44 per group, are required. The criteria for dropout is specified in the protocol (S2 Appendix).\n\n2*Z1\u00e2\u0088\u0092\u00ce\u00b12+Z1\u00e2\u0088\u0092\u00ce\u00b22*\u00cf\u00832\u00ce\u00bct\u00e2\u0088\u0092\u00ce\u00bcc=21.96+1.282*6.5252~36\n\nWhere \u00ce\u00b1 (two-tailed test significance level) = 0.05; \u00ce\u00b2 (type 2 error) = 0.1; 1-\u00ce\u00b2 (power) = 90%.", "id": 1649, "split": "test"} +{"trial_id": "NCT05622201", "pmid": "37872497", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults\n\nIncluded conditions:\n- Schizophrenia Spectrum and Other Psychotic Disorders\n\nStudy Armgroups:\n- {'label': 'Rituximab', 'type': 'EXPERIMENTAL', 'description': 'Rituximab 1000 mg, infusion', 'interventionNames': ['Drug: Rituximab']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Saline infusion', 'interventionNames': ['Drug: Rituximab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Infusion', 'armGroupLabels': ['Placebo', 'Rituximab'], 'otherNames': ['Saline']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of responders to treatment, rated as much or very much improved with CGI-I', 'description': 'Improvement according to clinical rated Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': 'Baseline up to week 12'}\n\nPlease estimate the sample size based on the assumption: \nThe calculations are based on two-sided tests with a power of 80% and a significance level of 5%. An estimated dropout rate of 10% is considered. For the secondary outcome, we expect 33% in the rituximab-treated group to be much or very much improved compared to 10% in the placebo group, with the same power and significance level.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical power\n \n Sample size calculation\n Different studies report vast variations in placebo response in randomized placebo-controlled trials on schizophrenia, which makes sample size calculation difficult to estimate. The placebo response has increased considerably in more recent studies [61, 62].\n An important factor that may affect the placebo response is the selection of patients. If inclusion criteria demand patients to be in relapse or in an acute exacerbation, the natural course of the disease predisposes to regression to the mean, which comes out as a placebo response [61]. We will mostly include chronic stable patients with schizophrenia, which should imply a lower risk for placebo response.\n Drop-out rates are also expected to be low, as we use few assessments, only administer one single dose of the research drug and offer a reimbursement (700:- SEK) at both endpoints.\n A mean baseline PANSS score of approximately 85 (SD\u00e2\u0080\u0089=\u00e2\u0080\u008917) is anticipated, based on the proposed selection of participants with mostly stable chronic course of their disease.\n \n \n Primary outcome\n We expect a mean reduction of 4 points in the PANSS score in the placebo group and a reduction of 14 in the rituximab treatment group, based on the expected low placebo response in this cohort and our results from the pilot study, resulting in endpoint scores of 81 and 71, respectively. With a SD of 17 in both groups and a 10-point difference between groups, an effect size Cohen\u00e2\u0080\u0099s d of 0.59 is expected. With an estimated dropout of 10%, a sample size of 51 in each group is needed. The calculations are based on two-sided tests with a power (1 \u00e2\u0080\u0093 risk of making a type II error) of 80% and a significance level (risk of type I error) of 5%.\n \n \n Secondary (categorical) outcome\n We expect 33% in the rituximab-treated group to be much or very much improved (i.e., score 1 or 2 on CGI-I), compared to an expected 10% in the placebo group. To reach a power of 80% with a significance level of 5% (two-sided), we need to include 47 participants in each group. To allow for a 10% drop-out, we need 52 (47/0.9) participants per group.\n Response criterion is defined as much or very much improved according to CGI-I.\n \n \n Sample size\n We aim to include\u00c2\u00a0a total of 120 participants to account for a loss of degrees of freedom when statistically\u00c2\u00a0adjusting for prognostic factors in the model.", "id": 1650, "split": "test"} +{"trial_id": "NCT05622201", "pmid": "37872497", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults\n\nIncluded conditions:\n- Schizophrenia Spectrum and Other Psychotic Disorders\n\nStudy Armgroups:\n- {'label': 'Rituximab', 'type': 'EXPERIMENTAL', 'description': 'Rituximab 1000 mg, infusion', 'interventionNames': ['Drug: Rituximab']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Saline infusion', 'interventionNames': ['Drug: Rituximab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Infusion', 'armGroupLabels': ['Placebo', 'Rituximab'], 'otherNames': ['Saline']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of responders to treatment, rated as much or very much improved with CGI-I', 'description': 'Improvement according to clinical rated Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': 'Baseline up to week 12'}\n\nPlease estimate the sample size based on the assumption: \nThe calculations are based on two-sided tests with a power of 80% and a significance level of 5%. An estimated dropout rate of 10% is considered. For the secondary outcome, we expect 33% in the rituximab-treated group to be much or very much improved compared to 10% in the placebo group, with the same power and significance level.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim to include\u00c2\u00a0a total of 120 participants to account for a loss of degrees of freedom when statistically\u00c2\u00a0adjusting for prognostic factors in the model.", "id": 1651, "split": "test"} +{"trial_id": "NCT05623111", "pmid": "38262642", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study\n\nIncluded conditions:\n- Diabetic Neuropathy, Painful\n\nStudy Armgroups:\n- {'label': 'Incobotulinumtoxin-A', 'type': 'ACTIVE_COMPARATOR', 'description': '100 units of incobotulinumtoxin-A in 5ml of sterile saline around both distal ischial nerves.', 'interventionNames': ['Drug: Incobotulinumtoxin-A 100 UNIT Injection']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '5ml sterile saline with small amounts of human albumin and sucrose (identical to binding agents in active vials)', 'interventionNames': ['Drug: Saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Incobotulinumtoxin-A 100 UNIT Injection', 'description': 'Perineural injection', 'armGroupLabels': ['Incobotulinumtoxin-A']}\n- {'type': 'DRUG', 'name': 'Saline', 'description': 'Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in daily neuropathic pain scores', 'description': 'Differences in pain scores, as measured by the Numeric Rating Scale (0-11), between groups.', 'timeFrame': 'Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Outcome is defined as differences in change from baseline of average daily and weekly pain scores between groups.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha=0.05, using a two-tailed formula, and compensating for dropout.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n A meta-analysis of subcutaneous BonT-A treatment for painful neuropathy showed an average reduction of 1.49 at 12 weeks (NRS or Visual Analogue Scale (VAS)).15 A study of 5514 Danish patients with diabetes reported an average pain score of 5.3 (NRS, SD=2.1) in those suffering from painful neuropathy.28 Assuming a power of 80% and alpha=0.05, using a two-tailed formula, a sample size of 31 participants in each arm is calculated. Compensating for dropout, we aim to include 40 participants in each arm, for a total of 80.\n The calculation is conservative by design, given the lack of data on this mode of administration. A recent RCT of intradermal BonT-A for treating DNP reported a mean change in pain from 6.8\u00c2\u00b11.1\u00e2\u0080\u0089to 2.1\u00c2\u00b11 at 4 weeks follow-up in the group treated with BTX-A in both feet.20", "id": 1652, "split": "test"} +{"trial_id": "NCT05624463", "pmid": "38238052", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery at a Tertiary Hospital in China: A 2x2 Factorial Randomized Controlled Trial Protocol\n\nIncluded conditions:\n- Thyroid Tumor\n\nStudy Armgroups:\n- {'label': 'Modified intubation protocol+early resumption of oral intake', 'type': 'EXPERIMENTAL', 'description': 'Participants receive modified intubation protocol and early resumption of oral intake.', 'interventionNames': ['Behavioral: Modified intubation protocol', 'Behavioral: Early resumption of oral intake']}\n- {'label': 'Modified intubation protocol+delayed resumption of oral intake', 'type': 'OTHER', 'description': 'Participants receive modified intubation protocol and delayed resumption of oral intake.', 'interventionNames': ['Behavioral: Modified intubation protocol', 'Behavioral: Delayed resumption of oral intake']}\n- {'label': 'Conventional intubation protocol+early resumption of oral intake', 'type': 'OTHER', 'description': 'Participants receive conventional intubation protocol and early resumption of oral intake.', 'interventionNames': ['Behavioral: Conventional intubation protocol', 'Behavioral: Early resumption of oral intake']}\n- {'label': 'Conventional intubation protocol+delayed resumption of oral intake', 'type': 'OTHER', 'description': 'Participants receive conventional intubation protocol and delayed resumption of oral intake.', 'interventionNames': ['Behavioral: Conventional intubation protocol', 'Behavioral: Delayed resumption of oral intake']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Modified intubation protocol', 'description': '1. Turn on the electromyography (EMG) monitor and connect the EMG monitor to the patient as the patient is anesthetized; 2. View the vocal cords with video laryngoscope and intubate the patient with the EMG endotracheal tube; 3. Check the EMG monitor to confirm the correct contact between the electrodes and vocal cords; 4. Adjust the tube to achieve proper and stable contact between the electrodes and vocal cords; 5. Tape the EMG endotracheal tube at the midline and position the patient.', 'armGroupLabels': ['Modified intubation protocol+delayed resumption of oral intake', 'Modified intubation protocol+early resumption of oral intake']}\n- {'type': 'BEHAVIORAL', 'name': 'Conventional intubation protocol', 'description': '1. Intubate the patient with the EMG endotracheal tube and note depth; 2. Position patient and verify the position via Glottic Exam or Respiratory Variation; 3. Fix tube position.', 'armGroupLabels': ['Conventional intubation protocol+delayed resumption of oral intake', 'Conventional intubation protocol+early resumption of oral intake']}\n- {'type': 'BEHAVIORAL', 'name': 'Early resumption of oral intake', 'description': 'Patients will drink 30-50ml of normal temperature water after Steward scores \u2265 4 at PACU. If patients swallow successfully and have no significant discomfort symptoms, physicians will guide patients to resume drinking and eating gradually.', 'armGroupLabels': ['Conventional intubation protocol+early resumption of oral intake', 'Modified intubation protocol+early resumption of oral intake']}\n- {'type': 'BEHAVIORAL', 'name': 'Delayed resumption of oral intake', 'description': 'Patients will resume drinking water 6h after the operation at ward. Before patients resume oral drinking, they will be provided 10ml/kg 5% glucose saline intravenously.', 'armGroupLabels': ['Conventional intubation protocol+delayed resumption of oral intake', 'Modified intubation protocol+delayed resumption of oral intake']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of Recovery-15 score on the first day after surgery', 'description': 'Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.', 'timeFrame': 'one day'}\n\nPlease estimate the sample size based on the assumption: \nThe power was estimated to be 88% with a two-sided \u03b1 level of 0.05 and a 20% drop-out rate.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n This study examines the following two hypotheses. The first hypothesis was that participants assigned to E group would get higher QoR-15 scores than those assigned to D group. The sample size was estimated by the QoR-15 scores on the first day after surgery. According to the research of Wang et al,21 we assumed that the mean QoR-15 scores at T1 of participants enrolled in E group and D group was 115 and 105, respectively, with an SD of 20. We estimated that the power was 88% to assess the differential QoR-15 scores between two groups when 200 participants were enrolled for study, assuming a two-sided \u00ce\u00b1 level of 0.05 and a 20% drop-out rate. The second hypothesis was that participants assigned to M group would get higher QoR-15 scores than those assigned to C group. Because there were no previous studies related to the second hypothesis, we hypothesised that intubation procedure and postoperative oral intake strategies had similar effects on participants\u00e2\u0080\u0099 QoR-15 scores on the first day after surgery. To meet both the hypotheses, we intended to enrol 200 participants in total.", "id": 1653, "split": "test"} +{"trial_id": "NCT05626049", "pmid": "40139699", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)\n\nIncluded conditions:\n- Pain, Back\n\nStudy Armgroups:\n- {'label': 'Usual Medical Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).', 'interventionNames': ['Other: Usual Care']}\n- {'label': 'Primary Spine Provider Model', 'type': 'EXPERIMENTAL', 'description': 'This group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care.', 'interventionNames': ['Other: Primary Spine Provider Model']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Primary Spine Provider Model', 'description': 'Patients with LBP seeking care at intervention clinics will be offered an appointment with a DC or PT at the initial point of contact.', 'armGroupLabels': ['Primary Spine Provider Model'], 'otherNames': ['PSP Model']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Patients in this arm will receive usual care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).', 'armGroupLabels': ['Usual Medical Care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)', 'description': 'The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.', 'timeFrame': 'Baseline, 3 Months'}\n- {'measure': 'Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)', 'description': 'The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.', 'timeFrame': 'Baseline, 3 Months'}\n\nPlease estimate the sample size based on the assumption: \nIntracluster correlation (ICC) of 0.03 for both primary outcomes. Two-sided type I error of 2.5% for two primary outcomes with 90% power. Maximum attrition rate of 20% during the first 3 months of the trial. For secondary outcomes, a 30% dropout rate during 12 months follow-up with >80% power.", "answer": 1800, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The primary end points are the PROMIS Pain Interference and Physical Function scores at 3-month follow-up between the PSP model and usual care. Because randomisation will occur at the clinic level and the enrolled patients\u00e2\u0080\u0099 outcomes may be correlated within clinics, we must account for the correlated observations in sample size calculations and in analysis. We assumed intracluster correlation (ICC) of 0.03 for both of our primary outcomes. We assumed effect sizes (mean change over SD) of 0.4 based on data from the pilot study by Goode et al.67 The changes in the PROMIS Physical Function were more conservative than those of the PROMIS Pain Interference. For the sample size calculation, we used a two-sided type I error of 2.5% to account for two primary outcomes with 90% power. Also, the calculations account for an assumed maximum attrition rate of 20% during the first 3\u00e2\u0080\u0089months of the trial. Table 3 presents the sample size requirements for effect sizes between 0.3 and 0.5, ICCs between 0.01 and 0.05, 80% and 90% power, a two-sided 2.5% type I error rate and a 20% dropout rate. Based on these assumptions, 1800 patients from 26 clinics (13 clinics randomised to each arm), with an average of 80 enrolled participants per clinic and an ICC of 0.03, we will have >90% power to detect a difference of differences in minimum effect sizes of 0.4 for both primary outcomes. We initiated the trial with 22 clinics. Due to slow enrolment early on in one of the health systems, we added four additional clinics from a better enrolling system for a total of 26 clinics as described above. The addition of these clinics did not materially affect the estimated total sample size of 1800 planned enrollees.\n \n Table 3\n \n Required sample size for different effect sizes and ICCs with 80% and 90% power, 2.5% type I error rate for cluster size of 26 clinics (13 clinics randomised to each arm) and 20% drop out\n \n \n \n \n ICC\n 90% power\n 80% power\n \n \n Effect size\n Effect size\n \n \n 0.3\n 0.4\n 0.5\n 0.3\n 0.4\n 0.5\n \n \n \n \n 0.01\n 1194\n 674\n 343\n 915\n 520\n 335\n \n \n 0.02\n 1721\n 972\n 625\n 1319\n 749\n 483\n \n \n 0.03\n 2248\n 1270\n 817\n 1723\n 979\n 631\n \n \n 0.04\n 2776\n 1567\n 1008\n 2127\n 1208\n 779\n \n \n 0.05\n 3303\n 1856\n 1200\n 2530\n 1437\n 927\n \n \n \n \n \n ICCintracluster correlation\n \n \n \n The main secondary outcomes are the PROMIS Pain Interference and PROMIS Physical Function scores at the 12-month follow-up visit between the intervention arm and usual care arm. With a total of 1800 patients in 26 clinics with an average cluster size of 80 and ICC of 0.03, a two-sided type I error of 2.5% and 30% dropout rate during 12 months follow-up, we will be able to detect a minimum effect size of 0.4 with >80% power.", "id": 1654, "split": "test"} +{"trial_id": "NCT05626205", "pmid": "37415712", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PARO: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia\n\nIncluded conditions:\n- Alzheimer Disease\n- Older Adults\n\nStudy Armgroups:\n- {'label': 'Experimental Group', 'type': 'EXPERIMENTAL', 'description': 'The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.', 'interventionNames': ['Device: PARO robot']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The Control Group will receive only the traditional therapy.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PARO robot', 'description': 'PARO is an advanced interactive robot. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties. PARO has five kinds of sensors: tactile, light, audition, temperature, and posture sensors, with which it can perceive people and its environment. PARO can learn to behave in a way that the user prefers, and to respond to its new name.', 'armGroupLabels': ['Experimental Group']}\n\nPrimary Outcomes:\n- {'measure': 'changes in quality of life', 'description': \"This outcome will be assesed by the Quality of life in Alzheimer's Disease (QoL-AD) test. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.\", 'timeFrame': 'baseline, 12 and 24 weeks later'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, significance level of 0.05, two groups, 3 repeated assessments, within-between interactions ANOVA model, and a drop-out rate of 20%", "answer": 20, "answer_type": "ESTIMATED", "explanation": "2.4.\n Sample size\n QoL-AD (20) was used to perform a sample size calculation. Assuming an effect size of 35%, the total sample size needed to capture this effect size was estimated to be 16 subjects, assuming a statistical power of 80%, a significance level of 0.05, two groups and 3 repeated assessments (one baseline, 2 follow-ups) in a within-between interactions ANOVA model. Even assuming a drop-out rate of 20%, the total required sample size would be 20 subjects (10 in each arm).\n This sample size is assumed to be more than sufficient to capture variation even for secondary outcomes for which treatment effect sizes are assumed to be similar or larger than those identified for the primary outcome.", "id": 1655, "split": "test"} +{"trial_id": "NCT05627167", "pmid": "38286683", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Enteral Nutrition\n\nStudy Armgroups:\n- {'label': 'Daytime Cyclic enteral nutrition', 'type': 'EXPERIMENTAL', 'description': 'Patients receive continuous isocaloric enteral feeding for 10 hours during the day (e.g. 08:00 to 18:00) via nasal or oro-gastric tube', 'interventionNames': ['Other: day time cyclic nutrition']}\n- {'label': 'Continuous enteral nutrition', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube', 'interventionNames': ['Other: continuous nutrition']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'day time cyclic nutrition', 'description': 'Continuous isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100 mL for 10 hours during the day (e.g. 08:00 to 18:00), via nasal or oro-gastric tube', 'armGroupLabels': ['Daytime Cyclic enteral nutrition']}\n- {'type': 'OTHER', 'name': 'continuous nutrition', 'description': 'Isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100ml, continuously 24 hours a day by nasal or oro-gastric tube', 'armGroupLabels': ['Continuous enteral nutrition']}\n\nPrimary Outcomes:\n- {'measure': 'Change of organ failures', 'description': 'Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups', 'timeFrame': 'Day 7'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 risk set at 0.05, power of 0.8, and a 10% increase to account for potential loss to follow-up and premature study discontinuation.", "answer": 318, "answer_type": "ACTUAL", "explanation": "Sample size\n The required number of subjects is determined based on the anticipated difference in mean \u00ce\u0094SOFA between the two groups. Based on the \u00ce\u0094SOFA of the enteral nutrition group in the NUTRIREA-2 trial,38 the mean \u00ce\u0094SOFA in the continuous feeding group is a priori estimated at 4, and the mean \u00ce\u0094SOFA in the daily cyclic feeding group is estimated at 6. The SD of the mean \u00ce\u0094SOFA is estimated at 6 in both groups, based on the discrete SD of the SOFA score of the control group in the NUTRIREA-2 trial measured at 3. With the \u00ce\u00b1 risk set at 0.05 and a power of 0.8, the total number of subjects required in each group is 143, for a total of 286.\n To account for potential loss to follow-up and premature study discontinuation, we increased this number by 10%, resulting in a total of 318 patients (159 patients per group).", "id": 1656, "split": "test"} +{"trial_id": "NCT05627570", "pmid": "38471681", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating the Effects of Diets with Different Types of Food Processing Following UK DietAry Guidance on HealTh OutcomEs: an 8-week Community-based Crossover Randomised Controlled Trial in People with Overweight or Obesity, Followed by a 6-month Behavioural Intervention\n\nIncluded conditions:\n- Obesity\n- Cardiometabolic Syndrome\n- Overweight\n\nStudy Armgroups:\n- {'label': 'Diet A then Diet B, followed by a 6-month behavioural support programme', 'type': 'EXPERIMENTAL', 'description': '8-weeks of Diet A then 8-weeks of Diet B, then 6 months of goal-based behavioural support for consuming a healthy, balanced diet, increasing physical activity and reducing sedentary behaviour.', 'interventionNames': ['Dietary Supplement: Healthy, balanced Diet A', 'Dietary Supplement: Healthy, balanced Diet B', 'Behavioral: Behavioural support intervention']}\n- {'label': 'Diet B then Diet A, followed by a 6-month behavioural support programme', 'type': 'EXPERIMENTAL', 'description': '8-weeks of Diet B then 8-weeks of Diet A, then 6 months of goal-based behavioural support for consuming a healthy, balanced diet, increasing physical activity and reducing sedentary behaviour.', 'interventionNames': ['Dietary Supplement: Healthy, balanced Diet A', 'Dietary Supplement: Healthy, balanced Diet B', 'Behavioral: Behavioural support intervention']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Healthy, balanced Diet A', 'description': 'Healthy, balanced diet following Eatwell Guide recommendations', 'armGroupLabels': ['Diet A then Diet B, followed by a 6-month behavioural support programme', 'Diet B then Diet A, followed by a 6-month behavioural support programme']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Healthy, balanced Diet B', 'description': 'Healthy, balanced diet following Eatwell Guide recommendations', 'armGroupLabels': ['Diet A then Diet B, followed by a 6-month behavioural support programme', 'Diet B then Diet A, followed by a 6-month behavioural support programme']}\n- {'type': 'BEHAVIORAL', 'name': 'Behavioural support intervention', 'description': 'Participants will work with a behavioural scientist to create a personal plan to eat a healthier diet and be more physically active. This support will last for 6 months, with ongoing monthly telephone/video calls with the research team.', 'armGroupLabels': ['Diet A then Diet B, followed by a 6-month behavioural support programme', 'Diet B then Diet A, followed by a 6-month behavioural support programme']}\n\nPrimary Outcomes:\n- {'measure': 'Mean difference in percent weight change (%WC) at 8 weeks between Diet A and Diet B', 'description': '%WC will be calculated using: %WC = ((weight at baseline - weight at timepoint after baseline)/weight at baseline) x 100, calculated at each intervention endpoint. Mean difference in percent weight change will be calculated as: percent weight change diet A - percent weight change diet B. Weight measured in kilograms.', 'timeFrame': 'Baseline to 8 weeks for both diets'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a power of 0.9, a significance level (alpha) of 0.05, and a 20% dropout rate. A two-sided paired t-test will be used.", "answer": 55, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size of 55 is based on21 showing 0.9\u00e2\u0080\u0089kg weight loss following a 2-week MPF diet, with an SD of the mean difference in weight change of 1.98\u00e2\u0080\u0089kg between MPF and UPF diets (mean: 1.85\u00e2\u0080\u0089kg), the predicted weight loss if the MPF diet were continued for 8\u00e2\u0080\u0089weeks (using the NIH bodyweight planner (https://www.niddk.nih.gov/bwp)).\n No interventional studies to date have compared diets differing in the nature, extent and purpose of food processing over this duration. To best estimate the expected difference in %WC over this time frame, the results from the only controlled feeding trial comparing UPF and MPF diets matched for diet quality on weight change were used,21 which lasted for 2\u00e2\u0080\u0089weeks. Inclusion criteria for UPDATE require participants to have a habitual diet high in UPF, thus the UPF diet is hypothesised at best to lead to no change in weight. Whereas, the MPF diet will result in weight loss, with a similar initial trajectory to that in Hall et al.21 The NIH bodyweight planner takes into account that weight change is not linear based on the initial calorie deficit and tends to plateau and considers key factors that influence metabolic rate. The mean age, height, weight and PA levels of the male and female participants from Hall et al were entered into the bodyweight planner to produce a quantitative estimate of weight change on the MPF diet over 8\u00e2\u0080\u0089weeks, which was converted percentage weight change. Male participants in Hall et al\n21 would achieve 2.8% (2.2 kg) weight loss after 8\u00e2\u0080\u0089weeks on the MPF diet, and female participants would achieve 2.7% (2.1 kg) weight loss. There is no clear value from the literature as to what the SD should be for the mean difference in weight change between 8\u00e2\u0080\u0089week MPF and UPF diets. The expected SD must, therefore, be estimated. The 1.98\u00e2\u0080\u0089kg value for the SD of the mean difference in weight change from Hall et al was used as the starting point for the expected SD after 8\u00e2\u0080\u0089weeks. This was around 1.1\u00c3\u0097 the mean difference in weight change between MPF and UPF diet interventions. By assuming that the SD would increase over 8\u00e2\u0080\u0089weeks compared with 2\u00e2\u0080\u0089weeks, the SD was assumed to increase to 2\u00c3\u0097 the mean difference in weight change between MPF and UPF diets. Other trials longer in duration than Hall et al were considered, but other trials have a number of fundamental differences to the planned trial, which limits the ability to extrapolate their findings (eg, not necessarily ad libitum or cross-over trials, testing diets that are unrelated to the concepts of MPF or UPF, or comparing an intervention to a control diet, (whereas UPDATE involves two interventions)). These generally reported SDs for the mean weight change of each group, rather than of the mean difference between groups. For each group over several weeks (eg, 12\u00e2\u0080\u0089weeks), the SDs tended to be around 0.1\u00e2\u0080\u00930.9\u00c3\u0097 the mean weight change. Therefore, the Hall et al\u00e2\u0080\u0099s estimate was considered most applicable, relevant and conservative.\n Assuming weight loss on the MPF diet and no weight change on the UPF diet, 44 participants are required to detect a mean difference of 2.7%\u00e2\u0080\u0089weight change between diets (SD of 5.4% (2\u00c3\u0097 the mean difference), power=0.9, alpha=0.05, with a two-sided paired t-test, using SPSS V.27.0). With a 20% drop-out rate based on previous controlled feeding trials,81 82 55 participants will be recruited. This is comparable to attrition rates in previous multiarm, community-based cross-over trials lasting several months, where participants are provided with all meals.83\u00e2\u0080\u009386\n\n The target sample size for the qualitative interviews is 20\u00e2\u0080\u009330. Data saturation is controversial, but researchers will aim for meaningful saturation, whereby further interviews produce minimal, or no changes to the coding framework and allow complete understanding of thematic codes.87 Where possible, participants will be selected to ensure representation from across ethnicities, night shift patterns, genders, treatment allocation arms. All participants will be offered the behavioural intervention calls, so will be asked about experiences of the provided trial diets.", "id": 1657, "split": "test"} +{"trial_id": "NCT05627596", "pmid": "39198824", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices\n\nIncluded conditions:\n- Cigarette Smoking\n\nStudy Armgroups:\n- {'label': 'Electric Toothbrush', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.', 'interventionNames': ['Behavioral: Ask-Advise-Refer']}\n- {'label': 'Nicotine Replacement Therapy', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.', 'interventionNames': ['Behavioral: Ask-Advise-Refer', 'Drug: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release', 'Drug: Nicotine lozenge']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Ask-Advise-Refer', 'description': 'All patients will be asked if they smoke, advised to quit, and referred to the state quitline', 'armGroupLabels': ['Electric Toothbrush', 'Nicotine Replacement Therapy']}\n- {'type': 'DRUG', 'name': 'Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release', 'description': '14 mg transdermal nicotine patch', 'armGroupLabels': ['Nicotine Replacement Therapy']}\n- {'type': 'DRUG', 'name': 'Nicotine lozenge', 'description': '4mg nicotine lozenge', 'armGroupLabels': ['Nicotine Replacement Therapy']}\n\nPrimary Outcomes:\n- {'measure': '7-day biochemically confirmed point prevalence abstinence', 'description': 'Proportion reporting no smoking in the 7 days prior to the 6-month follow-up timepoint and having an exhaled carbon monoxide value of less than 6 parts per million', 'timeFrame': '6 months post baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that provides >80% power for a 5.5 percentage point difference and >90% power for a 6.5 percentage point difference, with an 11% lost to follow-up/withdrawal rate, and an intraclass correlation coefficient of 0.013.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size and power calculations pertain to the primary outcome biochemically verified abstinence from combustible tobacco at 6\u00c2\u00a0months post quit. With a sample size of 1200 and a cluster size of 24, the study was designed to have acceptable (>\u00e2\u0080\u008980%) power to detect a difference in CO-verified quit rates of 5.5 percentage points, and good power (>\u00e2\u0080\u008990%) for effect sizes of 6.5 percentage points or higher. Sample size estimates account for 11% lost to follow-up/withdrawal among patients. The calculations were informed by a study of nicotine replacement therapy sampling in primary care and assume an intraclass correlation coefficient of 0.013 and a CO-confirmed quit rate of 4.7% in the ET arm [13, 16]. This is somewhat lower than in the usual care condition from the primary care trial because it is more common for primary care physicians than for oral health professionals to prescribe NRT [5].", "id": 1658, "split": "test"} +{"trial_id": "NCT05629221", "pmid": "37563665", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values\n\nIncluded conditions:\n- Diabetes type2\n\nStudy Armgroups:\n- {'label': 'TreC Diabete App users', 'type': 'EXPERIMENTAL', 'description': 'Sixty individuals allocated to the intervention group are prescribed with the TreC Diabete App for 12 months, one of the App created within the so-called TreC platform, which enables citizens from PAT to access, manage and share information about their health and wellbeing in the context of telemedicine. The use of the App is additional to the standard care, based on the integrated preventive and diagnostic care pathway (called \"Percorsi Preventivi Diagnostici Terapeutici Assistenziali - PPDTA\" in Italian).An appointment with the outpatient diabetes clinic staff is scheduled at 6 and 12 month from the first visit (taking place within 30 days of the study entry), either through telemedicine (remote visit) or face-to-face.', 'interventionNames': ['Other: TreC Diabete App']}\n- {'label': 'non-App users', 'type': 'NO_INTERVENTION', 'description': 'Sixty individuals are allocated to the control group. These participants will receive standard care, which is the best care for T2DM in line with the integrated preventive and diagnostic care pathway (called \"Percorsi Preventivi Diagnostici Terapeutici Assistenziali - PPDTA\" in Italian).An appointment with the outpatient diabetes clinic staff is scheduled at 6 and 12 month from the first visit (taking place within 30 days of the study entry), either through telemedicine (remote visit) or face-to-face. Participants are asked to register their data as per routine (e.g. paper diary).'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TreC Diabete App', 'description': 'Participants can download the App from Google Play or Apple Store and activate the App as soon as the clinician provides them a unique activation code, created through an online medical dashboard. The dashboard allows the interaction between healthcare staff and the participant through the use of a chat or a video-chat. Participants are asked to register some information in the App at set times (e.g. blood pressure). Reminders are periodically sent to remember the participants to perform some tasks. Clinicians will periodically check the information entered by the participant (min frequency 45 days).', 'armGroupLabels': ['TreC Diabete App users']}\n\nPrimary Outcomes:\n- {'measure': 'Haemoglobin glycated (Hb1Ac) mean changes', 'description': \"Difference in the participants' HbA1c level between the two arms. Blood test carried out by qualified nurses and processes by the local analysis laboratory. Blood tests results are automatically registered on the Hospital Information System (HIS) and reviewed by clinicians and research staff involved in the study.\", 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 5%, and a 20% dropout rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was calculated on the basis of the primary hypothesis (Hb1Ac levels are likely to decrease more in the subjects of the intervention group than for the subjects of the control group at 12\u00c2\u00a0months). A lower variability around the HbA1c mean level is also expected for the subjects in the intervention group when compared to the HbA1c mean level for the subjects in the control group. It was assumed that at 12\u00c2\u00a0months, the mean Hb1Ac level will be 49 (SD\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00893) mmol/mol in the intervention group and 52 (SD\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00897) mmol/mol in the control group. In order to achieve a power of 80% and to keep the significance level at 5%, the sample size was calculated to be 102 (51 in each group) by using Open Epi (a freely accessible software, https://www.openepi.com/Menu/OE_Menu.htm) as depicted in Fig.\u00c2\u00a01 below. Assuming 20% of drop-out, the required sample was calculated as 120.Fig. 1Sample size calculation\u00e2\u0080\u0094output from Open Epi", "id": 1659, "split": "test"} +{"trial_id": "NCT05629702", "pmid": "38225549", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Controlled Phase II Trial of Temozolomide with or Without Cannabinoids in Patients with Recurrent Glioblastoma\n\nIncluded conditions:\n- Glioblastoma\n- Brain Tumor\n- Cannabis\n- Brain Tumor, Recurrent\n\nStudy Armgroups:\n- {'label': 'Standard Temozolomide with Nabiximols', 'type': 'EXPERIMENTAL', 'description': '* Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles.\\n* Nabiximols up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1.', 'interventionNames': ['Drug: Nabiximols', 'Drug: Temozolomide']}\n- {'label': 'Standard Temozolomide with Nabiximols-matched placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '* Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles.\\n* Nabiximols-matched placebo up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1.', 'interventionNames': ['Drug: Temozolomide', 'Drug: Nabiximols-matched placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nabiximols', 'description': 'Oromucosal spray', 'armGroupLabels': ['Standard Temozolomide with Nabiximols'], 'otherNames': ['Sativex']}\n- {'type': 'DRUG', 'name': 'Temozolomide', 'description': 'Oral capsule', 'armGroupLabels': ['Standard Temozolomide with Nabiximols', 'Standard Temozolomide with Nabiximols-matched placebo']}\n- {'type': 'DRUG', 'name': 'Nabiximols-matched placebo', 'description': 'Nabiximols-matched placebo oromucosal spray', 'armGroupLabels': ['Standard Temozolomide with Nabiximols-matched placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival time (OS)', 'description': 'To establish whether the addition of cannabinoids (Nabiximols) to standard TMZ treatment improves overall survival time (OS) in MGMT methylated recurrent GBM compared to the addition of placebo to TMZ.', 'timeFrame': 'Time in whole days from date of randomisation to the date of death from any cause, assessed at a minimum of 12 months..'}\n\nPlease estimate the sample size based on the assumption: \nThe trial uses a one-sided significance level of 10% (\u03b1 = 0.1) and aims for 80% power (\u03b2 = 0.2). The recruitment period is 18 months with a follow-up period of 12 months. A randomisation ratio of 2:1 in favour of the experimental treatment arm is used. An additional 5% is added to cover potential dropouts.", "answer": 234, "answer_type": "ESTIMATED", "explanation": "Sample size\n The target sample size is 234 patients based on testing the null hypothesis of no difference between the treatment arms in terms of OS, i.e., a hazard ratio (HR)\u00e2\u0080\u0089=\u00e2\u0080\u00891 and assumes exponential distribution for survival times. Calculations assume a recruitment period of 18 months and follow-up period of 12 months. As a phase II trial, the design uses a relaxed one-sided significance level of 10% (i.e., \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.1) and a randomisation ratio of 2:1 in favour of the experimental treatment arm. The expected median survival time on the placebo arm is 12 months, which equates to a hazard rate of 0.058 [6, 24]. Given these design parameters, the trial requires 132 events to have 80% power (i.e., \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2) to detect a difference with a hazard ratio of 0.68, i.e., median survival time of 17.6 months on the experimental treatment arm and hazard rate of 0.039. Given the results from the phase I trial [16], we believe this is a plausible benefit to target. It is estimated that we need to recruit 222 patients during the 18-month recruitment period to observe this number of events; a further 5% to cover potential dropouts has been added to give a target sample size of 234. The trial includes an initial feasibility study that, based on a pragmatic rationale, will incorporate the first 40 patients recruited.", "id": 1660, "split": "test"} +{"trial_id": "NCT05633940", "pmid": "39164634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Primary Care Behavioral Health in Primary Care in Sweden\n\nIncluded conditions:\n- Primary Health Care\n- Mental Disorder\n- Behavioral Symptoms\n\nStudy Armgroups:\n- {'label': 'Implementation', 'type': 'EXPERIMENTAL', 'description': 'The centers that implement PCBH.', 'interventionNames': ['Behavioral: Implementation of the service delivery model primary care behavioral health']}\n- {'label': 'No implementation', 'type': 'NO_INTERVENTION', 'description': 'Control centers that do not implement PCBH.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Implementation of the service delivery model primary care behavioral health', 'description': 'The research project will study a real-world implementation of PCBH in routine primary care. The implementation is facilitated by a regional implementation group of psychologists with special training in PCBH. The active implementation period for each intervention center is 12 months, where continuous support, materials and training are offered by the implementation group.', 'armGroupLabels': ['Implementation']}\n\nPrimary Outcomes:\n- {'measure': 'Accessibility at the health care center, measured in number of visits', 'description': 'Number of visits to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).', 'timeFrame': 'Baseline to 24 months.'}\n- {'measure': 'Functional level of the patients.', 'description': 'Measured by Sheehan disability scale.', 'timeFrame': 'Baseline to 24 months.'}\n- {'measure': 'Work environment among the medical staff', 'description': 'Measured by the COPSOQ III questionnaire , which is an instrument that measures psychosocial factors, stress, and the well-being of employees.', 'timeFrame': 'Baseline to 24 months.'}\n- {'measure': 'Experience of primary care behavioral health among the medical staff', 'description': 'Data will be collected through qualitative interviews.', 'timeFrame': 'Baseline to 24 months.'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8, a significance level of 0.05, and considerations for heterogeneity in populations and primary care centers.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size\n Approximately 3% of all patients in primary care receive an intervention by a behavioral health consultant [6, 13]. We hypothesize that this number will be at least 50% higher in the intervention group compared to the control group. A sample size based on a 50% increase, a power of 0.8 and a significance level of 0.05 yields a minimum of 1983 participants per group. Since we are using a design where heterogeneity of the populations and primary care centers probably will reduce the likelihood to detect meaningful changes, it is reasonable to double the number of participants to 3966 individuals per group. One of the pilot primary care centers has 14,841 listed patients. A study regarding Swedish primary care showed that approximately 66% of the population receives care annually at a primary care center [5]. It can thus be estimated that 9,795 (14,841\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00890.66) individual patients receive care annually at this center. If we assume that 3% [6, 13] of these patients receive a behavioral health consultant intervention, approximately 294 (9,795\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00890.03) patients annually receive a PCBH-based intervention. After the implementation of the PCBH delivery model, we estimate that this number will increase to 441 individual patients per year for one single primary care center (i.e., a 50% increase in the intervention group: 294\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00891,5\u00e2\u0080\u0089=\u00e2\u0080\u0089441). Since the project will involve 24 primary care centers, the requested sample size of at least 3966 individuals will not pose any difficulties, even considering that the number of listed patients among these centers ranges from approximately 4,500 to 21,500 listed patients (in December 2022). It should be noted that it is difficult to estimate the power of cluster studies because there can be heterogeneity within and between clusters.", "id": 1661, "split": "test"} +{"trial_id": "NCT05634317", "pmid": "37673447", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Supporting Family Caregivers of People With Dementia and Identifying an Effective Adaptive Intervention to Reduce Their Depressive Symptoms: a Sequential Multiple Assignment Randomized Trial\n\nIncluded conditions:\n- Dementia\n\nStudy Armgroups:\n- {'label': 'Behavioral activation', 'type': 'EXPERIMENTAL', 'description': 'The SD-BA, consisting of 16 sessions (30 minutes each) twice a week over 8 weeks, will be delivered by the trained instructor through a videoconference mobile app. Participants will be asked to review their daily activity patterns and then choose activity goals and review their successes and areas of improvement. They will also be taught how to fill out the daily monitoring record, which will involve noting down their activities on the day of the session for each hour before the session, and rating the importance and degree of enjoyment associated with each activity.', 'interventionNames': ['Behavioral: Smartphone delivered Behavioral activation']}\n- {'label': 'Mindfulness', 'type': 'ACTIVE_COMPARATOR', 'description': 'A mindfulness instructor will deliver the program through a videoconference mobile app, and include various mindfulness practices (e.g., mindful walking, body scanning) and sharing. To standardize the interventions in this study, the previous approach will be changed from 7 weekly 120-minute sessions to 16 sessions (30 minutes each) twice a week over 8 weeks. The participants will also be encouraged to perform 30 minutes of mindfulness practice every day. All participants will be given an audio (mp3) recording of guided mindfulness activities to enhance their daily practice, and a logbook via a mobile app or in hardcopy (according to their preference) to record the frequency of their self-practice at home and monitor their compliance rate. Our volunteers will provide support via smartphone to answer questions and address difficulties.', 'interventionNames': ['Behavioral: Smartphone delivered Mindfulness']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Smartphone delivered Behavioral activation', 'description': 'Outline:\\n\\nSession 0 45-minute psychoeducation on caregiving and depression\\n\\nSession 1 Review the present use of time and use the monitoring form\\n\\nSession 2 Brain-storm pleasant events and schedule pleasant activities\\n\\nSession 3 Review scheduling of events and discuss how to improve\\n\\nSession 4 Review modifications and consolidate gains on scheduling\\n\\nSession 5 Review present social support and explore new sources of support\\n\\nSession 6 Examine communication skills and explore new options\\n\\nSession 7 Review new communications and discuss how to improve\\n\\nSession 8 Review modification and consolidate gains on support', 'armGroupLabels': ['Behavioral activation']}\n- {'type': 'BEHAVIORAL', 'name': 'Smartphone delivered Mindfulness', 'description': 'Outline:\\n\\nSession 0 45-minute psychoeducation on caregiving and depression\\n\\nSession 1 The Raisin exercise (eating meditation) and12-min body scan\\n\\nSession 2 Exercises on thoughts and feelings 12-min body scan\\n\\nSession 3 Exercises focusing on unpleasant experiences, practicing seeing and hearing , sitting meditation, 3-min breathing space, and mindful stretching and breath meditation\\n\\nSession 4 Practicing seeing and hearing, mindful communication, 3-min breathing space, and sitting meditation\\n\\nSession 5 Mindful walking, 3-min breathing space, and sitting meditation\\n\\nSession 6 Sitting meditation, exercises on thoughts and alternative viewpoints, and 3-min breathing space (responsive)\\n\\nSession 7 Sitting meditation, activity and mood exercise, identifying habitual emotional reactions to difficulties, and 3-min breathing space (responsive)\\n\\nSession 8 12-min body scan, exercise on looking forward, and exercise on preparing for the future', 'armGroupLabels': ['Mindfulness']}\n\nPrimary Outcomes:\n- {'measure': 'The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9)', 'description': 'PHQ-9\\\\* is a 9-question instrument to screen for depression. It requires participants to answer their depression experiences over the past 2 weeks.\\n\\nComparisons of changes of the Patient Health Questionnaire 9 will be considered as follows:\\n\\nT1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5', 'timeFrame': 'baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))'}\n\nPlease estimate the sample size based on the assumption: \n85% power at a two-sided 5% level of significance, 20% attrition rate, and a conservative non-response rate of 0.5.", "answer": 136, "answer_type": "ESTIMATED", "explanation": "Sample size\n A power analysis was conducted to estimate a sample size sufficient to detect the main effect on depressive symptoms in a SMART design.19 Two previous studies on dementia caregivers receiving mindfulness and BA had an attrition rate of 9.0% and 8.9%, respectively.12 22 After considering the effect size and their attrition rates, a conservative effect size of Cohen\u00e2\u0080\u0099s d=0.5 and 20% attrition will be adopted for the estimation. A sample size of 136 FC (68 per group) will be needed to achieve 85% power at a two-sided 5% level of significance for the first stage. Taking a conservative non-response rate of 0.5 for both BA and MP in the first stage of the intervention,22 a total sample of 136/0.5=272, 63 in each subgroup (eg, subgroup B+E, see figure 1) will be needed. To compare the effects between the four embedded adaptive interventions, a total sample of 166 will be needed to identify the best embedded adaptive intervention, considering at least a 95% probability with a medium effect size of 0.5 (Cohen\u00e2\u0080\u0099s d) and an attrition rate of 20%.23 After considering sample sizes of 136, 166 and 272 for different stages, we choose a conservative sample size of 272 FC for this study.", "id": 1662, "split": "test"} +{"trial_id": "NCT05635903", "pmid": "37590203", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Can Continuous or Intermittent Normal Saline Nebulisation Via a Vibrating Mesh Nebuliser or Intermittent Normal Saline Via a Standard Jet Nebuliser Improve the Lung Physiology and Secretion Viscosity in Mechanically Ventilated Patients?\n\nIncluded conditions:\n- Respiratory Failure\n- Critical Illness\n\nStudy Armgroups:\n- {'label': 'Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser', 'type': 'EXPERIMENTAL', 'description': 'Continuous nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24h continuous infusion using a syringe pump)', 'interventionNames': ['Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser']}\n- {'label': 'Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser', 'type': 'EXPERIMENTAL', 'description': 'Intermittent nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 0.9% normal saline nebulised every 6 hours)', 'interventionNames': ['Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser']}\n- {'label': 'Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intermittent standard nebulization of 0.9% normal saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser ((5mls 0.9% normal saline nebulised every 6 hours)', 'interventionNames': ['Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser', 'description': 'Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser', 'armGroupLabels': ['Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser']}\n- {'type': 'PROCEDURE', 'name': 'Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser', 'description': 'Intermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser', 'armGroupLabels': ['Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser']}\n- {'type': 'PROCEDURE', 'name': 'Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser', 'description': 'standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser', 'armGroupLabels': ['Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser']}\n\nPrimary Outcomes:\n- {'measure': 'Pourability of respiratory secretions (The QSA score will assess quantity, quality/stickiness/density and colour/appearance of secretions and is described and validated in the literature3,4)', 'description': 'Pourability of respiratory secretions as assessed by the QSA (Qualitative Sputum Assessment) Tool 0-4. . As the QSA Tool score ranges from 1 to 4 in increments of 0.5, with 1 being the most pourable and 4 the least pourable.\\n\\n(The QSA score will assess quantity, quality/stickiness/density and colour/appearance of secretions and is described and validated Lopez-Vidriero MT, Charman J, Keal E, De Silva DJ, Reid L. Sputum viscosity: correlation with chemical and clinical features in chronic bronchitis. Thorax. 1973 Jul;28(4):401-8. PubMed ID: 4741442', 'timeFrame': 'At 1000 and 1600 for 3 days'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size rationale\n A total of 60 patients will be recruited to the study (20 in each of the 3 treatment groups):\n \n \n Continuous VMN: continuous nebulisation of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24hrs via a syringe feed set).\n \n \n Intermittent VMN: intermittent nebulisation of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 6 hourly).\n \n \n Intermittent JN: intermittent nebulisation of 0.9% normal saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser (5mls 6 hourly)", "id": 1663, "split": "test"} +{"trial_id": "NCT05635968", "pmid": "37638435", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Multicenter Phase II Clinical Trial for Evaluation of Safety and Efficacy Using Low Dose Irradiation With Alzheimer's Disease\n\nIncluded conditions:\n- Alzheimer Disease\n\nStudy Armgroups:\n- {'label': 'Low-dose whole brain irradiation group 1 (4cGy/day)', 'type': 'EXPERIMENTAL', 'description': 'Low-dose whole brain irradiation with general AD medication treatment (4cGy/day, 2times/1wk, total 24cGy, 6 times/3wks)', 'interventionNames': ['Radiation: Low-dose whole brain irradiation']}\n- {'label': 'Low-dose whole brain irradiation group 2 (50cGy/day)', 'type': 'EXPERIMENTAL', 'description': 'Low-dose whole brain irradiation with general AD medication treatment (50cGy/day, 2times/1wk, total 300cGy, 6 times/3wks)', 'interventionNames': ['Radiation: Low-dose whole brain irradiation']}\n- {'label': 'Sham RT group', 'type': 'SHAM_COMPARATOR', 'description': 'Sham RT wtih general AD medication treatment (0cGy/day, 2times/1wk, total 0cGy, 6 times/3wks)', 'interventionNames': ['Radiation: Low-dose whole brain irradiation']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Low-dose whole brain irradiation', 'description': 'In the experimental group (1), 20 patients receive 4cGy x 6 times, a total of 24 cGy of irradiation. In the experimental group (2), 20 patients receive 50 cGy x 6 times, a total of 300 cGy of irradiation. All experimental groups and control group visit the hospital about 1, 6, and 12 months after irradiation to evaluate efficacy and safety.', 'armGroupLabels': ['Low-dose whole brain irradiation group 1 (4cGy/day)', 'Low-dose whole brain irradiation group 2 (50cGy/day)', 'Sham RT group']}\n\nPrimary Outcomes:\n- {'measure': 'saftey and efficacy', 'description': \"1) Changes in cognitive function test score compared to baseline after six months are estimated using Alzheimer's disease assessment scale-Korea (ADAS-K) (range 0-70, higher scrores mean a worse outcome). The amount of change is evaluated as a valid response if it shows an improvement of 5% or more compared to the baseline score.\", 'timeFrame': '6 months after completion of low-dose irradiation to whole brain'}\n- {'measure': 'saftey and efficacy', 'description': '2) Number of adverse events 6 months after baseline determined by the Radiation Therapy Oncology Group (RTOG) toxicity grading system.', 'timeFrame': '6 months after completion of low-dose irradiation to whole brain'}\n\nPlease estimate the sample size based on the assumption: \nBonferroni correction will be performed, with a comparative, parallel, three-arm design, 80% power, and a 2-sided alpha of 0.05.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This trial is intended to further evaluate the treatment effect of LDRT on AD, and it is difficult to calculate the appropriate effect size for the treatment and control groups. Therefore, the purpose of this study is exploratory, in the form of a pilot study to compare efficacy. Bonferroni correction will be performed, and a comparative, parallel, three-arm design will be adopted with 80% power and a 2-sided alpha of 0.05. Finally, 20 people per group, for a total of 60 people, is calculated as the number of samples considering the dropout rate.", "id": 1664, "split": "test"} +{"trial_id": "NCT05637008", "pmid": "37164478", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study\n\nIncluded conditions:\n- Ankle Sprains\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Chronic ankle instability', 'description': 'Based on the predetermined criteria of the International Ankle Consortium, participants will have developed chronic ankle instability or not.\\n\\nhttps://www.jospt.org/doi/10.2519/jospt.2013.0303 - table 1', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n10 events per variable, 20% dropout rate, 5% margin of error", "answer": 265, "answer_type": "ESTIMATED", "explanation": "Sample size\n It is difficult to calculate a precise sample size due to insufficient information regarding associations between presumed prognostic factors and the outcomes. The primary outcome will be CAI at 12-month follow-up. The definition of CAI will follow the consensus definition from the international ankle consortium.10 35 36 After LAS, we can conservatively estimate that 33% of individuals develop CAI within the first year.19 To identify at least 10 events per variable investigated37 and allowing for a 20% dropout rate, we will require 318 recruited subjects to obtain 265 participants with full data when considering a margin of error of 5%.38 We are not bound to any deadlines since we perform this study without funding. We estimate to recruit participants for a period of 4 years\u00e2\u0080\u0094based on the feasibility study mentioned below\u00e2\u0080\u0094and end the study in 2028.", "id": 1665, "split": "test"} +{"trial_id": "NCT05637047", "pmid": "37225266", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ultrasound-guided Pulsed Radiofrequency Versus Dry Needling for Pain Management in Chronic Neck and Shoulder Myofascial Pain Patients at a Tertiary Hospital in China: A Randomized Controlled Trial\n\nIncluded conditions:\n- Myofascial Pain\n\nStudy Armgroups:\n- {'label': 'pulsed radiofrequency', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: pulsed radiofrequency']}\n- {'label': 'Dry needling', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Dry needling']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'pulsed radiofrequency', 'description': 'ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation', 'armGroupLabels': ['pulsed radiofrequency']}\n- {'type': 'PROCEDURE', 'name': 'Dry needling', 'description': 'ultrasound-guided intramuscular and interfascial dry needling', 'armGroupLabels': ['Dry needling']}\n\nPrimary Outcomes:\n- {'measure': 'Pain VAS score', 'description': 'Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.', 'timeFrame': 'Postoperative six months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an \u03b1 of 0.05 and \u03b2 of 0.9, with a 20% dropout rate.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated based on a null hypothesis of the primary outcome, pain VAS at 6\u00e2\u0080\u0089months postoperatively. According to prior study and our pilot study experiences, the pain VAS after DN and PRF treatment was 38\u00c2\u00b115 mm and 26\u00c2\u00b118 mm, respectively.5 Assuming an \u00ce\u00b1 of 0.05 and \u00ce\u00b2 of 0.9, 42 patients will be needed in each group to detect significant differences. Accounting for a 20% dropout rate, a total of 108 patients will be recruited.", "id": 1666, "split": "test"} +{"trial_id": "NCT05637593", "pmid": "37438071", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease\n\nIncluded conditions:\n- Acoustic Stimulation\n- Parkinson Disease\n- Movement, Abnormal\n- Bradykinesia\n- Arm\n\nStudy Armgroups:\n- {'label': 'the RAS group', 'type': 'EXPERIMENTAL', 'description': 'The RAS group will receive upper-limb movement training with the aid of RAS;', 'interventionNames': ['Behavioral: Upper-limb movement training with the aid of RAS']}\n- {'label': 'the no-RAS group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The no-RAS group will receive upper-limb movement training without the aid of RAS.', 'interventionNames': ['Behavioral: Upper-limb movement training without the aid of RAS']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Upper-limb movement training with the aid of RAS', 'description': 'Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.\\n\\nPatients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement.\\n\\nEach daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.', 'armGroupLabels': ['the RAS group']}\n- {'type': 'BEHAVIORAL', 'name': 'Upper-limb movement training without the aid of RAS', 'description': 'Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient.\\n\\nPatients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible.\\n\\nEach daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.', 'armGroupLabels': ['the no-RAS group']}\n\nPrimary Outcomes:\n- {'measure': 'The box and block test (BBT)', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.', 'timeFrame': 'One week before the training. BBT requires 2 to 5 minutes to administer.'}\n- {'measure': 'The box and block test (BBT)', 'description': 'BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\\\\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.', 'timeFrame': 'One week after the training. BBT requires 2 to 5 minutes to administer.'}\n- {'measure': 'The Jebsen hand function test (JHFT)', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.', 'timeFrame': 'One week before the training. JHFT takes approximately 15 minutes to administer.'}\n- {'measure': 'The Jebsen hand function test (JHFT)', 'description': 'JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.', 'timeFrame': 'One week after the training. JHFT takes approximately 15 minutes to administer.'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical test used was analysis of covariance with an effect size f of 0.255, power of 0.8, alpha level of 0.05, 2 groups, and 10 covariates (age, gender, Hoehn and Yahr stage, disease duration, more-affected side, medication dosage, number of training sessions completed, depression score at pretest, anxiety score at pretest, and pretest score of an outcome variable).", "answer": 138, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Because of no existing PD studies testing effects of training involving PSE on upper-limb movements, we calculated the effect size of training involving PSE (f=0.255) according to data of the classic study20 examining effects of training involving RAS on gait speed in patients with PD. The G*Power software (V.3.1.9.7) was used to estimate the required sample size under the following conditions: analysis of covariance as the statistical test, an effect size f of 0.255, the power of 0.8, the alpha level of 0.05, 2 groups and 10 covariates (age, gender, the Hoehn and Yahr stage, disease duration, the more-affected side, medication dosage, the number of training sessions the participant completes, the score of the depression item in the first part of the Movement Disorder Society-sponsored revision of the unified Parkinson\u00e2\u0080\u0099s disease rating scale (MDS-UPDRS) at pretest, the score of the anxiety item in the first part of MDS-UPDRS at pretest, and a pretest score of an outcome variable, including the score of the box and block test (BBT), the error rate during executing BBT, the score of the Jebsen hand function test (JHFT) and the domain score of the third part of MDS-UPDRS). The estimated total sample size was 124. Considering the dropout rate of 10%, the final total sample size was 138 patients (69 patients per group).", "id": 1667, "split": "test"} +{"trial_id": "NCT05638360", "pmid": "40053806", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial\n\nIncluded conditions:\n- Colles' Fracture\n\nStudy Armgroups:\n- {'label': 'Ru-Yi-Jin-Huang-Saan', 'type': 'EXPERIMENTAL', 'description': 'Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.', 'interventionNames': ['Drug: Ru Yi Jin Huang Powder']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants received a starch patch topically twice daily for 6 days.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ru Yi Jin Huang Powder', 'description': 'Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.', 'armGroupLabels': ['Ru-Yi-Jin-Huang-Saan'], 'otherNames': ['golden patch']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Each patch contains 13g starch and 10c.c. water.', 'armGroupLabels': ['Placebo'], 'otherNames': ['starch']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6', 'description': 'The PRWE scale is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.\\n\\n1. Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0.\\n2. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.\\n\\nPossible scores range from 0 (best score) to 100 (worst score).\\n\\nChange = (Day 6 score - Baseline score)', 'timeFrame': 'Baseline and Day 6'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 level=.05, statistical power of 0.95, potential dropouts", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation\n Our study closely resembles the design of phase-2 studies in clinical trials, which aim to assess the effectiveness of drugs in participants with specific conditions or diseases. We used G*Power (Heinrich-Heine-Universit\u00c3\u00a4t D\u00c3\u00bcsseldorf) to estimate the necessary sample size for our study, taking into account repeated-measures ANOVA within-between interactions with a medium effect size of f=0.25 and \u00ce\u00b1 level=.05. To achieve a statistical power of 0.95, we calculated a total sample size of 86 [60]. To account for potential dropouts and satisfy our inclusion criteria, we will enroll 100 individuals who have been admitted to our orthopedic care ward and diagnosed with Colles fracture after surgery.", "id": 1668, "split": "test"} +{"trial_id": "NCT05639023", "pmid": "38178051", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis - A Randomized Controlled Study\n\nIncluded conditions:\n- Adolescent Idiopathic Scoliosis\n\nStudy Armgroups:\n- {'label': 'Manipulation Techniques Group', 'type': 'EXPERIMENTAL', 'description': 'Subjects will be received orthopedic manipulation and Physiotherapy Scoliosis-Specific Exercise(PSSE). For orthopedic manipulation, Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week. For PSSE, subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study.', 'interventionNames': ['Other: Manipulation Techniques', 'Other: Physiotherapy Scoliosis-Specific Exercise']}\n- {'label': 'Control Group', 'type': 'EXPERIMENTAL', 'description': 'Subjects will be received sham orthopedic manipulation and Physiotherapy Scoliosis-Specific Exercise(PSSE). For orthopedic manipulation, Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week. For PSSE, subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study.', 'interventionNames': ['Other: Physiotherapy Scoliosis-Specific Exercise']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Manipulation Techniques', 'description': 'Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.', 'armGroupLabels': ['Manipulation Techniques Group']}\n- {'type': 'OTHER', 'name': 'Physiotherapy Scoliosis-Specific Exercise', 'description': 'Subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study.', 'armGroupLabels': ['Control Group', 'Manipulation Techniques Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change of Scoliosis Research Society-22 (SRS-22)', 'description': 'Scoliosis Research Society-22 (SRS-22) questionnaire includes 5 dimensions : 1)function/activity,2) pain,3) self-perceived image, 4)mental health, satisfaction with treatment and 5)other health-related quality of life(HRQL) parameters with a total of 22 items, and is scored by the Likert 5-level scoring method. Possible score range from 0 (no pain)to 5(worst possible pain).A higher score indicates a better quality of life for the patient.', 'timeFrame': 'Baseline, Week 8,16,24'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 significance level, and a 20% dropout rate.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n PASS 12.0 was used for the sample size calculation. The Scoliosis Research Society-22 (SRS-22) questionnaire score was chosen as the primary outcome indicator. The minimal clinically important difference of SRS-22 ranges from 0.4\u00e2\u0080\u00930.7 [41]. The standard deviation was estimated to be 0.45 from previous studies about non-operative treatments in AIS patients [42]. To detect a clinically meaningful different of 0.4 in SRS-22, with 80% power at the 0.05 significance level and an assumed standard deviation of 0.45, 21 cases in each group are required. Allowing for a dropout rate of 20%, a total of 50 participants will be recruited with 25 participants for each group.", "id": 1669, "split": "test"} +{"trial_id": "NCT05639478", "pmid": "38316587", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life\n\nIncluded conditions:\n- Diabetes; Neuropathy, Polyneuropathy (Manifestation)\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the intervention group will perform face to face foot-related exercises for 12 weeks.', 'interventionNames': ['Other: Foot-related 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': 'Foot-related exercises', 'description': 'Face to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orienta\u00e7\u00e3o do P\u00e9 diab\u00e9tico, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression.', 'armGroupLabels': ['Intervention group'], 'otherNames': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument', '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 neuropathy)', 'timeFrame': '12 weeks'}\n- {'measure': 'Change From Baseline of the Foot and Ankle range of motion at 12-week', 'description': 'Ankle and first metatarsophalangeal joint will be measured by manual goniometers.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) of 0.05, statistical power of 0.80, margin of error of 5%, and standard deviation of 50%.", "answer": 356, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The population-based sample took into account the total inhabitants catered by the three eMulti teams. Each team is responsible for six primary health units, each one covers an average of 5000 individuals; thus the 18 clusters comprise 90\u00e2\u0080\u0089000 potential individuals. Considering that we will include only literate adults, 24.2% of the Limeira population is under 18 years old, and 6.6% of adults are illiterate, the target population is 63\u00e2\u0080\u0089718 individuals. In addition, the Brazilian prevalence of diabetes is 7.4%,23 therefore, we can estimate a total of 4715 people with diabetes in Limeira that can be considered our study population.\n The sample size was based on the finite population sample calculation (equation 1), which takes into account the population size (n=4715), margin of error (5%), and SD (50%), resulting in a sample of 356 people, 178 in the CG, and 177 in the IG. For sample selection, a stratified systematic sampling procedure will be used with proportional sharing by age in years and time since diagnosis in months.\n \n\n(1)\nn0=Z2.P(1\u00e2\u0088\u0092P|e2)1+Z2.P(1\u00e2\u0088\u0092P|e2.N)n0=356peoplewithdiabetestype1or2\n\n\n where n=population = 4.715; Z=Z score = 95%; e=margin of error=5%; p=SD=50%\n In addition, we checked if the sample size calculated would be enough to detect between-groups differences. For this additional calculus, we adopted a small effect size (0.15) for the primary outcome\u00e2\u0080\u0094DPN symptoms, according to results of previous trials published,24 a statistical power of 0.80 and a alpha value of 0.05. The sample size resulted in 262 individuals, which is lesser than that we calculated based on the population. Thus, the sample size of 356 would be completely adequate to detect between-group differences in the trial.", "id": 1670, "split": "test"} +{"trial_id": "NCT05641233", "pmid": "39317507", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study\n\nIncluded conditions:\n- Neuroendocrine Carcinoma of Pancreas\n- Duodenum Carcinoma\n- Pancreas Neoplasm\n- Distal Cholangiocarcinoma\n- GIST\n- Pancreas Fibrosis\n- Pancreatic Fistula\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'interventionNames': ['Radiation: Stereotactic radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Stereotactic radiotherapy', 'description': 'Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Safety - CTCAE grade 3-4-5 complications related to the intervention', 'timeFrame': 'Up to 30 days after surgery'}\n- {'measure': 'Hardness of pancreas texture, determined by Durometer measurement', 'description': 'Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO', 'timeFrame': 'Histopathological assesment of tissue after surgery'}\n\nPlease estimate the sample size based on the assumption: \nOne-sample t-test with a 5% one-sided significance level, 80% power, SD of 21.198, alpha=0.05, power 0.80, and a low expected risk of unforeseen circumstances.", "answer": 33, "answer_type": "ESTIMATED", "explanation": "Sample size and analyses\n With a sample size of 20 eligible patients and an expected reduction of 15% in POPF, a maximum of 3 (<15%) patients with grade 3\u00e2\u0080\u00934 toxicity related to the intervention (stereotactic radiotherapy) is accepted. Furthermore, for feasibility in 20 patients, a one-sample t-test with a 5% one-sided significance level will have 80% power to detect the difference between a null hypothesis mean of 11 and an alternative mean of 25 (on Durometer measurements), assuming that the SD is 21.198 as based on a recent publication.21 For the second part, focusing on clinical assessment to provide a reliable estimate of the rate of grade B/C POPF following the study intervention, an additional 13 patients are needed to calculate a reduction in POPF from the baseline risk of >25% to 10% (alpha=0.05, power 0.80), intended 15% reduction. A complete analysis of all endpoints (safety, feasibility and POPF) is required in 33 eligible patients to prevent Type II errors.\n Suppose an endpoint cannot be evaluated due to unforeseen circumstances (eg, a patient does not undergo resection due to the discovery of metastases during exploratory laparotomy or withdrawal of informed consent before the intervention). In that case, an additional patient will be included. All patients who received the intervention will remain in the study for follow-up. The expected risk of unforeseen circumstances in the study population is low.", "id": 1671, "split": "test"} +{"trial_id": "NCT05642897", "pmid": "39754194", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme\u00b4s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes\n\nIncluded conditions:\n- Breast Cancer Female\n\nStudy Armgroups:\n- {'label': 'Mind', 'type': 'EXPERIMENTAL', 'description': 'The Mind programme is an ACT, mindfulness and compassion intervention for women with breast cancer. It will include 8 weekly group sessions, with the duration of 120 minutes each, and will be delivered at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.', 'interventionNames': ['Behavioral: Mind']}\n- {'label': 'Support group', 'type': 'ACTIVE_COMPARATOR', 'description': 'A support group intervention, with 8 weekly 90-120-minute sessions, will be delivered to the active control group at the Radiotherapy Service of the CHUC or through an online platform. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis.', 'interventionNames': ['Behavioral: Support Group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mind', 'description': 'ACT, mindfulness, and compassion-based intervention', 'armGroupLabels': ['Mind']}\n- {'type': 'BEHAVIORAL', 'name': 'Support Group', 'description': 'This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.', 'armGroupLabels': ['Support group']}\n\nPrimary Outcomes:\n- {'measure': 'Cancer-specific quality of life', 'description': 'EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level', 'timeFrame': 'Baseline, post-treatment (2 months after baseline), and 6-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nBoth studies assume an alpha of 0.05 and a minimum of 80% power. Study 1 uses a repeated-measures linear mixed models analysis with a compound symmetry correlation matrix (rho=0.5) and three assessment points. Study 2 uses a three-armed linear mixed model with an unstructured correlation matrix and three measurements. Attrition rates are expected to be between 10% and 30%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Regarding study 1, power was considered according to a sensitivity analysis of the likely attainable sample size and compare with the effect sizes estimated by previous meta-analyses and studies suggesting improvements in mood and QoL between SMD\u00e2\u0080\u0089=\u00e2\u0080\u00890.2 to 0.6, favouring psychotherapies over controls [15, 16]. It is anticipated that up to N\u00e2\u0080\u0089=\u00e2\u0080\u0089150 (n\u00e2\u0080\u0089=\u00e2\u0080\u008975 per group) participants will be recruited, and attrition rates of between 10 and 30% can be expected. The planned analysis specifies a repeated-measures linear mixed models analysis, a group allocation of 1:1, alpha of 0.05, a minimum of 80% power, three assessment points and a compound symmetry correlation matrix (rho\u00e2\u0080\u0089=\u00e2\u0080\u00890.5; Lu et al., 2008). Under these parameters, the study is powered to reliably detect a between-group difference on cancer-specific QoL at follow-up of SMD\u00e2\u0080\u0089=\u00e2\u0080\u00890.51 (WebPower; [37]).\n For study 2, the GLIMMPSE software was used to calculate the minimum sample size required for a three-armed linear mixed model with three measurements. Assuming a comparable effect size to that estimated in study 1 (SMD\u00e2\u0080\u0089=\u00e2\u0080\u00890.5) favouring the Mind intervention group over waiting list at 6\u00c2\u00a0months for QoL, an unstructured correlation matrix, a group allocation of 2:2:1, alpha of 0.05 and a minimum of 80% power, the minimum sample size required is N\u00e2\u0080\u0089=\u00e2\u0080\u0089117. To account for up to 30% attrition, this sets the minimum total sample size at N\u00e2\u0080\u0089=\u00e2\u0080\u0089153 [38].", "id": 1672, "split": "test"} +{"trial_id": "NCT05645289", "pmid": "39135126", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Minodronate in the Treatment of Postmenopausal Osteoporosis With Low Back Pain: a Single-centre and Randomized Controlled Trial\n\nIncluded conditions:\n- Postmenopausal Osteoporosis\n\nStudy Armgroups:\n- {'label': 'minodronate', 'type': 'EXPERIMENTAL', 'description': 'Patients will take 1 mg of minodronate tablets orally in the morning.', 'interventionNames': ['Drug: Minodronate']}\n- {'label': 'alendronate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will be orally given 10 mg alendronate tablets daily in the morning.', 'interventionNames': ['Drug: Alendronate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Minodronate', 'description': 'The minodronate group: The group will include thirty-six patients. Patients will take 1 mg of minodronate tablets orally with 200 mL of water in the morning. They can not lie flat for at least 30 minutes after taking the tablets, and they can not eat anything except water for at least 30 minutes after taking the tablets once a day for 12 weeks, for a total of 84 times.', 'armGroupLabels': ['minodronate'], 'otherNames': ['Difumi']}\n- {'type': 'DRUG', 'name': 'Alendronate', 'description': 'The alendronate group: A total of 36 patients will be treated with alendronate. Patients will be orally given 10-mg alendronate tablets daily and 200 mL of water in the morning. They could not lie down and eat anything except water for at least 30 minutes after taking the tablets. The treatment lasted for 12 weeks, corresponding to a total of 84 doses.', 'armGroupLabels': ['alendronate'], 'otherNames': ['Fushanmei']}\n\nPrimary Outcomes:\n- {'measure': 'The time for a 10 point decrease in the VAS score within 24 weeks', 'description': 'The VAS scores were measured daily within 24 weeks. Back pain was evaluated using a 100-mm VAS score ( 0 = no pain, 100 = worst pain possible) after treatment, where the patients recorded their pain on the VAS by themselves everyday.', 'timeFrame': 'up to 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA 1:1 design method is adopted with \u03b1 = 0.05, power = 0.90, and a 10% loss to follow-up rate.", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study is an exploratory study with a small sample. According to a randomized controlled trial published in the Journal of Bone and Mineral Metabolism in 2013 [11], the mean percentage change in VAS score was 49.8% for alendronate and 56.4% for minodronate at 24\u00c2\u00a0weeks post-treatment. In this study, a 1:1 design method is adopted to estimate the sample size required by the T test of two independent samples, and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, 1\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.90, considering a 10% loss to follow-up rate. A total of 72 patients will be each required for the alendronate group and minodronate group, including 24 patients in the elderly group and 48 patients in the senior group.", "id": 1673, "split": "test"} +{"trial_id": "NCT05646589", "pmid": "38483869", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementation and Evaluation of a Person-centred Care Transition Support for People With Stroke/TIA\n\nIncluded conditions:\n- Stroke\n- Transient Ischemic Attack\n\nStudy Armgroups:\n- {'label': 'Person-centred care transition support', 'type': 'EXPERIMENTAL', 'description': 'Person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming.', 'interventionNames': ['Behavioral: Person-centred care transition support']}\n- {'label': 'Regular care transition', 'type': 'ACTIVE_COMPARATOR', 'description': 'Electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team', 'interventionNames': ['Behavioral: Regular care transition']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Person-centred care transition support', 'description': 'Person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming.for persons who are to be discharged from hospitals after stroke or TIA', 'armGroupLabels': ['Person-centred care transition support']}\n- {'type': 'BEHAVIORAL', 'name': 'Regular care transition', 'description': 'Regular care transitions, initiated by an electronic referral from hospital healthcare professionals to the receiving neurorehabilitation team', 'armGroupLabels': ['Regular care transition']}\n\nPrimary Outcomes:\n- {'measure': 'Care Transition Measure', 'description': 'Questionnaire that assesses perceived quality in care transitions. The total score (0-100) reflects the overall perceived quality of the care transition, with lower scores indicating a poor quality care transition, and higher scores indicating a higher quality care transition', 'timeFrame': '1 week after discharge from hospital'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of 0.05 (2-sided), 20% drop-out rate.", "answer": 168, "answer_type": "ESTIMATED", "explanation": "Sample size\n Results from our pre-studies show that participants had a mean of 62 points in the care transition measure and standard deviation of 21. Based on the estimation that satisfaction will be a mean of 72 in the person-centred multicomponent care transition, we will need to recruit 70 patients (80% power, p = 0.05, 2 sided). Allowing for 20% drop-out, we will need to recruit in total 84 patients per group, 168 patients in total.", "id": 1674, "split": "test"} +{"trial_id": "NCT05651659", "pmid": "38711048", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study\n\nIncluded conditions:\n- Frailty\n\nStudy Armgroups:\n- {'label': 'Interventions municipalities', 'type': 'EXPERIMENTAL', 'description': 'Locally adapted TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) intervention. Municipalities will be randomly assigned to either the intervention group or the control group. A biostatician will perform the randomisation procedure independently of the project management team and the municipalities. The project management team will provide the home care services in the municipalities with the randomisation and allocation results immediately following this procedure. The intervention will start with the educational sessions (described below) within one to two weeks after randomisation.', 'interventionNames': ['Other: TIME model in the prevention and treatment of crises in frail community-dwelling people']}\n- {'label': 'Control municipalities', 'type': 'NO_INTERVENTION', 'description': 'Care as usual'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TIME model in the prevention and treatment of crises in frail community-dwelling people', 'description': 'TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically.', 'armGroupLabels': ['Interventions municipalities']}\n\nPrimary Outcomes:\n- {'measure': 'Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months', 'description': 'The primary outcome of the trial is the difference in the change between intervention and control group in individual goal achievement to resolve or reduce the challenges of the crises.', 'timeFrame': 'Change from baseline at 3 months using the PGI (scale of 1-10)'}\n\nPlease estimate the sample size based on the assumption: \nTo observe a statistically significant difference with a power of 80%, an intracluster (municipality) correlation coefficient (ICC) of 10%, and an estimated attrition rate of 25% for the primary outcome at 3 months.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n \n Sample size calculation based on the primary outcome\n The proposed sample of 150 participants is based on a power calculation with clusters of approximately five participants from each of the 30 municipalities. Based on a previous trial, a minimal clinically important average difference on the PGSI scale between participants in the intervention and control groups was set to 2 points with a standard deviation (SD) for change of 2.83 in each group [40]. To observe a statistically significant difference with a power of 80%, an intracluster (municipality) correlation coefficient (ICC) of 10%, and an estimated attrition rate of 25% for the primary outcome at 3\u00c2\u00a0months, we will need approximately 150 participants. We assume a high attrition rate since the participants are at high risk for acute institutionalisation (see the inclusion criteria).", "id": 1675, "split": "test"} +{"trial_id": "NCT05651659", "pmid": "38711048", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study\n\nIncluded conditions:\n- Frailty\n\nStudy Armgroups:\n- {'label': 'Interventions municipalities', 'type': 'EXPERIMENTAL', 'description': 'Locally adapted TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) intervention. Municipalities will be randomly assigned to either the intervention group or the control group. A biostatician will perform the randomisation procedure independently of the project management team and the municipalities. The project management team will provide the home care services in the municipalities with the randomisation and allocation results immediately following this procedure. The intervention will start with the educational sessions (described below) within one to two weeks after randomisation.', 'interventionNames': ['Other: TIME model in the prevention and treatment of crises in frail community-dwelling people']}\n- {'label': 'Control municipalities', 'type': 'NO_INTERVENTION', 'description': 'Care as usual'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TIME model in the prevention and treatment of crises in frail community-dwelling people', 'description': 'TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically.', 'armGroupLabels': ['Interventions municipalities']}\n\nPrimary Outcomes:\n- {'measure': 'Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months', 'description': 'The primary outcome of the trial is the difference in the change between intervention and control group in individual goal achievement to resolve or reduce the challenges of the crises.', 'timeFrame': 'Change from baseline at 3 months using the PGI (scale of 1-10)'}\n\nPlease estimate the sample size based on the assumption: \nTo observe a statistically significant difference with a power of 80%, an intracluster (municipality) correlation coefficient (ICC) of 10%, and an estimated attrition rate of 25% for the primary outcome at 3 months.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size calculation based on the primary outcome\n The proposed sample of 150 participants is based on a power calculation with clusters of approximately five participants from each of the 30 municipalities. Based on a previous trial, a minimal clinically important average difference on the PGSI scale between participants in the intervention and control groups was set to 2 points with a standard deviation (SD) for change of 2.83 in each group [40]. To observe a statistically significant difference with a power of 80%, an intracluster (municipality) correlation coefficient (ICC) of 10%, and an estimated attrition rate of 25% for the primary outcome at 3\u00c2\u00a0months, we will need approximately 150 participants. We assume a high attrition rate since the participants are at high risk for acute institutionalisation (see the inclusion criteria).", "id": 1676, "split": "test"} +{"trial_id": "NCT05652673", "pmid": "38783238", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safe Stop IPI-NIVO Trial: Early Discontinuation of Nivolumab Upon Achieving a (confirmed) Complete or Partial Response in Patients with Irresectable Stage III or Metastatic Melanoma Treated with First-line Ipilimumab-nivolumab\n\nIncluded conditions:\n- Melanoma Stage IV\n- Melanoma Stage III\n- Immunotherapy\n- Toxicity, Drug\n\nStudy Armgroups:\n- {'label': 'Early discontinuation of nivolumab', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: nivolumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'nivolumab', 'description': 'Early discontinuation of nivolumab maintenance therapy in patients with irresectable stage III or metastatic melanoma', 'armGroupLabels': ['Early discontinuation of nivolumab']}\n\nPrimary Outcomes:\n- {'measure': 'Ongoing response', 'description': 'The rate of ongoing response at 12 months in patients with irresectable stage III or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early discontinue nivolumab upon achieving a CR or PR according to RECIST v1.1', 'timeFrame': '12 months after start of ipilimumab-nivolumab combination therapy'}\n\nPlease estimate the sample size based on the assumption: \nThe one-sample log-rank test was used with a one-sided type I error of 2.5%, 80% power, and a safety margin of <5% for loss to follow-up or non-melanoma related deaths.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculation was performed for the primary endpoint of ongoing response at 12 months. The sample size calculation of this trial is based on the results of the Checkmate-069 study [11] since this prospective study provides detailed patient-level data of first response and duration of response of patients who are treated with first-line combination therapy with ipilimumab-nivolumab. In the Checkmate-069, an ongoing response at 12 months was reported in 92% of patients who had a response within 3 months after start of treatment and were treated for at least 3 months. The hypothesis of the current trial is that the percentage of patients with an ongoing response at 12 months after start of treatment should not be more than 10% worse than the 92% reported in the Checkmate-069. Hence, the null-hypothesis is an ongoing response rate of 82%. Since the rate of ongoing response in the Checkmate-069 is based on a small subgroup, we assume that 90% (instead of 92%) of patients will have an ongoing response at 12 months after start of treatment as input for the alternative hypothesis.\n For the sample size calculation, the one-sample log-rank test was used [20]. Given a one-sided type I error of 2.5%, 80% power, a null hypothesis of 82% ongoing response at 12 months, and an alternative hypothesis of 90% ongoing response at 12 months, a total of 20 events (i.e. patients with disease progression) are required. Given an inclusion period of 2 years and 1 year of additional follow-up, 77 patients need to be included to reach this number of events within a total study duration of 3 years. Taking a safety margin of\u00e2\u0080\u0089<\u00e2\u0080\u00895% (n\u00e2\u0080\u0089=\u00e2\u0080\u00893 patients) for loss to follow-up or not-melanoma related deaths, the total sample size was set at 80 patients.", "id": 1677, "split": "test"} +{"trial_id": "NCT05652972", "pmid": "37155645", "question": "Here is the design of a clinical trial:\n\nOfficial Title: KETO-MINOX: The Effect of Isocaloric, Energy-restrictive, KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight and Obesity\n\nIncluded conditions:\n- Overweight and Obesity\n\nStudy Armgroups:\n- {'label': 'Ketogenic diet', 'type': 'EXPERIMENTAL', 'description': '40 women which will follow the ketogenic diet with 1700 kcal daily for 8 weeks', 'interventionNames': ['Other: Ketogenic diet']}\n- {'label': 'Control diet', 'type': 'ACTIVE_COMPARATOR', 'description': '40 women which will follow the standard diet with 1700 kcal daily for 8 weeks', 'interventionNames': ['Other: Control diet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Ketogenic diet', 'description': '1700 kcal ketogenic diet (fat: protein: carbohydrate ratio of 70:20:10)', 'armGroupLabels': ['Ketogenic diet']}\n- {'type': 'OTHER', 'name': 'Control diet', 'description': '1700 kcal standard diet (fat: protein: carbohydrate ratio of 20:30:50)', 'armGroupLabels': ['Control diet']}\n\nPrimary Outcomes:\n- {'measure': 'Inflammatory markers (G-CSF, GM-CSF, INF-gamma, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, MCP-1, MIP-1b, TNF-a)', 'description': 'Analysis using Bio-Plex Pro\u2122 Human Cytokine 17-plex Assay in serum.', 'timeFrame': '12 months'}\n- {'measure': 'Oxidative stress markers', 'description': 'analysis of malondialdehyde, superoxide dismutase, 8-isoprostane and 8-hydroxydeoxyguanosine (8-OHdG) using commercial ELISA kits in serum.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAt least 80% power to detect a standardised difference with alpha = 0.05 (two-sided), assuming a pre-post correlation in weight of 0.7. Lower number of drop-outs expected due to better engagement and compliance in dietary programs among women.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n On trial opening, the first 80 women meeting eligibility criteria who also do not meet any of the exclusion criteria will be selected. The focus on only female subjects was based on eliminating biological sex as a factor that could affect the results. Moreover, it is scientifically proven that women have better trust in healthy nutrition and more engagement and compliance in dietary programs [46, 47], thus a lower number of drop-outs is expected. At the end of the intervention, dietary efficacy is projected to be between the equivalent of one dress size to one and a half dress sizes, equating to a weight loss of approximately 5kg. For BMI between 28 and 35, the standard deviation of weight is approximately 5kg equating to an intra-group standardised effect of 1. However, a downward revision in standardised effect size for a between groups comparions for an intent-to-treat analysis Analysis of Covariance (ANCOVA) would indicate that n = 32 women per group would have at least 80% power to detect a standardised difference of Cohen\u00e2\u0080\u0099s d = 0.5 (alpha = 0.05, two-sided) assuming a pre- post- correlation in weight of 0.7. Inflation of sample sizes to account for loss to follow-up would indicate n = 40 per group would provide a safety margin for a comparison between group means. This sample size is conservatively consistent with Mohorko et al. [39]. The sample size will support within-groups, between-groups, and whole-group analyses for the secondary research questions.", "id": 1678, "split": "test"} +{"trial_id": "NCT05653414", "pmid": "37924101", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interest of a Short Early Psychological Care in Women With Miscarriage: a Controlled Randomized Study\n\nIncluded conditions:\n- Miscarriage\n\nStudy Armgroups:\n- {'label': '\"short early psychological care\" group', 'type': 'EXPERIMENTAL', 'description': 'Women with short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife', 'interventionNames': ['Other: short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife']}\n- {'label': '\"control\" group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Women with encouragement of early support consultation with generalist practitioner or midwife', 'interventionNames': ['Other: encouragement of early support consultation with generalist practitioner or midwife']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife', 'description': '4 consultations with a psychologist over 2 months maximum', 'armGroupLabels': ['\"short early psychological care\" group']}\n- {'type': 'OTHER', 'name': 'encouragement of early support consultation with generalist practitioner or midwife', 'description': 'encouragement of early support consultation with generalist practitioner or midwife', 'armGroupLabels': ['\"control\" group']}\n\nPrimary Outcomes:\n- {'measure': 'anxiety', 'description': 'Anxiety will be evaluated using the Scale Trait Anxiety Inventory version Y (STAI-Y-A). The STAI Form Y-A consists of a set of twenty item sonly focus on the psychological and not the somatic aspects of anxiety. The STAI Form Y-A is a self-reported questionnaire. Each item is scored from 1 to 4 and a sum score of all items is computed. Higher score indicates greater anxiety. Presence of anxiety will be defined by a score greater than or equal to 46.', 'timeFrame': 'Month 3'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, power of 90%, 20% dropout rate, and 20% consent rate.", "answer": 932, "answer_type": "ESTIMATED", "explanation": "Sample size\n The following hypotheses were used to calculate the sample size required for the present study:\n \nA percentage of women with anxiety at 3 months after randomization equal to 22% in the control group (without early psychological care) [20].A percentage of women with anxiety at 3 months after randomization equal to 13% in the intervention group (with early psychological care) (based on the average rate observed in populations with no history of miscarriage).\n\n At an alpha risk of 5% and with power of 90%, in a bilateral situation, the number of subjects needed is 373 per group, i.e. a total of 746 participants. Allowing for 20% of patients lost to follow-up at 3 months after randomization, total accrual of 932 women (466 per group) is planned. Assuming a consent rate of 20%, it is estimated that study information will have to be provided to around 5,000 women in total.\n Sample size calculations were performed using NQuery software version 4.0.", "id": 1679, "split": "test"} +{"trial_id": "NCT05654025", "pmid": "37369426", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens\n\nIncluded conditions:\n- Ectopia Lentis\n- Dislocation, Lens\n\nStudy Armgroups:\n- {'label': 'Non-surgical group: Refractive change, ocular parameter changes, and prognosis without surgery', 'description': 'To evaluate the long-term changes in refractive state, ocular parameter, ocular development and visual prognosis in patients without congenital ectopia lentis surgery.'}\n- {'label': 'Surgical group: Safety and efficacy of different congenital ectopia lentis surgeries', 'description': 'To compare the safety and efficacy of different congenital ectopia lentis surgeries, including phacoemulsification\uff0c phacoemulsification + Intraocular lens (IOL) implantation\uff0c phacoemulsification + IOL implantation + Capsular Tension Ring implantation or phacoemulsification + IOL implantation + transscleral fixation.'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Change of best corrected visual acuity', 'description': 'Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each visit.', 'timeFrame': 'Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation'}\n- {'measure': 'Incidence of complications', 'description': 'Estimate the incidence of complications for both non-surgical group and surgical group.', 'timeFrame': 'Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation.'}\n\nPlease estimate the sample size based on the assumption: \nFor a 5% significance level, Z\u00ce\u00b1/2 is 1.96 for the two-tailed alternative hypothesis. The loss ratio is assumed to be 10%.", "answer": 604, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size will be estimated as follows: assuming the incidence of complications in patients with CEL is 15%, and the margin of error is 20%. For a 5% significance level, Z\u00ce\u00b1/2 is 1.96 for the two-tailed alternative hypothesis. Sample size=(Z\u00ce\u00b1/2)2\u00c3\u0097P(1\u00e2\u0088\u0092P)\u00c3\u00971/E2=(1.96)2\u00c3\u009715%\u00c3\u0097(1\u00e2\u0080\u009315%)/(15%\u00c3\u009720%)=544. Assuming the loss ratio of 10%, the adjusted sample size will be 544/(1\u00e2\u0080\u00930.1)=544/0.9=604.", "id": 1680, "split": "test"} +{"trial_id": "NCT05655715", "pmid": "36717150", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Phase 2 Trial of Stereotactic Body Radiation Therapy, SBRT in Combination with Checkpoint Inhibitors in Metastatic Castration-resistant Prostate Cancer\n\nIncluded conditions:\n- Prostate Cancer Metastatic\n- Castrate Resistant Prostate Cancer\n- Metastatic Castration-resistant Prostate Cancer\n- Prostate Cancer Stage IV\n\nStudy Armgroups:\n- {'label': 'A SBRT + ipi/nivo', 'type': 'EXPERIMENTAL', 'description': 'Stereotactic body radiotherapy of 8 Gray (Gy) x 3 on one soft tissue or bone metastasis + Nivolumab 3mg/kg IV every 3 weeks (Q3W) + Ipilimumab 1mg/kg IV Q3W for four doses, then Nivolumab 480 mg IV every 4 weeks (Q4W) for up to 52 weeks treatment in total', 'interventionNames': ['Radiation: Stereotactic body radiotherapy', 'Drug: Ipilimumab Injection [Yervoy]', 'Drug: Nivolumab Injection [Opdivo]', 'Procedure: Biopsies']}\n- {'label': 'B ipi/nivo', 'type': 'EXPERIMENTAL', 'description': 'Nivolumab 3mg/kg IV Q3W + Ipilimumab 1mg/kg IV Q3W for four doses, then Nivolumab 480 mg IV Q4W for up to 52 weeks treatment in total', 'interventionNames': ['Drug: Ipilimumab Injection [Yervoy]', 'Drug: Nivolumab Injection [Opdivo]', 'Procedure: Biopsies']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Stereotactic body radiotherapy', 'description': '8 Gray x 3', 'armGroupLabels': ['A SBRT + ipi/nivo'], 'otherNames': ['8 Gray x 3']}\n- {'type': 'DRUG', 'name': 'Ipilimumab Injection [Yervoy]', 'description': '1 mg/kg IV Q3W for four doses,', 'armGroupLabels': ['A SBRT + ipi/nivo', 'B ipi/nivo'], 'otherNames': ['ipi']}\n- {'type': 'DRUG', 'name': 'Nivolumab Injection [Opdivo]', 'description': 'Nivolumab 3mg/kg IV Q3W for four doses, then then Nivolumab 480mg IV Q4W', 'armGroupLabels': ['A SBRT + ipi/nivo', 'B ipi/nivo'], 'otherNames': ['nivo']}\n- {'type': 'PROCEDURE', 'name': 'Biopsies', 'description': 'From soft tissue metastases.', 'armGroupLabels': ['A SBRT + ipi/nivo', 'B ipi/nivo']}\n\nPrimary Outcomes:\n- {'measure': 'Co-primary endpoint 1', 'description': 'Objective response rate (ORR) according to modified Response Evaluation Criteria in Solid Tumours (RECIST1.1) per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria for patients with measurable disease', 'timeFrame': 'From baseline until progression (up to 24 months)'}\n- {'measure': 'Co-primary endpoint 2', 'description': 'Prostate-specific antigen (PSA) response rate of \u2265 50% decline from baseline at any time from treatment start (confirmed after \u2265 4 weeks, all patients with measurable and non-measurable disease)', 'timeFrame': 'Any time after treatment start (confirmed \u2265 3 weeks later, up to 24 months)'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error is \u22645%, power is \u226580%, and dropout rate is 10%.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size and the two-stage procedure\n The sample size calculations are based on a two-stage design for randomised phase II trials with two experimental treatment arms and PSA decline \u00e2\u0089\u00a550% as the endpoint.24 At the time of sample size calculation, only response rates of single-agent CPI for mCRPC were available and reported up to 10% (null hypothesis). Overall, within each arm, a sample size of 40 is required to confirm the alternative hypothesis that the PSA 50% decline response rate is \u00e2\u0089\u00a525%. We expect a 10% dropout rate before the first evaluation, and 45 participants will be included in each arm. Additionally, we have prespecified the type 1 error to \u00e2\u0089\u00a45% of mistakenly selecting the inferior treatment for further study when the response rate in the inferior arm is lower than that in the unselected arm by 10%; and the power to \u00e2\u0089\u00a580% of selecting the superior treatment correctly for further study when the response rate in the superior arm is greater than or equal to 25% (alternative hypothesis) and also larger than that in the unselected arm by 20%. The first stage includes 20 participants in each arm. If less than two participants in one or both treatment arms have PSA decline 50%, the treatment arm or study is terminated. If only one treatment arm continues (\u00e2\u0089\u00a52 responses in any arm with \u00e2\u0089\u00a55 in difference between arm A and B), 20 additional participants will be enrolled in the promising treatment arm. If both treatment arms have \u00e2\u0089\u00a52 responses but <5 in difference in the first stage, both treatment arms continue to the second stage. Any treatment arm with observed responses for \u00e2\u0089\u00a58 out of 40 participants after complete enrolment may be considered promising for further investigation. However, in case of \u00e2\u0089\u00a58 responses with PSA decline \u00e2\u0089\u00a550% are observed in both arms, a difference of \u00e2\u0089\u00a55 responses in between arms allows to select the superior treatment arm.\n Soft tissue metastases in mCRPC are a bad prognostic factor, especially liver metastases.25 During the second amendment, where patients with predominant bone metastases could be enrolled, we chose not to stratify according to soft tissue metastasis versus only bony metastases. When the amendment was implemented, 31 participants had been enrolled, given a minimum of 40% of participants with soft tissue metastases in the whole study population. We expected that up to 80%\u00e2\u0080\u009390% of new participants would have only bone metastases; hence a stratification would have only a minor statistical impact given the anticipated sample size. Furthermore, by including participants with only bone metastases, the participants would be in earlier phases of their disease, given a \u00e2\u0080\u0098lead-time bias,\u00e2\u0080\u0099 which will be accorded for in interpreting the study results. We will present the data as a comprehensive table that can help distinguish between the different participant groups.", "id": 1681, "split": "test"} +{"trial_id": "NCT05657678", "pmid": "39582029", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy Comparison of Two Doses of Vitamin D3 in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy\n\nIncluded conditions:\n- Vitamin D3 Deficiency\n\nStudy Armgroups:\n- {'label': 'Interventional Arm', 'type': 'EXPERIMENTAL', 'description': 'a single administration of 750,000 IU of vitamin D3 via the enteral route (through a gastric tube) in ICU patients with severe vitamin D3 deficiency (measured plasma 25(OH)D3 levels \u226412.5 ng/ml) undergoing continuous renal replacement therapy with CVVHDF or CVVHF', 'interventionNames': ['Drug: Vitamin D3 - 750 000 IU']}\n- {'label': 'Control Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single administration of 500,000 IU of vitamin D3 via the enteral route (through a gastric tube) in ICU patients with severe vitamin D3 deficiency (measured plasma 25(OH)D3 levels \u226412.5 ng/ml) undergoing continuous renal replacement therapy with CVVHDF or CVVHF', 'interventionNames': ['Drug: Vitamin D3 - 500 000 IU']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Vitamin D3 - 750 000 IU', 'description': 'a single administration of 750,000 IU of vitamin D3', 'armGroupLabels': ['Interventional Arm']}\n- {'type': 'DRUG', 'name': 'Vitamin D3 - 500 000 IU', 'description': 'a single administration of 500,000 IU of vitamin D3', 'armGroupLabels': ['Control Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Supplementation', 'description': 'To evaluate and compare the effects of two different supplementation doses of vitamin D3 (25(OH)D3) - 500,000 IU or 750,000 IU administered as one enteral dose - on plasma levels of 25(OH)D3 in ICU patients undergoing continuous renal replacement therapy and diagnosed with severe vitamin D3 deficiency', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a power of 85% with a significance level of \u03b1=0.05, and assumes a drop-out rate of approximately 10%. The acceptable non-inferiority margin is \u03b4=0.", "answer": 138, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size for study groups was calculated using statistical software R1 version 4.1.1, with 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}$${n}_{2}=\\frac{{\\left({Z}_{\\alpha }+{Z}_{\\beta }\\right)}^{2}}{{\\left(\\varepsilon -\\delta \\right)}^{2}}\\left[\\frac{{p}_{1}\\left(1-{p}_{1}\\right)}{k}+{p}_{2}\\left(1-{p}_{2}\\right)\\right]$$\\end{document}n2=Z\u00ce\u00b1+Z\u00ce\u00b22\u00ce\u00b5-\u00ce\u00b42p11-p1k+p21-p2\\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}$${n}_{1}=k\\cdot {n}_{2}$$\\end{document}n1=k\u00c2\u00b7n2where:\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}$${Z}_{\\alpha }$$\\end{document}Z\u00ce\u00b1\u00e2\u0080\u0094critical value of the distribution for significance level.\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}$${Z}_{\\beta }$$\\end{document}Z\u00ce\u00b2\u00e2\u0080\u0094critical value of distribution for power (power\u00e2\u0080\u0089=\u00e2\u0080\u00891-\u00ce\u00b2).\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}$$\\delta$$\\end{document}\u00ce\u00b4\u00e2\u0080\u0094acceptable non-inferiority margin.\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}$$\\varepsilon$$\\end{document}\u00ce\u00b5\u00e2\u0080\u0094difference in percentages of patients that reached an endpoint in groups.\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}$$k$$\\end{document}k\u00e2\u0080\u0094sample size ratio between groups.\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}$${p}_{1}$$\\end{document}p1\u00e2\u0080\u0094percentage of patients that reached target serum 25(OH)D3 levels\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008930\u00c2\u00a0ng/ml on days 3 and 7 following vitamin D3 administration in the control arm.\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}$${p}_{2}$$\\end{document}p2\u00e2\u0080\u0094percentage of patients achieving target serum 25(OH)D3 levels\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008930\u00c2\u00a0ng/ml on days 3 and 7 following vitamin D3 administration in the treatment arm\n Assuming that the percentage of patients who achieve the target levels of 25(OH)D3 is 50% in the control group (vitamin D3 at a dose of 500,000\u00c2\u00a0IU) and 75% in the treatment group (vitamin D3 at a dose of 750,000\u00c2\u00a0IU), then in order to achieve a power of 85% with a significance level \\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}$$\\alpha =0.05$$\\end{document}\u00ce\u00b1=0.05 and without an acceptable non-inferiority margin (\\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}$$\\delta =0$$\\end{document}\u00ce\u00b4=0), the study should enrol a minimum of 62 patients per group. Assuming a drop-out rate of approximately 10%, the number of recruited patients should be 138 (69 patients per group).", "id": 1682, "split": "test"} +{"trial_id": "NCT05658341", "pmid": "38485475", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating Effectiveness of an Integrative Intervention Based on Physical Activity, Nutrition and Supportive Care to Improve Quality of Life of Breast Cancer Survivors: Protocol for a Pragmatic Cluster Randomized Trial and Embedded Qualitative Study\n\nIncluded conditions:\n- Quality of Life\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'ADA intervention', 'type': 'EXPERIMENTAL', 'description': 'The ADA intervention arm', 'interventionNames': ['Behavioral: ADA']}\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'The usual care arm', 'interventionNames': ['Behavioral: Usual Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ADA', 'description': 'The 12-weeks program will include one-hour in adapted physical activity (APA), and a discussion on relaxation techniques and the undertaking of deep breathing exercises (making them APA+ sessions). A series of \"minute for nutrition\" short information sheets will be distributed at the end of each session.\\n\\nTwo workshops on \"living better after breast cancer\" will also be offered: one on general mobility and the other on daily nutrition.\\n\\nMoreover, women will be asked to set personal challenges as a method of motivational reinforcement, and will also be called for motivational check-ins at least 3 times. Follow-up calls will allow for further individualization, motivation, and the reception of participants\\' concerns or remarks.\\n\\nFurther, participants in the intervention group will have access to a dedicated internet space containing several documents and videos on topics of concern to patients during the post-treatment phase.', 'armGroupLabels': ['ADA intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual Care', 'description': \"Participants in the control group will be offered weekly APA sessions for 12 weeks, these sessions are based on current practices within the Siel Bleu organization. Sessions' content is adapted to people who have been treated for (all types) cancer and are based on current recommendations.\\n\\nThese sessions are commonly organized by Siel Bleu in hospitals, community groups or local committees of the national league against cancer organization.\", 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Health-related quality of life', 'description': 'The primary endpoint will be the health-related quality of life, as measured by the FACIT-F global score. This score is based on the 27-items Functional Assessment of Cancer Therapy-General (FACT-G) scale ,and the 13-items fatigue subscale included in the FACIT-F. Higher score indicate better Quality of life.', 'timeFrame': '12 months after the beginning of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5% (\u03b1=0.05), power of 80% (\u03b2=0.20), standard deviation (SD) of 9, interclass correlation up to 0.5, and a 25% loss of follow-up rate.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome is the HRQoL, as measured by the FACIT-F global score at 12 months. The score varies between 0 and 160, with a higher score denoting a better HRQoL. We hypothesise that the mean score in the intervention group will be 10 points higher than in the control group at 12 months.51 62 Assuming a significance level of 5% (\u00ce\u00b1=0.05), a power of 80% (\u00ce\u00b2=0.20), a SD equal to 9 and an interclass correlation up to 0.5, a total number of 16 exercise groups (clusters) of 8 participants on average is required (calculated with the R package CRTSize and the function \u00e2\u0080\u0098n4means\u00e2\u0080\u0099).63 We also hypothesised a 25% loss of follow-up rate. Thus, we will recruit 160 participants in total, divided into 20 exercise groups (clusters) of 8 participants, that is, 80 participants in each comparison group (intervention vs control).", "id": 1683, "split": "test"} +{"trial_id": "NCT05659199", "pmid": "37853420", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study on the Intervention of Extracorporeal Shockwave Therapy and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome\n\nIncluded conditions:\n- Chronic Pelvic Pain Syndrome\n\nStudy Armgroups:\n- {'label': 'extracorporeal shockwave therapy', 'type': 'EXPERIMENTAL', 'description': 'extracorporeal shockwave group: Patients will be treated with extracorporeal shockwave therapy (ESWT) with bladder lithotomy position, twice a week for 4 weeks, 3,000 individually with a maximum total energy flow density of 0.25 mJ/mm2, rate 3Hz each time. Extracorporeal shockwave (RUIDI.SWT001, Shenzhen, China) can provide a kind of physical spark wave energy, that will be delivered by the probe. The water sac probe will be moved slowly over the groin, perineum and crura of the penis.', 'interventionNames': ['Device: extracorporeal shockwave']}\n- {'label': 'myofascial release therapy', 'type': 'EXPERIMENTAL', 'description': \"myofascial release group: Based on the palpation findings, pressure was applied at 1 kg/cm2 (within the patient's tolerable range depending on the individual) to the points where patients had a VAS pain score of 4 or more during palpation. Intermittent pressure will be applied for 180-210s at the tenderness until the muscle relaxed.\", 'interventionNames': ['Behavioral: myofascial release']}\n- {'label': 'extracorporeal shockwave combined with myofascial release therapy', 'type': 'EXPERIMENTAL', 'description': 'Combined therapy group: On top of the routine palpation, the combined intervention group will be then treated with extracorporeal shockwave and myofascial release therapy in identical format as that in the intervention A and B', 'interventionNames': ['Device: extracorporeal shockwave', 'Behavioral: myofascial release']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'extracorporeal shockwave', 'description': 'Patients will be treated with extracorporeal shockwave therapy (ESWT) with bladder lithotomy position, twice a week for 4 weeks, 3,000 individually with a maximum total energy flow density of 0.25 mJ/mm2, rate 3Hz each time. Extracorporeal shockwave (RUIDI.SWT001, Shenzhen, China) can provide a kind of physical spark wave energy, that will be delivered by the probe. The water sac probe will be moved slowly over the groin, perineum and crura of the penis.', 'armGroupLabels': ['extracorporeal shockwave combined with myofascial release therapy', 'extracorporeal shockwave therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'myofascial release', 'description': \"pressure was applied at 1 kg/cm2 (within the patient's tolerable range depending on the individual) to the points where patients had a VAS pain score of 4 or more during palpation. Intermittent pressure will be applied for 180-210s at the tenderness until the muscle relaxed.\", 'armGroupLabels': ['extracorporeal shockwave combined with myofascial release therapy', 'myofascial release therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Pelvic floor muscle surface electromyography changes', 'description': 'Pelvic floor muscle sEMG values will be collected using the Glazer pelvic floor muscle sEMG assessment (VISHEE SA9800) Pre-resting sEMG; Tense contraction phase sEMG; Endurance contraction phase sEMG; Post-resting EMG.', 'timeFrame': 'Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and at the 4th week after the end of the 8th intervention (T3),assessing changes between these time points.'}\n- {'measure': 'National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) changes', 'description': 'Questionnaire with 13 entries, including 4 aspects: pain and discomfort symptom score, urinary symptom score, symptom impact score, quality of life score, with a total score of 0 to 43. The severity of CP/CPPS can be graded according to the total scores: mild (1-14), moderate (15-29), or severe (30-43).\\n\\nThe efficacy evaluation criteria are developed with reference to the National Institutes of Health-Chronic Prostatitis Symptom Index score. Clinical control is defined as \u2265 90% decrease in the NIH-CPSI score; obvious improvement as \u2265 60% and \\\\< 89% decrease; improvement as \u2265 30% and \\\\< 59% decrease, and ineffective as \\\\< 30% decrease.', 'timeFrame': 'Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and at the 4th week after the end of the 8th intervention (T3),assessing changes between these time points'}\n\nPlease estimate the sample size based on the assumption: \nPower of 60%, significance level of 5%, 95% confidence level, and a 25% dropout rate", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Previous studies showed that myofascial release therapy had notable effects [32] (corresponding to a Cohen\u00e2\u0080\u0099s d of about 0.5) on improving quality of life, prostate-related symptoms, and pain. The primary outcome will be the change in NIH-CPSI scores, the clinical response rate, and the remission rate as measured by the NIH-CPSI 4\u00c2\u00a0weeks after the completed intervention. We assumed that extracorporeal shockwave combined with myofascial release therapy had similar effects on NIH-CPSI scores. A sample of 40 participants per group was computed by the G*power software to achieve a power of 60% and a level of significance of 5% and a 95% confidence level. To compensate for an estimated dropout rate of 25%, 150 participants will be ultimately required. (i.e., the number in each group is 50).", "id": 1684, "split": "test"} +{"trial_id": "NCT05662436", "pmid": "36737725", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol for the Open Sky School: A Two-arm Clustered Randomized Controlled Trial to Test the Effectiveness of a Nature-based Intervention on Mental Health of Elementary School Children\n\nIncluded conditions:\n- Child Behavior\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'The exposure to nature consists of teachers bringing their students to the highest quality green space within 1 km of a school which could be located on or off campus. The class will spend a total of 2 hours (i.e. 2 one hour visits or one 2 hours visits) per week for 12 weeks (transportation included). The teacher be provided with a toolkit of activities (mental health and academic competencies) that they will carry out with their students. Teachers will be provided with training and support.', 'interventionNames': ['Other: Open Sky School program']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Six months after the inception of the trial, elementary schools (and their teachers) in the control condition will receive an unguided version of the intervention, supplemented by an online peer support group. As the children of the control group will by then be in high school with different teachers, we will provide them with a toolkit of 10 mental health activities that they can practice alone, in addition of support via video-conference, phone or email if they require help practicing the activities from a member of the research team. As in the intervention group, we will provide support by licensed psychologists to any children who report high levels of psychological distress and orient children to appropriate services if needed.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Open Sky School program', 'description': 'Teachers lead students in 2 hours of outdoor activities per week for 12 weeks, as detailed in the arm description', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Child Mental Health at 3 months', 'description': \"The Social Behavior Questionnaire is a 30 items questionnaire that will be used to assess a range of mental health symptoms in children. The frequency of children's symptoms over the last 2 months is rated on a scale 3-point (never/not true = 0, sometimes/somewhat true = 1, often/very true = 2). Overall symptoms will be examined as outcomes, as well as internalizing symptoms (emotional distress and withdrawal; 11 items), externalizing symptoms (impulsive/hyperactive/inattentive and disruptive behaviors; 13 items), and social behaviors (pro-social behavior and peer relationships; 6 items). Ratings will be obtained by both child and teacher reports which will be analyzed separately.\", 'timeFrame': 'Baseline, 3 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha set at 0.05, power > 0.80, inter-class correlation of 0.02, and a refusal and attrition rate of 20%.", "answer": 2500, "answer_type": "ESTIMATED", "explanation": "Sample Size\n To determine sample size for primary outcome immediately after intervention, we conducted power analyses using a Monte Carlo simulation procedure (5000 samples). On the basis of the limited literature on outdoor education [11, 12], we expect to obtain a small effect size for our primary outcome, i.e. overall mental health problems in children. With 100 classes (n\u00e2\u0089\u00882500) which include typically 25 students (range between 18 to 26) per class, a refusal and attrition rate of 20% (n\u00e2\u0089\u00882,000) pre to post-test, an inter-class correlation of 0.02, an expected effect size of Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.20 and alpha set at 0.05, we expect that sufficient power will be achieved (>\u00e2\u0080\u00890.80) for our primary and secondary outcomes.", "id": 1685, "split": "test"} +{"trial_id": "NCT05662462", "pmid": "37164461", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching\n\nIncluded conditions:\n- Pre-Gestational Diabetes\n- Type2diabetes\n- Pregnancy in Diabetic\n- Pregnancy, High Risk\n\nStudy Armgroups:\n- {'label': 'ACHIEVE Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.', 'interventionNames': ['Device: DEXCOM G7 PRO Continuous Glucose Monitor', 'Device: Patient mHealth app linked to a provider dashboard', 'Behavioral: Care team coaching for medical and social needs (HUB)', 'Device: Provider dashboard']}\n- {'label': 'Standard of care', 'type': 'NO_INTERVENTION', 'description': 'Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'DEXCOM G7 PRO Continuous Glucose Monitor', 'description': 'Participants in the intervention arm will be provided with DEXCOM\u00ae G7 PRO CGM sensors and transmitters. The Dexcom G7 CGM system is accurate and safe in pregnant individuals with diabetes. Participants will be taught how to place and remove CGM sensors by a trained research nurse, and will be given sensors to change themselves at home every 10 days. Of note, the DEXCOM\u00ae G7 PRO can be applied as a patch on the abdomen, arm, or upper buttocks, is well-tolerated in pregnancy, and does not require calibration. Our mHealth app will allow for wireless synchronization with the CGM sensor so that data are seamlessly reported back to the healthcare team.', 'armGroupLabels': ['ACHIEVE Intervention']}\n- {'type': 'DEVICE', 'name': 'Patient mHealth app linked to a provider dashboard', 'description': \"The mHealth app is based on our team's prototype intervention developed at our study site. The mHealth app provides diverse functions, including education, reminders, care goals, care pathway recommendations, CGM data and PROs reporting and monitoring, messaging and video conferencing, and a calendar function. Content is based on clinical guidelines for diabetes in pregnancy. Participants will be directed to appropriate resources and online learning to help them navigate the app and its resources. PROs in the mHealth app will be embedded to address health and social needs, and rule-based algorithms will provide tailored care goals, show care pathways, and establish the frequency of elicited PROs.\", 'armGroupLabels': ['ACHIEVE Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Care team coaching for medical and social needs (HUB)', 'description': 'Participants will be screened at enrollment and throughout the intervention for social needs using a survey adapted from validated instruments, such as the Accountable Health Communities Health-Related Social Needs Screening Tool. The care team will refer participants with affirmative responses to the HUB through the provider dashboard to address social needs (e.g., food insecurity, housing, employment). HUB community health workers will perform comprehensive social needs assessments and connect participants to community resources through \"care pathways,\" a defined action plan addressing patient needs which is recorded and tracked.', 'armGroupLabels': ['ACHIEVE Intervention'], 'otherNames': ['Healthcare Collaborative of Greater Columbus Central Ohio Pathways HUB and social needs']}\n- {'type': 'DEVICE', 'name': 'Provider dashboard', 'description': 'The ACHIEVE intervention will include a bi-directional dashboard that displays information about individuals, including priority care goals and pathways, and recommendations generated via PROMPT. Healthcare team members can access the dashboard embedded within a portal to modify or update information and close the loop on participant tasks. The dashboard will present recommendations for participant goals and pathways provided by the PROMPT algorithms. Providers can use these recommendations or manually select ones for the participant. Providers can sequence goals and pathways by level of complexity. Both the HUB and the healthcare team can perform ongoing assessments of HUB pathway selections and assess recurring needs through the provider dashboard.', 'armGroupLabels': ['ACHIEVE Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery', 'description': 'A1c is a blood test that represents the average glucose over the previous three months. Our outcome threshold is slightly higher than the target of \\\\<6.0 recently recommended by ADA because: 1) our target population of pregnant individuals includes those with poor glycemic control at enrollment, 2) an aggressive target \\\\<6% can result in frequent episodes of hypoglycemia, of particular concern for participants in the standard care arm without CGM, and 3) the frequency of adverse neonatal outcomes are similar with third trimester A1c 6-6.4% vs. \\\\<6%. A1c will be assessed once per trimester, consistent with ADA and ACOG guidelines for T2D management in pregnancy, and at delivery. For participants with \\\\>1 value in the third trimester, the value closest to delivery will be used. A standard assay will be used for HbA1c. We will evaluate HbA1c as an absolute percentage of total hemoglobin using reference standards per the Diabetes Control and Complications Trial Reference Method.', 'timeFrame': 'From \u226420 weeks of gestation to delivery, an average of 5 months'}\n\nPlease estimate the sample size based on the assumption: \nAt least 80% power, 10% loss-to-follow-up, one-sided Fisher's exact test.", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Power calculations and sample size\n Recent pharmacological intervention trials in pregnancies complicated by T2D have assessed medium effect sizes approximating absolute changes of 15% to 30%.56 57 We target to detect a 25% absolute increase in the proportion of participants in the intervention versus standard care group with an A1c <6.5% by delivery (64% intervention vs 39% control). A total sample size of 124 participants (62 per study arm) will provide at least 80% power to detect such a difference between the two groups after accounting for up to 10% loss-to-follow-up based on a one-sided Fisher\u00e2\u0080\u0099s exact test. The loss-to-follow-up rate of 10% is based on prior diabetes in pregnancy trials at our centre.32 33", "id": 1686, "split": "test"} +{"trial_id": "NCT05662527", "pmid": "37349100", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Immunotherapy in Patients With MMR-deficient Localized Colon Cancer Scheduled for Curative Surgery - A Prospective, Phase II Study\n\nIncluded conditions:\n- Colon Cancer\n\nStudy Armgroups:\n- {'label': 'Neoadjuvant pembrolizumab', 'type': 'EXPERIMENTAL', 'description': 'Pembrolizumab', 'interventionNames': ['Drug: Pembrolizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'One dosage of 4mg/kg (maximum of 400mg)', 'armGroupLabels': ['Neoadjuvant pembrolizumab'], 'otherNames': ['Keytruda']}\n\nPrimary Outcomes:\n- {'measure': 'Pathological complete response (pCR)', 'description': 'Number of patients with pCR evaluated according to the Mandard tumour regression grading system', 'timeFrame': 'Tumour specimen evaluated within 2 weeks after surgery.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level at 0.05 (\u03b1=0.05), power at 90% (\u03b2=0.10), and a dropout rate of 10%.", "answer": 85, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary endpoint of the study is the number of patients with pCR (see box 1 for list of endpoints), which is the basis for the sample size calculations. The sample size is based on Simon\u00e2\u0080\u0099s two-stage minimax design.30 This design will ensure an early study termination if there is insufficient efficacy. A standard pathological response evaluation of the resected specimen will be done after surgery. A pCR rate of less than 20% after pembrolizumab treatment is not clinically relevant. Assuming a significance level at 0.05 (\u00ce\u00b1=0.05) and a power at 90% (\u00ce\u00b2=0.10) 42 patients should be included in the first part plus another 35 patients in the second part of the study. If 6 out of the first 42 patients achieve pCR, a pCR rate of at least 20% cannot be excluded and the study will continue until a total of 77 patients have been included. If 21 out of 77 patients achieve pCR, a pCR rate of 35% cannot be excluded, and it will be concluded that the treatment is effective enough to continue with future studies. Anticipating a dropout rate of 10% we will include a total of 85 patients.\n \n Box 1\n \n Study endpoints\n \n \n Primary endpoint:\n \n \n Number of patients with pathological complete response (pCR) evaluated according to the Mandard tumour regression grading system.34\n\n \n \n \n \n Secondary endpoints:\n \n \n Safety and tolerability of pembrolizumab administered before surgery. Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received pembrolizumab using Common Terminology Criteria for Adverse Events, V.5.0. Further, delay in surgery defined as surgery performed more than 5 weeks after dose of pembrolizumab will be assessed.\n \n \n Number of postoperative surgical complications determined by the Clavien-Dindo classification system.40\n\n \n \n Assessment of potential predictive biomarker by investigating immunological markers across pretreatment and post-treatment biopsies and sequential blood samples.\n \n \n Treatment response evaluated by methylated circulating cell-free DNA (cfDNA) specific for colon cancer analysed across sequential blood samples using the TriMeth test.35\n\n \n \n \n \n Exploratory endpoints:\n \n \n Tumour histology, gene expression, cfDNA, T-cell receptor repertoire, CT scans, endoscopic photo documentation and patient journals will be analysed with the purpose of identifying biomarkers for predicting patients with pCR.", "id": 1687, "split": "test"} +{"trial_id": "NCT05664945", "pmid": "39774509", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-trial)\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'pulmonary tele-rehabilitation (PTR)', 'type': 'EXPERIMENTAL', 'description': 'Recieve supervised PTR 2/weekly, session duration of 60 min; 35 min of exercise and 25min of patient education for 10-weeks (primary endpoint).\\n\\nDelivered from Hvidovre/Bispebjerg Hospital to groups of 4-6 patients who exercise at home and communicate via tablet-camera.\\n\\nAfter 10-weeks of PTR, participants are offered once weekly PTR for 60minuttes in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).', 'interventionNames': ['Behavioral: pulmonary tele-rehabilitation (PTR)']}\n- {'label': 'home-based pulmonary rehabilitation (HPR)', 'type': 'EXPERIMENTAL', 'description': 'HPR is an individual self-initiated home-based PR program. Patient goal is to achieve at least 20 min of self-initiated muscle-endurance based exercise 3days/weekly for 10-weeks (primary endpoint).\\n\\nThe first session is a home visit by an experienced respiratory physiotherapist and with focus on establishment of exercise goals, formal exercise prescription and education.\\n\\nThe home visit is followed by 1/weekly session for 10-weeks.The sessions is delivered from Hvidovre/Bispebjerg Hospital via tablet-camera or telephone call.\\n\\nAfter 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).', 'interventionNames': ['Behavioral: home-based pulmonary rehabilitation (HPR)']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Control group will receive usual care; medication, scheduled follow-up visit and possible phone contact with GP or the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered.', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'pulmonary tele-rehabilitation (PTR)', 'description': 'PTR is delivered from promoter hospital to a group of 4-6 patients who exercise at home and communicate via tablet-camera.\\n\\nEach session is 60 min; 35 min exercise/ 25 min patient education, two times per week for a duration of 10-weeks (primary endpoint).\\n\\nSpecific exercises are evidence-based; been used in several intervention studies on patients with COPD.\\n\\nExercises involves larger muscle groups with 50/50 exercises for upper and lower extremities. Volume, intensity and content exercise protocol follow both national and international exercise recommendations.\\n\\nThe education sessions consist of dialogue, reflections around empowerment and better living with COPD.\\n\\nEvery fourth education session consists of 25 min Mindfulness exercises developed for COPD patients.\\n\\nAfter 10-weeks of PTR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).', 'armGroupLabels': ['pulmonary tele-rehabilitation (PTR)']}\n- {'type': 'BEHAVIORAL', 'name': 'home-based pulmonary rehabilitation (HPR)', 'description': \"HPR is an individual self-initiated home-based PR aiming to achieve 20 min of self-initiated muscle-endurance based exercise; 3-days/weekly for 10-weeks (primary endpoint).\\n\\nExercises are evidence-based; used in several intervention studies on patients with COPD and involves larger muscle groups with 50/50 exercises for upper/lower extremities.\\n\\nFirst session is a home visit by a respiratory physiotherapist. During the visit the physiotherapist and patient establish exercise goals, exercise prescription and provision of mindfulness exercises and educationbook.\\n\\nThe home visit is followed by one weekly session for 10-weeks. A menu of topics relevant to COPD and self-management is discussed. A session is delivered from promoter hospital via tablet-camera or telephone call (patients' preference).\\n\\nAfter 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).\", 'armGroupLabels': ['home-based pulmonary rehabilitation (HPR)']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'Receive usual care; medication, scheduled follow-up visit and possible phone contact with GP and the outpatient respiratory department.\\n\\nExcept for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered.\\n\\nIf a patient changes his/her mind and wishes to participate in a conventional hospital- or community-based PR program, it will be granted as this is a highly recommended treatment (e.g. rehabilitation after hospital admitted exacerbation).', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Change in COPD Assessment Test (CAT)', 'description': 'Patient completed questionnaires that assess respiratory symptoms. Eight item questionaire with total score from 0-40 points.', 'timeFrame': 'Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of 4.5, power of 80%, significance level of 5%, expected withdrawal rate of 20%", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n Three primary pairwise comparisons are made in the study, equivalence test between the two interventions and the superiority test for each intervention compared to the control group for the primary outcome of respiratory symptoms (COPD assessment test). Sample size estimation for the equivalence is based on a t-test with equivalence margin of -2.5 to 2.5 (clinically relevant difference), standard deviation (SD) of 4.5, power of 80% and significance level of 5%, and estimated 56 patients necessary in each group. For both, superiority tests a minimal clinical difference of 2.5, SD of 4.5, power of 80% and significance level of 5% were used in a two-sample t-test, with fixed sample of 56 patients the intervention groups. This yields a necessary size of 32 patients in the control group. The sample size is increased to accommodate an expected withdrawal of 20% in each group and thus a total of 180 (70/70/40) patients.", "id": 1688, "split": "test"} +{"trial_id": "NCT05665426", "pmid": "37903112", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Acupuncture or Moxibustion at Acupoints Weizhong (BL40) and Chize (LU5) on the Change in Lumbar Temperature in Healthy People\n\nIncluded conditions:\n- Health\n\nStudy Armgroups:\n- {'label': 'AW group', 'type': 'OTHER', 'description': '(1) AW group: acupuncture at Weizhong point,', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'AC group', 'type': 'OTHER', 'description': '(2) AC group: acupuncture at Chize point,', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'MW group', 'type': 'OTHER', 'description': '(3) MW group: moxibustion at Weizhong point,', 'interventionNames': ['Other: moxibustion']}\n- {'label': 'MC group', 'type': 'OTHER', 'description': '(4) MC group: moxibustion at Chize point.', 'interventionNames': ['Other: moxibustion']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'acupuncture', 'description': 'Patients allocated to the acupuncture group will be punctured at the pre-specified acupoints. According to the theory of traditional Chinese medicine and clinical experience, we will use the Bilateral Weizhong point (BL 40). Because of the similar anatomy, the Chize point (LU 5) was chosen as a control. Sterile disposable stainless steel acupuncture needles (length: 40 mm, diameter: 0.25 mm; Hwato, Suzhou, China) will be used.', 'armGroupLabels': ['AC group', 'AW group']}\n- {'type': 'OTHER', 'name': 'moxibustion', 'description': 'Moxibustion Participants in the moxibustion group will receive moxibustion treatment via portable Moxibustion (Aikeshu, Bozhou, China); the moxibustion is composed of The inner tube (containing the moxa pillar) and the outer tube. To use, pull out the inner tube and light the moxa pillar, then insert the outer tube and fix the moxibustion on the acupuncture points. Two Moxibustion devices will be sequentially applied at two acupoints Weizhong (BL 40) and Chize (LU 5), for 30 minutes.', 'armGroupLabels': ['MC group', 'MW group']}\n\nPrimary Outcomes:\n- {'measure': '\u0394T at the waist between 30 minutes and the baseline.', 'description': 'The temperature difference (\u0394T)at the waist between 30 minutes and the baseline.', 'timeFrame': '30 minutes after the intervention has begin'}\n\nPlease estimate the sample size based on the assumption: \nA type I error of 5% (\u03b1 = 0.05) and 80% power (\u03b2 = 0.20) are assumed. The number of groups (k) is 4. A 20% dropout rate is also considered.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size\n We estimated the sample size based on mean temperature in the lumbar region at the last minute of the intervention period. As the primary outcome measure. Sample size calculations are performed to determine the number of participants needed to detect effect sizes. According to previously published results [6, 8] and our preliminary data, the mean average temperature difference are \u00ce\u00bc1 = 0.84 \u00ce\u00bc2 = 0.34, \u00ce\u00bc3 = 0.70, and \u00ce\u00bc4 = 0.20 in the Acu-BL40 group, Acu-LU5 group, Mox-BL40 group and Mox-LU5 group, respectively, and the SD \u00cf\u0083 = 0.26. k represents the number of groups and equals 4 in this trial. We will assume a type I error of 5% (\u00ce\u00b1 = 0.05) and 80% power (\u00ce\u00b2 = 0.20). The following formula was used to determine the number of people in each group:\n\nN=\u00ce\u00bb/1\u00cf\u00832\u00e2\u0088\u0091i=1k(X\u00c2\u00afi\u00e2\u0088\u0092X0\u00c2\u00af)2\n\nAccounting for a 20% dropout rate during the study, a total of 140 participants are required to obtain the target of 35 participants per group.", "id": 1689, "split": "test"} +{"trial_id": "NCT05669833", "pmid": "40102973", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)\n\nIncluded conditions:\n- Psoriatic Arthritis\n\nStudy Armgroups:\n- {'label': 'Guselkumab 100mg q4w', 'type': 'EXPERIMENTAL', 'description': 'Guselkumab (GUS) 100mg every 4 weeks', 'interventionNames': ['Drug: Guselkumab']}\n- {'label': 'Guselkumab 100mg q8w', 'type': 'EXPERIMENTAL', 'description': 'Guselkumab (GUS) 100mg every 8 weeks', 'interventionNames': ['Drug: Guselkumab']}\n- {'label': 'Golimumab 50mg q4w', 'type': 'ACTIVE_COMPARATOR', 'description': 'Golimumab (GOL) 50mg every 4 weeks', 'interventionNames': ['Drug: Golimumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Guselkumab', 'description': 'Guselkumab (GUS) subcutaneous injection', 'armGroupLabels': ['Guselkumab 100mg q4w', 'Guselkumab 100mg q8w'], 'otherNames': ['Tremfya']}\n- {'type': 'DRUG', 'name': 'Golimumab', 'description': 'Golimumab (GOL) subcutaneous injection', 'armGroupLabels': ['Golimumab 50mg q4w'], 'otherNames': ['Simponi']}\n\nPrimary Outcomes:\n- {'measure': 'Achievement of cDAPSA low disease activity', 'description': 'Clinical Disease Activity in Psoriatic Arthritis (cDAPSA): a combination score of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity. Scale from 0-154 where higher figures indicate worse status. Remission is considered \u22644 and low disease activity \\\\>4 to \u226413.', 'timeFrame': '12 Months'}\n- {'measure': 'Investigator Global Assessment of Psoriasis of Clear or Almost Clear', 'description': 'Investigator global assessment (IGA) of psoriasis. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).', 'timeFrame': '12 Months'}\n\nPlease estimate the sample size based on the assumption: \nAll analyses will be considered exploratory due to the reduced sample size.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n The initial planned sample size was a total of approximately 300 participants, with equal randomization across the three treatment groups. However, owing to recruitment challenges, the planned sample size was reduced to a total of 150 (i.e., 50 in each group), and all analyses will be considered exploratory. When applying the EVOLUTION inclusion criteria to biologic-experienced patients in the PARC cohort, approximately half would meet disease activity eligibility criteria for the current study (Table 2). Utilizing data from this EVOLUTION-eligible PARC cohort, we hypothesize that 50%, 45%, and 24% of patients in the guselkumab Q4W, guselkumab Q8W, and SC golimumab groups, respectively, will achieve the primary outcome of cDAPSA LDA\u00e2\u0080\u0089+\u00e2\u0080\u0089IGA 0/1 at Month 12.", "id": 1690, "split": "test"} +{"trial_id": "NCT05673278", "pmid": "38101846", "question": "Here is the design of a clinical trial:\n\nOfficial Title: To Examine the Feasibility of Non-Invasive Monitoring With Bowel Ultrasound in Paediatric Inflammatory Bowel Disease and Correlation With Inflammatory Markers, Disease Activity Scores and as a Predictor of Changes in Treatment (NIMBUS)\n\nIncluded conditions:\n- Inflammatory Bowel Diseases\n- Ulcerative Colitis\n- Crohn Disease\n- Pediatric Crohns Disease\n- Pediatric Ulcerative Colitis\n\nStudy Armgroups:\n- {'label': 'Children and young people diagnosed with inflammatory bowel disease aged 2-19 years', 'description': 'Diagnosis according to the modified Porto criteria All participants will undergo single ultrasound scan which will be evaluated with medical notes and results from routine care. No new samples will be taken outside of normal care.', 'interventionNames': ['Diagnostic Test: Bowel Ultrasound Scan']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Bowel Ultrasound Scan', 'description': 'Ultrasound scans will attempt to measure predefined criteria implemented in other research work using bowel ultrasound.\\n\\nI - Bowel wall thickness II - Colour Doppler signal III - Loss of wall layer stratification IV - Loss of haustration V - Fatty wrapping VI - Motility in terminal ileum (TI) VII - Lymphadenopathy VIII - Abscess IX - Stricture\\n\\n+ Image quality', 'armGroupLabels': ['Children and young people diagnosed with inflammatory bowel disease aged 2-19 years']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility metrics (recruitment, retention/follow up)', 'description': 'Reported as point estimates alongside 95% CIs, and assessed against the traffic light progression criteria:\\n\\n* Recruitment rate (number screened and approached / number consented): \\\\>60% green, 30-60% amber, \\\\<30% red\\n* Retention/follow up rate (number consented / number providing outcome data): \\\\>80% green, 70-80% amber, \\\\<70% red\\n* Availability rate of ultrasound scan attendance and specific parameters i.e. ability to obtain for example \"loss of bowel wall haustrations\" (number scanned/ number providing outcome data): \\\\>80% green, 70-80% amber, \\\\<70% red', 'timeFrame': '12-24 months'}\n- {'measure': 'Ultrasound parameter score total', 'description': 'Composite measure of bowel wall thickness (BWT), colour doppler signal, loss of wall layer stratification, loss of haustration, fatty wrapping, motility in TI, lymphadenopathy and abscess/ stricture. Bowel wall thickness will be defined as thickness in longitudinal plane + thickness in cross-sectional plane with the total being divided by 2. BWT \\\\> 3.0 mm for colonic segments and BWT \\\\> 2.0 mm for terminal ileum will be considered abnormal. Colour doppler signal will be graded from 0 to 3. All other parameters are binary and will be scored as either 0 (absent) or 1 (present). A total score will make up the primary outcome measure. Correlations with routine measures of inflammation (i.e blood tests and disease activity scores will be explored).', 'timeFrame': '12-24 months'}\n\nPlease estimate the sample size based on the assumption: \nLogistic factors within the Noah's Ark Children's Hospital for Wales, and feasibility within financial and time constraints.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n Sample size (n=50) based on similar research work in this population and demographic as well as logistic factors within the Noah\u00e2\u0080\u0099s Ark Children\u00e2\u0080\u0099s hospital for Wales. In their 2019 meta-analysis of studies looking to compare ultrasound findings with MRI or ileocolonoscopy, van Wassenaer et al reported on 12 studies with numbers of participants ranging from 9 to 50.26 Practically, at the Noah\u00e2\u0080\u0099s ark Children\u00e2\u0080\u0099s Hospital for Wales there are approximately 250 children and young people with IBD managed by the paediatric gastroenterology team. The investigating team estimates that recruiting the desired number from this population will be feasible and within financial and time constraints of study, while having an adequate size to demonstrate the feasibility of ultrasound for monitoring tool in this group.", "id": 1691, "split": "test"} +{"trial_id": "NCT05674071", "pmid": "37369421", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health\n\nIncluded conditions:\n- Mental Health Issue\n\nStudy Armgroups:\n- {'label': 'Articulation/HVT', 'type': 'EXPERIMENTAL', 'description': 'This intervention will use articulation and high-velocity thrust techniques', 'interventionNames': ['Behavioral: Articulation/HVT']}\n- {'label': 'Soft-tissue massage', 'type': 'EXPERIMENTAL', 'description': 'This intervention will use soft-tissue massage', 'interventionNames': ['Behavioral: Soft-tissue massage']}\n- {'label': 'Craniosacral techniques', 'type': 'EXPERIMENTAL', 'description': 'This intervention will use craniosacral techniques', 'interventionNames': ['Behavioral: Craniosacral techniques']}\n- {'label': 'Combination', 'type': 'EXPERIMENTAL', 'description': 'This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral', 'interventionNames': ['Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniques']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Articulation/HVT', 'description': 'Osteopathy 1', 'armGroupLabels': ['Articulation/HVT']}\n- {'type': 'BEHAVIORAL', 'name': 'Soft-tissue massage', 'description': 'Osteopathy 2', 'armGroupLabels': ['Soft-tissue massage']}\n- {'type': 'BEHAVIORAL', 'name': 'Craniosacral techniques', 'description': 'Osteopathy 3', 'armGroupLabels': ['Craniosacral techniques']}\n- {'type': 'BEHAVIORAL', 'name': 'Combination of the three interventions: HVT, soft-tissue and craniosacral techniques', 'description': 'This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques', 'armGroupLabels': ['Combination']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of study recruitment', 'description': 'Recruitment rate', 'timeFrame': '3 months'}\n- {'measure': 'Feasibility of time to complete study', 'description': 'Time to complete questionnaires', 'timeFrame': '3 months'}\n- {'measure': 'Feasibility of study data collection', 'description': 'Missing data reported', 'timeFrame': '3 months'}\n- {'measure': 'Feasibility of assessing physiological measurements', 'description': 'Time to take physiological measurements', 'timeFrame': '3 months'}\n- {'measure': 'Acceptability of intervention to participants', 'description': 'Feedback from participants in qualitative interviews', 'timeFrame': '3 months'}\n- {'measure': 'Acceptability of intervention and risk factors', 'description': 'Adverse events reported', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 32, "answer_type": "ACTUAL", "explanation": "Sample size\n The study will aim to recruit 32 participants. This number of participants is generally deemed sufficient for feasibility studies48 and would represent approximately 10% of the sample size required in a full trial.49 This sample size also falls within what is practical given the available resources.", "id": 1692, "split": "test"} +{"trial_id": "NCT05675150", "pmid": "39806623", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Unlocking Limitations Through Arts: A Mixed Methods Study on the Effectiveness of an Expressive Arts-based Intervention on Psychosocial Wellbeing of Adults With Age-related Visual Impairment\n\nIncluded conditions:\n- Age-Related Macular Degeneration\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'This arm of participants will be receiving expressive arts-based intervention as intervention', 'interventionNames': ['Behavioral: Expressive Arts-Based Intervention']}\n- {'label': 'Wait-list control', 'type': 'NO_INTERVENTION', 'description': 'This arm of participants will not receive any art-based intervention during the study and are allocated as a wait-list control group'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Expressive Arts-Based Intervention', 'description': 'The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflection and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in intervention may seek meaning, clarity, insight and healing.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change of Baseline Psychosocial Adaptation Questionnaire for visual impairment level at 2 months, 5 months, and 8 months', 'description': \"Administration of the Chinese translated version of the 38-item Psychosocial Adaptation Questionnaire:\\n\\n* The first factor was attitude, involving 10 items. The second factor was self-acceptance, involving six items. The third factor was self-esteem involving six items. The fourth factor was anxiety/depression, involving six items. The fifth factor was belonging, involving five items. The sixth factor was self-efficacy involving three items. The last factor was the sense of self-control, involving two items.\\n* Higher scores indicate a higher level of endorsement in a specific domain.\\n* Likert's scale with four points was used to quantify results. The four points included completely incorrect, more correct, most correct, and completely correct. The score for positive items was one point, two points, three points, and four points; negative items were scored oppositely.\\n* Q14, Q17, Q19, Q20, Q21, Q22, Q29, Q30, Q31, and Q32 are reversed (positive) items.\", 'timeFrame': 'Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)'}\n- {'measure': 'Change of Baseline Vision-related Quality of Life level at 2 months, 5 months, and 8 months', 'description': 'Administration of the Chinese translated version of the 13-item Vision-related Quality of Life Scale:\\n\\n* Vision-specific quality of life is measured by the 13-item Vision-Related Quality of Life Scale taken from 25-item National Eye Institute Visual Function Questionnaire.\\n* Social functioning of Vision-specific quality of life is Q11 and Q13 respectively.\\n* Mental health of Vision-specific quality of life is Q3, Q25, Q21, and Q22 respectively.\\n* Role limitation of Vision-specific quality of life is Q17 and Q18 respectively.\\n* Dependency of Vision-specific quality of life is Q20, Q23, and Q24 respectively.\\n* Ocular pain of Vision-specific quality of life is Q4 and Q19 respectively.\\n* Original numeric values from the survey are re-coded following the scoring rules. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 1', 'timeFrame': 'Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level of 0.05, statistical power of 80%, attrition rate of 20%", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Sample size\n G*power 3.1 was used to estimate the required sample size. Assuming an attrition rate of 20%, 154 participants (77 participants for each arm) will be required to reach a statistical power of 80% to detect the expected moderate effect size (Cohen\u00e2\u0080\u0099s d=0.5)26 in the two-arm RCT with four assessment time points at a significance level of 0.05. A subset of 25\u00e2\u0080\u009330 participants will be interviewed at T1 and T3, as a sample of 25 participants will be enough to attain data saturation.27", "id": 1693, "split": "test"} +{"trial_id": "NCT05678244", "pmid": "37983228", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit: A Feasibility Randomized Controlled Trial\n\nIncluded conditions:\n- Pain, Postoperative\n- Pain\n\nStudy Armgroups:\n- {'label': 'Comparator', 'type': 'ACTIVE_COMPARATOR', 'description': \"Standard of care + IV acetaminophen:\\n\\nBaseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of IV acetaminophen every 4 or 6 hours at weight-appropriate doses based on the patient's gestational age.\", 'interventionNames': ['Drug: Acetaminophen']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': \"Standard of care + placebo:\\n\\nBaseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of an IV saline placebo every 4 or 6 hours at a rate which would mimic their dose of acetaminophen.\", 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Acetaminophen', 'description': 'IV acetaminophen will be added to standard of care opioid based pain regimes.', 'armGroupLabels': ['Comparator']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'In control group placebo will be added to standard of care opioid based pain regimes.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rate', 'description': 'Mean number of patients randomized per month', 'timeFrame': 'through study completion, an average of 1.5 years'}\n- {'measure': 'Follow up rate', 'description': 'Number of patients followed in completion from postoperative day 0 to 7', 'timeFrame': '90 days'}\n- {'measure': 'Medication compliance', 'description': 'Number of patients who received at least 80% of doses of study drugs at the correct dose and interval', 'timeFrame': '7 days'}\n- {'measure': 'Blinding index', 'description': \"Responses of nurse's physician's, and research staff's guess of group assignment (control vs treatment) compared to actual group assignment\", 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated, but the guidelines suggest that 30 per arm is ideal for feasibility studies.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size of 30 per arm (a total of 60 patients) will be used. This decision is based on methodologic guidelines, suggesting that this is ideal for assessing feasibility and calculating future sample sizes [64\u00e2\u0080\u009366]. Daily communication with the surgical and medical teams will be used to achieve participant enrollment.", "id": 1694, "split": "test"} +{"trial_id": "NCT05681949", "pmid": "37684688", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols\n\nIncluded conditions:\n- Hepatocellular Carcinoma\n- Fibrolamellar Hepatocellular Carcinoma\n- Cholangiocarcinoma, Perihilar\n- Intrahepatic Cholangiocarcinoma\n- Metastasis to Liver\n- Gallbladder Carcinoma\n\nStudy Armgroups:\n- {'label': \"Participants' cases discussed in tumor conference without ADBoard\", 'type': 'NO_INTERVENTION', 'description': \"Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice.\"}\n- {'label': \"Participants' cases discussed in tumor conference with ADBoard\", 'type': 'EXPERIMENTAL', 'description': \"Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference.\", 'interventionNames': ['Other: ADBoard']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ADBoard', 'description': \"Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors\", 'armGroupLabels': [\"Participants' cases discussed in tumor conference with ADBoard\"]}\n\nPrimary Outcomes:\n- {'measure': 'Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation', 'description': 'Examples of possible treatment recommendations are liver resection (curative), regimen of chemotherapy, immunotherapy, radiotherapy, transarterial chemoembolisation, diagnostics, best-supportive care, follow-up by re-presentation.\\n\\nThe interrater reliability of the recommendations of ADBoard and the tumor conferences with regard to their agreement will be measured.', 'timeFrame': 'Through study completion, average of 30 months'}\n- {'measure': 'The reproducibility of the therapy recommendations made by ADBoard (yes/no)', 'description': 'The intrarater reliability will be measured by testing all participant cases several times by the ADBoard according to the required sample size with sufficient statistical power (test-retest). Interrater and intrarater reliability will be evaluated descriptively (percentage of agreement, contingency tables), and finally the Cohen-Kappa value will be assessed.', 'timeFrame': 'Through study completion, average of 30 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error (\u03b1) is set at 0.05. The power is considered at 80% and 90%.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Calculation of sample size\n The evaluation of the primary outcome is based on Cohen\u00e2\u0080\u0099s kappa test (inter- and intrarater comparison) for nondichotomous decision-making. There are five possible recommendation categories: surgical resection or transplantation, chemo-/immunotherapy, interventional therapy, re-intervention, and further diagnosis. A five-category nominal scale will be used between different raters or different ratings of the same instance. The frequency of each category is not evenly distributed here but is estimated to be 0.3 for resection or transplantation, 0.3 for chemotherapy, 0.2 for follow-up, 0.1 for intervention, and 0.1 for further diagnosis. To capture any deviation from this estimate, different expressions of the frequencies were included in Table 1. The null hypothesis was defined as a Cohen\u00e2\u0080\u0099s kappa value of 0.7, as reliability below this value can be considered clinically unacceptable. The reliability strength to be achieved was set at 0.8 (primary endpoint: kappa value\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.75). Based on these specifications, the required numbers of cases were taken from the calculations of Bujang and Adnan [12]. A total of 3000 patients will be included in the retrospective part of the study and 1200 patients will be included in the prospective part.\nTable 1Indication of the numbers of cases required for different relative frequencies of a 5-category nominal scale [12]. Number of categories: 5, type I error (\u00c9\u0091): 0.05, null hypothesis (Cohen\u00e2\u0080\u0099s kappa): 0.7, primary endpoint (Cohen\u00e2\u0080\u0099s kappa): 0.8Relative frequenciesRequired number of cases (power 80%)Required number of cases (power 90%)0.3, 0.3, 0.2, 0.1, 0.12403110.3, 0.25, 0.2, 0.1, 0.052543290.6, 0.1, 0.1, 0.1, 0.1306400\n The required numbers of cases depending on the relative frequencies of the recommendation types are displayed in Table 1.", "id": 1695, "split": "test"} +{"trial_id": "NCT05681949", "pmid": "37684688", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols\n\nIncluded conditions:\n- Hepatocellular Carcinoma\n- Fibrolamellar Hepatocellular Carcinoma\n- Cholangiocarcinoma, Perihilar\n- Intrahepatic Cholangiocarcinoma\n- Metastasis to Liver\n- Gallbladder Carcinoma\n\nStudy Armgroups:\n- {'label': \"Participants' cases discussed in tumor conference without ADBoard\", 'type': 'NO_INTERVENTION', 'description': \"Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice.\"}\n- {'label': \"Participants' cases discussed in tumor conference with ADBoard\", 'type': 'EXPERIMENTAL', 'description': \"Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference.\", 'interventionNames': ['Other: ADBoard']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ADBoard', 'description': \"Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors\", 'armGroupLabels': [\"Participants' cases discussed in tumor conference with ADBoard\"]}\n\nPrimary Outcomes:\n- {'measure': 'Concordance (yes/no) of interdisciplinary tumor conference treatment recommendation with ADBoard-supported recommendation', 'description': 'Examples of possible treatment recommendations are liver resection (curative), regimen of chemotherapy, immunotherapy, radiotherapy, transarterial chemoembolisation, diagnostics, best-supportive care, follow-up by re-presentation.\\n\\nThe interrater reliability of the recommendations of ADBoard and the tumor conferences with regard to their agreement will be measured.', 'timeFrame': 'Through study completion, average of 30 months'}\n- {'measure': 'The reproducibility of the therapy recommendations made by ADBoard (yes/no)', 'description': 'The intrarater reliability will be measured by testing all participant cases several times by the ADBoard according to the required sample size with sufficient statistical power (test-retest). Interrater and intrarater reliability will be evaluated descriptively (percentage of agreement, contingency tables), and finally the Cohen-Kappa value will be assessed.', 'timeFrame': 'Through study completion, average of 30 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error (\u03b1) is set at 0.05. The power is considered at 80% and 90%.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Calculation of sample size\n The evaluation of the primary outcome is based on Cohen\u00e2\u0080\u0099s kappa test (inter- and intrarater comparison) for nondichotomous decision-making. There are five possible recommendation categories: surgical resection or transplantation, chemo-/immunotherapy, interventional therapy, re-intervention, and further diagnosis. A five-category nominal scale will be used between different raters or different ratings of the same instance. The frequency of each category is not evenly distributed here but is estimated to be 0.3 for resection or transplantation, 0.3 for chemotherapy, 0.2 for follow-up, 0.1 for intervention, and 0.1 for further diagnosis. To capture any deviation from this estimate, different expressions of the frequencies were included in Table 1. The null hypothesis was defined as a Cohen\u00e2\u0080\u0099s kappa value of 0.7, as reliability below this value can be considered clinically unacceptable. The reliability strength to be achieved was set at 0.8 (primary endpoint: kappa value\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.75). Based on these specifications, the required numbers of cases were taken from the calculations of Bujang and Adnan [12]. A total of 3000 patients will be included in the retrospective part of the study and 1200 patients will be included in the prospective part.\nTable 1Indication of the numbers of cases required for different relative frequencies of a 5-category nominal scale [12]. Number of categories: 5, type I error (\u00c9\u0091): 0.05, null hypothesis (Cohen\u00e2\u0080\u0099s kappa): 0.7, primary endpoint (Cohen\u00e2\u0080\u0099s kappa): 0.8Relative frequenciesRequired number of cases (power 80%)Required number of cases (power 90%)0.3, 0.3, 0.2, 0.1, 0.12403110.3, 0.25, 0.2, 0.1, 0.052543290.6, 0.1, 0.1, 0.1, 0.1306400\n The required numbers of cases depending on the relative frequencies of the recommendation types are displayed in Table 1.", "id": 1696, "split": "test"} +{"trial_id": "NCT05688163", "pmid": "38551981", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Daily Cognition Training Programme on Cognitive Function, Emotional State, Frailty and Functionality in Older Adults Without Cognitive Impairment\n\nIncluded conditions:\n- Functional Status\n- Cognitive Impairment\n- Occupational Therapy\n\nStudy Armgroups:\n- {'label': 'traditional cognitive stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will carry out the programme based on traditional cognitive stimulation. Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.', 'interventionNames': ['Other: traditional cognitive stimulation']}\n- {'label': 'programme based on everyday cognition', 'type': 'EXPERIMENTAL', 'description': 'The experimental group, on the other hand, will carry out a programme based on everyday cognition, i.e. the use of cognitive functions to solve real everyday problems that occur in our daily lives and that allow us to be autonomous in our homes, such as preparing food, taking care of the house, using transport, shopping, using the telephone, medication, financial management and access to information and current affairs. As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above.', 'interventionNames': ['Other: programme based on everyday cognition']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'programme based on everyday cognition', 'description': 'Will carry out a programme based on everyday cognition, As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above. Each day one of these tasks will be worked on.', 'armGroupLabels': ['programme based on everyday cognition']}\n- {'type': 'OTHER', 'name': 'traditional cognitive stimulation', 'description': 'Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.', 'armGroupLabels': ['traditional cognitive stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Everyday cognition.', 'description': \"The Test for the Assessment of Everyday Cognition measures the ability of older people to solve everyday problems through performance tasks whose resolution depends on their cognitive capacity. The abilities tested are planning ability and cognitive flexibility, verbal working memory, reasoning, episodic memory, episodic memory and crystallised intelligence. The result is a direct estimation of the person's functional capacity by means of 12 real situations grouped into 6 areas: medication, administrative management, financial management, meal preparation, transport and shopping. The administration time is about 35 minutes.\", 'timeFrame': '35 minutes'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided approach with a confidence level of 95%, a statistical power of 80%, equal group sizes, and an expected population loss of 20%. The Yates correction will not be applied.", "answer": 99, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size has been estimated using Epidat 4.2. A one-sided approach has been assumed with a confidence level of 95% and a statistical power of 80%. It has been decided to take equal sizes in the two groups (i.e. R = n2/n1) and the Yates correction will not be applied. The sample size calculation was based on the results of a similar RCT, specifically the study conducted by Fern\u00c3\u00a1ndez et al. in 2018 [16] which compared the outcomes of a traditional cognitive stimulation intervention versus an intervention based on everyday cognition. The primary variable chosen in both studies was everyday cognition. The study found that the experimental group (those who received everyday cognition training) demonstrated an improvement of 2.57 points in the primary variable, while the control group (those who received traditional cognitive stimulation) only demonstrated an improvement of 0.39 points. With an expected population loss of 20%, the final sample size was n = 99 participants, with 50 in the experimental group and 49 in the control group.", "id": 1697, "split": "test"} +{"trial_id": "NCT05688592", "pmid": "37355275", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Multicenter Study to Determine the Usefulness of Systematic 18-FDG-PET-TC for the Management of Invasive Fungal Infection (PETIFI Project)\n\nIncluded conditions:\n- Invasive Fungal Infections\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'PET-CT', 'description': 'This is a before-and-after study (not a clinical trial)\\n\\n* in the case of fungemia, 2 weeks after the initial staging 18F-FDG PET-CT.\\n* in the case of focal IFIs, 2-4 and 12 weeks after the initial staging 18F-FDG PET-CT', 'otherNames': ['Before-and-after study']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of antifungal treatment', 'description': 'Length of anti fungal therapy', 'timeFrame': '6 months'}\n- {'measure': 'Survival', 'description': 'Alive at the last visit', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \n6% accuracy in estimating a proportion using a bilateral 95% normal asymptotic CI, assuming the proportion is 25%, with a 10% dropout rate.", "answer": 224, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the literature, we assume that 18F-FDG PET/CT will detect lesions not previously visualised in approximately 50% of patients.1 We anticipate that the findings in 50% of these patients will cause the management of IFI to change,7 which corresponds to 25% of the total number of patients. To achieve a 6% accuracy in estimating a proportion using a bilateral 95% normal asymptotic CI, assuming that the proportion is 25%, it will be necessary to include 201 patients in the study. Assuming 10% of abandonments, or loss of information, it would be necessary to enrol 224 patients.", "id": 1698, "split": "test"} +{"trial_id": "NCT05688982", "pmid": "38072485", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MOLAR: Mapping Oral Health and Local Area Resources\n\nIncluded conditions:\n- Dental Diseases\n\nStudy Armgroups:\n- {'label': 'A--general information', 'type': 'OTHER', 'description': 'Patients in Arm A will receive paper handouts with general oral health and aSDoH resources', 'interventionNames': ['Behavioral: General information provision']}\n- {'label': 'B--geographic information', 'type': 'OTHER', 'description': 'Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources.', 'interventionNames': ['Behavioral: Geographic information provision']}\n- {'label': 'C--geographic information and navigational assistance', 'type': 'OTHER', 'description': 'Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.', 'interventionNames': ['Behavioral: Geographic information provision', 'Behavioral: Navigational assistance']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'General information provision', 'description': 'Patients will receive information with general oral health and aSDoH resources.', 'armGroupLabels': ['A--general information']}\n- {'type': 'BEHAVIORAL', 'name': 'Geographic information provision', 'description': 'Patients will receive information with geographically-proximate oral health and aSDoH resources based on a directory created by the study team.', 'armGroupLabels': ['B--geographic information', 'C--geographic information and navigational assistance']}\n- {'type': 'BEHAVIORAL', 'name': 'Navigational assistance', 'description': 'Patients will receive phone-based navigational assistance from the study navigator.', 'armGroupLabels': ['C--geographic information and navigational assistance']}\n\nPrimary Outcomes:\n- {'measure': 'Linkage to oral health care', 'description': 'binary, completion of a dental appointment or not', 'timeFrame': 'Within 12 months of randomization'}\n\nPlease estimate the sample size based on the assumption: \nOver 80% power to see a 6 percentage point difference in linkage to care at 3 months; 80%-90% power under the assumptions; Bonferroni correction for multiple comparisons; assuming 70% follow-up at 1 month; 60% consent and enrolment rate.", "answer": 2049, "answer_type": "ESTIMATED", "explanation": "Sample size\n There are little data on linkage to care for patients with unmet oral health needs in the ED setting to power this study. The best information that we have is that a pilot evaluation of patients admitted to one of the three hospitals for non-dental concerns, completed by our team, found that 68% of subjects had at least moderate periodontal disease.30 Regarding follow-up and outcomes, our pilot work on text messaging for aSDoH in the ED showed 74% of patients completed the text message follow-up. In that study, none of the control participants used the resources, compared with 9% of those in the intervention arm. Assuming a control group linkage to care rate of either 1% or 10% (based on the baseline and intervention states from our pilot) and that the intervention group response is 5\u00e2\u0080\u009310\u00e2\u0080\u0089percentage points higher (similar to our pilot data), a range of 255\u00e2\u0080\u00932049 patients would be required for analysis conservatively accounting for multiple comparisons between arms with a Bonferroni correction.31\n Because of the limited data to power the study, we have planned for a conservative enrolment size of 2049 (683 per arm). Based on a sample of 683 patients in usual care and 683 patients in oral health information and aSDoH groups, we will have over 80% power to see a 6 percentage point difference in linkage to care at 3 months. Based on the demographics of included hospitals, we estimate that 60% of patients will present from a low dental density neighbourhood. It is possible that the intervention will be only effective in high dental density areas (ie, with a 10% increase in completion of dental appointments); in contrast, a previous paediatric study suggested that neighbourhood factors explain only 2% of the difference in dental attendance yearly.32 With the 1366 patients receiving the dental intervention, with the recognition that robust SEs will be used to account for clustering, we would have between 80% and 90%\u00e2\u0080\u0089power under the assumptions above.\n For an analysis sample of 2049, assuming 70% will follow-up at 1 month, we will need to enrol 2927 people; if 60% of those approached consent and enrol, we would need to approach 4879 individuals. We therefore budgeted to approach 4900 individuals.", "id": 1699, "split": "test"} +{"trial_id": "NCT05689788", "pmid": "37653525", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of High-intensity Laser Therapy in Patients With Chronic Nonspecific Neck Pain. Randomized Clinical Trial\n\nIncluded conditions:\n- Non-specific Chronic Neck Pain\n\nStudy Armgroups:\n- {'label': 'HILT + stretching exercise', 'type': 'EXPERIMENTAL', 'description': 'High-intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.', 'interventionNames': ['Device: High-intensity laser therapy', 'Procedure: Stretching exercise']}\n- {'label': 'Sham HILT + stretching exercise', 'type': 'SHAM_COMPARATOR', 'description': 'The group will receive a sham treatment of high-intensity laser therapy (HILT). The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.', 'interventionNames': ['Procedure: Stretching exercise', 'Device: Sham High-intensity laser therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'High-intensity laser therapy', 'description': 'punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used.', 'armGroupLabels': ['HILT + stretching exercise']}\n- {'type': 'PROCEDURE', 'name': 'Stretching exercise', 'description': 'Three sets of bilateral passive static stretching will be performed for the upper trapezius, levator scapulae, and scalene muscles. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.', 'armGroupLabels': ['HILT + stretching exercise', 'Sham HILT + stretching exercise']}\n- {'type': 'DEVICE', 'name': 'Sham High-intensity laser therapy', 'description': 'Intervention in which the therapist performs a HILT simulation application, performing all of the steps and movements for an administration without actually receiving the treatment.', 'armGroupLabels': ['Sham HILT + stretching exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Pain pressure thereshold (PPT)', 'description': 'Pain pressure threshold differences evaluated with algometry at six neck and shoulder locations: 2 cm lateral to the spinous processes of C2, C5, T4, and T8, midpoint of the upper trapezius muscle belly (between the spinous process of C7 and the acromion), and the levator scapula muscle (2 cm superior to the superior angle of the scapula).', 'timeFrame': 'Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)'}\n- {'measure': 'Pain intensity at rest (RPI)', 'description': 'Magnitude of neck pain reported by participants at rest evaluated with visual anologue scale (VAS)', 'timeFrame': 'Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)'}\n- {'measure': 'Pain intensity at movement (MPI)', 'description': 'Magnitude of pain reported by the participants when performing movements of the cervical spine in flexion, extension, inclination, and right and left rotation evaluated with visual anologue scale (VAS).', 'timeFrame': 'Baseline and 4 weeks (8 sessions)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.80 (1-\u03b2), a reliability of 95%, an error of 5% (\u03b1), and an additional 15% of participants considered for possible losses during follow-up.", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was determined with the G-Power program using a power of 0.80 (1-\u00ce\u00b2), a reliability of 95%, an error of 5% (\u00ce\u00b1), and an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.6 (Cohen\u00e2\u0080\u0099s d) with reference to previous studies that determined differences in mean pain intensity between experimental and control groups after HILT treatment with effect sizes of 0.53 [30, 40]. Based on the above, the calculated sample size is 72 subjects, with at least 36 subjects per group. The study will include 84 participants (42 per group) in recognition of the crucial role of sample size in determining the power and impact of the study. An additional 15% of participants were considered for possible losses during the follow-up (bias due to abandonment). This is consistent with what the literature recommends, which suggests including at least 10% more participants, and with the PEDro scale (criterion 8), which advocates for analyzing at least 85% of the data to maintain data validity and obtain more robust statistical results and analysis [41, 42].", "id": 1700, "split": "test"} +{"trial_id": "NCT05690347", "pmid": "36927339", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol for a Multicenter Study on (Cost)Effectiveness of the Back At Work After Surgery (BAAS): a Clinical Pathway for Knee Arthroplasty\n\nIncluded conditions:\n- Arthropathy of Knee\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Back At work After Surgery (BAAS)', 'description': 'see protocol'}\n\nPrimary Outcomes:\n- {'measure': 'Return to work', 'timeFrame': '1 year'}\n- {'measure': 'costs', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8, a significance level of 0.05, and an expected loss to follow-up of 20%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n A minimal required sample size was calculated using R (version 3.6.3) with a power of 0.8 and a significance level of 0.05. The effect size was calculated with a mean difference of two weeks in comparison to a Dutch study on RTW after KA [15]. With a calculated minimal required sample size of 125 and an expected loss to follow-up of 20%, we intend to include 150 patients (75 in NS and 75 in ETZ).", "id": 1701, "split": "test"} +{"trial_id": "NCT05691647", "pmid": "38171633", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Chronotherapy for Patients With a Depressive Episode in a Public Outpatient Mental Health Care Clinic in Norway: A Randomized Controlled Trial\n\nIncluded conditions:\n- Depressive Episode\n\nStudy Armgroups:\n- {'label': 'Chronotherapy + treatment as usual', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Chronotherapy', 'Behavioral: Treatment as usual']}\n- {'label': 'Treatment as usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'medication, cognitive behavioral therapy, and other psychotherapies.', 'interventionNames': ['Behavioral: Treatment as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Chronotherapy', 'description': 'Chronotherapy involves three different interventions. Sleep deprivation/wake therapy will be conducted for 34 hours. To assist wake and to ensure that the participants adhere to the sleep deprivation, they will be admitted to a one-night stay at the inpatient ward that is connected to the outpatient clinic at Nidaros DPS. Upon discharge, participants are encouraged to adhere to the sleep schedule which presents the sleep-wake phase advancement and later stabilization of the sleep-wake phase. Light therapy is provided for half an hour every day from day four in the study. In addition to the chronotherapeutic interventions, the participants will receive treatment as usual (TAU) with their assigned therapist.', 'armGroupLabels': ['Chronotherapy + treatment as usual']}\n- {'type': 'BEHAVIORAL', 'name': 'Treatment as usual', 'description': 'Participants allocated to receive TAU alone, will receive standard treatment for a depressive episode in the outpatient clinic. This study will not give restrictions or guidelines on how this treatment should be performed. The TAU-group will receive the treatment the responsible therapist considers and evaluate best fitting in the situation. Typical interventions administered in therapy for a depressive episode includes medication, cognitive behavioral therapy, and other psychotherapies.', 'armGroupLabels': ['Chronotherapy + treatment as usual', 'Treatment as usual']}\n\nPrimary Outcomes:\n- {'measure': 'Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization', 'description': 'Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.', 'timeFrame': '1 week after randomization'}\n\nPlease estimate the sample size based on the assumption: \nA two-sample t-test with alpha=0.05, 80% power, and an anticipated 25% dropout rate.", "answer": 76, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome is the between-group difference in IDS-SR scores 1\u00e2\u0080\u0089week after randomisation, with additional outcomes assessed on days 3, 4, 14 and weeks 4, 8, 24 and 52\u00e2\u0080\u0089weeks after randomisation.\n A meta-analysis of four RCTs of sleep deprivation for depression found a standardised effect size (ES) of Hedges g=0.62.11 In a feasibility trial of TCT in a primary care sample, the authors reported a mean effect size of d=0.89\u00e2\u0080\u0089on the QIDS-SR at 1\u00e2\u0080\u0089week.10 We anticipate that 25% of participants in our sample will not complete the follow-up assessments and that the between-group effect of TCT will be somewhat lower than Veale et al10 reported due to differences in design and sample. Therefore, we aim to recruit 76 participants to retain 60 participants (30 in each treatment arm) at the end of the week 1 assessment. For a two-sample t-test with alpha=0.05, a sample size of 60 participants will provide an 80% chance of detecting a between-group difference of Cohen\u00e2\u0080\u0099s d=0.75. This corresponds to a moderate-large effect size difference between the two groups and is considered clinically meaningful.", "id": 1702, "split": "test"} +{"trial_id": "NCT05692843", "pmid": "37429687", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)\n\nIncluded conditions:\n- Atopic Dermatitis\n\nStudy Armgroups:\n- {'label': 'Start of Cyclosporin treatment', 'type': 'OTHER', 'description': 'Patients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center).\\n\\nOnce the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:\\n\\n1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;\\n2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.', 'interventionNames': ['Drug: Cyclosporin A']}\n- {'label': 'Receiving or received cyclosporin', 'type': 'OTHER', 'description': 'If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.\\n\\nIf the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.', 'interventionNames': ['Other: Follow-up of Cyclospoin treatment already started']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cyclosporin A', 'description': 'Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:\\n\\n1. The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;\\n2. Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.', 'armGroupLabels': ['Start of Cyclosporin treatment'], 'otherNames': ['Prospective']}\n- {'type': 'OTHER', 'name': 'Follow-up of Cyclospoin treatment already started', 'description': 'If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.\\n\\nIf the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.', 'armGroupLabels': ['Receiving or received cyclosporin'], 'otherNames': ['Ambispective']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of patients with primary non-response to treatment with cyclosporine.', 'description': 'Fail to achieve EASI-75 (a 75% improvement in EASI score)', 'timeFrame': 'Week 16'}\n\nPlease estimate the sample size based on the assumption: \nNot based on statistical considerations", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n A total of 100 patients are estimated to be included in this trial over a 1-year period, including the adult and paediatric populations of both cohorts. This sample size is based on clinical considerations, the feasibility of recruitment and the investigational product rather than statistical considerations.", "id": 1703, "split": "test"} +{"trial_id": "NCT05693025", "pmid": "39342204", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Process and Outcome Evaluation of the Walk With Ease Program for Fall Prevention\n\nIncluded conditions:\n- Exercise\n- Frailty\n- Arthritis\n- Accidental Falls\n\nStudy Armgroups:\n- {'label': 'Standard Implementation (SI)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants the Standard Implementation (SI) model complete a 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete standard exercises recommended in the base program.', 'interventionNames': ['Behavioral: Group Exercise']}\n- {'label': 'Enhanced Implementation (EI)', 'type': 'EXPERIMENTAL', 'description': 'Participants the Enhanced Implementation (SI) model complete the 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete personalized exercises prescribed by a licensed Physical Therapist to help reduce potential risks of falling.', 'interventionNames': ['Behavioral: Group Exercise']}\n- {'label': 'Standard Training (ST)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants the Standard Training (ST) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide standard knowledge-based training about how to become more physically active.', 'interventionNames': ['Behavioral: Behavioral Training']}\n- {'label': 'Enhanced Training (ET)', 'type': 'EXPERIMENTAL', 'description': \"Participants the Enhanced Training (ET) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide habit-formation training about how to form regular habits for physical activity. Participants are paired with a student 'coach' trained in motivational interviewing skills to provide virtual assistance in maintaining motivation during the programming.\", 'interventionNames': ['Behavioral: Behavioral Training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Group Exercise', 'description': 'The study evaluates two different approaches for group exercise. Participants in the Standard Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. Participants are guided to learn and perform a series of stretching and strengthening exercises recommended in the base WWE program. Primary BCTs include instruction on how to perform behavior (#4.1) and Graded tasks (#8.7). Participants in the Enhanced Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. They may perform some of the same exercises as those in the SI group but they are also guided to learn and perform specific exercises prescribed by a physical therapist to improve balance and reduce risks of falling. The primary BCTs include instruction on how to perform behavior (#4.1), Graded tasks (#8.7) from the base program as well as Information on health consequences (#5.1) and Credible source (#9.1).', 'armGroupLabels': ['Enhanced Implementation (EI)', 'Standard Implementation (SI)']}\n- {'type': 'BEHAVIORAL', 'name': 'Behavioral Training', 'description': 'The study evaluates two different approaches for promoting behavior change. Participants in the Standard Training (ST) model follow the standardized Walk with Ease training to support behavior change. Participants are provided with goal setting tools and an online tracker to monitor their progress. Weekly video-based lessons, resource links and eBook content support behavior change. Primary BCTs include Goal Setting (BCT #1.1) and self-monitoring (BCT#2.3). Participants in the Enhanced Training (ET) model access the same basic content as the ST model, but the weekly education-based videos are replaced with lessons focus on habit-formation training. Student coaches are also assigned to individual participants to support behavior change efforts using motivational interviewing strategies. Thus, participants in the ET model also receive two additional theory- and evidence-based BCTs: (1) habit formation training (BCT#1.2, #1.4, #8.3) and (2 health coaching (BCT# 3.3).', 'armGroupLabels': ['Enhanced Training (ET)', 'Standard Training (ST)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Fall Risk', 'description': 'Reported falls will be tracked using surveys as well as from the electronic medical record data. Reductions in fall risk will be evaluated using indicators from the established STEADI protocol with continuous fall risk scores computed using a validated algorithm.', 'timeFrame': '0, 6 weeks, 6 months, 12 months'}\n- {'measure': 'Change in Physical Activity Behavior', 'description': 'PA behavior will be captured using the International Physical Activity Questionnaire - Elderly (IPAQ-E) will be evaluated at all time points to estimate minutes of physical activity. While less robust than monitor-based methods, the IPAQ-E has been validated against criterion measures of physical activity and has demonstrated adequate sensitivity and specificity for evaluating physical activity among adults aged 65 years and older.', 'timeFrame': '0, 6 weeks, 6 months, 12 months'}\n\nPlease estimate the sample size based on the assumption: \n25% dropout rate, 80% power, 95% power", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size\n We will recruit 240 participants into the overall trial and project a final sample of 180 completers, based on a 25% dropout rate seen during pilot testing, providing a final sample size of 90 participants per treatment group for each of the main hypotheses, and 45 participants per group for testing of potential interactions between groups. Based on outcomes from a related clinical trial by Li et al. [20] we would have 80% power to detect a 14% reduction in fall frequency between conditions and 95% power to detect a 18% reduction in fall frequency between conditions.", "id": 1704, "split": "test"} +{"trial_id": "NCT05693467", "pmid": "37225277", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery\n\nIncluded conditions:\n- Pain, Postoperative\n\nStudy Armgroups:\n- {'label': 'The dexamethasone palmitate emulsion(DXP) plus ropivacaine group', 'type': 'EXPERIMENTAL', 'description': 'The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.', 'interventionNames': ['Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaine']}\n- {'label': 'The ropivacaine alone group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.', 'interventionNames': ['Drug: Ropivacaine alone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone palmitate emulsion(DXP) plus ropivacaine', 'description': 'The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.', 'armGroupLabels': ['The dexamethasone palmitate emulsion(DXP) plus ropivacaine group'], 'otherNames': ['DXP plus ropivacaine']}\n- {'type': 'DRUG', 'name': 'Ropivacaine alone', 'description': 'The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 7.5mL of ropivacaine added to 22.5mL of saline for Group B . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.', 'armGroupLabels': ['The ropivacaine alone group']}\n\nPrimary Outcomes:\n- {'measure': 'The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.', 'description': 'All participates will receive an electronic intravenous patient-controlled analgesia (PCA) pump. Participates will be advised to push the analgesic demand button if they feel pain.', 'timeFrame': 'Within 24 hours after spinal surgery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power (1-\u03b2) = 90%, dropout rate = 20%.", "answer": 124, "answer_type": "ACTUAL", "explanation": "Sample size\n It is generally recommended that the minimal clinically important difference of postoperative opioid consumption is an absolute reduction of 10 mg intravenous morphine in morphine milligram equivalent of 24 hours opioid consumption.37 The degree of analgesia provided by 1 mg morphine is equal to that by 1 \u00c2\u00b5g sufentanil. Hence, a difference of at least 10 \u00c2\u00b5g in sufentanil consumption within 24 hours postoperatively between groups is considered clinically relevant. Based on the previous study by Li et al, we hypothesise that the SD of sufentanil consumption within 24 hours after spine surgery will be 15 \u00c2\u00b5g.38 PASS V.15 software (NCSS, Kaysville, Utah, USA) was used for sample size calculation, assuming \u00ce\u00b1=0.05, \u00ce\u00b2=0.1 and power=90%, dropout rate=20%, a total of 124 patients will be required in this study (n=62 per group).", "id": 1705, "split": "test"} +{"trial_id": "NCT05694026", "pmid": "37643847", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Management of Dry Eye With Intense Pulsed Light in Combination With Diquafosol\n\nIncluded conditions:\n- Dry Eye\n\nStudy Armgroups:\n- {'label': 'IPL+', 'type': 'EXPERIMENTAL', 'description': 'Participants in the IPL+ group used DQS 1 drop 6 times/per day for four weeks along with 2 sessions of IPL, 2 weeks apart.', 'interventionNames': ['Device: Intense pulsed light', 'Drug: Diquafosol tetrasodium']}\n- {'label': 'IPL', 'type': 'EXPERIMENTAL', 'description': 'IPL treatment sessions were administered once at 2- weeks interval to all participants for 4 weeks.', 'interventionNames': ['Device: Intense pulsed light']}\n- {'label': 'DQS', 'type': 'EXPERIMENTAL', 'description': 'DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 4 weeks.', 'interventionNames': ['Drug: Diquafosol tetrasodium']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Intense pulsed light', 'description': 'IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.', 'armGroupLabels': ['IPL', 'IPL+'], 'otherNames': ['IPL']}\n- {'type': 'DRUG', 'name': 'Diquafosol tetrasodium', 'description': '3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms', 'armGroupLabels': ['DQS', 'IPL+'], 'otherNames': ['Diquas']}\n\nPrimary Outcomes:\n- {'measure': 'Non-invasive tear break-up time (NIBUT)', 'description': 'Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.\\n\\n* Changes at day-14 and day-28 will be compare with baseline measurements.\\n* Comparison between groups at baseline, day-14 and day-28 will also be examined.', 'timeFrame': 'Day-0 (baseline), day-14 and day-28'}\n- {'measure': 'Ocular Surface Disease Index (OSDI)', 'description': \"OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome.\\n\\n* Changes at day-14 and day-28 will be compare with baseline measurements.\\n* Comparison between groups at baseline, day-14 and day-28 will also be examined\", 'timeFrame': 'Day-0 (baseline), day-14 and day-28'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed t-test with 90% power and a 5% level of significance. Dropout rate of 8%. Primary and secondary efficacy analyses using two-way ANOVA and paired t-tests with alpha level 0.05.", "answer": 360, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation is based on the primary outcome measures, namely NITBUT and OSDI scores, to establish the non-inferiority of the IPL+ group compared with IPL group and DQS group in terms of the changes in the mean from the baseline in OSDI score at day 28. For the NITBUT scores, a sample size of 106 is sufficient to detect a clinically significant difference of 0.51 between the IPL+ group\u00e2\u0080\u0089and either of the two other groups (IPL group and DQS group) while assuming a SD of 1.15, using a two-tailed t-test of difference between means with 90% power and a 5% level of significance. For the OSDI scores, a sample size of 98 is sufficient to detect a clinically significant difference of 1.2 between the IPL+ group\u00e2\u0080\u0089and either of the two other groups (IPL group and DQS group) while assuming a SD of 2.6, using a two-tailed t-test of difference between means with 90% power and a 5% level of significance. Therefore, the required sample size is max (106, 98)=106 in each group.\n With the inclusion of the multidose treatment groups and a drop-out rate of 8%, it is estimated that about 350 individuals. Therefore 360 individuals will be enrolled, 120 in each group. The intended-to-treat population will be randomly allocated to the three groups.\n The primary and secondary efficacy analyses will use a two-way analysis of variance that will account for treatment and baseline OSDI score stratification to compare treatment differences. Using paired t-tests, within-treatment differences from baseline will be evaluated (alpha level 0.05). Additional analyses of OSDI subgroups and questionnaire data will be conducted using an analysis of variance. Using descriptive statistics, safety data will be summarised.", "id": 1706, "split": "test"} +{"trial_id": "NCT05694143", "pmid": "38232100", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness Of Health Literacy Intervention On Physical Activity And Healthy Diet Among Middle Eastern Adolescents In Malaysia\n\nIncluded conditions:\n- Adolescents Obesity\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'OTHER', 'description': \"Intervention group: Participants assigned to the intervention group will receive both will receive educational intervention including educational booklet will be distributed to the participants in the first session, and they will be asked to take it home and read it within one week. The booklet's content will include the risk factors of NCD and the benefits of adopting a healthy diet and physical activity in reducing overweight and obesity. Then, the educational classes will include six weekly teaching units. The general objective is to prevent obesity among students by delivering education and behavioural skills. The training units will be carried out in the schools. Each training unit will end with activities. The adolescents will learn more about their susceptibility to obesity and weight gain and how to make better decisions and feel better about themselves through these activities.\", 'interventionNames': ['Other: Education Intervention']}\n- {'label': 'Control group: No Intervention', 'type': 'OTHER', 'description': 'Participants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine).', 'interventionNames': ['Other: No Intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Education Intervention', 'description': \"This intervention is based on the Health Belief Model Theory, which examines the attitudes and beliefs of adolescents with enhanced knowledge and perceived disease risk. As a result, It aims to build on adolescents' skills and behaviours rather than increase their knowledge, beliefs, and relative skills. In order to develop the education program, health promotion experts with a special interest in changing obesity-related behaviours will assist the researcher.\\n\\nThe intervention is specifically designed to help adolescents:\\n\\n* To know facts, statistics and harmful effects of obesity and overweight.\\n* To know facts about physical activity and its importance.\\n* To know facts about a healthy diet and its importance.\\n* Definition of BMI and calculating the BMI.\\n* To read the Nutrition Facts label.\\n* To develop decision-making and self-care education.\", 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'No Intervention', 'description': 'They will have their regular curriculums and normal physical activity routine', 'armGroupLabels': ['Control group: No Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change Knowledge, Attitude and Practice of Nutrition and Physical Activity.', 'description': 'The Knowledge, Attitude, and Practice of Nutrition and Physical Activity will be measured using a self-report instrument Knowledge, Attitude, and Practice of Nutrition and Physical Activity Questionnaire (KAP-Q). The questionnaire consists of 73 items: knowledge (30), attitude (22), and practice (21). The presented knowledge part consists of 30 items to determine participants\\' knowledge level on Nutrition and Physical Activity. There are multiple-choice questions ell be each choice has \"True\", \"False\", and \"I do not know\" response options. Having a score above the mean means good knowledge. In the attitude section, there are 22 items with five Likert scales for assessing the attitude. A more positive attitude has higher scores. Practice includes 21 questions with five Likert scales for assessing the practice. A higher score shows more positive practice.', 'timeFrame': '[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]'}\n- {'measure': 'Change Physical Activity of the adolescent.', 'description': 'The Physical Activity will be measured using a self-report instrument Physical Activity Questionnaire for Older Children (PAQ-C). PAQ-C gives an overview of physical activity levels among participants of this study because PAQ-C is suitable for school children (8-14 years of age). PAQ-C has ten items. Each of the 9 PAQ-C questionnaire items is scored from 1 (low physical activity) to 5 (high physical activity), and a mean score of all items constitutes the overall PAQ-C score.', 'timeFrame': '[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a 95% confidence level, an intra-cluster correlation of 0.05, and a design effect of 2.2. An attrition rate of 15% is also considered.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n The cluster randomized control trial formula was applied to calculate the sample size, taking into consideration a power of 80%, and a 95% confidence level [28]. According to the proportion of overweightness among adolescents, calculated in a previous study conducted by James et al. [29]:\n\nn=DE\u00c3\u0097(Z1\u00e2\u0080\u0090\u00ce\u00b1/2+Z1\u00e2\u0080\u0090\u00ce\u00b2)2P1(1\u00e2\u0088\u0092P1)+P2(1\u00e2\u0088\u0092P2)(P1\u00e2\u0088\u0092P2)2\n\n DE = 1+ p (m-1)\n where:\n \n \n Z1-\u00ce\u00b1/2 = Standard score for (1\u00e2\u0080\u00930.025) = 1.96\n \n \n Z1-\u00ce\u00b2 = Standard score (1\u00e2\u0080\u00930.20) = 0.84 (80% power)\n \n \n P1 = The proportion of those overweight from control group (p1) = 27.6%\n \n \n P2 = The proportion of those overweight from Intervention group (p2) = 23.1%\n \n \n Intra-cluster correlation (P) = 0.05\n \n \n Number of individuals in each cluster (m)\n \n \n DE = Design Effect = 2.2\n \n \n \nn=2.2\u00c3\u0097(1.96+0.84)20.276(1\u00e2\u0088\u00920.276)+0.231(1\u00e2\u0088\u00920.23)(0.276\u00e2\u0088\u00920.23)2\n\n Sample size = 220\n Adding 15% to the number of subjects as attrition rate = 250\n Therefore, the total sample size is 250 participants (125 participants for each group).", "id": 1707, "split": "test"} +{"trial_id": "NCT05698680", "pmid": "37798801", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care\n\nIncluded conditions:\n- Acute Gout\n\nStudy Armgroups:\n- {'label': 'Prednisolone 30mg (Day 0-4)', 'type': 'EXPERIMENTAL', 'description': 'As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the prednisolone arm will receive prednisolone plus a colchicine placebo. The prednisolone placebos contain a bittering agent due to the bitter taste of prednisolone to ensure a similar taste.\\n\\nThe dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 150 mg for prednisolone.', 'interventionNames': ['Drug: Prednisolone 30 mg Tablet']}\n- {'label': 'Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)', 'type': 'ACTIVE_COMPARATOR', 'description': 'As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the colchicine arm will receive colchicine plus prednisolone placebo.\\n\\nThe dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 5.5mg for colchicine.', 'interventionNames': ['Drug: Colchicine 0.5 mg Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Prednisolone 30 mg Tablet', 'description': 'See treatment arm \"Prednisolone\"', 'armGroupLabels': ['Prednisolone 30mg (Day 0-4)'], 'otherNames': ['+ Placebo']}\n- {'type': 'DRUG', 'name': 'Colchicine 0.5 mg Oral Tablet', 'description': 'See treatment arm \"Colchicine\"', 'armGroupLabels': ['Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)'], 'otherNames': ['+ Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Most severe pain in the last 24 hours', 'description': \"To investigate whether the efficacy of prednisolone in General Practitioner's care is equally good or only marginally weaker than treatment with low-dose colchicine, the most severe pain in the last 24 hours on day 3 after baseline on an 11-point numerical rating scale is used and compared across groups. The study participants take their study medication for the first time on day 0 and are then asked to fill out their diary daily at the same time to quantify their pain. 0 stands for no pain and 10 for the strongest pain imaginable.\", 'timeFrame': 'Day 3'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 90%, the significance level at 5%, and an expected dropout rate of 10%.", "answer": 314, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A power analysis was conducted using PROC POWER of SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). Based on the minimal clinically important difference in pain (primary outcome measured on a 11-point NRS), the non-inferiority margin was set to \\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}$${\\delta }_{NI}=1$$\\end{document}\u00ce\u00b4NI=1 [15]. Previous studies of prednisolone vs. naproxen and naproxen vs. colchicine suggest that the difference of mean pain levels between prednisolone and colchicine will most likely not exceed 0.22 units [6, 7]. Based on these assumptions with a 90% power and a significance level of \\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}$$\\alpha =5$$\\end{document}\u00ce\u00b1=5, the sample size required would be 142 participants per arm. To account for 10% expected dropout, a total sample size of 314 (157 per trial arm) is needed.", "id": 1708, "split": "test"} +{"trial_id": "NCT05699369", "pmid": "37816010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Cluster Randomised Controlled Trial to Evaluate the Effectiveness of Digital Health Interventions in Improving Non-communicable Disease Management During the Pandemic in Rural Pakistan\n\nIncluded conditions:\n- Noncommunicable Diseases\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'A comprehensive package of digital health interventions to connect patients, patient champions and public health providers to improve the management of non-communicable diseases (NCDs) during the pandemic will be implemented, including 1) providing training to health providers regarding an integrated NCD-COVID guideline; 2) using a smartphone app to improve NCD case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. Patient champions are experienced patients who can provide peer support.', 'interventionNames': ['Other: Digital health interventions']}\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Usual care, which is routine hypertension and diabetes diagnosis and treatment under the World Diabetes Foundation (WDF) project will be implemented. The WDF project provides initial Zoom-based training of NCD care to rural health center (RHC) staff, but no tele-mentorship is offered. Under the usual care, patients with hypertension or diabetes are required to visit RHCs every month to renew their medications and measure their blood pressure. No other interventional components will be implemented in the control arm.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Digital health interventions', 'description': 'Described in arm descriptions.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Systolic blood pressure (mmHg) measured in the rural health center', 'timeFrame': 'At 10 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error probability is set at 0.05. The power is calculated for 85% and 90%. An intra-class correlation of 0.03 is assumed. A 20% loss-to-follow-up rate is considered.", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size\n The computation of the sample size is based on demonstrating the intervention improves systolic blood pressure. A difference of 3 mmHg in systolic blood pressure at the population level is deemed to be the minimal clinically important difference to detect. Due to the pragmatic nature of this trial, which tends to attenuate treatment effects, a difference of 3 mmHg in this setting indicates an effective treatment [39]. Based on prior work, the standard deviation of systolic blood pressure is expected to be about 11 mmHg [40, 41]. We will further assume a modest intra-class correlation of 0.03 and set a Type I error probability of 0.05 and plan on 40 patients per cluster for the sample size estimation. Sample size calculations for the comparison of means in cluster trials (Equation 5.1 in Donner and Klar, 2000) indicate that 524 patients per group would be required for 85% power and 614 patients per group would be required for 90% power [42]. Although 614 is slightly higher than the 600 expected from 15 clusters of 40 each, the adjustment of baseline systolic blood pressure in the analysis will increase the power relative to the simple unadjusted analysis reflected in the sample size estimation. Considering a 20% loss-to-follow-up rate based on our previous trials in Pakistan and China we aim to increase to 50 patients per cluster, that is a total of 1500 patients to be recruited [23, 43]. We do not anticipate loss-to-follow-up at the cluster level. Power will increase if all clusters meet the enrolment target of 50 patients.", "id": 1709, "split": "test"} +{"trial_id": "NCT05700305", "pmid": "39913349", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Feasibility Study to Explore the Role of Exercise and Nutrition to Target Frailty in People With Problematic Substance Use and Homelessness\n\nIncluded conditions:\n- Social Isolation\n- Chronic Disease\n- Physical Disability\n- Addiction\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': '12-week, low threshold physical rehabilitation intervention with protein supplementation', 'description': '12 week, low threshold, rolling exercise intervention with protein supplementation', 'otherNames': ['Physical rehabilitation intervention with protein supplementation']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment', 'description': 'Number recruited to study', 'timeFrame': 'October to December 2022'}\n- {'measure': 'Adverse events', 'description': 'Any injuries or incidence will be recorded', 'timeFrame': 'Through to study completion, up to 12 weeks'}\n- {'measure': 'Adherence', 'description': 'Number of repeat visits', 'timeFrame': 'Through to study completion, up to 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%", "answer": 45, "answer_type": "ACTUAL", "explanation": "Sample size\n A sample size calculation was conducted on the statistical package R, based on an expected adherence of 60%, a minimal acceptable adherence of 45% and a power of 80%, which indicated that a target sample size of 68 would be required. Due to the novelty of this study, the challenges of recruitment in this \u00e2\u0080\u0098hard to reach\u00e2\u0080\u0099 population and the feasibility focus of this study, while 68 will be the recruitment target, a minimal of 24 will be sought [53].", "id": 1710, "split": "test"} +{"trial_id": "NCT05701514", "pmid": "36931672", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) Trial\n\nIncluded conditions:\n- Congenital Pulmonary Airway Malformation\n\nStudy Armgroups:\n- {'label': 'Conservative arm', 'type': 'NO_INTERVENTION', 'description': 'Children assigned to this treatment arm will be conservatively managed, and will continue to be followed until the age of 5 years (end of study inclusion).'}\n- {'label': 'Surgical arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Children assigned to this treatment arm will undergo elective surgical resection at the age of 6-9 months, and will continue to be followed until the age of 5 years (end of study inclusion).', 'interventionNames': ['Procedure: Elective surgical resection of CPAM between 6 and 9 months of age']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Elective surgical resection of CPAM between 6 and 9 months of age', 'description': 'Surgical resection of the CPAM between 6 and 9 months of age', 'armGroupLabels': ['Surgical arm']}\n\nPrimary Outcomes:\n- {'measure': 'Exercise tolerance', 'description': 'BRUCE treadmill test protocol. Total endurance time will be converted to a sex and age matched percentile score based on pre-defined reference values.', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided significance level of 0.05, Mann-Whitney U test, 20% increase to account for dropout and missing data.", "answer": 176, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is a power analysis for the difference in mean SD scores (SDS) of maximal exercise endurance between conservatively and patients with surgically treated asymptomatic CPAM. Our calculations are based on data from patients with CPAM in our surgical long-term follow-up cohort, which includes all patients with CPAM either born in or referred to the Erasmus MC Sophia Children\u00e2\u0080\u0099s Hospital, Rotterdam, The Netherlands from January 1999 onward. We found a mean Bruce SDS of \u00e2\u0088\u00920.41 with an SD of 1.09 in the surgical group, that is, patients with CPAM that had undergone a surgical resection. A mean of 0.1 with an SD of 0.7 was found for the conservative group. To obtain 90% power with a two-sided significance level of 0.05 in a Mann-Whitney U (ie, without adjustment for confounding), 73 patients are needed in each study group. To make sure that the power remains sufficient after adjustment for relevant confounder variables, and to account for dropout and missing data, we increased the sample size by 20%. This calculation leads to a planned inclusion of 176 patients (88 patients per group). Inclusion of subjects will take place up to the moment this number of patients has visited the hospital for their follow-up visit at the age of 1\u00e2\u0080\u0089year. On average, a large metropolitan paediatric hospital treats approximately 10\u00e2\u0080\u009320 patients with asymptomatic CPAM per year. Considering this, each participating centre is committed to include 8\u00e2\u0080\u009312 patients each year.", "id": 1711, "split": "test"} +{"trial_id": "NCT05701891", "pmid": "36803315", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The (Cost-)Effectiveness of an Innovative, Personalised Intervention of Therapeutic VirtuAl Reality IntEgrated Within physioTherapY for a Subgroup of Complex Chronic Low Back Pain Patients\n\nIncluded conditions:\n- Chronic Low-back Pain\n\nStudy Armgroups:\n- {'label': 'Physiotherapy with integrated VR', 'type': 'EXPERIMENTAL', 'description': 'Our intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by our partners (i.e. Reducept and SyncVR) will be integrated into physiotherapy treatment. The following VR modules will be used: education (Reducept), relaxation and distraction (SyncVR Relax \\\\& Distract), activation (SyncVR Fit). Patients will use the Pico Neo 3 VR headset at the physiotherapy practice and at home 5 days a week for 10-30 minutes. In addition, physiotherapists will help patients transition from movements performed in a VR context to daily activities without VR.', 'interventionNames': ['Combination Product: Physiotherapy with integrated Virtual Reality']}\n- {'label': 'Physiotherapy (usual care)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control condition is usual physiotherapy care for 12 weeks.', 'interventionNames': ['Other: Physiotherapy (usual care)']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Physiotherapy with integrated Virtual Reality', 'description': 'A 12-week personalised, VR-integrated physiotherapy intervention.', 'armGroupLabels': ['Physiotherapy with integrated VR'], 'otherNames': ['Reducept', 'SyncVR Relax & Distract', 'SyncVR Fit']}\n- {'type': 'OTHER', 'name': 'Physiotherapy (usual care)', 'description': 'A 12-week usual physiotherapy care intervention.', 'armGroupLabels': ['Physiotherapy (usual care)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in physical functioning measured using the Oswestry Disability Index (ODI)', 'description': 'This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).', 'timeFrame': 'baseline, 1, 3 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) = 0.05, power = 90%, ICC for clusters = 0.05, 15% drop-out rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n A clinically relevant between-group difference of at least 10 points on the ODI [35] at 3-months follow-up is expected, which seems plausible based on recent pilot studies with VR from our research group [33, 54] and others [27, 55\u00e2\u0080\u009357]. For this expected and clinically relevant difference of 10 and a standard deviation of 15 (based on previous studies from our group (e.g. [58]), 60 patients are needed per group (a\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; power\u00e2\u0080\u0089=\u00e2\u0080\u008990%; ICC for clusters 0.05; 15% drop-out). We expect to include 1 patient every 2\u00e2\u0080\u0089months per physiotherapist. A total of 20 participating physiotherapists will result in a total of 120 patients after 12\u00e2\u0080\u0089months.", "id": 1712, "split": "test"} +{"trial_id": "NCT05703919", "pmid": "38273393", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease\n\nIncluded conditions:\n- COPD Exacerbation\n- COPD Exacerbation Acute\n\nStudy Armgroups:\n- {'label': 'Titrated Oxygen', 'type': 'EXPERIMENTAL', 'description': 'If the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures).\\n\\nFollowing scenarios regarding SpO2 can occur during treatment:\\n\\nSpO2 \\\\<88%: Supplemental oxygen via the EtCO2-meter up to 10 l/min, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter.\\n\\nSpO2 88-92%: No intervention.\\n\\nSpO2 \\\\>92%: No intervention.\\n\\nIf repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.', 'interventionNames': ['Drug: Titrated Oxygen']}\n- {'label': 'Standard Oxygen', 'type': 'ACTIVE_COMPARATOR', 'description': 'If the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP.\\n\\nFollowing scenarios regarding SpO2 can occur during treatment:\\n\\nSpO2 \\\\<88%: Supplemental oxygen via the EtCO2 -meter up to 10 l/min.\\n\\nSpO2 88-92%: No intervention.\\n\\nSpO2 \\\\>92%: No intervention.\\n\\nIf repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.', 'interventionNames': ['Drug: Standard Oxygen']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Titrated Oxygen', 'description': 'Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%', 'armGroupLabels': ['Titrated Oxygen']}\n- {'type': 'DRUG', 'name': 'Standard Oxygen', 'description': 'Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators', 'armGroupLabels': ['Standard Oxygen']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality, 30-day', 'timeFrame': 'Day 30 from randomization'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, expected dropout rate of max. 4%, and a significance level of 5%.", "answer": 1888, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size estimate for the STOP-COPD trial is based on results from the CRT by Austin et al. [5]. An absolute risk reduction of 5% for in-hospital mortality was found in the intention-to-treat analysis in favour of a restricted titrated oxygen treatment to patients with suspected AECOPD.\n However, the STOP-COPD trial differs from the CRT by Austin et al. with respect to study setup. In the CRT, not all included patients were treated with inhaled bronchodilators, and the control group received higher oxygen concentrations than prescribed in current standard practice. Furthermore, a larger uncertainty is associated with a CRT setup as a result of reduced power. In addition, a limited number of clusters increases the risk of cluster-specific confounding, considering administrative differences between sites, etc. To accommodate for these differences, we translated the findings in the CRT by Austin et al. to our study by using a conservative estimate of a 3% reduced (risk difference) (from 7% in the control arm to 4% in the intervention arm) 30-day mortality in favour of titrated oxygen treatment. At a power of 80%, an expected drop out of max. 4%, and a significance level of 5%, the total required sample size will be 1888 patients\u00e2\u0080\u0094944 in each treatment arm. Due to the uncertainty of the estimated risk reduction, a sample size re-estimation is planned. When data have been collected for the first 500 patients, a re-estimation of the sample size will be made based on the observed risk difference seen in this interim analysis. A new sample size from the re-estimation will be considered in terms of its clinical relevance and feasibility and forwarded as a recommendation from the DMC.", "id": 1713, "split": "test"} +{"trial_id": "NCT05704270", "pmid": "38423771", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy of Computerized Cognitive Training in Patients With Hypertension and Cognitive Impairment, no Dementia: a Randomized Controlled Trial\n\nIncluded conditions:\n- Mild Cognitive Impairment\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Adaptive cognitive training', 'type': 'EXPERIMENTAL', 'description': 'This arm is the intervention arm. Participants randomized to this arm will use a tablet to receive the multi-domain adaptive cognitive training, which will be delivered 30 minutes at least 5 times a week for 12 weeks.', 'interventionNames': ['Behavioral: Multi-domain adaptive cognitive training']}\n- {'label': 'Active control', 'type': 'ACTIVE_COMPARATOR', 'description': 'This arm is the control arm. Participants randomized to this arm will use the same tablet to receive the cognitive training of low difficulty level with no adaptive change. The intervention dosage will be the same, which is 30 minutes each time, at least 5 times a week for 12 weeks.', 'interventionNames': ['Behavioral: Basic cognitive training with no difficulty change']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Multi-domain adaptive cognitive training', 'description': 'The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.', 'armGroupLabels': ['Adaptive cognitive training']}\n- {'type': 'BEHAVIORAL', 'name': 'Basic cognitive training with no difficulty change', 'description': 'The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.', 'armGroupLabels': ['Active control']}\n\nPrimary Outcomes:\n- {'measure': 'Global cognitive function change measured by BCAT in 12 weeks', 'description': 'The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability Test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.', 'timeFrame': '12 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided test will be performed with an alpha of 5%, power of 90% and dropout rate of 20%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated according to the following hypotheses. (1) The intervention group could achieve the defined improvement in global cognitive function in 30% of participants after 12 weeks of intervention.23 (2) The control group could achieve overall cognitive function improvement in 10% of the participants. (3) A two-sided test will be performed with an alpha of 5%, power of 90% and dropout rate of 20%. The number of required patients would be 99 per group with a 1:1 allocation. We therefore decided to recruit 200 subjects for the trial.", "id": 1714, "split": "test"} +{"trial_id": "NCT05704621", "pmid": "39164041", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance\n\nIncluded conditions:\n- Ovarian Cancer\n- Drug Related Neoplasm/Cancer\n\nStudy Armgroups:\n- {'label': 'secondary cytoreductive surgery followed by chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'surgery arm', 'interventionNames': ['Procedure: secondary cytoreductive surgery', 'Drug: chemotherapy']}\n- {'label': 'chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'no surgery arm', 'interventionNames': ['Drug: chemotherapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'secondary cytoreductive surgery', 'description': 'Maximum effort cytoreductive surgery', 'armGroupLabels': ['secondary cytoreductive surgery followed by chemotherapy'], 'otherNames': ['secondary cytoreductive surgery followed by chemotherapy']}\n- {'type': 'DRUG', 'name': 'chemotherapy', 'description': 'six cycles of platinum-based chemotherapy +/- bevacizumab', 'armGroupLabels': ['chemotherapy', 'secondary cytoreductive surgery followed by chemotherapy'], 'otherNames': ['no surgery and only chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'progression-free survival', 'description': 'interval between date of randomization and the date of second relapse/progression or death, whatever occurs first', 'timeFrame': 'Up to 2 year'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Sample Size124 patients.", "id": 1715, "split": "test"} +{"trial_id": "NCT05704621", "pmid": "39164041", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance\n\nIncluded conditions:\n- Ovarian Cancer\n- Drug Related Neoplasm/Cancer\n\nStudy Armgroups:\n- {'label': 'secondary cytoreductive surgery followed by chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'surgery arm', 'interventionNames': ['Procedure: secondary cytoreductive surgery', 'Drug: chemotherapy']}\n- {'label': 'chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'no surgery arm', 'interventionNames': ['Drug: chemotherapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'secondary cytoreductive surgery', 'description': 'Maximum effort cytoreductive surgery', 'armGroupLabels': ['secondary cytoreductive surgery followed by chemotherapy'], 'otherNames': ['secondary cytoreductive surgery followed by chemotherapy']}\n- {'type': 'DRUG', 'name': 'chemotherapy', 'description': 'six cycles of platinum-based chemotherapy +/- bevacizumab', 'armGroupLabels': ['chemotherapy', 'secondary cytoreductive surgery followed by chemotherapy'], 'otherNames': ['no surgery and only chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'progression-free survival', 'description': 'interval between date of randomization and the date of second relapse/progression or death, whatever occurs first', 'timeFrame': 'Up to 2 year'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Sample Size\n For power and sample size calculation, an HR of 0.65 corresponding to a prolongation of the median PFS from 8 months in the no surgery group based on previous studies11 12 14 in favor of secondary cytoreductive surgery is considered clinically relevant.6 With a planned accrual period of 3 years, a subsequent 2-year follow-up period, and accounting for a dropout rate of 10%, 124 patients would be needed to ensure 80% power using a type I error rate of 0.1 (one-sided) to reject the null hypothesis.", "id": 1716, "split": "test"} +{"trial_id": "NCT05704920", "pmid": "38355174", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Study of Including a Deep Learning-based Analysis of Chest Computed Tomography as an Aid to Decision Making of Multidisciplinary Team Meetings for Lung Cancer Screening in Eligible Patients\n\nIncluded conditions:\n- Lung Cancer\n\nStudy Armgroups:\n- {'label': 'IA Group', 'type': 'EXPERIMENTAL', 'description': 'Patients with at least one nodule (\\\\> 6mm) for whom the multidisciplinary team meeting discussion is informed of the AI-based analysis of their chest computed tomography', 'interventionNames': ['Other: IA']}\n- {'label': 'Group not IA analysis', 'type': 'OTHER', 'description': 'Patients with at least one nodule (\\\\> 6mm) for whom the multidisciplinary team meeting discussion is not informed of the AI-based analysis of their chest computed tomography', 'interventionNames': ['Other: Not IA']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'IA', 'description': 'The multidisciplinary team meeting discussion is informed of the AI-based analysis of their chest computed tomography', 'armGroupLabels': ['IA Group']}\n- {'type': 'OTHER', 'name': 'Not IA', 'description': 'The multidisciplinary team meeting discussion is not informed of the AI-based analysis of their chest computed tomography', 'armGroupLabels': ['Group not IA analysis']}\n\nPrimary Outcomes:\n- {'measure': 'Diagnosis of lung disease', 'description': 'Elapsed time between lung nodule discovery and MDT decision making.', 'timeFrame': 'At 3 years'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided test with a power of 90% and a significance level of 5%. The proportion of subjects with a solid ILN is estimated at 25% at baseline or in the first year of follow-up. There is an estimated 5% loss to follow-up.", "answer": 2722, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size\n We considered that with the SOC strategy, the estimated median time between the discovery of a solid ILN and the definitive classification by MDT into benign or malignant is 12 months and that the addition of ScanRads analysis could reduce this median time to 9 months. This 3-month improvement interval is not based on trials. First, it is based on clinical pertinence as evaluated by thoracic oncologists in France. Also, the 3 months delay is the usual minimal interval between follow-up chest CT scans in patients with a suspicious nodule.\n Considering that a two-sided test has a power of 90% and a level of significance of 5%, the estimated number of subjects with a solid ILN is 324 (log-rank test, nQuery Advisor, V.9.1). The proportion of subjects with a solid ILN is estimated at 25% at baseline or on the first year of follow-up. Considering that there will be 5% of possible loss to follow-up, it will be necessary to include 2722 volunteers in the study.\n In the absence of a decision by the end of 24 months of follow-up, patients will be censored on this date. Data from patients lost to follow-up or who died during the 24 months of follow-up after the discovery of a ILN will be censored at the last date of follow-up. The time to definitive classification will be described for each group using Kaplan-Meier survival curves and compared using the log-rank test.", "id": 1717, "split": "test"} +{"trial_id": "NCT05705479", "pmid": "39542469", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared with Latarjet Procedure Evaluation\n\nIncluded conditions:\n- Shoulder Dislocation\n- Sport Injuries\n- Anterior Dislocation\n\nStudy Armgroups:\n- {'label': 'Bankart + Remplissage Procedure', 'type': 'EXPERIMENTAL', 'description': 'Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.', 'interventionNames': ['Procedure: Bankart + Remplissage Procedure']}\n- {'label': 'Latarjet Procedure', 'type': 'EXPERIMENTAL', 'description': 'Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.', 'interventionNames': ['Procedure: Latarjet Procedure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Bankart + Remplissage Procedure', 'description': 'Participants will undergo arthroscopic stabilization.', 'armGroupLabels': ['Bankart + Remplissage Procedure']}\n- {'type': 'PROCEDURE', 'name': 'Latarjet Procedure', 'description': 'Participants will undergo open or arthroscopic Latarjet procedure.', 'armGroupLabels': ['Latarjet Procedure']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical Outcome - Shoulder function', 'description': 'The change from baseline to 24 months post-intervention difference in Western Ontario Shoulder Instability Index (WOSI) scores between patients with recurrent dislocations treated with Bankart Procedure + Remplissage versus Latarjet procedure.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nalpha 0.05, power 0.80, 15% drop-out/loss to follow-up", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size estimate was based on the WOSI with a mean score of 69.6% and SD of 17.4, a 10% minimal clinically important difference, at alpha 0.05 and power 0.80.38 Based on these parameters, 96 participants are required. If we account for 15% drop-out/loss to follow-up we require a total of 114 participants. Therefore, we propose a sample size of at least 114 participants (57 participants per treatment arm).", "id": 1718, "split": "test"} +{"trial_id": "NCT05706766", "pmid": "39701583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial\n\nIncluded conditions:\n- Multiple Myeloma\n- Stem Cell Transplant Complications\n\nStudy Armgroups:\n- {'label': 'Exercise Group (PARE)', 'type': 'EXPERIMENTAL', 'description': 'Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined:\\n\\n* 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet.\\n* Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT).\\n* Questionnaires and surveys.', 'interventionNames': ['Behavioral: PARE']}\n- {'label': 'Waitlist Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined:\\n\\n* 8 weeks of continuing with normal daily activities.\\n* Option to participate in PARE exercise program after study completion.\\n* 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion.', 'interventionNames': ['Behavioral: Waitlist Control Group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PARE', 'description': 'Aerobic and resistance exercise program via Zoom platform.', 'armGroupLabels': ['Exercise Group (PARE)'], 'otherNames': ['Prehabilitation Aerobic and Resistance Exercise training program']}\n- {'type': 'BEHAVIORAL', 'name': 'Waitlist Control Group', 'description': 'Normal Activities.', 'armGroupLabels': ['Waitlist Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in Muscular Strength', 'description': 'The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.', 'timeFrame': 'Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 10% dropout rate, .05 two-sided significance level", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample Size\n We anticipate recruiting 1-2 participants per month, based on the accrual rates (3 to 4 participants per month) of previous exercise intervention studies [48]. A total of 30 eligible participants will be entered into this study and randomly assigned to the intervention and the control groups in a 1:1 ratio (15 per group). The sample size is based on general recommendations (24 to 50) for pilot studies in general [49-51] and this study provides 80% power to detect the effect size of Cohen d=1.15 (taking account of 10% dropout) at .05 two-sided \u00ce\u00b1 level.", "id": 1719, "split": "test"} +{"trial_id": "NCT05709002", "pmid": "38657227", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Fully Automated and Culturally-Adapted MHealth Intervention for Smoking Cessation Among Black Smokers with HIV\n\nIncluded conditions:\n- Cigarette Smoking\n\nStudy Armgroups:\n- {'label': 'MASP+ app & NRT', 'type': 'EXPERIMENTAL', 'description': 'MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.\\n\\nNicotine patches will be made available to provide adjunctive support.', 'interventionNames': ['Behavioral: MASP+']}\n- {'label': 'QuitGuide app + NRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages.\\n\\nNicotine patches will be made available to provide adjunctive support.', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'MASP+', 'description': 'mHealth (mobile app) for smoking cessation', 'armGroupLabels': ['MASP+ app & NRT']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'A mobile app designed to assist the general population with smoking cessation.', 'armGroupLabels': ['QuitGuide app + NRT'], 'otherNames': ['National Cancer Institute (NCI) QuitGuide app']}\n\nPrimary Outcomes:\n- {'measure': 'Biochemically verified smoking abstinence', 'description': 'Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \\\\< 7 ppm. This will be used to verify smoking status, as well as change in smoking behaviors throughout the study. As well, self-report measures of the Smoking History questionnaire (SHQ) will also be used to assess self-reported abstinence.', 'timeFrame': 'Weeks 1,2,3,4,5,6, & 28'}\n\nPlease estimate the sample size based on the assumption: \nThe study focuses on feasibility and preliminary effect size estimates rather than full-scale statistical power. Power calculations are based on Repeated Measures and Sample Size and simulation studies. Conclusions will be based on effect sizes and associated confidence intervals (CIs).", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample Size Determination\n As this is the first empirical evaluation of the MASP+ intervention in this population, our focus is on determining the feasibility of the new intervention and obtaining preliminary estimates of effect sizes on smoking and HIV outcomes and the hypothesized mechanism of change, rather than conducting a full-scale and statistically powered examination of comparative efficacy. We expect that MASP+ will be superior to the NCI QuitGuide on all outcomes examined, but that the effects of MASP+ may vary and be larger for smoking outcomes than for HIV outcomes. On the basis of power calculations conducted using Repeated Measures and Sample Size and simulation studies identifying the sample sizes necessary to detect indirect effects [105,106], a target sample size of 72 would provide sufficient statistical power to detect a medium to large effect (Cohen d\u00e2\u0089\u00a50.6) and an indirect effect for H3 if the treatment effect on AS is large (Cohen d=0.8) and the effect of AS on outcomes is medium to large (Cohen d=0.5). Our conclusions will primarily be based on effect sizes and associated CIs, and the effect size estimates (and associated CIs) from this trial will be used to guide future larger trials of comparative efficacy.\n Qualitative interviews are conducted with all MASP+ and QuitGuide participants. The recommended minimum size for any subgroup is 20 interviews [107]. However, based on our prior work [48], interviews vary substantially in the content provided, so interviews will be conducted with all enrolled study participants in MASP+ and QuitGuide to meet the saturation of key study questions. Interviewing all MASP+ participants should be sufficient for the saturation of key study questions. The QuitGuide interviews will be used as a comparative group following the analysis of the MASP+ content, based on our prior work.", "id": 1720, "split": "test"} +{"trial_id": "NCT05709054", "pmid": "39359613", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma: Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Asthma\n\nStudy Armgroups:\n- {'label': 'Diaphragmatic excursion assessment with Ultrasonography', 'type': 'EXPERIMENTAL', 'description': 'The time motion mode (M-mode) may be used to measure the diaphragm excursion in a curvilinear low-frequency transducer placed in the midclavicular line and angled in a cranial direction.', 'interventionNames': ['Other: Experimental: Diaphragmatic Manual Therapy Group A', 'Other: Sham Breathing Retraining Exercises Group B']}\n- {'label': 'Chest wall expansion', 'type': 'EXPERIMENTAL', 'description': 'The difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome.', 'interventionNames': ['Other: Experimental: Diaphragmatic Manual Therapy Group A', 'Other: Sham Breathing Retraining Exercises Group B']}\n- {'label': 'Nijmegen Questionnaire', 'type': 'EXPERIMENTAL', 'description': 'Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores\\\\>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 \u00b1 7 and values do tend to decrease towards these levels after breathing retraining.', 'interventionNames': ['Other: Experimental: Diaphragmatic Manual Therapy Group A', 'Other: Sham Breathing Retraining Exercises Group B']}\n- {'label': 'Asthma Control Test', 'type': 'EXPERIMENTAL', 'description': 'The ACT evaluates how well asthma affects daily functioning, and overall asthma control self-assessment. The score ranges from 5 (poor control of asthma) to 25 (well control of asthma). An ACT score \\\\>19 indicates well-controlled asthma.', 'interventionNames': ['Other: Experimental: Diaphragmatic Manual Therapy Group A', 'Other: Sham Breathing Retraining Exercises Group B']}\n- {'label': 'Sf-12v2 questionnaire', 'type': 'EXPERIMENTAL', 'description': 'With one or two questions per domain, it evaluates the exact eight health dimensions as the SF-36v2: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher ratings indicate better physical and mental well-functioning, ranging from 0 to 100. It has been suggested that a cut-off of 50 or less be used to identify a physical condition, while a score of 42 or less may signify clinical depression', 'interventionNames': ['Other: Experimental: Diaphragmatic Manual Therapy Group A', 'Other: Sham Breathing Retraining Exercises Group B']}\n- {'label': 'Borg scale', 'type': 'EXPERIMENTAL', 'description': 'The Borg dyspnea scale is a simple, scoring system extensively used to evaluate symptoms of shortness of breath and provides valuable data. It begins with 0, where you have no breathing problems, and rises to 10, where you have the most respiratory distress. As a result, healthcare professionals need to give patients enough time to learn and make sure they comprehend before using it', 'interventionNames': ['Other: Experimental: Diaphragmatic Manual Therapy Group A', 'Other: Sham Breathing Retraining Exercises Group B']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Experimental: Diaphragmatic Manual Therapy Group A', 'description': 'Experimental: Diaphragmatic Manual Therapy plus Breathing Retraining Exercises group:\\n\\nDiaphragm manual therapy will be carried out and consists of a technique intended to stretch and mobilise the diaphragmatic muscle fibers indirectly. The maneuver will be performed in two sets of 10 repetitions, within a 1-minute interval for 10 minutes.\\n\\nBreathing retraining exercises will be implemented for 30 minutes, consisting of:\\n\\ni) recognition of the abnormal breathing pattern ii) diaphragmatic breathing ii) nose breathing iii) slow breathing and controlled breath holding after exhalation iv) adaptation of the new breathing pattern in everyday life activities and various positions (supine, semi-sitting, sitting) v) breathing control in speech.', 'armGroupLabels': ['Asthma Control Test', 'Borg scale', 'Chest wall expansion', 'Diaphragmatic excursion assessment with Ultrasonography', 'Nijmegen Questionnaire', 'Sf-12v2 questionnaire']}\n- {'type': 'OTHER', 'name': 'Sham Breathing Retraining Exercises Group B', 'description': 'Sham Breathing Retraining Exercises Group B:\\n\\nBreathing retraining exercises will be implemented for 30 minutes, consisting of :\\n\\ni) recognition of the abnormal breathing pattern ii) diaphragmatic breathing ii) nose breathing iii) slow breathing and controlled breath holding after exhalation iv) adaptation of the new breathing pattern in everyday life activities and various positions (supine, semi-sitting, sitting) v) breathing control in speech.', 'armGroupLabels': ['Asthma Control Test', 'Borg scale', 'Chest wall expansion', 'Diaphragmatic excursion assessment with Ultrasonography', 'Nijmegen Questionnaire', 'Sf-12v2 questionnaire']}\n\nPrimary Outcomes:\n- {'measure': 'Diaphragmatic excursion assessment with Ultrasonography', 'description': 'The M-mode line is placed at the posterior part of the diaphragm where there is maximal movement and excursion. On the right side, the liver acts as an acoustic window, and the diaphragm is easily identified as a hyperechoic curved line abutting the liver.', 'timeFrame': 'Change from baseline up to 6 weeks and up to 3 months'}\n- {'measure': 'Chest wall expansion', 'description': 'By placing the tape measure at the level of the axilla (about the level of the sternal angle of Louis), the level of the xiphoid process, or between the xiphoid process and the umbilicus, the therapist identifies the upper, middle, and lower chest wall expansion, respectively. The therapist should repeat the measurement at least three times for each level for higher fidelity.', 'timeFrame': 'Change from baseline up to 6 weeks and up to 3 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha (\u00ce\u00b1) level of 0.01, a power (\u00ce\u00b2) of 0.85, and an anticipated attrition rate of approximately 15% for a two-tailed independent t-test.", "answer": 6, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was based on an alpha (\u00ce\u00b1) level of 0.01, a power (\u00ce\u00b2) of 0.85, and a large effect size, Cohen\u00e2\u0080\u0099s d, of 1.86 for a two-tailed independent t-test. This effect size was calculated based on the results reported by Rocha et al. (2015),\n\n18\n specifically from the mean (SD) values of the control and experimental groups following six manual therapy intervention sessions. Furthermore, the calculation accounted for an anticipated attrition rate of approximately 15%, foreseeing the potential for participant dropout or exclusion. This comprehensive approach to sample size calculation ensures the robustness and reliability of the study\u00e2\u0080\u0099s findings, enabling a precise detection of the large effect size with high statistical confidence. This resulted in a total sample size of 24 people (12 per group) considering a withdrawal rate of 15%.\n\n75\n\n\n \nData collection methods\n\n Data regarding the outcomes pre and post-intervention will be meticulously collected from the main researcher. The collected information will undergo a thorough examination to analyze the outcomes. Throughout the study, the professor of chest physiotherapy (supervisor) will closely oversee the main researcher administering the study\u00e2\u0080\u0099s data. To ensure the patient adheres to the study, timely messages will be sent to their mobile phones, providing information and reminders regarding upcoming sessions. A 10% drop-out rate has been considered in the sample size calculation, thus minimizing potential interference with the study results.\n \nData management\n\n Evaluation data will be sourced from a predefined spreadsheet containing baseline characteristics. A secure database will be employed to store all research-related data securely. Paper copies of evaluation forms signed informed consent forms, and other non-electronic documents will be securely stored in the study environment. A comprehensive backup of the data entries will be generated once a month until the conclusion of the trial.\n Upon completion of the study, the Excel spreadsheet will be published and forwarded to the statistician for the necessary analysis. A checklist will help prevent data loss from inefficient staff procedures. Given the extensive follow-up assessment for this experiment, participant retention and completion of follow-up assessments will be notably high. After six weeks from the end of interventions, the participants will be invited to a follow-up examination (12 weeks from the beginning of the trial).", "id": 1721, "split": "test"} +{"trial_id": "NCT05709249", "pmid": "37461034", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer\uff1aa Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Colon Cancer\n\nStudy Armgroups:\n- {'label': 'intervention group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects in the intervention group will be treated with XLJDOD compound granule.', 'interventionNames': ['Drug: XLJDOD compound granule']}\n- {'label': 'control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).', 'interventionNames': ['Drug: placebo (XLJDOD mimetic agent)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'XLJDOD compound granule', 'description': 'Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.', 'armGroupLabels': ['intervention group']}\n- {'type': 'DRUG', 'name': 'placebo (XLJDOD mimetic agent)', 'description': 'The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.', 'armGroupLabels': ['control group']}\n\nPrimary Outcomes:\n- {'measure': 'Two-year disease-free survival (DFS)', 'description': '2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date.', 'timeFrame': 'Assess once 24 months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 5% and power of 80% are used, with a dropout rate of 20%.", "answer": 730, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary Outcome of this study is the rate of 2-year DFS in stage IIIB or IIIC colon cancer. Based on the literature and previous study, it is assumed that the 2-year DFS rate of control group is 0.70 (70%) and of the intervention group is 0.80 (80%). Taking a two-sided significance level of 5% and power of 80% (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.10), the intervention group and the control group are allocated at a ratio of 1:1. Considering a dropout rate of 20%, the sample size is not less than 364 cases in each group. Therefore, a total sample size of 730 cases is set up in this study (n\u00e2\u0080\u0089=\u00e2\u0080\u0089365 in each group).", "id": 1722, "split": "test"} +{"trial_id": "NCT05710679", "pmid": "37400806", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer\n\nIncluded conditions:\n- Locally Advanced Head and Neck Carcinoma\n\nStudy Armgroups:\n- {'label': 'Interventional', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: Blood sample']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Blood sample', 'description': 'The intervention consist in a blood sample that will be taken twice :\\n\\n* at the inclusion (before treatment)\\n* 3 months after the potentiated radiotherapy in case of incomplete response (PET-CT)', 'armGroupLabels': ['Interventional']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of patients with incomplete cervical lymph node response on PET-CT after radiation therapy potentiated having circulating DNA (cDNA)', 'description': 'Presence/absence of circulating DNA after treatment versus presence/absence of residual disease', 'timeFrame': '3 months after potentiated radiotherapy'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) is set at 5%, power is 80%, and the attrition rate is assumed to be 10%.", "answer": 63, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Since the negative predictive value (NPV) of PET-CT to detect residual nodal disease in the context of our study is known to be very good (95\u00e2\u0080\u009397%), we choose to focus on the group of patients with an indication for salvage adenectomy. The detection of ct/cvDNA should enable the identification of patients for whom this adenectomy is indeed necessary. This question means assessing the positive predictive value (PPV) of the ct/cvDNA predictor (detectable versus non-detectable) in relation to the lymph node dissection result (positive versus negative). For sample size determination, we hypothesise that the PPV of ct/cvDNA is at least 85% (the value obtained by Tanaka et al. being 100% from a calculation performed on 6 patients with detectable cvDNA [20]). Given an estimated 50% positive dissection rate among patients with an indication for salvage adenectomy, the inclusion of 28 patients is required to ensure a power of 80% at an alpha risk of 5% to show a PPV is greater than 50% (value taken as reference, equal to the upper limit of the imagery PPV estimate). This sample size will also enable the estimation of the NPV with a 95% confidence interval (CI) (Wilson) with a half-length equal to 16.5% (for an expected NPV of 89.7% obtained by Tanaka et al. [20]). To ensure the inclusion of 28 patients with adenectomy indication, n\u00e2\u0080\u0089=\u00e2\u0080\u008956 patients are required, since the proportion of patients with this indication after imagery following potentiated radiotherapy is estimated to be about 50% in our study population. Finally, assuming a low attrition rate of 10% (the time between inclusion and end of treatment being relatively short), n\u00e2\u0080\u0089=\u00e2\u0080\u008963 patients are required. Taking into account the additional risk that only 85% of the patients will have detectable ct/cvDNA [21], we estimate that it will be necessary to screen around 75 patients.\n Recruitment will be complete once 32 patients with an indication for neck dissection are included and evaluable (this sample size takes into account the 10% attrition rate).", "id": 1723, "split": "test"} +{"trial_id": "NCT05714007", "pmid": "38267243", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study\n\nIncluded conditions:\n- Perioperative Anemia\n- Surgery\n- Spinal Deformity\n- Adult\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': 'Iron to be administered as intravenous ferric derisomaltose:\\n\\nWhere Hb (hemoglobin) \u2265100 g/L, dosage according to body weight is as follows:\\n\\nBody weight \\\\<50 kg: 500mg; Body weight 50 to \\\\<70 kg: 1000 mg; Body weight \u226570 kg: 1500 mg.\\n\\nWhere Hb \\\\<100 g/L, dosage according to body weight is as follows:\\n\\nBody weight \\\\<50 kg: 500mg; Body weight 50 to \\\\<70 kg: 1500mg; Body weight \u226570 kg: 2000 mg.\\n\\nThe maximial dose should not exceed 20mg/kg body weight, rounded off to the nearest 100mg', 'interventionNames': ['Drug: Ferric derisomaltose']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Iron to be administered as oral ferrous succinate:\\n\\n1 tablet (100 mg) tid (three times daily), starting on the first postoperative day and continuing for 4 weeks.', 'interventionNames': ['Drug: Ferrous succinate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ferric derisomaltose', 'description': 'Single intravenous dose ferric derisomaltose', 'armGroupLabels': ['Treatment group'], 'otherNames': ['MONOFER\u00ae']}\n- {'type': 'DRUG', 'name': 'Ferrous succinate', 'description': 'Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in hemoglobin concentration', 'description': 'Change in hemoglobin concentrations from POD(postoperative day)1 to POD14', 'timeFrame': 'At 14 days'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided significance test, SD of Hb on POD1 is 8.7 g/L, power of 80%, two-sided type I error of 0.05, drop-out rate of 20%", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size consideration\n The main objective of this study is to conduct a clinical trial on the superior efficacy of ferric derisomaltose over oral ferrous succinate in the treatment of postoperative anaemia in patients receiving spinal deformity surgery. The sample size was calculated based on a two-sided significance test and the preliminary results from the literature review and pilot studies.20 The SD of the Hb on POD1 is 8.7\u00e2\u0080\u0089g/L. On account of superiority trial design, we consider 5\u00e2\u0080\u0089g/L higher in the increase of Hb from POD1 to POD14 between the treatment group and the control group to represent a clinically significant improvement. With a power of 80%, a two-sided type I error of 0.05 and a drop-out rate of 20%, a total of 120 patients are aimed to be enrolled.", "id": 1724, "split": "test"} +{"trial_id": "NCT05715138", "pmid": "37832982", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia\uff08the PASTS-CD Study\uff09\n\nIncluded conditions:\n- Cervical Dystonia\n\nStudy Armgroups:\n- {'label': 'GPi-DBS', 'type': 'EXPERIMENTAL', 'description': 'The DBS electrodes are implanted into posteroventral GPi bilaterally.', 'interventionNames': ['Procedure: GPi-DBS', 'Device: GPi-DBS devices']}\n- {'label': 'STN-DBS', 'type': 'EXPERIMENTAL', 'description': 'The DBS electrodes are implanted into dorsolateral STN bilaterally.', 'interventionNames': ['Procedure: STN-DBS', 'Device: STN-DBS devices']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'GPi-DBS', 'description': 'An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into the posteroventral part of bilateral GPi nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.', 'armGroupLabels': ['GPi-DBS']}\n- {'type': 'PROCEDURE', 'name': 'STN-DBS', 'description': 'An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 0.5mm) will be inserted into the dorsolateral part of bilateral STN nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.', 'armGroupLabels': ['STN-DBS']}\n- {'type': 'DEVICE', 'name': 'GPi-DBS devices', 'description': '1. DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China);\\n2. Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China);\\n3. Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).', 'armGroupLabels': ['GPi-DBS']}\n- {'type': 'DEVICE', 'name': 'STN-DBS devices', 'description': '1. DBS electrode: 3389 (Medtronic, Minneapolis, MN, USA) or L301 (PINS Medical, Beijing, China) or 1200 (SceneRay, Suzhou, China);\\n2. Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China);\\n3. Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).', 'armGroupLabels': ['STN-DBS']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 3 months', 'description': 'TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.', 'timeFrame': 'Three months postoperatively.'}\n- {'measure': 'Change from baseline Tsui scale at 3 months', 'description': 'Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A\\\\*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.', 'timeFrame': 'Three months postoperatively.'}\n- {'measure': 'Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 6 months', 'description': 'TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.', 'timeFrame': 'Six months postoperatively.'}\n- {'measure': 'Change from baseline Tsui scale at 6 months', 'description': 'Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A\\\\*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.', 'timeFrame': 'Six months postoperatively.'}\n- {'measure': 'Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 1 year', 'description': 'TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.', 'timeFrame': 'One year postoperatively.'}\n- {'measure': 'Change from baseline Tsui scale at 1 year', 'description': 'Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A\\\\*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.', 'timeFrame': 'One year postoperatively.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5% (two-tailed), 80% power, 5% withdrawal rate, and 10% loss to follow-up rate.", "answer": 98, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is calculated based on one of the primary outcomes\u00e2\u0080\u0094the improvement rate of TWSTRS-severity subscore. According to the results of the latest meta-analysis comparing GPi-DBS with STN-DBS for CD treatment, the improvement rates (%) of TWSTRS-severity subscore at the same follow-up time (3 years) were 53.7\u00c2\u00b120.4 (GPi-DBS) and 39.3\u00c2\u00b126.4 (STN-DBS), respectively.35 Based on the model of two independent sample t-test, 41 patients for each group are required to reach a significant level of 5% (two-tailed) with 80% power. Assuming that 5% of CD patients would be withdrawn from the trial and another 10% of CD patients would be lost to follow-up, a total of 98\u00e2\u0080\u0089CD patients are required (49 patients for each group).", "id": 1725, "split": "test"} +{"trial_id": "NCT05715151", "pmid": "37038126", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Externally Facilitated Continuous Quality Improvement Cohorts on Advanced Access to Support Primary Healthcare Teams\n\nIncluded conditions:\n- Primary Health Care\n\nStudy Armgroups:\n- {'label': 'CQI intervention', 'type': 'EXPERIMENTAL', 'description': 'The proposed CQI cohort consists of three activities carried out iteratively until the improvement objectives are achieved.', 'interventionNames': ['Other: CQI intervention']}\n- {'label': 'Audit and feedback', 'type': 'ACTIVE_COMPARATOR', 'description': 'Clinics in the control group will receive feedback on six key AA indicators, patients reported experience about access and selected AA processes.', 'interventionNames': ['Other: Audit and Feedback']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CQI intervention', 'description': 'Activity 1: Reflective sessions and problem prioritisation. Activity 2: PDSA cycles. Activity 3: Group mentoring.', 'armGroupLabels': ['CQI intervention']}\n- {'type': 'OTHER', 'name': 'Audit and Feedback', 'description': 'Audit and Feedback on six key AA indicators, patients reported experience about access and selected AA processes.', 'armGroupLabels': ['Audit and feedback']}\n\nPrimary Outcomes:\n- {'measure': '3rd next available appointment (weekly)', 'description': 'Delay before the 3rd next available appointment. The 3rd next available appointment is used (rather than the 1st or 2nd) to decrease variation.', 'timeFrame': '18 month'}\n- {'measure': 'Percent of relational continuity (monthly)', 'description': \"Total number of medical consultations with a patient's attached family physician (or specialised nurse) out of the total number of consultations with any family physician (or specialised nurse) from the clinic. Evaluates relational continuity between the provider and their registered patients.\", 'timeFrame': '18 month'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an intracluster correlation (ICC) of 0.364, 80% power, and no inflation for loss to follow-up as data is obtained from the EMR system. An interim analysis is planned 12 months post-recruitment using the Demets and Lan's alpha spending function approach.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n The Quebec CQI pilot project showed that the average time to the 3rd next available appointment (primary outcome) is 11\u00c2\u00a0days (sd\u00e2\u0080\u0089=\u00e2\u0080\u008910). Forty-eight clinics (clusters) averaging 15 professionals per clinic for a total of 720 professionals over six measurement time points will be measured every week or month (depending on the measure). An assumed intracluster correlation (ICC) of 0.364 (from the pilot project) provides about 80% power to detect a small effect size of 0.25 (Cohen\u00e2\u0080\u0099s d, assuming that variation will increase over the course of the intervention). This translates into a 50% reduction in time to the 3rd next available appointment from the baseline assessment [83]. Variations in clinic size have been considered (coefficient of variation of 0.49 according to the pilot project) [84]. No inflation for loss to follow-up is planned because the data is readily obtained from the EMR system for all professionals. Provision for one interim analysis 12-months post recruitment is planned using the Demets and Lan\u00e2\u0080\u0099s alpha spending function approach [85]. Thus, we aim to recruit 48 PHC clinics (24 interventions and 24 controls) for the trial proposed in this study.", "id": 1726, "split": "test"} +{"trial_id": "NCT05717166", "pmid": "39244532", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.\n\nIncluded conditions:\n- Metastatic Tumor\n\nStudy Armgroups:\n- {'label': 'Standard Arm (Arm 1)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.', 'interventionNames': ['Radiation: Palliative Radiotherapy', 'Drug: Chemotherapy', 'Drug: Hormone therapy', 'Drug: Immunotherapy', 'Drug: Targeted Systemic Therapy', 'Other: Observation']}\n- {'label': 'Experimental Arm (Arm 2)', 'type': 'EXPERIMENTAL', 'description': 'Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.', 'interventionNames': ['Radiation: Palliative Radiotherapy', 'Drug: Chemotherapy', 'Drug: Hormone therapy', 'Drug: Immunotherapy', 'Drug: Targeted Systemic Therapy', 'Other: Observation', 'Radiation: Stereotactic Ablative Radiotherapy', 'Procedure: Surgery', 'Other: Radiofrequency Therapy (RFA)', 'Radiation: Fractionated Radiation']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Palliative Radiotherapy', 'description': 'Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.', 'armGroupLabels': ['Experimental Arm (Arm 2)', 'Standard Arm (Arm 1)']}\n- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': 'Pre-specified based on the standard of care approach for that patient.', 'armGroupLabels': ['Experimental Arm (Arm 2)', 'Standard Arm (Arm 1)'], 'otherNames': ['Cytotoxic Systemic Therapy']}\n- {'type': 'DRUG', 'name': 'Hormone therapy', 'description': 'Pre-specified based on the standard of care approach for that patient.', 'armGroupLabels': ['Experimental Arm (Arm 2)', 'Standard Arm (Arm 1)'], 'otherNames': ['Hormonal Systemic Therapy']}\n- {'type': 'DRUG', 'name': 'Immunotherapy', 'description': 'Pre-specified based on the standard of care approach for that patient.', 'armGroupLabels': ['Experimental Arm (Arm 2)', 'Standard Arm (Arm 1)']}\n- {'type': 'DRUG', 'name': 'Targeted Systemic Therapy', 'description': 'Pre-specified based on the standard of care approach for that patient.', 'armGroupLabels': ['Experimental Arm (Arm 2)', 'Standard Arm (Arm 1)']}\n- {'type': 'OTHER', 'name': 'Observation', 'description': 'Pre-specified based on the standard of care approach for that patient.', 'armGroupLabels': ['Experimental Arm (Arm 2)', 'Standard Arm (Arm 1)']}\n- {'type': 'RADIATION', 'name': 'Stereotactic Ablative Radiotherapy', 'description': 'The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board.\\n\\nPreferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).', 'armGroupLabels': ['Experimental Arm (Arm 2)']}\n- {'type': 'PROCEDURE', 'name': 'Surgery', 'description': 'Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.\\n\\nThe primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.', 'armGroupLabels': ['Experimental Arm (Arm 2)']}\n- {'type': 'OTHER', 'name': 'Radiofrequency Therapy (RFA)', 'description': 'Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.', 'armGroupLabels': ['Experimental Arm (Arm 2)']}\n- {'type': 'RADIATION', 'name': 'Fractionated Radiation', 'description': 'Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.\\n\\nTumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.', 'armGroupLabels': ['Experimental Arm (Arm 2)']}\n\nPrimary Outcomes:\n- {'measure': 'Overall Survival', 'description': 'Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.', 'timeFrame': 'Approximately end of year 6 (Study Completion)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, 80% power, 2-sided testing, and a 5% dropout rate.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation\n We hypothesize that the median OS will be 12\u00c2\u00a0months in Arm 1 and 20\u00c2\u00a0months in Arm 2. In order to detect this difference, with an alpha of 0.05, 80% power, 2-sided testing and a 5% dropout rate, 180 patients will be required. The study projects accrual over 60\u00c2\u00a0months with 12\u00c2\u00a0months of additional follow-up.", "id": 1727, "split": "test"} +{"trial_id": "NCT05717192", "pmid": "38806430", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation\n\nIncluded conditions:\n- Emphysema or Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'InterVapor\u00ae-System', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention to be tested is bronchoscopic lung volume reduction (BTVA) using thermal ablation (InterVapor\u00ae, Uptake Medical, California, USA). This is performed in addition to standard conservative therapy in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. The intervention can consist of a maximum of two partial interventions', 'interventionNames': ['Device: InterVapor\u00ae-System']}\n- {'label': 'Standard of care', 'type': 'NO_INTERVENTION', 'description': 'Standard conservative therapy in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines without the use of a BTVA (patient-specific documentation of therapeutic measures).'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'InterVapor\u00ae-System', 'description': 'The InterVapor System uses heated water vapor to ablate the airways and parenchyma within targeted regions of the lung. Lung remodeling occurs after an initial localized inflammatory response and a subsequent healing and repair. The remodeling of the tissue results in reductions in tissue and air volume in the targeted regions of the lung. The remodeled lung tissue does not re-inflate as a result of collateral ventilation.\\n\\nThe lung volume reduction of diseased hyper-inflated lung segments after InterVapor treatment is expected to increase elastic recoil by reducing the most compliant segments of the lung, decompressing segments of healthier lung allowing for alveolar recruitment, and improving the mechanical efficiency of the respiratory muscles. These mechanical changes are anticipated to improve pulmonary function, exercise capacity and quality of life.', 'armGroupLabels': ['InterVapor\u00ae-System']}\n\nPrimary Outcomes:\n- {'measure': 'Change in patient-reported disease-specific quality of life', 'description': \"Change in patient-reported, disease-specific quality of life based on St. George's Respiratory Questionnaire (SGRQ-C) between randomisation and 9-month visit.\\n\\nThe instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.\", 'timeFrame': '9 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided t-test, significance level 2.5%, power 80%, 15% loss to follow-up (LTF).", "answer": 224, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Data from the STEP-UP study show that the primary endpoint \u00e2\u0080\u0098change in disease-specific quality of life (SGRQ-C)\u00e2\u0080\u0099 had a group difference of \u00e2\u0088\u00926.1 points (95%\u00e2\u0080\u0089CI 1.3 to 13.7; p=0.1089) after 6 months. After 12 months, the difference was \u00e2\u0088\u00928.4 points (95%\u00e2\u0080\u0089CI 0.7 to 17.5; p=0.0721).7\n\n Assumptions and specifications:\n \n \n An expected group difference in SGRQ-C of at least six points with an SD of 14 is assumed.\n \n \n One-sided t-test.\n \n \n Significance level 2.5%.\n \n \n Power 80%.\n \n \n 15% loss to follow-up (LTF).\n \n \n If randomised in a 2:1 ratio:\n \n \n n=195 (130:65) subjects to be analysed.\n \n \n Considering an LTF rate of 15%, N=224 (150:74) subjects to be included in the clinical trial.", "id": 1728, "split": "test"} +{"trial_id": "NCT05717803", "pmid": "38960464", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial\n\nIncluded conditions:\n- Segmentectomy\n- Lung Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Segmentectomy', 'type': 'EXPERIMENTAL', 'description': 'Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm.', 'interventionNames': ['Procedure: Segmentectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Segmentectomy', 'description': 'The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.', 'armGroupLabels': ['Segmentectomy'], 'otherNames': ['Segment resection', 'Segment removal']}\n\nPrimary Outcomes:\n- {'measure': '5-year disease-free survival', 'description': 'The event is defined as the tumor recurrence or the death due to any causes.', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \n90.193% power, non-inferiority proportion of 90%, one-sided exact test, significance level of 0.0250, 5% dropout rate.", "answer": 307, "answer_type": "ESTIMATED", "explanation": "Calculation of sample size\n According to the results of previous studies, for patients undergoing lobectomy with tumour sizes of 2\u00e2\u0080\u00933 cm, CTR\u00e2\u0089\u00a40.5 and the 5 year DFS was 97.0% after surgery.13 In this trial, we assumed that the expected 5 year DFS for these patients undergoing segmentectomy is 95%. A sample size of 292 achieves 90.193% power to detect a non-inferiority proportion of 90% (5% as the non-inferior boundary) using a one-sided exact test with a target significance level of 0.0250. Considering a possible dropout rate of 5%, a total of 307 cases need to be included in this trial.", "id": 1729, "split": "test"} +{"trial_id": "NCT05718609", "pmid": "37479526", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Quadruple Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests as First-line Treatment for Helicobacter Pylori Infection\n\nIncluded conditions:\n- Helicobacter Pylori Infection\n\nStudy Armgroups:\n- {'label': 'Amoxicillin- and Clarithromycin-based BQT', 'type': 'ACTIVE_COMPARATOR', 'description': 'rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Colloidal Bismuth Pectin Granules', 'Drug: Amoxicillin', 'Drug: Clarithromycin']}\n- {'label': 'Clarithromycin medication history-based BQT', 'type': 'EXPERIMENTAL', 'description': 'The clarithromycin medication history will be asked before the treatment and the therapy will be performed as follows: with clarithromycin medication history: rabeprazole 10mg bid, amoxicillin 1g bid, furazolidone 100mg bid, colloidal bismuth 200mg bid for 14 days; without clarithromycin medication history: rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days.', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Colloidal Bismuth Pectin Granules', 'Drug: Amoxicillin', 'Drug: Furazolidone', 'Drug: Clarithromycin']}\n- {'label': 'Antimicrobial susceptibility tests-based BQT', 'type': 'EXPERIMENTAL', 'description': 'Fecal molecular biology antimicrobial susceptibility tests will be performed before the treatment. The susceptibility of clarithromycin will be evaluated. The treatment regimen will be chosen according to the results of the antimicrobial susceptibility tests as follows: clarithromycin-sensitive: rabeprazole 10mg bid, amoxicillin 1g bid, clarithromycin 500mg bid, colloidal bismuth 200mg bid for 14 days; clarithromycin-resistant: rabeprazole 10mg bid, amoxicillin 1g bid, furazolidone 100mg bid, colloidal bismuth 200mg bid for 14 days.', 'interventionNames': ['Drug: Rabeprazole', 'Drug: Colloidal Bismuth Pectin Granules', 'Drug: Amoxicillin', 'Drug: Furazolidone', 'Drug: Clarithromycin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rabeprazole', 'description': 'proton-pump inhibitor (PPI)', 'armGroupLabels': ['Amoxicillin- and Clarithromycin-based BQT', 'Antimicrobial susceptibility tests-based BQT', 'Clarithromycin medication history-based BQT']}\n- {'type': 'DRUG', 'name': 'Colloidal Bismuth Pectin Granules', 'description': 'Gastric mucosal protective drug with anti-H. pylori effect', 'armGroupLabels': ['Amoxicillin- and Clarithromycin-based BQT', 'Antimicrobial susceptibility tests-based BQT', 'Clarithromycin medication history-based BQT']}\n- {'type': 'DRUG', 'name': 'Amoxicillin', 'description': 'Antibiotic for H. pylori eradication', 'armGroupLabels': ['Amoxicillin- and Clarithromycin-based BQT', 'Antimicrobial susceptibility tests-based BQT', 'Clarithromycin medication history-based BQT']}\n- {'type': 'DRUG', 'name': 'Furazolidone', 'description': 'Antibiotic for H. pylori eradication', 'armGroupLabels': ['Antimicrobial susceptibility tests-based BQT', 'Clarithromycin medication history-based BQT']}\n- {'type': 'DRUG', 'name': 'Clarithromycin', 'description': 'Antibiotic for H. pylori eradication', 'armGroupLabels': ['Amoxicillin- and Clarithromycin-based BQT', 'Antimicrobial susceptibility tests-based BQT', 'Clarithromycin medication history-based BQT']}\n\nPrimary Outcomes:\n- {'measure': 'Helicobacter pylori Eradication Rate', 'description': 'Helicobacter pylori Eradication will be determined by 13C-urea breath test or 14C-urea breath test six to eight weeks after completion of the medication.', 'timeFrame': 'Six to eight weeks after completion of the medication'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided \u03b1 value of 0.05, power of 90%, and a 20% loss to follow-up rate.", "answer": 855, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on previous studies, we assume the eradication rate of each group as 85%, 90% and 95%, respectively.7 11 22 28\u00e2\u0080\u009330 We calculated that at least 855 participants (285 patients per treatment group) were required for recruitment for a two-sided \u00ce\u00b1 value of 0.05 and power of 90%, with a rate of loss to follow-up of 20%. The sample size was calculated using PASS software, V.11.0.10 (NCSS, LLC).", "id": 1730, "split": "test"} +{"trial_id": "NCT05719467", "pmid": "40032397", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor\n\nIncluded conditions:\n- Labor Complication\n- Induced; Birth\n- Pregnancy Related\n\nStudy Armgroups:\n- {'label': 'Buscopan and bicarbonate', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Buscopan 20 MG/ML Injectable Solution', 'Drug: Sodium bicarbonate']}\n- {'label': 'Buscopan and placebo', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Buscopan 20 MG/ML Injectable Solution', 'Drug: Placebo']}\n- {'label': 'Placebo and bicarbonate', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Sodium bicarbonate', 'Drug: Nacl 0.9%']}\n- {'label': 'Placebo and placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo', 'Drug: Nacl 0.9%']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Buscopan 20 MG/ML Injectable Solution', 'description': '1 mL intravenously', 'armGroupLabels': ['Buscopan and bicarbonate', 'Buscopan and placebo']}\n- {'type': 'DRUG', 'name': 'Sodium bicarbonate', 'description': '4 g orally', 'armGroupLabels': ['Buscopan and bicarbonate', 'Placebo and bicarbonate']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': '4g orally', 'armGroupLabels': ['Buscopan and placebo', 'Placebo and placebo'], 'otherNames': ['Oral Tab']}\n- {'type': 'DRUG', 'name': 'Nacl 0.9%', 'description': '1 mL intravenously', 'armGroupLabels': ['Placebo and bicarbonate', 'Placebo and placebo'], 'otherNames': ['Intravenous placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Spontaneous vs operative birth', 'description': 'Number of participants with operative birth as compared to spontaneous birth', 'timeFrame': 'Through study completion, an average of one week'}\n\nPlease estimate the sample size based on the assumption: \nA Bonferroni correction was applied by dividing the overall significance level of 0.05 by 3. The statistical power was set at 0.80. Approximately 56% of all deliveries at term by induced nulliparous women with a singleton pregnancy and cephalic presentation result in spontaneous delivery.", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and recruitment\n This trial is primarily designed to establish superiority of active treatment over double-placebo in increasing the rate of spontaneous delivery. As the primary outcome is dichotomous (spontaneous delivery vs operative delivery), the sample size calculation was based on a two-sample test of proportions. To correct for the multiple pairwise comparisons between the three active treatment groups and the double-placebo group, a Bonferroni correction was applied by dividing the overall significance level of 0.05 by 3. The statistical power was set at 0.80. Approximately 56% of all deliveries at term by induced nulliparous women with a singleton pregnancy and cephalic presentation result in spontaneous delivery.15 A relative risk of 1.15 between an active treatment group and the double-placebo group, corresponding to a 15% increase in spontaneous delivery in the active treatment group, is considered clinically significant. Detection of such a treatment difference requires 710\u00e2\u0080\u0089women in each group. Hence, a total of 2840 (710\u00c3\u00974) women are required when using an allocation ratio of 1:1:1:1 (ie, equal sample sizes of the treatment groups). Based on previous annual induction numbers, approximately 5100\u00e2\u0080\u0089women will be screened to achieve 3000 participants randomly assigned to one of the study arms, taking potential drop-out and non-compliance into account.", "id": 1731, "split": "test"} +{"trial_id": "NCT05719922", "pmid": "37461024", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low-load Blood Flow Restriction Exercise Versus Conventional Heavier Load Resistance Training Exercise in UK Military Personnel With Persistent Knee Pain: A Multi-centre Randomized Controlled Trial\n\nIncluded conditions:\n- Musculoskeletal Injury\n- Muscle Weakness\n\nStudy Armgroups:\n- {'label': 'Low-load blood flow restriction training (LL-BFR)', 'type': 'EXPERIMENTAL', 'description': 'Twice daily LL-BFR for 3 weeks', 'interventionNames': ['Other: Resistance Training']}\n- {'label': 'Heavier load resistance training (HL-RT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Three sessions per week for 3 weeks', 'interventionNames': ['Other: Resistance Training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Resistance Training', 'description': 'Comparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain.', 'armGroupLabels': ['Heavier load resistance training (HL-RT)', 'Low-load blood flow restriction training (LL-BFR)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Lower Extremity Functional Scale (LEFS) over time', 'description': 'LEFS is a 20-question patient-reported outcome measure (PROM) that measures functional status in patients with lower limb musculoskeletal injury. Questions on activity vary in physical demand from walking to running on uneven ground. The LEFS is a validated tool and has demonstrated good test-retest reliability and responsiveness in individuals with persistent knee pain.', 'timeFrame': 'Baseline, week 3 and week 15'}\n\nPlease estimate the sample size based on the assumption: \nFor the main RCT, the significance level is \u03b1 = 0.05, power is 0.80, and an approximate 20% dropout rate is considered. For the nested study, a 20% dropout rate is also considered.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Main randomised control trial\n A sample size of 150 participants (75 in each arm) will be recruited into the study. The study is powered to detect a minimum clinically important difference (MCID) in the Lower Extremity Functional Scale (LEFS) using a between group MCID of 9 points and an estimated standard deviation of 15.8 [61]. From this an effect size, f, of 0.285 was calculated. The expected sample size for 0.80 power to detect an effect size (f) of 0.285 at a level of significance \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 is 122 participants (61 In each group). By estimating an approximate 20% dropout rate we concluded a sample size of 150, with 75 in each intervention arm. The G Power 3.1.9.7 software was used to calculate the sample size. This sample size is also sufficient to detect a MCID of 8 points in the KOOS ADL subscale with a statistical significance of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power of\u00e2\u0080\u0089>\u00e2\u0080\u00890.80 where the MCID is 8 points and expected standard deviation is 8.9 [122, 123].\n \n \n Nested mechanistic study\n The nested study will recruit a sub-sample of participants from the main RCT. No group x time interaction is hypothesised to occur for the primary dependent variable of quadriceps femoris muscle volume. Therefore, a within factors priori power analysis was performed to calculate the sample size required to detect a within group change in quadriceps femoris muscle volume between T1 and T2. Based on data from the ADAPT pilot study [26], which reported an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.35, the minimum sample size required is n\u00e2\u0080\u0089=\u00e2\u0080\u008952. By estimating an approximate 20% dropout rate we concluded a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008964 (n\u00e2\u0080\u0089=\u00e2\u0080\u008932 in each intervention arm) is required.", "id": 1732, "split": "test"} +{"trial_id": "NCT05721326", "pmid": "37932730", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine\n\nIncluded conditions:\n- Genetic Predisposition to Disease\n- Breast Cancer Female\n- Ovarian Cancer\n- Hereditary Breast and Ovarian Cancer\n- Hereditary Cancer Syndrome\n- Hereditary Diseases\n- Gene Mutation-Related Cancer\n\nStudy Armgroups:\n- {'label': 'Sequential Communications', 'type': 'EXPERIMENTAL', 'description': \"This sequential arm contains three types of communication to be employed following non-response to the previous type. The initial communication will be a direct message to the patient via the MyPennMedicine. The subsequent message will be sent as a text via the Way To Health app(lication). The final communication will be a nudge to the patient's physician which will send upon opening the patient's chart and will remain as a flag thereafter.\", 'interventionNames': ['Other: Sequential EHR Communications']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Sequential EHR Communications', 'description': 'The intervention includes 3 message types: an EHR message, followed by a text message, followed by physician nudge. Each subsequent type will be activated if the previous type does not yield a response.', 'armGroupLabels': ['Sequential Communications']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Genetic Counseling Appointments Completed Following MPM Delivery', 'description': 'Scheduling and completion of genetic counseling appointments will be monitored through EHR. MPM stands for MyPennMedicine message which will be sent directly to the patient through the medical record.', 'timeFrame': 'Within six months of MPM delivery'}\n- {'measure': 'Number of Genetic Counseling Appointments Completed Following Provider Nudge', 'description': \"Scheduling and completion of genetic counseling appointments will be monitored through EHR. The provider nudge will be delivered as a Best Practice Alert (BPA) upon opening the patient's chart.\", 'timeFrame': 'Within six months of provider nudge'}\n\nPlease estimate the sample size based on the assumption: \nCorrelations of 0 to 0.2, 80% power, two-sided type 1 error rate of 5%, hierarchical testing with alpha = 5%", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Sample size, power, and statistical analysis\n Based on preliminary assessments via electronic phenotyping in the EHR, we have identified a target sample of around 3000 patients (clustered within approximately 30 physicians at the two Penn Medicine sites) who may benefit from genetic testing for familial high-risk breast and ovarian cancer predisposition but have not done so. We calculated power conservatively by assuming correlations of 0 to 0.2, using PASS (Power and Sample Size, NCSS Software, Kaysville, UT). We found our sample gives us 80% power to detect at least a 5% improvement in our cumulative incidence of testing using a two-sided type 1 error rate of 5%, for planned comparisons between each stage in the sequence.\n We will analyze the change in the incidence of scheduling counseling appointments across the three sequences (all time to event outcomes) using Cox regression, with variances adjusted for physician clustering. The models will contain time-varying binary predictor terms for each nudge, making adjustments for time in months, and fixed effects for site. We will control for type 1 error inflation by hierarchical testing, starting with the overall model significance, followed by the effect of each strategy. Once we have fitted the main effects model, we will test for each sequence and retain terms if significant (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%). Variability in outcomes by sequence and moderators (particularly health equity variables) will be assessed using interaction terms within Cox regression models. We will fit an adjusted Cox regression model using the same approach described in the primary analysis. Covariates of interest available through the EHR will be added to the model, including patient-level (e.g., race), clinician-level (e.g., physician type), and practice-level (e.g., community vs. hospital-based) data.", "id": 1733, "split": "test"} +{"trial_id": "NCT05723263", "pmid": "37337181", "question": "Here is the design of a clinical trial:\n\nOfficial Title: IGHID 12118 - Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China: The PIONEER Pragmatic Randomized Controlled Trial\n\nIncluded conditions:\n- Gonorrhea\n\nStudy Armgroups:\n- {'label': 'Standard Pay-it-forward', 'type': 'EXPERIMENTAL', 'description': '* free gonorrhea/chlamydia testing\\n* minimal engagement', 'interventionNames': ['Behavioral: Standard Pay-it-forward']}\n- {'label': 'Community engaged Pay-it-forward', 'type': 'EXPERIMENTAL', 'description': '* Free gonorrhea/chlamydia testing\\n* Stronger engagement', 'interventionNames': ['Behavioral: Community Engaged Pay-it-forward']}\n- {'label': 'Control arm', 'type': 'OTHER', 'description': '* Test available for a fee\\n* No engagement', 'interventionNames': ['Other: Control arm']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Standard Pay-it-forward', 'description': '400 men who have sex with men (MSM) at 4 clinics will be enrolled. The standard pay-it-forward arm will include free point-of-care gonorrhea testing, as well as a passive community engagement component (such as viewing postcards and materials written by others encouraging gonorrhea/chlamydia testing).', 'armGroupLabels': ['Standard Pay-it-forward']}\n- {'type': 'BEHAVIORAL', 'name': 'Community Engaged Pay-it-forward', 'description': '400 MSM at 4 clinics will be enrolled. The community engaged pay-it-forward arm will include free point-of-care gonorrhea testing, as well as an active community engagement component (such as multi-stakeholder co-creation activities to develop essential components of the intervention and implementation strategies; writing postcards; designing fans with stickers; sending out testing promotion messages on social media; and opportunity to donate to support others)', 'armGroupLabels': ['Community engaged Pay-it-forward']}\n- {'type': 'OTHER', 'name': 'Control arm', 'description': '400 MSM at 4 clinics will be enrolled. The control arm will include a fee-based point-of-care gonorrhea testing (approximately 20 USD per test) and no community engagement component', 'armGroupLabels': ['Control arm']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants testing for gonorrhea', 'description': 'gonorrhea test uptake will be ascertained by administrative review of records from participating clinics', 'timeFrame': 'During enrollment visit'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 0.05 type-I error", "answer": 1200, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n We used a binary outcome (uptake of gonorrhea/chlamydia test) cluster RCT design for sample size calculation where the unit of randomization is the clinic. In order to achieve a 90% power and allow for a 0.05 type-I error, 12 overall clusters (4 in each arm) are needed. Thus, the sample size includes 12 clusters and 1200 participants (100 per cluster), estimated based on the sample size calculation principles for cluster randomized trials. We expect this study will have a 90% power to detect a 10% difference in azithromycin resistance between intervention arms and routine gonorrhea and chlamydia antibiotic surveillance data from other cities in the same province. Nevertheless, further calculations will be made following formative research endeavors that will estimate the prevalence of these outcomes. The calculation would be performed using the software PASS (version 15) with the formulas developed by Hussey and colleagues [48].", "id": 1734, "split": "test"} +{"trial_id": "NCT05723484", "pmid": "38692732", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-centre Diagnostic Study to Evaluate the Feasibility and Performance of the Genital InFlammation Test (GIFT)\n\nIncluded conditions:\n- STI\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'GIFT Device', 'description': 'The GIFT device - immune-based lateral flow test for reproductive-aged, non-pregnant in resource-limited settings attending sexual reproductive health (family planning) clinics, community health centers, hospitals, and mobile clinics. The test involves the qualitative detection of genital inflammation caused by asymptomatic STIs and BV in self- or clinician-collected lateral vaginal wall swabs, with results available in less than 20 minutes.'}\n\nPrimary Outcomes:\n- {'measure': 'Estimates of sensitivity and specificity for the GIFT device', 'description': 'Detecting the presence of any STI or BV with 95% confidence intervals, using NAATs and Nugent scoring in a composite reference standard.', 'timeFrame': 'Start- quarter 1/2023; End- quarter 4/2023'}\n- {'measure': 'How the GIFT device could be integrated into routine care', 'description': 'Integration into healthcare guidelines', 'timeFrame': 'Start- quarter 1/2023; End- quarter 4/2023'}\n\nPlease estimate the sample size based on the assumption: \nFor the DCE component, econometric criteria such as choice probability, confidence level, accuracy level, attrition rate, and number of choice tasks are considered. Subgroups of more than 30 individuals are required for meaningful statistical analysis.", "answer": 675, "answer_type": "ESTIMATED", "explanation": "Sample size\n A total number of 675\u00e2\u0080\u0089women (225\u00e2\u0080\u0089women per site) will be enrolled for the diagnostic evaluation of the prototype GIFT device. The sample size calculation is based on 7% precision, and an assumed sensitivity of 77% and a specificity of 71% of GIFT compared with NAATs for STIs and Nugent scoring for BV.40\n\n No sample size calculations were performed for the qualitative research. A purposive sampling strategy will be adopted to reflect maximum variation, as feasible, across the sample. It is anticipated that the proposed number of participants per activity (FGDs and IDIs), per country, will enable adequate data to be collected and saturation to be reached in the thematic analysis.41 42 Data collection may be finalised before the planned sample size is reached, if saturation is reached first.\n For the DCE component of the study, using econometric criteria (including choice probability, confidence level, accuracy level, attrition rate and number of choice tasks), subgroups of more than 30 individuals are required to conduct meaningful statistical analysis.43 44 Because the DCE study will undertake subgroup analysis on four to five groups (including respondent age group, socioeconomic status, location of residence and experience with the GIFT device), up to 200 participants per site will be recruited for the DCE study, with a quarter of the participants recruited on the diagnostic study of the GIFT device, and reminder from women coming for gynaecological consultations at the study clinic.\n No sample size calculation is needed for the decision tree algorithm study, which will use data from the diagnostic study. Equally, there are no sample size requirements for the economic evaluation.", "id": 1735, "split": "test"} +{"trial_id": "NCT05725928", "pmid": "37488588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Trial of Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients\n\nIncluded conditions:\n- Mobility Limitation\n- Frailty\n- Hospital Acquired Condition\n- Weakness, Muscle\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n- {'label': 'Mobility Technician', 'type': 'EXPERIMENTAL', 'description': \"Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session\", 'interventionNames': ['Behavioral: Mobility technician']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mobility technician', 'description': \"Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session.\", 'armGroupLabels': ['Mobility Technician']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Short Physical Performance Battery (SPPB) from admission', 'description': 'Every patient will have an SPPB score on admission to the study. A blinded assessor will measure the SPPB again at discharge or on day 10 if the patient is still hospitalized. The primary outcome is change from admission to discharge. Investigators will also compare the percentage of patients who reach the minimal clinically important difference of 1 point.\\n\\nSPPB minimum value= 0 SPPB maximum value= 12 (higher score indicates a better outcome). If no blinded team member is available, the evaluation may be carried out by any unblinded team member. The blinding status of the evaluator will be noted in REDCap.', 'timeFrame': 'Up to 10 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided alpha of 0.05, >99% power for primary outcome detection, 92% power for smaller differences, 98% power for discharge disposition, 85% power for binary secondary outcomes, and 95% power for continuous secondary outcomes. Assumptions include 20% non-compliance, 10% dropouts, and no dropouts for binary outcomes.", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample size of 3000 has >99% power to detect a difference in SPPB change as small as 0.54 points (the MCID) between the two groups at a two-sided alpha of 0.05, assuming a common SD of 2.7 for the SPPB change, 20% non-compliance, 10% dropouts, and an interim analysis. The estimates for MCID and SD are based on observation of older acute care medical patients [43, 44]. Using these same assumptions, the power is still 92% for detecting a smaller difference of 0.35. Therefore, we expect ample statistical power for analyzing the primary outcome. The main reason for selecting this sample size is to ensure that the analyses of important secondary outcomes are not underpowered. The most important of these is discharge disposition, because even a small absolute difference in the number of patients discharged to home, as opposed to a skilled nursing facility, is clinically important. We will be able to detect a 7% difference in discharge to home vs. SNF with 98% power.\n For other binary secondary outcomes (a combination of venous thromboembolism, pneumonia and falls, 30-day mortality, or 30-day readmission), the study will have 85% power to detect a 33% reduction assuming an 8% rate in the control group. Because these outcomes are not contingent on patient cooperation, we anticipate no dropouts. For secondary continuous outcomes such as length of stay, assuming 20% non-compliance rate, the power to detect a 4-h difference (0.167 days) is 95%.\n Regarding the cost analysis, there is no accepted way of doing a power calculation. However, we tried adding $300 (an approximation of the cost of the intervention) to the costs of each of 1500 patients drawn randomly from a sample of 3000 Cleveland Clinic medical inpatients over the age of 65 with an AM-PAC 6-Clicks score between 16 and 20. We then performed a t-test on the log-transformed costs, as described in the economic analysis section, and we were able to detect the increase with a p-value of 0.03, indicating that should the intervention increase costs by an amount equal to the cost of the intervention, we should be able to identify it. Similarly, if the intervention decreases total costs by $300 or more (not including the costs of the intervention), we should have sufficient power to detect it.", "id": 1736, "split": "test"} +{"trial_id": "NCT05726045", "pmid": "39987116", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation\n\nIncluded conditions:\n- Tobacco Use Disorder\n\nStudy Armgroups:\n- {'label': 'HIIT morning', 'type': 'ACTIVE_COMPARATOR', 'description': 'High-intensity interval training (HIIT) in the morning', 'interventionNames': ['Behavioral: Standard smoking cessation program (SCP)']}\n- {'label': 'HIIT evening', 'type': 'EXPERIMENTAL', 'description': 'High-intensity interval training (HIIT) in the evening', 'interventionNames': ['Behavioral: Standard smoking cessation program (SCP)', 'Behavioral: High-intensity interval training (HIIT evening)']}\n- {'label': 'HIIT morning + CRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)', 'interventionNames': ['Behavioral: Standard smoking cessation program (SCP)', 'Behavioral: Cognitive remediation treatment (CRT)']}\n- {'label': 'HIIT evening + CRT', 'type': 'EXPERIMENTAL', 'description': 'High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)', 'interventionNames': ['Behavioral: Standard smoking cessation program (SCP)', 'Behavioral: Cognitive remediation treatment (CRT)', 'Behavioral: High-intensity interval training (HIIT evening)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Standard smoking cessation program (SCP)', 'description': 'Each subject will receive a standard SCP as group treatment once a week (1h) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra \\\\& Buchkremer, 2004), and will be carried out by a qualified therapist.', 'armGroupLabels': ['HIIT evening', 'HIIT evening + CRT', 'HIIT morning', 'HIIT morning + CRT']}\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive remediation treatment (CRT)', 'description': 'The cognitive remediation treatment (CRT) employs a chess-based battery of tasks (delivered through an app-based online tool), two times per week over six weeks (60min duration per session).', 'armGroupLabels': ['HIIT evening + CRT', 'HIIT morning + CRT']}\n- {'type': 'BEHAVIORAL', 'name': 'High-intensity interval training (HIIT evening)', 'description': 'The high-intensity interval training will be delivered through an app environment with several choices of exercise, two times per week over six weeks.\\n\\nThe training will include a 5-minutes warm-up and cool down phase. In between, participants will perform four 4-minutes blocks of exercise at high intensity, interspersed with three 3-minute blocks of low intensity (total of 35 minutes exercise).', 'armGroupLabels': ['HIIT evening', 'HIIT evening + CRT']}\n\nPrimary Outcomes:\n- {'measure': 'Time until first severe relapse', 'description': 'days until the first severe smoking relapse after treatment', 'timeFrame': 'timepoint 3: follow-up 3 months after end of SCP'}\n- {'measure': 'Percentage of abstinent days', 'description': 'Percentage of abstinent days in the 3 months after treatment', 'timeFrame': 'timepoint 3: follow-up 3 months after end of SCP'}\n- {'measure': 'Change in smoking urges', 'description': 'questionnaire of smoking urges (QSU, M\u00fcller et al. 2001)', 'timeFrame': '2 time points: before and after 6 weeks SCP'}\n- {'measure': 'Change in neural measures of response inhibition', 'description': 'SST fMRI task (Gan et al., 2014)', 'timeFrame': '2 time points: before and after 6 weeks SCP'}\n- {'measure': 'Change in neural measures of working memory', 'description': 'Nback fMRI task (Charlet et al., 2014)', 'timeFrame': '2 time points: before and after 6 weeks SCP'}\n- {'measure': 'Change in neural functional connectivity in the salience network', 'description': 'resting state connectivity to seed region right anterior insula', 'timeFrame': '2 time points: before and after 6 weeks SCP'}\n\nPlease estimate the sample size based on the assumption: \npower of 80%, 5% alpha level, and accounting for potential dropouts", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated via the software package G*Power (version 3.1.9.4 [51]) on the basis of the number of days of abstinence at posttreatment (day 42). With a sample size of 128 participants (32 participants per group), we achieve a power of 80%, assuming a minimum effect size of f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 in an ANOVA at a 5% alpha level. This ensures an optimal balance of sample size, information gain, and resource allocation [52]. To account for potential dropouts, three participants per group will be added, resulting in a total population of 140 participants.", "id": 1737, "split": "test"} +{"trial_id": "NCT05726266", "pmid": "37696633", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect and Safety of Listening to Music or Audiobooks as a Coadjunvant Treatment for Chronic Pain Patients Under Opioid Treatment: A Single-Center, Open-Label, Parallel Groups, Controlled, Randomized Pilot Clinical Trial\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Music Group', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to this group will listen daily to a musical playlist for 30 - 60 minutes in a row through a mobile device. This will be performed in addition to the opioid treatment.', 'interventionNames': ['Other: Music']}\n- {'label': 'Audiobooks Group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients randomized to this group will listen to an audiobook daily for 30 - 60 minutes in a row through a mobile device. This will be performed in addition to the opioid treatment.', 'interventionNames': ['Other: Audiobook']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Music', 'description': \"Patients will listen daily to a musical playlist for 30 - 60 minutes in a row; the psychologist will set up a music playlist according to the patient's individual interests. Patients will be asked to focus on this activity, that is, without performing any other activity simultaneously.\", 'armGroupLabels': ['Music Group']}\n- {'type': 'OTHER', 'name': 'Audiobook', 'description': \"Patients will listen daily to an audiobook for 30 - 60 minutes in a row; the psychologist will set up a list of audiobooks according to the patient's individual interests. Patients will be asked to focus on this activity, that is, without performing any other activity simultaneously.\", 'armGroupLabels': ['Audiobooks Group']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity measured by the Visual Analog Scale', 'description': 'The Visual Analog Scale is a continuous variable on a 10 cm line representing \"no pain\" (0 cm) to \"worst imaginable pain\" (10 cm).\\n\\nWe will consider as responders those patients with a \u226530% reduction in the \"maximum pain intensity in the last 24 hours\" at any time during the study compared to the baseline score (study start visit) for at least 3 consecutive days.', 'timeFrame': '4 weeks'}\n- {'measure': 'Pain intensity differences from baseline during the 4 weeks of treatment', 'description': 'We will assess the mean pain intensity differences from baseline during the 4 weeks of treatment. These mean pain intensity differences will be used to obtain the sum of pain intensity differences (by calculating the area under the time-analgesic effect curve).', 'timeFrame': '4 weeks'}\n- {'measure': 'Scores on the McGill Multidimensional Pain Questionnaire', 'description': 'The McGill Multidimensional Pain Questionnaire scores range from 0 (No Pain) to 78 (Severe Pain). Changes between the baseline and end-of-treatment scores will be assessed.', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 81.7% at a significance level of 5%, with a moderate autocorrelation of 0.3 and a standard deviation of 4 cm. The design includes at least three summary measurements per patient.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size\n Given the proof-of-concept and exploratory nature of the present clinical trial, the sample size is not based on ensuring statistical power but vice versa, the statistical power yielded by the feasible sample size was prechecked to ensure relevance. We will include a total of 70 consecutive eligible patients; 35 will be randomised to each of the groups. With such sample size, the statistical power to detect a minimal clinically important difference in pain intensity of 2\u00e2\u0080\u0089cm in the 10\u00e2\u0080\u0089cm Visual Analogue Scale (VAS) between study arms in a repeated measures design,39 with at least three summary measurements per patient and a moderate autocorrelation of 0.3, will be 81.7% at a significance level of 5% when the SD is 4\u00e2\u0080\u0089cm.\n After performing some simulations, we have verified that if there were differences in pain intensity of such magnitude between the study groups, we would come out with significant total and, probably, direct effects of music listening with a causal interpretation. However, if the differences only concerned the opioid doses but not pain intensities, the planned sample size would be insufficient to declare the indirect effects as significant. In such a case, nevertheless, we could almost certainly declare a benefit in terms of significant reductions of opioid requirements, which would have also a causal interpretation because the primary intervention (music or audiobook listening) is actually randomised.", "id": 1738, "split": "test"} +{"trial_id": "NCT05726786", "pmid": "39415282", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)\n\nIncluded conditions:\n- Bladder Cancer\n- Interstitial Cystitis\n- Painful Bladder Syndrome\n- Neurogenic Bladder\n- Hemorrhagic Cystitis\n- Endometriosis\n- Bladder Disease\n\nStudy Armgroups:\n- {'label': 'Immunonutrition', 'type': 'EXPERIMENTAL', 'description': 'Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition', 'interventionNames': ['Drug: Immunonutrition']}\n- {'label': 'No immunonutrition (control)', 'type': 'NO_INTERVENTION', 'description': 'Standard of care'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Immunonutrition', 'description': 'Immunonutrition: Oral Impact\u00ae, Nestle\u0301 Health Science, Switzerland.\\n\\nIN will be administered as per manufacturer suggestion, i.e. three times a day during 7 days preoperatively. Oral Impact\u00ae is a powdered oral feed that provides 309 kcal/bag', 'armGroupLabels': ['Immunonutrition']}\n\nPrimary Outcomes:\n- {'measure': 'Infectious complication after cystectomy', 'description': 'Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).', 'timeFrame': '30-days afetr surgery'}\n\nPlease estimate the sample size based on the assumption: \nAssumptions include a normal distribution for infectious complications, a common standard deviation in both study arms, a type I error (\u03b1) of 5%, a type II error (\u03b2) of 20% (80% power), and a possible dropout rate of up to 5%.", "answer": 232, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n The literature review showed a postoperative infectious rate between 25 and 45% among patients treated with cystectomy [4, 5]. Prior clinical data from cystectomy patients at CHUV resulted in an infectious rate at 30\u00c2\u00a0days after surgery of 30%. As showed before, the literature review showed an infection between 25 and 45% among patients treated with cystectomy. Assuming a normal distribution for infectious complications after cystectomy and a common standard deviation in both study arms, desired probabilities of type I error (\u00ce\u00b1) of 5% and of type II error (\u00ce\u00b2) of 20% (i.e., 80% statistical power) and applying a two-sided test, 110 informative patients per arm (i.e., a total of 220) would be needed to decrease the rate of infectious complications by 17% in the IN group (37% infections at 30\u00c2\u00a0days after surgery in the control group vs 20% in the IN group). Since we anticipate a possible dropout rate of up to 5%, a total of 232 patients are intended for enrolment in the study (116 patients per group). To achieve adequate participant enrolment, three Swiss hospitals participate to this study: University Hospital of Lausanne, University Hospital of Bern, and Hospital of Riviera-Chablais, with an estimated rate of recruitment of 50, 25, and 10 patients per year, respectively.", "id": 1739, "split": "test"} +{"trial_id": "NCT05730257", "pmid": "39762978", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Open-label Randomized Clinical Trial Investigating Whether Robot-Assisted Kidney Transplantation Can Reduce Surgical Complications Compared to Open Kidney Transplantation; The ORAKTx Trial\n\nIncluded conditions:\n- End Stage Renal Disease\n- Kidney Transplant; Complications\n\nStudy Armgroups:\n- {'label': 'Robot-assisted Kidney Transplantation (RAKT)', 'type': 'EXPERIMENTAL', 'description': 'Participants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels.\\n\\nParticipants will be managed according to the standard protocol for renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality. The anaestethic protocol will be tailored to suit robot-assisted surgery', 'interventionNames': ['Procedure: Robot-Assisted Kidney Transplantation']}\n- {'label': 'Open Kidney Transplantation (OKT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will undergo standard work-up prior to transplantation according to the KDIGO guidelines, in addition, participation in the study will require a non-contrast CT of the abdomen to exclude severe calcification of the iliac vessels.\\n\\nParticipants will be managed according to the standard protocol for anaesthesia and renal transplantation at Rigshospitalet and will follow standard pre-, peri- and post-operative care aside from operating modality.', 'interventionNames': ['Procedure: Open Kidney Transplantation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Robot-Assisted Kidney Transplantation', 'description': \"Robot-Assisted Kidney Transplantation takes place with the patient under general anaesthesia. Several ports are placed in the lower abdomen, for the entry of the camera, surgical instruments and manuel access. The DaVinci robot is placed between the patient's legs and docked to the ports. The iliac vascular bed is prepared and a peritoneal cavity created laterally. The kidney is introduced through the handport, regional hypothermia obtained via iceslush in the cavity and the vessel lumens flushed with heparin. The vessels are blocked during suturing with the kidney graft vessels anastomosed end-to-side to the external iliac vessels. The kidney graft is placed in the retroperitoneal cavity and a ureterovesical anastomosis performed ad modem Woodruff over double J stent. The ureter is placed extra peritoneally, fascia closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed.\", 'armGroupLabels': ['Robot-assisted Kidney Transplantation (RAKT)']}\n- {'type': 'PROCEDURE', 'name': 'Open Kidney Transplantation', 'description': 'Open Kidney Transplantation takes place with the patient under general anaesthesia. A jockey-stick (Gibson) incision is made in the left or right iliac fossa and the peritoneum is displaced. With the kidney under hypothermia, the iliac vascular bed is prepared, the vessel lumens flushed with heparin and a vascular clamp instrument is used to block the vessels during suturing. The kidney graft vessels are anastomosed end-to-side to the external iliac vessels and the ureterovesical anastomosis performed ad modem Woodruff over a double J stent. The kidney graft is placed in the cavity and the fascia is closed in layers and the skin using intracutaneous suturing. Perioperative prophylactics entail piperacillin/tazobactam and an indwelling bladder catheter is placed.', 'armGroupLabels': ['Open Kidney Transplantation (OKT)']}\n\nPrimary Outcomes:\n- {'measure': 'Vascular complications', 'description': 'Composite outcome consisting of a) bleeding requiring reoperation, b) renal/graft vascular thrombosis, c) symptomatic hematomas d) renal/graft arterial stenosis', 'timeFrame': '30 days after surgery'}\n- {'measure': 'Surgical complications Clavien-Dindo >grade 2', 'description': 'All postoperative complications will be recorded and graded according to the Clavien-Dindo classification with major complications defined as \\\\>grade 2.', 'timeFrame': '30 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% and the significance level is set at 5%. The anticipated drop-out rate is 10%. The significance level was not adjusted for having two primary outcomes as they were deemed of equal importance.", "answer": 106, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n To estimate the number of participants needed to detect the two primary outcomes a power calculation was performed using the statistical analyses program R version 4.2.1 (R Development Core Team, Vienna, Austria) running on RStudio version 2022.07.01 (\u00c2\u00a9 2009\u00e2\u0080\u00932022 by RStudio, Inc). The calculation yielded a sample size of 106 participants with an anticipated drop-out of 10% (n\u00e2\u0080\u0089=\u00e2\u0080\u008996).The current rate of vascular complications for OKT is 17.3% [30]. With a power set at 80% and a significance level set at 5%, we hypothesise that RAKT will lead to an absolute reduction in vascular complications of 15% within 30\u00c2\u00a0days of transplantation compared to OKT.The current rate of major surgical complications (Clavien-Dindo grade\u00e2\u0080\u0089>\u00e2\u0080\u00892) is 22.8% [30]. With a power set at 80% and a significance level set at 5%, we hypothesise that RAKT will lead to an absolute reduction in Clavien-Dindo\u00e2\u0080\u0089>\u00e2\u0080\u00892 of 20% within 30\u00c2\u00a0days after transplantation compared to OKT.\n Based on having two primary outcomes, we did not adjust our significance level for sample size calculations as they were deemed of equal importance to determine the risk and benefit of both procedures. As such, the number of the sample size is defined by having the power to prove the significance of the primary outcome requiring the largest number of included patients. The anticipated reduction in vascular complications required the largest sample size with 48 participants in each arm (to a total of 96, with an added 10% drop-out\u00e2\u0080\u0089=\u00e2\u0080\u0089106). The anticipated reduction in major surgical complications required 34 participants in each arm (to a total of 68, with an added 10% drop-out\u00e2\u0080\u0089=\u00e2\u0080\u008975).\n The anticipated drop-out rate of 10% was chosen to account for any participants where outcome data will not be available while ensuring adequate power is maintained. At Rigshospitalet transplantation is performed in patients from the Faroe Islands and Greenland, which do not allow access to the EHR. While the majority of these patients are not expected to travel home before the 30-day primary outcomes, it may affect the long-term outcomes as the date of return is not predetermined and depends on the post-operative course. Drop-outs, in this sense, refer to these participants who live in the Faroe Islands or Greenland as well as those who withdraw both consent and data or move away from Denmark.", "id": 1740, "split": "test"} +{"trial_id": "NCT05731973", "pmid": "38531584", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum: a Randomized Clinical Trial (ICE Trial)\n\nIncluded conditions:\n- Pectus Excavatum\n- Funnel Chest\n\nStudy Armgroups:\n- {'label': 'Intercostal nerve cryoablation', 'type': 'EXPERIMENTAL', 'description': 'When a patient is allocated to the intercostal nerve cryoablation group, cryoablation will be performed prior to bar placement. In brief, cryoablation will be performed at the level of the bar and two levels above and below, bilaterally. For this, a second portal access will be placed for video guidance on the contralateral side, and the cryoprobe (cryoICE, Atricure, Masion, OH, USA) will be inserted through the thoracic incisions that are already made for bar placement. The probe will be placed at the inferior aspect of the ribs, posterior to the midaxillary line, directly on the neurovascular bundle. One freezing cycle takes 2 minutes, and a temperature of -60 \u2070C will be applied. The probe will be warmed to room temperature before removing it from the pleura to prevent additional trauma. Furthermore, intercostal nerve cryoablation will be combined with single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks placed just anterior to the side of the cryoablation.', 'interventionNames': ['Procedure: Intercostal nerve cryoablation', 'Drug: Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))', 'Drug: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)']}\n- {'label': 'Thoracic epidural (local continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))', 'type': 'ACTIVE_COMPARATOR', 'description': 'Prior to surgery, an anesthesiologist will place the thoracic epidural at T5-T6 or T6-T7 interspace in the awake patient. After correct placement, a local continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml) will be started. At the third postoperative day, thoracic epidural analgesia will be ceased and transitioned to oral pain medication at discretion of the pain management team. In general, opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours as needed) will be provided 12 hours before thoracic epidural analgesia is ceased.', 'interventionNames': ['Drug: Thoracic epidural analgesia (continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))', 'Drug: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Intercostal nerve cryoablation', 'description': 'Intercostal nerve cryoablation is applied during Nuss procedure.', 'armGroupLabels': ['Intercostal nerve cryoablation'], 'otherNames': ['Cryoablation']}\n- {'type': 'DRUG', 'name': 'Thoracic epidural analgesia (continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))', 'description': 'Thoracic epidural is placed prior to Nuss procedure', 'armGroupLabels': ['Thoracic epidural (local continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))'], 'otherNames': ['Epidural']}\n- {'type': 'DRUG', 'name': 'Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))', 'description': 'Single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks are placed just anterior to the side of the cryoablation.', 'armGroupLabels': ['Intercostal nerve cryoablation'], 'otherNames': ['Intercostal nerve block']}\n- {'type': 'DRUG', 'name': 'Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)', 'description': 'Opioids', 'armGroupLabels': ['Intercostal nerve cryoablation', 'Thoracic epidural (local continuous infusion with sufentanyl (1 \u00b5g/ml) and bupivacaine (1.25 mg/ml))'], 'otherNames': ['opioids, oxycodone (with prolonged discharge)']}\n\nPrimary Outcomes:\n- {'measure': 'Length of hospital stay', 'description': 'Number of days of hospital admittance after the Nuss procedure.', 'timeFrame': 'Hospitalization period, average of 5 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level alpha is 0.05, beta is 0.1 for 90% power, and a 20% follow-up loss per treatment arm is anticipated.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size is determined based on the worst-case scenario reported in the meta-analysis by Daemen et al.23 In specific, the lower limit of the 95% CI of the mean reduction in hospitalisation was 2.15\u00e2\u0080\u0089days when INC was applied. An SD of 2 was derived from the article by de Loos et al,34 reporting the standard LOHS at our institution for patients who undergo the Nuss procedure.34 Significance level alpha is chosen at 0.05 and beta at 0.1 for 90% power. A sample size of 40 patients (n=20 per group) will have 90% power. A 20% follow-up loss per treatment arm is anticipated and therefore 50 patients are recruited. To improve the adherence to our follow-up programme and minimise the loss to follow-up, different strategies will be implemented (eg, reschedule appointment in case of no-show or replace the appointment by a video-conference appointment).", "id": 1741, "split": "test"} +{"trial_id": "NCT05733208", "pmid": "37355267", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events\n\nIncluded conditions:\n- Myocardial Injury\n- Non-cardiac Surgery\n- Remote Ischemic Preconditioning\n\nStudy Armgroups:\n- {'label': 'Remote ischemic preconditioning', 'type': 'EXPERIMENTAL', 'description': 'Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm', 'interventionNames': ['Procedure: Remote ischemic preconditioning']}\n- {'label': 'Sham-remote ischemic preconditioning', 'type': 'SHAM_COMPARATOR', 'description': 'Transient ischemic ischemia will not actually occur on the upper arm', 'interventionNames': ['Procedure: Sham-remote ischemic preconditioning']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Remote ischemic preconditioning', 'description': 'Remote ischemic preconditioning will consist of four cycles of 5-minute inflation of an blood pressure cuff on the upper arm to 200 mmHg followed by 5-minute deflation. RIPC will be performed twice, one at approximately 24 hours before anaesthesia and the other at approximately 1 hour before anaesthesia.', 'armGroupLabels': ['Remote ischemic preconditioning']}\n- {'type': 'PROCEDURE', 'name': 'Sham-remote ischemic preconditioning', 'description': \"The identical looking cuff will be placed around the upper arm but not actually inflated for 40 minutes. The control device's components and external appearance are identical to that of the RIPC. However, as compared to the RIPC, the blood pressure cuff's line of inflation is disconnected such that the cuff cannot be inflated. Control treatment will be performed twice, one at approximately 24 hours before anaesthesia and the other at approximately 1 hour before anaesthesia.\", 'armGroupLabels': ['Sham-remote ischemic preconditioning']}\n\nPrimary Outcomes:\n- {'measure': 'Myocardial injury after non-cardiac surgery (MINS)', 'description': 'Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021', 'timeFrame': 'Within the first three days after surgery'}\n\nPlease estimate the sample size based on the assumption: \n5% type I error, 90% power, 15% dropout rate and non-compliance.", "answer": 766, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on the results of PIXIE trial in 201925 and the VISION study in 2017,5 30%\u00e2\u0080\u009335% of the patients developed MINS according to the diagnostic criteria established by the American Heart Association. We estimated that RIPC would reduce the incidence to 20%. Therefore, assuming an incidence of 31% in the control group and 20% in the RIPC group, we calculated that 650 participants would be required to detect this difference using R software (V.4.2.1), with a 5% type I error and a power of 90% in a two-sided test. The planned number of patients for enrolment was finally set at 766 (383 participants in each group), considering a 15% dropout rate and non-compliance.", "id": 1742, "split": "test"} +{"trial_id": "NCT05736068", "pmid": "38937792", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? A Pragmatic, Randomized, Controlled Non-inferiority Multicenter Trial\n\nIncluded conditions:\n- Distal Forearm Fracture\n- Distal Radius Fracture\n\nStudy Armgroups:\n- {'label': 'Non-surgical', 'type': 'EXPERIMENTAL', 'description': 'No reduction. Application of a cast.', 'interventionNames': ['Procedure: Non-surgical treatment']}\n- {'label': 'Surgical', 'type': 'ACTIVE_COMPARATOR', 'description': \"Closed reduction under general anesthesia with or without additional pin fixation of surgeons' choice followed by cast immobilization.\", 'interventionNames': ['Procedure: Surgical treatment']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Non-surgical treatment', 'description': 'If allocated to non-surgical group, cast optimization in the outpatient clinic may be necessary if the cast from the emergency room is considered insufficient.', 'armGroupLabels': ['Non-surgical']}\n- {'type': 'PROCEDURE', 'name': 'Surgical treatment', 'description': 'Closed reduction with or without fixation', 'armGroupLabels': ['Surgical']}\n\nPrimary Outcomes:\n- {'measure': 'QuickDASH', 'description': 'Reporting of disability experienced and monitoring changes in symptoms and function over time. The patient (with help by parents if the patient is too young to self-report) rates each item according to the perceived degree of severity using a 5-point Likert Scale. Then, the overall score is transformed to a score between 0 and 100 (0 = no disability, 100 = maximum disability) according to the algorithm \\\\[(sum of responses N/N)-1\\\\]\\\\*25, where N is equal to the number of responses.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate is 2.5%, power is 80%, and dropout rate is 20%.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n We defined a non-inferiority margin as NIM\u00e2\u0080\u0089=\u00e2\u0080\u0089MCID\u00e2\u0080\u0089=\u00e2\u0080\u008915 QuickDASH points. Thereby, we will only reject the null-hypothesis, if the between-group difference is both more than NIM and clinically relevant. With an SD\u00e2\u0080\u0089=\u00e2\u0080\u008915 and type I error rate of 2.5%, 16 patients per group (32 in total) would be required for 80% power that the lower limit of a 95% two-sided confidence interval (CI) would be above the non-inferiority limit [44]. Allowing for 20% dropouts, the total sample size required is 40 patients (20 in each group).", "id": 1743, "split": "test"} +{"trial_id": "NCT05737472", "pmid": "37619218", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Proof-of-concept Randomized Control Trial on the Role of Higher Protein Quantity and Quality-ready-to-use Therapeutic Food in Improving Linear Growth Among 6-23-month-old Children With Severe Wasting\n\nIncluded conditions:\n- Severe Wasting\n- Severe Acute Malnutrition\n\nStudy Armgroups:\n- {'label': 'Standard RUTF', 'type': 'ACTIVE_COMPARATOR', 'description': 'The standard RUTF dose is according to weight as per the WHO 2013 guideline, thus 150-220Kcal/kg/day. A child will receive a weekly ration for 8 consecutive weeks from enrolment.', 'interventionNames': ['Dietary Supplement: Standard RUTF']}\n- {'label': 'High-protein RUTF', 'type': 'EXPERIMENTAL', 'description': 'The high-protein RUTF dose is according to weight as per the WHO 2013 guideline, thus 150-220Kcal/kg/day. A child will receive a weekly ration for 8 consecutive weeks from enrolment.', 'interventionNames': ['Dietary Supplement: High-protein RUTF']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'High-protein RUTF', 'description': 'The high-protein RUTF is isocaloric to the standard RUTF. To have a higher protein quantity and quality, the recipe has greater proportions of milk powder plus whey protein and vegetable oil. A total of 15% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS )of the high protein, RUTF is 1.18 which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.19', 'armGroupLabels': ['High-protein RUTF']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Standard RUTF', 'description': 'The standard RUTF was manufactured according to WHO recommendations, with at least 50% of protein-sourced dairy, mainly skim milk. A total of 10% of energy is from protein. The protein quality score, digestible indispensable amino acid score (DIAAS) of the standard RUTF is 0.76, which is equivalent to a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 0.86.', 'armGroupLabels': ['Standard RUTF']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in plasma IGF-1', 'description': 'To assess the efficacy of high-protein-RUTF with higher protein quality and quantity compared to standard RUTF in increasing circulating IGF- 1 in 6-23-month-old children with severe wasting.', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha of 0.05, 20% attrition rate, and 10% mortality rate.", "answer": 128, "answer_type": "ACTUAL", "explanation": "Sample size and sampling\n The sample size for this PoC randomized control trial was calculated based on a study from Hoppe et al. (2004) [28]. The expected group difference in mean change of IGF-1 is 39.7 ng/ml with a standard deviation of 66 ng/ml [28] which yielded 46 children per arm for a power of 80% and alpha of 0.05. The sample size was then adjusted to account for 20% attrition and 10% mortality [29], resulting in 64 participants per study arm, and a total of 128 severely wasted children be recruited.\n Participants will be identified using the convenience sampling method [30], where all children that meet the eligibility criteria at the selected outpatient clinics will be asked to participate. Additionally, in-depth interviews (IDIs) will be conducted with a subset of participants to assess the acceptability and use of the two RUTFs. The first recruited caregivers will be sequentially asked to participate in IDIs until 17 caregivers have completed the IDIs in each study arm to reach saturation of themes [31]. If theme saturation is not achieved after analysing the 34 IDIs, additional interviews will be conducted until saturation is reached.", "id": 1744, "split": "test"} +{"trial_id": "NCT05738278", "pmid": "37060049", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial\n\nIncluded conditions:\n- Autism Spectrum Disorder\n- Intellectual Disability\n- Communication, Nonverbal\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.', 'interventionNames': ['Behavioral: HR-informed change in routine']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.', 'interventionNames': ['Behavioral: Delayed HR-informed specific change in routine']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'HR-informed change in routine', 'description': 'The intervention is given for a situation occuring at least ten times and accompanied by an increase in HR at least 80% of the time, during the two-week registration period. Change in care (intervention) is introduced from week 3.\\n\\nThe intervention is in one of four forms:\\n\\n1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,\\n2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,\\n3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or\\n4. revised personal hygiene procedure.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Delayed HR-informed specific change in routine', 'description': 'The intervention is given for a situation occuring at least twenty times and accompanied by an increase in HR at least 80% of the time, during the four-week registration period. Change in care (intervention) is introduced from week 5.\\n\\nThe intervention is in one of four forms:\\n\\n1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,\\n2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,\\n3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or\\n4. revised personal hygiene procedure.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Situations identified by 2 standard deviation increase in HR', 'description': 'The hypothesis is that a 2 standard deviation increase in HR can identify potentially painful care situations that require re-evaluation. Mean HR spike counts will be compared using a one-tailed paired sampled t-test to differentiate between suitable and unsuitable situations for care adjustments.', 'timeFrame': '11 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided paired samples t-test with 80% power and a significance level (alpha) of 0.05 is assumed. A dropout rate of 15% is also considered.", "answer": 38, "answer_type": "ESTIMATED", "explanation": "Sample size\n There are various approaches for calculating sample size [64]. Here we have decided to design the study to reliably detect our effect size of interest. We will recruit 38 patients, allowing for a dropout of 15%. With 38 patients, a one-sided paired samples t-test can reliably detect (80% power) an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.84, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (Fig.\u00c2\u00a03). We have chosen a one-sided test as we have a directional hypothesis. This is a realistic effect size of interest given that heart rate increases in response to stressors are associated with effect sizes larger than d\u00e2\u0080\u0089=\u00e2\u0080\u00891 [65].Fig. 3A power contour plot. Power analysis suggests that a paired samples t-test including 38 participants will reliably detect (power\u00e2\u0080\u0089=\u00e2\u0080\u008980%) an effect size of 0.82, or higher. Statistical power is also shown by assuming smaller or larger hypothetical effect sizes. Analysis and visualisation were performed using the \u00e2\u0080\u0098jpower\u00e2\u0080\u0099 JAMOVI module: https://github.com/richarddmorey/jpower", "id": 1745, "split": "test"} +{"trial_id": "NCT05740150", "pmid": "36944461", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy of a Lock Solution Containing Taurolidine, Citrate and Heparin for the Prevention of Tunneled Central Line-associated Bloodstream Infections in Pediatric Oncology Patients, a Randomized Controlled, Mono-center Trial.\n\nIncluded conditions:\n- Central Line-associated Bloodstream Infection (CLABSI)\n\nStudy Armgroups:\n- {'label': 'TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)']}\n- {'label': 'Heparin lock (heparin 100 IU/mL)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: Heparin lock (heparin 100 IU/mL)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)', 'description': 'The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.', 'armGroupLabels': ['TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)']}\n- {'type': 'DEVICE', 'name': 'Heparin lock (heparin 100 IU/mL)', 'description': 'The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.', 'armGroupLabels': ['Heparin lock (heparin 100 IU/mL)']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of central line associated bloodstream infections', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided \u03b1 of 0.05, power of 80%, and a two-sided Z-test with unpooled variance. An extra 50 patients are included to account for potential drop-outs.", "answer": 462, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Assuming a CLABSI rate of 12.8%, an estimated total number of 412\u00e2\u0080\u0089patients is needed to detect a difference between group proportion of 7.8%, with a two-sided \u00ce\u00b1 of 0.05 and power of 80% (two-sided Z-test with unpooled variance).19\u00e2\u0080\u009324 The CLABSI rate of 12.8% was based on the data from the CVAD complication database of the Princess M\u00c3\u00a1xima Centre, partially published by van den Bosch et al,\n3 using the same inclusion and exclusion criteria and follow-up period as described for this study.3 The estimated reduction of 12.8%\u00e2\u0080\u00935.0% was based on previously performed RCT, of which the vast majority showed a reduction of at least more than 60%; IRR of 0.30 (95% CI 0.19 to 0.46). For paediatric oncology specifically, two RCTs have been performed which showed reductions of 74% and 77%.6 For each patient that prematurely drops-out of the study an extra patient will be included, we estimated that an extra 50\u00e2\u0080\u0089patients would be needed to account for potential drop-outs. The drop-out inflated total sample size is therefore calculated as 462\u00e2\u0080\u0089patients, 231 per group.", "id": 1746, "split": "test"} +{"trial_id": "NCT05740397", "pmid": "38491507", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mean Arterial Pressure (MAP) Trial: Study Protocol for a Multicenter, Randomized, Controlled Trial to Compare Three Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass\n\nIncluded conditions:\n- Heart; Surgery, Heart, Functional Disturbance as Result\n\nStudy Armgroups:\n- {'label': 'Standard MAP', 'type': 'OTHER', 'description': 'Control group: MAP values between 50-60 mmHg', 'interventionNames': ['Other: Management of mean arterial pressure during cardiopulmonary by-pass in cardiac surgery interventions. The MAP will be mantained in the range of values of each study arm']}\n- {'label': 'High MAP', 'type': 'OTHER', 'description': 'First Comparator group: MAP values between 70-80 mmHg', 'interventionNames': ['Other: Management of mean arterial pressure during cardiopulmonary by-pass in cardiac surgery interventions. The MAP will be mantained in the range of values of each study arm']}\n- {'label': 'Patient-tailored MAP', 'type': 'OTHER', 'description': 'Second Comparator group: MAP comparable to the patient\\'s pre-operative MAP. This one will be calculated by performing 3 blood pressure measurement in three different moments of the day before surgery (at 8 am, at 3 pm, and at 9 pm), and will be calculated using the standard formula \"Diastolic AP + 0,33 x (systolic AP - Diastolic AP)\". The preoperative MAP value obtained will be target during CPB, within a range of \u00b1 10 mmHg', 'interventionNames': ['Other: Management of mean arterial pressure during cardiopulmonary by-pass in cardiac surgery interventions. The MAP will be mantained in the range of values of each study arm']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Management of mean arterial pressure during cardiopulmonary by-pass in cardiac surgery interventions. The MAP will be mantained in the range of values of each study arm', 'description': 'The patients enrolled to elective cardiac surgeries will be evaluated during a pre-operative outpatient visit and widely informed about the chance to participate in the study. When patients undergo to the elective surgery general anaesthesia is administered and CPB is installed. The nominal flow for each patient will be 2,4 l/min/m2.\\n\\nTo keep the MAP values around those corresponding to the randomized group, vasodilator (if MAP overcomes the assigned MAP value) or vasoconstrictor drugs will be used (if MAP value is lower than the assigned group). The following drugs will be used: nitroglicerine at incremental dose of 0,01 mcg/kg/min for a vasodilator effect and norepinephrine at incremental dose of 0,01 mcg/kg/min for a vasoconstrictor effect', 'armGroupLabels': ['High MAP', 'Patient-tailored MAP', 'Standard MAP']}\n\nPrimary Outcomes:\n- {'measure': 'Serum lactate peak (Lmax) (mmol/l) detected during Cardiopulmonary by-pass time', 'description': 'The mean of this value will be compared in the three groups of treatment.', 'timeFrame': 'at the beginning of CPB, every 20 minutes during CPB, at the end of CPB, at the end of surgery'}\n\nPlease estimate the sample size based on the assumption: \nMann-Whitney non-parametric test, alpha of 0.05 with Bonferroni correction (corrected Alpha= 0.01667), power of 80%, and a potential drop-out rate of 10%.", "answer": 900, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size has been calculated for the primary endpoint: the maximum serum lactate value (Lmax). A preliminary analysis was performed on a sample size of 128 consecutive patients undergone to elective cardiac surgery at Cardiac Surgery Division at AOUI of Verona (about the 10% of the annual volume cases at our Institution). All patients were treated with standard MAP (standard of care) and the estimated mean of Lmax during CPB was 1.25 mmol/l, with a standard deviation of 0.7 mmol/l. Starting from this value, a reduction of \u00e2\u0088\u009215% of the mean Lmax was considered clinically significant for every comparison that will be performed in the study, as listed below:Standard MAP vs High MAP (\u00e2\u0088\u009215%) difference d=\u00e2\u0088\u00920,19Standard MAP vs patient-tailored MAP (\u00e2\u0088\u009215%) difference d=\u00e2\u0088\u009219High MAP vs patient-tailored MAP (\u00e2\u0088\u009215%) difference d=\u00e2\u0088\u009219\n Based on these assumptions, performing the Mann-Whitney non-parametric test and considering an alpha of 0.05 s. Bonferroni for all the three comparisons (corrected Alpha= 0.01667) and a power of 80%, 300 patients should be enrolled for each group, for a total of 900 patients (PASS 14). To account for a potential drop-out of 10%, the size becomes 333 patients per group, then a total of 999 patients. The number of patients that each Participating Centres should recruit has been calculated based on the annual cases volume of each Centre, as follows:\n \nCardiac Surgery Division of AOUI Verona: 327 cases (109 per group)Cardiac Surgery Division of Ospedale Maggiore di Parma: 162 cases (54 per group)Cardiac Surgery Division of Azienda Sanitaria Universitaria Friuli Centrale di Udine: 231 cases (77 per group)Cardiac Surgery Division of Hospital Clinic de Barcelona, Spain: 279 cases (93 per cases)", "id": 1747, "split": "test"} +{"trial_id": "NCT05741866", "pmid": "39013653", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).\n\nIncluded conditions:\n- Vascular Access Complication\n- Device Related Infection\n- Device Related Sepsis\n- Device Site Reactions\n- Catheter Infection\n- Catheter Complications\n- Catheter-Related Infections\n- Catheter Related Complication\n- Occlusive Dressings\n- Wound Infection\n- Wound of Skin\n- Wound\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Bordered Polyurethane Dressing', 'interventionNames': ['Device: Standard bordered polyurethane dressing']}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'CHG Bordered Polyurethane Dressing', 'interventionNames': ['Device: Chlorhexidine gluconate impregnated bordered polyurethane dressing']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Chlorhexidine gluconate impregnated bordered polyurethane dressing', 'description': 'PIVCs will be dressed and secured at the participating sites\\n\\n* RBWH and PUH: PIVCs will be dressed with Tegaderm\u2122 Antimicrobial I.V. Advanced Securement (9132) dressing and secured with non-sterile tape over extension tubing.\\n* QCH: PIVCs will be dressed with Tegaderm\u2122 Antimicrobial I.V. Advanced Securement (9132) dressing and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference.', 'armGroupLabels': ['Intervention'], 'otherNames': ['Tegaderm\u2122 Antimicrobial I.V. Advanced Securement (9132)']}\n- {'type': 'DEVICE', 'name': 'Standard bordered polyurethane dressing', 'description': 'PIVCs will be dressed and secured as per standard practice at the participating sites\\n\\n* RBWH and PUH: Bordered polyurethane dressing (Tegaderm\u2122 IV Advanced 1683) and non-sterile tape strip over extension tubing.\\n* QCH: Bordered polyurethane dressing (Tegaderm\u2122 IV Advanced 1682 or 1683) and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference.', 'armGroupLabels': ['Control'], 'otherNames': ['Tegaderm\u2122 IV Advanced (1682 or 1683)']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility for a definitive RCT', 'description': 'The feasibility of conducting a definitive RCT will be assessed against the following criteria:\\n\\ni. Study Eligibility as per inclusion/exclusion criteria (\u226580% of screened participants will be eligible for study inclusion) ii. Participant Recruitment onto study (\u226580% of eligible participants will provide informed consent to participate in the study) iii. Retention of study participants (\\\\<10% will be lost to follow up) iv. Protocol fidelity of study participants (\u226580% will receive the allocated intervention) v. Missing data for primary outcome 2 (\\\\<5% of primary outcome 2 data will be unable to be collected) vi. Satisfaction of participants/parents and staff (\\\\<10% report \"low\" satisfaction with the intervention arm (rated low/medium/high) vii. An estimate of catheter-related infectious complications (defined as per primary outcome 2) in the control group that indicate a fully powered multi-site RCT is achievable', 'timeFrame': 'On completion of 300 participants'}\n- {'measure': 'Catheter-related infectious complications and phlebitis', 'description': 'Proportion of patients with a composite measure of PIVC Colonization; PIVC local infection; PIVC-associated Bloodstream Infection (BSI) and Phlebitis. These measures are defined below in secondary outcomes.\\n\\nIf patients meet more than one of the following \\\\[e.g., phlebitis and PIVC local infection\\\\], both will be collected however only counted once for the composite measure.', 'timeFrame': 'Daily until 48hours after study PIVC is removed.'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided alpha 0.05", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In Phase 1, an internal pilot, we will recruit 300 patients (200 in Australia and 100 in France) with 150 patients per arm. This sample size is not determined by statistical power but to test protocol feasibility.16 17\n In Phase 2, we will continue recruitment to a sample of 2624 participants in total (1312 per group, 875 per centre), which would have 90% power to detect a predicted absolute 5% reduction in the primary outcome from 22% to 17% (two-sided alpha 0.05). Sample size calculation was based on rates observed in previous trials of PIVC interventions at the study sites and undertaken using an on-line calculator (http://powerandsamplesize.com/calculators). We do not expect hospital site differences in the effect of the intervention.", "id": 1748, "split": "test"} +{"trial_id": "NCT05741944", "pmid": "37918933", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients\n\nIncluded conditions:\n- Soft-tissue Sarcoma\n- Predictive Cancer Model\n\nStudy Armgroups:\n- {'label': 'Care with the use of PERSARC (intervention)', 'type': 'EXPERIMENTAL', 'description': 'Patients in the intervention condition receive usual care with PERSARC added at two points in the decision making process. First, PERSARC will be used in multidisciplinary tumour boards (MTB) by STS professionals to guide treatment advice. Second, PERSARC will be used in patient consultations where the oncological/orthopaedic surgeon informs the patient about his/her diagnosis and discusses the benefits and harms of all relevant treatment options.', 'interventionNames': ['Other: Care with the use of PERSARC']}\n- {'label': 'standard care (control)', 'type': 'SHAM_COMPARATOR', 'description': 'All patients in the control condition receive standard care', 'interventionNames': ['Other: standard care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Care with the use of PERSARC', 'description': \"PERSARC is a personalized risk assessment tool which provides patients and STS professionals insight into the personalized risks and benefits of each treatment option based on patient's age, tumor size, tumor depth and histology. PERSARC will be used in multidisciplinary tumour boards to guide treatment advice and in consultation in which the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and discusses the benefits and harms of all relevant treatment options\", 'armGroupLabels': ['Care with the use of PERSARC (intervention)']}\n- {'type': 'OTHER', 'name': 'standard care', 'description': 'All patients in control condition receive usual care.', 'armGroupLabels': ['standard care (control)']}\n\nPrimary Outcomes:\n- {'measure': 'Decisional Conflict Scale', 'description': 'Decisional conflict scale\\n\\nItems are given a score value of:\\n\\nstrongly agree (0) - strongly disagree (4)\\n\\nTotal score:\\n\\n16 items are a) summed, b) divided by 16, and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)', 'timeFrame': 'T1 (one week after treatment decision)'}\n- {'measure': 'Informed choice', 'description': 'combined outcome incorporating knowledge (self-developed questionnaire), attitudes concerning trade-offs between quality and length of life (QQ_Questionnaire, see below) and treatment decision\\n\\nself-developed knowledge questionnaire: a knowledge score was considered to reflect adequate decision-relevant knowledge if at least 50% of knowledge statements were correctly answered, which means a knowledge score \u22653 for the present study; no knowledge (0) - high knowledge (6)', 'timeFrame': 'T1 (one week after treatment decision)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 95% reliability, intraclass correlation of 0.01, and a 10% loss to follow-up rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is based on one of the primary outcomes, the DCS. The user manual of the DCS reports effect sizes of 0.4\u00e2\u0080\u00931.2 for studies that assess decision supporting interventions.15 In previous studies of patients with cancer considering treatment options using a decision supporting intervention, differences in mean pre-DCS and post-DCS scores of 0.3\u00e2\u0080\u00930.6 were reported.35 36 To calculate the required sample size for this study, a conservative difference in mean of 0.30 was used with an SD of 0.5,36 arriving at an effect size of 0.6. To detect this effect size with 80% power and 95% reliability, assuming an intraclass correlation of 0.01, 52 patients per arm (sample size of 104) are needed, that is, 18 patients per hospital. Accounting for a loss to follow of 10%, we aim to include 20 patients per hospital. With 6 hospitals, a total sample size of 120 patients is needed. With this sample size, we would be able to detect a difference of 80% of patients indicating adequate knowledge in the intervention group vs 50% in the control group (as reported by Hersch et al).37", "id": 1749, "split": "test"} +{"trial_id": "NCT05746260", "pmid": "38355178", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating Consolidation of Motor Learning in the Context of Recovery After Stroke\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Sleep fragmentation at 1-month', 'description': 'Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).', 'timeFrame': '1 month post-stroke'}\n- {'measure': 'Symptoms of insomnia at 1-month', 'description': 'Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)', 'timeFrame': '1 month post-stroke'}\n- {'measure': 'Upper limb ability', 'description': 'Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)', 'timeFrame': '6 month post-stroke'}\n- {'measure': 'Behavioural motor consolidation', 'description': 'Assessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest', 'timeFrame': '1 month post-stroke'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.9, significance level of <0.05, linear multiple regression with a fixed model", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Based on findings from previous work in inpatients with brain injury,23 we predict that sleep measures increase variance in motor outcomes explained by ~10%. Therefore, to achieve a power of 0.9 (1\u00e2\u0088\u0092\u00ce\u00b2 error probability) with a significance level (alpha) of <0.05, a total sample size of ~n=100 is recommended (calculated using G*Power; linear multiple regression, with a fixed model). In anticipation of participant attrition, we will aim to recruit 150 participants.", "id": 1750, "split": "test"} +{"trial_id": "NCT05746806", "pmid": "38296279", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Single Arm Phase II Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy\n\nIncluded conditions:\n- Recurrent Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Single arm', 'type': 'EXPERIMENTAL', 'description': 'Patients with locally recurred prostate cancer will receive a ultrahypofractionated stereotactic radiotherapy to the radiologically identified lesion (Dose: 5 fractions with 7Gray every second work week day) combined with an androgen deprivation therapy (LHRH-agonist / -antagonist) for 6 months.', 'interventionNames': ['Radiation: Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy', 'Drug: Androgen deprivation therapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy', 'description': 'Ultrahypofractioned radiotherapy for patients with isolated local recurrence after radical prostatectomy in 5 fractions', 'armGroupLabels': ['Single arm']}\n- {'type': 'DRUG', 'name': 'Androgen deprivation therapy', 'description': 'In combination to the radiotherapy a short term androgen deprivation drug for 6 months will be applied.\\n\\nThe drug concept used is:\\n\\n- LHRH(Luteinizing hormone releasing hormone)-agonist with 3-month subcutaneous depot injection (e.g. Pamorelin\u00ae LA (Triptorelin) 11.25mg s.c.) in combination with nonsteroidal antiandrogen (e.g. Bicalutamide 50mg/day) as flare protection at least 5 days before and max. 15 days after first LHRH-injection', 'armGroupLabels': ['Single arm']}\n\nPrimary Outcomes:\n- {'measure': 'Biochemical relapsefree survival', 'description': 'The initial prostate specific antigen (PSA) at time of registration will be the starting point. Freedom from biochemical progression is counted from the day of registration to the day of either first recorded biochemical progression as defined below, clinical progression or death due to clinical progression.\\n\\nBiochemical relapsefree survival measured with PSA (prostate specific antigen) lab testing at 1, 3, 6, 12, 18 and 24 months after radiotherapy. The duration of biochemical relapsefree survival is measured and documented in months for each patient.\\n\\nA biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/mL with a confirmatory rise at least 2 weeks later. For those patients whose PSA does not drop below 0.20 ng/mL at time of first response assessment at 3 months are considered as non-responders to treatment and are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA above this level.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nOne-sample binomial exact test with a one-sided alpha of 5%, power of 80%, and safety control for acute side effects (grade 3 or higher) at 90 days after 12 and 24 patients, with a stopping rule if the proportion of patients with acute side effects is larger than 27%.", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Study design and sample size\n This is a single-arm, prospective, phase II multicentre study. According to the published prospective trials and retrospective series reporting the outcomes of the normo-fractionated sRT, we define biochemical relapse-free survival at 2 years of 60% as poor and of 80% as the promising outcome that would justify further investigation.30\u00e2\u0080\u009333 We will, therefore, test the null hypothesis that the biochemical relapse-free survival at 2 years is lower than 60% against the alternative that it is at least 80%. Based on a one-sample binomial exact test with a one-sided alpha of 5%, 36 patients are required to reach a power of 80%, not taking into account patients lost to follow-up. We will control the safety of the intervention during the trial by assessing acute side effects (grade 3 or higher) at 90 days after 12 and 24 patients. The trial will be stopped if there is evidence that the proportion of patients with acute side effects (grade 3 or higher) is larger than 27%; the proportion observed would be tested using one-sample binomial exact tests with a one-sided alpha of 5%. Figure 1 shows a summary of the study design and schedule.\n \n Figure 1\n \n Summary of the study design and schedule. LHRH, luteinising hormone-releasing hormone; mpMRI, multiparametric MRI; PET, positron emission tomography; PSMA, prostate-specific membrane antigen; SBRT, stereotactic radiotherapy.", "id": 1751, "split": "test"} +{"trial_id": "NCT05747040", "pmid": "37993169", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pain Assessment in Neurorehabilitation Through Physiological Signals Recorded by Wearable Devices in Real-world Context: an Exploratory Study\n\nIncluded conditions:\n- Pain\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': '48-h monitoring', 'type': 'OTHER', 'description': \"The intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline:\\n\\n* t0: baseline\\n* t1: pre-treatment\\n* t2: post-treatment\\n* t3: follow-up\", 'interventionNames': ['Diagnostic Test: monitoring']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'monitoring', 'description': \"The intervention consists of 48-h monitoring by using two types of monitoring: an objective monitoring, through a class IIa wearable medical device recording four physiological signals, and a subjective monitoring through a questionnaire developed with Microsoft Forms that can be compiled with a smartphone. The monitoring will be conducted during a motor neurorehabilitation treatment, 24 hours before and 24 hours after the treatment at the participant's home. Besides this monitoring, stratification questionnaires will be administered to each participant to be stratified in one of the three categories (absence of pain, nociceptive pain, or neuropathic pain) based on the following timeline:\\n\\nt0: baseline t1: pre-treatment t2: post-treatment t3: follow-up\", 'armGroupLabels': ['48-h monitoring']}\n\nPrimary Outcomes:\n- {'measure': 'Number of registrations', 'description': 'Number of concurrent physiological signal registrations and pain assessments through CRF monitoring questionnaire and CRF monitoring questionnaire-intervention. Diagnostic performance of the classifier (i.e., sensitivity, specificity, predictive value) against the gold standard (outcomes from CRF monitoring questionnaire and CRF monitoring questionnaire-intervention).', 'timeFrame': 'The monitoring will be conducted during the intervention time frame [48 hours]'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on practical considerations and previous literature on pilot and feasibility study design.", "answer": 15, "answer_type": "ESTIMATED", "explanation": "Sample size\n Given the study\u00e2\u0080\u0099s exploratory nature, the effect size is unknown; thus, it is not possible to calculate the sample size accurately. However, the decision to include at least 15 participants is in line with the previous literature on pilot and feasibility study design, based on practical considerations41 as well as the specific aims of this study.42", "id": 1752, "split": "test"} +{"trial_id": "NCT05752643", "pmid": "37844988", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Impact of Online HIV/STI Screening Addressed to Men Who Have Sex With Men and Transgender Women Pre-exposure Prophylaxis (PrEP) Users in Spain\n\nIncluded conditions:\n- HIV\n- STI\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants will have 4 face-to-face quarterly follow up visits per year'}\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Participants will alternate face-to-face visits with online screening every three months. They will have two face-to-face and two online screenings per year', 'interventionNames': ['Other: Online follow up']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Online follow up', 'description': 'The online follow up will include screening for HIV and STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP)) based in a self-sampling strategy', 'armGroupLabels': ['Experimental']}\n\nPrimary Outcomes:\n- {'measure': 'Retention to PrEP follow up', 'description': 'Proportion of PrEP users that who have not missed any follow-up visit: Number of participants who have not missed a follow up visit /total number of participants in follow up for PrEPx100 (%)', 'timeFrame': 'Two years follow-up (from baseline to year 2)'}\n- {'measure': 'Healthcare burden', 'description': 'Median number of visits per participant and year at the PrEP Service', 'timeFrame': 'Two years follow-up (from baseline to year 2)'}\n\nPlease estimate the sample size based on the assumption: \nFor both evaluations, the power is 80.0%, the significance level is 5.00%, and the ratio of control to treated patients is 1:1. The non-inferiority limit is 8.0% for the intervention evaluation and -5.0% for the DBS sample validation.", "answer": 218, "answer_type": "ESTIMATED", "explanation": "Sample size\n Evaluation of the feasibility and impact of the intervention: The sample size calculation was based on the percentage of participants who exhibited non-adherence to the PrEP follow-up within the same STI clinic as our trial.24 To obtain a power of 80.0% to reject the null hypothesis from a one-sided proportion non-Inferiority test for two independent samples, taking into account that the ratio of patients control-treated is 1:1, and the significance level is 5.00% and assuming that the proportion in the control arm is 12.70%, the proportion in the experimental arm is 10.0%, the proportion of participants in the control group with respect to the total is 50.0%, and the non-inferiority limit is 8.0%, therefore, it will be necessary to include 109 experimental units in the control arm and 109 units in the experimental arm. The total number of participants in the study will be 218.\n Validation of DBS samples for microbiological syphilis diagnosis: To obtain a power of 80.0% to reject the null hypothesis from a one-sided proportion non-inferiority test for two related samples, taking into account that the ratio of patients control-treated is 1:1, and the significance level is 5.00%, and assuming that the proportion in the reference group is 99.9%, the proportion of participants in the control group with respect to the total is 99.0% and the non-inferiority limit is\u00e2\u0080\u00945.0%, therefore, it will be necessary to include 62 matches of experimental units in the study. The total number of participants in the study will be 124 individuals (62 positive syphilis and 62 negative syphilis).", "id": 1753, "split": "test"} +{"trial_id": "NCT05753137", "pmid": "39378079", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Glaucoma\n- Acupuncture\n- Intraocular Pressure\n\nStudy Armgroups:\n- {'label': 'Ophthalmic Acupoint Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'Ophthalmic acupoint treatment group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.\\n\\nAcupuncture points: Fengchi(GB20), Cuanzhu(BL2), Sibai(ST2), Taiyang(EX-HN5), Hegu(LI4), Taichong(LR3), a total of six acupoints.', 'interventionNames': ['Other: Acupuncture']}\n- {'label': 'Non-ophthalmological Acupoint Control Group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Non-ophthalmological acupoint control group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.\\n\\nAcupuncture points: Yinlingquan(SP9), Liangqiu (ST34),Xiajuxu(ST39), Yanglingquan (GB34), Shousanli(LI10), Sanyangluo(TE8), a total of six acupoints. The Non-ophthalmological acupoint control group points are not indicated for the treatment of ophthalmological related pathologies, and are not reported to improve ophthalmological function.', 'interventionNames': ['Other: Acupuncture placebo']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Acupuncture', 'description': \"The treatment will take place once a week, over six weeks. The needles will placed in the body for 20 minutes. A total of 12 Needles(6 acupoints, bilaterally) will be used in each session.Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation.\", 'armGroupLabels': ['Ophthalmic Acupoint Treatment Group']}\n- {'type': 'OTHER', 'name': 'Acupuncture placebo', 'description': \"A total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.The control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation.\", 'armGroupLabels': ['Non-ophthalmological Acupoint Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Intraocular pressure-pre-treatment', 'description': 'Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.', 'timeFrame': 'Every weeks pre-acupuncture treatment up to six weeks.'}\n- {'measure': 'Intraocular pressure-after-treatment', 'description': 'Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.', 'timeFrame': 'Every weeks 15 minutes after acupuncture treatment up to six weeks.'}\n- {'measure': 'Intraocular pressure-Change', 'description': 'Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.', 'timeFrame': 'Change from baseline intraocular pressure at 12 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nType I error (\u00ce\u00b1) of .05, statistical power of 95%, dropout rate of 25%", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation and Power\n Assuming an effect size of 0.40 and a type I error (\u00ce\u00b1) of .05, a sample size of 40 people (20 in each group) is required to achieve a statistical power of 95% CI. Assuming a dropout rate of 25%, a total of 50 people (25 in each group) is needed (Textbox 1).\n \n \n Inclusion and exclusion criteria.\n \n \nInclusion criteria\n\n \n \n Primary open-angle glaucoma was diagnosed at least 3 months ago\n \n \n Diagnosed with mild or moderate open-angle glaucoma\n \n \n Use 1 or 2 kinds of glaucoma drugs\n \n \n Age \u00e2\u0089\u00a520 years old\n \n \n All participants will be required to sign an informed consent form and cooperate with the experimental procedures\n \n \n \nExclusion criteria\n\n \n \n Accept any ophthalmic laser or surgery within 1 year\n \n \n High myopia (\u00e2\u0089\u00a46.0D)\n \n \n Use of any drugs that affect intraocular pressure\n \n \n Visual acuity with correction lower than 0.2\n \n \n Previous or existing uveitis or retinopathy\n \n \n Unable to receive acupuncture treatment continuously or allergic to acupuncture needles\n \n \n Pregnancy or breastfeeding\n \n \n Refusal to sign the informed consent form", "id": 1754, "split": "test"} +{"trial_id": "NCT05753761", "pmid": "38060584", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS)', 'type': 'EXPERIMENTAL', 'description': 'Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour.', 'interventionNames': ['Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention']}\n- {'label': 'Usual care:', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control arm program will consist of usual inpatient care including therapeutic mobilization by the physical therapy team and general mobilization, as tolerated, by the nursing team.', 'interventionNames': ['Behavioral: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention', 'description': 'Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.', 'armGroupLabels': ['Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS)', 'Usual care:']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks', 'description': 'Measure of global disability using the mRS score \\\\[grade 0-2 vs \u22653\\\\]', 'timeFrame': '6 and 12 weeks'}\n- {'measure': 'Change from Baseline Timed-Up and Go (TUG) test at 6 and 12 weeks', 'description': 'Functional mobility will be assessed using the TUG test', 'timeFrame': '6 and 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \npower of 0.81, significance level (\u03b1) of 0.05, 10% attrition rate", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n The sample size was estimated based on data from a previous feasibility study using an assumed difference of 3.8 seconds on the TUG test [9]. Thus, a sample of 45 participants will achieve a power of 0.81 in repeated measures using GEE at \u00ce\u00b1 = 0.05. With an anticipated 10% attrition, 50 participants will be recruited.", "id": 1755, "split": "test"} +{"trial_id": "NCT05754398", "pmid": "38241265", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Measuring the Effects of a Nurse-led Intervention on Frailty Status of Older Persons Living in the Community in Ethiopia: A Protocol for a Quasi-experimental Study\n\nIncluded conditions:\n- Frailty\n\nStudy Armgroups:\n- {'label': 'Single group will receive the nurse-led intervention', 'type': 'OTHER', 'description': 'A single group of community-dwelling older persons will receive a nurse-led intervention after an initial screening and eligibility checks.', 'interventionNames': ['Behavioral: six independent and interconnected educational training sessions']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'six independent and interconnected educational training sessions', 'description': 'Each of the six components will be offered each month for six consecutive months. Each session will last approximately 30 to 40 minutes.\\n\\nAll the six sessions will be delivered through a face-to-face approach.', 'armGroupLabels': ['Single group will receive the nurse-led intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in frailty status of community-dwelling older persons.', 'description': 'Changes in frailty will be measured using the Tilburg Frailty Indicator (TFI). The TFI comprises 15 self-reported questions, divided into three distinct domains. The physical, psychological, and social domains are the three distinct domains that constitute the TFI. The physical domain consists of eight questions related to different physical health of older persons. The psychological domain contains four items related to the psychological health of older persons. The last domain, the social domain has three questions related to social relations. Eleven items of the TFI have two response categories as \"yes\" or \"no\" options, while three items from the psychological domain and one item from the social domain have three response categories as \"yes\", \"no,\" or \"sometimes\". The instrument\\'s total score ranges from 0 to 15: the higher the score, the higher one\\'s frailty. Frailty is diagnosed when the total TFI score is \u22655.', 'timeFrame': 'Change in frailty will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention'}\n\nPlease estimate the sample size based on the assumption: \ntwo-tailed test with an alpha value of 0.05, power of 0.95, Wilcoxon signed-rank test, 10 to 20% withdrawal rate", "answer": 68, "answer_type": "ACTUAL", "explanation": "Sample size\n The study sample size was calculated using a priori computation of sample size using G* Power version 3.1.9.4 [68] with assumption of a two-tailed test with an alpha value of 0.05, effect size (f) of 0.5, and a power of 0.95. The power was set using a Wilcoxon signed-rank test based on normal parent distribution methods. Using this equation, we estimate that 57 participants will be recruited for this study. By considering a 10 to 20% [23, 29] withdrawal rate during the intervention, at least 68 study participants will be required.", "id": 1756, "split": "test"} +{"trial_id": "NCT05755789", "pmid": "39880423", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery: a Multicentre, Double-blind, Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Antibiotic Prophylaxis\n- Colorectal Surgery\n\nStudy Armgroups:\n- {'label': 'Intervention group (innovative administration scheme)', 'type': 'EXPERIMENTAL', 'description': 'Continuous infusion of cefoxitin + Intermittent placebo', 'interventionNames': ['Drug: Loading bolus of cefoxitin', 'Drug: Continuous infusion of cefoxitin', 'Drug: Intermittent placebo']}\n- {'label': 'Control group (recommended administration scheme)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intermittent cefoxitin + Continuous infusion of placebo', 'interventionNames': ['Drug: Loading bolus of cefoxitin', 'Drug: Intermittent cefoxitin', 'Drug: Continuous infusion of placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Loading bolus of cefoxitin', 'description': 'Cefoxitin \\\\[2g\\\\] before incision', 'armGroupLabels': ['Control group (recommended administration scheme)', 'Intervention group (innovative administration scheme)']}\n- {'type': 'DRUG', 'name': 'Intermittent cefoxitin', 'description': 'Additional bolus of cefoxitin \\\\[1g\\\\] every 2 hours until the end of surgical closure', 'armGroupLabels': ['Control group (recommended administration scheme)']}\n- {'type': 'DRUG', 'name': 'Continuous infusion of placebo', 'description': 'Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure', 'armGroupLabels': ['Control group (recommended administration scheme)']}\n- {'type': 'DRUG', 'name': 'Continuous infusion of cefoxitin', 'description': 'Continuous infusion of cefoxitin \\\\[0.5g/h\\\\] from the end of the loading bolus until the end of surgical closure', 'armGroupLabels': ['Intervention group (innovative administration scheme)']}\n- {'type': 'DRUG', 'name': 'Intermittent placebo', 'description': 'Additional bolus of placebo every 2 hours until the end of surgical closure', 'armGroupLabels': ['Intervention group (innovative administration scheme)']}\n\nPrimary Outcomes:\n- {'measure': 'Surgical site infection', 'description': 'Proportion of patients with any surgical site infection according to the CDC criteria', 'timeFrame': 'within 30 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \n5% type I error, 80% power, 3% to 5% lost to follow-up", "answer": 2000, "answer_type": "ESTIMATED", "explanation": "Sample size\n Including studies on elective and emergency surgeries of colon and rectum, the last Cochrane meta-analysis reported an SSI incidence rate of 13.3%.3 In a previous PK/PD study, we have demonstrated that a loading dose followed by continuous infusion regimen doubled the proportion of patients fully covered by SAP (from 47% to 97% of patients).15 Assuming a 13% rate of SSI in the control group and 30% reduction of SSI rate in the intervention group, a total of 2000 patients are needed to demonstrate this difference between the two groups with a 5% type I error and a power of 80% in a two-sided test with lost to follow-up of 3% to 5%.", "id": 1757, "split": "test"} +{"trial_id": "NCT05758740", "pmid": "37198670", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of an E-health Brisk Walking Intervention in Increasing Moderate to Vigorous Physical Activity in Physically Inactive Older People With Cognitive Frailty: A Randomised Controlled Trial\n\nIncluded conditions:\n- Cognitive Frailty\n\nStudy Armgroups:\n- {'label': 'E-health enhanced behavioural change intervention', 'type': 'EXPERIMENTAL', 'description': 'The investigators will administer e-health behavioural change techniques (e.g., automated advice, tele-counselling, digital-tailored advice) on top of the conventional behavioural change techniques (e.g., information provision, goal setting) via digital devices (i.e., smartphone) to promote moderate-to-vigorous physical activity of the participants.', 'interventionNames': ['Behavioral: E-health enhanced behavioural change intervention']}\n- {'label': 'Conventional behavioural change intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'The investigators will administer conventional behavioural change techniques (e.g., information provision, goal setting) via conventional methods (i.e., face-to-face meetings) to promote moderate-to-vigorous physical activity of the participants.', 'interventionNames': ['Behavioral: Conventional behavioural change intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'E-health enhanced behavioural change intervention', 'description': 'Participants will first receive a face-to-face brisk-walking training programme with lectures and demonstrations following a standardized brisk training content. The training will be provided face-to-face at the elderly community centres and parks. Each training session lasts for one hour and is two times per week for two weeks. After that, a conventional behavioural change intervention will begin following a standardized intervention implementation manual and the physical activity amount will be logged by the participants using a logbook. Physical activity counselling will be conducted by a trained research assistant face-to-face at the elderly community centre. Each counselling session lasts for one hour and is once per week for 12 weeks.', 'armGroupLabels': ['E-health enhanced behavioural change intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Conventional behavioural change intervention', 'description': \"Participants will first receive a face-to-face brisk-walking training programme with lectures and demonstrations following a standardized brisk training content. The training will be provided face-to-face at the elderly community centres and parks. Each training session lasts for one hour and is two times per week for two weeks. After that, e-health enhanced behavioural change intervention will begin following a standardized intervention implementation manual and using participants' own smartphones installed with two Apps (i.e., Samsung Health and WhatsApp). The physical activity amount will be logged by the smartphone using Samsung Health. Physical activity counselling will be conducted by a trained research assistant remotely using a smartphone. The remote counselling sessions totally last for accumulatively 1 hour per week for 12 weeks.\", 'armGroupLabels': ['Conventional behavioural change intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Moderate-to-vigorous physical activity (MVPA) minute, measured by Actigraph', 'description': 'ActiGraph mounted on the right wrist measures physical movement (i.e., vector magnitude) that counts an MVPA minute when it has measured 4,212.9 counts within a minute. Only at least 10 min of continuous MVPA will be counted as valid MVPA minutes. This variable measures valid MVPA minutes accumulated over 7 consecutive days.', 'timeFrame': '14 weeks'}\n- {'measure': 'Moderate-to-vigorous physical activity (MVPA) minute, measured by Actigraph', 'description': 'ActiGraph mounted on the right wrist measures physical movement (i.e., vector magnitude) that counts an MVPA minute when it has measured 4,212.9 counts within a minute. Only at least 10 min of continuous MVPA will be counted as valid MVPA minutes. This variable measures valid MVPA minutes accumulated over 7 consecutive days.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level at 0.05, power at 0.9, 3 repeated measures (T0, T1, T2), 2 groups (intervention and control) with a 1:1 allocation ratio, and a cumulative dropout rate of 18.1% at T1 and T2.", "answer": 184, "answer_type": "ESTIMATED", "explanation": "Sample size\n We adopt a priori power analysis using the Web-based software GLIMMPSE and employ a general linear mixed model [54]. We set the level of significance at 0.05, the power at 0.9, the number of repeated measures at 3 (i.e. T0, T1, T2), the number of groups at 2 (i.e. the intervention and control groups) and the allocation ratio between the two groups at 1:1. To estimate the effects, we estimate the immediate effect of the intervention according to the effect on the primary outcome compared between two groups with the same interventions (i.e. e-health vs conventional behavioural change intervention) as reported in the pilot study of this project [55]. We assume the effects to be sustained until the 6-month follow-up. We estimate that the sample size is 132. We assume a cumulative drop-up rate of 18.1% at T1 and T2 [56]. The total sample size estimated is 184 participants, with 92 participants in each group.", "id": 1758, "split": "test"} +{"trial_id": "NCT05760339", "pmid": "39842917", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial\n\nIncluded conditions:\n- Perioperative Care\n- Intermittent Fasting\n- Carbohydrate Loading\n- Preoperative Fasting\n- Orthopedic Surgery\n- Insulin Resistance\n\nStudy Armgroups:\n- {'label': 'Time-restricted feeding', 'type': 'EXPERIMENTAL', 'description': 'Subjects will follow a daily time-restricted feeding regimen consisting of an 8h ad libitum eating period and a 16h water fasting period during the last two weeks before surgery, followed by routine preoperative fasting before surgery.', 'interventionNames': ['Behavioral: Time-restricted feeding']}\n- {'label': 'Carbohydrate loading', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects will follow their usual diet in the pre-surgical weeks and will receive a maltodextrin beverage on the evening before surgery, as well as two hours before induction of anaesthesia', 'interventionNames': ['Dietary Supplement: Carbohydrate loading']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Subjects will continue their usual diet and proceed with standard preoperative fasting (i.e., eat up until 6 hours and take clear liquids up until 2 hours before induction of anaesthesia).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Time-restricted feeding', 'description': 'Subjects in the will be instructed to follow a TRF regimen consisting of a daily 8h ad libitum eating period and 16h water fasting period during the last 2 weeks before surgery. Participants will be encouraged to begin their eating period at 08:00h and end it at 16:00h, since the metabolic benefits of TRF appear to be considerably more pronounced when the eating period starts early in the day.', 'armGroupLabels': ['Time-restricted feeding']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Carbohydrate loading', 'description': 'Subjects will continue their usual diet and will receive two quantities of a clear beverage containing 12.5 g/100 mL maltodextrin (50 kCal/100 mL, pH 5.0); 800 mL at 22.00h on the evening before surgery and 400 mL two hours before anaesthesia induction.', 'armGroupLabels': ['Carbohydrate loading']}\n\nPrimary Outcomes:\n- {'measure': 'Insulin resistance on postoperative day 1', 'description': 'Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)', 'timeFrame': 'Postoperative day 1'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, significance level (\u03b1) of 2.5% for two comparisons with two-sided Student\u2019s t-tests, and a 20% dropout rate in the TRF group.", "answer": 75, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was estimated using the sample size calculation software nQuery V.8.5.1 (Statsols, San Diego, California, USA). In a previous trial, HOMA2-IR on postoperative day 1 was 1.2\u00c2\u00b10.1 in a CHL group.41 In order to detect a 10% difference with a power of 90%, using an \u00ce\u00b1 of 2.5% to account for two comparisons with two-sided Student\u00e2\u0080\u0099s t-tests, we would need 23 patients per group. Considering a 20% dropout rate in the TRF group, we would require 29 patients in the TRF group in order to reach 23 patients in each group for the \u00e2\u0080\u0098as-treated analysis\u00e2\u0080\u0099, amounting to a total sample size of 75 patients.", "id": 1759, "split": "test"} +{"trial_id": "NCT05761275", "pmid": "37678943", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial\n\nIncluded conditions:\n- Gynecologic Disease\n- Adnexal Mass\n- Adnexal Cyst\n- Sexuality\n- Adnexal Diseases\n- Sexual Dysfunction\n- Quality of Life\n- Pathology\n- Dyspareunia\n- Pelvic Pain\n- Complication\n\nStudy Armgroups:\n- {'label': 'Conventional Abdominal Laparoscopy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Use of conventional transabdominal laparoscopy as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization).', 'interventionNames': ['Procedure: Elective cystectomy', 'Procedure: Elective oophorectomy', 'Procedure: Elective salpingectomy', 'Procedure: Elective tubal sterilization']}\n- {'label': 'vNOTES', 'type': 'EXPERIMENTAL', 'description': 'Use of vNOTES (Transvaginal Natural Orifice Transluminal Endoscopic Surgery) as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization).', 'interventionNames': ['Procedure: Elective cystectomy', 'Procedure: Elective oophorectomy', 'Procedure: Elective salpingectomy', 'Procedure: Elective tubal sterilization']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Elective cystectomy', 'description': 'Adnexal cyst removal for presumed benign adnexal pathology.', 'armGroupLabels': ['Conventional Abdominal Laparoscopy', 'vNOTES']}\n- {'type': 'PROCEDURE', 'name': 'Elective oophorectomy', 'description': 'Ovarian removal for presumed benign adnexal pathology.', 'armGroupLabels': ['Conventional Abdominal Laparoscopy', 'vNOTES']}\n- {'type': 'PROCEDURE', 'name': 'Elective salpingectomy', 'description': 'Tubal removal for presumed benign adnexal pathology.', 'armGroupLabels': ['Conventional Abdominal Laparoscopy', 'vNOTES']}\n- {'type': 'PROCEDURE', 'name': 'Elective tubal sterilization', 'description': 'Tubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips/ligatures).', 'armGroupLabels': ['Conventional Abdominal Laparoscopy', 'vNOTES']}\n\nPrimary Outcomes:\n- {'measure': \"Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire.\\n\\nFSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.\", 'timeFrame': 'Preoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire.\\n\\nFSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.\", 'timeFrame': '3 months postoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire.\\n\\nFSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.\", 'timeFrame': '6 months postoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire.\\n\\nCSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.\", 'timeFrame': 'Preoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire.\\n\\nCSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.\", 'timeFrame': '3 months postoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire.\\n\\nCSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.\", 'timeFrame': '6 months postoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia.\\n\\nThis questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.\", 'timeFrame': 'Preoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia.\\n\\nThis questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.\", 'timeFrame': '3 months postoperative'}\n- {'measure': \"Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia\", 'description': \"Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia.\\n\\nThis questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.\", 'timeFrame': '6 months postoperative'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 80%, SD of 3, and a dropout rate of 10%. Sensitivity analyses will be conducted to verify the results.", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size was calculated considering the mean difference in the preoperative and postoperative FSFI score, and comparing such difference between women treated with CAL and with a vNOTES approach (www.sealedenvelope.com). If there is truly no difference between CAL and vNOTES in terms of FSFI score, then a sample size of 56 patients (28\u00e2\u0080\u0089women per group) is needed to be 80% sure that the lower limit of a one-sided 95% CI will be above \u00e2\u0088\u0086 \u00e2\u0088\u00922, with a significance level of 5%.\n We considered an SD of 3. We selected the non-inferiority margin based on previously published literature according to which a mean difference of FSFI score by as much as 2 was not statistically significant between the abdominal laparoscopic and vaginal approach for hysterectomy.20 Similarly, a study evaluating the FSFI after surgery for endometriosis found a statistically significant difference between the preoperative score of 19.1 and the postoperative score of 22.7.21\n We expect a dropout rate of 10% over the study period, which makes it reasonable to increase the total sample size to 62 patients (31 patients per group).\n Sensitivity analyses will be conducted to verify whether the exclusion of participants who no longer conform to the protocol may alter the study\u00e2\u0080\u0099s final results in order to show non-inferiority in both the intention-to-treat and the per-protocol populations.22 Reasons for non-conformity may include, among others, the patient\u00e2\u0080\u0099s preference for one of the two surgical techniques, the patient\u00e2\u0080\u0099s personal decision to dropout of the study after initial inclusion and surgical complications affecting the woman\u00e2\u0080\u0099s intraoperative and postoperative course.\n The division of Gynaecology of the Geneva University Hospitals surgically treats an average of 100 BAS per year. Expecting a recruitment rate of 31%, we believe that our study will take 2\u00e2\u0080\u0089years to be completed. A 6-month pilot phase will be conducted to test our recruitment rate and extend the study duration if necessary.", "id": 1760, "split": "test"} +{"trial_id": "NCT05761613", "pmid": "38309761", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ceragenin Coated Endotracheal Tubes for the Eradication of Ventilator Associated Pneumonia - A Prospective, Longitudinal, Cross-over, Interrupted Time, Implementation Study (CEASE VAP Study)\n\nIncluded conditions:\n- Ventilator Associated Pneumonia\n\nStudy Armgroups:\n- {'label': 'Endotracheal Tube with Subglottic Secretion Drainage', 'type': 'ACTIVE_COMPARATOR', 'description': 'All patients in this arm will be intubated with an ETT with subglottic secretion drainage', 'interventionNames': ['Device: Endotracheal tube with subglottic secretion drainage']}\n- {'label': 'CeraShield Endotracheal Tube', 'type': 'ACTIVE_COMPARATOR', 'description': 'All patients in this arm will be intubated with a ceragenin coated ETT', 'interventionNames': ['Device: CeraShield Endotracheal Tube']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CeraShield Endotracheal Tube', 'description': 'An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)', 'armGroupLabels': ['CeraShield Endotracheal Tube']}\n- {'type': 'DEVICE', 'name': 'Endotracheal tube with subglottic secretion drainage', 'description': 'An endotracheal tube with subglottic secretion drainage', 'armGroupLabels': ['Endotracheal Tube with Subglottic Secretion Drainage']}\n\nPrimary Outcomes:\n- {'measure': 'Occurrence of Ventilator Associated Pneumonia', 'description': 'The primary outcome will be the occurrence of VAP defined as new, progressive, or persistent radiographic infiltrate on chest radiograph plus any 2 of the following: (1) fever (core temperature \\\\>38\u00b0C) or hypothermia (temperature \\\\<36\u00b0C); (2) white blood cell count less than 3.0 \u00d7 106/L or exceeding 10 \u00d7 106/L, and (3) purulent sputum', 'timeFrame': 'Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error rate of 5%, 80% power, less than 10% missing data considered acceptable.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n All critically ill adult patients with respiratory failure requiring intubation and who receive the assigned ETT during the respective study periods will be included. Patients admitted to the hospital or ICU with a non-study ETT already in place and those unable to be intubated with a study ETT will be excluded. We will also exclude patients with a tracheostomy on ICU admission and those who decline participation in research in general or data collection. There will be two a priori specified subgroups: (1) patients who are intubated for greater than 48 hours and (2) patients in whom a tracheotomy is performed according to clinical indications. The tracheostomy will be performed with a standard tracheotomy tube.\n Each ETT will be used for two study periods of 11\u00e2\u0080\u009312 weeks, with an anticipated enrollment rate of 100 mechanically ventilated patients during each study period based on current centre data.8 This yields an estimated 200 patients for each type of ETT or a total sample size of 400 patients overall. With a baseline VAP incidence of 20%, 200 patients per group and a type 1 error rate of 5%, there will be 80% power to detect a relative risk of 0.50 or a 50% reduction in VAP using a Z-test for two proportions. Although not powered to detect small differences between the ETTs, this study is not designed as definitive, and the data collected will be used to determine the acceptability and feasibility of a larger definitive study.\n To account for potential clustering, a modified Poisson regression model with robust SEs controlling for intervention period, calendar season and admission diagnosis will be used to determine a relative risk of VAP using the CSA ETT versus the standard ETT.\n For secondary outcomes, between-group differences in ventilator-free days and antibiotic-free days will be assessed via a Wilcoxon rank-sum test. Differences in incidence of postextubation stridor, lack of cuff leak and reintubation will be assessed via a \u00cf\u00872 test. Differences in duration of ICU stay and hospital stay will be assessed via the Fine and Gray subdistribution hazards model to account for death as a competing risk.41\n A priori set targets will be used to determine feasibility. For acceptability of the intervention, 80% of surveyed staff and patients/substitute decision-makers will need to indicate acceptability to be deemed feasible. Resources required for study implementation will be recorded and will need to be similar between study periods. Sample size considerations supported by preliminary evidence of efficacy will determine the size and resources required for the definitive study and will also inform its feasibility. It will be important for the conduct of future studies that only data generated from routine care be used to ensure generalisability for wide-scale implementation; less than 10% missing data will be considered acceptable a priori. Adverse events directly attributed to the ETTs will be assessed via a \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test if expected cell counts are less than 10.", "id": 1761, "split": "test"} +{"trial_id": "NCT05764369", "pmid": "38816058", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing Residential Treatment Gains for Adolescents Through Tailored Behavioral Parent Training\n\nIncluded conditions:\n- Parenting\n- Adolescent - Emotional Problem\n- Mental Disorder in Adolescence\n\nStudy Armgroups:\n- {'label': 'Parenting Wisely Residential Treatment (PWRT)', 'type': 'EXPERIMENTAL', 'description': 'In the PWRT condition, parents will complete a total of ten web-based modules in an online parent training program called Parenting Wisely. Each week, parents will also attend a 90-minute facilitated discussion group via Zoom. Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap. While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3).', 'interventionNames': ['Behavioral: Parenting Wisely Residential Treatment (PWRT)']}\n- {'label': 'Treatment as Usual (TAU)', 'type': 'PLACEBO_COMPARATOR', 'description': \"The TAU condition is the standard of care offered to parents in RT settings. Parents in the TAU condition will receive traditional programming, including family therapy offered weekly during the RT admission. Parents will attend discharge planning meetings with caseworkers (if assigned) to discuss the adolescent's progress, continued treatment needs, safety plans, upcoming appointments, and medication needs. Following discharge, programs frequently recommend follow-up with an outpatient provider for medication management and therapy for the adolescent. Parents will complete assessments at baseline (T1), six weeks post-baseline (T2), and six months post-baseline (T3) via REDCap. While adolescents (n=60) will not directly receive the intervention, they will complete assessments at baseline, six weeks post-baseline (T2), and six months post-baseline (T3).\", 'interventionNames': ['Behavioral: TAU']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Parenting Wisely Residential Treatment (PWRT)', 'description': 'PWRT experimental intervention', 'armGroupLabels': ['Parenting Wisely Residential Treatment (PWRT)'], 'otherNames': ['Parenting Wisely', 'PW']}\n- {'type': 'BEHAVIORAL', 'name': 'TAU', 'description': 'The TAU condition is the standard of care offered to parents in RT settings.', 'armGroupLabels': ['Treatment as Usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Group attendance frequency (Feasibility)', 'description': 'Group attendance is tracked and an average attendance rate across all sessions will be calculated', 'timeFrame': 'Average calculated from baseline to 6-weeks post-baseline'}\n- {'measure': 'Parenting Wisely login frequency (Feasibility)', 'description': 'The number of logins to Parenting Wisely is tracked and an average logins across all sessions will be calculated', 'timeFrame': 'Average calculated from baseline to 6-weeks post-baseline'}\n- {'measure': 'Dose of PWRT (Feasibility)', 'description': 'The number of modules in Parenting Wisely that are completed are tracked and an average completion rate across all sessions will be calculated', 'timeFrame': 'Average calculated from baseline to 6-weeks post-baseline'}\n- {'measure': 'Duration of PW modules (Feasibility)', 'description': 'The time spent completing modules in Parenting Wisely are tracked and an average duration rate across all sessions will be calculated', 'timeFrame': 'Average calculated from baseline to 6-weeks post-baseline'}\n- {'measure': 'Duration of group (Feasibility)', 'description': 'The time spent in group is tracked and an average duration rate across all sessions will be calculated', 'timeFrame': 'Average calculated from baseline to 6-weeks post-baseline'}\n- {'measure': 'PWRT Acceptability', 'description': 'Parents will complete an investigator-developed satisfaction survey to evaluate the acceptability of PWRT. The satisfaction survey consists of 13-items. Total scores range from 0-39; higher scores indicate greater perceptions of acceptability.', 'timeFrame': '6-weeks post-baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided alpha level of 0.025 to adjust for multiple comparisons, with a power of 80% to detect a large effect size. The attrition rate is assumed to be 20% at 6 months post baseline. The statistical power for small-to-medium effect sizes is 6%-29%. The study will report point estimates, precision (95% CI), and effect sizes.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n We will recruit 60 parents (30 per condition) to account for an attrition rate of 20% at 6 months post baseline, resulting a final sample of 48 (24 per condition) for analysis. The sample size is sufficient for assessing feasibility and acceptability measures of targeted \u00e2\u0089\u00a550% within a width of \u00c2\u00b121% for a two-sided 95% CI. The study was not designed to be adequately powered to detect efficacy. We conducted a power analysis using mixed effects linear modelling for repeated measures and a two-sided alpha level of 0.025 to adjust for multiple comparisons from two repeated post-treatment measures for the purpose of guiding result interpretation. A sample size of 48 parents has sufficient power (80%) to detect a large effect size (Cohen\u00e2\u0080\u0099s d=0.9) for between-group differences. Published studies reported small-to-medium effect sizes of 0.2 (eg, for parenting practices) to 0.46 (eg, for adolescent behaviours) for the intervention effect of PW.14 23 We expect the intervention augmentation (ie, adding a group to PW) will result in additional improvement in the outcomes with small-to-medium effect sizes of 0.2 to 0.5. The corresponding statistical power is 6%\u00e2\u0080\u009329%. Due to this study\u00e2\u0080\u0099s pilot nature, we will not rely on statistical power, but will report point estimates, precision (eg, 95% CI) and effect sizes. With our sample size and a two-sided 95% CI, we will have \u00c2\u00b10.40\u00cf\u0083 precision to estimate group-specific means and \u00c2\u00b10.58\u00cf\u0083 precision to estimate between-group mean differences.", "id": 1762, "split": "test"} +{"trial_id": "NCT05770908", "pmid": "39038866", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial\n\nIncluded conditions:\n- Rotator Cuff Impingement Syndrome\n- Rotator Cuff Tendinitis\n- Rotator Cuff Related Shoulder Pain\n\nStudy Armgroups:\n- {'label': 'Multimedia animation videos plus paper-based therapeutic exercise program', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Therapeutic exercise program', 'Other: Multimedia animation information', 'Other: Paper-based information']}\n- {'label': 'Paper-based therapeutic exercise program', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Therapeutic exercise program', 'Other: Paper-based information']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Therapeutic exercise program', 'description': 'Therapeutic exercise program based on increasing resistance with elastic bands or weights. The programmes are composed of combinations of the following exercises:\\n\\n* Scaption with elastic band.\\n* External rotation at 0\u00ba of abduction with elastic band.\\n* Internal rotation at 0\u00ba of abduction with elastic band.\\n* Shoulder protraction in supine position with weights.\\n* Low row with elastic band.\\n* Horizontal adduction stretching.', 'armGroupLabels': ['Multimedia animation videos plus paper-based therapeutic exercise program', 'Paper-based therapeutic exercise program']}\n- {'type': 'OTHER', 'name': 'Multimedia animation information', 'description': 'Multimedia animation videos (including audio) showing the performance of the prescribed exercises.', 'armGroupLabels': ['Multimedia animation videos plus paper-based therapeutic exercise program']}\n- {'type': 'OTHER', 'name': 'Paper-based information', 'description': 'Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.', 'armGroupLabels': ['Multimedia animation videos plus paper-based therapeutic exercise program', 'Paper-based therapeutic exercise program']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Shoulder Pain and Disability Index (SPADI)', 'description': 'The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)', 'timeFrame': 'Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week'}\n\nPlease estimate the sample size based on the assumption: \n1:1 allocation ratio, 95% confidence interval, and a 15% drop-out rate.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was conducted using the \u00e2\u0080\u0098MBESS\u00e2\u0080\u0099 package32 of the software R v4.1.0 and was based on the precision of the adjusted between-group mean difference in Shoulder Pain and Disability Index (SPADI) at 3-month follow-up (primary outcome), from an analysis of covariance including baseline measure as a covariate. According to the results of previous publications, an equal SD of 25 points was considered for both groups.33 It was assumed a 1:1 allocation ratio, and a correlation of 0.50 between repeated measures.34 A 95% CI width of 16 was considered acceptable because the smallest value of the minimum clinically important difference reported in the literature for SPADI is eight points.35 The estimated sample size was 112 subjects. Assuming a 15% drop-out rate, the final sample size was composed of 132 subjects (66 per group).", "id": 1763, "split": "test"} +{"trial_id": "NCT05774236", "pmid": "39349375", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cook\u00b4s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)\n\nIncluded conditions:\n- Fetal Growth Retardation\n\nStudy Armgroups:\n- {'label': 'Cook\u00b4s balloon', 'type': 'EXPERIMENTAL', 'description': 'Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet', 'interventionNames': ['Device: Cook\u00b4s balloon']}\n- {'label': 'Vaginal dinoprostone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Vaginal delivery system containing 10 mg dinoprostone (Prostaglandin E2) dispersed throughout its matrix and releasing approximately 0.3 mg/hour dinoprostone over a 24-hour period.', 'interventionNames': ['Drug: Vaginal dinoprostone']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Cook\u00b4s balloon', 'description': 'Cervical ripening for induction of labor with a mechanical method (Cook\u00b4s balloon)', 'armGroupLabels': ['Cook\u00b4s balloon'], 'otherNames': ['Cook\u00ae Cervical Ripening Balloon with Stylet', 'Double balloon catheter']}\n- {'type': 'DRUG', 'name': 'Vaginal dinoprostone', 'description': 'Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone)', 'armGroupLabels': ['Vaginal dinoprostone'], 'otherNames': ['Dinoprostone vaginal insert', 'Controlled-release dinoprostone delivery system', 'Vaginal prostaglandin E2']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of vaginal delivery', 'description': 'To assess whether cervical ripening with a Cook balloon for induction of labor of term pregnancies with FGR increases the rates of vaginal delivery with respect to the use of vaginal dinoprostone, without increasing neonatal morbidity.', 'timeFrame': '2 days (from admission to delivery)'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided test with early stopping, alpha level of 0.025, statistical power of 90%, two-stage sequential design using the O'Brien-Fleming method, 1:1 allocation to treatment.", "answer": 172, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size needed to evaluate that cervical ripening with Cook\u00e2\u0080\u0099s balloon for induction of labour at term in singleton pregnancies with stage I FGR achieves an increased probability of vaginal delivery compared with the use of vaginal dinoprostone, was calculated assuming that the vaginal delivery rate was 84.5% with mechanical methods vs 62.3% with prostaglandins (reported effect size: relative risk of 1.4, 95% CI 1.1 to 1.6 and absolute risk reduction of caesarean section of 22.2%).12 In a one-sided test (H1) with early stopping to reject or accept H0 at an alpha level of 0.025 and statistical power of 90% with two-stage sequential design using the O'Brien-Fleming method, with 1:1 allocation to treatment, a total of 162 participants are required, 81 in each group. Due to possible losses, the sample is increased by 5% and consists of a total of 172 pregnant women, 86 in each group.\n The programming code and the result are provided in the statistical analysis plan provided in online supplemental material.", "id": 1764, "split": "test"} +{"trial_id": "NCT05776381", "pmid": "37963688", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study\n\nIncluded conditions:\n- Shared Decision Making\n- Colonic Polyp\n- Decision Aids\n- Rectal Polyp\n- Colorectal Polyp\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Shared Decision Making (SDM)', 'type': 'EXPERIMENTAL', 'description': 'Patients with an unexpected malignant colorectal polyp where a decision needs to be made concerning the management of care.', 'interventionNames': ['Other: Shared Decision Making using a Patient Decision Aid.']}\n- {'label': 'Historical data arm', 'type': 'NO_INTERVENTION', 'description': 'Historical data on the management of patients with an unexpected malignant colorectal polyp from February 2018 to the end of 2022 retrieved through the Danish Colorectal Cancer Group Database, the National Pathology database and the National Patient Register.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Shared Decision Making using a Patient Decision Aid.', 'description': 'The intervention comprises the surgeon actively using the tailored PtDA and SDM with the patient when deciding on the management of an unexpected malignant colorectal polyp.', 'armGroupLabels': ['Shared Decision Making (SDM)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe trial uses Simon's two-stage mini-max design with a significance level of 5% and power of 80%. An estimated drop-out rate of 20% is considered. Data from stage 1 will be analyzed using interim analyses, and if the trial continues to stage 2, data will be further analyzed using inference analyses.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size\n The trial is based on Simon\u00e2\u0080\u0099s two-stage mini-max design.27 According to the DCCG database, approx. 45% of all patients with a small polyp cancer are currently treated with a subsequent bowel resection. The hypothesis is that the use of SDM principles and a PtDA will reduce the number of subsequent bowel resections by 30% (to 0.7%\u00c3\u009745%=32%; absolute risk reduction of 13%). In other words, the target is to increase the percentage of non-resected patients from 55% to 68%; With a significance level of 5% and power of 80%, the trial must initially include 51 patients in stage 1 of Simon\u00e2\u0080\u0099s two-stage design. If 27 or fewer of these patients end up being treated conservatively (ie, without resection), the trial will be terminated owing to insufficient effect. However, if more than 27 patients are treated conservatively, the study will move on to stage 2 and include a further 36 patients. The total number of included patients will amount to 87, and if more than 56 of these are treated conservatively, we will conclude that the PtDA intervention is sufficiently promising to warrant a phase III trial. To account for a drop-out rate of 20%, a total of 110 patients will be included. Data from stage 1 will be analysed using interim analyses and if the trial continues to stage 2, data will be further analysed using inference analyses.\n The yearly numbers of registered endoscopically resected malignant colorectal polyps have been identified in the DCCG database for each department in Denmark. The departments participating will be selected based on this patient flow and their number of cases per year. With an estimated accrual rate of 70% the participating departments will be able to recruit the estimated number of patients within approximately 12 months.", "id": 1765, "split": "test"} +{"trial_id": "NCT05777005", "pmid": "39312291", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Promoting Smoking Cessation in Campus Via Smoking Cessation Contest: a Chatbot-based Smoking Cessation Intervention\n\nIncluded conditions:\n- Smoking Cessation\n- Mobile Health\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': \"5A's/5R's advice+ Chatbot-led group support+ Counselor-led individual support+ health warning leaflet+ Self-help booklet\", 'interventionNames': [\"Behavioral: 5A's/5R's advice\", 'Other: Brief leaflet on health warning and smoking cessation', 'Other: Self-help smoking cessation booklet', 'Behavioral: Counselor-led individual support', 'Behavioral: Chatbot-led group support']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': \"5A's/5R's advice+ Chatbot-led group support+ health warning leaflet+ Self-help booklet\", 'interventionNames': [\"Behavioral: 5A's/5R's advice\", 'Other: Brief leaflet on health warning and smoking cessation', 'Other: Self-help smoking cessation booklet', 'Behavioral: Chatbot-led group support']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': \"5A's/5R's advice\", 'description': \"5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.\", 'armGroupLabels': ['Control group', 'Intervention group']}\n- {'type': 'OTHER', 'name': 'Brief leaflet on health warning and smoking cessation', 'description': 'The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.', 'armGroupLabels': ['Control group', 'Intervention group']}\n- {'type': 'OTHER', 'name': 'Self-help smoking cessation booklet', 'description': 'The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.', 'armGroupLabels': ['Control group', 'Intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Counselor-led individual support', 'description': 'Participants will receive three months of counselor-led individual support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Chatbot-led group support', 'description': 'Participants will receive three months of chatbot-led group support via WeChat.', 'armGroupLabels': ['Control group', 'Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Participation rate of eligible smokers', 'description': 'the percentage of eligible smokers out of the total number of smokers screened', 'timeFrame': 'Baseline'}\n- {'measure': 'Biochemical validated quit rate at 6 months follow-up', 'description': 'The primary outcomes are biochemically validated quit rate (exhaled CO \\\\< 4 ppm or salivary cotinine \\\\< 30 ng/ml)', 'timeFrame': '6 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 10% attrition rate", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample Size\n There is no fixed rule for calculating sample size for a pilot study [29]. Prior research on the estimation of sample sizes for pilot studies indicates that a sample of 50 participants per group should be sufficient to achieve 80% power to detect differences between groups [30] on the assumption of a 5% significance level and a 10% attrition rate. Therefore, a total of 150 participants will be recruited for this study.", "id": 1766, "split": "test"} +{"trial_id": "NCT05777070", "pmid": "37770277", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Remote Ischemic Conditioning Combined With Bimanual Task Training to Enhance Bimanual Skill Learning and Corticospinal Excitability in Children With Unilateral Cerebral Palsy\n\nIncluded conditions:\n- Unilateral Cerebral Palsy\n\nStudy Armgroups:\n- {'label': 'Remote Ischemic Conditioning (RIC)', 'type': 'EXPERIMENTAL', 'description': 'RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 1-7.', 'interventionNames': ['Behavioral: Bimanual Cup Stacking Training']}\n- {'label': 'Sham conditioning', 'type': 'SHAM_COMPARATOR', 'description': 'Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 1-7.', 'interventionNames': ['Behavioral: Bimanual Cup Stacking Training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Bimanual Cup Stacking Training', 'description': 'Children practices bimanual cup stacking, 15 trials/day for 5 consecutive days', 'armGroupLabels': ['Remote Ischemic Conditioning (RIC)', 'Sham conditioning'], 'otherNames': ['Remote limb ischemic conditioning', 'Sham conditioning']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Bimanual Learning', 'description': 'The time (seconds) to complete each trial of cup stack, which will be averaged across nine trials. This will be measured at visit 1 (pre-) and visit 7 (post-intervention).', 'timeFrame': 'Baseline and 1 week'}\n- {'measure': 'Change in Symmetric performance and tangential velocities', 'description': 'Symmetric performance is characterized as a time-lag between the affected and less affected arm during movement onset and task completion.', 'timeFrame': 'Baseline and 1 week'}\n- {'measure': 'Change in Resting Motor Threshold (rMT)', 'description': 'The rMT is the stimulator output required to produce a motor evoked potential (MEP) of \\\\> 50 \u03bcV in at least 5/10 trials in FDI muscle.', 'timeFrame': 'Baseline and 1 week'}\n- {'measure': 'Change in Active Motor Threshold (aMT)', 'description': 'The aMT is the stimulator output required to produce a motor evoked potential (MEP) of \\\\> 200 \u03bcV in FDI muscle during 30% of MVIC of FDI muscle using a pinch grip. aMT is a measure of motor cortex excitability.', 'timeFrame': 'Baseline and 1 week'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided t-test, significance level (\u03b1) of 0.05, 80% power, and a 15% dropout rate.", "answer": 46, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our sample size estimates are based on hypothesised effects (effect size=0.90) for the kinematic variable goal synchronisation time based on our preliminary data. This is the smallest effect size seen across all the primary outcome variables in our preliminary study. Sample size has been computed using G*Power and based on a two-sided t-test. Our preliminary study compared the effects of 75 speed stack trials (15 practice trials/session for 5\u00e2\u0080\u0089days) on bimanual performance (bimanual learning and coordination) between RIC and sham groups. Goal synchronisation time, which is defined as a lag between the initiation of the affected and less affected hand was the primary kinematic analysis outcome measure. Smaller time lag indicates greater bimanual coordination. Children with UCP in RIC group decreased their goal synchronisation time from pretraining to post-training by 256\u00c2\u00b125 ms and sham group decreased their goal synchronisation time by 282\u00c2\u00b133 ms. To detect a similar between group difference in the change score of goal synchronisation time, a total of 40 participants (20 in each group) will provide 80% power to detect an effect size of 0.90 (\u00ce\u00b1=0.05). After accounting for a 15% drop out rate, we will need a total of 46 participants (23 in each group) for this investigation.", "id": 1767, "split": "test"} +{"trial_id": "NCT05781243", "pmid": "39434191", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation, an Open-label Multicenter Randomized Controlled Trial: the WATERLAND Trial\n\nIncluded conditions:\n- Acute Pancreatitis\n\nStudy Armgroups:\n- {'label': 'Lactated Ringer solution (LR)', 'type': 'EXPERIMENTAL', 'description': \"LR: Lactated Ringer solution. Patients in the LR treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.\", 'interventionNames': ['Drug: Lactated Ringer Solution']}\n- {'label': 'Normal saline (NS)', 'type': 'ACTIVE_COMPARATOR', 'description': 'NS: Normal Saline. Patients in the NS treatment arm will receive fluid therapy based on normal saline for a minimum of 48 hours.', 'interventionNames': ['Drug: Normal saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lactated Ringer Solution', 'description': \"Patients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.\", 'armGroupLabels': ['Lactated Ringer solution (LR)']}\n- {'type': 'DRUG', 'name': 'Normal saline', 'description': \"Patients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.\", 'armGroupLabels': ['Normal saline (NS)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants with moderately severe or severe acute pancreatitis', 'description': 'Presence of local complications, exacerbation of previous comorbidity or organ failure, according to the definitions of these complications provided by the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779)', 'timeFrame': 'From date of randomization until 30 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe trial aims for 90% power to detect the difference, with a significance level of 0.05. A loss to follow-up rate of 10% is expected.", "answer": 792, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The WATERFALL trial had a frequency of moderately severe or severe AP in the moderate fluid resuscitation arm of treatment (based on LR) of 17% [14]. In a recent systematic review, patients who received LR-based fluid resuscitation were less likely to develop moderately severe or severe pancreatitis than patients receiving NS, with an OR of 0.49, 95% CI 0.25\u00e2\u0080\u00930.97 [23]. The differences in the incidence of moderately severe or severe pancreatitis in the four included randomized controlled trials between LR and NS ranged from 10 to 14%, favoring LR [23]. For this reason, we expect an incidence of moderately severe or severe AP in the NS arm of 27%. Patients will be assigned in a 1:1 ratio. A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10% (the smaller difference observed in the four RTCs [23]), assuming that the frequency of moderately severe or severe AP in LR group will be 17%. The frequency in the NS group is assumed to be 17% under the null hypothesis and 27% under the alternative hypothesis. A loss to follow-up of 10% of patients is expected, so the sample size will be 396 patients in each treatment arm (792 patients in total). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level.", "id": 1768, "split": "test"} +{"trial_id": "NCT05783505", "pmid": "38082351", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention\n\nIncluded conditions:\n- Agitation,Psychomotor\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': 'Multicomponent intervention program', 'interventionNames': ['Other: Multicomponent intervention program']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Standard care'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Multicomponent intervention program', 'description': 'Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed', 'armGroupLabels': ['Treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'ICU-free days', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nPower > 80%, intraclass correlation coefficient of 0.10, significance level (\u03b1) of 0.05, and an attrition loss of 10%.", "answer": 480, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based on the study of Francken et al. [13], and all data were log-transformed for the purpose of sample size calculation. In the study, physically restrained ICU patients (n\u00e2\u0080\u0089=\u00e2\u0080\u0089341) had a mean ICU-LOS of 6.27\u00c2\u00a0days, while non-restrained patients (n\u00e2\u0080\u0089=\u00e2\u0080\u00891825) had a mean ICU-LOS of 2.53\u00c2\u00a0days. Since data on sedation usage was not available, which could have affected ICU-LOS, a more conservative ICU-LOS of 4.27\u00c2\u00a0days for non-restrained patients was used. To detect a difference of 2\u00c2\u00a0days on ICU-LOS between restrained vs. non-restrained patients with a power\u00e2\u0080\u0089>\u00e2\u0080\u008980%, an intraclass correlation coefficient of 0.10, and \u00ce\u00b1 of 0.05, a total of 432 patients are needed. Anticipating an attrition loss of 10%, a total of 480 patients will be included, amounting to 3\u00e2\u0080\u00934 patients per center per month (480 patients divided by 6 centers in 24\u00c2\u00a0months).", "id": 1769, "split": "test"} +{"trial_id": "NCT05783531", "pmid": "37669289", "question": "Here is the design of a clinical trial:\n\nOfficial Title: AIMDiV: Accessing Innovative Mental Health Services for Depression in Vietnam\n\nIncluded conditions:\n- Depression\n- Anxiety Disorders\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'This arm will receive the VMood digital mental health intervention. This consists of bibliotherapy that is delivered via a smartphone app, with coaching support provided by social workers for a duration of three months. The skills in the workbook are grounded in principles of Cognitive Behavioural Therapy.', 'interventionNames': ['Other: VMood']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'This arm will receive enhanced treatment as usual, which consists of regular care as provided by primary care centres and a brief introduction video about depression via the app. The control arm will receive the intervention after the intervention arm has completed the intervention period.', 'interventionNames': ['Other: Enhanced treatment as usual']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'VMood', 'description': 'VMood is a digital mental health intervention adapted from an evidence-based in-person intervention. It uses supported self-management approaches, consisting of bibliotherapy (the Antidepressant Skills Workbook) and supportive coaching from a social worker that are provided via the smartphone app. The individual is supported in the use of the skills over the course of three months. The skills in the workbook are grounded in principles of Cognitive Behavioural Therapy.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Enhanced treatment as usual', 'description': 'Participants in the control arm will receive enhanced treatment as usual in the form of usual care from primary care centres and a brief introduction to depression video through the VMood app.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Patient Health Questionnaire (PHQ-9) - change in depression scores', 'description': 'A brief (9-item) measure for diagnosing and measuring severity of depression', 'timeFrame': 'Monthly from baseline until three months, with a follow-up at six months'}\n- {'measure': 'Generalized Anxiety Disorder (GAD-7) - change in anxiety scores', 'description': 'A brief (7-item) measure for assessing generalized anxiety disorder', 'timeFrame': 'Monthly from baseline until three months, with a follow-up at six months'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate of 0.05, intracluster correlation coefficient (ICC) of 0.01, and at least 80% power. The study assumes an average of 8 participants per commune with 7 retained after attrition.", "answer": 336, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n The power calculation assumes that each commune would recruit an average of 8 participants and retain 7 participants after attrition and that the proportion of depression caseness (defined as PHQ-9 score between 10\u00e2\u0080\u009319) in the control group is 42%, the same as in the previous study [25]. The calculation shows that for a type I error rate of 0.05, and an intracluster correlation coefficient (ICC) of 0.01 (based on data from the previous study on the binary outcome of having depression), a total of 336 participants recruited from 48 clusters (i.e., communes) have at least 80% power to detect treatment differences when the proportion of depression caseness in the intervention group is \u00e2\u0089\u00a4 30% (Table 4 below) [46]. The power calculation was performed using Stata 17 [46].\n \n 10.1371/journal.pone.0290328.t004\n Table 4\n \n Power analysis.\n \n \n \n \n \n \n \n \n \n \n Proportion of depression caseness in Intervention Condition\n Power\n \n \n \n \n 0.30\n 81%\n \n \n 0.31\n 74%\n \n \n 0.32\n 66%\n \n \n 0.33\n 57%\n \n \n 0.34\n 48%", "id": 1770, "split": "test"} +{"trial_id": "NCT05784428", "pmid": "38310262", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Single vs. Multiple Fraction Non-Inferiority Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligo-metastases/Progression: SIMPLIFY-SABR-COMET\n\nIncluded conditions:\n- Oligometastatic Disease\n- Oligoprogression\n- Toxicity Due to Radiotherapy\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Multiple fraction SABR (Arm 1)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomized to this arm will receive multiple fraction SABR', 'interventionNames': ['Radiation: Multiple fraction SABR']}\n- {'label': 'Single fraction SABR (Arm 2)', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to this arm will receive single fraction SABR', 'interventionNames': ['Radiation: Single fraction SABR']}\n- {'label': 'Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will complete the EuroQoL-5Dimensions-5levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G) prior to each scheduled follow-up (FU).', 'interventionNames': ['Other: QoL reporting alone']}\n- {'label': 'QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)', 'type': 'EXPERIMENTAL', 'description': '* Patients complete EQ-5D-5L and FACT-G prior to each scheduled FU\\n* Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment', 'interventionNames': ['Other: QoL reporting, symptom screen and healthcare provider intervention']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Single fraction SABR', 'description': 'Participants randomized to this arm will receive SF SABR\\n\\nTreatment recommendations are as follows:\\n\\nLung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory OAR constraints are met: 30 Gy in 1 fraction\\n\\nLung: Within 2 cm of mediastinum or brachial plexus 20 Gy in 1 fraction\\n\\nBone, Spine, Adrenal, lymph node/soft tissue: 20 Gy in 1 fraction\\n\\nLiver: 30 Gy in 1 fraction\\n\\nBrain: dose as per institutional policy', 'armGroupLabels': ['Single fraction SABR (Arm 2)']}\n- {'type': 'RADIATION', 'name': 'Multiple fraction SABR', 'description': 'Participants randomized to this arm will receive MF SABR:\\n\\nDose/Fractionation are as follows:\\n\\nLung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory organ-at-risk (OAR) constraints are met: 48 Gy in 4 fractions (12 Gy/#), 54 Gy in 3 fractions (18 Gy/#), daily or every second day\\n\\nLung: Within 2 cm of mediastinum or brachial plexus 60 Gy in 8 fractions (7.5 Gy/#), 50 Gy in 5 fractions (10 Gy/#), daily\\n\\nBone: Any bone except spine: 35 Gy in 5 fractions (7 Gy/#), daily\\n\\nLiver: 54 Gy in 3 fractions (18 Gy/#) or 5 fractions (10.8 Gy/#), daily or every second day\\n\\nSpine: 24 Gy in 2 fractions (12 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily\\n\\nAdrenal: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily\\n\\nLymph node/soft tissue: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily\\n\\nBrain - dose per institutional policy for stereotactic lesions (no whole brain RT).', 'armGroupLabels': ['Multiple fraction SABR (Arm 1)']}\n- {'type': 'OTHER', 'name': 'QoL reporting alone', 'description': 'Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit', 'armGroupLabels': ['Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)']}\n- {'type': 'OTHER', 'name': 'QoL reporting, symptom screen and healthcare provider intervention', 'description': 'Participants randomized to this arm will complete the FACT,G, EQ-5D-5L, radiation-symptom screen and receive healthcare provider-guided intervention based on their symptom reports.', 'armGroupLabels': ['QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)']}\n\nPrimary Outcomes:\n- {'measure': 'Adverse events', 'description': 'Occurrences and changes in grade 3 or higher adverse events related to treatment, according to CTCAE v5.0', 'timeFrame': 'At 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months'}\n- {'measure': 'Change in patient-reported quality of life', 'description': 'As measured by the EQ-5D-5L. This questionnaire provides measures for mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a numbered scale from 0 to 100 where 100 means the best health one can imagine, and 0 means the worst health one can imagine.', 'timeFrame': 'At 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months'}\n\nPlease estimate the sample size based on the assumption: \nFor the 1st randomization, the significance level (alpha) is 0.025, and the power is 80%. For the 2nd randomization, the significance level (alpha) is 0.05, and the power is 80%.", "answer": 598, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n \n 1st randomization\n The sample size is based on toxicity of SABR (grade 3-5 AEs possibly, probably, or definitely related to SABR collected by HCP). The previously published SABR-5 protocol pre-defined a 10% rate of grade \u00e2\u0089\u00a5 4 AEs as acceptable, and we will conservatively set a 10% grade \u00e2\u0089\u00a5 3 AE rate as acceptable for this study [8]. The standard and intervention arms will be accrued 1:1. Sample sizes of 299 in Arm 1 and 299 in Arm 2 are required to achieve 80% power to detect a non-inferiority margin difference of 5%, with the reference group grade \u00e2\u0089\u00a5 3 AEs set at 5% based on the results of SABR-5. Based on our clinical judgement, the treatment group is assumed to be 10% under the null hypothesis of inferiority and coincides with our pre-defined < 10% grade \u00e2\u0089\u00a5 3 AE rate. The power was computed for the case when the actual treatment group proportion is 5%. This was based on a one-sided z test (unpooled) and alpha of 0.025.\n In addition, given the importance of efficacy as a secondary outcome, we wanted to ensure that this sample size would have sufficient power to rule out large effect size differences in LCR. Based on our SABR-5 trial data, the estimated LCR at 1 year is 90%. With 584 patients, assumed to be accrued over five years with an additional five years of follow-up, then we would achieve > 80% difference to rule out a non-inferiority hazard ratio margin of 1.32 (which is equivalent to SF arm having a 1-year LCR of 87%). Hence, this sample size is sufficient to provide evidence of non-inferiority for efficacy.\n \n \n 2nd randomization\n The sample size is based on hypothesized QoL differences (mean difference of 5.7) between the intervention arms based on the landmark Basch et al. study, as well as the unpublished standard deviation of 15.6 for EQ-5D-5L scores from our ongoing SABR-COMET-3 study to capture expected standard deviation for our patient population [13, 14]. Group sample sizes of 125 and 125 will provide 80% power to detect a significant difference based on an alpha of 0.05. We will plan an analysis of Arm A and B after 250 patients.\n The total sample size for this trial is 598 based on the primary objective of the first randomization.", "id": 1771, "split": "test"} +{"trial_id": "NCT05785455", "pmid": "39979041", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy Of Pain Neuroscience Communication, Motivational Interviewing And Cognitive Exercise Therapy In Patients With Chronic Neck Pain\n\nIncluded conditions:\n- Chronic Pain\n- Neck Pain\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects will receive a health education program during 5 group sessions of 60 minutes, taught by physical therapists without training in pain neuroscience education.\\n\\nAll patients will receive 5 sessions, regardless of the group they belong to. Group education sessions will be in groups (of 5-6 patients), respecting the safety distance. Group sessions will be held in person, in small groups, at the health center, on a weekly basis. Both groups will receive online monitoring of the exercise program. An image with more information about the intervention and control is attached in Annex 2.', 'interventionNames': ['Other: Usual Care']}\n- {'label': 'COGMO Intervention', 'type': 'EXPERIMENTAL', 'description': 'Each subject will receive. a first individual session to assess their beliefs about pain and coping strategies, combining motivational interviewing and pain neuroscience education techniques, followed by 4 group sessions of 60 minutes, focused on the neurophysiology of pain and self-efficacy techniques in pain control, emphasizing . in two-way communication and followed by cognition targeted exercise therapy. These sessions will be taught by physiotherapists with specific training in motivational interviewing, pain neuroscience education and cognition targeted exercise', 'interventionNames': ['Other: COGMO Intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'COGMO Intervention', 'description': 'Group sessions in which each patient, after motivational interviewing sessions will follow a goup education in pain neuroscince program followed by a cognition targeted exercise therapy', 'armGroupLabels': ['COGMO Intervention']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Usual Primary Care health education and treatment for patients with chronic neck pain', 'armGroupLabels': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Pain Intensity', 'description': 'The visual analog scale (VAS). This is a 100-mm line with \"no pain\" on the left side of the line and \"worst pain imaginable\" on the right side. The patient marks the intensity of her pain on a flat line, which allows observing the result obtained on the 100 mm line, being able to quantify her pain in this way. A score of less than 30 mm is considered mild pain, between 31 and 54 mm, moderate, and 55 mm, severe.', 'timeFrame': 'Up to 1 week before the intervention, up to 1 day after the intervention, and at 3, 6 and 12 months after intervention'}\n\nPlease estimate the sample size based on the assumption: \nFor a 95% confidence level and 80% power, considering an average cluster size of 6 patients per physiotherapist, an intercalary correlation coefficient of 0.02, and overestimating due to possible losses of 10%.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to two systematic reviews, chronic neck pain with manual physiotherapy treatment improved by 11% (in the first review) and 29% (in the second) compared with the control group.18 22 Expecting to find a difference in percentages of patients achieving a clinically significant decrease in pain (at least 30\u00e2\u0080\u0089mm on the visual scale), of 25% more patients in the COGMO intervention group than in the control group, for a 95% confidence level and 80% potency, 58 subjects would be needed in each group. Considering that the average cluster size of patients per physiotherapist is 6 patients, and for an intercalary correlation coefficient of 0.02 the design effect will be 1.1 [(ED=1+(6\u00e2\u0088\u00921)\u00c3\u00970.02=1.1, (58+58)\u00c3\u0097ED(1.1)], the sample size required will be 128 patients; overestimating due to possible losses of 10%, the final size is 142 patients (71 per branch).\n \n Sampling\n Consecutive sampling of patients included in the waiting list of patients referred to the physiotherapy unit in each health centre.", "id": 1772, "split": "test"} +{"trial_id": "NCT05792449", "pmid": "37468898", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tele-rehabilitation Program: An Innovative and Sustainable Early Intervention Service for Children With Autism Spectrum Disorders\n\nIncluded conditions:\n- Autism Spectrum Disorder\n\nStudy Armgroups:\n- {'label': 'Standard Program', 'type': 'ACTIVE_COMPARATOR', 'description': \"The current standard program for early intervention treatment is in-clinic therapy based on the Foundational Skills Curriculum (FSC): a framework for early intervention developed from outcomes of an Autism research project conducted in the UK. This framework provides a clear and systematic approach to understanding the child's functioning in 3 core areas of development (across 141 items): Play, Social Interaction, and Communication. Children and their parents will receive the standard program which consists of 16 clinic-based intervention sessions of 60 minutes each, separated into 3 intervention blocks, with breaks in between so that parents will have opportunities to practise at home.\", 'interventionNames': ['Behavioral: Foundational Skills Curriculum']}\n- {'label': 'Telerehab Program', 'type': 'EXPERIMENTAL', 'description': \"The telerehab program will provide parent coaching through video conferencing using the FSC. The telerehabilitation program commences with 2 clinic-based intervention sessions of 60 minutes each followed by 16 video conferencing-based sessions of 45 minutes each. For clinic-based sessions, an additional 15 minutes is allocated to allow parent-child dyads to transit into and out of the therapist's room.\", 'interventionNames': ['Behavioral: Foundational Skills Curriculum - Telerehabilitation']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Foundational Skills Curriculum', 'description': 'The therapist will coach parents in the context of clinic-based play activities and help parents identify contexts and activities at home where the parents could follow up on the program at home. Intervention sessions empower and equip parents with skills and strategies to engage with their child at home. Since the program involves behavioural intervention and parent coaching, active participation of parent and child are key to each session.', 'armGroupLabels': ['Standard Program'], 'otherNames': ['Naturalistic, parent-implemented intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Foundational Skills Curriculum - Telerehabilitation', 'description': \"Parent-child interactions during activities at home will be observed through video conferencing. Parents will be encouraged to interact with their child using strategies aimed at increasing their child's attention and motivation, turn-taking routines, initiating and responding to joint attention, communication, etc. Intervention sessions empower and equip parents with skills and strategies to engage with their child at home. Since the program involves behavioural intervention and parent coaching, active participation of parent and child are key to each session.\", 'armGroupLabels': ['Telerehab Program'], 'otherNames': ['Naturalistic, parent-implemented intervention delivered through vide conferencing']}\n\nPrimary Outcomes:\n- {'measure': \"Mullen's Scale of Early Learning (MSEL)\", 'description': 'MSEL is a standardized developmental assessment to examine developmental skills using 5 subscales: Gross Motor, Visual Reception, Fine Motor, Expressive Language and Receptive Language. For each scale, the assessment derives a T-score with a mean of 50 and standard deviation of 10, a percentile score, and an age equivalent. An early learning composite (ELC) score is calculated from the total of the subscale scores (except the gross motor scale) with a mean of 100 and standard deviation of 15 (Bacon et al., 2014). The use of MSEL subscale scores allow for greater granularity of analysis, to examine the impact of intervention on specific functions of the child and for separate assessment of verbal and non-verbal abilities (Vismara et al, 2009). Differences in the T-scores on the subscales of the MSEL as well as MSEL ELC from baseline to program conclusion will be calculated and compared between the two intervention groups. The margin of non-inferiority is set at 5 units.', 'timeFrame': 'Change from baseline MSEL assessment at study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided non-inferiority test at 95% confidence level, 80% power, considering withdrawals and lost to follow-up.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The sample size calculation is based on a one-sided non-inferiority test at 95% confidence. We defined our non-inferiority margin as 5 points on the primary outcome measure of MSEL ELC that has a standard deviation of 15 points [32]. The non-inferiority margin of 5 was informed by clinical expertise and existing literature [33]. If there is no truly no difference in the pre-post change between the standard arm and telerehabilitation arm, then 132 participants are required to be 80% sure that the lower limit of a one-sided 95% confidence interval for the difference will be above the non-inferiority limit of \u00e2\u0088\u00925. We decided to recruit 200 subjects in total (100 in each arm) after considering withdrawals and lost to follow-up. The computation was performed using a proprietary software programmed in R.", "id": 1773, "split": "test"} +{"trial_id": "NCT05792826", "pmid": "40122554", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of BSZY Cream for Atopic Facial Dermatitis: a Randomized, Double-blind, Controlled Trial.\n\nIncluded conditions:\n- Atopic Dermatitis of Face (Diagnosis)\n\nStudy Armgroups:\n- {'label': 'BSZY Cream group', 'type': 'EXPERIMENTAL', 'description': 'receiving BSZY Cream twice a day,in the morning and evening, for a period of four weeks.', 'interventionNames': ['Other: BSZY Cream']}\n- {'label': 'emulsion matrix group', 'type': 'PLACEBO_COMPARATOR', 'description': 'receiving the emulsion base twice a day, in the morning and evening, for a period of four weeks.', 'interventionNames': ['Other: emulsion matrix']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'BSZY Cream', 'description': 'The patients receive BSZY Cream twice a day, in the morning and evening, for a period of four weeks.The patients can continue using their usual sunscreen and cleansing products, and their skin care steps should follow their daily habits. It is not recommended to add or replace any previously unused skin care products during the testing period.', 'armGroupLabels': ['BSZY Cream group']}\n- {'type': 'OTHER', 'name': 'emulsion matrix', 'description': 'The patients receive emusion matrix twice a day, in the morning and evening, for a period of four weeks.The patients can continue using their usual sunscreen and cleansing products, and their skin care steps should follow their daily habits. It is not recommended to add or replace any previously unused skin care products during the testing period.', 'armGroupLabels': ['emulsion matrix group']}\n\nPrimary Outcomes:\n- {'measure': 'SCORAD', 'description': \"The SCORAD score was calculated based on the types of lesions and body areas and was assessed separately for the head, neck, arms, legs, anterior trunk, back, and genitalia based on the area of skin involved and the severity of erythema, exudation, crusting, lichenification, and dryness. The scores report the severity of the patients' symptoms, with a total score ranging from 0 to 103, scores of 25 or lower indicating mild severity, scores of 26 to 50 indicating moderate severity, and scores of 51 to 103 indicating severe severity.. Patients were monitored for changes in SCROAD during treatment, observed for improvement in atopic dermatitis, and changes in points were calculated and compared before and after.\", 'timeFrame': \"At weeks 0 after the patient's admission\"}\n- {'measure': 'SCORAD', 'description': \"The SCORAD score was calculated based on the types of lesions and body areas and was assessed separately for the head, neck, arms, legs, anterior trunk, back, and genitalia based on the area of skin involved and the severity of erythema, exudation, crusting, lichenification, and dryness. The scores report the severity of the patients' symptoms, with a total score ranging from 0 to 103, scores of 25 or lower indicating mild severity, scores of 26 to 50 indicating moderate severity, and scores of 51 to 103 indicating severe severity.. Patients were monitored for changes in SCROAD during treatment, observed for improvement in atopic dermatitis, and changes in points were calculated and compared before and after.\", 'timeFrame': \"At weeks 2 after the patient's admission\"}\n- {'measure': 'SCORAD', 'description': \"The SCORAD score was calculated based on the types of lesions and body areas and was assessed separately for the head, neck, arms, legs, anterior trunk, back, and genitalia based on the area of skin involved and the severity of erythema, exudation, crusting, lichenification, and dryness. The scores report the severity of the patients' symptoms, with a total score ranging from 0 to 103, scores of 25 or lower indicating mild severity, scores of 26 to 50 indicating moderate severity, and scores of 51 to 103 indicating severe severity.. Patients were monitored for changes in SCROAD during treatment, observed for improvement in atopic dermatitis, and changes in points were calculated and compared before and after.\", 'timeFrame': \"At weeks 4 after the patient's admission\"}\n\nPlease estimate the sample size based on the assumption: \nThe ratio of both groups is 1:1, the two-sided significance level is 0.05, the power is 0.8, and the expected drop-out rate is 20%.", "answer": 130, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Based on our previous study and related literature (a randomised trial of Lactobacillus rhamnosus IDCC 3201 tyndallization (RHT3201) for treating AD),16 the estimated changes in the SCORAD Score after 4 weeks are \u00e2\u0088\u009213.89\u00c2\u00b110.05 (SD=10) and \u00e2\u0088\u00928.37\u00c2\u00b19.95 (SD=10) in the intervention group and control group, respectively. The ratio of both groups is 1:1, the two-sided significance level is set as 0.05, and the power is 0.8. According to the sample size estimation Formula n=(Z\u00ce\u00b1+Z\u00ce\u00b2)\u00c3\u00972\u00cf\u00832\u00ce\u00b42, 52 patients in each group are calculated. The expected drop-out rate is 20%, with a total of 130 patients in the two groups.", "id": 1774, "split": "test"} +{"trial_id": "NCT05794789", "pmid": "39333930", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"We Are an Active Family\": Promoting Child Physical Activity Through Social Identity Formation in the Family System\n\nIncluded conditions:\n- Physical Activity\n- Social Identity\n\nStudy Armgroups:\n- {'label': 'PA education and planning condition', 'type': 'NO_INTERVENTION', 'description': \"This group will receive sessions and information-based booklet and series of worksheets that provide a tangible knowledge translation product for the family. The material will consist of Canada's PA guidelines recommending 60 minutes of MVPA a day and a breakdown of ways for the parent to help their child achieve this PA, outlining three main domains of parental support (encouragement, logistical support, and PA together). The material also contains information about the benefits of PA for the child and how to plan for family PA. The material specifically includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past. The investigators 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. An additional two sessions will include education and planning material related to family healthy eating.\"}\n- {'label': 'Identity formation condition', 'type': 'EXPERIMENTAL', 'description': 'This group will receive the same content as the education+planning comparison condition but with two additional coaching sessions. The session will include short overviews of the benefits of PA as a family, brainstorming how a family can each assist each other in PA, and an activity for developing a family PA action plan. Behavior change techniques that align with these approaches and are included in the coaching session include identity salience, identity similarity, as well as identity fit and contrast. This will be supplemented by an organization of fun family PA roles for all members (e.g., activity planner, goal setter, supporter, etc.) to instill involvement as well as items (creation of a family PA t-shirt, family PA photos and display, etc.) to instill distinctiveness, which is a central feature of a social identity.', 'interventionNames': ['Behavioral: Social Identity']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Social Identity', 'description': 'This group will receive the same content as the education+planning as well as two additional sessions. This includes short overviews of the benefits of PA as a family, brainstorming how a family can each assist each other in PA, and an activity for developing a family PA action plan. Behavior change techniques such as identity salience, identity similarity, and identity fit and contrast are included in the coaching session include. This will be supplemented by an organization of fun family PA roles for all members (e.g., activity planner, goal setter, supporter, etc.) to instill involvement as well as items (creation of a family PA t-shirt, family PA photos and display, etc.) to instill distinctiveness, which is a central feature of a social identity. Worksheets and discussion will be included. The second session will involve only the parent(s) to focus on parental support identity and the content is based on the behavior change principles of self-identity theory.', 'armGroupLabels': ['Identity formation condition']}\n\nPrimary Outcomes:\n- {'measure': \"Change from baseline in children's moderate to vigorous 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, 6 weeks, 3 months, and 6 months.\", 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months'}\n\nPlease estimate the sample size based on the assumption: \npower = 0.80, four repeated assessments, one-between group factor, alpha = 0.05, expected attrition rate = 15%", "answer": 148, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A power calculation was conducted to estimate the required sample size. Power was set at 0.80 with four repeated assessments, one-between group factor, an alpha of 0.05, and a medium effect size (Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25), indicated that 128 families are needed to show a significant condition by time effect for PA [12, 45]. This effect size is consistent with previous studies examining physical activity interventions [46, 47]. With an expected attrition rate of 15% [14], 148 families (74 children per condition) will therefore be recruited.", "id": 1775, "split": "test"} +{"trial_id": "NCT05795855", "pmid": "39570957", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Adaptive Prenatal Intervention to Increase Childhood Vaccinations\n\nIncluded conditions:\n- Vaccination Refusal\n\nStudy Armgroups:\n- {'label': 'ADEPT', 'type': 'EXPERIMENTAL', 'description': 'Individuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention.', 'interventionNames': ['Behavioral: ADEPT']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': 'Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ADEPT', 'description': 'Prenatal providers will participate in trainings that will lay the foundation for an effective vaccination recommendation. After the completion of training, prenatal care providers will begin making recommendations promoting the importance of maternal and childhood vaccinations to pregnant individuals, as part of routine prenatal care. The core component of ADEPT is prenatal provider training to enable a vaccination recommendation, encouraging pregnant individuals to receive vaccines during pregnancy and for their child after birth. Pregnant individuals who remain vaccine hesitant despite the provider recommendation, will be eligible to receive the adaptive components of ADEPT in the form of evidence-based educational materials on vaccinations and phone consultations with a vaccine navigator to discuss residual concerns.', 'armGroupLabels': ['ADEPT']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of children receiving timely vaccinations', 'description': 'The proportion of children who receive vaccinations per the Advisory Committee on Immunization Practices (ACIP) recommended schedule at 2 months-post birth, by study arm.', 'timeFrame': '2 months post birth'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 90% to detect a 10% difference between arms at a two-sided alpha level of 5%, with a coefficient of variation of 0.15. The target sample size is inflated by 10% to account for variable enrollment and missing data. Sensitivity analyses show 80% power if the baseline proportion is 30% with a CV of 0.125 to 0.2. For the NMM study, exact binomial methods are used to estimate a 95% confidence interval for the proportion vaccine-hesitant.", "answer": 770, "answer_type": "ESTIMATED", "explanation": "Sample sizes\n Provider trainings. Only individuals from the intervention practices will be offered access to the trainings. All providers, staff and trainees at these practices will be eligible to participate in the training.\n CRT. We anticipate the proportion of children who receive delayed or no vaccination at 2 months of age at baseline to be 20% [6]. We estimate that the intervention will reduce this proportion to 10%. We used a sample size formula for a two-sided Z-test comparing two proportions that accounts for the CRT design and incorporates a small-sample bias correction suitable for CRTs with fewer than 30\u00e2\u0080\u009340 clusters in total (see equation (3) of Thomson et al, and more details in S5 File) [27]. With a sample size of 7 practices in each arm (14 total) and with at least 55 PIs/practice (770 total) the study would be powered at 90% to detect a difference in the proportion of 10% between arms at a two-sided alpha level of 5%, assuming that the coefficient of variation of cluster (i.e., practice-level) proportions with the primary outcome is 0.15 [27]. The target sample size is further inflated by 10% (total: 850) to accommodate a small reduction in power anticipated due to variable enrollment by practice and a small proportion of children with missing effectiveness outcomes due to out-of-state movement [28, 29]. In reality, the sample size for each practice will depend on practice size and eligibility of the PI population seen during the study period. Given that the primary outcome will be measured via data linkage of practice-level data to the state immunization registry using an honest broker, we will request an extract of data for all eligible PIs who are seen at the practice during the study period with the goal that the majority of enrolled practices would be expected to meet this target. Sensitivity analyses show that 80% power would be achieved if the proportion of children who delayed or refused vaccination at 2 months of age is 30% (rather than 20%) with a slightly smaller CV of 0.125 or even if the coefficient of variation is as large as 0.2 (S5 File).\n NMM. Sample size for the quantitative surveys will be estimated with the assumption that 20% of 425 PIs in the intervention arm are vaccine hesitant, and, hence, 85 PIs will be eligible to receive the adaptive intervention components as part of the NMM study. Of these, 68 are expected to agree to participate and to have midline survey data available (accounting for loss to follow-up) and estimate that the intervention will reduce the proportion of vaccine-hesitant to 80% at that time point. Using exact binomial methods, data from 68 PIs in a non-clustered setting would provide a 95% confidence interval ranging from 68% to 89% for a proportion vaccine-hesitant of 80% with a small increase due to the small design effect anticipated due to clustering. For the qualitative portion, existing research suggests that thematic saturation can be achieved with 12 interviews, with meta-themes presenting as early as six interviews [30, 31]. The proposed sample size of 24 PIs should be sufficient to achieve thematic saturation of reasons for delayed/refused vaccinations (n = 12) or timely vaccinations (n = 12).", "id": 1776, "split": "test"} +{"trial_id": "NCT05798403", "pmid": "39266323", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder: A Multicenter, Randomized, Controlled, Noninferiority Trial\n\nIncluded conditions:\n- Overactive Bladder\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive electroacupuncture treatment at Shenshu (BL23), Ciliao (BL32), Zhonglvshu (BL29), Huiyang (BL35), Weizhong (BL40), Zhongji (CV3), Dahe (KI12), Shuidao (ST28), Sanyinjiao (SP6). It should be noted that CV3, KI12, ST28, SP6 are used as the group A acupoints and BL23, BL32, BL29, BL35, BL40 as the group B acupoints. Patients will be treated with alternating group A and B acupoints. The frequency of treatment is 3 times a week and each treatment will last for 30 minutes for a total of 12 sessions over the course of four weeks. The follow-up observation will be recorded on week 8 and 16.\\n\\nAt the same time, participants will also receive placebo medication. Oral Solifenacin Succinate placebo will be used and taken once a day for 4 weeks.', 'interventionNames': ['Device: electroacupuncture']}\n- {'label': 'Solifenacin Succinate group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will take Solifenacin Succinate (Wuhan Human well Puracap (Likang) Pharmaceuticals Co., Ltd.) orally before breakfast for 4 consecutive weeks at 5 mg (1 tablet) per day.\\n\\nAt the same time, the participants will receive sham electroacupuncture with a pragmatic placebo needle on sham acupoints. Participants will have the same needle retention time, treatment time, and follow-up time as the electroacupuncture group.', 'interventionNames': ['Drug: Solifenacin Succinate Tablets']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'electroacupuncture', 'description': 'All acupuncture locations will be sterilized on a routine basis. As acupuncture needles are inserted, all needles will be lifting, twirling, and thrusting to reach de qi, a sensation generally associated with acupuncture, including swelling, soreness, numbness, and heaviness.\\n\\nAn electrical stimulator is applied to ipsilateral BL32 and BL35 (KI12 and ST28) with continuous waves of 30 Hz and currents of 1 to 5.0 mA. During the study, oral Solifenacin Succinate placebo will be used.', 'armGroupLabels': ['Electroacupuncture group'], 'otherNames': ['placebo medication']}\n- {'type': 'DRUG', 'name': 'Solifenacin Succinate Tablets', 'description': 'During the study, participants will take Solifenacin Succinate. The acupuncture points are the same as the electroacupuncture group, without the insertion of needles. The procedures, electrode positions and other treatment settings are the same as the electroacupuncture group, without the skin penetration, power output or needle manipulation of the de qi. At the end of the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball to allow the patient to feel the \"needles\"being pulled out.', 'armGroupLabels': ['Solifenacin Succinate group'], 'otherNames': ['Sham electroacupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'the percentage change in the number of voids every 24 hours at week 4.', 'description': 'The percentage change in the number of voids every 24 hours at week 4 compared to baseline. It is measured by a three-day voiding diary.', 'timeFrame': 'At week 4 (end of treatment).'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided alpha of 0.025 and a power of 80% (\u00ce\u00b2=0.2) were used. An additional 20% was added for potential dropouts.", "answer": 204, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size in this study was determined based on the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. According to the previous studies,40 41 in the solifenacin succinate group, the mean number of micturition episodes every 24 hours before treatment was 11.5. The mean reduction in the number of micturition episodes every 24 hours at week 4 after treatment was 2.21, and the SD was 2.45. This corresponded to a 19.2% reduction in the number of micturition episodes. In the placebo group, the mean number of micturition episodes every 24 hours before treatment was 11.1, and the mean reduction in the number of micturition episodes every 24 hours at week 4 after treatment was 1.03, resulting in a 9% reduction. The non-inferiority margin for the two groups was determined to be 2% by experts. Based on the preliminary trial, it was estimated that the mean reduction number of micturition episodes every 24 hours at week 4 in the electroacupuncture group after treatment was 3.00, and the SD was 2.45. This translates to a 26.1% reduction in micturition episodes. The percentage decrease in micturition episodes every 24 hours at week 4 between the electroacupuncture and solifenacin succinate groups was found to be 6.9%, calculated using an equal SD of 0.2 as per literature findings. A 1:1 ratio was conducted between the two groups with a one-sided alpha of 0.025 and a power of 80% (\u00ce\u00b2=0.2). According to PASS V.15.0 software, each group will require 81 cases, with an additional 20% for potential dropouts, resulting in a final sample size of 102 cases per group and a minimum total of 204 subjects.", "id": 1777, "split": "test"} +{"trial_id": "NCT05799391", "pmid": "38969378", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Soothing Cream Jel in Improving the Range of Motion and Chronic Pain at Shoulder and Elbow: A Double-blinded, Randomized, Placebo-Controlled Trial\n\nIncluded conditions:\n- Upper Extremity Problem\n\nStudy Armgroups:\n- {'label': 'Active treatment (Soothing cream jel)', 'type': 'EXPERIMENTAL', 'description': 'Soothing cream jel', 'interventionNames': ['Drug: SJC']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo cream jel', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'SJC', 'description': 'Soothing cream jel', 'armGroupLabels': ['Active treatment (Soothing cream jel)'], 'otherNames': ['Soothing cream jel']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo cream jel', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change of the range of motion', 'description': 'The range of motion of upper (shoulder or elbow) will be measured by a digital goniometer.\\n\\nFor the shoulder, active flexion and abduction ROMs are measured using a goniometer while the participants are standing. For the elbow, both flexion and extension will be measured by a goniometer in a standing position.', 'timeFrame': 'From baseline to week 2'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided significance level of 0.05, power of 80%, and a 20% dropout rate.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome is the ROM of active shoulder abduction at week 2 measured with a digital goniometer. Because there is no previous clinical study about soothing cream for patients with chronic shoulder pain on ROM measured by a goniometer, the data from other studies on acupuncture or physiotherapy were used for estimation of clinically meaningful mean difference in ROM and SD.46 47 In this trial, the software Power Analysis & Sample Size and a linear mixed model will be used to calculate the sample size. In order to detect an estimated clinically meaningful difference of 20\u00c2\u00b0 in the ROM of shoulder abduction between treatment and placebo control groups, 28 participants in each group will be needed based on the assumed SD of 26.5 with a two-sided significance level of 0.05 and a power of 80%. Therefore, a total of 70 patients will be needed in this trial, presuming a 20% dropout rate.", "id": 1778, "split": "test"} +{"trial_id": "NCT05803473", "pmid": "38711112", "question": "Here is the design of a clinical trial:\n\nOfficial Title: In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'POC-arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects are monitored by point-of-care (POC) glucose testing. Diabetes management is done by usual ward nurses and guided by an in-hospital diabetes team. A blinded CGM is mounted in the POC-arm for outcome analysis.', 'interventionNames': ['Device: FreeStyle Precision Pro Glucometer for glucose POC testing']}\n- {'label': 'CGM-arm', 'type': 'EXPERIMENTAL', 'description': 'CGM-arm subjects are monitored by CGM viewed by the in-hospital diabetes team in addition to POC glucose testing performed by usual ward nurses. Diabetes management is done by usual ward nurses by POC glucose testing and guided by an in-hospital diabetes team with acces to CGM data.', 'interventionNames': ['Device: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)', 'description': 'For CGM-arm subjects, glucose data are obtained by the CGM Dexcom G6 which via an iPhone SE 3 transmits data to the in-hospital diabetes team stations to be displayed on an iPad 9 10.2\".', 'armGroupLabels': ['CGM-arm']}\n- {'type': 'DEVICE', 'name': 'FreeStyle Precision Pro Glucometer for glucose POC testing', 'description': 'For the POC-arm subjects, glucose assessment is done by standard ward glucometer.', 'armGroupLabels': ['POC-arm']}\n\nPrimary Outcomes:\n- {'measure': 'Time in range', 'description': 'Time in range (TIR) is defined as the percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.', 'timeFrame': 'During hospitalization (up to 30 days)'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power to 80%, alfa level of 5%, dropout rate of 20%", "answer": 166, "answer_type": "ACTUAL", "explanation": "The sample size for the primary outcome\n From our own studies on patients with diabetes admitted with pneumonia at NOH, we know that the mean TIR (\u00c2\u00b1SD) is approximately 60\u00e2\u0080\u009370%\u00c2\u00b120\u00e2\u0080\u009325%\u00c2\u00a0 [10, 15]. A recent in-hospital CGM trial found a TIR (\u00c2\u00b1SD) of 50%\u00c2\u00b125% [23]. If the expected difference between arms on TIR is set at 10 percentage points, SD to 23%, statistical power to 80%, and an alfa level of 5%, the inclusion of 166 patients is required. With a dropout rate of 20%, we aim to include 208 patients.", "id": 1779, "split": "test"} +{"trial_id": "NCT05804591", "pmid": "38849875", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Preemptive Oral Pregabalin As an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. a Randomized, Prospective, Double Blind Study.\n\nIncluded conditions:\n- Obesity\n- Postoperative Pain\n- Postoperative Nausea and Vomiting\n- Opioid Use\n\nStudy Armgroups:\n- {'label': 'Multimodal analgesia group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Multimodal analgesia with preemptive pregabalin group', 'type': 'EXPERIMENTAL', 'description': 'Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.', 'interventionNames': ['Drug: Pregabalin 150mg']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pregabalin 150mg', 'description': 'Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.', 'armGroupLabels': ['Multimodal analgesia with preemptive pregabalin group']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': '1 capsule containing placebo per os 1 hour before start of the operation.', 'armGroupLabels': ['Multimodal analgesia group']}\n\nPrimary Outcomes:\n- {'measure': 'Total postoperative oxycodone consumption', 'description': \"PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes\", 'timeFrame': 'Day \"0\"'}\n- {'measure': 'Postoperative pain score in NRS scale', 'description': 'NRS range from 0 for no pain to 10 for worst pain imaginable', 'timeFrame': 'Day \"0\", assessed 1 hour after operation'}\n- {'measure': 'Postoperative pain score in NRS scale', 'description': 'NRS range from 0 for no pain to 10 for worst pain imaginable', 'timeFrame': 'Day \"0\", assessed 6 hour after operation'}\n- {'measure': 'Postoperative pain score in NRS scale', 'description': 'NRS range from 0 for no pain to 10 for worst pain imaginable', 'timeFrame': 'Day \"0\", assessed 12 hour after operation'}\n- {'measure': 'Postoperative pain score in NRS scale', 'description': 'NRS range from 0 for no pain to 10 for worst pain imaginable', 'timeFrame': 'Day \"0\", assessed 24 hour after operation'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error (\u03b1) was set at 0.05; type 2 error (\u03b2) at 0.9 based on two-tailed testing. An assumed mean drop-out rate of 15% was considered.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The primary outcome of the study is 24-h oxycodone consumption. The mean 24-h oxycodone consumption in our previous study was 31.31\u00c2\u00a0mg in patients on multimodal anesthesia [18] and SD was 13.7. In order to calculate sample size, we made the following assumptions: type 1 error (\u00ce\u00b1) was set at 0.05; type 2 error (\u00ce\u00b2) at 0.9 based on two-tailed testing. We considered a difference between groups (\u00ce\u00b4) greater than 10\u00c2\u00a0mg, this being roughly 30% of the mean dose given above, and a standard maximal single dose of oxycodone in an adult patient, to be clinically significant. Using a sample size formula for two-tailed testing recommended in [27], a sample size of 76 should be enough to detect a substantial difference, as stated above. Taking into account an assumed mean drop-out of 15%, we have adopted a rounded-up sample size of 90 patients.", "id": 1780, "split": "test"} +{"trial_id": "NCT05805761", "pmid": "37730405", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria - Study Protocol for Randomized Clinical Trial\n\nIncluded conditions:\n- Dental Plaque\n\nStudy Armgroups:\n- {'label': 'Conventional Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive the conventional treatment for the removal of dental biofilm (prophylaxis with bicarbonate jet).', 'interventionNames': ['Procedure: Conventional Treatment']}\n- {'label': 'aPDT + Conventional Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive both the antimicrobial photodynamic therapy and the conventional treatment (prophylaxis with bicarbonate jet) for the removal of dental biofilm.', 'interventionNames': ['Procedure: Conventional Treatment', 'Procedure: Antimicrobial Photodynamic Therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Conventional Treatment', 'description': 'A bicarbonate jet will be used to remove the biofilm from the surface of the teeth.', 'armGroupLabels': ['Conventional Treatment Group', 'aPDT + Conventional Treatment Group']}\n- {'type': 'PROCEDURE', 'name': 'Antimicrobial Photodynamic Therapy', 'description': 'aPDT will be performed before each cleaning/prophylaxis session, only in one of the groups. Participants will swish with the photosensitizer erythrosine for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. The D-2000 LED (DMC) will be applied, emitting at a wavelength of \u028e = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2.', 'armGroupLabels': ['aPDT + Conventional Treatment Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Colony Forming Units', 'description': \"The microbiological examination will be carried out from biofilm samples collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the prophylaxis procedure or irradiation. To collect the subgingival biofilm, the teeth will be isolated with cotton rolls, the supragingival biofilm will be removed with sterile gauze, and the subgingival biofilm sample will be obtained by introducing a tip of sterile absorbent paper (#30) inside of the periodontal pocket, being kept in position for 30 s. The tips will be removed and stored in properly identified sterile plastic microtubes, each tube containing 1 mL of sterile Brain Heart Infusion (BHI) culture medium will be packed on ice and analyzed immediately after collection.\\n\\nThe samples will be used to determine the CFU's (Colony Forming Units). Each tube with 1 mL BHI will be vortexed and will undergo serial dilution from 10-1 to 10-5 times the original concentration.\", 'timeFrame': 'Baseline and immediately after treatment.'}\n\nPlease estimate the sample size based on the assumption: \nA power of 95% and a significance level (alpha) of 0.05 were used. The calculation also considered a dropout rate, but the exact rate is not specified.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The number of participants (n=30) was based on a previous study carried out by Bhat et al.23 With the medians obtained in this study, the calculation was performed on the ClinCalc.com website, using a power of 95% (alpha 0.05), usually adopted in clinical/microbiological trials. The calculation showed that 30 participants would be needed per group.\n \n\nk=n2n1=1\n\n\n \n\nn1=(\u00cf\u008312+\u00cf\u00832/K2)(Z1\u00e2\u0088\u0092\u00ce\u00b1/2+Z1\u00e2\u0088\u0092\u00ce\u00b2)2\u00e2\u0096\u00b32\n\n\n \n\nn1=(0,942+0,9421)(1.96+1.64)20,872\n\n\n \n\nn1=30\n\n\n \n\nn2=K\u00c3\u0097n1=30", "id": 1781, "split": "test"} +{"trial_id": "NCT05806346", "pmid": "39334224", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration\n\nIncluded conditions:\n- Heart Diseases\n- Vascular Diseases\n- Transfusion Related Complication\n- Coagulation Disorder, Blood\n- Fibrinolysis; Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Empirical 1: TXA and Placebo administration', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tranexamic acid administration, regardless of the result of rotational thromboelastometry.\\n\\nPlacebo administration, at LI60 \\\\< 85 % or A10\\\\< 40 mm in EXTEM of rotational thromboelastometry', 'interventionNames': ['Drug: TXA administration', 'Drug: Placebo administration']}\n- {'label': 'Empirical 2: TXA administration', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tranexamic acid administration, regardless of the result of rotational thromboelastometry.\\n\\nPlacebo discard, at LI60 \u2265 85% or A10 \u2265 40 mm in EXTEM of rotational thromboelastometry', 'interventionNames': ['Drug: TXA administration']}\n- {'label': 'Goal-directed 1: Placebo administration', 'type': 'EXPERIMENTAL', 'description': 'Placebo administration, regardless of the result of rotational thromboelastometry.\\n\\nTranexamic acid administration at LI60 \\\\< 85 % or A10 \\\\< 40 mm in EXTEM of rotational thromboelastometry', 'interventionNames': ['Drug: TXA administration', 'Drug: Placebo administration']}\n- {'label': 'Goal-directed 2: TXA and Placebo administration', 'type': 'EXPERIMENTAL', 'description': 'Placebo administration, regardless of the result of rotational thromboelastometry.\\n\\nTranexamic acid discard at LI60 \u2265 85% or A10 \u2265 40 mm in EXTEM of rotational thromboelastometry', 'interventionNames': ['Drug: Placebo administration']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'TXA administration', 'description': 'Tranexamic acid intravenous administration', 'armGroupLabels': ['Empirical 1: TXA and Placebo administration', 'Empirical 2: TXA administration', 'Goal-directed 1: Placebo administration'], 'otherNames': ['Tranexamic acid']}\n- {'type': 'DRUG', 'name': 'Placebo administration', 'description': 'Placebo (normal saline) intravenous administration', 'armGroupLabels': ['Empirical 1: TXA and Placebo administration', 'Goal-directed 1: Placebo administration', 'Goal-directed 2: TXA and Placebo administration'], 'otherNames': ['Placebo (normal saline)']}\n\nPrimary Outcomes:\n- {'measure': 'postoperative bleeding', 'description': 'bleeding amount though chest drainage tubes during the 1st postoperative 24 hour', 'timeFrame': '24 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe trial aims for a 2.5% one-sided significance level (\u03b1) and 80% power (1-\u03b2). A dropout rate of 5% is considered.", "answer": 764, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The trial was designed as a non-inferiority trial, hypothesizing that the mean postoperative 24-h bleeding in Group-GDT would be non-inferior to that of Group-P. In previous studies using TXA on the bleeding in cardiac surgery [8, 10], the minimum effect of TXA administration on reducing the postoperative 24-h bleeding (the chest tube drainage during postoperative 24\u00c2\u00a0h) was around 200\u00c2\u00a0ml. Investigators set the non-inferiority margin of the present trial as 100\u00c2\u00a0ml, which is 50% of the minimum effect in the previous study [8]. Additionally, we estimated that the standard deviation of the postoperative bleeding would be approximately 480\u00c2\u00a0ml.\n The sample size was 724 patients (362 patients per group) to achieve a 2.5% one-sided significance level (\u00ce\u00b1) and 80% power (1-\u00ce\u00b2) with the following assumptions: an expected inter-group difference of the mean postoperative bleeding is 0\u00c2\u00a0ml, and a non-inferiority margin is 100\u00c2\u00a0ml with the standard deviation of 480\u00c2\u00a0ml in both groups. Considering a dropout rate of 5% after recruitment, 764 patients (382 patients per group) are recruited in total. The sample size was calculated using PASS 15 program\u00e2\u0084\u00a2 (NCSS, Kaysville, UT, USA).", "id": 1782, "split": "test"} +{"trial_id": "NCT05808894", "pmid": "38199635", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT): a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Laparoscopic Pancreaticoduodenectomy\n\nStudy Armgroups:\n- {'label': 'extended transection group', 'type': 'EXPERIMENTAL', 'description': 'the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy.', 'interventionNames': ['Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy']}\n- {'label': 'conventional transection group', 'type': 'NO_INTERVENTION', 'description': 'the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy', 'description': 'Transect the pancreatic neck at \u22655mm and \u226410mm beyond the left side of the portal vein.', 'armGroupLabels': ['extended transection group']}\n\nPrimary Outcomes:\n- {'measure': 'the incidence of clinically relevant pancreatic fistula', 'description': \"the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading\", 'timeFrame': '3 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThis is a superiority trial using a one-sided test with 80% power (1-\u03b2) at a significance level of 5% (\u03b1). A 10% increase in sample size is considered for loss of follow-up and washout.", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was determined based on the primary objective of comparing the incidence of CR-POPF between the two groups. According to the retrospective study,13 extended pancreatic neck transection (\u00e2\u0089\u00a5+7\u00e2\u0080\u0089mm) was associated with a lower incidence of CR-POPF than conventional pancreatic neck transection (15.4% vs 33.3%). Considering this study is a superiority trial, using the one-sided test with 80% power (1\u00e2\u0080\u0093\u00ce\u00b2) at a significance level of 5% (\u00ce\u00b1), the minimal sample size needed to detect a significant difference is calculated to be 70 patients in each group. Considering the loss of follow-up and washout, we enlarged the sample size by 10%. Then, there are 77 patients in each group, and the final sample size is 154 patients.", "id": 1783, "split": "test"} +{"trial_id": "NCT05809414", "pmid": "38176857", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis: Phase III Study, Controlled, Randomized, Crossed Over and Double Blind.\n\nIncluded conditions:\n- Multiple Sclerosis\n- Fatigue\n\nStudy Armgroups:\n- {'label': 'Amantadine', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule']}\n- {'label': 'TMS', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}\n- {'label': 'TMS sham', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcranial Magnetic Stimulation', 'description': 'TMS is a technique for electrical stimulation of brain tissue by generating a magnetic field, which modulates neural activity at the stimulation site and in interconnected neural networks.\\n\\nThe treatment will be applied to the left dorsolateral prefrontal region. Each patient will receive 3 sessions per week of approximately 10 minutes for 6 weeks.\\n\\nIn the case of TMS sham, a placebo coil will be used, which is indistinguishable from the therapeutic one. In addition, the sessions will be carried out with the same frequency, so the patient will be unaware of the treatment they are receiving.', 'armGroupLabels': ['TMS', 'TMS sham'], 'otherNames': ['TMS']}\n- {'type': 'DRUG', 'name': 'Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule', 'description': 'It will be used at a dose of 100 mg, 1 capsule a day for 1 week, followed by 2 daily doses of 100 mg until completing 6 weeks in total. After completing the treatment phase, the dose will be de-escalated (1 capsule a day for 5 days and discontinued).\\n\\nIn the case of placebo amantadine capsules, they will have the same organoleptic characteristics as amantadine. The start, maintenance and de-escalation pattern will be identical.', 'armGroupLabels': ['Amantadine', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the fatigue severity', 'description': 'To compare the effect of TMS and amantadine alone or in combination therapy compared with placebo on fatigue determined using the Modified Fatigue Impact Scale (Total MFIS score: Range from 0 to 84, from minimal to severe fatigue).', 'timeFrame': '6 weeks after starting treatment'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a power of 90%, a type I error of 0.05 corrected by Bonferroni (six comparisons), an intraclass correlation coefficient of 0.7, and a 20% loss to follow-up.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n One hundred and forty-four patients will be enrolled. According to previous studies, a change of at least 10 points in Modified Fatigue Impact Scale (MFIS) is considered as clinically significant.20 Assuming a power of 90%, a type I error of 0.05 corrected by Bonferroni (six comparisons) and an intraclass correlation coefficient of 0.7, we would need 91 patients to detect a difference of at least 10 points between placebo and the interventions. Considering the duration and number of periods of the study, a 20% of loss to follow-up has been estimated, pointing a sample size of at least 136. We have increased the sample to 144 to allow the same number of patients per any of the 24 sequences of the four combinations of treatments (TMS+amantadine/TMS+placebo/sham-TMS+amantadine/shamTMS+placebo) required for a full randomisation scheme.", "id": 1784, "split": "test"} +{"trial_id": "NCT05812885", "pmid": "38582874", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcutaneous Electrical Nerve Stimulation (TENS) and Chronic Low-Back Pain: A Randomized Crossover Trial\n\nIncluded conditions:\n- Chronic Low-back Pain\n\nStudy Armgroups:\n- {'label': 'Active TENS', 'type': 'EXPERIMENTAL', 'description': 'Active TENS: 100 Hz, 200 \u03bcs at maximal tolerable intensity', 'interventionNames': ['Device: TENS']}\n- {'label': 'Placebo TENS', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo TENS: 100 Hz, 200 \u03bcs on for 45 seconds and then ramps off.', 'interventionNames': ['Device: TENS']}\n- {'label': 'No TENS', 'type': 'NO_INTERVENTION', 'description': 'Participants will wear a TENS unit that will be turned off to blind the outcome assessor'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'TENS', 'description': 'Active TENS', 'armGroupLabels': ['Active TENS', 'Placebo TENS']}\n\nPrimary Outcomes:\n- {'measure': 'Pain at Rest', 'description': 'Pain at Rest Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).', 'timeFrame': '3 weeks'}\n- {'measure': 'Pain With Movement', 'description': 'Pain With Movement Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).', 'timeFrame': '3 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, 5% alpha, and a possible sample loss of 15%.", "answer": 34, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size was calculated to determine the total number of study participants needed to detect a difference of 2 points for the pain intensity outcome, which is considered a clinically relevant value for LBP [32], as measured using the NPRS, with a standard deviation of 1.9 points [13]. An 80% statistical power, 5% alpha, and a possible sample loss of 15% were considered. Thus, a total of 34 participants will be needed. This calculation was performed using Minitab v.17 software (State College, PA, USA).", "id": 1785, "split": "test"} +{"trial_id": "NCT05814055", "pmid": "39709468", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence\n\nIncluded conditions:\n- Smoking\n\nStudy Armgroups:\n- {'label': 'AB-free kava', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: AB-free kava']}\n- {'label': 'Placebo control', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.', 'armGroupLabels': ['Placebo control']}\n- {'type': 'DRUG', 'name': 'AB-free kava', 'description': 'Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.', 'armGroupLabels': ['AB-free kava']}\n\nPrimary Outcomes:\n- {'measure': 'Subject Compliance with Intervention', 'description': 'Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses', 'timeFrame': '4 weeks'}\n- {'measure': 'Subject Compliance with Intervention', 'description': 'Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nWithin-participant correlation rho varies from 0 to 0.8. The Bonferroni-corrected alpha level is 2.5%. The study aims for at least 90% power. An 80% retention rate is assumed.", "answer": 76, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our targeted accrual goal is 76 active smokers. Based on our previous enrolling experience at the UF Health Family Medicine Clinic and our rather strict eligibility criteria, the enrollment is expected to be 1.5\u00e2\u0080\u00932.5 years with the study duration of each participant to be approximately 12 weeks.\n The sample size was determined based on our primary biological signature endpoint data (TNE and PRKACA) from our pilot results. Using the pilot result of TNE as an example, the ratio of geometric mean of TNE after one week kava treatment is 0.68 with a standard error of 0.06. By taking into consideration that the placebo group demonstrates 15% of the treatment impact, a figure widely agreed upon in existing literature [37, 38], and apply the identical standard error as observed in the kava treatment group, the standardized effect size (Cohen\u00e2\u0080\u0099s d) equals d\u00e2\u0080\u0089=\u00e2\u0080\u00891.01. Similarly, the Cohen\u00e2\u0080\u0099s d for PRKACA is 0.89. Since in our proposed study, we will repeatedly measure these biomarkers in each participant, we further assume the same Kava effect from week one through week four. By (i) varying within-participant correlation rho\u00e2\u0080\u0089=\u00e2\u0080\u00890, 0.2, 0.4, 0.6, and 0.8; (ii) at Bonferroni-corrected alpha level 2.5% (5%/2), and (iii) using a linear mixed model, 60 participants (30 per group) are needed to have at least 90% power for both TNE and PRKACA. Additionally, supposing an 80% retention rate, consistent with rates in comparable studies [39], tour plan entails recruiting 76 participants, with 38 assigned to each group.\n The research team will exclude pregnant women from this study due to the proposed method involving AB-free kava to help reduce tobacco use by managing stress. This decision is based on the anticipation that pregnancy may induce substantial alterations in mental state and hormonal physiology. These discrepancies are likely to impede the primary objective of this early-phase clinical investigation by weakening the justification for determining the sample size.", "id": 1786, "split": "test"} +{"trial_id": "NCT05814341", "pmid": "39327056", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Increasing Post-Filter Ionized Target on the Efficacy of Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy in Intensive Care: a Multicenter Randomized Controlled Non-Inferiority Trial\n\nIncluded conditions:\n- Renal Replacement Therapy\n\nStudy Armgroups:\n- {'label': 'High iCa target', 'type': 'EXPERIMENTAL', 'description': 'Post-filter iCa between 0,35-0.45 mmol/L', 'interventionNames': ['Drug: Citrate']}\n- {'label': 'Low iCa target', 'type': 'ACTIVE_COMPARATOR', 'description': 'Post-filter iCa between 0.25-0.35 mmol/L', 'interventionNames': ['Drug: Citrate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Citrate', 'description': 'Comparison of two dosage adjustment protocols for medication according to different post-filter iCa targets', 'armGroupLabels': ['High iCa target', 'Low iCa target'], 'otherNames': ['REGIOCIT\u00ae']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of filter clotting', 'description': 'Filter clotting was defined by increased transmembrane pressure greater than 300 mmHg', 'timeFrame': '72 hours'}\n- {'measure': 'Incidence of filter clotting', 'description': 'Filter clotting was defined by visible thrombus in circuit or filter', 'timeFrame': '72 hours'}\n- {'measure': 'Incidence of filter clotting', 'description': 'Filter clotting was defined by inability to rotate the blood pump due to an obstructing thrombus', 'timeFrame': '72 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe observed incidence of filter clotting in the reference group (post-filter iCa target between 0.25 and 0.35 mmol/L) was 18.5% based on retrospective data analysis.", "answer": 412, "answer_type": "ESTIMATED", "explanation": "Sample size\n Estimating the filter clotting rates for the reference group (post-filter iCa target between 0.25 and 0.35\u00e2\u0080\u0089mmol/L) is challenging due to wide heterogeneity found in the literature, ranging from 9.5%18 to 57.9%.6 Therefore, we conducted a retrospective analysis of data from our centre between January 2016 and April 2018.17 The observed incidence of filter clotting was 18.5% out of a total of 473 CRRT sessions analysed, with a post-filter iCa target between 0.25 and 0.35\u00e2\u0080\u0089mmol/L. We thus consider it clinically acceptable to conclude non-inferiority if the intervention group (post-filter iCa target between 0.35 and 0.45\u00e2\u0080\u0089mmol/L) has a filter clotting incidence of up to 21%, representing a difference of 2.5\u00e2\u0080\u0089percentage points, with a non-inferiority margin set at 9%. Therefore, it will be necessary to include 412 analysable RCA-CRRT sessions in the study.", "id": 1787, "split": "test"} +{"trial_id": "NCT05814640", "pmid": "37891522", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) a Multicentre Open-label Randomized Controlled Trial Protocol\n\nIncluded conditions:\n- Depression\n- Sequestra\n\nStudy Armgroups:\n- {'label': 'Fluoxetine', 'type': 'EXPERIMENTAL', 'description': 'Dosage form: po Dosage: 10-60mg Frequency: qn Course of treatment: 8 weeks. At week 8, patients will be evaluated as \"in remission\" or \"not in remission.\" \"Patients who are not in remission\" will be randomized to phase II treatment based on the patient\\'s wishes.', 'interventionNames': ['Drug: Fluoxetine']}\n- {'label': 'group cognitive behavioral therapy\uff08GCBT\uff09', 'type': 'EXPERIMENTAL', 'description': 'GCBT was administered in addition to fluoxetine and consisted of 11 sessions for 8 weeks. It lasts 90 to 120 minutes, once or twice a week. At week 8, patients will be evaluated as \"in remission\" or \"not in remission.\" \"Patients who are not in remission\" will be randomized to phase II treatment based on the patient\\'s wishes.', 'interventionNames': ['Behavioral: GCBT']}\n- {'label': 'Sertraline', 'type': 'EXPERIMENTAL', 'description': \"dosage form: po dosage:25-200mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given Sertraline as a switching treatment to fluoxetine.\", 'interventionNames': ['Drug: Sertraline']}\n- {'label': 'Votioxetine', 'type': 'EXPERIMENTAL', 'description': \"dosage form: po dosage: 10-20mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given votioxetine as a switching treatment to fluoxetine.\", 'interventionNames': ['Drug: Vortioxetine']}\n- {'label': 'Duloxetine', 'type': 'EXPERIMENTAL', 'description': \"dosage form: po dosage: 60-120mg frequency: qn duration: At Week 8, patients assessed as 'non-remission' will be given duloxetine as an add-on treatment to fluoxetine.\", 'interventionNames': ['Drug: Duloxetine']}\n- {'label': 'Aripiprazole', 'type': 'EXPERIMENTAL', 'description': \"dosage form: po dosage: 2.5-15mg frequency:qn duration: At Week 8, patients assessed as 'non-remission' will be given aripiprazole as an add-on treatment to fluoxetine.\", 'interventionNames': ['Drug: Aripiprazole']}\n- {'label': 'Lithium carbonate', 'type': 'EXPERIMENTAL', 'description': \"dosage form:po dosage: 125-500mg frequency: qn duration: At Week 8, patients assessed as 'non-remission' will be given lithium carbonate as an add-on treatment to fluoxetine.\", 'interventionNames': ['Drug: Lithium Carbonate']}\n- {'label': 'Olanzapine', 'type': 'EXPERIMENTAL', 'description': \"dosage form:po dosage: 1.25-10mg frequency:qn duration: At Week 8, patients assessed as 'non-rremission' will be given olanzapine as an add-on treatment to fluoxetine.\", 'interventionNames': ['Drug: Olanzapine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fluoxetine', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Fluoxetine']}\n- {'type': 'DRUG', 'name': 'Sertraline', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Sertraline']}\n- {'type': 'DRUG', 'name': 'Vortioxetine', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Votioxetine']}\n- {'type': 'DRUG', 'name': 'Duloxetine', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Duloxetine']}\n- {'type': 'DRUG', 'name': 'Aripiprazole', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Aripiprazole']}\n- {'type': 'DRUG', 'name': 'Lithium Carbonate', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Lithium carbonate']}\n- {'type': 'DRUG', 'name': 'Olanzapine', 'description': 'Commonly used oral antipsychotics intervention therapy.', 'armGroupLabels': ['Olanzapine']}\n- {'type': 'BEHAVIORAL', 'name': 'GCBT', 'description': 'Commonly used intervention therapy of psychotherapy.', 'armGroupLabels': ['group cognitive behavioral therapy\uff08GCBT\uff09']}\n\nPrimary Outcomes:\n- {'measure': \"Change in CDRS-R (Children's Depression Rating Scale) scores from baseline\", 'description': 'Clinical response (\u2265 50% reduction in CDRS-R scores from baseline)', 'timeFrame': 'Baseline of treatment period, 2 weeks, 1 month, 2 months, 3 months\uff0c4months; The follow-up period was 1 month, 3 months, 6 months and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u00ce\u00b1) was set at 0.025 (one-tailed), the test power (1-\u00ce\u00b2) was set to 0.8, and a 20% dropout rate was considered.", "answer": 520, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the preliminary pilot study, we hypothesized that the response rates of fluoxetine and combination therapy in stage 1 were 40% and 60%, respectively. The significance level (\u00ce\u00b1) was set at 0.025 (one-tailed), the test power (1-\u00ce\u00b2) was set to 0.8, and the distribution ratio of fluoxetine and combination therapy in phase 1 was established as 1:1 according the preliminary pilot study. Considering a 20% dropout rate, the sample size must be greater than 238.\n However, in order to achieve statistical significance, phase 2 of clinical trials necessitates a minimum sample size of at least 30 patients in each group [59]. Considering a 20% dropout rate, the sample size going into phase 2 cannot be less than 216. Therefore, combining the sample size from both stages and accounting for the response rate in the first phase, our sample size target for this trial is 520 patients.\n \n Randomization\n After week 8 of the Phase 1 intervention, nonresponding patients and those with a response without remission will be randomly assigned by central allocation. The randomization sequence will be created using StataPM.14 software and stratified by the centre, ensuring these patients will be ramdomly equally assigned to one of six treatment groups. To simulate a clinical environment reflecting real-world conditions, the medications are administered in an open-label manner with flexible dosing. The patient, psychiatrist, and outcome assessor are aware of the group allocation, whereas the data analyst will remain blinded to this information. The clinicians providing the intervention will not conduct the evaluation. All investigators, staff, and participants will maintain strict confidentiality regarding the outcome measures and trial results.\n \n \n Data collection and management\n We will use Yiducloud (https://www.yiducloud.com.cn/), a secure and extensively utilized web-based research application, for data collection and entry. The application offers a user-friendly interface for accurate data entry, allows tracking of data manipulation through audit trails, and provides automated export functions for convenient data downloads to Excel. Our database will require complete responses to all interview questions and survey, and will include tools to bring in data from external sources.\n We will implement a robust data management strategy to ensure the reliability and availability of the study data. All participant information will be securely stored in a Yiducloud database and managed for efficient updating, tracking, and exporting of data in various formats. We will implement procedures to ensure compliance with local institutional review boards and manage data requests through a data use agreement.\n Data entry will be conducted by a trained officer and each data entry is then carefully double-checked by another research team member. Data completeness will be reviewed monthly. Reasons for missing data will be documented in real time during data collection and entry, and a second reviewer will review and verify 10% of the data for quality control. This plan will ensure the reliability of data used for analysis and dissemination while ensuring ethical and regulatory compliance.", "id": 1788, "split": "test"} +{"trial_id": "NCT05814913", "pmid": "37328751", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial\n\nIncluded conditions:\n- Psychosis\n\nStudy Armgroups:\n- {'label': 'CaCBT for psychosis', 'type': 'EXPERIMENTAL', 'description': 'CaCBT is a culturally adapted psychosocial intervention for people with early psychosis that comprises of 12 sessions. These sessions are conducted individually on a weekly basis and last 45-60 minutes', 'interventionNames': ['Behavioral: CaCBT for psychosis']}\n- {'label': 'CulFI Intervention', 'type': 'EXPERIMENTAL', 'description': 'CulFI is a culturally adapted psychosocial intervention delivered over 10 sessions of 40-60 minutes, weekly for the first 8 weeks and fortnightly for the remaining 4 weeks. Sessions are delivered to patients and their carers, though patient participation in sessions is not necessary.', 'interventionNames': ['Behavioral: Culturally adapted Family Intervention (CulFI) for psychosis']}\n- {'label': 'Treatment as Usual (TAU)', 'type': 'NO_INTERVENTION', 'description': \"TAU will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of TAU delivered to each participant over a period of 3 months.\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CaCBT for psychosis', 'description': 'The CaCBT intervention is based on the intervention manual developed by David Kingdon and Douglas Turkington, and culturally adapted by our group. CaCBT aims to take a collaborative approach to gaining an understanding of the symptoms', 'armGroupLabels': ['CaCBT for psychosis']}\n- {'type': 'BEHAVIORAL', 'name': 'Culturally adapted Family Intervention (CulFI) for psychosis', 'description': 'CulFI intervention comprises of Family psychoeducation; cognitive-behavioural skills training for stress-management, coping and problem solving; crisis intervention and suicide risk management; relapse prevention; education and support regarding the family environment, including communication training. The components are designed to facilitate an understanding about psychosis, the emotional impact of the illness on family relationships, to promote more adaptive coping strategies and minimize relapse risk.', 'armGroupLabels': ['CulFI Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Positive and Negative Syndrome Scale', 'description': 'The PANSS is a structured interview use to evaluate the prevalence and severity of the positive, negative and general psychiatric symptoms of schizophrenia. The higher the score the greater symptoms severity. potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale.', 'timeFrame': 'Change in scores from baseline to months 3, 6, and 12'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated. Power: 80%. Attrition rate: 20% at post-treatment. Standard deviation: 17.18. Longitudinal analysis expected to be more powerful.", "answer": 390, "answer_type": "ESTIMATED", "explanation": "Sample size\n With the proposed total sample size of 390 (130 per condition), we have sufficient power (80%) to detect a small to medium treatment effect (Cohen\u00e2\u0080\u0099s D\u00e2\u0080\u0089=\u00e2\u0080\u00890.39) of either CaCBT or CulFI over TAU on PANSS total score at post-treatment (3-month). The selection of effect size has been informed by a meta-analysis of culturally adapted psychosocial interventions [34] and effect sizes generated from meta-analysis of CBT for psychosis [35]. Cohen\u00e2\u0080\u0099s D of 0.39 is also equivalent to a clinically meaningful reduction in PANSS of 6.70 points. The standard deviation, informed by our pilot work, was taken as 17.18 [26]. For sex or gender-based subgroup analysis, the minimum detectable effect sizes to attain sufficient power increase to 0.48 and 0.67 for men and women respectively. Our exploratory analysis will compare the effect of CulFI with CaCBT in improving patient and carer related outcomes. Although this exploratory outcome is not adequately powered for a non-inferiority analysis, it will inform sample size for future comparative clinical trials. The power calculation has considered 20% attrition at post treatment and was based on an end-point analysis. Longitudinal analysis will be more powerful with reduction in measurement error due to repeated measures.", "id": 1789, "split": "test"} +{"trial_id": "NCT05817396", "pmid": "38750590", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Take Care! - Dissemination Von Bewegungsbezogener Gesundheitskompetenz in Der Pflegeausbildung\n\nIncluded conditions:\n- Physical Activity\n- Exercise\n- Education\n- Nursing\n- Competence\n\nStudy Armgroups:\n- {'label': 'Cooperative Planning for Promoting PAHCO', 'type': 'EXPERIMENTAL', 'description': 'Participatively developed intervention concept by means of cooperative planning (R\u00fctten, 1997) to promote physical activity-related health competence (PAHCO): A separate cooperative planning process will take place in each of the four schools in this study arm from April to November 2023. Within the framework of these processes, suitable interventions tailored to the target group and the school will be developed for the implementation of the curriculum content \"PAHCO\" with the participation of actors from science and practice (e.g., teachers, nursing students of the schools). The developed interventions will be implemented from December 2023 under the responsibility of the actors in the schools.', 'interventionNames': ['Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)']}\n- {'label': 'Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists', 'type': 'EXPERIMENTAL', 'description': 'Expert-based intervention concept with external physical activity specialists to promote physical activity-related health competence (PAHCO). We will develop a specific intervention concept for the implementation of the curriculum content \"PAHCO\" at nursing schools in Bavaria from April to November 2023. Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes. The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content). Physical activity specialists (e.g. sports scientists, physiotherapists) will be trained to implement this expert-based intervention concept from December 2023 to March 2024.', 'interventionNames': ['Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)']}\n- {'label': 'Expert-Based Intervention for Promoting PAHCO Delivered by Teachers', 'type': 'EXPERIMENTAL', 'description': 'Expert-based intervention concept with teachers as multipliers to promote physical activity-related health competence (PAHCO). We will develop a specific intervention concept for the implementation of the curriculum content \"PAHCO\" at nursing schools in Bavaria from April to November 2023. Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes. The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content). Teachers of the participating nursing schools of this study arm will be trained to implement this expert-based intervention concept in their school from December 2023 to March 2024.', 'interventionNames': ['Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)']}\n- {'label': 'Regular Education and Health Promotion', 'type': 'NO_INTERVENTION', 'description': 'No systematic intervention concept: In the schools of this study arm, there is no systematic and scientifically supported intervention for the implementation of the curriculum content \"PAHCO\".'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Promotion of Physical Activity-related Health Competence (PAHCO)', 'description': 'Intervention for the curriculum content \"PAHCO\" at nursing schools in Bavaria', 'armGroupLabels': ['Cooperative Planning for Promoting PAHCO', 'Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists', 'Expert-Based Intervention for Promoting PAHCO Delivered by Teachers']}\n\nPrimary Outcomes:\n- {'measure': 'Physical Activity-related Health Competence (Short Term)', 'description': 'Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome', 'timeFrame': 'Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)'}\n- {'measure': 'Psychological Movement Quality (Short Term)', 'description': 'Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome', 'timeFrame': 'Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)'}\n- {'measure': 'Quality Physical Activity (Short Term)', 'description': 'The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)', 'timeFrame': 'Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)'}\n- {'measure': 'Physical Activity-related Health Competence (Medium Term)', 'description': 'Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome', 'timeFrame': 'Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)'}\n- {'measure': 'Psychological Movement Quality (Medium Term)', 'description': 'Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome', 'timeFrame': 'Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)'}\n- {'measure': 'Quality Physical Activity (Medium Term)', 'description': 'The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)', 'timeFrame': 'Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)'}\n\nPlease estimate the sample size based on the assumption: \nWe assume a power of 0.80, an autocorrelation of 0.50, an intraclass correlation coefficient (ICC) of 0.02, a design effect of 1.78, a non-consent rate of 20%, and a longitudinal dropout rate of 30%.", "answer": 640, "answer_type": "ESTIMATED", "explanation": "Primary analyses with sample size calculation\n PAHCO (including its three model components), the leisure-time/sport versus occupation PA index, and psychological movement quality serve as primary outcomes, both at T2 (post-implementation) and at T3 (follow-up). To illuminate the differential change evoked by the interventions, we run linear mixed models separately adopting a short-term (T2) and medium-term (T3) perspective. Setting-specific readiness for change (via RTT) is considered to be treated as a covariate on the cluster level for minimizing the potential bias that intervention effects may be referred to significant institutional differences in this variable across the study arms. In case of rejected equality of variances across time (as indicated by Mauchly\u00e2\u0080\u0099s Test for Sphericity), we apply corrections or models with robust assumptions. Main attention is paid to group*time interactions, expressing differential developments of indicator measurements over time. We include all participants into the analyses who initially met the inclusion criteria and participated in the baseline assessment (intention-to-treat assumption). Accordingly, all potential missing data are handled using imputation procedures [63]. We conduct all calculations in the open-source software R (version 4.1.3 or higher). All quantitative questionnaire data are stored and processed in SPSS (IBM, Armonk, USA) after cultivating double checks of data entry with at least one other assistant.\n The present trial involves four study arms and four measurement time points (T0, T1, T2, T3). Informed by previous experiences in the context of PAHCO, we anticipate longitudinal construct stability of rt\u00e2\u0080\u0089=\u00e2\u0080\u00890.50 (autocorrelation). Calculations in G*Power (v3.1) [64] with an assumed a power (1\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089\u00ce\u00b2) of 0.80 revealed that we require a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089200 for registering at least a small effect (d\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.20, f\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.10) in comparison to the CG [65]. However, given that nursing students are nested within schools and that the settings may assign different importance to health and PA promotion, we account for clustering (ICC\u00e2\u0080\u0089=\u00e2\u0080\u00890.02) by considering a design effect of DE\u00e2\u0080\u0089=\u00e2\u0080\u00891.78 (ncor\u00e2\u0080\u0089=\u00e2\u0080\u0089356). In addition, we consider a substantial rate of non-consent to participation (20%) in the first step and longitudinal dropout (30%) in the second step, resulting in nfinal\u00e2\u0080\u0089=\u00e2\u0080\u0089636. On average, Bavarian nursing schools have 20 students per class and, in turn, two classes per cohort (corresponding to 40 annual students per year). Given these sample size calculations, we have to recruit a total of 16 schools for the present trial (resulting in an overall potential of 640 nursing students).", "id": 1790, "split": "test"} +{"trial_id": "NCT05819346", "pmid": "38453202", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of a Digital Lifestyle Intervention on Health-Related Quality of Life in Non-Small Cell Lung Cancer Survivors (QUALUCA): a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Non-Small Cell Lung Cancer (NSCLC)\n\nStudy Armgroups:\n- {'label': 'Digital lifestyle intervention', 'type': 'EXPERIMENTAL', 'description': 'Self-management mobile application covering physical activity, nutrition, and breathing/relaxation', 'interventionNames': ['Behavioral: Lifestyle']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Usual care (study participation does not interfere with or change any other planned treatments)'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Lifestyle', 'description': 'Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after rehabilitation or treatment has finished. The digital program is target group-specific and includes personalization and interactive elements without face-to-face appointments during the intervention. One virtual appointment at the beginning of the intervention with the study staff ensures that participants familiarize themselves with the mobile application and that they are assigned to a suitable program level. The intervention is mainly based on the following behavior change technique (BCT) clusters: goals and planning, feedback and monitoring, shaping knowledge, and comparison of behavior.', 'armGroupLabels': ['Digital lifestyle intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Health-related quality of life (Scale-Global health status)', 'description': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (2 items; 7-point Likert-type scale; the score ranges from 0 to 100; a high score for the global health status represents a high HRQoL)', 'timeFrame': 'Change from baseline to 3 months'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% at a significance level of 5% (two-sided) and an anticipated dropout rate of 25%. The correlation coefficient between baseline and follow-up scores is estimated to be 0.4, resulting in a design factor of 0.84.", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on analysis of covariance (ANCOVA) to compare the change in the EORTC QLQ-C30 (Global Health Status Scale) from baseline to follow-up. The sample size for the ANCOVA was determined using a two-step method proposed by Borm et al.91 First, the sample size (n) was calculated as if a t-test on the follow-up score was conducted, and then one additional individual per group was added. Second, the number of participants was multiplied by a \u00e2\u0080\u0098design factor\u00e2\u0080\u0099 of (1\u00e2\u0080\u0093r2), where r denotes the correlation coefficient between baseline and follow-up scores, to obtain the total number of participants required for the ANCOVA. In this study, a conservative estimate was used with r=0.4, resulting in a \u00e2\u0080\u0098design factor\u00e2\u0080\u0099 of 0.84. To detect a change of 15 points (\u00ce\u00bci-\u00ce\u00bcc) in the EORTC QLQ-C30, which corresponds to a moderate change from the patient\u00e2\u0080\u0099s perspective,92 93 and assuming a standard deviation (\u00cf\u0083) of 23,94 95 a total of 66 participants are needed to achieve a power of 80% at a significance level of 5% (two sided) (equations 3 and 4). Considering an anticipated dropout rate of 25%, the study aims to include a required total sample size (N) of 88 participants.\n \n\n(3)\n\u00ce\u00b4=|\u00ce\u00bci\u00e2\u0088\u0092\u00ce\u00bcc|\u00cf\u0083\n\n\n \n\n(4)\nN=(4(Z1\u00e2\u0088\u0092\u00ce\u00b12+Z1\u00e2\u0088\u0092\u00ce\u00b2)2\u00ce\u00b42+Z1\u00e2\u0088\u0092\u00ce\u00b1222){1\u00e2\u0088\u0092r2}", "id": 1791, "split": "test"} +{"trial_id": "NCT05821647", "pmid": "37130670", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of a Machine Learning-Derived Early Warning System for Hypotension vs Standard Care on Depth and Duration of Intra- and Postoperative Hypotension in Elective Cardiac Surgery\n\nIncluded conditions:\n- Intraoperative Hypotension\n- Postoperative Hypotension\n- Hypotension\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Objective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution.\\n\\nThis is done using standard hemodynamic monitoring, which in our center consists of continuous arterial blood pressure monitoring and the pulse pressure variation parameter. The clinician will administer either fluids, inotropes, vasopressors, or a combination, or apply positional changes to maintain the set MAP threshold.'}\n- {'label': 'Additional HPI guided treatment', 'type': 'EXPERIMENTAL', 'description': 'Objective to maintain a mean arterial blood pressure (MAP) above or equal to 65 mm Hg, as is standard care in out institution.\\n\\nThis is done using standard hemodynamic monitoring (as described for the control group) but is assisted by the Hypotension Prediction Index (HPI). This parameter is made available to the clinicians with the HemoSphere Advanced Monitoring Platform (HemoSphere) and is used to initiate treatment when the HPI values is \u2265 75.\\n\\nIt also provides additional advanced hemodynamic variables (e.g. cardiac output, systemic vascular resistance). The treating clinicians are trained to use these variables and are provided with a diagnostic flowchart to determine the cause (preload, contractility and afterload) of the upcoming hypotensive (MAP \\\\< 65 mmHg) event. Timing of treatment and choice of treatment is then left to the discretion of the attending clinician.', 'interventionNames': ['Other: HPI guided treatment advice']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'HPI guided treatment advice', 'description': 'Administer hemodynamic altering intervention aimed at either a preload, contractility, or afterload problem to prevent impending hypotension. Treatment options include: administering either fluids, inotropes, vasopressors, positional changes, or a combination.', 'armGroupLabels': ['Additional HPI guided treatment']}\n\nPrimary Outcomes:\n- {'measure': 'The overall time-weighted average (TWA) of hypotension (severity of hypotension)', 'description': \"TWA is a calculation of the depth (in mmHg) of hypotension below the 'threshold' MAP of 65 mmHg x the time spent in hypotension in minutes, this resulting in an 'area'. To better compare this value between different patients the 'area' can be divided by the total duration of the measurement.\", 'timeFrame': 'During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)'}\n\nPlease estimate the sample size based on the assumption: \nA Student\u2019s t-test with an \u03b1=0.05 and 80% power was used. The incidence of hypotension in the population is 94%, and the data was transformed to normality using a Box-Cox procedure.", "answer": 130, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The prior HYPE trial16 found a median TWA reduction of 77%, favouring HPI with diagnostic guidance in a non-cardiac surgery population. However, a slightly dampened effect is expected resulting from physiological changes caused by the CPB period (eg, systemic inflammatory response8) and a likely slower response time to HPI alerts in the ICU setting as the treating personnel is not continuously present at the bedside. Therefore, a 60% reduction in TWA of hypotension was considered both feasible and clinically relevant.\n Representative haemodynamic data from two prospective observational studies done in cardiac surgery populations at our institution was used for this calculation. The first study, the PREP-trial (ongoing (NL7810 at www.trialregister.nl)), provides intraoperative measurements. The second study, the PHYSIC I trial26 collected data during the postoperative ICU admission. The combined TWA of hypotension was calculated from patients undergoing CABG with or without additional single heart valve surgery in these studies to estimate the current intraoperative and postoperative average for this population (median 1.02\u00e2\u0080\u0089mm Hg, IQR 0.32\u00e2\u0080\u00932.12). Of all included patients, 94% had hypotension during admission. As expected, the TWA in these patients showed a skewed distribution which was transformed to normality with a Box-Cox procedure.26 This resulted in a mean of 0.983\u00e2\u0080\u0089mm Hg and an SD of 1.15\u00e2\u0080\u0089mm Hg. Anticipating a mean reduction of 60% resulted in a mean difference of 0.59\u00e2\u0080\u0089mm Hg (0.983\u00e2\u0080\u0089mm Hg\u00c3\u00970.6). Dividing this mean difference by the SD gives an effect size of 0.51 (0.59/1.15). Using a Student\u00e2\u0080\u0099s t-test with an \u00ce\u00b1=0.05 and 80% power, these parameters translate to a sample size of 122. Correcting for the incidence of hypotension in this population resulted in the required sample size of 130 (122/0.94). All statistical analyses were performed using R Project for Statistical Computing (R Core Team, 201727).", "id": 1792, "split": "test"} +{"trial_id": "NCT05821881", "pmid": "37185193", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Discontinuation of Levothyroxine Treatment in Older Adults: a Self-controlled Study\n\nIncluded conditions:\n- Hypothyroidism\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Discontinuation of levothyroxine treatment', 'description': 'Step-wise reduction of levothyroxine treatment guided by thyroid function and symptoms'}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants successfully withdrawn from levothyroxine treatment', 'description': 'The proportion of participants that withdraw from levothyroxine treatment successfully (defined as normal fT4 levels and TSH levels \\\\<10 mU/L) at 52 weeks after the start of the discontinuation.', 'timeFrame': '52 weeks after start of discontinuation'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size allows for a 95% confidence interval with a deviation of 5 percentage points from the found percentage. A maximum of 25% loss to follow-up is considered over 15 months.", "answer": 513, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based on the primary outcome, the proportion of participants successfully stopping levothyroxine treatment between baseline and final follow-up at 52 weeks. Since population proportions of successful levothyroxine treatment cessation are unknown (the aim of this study), we estimated a proportion of 50% of the participants who successfully discontinue levothyroxine treatment. An estimated proportion of 50% results in the most conservative estimate (resulting in the highest calculated sample size) and is in line with the limited available evidence.37\u00e2\u0080\u009339 We have chosen a sample size of 385 participants because this allows us to estimate the expected proportion of 50% with a 95% CI of which the lower and upper limit is expected to deviate by 5\u00e2\u0080\u0089percentage points from the found percentage (ie, 45% to 55% when the found percentage is indeed 50%).\n Taking a maximum of 25% loss to follow-up into account over the duration of 15 months (exclusion at T-12 when TSH level \u00e2\u0089\u00a510\u00e2\u0080\u0089mU/L and/or fT4 below reference range, withdrawal, moving away or death between T-12 and T52) a maximum of 513 participants will be recruited. Based on a data query from the academic network of general practices in the region of Leiden, it was estimated that the projected sample size will be reached after inclusion of 53 standard general practices.", "id": 1793, "split": "test"} +{"trial_id": "NCT05822297", "pmid": "38862912", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Myokines and Cognitive Aging in People With Spinal Cord Injury: a Single Case Experimental Design Study\n\nIncluded conditions:\n- Spinal Cord Injuries\n- Cognitive Decline\n\nStudy Armgroups:\n- {'label': 'All participants', 'type': 'EXPERIMENTAL', 'description': 'Each participant will undergo the same procedures and intervention, consisting of a baseline phase, intervention phase and follow-up phase. The length of the baseline phase will be randomized 3, 4, 5 or 6 weeks.', 'interventionNames': ['Device: Neuromuscular electrical stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Neuromuscular electrical stimulation', 'description': 'NMES will consist of a 12 week electrical stimulation program, three times a week. Electrical stimulation will be done on the quadriceps muscles of both legs simultaneously. For each leg, one electrode is placed on the proximal side and one on the distal side of the quadriceps muscle. Electrical stimulation sessions will take 30min, at a stimulation frequency of 50Hz, an intensity where we can at least see a visible or palpable contraction with a maximum intensity of 100mA (we will choose the highest intensity that is easily supported by the participant without inducing discomfort) and a pulse width of 400\u03bcs. The activation within the activation-rest cycle consists of a 1s ramp-up, 7s full activation and 1s ramp-down, followed by 18s rest. Every 4 weeks the rest period will be diminished with 3s until a total of 9s.', 'armGroupLabels': ['All participants']}\n\nPrimary Outcomes:\n- {'measure': 'Change in executive function', 'description': 'response time (in ms) on the momentary digital symbol substitution task', 'timeFrame': 'measured a total of 54-63 times in 30-33 weeks time'}\n\nPlease estimate the sample size based on the assumption: \nFor the single-armed prospective study design, the power is set at 0.80 for evaluating a Time effect over 4 time points using repeated measures ANOVA. The correlation among repeated measures for the cognitive test battery was found to be \u22650.77 in a previous SCI study. The lowest attainable p-value for randomization tests in the SCED design is 0.05, based on 20 possible permutations.", "answer": 15, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n \n Single-case data\n The sample size needed for the abovementioned statistical analyses is different for the SCED and single-armed prospective study design. For the SCED design, the minimum sample size is n\u00e2\u0080\u0089=\u00e2\u0080\u00891. Instead, the power of the analysis depends on the number of observations [40, 41]. For randomization tests the lowest attainable p-value is calculated by dividing 1 by the number of possible permutations. In this study, the baseline phase, after removing the first four values because of a learning effect, can contain 5 to 24 measurement points, allowing 20 possible permutations. This corresponds with a lowest attainable p-value of 0.05 [56]. Of note, successful replication of the single-case experiment in additional participants with similar symptoms will improve the generalizability of the results [40, 41].\n \n \n Secondary data\n For the single-armed prospective study design we have estimated the sample size needed in order to have sufficient power (Power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80) for evaluating a Time effect (over 4 time points) of cognitive test performance changes with repeated measures ANOVA. We found no previous studies examining the effect of any muscle activity intervention in spinal cord injury subjects. Therefore, the required effect size was estimated to be similar to that from a meta-analysis examining the effect of resistance exercise interventions on general cognitive function in healthy adults [66]. The overall effect size (Cohen\u00e2\u0080\u0099s d) was 0.71 (0.30\u00e2\u0080\u00931.12) for resistance exercise. The correlation among repeated measures for this cognitive test battery that was found to be\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.77 in a previous SCI study [43]. G*Power 3.1.9.7 estimated that the minimum total sample size should be 7. Taking into account potential drop-outs and the uncertainty of the effect, we decided to aim for a total sample of 15 included participants.", "id": 1794, "split": "test"} +{"trial_id": "NCT05825560", "pmid": "39832962", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Opioid-free Analgesia in Intensive Care Unit: a Prospective, Monocentric, Randomized, Double Blind, Feasability Clinical Trial\n\nIncluded conditions:\n- Intubation\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': \"Analgesia combines paracetamol (1g every 6 to 8 hours according to age and weight recommendations) and remifentanil, adapted according to a tiered administration system depending on the Behavior Pain Scale (BPS) and the theoretical ideal weight. Remifentanil doses are adjusted so that the patient has a BPS score of 4 or less. Reassessment of analgesia will be carried out every 30 minutes until analgesic adaptation is complete, then every 2 hours as is usually done in our department.\\n\\nIf the BPS is less than or equal to 4, the therapeutic de-escalation will be done with a reverse algorithm until the analgesic drugs are stopped.\\n\\nAfter the sedation balance phase, the patient's BPS will be assessed every 2 hours.\", 'interventionNames': ['Drug: Standard multimodal analgesia']}\n- {'label': 'OFA Group', 'type': 'EXPERIMENTAL', 'description': 'A fixed combination of nefopam and tramadol will be initiated at daily doses. An initial dose of 50mg tramadol and 20mg nefopam IV over 30 min. will be administered. Reassessment of analgesia will be performed every 30 min. for two hour and then every 2 hours.\\n\\n* If BPS is \\\\> 4, administration of ketamine with an initial bolus of 0.15mg/kg followed by continuous administration at a dose of 0.15mg/kg/hour.\\n* If the BPS is \\\\< 4, remifentanil is introduced at the minimum effective dose, in a stepwise fashion according to the theoretical ideal weight\\n* In the event of maximum pain requiring the full range of therapies in the algorithm the total dose of tramadol will be 450mg/day and nefopam 120mg/day, in accordance with summaries of product characteristics.\\n* If the BPS \\\\< or = 4, the therapeutic de-escalation will be done with a reverse algorithm until the analgesic drugs are stopped, according to the following scheme: remifentanil, ketamine, tramadol and then nefopam.', 'interventionNames': ['Drug: OFA multimodal analgesia']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'OFA multimodal analgesia', 'description': 'Multimodal opioid free analgesia', 'armGroupLabels': ['OFA Group']}\n- {'type': 'DRUG', 'name': 'Standard multimodal analgesia', 'description': 'Standard remifentanil analgesia', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Daily remifentanil consumption (after randomisation)', 'description': 'daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 48 hours of mechanical ventilation', 'timeFrame': '48th hour after randomisation'}\n\nPlease estimate the sample size based on the assumption: \nThe daily dose of remifentanil is 9 \u00b5g/kg/hour with an SD of 1.5 \u00b5g/kg/hour in the control group. The study aims for an 80% statistical power and a two-sided \u03b1 level of 0.05. A dropout rate of 10% is considered.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the available literature, the daily dose of remifentanil is defined as 9\u00e2\u0080\u0089\u00c2\u00b5g/kg/hour, with an SD of 1.5\u00e2\u0080\u0089\u00c2\u00b5g/kg/hour in the control group, constant during ICU stay.32\n We hypothesised that the multimodal analgesia strategy in the intervention arm would allow a 15% decrease in the daily consumption of remifentanil.\n We calculated that a total of 46\u00e2\u0080\u0089patients (23 in each arm) are necessary for an 80% statistical power in the primary outcome and a two-sided \u00ce\u00b1 level of 0.05. To consider a dropout of 10%, we plan to include 50\u00e2\u0080\u0089patients in our study (25 in each arm).\n Patients\u00e2\u0080\u0099 distribution is shown in the flowchart, available in figure 3.\n \n Figure 3\n \n Flowchart.", "id": 1795, "split": "test"} +{"trial_id": "NCT05825625", "pmid": "40147985", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neoadjuvant TiRagolumab, Atezolizumab and Chemotherapy - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing: a Non-randomized, Open-label, Single-arm Phase II Study\n\nIncluded conditions:\n- Non-small Cell Lung Cancer\n\nStudy Armgroups:\n- {'label': 'Platinum-based chemotherapy in combination with atezolizumab and tiragolumab', 'type': 'EXPERIMENTAL', 'description': \"Patients will receive 2 cycles of SOC platinum-based chemotherapy as per investigator's choice in combination with atezolizumab and tiragolumab administrated by IV infusion.\\n\\nCurative intended surgery will follow after last dose of neoadjuvant treatment. After surgery, patients will receive adjuvant treatment including 2 cycles of platinum-based chemotherapy and atezolizumab plus tiragolumab for up to 1 year. Patients who achieved pCR will receive only atezolizumab plus tiragolumab for up to one year as maintenance therapy.\", 'interventionNames': ['Drug: Atezolizumab', 'Drug: Tiragolumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Atezolizumab 1,200 mg by IV infusion Q3W.', 'armGroupLabels': ['Platinum-based chemotherapy in combination with atezolizumab and tiragolumab'], 'otherNames': ['Tecentriq']}\n- {'type': 'DRUG', 'name': 'Tiragolumab', 'description': 'Tiragolumab by IV infusion Q3W.', 'armGroupLabels': ['Platinum-based chemotherapy in combination with atezolizumab and tiragolumab'], 'otherNames': ['no other name available']}\n\nPrimary Outcomes:\n- {'measure': 'MPR rate after curative intent surgery', 'description': 'number of patients with \u2264 10% of residual viable tumor in lung and lymph nodes as evaluated by pathology review, divided by the number of all patients with posttreatment tumor tissue available', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nNo formal statistical hypotheses testing. 95% Wilson-type CI for the MPR response rate with a width of 31.40%. Screening failure rate of approximately 25%.", "answer": 35, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This is an exploratory trial without testing of statistical hypotheses. No formal sample size calculation was conducted. Determination of sample size was based on the recruiting feasibility in this patient population.\n A sample size of 35 with the assumption of an MPR rate of 36.9\u00e2\u0080\u009357%1 12 results in an expected binomial proportion of 46.95%. The 95% Wilson-type CI for the MPR response rate is expected to have a width of 31.40% (the maximal width, which is observed if the MPR rate amounts to 50%, being 31.45%). The sample size calculation was conducted using the PASS V.16.03.\n Assuming a screening failure rate of approximately 25% due to unexpected events, and detection of molecular alterations/mutations that at the time of this trial will presumably guide these patients to a different therapy scheme, it is planned to screen 46 patients for this study within a recruitment period of 30 months.", "id": 1796, "split": "test"} +{"trial_id": "NCT05828823", "pmid": "38943204", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis\n\nIncluded conditions:\n- End-Stage Kidney Disease\n\nStudy Armgroups:\n- {'label': 'Clinically-matched Incremental Hemodialysis ( CMIHD)', 'type': 'EXPERIMENTAL', 'description': 'Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.', 'interventionNames': ['Device: Hemodialysis twice weekly']}\n- {'label': 'Conventional Hemodialysis (CHD)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Randomized group to conventional three times a week hemodialysis.', 'interventionNames': ['Other: Hemodialysis thrice weekly']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Hemodialysis twice weekly', 'description': 'Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer)', 'armGroupLabels': ['Clinically-matched Incremental Hemodialysis ( CMIHD)']}\n- {'type': 'OTHER', 'name': 'Hemodialysis thrice weekly', 'description': 'Conventional hemodialysis regimen', 'armGroupLabels': ['Conventional Hemodialysis (CHD)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Clinical events of safety', 'description': 'composite of all-cause Emergency Department visits, hospitalizations, or death', 'timeFrame': 'year 2'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a negative binomial distribution for safety events with overdispersion equal to 0.12, a 20% dropout rate, an average of 2.06 years of HD per participant, \u226585% power, and a one-sided significance level of 0.025. For secondary outcomes, a correlation of 0.8 between baseline and follow-up values is assumed, with detectable standardized effect sizes of 0.201 and 0.233 for 80% and 90% power, respectively.", "answer": 350, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n \n Power considerations for the primary outcome\n The sample size of 350 total (175 per treatment group) was calculated under the following assumptions and conditions: (a) reported combined 2-year incidence of all-cause mortality, all-cause ED visits not leading to hospitalization, and all-cause hospital admissions from the ED is 2.954 per person-year for CHD [81]; (b) clinical trial participants tend to be healthier than the overall population with KDRD [82]; thus, our null safety rate will assume a conservative downward adjustment in all-cause mortality estimate by 50% and all-cause ED/hospitalization visit estimate by 30% to yield an incidence rate of 2.021 events per person-year with CHD; (c) a lower incidence rate with CMIHD, i.e., IRR equal to 0.9 [64, 83]; (d) safety events follow a negative binomial distribution using a restricted likelihood estimation variance calculation method and overdispersion equal to 0.12 [57]; (e) 20% dropout rate across groups; (f) average of 2.06 years of HD per participant; (g) non-inferiority margin for IRR of 1.20, corresponding to an unacceptable worsening of safety event rate of 2.426 or higher per person-year in the CMIHD group; (h) \u00e2\u0089\u00a585% power; and (i) one-sided level of significance equal to 0.025. This sample size is conservatively adjusted for the healthier population incidence rate of 2.021 events per person-year as suggested in (b); if we use the unadjusted 2-year safety event rate of 2.954 per person-year in (a) for our null safety rate, our sample size of 350 would have >93% power to detect the same non-inferiority margin of 1.20 (Additional file 1, Table S2).\n \n \n Power considerations for secondary outcomes\n We calculated statistical power based on a 2-year average follow-up, assuming an analysis of covariance model (ANCOVA) [84], which provides an intuitive interpretation that is less dependent on the number of intermediary measurements. We also assume a correlation of 0.8 between baseline and follow-up values based on preliminary data [57, 66, 68, 83, 85]. Our calculations show detectable standardized effect sizes of 0.201 and 0.233 for 80 and 90% power, respectively, based on an average sample size of 280 participants across the five assessments (baseline and semi-annual for 2 years) (Additional file 1, Table S3). There is no consensus on the appropriate type I error level for secondary outcomes or even whether they should be tested when the primary endpoint is not statistically significant [86\u00e2\u0080\u009388]. However, for completeness, with a strict Bonferroni correction for the two main secondary outcomes, the detectable effect sizes become 0.221 and 0.253 for 80 and 90% power, respectively, leading to slightly higher detectable average differences for the secondary outcomes.", "id": 1797, "split": "test"} +{"trial_id": "NCT05831735", "pmid": "38012776", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adapted Physical Activity as Complementary Treatment to Alleviate the Symptoms of Endometriosis? The CRESCENDO Program (inCRease Physical Exercise and Sport to Combat ENDOmetriosis)\n\nIncluded conditions:\n- Endometriosis\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis'}\n- {'label': 'Physical activity', 'type': 'EXPERIMENTAL', 'description': 'This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis + with 1h to 3 h of adapted physical activity delivered by videoconference.', 'interventionNames': ['Behavioral: Physical activity']}\n- {'label': 'Physical activity and education', 'type': 'EXPERIMENTAL', 'description': 'This group will be provided with a video showing the movement to do in case of pain, or endometriosis crisis + with 1h to 3 h of adapted physical activity delivered by videoconference + 6 session of educational and discussion groups', 'interventionNames': ['Behavioral: Physical activity', 'Behavioral: Physical activity and education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical activity', 'description': \"The 6-month APA program is supervised via the videoconference platform and/or carried out independently based on a personalized written program that is updated weekly. The program is based on structured sessions alternating 3 types of PA: aerobic sessions, stretching sessions and muscle strengthening sessions (to be practiced following the teacher's oral or written instructions).\\n\\nThe sessions last from 20 minutes to 1 hour and are of low to moderate intensity depending on the initial level of fitness. The sessions are structured, adapted and progressive. During the sessions, the exercises are adapted according to the means and materials available to the patients at home or in their immediate environment.\\n\\nThe patients will be progressively led to practice in an autonomous way (i.e., without supervision) but following an adapted, personalized and structured program. These PA sessions can be declared afterwards to the PA teacher,(duration and the exercises actually performed).\", 'armGroupLabels': ['Physical activity', 'Physical activity and education']}\n- {'type': 'BEHAVIORAL', 'name': 'Physical activity and education', 'description': \"In addition to the intervention in physical activity, the people participating in this program will benefit from 6 months of educational activity (EA). The EA program includes 6 sessions scheduled according to the patients' availability in groups and by videoconference.\\n\\nFollowing their entry into the study and their allocation to the programs (1 month maximum), the patients will be invited to a first individual EA session, in order to establish an educational diagnosis (1 hour). This session will allow for an assessment of their needs and the presentation of the workshops. Then, between the second and the sixth month following randomization, patients will benefit from 5 collective EA sessions per group of 6 patients maximum (1h30 to 2h). These sessions will be about PA, nutrition, pain management. An individual session will be held at the end of the intervention and will allow for an educational assessment.\", 'armGroupLabels': ['Physical activity and education']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Perceived pain and fatigue', 'description': '10 point scale from 0 (none) to 10 (extreme pain or fatigue), today, last week en during an endometriosis episode', 'timeFrame': 'before the start of the intervention and at the end of the intervention (6 months)'}\n- {'measure': 'Change in Perceived Quality of life; Endometriosis Health Profile 30', 'description': 'Likert scale questionnaire about quality of life in different life domains (1 to 7 )', 'timeFrame': 'before the start of the intervention and at the end of the intervention(6 months)'}\n- {'measure': 'Change in Physical activity (PA) ; International Physical Activity Questionnaire & International Sedentary Assessment Tool', 'description': 'complete the number of hour and minutes spend in Light, moderate and vigourous PA and in sedentary behaviors', 'timeFrame': 'before the start of the intervention and at the end of the intervention(6 months)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (\u03b2) = 0.90, Dropout rate = 20%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Two hundred participants will be recruited. This sample size was chosen for several reasons: lack of article on the topic and resource limitations [55]. Except for one, all previous studies recruited or planned to recruit a sample size below 200. Furthermore, the specialists working on the project receive between 5 and 30 endometriosis patients per week. By taking the smallest number of patients and considering the possibility that these patients may refuse to participate or fall into the exclusion criteria, we can assume that only 2 women per week will be included in the study (N = 2 \u00c3\u0097 7 hospitals \u00c3\u0097 20 weeks of recruitment = 280). Of these participants, 20% may drop out of the study (N = 224). We performed sensitivity analyses for repeated measures ANOVA analysis. Effect sizes found were small to medium (N = 200 to be more conservative, \u00ce\u00b1 = 0.05, \u00ce\u00b2 = 0.90).", "id": 1798, "split": "test"} +{"trial_id": "NCT05832047", "pmid": "38955368", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis : Multicenter, Double Blind, Randomized Controlled Trial\n\nIncluded conditions:\n- Pancreatic Disease\n\nStudy Armgroups:\n- {'label': 'Plasma solution', 'type': 'EXPERIMENTAL', 'description': 'Plasma solution (HK inno.N Corp., Seoul, Republic of Korea) is a balanced crystalloid solution that contains the same ingredients as Plasma-Lyte A (Baxter International, Deer field, Ill) .\\n\\nPreprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour).', 'interventionNames': ['Drug: Plasma solution (4-hour aggressive hydration)', 'Drug: 8-hour aggressive hydration']}\n- {'label': \"Lactated Ringer's solution\", 'type': 'ACTIVE_COMPARATOR', 'description': 'Preprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour).', 'interventionNames': ['Drug: Lactated Ringer solution (4-hour aggressive hydration)', 'Drug: 8-hour aggressive hydration']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Plasma solution (4-hour aggressive hydration)', 'description': 'Aggressive hydration : 10 mL/kg injection within 30\\\\~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30\\\\~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours.', 'armGroupLabels': ['Plasma solution'], 'otherNames': ['Plasma solution-A Inj.']}\n- {'type': 'DRUG', 'name': 'Lactated Ringer solution (4-hour aggressive hydration)', 'description': 'Aggressive hydration : 10 mL/kg injection within 30\\\\~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30\\\\~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours.', 'armGroupLabels': [\"Lactated Ringer's solution\"], 'otherNames': ['Hartmann Solution inno.N']}\n- {'type': 'DRUG', 'name': '8-hour aggressive hydration', 'description': 'If patients experienced postprocedural abdominal pain Numerical Rating Scale (NRS score\\\\>3) or a worsening of abdominal pain compared with the pain before ERCP, the administration of study fluid continues until 8 hours (3 mL/kg/hr ) regardless of the results of serum amylase/lipase within 4 hours after ERCP because serum amylase/lipase within 4 hours after ERCP may have a result approximately 1-2 hours (5 hours-6 hours after ERCP) after blood sampling', 'armGroupLabels': [\"Lactated Ringer's solution\", 'Plasma solution'], 'otherNames': ['8-h AH']}\n\nPrimary Outcomes:\n- {'measure': 'Occurrence of pancreatitis after ERCP', 'description': 'The new onset or worsening of pain in the upper abdomen, accompanied by an elevation of pancreatic enzymes to at least three times the upper normal level within 24 hours after the procedure, requiring hospitalization for a minimum of two nights.', 'timeFrame': 'the next morning or within 24 hours after ERCP'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 alpha level, 5% dropout rate, and the use of a two-sided Fisher's exact test.", "answer": 844, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This is an evaluation of the superiority of PEP prevention between plasma solution (group 1) and lactated Ringer\u00e2\u0080\u0099s solution (group 2). Recently, Weiland and colleagues reported an open-label RCT, noting an 8% incidence of PEP in the group receiving aggressive fluid hydration with Ringer\u00e2\u0080\u0099s lactate solution.16 Consequently, we presume an 8% occurrence of PEP in group 2. However, PEP prevention with plasma solution is a novel approach that has not been previously studied. Therefore, so in this study, we assume a 60% risk reduction in PEP in group 1 compared with group 2, resulting in an assumed PEP incidence rate of 3.2%.16 These assumptions were validated after a thorough review by the statistical team and the IRB of Asan Medical Centre, the host institution of this study. To determine a 60% reduction in PEP rates in group 1 with 80% power and an alpha level of 0.05, 400 patients in each group are required. The proportion in group 1 is assumed to be 0.032 in the alternative hypothesis and 0.08 in the null hypothesis, with group 2 maintaining a rate of 0.08. The two-sided Fisher\u00e2\u0080\u0099s exact test will be used as the test statistic at a significance level of 0.05. A total of 844 patients will be recruited, considering a 5% dropout rate, which results in 422 patients per group.", "id": 1799, "split": "test"} +{"trial_id": "NCT05833087", "pmid": "38627837", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of Schema Therapy for Patients With Chronic Treatment Resistant Depression\n\nIncluded conditions:\n- Treatment Resistant Depression\n- Chronic Depression\n\nStudy Armgroups:\n- {'label': 'Schema therapy', 'type': 'EXPERIMENTAL', 'description': 'The participants in this arm will receive up to 30 individual, weekly sessions of consecutive Schema Therapy (ST). A treatment manual for ST has been written for the study, based on former studies of ST on chronic depression as well as the manual for a major clinical trial on ST for avoidant personality disorder.', 'interventionNames': ['Behavioral: Schema therapy', 'Other: Standard care package content']}\n- {'label': 'Treatment as Usual', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients with moderate-severe depression in the Danish secondary psychiatric sector are treated according to standard 'treatment packages', in the 'Main Function' offering from 6 to 16 weekly sessions of psychotherapy, in group or individually, typically Cognitive Behavioral Therapy, psychodynamic or interpersonal therapy or other evidence-based therapies.\", 'interventionNames': ['Behavioral: Other psychotherapy', 'Other: Standard care package content']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Schema therapy', 'description': '30 sessions of schema therapy. The therapy was developed by Jeffrey Young and others and encompasses elements from cognitive behavioral, psychodynamic, and gestalt therapies, as well as attachment theory.', 'armGroupLabels': ['Schema therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'Other psychotherapy', 'description': 'In this arm, psychotherapy can be psychodynamic, cognitive behavioral, interpersonal or other evidence-based psychotherapies, aimed at changing cognitions, behavior, improve social relations and uncover unconstructive psychological patterns.', 'armGroupLabels': ['Treatment as Usual']}\n- {'type': 'OTHER', 'name': 'Standard care package content', 'description': 'The patient is offered prescription and monitoring of psychopharmacological treatment of up to 5 hours by a psychiatrist, when appropriate.\\n\\nAdditionally, patients have up to 3 hours of preparatory and diagnostic sessions and up to 4 hours of meetings with the participation of next-of-kin and/or collaboration partners in other public instances.', 'armGroupLabels': ['Schema therapy', 'Treatment as Usual']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in depression symptoms on the clinician-rated Hamilton-6 Rating Scale for Depression at 12 months after baseline measurements', 'description': '6-item clinician rated instrument', 'timeFrame': 'From baseline measurements to end of treatment (of schema therapy) at 12 months'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of HAMD-6 scores at end-of-treatment is around 3.5. Significance level is set at \u03b1 = 0.05 (two-tailed) with 80% power. Dropout rate is assumed to be approximately 20%. Intra-cluster correlation is 0.01.", "answer": 129, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size planning is based on previous studies that used the short form of the Hamilton Rating Scale for Depression (HAMD-6) as their primary or secondary outcome. In previous studies, the standard deviation of HAMD-6 scores at end-of-treatment was around 3.5 within the intervention arms ( [49, 76]; for a review, see [77]). A difference of 2 units on the HAMD-6 (i.e. d\u00e2\u0080\u0089=\u00e2\u0080\u00890.57) is considered clinically relevant [78]; this is the difference we would not like to miss in the comparison of the group averages at the 12-month measurement point. On the HAMD-6 scale (range 0\u00e2\u0080\u00a622), 2 units correspond to an improvement on two of the six items (depressed mood, guilt feelings, work and interest, psychomotor retardation, psychic anxiety, general somatic symptoms). At the conventional significance level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 two-tailed, a total of N\u00e2\u0080\u0089=\u00e2\u0080\u0089100 participants need to be randomized to detect the relevant group difference with 80% power (as calculated in the software program G*power3 [79]).\n The number of randomized participants is increased to account for clustering and dropout: ST is administered individually (not in groups); therefore, cluster effects are expected to be low (intra-cluster correlation\u00e2\u0080\u0089=\u00e2\u0080\u00890.01), but not zero because several participants are treated by the same therapist. Dropout is assumed to be substantial in this patient population and is compensated in the sample size calculation even if the main analysis uses imputation of missing data. With a cluster size of around 5 participants per therapist, and accounting for a dropout of approximately 20%, the total sample size is increased to a total of 129 participants, randomized 1:1 in each intervention arm.", "id": 1800, "split": "test"} +{"trial_id": "NCT05833529", "pmid": "38937824", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Virtual Reality Cue Exposure Therapy for Cocaine Craving: an Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder (Psychoth\u00e9rapie Innovante COmportementale et Cognitive Pour le Trouble d'Usage de Coca\u00efne; PICOC)\n\nIncluded conditions:\n- Cocaine Use Disorder\n\nStudy Armgroups:\n- {'label': 'VRCET for Cocaine Craving then MFCT', 'type': 'EXPERIMENTAL', 'description': '3 weeks treatment consisting of 10 meetings of Virtual Reality Cue Exposure Therapy (VRCET) for cocaine craving, followed by 5 meetings of Memory Focused Cognitive Therapy (MFCT). All meetings will last 90 minutes. VRCET meetings will take place in a 2 weeks period (weeks 1 and 2) at a daily frequency from monday to friday included. MFCT meetings will take place in the 1 week period following VRCET (week 3) at a daily frequency from monday to friday included.', 'interventionNames': ['Behavioral: Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks', 'Other: Memory Focused Cognitive Therapy (MFCT) - 1 week']}\n- {'label': 'PCET for Cocaine Craving', 'type': 'ACTIVE_COMPARATOR', 'description': '3 weeks treatment consisting of 15 meetings of Picture-based Cue Exposure Therapy (PCET) for cocaine craving. All meetings will last 90 minutes. PCET meetings will take place in a 3 weeks period (weeks 1 to week 3) at a daily frequency from monday to friday included.', 'interventionNames': ['Behavioral: Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Virtual Reality Cue Exposure (VRCE) Therapy for Cocaine Craving - 2 weeks', 'description': '40 10 mins VRCEs for cocaine craving (desensitization to only cocaine craving cues; no others interventions). 4 VRCE and 2 different VRCE situations by meeting. Same VRCE situations spaced intra (30 mins) and inter meetings (48 hrs). 5 standard VRCE situations (appearance and dialogues adapted to Martinique field) varying from \"only peers cocaine use talk\" to \"peers and participant prepare and use cocaine\" and ranging from the lowest to the highest participant related cocaine craving level. Situation switch to another when its initial cocaine craving level has decreased to its half for 5 continuous VRCE mins (must be \u2264 3/10; 0 = none; 10 = very high). Meetings end with relaxation/relapse prevention in any case of distress still over convenient levels. VRCE use Meta Quest 2, are visuo-auditively immersive (360\u00b0; 1st person), interactive (using virtual objects), semi-stationnary (360\u00b0-rotating stool and teleportation system). Participant skin color and cocaine using mode individualized.', 'armGroupLabels': ['VRCET for Cocaine Craving then MFCT']}\n- {'type': 'OTHER', 'name': 'Memory Focused Cognitive Therapy (MFCT) - 1 week', 'description': 'In accordance with the \"Memory Focused Cognitive Therapy for Cocaine Use Disorder\" Therapist Guide (Marsden and Goetz, 2018), MFCT meetings will consist in 5 sequential components: Cognitive case conceptualisation of cocaine use disorder maintaining processes to inform a treatment plan; Education about cocaine\\'s cognitive and physical effects; Cocaine related cue-induction to elicit images and affective responses; Memory reconsolidation procedures; Standard CBT techniques (e.g. behavioural experiments of cocaine-related expectancies and skills for adaptive emotion regulation).', 'armGroupLabels': ['VRCET for Cocaine Craving then MFCT']}\n- {'type': 'BEHAVIORAL', 'name': 'Pictures-based Cue Exposure (PCE) Therapy for Cocaine Craving - 3 weeks', 'description': '60 x 10 mins PCE (desensitization to only cocaine craving cues; no others interventions). A standard audio of VRE songs is played in PCE. 4 PCE and 2 different PCE situations by meeting. Same PCE situations spaced intra (30 mins) and inter meetings (48 hrs). 5 standard PCE situations (appearance and dialogues adapted to Martinique field) varying from \"only peers cocaine use talk\" to \"peers and participant prepare and use cocaine\" and ranging from the lowest to the highest participant related cocaine craving level. Situation switch to another when its initial cocaine craving level has decreased to its half for 5 continuous PCE mins (must be \u2264 3/10; 0 = none; 10 = very high). Meetings end with relaxation/relapse prevention if any distress over convenient levels. PCE use a laptop standard PowerPoint slide show (2D pictures from VRCE; non-spatialized audio from laptop speakers), are non-interactive (seated on a stool). Participant skin color and cocaine using mode individualized.', 'armGroupLabels': ['PCET for Cocaine Craving']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Cocaine Craving Intensity (in Virtual Reality Cue Exposure for Cocaine Craving) at the End of Treatment', 'description': 'Self-reported cocaine craving intensity in virtuo exposure to cocaine craving according to the Craving Exp\u00e9rience Questionnaire (french version; CEQ-F \"Envie la Plus Forte\" total score; Ceschi et Pictet, 2018). CEQ-F \"Envie la Plus Forte\" total score varies from 11 to 111 (higher score suggesting higher craving intensity). CEQ-F \"Envie la Plus Forte\" is administrated immediatly after a standard 5 mins virtual reality cue exposure for cocaine craving and focuses on the strongest cocaine craving felt during the exposure. The virtual reality cue exposure environment is different from the one to which participants were exposed during treatment, in contrary to VR settings which are similar.', 'timeFrame': 'Right before treatment and at the end of \"VRCET then MFCT\" and \"PCET\" (end of treatment; week 3)'}\n- {'measure': 'Change from Baseline Cocaine Craving Frequency (Last 14 Days) at the End of Treatment', 'description': 'Self-reported retrospective cocaine craving frequency in the last 14 days according to the Craving Exp\u00e9rience Questionnaire (french version; CEQ-F \"A Quelle Fr\u00e9quence\" total score; Ceschi et Pictet, 2018). CEQ-F \"A Quelle Fr\u00e9quence\" total score varies from 11 to 111 (higher score suggesting higher craving frequency). CEQ-F \"A Quelle Fr\u00e9quence\" focuses on the frequence of cocaine craving in the last 14 days.', 'timeFrame': 'Right before treatment and at the end of \"VRCET then MFCT\" and \"PCET\" (end of treatment; week 3)'}\n\nPlease estimate the sample size based on the assumption: \ntwo-tailed independent t-tests, 0.05 statistical significance threshold, 0.95 statistical power, accounting for potential dropouts", "answer": 54, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We calculated a required sample size of 54 participants to randomize with G*Power [64], on the basis of two-tailed independent t-tests, to detect large effect from our experimental treatment (VRCET\u00e2\u0080\u0089+) over our control therapeutic condition (PCET) in reducing cocaine craving [39, 65], given a 0.05 statistical significance threshold, a 0.95 statistical power, and accounting for potential dropouts in our hospitalized inpatients.", "id": 1801, "split": "test"} +{"trial_id": "NCT05833568", "pmid": "38991682", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-blind Randomized Controlled Trial of a 10-Hz Transcranial Alternating Current Stimulation to Modulate Brain Activity in Brain-injured Patients With Disorders of Consciousness\n\nIncluded conditions:\n- Brain Injury Traumatic Severe\n- Disorder of Consciousness\n- Brain Injuries\n\nStudy Armgroups:\n- {'label': '10-Hz tACS Stimulation Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'tACS stimulation will be delivered over to parieto-occipital sites using only 2-minute ramp up and down and a continuous 20-minute 10 Hz sinusoidal current administered. The stimulation electrode montage will be identical for both conditions.', 'interventionNames': ['Device: Active Transcranial alternative current stimulation']}\n- {'label': 'Sham Stimulation Group', 'type': 'SHAM_COMPARATOR', 'description': 'Sham stimulation will be delivered over to parieto-occipital sites using only 2-minute ramp up and down, without any sinusoidal current administered for 20 minutes. The stimulation electrode montage will be identical for both conditions.', 'interventionNames': ['Device: SHAM Transcranial alternative current stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active Transcranial alternative current stimulation', 'description': 'GTEN 200 (Magstim-EGI, OREGON, USA). The current will be administered via an amplifier connected to an EEG system of 128-Channel Geodesic Sensor Net (Magstim-EGI, Oregon, USA) with sponge-based electrode nets.\\n\\ntACS stimulation will be applied for 20 minutes for 5 consecutive days via a bilateral electrode montage of 5 electrodes per hemisphere over parieto-occipital cortical sites. Specific stimulation electrodes for both conditions will be: \\\\[right hemisphere: E83, E90, E96, E84, E91\\\\] and for the \\\\[left hemisphere: E58, E65, E70, E66, E59\\\\]. The intensity of the applied alternative current (AC) will be a maximum of 1 mA peak-to-peak. The stimulation frequency will be adjusted to 10 Hz (median value of the alpha frequency band) for the tACS condition.', 'armGroupLabels': ['10-Hz tACS Stimulation Group']}\n- {'type': 'DEVICE', 'name': 'SHAM Transcranial alternative current stimulation', 'description': 'GTEN 200 (Magstim-EGI, OREGON, USA). The current will be administered via an amplifier connected to an EEG system of 128-Channel Geodesic Sensor Net (Magstim-EGI, Oregon, USA) with sponge-based electrode nets.\\n\\nSHAM stimulation will be applied for a 2-minute ramp-up, then the current will stop for 20 minutes, followed by a 2-minute ramp-down. This will be applied for 5 consecutive days via a bilateral electrode montage of 5 electrodes per hemisphere over parieto-occipital cortical sites. Specific stimulation electrodes for both conditions will be: \\\\[right hemisphere: E83, E90, E96, E84, E91\\\\] and for the \\\\[left hemisphere: E58, E65, E70, E66, E59\\\\]. The intensity of the applied alternative current (AC) will be a maximum of 1 mA peak-to-peak. The stimulation frequency will be adjusted to 10 Hz (median value of the alpha frequency band) for the ramp-up and down in the SHAM conditions.', 'armGroupLabels': ['Sham Stimulation Group']}\n\nPrimary Outcomes:\n- {'measure': 'Single-site recruitment rates', 'description': \"Quantify the frequency of recruitment in the entire study's protocol for the specific population in the Intensive Care Unit.\", 'timeFrame': '1 year'}\n- {'measure': 'Retention rates', 'description': \"Assess completion and participation in the entire study's from participants and their caregivers; for the intervention protocol as well as for longitudinal measures over time \\\\[3,6,12 months\\\\]\", 'timeFrame': 'over the 2-week course of the experimental protocol and at 3, 6 and 12 month time points'}\n- {'measure': 'Change in EEG spectral power of the alpha band activity', 'description': \"EEG measures cortical electrical activity. Increase in the alpha band spectral power after the end of the 5-day 20-minute 10 Hz tACS intervention would indicate the specificity of the modulation's effect.\", 'timeFrame': 'It will be measured over the 2-week course of the experimental protocol'}\n- {'measure': 'Change in Functional Connectivity based on EEG signal', 'description': 'Examine changes in the statistical relationship between specific electrophysiological signal parameters in time.', 'timeFrame': 'It will be measured over the 2-week course of the experimental protocol'}\n\nPlease estimate the sample size based on the assumption: \nAdjustments will be made according to feasibility, including the number of patients in this condition yearly (~20), recruitment rates, and retention.", "answer": 138, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n For the clinical trial phase, the estimated sample size of 138 (n=69 per group) is based on a study that used repeated tDCS in chronic DoC patients.73 Prior to the clinical trial phase, this estimated sample size will be adjusted according to feasibility (ie, number of patients in this condition yearly (~20), recruitment rates and retention).", "id": 1802, "split": "test"} +{"trial_id": "NCT05838638", "pmid": "39357051", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Serious Gaming for Chemotherapy-induced Nausea and Vomiting in Older Adults With Cancer: A Randomized Clinical Trial\n\nIncluded conditions:\n- Neoplasms\n- Chemotherapy-induced Nausea and Vomiting\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'This intervention is a serious game which allows older adults under treatment for cancer to practice making self-care decisions for an avatar that is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with the research assistant about choices related to managing nausea and vomiting at home', 'interventionNames': ['Behavioral: eSSET-CINV']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will receive standard education related to managing nausea and vomiting and will have the opportunity to participate in the intervention at the end of the study', 'interventionNames': ['Behavioral: eSSET-CINV']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'eSSET-CINV', 'description': 'Participants in the intervention group will be asked to play the serious game on an iPad at their first chemotherapy treatment visit. The control group will be able to play at time 6.', 'armGroupLabels': ['Control', 'Intervention'], 'otherNames': ['Managing at Home- CINV']}\n\nPrimary Outcomes:\n- {'measure': 'Healthcare resource use', 'description': 'any emergency department or hospital admission will be recorded using a dichotomous variable (yes/no)', 'timeFrame': 'From baseline through the end of the study at 12 or 24 weeks'}\n- {'measure': 'CINV severity', 'description': 'The Symptom Management Checklist will measure the presence and severity of nausea and vomiting. Participants will be sent a text link every day for 6 days after chemotherapy or complete this data on a form at home. This starts right after time 1. Nausea will be reported on a 0-10 scale. Higher numbers equal more nausea.', 'timeFrame': 'From baseline1 through the end of the study at 12 or 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at .05 for all analyses. The power is 0.904 for continuous outcomes with 100 participants, 0.90 for count outcomes with 254 participants, and 0.90 for binary outcomes with 357 participants. Missing values are assumed to occur completely at random (MCAR) with anticipated proportions missing at each measurement time being 0.00, 0.08, 0.16, 0.24, 0.32, and 0.40. The autocorrelation matrix follows a specific pattern for each outcome type. For aim 2, the power is 87% with an attrition rate of ~22% anticipated.", "answer": 610, "answer_type": "ESTIMATED", "explanation": "Power Analysis and Sample Size\n For aim 1, when the outcome of interest is continuous (eg, CINV severity and number of self-management behaviors), a sample of 100 participants, measured continuously throughout the study period between T1 and T6, achieves a power of 0.904 when using a chi-square test from a generalized estimating equation (GEE) analysis to test whether the average slope of the participants differs significantly at a significance level of .05. The residual SD is anticipated to be 1.00. Missing values are assumed to occur completely at random (missing completely at random [MCAR]). These missing value proportions will be combined to form the pairwise observant probabilities using the independent method. The anticipated proportions missing at each measurement time are 0.00, 0.08, 0.16, 0.24, 0.32, and 0.40. The first row of the autocorrelation matrix of the responses within a participant is assumed to be 1.0000, 0.4000, 0.1600, 0.0640, 0.0256, and 0.0102. Other rows follow the same pattern. For aim 1, a total of 254 participants, each scheduled to be measured 6 times, achieves a power of 0.90 when using a 2-sided Wald test from a GEE analysis with a count outcome (eg, QOL) to test whether a \u00ce\u00bc1(1) of 0.500 differs from a \u00ce\u00bc2(1) of 1.000 at a significance level of .05. \u00ce\u00bc1(0) and \u00ce\u00bc2(0) are assumed to be 1.000. Missing values are assumed to occur completely at random (MCAR). These missing value proportions will be combined to form the pairwise observant probabilities using the independent method. The anticipated proportions missing at each measurement time are 0.00, 0.08, 0.16, 0.24, 0.32, and 0.40. The first row of the autocorrelation matrix of the responses within a participant is assumed to be 1.000, 0.500, 0.250, 0.125, 0.063, and 0.031. Other rows follow the same pattern.\n For aim 1, when the outcome of interest in binomial (eg, resource use), a sample of 357 participants, each scheduled to be measured 6 times, achieves a power of 0.90 when using a 2-sided Wald test from a GEE analysis with the binary outcome to test whether a P1(1) of 0.500 differs from a P2(1) of 0.250 at a significance level of .05. P1(0) and P2(0) are assumed to be 0.500. Missing value (MCARs) proportions will be combined to form the pairwise observant probabilities using the independent method. The anticipated proportions missing at each measurement time are 0.00, 0.08, 0.16, 0.24, 0.32, and 0.40. The first row of the autocorrelation matrix of the responses within a participant is assumed to be 1.000, 0.500, 0.250, 0.125, 0.063, and 0.031. Other rows follow the same pattern.\n For aim 2, based on the assumption of a nausea severity mean score of 6.20, range from 2 to 9, an SD of 2.44, and a clinically meaningful difference in mean nausea severity score of 1 between the IG and control group, a sample size of 500 participants (250 per group), measured between 6 and up to 30 times (depending on the outcome variable of interest), achieves 87% power to detect a difference between the (fixed) group means. The ratio of the subject-specific slope variance to \u00cf\u0083\u00c2\u00b2 is 0.100. The correlation between measurements within a participant is 0.100. The test was based on a mixed model regression analysis using a significance level of .05. This power analysis was calculated using PASS 20 (NCSS LLC). Anticipating an attrition rate of ~22%, we will seek to enroll 610 older adults for this study. Attrition to mortality is not expected to be high due to the exclusion criteria for those with less than 6 months to live.", "id": 1803, "split": "test"} +{"trial_id": "NCT05839548", "pmid": "37865418", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Articaine Efficacy and Safety for 3 Years Old Children: a Clinical Randomized Control Trial\n\nIncluded conditions:\n- Dental Caries in Children\n- Dental Diseases\n- Pulp Disease, Dental\n- Behavior, Child\n\nStudy Armgroups:\n- {'label': '2% Mepivacaine with epinephrine 1:100,000.', 'type': 'ACTIVE_COMPARATOR', 'description': 'Brand Name: 2% Medicaine with epinephrine 1:100,000.', 'interventionNames': ['Drug: Mepivacaine 2% with epinephrine 1:100,000']}\n- {'label': '4% Articaine with epinephrine 1:100,000', 'type': 'EXPERIMENTAL', 'description': 'Brand Name: 4% Septanest with epinephrine 1:100,000.', 'interventionNames': ['Drug: Articaine (4%) with epinephrine 1:100,000']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mepivacaine 2% with epinephrine 1:100,000', 'description': 'Local Anesthesia', 'armGroupLabels': ['2% Mepivacaine with epinephrine 1:100,000.'], 'otherNames': ['medicaine 2%']}\n- {'type': 'DRUG', 'name': 'Articaine (4%) with epinephrine 1:100,000', 'description': 'Local Anesthesia', 'armGroupLabels': ['4% Articaine with epinephrine 1:100,000'], 'otherNames': ['septanest 4%']}\n\nPrimary Outcomes:\n- {'measure': 'Change in systolic and diastolic blood pressure (mmHg).', 'description': 'Normal blood pressure, defined as a systolic pressure less than 120, and a diastolic pressure less than 80.', 'timeFrame': '5 minutes before, during, and after 30 minutes of dental procedure.'}\n- {'measure': 'Change in pulse rate (beats per minute).', 'description': 'Pulse rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute.', 'timeFrame': '5 minutes before, during, and after 30 minutes of dental procedure.'}\n- {'measure': 'Change in respiratory rate (breaths per minute).', 'description': 'The respiration rate is the number of breaths a person takes per minute.', 'timeFrame': '5 minutes before, during, and after 30 minutes of dental procedure.'}\n- {'measure': 'Dental pain assessment: Frankl Behavior Rating Scale (FBRS).', 'description': 'Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).', 'timeFrame': 'up to 30 minutes after dental procedure.'}\n- {'measure': 'Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC).', 'description': 'Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0: relaxed and comfortable,1-3: mild discomfort, 4-6: moderate discomfort, 7-10: sever discomfort or pain or both.', 'timeFrame': 'up to 30 minutes after dental procedure.'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level was set at 5% (p<0.05) and the power of the trial at 80% (\u03b2=0.2). An additional 20% of participants were added to account for dropouts.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size and power of the study\n Based on the results of previous studies,8\u00e2\u0080\u009310 the difference in efficiency between the two local anaesthetic agents was specified at \u00c2\u00b10.2, and the prevalence of success in the two groups was equal and defined at 0.7. Therefore, the level of significance and power of the trial were adjusted to 5% (p<0.05) and 80% (\u00ce\u00b2=0.2), respectively. An additional 20% of participants were added to compensate for dropouts. Therefore, 100 children per group (200 children in total) were considered suitable to determine the difference between the two local anaesthetic agents at a 95% confidence level (95%\u00e2\u0080\u0089CI).", "id": 1804, "split": "test"} +{"trial_id": "NCT05839587", "pmid": "39118135", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Short-term Outcome and Inflammatory Stress Response Following Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - A Prospective, Randomized Trial Comparing Laparoscopy to the Robotic-assisted Approach\n\nIncluded conditions:\n- Hernia, Inguinal\n- Laparoscopy\n\nStudy Armgroups:\n- {'label': 'Robotic TAPP', 'type': 'EXPERIMENTAL', 'description': 'Repair of primary unilateral and bilateral hernias with robotic technology', 'interventionNames': ['Procedure: Robotic TAPP']}\n- {'label': 'Laparoscopic TAPP', 'type': 'ACTIVE_COMPARATOR', 'description': 'Repair of primary unilateral and bilateral hernias with laparoscopic repair', 'interventionNames': ['Procedure: Laparoscopic TAPP']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Robotic TAPP', 'description': 'Robotic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of docking of the robot and port placement and part 4 consists of de-docking and skin closure', 'armGroupLabels': ['Robotic TAPP']}\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic TAPP', 'description': 'Laparoscopic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of port placement only and part 4 consists of skin closure only.', 'armGroupLabels': ['Laparoscopic TAPP']}\n\nPrimary Outcomes:\n- {'measure': 'Surgical stress response (CRP)', 'description': 'Change of serum CRP over time.', 'timeFrame': 'CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 90% for the complicated group and 80% for the uncomplicated group.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n A Monte Carlo simulation was employed to calculate the power of the mixed-effect model utilized for the log-normally distributed outcome, CRP. No power calculations were performed for other outcomes. The sample size was determined based on the premise that the CRP levels in patients undergoing r-TAPP were anticipated to be 15% lower compared to those undergoing traditional TAPP surgery. This assumption was grounded on a study from 2019, which reported an average CRP value of 16.5\u00c2\u00a0mg/L 24\u00c2\u00a0h post-TAPP surgery for inguinal hernia repair [22]. Additionally, an observational study with data from 298 patients who underwent surgery for colon cancer with either a robotic-assisted or a laparoscopic approach between 2017 and 2019 at the Surgical Department of the Hospital of Southern Jutland informed this assumption [15]. The latter study observed that CRP levels measured on the third postoperative day were 28% lower in patients who received the robotic-assisted procedure compared to those who underwent the laparoscopic method. Given that inguinal hernia repair is less invasive than colonic resection, a smaller difference in CRP levels was anticipated. Consequently, a 15% difference was adopted for the basis of our calculations. With a cohort of 150 patients\u00e2\u0080\u0094112 presenting uncomplicated cases and 38 complicated\u00e2\u0080\u0094we achieved a statistical power of 90% for the complicated group and 80% for the uncomplicated group.", "id": 1805, "split": "test"} +{"trial_id": "NCT05839704", "pmid": "39342346", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Bilateral Erector Spinae Plane Block Versus Serratus Anterior Plane Block Plus Subcostal Transversus Abdominus Plane Block for Bariatric Sleeve Gastrectomy Surgery: A Randomised Clinical Trial\n\nIncluded conditions:\n- Bariatric Surgery Candidate\n- Weight Loss\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Bilateral Erector Spinae Plane Block', 'type': 'EXPERIMENTAL', 'description': 'Patients in this arm will receive standard anaesthesia as per our bariatric anaesthesia protocol. They will also receive preoperative ultrasound guided bilateral single shot erector spinae plane blocks at the level of the 8th transverse process.', 'interventionNames': ['Procedure: Bilateral Erector Spinae Plane Block']}\n- {'label': 'Abdominal Wall Blocks', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in this arm will receive standard anaesthesia as per our bariatric anaesthesia protocol. They will also receive bilateral subcostal transversus abdominus plane blocks and a left sided serrratus plane block, postoperatively, while under general anaesthetic.', 'interventionNames': ['Procedure: Abdominal Wall Blocks']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Bilateral Erector Spinae Plane Block', 'description': 'Patient will receive local ropivacaine 0.75% with lignocaine 1% with adrenaline, administered under ultrasound into the erector spinae plane at the level of T8.', 'armGroupLabels': ['Bilateral Erector Spinae Plane Block']}\n- {'type': 'PROCEDURE', 'name': 'Abdominal Wall Blocks', 'description': 'Patient will receive local ropivacaine 0.75% with lignocaine 1% with adrenaline, administered under ultrasound into the subcostal transversus abdominus plane bilaterally and the serratus plane on the left side', 'armGroupLabels': ['Abdominal Wall Blocks']}\n\nPrimary Outcomes:\n- {'measure': 'QoR-15 score at 24h', 'description': 'The QoR-15 score will be taken by the outcome assessor on the post operative ward.', 'timeFrame': '24 hours after the block is administered'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error (alpha) = 0.05, Type 2 error (beta) = 0.2, Power = 0.8, and an allowance for patient withdrawal or loss to follow-up.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome in this study will be the QoR-15 score at 24\u00c2\u00a0h postoperatively. The established minimum clinically important difference in QoR-15 across a range of minor, intermediate and major surgeries is 6.0 [19, 20] and the mean SD of QoR-15 scores is in the order of 8\u00e2\u0080\u009316 [21]. Taking an SD of 8, assuming type 1 error\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and type 2 error\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, the power calculation requires 29 patients in each group. To accommodate for patients who may withdraw from the study or be lost to follow-up, our aim is to recruit 35 patients to each study arm, giving a total study sample size of 70.", "id": 1806, "split": "test"} +{"trial_id": "NCT05840302", "pmid": "38830744", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Pain Neuroscience Education Programme on Physical Activity in Patients With Chronic Low Back Pain. Randomised Controlled Trial\n\nIncluded conditions:\n- Low Back Pain, Recurrent\n\nStudy Armgroups:\n- {'label': 'Pain Neuroscience Education', 'type': 'EXPERIMENTAL', 'description': 'The Pain Neuroscience Education program takes place over ten days consisting of providing knowledge about the neurophysiology and central processes of pain (nociceptive pathways, inhibitory circuits, peripheral and central sensitization, nervous system plasticity) as well as psychosocial factors and beliefs contributing to chronic pain. Workshops will use experimental data from neuroscience, but also analogies, brainstorming or games. Questions are proposed to the patient at the end of each theme.', 'interventionNames': ['Device: Activity monitor', 'Other: Questionnaire']}\n- {'label': 'Back School', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Back School program takes place over ten days. It begins with a presentation of spinal economy, which consists of promoting the protection of the back. Then, the anatomy and biomechanics of the spine as well as the most common spinal pathologies are presented. On this biomechanical basis, the other sessions consist in indicating the gestures and postures to adopt, always according to the protection policy, in different situations. These different sessions alternate between theory and practical exercises.', 'interventionNames': ['Device: Activity monitor', 'Other: Questionnaire']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Activity monitor', 'description': 'Measure of number of steps and physical activity during one week using the activity monitor (connected watch) named the ActiGraph-wGT3X-BT medical device, Pre-test before intervention, post-test 3-months and 1-year after intervention', 'armGroupLabels': ['Back School', 'Pain Neuroscience Education']}\n- {'type': 'OTHER', 'name': 'Questionnaire', 'description': 'Self and hetero assessments measuring pain, different determinants of chronic pain and physical activity', 'armGroupLabels': ['Back School', 'Pain Neuroscience Education']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Steps 3 months after rehabilitation program', 'description': 'Comparison between the two arms of the average number of daily steps calculated over 7 days by an activity monitor (connected watch) named Actigraph wGT3X-BT', 'timeFrame': '3 months after rehabilitation program'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, power of 90%, and a loss of follow-up rate of 10%.", "answer": 82, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In their cross-sectional study of 118 patients with chronic low back pain, Lotzke and colleagues24 measured that 56% of their sample took less than 7500 steps per day and 16% took only 5000. The WHO recommends 10\u00e2\u0080\u0089000 steps per day and the HAS in France, in its physical activity promotion guide, recommends a gradual increase from 1000 to 3000 daily steps in order to adapt to individual abilities. For our study, we chose a difference between the two groups of 2000 daily steps, which corresponds to the average recommendation of the HAS.30 The normative value of the primary endpoint is 8609 daily steps (SD 2625).47 To show a significant difference between the groups at an alpha risk of 5%, and with a power of 90%, it is necessary to analyse 37 patients per group. Taking into account a rate of loss of follow-up of 10%, it will be necessary to recruit 41 patients per group, that is, 82 patients in total.\n In order to take into account patients who have not started the multidisciplinary rehabilitation programme, we plan to include up to a maximum of 100 subjects; inclusions will be stopped as soon as 41 patients per group are obtained.", "id": 1807, "split": "test"} +{"trial_id": "NCT05840549", "pmid": "37802612", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Feasibility Study COmparing Urolift and Standard Transurethral Resection of Prostate Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'TURP', 'type': 'ACTIVE_COMPARATOR', 'description': 'Transurethral Resection of Prostate', 'interventionNames': ['Procedure: TURP']}\n- {'label': 'UroLift', 'type': 'EXPERIMENTAL', 'description': 'UroLift', 'interventionNames': ['Procedure: UroLift']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'TURP', 'description': 'TURP is an operation which can be performed under a general / regional anaesthetic. A cystoscope is passed into the urethra meatus, along the length of the urethra to the level of the prostate. The obstructing prostate lobes are resected using mono polar or bipolar energy to create a channel for improved urinary flow. Haemostasis is achieved by coagulation followed by insertion of a catheter for irrigation post procedure. Generally, patients stay for 1-2 nights post operatively. On the day of discharge the catheter is removed.', 'armGroupLabels': ['TURP']}\n- {'type': 'PROCEDURE', 'name': 'UroLift', 'description': \"UroLift (Neotract) is a NICE-approved alternative to TURP that can be performed under local anaesthetic, sedation or general anaesthetic. The system comprises of two single-use components, a delivery device and an implant. The implant is made of a nitinol capsular tab, a polyethylene terephthalate monofilament and a stainless-steel end-piece. Again, a modified cystoscope is passed into the urethral meatus, along the length of the urethra to the level of the prostate. The delivery device deploys the implants into the prostate to 'pin' back the lobes of the prostate to create a channel for improved flow. Typically, 2-4 implants are used per procedure. Nine out of ten patients do not require a catheter post procedure\", 'armGroupLabels': ['UroLift']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 3 months'}\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 6 months'}\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 9 months'}\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 12 months'}\n- {'measure': 'Retention rate', 'description': 'We will assess the proportion of patients who will complete the trial protocol', 'timeFrame': 'End of study (24 months)'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 45, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is 45 patients. Recruitment is expected to be completed within 12 months.", "id": 1808, "split": "test"} +{"trial_id": "NCT05840549", "pmid": "37802612", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Feasibility Study COmparing Urolift and Standard Transurethral Resection of Prostate Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'TURP', 'type': 'ACTIVE_COMPARATOR', 'description': 'Transurethral Resection of Prostate', 'interventionNames': ['Procedure: TURP']}\n- {'label': 'UroLift', 'type': 'EXPERIMENTAL', 'description': 'UroLift', 'interventionNames': ['Procedure: UroLift']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'TURP', 'description': 'TURP is an operation which can be performed under a general / regional anaesthetic. A cystoscope is passed into the urethra meatus, along the length of the urethra to the level of the prostate. The obstructing prostate lobes are resected using mono polar or bipolar energy to create a channel for improved urinary flow. Haemostasis is achieved by coagulation followed by insertion of a catheter for irrigation post procedure. Generally, patients stay for 1-2 nights post operatively. On the day of discharge the catheter is removed.', 'armGroupLabels': ['TURP']}\n- {'type': 'PROCEDURE', 'name': 'UroLift', 'description': \"UroLift (Neotract) is a NICE-approved alternative to TURP that can be performed under local anaesthetic, sedation or general anaesthetic. The system comprises of two single-use components, a delivery device and an implant. The implant is made of a nitinol capsular tab, a polyethylene terephthalate monofilament and a stainless-steel end-piece. Again, a modified cystoscope is passed into the urethral meatus, along the length of the urethra to the level of the prostate. The delivery device deploys the implants into the prostate to 'pin' back the lobes of the prostate to create a channel for improved flow. Typically, 2-4 implants are used per procedure. Nine out of ten patients do not require a catheter post procedure\", 'armGroupLabels': ['UroLift']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 3 months'}\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 6 months'}\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 9 months'}\n- {'measure': 'Recruitment rate (number of patients enrolled)', 'description': 'We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena', 'timeFrame': 'Number of patients recruited measured at 12 months'}\n- {'measure': 'Retention rate', 'description': 'We will assess the proportion of patients who will complete the trial protocol', 'timeFrame': 'End of study (24 months)'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 45, "answer_type": "ESTIMATED", "explanation": "Sample size\n An estimated sample size calculation was performed based on an expected number of patients who are referred to the sponsor site for radiotherapy each year. Of the 600 patients who have radiotherapy each year, at least half will have symptoms associated with prostate enlargement. An estimate of approximately 90 patients will be eligible for randomisation and that 50% will be successfully randomised (n=45) with a 95% CI of \u00c2\u00b110%.\n Similarly, an estimated 80% of patients will complete the trial protocol with a CI of \u00c2\u00b112%.", "id": 1809, "split": "test"} +{"trial_id": "NCT05840991", "pmid": "37828585", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial\n\nIncluded conditions:\n- Varicose Veins\n\nStudy Armgroups:\n- {'label': 'Short-term compression group', 'type': 'EXPERIMENTAL', 'description': 'Patients randomised to group A will be provided with bandages to wear for 48 hours only', 'interventionNames': ['Device: elastic bandage']}\n- {'label': 'Long-term compression group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomised to group B will be asked to wear bandages for the first 24h and then a Class 2 compression full-length stocking (23-32mm Hg) for 1 week', 'interventionNames': ['Device: elastic bandage', 'Device: compression stocking']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'elastic bandage', 'description': '3M\u2122 Coban\u2122 elastic bandage', 'armGroupLabels': ['Long-term compression group', 'Short-term compression group']}\n- {'type': 'DEVICE', 'name': 'compression stocking', 'description': 'Class 2 compression full-length stocking (23-32mm Hg)', 'armGroupLabels': ['Long-term compression group']}\n\nPrimary Outcomes:\n- {'measure': 'Target vein occlusion rate as assessed by duplex ultrasound scan', 'description': 'The primary outcome of the study is target vein occlusion rate at 3 months assessed with duplex ultrasound scan. Recanalisation will be defined by a segment of vein\u22655cm.\\n\\nTarget vein occlusion rate = Number of target venous closure cases in the group/total number of cases in the group', 'timeFrame': '3 months post-op'}\n\nPlease estimate the sample size based on the assumption: \nA power of 90%, a 2.5% (unilateral) significance level, and a potential drop-out rate of 20% are assumed.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size and study duration\n According to the literature [29\u00e2\u0080\u009331] and clinical experts\u00e2\u0080\u0099 recommendations, the target vein occlusion rate in the control group (group B) was set to 98%, and a non-inferiority threshold \u00ce\u00b4 of\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00896% was taken [17]. With a power of 90% and 2.5% (unilateral) significance equivalence, a minimum of 230 patients (115 per group) will need to be recruited. However, considering a potential drop-out rate of 20%, combined with the low probability of adverse events in this trial, the total sample size was expanded to 360 patients. With 3\u00c2\u00a0months follow-up, the study will run for 12\u00c2\u00a0months.", "id": 1810, "split": "test"} +{"trial_id": "NCT05841732", "pmid": "38840084", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MyBack - Effectiveness and Implementation of a Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences: a Hybrid Effectiveness-implementation Randomized Controlled Study\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'OTHER', 'description': 'Participants allocated to the usual care group will be informed that they can access their GP in the usual way (GPs consultation, pain medication, referral for other treatments/ services) and that they should contact their GP if their condition worsens. In addition, they will receive a minimal educational intervention focused on symptom management and promotion of physical activity (\"stay active\").', 'interventionNames': ['Other: Usual Care']}\n- {'label': 'MyBack', 'type': 'EXPERIMENTAL', 'description': 'Patients in the MyBack group will participate in a patient-centred, tailored exercise programme informed by a behavioural change approach in addition to receiving usual care. The MyBack intervention programme will consist of 12 bi-weekly sessions (60 minutes each) over 6 weeks complemented by 12 exercise sessions to be carried out autonomously by the participants over the following 6 weeks', 'interventionNames': ['Other: Usual Care', 'Other: MyBack Program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Education; Pain Medication, imaging, referrals to other health services, other health care appointments', 'armGroupLabels': ['MyBack', 'Usual Care'], 'otherNames': ['Minimal intervention']}\n- {'type': 'OTHER', 'name': 'MyBack Program', 'description': 'A tailored exercise and behavioural change program', 'armGroupLabels': ['MyBack'], 'otherNames': ['Physiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '1 month after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '2 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '3 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '4 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '5 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '6 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '7 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '8 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '9 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '10 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '11 months after baseline'}\n- {'measure': 'Risk of low back pain recurrence', 'description': 'Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity \u22652 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.', 'timeFrame': '12 months after baseline'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha value of 0.05, a power of 80%, a dropout rate of 5% during the MyBack programme, and a 10% loss of participants during follow-up.", "answer": 186, "answer_type": "ESTIMATED", "explanation": "Sample size (Aim I: effectiveness)\n The sample size was estimated to the primary outcome (risk of recurrence) and based on recurrence rates described in previous studies. Assuming a recurrence proportion of 40% in 12 months [11], an alpha value of 0.05 and a power of 80%, a sample size of 81 participants per group will be necessary to detect a difference of, at least, 20% between the two groups (relative risk\u00e2\u0080\u0089=\u00e2\u0080\u00890.50) [14, 63]. The choice of the minimal clinically relevant difference was informed by a previous systematic review [14] and was considered realistic considering the study hypothesis. Based on previous studies carried out in the same settings [64], it is expected a dropout rate of 5% during the MyBack programme and a 10% loss of participants during follow-up. Therefore, the total sample size to be recruited will be 186 participants, 93 for each group.", "id": 1811, "split": "test"} +{"trial_id": "NCT05842083", "pmid": "38730382", "question": "Here is the design of a clinical trial:\n\nOfficial Title: On-site Supportive Communication Training in Doctor-patient Communication: A Randomized, Controlled Trial\n\nIncluded conditions:\n- Communication Programs\n- Communication, Manual\n- Communication Research\n- Oncology\n- Doctor Patient Relation\n- Job Stress\n- Burnout\n- Satisfaction, Patient\n- Efficacy, Self\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Each oncologist will have a total of three intervention days with a psychologist sitting in and observing the doctor-patient consultations and subsequently providing feedback.', 'interventionNames': ['Behavioral: On-site supportive communication training']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Oncologists in the control group will conduct consultations as usual.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'On-site supportive communication training', 'description': 'On-site supportive communication training', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in rate of \"Excellent\" scores on the Communication Assessment Tool between the intervention and the control group.', 'description': \"Patients rate the doctor's communication skills right after the consultation.\", 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a two-sided Z Test (unpooled) with intracluster correlation (ICC) set at 0.005, significance level of the test at 0.05, and a power of 80%.", "answer": 89, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Approximately 80 out of the around 90 eligible doctors (89%) are expected to participate in the study.\n To achieve a power of 80%, a sample size of 2,080 patients (1,040 in each group) will be obtained by sampling 40 clusters (doctors) with 26 patient questionnaires in each group. In total we thus aim to collect 4160 questionnaires. The proportion in the intervention group is assumed to be 0.28 under the null hypothesis and 0.34 [33] under the alternative hypothesis assuming a difference between the group proportions of 0.06. Due to the lack of international consensus in this research area, an absolute change of 6% was agreed upon by mutual consensus in the steering group, as we believe such change would represent a clinical relevant difference for the patients. The proportion in the control group is assumed to be 0.28. The sample size calculation is based on a two-sided Z Test (unpooled) with intracluster correlation (ICC) set at 0.005, and significance level of the test at 0.05.\n Each cluster size of 26 completed questionnaires per doctor at baseline and evaluations aligns with the recommendations from the CAT developers [32]. To meet the target we aim to distribute 30\u00e2\u0080\u009340 questionnaires per doctor. Staff at each outpatient clinic will assist in the process.", "id": 1812, "split": "test"} +{"trial_id": "NCT05842330", "pmid": "38178233", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Benefits of In-prison OROS-methylphenidate Vs. Placebo Treatment in Detained People with Attention-deficit/hyperactivity Disorder: a Randomized Controlled Trial\n\nIncluded conditions:\n- ADHD\n\nStudy Armgroups:\n- {'label': 'Pharmaceutical intervention (OROS-MPH)', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive OROS-MPH (Concerta\u00ae available in Switzerland as first-line treatment for ADHD). Dosages will be defined according to the Swiss Compendium. The psychiatrist (blinded during detention) will start with the smallest dosage (18 mg, Concerta\u00ae). The treatment will be monitored weekly the first month, and then monthly. The pharmacy of the Geneva University Hospitals will be in charge of over-encapsulating medications.', 'interventionNames': ['Drug: Concerta']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Concerta', 'description': \"Dosages of Concerta\u00ae will be defined according to the Swiss Compendium (from 18 to 72 mg/d).\\n\\nThe psychiatrist will start with the smallest dosage (18 mg) and will adapt it on a weekly basis or on need, depending on tolerance (side effects measured at each visit), clinical response (subjective improvement felt by the patient in terms of attention, impulsivity, and hyperactivity), and according to the observations made by the professionals or patient's entourage in term of attention, impulsivity, hyperactivity, and for this project, behavioral problems. In general, the dose can be increased in 18 mg at weekly intervals.\\n\\nThe treatment will be monitored weekly the first month, and then monthly, except for side effects which will be monitored daily in prison and every two weeks after release.\", 'armGroupLabels': ['Pharmaceutical intervention (OROS-MPH)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'The placebo will be strictly identical (same packaging, size no. 2 and color according to dosage, with no label).\\n\\nProcedure for adjustment of dosage will be the same as in the Concerta arm.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Severity of ADHD core symptoms', 'description': 'Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 = .05, \u00c3\u009f = .80, allocation 1:1, equal variances between groups, stratified by prison, 16% attrition rate", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated the sample size using G*Power 3.1, with means difference between two independent groups (t-test), assuming equal variances between groups. Participants will be stratified by prison, but on average, we expect no difference between participants in the two prisons. With \u00ce\u00b1 = .05, \u00c3\u009f = .80, allocation 1:1, and standardized mean difference = 0.5 (average standardized effect size of 12-week treatment with OROS-MPH on change in severity of core ADHD symptoms, 25), we need n = 126. To account for potential attrition (e.g., participants transferred to another prison), we increased the sample to n = 150 (n = 75 in each group), which represents an attrition rate of 16%.", "id": 1813, "split": "test"} +{"trial_id": "NCT05846334", "pmid": "37715203", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease\n\nIncluded conditions:\n- Ischemic Heart Disease\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: mindfulHeart']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'mindfulHeart', 'description': \"'mindfulHeart' is an interactive, self-guided and patient-oriented mHealth intervention for the reduction of stress in patients with IHD and includes automated feedback via visualization of changes in patient reported outcome measures (PROMs).\", 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'combined global stress measure', 'description': 'The outcome is based on a published RCT in Circulation by Blumenthal et al. \\\\[34\\\\]. A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2. (see also NCT00981253)', 'timeFrame': '3 months, after intervention'}\n\nPlease estimate the sample size based on the assumption: \nPreferred test power of 1-\u03b2 = 0.80, correlation between repeated measures r = 0.5, and a dropout rate of 30%.", "answer": 128, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was performed using the R-package \u00e2\u0080\u009cSuperpower\u00e2\u0080\u009d [53]. The primary hypothesis is that the intervention is superior in terms of reducing stress compared to standard care (control group) at T1. To assess the efficacy of the intervention, an ANCOVA with the primary outcome variable at T1 as the criterion, the group variable (intervention vs. control group) as a between-subject factor, and the individual baseline levels at T0 as a covariate will be performed. A subsequent mixed ANOVA with the respective measurements (T0\u00e2\u0080\u0093T5) as a within-subject factor and the group variable (intervention vs. control group) as a between-subject factor will then serve to explore the intervention\u00e2\u0080\u0099s effect at follow-up. For the sample size calculation, a preferred test power of 1-\u00c3\u009f\u00e2\u0080\u0089=\u00e2\u0080\u00890.80 was chosen. We assume a moderate effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 for the baseline-adjusted comparison between the intervention and control group at T1. Furthermore, and based on previous studies [54], we expected the correlation between repeated measures to be r\u00e2\u0080\u0089=\u00e2\u0080\u00890.5. According to the power analyses, an effective sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008998 (i.e., 49 participants per group) would yield a statistical power of 80.34 for the above mentioned ANCOVA analysis. With the same amount of participants, we reach a power of 95.8 for the above-mentioned mixed ANOVA (given a rather conservative assumption of the sole difference between the intervention and control group to occur at T1). Based on existing literature regarding eHealth trials [55], we assume a dropout rate of 30%. Based on the preliminary work related to this study protocol [31, 32] and recommended measures to increase usability, especially user experience [55], a dropout rate in the lower level was assumed. Consequently, 128 participants (64 per group) are needed.", "id": 1814, "split": "test"} +{"trial_id": "NCT05846984", "pmid": "38851719", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Learning Skills Together: A Randomized Controlled Trial of a Complex Care Skills Intervention to Improve AD/ADRD Caregiver Self-Efficacy\n\nIncluded conditions:\n- Dementia\n- Alzheimer Disease\n- Caregiver Burden\n- Self Efficacy\n\nStudy Armgroups:\n- {'label': 'Learning Skills Together Intervention', 'type': 'EXPERIMENTAL', 'description': 'Complex care psychoeducation training intervention for family caregivers', 'interventionNames': ['Behavioral: Learning Skills Together Intervention']}\n- {'label': 'Caregiver Healthy Living Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Healthy living intervention for family caregivers', 'interventionNames': ['Behavioral: Caregiver Healthy Living Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Learning Skills Together Intervention', 'description': \"Learning Skills Together is a 6-week psychoeducational intervention developed to improve caregivers' confidence when completing complex care tasks (e.g., using a gait belt). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to communicate with someone who is living with dementia, medication management, and home safety. Participants are also provided with a workbook that accompanies each lesson, and includes short readings, videos, additional resources, as well as weekly practice and reflection exercises.\", 'armGroupLabels': ['Learning Skills Together Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Caregiver Healthy Living Intervention', 'description': 'Participants in the Caregiver Healthy Living Intervention will participate in a 6-week educational intervention to help improve caregiver health behaviors (e.g., getting enough sleep). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to eat a healthy diet, getting enough physical activity, and taking care of mental health. Participants are also provided a workbook that includes short readings and additional resources.', 'armGroupLabels': ['Caregiver Healthy Living Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Caregiver Self-Efficacy', 'description': 'Self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale (CSES-8; \u03b1=0.88 to 0.89; Ritter et al., 2020) Participants are asked to rate on a scale of 1 to 10 how confident they are with 8 aspects of caregiving (e.g., controlling upsetting thoughts). Scores range from 8 to 80, where higher scores indicate higher levels of caregiver self-efficacy. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention).', 'timeFrame': 'Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)'}\n- {'measure': 'Change in Caregiver Self-Efficacy with Complex Care (Author Generated)', 'description': 'The investigators developed a caregiver complex care self-efficacy measure based upon discussions with healthcare faculty (Meyer et al., 2022). This 16-item scale asks about how confident caregivers feel with various complex care tasks (e.g., \"Managing incontinence issues\") and asks caregivers to rate their confidence from 0 (\"Not at all confident\") to 5 (\"Very confident\"). Pilot data showed high internal consistency (\u03b1=0.89). Higher scores indicate higher levels of self-efficacy with complex care tasks. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention).', 'timeFrame': 'Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)'}\n- {'measure': 'Change in Caregiver Self-Efficacy with Complex Care', 'description': 'Self-efficacy with complex care will also be measured using the Caregiver Confidence in Sign/Symptom Management Scale (\u03b1=0.91), which subscales for Knowledge of Symptoms (\u03b1=0.56), Management of Cognitive Symptoms (\u03b1=0.82), Management of Medical Symptoms (\u03b1=0.78), and General Medical Management (\u03b1=0.94). Caregivers are asked how \"true\" statements are regarding their 1) knowledge, 2) ability to care for, and 3) make decisions about complex care tasks, as well as their level of confidence with various tasks. Scores range from 25 to 125, where higher scores indicate higher levels of caregiver self-efficacy with complex care. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention).', 'timeFrame': 'Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 80% statistical power with a significance level (\u03b1) of 0.05. The correlation coefficient for repeated measurements is 0.2. A conservative estimate accounts for dropout rates.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We will enroll a sample of N\u00e2\u0080\u0089=\u00e2\u0080\u0089200 caregivers for randomization with a 1:1 ratio. This number is based on an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.68 identified in a 2-month pre- and post-test pilot study for self-efficacy scores [28]. Given that control group participants may also experience some improvement from baseline, we reduced the anticipated effect size to d\u00e2\u0080\u0089=\u00e2\u0080\u00890.54 at 6 months. The corresponding sample size estimate is N\u00e2\u0080\u0089=\u00e2\u0080\u0089110 to detect an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.54 with 80% statistical power using two-sample t-tests with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05. Because using longitudinal data can increase power, we also performed power analysis using PASS v14 to calculate the detectable time-averaged effect size based on changes from baseline. A sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089110 can detect the time-averaged effect size of 0.42 when repeated measurements have an AR(1) covariance structure with a correlation coefficient of 0.2. We anticipate that the effect sizes at post-intervention and 3 months will be at least 0.4 and 0.5, respectively, and thus a significant intervention effect will be observed if the effect size at 6 months is at most 0.36. Given anticipated dropout based on prior studies, including between enrolment and randomization, we conservatively estimate we will need to recruit 200 participants to reach a sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089110 after 6 months.", "id": 1815, "split": "test"} +{"trial_id": "NCT05847309", "pmid": "38835061", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimal Ventilation Time After Endovascular Treatment Under General Anesthesia for Acute Ischemic Stroke. a Prospective, Randomized Comparison Between Early Vs Delayed Extubation\n\nIncluded conditions:\n- Acute Ischemic Stroke\n- Endovascular Treatment\n\nStudy Armgroups:\n- {'label': 'Early extubation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to early extubation, will be extubated \\\\< 6 hours after endovascular treatment under general anesthesia.', 'interventionNames': ['Other: Early extubation']}\n- {'label': 'Delayed extubation', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.', 'interventionNames': ['Other: Delayed extubation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Delayed extubation', 'description': 'Patients randomized to delayed extubation, will be extubated 6-12 hours after endovascular treatment under general anesthesia.', 'armGroupLabels': ['Delayed extubation']}\n- {'type': 'OTHER', 'name': 'Early extubation', 'description': 'Patients randomized to early extubation, will be extubated \\\\< 6 hours after endovascular treatment under general anesthesia.', 'armGroupLabels': ['Early extubation']}\n\nPrimary Outcomes:\n- {'measure': 'Modified Ranking Scale (mRS)', 'description': 'Comparison of independent functional outcome as measured by the percentage of patients with a 0 to 2 on the modified Rankin Scale (mRS) at 90 days assessed by study personal blinded to the treatment (early vs delayed extubation)\\n\\nThe scale of mRS is 0 to 6. The best neurological outcome is the mRS with 0, indicating no any symptom left, and a good neurological outcome is agreed with a mRS 0 to 2. mRS of 6 is the worst, indicating death. mRS will be evaluated by outcome assessor who is blinded to the group', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power (\u03b2) = 0.80, bilateral test, balanced groups, 5% expected loss rate.", "answer": 174, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We aim to compare neurological functional status at 90\u00c2\u00a0days according to the modified Rankin scale (mRS), of patients with stroke who underwent endovascular thrombectomy with satisfactory results and who underwent early extubation (<\u00e2\u0080\u00896\u00c2\u00a0h) compared to delayed extubation (6\u00e2\u0080\u009312\u00c2\u00a0h). Efficacy will be assessed with the proportion of patients with functional independence (mRS scale\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00892).\n A previous observational study [20] reported that 55.5% of patients achieved an mRS score of\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00892 after receiving early extubation (mechanical ventilation for less than 6\u00c2\u00a0h), compared to 33.9% when extubation was delayed (mechanical ventilation for more than 6\u00c2\u00a0h). In present trial, we hypothesize that early extubation, compared with delayed extubation, is associated with a better functional outcome 3\u00c2\u00a0months after endovascular thrombectomy under general anesthesia for acute ischemic stroke. We have decided to set the level of significance at 5% (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), with a power of 80% (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.80), and to use a bilateral test (c\u00e2\u0080\u0089=\u00e2\u0080\u00892). We will work with two independent samples and both groups will be balanced (w1\u00e2\u0080\u0089=\u00e2\u0080\u00890.5). Considering an expected percentage of losses is 5.00%, it would be necessary to include 87 individuals in each group, totaling 174 patients in the study. Depending on the course of the study, an interim analysis will be conducted when 70% of the recruited sample is reached, if deemed appropriate by the research team.We hypothesized that early compared with delayed extubation is associated with a better functional outcome 3\u00c2\u00a0months after endovascular thrombectomy treatment under general anesthesia for acute ischemic stroke.", "id": 1816, "split": "test"} +{"trial_id": "NCT05847478", "pmid": "40053799", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial\n\nIncluded conditions:\n- Obesity, Childhood\n\nStudy Armgroups:\n- {'label': 'Auricular acupressure therapy group (AAT)', 'type': 'EXPERIMENTAL', 'description': 'The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months.', 'interventionNames': ['Other: Auricular acupressure of traditional Chinese Medicine', 'Behavioral: Health education']}\n- {'label': 'Intermittent low carbohydrate diet group (ILCD)', 'type': 'EXPERIMENTAL', 'description': 'The participants will be randomly assigned to receive the intermittent low carbohydrate diet. The duration of the study is 3 months, including 1-month intervention period and 2-month self maintenance period.', 'interventionNames': ['Behavioral: Intermittent low carbohydrate diet', 'Behavioral: Health education']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Auricular acupressure of traditional Chinese Medicine', 'description': 'The participants will be randomly assigned to receive the auricular point patch therapy.\\n\\nThe selected acupoints include Shenmen, hungry point, endocrine, stomach, mouth and subcortical. The opaque patch with vaccaria seed is used for acupoint pressing. Pressing the acupoints once a day before and after eating, each time for 1 minute, lasting for 2-3 days, follow up visit once a week. The intervention period is 3 months.', 'armGroupLabels': ['Auricular acupressure therapy group (AAT)']}\n- {'type': 'BEHAVIORAL', 'name': 'Intermittent low carbohydrate diet', 'description': 'The participants will be randomly assigned to the intermittent low carbohydrate diet group.\\n\\nThe intermittent carbohydrate diet includes 7 days of low carbohydrate diet within 2 weeks (consecutive or nonconsecutive, carbohydrate intake be controlled as \u2264 50g per day). The study duration is 3 months, including 1-month intervention period and 2-month self-maintenance period.', 'armGroupLabels': ['Intermittent low carbohydrate diet group (ILCD)']}\n- {'type': 'BEHAVIORAL', 'name': 'Health education', 'description': 'Health education is conducted once a week during 3-month intervention for all participants. Health education including the understanding of childhood obesity and cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.', 'armGroupLabels': ['Auricular acupressure therapy group (AAT)', 'Intermittent low carbohydrate diet group (ILCD)']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in body weight', 'description': 'The body weight will be measured by fixed research staff at baseline and one month after intervention.', 'timeFrame': 'From baseline to one month after intervention'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, a 2-sided \u03b1 of .05, a sample size ratio of 3:1, and a dropout rate of 15%.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample Size\n The primary outcome was the change in body weight from baseline to 1 month. The sample size calculation was based on the difference in weight change between the 2 groups: the TAAT group and the ILCD group.\n Our pilot data from 12 patients revealed a weight loss of 1.9 kg after 4 weeks of TAAT and a weight reduction of 1.4 kg after 4 weeks of ILCD, with an SD of 1.1 kg. We assumed a 0.5 kg difference in weight reduction between the 2 arms, power of 0.80, a 2-sided \u00ce\u00b1 of .05, and a sample size ratio of 3:1, a minimum sample size of 150 for the TAAT group and 50 for the ILCD group were required, respectively. Assuming a dropout rate of 15%, the trial enrolled at least 240 participants. The \u00e2\u0080\u009ctest for 2 means module\u00e2\u0080\u009d of the PASS 16.0 software was used.", "id": 1817, "split": "test"} +{"trial_id": "NCT05848765", "pmid": "38528445", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms\n\nIncluded conditions:\n- Relapsed Follicular Lymphoma\n- Refractory Follicular Lymphoma\n\nStudy Armgroups:\n- {'label': 'Round 1: Epcoritamab and lenalidomide', 'type': 'EXPERIMENTAL', 'description': 'Epcoritamab (weekly for cycles 1 and 2 and on day 1 of cycles 3-12 for up to 12 cycles) and lenalidomide (daily for days 1-21 of each cycle for up for 12 cycles), cycles will be 28 day cycles.', 'interventionNames': ['Drug: Epcoritamab', 'Drug: Lenalidomide']}\n- {'label': 'Round 2', 'type': 'EXPERIMENTAL', 'description': 'Investigation agent 2', 'interventionNames': ['Drug: Investigation agent 2']}\n- {'label': 'Round 3', 'type': 'EXPERIMENTAL', 'description': 'Investigation agent 3', 'interventionNames': ['Drug: Investigation agent 3']}\n- {'label': 'All rounds: Investigator Choice Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Choice of therapy to be selected by the Investigator for each patient prior to randomisation. The Investigator will choose between; RCHOP, RCVP, rituximab and bendamustine, rituximab and lenalidomide or bendamustine and obinutuzumab.', 'interventionNames': ['Drug: Lenalidomide', 'Drug: Rituximab', 'Drug: Obinutuzumab', 'Drug: Bendamustine', 'Drug: Vincristine', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Prednisone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Epcoritamab', 'description': 'Bispecific antibody', 'armGroupLabels': ['Round 1: Epcoritamab and lenalidomide']}\n- {'type': 'DRUG', 'name': 'Lenalidomide', 'description': 'Immunomodulatory agent', 'armGroupLabels': ['All rounds: Investigator Choice Therapy', 'Round 1: Epcoritamab and lenalidomide']}\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Monoclonal antibody', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Obinutuzumab', 'description': 'Monoclonal antibody', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Bendamustine', 'description': 'Alkylating agent (chemotherapy drug)', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Vincristine', 'description': 'Antineoplastic, Vinca Alkaloid', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Anthracycline', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Alkylating agent (chemotherapy drug)', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Corticosteroid', 'armGroupLabels': ['All rounds: Investigator Choice Therapy']}\n- {'type': 'DRUG', 'name': 'Investigation agent 2', 'description': 'The drug used in round 2 is yet to be confirmed, round 2 is estimated to open in Q4 2025 and the record will be updated when the drug has been confirmed', 'armGroupLabels': ['Round 2']}\n- {'type': 'DRUG', 'name': 'Investigation agent 3', 'description': 'The drug used in round 3 is yet to be confirmed, round 3 is estimated to open in Q3 2027 and the record will be updated when the drug has been confirmed', 'armGroupLabels': ['Round 3']}\n\nPrimary Outcomes:\n- {'measure': 'Complete metabolic response (CMR)', 'description': \"CMR will be assessed by PET-CT using the Deauville 5-point scale and Lugano 2014 criteria. Patients who die from any cause or relapse/progress prior to this time-point will be considered non-responders. Patients who don't have a PET-CT scan within the protocol defined window or withdraw from the trial prior to this time-point will be considered non outcome evaluable. Patients who undergo stem-cell transplant (SCT) within 24 weeks of randomisation, patients who fail to start treatment and patients whose ineligibility is deemed to impact upon response to treatment will be replaced and hence not included in the analysis of this outcome\", 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nBayesian operating characteristics were used, and data from previous control arms will be incorporated into subsequent rounds using power priors.", "answer": 284, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Based on feasibility assessments a total sample size for all three rounds of 284 patients (95 control\u00e2\u0080\u0089+\u00e2\u0080\u0089189 novel arm patients in total) was deemed appropriate. R1 will treat 126 patients (63 patients per arm, 1:1 randomisation). R2 and R3 will treat 63 patients in the novel arm and 16 in the control arm (4:1 randomisation). In order to make the most efficient use of patients\u00e2\u0080\u0099 contributions and reduce the number of control arm patients required in R2 and 3, data from patients recruited to previous control arms will be incorporated into subsequent rounds using power priors [24]. Bayesian operating characteristics were used to calculate the probability that the PET-CT CMR rate in the novel arm is greater than a given value, under predefined conditions. A more detailed description of the Bayesian methodology using power priors is described elsewhere (manuscript submitted), sample size determinations can be found in the predefined statistical analysis plan (Supplementary Appendix 10).", "id": 1818, "split": "test"} +{"trial_id": "NCT05850936", "pmid": "38839388", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Medically Intraocular Pressure Lowering on Progressive High Myopia\n\nIncluded conditions:\n- High Myopia\n- Intraocular Pressure\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'medical reduction of IOP by eyedrops', 'interventionNames': ['Drug: Assigned Interventions: IOP-lowering eye drops']}\n- {'label': 'control arm', 'type': 'NO_INTERVENTION', 'description': 'follow up without medication'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Assigned Interventions: IOP-lowering eye drops', 'description': 'IOP-lowering eye drops Xalacom eyedrops (combination drops, fixed latanoprost with timolol) will be the choice for treatment.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'progression of axial length (AL)', 'description': 'The number of subjects whose AL progressed during the follow up', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve a statistical power of 80% with a two-sided significance level of 0.05, accounting for an estimated 15% loss to follow-up at the 12 months mark.", "answer": 152, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation for this study is determined based on the primary outcome and the study hypothesis, taking into account relevant findings from previous studies. The objective of this study is to evaluate the potential of IOP-lowering therapy to reduce axial elongation during a study period of 1-year growth in eyes with PHM. It is hypothesised that the intervention group receiving IOP-lowering therapy will exhibit a 70% reduction in axial elongation compared with the control group. The control group is estimated to experience a 0.1\u00e2\u0080\u0089mm axial elongation over 12 months, while the intervention group is expected to have a mean axial elongation of 0.03\u00e2\u0080\u0089mm. The common SD is estimated to be 0.14\u00e2\u0080\u0089mm. To achieve a statistical power of 80% with a two-sided significance level of 0.05, a total of 64 individuals per group is required. Accounting for an estimated 15% loss to follow-up at the 12\u00e2\u0080\u0089months mark, the final sample size is determined to be 76 individuals per group, resulting in a total of 152 participants. The sample size calculation was performed using PASS V.16.0 software (NCSS, LLC, Kaysville, Utah, USA).", "id": 1819, "split": "test"} +{"trial_id": "NCT05851508", "pmid": "39209781", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENi\u00e8re's Disease (PREDMEN Trial).\n\nIncluded conditions:\n- Meniere Disease\n\nStudy Armgroups:\n- {'label': 'Methylprednisolon', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intratympanal injection with Methylprednisolon 62.5 mg/ ml', 'interventionNames': ['Drug: Methylprednisolon']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Intratympanal injection with saline, natriumchloride 0.9%', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methylprednisolon', 'description': 'Intratympanal injection with Methylprednisolon 62.5 mg/ ml', 'armGroupLabels': ['Methylprednisolon']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Intratympanal injection with saline, natriumchloride 0.9%', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Vertigo spells', 'description': 'A definitive vertigo spell is defined as a spontaneous rotational vertigo symptom, which lasts at least 20 minutes and is often accompanied by disequilibrium and vomiting. No loss of consciousness is present. Vertigo spells are measured daily with the dizzy quest ap. Futhermore, at baseline after 6 and 12 months, caloric testing and a video-head impusle test are performend. Additionally the dizziness handicap inventory will be taken.', 'timeFrame': 'Daily, change from baseline to one year'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, type 1 error of 5%, and an estimated 10% loss-to-follow-up.", "answer": 148, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size calculation was performed based on recommendations as summarised in the Clinical Practice Guideline for Meni\u00c3\u00a8re\u00e2\u0080\u0099s disease.1 An expected proportion of subjects achieving vertigo control of 87.5% was assumed for methylprednisolone treatment compared with an assumed 67.5% for placebo, that is, a difference in treatment effect of 20%. With a statistical power (1-\u00ce\u00b2) of 80% and a type 1 error (\u00ce\u00b1) of 5%, 67 patients per group are required. With an estimated 10% loss-to-follow-up, 74 patients will be included in each arm, giving a total sample size of 148. In total, over the six participating centres, 340 MD patients yearly visit the Otolaryngology department and will be screened for the trial. It is expected that 15% will meet the inclusion criteria and will be willing to participate. This will result in approximately 50 eligible patients for inclusion per year.", "id": 1820, "split": "test"} +{"trial_id": "NCT05856851", "pmid": "39500603", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial\n\nIncluded conditions:\n- Stroke, Acute Ischemic\n\nStudy Armgroups:\n- {'label': 'Intra-arterial alteplase', 'type': 'EXPERIMENTAL', 'description': 'Participants in the experimental group will receive a 15-minute continuous infusion of intra-arterial alteplase at a drug concentration of 1.0 mg/ml. 15 minutes after the start of intra-arterial thrombolysis, the infusion will be stopped and an angiogram will be performed to assess the eTICI score. If the angiographic eTICI score improves from the baseline score, the procedure will be terminated, otherwise, a new angiogram will be repeated 5-10 minutes after the end of drug administration.', 'interventionNames': ['Drug: Alteplase']}\n- {'label': 'Standard medical treatment', 'type': 'NO_INTERVENTION', 'description': 'Participants allocated to the control group will receive standard medical treatment without intra-arterial alteplase after mechanical thrombectomy.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Alteplase', 'description': 'See arm/group descriptions.', 'armGroupLabels': ['Intra-arterial alteplase'], 'otherNames': ['Intra-arterial alteplase after mechanical thrombectomy']}\n\nPrimary Outcomes:\n- {'measure': 'The modified Rankin Scale score (mRS) 0-1', 'description': 'The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.', 'timeFrame': '90(\u00b17) days'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power is 80%, significance level is 0.05, and dropout rate is 5%. Interim analysis will be performed at a two-sided test level of 0.003, and final analysis at 0.049 using the O'Brien-Fleming method.", "answer": 324, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The primary efficacy outcome is the proportion of 90-day mRS of 0\u00e2\u0080\u00931. The CHOICE study found that the proportion of 90-day mRS scores 0\u00e2\u0080\u00931 in the control group was 40.4%, and the experimental group had an 18.6% improvement in the primary outcome.12 Given that the CHOICE study stopped early and may have overestimated efficacy, we assumed a 16% improvement in the proportion of 90-day mRS scores 0\u00e2\u0080\u00931 in the experimental group compared with that in the control group, with a statistical power of 80%, a two-sided test level of 0.05, and a drop-out rate of 5%; therefore, a total of 324 participants will be enrolled, and 162 participants will be needed for each group.\n The interim analysis will be performed when half of the participants have completed the 90-day follow-up visits (162 participants). The test levels for the interim and final analyses will be two-sided test levels of 0.003 and 0.049, respectively, using the O'Brien-Fleming method to avoid type I error inflation.", "id": 1821, "split": "test"} +{"trial_id": "NCT05856942", "pmid": "39312771", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington\n\nIncluded conditions:\n- HIV Prevention\n- Pre-exposure Prophylaxis\n- STI\n\nStudy Armgroups:\n- {'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive standard PrEP care in the clinic including in-person visits for triannual (every 4 months) HIV \\\\& STI screening and comprehensive sexual health care.'}\n- {'label': 'Home-based care', 'type': 'EXPERIMENTAL', 'description': 'Patients will have the option to complete their PrEP care from home including 1) self-collection of blood specimens for HIV, syphilis and creatinine; 2) self-swabs for extragenital GC/CT screening; and 3) telehealth follow-up. A maximum of two triannual follow-up visits per year may be conducted remotely; one visit per year must be in person. Participants also have the option to attend visits in person and are otherwise eligible to continue receiving comprehensive sexual health services in the clinic.', 'interventionNames': ['Other: Health service - home-based PrEP monitoring']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Health service - home-based PrEP monitoring', 'description': 'Home-based PrEP care', 'armGroupLabels': ['Home-based care']}\n\nPrimary Outcomes:\n- {'measure': 'PrEP retention', 'description': 'Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nA dropout rate of 6% in both groups, 80% power to detect a 13% point difference in PrEP retention, and a significance level implied by standard methods.", "answer": 458, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power Considerations\n Sample size calculations for the primary Kaplan-Meier survival analysis were based on standard methods [33]. Assuming that 2.5% of individuals discontinue PrEP per month in the control arm, we expect 45% of SOC participants to discontinue PrEP (55% retention) over the 20-month study period. In the intervention arm, we estimate that 70% will adopt HB-PrEP. We assume a relative risk of discontinuation of 0.6 among participants assigned to receive HB-PrEP leading to a 32% discontinuation rate (68% retention) in the HB-PrEP arm. We also allowed for an overall dropout rate in both groups of 6% [15]. Thus, a sample size of 458 participants should yield 80% power to detect a 13% point difference in PrEP retention. All eligible participants are assigned through simple 1:1 randomization to either the intervention arm (n=229) or SOC arm (n=229) and followed for 20 months. RCT procedures are detailed in Textbox 1.", "id": 1822, "split": "test"} +{"trial_id": "NCT05860881", "pmid": "39578921", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Double-blind Placebo-controlled Trial of Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients\n\nIncluded conditions:\n- Solid Organ Transplant Recipients\n- Skin Cancer\n\nStudy Armgroups:\n- {'label': 'Topical Sirolimus', 'type': 'EXPERIMENTAL', 'description': 'Topical 1% sirolimus cream applied daily to the face for 24 weeks', 'interventionNames': ['Drug: Sirolimus Topical Cream']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Topical placebo cream applied daily to the face for 24 weeks', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sirolimus Topical Cream', 'description': 'The intervention topical cream consists of sirolimus 1% in a vehicle. Patients randomised to the intervention will be required to apply the sirolimus topical cream to their face for 6 months', 'armGroupLabels': ['Topical Sirolimus'], 'otherNames': ['Rapamycin']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Cream containing only the base, or vehicle.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Vehicle alone']}\n\nPrimary Outcomes:\n- {'measure': 'KC development', 'description': 'The number of keratinocyte carcinomas (KCs) on the treated area compared with placebo, at the completion of 24 weeks of topical 1% sirolimus then at 12 and 24 months.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nThe IEC rate within each arm is Poisson distributed. To achieve 80% power with a two-sided type I error rate of 0.05, and accounting for a 36% dropout rate.", "answer": 146, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Assuming that all of the IECs detected at 24\u00c2\u00a0weeks in our preliminary study will become invasive at a later stage, we used the average number of IECs per participant to inform the sample size calculation of this trial. Based on that pilot data, in which 12 IECs were diagnosed in 29 placebo participants in 2\u00c2\u00a0years, and 4 IECs were detected in 29 sirolimus participants in the same time period, we assume that the underlying diagnosis rates in the placebo and sirolimus arms are 0.414 and 0.138 SCC/participant respectively over 2\u00c2\u00a0years. Assuming that the IEC rate within each arm is Poisson distributed, to achieve power of 80% with a two-sided type I error rate of 0.05, 47 participants are required to be accrued in each arm with a 1:1 enrolment ratio between arms. Factoring in the expected high level of trial dropouts (36%), we will aim to recruit a minimum of 73 participants per arm, totalling 146 participants.", "id": 1823, "split": "test"} +{"trial_id": "NCT05861609", "pmid": "39133680", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.\n\nIncluded conditions:\n- Persistent Spinal Pain Syndrome Type 2\n- Spinal Cord Stimulation\n\nStudy Armgroups:\n- {'label': 'No pain medication tapering (usual care)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual care', 'interventionNames': ['Procedure: Usual care']}\n- {'label': 'Standardized pain medication tapering', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standardized pain medication tapering', 'interventionNames': ['Procedure: Standardized pain medication tapering']}\n- {'label': 'Personalized pain medication tapering', 'type': 'ACTIVE_COMPARATOR', 'description': 'Personalized pain medication tapering', 'interventionNames': ['Procedure: Personalized pain medication tapering']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Usual care', 'description': 'Usual care with respect to Spinal Cord Stimulation implantation', 'armGroupLabels': ['No pain medication tapering (usual care)']}\n- {'type': 'PROCEDURE', 'name': 'Standardized pain medication tapering', 'description': 'A standardized pain medication tapering program before Spinal Cord Stimulator implantation.', 'armGroupLabels': ['Standardized pain medication tapering']}\n- {'type': 'PROCEDURE', 'name': 'Personalized pain medication tapering', 'description': 'A personalized pain medication tapering program before Spinal Cord Stimulator implantation.', 'armGroupLabels': ['Personalized pain medication tapering']}\n\nPrimary Outcomes:\n- {'measure': 'Disability', 'description': 'Disability, evaluated with the Oswestry Disability Index', 'timeFrame': 'The change between the baseline assessment and the evaluation 1 month, 3 months, 6 months, and 12 months after receiving Spinal Cord Stimulation'}\n\nPlease estimate the sample size based on the assumption: \nThe common standard deviation is 16.789. The trial is designed with 80% power to detect differences in means at a 5% two-sided significance level with Bonferroni correction. An SCS trial failure rate of 11.3% and a general loss-to-follow-up rate of 20% are also considered.", "answer": 195, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was performed on the primary outcome measure, i.e., \u00e2\u0080\u009cdisability, measured with the ODI\u00e2\u0080\u009d, at 12 months. The following assumptions were made:\n \n \n The mean disability score at 12 months with SCS is 33.34 (SD: 16.86) [71].\n \n \n The expected difference between tapering and no tapering at 12 months of SCS is 19.64% [24], leading to an expected total ODI score of 26.79 in the tapering groups.\n \n \n A 10% decrease in ODI score is assumed with the personalized tapering protocol compared to a standardized tapering protocol (assumption since no ODI data is available to estimate the actual beneficial effect).\n \n \n The common standard deviation (16.789) is based upon 4 repeated measures from an earlier trial in an identical study population [71].\n \n \n To conduct a three-arm parallel group, randomized clinical trial with 5 assessments, and estimated true mean ODI responses for the no tapering group of 33.34, standardized tapering group of 26.79 and personalized tapering group of 24.11, with a common standard deviation of 16.789, and 80% power to detect differences in means at a 5% two-sided significance level with Bonferroni correction, a total sample size of 147 patients is needed. This calculation was performed by the guidelines provided in the book of Chow et al. concerning sample size calculations in clinical research [72] and controlled with G power version 3.1. To account for a SCS trial failure rate of 11.3% [71] and a general loss-to-follow-up of 20%, a sample size of 65 patients per arm will be needed. This results in a total sample size of 195 patients for this study.", "id": 1824, "split": "test"} +{"trial_id": "NCT05863312", "pmid": "38124155", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rhegmatogenous rEtinal Detachment With or withOut Scleral Buckle (REDOS) Trial: a Factorial, Randomized Controlled Trial\n\nIncluded conditions:\n- Retinal Detachment\n\nStudy Armgroups:\n- {'label': 'Pars plana vitrectomy + sulfur hexafluoride gas tamponade', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Pars plana vitrectomy', 'Other: Sulfur hexafluoride gas tamponade']}\n- {'label': 'Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Pars plana vitrectomy with scleral buckle', 'Other: Sulfur hexafluoride gas tamponade']}\n- {'label': 'Pars plana vitrectomy + perfluoropropane gas tamponade', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Pars plana vitrectomy', 'Other: Perfluoropropane gas']}\n- {'label': 'Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Pars plana vitrectomy with scleral buckle', 'Other: Perfluoropropane gas']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Pars plana vitrectomy', 'description': \"Pars plana vitrectomy will be performed in a standard fashion starting with central vitrectomy, then by localizing retinal breaks, and marking them with endodiathermy. Perfluorocarbon will be used to displace subretinal fluid which will be aspirated at its exit from the retinal break as much as possible and maximal vitreous base shaving will be performed in all cases. This will be followed by an air-fluid exchange. Use of cryotherapy to solidify the retina intraoperatively and use of internal limiting membrane peeling of the posterior pole will be at the discretion of the surgeon. In all cases, laser photocoagulation around retinal breaks, holes, areas of lattice degeneration, and posterior to sclerotomy sites will be done and then a 360\u00b0 laser retinopexy will be performed at the surgeon's discretion and consisted of three rows of medium-white burns anterior to the level of the vortex vein, towards and beyond the equator.\", 'armGroupLabels': ['Pars plana vitrectomy + perfluoropropane gas tamponade', 'Pars plana vitrectomy + sulfur hexafluoride gas tamponade'], 'otherNames': ['PPV']}\n- {'type': 'PROCEDURE', 'name': 'Pars plana vitrectomy with scleral buckle', 'description': 'In cases with SB, after 360\u00b0 peritomy and dissection in 4 quadrants, a 41-circling band with 3082 sleeves (Labtician Ophthalmics, Oakville, ON Canada) will be used in all cases and fixed to the sclera at approximatively 11.5 mm from the limbus (or 5.5 from the insertion of rectus muscles) using partial thickness scleral tunnel or mattress sutures with 5.0 prolene or nylon performed in 4 quadrants depending on the surgeon preferences. Pars plana vitrectomy will then be performed as in the PPV only group.', 'armGroupLabels': ['Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade', 'Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade'], 'otherNames': ['PPV-SB']}\n- {'type': 'OTHER', 'name': 'Sulfur hexafluoride gas tamponade', 'description': 'At the end of the surgery, the eye is filled with sulfur hexafluoride gas tamponade.', 'armGroupLabels': ['Pars plana vitrectomy + sulfur hexafluoride gas tamponade', 'Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade'], 'otherNames': ['SF6']}\n- {'type': 'OTHER', 'name': 'Perfluoropropane gas', 'description': 'At the end of the surgery, the eye is filled with perfluoropropane gas tamponade.', 'armGroupLabels': ['Pars plana vitrectomy + perfluoropropane gas tamponade', 'Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade'], 'otherNames': ['C3F8']}\n\nPrimary Outcomes:\n- {'measure': 'Single surgery anatomic success', 'description': 'Freedom from reoperation for recurrent RRD', 'timeFrame': 'Until final 1 year follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that allows for a power greater than 80% to detect an effect size of 0.25, considering a 10% dropout rate.", "answer": 560, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We based our sample size calculations on the size necessary to detect a clinically significant effect in surgical technique, given that estimates of effect size among gas tamponades are not as precise in the literature and are a secondary purpose of our study. Based on previous results from our center, SSAS is achieved in 92% and 88% of phakic patients undergoing PPV and PPV-SB, respectively, compared to 91% and 90% in pseudophakic patients. We therefore have at most a 4% difference between the treatment groups. In the PRO study reports, SSAS rates differed between PPV and PPV-SB with 83% and 91%, respectively, in phakic patients and 84% and 92% in pseudophakic patients. Based on our previous results, this would yield a small effect size of about 0.13, while this would be approximately 0.25 according to the treatment differences in the PRO study reports. Considering that a treatment difference smaller than what was found in the PRO study could be deemed not clinically significant, we are proposing a total sample size of 560 patients (n\u00e2\u0080\u0089=\u00e2\u0080\u0089140 per group) which, assuming a 10% drop-off rate, would still allow us to detect an effect size of 0.25 with a power greater than 80% (see Table 3).\nTable 3Total sample size calculation to detect an effect in the ranges of 0.20 to 0.30 for surgical technique (i.e., PPV and PPV-SB) at various study powers. We are proposing a sample size of 560 patients. Corresponding effect size and power will be achieved for the analysis of gas tamponades (i.e., SF6 and C3F8)Effect sizePower80%85%90%0.2078490010520.255045766720.30348400468", "id": 1825, "split": "test"} +{"trial_id": "NCT05864586", "pmid": "37699050", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers\n\nIncluded conditions:\n- Nicotine\n- Nicotine Vaping\n- E-cigarette Use\n\nStudy Armgroups:\n- {'label': 'Young adult EC users', 'type': 'ACTIVE_COMPARATOR', 'description': 'Young Adult EC users', 'interventionNames': ['Behavioral: Vaping study EC A', 'Behavioral: Vaping study EC B', 'Behavioral: Vaping study EC C', 'Behavioral: Vaping study EC D', 'Behavioral: Vaping study EC E', 'Behavioral: Vaping study EC F', 'Behavioral: Vaping study EC G', 'Behavioral: Vaping study EC H', 'Behavioral: Vaping study EC I', 'Behavioral: Vaping study EC J']}\n- {'label': 'Older adult smokers', 'type': 'ACTIVE_COMPARATOR', 'description': 'Adult smokers', 'interventionNames': ['Behavioral: Vaping study EC A', 'Behavioral: Vaping study EC B', 'Behavioral: Vaping study EC C', 'Behavioral: Vaping study EC D', 'Behavioral: Vaping study EC E', 'Behavioral: Vaping study EC F', 'Behavioral: Vaping study EC G', 'Behavioral: Vaping study EC H', 'Behavioral: Vaping study EC I', 'Behavioral: Vaping study EC J']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC A', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC B', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC C', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC D', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC E', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC F', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC G', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC H', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC I', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n- {'type': 'BEHAVIORAL', 'name': 'Vaping study EC J', 'description': 'Vaping two puffs using the study EC device', 'armGroupLabels': ['Older adult smokers', 'Young adult EC users']}\n\nPrimary Outcomes:\n- {'measure': 'Behavioral Intentions for continued use', 'description': 'The self-report measure on a 7-point scale will be completed following e-cigarette self-administration.', 'timeFrame': '1 hour'}\n- {'measure': 'Intensity of sensory attributes', 'description': 'The 5-item self-report measure will be completed following e-cigarette self-administration, using the general Labeled Magnitude Scale.', 'timeFrame': '1 hour'}\n- {'measure': 'Degree of liking or disliking of sensations', 'description': 'The self-report measure will be completed following e-cigarette self-administration, using the Labeled Hedonic Scale.', 'timeFrame': '1 hour'}\n\nPlease estimate the sample size based on the assumption: \nCorrelation of 0.5, alpha of 0.01, 80% power, and a 10% replacement rate for participants failing to abstain from nicotine use. For categorical interactions, p-value adjusted to 0.0017 for pairwise comparisons.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Sample size\n A total of 132 participants will be recruited, including young adult e-cigarette (EC) users with minimal or no history of smoking (n = 66) and older adult smokers (n = 66). Conservatively, 10% of 132 participants are assumed to need to be replaced post hoc with another participant due to failing to abstain from nicotine use prior to the study visit. With 120 participants, a correlation of 0.5, and an alpha of 0.01, a two-sided paired t-test has 80% power to detect an effect size of 0.32 standard deviations of the measurement for the concentration main effect. For the FB fraction main effect, the model has 80% power to identify a slope of 0.31 with 120 participants with an alpha value of 0.01. The effect sizes are conservative, given that a previous study [19], which investigated the impact of nicotine formulation on appeal and sensory attributes, observed relatively larger effect sizes, with Cohen\u00e2\u0080\u0099s d values ranging from 0.53 to 1.20. For categorical interactions, the power is estimated by conducting pairwise comparisons of the two interacting groups (a total of 4 groups with two 2-level variables) and adjusting the p-value to 0.0017, accounting for the 6 possible pairwise comparisons (0.01/6). With 30 samples per group, A two-sided, two-sample t-test has over 80% power to detect a 1.7-fold difference between any of the two groups in the interaction term, considering an alpha value of 0.0017 and coefficient of variation value of 0.5. For interactions with FB fraction, group sizes of 60 have 80% power to detect a difference in slopes of 0.43, assuming alpha = 0.01.", "id": 1826, "split": "test"} +{"trial_id": "NCT05866081", "pmid": "39633425", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)\n\nIncluded conditions:\n- Stone, Kidney\n- Stone Ureter\n\nStudy Armgroups:\n- {'label': 'Randomized cohort- No stent placement', 'type': 'OTHER', 'description': 'Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed.\\n\\nIf participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.\\n\\nIn randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.', 'interventionNames': ['Other: No stent placement', 'Other: Surveys']}\n- {'label': 'Randomized cohort- Stent placement', 'type': 'EXPERIMENTAL', 'description': 'Participants that are eligible and consent for the randomization cohort trial will have a stent placed.\\n\\nIf participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.\\n\\nIn randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.', 'interventionNames': ['Device: Standard of care stent placement', 'Other: Surveys']}\n- {'label': 'Observational participants - not randomized', 'type': 'OTHER', 'description': 'Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.', 'interventionNames': ['Other: Surveys']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Standard of care stent placement', 'description': 'Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.', 'armGroupLabels': ['Randomized cohort- Stent placement']}\n- {'type': 'OTHER', 'name': 'No stent placement', 'description': 'Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.', 'armGroupLabels': ['Randomized cohort- No stent placement']}\n- {'type': 'OTHER', 'name': 'Surveys', 'description': 'All participants in the trial cohort and observational arms will be asked to complete survey instruments (evaluating their pain, quality of life, and experiences following ureteroscopy, as well as surveys evaluating their opinions and preferences around ureteral stenting, etc.).\\n\\nParticipants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.', 'armGroupLabels': ['Observational participants - not randomized', 'Randomized cohort- No stent placement', 'Randomized cohort- Stent placement']}\n\nPrimary Outcomes:\n- {'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS\u00ae) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative', 'description': 'This survey has 6 questions that participants select from 1(not at all) to 5 (very much) for questions 1-5 related to pain interference. For question 6 participants select from 1 (Never) to 5 (Always). There are total of 6-30 points where the higher the score the more pain interference.', 'timeFrame': 'Preoperative, Day 7-10'}\n- {'measure': 'Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score', 'description': 'Compare within each cohort each No Stent Placement patient head-to-head against each Stent Placement patient using a hierarchical composite comprised of:\\n\\n* Intensive care unit (ICU) care during hospitalization\\n* Unplanned hospitalization\\n* Unplanned additional procedure related to ureteroscopy: operating room or interventional radiology procedure\\n* Emergency department visit\\n* Unplanned clinic visit and/or diagnostic testing (blood, urine testing and/or imaging)\\n* Number of ambulatory patient-provider interactions: phone calls / Electronic Medical Record (EMR) messages', 'timeFrame': 'within 30 days after ureteroscopy'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 2.5% and 90% power are used for both endpoints. A 10% loss to follow-up and a 15% dropout rate due to intra-surgical factors are assumed.", "answer": 792, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was derived by the sample needed to power each co-primary endpoint for the RCT cohort. The larger sample size among the co-primary endpoints was used to estimate the final RCT cohort size. Each power calculation used a two-sided significance level of 2.5% to allow for two primary endpoints for a trial-level type I error of 5% as described below.\n Postoperative days 7\u00e2\u0080\u009310 PROMIS\u00c2\u00ae Pain Interference change from pre-surgery is a co-primary endpoint; 101 participants per treatment arm will provide the RCT cohort with at least 90% power to detect a mean difference between stent placement vs. omission treatment groups of 5 points with an assumed standard deviation (SD) of 10 points, based on a two-sample t test (SAS 9.4), with a two-sided significance level of 2.5%. Previous work estimated that a clinically meaningful difference in PROMIS\u00c2\u00ae Pain Interference is 2\u00e2\u0080\u00936 points [25, 26]. A pilot study at our institution found an initial difference between stent omission and placement of 7.2 points with a SD of 13 for change and a SD of 10 at each time point. We expect our pilot may overestimate the treatment effect. Thus, we have targeted a difference of 5 points to represent a clinically significant target. A 10% loss to follow-up (failure to respond to the 7\u00e2\u0080\u009310-day questionnaire) is assumed. Thus, 112 patients are needed per arm (total 224 patients). After consent, we estimate that 15% of patients who plan to be randomized will be unable to do so owing to intra-surgical factors that deem the procedure as complicated requiring 264 patients consented to the randomization cohort to attain 224 randomized patients.\n Unplanned healthcare utilization within 30 days of ureteroscopy is the second co-primary endpoint.\n With a modest probability of improvement in the reduction of healthcare utilization in ureteroscopy with stent omission, the impact in morbidity reduction and cost reduction would be great. There are no current estimates in the literature that help inform a minimum important difference for the win ratio estimate of healthcare utilization, our co-primary endpoint. So, we reasoned that a marginal probabilistic index, which is the effect size measure corresponding to the nonparametric Mann\u00e2\u0080\u0093Whitney U statistic that is used to test the hierarchical composite \u00e2\u0080\u009cwin ratio\u00e2\u0080\u009d endpoint [27], of at least 67%, would be impactful as the study could conclude that a randomly chosen participant with stent omission has a two-thirds or greater probability of lower healthcare utilization than a randomly chosen participant treated with a stent. In the RCT with a two-sided 2.5% alpha and requiring 90% power to detect a treatment effect of 67%, 72 patients would be required per treatment arm. The sample size is based on the Finkelstein and Schoenfeld methods [28] for analysis of hierarchical composite endpoints, later called the win ratio by Pocock et al. based on the nonparametric Mann\u00e2\u0080\u0093Whitney U statistic [29]; the formula is provided in Yosef et al. [30].\n The observational cohort sample size was derived from an assumption that 1/3 of patients approached and consented would be willing to be randomized. Thus, the observational cohort will consist of the estimated 2/3 (528) of patients who are approached and decline the RCT. With those assumptions, we find the following power for each primary endpoint.\n Approximately 85% (449) of the observational cohort consented patients are expected to undergo an eligible ureteroscopy. From our prior data, approximately 70% (314) of these patients will receive a stent during ureteroscopy, and 135 (30%) will have stent omission. Assuming a 10% loss-to-follow-up (days 7\u00e2\u0080\u009310 pain interference questionnaire not completed), this will result in 283 stent placement patients and 121 stent omission patients evaluable for the primary analysis of the observational cohort. Assuming a two-sided 2.5% type I error for each primary endpoint, 283 patients in the stent placement arm and 121 patients in the stent omission arm will provide 99.1% power to detect a clinically meaningful difference of 5 points between treatment arms for the change from pre-surgery in PROMIS\u00c2\u00ae pain interference measure at days 7\u00e2\u0080\u009310, assuming a standard deviation of 10 using a two-sample t-test. Sensitivity to the stented proportion and proportion agreeing to randomization (Table\u00c2\u00a02) demonstrates at least 84% power to detect a clinically significant difference in pain interference.\nTable 2Observational cohort power with sensitivity to our assumptionsProportion agrees to randomization(total approached)Proportion stentedSample size total (stented:stent omission)Power33% (792)70%404 (121:283)99.1%50%404 (202:202)99.7%25%404 (101:303)99.1%50% (528)70%202 (141:61)84.2%50%202 (101:101)90.0%25%202 (51:151)86.7%\n The power estimates presented assume that each observation is independent. However, due to surgeon preference in the observational cohort, there may be a potential for clustering which could impact the power of the study. We expect that surgeons within a site may behave more similarly and the variability between sites will be the correlation that will be important. The intraclass correlation (ICC) across multiple studies and therapeutic areas has been shown to likely be small, with a range between 0.01 and 0.05 [31]. Using our planned sample sizes, we can estimate the sample size needed under a range of ICCs using a method described by Klar and Donner [32] with an estimate of the sample size inflation factor (IF) based upon the ICC and the average sample size per cluster. Table 3 provides the power from using the effective sample size and the assumed proportions for each arm (stent vs stent omission using standard power calculations for the two-arm mean difference using a t-test with a two-sided type I error of 0.025 with the assumptions used for Pain Interference described above.\nTable 3Power for pain interference co-primary endpoint in observational cohort with clustering effect (ICC), assuming 14 participating sitesProportion agrees to randomizationTotal approachedFinal observational cohort sample sizeProportion stentedICC group00.010.020.0533%79240470%99.1%96.5%92.3%76.3%50%99.7%98.6%96.1%83.7%25%99.1%94.4%89.0%71.0%50%52820270%84.2%78.6%73.4%59.6%50%90.0%85.8%81.2%68.0%25%86.7%73.5%68.0%54.2%\n For the co-primary endpoint of healthcare utilization in the observation cohort, if we assume that the stented proportion is 50%, with 202 participants per treatment group and a two-sided 2.5% type I error (alpha), we have 90% power to detect a treatment effect, marginal probabilistic index, of 60.1%. If the stented proportion is as low as 25% or as great as 75%, then we can infer that with 90% power, we will be able to detect a treatment effect between 60.1% and 64.3% as the sample size will be at least 101 per stent group.", "id": 1827, "split": "test"} +{"trial_id": "NCT05866237", "pmid": "40107676", "question": "Here is the design of a clinical trial:\n\nOfficial Title: COVER-ME: Covid-19 Vaccination Coverage Among Underserved Populations: Developing and Evaluating Community-based Interventions in East London Minority Ethnicity (ME) Populations; Underserved Migrants and Persons With Low Income.\n\nIncluded conditions:\n- COVID-19\n- Influenza\n- Vaccination Refusal\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Individuals allocated to this group will be receiving care from their GP as well as the patient engagement tool (intervention). This will include messages being sent to patients in regards to vaccine information and uptake at different time points (three times).', 'interventionNames': ['Device: Patient Engagement tool']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The individuals in this group will receive standard care from their GP and nothing additional to this.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Patient Engagement tool', 'description': 'The study intervention (PET) aims to increase uptake of vaccines that are already recommended through national guidance.The PET will help educate and inform individuals about the benefits of COVID-19 and Flu vaccinations through culturally adapted educational support, including content, design, mode and timing of delivery of messages (text, video or voice messages).', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Vaccine uptake through engagement with tool (PET)', 'description': 'To determine the feasibility, acceptability, and implementation of a patient-engagement tool (PET) for increasing uptake of COVID-19 and Flu vaccination.', 'timeFrame': 'Through study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of 5%, a power of approximately 90%, and a small loss to follow-up. A z-test will be used for testing between the two groups.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size\n In each GP practice, with a size of 10\u00e2\u0080\u0089000 patients, we estimate that at least 40% meet the eligibility criteria based on their ethnicity or deprivation quintile. If 90% of these are already vaccinated, then at least 400 patients will be eligible for randomisation at each GP; therefore, a total of 2400 eligible patients from six GP practices will be randomised 1:1. If 10% of these patients would get vaccinated over 6 months without intervention, then our study would have approximately 90% power to show a 40% increase in vaccination rate (from 10% to 14.4%) when testing between the two groups using a z-test at the 5% level. While we expect the loss to follow-up to be small, we will report the number of participants who withdraw from the study after randomisation.\n \n Analysis\n All analysis will be undertaken using the statistical software R (V.4.0 or greater) or STATA (V.17 or greater). We will summarise baseline characteristics, including demographics, socioeconomic variables, comorbidities and vaccination status.\n Characteristics will be presented in groups based on an intention-to-treat (ITT) basis with categorical data as number and percentage and continuous data as mean/SD or median/IQR.\n In the primary analysis, we will present the uptake of COVID-19 and influenza vaccinations in each arm on an ITT basis. We will assess the individual-level randomised component. This analysis will include all patients who are eligible for the intervention and who were randomised to receive one of the two workflows on an individual basis (standard of care or the PET). All patients from the first group of GPs (n=3) in both study periods and only patients from the second group (n=3) who are eligible in the second period (ie, any eligible patient from the first period in the second group of GPs who was vaccinated in the first period would not be part of the analysis sample) will be included. The uptake (from the time of randomisation) will be estimated overall. An uptake of 95% CIs will be obtained based on binomial assumption, as well as from a mixed-effects model that allows for hierarchical (random effects) variation by GP and booster groups. Logistic regression with the adjustment described below will be used to estimate the marginal OR of the PET compared with the standard of care, and a profile-likelihood ratio CI for the OR will be reported. Adjustment of prior COVID-19 and influenza vaccination status, GP practice, age and sex will be used for the logistic regression model.\n Secondary endpoints will be reported as point estimates with 95% CIs as appropriate. Summary statistics for each outcome by arm will be presented on an ITT basis. Categorical data will be shown with numbers and percentages. Continuous data will be shown as median and IQR or mean and SD if following approximal normal distribution.\n Analysis of the primary and secondary endpoints and potential heterogeneity in uptake by prespecified subgroups will be undertaken. This includes GP practice, deprivation, age group, sex and ethnicity.\n We will explore the cluster-randomised component of this study. This analysis of uptake will take clustering in the design into account by using generalised linear models with normal random intercepts, and the model will also be used to obtain an estimate of the intraclass correlation coefficient. CIs will be based on methods that are most suitable when the number of clusters is not large. We will also explore whether a per-protocol analysis would be possible by determining the feasibility of defining compliance/contamination from individual randomised allocation using process data.", "id": 1828, "split": "test"} +{"trial_id": "NCT05867836", "pmid": "38685109", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Trial of Adherence and Acceptance of Multiple Micronutrient Supplementation (MMS) vs Iron and Folic Acid (IFA) Among Pregnant Women and Health System Enablers and Constraints Related to MMS in Cambodia\n\nIncluded conditions:\n- Pregnancy Related\n- Antenatal Care\n- Iron Folic Acid Supplementation\n\nStudy Armgroups:\n- {'label': 'IFA-90', 'type': 'ACTIVE_COMPARATOR', 'description': 'Iron and folic acid (IFA) for 90 days', 'interventionNames': ['Dietary Supplement: IFA vs. MMS during pregnancy']}\n- {'label': 'MMS-90', 'type': 'EXPERIMENTAL', 'description': 'Multiple micronutrient supplementation (MMS) for 90 days with 2 distributions of MMS supplements (2 x 90 pill bottles; distributed at different ANC visits)', 'interventionNames': ['Dietary Supplement: IFA vs. MMS during pregnancy']}\n- {'label': 'MMS-180', 'type': 'EXPERIMENTAL', 'description': 'Multiple micronutrient supplementation (MMS) for 180 days but with 1 distribution of MMS supplements (1 x 180 pill bottle)', 'interventionNames': ['Dietary Supplement: IFA vs. MMS during pregnancy']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'IFA vs. MMS during pregnancy', 'description': 'Iron and folic acid, or multiple micronutrient supplements provided during pregnancy', 'armGroupLabels': ['IFA-90', 'MMS-180', 'MMS-90']}\n\nPrimary Outcomes:\n- {'measure': 'Adherence (counts)', 'description': 'Adherence as per pill count at the final visit', 'timeFrame': '90 days for the IFA-90 group and 180 days for the MMS-180 group'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation considers a 2-sided test, 90% power, an alpha of .025 for a one-sided confidence interval, a design effect of 2, and a 10% loss to follow-up.", "answer": 1545, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n A sample of 1545 pregnant women is required for the statistical power determination for the adherence non-inferiority tests. Sample size estimations were calculated\u00c2\u00a0using adherence as both a binary and a continuous outcome. The more conservative sample size calculation for adherence as a binary outcome\u00c2\u00a0was chosen to ensure we were powered for both outcomes. The sample size was determined using a design effect of 2, twice as large as would be\u00c2\u00a0expected with simple random sampling. This\u00c2\u00a0accounts for the clustering within health centers (across 48 clusters) and the testing of three different arms. As the study arms are all within the same province and within three similar operational districts, large differences within clusters are not expected. Therefore, a design effect of 2 was deemede appropriate.\n In addition, the sample size was calculated considering a 2-sided test, 90% power, an alpha of .025 for a one-sided confidence interval (CI), and a non-inferiority parameter of 15%. This sample size will allow for the detection of a significant difference in intake between the arms equal to 2% prevalence difference between arms (76% vs 74%) and a non-inferiority limit was determined \u00e2\u0080\u0098a priori\u00e2\u0080\u0099 as 15%. To compensate for a potential 10% loss to follow-up, a total of 515 women per arm will be recruited. Thus, the total sample size of pregnant women enrolled in the\u00c2\u00a0non-inferiority trial is 1545.", "id": 1829, "split": "test"} +{"trial_id": "NCT05867875", "pmid": "39283873", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of the Non-invasive Oxygen-reserve-index (ORI) Versus Standard of Care on Peripheral Oxygen Saturation (SpO2) During Endotracheal Intubation (ETI) in Intensive Care Unit: Randomised Superiority Multi-center 2 Arms, Open Trial\n\nIncluded conditions:\n- Intensive Care Unit\n\nStudy Armgroups:\n- {'label': 'Experimental group (ORI)', 'type': 'EXPERIMENTAL', 'description': 'ORI and SpO2 monitoring values during preoxygenation of patients will be provided to investigator to determine anaesthesia induction initiation. Anesthesic induction is provided after 30 secondes at ORI \\\\> 0.6 and at least 2 min 30 of preoxygenation (so globaly 3 minutes of preoxygenation)', 'interventionNames': ['Other: Unblinded ORI values']}\n- {'label': 'Standard of care (SoC) group', 'type': 'OTHER', 'description': 'Only SpO2 values during preoxygenation of patients will be provided to investigator to determine anaesthesia induction initiation. Anesthesic induction is provided at least 3 min of preoxygenation', 'interventionNames': ['Other: Blinded ORI values']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Unblinded ORI values', 'description': 'ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator', 'armGroupLabels': ['Experimental group (ORI)']}\n- {'type': 'OTHER', 'name': 'Blinded ORI values', 'description': 'ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator', 'armGroupLabels': ['Standard of care (SoC) group']}\n\nPrimary Outcomes:\n- {'measure': 'Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI', 'description': 'Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Experimental and Control groups', 'timeFrame': 'From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI'}\n\nPlease estimate the sample size based on the assumption: \nstandard deviation of 10% for the lowest SpO2 value in the control group, no missing data, 5% crossover of patients, bilateral alpha risk set at 0.05, 85% power", "answer": 950, "answer_type": "ESTIMATED", "explanation": "Sample size\n Assuming a standard deviation of 10% for the lowest SpO2 value in the control group [1], no missing data, and crossover of 5% of patients, with the bilateral alpha risk set at 0.05, the inclusion of 950 patients provides 85% power for detecting a 2% absolute between-group difference in the lowest SpO2 value.\n The recruitment rate predicted based on data from each participating center was 5 patients per month. The observed recruitment rate from trial initiation on August 1, 2023, to January 11, 2024, is consistent with this prediction.", "id": 1830, "split": "test"} +{"trial_id": "NCT05868005", "pmid": "39496367", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations\n\nIncluded conditions:\n- Hiv\n- Hepatitis B\n- Hepatitis C\n- Tuberculosis\n- Chagas Disease\n- Schistosomiasis\n- Strongyloidiasis\n- Female Genital Mutilation Type I Status\n- Female Genital Mutilation Type II Status\n- Female Genital Mutilation Type III Status\n\nStudy Armgroups:\n- {'label': 'Primary care centres with the ISMiHealth software tool.', 'type': 'EXPERIMENTAL', 'description': 'Primary care centres implementing the screening programme through the ISMiHealth software (tool-based arm).', 'interventionNames': ['Other: Clinical decision support system for screening of migrants using the ISMiHealth software tool.']}\n- {'label': 'Primary care centres that follow current routine care.', 'type': 'NO_INTERVENTION', 'description': 'Primary care centres that follow the current practices in routine care (non tool-based arm).'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Clinical decision support system for screening of migrants using the ISMiHealth software tool.', 'description': \"The implementation of the screening programme will be facilitated using a simple and user-friendly software tool (ISMiHealth).\\n\\nWhen an individual attends the PCC for any reason, the tool will generate an alert for health professionals in the EPR system, with recommendations on the conditions that should be considered for screening, based on this patient's characteristics (country of birth, age and sex). Health professionals will decide what diseases/conditions should be screened for, supported by the recommendations of the digital software (intervention centres) or based on their knowledge on the epidemiological background of the diseases (control centres). In any case, health professionals will be responsible for requesting serology tests, chest radiographies and/or referrals to specialists.\", 'armGroupLabels': ['Primary care centres with the ISMiHealth software tool.'], 'otherNames': ['Former intervention: Screening migrant patients using a computer tool adapted to clinical histories in primary care (CRIBMI).', 'Former acronym of current study: INNoMiGs']}\n\nPrimary Outcomes:\n- {'measure': 'Comparison of the detection rate per month of all aggregated infections (HIV, HBV, HCV, TB, T.cruzi, S.stercoralis and Schistosoma spp. infections) between the intervention and control centres', 'description': 'In the Andalusian site, syphilis, latent TB and intestinal parasites will also be included. The monthly detection rate will be based on positive serologies, chest radiographies, the ICD-9 (for Andalusia) or ICD-10 (for Catalonia) of FGM and/or gynaecologist referrals, within the migrant patients who visited their assigned centre during the intervention period. Also, positive tuberculin skin test (TST) and/or Interferon Gamma Release Assay (IGRA) and stool samples will be considered for the Andalusian site. Control and intervention PCCs will be compared before and after the implementation.', 'timeFrame': 'Over at least 5 years until the end of the intervention (1 year).'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence interval, p-value < 0.001, and a difference-in-difference detection rate of two.", "answer": 980, "answer_type": "ESTIMATED", "explanation": "Sample size\n Preliminary data from the pilot cluster randomised trial showed that there was a 2.1 (95% CI 1.6\u00e2\u0080\u00932.6, p-value<0.001) increase of the diagnostic yield in intervention centres (tool-based arm) in comparison with control centres (non-tool based arm),.18 Therefore, to achieve a difference-in-difference detection rate of all aggregated infections of two (with 95% precision) between the intervention and control centres, it was estimated that at least 32 centres should be included in the study. The sample size was estimated using PASS V.16 (NCSS, Kaysville, Utah, USA).\n There will be 35 PCCs of which 18 PCCs will be intervention centres and 17 control ones, with one unmatched centre. Approximately 980 health professionals that work in these centres will participate in the study.\n The technical pilot test will be conducted from October to December 2023, and the intervention will start in January 2024.", "id": 1831, "split": "test"} +{"trial_id": "NCT05870566", "pmid": "38448965", "question": "Here is the design of a clinical trial:\n\nOfficial Title: UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]\n\nIncluded conditions:\n- Corneal Transplantation\n\nStudy Armgroups:\n- {'label': 'Corneal Crosslinking (CXL)', 'type': 'EXPERIMENTAL', 'description': 'In the intervention group, the study intervention (CXL) will be administered to stabilize therecipient cornea (which remains in place after penetrating keratoplasty) and to reduce CoNV 8 to 10 weeks prior to corneal transplantation. The study intervention will be repeated once (after 4 weeks prior to transplantation at the latest at the earliest) if insufficient (less than 50%) reduction of CoNV should be observed (to be decided by the respective surgeon). (Protocol V04_0 Page 45) Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (6.5 to 8.25 in diameter) will be secured with 16-24 interrupted single or 2 double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV in the intervention group, visible vessels will may be thermally occluded by fine needle diathermy to avoid intraoperative bleeding and reduce complications (to be decided by the respective surgeon at start of surgery). (Protocol V04_0 Page 46)', 'interventionNames': ['Device: Corneal Crosslinking']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'In the control group subjects will be directly scheduled for corneal transplantation without previous CXL. A sham CXL procedure will not be performed. Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (6.5 to 8.25 in diameter) will be secured with 16-24 interrupted single or 2 double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV in the intervention group, visible vessels will may be thermally occluded by fine needle diathermy to avoid intraoperative bleeding and reduce complications (to be decided by the respective surgeon at start of surgery). In the control group, no fine needle diathermy will be performed, as this procedure combined with corneal transplantation in previously non-crosslinked eyes might lead to fistulas and thereby to potential intraocular infections. (Protocol V04_0 Page 46)'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Corneal Crosslinking', 'description': 'Riboflavin isotonic, 0,1 % Vitamin B2, with Dextran 20,0%, for epi-off procedure or Riboflavin isotonic 0,1% (Vitamin B2), 1,1% HPMC without Dextran for epi-off) 0.1% riboflavin-5-phosphate and 20% dextran T-500) will be applied to the cornea after epithelial debridement every 2 min for 10 minutes before irradiation and every 2 minutes during the course of a 10 minute exposure to 365 nm UV-A with an irradiance rate of 9 mW/cm2. This dose, mode and scheme of the intervention follows the internationally recognized \"accelerated CXL protocol\" (Elbaz et al. 2014). The data existing shows equivalent outcome regarding efficacy and safety compared to the standard protocol. To avoid any damage to the limbal stem cells, the limbus will not be irradiated during the procedure, as a CXL device (with maximal diameter of 11 mm) will be used. Furthermore, the limbal area will additionally be protected by a custom-cut LSC protection shield. (Protocol V04_0 Page 45-46)', 'armGroupLabels': ['Corneal Crosslinking (CXL)']}\n\nPrimary Outcomes:\n- {'measure': 'First episode of endothelial graft rejection', 'description': 'Endothelial graft rejection episode is defined by at least 2 of the following criteria: new endothelial precipitates, new anterior chamber cells/flare, new focal or diffuse edema of the graft. All signs will be analyzed by slit lamp examination, on standardized digital slit lamp pictures, by LaserFlareCellMeter (if available), SL-OCT and corneal tomography. (Protocol V04_0 Page 48)', 'timeFrame': 'within 24 months after transplantation'}\n\nPlease estimate the sample size based on the assumption: \nThe study was powered with 80% power at a significance level of 0.05, assuming exponential survival curves, 22 months of accrual, a follow-up period of at least 24 months, an allocation rate of 5:4, and a 20% loss-to-follow-up at 2 years.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation is based on the primary endpoint, time from surgery to the first graft rejection episode, comparing the intervention and control groups using the log-rank test. The expected rejection rate in the control group was estimated using rates given in previously published studies [6, 21]. An overall 2-year rejection rate of 50% was assumed for the control group. The study was powered to detect a reduction in the 2-year rejection rate from 50 to 25% (hazard ratio 0.42) with 80% power at a significance level of 0.05 (assuming exponential survival curves and accrual of 22 months, with a subsequent follow-up period of at least 24 months). An allocation rate of 5:4 and continuous loss-to-follow-up cumulating to 20% at 2 years was accounted for, yielding a total sample size of 110 (intervention group: n = 61, control group: n = 49). Calculations were performed using SAS 9.4 (Proc Power).", "id": 1832, "split": "test"} +{"trial_id": "NCT05871502", "pmid": "39117402", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy\n\nIncluded conditions:\n- Cerebral Infarction\n\nStudy Armgroups:\n- {'label': 'Subcutaneous blood glucose monitoring device', 'type': 'EXPERIMENTAL', 'description': 'After signing the informed consent and before the start of the endovascular procedure, a subcutaneous blood glucose monitoring device will be implanted, which will be removed on day 15 (or at hospital discharge if this takes place before 15 days).', 'interventionNames': ['Device: Subcutaneous blood glucose monitoring device']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Subcutaneous blood glucose monitoring device', 'description': 'After signing the informed consent and before the start of the endovascular procedure, a subcutaneous blood glucose monitoring device will be implanted, which will be removed on day 15 (or at hospital discharge if this takes place before 15 days). This device will be selected from those currently available on the market, with CE marking, and with previous studies documenting its safety and feasibility for radiological procedures.', 'armGroupLabels': ['Subcutaneous blood glucose monitoring device']}\n\nPrimary Outcomes:\n- {'measure': 'Blood glucose levels at the time of reperfusion', 'description': 'Blood glucose levels at the time of reperfusion in patients achieving TICI-2b, TICI-2c or TICI3 recanalization pattern after mechanical thrombectomy.', 'timeFrame': 'During reperfusion procedure'}\n- {'measure': 'Modified Rankin scale at 3 months', 'description': 'Its dichotomized assessment (Modified Rankin Scale or mRS 0-2 indicating good functional recovery and 3-6 indicating death or dependence) is commonly used in acute stroke studies.', 'timeFrame': 'From baseline to month 3'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.20, and a 15% loss to sensor failure or loss to follow-up.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n There have been no previous studies using CGM devices to assess the dynamics of glucose levels in patients treated with MT, which would allow a formal calculation of the sample size. Furthermore, the proportion of patients in whom technical failures may impede the recording of glycaemia at the time of reperfusion remains unknown. Using previous studies,29 30 if we consider a 15% loss to sensor failure or loss to follow-up, we can calculate, with an alpha risk of 0.05, a beta risk of 0.20 and an estimated difference in death-dependence of 30%, that it is recommended a sample size of 50 patients per group be used, taking into account that the death-dependence ratio in the control group might be 0.66 (according to GLIAS-II data). However, given that the actual percentage of possible technical failures of the sensor is unknown, we propose to perform an intermediate analysis and recalculate the sample size after the inclusion of 50 patients. The inclusion of 100 patients over a 2-year recruitment period is considered feasible, given that the number of MT procedures in our centre exceeds 100 per year. This sample size will allow us to investigate the differences in glycaemic levels at the time of reperfusion between patients with good or poor functional recovery at 3 months. After enrolling 100 patients, further power calculations will be performed to estimate the sample size for future studies. Recruitment began on 30 August 2023 and is ongoing.", "id": 1833, "split": "test"} +{"trial_id": "NCT05874258", "pmid": "39039582", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving Vision and Quality of Life in Patients With Glaucoma Using Non-invasive Brain Stimulation and Perceptual Learning: A Randomized Clinical Trial\n\nIncluded conditions:\n- Glaucoma\n\nStudy Armgroups:\n- {'label': 'Real-PL + Real-tES (tDCS)', 'type': 'EXPERIMENTAL', 'description': 'Participant will receive 30 training sessions with real PL and real tES (tDCS): 3-4 sessions per week, about 1 hour per session', 'interventionNames': ['Other: Real-PL training + Real-tES(tDCS)']}\n- {'label': 'Real-PL + Sham-tES (tDCS)', 'type': 'EXPERIMENTAL', 'description': 'Participant will receive 30 training sessions with real PL and sham tES (tDCS): 3-4 sessions per week, about 1 hour per session', 'interventionNames': ['Other: Real-PL training + Sham-tES (tDCS)']}\n- {'label': 'Placebo-PL + Sham-tES (tDCS)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participant will receive 30 training sessions with placebo PL and sham tES (tDCS): 3-4 sessions per week , about 1 hour per session', 'interventionNames': ['Other: Placebo-PL training + Sham-tES (tDCS)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Real-PL training + Real-tES(tDCS)', 'description': 'PLtraining : around 40mins, tDCS: 20mins', 'armGroupLabels': ['Real-PL + Real-tES (tDCS)']}\n- {'type': 'OTHER', 'name': 'Real-PL training + Sham-tES (tDCS)', 'description': 'PL training : around 40mins, tDCS: 20mins', 'armGroupLabels': ['Real-PL + Sham-tES (tDCS)']}\n- {'type': 'OTHER', 'name': 'Placebo-PL training + Sham-tES (tDCS)', 'description': 'PL training : around 40mins, tDCS: 20mins', 'armGroupLabels': ['Placebo-PL + Sham-tES (tDCS)']}\n\nPrimary Outcomes:\n- {'measure': 'Visual field test', 'description': 'Visual field test is measured monocularly using the 24-2 Swedish interactive threshold algorithm (SITA) standard tests by Humphrey Visual Field Analyzer (HFA, Carl Zeiss Meditec Inc., California). The mean deviation (MD), pattern standard deviation (PSD), and visual field index (VFI) are recorded and the MD of 24-2 visual field test is used as primary outcome of intervention effectiveness.', 'timeFrame': 'Change from baseline at 5weeks, change from baseline at 10weeks, change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 2-tailed 0.05 alpha level, 20% dropout rate", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation for linear multiple regression with three groups and six time points was performed using G*Power (version 3.1). According to the HRP results from phase 1 study [37] in the GREAT project (Cohen\u00e2\u0080\u0099s f2\u00e2\u0080\u0089=\u00e2\u0080\u00890.1), a sample of 144 glaucoma patients will be needed to provide 80% power to detect a significant difference in visual field among three groups at the 2-tailed 0.05 alpha level, assuming a 20% dropout rate.", "id": 1834, "split": "test"} +{"trial_id": "NCT05874856", "pmid": "38925684", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders\n\nIncluded conditions:\n- Depression\n- Burnout\n- Stress Related Disorder\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Heart rate variability, blood pressure and pulse wave velocity', 'description': 'Resting HRV in supine and standing position, blood pressure and pulse wave velocity in supine position at first and last week of inpatient treatment'}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Assessment of cognitive function, balance, strength and cardiorespiratory fitness', 'description': 'THINC-it test for cognitive function; One-leg Standing test for balance assessment; 10-time chair rise test and hand grip test for strength assessment; \u00c5strand-Ryhming Test for cardiorespiratory fitness.\\n\\nAll assessments will be performed at first and last week of inpatient treatment.'}\n- {'type': 'BEHAVIORAL', 'name': 'Monitoring of physical activity and sleep', 'description': 'GENEActiv accelerometer will be worn on the wrist daily during 8-week inpatient treatment.'}\n- {'type': 'BEHAVIORAL', 'name': 'Monitoring of self-rated exhaustion, mood and tension', 'description': 'Using the customized PsyMate app.'}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Orthostatic Test Heart Rate Variability (HRV) at 8 weeks.', 'description': 'Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.', 'timeFrame': 'Orthostatic Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.'}\n- {'measure': 'Change from Baseline 24-hour Heart Rate Variability (HRV) at 8 weeks.', 'description': 'Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.', 'timeFrame': '24-hour HRV will be measured in the first and last week of up to 8-week inpatient treatment.'}\n- {'measure': 'Change from Baseline Exercise Test Heart Rate Variability (HRV) at 8 weeks.', 'description': 'Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.', 'timeFrame': 'Exercise Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.'}\n\nPlease estimate the sample size based on the assumption: \nPower 80%, two-sided \u03b1=0.05, paired t-test, dropout rate expected to be 13%.", "answer": 153, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on relevant literature on inpatients with stress-related disorders and HRV,18 24 25 correlation between RMSSD and BDI-II score at baseline (T1) was estimated with r=\u00e2\u0088\u00920.25 (power 80%, two-sided \u00ce\u00b1=0.05). Simulations showed a need for 123 participants at T1 for cross-sectional analysis between RMSSD and BDI-II. Due to various HRV measurement procedures,23 117\u00e2\u0080\u0093119 literature does not provide suitable estimates for within subject differences in RMSSD at T1 and T2. However, HRV data from former patients at the Clinica Holistica Engiadina were used for estimation of within subject differences. Simulations showed a need for 135 participants for within subject differences in RMSSD at T1 and T2 (power 80%, two-sided \u00ce\u00b1=0.05, paired t-test, correlation between groups=0.4). Based on reported dropout rates,22 24 26 dropout rate was expected to be 13%. In conclusion, a total sample size of 153 participants will be planned for HARMODI.", "id": 1835, "split": "test"} +{"trial_id": "NCT05875064", "pmid": "39915031", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial\n\nIncluded conditions:\n- Dental Caries in Children\n\nStudy Armgroups:\n- {'label': 'conventional restoration group (control)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The teeth allocated in the conventional restoration group (control) will receive restorations in resin composed by incremental technique, using opaque resin. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire dental surface, photoactivation of the adhesive and restoration by incremental technique and photoactivation of each layer of resin for 20 seconds. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).', 'interventionNames': ['Procedure: Restoration with conventional resin composite']}\n- {'label': 'polyvinyl crown - experimental group', 'type': 'EXPERIMENTAL', 'description': 'The teeth allocated in the experimental group will have the restorations carried out through monochromatic composite resin with chameleon effect in single insertion through polyvinyl crown. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire tooth surface, photoactivation of the adhesive and adaptation of the crown matrix in acetate filled with resin in the tooth. Photoactivation will be done for 20 seconds per dental face, and the acetate matrix is then removed. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).', 'interventionNames': ['Combination Product: Restoration with resin composite and polyvinyl crown']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Restoration with resin composite and polyvinyl crown', 'description': 'Restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared to the effectiveness of conventional restoration.', 'armGroupLabels': ['polyvinyl crown - experimental group']}\n- {'type': 'PROCEDURE', 'name': 'Restoration with conventional resin composite', 'description': 'Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue', 'armGroupLabels': ['conventional restoration group (control)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in progression of caries lesion through clinical criteria and longevity of restorations', 'description': 'The integrity of the restoration, its adaptation in all dental faces and identified possible failures related to structural fracture, resin wear, maladaptation or functional maintenance of the restored tooth will be verified.\\n\\nThe clinical evaluation of the retention of the restorations will be performed after 6, 12, 18 and 24 months, using the criteria: total retention; Partial retention 1 - presence of the resin in two thirds of the surface of each dental face; Partial retention 2 - presence of the resin in one third d and each face of the dental surface, total loss of resin on the surface of the dental surface.\\n\\nIt will also be evaluated the degree of tooth mobility and its relationship with the usual exfoliation period in the teeth belonging to both groups. In teeth where the restoration is intact and clinical features of associated lesions are not verified, the lesions will be considered as inactive.', 'timeFrame': 'Baseline and after 6, 12, 18 and 24 months.'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test, significance level of 0.05, power of 0.80, 20% cluster per child, and 20% possible sample loss.", "answer": 194, "answer_type": "ESTIMATED", "explanation": "Sample size\n To perform the sample size calculation with independent samples, it was considered that the retention of previous restorations of primary teeth is 80%5 and that a clinically relevant difference of 10% (based on previous studies evaluating restorative longevity and caries progression in primary teeth5 13) and a non-inferiority limit of 5% are expected. Thus, considering a two-tailed test and adopting a significance level of 0.05 and a power of 0.80, we reached the number of 69 teeth per group. Since each child can contribute more than one tooth, we added 20% (cluster per child) and another 20% for a possible sample loss. Thus, a final required number of 97 teeth per experimental group was obtained, totaling 194 teeth for the study (https://www.sealedenvelope.com/power/binary-noninferior/).", "id": 1836, "split": "test"} +{"trial_id": "NCT05875792", "pmid": "38719328", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EvolvRehab - MoveWell Virtual Platform for Stroke Survivors Rapid Rehabilitation Through Fun Exergaming-based Learning\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'people who have recently had a stroke and need upper limb rehabilitation', 'interventionNames': ['Device: EvolvRehab - MoveWell']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'EvolvRehab - MoveWell', 'description': 'The Intervention has been developed and has a CE mark and has medical device level 1 approvals in the UK. It will be developed with patients in Phase 1 and will consist of initial staff training \\\\[training package\\\\]. Exercise prescription will be encouraged, in line with usual care, for the either one week (stage 1, phase 2) or six weeks (stage 2, phase 2). Individuals will be able to continue using the EvolvRehab - MoveWell system beyond 6 weeks from stage 2, phase 2, and technical support will continue until the end of the study completion, participants will not be limited in the additional activity that can be performed during this time, and encouraged to do as much as they wish, except if needed for clinical reasons. The intervention will be supported by the clinical team in keeping with routine care. The research therapist will attend clinical visits and support as required. The number of visits will be recorded, and will hopefully reduce to zero over the study.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Fugl Meyer Assessment', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total:\\n\\nMovements are scored between 0 (none), 1 (partial) or 2 (full/ can be elicited) for reflex activity, volitional movement within synergies, volitional movement mixing synergies, volitional movement with little or no synergy, for upper body including wrist and hand.\\n\\nNormal reflex activity is scored 0 (hyper), 1 (lively) or 2 (normal).\\n\\nCo-ordination is scored 0 (marked), 1 (slight) or 2 (none).\\n\\nSensation is scored 0 (anesthesia), 1 (hypoesthesia or dysesthesia), 2 (normal)\\n\\nJoint motion is scored 0 (only few degrees), 1 (decreased), 2 (normal)\\n\\nJoint pain is scored 0 (pronounced pain), 1 (some pain), 2 (no pain)', 'timeFrame': '6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nApproximately 50% of eligible participants recruited, with consideration for participant drop-out.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size stage 2.2\n The choice of this sample size for the main trial (n=70, 50 with complete data) reflects a balance between a large enough sample to represent population diversity and provide estimates of variability, while ensuring that recruitment is achievable (participant drop-out and approximately 50% of eligible participants recruited). Statistician (Gordon Taylor) is a member of the study team and has advised on sample size. 20\u00e2\u0080\u009330 people is generally sufficient to estimate SD of outcome measures that can then be used to estimate the sample size for a definitive clinical trial based on known estimates of minimal clinically important differences.", "id": 1837, "split": "test"} +{"trial_id": "NCT05880160", "pmid": "39909533", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction\n\nIncluded conditions:\n- Cardiotoxicity\n- HER2-positive Breast Cancer\n- Heart Failure\n- Cancer, Therapy-Related\n\nStudy Armgroups:\n- {'label': 'Treatment Withdrawal', 'type': 'EXPERIMENTAL', 'description': \"Participants will undergo phased withdrawal of heart failure/ cardioprotective treatments according to a pre-specified algorithm based on the 'Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy' (TRED-HF) study protocol (Halliday et al 2019). Medications will be down titrated in a phased process every 2 weeks over 16 weeks maximum. Drug doses will be reduced by 50% every 2 weeks, until the patient is taking 25% or less of the maximum recommended dose at which point they will be stopped. Monitoring with fortnightly virtual consultations will confirm dose reduction and provide support. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken.\", 'interventionNames': ['Other: Phased withdrawal of heart failure medications']}\n- {'label': 'Treatment Continuation', 'type': 'NO_INTERVENTION', 'description': 'Participants will continue their current heart failure/ cardioprotective treatments. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Phased withdrawal of heart failure medications', 'description': 'As per arm/group description', 'armGroupLabels': ['Treatment Withdrawal']}\n\nPrimary Outcomes:\n- {'measure': 'Relapse in Cardiotoxicity', 'description': 'Number of participants with relapse in cardiotoxicity, defined based on International Cardio-Oncology Society 2021 Guidelines as (at least one of):\\n\\n1. Asymptomatic left ventricular ejection fraction (LVEF) reduction by \u226510 percentage points to a LVEF of \\\\<50%\\n2. Asymptomatic LVEF reduction by \u22655 percentage points to an LVEF of \\\\<50% plus new relative decline in global longitudinal strain (GLS) by \\\\>15% from baseline AND/OR new rise in cardiac biomarkers (\\\\>2 fold increase in N-terminal pro B-type natriuretic peptide \\\\[NTproBNP\\\\] to \\\\>400ng/L, or high sensitivity Troponin \\\\>99th percentile)\\n3. Clinical heart failure (based on symptoms and clinical examination) with at least one of the following: fall in LVEF \u22655%, increase in cardiac biomarkers (as above), relative fall in GLS \\\\> 15%, new arrhythmia (excluding ectopy)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nNon-inferiority design with \u03b1=0.05 (one-sided) and 80% power, assuming a 10% dropout rate.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n TRED-HF22 recruited 51 participants with 25 randomised to treatment withdrawal, 26 to treatment continuation. \u00e2\u0080\u0098Relapse\u00e2\u0080\u0099 outcome events occurred in 11/25 withdrawal patients within 6 months, with 0/25 outcomes in the continuation participants. Our retrospective pilot data (using local cardio-oncology service records) demonstrated 0/35 and 0/12 \u00e2\u0080\u0098relapse\u00e2\u0080\u0099 outcomes in study eligible patients who continued HFT compared with those who withdrew respectively (median 6 months of follow-up, IQR 6\u00e2\u0080\u009310). Following discussion with patients from our pilot dataset, a 10% relapse rate following HFT withdrawal was considered acceptable, provided participants are under close surveillance. Using a binary outcome (\u00e2\u0080\u0098relapse\u00e2\u0080\u0099 vs \u00e2\u0080\u0098no relapse\u00e2\u0080\u0099) non-inferiority design with \u00ce\u00b1=0.05 (one sided) and 80% power, 74 participants (37 per study arm) are required to exclude a difference in favour of the controlled group of more than 10\u00e2\u0080\u0089percentage points. Assuming a 10% dropout rate, a sample size of n=90 is therefore considered sufficient.", "id": 1838, "split": "test"} +{"trial_id": "NCT05880368", "pmid": "38684080", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Partnership in Resilience for Medication Safety\n\nIncluded conditions:\n- Patient Engagement\n- Patient Empowerment\n- Patient Activation\n\nStudy Armgroups:\n- {'label': 'Patient partnership tool', 'type': 'EXPERIMENTAL', 'description': 'Study participants as patients visiting primary care providers in the clinics using the study patient engagement tools aimed to reduce preventable adverse drug events.', 'interventionNames': ['Other: Patient partnership tools']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Study participants as patients visiting primary care providers in the clinics without the study patient engagement tools.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Patient partnership tools', 'description': \"The intervention consists of two patient partnership tools: (1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the primary care provider, with the intention to improve communication and shared decision-making; and (2) a series of short educational videos that clinic staff can encourage patients to watch. The interventions will be included in the workflow of the clinics during the intervention periods (i.e., clinics either do not use the intervention or use them for all relevant patients depending on study period).\", 'armGroupLabels': ['Patient partnership tool']}\n\nPrimary Outcomes:\n- {'measure': 'Medication use and self-efficacy', 'description': \"Medication use and self-efficacy, which is a validated 8-item, 4-point Likert scale survey with a score range of 8-32 and higher indicating higher self-efficacy. The items are: (1) It is easy for me to take my medicine on time, (2) It is easy to remember to take all my medicines, (3) It is easy for me to set a schedule to take my medicines each day, (4) It is easy for me to take my medicines each day, (5) It is easy for me to ask my pharmacist questions about my medicine, (6) It is easy for me to understand my pharmacist's instructions for my medicine, (7) It is easy for me to understand instructions on medicine bottles, (8) It is easy for me to get all the information I need about my medicine.\", 'timeFrame': 'Within 4 hours after primary care visit (one time assessment)'}\n\nPlease estimate the sample size based on the assumption: \nThe trial uses a 2-tailed significance level of 0.05, power set at 80%, an intracluster correction of 0.07, and a cluster autocorrelation of 0.9.", "answer": 405, "answer_type": "ACTUAL", "explanation": "Sample Size\n The study is a superiority trial, on the hypothesis that interventions will improve patients\u00e2\u0080\u0099 self-efficacy in medication use. We powered the trial to detect a difference of 3.8 units on the MUSE scale from pre to postintervention, with a pooled SD of 4.7 (standardized effect size of 0.79) based on a validation study on MUSE [36] using a 2-tailed significance level of 0.05. Power analysis was computed using the R package (version 4.1.0; University of Washington) swCRTdesign [44] via a web-based tool [45]. The transition period was excluded from the sample size calculations. We used 0.07 for intracluster correction and 0.9 for cluster autocorrelation based on study design recommendations [46,47]. With power set at 80%, the requisite numbers of visits to collect data for each period are in Table 2, with a total sample size of 405.\n \n Table 2\n \n Sample size calculation. Sample size is the number of visits, not the number of patients, using a cross-sectional design.\n \n \n \n \n \n \n \n \n \n \n \n \n\n\n Period 1\n Period 2\n Period 3\n Period 4\n Period 5\n Period 6\n \n \n \n \n Clinic A\n 15\n N/Aa\n 35\n 20\n 15\n 15\n \n \n Clinic B\n 30\n 50\n N/A\n 45\n 30\n 30\n \n \n Clinic C\n 20\n 20\n 20\n 20\n 20\n 20\n \n \n \n \n \n aN/A: not applicable (transition period with no data collection efforts).", "id": 1839, "split": "test"} +{"trial_id": "NCT05882188", "pmid": "39581724", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Is, in Infertile Women Undergoing a Basic Fertility Work-up, Tubal Flushing With Oil-based Contrast Medium During Hysterosalpingography (HSG) Cost-effective Compared to Tubal Flushing by Hysterosalpingo-foam Sonography (HyFoSy)?\n\nIncluded conditions:\n- Infertility\n\nStudy Armgroups:\n- {'label': 'Tubal flushing during HSG with oil-based contrast', 'type': 'EXPERIMENTAL', 'description': 'Tubal flushing during HSG HSG will be performed by a gynaecologist, fertility doctor or nurse according to local protocols. HSG will be performed in the follicular phase of the cycle. Preferably, HSG is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. After cleaning the vagina and cervix, a vacuum cervix adapter will be applied to the cervix or a Lipiodol resistant balloon catheter or hysterophore will be placed through the cervix. Up to 15ml of Lipiodol Ultra Fluid will be injected into the uterine cavity and its spread directly monitored by fluoroscopy. Six to eight radiographs will be taken and assessed by a gynaecologist or radiologist. The maximum amount of oil-based contrast medium is set at 15ml.', 'interventionNames': ['Procedure: Oil-based contrast']}\n- {'label': 'Tubal flushing HyFoSy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tubal flushing during HyFoSy will be performed by a gynaecologist, fertility doctor, sonographer or nurse according to local protocols. HyFoSy will be performed in the follicular phase of the cycle. Preferably, HyFosy is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. During HyFoSy approximately 5-10cc of foam will be introduced through a little cervical balloon-less applicator into the uterine cavity. During infusion of the foam into the uterine cavity, a transvaginal ultrasound will be performed which shows whether the Fallopian tubes are patent. The assessment of the procedure will be done by the one who performed the procedure.', 'interventionNames': ['Procedure: ExEm Foam']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Oil-based contrast', 'description': 'oil-based contrast fluid, Lipiodol Ultra Fluid. Lipiodol is a solution of iodinated ethyl esters of fatty acids of poppyseed oil. Equivalent to 480 mg iodine per ml. The maximum dosage is 15ml. Lipiodol is produced by Guerbet, France. Lipiodol is FDA approved and registered as contrast agent for HSG.', 'armGroupLabels': ['Tubal flushing during HSG with oil-based contrast']}\n- {'type': 'PROCEDURE', 'name': 'ExEm Foam', 'description': 'ExEm Foam which is created by mixing 5ml ExEm-gel and 5ml of purified water. ExEm-gel contains hydroxyethylcellulose and glycerol. The ExEm Foam is distributed by IQ Medical Ventures, the Netherlands. ExEm Foam is FDA approved, CE marked and registered as contrast agent for HyFoSy.', 'armGroupLabels': ['Tubal flushing HyFoSy']}\n\nPrimary Outcomes:\n- {'measure': 'Number of pregnancies leading to live birth.', 'description': 'Pregnancy is defined as a positive pregnancy test, increase in human chorionic gonadotropin (HCG) level or a pregnancy shown on ultrasonographic examination. Live birth is defined as the birth of live baby born beyond 24 weeks of pregnancy.', 'timeFrame': 'within six months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (alpha) of 0.05, and 2% lost to follow-up.", "answer": 1102, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We hypothesise that a difference of 8% in conception leading to live birth rate in favour of tubal flushing with oil-based contrast during HSG will be effective. To detect or refute this increase in live births, a total of 1102\u00e2\u0080\u0089women (551\u00e2\u0080\u0089women per group) should be randomised with a power of 80% and an alpha of 0.05. We included 2% lost to follow-up. The sample size is based on Lindborg et al who demonstrated a live birth rate of 29% after tubal flushing by hysterosalpingo contrast sonography (HyCoSy).26", "id": 1840, "split": "test"} +{"trial_id": "NCT05882708", "pmid": "39443954", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis: a Prospective, Multicenter, Randomized Controlled Trial\n\nIncluded conditions:\n- Sepsis\n- Ivabradine\n- Hemodynamics\n- Heart Rate Control\n\nStudy Armgroups:\n- {'label': 'standard treatment group', 'type': 'NO_INTERVENTION', 'description': 'Standard treatment refers to that patients received active anti-infection and treatment of primary diseases according to the 2016 International Guidelines for the Management of Sepsis and septic shock. In addition, adequate volume resuscitation and vasoactive drug support can be given to maintain MAP\u226565mmHg, and life support technologies such as ventilators and CRRT were given as needed.\\n\\nThe target of heart rate control not mentioned in the above guidelines, was not mandatory for this group of patients with sinus tachycardia, so pharmacologic intervention was not administered.'}\n- {'label': 'Ivabradine group', 'type': 'EXPERIMENTAL', 'description': 'Standard treatment for sepsis plus enteral ivabradine.', 'interventionNames': ['Drug: Ivabradine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ivabradine', 'description': 'After randomization, the starting dose of ivabradine, 5mg, is given via the gastrointestinal tract every 12 hours. Heart rate control ranged from 70 to 94 bpm. Ivabradine was maintained until 96 hours after initiation of therapy. Beyond this period, the decision to continue ivabradine is left to the discretion of the treating intensivist. During the drug intervention period, heart rate is assessed before each dose. Ivabradine is tapered or discontinued if the heart rate is lower than the target rate; If the heart rate remains \u226595 bpm after 48 hours, the dose is increased to 7.5mg. If a heart rate of 95 or more bpm recurs after discontinuation during the intervention period, treatment with ivabradine can be resumed. Furthermore, Ivabradine is also discontinued at any time in the presence of severe liver impairment, malignant arrhythmia, cardiac conduction block, allergy, the need to take drugs with potentially harmful effects of ivabradine.', 'armGroupLabels': ['Ivabradine group']}\n\nPrimary Outcomes:\n- {'measure': 'The difference of a reduction in heart rate', 'description': 'Heart rate is a continuous variable with repeated measurements during the first 96 hours after enrollment, the area under the curve (AUC) relative to baseline are calculated for each group, and then difference in AUC are compared.', 'timeFrame': '96 hours'}\n- {'measure': 'The difference in MAP', 'description': 'MAP will be recorded every 12 hours for each patient during the first 96 hours after enrollment. The area under the curve (AUC) relative to baseline are calculated for each group, and then difference in AUC are compared. The change in this index will be used to evaluate the hemodynamic effects of ivabradine.', 'timeFrame': '96 hours'}\n- {'measure': 'The difference in CI', 'description': 'Cardiac index (CI) will be recorded every 12 hours for each patient during the first 96 hours after enrollment. The area under the curve (AUC) relative to baseline are calculated for each group, and then difference in AUC are compared. The change in this index will be used to evaluate the hemodynamic effects of ivabradine.', 'timeFrame': '96 hours'}\n- {'measure': 'The difference in LVEF', 'description': 'Left ventricular ejection fraction (LVEF)\uff0cmeasured by bedside ultrasound, will be recorded every 12 hours for each patient during the first 96 hours after enrollment. The area under the curve (AUC) relative to baseline are calculated for each group, and then difference in AUC are compared. The change in this index will be used to evaluate the hemodynamic effects of ivabradine.', 'timeFrame': '96 hours'}\n- {'measure': 'The difference in SVI', 'description': 'Stroke volume index (SVI), obtained through PiCCO, will be recorded every 12 hours for each patient during the first 96 hours after enrollment. The area under the curve (AUC) relative to baseline are calculated for each group, and then difference in AUC are compared. The change in this index will be used to evaluate the hemodynamic effects of ivabradine.', 'timeFrame': '96 hours'}\n- {'measure': 'The difference in VIS', 'description': 'Vasopressor requirement during the trial observation (or intervention) period ought to be recorded as vasoactive inotropic score (VIS) according to the formula. The area under the curve (AUC) relative to baseline are calculated for each group, and then difference in AUC are compared. The change in this index will be used to evaluate the hemodynamic effects of ivabradine.', 'timeFrame': '96 hours'}\n\nPlease estimate the sample size based on the assumption: \nDifferences between two groups will be detected with a power of 90% at a bilateral \u03b1 risk of 0.05. A potential loss to follow-up and withdrawals is estimated at 10%.", "answer": 172, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n Although multiple outcome parameters are used as the primary end point, improvement of only one of these measures is considered to be required for the intervention to be effective. The primary focus of this study is to assess the difference in the area under the curve (AUC) of the subthreshold heart rate. According to previous study, the median difference in AUC between ivabradine and placebo was\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008925.6 (95%CI\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008931.4 to\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008915.9) bpm [18]. We assume that differences between two groups will be detected with a power of 90% at a bilateral \u00ce\u00b1 risk of 0.05. Additionally, we have considered potential loss to follow-up and withdrawals, estimating it at 10% for patients. Hence, a total sample size of 172 subjects will be assigned equally to GI and GS groups in order to meet these requirements. Power calculations were performed using Power Analysis & Sample Size (PASS) V.14.0 software.\n Since the recruitment period is 18\u00c2\u00a0months, furthermore, the centers participating in this study are high-volume tertiary hospitals in China, and it was estimated that only one or two patients per month would be enrolled at each centers to meet the required sample size.", "id": 1841, "split": "test"} +{"trial_id": "NCT05889507", "pmid": "39026197", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy: A Multicentre Randomised Controlled Trial\n\nIncluded conditions:\n- Neonatal Encephalopathy\n- Newborn Asphyxia\n\nStudy Armgroups:\n- {'label': 'Whole body hypothermia', 'type': 'EXPERIMENTAL', 'description': 'Whole-body hypothermia (33.5\u00b10.5\u00b0C) will be initiated within 6 hours of birth and continued for 72 hours using a servo-controlled cooling machine at the nearest available neonatal intensive care unit (cooling centre).', 'interventionNames': ['Procedure: Whole body hypothermia', 'Other: Supportive neonatal intensive care', 'Diagnostic Test: Follow up assessment at 2 years of age']}\n- {'label': 'Normothermia', 'type': 'ACTIVE_COMPARATOR', 'description': 'The rectal temperature will be maintained at 36.5\u00b10.5\u00b0C using servo-controlled incubators for the first 80 hours and any hyperthermia will be treated with a standardised protocol.', 'interventionNames': ['Procedure: Targeted normothermia', 'Other: Supportive neonatal intensive care', 'Diagnostic Test: Follow up assessment at 2 years of age']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Whole body hypothermia', 'description': 'Whole-body hypothermia (33.5\u00b10.5\u00b0C) initiated within 6 hours of birth and continued for 72 hours. The rectal temperature will be maintained at 33.5\u00b10.5\u00b0C using a servo-controlled cooling machine.', 'armGroupLabels': ['Whole body hypothermia']}\n- {'type': 'PROCEDURE', 'name': 'Targeted normothermia', 'description': 'The rectal temperature will be maintained at 36.5\u00b10.5\u00b0C using servo-controlled incubators for the first 80 hours and any hyperthermia will be treated with a standardised protocol.', 'armGroupLabels': ['Normothermia']}\n- {'type': 'OTHER', 'name': 'Supportive neonatal intensive care', 'description': 'Neonatal intensive care monitoring and support including ventilatory and inotropic support as clinically indicated', 'armGroupLabels': ['Normothermia', 'Whole body hypothermia']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Follow up assessment at 2 years of age', 'description': 'The assessment will be carried out using the Bayley Scales of Infant and Toddler Development IV. In addition, all infants will have a detailed neurological examination, including Gross Motor Function Classification System (GMFCS) for cerebral palsy, vision, and hearing assessment. Babies who die or who cannot be assessed with the Bayley-IV due to severe disability will be allocated a Cognitive Scale Composite score one point below the basal test score. PARCA-R will be completed by the parents immediately.', 'armGroupLabels': ['Normothermia', 'Whole body hypothermia']}\n\nPrimary Outcomes:\n- {'measure': 'Mean Cognitive Composite Scale score from the Bayley IV examination', 'description': 'The Bayley scales of Infant and toddler development IV is a validated and standardised scoring system that assesses development of three domains, that is cognition, language, and motor development. Babies who die or who cannot be assessed with the Bayley IV due to severe disability will be allocated a Cognitive Scale Composite score one point below the basal test score similar to the previous whole-body hypothermia trials.', 'timeFrame': '22 to 26 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level is 0.05, power is 90%, and a conservative 10% drop-out rate is assumed. The total duration of the trial is 66 months, including a six-month trial set up period, 30 months of recruitment, and outcome assessments at the age of 24 (\u00b12) months.", "answer": 426, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The Bayley-IV Cognitive Scale Composite score has a normative mean of 100 and SD of 15. To detect a clinically important minimum difference of 5 points (0.3 SD), at a 0.05 significance level and 90% power, we would need 191 neonates per group, 382 in total. This increases to 426, after allowing for a conservative 10% drop-out rate (Table\u00c2\u00a02). The total duration of the trial is 66 months which will include a six-month trial set up period, 30 months of recruitment, and outcome assessments at the age of 24 (\u00c2\u00b1\u00e2\u0080\u00892) months.\n \nTable 2Sample size calculationSize of group differenceTotal study sample size90% power80% power4 points6604945 points4263186 points2962247 points2181668 points1681289 points13410010 points11084\n\n The implication of changing the power of the study and the size of outcome differences between groups has been examined and is shown in the subsequent table. This shows the total sample size required in both groups combined, after allowing for a 10% drop-out rate (Table\u00c2\u00a03).\n \nTable 3Effect of drop out on study powerDrop-out rateStudy power10%90.0%12.5%89.4%15%88.5%17.5%87.7%20%86.5%\n\n The assumed attrition rate of 10% is conservative, as we have consistently obtained\u00e2\u0080\u0089>\u00e2\u0080\u008997% follow up at 18 to 22 months in previous trials performed in the UK. The implications of a higher drop-out rate upon the power of the trial are shown below. If the drop-out rate is 20%, the study would still have an 87% power to detect a 5-point difference between groups.", "id": 1842, "split": "test"} +{"trial_id": "NCT05890339", "pmid": "38964794", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer: a Multi-center Randomized Controlled Trial\n\nIncluded conditions:\n- Stomach Neoplasms\n\nStudy Armgroups:\n- {'label': 'Laparoscopic Proximal Gastrectomy With Double-flap Technique', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Laparoscopic Proximal Gastrectomy With Double-flap Technique']}\n- {'label': 'Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic Proximal Gastrectomy With Double-flap Technique', 'description': 'Patients in this group receive laparoscopic proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA\uff1aNos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9, 11p\uff1bD2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9, 11p and 11d). The double-flap technique is used for the esophagogastric reconstruction.', 'armGroupLabels': ['Laparoscopic Proximal Gastrectomy With Double-flap Technique']}\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction', 'description': 'Patients in this group receive laparoscopic total gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA\uff1aNos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p\uff1bD2 for stage IB: Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p and 11d, 12a). The Roux-en-Y esophagojejunostomy method is used for the esophagojejunal reconstruction.', 'armGroupLabels': ['Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction']}\n\nPrimary Outcomes:\n- {'measure': 'The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively', 'description': 'During follow-up endoscopy 1 year after surgery, reflux esophagitis are graded according to the Los Angeles (LA) classification.', 'timeFrame': '12 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \n80% power at the 0.025 level of one-sided significant difference, with an estimated dropout rate of 20%.", "answer": 216, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome is the proportion of patients with reflux esophagitis within 12 months in the full analysis set (FAS). The calculation of the sample size is according to Masaru Hayami \u00e2\u0080\u0099s research18; the incidence of reflux esophagitis between PG with DFT and TG with RY in this research was 2.3% versus 14.9%. We also combined retrospective data from our centre, which the incidence of reflux esophagitis for PG with DFT was 2.9% (1/34) and TG with RY was 16.6% (85/512). Overall, the assumptions of the sample size calculation are as follows: the 12-month postoperative reflux esophagitis rate (Los Angeles grade B or more) after LPG-DFT for proximal early gastric cancer is 3% and that in LTG-RY is 15%.18 By taking into account achieving 80% power at the 0.025 level of one-sided significant difference, 86 patients needed to be recruited to each arm. With an estimated dropout rate of 20%, the total sample size was calculated with 216 patients with 108 in each of the 2 arms. Sample size calculation was performed using the Process Automation Software System software (V.15.0.13).", "id": 1843, "split": "test"} +{"trial_id": "NCT05890677", "pmid": "39961719", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial\n\nIncluded conditions:\n- Lymphedema, Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Group A : Surgical Group', 'type': 'EXPERIMENTAL', 'description': 'According to the pragmatic study design, neither the diagnostic workup nor the surgery will be standardized in order to offer surgeons considerable leeway on how to perform lymphatic surgery, which resembles the flexibility in usual care. The key aspects of the preoperative workup and the surgery including the number of LVAs (Lymphovenous Anastomosis), harvesting of lymph nodes (\"donor site\"), time of surgery, and practical details will be registered.', 'interventionNames': ['Procedure: Surgical Intervention']}\n- {'label': 'Group B: Conservative Complex Physical Decongestion Therapy (control group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'CDT (Conservative Complex Physical Decongestion Therapy) will be performed as in usual care, following the pragmatic study design. The key aspects like frequency of lymphatic drainage, time when lymphatic drainage is performed and time and class of compressive garments are used will be documented. CDT incorporates two stages of treatment. The first treatment phase (intensive phase) entails skincare, MLD (manual lymphatic drainage), exercises aimed at improvement of mobility/range of motion in the shoulder, elbow or wrist joints, and compression therapy through bandaging. Most patients undergo this phase shortly after the diagnosis of LE. CDT in the second phase (maintenance phase) aims to maintain the achieved limb volume/ circumference reduction through compression with therapeutic elastic compression garment for the arm. Skincare, mobility exercises and MLD is continued in this phase if needed', 'interventionNames': ['Procedure: Conservative Complex Physical Decongestion Therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Surgical Intervention', 'description': 'LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer) are two advanced microsurgical techniques that are increasingly implemented in clinical practice in specialized centers and that are already carried out after health insurance application according to local standard of care. They have been studied in their respective mode of action as well as in their effectiveness in treating chronic BCRL (Breast Cancer-Related Lymphedema) in a multitude of mostly observational and single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.', 'armGroupLabels': ['Group A : Surgical Group']}\n- {'type': 'PROCEDURE', 'name': 'Conservative Complex Physical Decongestion Therapy', 'description': 'Patients randomized to the control arm will receive CDT (Conservative Complex Physical Decongestion Therapy), which currently is considered as the best available standard of care. For this, patients will be referred to one of the dedicated LE (physical/skin) therapy clinics, if not already treated by one, according to their place of residence for continuation of standard conservative therapy. Recommendations to the procedures and treatment frequency of the conservative therapy will be made, but CDT will be done at the discretion of the treating physiotherapist.', 'armGroupLabels': ['Group B: Conservative Complex Physical Decongestion Therapy (control group)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Quality of Life Questionnaire (Lymph-ICF-UL)', 'description': 'The LYMPH-ICF-UL-Questionnaire (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema) is a widely used, rigorously developed, and validated patient-reported outcome (PRO) instrument for chronic breast cancer-related lymphedema. It assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb lymphedema (LE). Consisting of 29 items (questions) across five different domains, each item is scored on a VAS (visual analog scale) ranging from 0 to 10. The total score on the LYMPH-ICF is equal to the sum of the item scores divided by the total number of answered items. A higher score on the Lymph-ICF indicates a greater impact on the functioning in daily life related to upper limb LE. This questionnaire helps determine if lymphatic surgery improves quality of life and patient satisfaction compared to conservative therapy.', 'timeFrame': 'two time assessment at baseline and 15 month after randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 5%, the standard deviation is assumed to be 21.9, and the power is set at 90%. An anticipated drop-out rate of 10% and a total arm-switching rate of 5% are also considered.", "answer": 280, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated with the objective of detecting a difference in the primary end point (LE-related QoL at 15 months) between the two study groups, at a significance level \u00ce\u00b1=5%.\n The clinically relevant difference in the Lymph-ICF-UL score between surgical techniques and CDT was defined as \u00ce\u00b8=10 points on a scale ranging from 0 to 10. This choice was made in consultation with the patient advocacy group, as an improvement of 10 points in the total Lymph-ICF-UL score corresponds to altering three responses from \u00e2\u0080\u0098not at all\u00e2\u0080\u0099 to \u00e2\u0080\u0098very well\u00e2\u0080\u0099, or enhancing each individual response by one point. The choice of a 10-point difference as being clinically relevant is supported by the data of Devoogdt et al and De Vrieze et al,94 95 as it aligns with 2 SD of the within-subject variability in the total Lymph-ICF-UL score. Moreover, the findings of Qiu et al51 demonstrate that achieving such an improvement in the primary end point is clearly feasible.\n Based on the results documented by Devoogdt et al and De Vrieze et al,94 95 it was assumed that the Lymph-ICF-UL scores for both surgical techniques and CDT follow an approximately normal distribution with an SD of \u00cf\u0083=21.9. A Student\u00e2\u0080\u0099s t-test will be used to compare the average Lymph-ICF-UL scores between the two study groups.\n With an anticipated drop-out rate of 10% and a total arm-switching rate of 5% (corresponding to 10% of patients in the CDT arm switching to the surgery arm and no patients in the surgery arm switching to the CDT arm), the recruitment goal is set at 280 patients. This number is intended to yield a total of n=252 evaluable patients (126 in each study arm), providing a power of 90% when the absolute treatment effect is \u00ce\u00b8=10.", "id": 1844, "split": "test"} +{"trial_id": "NCT05891886", "pmid": "39532350", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Supplemental Oxygen in Pulmonary Embolism (SO-PE)\n\nIncluded conditions:\n- Pulmonary Embolism\n- Venous Thromboembolism\n- Metabolomics\n- Oxygen Inhalation Therapy\n\nStudy Armgroups:\n- {'label': 'Supplemental oxygen delivered by facemask', 'type': 'EXPERIMENTAL', 'description': 'Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first.\\n\\nSubjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.', 'interventionNames': ['Drug: Oxygen Therapy', 'Device: Non-rebreather mask']}\n- {'label': 'Room air delivered by facemask', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first.\\n\\nSubjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.', 'interventionNames': ['Device: Non-rebreather mask']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oxygen Therapy', 'description': 'Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.', 'armGroupLabels': ['Supplemental oxygen delivered by facemask']}\n- {'type': 'DEVICE', 'name': 'Non-rebreather mask', 'description': 'Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.', 'armGroupLabels': ['Room air delivered by facemask', 'Supplemental oxygen delivered by facemask'], 'otherNames': ['NRM (Non-rebreather mask)']}\n\nPrimary Outcomes:\n- {'measure': 'Pulmonary artery systolic pressure (PASP)', 'description': 'PASP is measured on bedside echocardiogram', 'timeFrame': '30 minutes after study treatment (supplemental oxygen) or placebo (room air)'}\n- {'measure': 'Pulmonary artery systolic pressure (PASP)', 'description': 'PASP is measured on bedside echocardiogram', 'timeFrame': '60 minutes after study treatment (supplemental oxygen) or placebo (room air)'}\n- {'measure': 'Pulmonary artery systolic pressure (PASP)', 'description': 'PASP is measured on bedside echocardiogram', 'timeFrame': '90 minutes after study treatment (supplemental oxygen) or placebo (room air)'}\n- {'measure': 'Pulmonary artery systolic pressure (PASP)', 'description': 'PASP is measured on bedside echocardiogram', 'timeFrame': '180 minutes after study treatment (supplemental oxygen) or placebo (room air)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha=0.05, beta=0.20, 15% dropout rate.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In our porcine study,16 supplemental oxygen lowered systolic PA pressure to 20\u00e2\u0080\u0089mm Hg (SD 9\u00e2\u0080\u0089mm Hg) from 45\u00e2\u0080\u0089mm Hg. In our conservative sample size calculations, we assumed lower post-PE pulmonary pressures, reduced effect size and greater variation in patients with PE compared with research pigs. We estimate a pulmonary pressure change of 7\u00e2\u0080\u0089mm Hg (eg, from 35 to 28\u00e2\u0080\u0089mm Hg) with oxygen and no change with room air, SD of 10\u00e2\u0080\u0089mm Hg in each group, alpha=0.05 and beta=0.20. Comparing two means, a sample size of n=68 (34 per group) is needed. Conservatively assuming 15% dropout, we aim to include 80 patients (40 per group).", "id": 1845, "split": "test"} +{"trial_id": "NCT05892900", "pmid": "38898522", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcutaneous Vagus Nerve Stimulation (tVNS) to Acutely Reduce Emotional Vulnerability and Improve Emotional Regulation in Borderline Personality Disorder (tVNS-BPD): a Randomized, Single-blind, Sham-controlled Trial\n\nIncluded conditions:\n- Borderline Personality Disorder\n\nStudy Armgroups:\n- {'label': 'Transcutaneous vagus nerve stimulation (tVNS)', 'type': 'EXPERIMENTAL', 'description': '1 tVNS session of ca 45 minutes\\n\\nThe electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve', 'interventionNames': ['Device: Transcutaneous vagus nerve stimulation (tVNS)']}\n- {'label': 'Sham Transcutaneous vagus nerve stimulation (tVNS)', 'type': 'SHAM_COMPARATOR', 'description': '1 sham tVNS session of ca 45 minutes\\n\\nThe electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation', 'interventionNames': ['Device: Sham transcutaneous vagus nerve stimulation (Sham tVNS)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcutaneous vagus nerve stimulation (tVNS)', 'description': 'The electrodes are placed at the left ear concha. The ear concha is principally innerved by the afferent branch of the vagus nerve', 'armGroupLabels': ['Transcutaneous vagus nerve stimulation (tVNS)'], 'otherNames': ['Transcutaneous auricular vagus nerve stimulation (taVNS)']}\n- {'type': 'DEVICE', 'name': 'Sham transcutaneous vagus nerve stimulation (Sham tVNS)', 'description': 'The electrodes are attached to the center of the left ear lobe, which is known to be free of cutaneous vagal innervation', 'armGroupLabels': ['Sham Transcutaneous vagus nerve stimulation (tVNS)'], 'otherNames': ['Sham Transcutaneous auricular vagus nerve stimulation (Sham taVNS)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in negative emotional arousal from baseline at immediately after affect-induction (post-induction ratings) as assessed by PANAS', 'description': 'The emotional arousal will be measured through the self-reported ratings of negative emotions on the PANAS (PANAS-N). The scale uses adjectives that describe mood states rather than discrete emotions and are rated from 1 = very slightly or not at all to 5 = extremely.', 'timeFrame': 'Baseline and immediately after every of the four videos.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) of 0.05, power (1-\u03b2) of 0.8, and an expected attrition rate of 20%", "answer": 42, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We are going to recruit 42 participants (21 participants per arm). The total sample size has been calculated using G*Power 3.1 Software to test an effect size of 0.25 with a power (1\u00e2\u0088\u0092\u00ce\u00b2) = 0.8 for a sample with two independent groups (taVNS vs Sham-taVNS) and 4 dependent measures (PANAS-N score post-induction for neutral, funeral, sex-assault and domestic violence videos). The sample size needed is n = 34, calculated with an alpha level of 0.05. With an expected level of attrition of about 20%, the sample size has been increased by a factor of 1/(1\u00e2\u0080\u00930.2) = 1.25 or 25% to 42 subjects.", "id": 1846, "split": "test"} +{"trial_id": "NCT05895058", "pmid": "38389113", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of 2D 4K vs. 3D HD Laparoscopic Imaging Systems in Bariatric Surgery: a Randomized Controlled Prospective Trial\n\nIncluded conditions:\n- Laparoscopy\n\nStudy Armgroups:\n- {'label': '2D 4K laparoscopic imaging system', 'type': 'EXPERIMENTAL', 'description': 'Performing gastric bypass surgery intervention using a 2D 4K laparoscopic imaging system.', 'interventionNames': ['Device: Gastric bypass surgery with 2D 4K laparoscopic imaging']}\n- {'label': '3D HD laparoscopic imaging system', 'type': 'ACTIVE_COMPARATOR', 'description': 'Performing gastric bypass surgery intervention using a 3D HD laparoscopic imaging system.', 'interventionNames': ['Device: Gastric bypass surgery with 3D HD laparoscopic imaging']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Gastric bypass surgery with 2D 4K laparoscopic imaging', 'description': 'All patients involved in the investigation will receive a laparoscopic Roux-en-Y gastric bypass (LRYGB). The interventions are performed by three defined surgeons.', 'armGroupLabels': ['2D 4K laparoscopic imaging system']}\n- {'type': 'DEVICE', 'name': 'Gastric bypass surgery with 3D HD laparoscopic imaging', 'description': 'All patients involved in the investigation will receive a laparoscopic Roux-en-Y gastric bypass (LRYGB). The interventions are performed by three defined surgeons.', 'armGroupLabels': ['3D HD laparoscopic imaging system']}\n\nPrimary Outcomes:\n- {'measure': 'Operation time', 'description': 'Operation time (OT) is defined from the beginning of the operation by incision of the skin to the end of the operation by the end of the skin suture.', 'timeFrame': 'intraoperative'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a group sequential design with a maximum of 2 looks, an overall significance level of 2.5% (one-sided), a power of 90%, a minimal detectable difference of 15 minutes, a standard deviation of 15 minutes, and a futility bound of 0 at interim analysis.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was calculated for the primary outcome (operating time). As the study is mainly based on knowledge from preclinical studies and there is not much guiding literature in the clinic, some assumptions had to be made at the beginning. We assume that an operator needs approximately 75\u00e2\u0080\u0089min to perform a gastric bypass using 3D HD imaging, while performing the exact same operation using 2D 4K imaging takes 90\u00e2\u0080\u0089min. This assumption is supported by the literature, which states that a gastric bypass operation takes approximately 90\u00e2\u0080\u0089min for experienced operators using 2D laparoscopy, by the results of studies that showed a time savings of approximately 15\u00e2\u0080\u0089min using 3D laparoscopy, and by the results of our preliminary study, which showed an average time savings of almost one fifth using 3D laparoscopy compared to 2D 4K [18\u00e2\u0080\u009320]. The EAES systematic review also suggests an average difference of 15\u00e2\u0080\u0089min for procedures involving laparoscopic suturing [2]. Calculation is as follows: sequential analysis with a maximum of 2 looks (group sequential design, O\u00e2\u0080\u0099Brian-Fleming alpha spending), overall significance level 2.5% (one-sided); the sample size was calculated for a two-sample t-test, minimal detectable difference\u00e2\u0080\u0089=\u00e2\u0080\u008915, standard deviation\u00e2\u0080\u0089=\u00e2\u0080\u008915, power 90%; futility bound of 0 at interim analysis; number of subjects at interim 22.3, final: 44.6. Sample size calculation is based on RPACT (R package version 3.2.1) [21].\n Therefore, we will recruit 48 patients in blocks of four with gastric bypass indications and randomize them to the two groups (2D 4K and 3D HD).", "id": 1847, "split": "test"} +{"trial_id": "NCT05895643", "pmid": "39779270", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does the Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?\n\nIncluded conditions:\n- Alcohol Abuse\n- Alcohol Addiction\n- Alcohol Dependence\n- Alcohol Use Disorder\n\nStudy Armgroups:\n- {'label': 'semaglutide', 'type': 'EXPERIMENTAL', 'description': 'Wegovy once-weekly s.c.titrated to a maximum dose of 2.4 mg', 'interventionNames': ['Drug: Semaglutide Injectable Product']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Saline s.c. once-weekly', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Semaglutide Injectable Product', 'description': 'Once weekly injections s.c with semaglutide (Wegovy)', 'armGroupLabels': ['semaglutide'], 'otherNames': ['Wegovy']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Once weekly injections s.c with placebo (BD Posiflush)', 'armGroupLabels': ['placebo'], 'otherNames': ['BD Posiflush (saline)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in heavy drinking days', 'description': 'Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)). A heavy drinking day is defined as more than 60/48 grams (men/women) of alcohol in one day, measured with the validated timeline follow-back (TLFB) method.', 'timeFrame': 'From baseline to 26 weeks of treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a power of 90%, an alpha of 5%, an estimated SD of 26.44, and an anticipated dropout rate of 40%.", "answer": 108, "answer_type": "ACTUAL", "explanation": "Sample size calculation and randomisation\n The power calculation is based on the primary endpoint, that is, the change in heavy drinking days. No other studies have reported the effects of semaglutide in patients with AUD. The sample size calculation is based on the alcohol trial by Bogenschutz et al,70 exploring psilocybin-assisted therapy as a novel treatment of AUD. They showed a reduction in the total number of heavy drinking days of 47% in the intervention group and 25% in the placebo group. With a power of 90%, an alpha of 5% and an estimated SD of 26.44, we will need 64 patients, with 32 patients in each treatment group. However, large dropout rates are often observed in AUD intervention trials, with attrition rates between 10% and 35%.71 We anticipate a 40% dropout rate, making the total sample size 108, with 54 patients in each treatment group. The randomisation will be performed by unblinded personnel, using the randomisation module in REDCap72 stratified by age (two levels), gender (two levels) and baseline heavy drinking days (four levels). The block sizes will be randomised evenly between 2 and 4. The allocation sequence is generated at the webpage www.sealedenvelope.com and uploaded into REDCap by unblinded personnel. An unblinded personnel will inform the unblinded study personnel about the allocated treatment.", "id": 1848, "split": "test"} +{"trial_id": "NCT05896540", "pmid": "38835035", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study Protocol: a Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention in Chilean Students\n\nIncluded conditions:\n- Sexuality\n\nStudy Armgroups:\n- {'label': 'STUDY GROUP ENFOCATE', 'type': 'EXPERIMENTAL', 'description': 'The selected students will be randomly divided into the study and control groups; the intervention will take place in the same schools that the students attend. The assignment to groups will use simple random sampling, performed in two stages. In the first stage the available schools will be randomly assigned to the study and control groups, while the second stage will select randomly the groups in each school that will participate in the study. The study groups will receive a 10-session intervention in sexual education, covering topics related to preventive sexual conduct, gender equity and mental health.', 'interventionNames': ['Behavioral: ENFOCATE']}\n- {'label': 'CONTROL GROUP', 'type': 'NO_INTERVENTION', 'description': 'The control groups will not receive intervention; they will continue with the sexual orientation that each school provides to its students.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ENFOCATE', 'description': 'ENFOCATE is a comprehensive program of sexual education for adolescents. Its design follows the guidelines of the Intervention Mapping Approach and the orientations proposed by the Framework for Gender-Transformative Health Promotion. The intervention has a participative focus, thus the activities are designed to promote processes of knowledge, understanding, application and reflection in the adolescents. The activities aim to improve the capacity for critical thinking, increase the motivation to listen and learn actively, and to improve interpersonal abilities. The execution of the intervention uses three pillars: (i) preventive sexual behavior; (ii) gender equity; and (iii) mental health. The intervention consists of ten weekly sessions, each lasting one hour. The teams that will perform the intervention will be composed of at least two professionals of the psychosocial area (mainly psychologists, social workers and/or guidance counsellors) of the schools included in the study.', 'armGroupLabels': ['STUDY GROUP ENFOCATE']}\n\nPrimary Outcomes:\n- {'measure': 'Change in knowledge of sexuality', 'description': 'Related to information about the biological components of sexuality. The test used will be the Knowledge Test (KT). This is a 34-item multiple choice instrument which was designed to evaluate the knowledge on sexuality in adolescents; it evaluates areas including pregnancy, STI, physical development. Higher scores represent more favorable attitudes. Its reliability is \u03b1=0.89. These assessed areas will be combined to report the level of knowledge.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n- {'measure': 'Change in preventive sexual behavior', 'description': 'Related to behavior in sexuality and preventive behavior in sexuality. Ad-hoc survey. It will be elaborated by the research team to evaluate the behavior and intention, self-efficacy and empowerment in sexuality in LGTB and female-male students. Ad-hoc surveys have been used and reported in other RCT of interventions in sexual health.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n- {'measure': 'Change in gender actitude', 'description': 'Related to positive disposition towards persons of different genders. The test used will be the Scale for Detection of Sexism in adolescents (DSA). This is an instrument of 26 items developed for adolescents. It evaluates sexism, differentiating between hostile and benevolent sexism. The response scale for the items is a Likert type with six alternatives (from 1=disagree completely to 6=agree completely). Higher scores indicate more sexism. Its reliability is \u03b1= .881.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n- {'measure': 'Change in gender actitude', 'description': 'Related to positive disposition towards persons of different sexual orientation. The test used will be the Scale of negative attitudes toward trans persons (NATP). It measures attitude as an expression of prejudice towards trans persons. It has nine items with a Likert scale with five response options, from 1= disagree completely to 5=agree completely. Higher scores are indicators of higher levels of negative attitudes toward persons of different sexual orientation. Its reliability is \u03b1= .886.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n- {'measure': 'Change in gender actitude', 'description': 'Related to positive disposition towards persons of different sexual orientation. The test used will be the Short version of Modern Homophobia Scale (MHS). It measures homophobic attitudes in the dimension personal discomfort, institutional and deviation/changeability. It is composed of 46 items that evaluate attitudes towards lesbians and gay in a Likert scale of 1-5 in which higher scores interpret more positive attitudes towards homosexuality and lesbianism. Its reliability is \u03b1= .80.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n- {'measure': 'Change in components of mental health related to sexual health', 'description': 'Decrease of internalizing symptomology. The test used will be the Pediatric Symptom Checklist (PSC-17). It evaluates general psychosocial functioning, detecting emotional and behavioral difficulties in children and adolescents. Higher scores represent more internalizing behaviors. reliability is \u03b1= .72.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n- {'measure': 'Change in components of mental health related to sexual health', 'description': 'Decrease of externalizing symptomology. The test used will be the Pediatric Symptom Checklist (PSC-17). It evaluates general psychosocial functioning, detecting emotional and behavioral difficulties in children and adolescents. Higher scores represent more externalizing behaviors. Its reliability is \u03b1= .72.', 'timeFrame': 'One-week pre-intervention, immediately post-intervention and a 3-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \n99% confidence level, 5% error margin, significance level of 0.05, statistical power of at least 0.8, and analysis of variance.", "answer": 609, "answer_type": "ESTIMATED", "explanation": "Sample size\n There are currently 6518 students enrolled in the 10th and 11th grades in State-financed schools in the commune of Santiago. Using a 99% confidence level and a 5% error margin, the sample framework is 605 students, which will be divided into the study and control groups. The statistical power is determined using an analysis of variance with a significance level of 0.05, a sample size of 605 and an expected difference of 0.2 points between groups, which will provide a statistical power of at least 0.8. The 0.2 difference is the smallest reported in previous studies comparing the scores of two groups with the instruments that will be used; it was reported in the analysis of the scores of the scale of ambivalent sexism [24].\n The statistical power was calculated using the software G*Power [25]. After making a slight adjustment due to the number of students currently enrolled in each school at each level, the definitive size of the experimental phase of the study will be 609 students.", "id": 1849, "split": "test"} +{"trial_id": "NCT05897073", "pmid": "38267239", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Time-Restricted Eating and Supervised Exercise on Hepatic Steatosis and Cardiometabolic Health in Adults With Obesity\n\nIncluded conditions:\n- Time Restricted Feeding\n- Exercise\n- Hepatic Steatosis\n- Cardiometabolic Syndrome\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Time-restricted eating intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window.', 'interventionNames': ['Behavioral: Time-restricted eating intervention']}\n- {'label': 'Supervised exercise intervention', 'type': 'EXPERIMENTAL', 'description': 'The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \\\\>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \\\\>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.', 'interventionNames': ['Behavioral: Exercise intervention']}\n- {'label': 'Usual-care control group', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.'}\n- {'label': 'Time-restricted eating plus Supervised exercise', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \\\\>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \\\\>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-', 'interventionNames': ['Behavioral: Time-restricted eating plus exercise intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Time-restricted eating intervention', 'description': 'Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window.', 'armGroupLabels': ['Time-restricted eating intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Exercise intervention', 'description': 'The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \\\\>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \\\\>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). This intervention has already been tested previously in our lab. Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.', 'armGroupLabels': ['Supervised exercise intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Time-restricted eating plus exercise intervention', 'description': 'Participants will be asked to reduce their daily eating time window to a maximum of 8 hours/day. They can choose when to begin their eating window but will be advised that the last meal should be completed before or at 20:00 hours. No calorie-containing food or beverage intake will be allowed outside the 8 hours eating window. The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \\\\>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \\\\>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). This intervention has already been tested previously in our lab. Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program consisting of increasing 15% daily steps per week.', 'armGroupLabels': ['Time-restricted eating plus Supervised exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Change in hepatic fat content', 'description': 'Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)', 'timeFrame': 'Change from baseline to 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a pre-post correlation of 0.8 and an SD of 6 points in the main outcome, with a significance level (\u03b1) of 0.05 and a power of 0.8. We also account for a maximum drop-out rate of 20%.", "answer": 184, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on previous findings from a recent trial on the combination of alternate day fasting and exercise on hepatic fat content,22 we anticipate approximately 5.0% reduction in hepatic fat content in the TRE+Exercise group, 2.5% in the TRE group, 2.5% in the exercise group and no significant change in this outcome in the usual-care group. Assuming a pre\u00e2\u0080\u0093post correlation of 0.8 and an SD of 6 points in the main outcome, we estimate a medium effect size of 0.45. To detect this effect size as statistically significant in a one-way analysis of variance with \u00ce\u00b1=0.05\u00e2\u0080\u0089and a power of 0.8, a minimum of 19 patients per group is required. Accounting for subgroup analyses based on sex and a maximum drop-out rate of 20%, we will aim to recruit 46 participants for each trial group, resulting in a total sample size of 184 participants, with 92\u00e2\u0080\u0089women included.\n To ensure a balanced representation of both sexes and maintain an adequate sample size, we will implement several strategies:\n \n \n Recruitment process: A specific recruitment process will be used to aim for an equal enrolment of men and women. For each woman recruited, we will encourage her to invite one man to participate in the study. This approach has been successfully employed in our previous intervention studies and has proven effective in achieving a balanced sex distribution. 23\u00e2\u0080\u009325\n \n \n Sample size calculations: Our sample size calculations have taken into account subgroup analyses by sex. We have conservatively estimated a maximum drop-out rate of approximately 20%. By considering this drop-out rate, we have ensured that our study is adequately powered to detect the specified effect size even if there are differential drop-out rates between men and women. For example, if men have a drop-out rate of 5% and women have a drop-out rate of 15%, our study will still have sufficient power to analyse the data separately in men and women.\n \n \n Expected drop-out rate: While we have conservatively estimated the maximum dropout rate, we anticipate that the actual drop-out rate will be relatively lower and similar between both sexes. This expectation is based on our previous studies and the measures we have to promote participant engagement and adherence.23\u00e2\u0080\u009325", "id": 1850, "split": "test"} +{"trial_id": "NCT05897099", "pmid": "38528570", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial\n\nIncluded conditions:\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'Comprehensive Tele-harm Reduction', 'type': 'EXPERIMENTAL', 'description': 'Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months.', 'interventionNames': ['Behavioral: Comprehensive Tele-harm Reduction']}\n- {'label': 'Off-site Linkage to HIV prevention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months.', 'interventionNames': ['Behavioral: Off-site Linkage to HIV Prevention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Comprehensive Tele-harm Reduction', 'description': 'Comprehensive Tele-Harm Reduction is on-demand services including low-barrier access to PrEP, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, peer harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an syringe services program.', 'armGroupLabels': ['Comprehensive Tele-harm Reduction']}\n- {'type': 'BEHAVIORAL', 'name': 'Off-site Linkage to HIV Prevention', 'description': 'The community engagement team is comprised of peers and social workers and provides the wraparound support needed.The team will assist participants in scheduling appointments at community health clinics. The community engagement team provides active clinic referral- that is, a member of the team will accompany patients to the first clinic visit.', 'armGroupLabels': ['Off-site Linkage to HIV prevention']}\n\nPrimary Outcomes:\n- {'measure': 'HIV prevention via pre-exposure prophylaxis (PrEP)', 'description': 'Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks by electronic health record abstraction', 'timeFrame': 'up to 12 months'}\n- {'measure': 'HIV prevention via medications for opioid use disorder', 'description': 'Norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction', 'timeFrame': 'up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) = 0.025, power = 0.80, dropout rate up to 10% at each follow-up, within-subject correlation (\u00cf\u0081) varied from 0.10 to 0.80.", "answer": 350, "answer_type": "ESTIMATED", "explanation": "Sample size\n Power analyses were generated using the two-group repeated proportions module in PASS 2020 [68] to compute minimum detectable effect sizes for the proposed primary analysis. The study will include 350 participants equally assigned to the intervention and control groups. We assume that as much as 10% of the sample may drop-out at each follow-up; however, we anticipate better retention due to SSP staff engagement in the study [69]. The expected sample sizes at the four follow-ups are thus 315, 284, 255, and 230. Using these sample sizes and assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025, power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, and\u00c2\u00a0that the proportion with PrEP or MOUD engagement will be 30% of the control arm, we computed the minimum detectable odds ratio (OR) 1.56 and absolute proportion difference (pdiff) of 0.101, assuming that all post-intervention time points are part of the contrast.\u00c2\u00a0We varied the within-subject correlation \u00cf\u0081 from 0.10 to 0.80.\u00c2\u00a0Power for a binomial is lowest when the base-rate (control group) probability (P0) is near 50%.", "id": 1851, "split": "test"} +{"trial_id": "NCT05898516", "pmid": "38575945", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Increasing Access to Mental Health Support for 12-17 Year Old Indigenous Youth with the JoyPop Mobile Mental Health App: Randomized Controlled Trial\n\nIncluded conditions:\n- Emotion Regulation\n- Depression\n- Anxiety\n- Stress\n\nStudy Armgroups:\n- {'label': 'Usual Practice + JoyPop', 'type': 'EXPERIMENTAL', 'description': 'Participants will be monitored through the existing wait-list practices, which involve regular phone calls to check in and assess functioning, and will receive access to the JoyPop app for 4 weeks.', 'interventionNames': ['Behavioral: Usual Practice + JoyPop']}\n- {'label': 'Usual Practice', 'type': 'NO_INTERVENTION', 'description': 'Participants will be monitored through existing wait-list practices which involve regular phone calls to check in and assess functioning. After 4 weeks in the Usual Practice condition, participants will be offered access to the JoyPop app.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Usual Practice + JoyPop', 'description': 'Participants will be asked to use the app at least twice daily but will otherwise not be provided with requirements related to feature or total usage.', 'armGroupLabels': ['Usual Practice + JoyPop']}\n\nPrimary Outcomes:\n- {'measure': 'Change in emotion regulation (overall)', 'description': 'Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale - Short Form. Total scores range from 18 to 90 with higher scores indicating greater difficulties in emotion regulation.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (strategies)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form strategies subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (non-acceptance)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form non-acceptance subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (impulse)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form impulse subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (goals)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form goals subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (awareness)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form awareness subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (clarity)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form clarity subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n\nPlease estimate the sample size based on the assumption: \nalpha = 0.05, power = 0.95, compound symmetry, 60% retention (40% attrition)", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Our past research suggests a medium effect for the primary outcome [43]. We estimated conservatively in calculating sample size, using f\u00e2\u0080\u0089=\u00e2\u0080\u00890.2 (small to medium effect), alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.95 for a 2 (between subjects; treatment condition) by 3 (within subjects; time) mixed design, which approximates the statistical power needed for the planned linear mixed model under the assumption of compound symmetry (i.e., homogeneity of variance and covariance) [44]. Results suggested a sample size of 66 would achieve necessary power. Given our pilot data [34], we estimate 60% retention throughout the study (40% attrition), meaning we will need an initial sample size of 110.", "id": 1852, "split": "test"} +{"trial_id": "NCT05898633", "pmid": "39153779", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase 1 Safety Trial of Recombinant Surfactant Protein D to Prevent Neonatal Chronic Lung Disease\n\nIncluded conditions:\n- Chronic Lung Disease of Prematurity\n- Respiratory Distress Syndrome in Premature Infant\n- Bronchopulmonary Dysplasia\n\nStudy Armgroups:\n- {'label': 'Recombinant fragment of human surfactant protein D (rfhSP-D) administration', 'type': 'EXPERIMENTAL', 'description': 'This is a single arm trial with administration of rfhSP-D.\\n\\nAll participants will be administered rfhSP-D via an endotracheal tube in 1-3 doses in the first 24-48hrs after birth whilst the infant is still intubated and ventilated.\\n\\nA dose escalation design from 1mg/kg to 4mg/kg will be used. Infants are enrolled in cohorts of three, with the first cohort receiving the lowest dose 1mg/kg.\\n\\nParticipants are followed up until they are discharged from hospital.', 'interventionNames': ['Drug: Recombinant fragment of human surfactant protein D (rfhSP-D)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Recombinant fragment of human surfactant protein D (rfhSP-D)', 'description': 'Administration of rfhSP-D', 'armGroupLabels': ['Recombinant fragment of human surfactant protein D (rfhSP-D) administration'], 'otherNames': ['rfhSP-D']}\n\nPrimary Outcomes:\n- {'measure': 'Occurence of Dose Limiting Events to assess the safety profile of the IMP (rfhSP-D)', 'description': 'To assess the safety profile of rfhSP-D across dose levels based on the occurrence of Dose Limiting Events (DLEs) which are events Garde 3 or above on the NAESS scale related to the IMP', 'timeFrame': 'Day 0 to 96 hours'}\n- {'measure': 'To find recommended Phase 2 Dose of rfhSP-D', 'description': 'To establish the Recommended Phase 2 Dose (RP2D) of rfhSP-D for preterm infants born at gestational age of 23 weeks to 29 weeks + 6 days.', 'timeFrame': 'Day 0 to the point of hospital discharge (40 weeks post-menstrual age)'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size calculation was performed. The study plans to recruit 24 infants. Participants with unclear safety outcomes or who have not started treatment will be replaced. Interim analyses will be conducted after each infant (for the first three participants at each dose level) and after cohorts of three participants are recruited at any dose level. The study will be terminated if there is at least a 90% chance that the risk of DLE at dose level 1 is greater than 20%, if the number of participants treated without side effects is sufficient, or if there is evidence of increased mortality or morbidity.", "answer": 24, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n As this is a safety study, no formal sample size calculation has been performed. A sample size of 24 infants is planned to meet practical recruitment and time targets and to collect sufficient data to quantify the estimated risk of DLE at each dose level. Participants with unclear safety outcomes or who have not started study treatment will be replaced to meet our planned effective sample size of 24 participants.\n The primary outcome of interest is the occurrence of DLEs at the dose levels under investigation and the identification of the dose(s) that, for infants of particular risk profiles defined by GA, have an estimated risk of DLE closest to the target side effect level of no greater than 20%. The use of Bayesian methodology to estimate risks will allow information to be borrowed across dose levels, making the dose-escalation and RP2D identification procedure more efficient than a standard rule-based approach.\n The operating characteristics of the design, for three specific scenarios, are shown in table 3. The first scenario is one where the initial a priori DLE probabilities calculated by calibration (halfwidth of the indifference interval set at 0.05) correspond to the true underlying probabilities of DLE. The second scenario is such that the true DLE rate of the second dose level corresponds to the target DLE rate. The third scenario is one where the true probabilities are much lower than the a priori probabilities.\n Type and grade of DLEs, SAEs and AEs will be tabulated per dose level, and further summarised by risk group defined by GA. Mean estimated risk of DLE per dose level and 95% credibility intervals will be calculated using the study model. Secondary objectives will be described per dose level and risk category. Categorical variables will be summarised by frequencies and percentages, and continuous variables by means/medians and SD/IQRs per dose level.\n \n Interim analyses of DLEs\n Interim analysis will done to assess if DLEs have occurred after each infant (for the first three participants at each dose level) has received the final dose of IMP and 72 hours of monitoring and all NAESS data will be reviewed by the DSMB. The DSMB will evaluate the safety data before further participants can be recruited, this will only be for the first three infants at each dose level. The purpose of this is to ensure there are no safety concerns. For the remainder of the study, interim analysis will be done after cohorts of three participants are recruited at any dose level to assess the occurrence of DLE and review all clinical data. Overall DSMB review of all data to advise the TSC regarding dose escalation will take place after recruitment of 3 infants at any dose level. The trial statistician will calculate and provide updated summaries of the estimated risk of dose-limiting toxicity at each dose level. The DSMB will then advise if dose escalation can occur. There will be no interim analysis for the secondary outcomes.\n The study will be terminated if any of the following stopping rules are satisfied:\n \n \n There is at least a 90% chance that the risk of DLE at dose level 1 is greater than the target of 20%. If the trial is terminated under this rule, no drug dose will be recommended due to safety concerns.\n \n \n The number of participants who have been treated without side effects is deemed sufficient.\n \n \n There is evidence of increased mortality or morbidity in the participants treated with the IMP.", "id": 1853, "split": "test"} +{"trial_id": "NCT05899374", "pmid": "39653558", "question": "Here is the design of a clinical trial:\n\nOfficial Title: KindMap - an E-mental Health Intervention Tool for Improving Well-being and Mental Health in People Facing Infertility: A Feasibility Randomized Control Trial\n\nIncluded conditions:\n- Infertility\n\nStudy Armgroups:\n- {'label': 'Experimental KindMap Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the experimental group will register, complete the baseline assessment and have immediate access to the KindMap web app.', 'interventionNames': ['Behavioral: KindMap']}\n- {'label': 'Wait-list Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the WL-CG will complete the baseline assessment and will be able to register and have access to the KindMap web app 10 weeks later.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'KindMap', 'description': \"The KindMap is a stand-alone, cost-free e-mental health tool presenting a low-intensive psychological intervention adapted from the MBPI to fit a web app format. KindMap is to be used at users' own time and pace, and includes ten modules addressing psychoeducation, mindfulness and compassion guided practices, and ACT-based experiential exercises. These components are delivered through text, videos, audio, experiential exercises, and interactive contents.\", 'armGroupLabels': ['Experimental KindMap Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes from baseline in Well-being', 'description': 'Measured with World Health Organisation- Five Well-Being Index (WHO-5). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.', 'timeFrame': 'baseline and 10 weeks'}\n\nPlease estimate the sample size based on the assumption: \np=0.05, power=0.95, participation rate=60%, retention rate=34%", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n G*Power calculations for within-between interaction Analysis of Variance (ANOVA) repeated measures (two-conditions, two-time points), assuming a p=0.05, effect size f=0.25, power=0.95, recommend a sample size of 54. Assuming participation and retention rates of 60% and 34% (observed in similar apps), we will recruit n=180 participants. This sample size is in accordance with Sim and Lewis37 recommendation of at least 50 participants for feasibility studies.", "id": 1854, "split": "test"} +{"trial_id": "NCT05900284", "pmid": "38688665", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Clinical Trial of the Safety and Feasibility of Metformin as a Treatment for Sepsis Induced AKI.\n\nIncluded conditions:\n- Sepsis\n- Septic Shock\n- Acute Kidney Injury\n- Metformin\n\nStudy Armgroups:\n- {'label': 'Metformin 500 mg', 'type': 'EXPERIMENTAL', 'description': 'One 500mg tablet will be administered twice a day for the first (5) days of study treatment.', 'interventionNames': ['Drug: Metformin low dose']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'One inactive tablet will be administered twice a day for the first (5) days of study treatment.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Metformin 1,000 mg', 'type': 'EXPERIMENTAL', 'description': 'One 1,000mg tablet will be administered twice a day for the first (5) days of study treatment.', 'interventionNames': ['Drug: Metformin high dose']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metformin low dose', 'description': 'If randomized to the 500 mg. Metformin arm, a tablet will be administered orally to the study participant twice a day for the initial five days starting on the date of study enrollment. Clinical research coordinators will collect blood and urine samples from study participants in both treatment arms. The blood will be collected at Baseline, Day 1 thru 7, and at hospital discharge or Day 30, whichever occurs first. On Day 2 and Day 5, the blood will be collected at hour-based intervals of 0.5h, 1h, 2h, 4h, 8h, 12h for a pharmacokinetic profile and delivered to the University of Pittsburgh Medical Center Clinical Laboratory for analysis. The remaining blood collection tubes will be delivered to the Clinical Research Biospecimen Core laboratory to be processed, separated into microtubes, and stored at -80\u00b0. Urine samples will be collected at Baseline, Day 1, 3, and 5. The urine will be processed, separated into microtubes, and frozen at -80\u00b0.', 'armGroupLabels': ['Metformin 500 mg'], 'otherNames': ['Glumetza low dose']}\n- {'type': 'DRUG', 'name': 'Metformin high dose', 'description': 'If randomized to the 1000 mg. Metformin arm, a tablet will be administered orally to the study participant twice a day for the initial five days starting on the date of study enrollment. Clinical research coordinators will collect blood and urine samples from study participants in both treatment arms. The blood will be collected at Baseline, Day 1 thru 7, and at hospital discharge or Day 30, whichever occurs first. On Day 2 and Day 5, the blood will be collected at hour-based intervals of 0.5h, 1h, 2h, 4h, 8h, 12h for a pharmacokinetic profile and delivered to the University of Pittsburgh Medical Center Clinical Laboratory for analysis. The remaining blood collection tubes will be delivered to the Clinical Research Biospecimen Core laboratory to be processed, separated into microtubes, and stored at -80\u00b0. Urine samples will be collected at Baseline, Day 1, 3, and 5. The urine will be processed, separated into microtubes, and frozen at -80\u00b0.', 'armGroupLabels': ['Metformin 1,000 mg'], 'otherNames': ['Glutzema high dose']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'If randomized to the Placebo arm, a tablet will be administered orally to the study participant twice a day for the initial five days starting on the date of study enrollment. Clinical research coordinators will collect blood and urine samples from study participants in both treatment arms. The blood will be collected at Baseline, Day 1 thru 7, and at hospital discharge or Day 30, whichever occurs first. On Day 2 and Day 5, the blood will be collected at hour-based intervals of 0.5h, 1h, 2h, 4h, 8h, 12h for a pharmacokinetic profile and delivered to the University of Pittsburgh Medical Center Clinical Laboratory for analysis. The remaining blood collection tubes will be delivered to the Clinical Research Biospecimen Core laboratory to be processed, separated into microtubes, and stored at -80\u00b0. Urine samples will be collected at Baseline, Day 1, 3, and 5. The urine will be processed, separated into microtubes, and frozen at -80\u00b0.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo dose']}\n\nPrimary Outcomes:\n- {'measure': 'The development of metformin associated serious adverse events (mSAE) which will include hyperlactatemia, hypoglycemia, metabolic acidosis and/or gastrointestinal intolerance during the treatment period', 'description': 'Safety will be measured by monitoring the patient for the development of metformin associated serious adverse events (mSAE) which will include hyperlactatemia, hypoglycemia, metabolic acidosis and/or gastrointestinal intolerance during the treatment period. In addition, patients will be monitored for any adverse event or any significant adverse event.', 'timeFrame': 'Hospital discharge or 30 days, whatever occurs first'}\n- {'measure': 'Feasibility: Recruitment, retention and adherence', 'description': 'Investigators will quantify the number of patients screened and consented, the number of patients completing the study treatment, and the number of protocol deviations.', 'timeFrame': 'Hospital discharge or 30 days, whatever occurs first'}\n- {'measure': 'Feasibility: Investigating the reasons for denial of enrollment by patients, surrogates or clinicians', 'description': \"Investigators will identify barriers to implementing the intervention perceived by physicians, patients, or patients' surrogates who decline to participate or who drop out by requesting their feedback.\", 'timeFrame': 'Hospital discharge or 30 days, whatever occurs first'}\n- {'measure': 'Feasibility: Data accrual and loss to follow-up', 'description': 'Investigators will estimate the proportion of randomized patients that achieve complete acquisition of outcome and ancillary data and lost to follow-up, and the proportion of missing data per variable.', 'timeFrame': 'Hospital discharge or 30 days, whatever occurs first'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a power of 80% to detect the specified win ratio, with various proportions of ties considered for all mSAEs. The recruitment ratio is 1:1:1 for metformin low dose, metformin high dose, and placebo control.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n LiMiT AKI will test the primary hypothesis that the proportion of metformin-associated serious adverse effects (mSAEs) are different between the metformin groups and control. We have considered four key mSAEs and ranked them in order of clinical priority as follows: hyperlactatemia, metabolic acidosis, hypoglycaemia and gastrointestinal (GI) intolerance (see below for specific definitions). The analysis of the primary outcome will be based on the mSAEs that are blindly adjudicated to be associated with the study intervention by the study\u00e2\u0080\u0099s steering committee. We have chosen to use mSAEs as a composite outcome because in critical illness, serious adverse effects (SAEs) are very common which increases the signal-to-noise ratio in the data, making it less likely to find meaningful differences.38 In addition, traditional reporting of composite outcomes may be problematic because these methodologies are very sensitive to the first (and likely the most frequent) event, and risk dismissing the presentation of other less frequently occurring events. For this study, this would result in mSAE rates driven by the presence of GI intolerance (the most frequent mSAE) while ignoring the potential effect of the intervention on other more clinically relevant mSAEs that can lead to death like hyperlactatemia and metabolic acidosis. To overcome these limitations, we will use the win ratio to estimate the difference in mSAEs between study groups.39 By ranking mSAEs based on their clinical importance, the most frequent but less life-threatening mSAE (GI discomfort) will only be compared between pairs of patients after the most clinically relevant mSAEs (ie, hyperlactatemia and metabolic acidosis) have been compared.39\n\n We calculated a sample size of 60\u00e2\u0080\u009380 to have a power of 80% to detect a win ratio of 2.5:3.0 with various proportions of ties for all mSAEs based on a 1:1:1 metformin low dose:metformin high dose:placebo control recruitment ratio (table 2). The rates of GI disturbances in patients with diabetes treated with metformin ranged from 1.5 to 2.5 times that of patients using other medications, and higher when compared with placebo.40 We considered that the addition of the other potential adverse events (ie, hyperlactatemia, acidosis, hypoglycaemia) can increase the rate of events in the metformin arm beyond 2.8. While the risk ratio is calculated based on the risk of events in the intervention group over the risk of events in the control group, the win ratio is calculated as the ratio of the events in the intervention group (wins for metformin), over the events in the control group (losses for metformin). Thus, while the risk ratio and the win ratio are not the same, the win ratio will resemble the risk ratio of the composite of adverse events occurring in patients receiving metformin when compared with placebo. Because the risk ratio for GI disturbances can be as high as 2.8 when compared with placebo, we considered that the addition of the other potential metformin-associated adverse events (ie, hyperlactatemia, acidosis, hypoglycaemia) can increase the rate of events in the metformin arm beyond this risk ratio, and therefore, that a win ratio of 2.5:3 is in line with the literature and will account for all high-risk adverse events potentially associated with the study intervention.\n \n Table 2\n \n Sample size calculation using the win ratio (WR) with multiple possibilities of ties\n \n \n \n \n Proportion of ties\n Detectable WR\n \n \n WR=2.5\n WR=2.7\n WR=3\n \n \n \n \n 0.1\n 60\n 52\n 41\n \n \n 0.2\n 74\n 64\n 52\n \n \n 0.3\n \n 78\n 64\n \n \n 0.4\n \n \n 80", "id": 1855, "split": "test"} +{"trial_id": "NCT05902702", "pmid": "38233083", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority Trial\n\nIncluded conditions:\n- Bronchiolitis\n- Respiratory Disease\n- Asthma in Children\n- Viral Infection\n- Acute Respiratory Infection\n\nStudy Armgroups:\n- {'label': 'Nebulized isotonic saline', 'type': 'EXPERIMENTAL', 'description': '5 ml of isotonic saline is administered through a nebulizer with a flow of 10 l oxygen/min', 'interventionNames': ['Other: Nebulized isotonic saline']}\n- {'label': 'Nasal irrigation with isotonic saline', 'type': 'EXPERIMENTAL', 'description': '0.5-2 ml isotonic saline in each nostril administered as nasal drops', 'interventionNames': ['Other: Nasal irrigation with isotonic saline']}\n- {'label': 'No treatment with saline', 'type': 'NO_INTERVENTION', 'description': 'These children will not receive any treatment with isotonic saline, but superficial suctioning of nasal secretions as needed (as part of standard care).'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Nebulized isotonic saline', 'description': 'The intervention will constitute nebulized isotonic saline.', 'armGroupLabels': ['Nebulized isotonic saline']}\n- {'type': 'OTHER', 'name': 'Nasal irrigation with isotonic saline', 'description': 'The intervention will constitute isotonic saline administered as nasal drops.', 'armGroupLabels': ['Nasal irrigation with isotonic saline']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of hospitalization', 'description': 'In hours', 'timeFrame': '0-7 days typically (max 14 days)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha 2.5%, power 80%, mean duration of hospitalisation 32 hours (\u00b1 25)", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Among children admitted with bronchiolitis, the mean duration of hospitalisation is estimated to be 32 hours (\u00c2\u00b1 25).19 By including 249 children in total (83 in each arm), we can prove non-inferiority of no saline relative to nasal irrigation with NS or nebulised NS with a non-inferiority limit of 12 hours admission, alpha 2.5% and a power of 80%. We aim to include 300 children in total to account for dropouts.", "id": 1856, "split": "test"} +{"trial_id": "NCT05905276", "pmid": "38858157", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol\n\nIncluded conditions:\n- Bladder Cancer\n\nStudy Armgroups:\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the usual care arm of the trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.', 'interventionNames': ['Other: Standard of Care']}\n- {'label': 'ERAS Protocol', 'type': 'EXPERIMENTAL', 'description': 'The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings.', 'interventionNames': ['Other: ERAS Protocol']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ERAS Protocol', 'description': 'The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings.', 'armGroupLabels': ['ERAS Protocol']}\n- {'type': 'OTHER', 'name': 'Standard of Care', 'description': 'Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.', 'armGroupLabels': ['Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)', 'description': 'The QoR-15 score is a validated 15-item questionnaire that assesses quality of recovery in five dimensions: pain, physical comfort, functional autonomy, emotions, and psychological support. Each item is scored 0 to 10 with higher scores representing superior quality of recovery. The QoR-15 score is patient-reported outcome measure and has been extensively used to evaluate ERAS for both inpatient and ambulatory surgeries. It is a shorter and more patient-friendly version of the QoR-40 with equivalent psychometric properties.', 'timeFrame': 'Measured at enrollment through study completion, an average of 7 days.'}\n\nPlease estimate the sample size based on the assumption: \nSD=12, compound symmetry covariance structure, two-sided alpha=0.05, 87% and 82% power with correlation of 0.3 and 0.5 respectively, one-sided test power of 93% and 89%, power calculated with PASS 2021.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n We hypothesise that the ERAS protocol will improve the mean change in QoR-15 score between DOS and POD1 by a minimum of 6 points compared with usual care, which would reflect a clinically important difference in quality of recovery.36 We assumed an SD=12 based on prior literature,30 compound symmetry covariance structure and two-sided alpha=0.05. With 50 patients per group (n=100), the study has 87% and 82% power to detect a minimum 6-point difference in the mean change in QoR-15 between ERAS vs usual care,36 conservatively assuming a correlation between the DOS and POD1 scores of 0.3 and 0.5, respectively.37 Of note, under the less conservative assumption that the ERAS protocol is unlikely to be worse than usual care, a one-sided test would achieve 93% and 89% power. Power was calculated with PASS 2021 (NCSS Software, Kaysville, Utah, USA).", "id": 1857, "split": "test"} +{"trial_id": "NCT05906485", "pmid": "39645257", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trials of the Effects of Near-infrared Spectroscopy (fNIRS) Neurofeedback Training Coupled With Virtual Reality Technology in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)\n\nIncluded conditions:\n- ADHD\n\nStudy Armgroups:\n- {'label': 'Experimental Group: fNIRS Neurofeedback-VR Training Group', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated using VR and participants will be asked to complete some academic-related tasks during the stimulated lessons. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants will learn to manipulate their attention, presumably by altering brain activities.', 'interventionNames': ['Behavioral: fNIRS Neurofeedback-VR Training']}\n- {'label': 'Active Control Group: Computerized Cognitive Training Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The computerized cognitive training group will receive 16 sessions of training, 35 minutes each, conducted twice per week over a period of 8 weeks. Participants will be asked to complete a set of computerized tasks using Cogmed, a digital training programme which is proven to enhance working memory and attention level in children.', 'interventionNames': ['Behavioral: Computerized Cognitive Training']}\n- {'label': 'Waitlist Control Group', 'type': 'OTHER', 'description': 'The waitlist control group will not receive any intervention until the intervention arms complete their training. Depending on the availability, either the fNIRS Neurofeedback-VR Training or the Computerized Cognitive Training will be offered to this group.', 'interventionNames': ['Behavioral: fNIRS Neurofeedback-VR Training', 'Behavioral: Computerized Cognitive Training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'fNIRS Neurofeedback-VR Training', 'description': 'In the fNIRS Neurofeedback-VR Training, we have designed a classroom scenario modeled and children are expected to learn how to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.', 'armGroupLabels': ['Experimental Group: fNIRS Neurofeedback-VR Training Group', 'Waitlist Control Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Computerized Cognitive Training', 'description': 'In the Computerized Cognitive Training, children will complete a range of tasks covering attention control and working memory using a conventional training programme, namely Cogmed.', 'armGroupLabels': ['Active Control Group: Computerized Cognitive Training Group', 'Waitlist Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Conners Continuous Performance Test 3rd Edition (CPT 3)', 'description': 'A standardized computerized test on sustained attention and inhibitory control', 'timeFrame': 'Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)'}\n- {'measure': 'Conners Continuous Performance Test 3rd Edition (CPT 3)', 'description': 'A standardized computerized test on sustained attention and inhibitory control', 'timeFrame': 'Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)'}\n- {'measure': 'Conners Continuous Performance Test 3rd Edition (CPT 3)', 'description': 'A standardized computerized test on sustained attention and inhibitory control', 'timeFrame': 'Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)'}\n- {'measure': \"Number subtest of Children's Memory Scale (CMS)\", 'description': 'A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30.', 'timeFrame': 'Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)'}\n- {'measure': \"Number subtest of Children's Memory Scale (CMS)\", 'description': 'A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30.', 'timeFrame': 'Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)'}\n- {'measure': \"Number subtest of Children's Memory Scale (CMS)\", 'description': 'A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30.', 'timeFrame': 'Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)'}\n- {'measure': 'Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)', 'description': 'A measure of attentional control/switching that requires the child to make cognitive reversals.', 'timeFrame': 'Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)'}\n- {'measure': 'Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)', 'description': 'A measure of attentional control/switching that requires the child to make cognitive reversals.', 'timeFrame': 'Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)'}\n- {'measure': 'Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)', 'description': 'A measure of attentional control/switching that requires the child to make cognitive reversals.', 'timeFrame': 'Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)'}\n- {'measure': 'Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)', 'description': 'A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.', 'timeFrame': 'Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)'}\n- {'measure': 'Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)', 'description': 'A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.', 'timeFrame': 'Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)'}\n- {'measure': 'Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)', 'description': 'A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.', 'timeFrame': 'Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)'}\n- {'measure': 'Functional NIRS', 'description': 'The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.', 'timeFrame': 'Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)'}\n- {'measure': 'Functional NIRS', 'description': 'The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.', 'timeFrame': 'Up to 8 to 10 weeks (within the intervention period)'}\n- {'measure': 'Functional NIRS', 'description': 'The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.', 'timeFrame': 'Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)'}\n- {'measure': 'Functional NIRS', 'description': 'The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.', 'timeFrame': 'Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a power of 0.8, an alpha level of 5%, and an anticipated attrition rate of 10%.", "answer": 138, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n The sample size calculation is based on measures of executive function, using the Conners Continuous Performance Test third Edition (CPT3) as a reference. A multiarm clinical trial sample size calculator was used for this calculation, based on an intention-to-treat design.38 For a single-stage, three-arm clinical trial with equal allocation across arms, a power of 0.8, a treatment effect size of 0.5,19 39 and an alpha level of 5%, a total sample size of 123 participants is required. To account for an anticipated attrition rate of 10%, we plan to recruit 46 participants for each condition (ie, 138 participants in total).\n Participants are identified from several sources in Hong Kong, including local paediatricians, psychiatrists, school psychologists, online social media advertising and ADHD parent associations. Formal diagnostic reports from qualified clinical health professionals are required for screening purposes in the project. In addition, the parents and teachers of potential participants are asked to complete a battery of questionnaires to assess the children\u00e2\u0080\u0099s ADHD symptoms and behavioural problems for screening.", "id": 1858, "split": "test"} +{"trial_id": "NCT05907252", "pmid": "39438105", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of Supervised Group-based Walking Program on Physical, Psychological and Social Outcomes Among Older Adults: A Randomized Controlled Trial\n\nIncluded conditions:\n- Physical Inactivity\n- Social Interaction\n\nStudy Armgroups:\n- {'label': 'Supervised Group-based Intervention', 'type': 'EXPERIMENTAL', 'description': 'Supervised Group-based intervention involves a professional walking fitness coach and 2 assistant coach. The coach is expected to require the participants to engage in the intervention in a form of group. The intervention groups will receive an 18-week walking training (3 sessions per week, 1 hour per session )in accordance with the intervention.', 'interventionNames': ['Behavioral: Supervised Group-based Intervention']}\n- {'label': 'Non-supervised Group-based Intervention', 'type': 'EXPERIMENTAL', 'description': 'Supervised Group-based intervention involves no professional walking fitness coach; however, the research team member will ask the participants to engage in the intervention in a form of group, and complete the intervention according to goals and targets of each session. The intervention groups will receive an 18-week walking training (3 sessions per week, 1 hour per session )in accordance with the intervention.', 'interventionNames': ['Behavioral: Non-supervised Group-based Intervention']}\n- {'label': 'Non-supervised Individual-based Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Non-supervised Individual-based Intervention involves no professional walking fitness coach; and no group forming is required. The participants will engage and complete the intervention individually. The intervention groups will receive an 18-week walking training (3 sessions per week, 1 hour per session )in accordance with the intervention.', 'interventionNames': ['Behavioral: Non-supervised Individual-based Intervention']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group (CG) will not be arranged to participate in any walking or physical activity intervention during the whole study period (the 18-week intervention and 12-week follow-up periods), but they will be asked to keep a daily log on their physical activity, use of medicines, illness, and other health-related activities. Besides, the CG participants will be asked to report to the research resistant (RA) if a major change has been made in the aforementioned aspects. The RA will also check the daily logs of the participants through telephone or mobile phone every two weeks. Data from those who changed their normal lifestyles (especially taking up regular physical activity) will be excluded in the subsequent data analysis.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Supervised Group-based Intervention', 'description': 'The intervention will be an 18-week walking program, with 3 times per week on alternative days. A 2-week basic walking practice with 3 sessions per week, 30-45 minutes per session, and being led by a certified walking trainer. The walking practice will take reference from the exercise procedure recommended by the \"Healthy Exercise for All Campaign\" (LCSD, Department of Health, and Physical Fitness Association Hong Kong, China, 2013). Upon completion of the 2-week basic walking practice, participants will enter week-3 to week-18 main walking program, in which the duration of each training session will increase to 45-70 minutes, depending on the levels of training. In the walking programs, the progressive training principle (ACSM, 2009) will be adopted, using 4 levels as prescribed, in which weeks 3 to 6 are Level-1; weeks 7 to 10 are Level-2, weeks 11 to 14 are Level-3, week 15-18 are Level-4.', 'armGroupLabels': ['Supervised Group-based Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Non-supervised Group-based Intervention', 'description': 'The intervention will be an 18-week walking program, with 3 times per week on alternative days. A 2-week basic walking practice with 3 sessions per week, 30-45 minutes per session, and without being led by a certified walking trainer. The walking practice will take reference from the exercise procedure recommended by the \"Healthy Exercise for All Campaign\" (LCSD, Department of Health, and Physical Fitness Association Hong Kong, China, 2013). Upon completion of the 2-week basic walking practice, participants will enter week-3 to week-18 main walking program, in which the duration of each training session will increase to 45-70 minutes, depending on the levels of training. In the walking programs, the progressive training principle (ACSM, 2009) will be adopted, using 4 levels as prescribed, in which weeks 3 to 6 are Level-1; weeks 7 to 10 are Level-2, weeks 11 to 14 are Level-3, week 15-18 are Level-4.', 'armGroupLabels': ['Non-supervised Group-based Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Non-supervised Individual-based Intervention', 'description': 'The intervention will be an 18-week walking program, with 3 times per week on alternative days. A 2-week basic walking practice with 3 sessions per week, 30-45 minutes per session, and without being led by a certified walking trainer. The walking practice will take reference from the exercise procedure recommended by the \"Healthy Exercise for All Campaign\" (LCSD, Department of Health, and Physical Fitness Association Hong Kong, China, 2013). Upon completion of the 2-week basic walking practice, participants will enter week-3 to week-18 main walking program, in which the duration of each training session will increase to 45-70 minutes, depending on the levels of training. In the walking programs, the progressive training principle (ACSM, 2009) will be adopted, using 4 levels as prescribed, in which weeks 3 to 6 are Level-1; weeks 7 to 10 are Level-2, weeks 11 to 14 are Level-3, week 15-18 are Level-4.', 'armGroupLabels': ['Non-supervised Individual-based Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Physical Health Parameters - Body Composition', 'description': 'Body Composition will be measured using the TANITA.', 'timeFrame': 'Baseline Test: Before the intervention; Post-test: within 1 week after the intervention; Follow-up test: 3 months after the intervention (Assessing the change among the 3 time points)'}\n- {'measure': 'Physical Health - Resting Heart Rate', 'description': \"Resting Heart Rate will be measured using the Fibit smart watch 2. Walking Performance The walking effects on participants' physical health parameters, including body composition, resting heart rate, and resting blood pressure will be assessed.\", 'timeFrame': 'Baseline Test: Before the intervention; Post-test: within 1 week after the intervention; Follow-up test: 3 months after the intervention (Assessing the change among the 3 time points)'}\n- {'measure': 'Physical Health - Resting Blood Pressure', 'description': \"Both Systolic and Diastolic Resting Heart Rate will be measured. 2. Walking Performance The walking effects on participants' physical health parameters, including body composition, resting heart rate, and resting blood pressure will be assessed.\", 'timeFrame': 'Baseline Test: Before the intervention; Post-test: within 1 week after the intervention; Follow-up test: 3 months after the intervention (Assessing the change among the 3 time points)'}\n- {'measure': 'Walking Performance Walking Performance', 'description': 'The time for completing the targeted steps in targeted heart rate zones of each participant in each training session will be recorded for analysis of performance and improvement on walking.', 'timeFrame': 'During the procedure/intervention'}\n- {'measure': 'Psychological Outcomes - Loneliness', 'description': 'Loneliness will be measured using the perceived loneliness scale.', 'timeFrame': 'Baseline Test: Before the intervention; Post-test: within 1 week after the intervention; Follow-up test: 3 months after the intervention (Assessing the change among the 3 time points)'}\n- {'measure': 'Psychological Outcomes - Perceived social support', 'description': 'Perceived social support will be measured using the Multidimensional Scale of Perceived Social Support Scale.', 'timeFrame': 'Baseline Test: Before the intervention; Post-test: within 1 week after the intervention; Follow-up test: 3 months after the intervention (Assessing the change among the 3 time points)'}\n- {'measure': 'Psychological Outcomes - Physical Activity Enjoyment', 'description': 'Physical Activity Enjoyment will be measured using the 8-item Physical Activity Enjoyment Scale (PACES).', 'timeFrame': 'Baseline Test: Before the intervention; Post-test: within 1 week after the intervention; Follow-up test: 3 months after the intervention (Assessing the change among the 3 time points)'}\n\nPlease estimate the sample size based on the assumption: \n95% power, 5% significance level, 25% potential dropout rate.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n G*Power is used to determine the sample size. Based on the previous intervention studies, the most frequently reported effect size on physical health ranged from low (0.12) to moderate (0.35),10 an average effect size of 0.245 will be adopted for the current study. To ensure a power of 95% probability for detecting a treatment difference at a two-sided 5% level of significance, a sample size of 40 participants per group (total 160 for 4 groups) is expected. Also taking into account a 25% potential dropout rate, a sample size of 50 participants per group (total 200 for 4 groups) will be required in the current study.", "id": 1859, "split": "test"} +{"trial_id": "NCT05907369", "pmid": "38001473", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Disgust Reduction Through Evaluative Conditioning and tDCS in Patients With Contamination-Based OCD\n\nIncluded conditions:\n- Obsessive-Compulsive Disorder\n\nStudy Armgroups:\n- {'label': 'aEC/ stDCS', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group receive active EC training but sham tDCS.', 'interventionNames': ['Other: Active EC training', 'Other: Sham tDCS']}\n- {'label': 'sEC/atDCS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group receive active tDCS training but sham EC training.', 'interventionNames': ['Other: Sham EC training', 'Other: Active tDCS']}\n- {'label': 'aEC/atDCS', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group receive both active EC training and active tDCS.', 'interventionNames': ['Other: Active EC training', 'Other: Active tDCS']}\n- {'label': 'sEC/stDCS', 'type': 'SHAM_COMPARATOR', 'description': 'Participants in this group receive the sham EC training and also sham tDCS.', 'interventionNames': ['Other: Sham EC training', 'Other: Sham tDCS']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Active EC training', 'description': 'The active EC includes pairing contamination-related pictures (CSs) with pleasant pictures (USs). The EC training takes about 15 minutes and is administered for ten sessions (5 days a week) in 4 difficulty levels.', 'armGroupLabels': ['aEC/ stDCS', 'aEC/atDCS']}\n- {'type': 'OTHER', 'name': 'Sham EC training', 'description': 'The active EC includes pairing contamination-related pictures (CSs) with neutral pictures (USs). The EC training takes about 15 minutes and is administered for ten sessions (5 days a week) in 4 difficulty levels, the same as active EC training.', 'armGroupLabels': ['sEC/atDCS', 'sEC/stDCS']}\n- {'type': 'OTHER', 'name': 'Active tDCS', 'description': 'For the active tDCS, the cathode is placed over the left OFC and the anode over the right cerebellum. The brain stimulation is delivered with a 2mA current intensity for 20 minutes in 10 sessions (5 days a week).', 'armGroupLabels': ['aEC/atDCS', 'sEC/atDCS']}\n- {'type': 'OTHER', 'name': 'Sham tDCS', 'description': 'For the sham tDCS, the cathode is placed over the left OFC and the anode over the right cerebellum, the same as active tDCS. The device is on for 20 minutes, but the current intensity is under the threshold of affecting cortical activity modulation. The participants receive the sham tDCS in 10 sessions (5 days a week).', 'armGroupLabels': ['aEC/ stDCS', 'sEC/stDCS']}\n\nPrimary Outcomes:\n- {'measure': 'Disgust Feeling', 'description': 'Effect of evaluative conditioning, cathodal tDCS over OFC, and both on changing disgust feeling intensity measured by disgust rating scale. The scale rates from 0 (not disgusting) to 10 (very disgusting). Lower scores show less disgust feeling.', 'timeFrame': 'From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)'}\n- {'measure': 'Clinical Symptoms Severity of Contamination-Based OCD', 'description': 'Change in Clinical symptoms of contamination-based OCD after evaluative conditioning, cathodal tDCS over OFC, and both, measured by Yale-Brown Obsessive-Compulsive scale. It is scored on a 5-point rating. The lower scores show less symptom severity.', 'timeFrame': 'From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 80% power, 20% attrition rate", "answer": 55, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated the sample size using the G*Power 3.1 software. To be able to get an effect on our primary outcomes (disgust feeling and clinical symptoms) in three measurements (pre-, post-, and follow-up) at repeated-measure-MANOVA approach, with 95% confidence and 80% power, estimating large effect size with Cohen\u00e2\u0080\u0099s f value 0.40, a sample size of 46 participants was calculated. With an attrition rate of 20%, we aim to enroll 55 participants.", "id": 1860, "split": "test"} +{"trial_id": "NCT05911633", "pmid": "39972606", "question": "Here is the design of a clinical trial:\n\nOfficial Title: BioPearl\u2122 Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC): Prospective, Single Arm, Multi-center, Post-Market Clinical Follow-up (PMCF) Study\n\nIncluded conditions:\n- Hepatocellular Carcinoma Non-resectable\n\nStudy Armgroups:\n- {'label': 'Single arm', 'type': 'OTHER', 'description': 'Transarterial Chemo Embolization (TACE) with BioPearl\u2122 microspheres loaded with Doxorubicin', 'interventionNames': ['Device: BioPearl\u2122']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'BioPearl\u2122', 'description': 'TACE', 'armGroupLabels': ['Single arm']}\n\nPrimary Outcomes:\n- {'measure': 'Safety: by evaluating all procedural or study device related grade 3-4-5 adverse events (AEs)', 'description': 'By evaluating all procedural or study device related grade 3-4-5 adverse events (AEs) during a period of 4 weeks post initial treatment as per local investigator assessment', 'timeFrame': 'Day 29'}\n- {'measure': 'Technical success', 'description': 'Ability to reach near stasis in the treated tumor feeding arteries during chemoembolization procedure', 'timeFrame': 'Day 1'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "2.7.1.\n Sample size\n The planned sample size is based on regulatory requirements. A total of 50 subjects will provide sufficient precision around the estimated proportion of subjects with any grade 3 to 5 procedure/device related adverse event and estimated proportion of subjects with technical success.", "id": 1861, "split": "test"} +{"trial_id": "NCT05916651", "pmid": "39948492", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The PRYME Study: Promoting Resilience in Youth Through Mindfulness mEditation.\n\nIncluded conditions:\n- Internalizing Problems\n\nStudy Armgroups:\n- {'label': 'Intervention (LOS training) + care as usual (intervention group)', 'type': 'EXPERIMENTAL', 'description': 'Intervention group: mindfulness (LOS) training + CAU', 'interventionNames': ['Behavioral: Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training', 'Behavioral: Care as usual']}\n- {'label': 'Care-as-usual (CAU)-only (control group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Control group: CAU-only', 'interventionNames': ['Behavioral: Care as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training', 'description': 'The investigational treatment is the LOS training, which is an adaptation of two previously validated mindfulness-based programs: Mindfulness-Based Cognitive Therapy (MBCT) developed by Segal, Williams, and Teasdale (2002) and the Mindful2Work (M2W) program developed by de Bruin, Formsma, and B\u00f6gels (2018). The M2W program combines mindful physical activity, yoga, and mindfulness meditation to target stress symptoms and burn-out in adults. The LOS training was adapted from these programs to meet the needs of youth with internalizing problems. The training consists of 8 weekly 2-hour sessions that each comprise three elements: mindful physical activity (15-20 minutes), yoga (15-20 minutes), and mindfulness meditation exercises (80-90 minutes). In addition to attending group sessions, participants are invited to practice at home on a daily basis. Home practice consists of daily mindfulness practices comprising mindfulness exercises, yoga and mindful physical activity.', 'armGroupLabels': ['Intervention (LOS training) + care as usual (intervention group)']}\n- {'type': 'BEHAVIORAL', 'name': 'Care as usual', 'description': 'Youth who seek help for internalizing problems from a primary mental health practitioner, including student psychologists or mental health nurse practioners, but do not (yet) meet criteria for (major) mental illness are typically offered supportive counselling, aimed primarily at helping people feel understood and supported. Supportive counselling may also include instructions on behavioral activation, particularly when individuals report reduced activity and behavioral avoidance including social withdrawal. In addition, mental health practitioners commonly employ a \"watchful waiting\" policy for people with symptoms in the milder range, where they check-in with clients on a regular basis and refer for more intensive treatment if and when symptoms worsen.', 'armGroupLabels': ['Care-as-usual (CAU)-only (control group)', 'Intervention (LOS training) + care as usual (intervention group)']}\n\nPrimary Outcomes:\n- {'measure': 'The total number of internalizing problems as measured with the ASR, computed as the sum of responses on the items comprising withdrawn, somatic complaints, anxiety and depression subscales.', 'description': 'The ASR is a 126-item self-report questionnaire assessing aspects of adaptive functioning and problems. Items are rated on a 3-point scale: 0-Not True, 1-Somewhat or Sometimes True, 2-Very True or Often True.', 'timeFrame': 'end-of-treatment (T1), approximately 3 months after the baseline assessment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes 80% power, a two-sided significance level of p < 0.05, a correlation of 0.65 between baseline and end of treatment, and a conservative dropout rate of 20%. The design effect due to clustering is 0.62.", "answer": 155, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated to ensure sufficient power to detect significant group-differences from T0 to T1 in the primary outcome measure: i.e., internalizing problems measured with broadband internalizing subscale of the Adult Self Report (ASR) [69]. The estimated effect size for the power analysis was d\u00e2\u0080\u0089=\u00e2\u0080\u00890.4, based on a meta-analysis of MBIs in youth, reporting an average effect of MBIs on internalizing problems of g\u00e2\u0080\u0089=\u00e2\u0080\u00890.392 across 29 controlled studies including almost 3000 participants [23]. Given that most of these studies involved non-clinical, school-based samples (with lower variance in internalizing problems), this effect size is expected to be a conservative estimate for the target population of help-seeking youth, as transdiagnostic clinical samples tend to report effect sizes in the 0.40\u00c2\u00a0s and 0.50\u00c2\u00a0s range (e.g., [70]). The required sample size for the current trial was calculated with correction for correlations between internalizing problems at baseline and end of treatment [71], as test\u00e2\u0080\u0093retest reliability of the ASR is in the 0.80\u00c2\u00a0s and 0.90\u00c2\u00a0s range [69] and repeated measurements of internalizing problems in adolescents at one-year intervals have been reported in the 0.50\u00c2\u00a0s and 0.60\u00c2\u00a0s range [72]. Given that the assessment interval in the current study is much shorter at 2\u00c2\u00a0months, 0.65 was taken as a reasonable estimate of the correlation in internalizing problems between baseline and end of treatment. Clustering of data in the intervention arm is accounted for, as mindfulness training is given in groups. Based on prior research in the Radboudumc Expertise Center for Mindfulness (cf. [73]) demonstrating low intraclass coefficients (ICC) in large multicenter trials, the clustering effect in the current single-center trial is anticipated to be small at \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.01. The design effect (DE), also known as the variance inflation ratio, is calculated to account for clustering in the data and its impact on the variance of the estimate [74]. With group sizes of around 9 participants on average and no expected change in standard deviation of the outcome due to the intervention, the design effect for this design is .62, given by:\\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}$$D{E}_{equal}=\\frac{1}{2}\\left\\{\\left[1+\\left({n}_{1}-1\\right){\\rho }_{1}\\right]\\cdot \\left(\\frac{{\\sigma }_{1}^{2}}{{\\sigma }_{base}^{2}}\\right)+\\left(\\frac{{\\sigma }_{0}^{2}}{{\\sigma }_{base}^{2}}\\right){ -2r}^{2}\\right\\}$$\\end{document}DEequal=121+n1-1\u00cf\u00811\u00c2\u00b7\u00cf\u008312\u00cf\u0083base2+\u00cf\u008302\u00cf\u0083base2-2r2\\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}$$=\\frac12\\left\\{\\left[1+\\left(9-1\\right)0.01\\right]\\cdot1+1-2\\left(0.65\\right)^2\\right\\}=0.62$$\\end{document}=121+9-10.01\u00c2\u00b71+1-20.652=0.62where \u00cf\u0083 is the standard deviation (SD) in the intervention group (subscript 1), control group (subscript 0) and of both groups at baseline (base) [75]. The sample size for a post-test design (only follow-up measurement) with 80% power and two-sided significance testing at p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05 is 200 subjects. Multiplying with the above design effect yields 124 subjects. With a conservative drop-out rate of around 20% (based on clinical trial experience at the Radboud Expertise Center for Mindfulness), a total of N\u00e2\u0080\u0089=\u00e2\u0080\u0089124/0.8\u00e2\u0080\u0089=\u00e2\u0080\u0089155 youth (i.e., approximately N\u00e2\u0080\u0089=\u00e2\u0080\u008978 per group, effective sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089124 participants) will be recruited. Based on consultations with regional mental health care providers, a sufficiently large source population for the recruitment of study participants is anticipated.", "id": 1862, "split": "test"} +{"trial_id": "NCT05916937", "pmid": "39762098", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Extending Omalizumab Treatment Intervals in Patients with Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial\n\nIncluded conditions:\n- Chronic Spontaneous Urticaria\n- Chronic Urticaria, Idiopathic\n\nStudy Armgroups:\n- {'label': 'omalizumab 300 mg every six weeks', 'type': 'ACTIVE_COMPARATOR', 'description': '20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.', 'interventionNames': ['Drug: omalizumab 300 mg every six weeks']}\n- {'label': 'omalizumab 300 mg every four weeks', 'type': 'ACTIVE_COMPARATOR', 'description': '20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.', 'interventionNames': ['Drug: omalizumab 300 mg every four weeks']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'omalizumab 300 mg every four weeks', 'description': 'Continue standard treatment with omalizumab 300 mg every four weeks from week 12 to week 36.\\n\\nBoth arms are treated with omalizumab 300 mg from week 0 to week 12.', 'armGroupLabels': ['omalizumab 300 mg every four weeks'], 'otherNames': ['Standard treatment']}\n- {'type': 'DRUG', 'name': 'omalizumab 300 mg every six weeks', 'description': 'Treatment in an extended interval of omalizumab 300 mg every six weeks from week 12 to week 36.\\n\\nBoth arms are treated with omalizumab 300 mg from week 0 to week 12.', 'armGroupLabels': ['omalizumab 300 mg every six weeks'], 'otherNames': ['Extended treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Absolute difference in average Urticaria Control Test (UCT) score at week 36', 'description': 'The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.', 'timeFrame': 'Through study completion, an average of 36 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, one-sided significance level of 0.025, and a drop-out rate of 20%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n A mean UCT score of 14 with a SD of 3 points is expected in both arms prior to the intervention. Assuming no difference between the standard and experimental treatment, 32 patients are required to reject the null hypothesis, that omalizumab 300\u00e2\u0080\u0089mg Q6W is inferior to omalizumab 300\u00e2\u0080\u0089mg Q4W, with 80% power and a one-sided significance level of 0.025. A total of 40 patients, with 20 patients in each arm, are therefore included to allow a drop-out rate of 20%.", "id": 1863, "split": "test"} +{"trial_id": "NCT05916963", "pmid": "38965611", "question": "Here is the design of a clinical trial:\n\nOfficial Title: FIRESTONES : Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser: a Randomized Controlled Two-parallel Group Multicenter Trial With Blinding Evaluation\n\nIncluded conditions:\n- Kidney Stone\n\nStudy Armgroups:\n- {'label': 'Furosemide', 'type': 'EXPERIMENTAL', 'description': 'Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.', 'interventionNames': ['Drug: Furosemide 40 mg']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Usual care, without injection of Furosemide.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Furosemide 40 mg', 'description': 'Injection of 40 mg of Furosemide during 10 minutes after the end of the flexible ureteroscopy for destruction of kidney stones with laser.', 'armGroupLabels': ['Furosemide']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of stone free patients', 'description': 'Rate of stone-free patients 3 months after a flexible ureteroscopy for renal stone laser destruction, evaluated on the low dose abdomino-pelvic CT-Scan.\\n\\nA centralized review of the images will be performed by two specialized radiologists, in a blind and crossed way to allow a homogenization of the results', 'timeFrame': 'At 3 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided type I error level of 5%, a power of 90%, and a 10% non-randomization rate.", "answer": 374, "answer_type": "ESTIMATED", "explanation": "Sample size\n The proportion of stone-free patients at 3 months is expected to be 95% in the furosemide group, as compared to 85% in the control group. Indeed, in the literature, the stone-free rate is estimated at 85% [16]. We hypothesize that our treatment will increase this percentage by 10% to have an impact in current. Considering a two-sided type I error level of 5% and a power of 90%, we need to randomize 374 patients.\n Because patients will be pre-included, and randomized only at the end of the surgical procedure, we plan to include 416 patients, thus considering that 10 % of them will not be randomized.", "id": 1864, "split": "test"} +{"trial_id": "NCT05917340", "pmid": "38693583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis : an Open-label Randomized Controlled Trial\n\nIncluded conditions:\n- Tuberculous Meningitis\n\nStudy Armgroups:\n- {'label': 'Arm- 1( Intervention arm with aspirin)', 'type': 'EXPERIMENTAL', 'description': 'Intensified with high dose rifampicin, moxifloxacin, aspirin and steroids in the initial two months.', 'interventionNames': ['Drug: High dose rifampicin (25mg/kg)', 'Drug: Moxifloxacin 400mg', 'Drug: Aspirin 150 mg', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Steroid', 'Drug: Rifampicin']}\n- {'label': 'Arm -2 (Intervention arm without aspirin)', 'type': 'EXPERIMENTAL', 'description': 'Intensified with high dose rifampicin, moxifloxacin and steroids in the initial two months.', 'interventionNames': ['Drug: High dose rifampicin (25mg/kg)', 'Drug: Moxifloxacin 400mg', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Steroid', 'Drug: Rifampicin']}\n- {'label': 'Arm -3 (Control)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Regimen as per the current National Tuberculosis Elimination Program in India.', 'interventionNames': ['Drug: HRZE', 'Drug: HRE']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'High dose rifampicin (25mg/kg)', 'description': 'Given for 2 months', 'armGroupLabels': ['Arm -2 (Intervention arm without aspirin)', 'Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'Moxifloxacin 400mg', 'description': 'Given for 2 months', 'armGroupLabels': ['Arm -2 (Intervention arm without aspirin)', 'Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'Aspirin 150 mg', 'description': 'Given for 2 months', 'armGroupLabels': ['Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'Isoniazid', 'description': 'Given for 6 months', 'armGroupLabels': ['Arm -2 (Intervention arm without aspirin)', 'Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'Pyrazinamide', 'description': 'Given for 6 months', 'armGroupLabels': ['Arm -2 (Intervention arm without aspirin)', 'Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'Steroid', 'description': 'Tapering dose of dexamethasone or prednisolone upto 8 weeks', 'armGroupLabels': ['Arm -2 (Intervention arm without aspirin)', 'Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'Rifampicin', 'description': 'Standard dose for 4 months after the initial treatment with high dose', 'armGroupLabels': ['Arm -2 (Intervention arm without aspirin)', 'Arm- 1( Intervention arm with aspirin)']}\n- {'type': 'DRUG', 'name': 'HRZE', 'description': '2 months', 'armGroupLabels': ['Arm -3 (Control)']}\n- {'type': 'DRUG', 'name': 'HRE', 'description': '7-10 months as per TB program guidelines', 'armGroupLabels': ['Arm -3 (Control)']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality rate', 'description': 'Between two groups', 'timeFrame': '12 months'}\n- {'measure': 'Disability rate', 'description': 'Measured by Modified Rankin scale. A score of 0 to 2 will be considered as no disability and 3-5 will be considered as disability. 0 - no symptoms ; 5 - severe disability', 'timeFrame': '12 months'}\n- {'measure': 'Mortality rate', 'timeFrame': '12 months'}\n- {'measure': 'Disability rate', 'description': 'Measured by Modified Rankin scale. A score of 0 to 2 will be considered as no disability and 3-5 will be considered as disability. 0 - no symptoms ; 5 - severe disability', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes 85% power, a 5% level of significance, a 2-sided significance test, and a 10% loss to follow-up.", "answer": 372, "answer_type": "ESTIMATED", "explanation": "Sample size\n The trial is powered to assess the superiority of intensified regimen (arm 1) compared to control regimen (arm 3). A systematic review and meta-analysis on treatment outcomes in TBM done by Stadelman et al. reported the proportion of mortality and disability after treatment is 24% and 32%, respectively [7]. The proportion of composite outcome (death or disability) is 56%. We assume a 20% reduction of composite outcome with our intervention (i.e., from 56 to 36%). We used the formula for Z test for comparing proportion between two groups (arm 1 and arm 3). Hence, to study the impact of \u00e2\u0080\u009cIntervention\u00e2\u0080\u009d compared to \u00e2\u0080\u009cStandard care\u00e2\u0080\u009d in reducing the composite outcome (death or disability), expecting a minimum difference of 20% between intervention arm with aspirin (arm 1) and control arm (arm 3), assuming 85% power of the study, 5% level of significance, 2-sided significance test; the required sample size was 112 patients in each arm. Considering 10% lost to follow-up, the total sample size was calculated as 372 with 124 in each arm. Previous clinical trials in TBM have evaluated mortality as an outcome and considered 30% reduction [14]. Since we propose to evaluate composite outcome of death or disability, we have assumed a conservative effect size of 20% reduction. The 10% loss to follow-up is assumed based on the previous TBM trials as well as randomized controlled trials conducted at ICMR-NIRT, Chennai [20, 21].", "id": 1865, "split": "test"} +{"trial_id": "NCT05920967", "pmid": "39819928", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Continuous Paravertebral Nerve Block Combined With Dexamethasone Palpitate vs Combined With Dexamethasone Sodium Phosphate on Chronic Postoperative Pain in Patients Undergoing Minimally Invasive Cardiac Surgery\n\nIncluded conditions:\n- Chronic Postoperative Pain\n\nStudy Armgroups:\n- {'label': 'DXP group', 'type': 'EXPERIMENTAL', 'description': 'The participants in DXP group will receive a first dose of a single paravertebral space infusion of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml.', 'interventionNames': ['Drug: Dexamethasone Palmitate']}\n- {'label': 'DXM group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The participants in DXM group will receive a single infusion of a paravertebral space first dose of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml.', 'interventionNames': ['Drug: Dexamethasone Sodium Phosphate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone Palmitate', 'description': 'a single paraverteal space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. Then, a continuous paraverteal nerve block pump was connected for postoperative analgesia. The liquid of the pump was 250 ml 0.2 percentage ropivacaine. The background of the pump was set to 5 ml/h and PCA was set to 5 ml at an interval of 30 min.', 'armGroupLabels': ['DXP group']}\n- {'type': 'DRUG', 'name': 'Dexamethasone Sodium Phosphate', 'description': 'a single paraverteal space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. Then, a continuous paraverteal nerve block pump was connected for postoperative analgesia. The liquid of the pump was 250 ml 0.2 percentage ropivacaine. The background of the pump was set to 5 ml/h and PCA was set to 5 ml at an interval of 30 min.', 'armGroupLabels': ['DXM group']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence of chronic postoperative pain', 'description': 'Pain status score on the Brief Pain Inventory\uff08BPI-NRS score range, 0-10; \u22651 indicates it happens\uff09', 'timeFrame': '3 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to maintain a power of 80% at a 5% significance level. One interim analysis at a 50% information rate with futility and efficacy bounds approximated using the O'Brien and Fleming method. A 10% drop-out rate is considered.", "answer": 902, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical considerations\n The sample size was determined based on the group sequential design to maintain a power of 80% at a 5% significance level. The pilot observation of 50 patients who underwent total thoracoscopic assisted cardiac surgery, intercostal small-incision coronary bypass surgery and intercostal small-incision heart valve replacement in Xijing Hospital indicated that CPSP at 3 months following surgery was around 50%. We thus hypothesised that the use of D-PAL can reduce the incidence rate of CPSP by 20%; that is, the hypothetical incidence rate in D-PAL and DSP groups are 40% and 50%, respectively. One interim analysis at a 50% information rate with futility and efficacy bounds approximated using the O\u00e2\u0080\u0099Brien and Fleming method by the Data and Safety Monitoring Board (DSMB). The rpact package was used for calculating the sample size. A total of 902 (451 in each group) participants are required considering 10% drop-out rates.\n Demographic and baseline information will be succinctly described using descriptive statistics. Categorical variables will be represented as counts (percentages) and assessed with \u00cf\u00872 or Fisher\u00e2\u0080\u0099s exact test, as appropriate. Unadjusted univariable analyses for between-group incidence differences will employ relative risks and 95% CIs, derived from contingency table and distribution asymptotic approximations. Continuous variables will be presented as mean (\u00c2\u00b1SD) or median (IQR). Normality will be checked using visual histogram evaluation and Shapiro-Wilk tests. Between-group differences in continuous variables will be examined using t-tests or Wilcoxon rank-sum tests, depending on distribution normality.\n The primary analyses will be conducted on an intention-to-treat basis with all participants randomised included. In addition, complementary analyses will be performed on the per-protocol data set. The primary outcome will crudely be compared using a \u00cf\u00872 test and reported with risk difference and 95% CI. The estimated risk ratio with a 95% CI will also be obtained using Wald\u00e2\u0080\u0099s likelihood ratio approximation test. A generalised linear regression of the binomial family with either logit or log link will be used depending on the incidence rate and will also be applied to estimate adjusted ORs or relative risks with 95% corresponding CIs. Any pre-randomisation data will be adjusted if they are determined to be strong or important prognostic factors.45 We will assess the balance of randomised groups on the baseline and procedural characteristics using absolute standardised difference, defined as the absolute difference in means, mean ranks or proportions divided by the pooled SD. Baseline variables with standardised differences>0.131 (1.96\u00c3\u0097sqrt (1/451+1/451)) will be defined as imbalanced and be adjusted.\n The secondary outcomes will follow the same procedures as described above: crude comparisons will be conducted using the \u00cf\u00872 test; risk differences and relative risks will be provided together with 95% CIs; binomial regressions with either log or logit links will be employed for binary data. For continuous responses, linear regressions with appropriate transformations (eg, log, square root, inverse) where necessary will be conducted. For circumstances where response variables fit better with the log-Gaussian assumption, generalised linear regression will be employed. Cox proportional hazard models will be used for time-to-event (eg, when the pain was first reported) where proportionality will be inspected via Kaplan-Meier curves, log-log plots and Schoenfeld residuals. Estimated HRs will be reported with 95% CIs, and non-parametric comparisons will be done using log-rank tests. All adverse reactions will be reported and analysed, where comparisons will be conducted as described above.\n The following sensitivity analyses are planned for the primary outcome. First, the same analysing procedures will be conducted on the per-protocol set. Second, the BPI-SF score will be treated as a continuous variable and compared using t-tests. Adjusted inference will be carried out based on appropriate regression methods depending on data distribution. The between-group differences will be estimated and reported with 95% CIs. Third, the interaction between the group and timing for BPI-SF score at 3, 6 and 12 months will be analysed using repeated measure analysis of variance. We anticipate a low missing rate of the primary outcome. If more than 5% of data are missing for the primary outcome, multiple imputations will be carried out as a sensitivity analysis.\n Preplanned subgroup analysis considers age (median of the whole cohort), gender (male, female), BMI (\u00e2\u0089\u00a424, >24), incision type (video-assisted thoracic ports incision that involves several intercostal spaces, single long intercostal incision), CPB (yes, no) and block side (left, right). The interaction effect will be assessed via the inclusion of interaction terms between stratified variables and intervention groups in the corresponding models. Exploratory analysis of the interaction between the randomisation group and different time points will be done on repetitively collected secondary outcomes with risk ratio and 95% CIs estimated. Length of intubation, postoperative length of stay in bed and in hospital will be described and analysed using survival methods. The stress response indices, information on the first insulin administration within 24 hours, and the cumulative dose of insulin within 48 hours will be described and compared without adjustment for multiple comparisons.", "id": 1866, "split": "test"} +{"trial_id": "NCT05921955", "pmid": "38254137", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Maternal Oxygen Supplementation by High-flow Nasal Oxygen Compared With Room Air on Fetal Acidemia\n\nIncluded conditions:\n- Fetal Acidemia\n\nStudy Armgroups:\n- {'label': 'air group', 'type': 'NO_INTERVENTION', 'description': 'the patients of the air group receive the 2L/min with air pattern by the Optiflow high-flow nasal cannula system from anesthesia to fetal delivery.'}\n- {'label': 'HFNO group', 'type': 'EXPERIMENTAL', 'description': 'For HFNO group, a flow rate of 40L/min, with 100% oxygen concentration and a temperature of 37\u2103 by the Optiflow high-flow nasal cannula system from anesthesia to fetal delivery.', 'interventionNames': ['Device: Optiflow high-flow nasal cannula system']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Optiflow high-flow nasal cannula system', 'description': 'Using the Optiflow high-flow nasal cannula system to supply oxygen for maternal.', 'armGroupLabels': ['HFNO group']}\n\nPrimary Outcomes:\n- {'measure': 'umbilical artery lactate, mmol/L', 'description': 'mmol/L', 'timeFrame': 'the fetal delivery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (1-\u03b2) = 0.80, 15% patient loss.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n According to a retrospective observational study, there was a strong inverse correlation between lactate and pH (r\u00e2\u0080\u0089=\u00e2\u0080\u0089\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.77, p\u00e2\u0080\u0089<\u00e2\u0080\u00890.001) [18], and the clinically significant change of UA pH is assumed to be 0.02 pH units [19]. According to the experience of our hospital, the mean of the UA lactate is 2.0 (0.028) mmol/l. With a probability of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, and power of 0.80, the sample size was 53 according to a 2-side 2-sample equal-variance t test. Considering 15% patient loss, we are going to recruit 120 patients. The sample size was calculated with PASS software.", "id": 1867, "split": "test"} +{"trial_id": "NCT05922982", "pmid": "38926148", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery\n\nIncluded conditions:\n- Vasoplegia\n- Shock\n- Norepinephrine\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Standard care arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol', 'interventionNames': ['Drug: norepinephrine weaning protocol']}\n- {'label': 'Experimental arm (HPI-guided)', 'type': 'EXPERIMENTAL', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\\\\<80) delivered by the Acumen IQ medical device.', 'interventionNames': ['Drug: norepinephrine weaning protocol and guided by the HPI']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'norepinephrine weaning protocol', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol', 'armGroupLabels': ['Standard care arm']}\n- {'type': 'DRUG', 'name': 'norepinephrine weaning protocol and guided by the HPI', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\\\\<80) delivered by the Acumen IQ medical device.', 'armGroupLabels': ['Experimental arm (HPI-guided)']}\n\nPrimary Outcomes:\n- {'measure': 'Comparison of the duration of norepinephrine administration between both groups', 'description': 'The duration will be defined as the difference in time between the beginning of the study (day 0) and the end of the study protocol (day 3).', 'timeFrame': '72 hours'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed alpha level of 5%, power of 80%, and a 10% dropout rate. No interim analysis is planned.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Statistical method and sample size calculation\n For the primary endpoint, the null hypothesis (the duration of NE administration is the same between the two groups) will be rejected in favour of the alternative hypothesis (there is a difference) using an independent samples t-test (or Mann-Whitney test depending on the normality of the data) with a two-tailed alpha level of 5%. An analysis of covariance model will validate the difference between the two groups after adjusting for Euroscore II and the NE dose at randomisation. An analysis of variance tests for repeated haemodynamic measures will be used for the secondary endpoints. The number of failures in the weaning NE protocol, postoperative complications and mortality rate will be compared using a \u00cf\u00872 test. The total dose of NE, cumulative diuresis, fluids administered during the NE weaning protocol, ICU and hospital stay will be compared using a Student\u00e2\u0080\u0099s t-test. (or the Mann-Whitney test, depending on the normality of the data. A p value of 0.05 will be considered significant. No interim analysis is planned in the trial.\n \n Sample size calculation\n According to a previous study, the SD of the duration of NE administration in patients with vs postcardiac surgery was 6\u00e2\u0080\u0089hours.14 Therefore, to demonstrate a difference of 3\u00e2\u0080\u0089hours between the two groups, it is necessary to include 128 patients. These calculations were performed with a two-tailed alpha level of 5% and a power of 80%. Considering that 10% of patients may not be evaluable for the primary criterion, 142 patients will be included. Amiens University Hospital annually conducts approximately 550 cardiac surgery procedures with on-pump CPB surgery. A recent study conducted at our centre revealed an incidence of 30% of vs following cardiac surgery. Assuming that 50% of vs cases will meet eligibility, the criteria suggest a potential enrolment of 82 patients annually. Considering possible exclusions due to vacations and operating room closures, we anticipate a total enrollment period of 24 months, with a target of 142 patients (71 patients in each group\u00e2\u0080\u0094standard and interventional).", "id": 1868, "split": "test"} +{"trial_id": "NCT05922982", "pmid": "38926148", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery\n\nIncluded conditions:\n- Vasoplegia\n- Shock\n- Norepinephrine\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Standard care arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol', 'interventionNames': ['Drug: norepinephrine weaning protocol']}\n- {'label': 'Experimental arm (HPI-guided)', 'type': 'EXPERIMENTAL', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\\\\<80) delivered by the Acumen IQ medical device.', 'interventionNames': ['Drug: norepinephrine weaning protocol and guided by the HPI']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'norepinephrine weaning protocol', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol', 'armGroupLabels': ['Standard care arm']}\n- {'type': 'DRUG', 'name': 'norepinephrine weaning protocol and guided by the HPI', 'description': 'MAP-based (MAP \\\\> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\\\\<80) delivered by the Acumen IQ medical device.', 'armGroupLabels': ['Experimental arm (HPI-guided)']}\n\nPrimary Outcomes:\n- {'measure': 'Comparison of the duration of norepinephrine administration between both groups', 'description': 'The duration will be defined as the difference in time between the beginning of the study (day 0) and the end of the study protocol (day 3).', 'timeFrame': '72 hours'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed alpha level of 5%, power of 80%, and a 10% dropout rate. No interim analysis is planned.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to a previous study, the SD of the duration of NE administration in patients with vs postcardiac surgery was 6\u00e2\u0080\u0089hours.14 Therefore, to demonstrate a difference of 3\u00e2\u0080\u0089hours between the two groups, it is necessary to include 128 patients. These calculations were performed with a two-tailed alpha level of 5% and a power of 80%. Considering that 10% of patients may not be evaluable for the primary criterion, 142 patients will be included. Amiens University Hospital annually conducts approximately 550 cardiac surgery procedures with on-pump CPB surgery. A recent study conducted at our centre revealed an incidence of 30% of vs following cardiac surgery. Assuming that 50% of vs cases will meet eligibility, the criteria suggest a potential enrolment of 82 patients annually. Considering possible exclusions due to vacations and operating room closures, we anticipate a total enrollment period of 24 months, with a target of 142 patients (71 patients in each group\u00e2\u0080\u0094standard and interventional).", "id": 1869, "split": "test"} +{"trial_id": "NCT05923333", "pmid": "37853370", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial\n\nIncluded conditions:\n- Hiv\n- Vaccine Reaction\n- Microbial Colonization\n- Infant Development\n\nStudy Armgroups:\n- {'label': 'B. infantis Rosell\u00ae-33', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 8 x 109 CFU B. infantis Rosell\u00ae-33 per dose (single microbial active ingredient) and carrier material (maltodextrin) for 28 days from day 1-3 of life.', 'interventionNames': ['Dietary Supplement: B. infantis Rosell\u00ae-33']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will receive placebo (containing all materials besides B. infantis Rosell\u00ae-33) for 28 days from day 1-3 of life.', 'interventionNames': ['Dietary Supplement: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'B. infantis Rosell\u00ae-33', 'description': 'B. infantis Rosell\u00ae-33 + maltodextrin', 'armGroupLabels': ['B. infantis Rosell\u00ae-33']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Gut microbiome', 'description': 'Alpha (Shannon) and Beta (Bray Curtis and UniFrac) diversity metrics on the entire microbial communities, assessed by bacterial shotgun metagenomics of infant stool, will be compared between treatment arms', 'timeFrame': '4 weeks of age'}\n- {'measure': 'Markers of intestinal inflammation and microbial translocation', 'description': 'Concentration of markers of intestinal inflammation and microbial translocation (Lipocalin-2 (Lcn-2), sCD163, I-FABP and LBP measured by ELISA in infant plasma) will be compared cross-sectionally at each time point between groups using Mann-Whitney U tests', 'timeFrame': '4 - 36 weeks of age'}\n- {'measure': 'BCG vaccine respone', 'description': 'Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.', 'timeFrame': '7 weeks of age'}\n- {'measure': 'BCG vaccine respone', 'description': 'Frequencies of total net cytokine producing cells in response to stimulation with BCG will be compared between arms.', 'timeFrame': '36 weeks of age'}\n\nPlease estimate the sample size based on the assumption: \nObjective 1: Generalized linear regression with betabinomial error model, 9% lost-to-follow-up rate at week 36. Objective 2: 80% power, standard deviation of 0.164, 20% difference detection. Objective 3: 80% power, standard deviation of 0.8, 2.5% to 7% lost-to-follow-up rate at week 7.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n We propose to enrol 200 iHEU based on sample size calculation conducted for each of the three primary objectives.Objective 1: Sample size calculations were based on metagenomic data from D\u00e2\u0080\u0099Souza et al. (2020) [44], and on B. infantis copies in the stool collected at day 4\u00e2\u0080\u00937 of life from infants in our current observational cohort from the same clinical site, where the mean B. infantis copy number was 3000 per 2.5\u00c2\u00a0ng gDNA. The power analysis was based on a generalized linear regression approach, with a betabinomial error model for the dependent variable where varying effect sizes were injected to calculate effective power. The sample size of 100 iHEU per group is adequately powered to detect a difference of at least twofold for differential abundance testing and R2 values of 0.01 or higher in PERMANOVA analyses between iHEU administering B. infantis Rosell\u00c2\u00ae-33 versus those administering placebo, even after accounting for a lost-to-follow-up rate of 9% at week 36 (based on our observational cohort).Objective 2: Based on data from our observational cohort where the mean log intestinal fatty-acid binding protein (iFABP) plasma concentration in iHEU at day 4\u00e2\u0080\u00937 was 0.454\u00c2\u00a0ng/ml with a standard deviation of 0.164, we will have 80% power to detect a 20% difference in iFABP with n\u00e2\u0080\u0089=\u00e2\u0080\u008951 per group. Therefore, our proposed sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089100 per group will be ample to detect what we think is a meaningful difference.Objective 3: A sample size of 78 per group (total n\u00e2\u0080\u0089=\u00e2\u0080\u0089156) will provide 80% power to detect a 45% increase in total net Th1 cytokine responses to BCG based on preliminary data in iHEU where the mean response was 0.78 and standard deviation 0.8, and the proposed sample size of 100 iHEU per arm accounts for a predicted loss-to-follow-up rate of 2.5% to 7\u00c2\u00a0weeks, resulting in an expected sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089195 at week 7.", "id": 1870, "split": "test"} +{"trial_id": "NCT05923944", "pmid": "38243201", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Effect of Gamified Cognitive Training and of Casual Videogame Play on Anxiety in Adolescents: Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Anxiety\n- Anxiety Disorders and Symptoms\n\nStudy Armgroups:\n- {'label': 'Eco-Rescue - Attentional Control - intervention', 'type': 'EXPERIMENTAL', 'description': \"The Eco-Rescue training intervention will be delivered through a dedicated video game installed on each participant's personal computer through the Steam platform, following a recommended training regimen of 30 minutes per day, 4 days per week for 6 weeks, for an expected total training duration of 12 hours.\", 'interventionNames': ['Behavioral: Eco-Rescue']}\n- {'label': 'Bejeweled 3 - Casual gaming - intervention', 'type': 'EXPERIMENTAL', 'description': \"The Bejeweled 3 training intervention will be delivered through a dedicated video game installed on each participant's personal computer through the Steam platform, following a recommended training regimen of 30 minutes per day, 4 days per week for 6 weeks, for an expected total training duration of 12 hours.\", 'interventionNames': ['Behavioral: Bejelewed 3']}\n- {'label': 'No-training intervention', 'type': 'NO_INTERVENTION', 'description': 'The No-training intervention group does not involve any specific training program. Instead, participants assigned to this group will receive weekly phone calls, similar to the other groups, to answer the same questions as the other groups concerning their mental and emotional states and maintain regular contact throughout the 6-week study duration.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Eco-Rescue', 'description': 'Ecorescue is a gamified adaptation of the multiple object tracking task (MOT) combined with a detection task. It requires to track the spatial position of specific moving targets among visually similar moving distractors, while at the same time detecting briefly flashed events. It was designed to load on attentional control and visuo-spatial working memory. Additionally, targets may express various facial emotions (happy, angry or neutral) requiring some emotional control in addition to attentional control.', 'armGroupLabels': ['Eco-Rescue - Attentional Control - intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Bejelewed 3', 'description': 'Bejeweled 3 is a commercially available puzzle video game developed and edited by PopCap Games. The main objective is to swap two adjacent gems of seven colors to create a line or row of 3 or more gems of the same type. When these gems are aligned, they disappear, and points are earned. The goal is to get as many points as possible until it is impossible to line up gems. Bejeweled 3 offers a variety of game modes that players can freely explore at their own pace, enhancing the overall enjoyment and providing increased variability during each gaming session. These game modes typically have shorter durations, with a single game usually lasting less than 5 minutes. Bejeweled 3 was chosen as it requires fewer attentional resources compared to Eco-Rescue and because it was reported to reduce stress and anxiety in adult samples (Russoniello et al. 2009, 2013).', 'armGroupLabels': ['Bejeweled 3 - Casual gaming - intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Anxiety assessed through the Screen for Child Anxiety Related Emotional Disorders Child Version (SCARED-C; Birmaher et al. 1999)', 'description': 'The SCARED-C is a 41 items self-report anxiety questionnaire with subscales measuring General Anxiety Disorder, Social Phobia Disorder, Panic Disorder, Separation Anxiety Disorder and School Avoidance. Participants are asked to rate each statement, referring to the past four weeks, on a scale ranging from 0 (Not True or Hardly Ever True) to 2 (Very True or Often True). A score of 25 or higher may indicate the presence of an Anxiety Disorder. Analysis of primary outcome will be based on this total score.', 'timeFrame': 'Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)'}\n\nPlease estimate the sample size based on the assumption: \nalpha level of 0.05, power of 0.8, repeated-measure correlation of 0.70, and a 30% dropout rate", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n A power analysis indicates 26 participants per group are needed given a repeated measure ANOVA design looking at a 3-within (time of assessment) x 3\u00e2\u0080\u0093between (training conditions) interaction, Hedge\u00e2\u0080\u0099s G of -0.25, alpha level of 0.05 and power of 0.8, and a repeated-measure correlation of 0.70 (test-retest correlation on SCARED from Behrens et al., [73]; and Hedge\u00e2\u0080\u0099s G from the meta-analytic work of Wang et al. [74]. Our analyses design, however, calls for assessing differences between each of the training groups and the control group, or between the 2 training groups. For such 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892 ANOVA design, with the same characteristics as above, 38 participants per intervention group is needed. We therefore plan on a total of 114 participants (38 for each of the three groups) in the final sample. Planning a 30% drop-out rate, we therefore expect to recruit 150 participants (50 for each of the three groups).", "id": 1871, "split": "test"} +{"trial_id": "NCT05923983", "pmid": "39558377", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reduction of Acute Renal Failure and/or Hyperkaliemia Adverse Drug Events in Older Inpatients by Incorporating Specific Rules Into a Computerized Support System and Dedicated Procedures: a Randomized Trial.\n\nIncluded conditions:\n- Patient Acceptance of Health Care\n- Acute Renal Failure\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Clinical decision support']}\n- {'label': 'Control Group', 'type': 'OTHER', 'interventionNames': ['Other: Will not receive Clinical Decision Support']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Clinical decision support', 'description': 'In the intervention group, the pharmaceutical validation will be based on routine care, often on entry to a ward and by analysis of all the alerts produced by the CDSS. Some alerts will result in a pharmaceutical intervention being provided to the medical team', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'OTHER', 'name': 'Will not receive Clinical Decision Support', 'description': 'In the control group, the pharmaceutical validation will be based on routine care, often on entry to a ward or in a particular situation', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Number of adverse drug events such as acute renal failure and/or hyperkalemia in older hospitalized patients.', 'timeFrame': 'through study completion, an average of 20 days'}\n\nPlease estimate the sample size based on the assumption: \nThe intraclass correlation coefficient (ICC) is estimated to be 0.005. The significance level (alpha) is set at 5%, and the power is set at 80%.", "answer": 4920, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In this stepped-wedge, cluster-randomized, controlled trial, the unit of randomization is the center. The number of participants depends on the correlation between the participants in the same cluster, as estimated with the intraclass correlation coefficient (ICC). No data are available for determining the ICC for the primary endpoint ADE in a population similar to that expected in our study. However, we have estimated the ICC to be 0.005 on the basis of on the ADAMS study [32], which provides ICC values for a large number of variables in primary care. The estimateADE rate is 10% in the control group (4.5% for hyperkalemia and 8.0% for AKI, with both events concomitantly in some cases) [20]. Based on these values, we estimated that 7% in the interventional group were at risk of hyperkalemia and/or AKI (70% of ADEs are considered to be preventable, and the system will correct about 40% of these). With the five-cluster, six-phase design, a total of 4920 patients will have to be recruited (164 per cluster and per phase, in a two-sided test with an alpha risk of 5% and a power of power = 80%). All cases of AKI and hyperkalemia are included as events, regardless of the causes; this has been taken into account in the sample size calculation.", "id": 1872, "split": "test"} +{"trial_id": "NCT05927376", "pmid": "39806712", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MediMood: A Randomised Controlled Trial Investigating the Acute Impact of a Plant Based Mediterranean-style Dietary Pattern (MDP) on Mood, Anxiety and Cognition in UK Adults With Mild to Moderate Mental Health Complaints\n\nIncluded conditions:\n- Depression, Anxiety\n\nStudy Armgroups:\n- {'label': 'Mediterranean-style dietary pattern', 'type': 'EXPERIMENTAL', 'description': 'A Mediterranean-style diet (as a whole diet, no supplements)', 'interventionNames': ['Behavioral: Mediterranean diet']}\n- {'label': 'Western-style dietary pattern', 'type': 'ACTIVE_COMPARATOR', 'description': 'A Western-style diet (as a whole diet, no supplements)', 'interventionNames': ['Behavioral: Western diet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mediterranean diet', 'description': 'All foods, meal plans and instructions provided.', 'armGroupLabels': ['Mediterranean-style dietary pattern']}\n- {'type': 'BEHAVIORAL', 'name': 'Western diet', 'description': 'All foods, meal plans and instructions provided.', 'armGroupLabels': ['Western-style dietary pattern']}\n\nPrimary Outcomes:\n- {'measure': 'Change in mood', 'description': 'Established by the Bond-Lader visual analogue scale (includes 16 items each having antonyms on two ends, on a scale of 1 to 100, 50 being the neutral point)', 'timeFrame': 'Baseline (morning of day 1), Postprandial (after lunch on Established by the Bond-Lader visual analogue scale (includes 16 items each having day 1), 24-hours (morning of day 2), day 5 (morning of day 6 upon completion of 5 full days intervention)'}\n- {'measure': 'Change in anxiety', 'description': 'Established by the Profile of Mood States (includes 65 items on a 5 point Likert scale)', 'timeFrame': 'Baseline (morning of day 1), Postprandial (after lunch on day 1), 24-hours (morning of day 2), day 5 (morning of day 6 upon completion of 5 full days intervention)'}\n\nPlease estimate the sample size based on the assumption: \nerror rate of 0.05, 90% power, 20% dropout rate", "answer": 25, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size calculation was based on data from a previous cross-over trial of the effect of MDP adherence in a young healthy adult group.67 Assuming an error rate of 0.05 and 90% power, we would require 15 and 20 participants to complete each arm for the primary outcome, which is the contentment, a mood domain from the Bond-Lader scale (9.6 unit expected difference, SD 10.3). To account for up to 20% dropout between random allocation to treatment sequence and study completion, we recruited 25 individuals.", "id": 1873, "split": "test"} +{"trial_id": "NCT05927935", "pmid": "38908842", "question": "Here is the design of a clinical trial:\n\nOfficial Title: First-line Treatment for Femoroacetabular Impingement Syndrome: a Multicenter Randomized Controlled Trial Comparing a Supervised Strength Exercise Intervention to Usual Care on Hip-related Quality of Life. (Better Hip Trial)\n\nIncluded conditions:\n- Femoroacetabular Impingement Syndrome\n\nStudy Armgroups:\n- {'label': 'Supervised strength exercise intervention', 'type': 'EXPERIMENTAL', 'description': 'Group 1', 'interventionNames': ['Other: Supervised strength exercise intervention']}\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Group 2', 'interventionNames': ['Other: Minimal educational intervention (usual care)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Supervised strength exercise intervention', 'description': 'A 6 months exercise intervention of training 2 times a week. Patients will be instructed by a physiotherapist during the first session, in order to be able to perform the exercises at home or in a local gymnasium based on personal preference. Subsequently, there are supervised sessions once every second week (12 sessions in total). The intervention will consist of 6 exercises. 4 targeting planes of hip movement (i.e., flexion, extension, abduction and adduction), a general lower extremity- and a trunk exercise. Progression is made when an exercise is performed with the designated number of sets and repetitions, with good performance quality and tolerable pain. Progression is provided by 3 levels of difficulty and secondly by the number of repetitions or where possible by increasing the external load. In addition, patient information and education is identical to what is delivered in the usual care group.', 'armGroupLabels': ['Supervised strength exercise intervention']}\n- {'type': 'OTHER', 'name': 'Minimal educational intervention (usual care)', 'description': 'Usual care varies slightly across regions in Denmark and between Denmark and Australia. The consensus is that the patient should be advised to remain physically active and reduce symptom provoking activities. Therefore, patients will receive a referral for physiotherapy and supplementary a minimal educational intervention is provided as usual care. Patients allocated to the usual care group will receive written information on self-management of hip symptoms including advice about staying physically active in accordance with the World Health Organization guidelines on physical activity and sedentary behavior. Moreover, self-management of hip symptoms will include advice to reduce symptoms by focusing on symptom-lowering activities and sports. The content of the information provided as usual care will be identical to the information provided to the patients in the intervention group. Patients in the usual care group can continue to seek any additional treatment they would like.', 'armGroupLabels': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.', 'description': 'The iHOT-33 is a 33-item self-administered valid and reliable outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The total score ranges from 0 to 100, with higher scores indicating better hip-related quality of life.', 'timeFrame': 'Measured at baseline, 3, 6 and 12 months.'}\n\nPlease estimate the sample size based on the assumption: \nAn SD of 19.2, a power of 80%, an alpha level of 5%, and a drop-out rate of up to 28%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on a clinical superiority calculation68 using data from a pilot RCT by Kemp et al.15 Kemp et al found a mean change of 27 (SD 26) points in their strength exercise group and a mean change of 11 (SD 8) points in their stretching group after 12 weeks of intervention (between-group difference of 16 (95% CI \u00e2\u0088\u00929 to 38) points) on the iHOT-33. The superiority margin is just under 10 points (ie, 16\u00e2\u0080\u00936.1 points) in the between-group change on the iHOT-33.27 The estimated mean difference of 16 points, a superiority margin of 10 points,27 an SD of 19.2,15 a power of 80%, and an alpha level of 5% result in a total sample size of n=94 (n=47 in each group) After allowing a drop-out rate of up to 28%, our required sample size will be n=120 (n=60 in each group). See a flow chart for the patient recruitment in figure 2. The strategy for achieving adequate patient enrolment to reach the target sample size is to recruit from multiple hospitals.\n \n Figure 2\n \n Flow chart describing patient recruitment and randomisation in the Better Hip Trial.", "id": 1874, "split": "test"} +{"trial_id": "NCT05929417", "pmid": "40037665", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting\n\nIncluded conditions:\n- Benzodiazepine Deprescribing\n\nStudy Armgroups:\n- {'label': 'END-IT intervention for the community setting', 'type': 'EXPERIMENTAL', 'description': 'The community pharmacist will distribute an educational brochure to the patient. He will also propose to the patient to communicate about a potential benzodiazepine deprescribing with his/her general practitioner through a document called pharmaceutical proposal.', 'interventionNames': ['Other: END-IT intervention for the community setting']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The participants will receive the usual care. The community pharmacists allocated to the control group will have access to the intervention material at the end of the study.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'END-IT intervention for the community setting', 'description': 'The intervention was described in the arm/group descriptions.', 'armGroupLabels': ['END-IT intervention for the community setting']}\n\nPrimary Outcomes:\n- {'measure': \"Pharmacists' adherence to the intervention\", 'description': 'Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)', 'timeFrame': 'At 3 months'}\n- {'measure': \"Pharmacists' adherence to the intervention\", 'description': 'Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)', 'timeFrame': 'At 6 months'}\n- {'measure': \"Participants' responsiveness\", 'description': 'How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).', 'timeFrame': 'At 3 months'}\n- {'measure': \"Participants' responsiveness\", 'description': 'How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).', 'timeFrame': 'At 6 months'}\n- {'measure': 'Feasibility of the recruitment process', 'description': 'The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).', 'timeFrame': 'At 6 months'}\n- {'measure': 'Feasibility of the data collection process', 'description': 'The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).', 'timeFrame': 'At 6 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, statistical significance of 5%, cluster size of 7-8 patients, intraclass correlation coefficient of 0.05 to 0.50.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n As the sending of the pharmaceutical proposal would be new in Belgium, we chose a conservative approach and based our sample size estimation on the EMPOWER trial results (that tested the effect of the EMPOWER brochure alone) rather than on the results of the D-PRESCRIBE trial.15 Therefore, considering a power of 80%, a statistical significance of 5%, a cluster size of 7\u00e2\u0080\u00938 patients, and an intraclass correlation coefficient of 0.05 (lowest value) or 0.50 (highest value), we have estimated that the required sample size for a full implementation trial would be between 88 and 300 patients. For this feasibility study, we aim to recruit 56\u00e2\u0080\u009380 participants, within 8\u00e2\u0080\u009310 pharmacies. This sample will represent approximately 20\u00e2\u0080\u009325% of the maximal required sample size. We expect this sample to allow us to inform sufficiently our research objectives, and we will further refine the sample size calculation for a full trial.", "id": 1875, "split": "test"} +{"trial_id": "NCT05929430", "pmid": "38696406", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Mindfulness Program on the Occupational Balance and Mental Health of University Students. Protocol for a Randomized Controlled Trial Study. ATENEU Program (Mindfulness in University Students)\n\nIncluded conditions:\n- Occupational Balance\n- Mental Health Wellness\n- University Students\n- Burnout, Student\n\nStudy Armgroups:\n- {'label': 'Mindfulness-Based Health Care Program (MBHC).', 'type': 'EXPERIMENTAL', 'description': 'Mindfulness skills will take over a 6-week period. Mindfulness skills will deliver in a weekly group format. Participants will be instructed to follow mindfulness practice at home. The program is focused on cultivating mindfulness of present-moment, cultivating a nonreactive, nonjudgmental attitude toward the experience, and includes specific formal and informal practices aimed at cultivating healthy habits and lifestyle (e.g., activities of daily living such as feeding, bathing, or showering and other occupations such as communication management, health management, etc.; and prosocial components (e.g., kindness and compassion).', 'interventionNames': ['Behavioral: Mindfulness program']}\n- {'label': 'Mindfulness-Based Health Care program with virtual reality (MBHC-VR).', 'type': 'EXPERIMENTAL', 'description': 'This program combines mindfulness practice with immersion in a virtual environment. The content and objectives of MBHC-VR program are the same that MBHC, with the main difference being that all formal practices of each session will be performed using VR.', 'interventionNames': ['Behavioral: Mindfulness program with Virtual Reality']}\n- {'label': 'Waiting list control group (WL).', 'type': 'NO_INTERVENTION', 'description': 'Participants in the WL control group will not receive any intervention during the study. However, for ethical reasons, at the end of the 3-month follow-up assessment, participants of this WL control group will be invited to participate in the MBHC program free of charge.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness program', 'description': 'Six weeks mindfulness program. The program is explained in arm descriptions.', 'armGroupLabels': ['Mindfulness-Based Health Care Program (MBHC).']}\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness program with Virtual Reality', 'description': 'Six weeks mindfulness program. The program is explained in arm descriptions.', 'armGroupLabels': ['Mindfulness-Based Health Care program with virtual reality (MBHC-VR).']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Occupational Balance', 'description': 'Occupational Balance Questionnaire (OBQ) is a brief 13-item tool scored on a 6-point Likert-type response scale, ranging from 0 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 65, where a higher score indicates greater occupational balance. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.', 'timeFrame': 'Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).'}\n- {'measure': 'Change in Anxiety, Depression and Stress', 'description': 'Anxiety, Depression and Stress Scale (DASS 21) consists of 21 items, 7 items for each subscale: DASS-D (depression), DASS-A (anxiety) and DASS-S (stress). Participants are asked to rate the degree to which this statement has happened to them in the past week on a scale from 0 (has not happened to me) to 3 (has happened to me a lot or most of the time). A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.', 'timeFrame': 'Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).'}\n- {'measure': 'Change in Academic stress', 'description': 'SISCO Inventory which consists of 31 items distributed into: 1 filter item (yes-no), 1 item on a Likert-type scale from 1 (a little) to 5 (a lot), 8 items on a Likert-type scale from 1 (never) to 5 (always) that allow identifying stressful stimuli, 15 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify stressful stimuli divided into physical, psychological and behavioural reactions and 6 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify the frequency of use of coping strategies. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.', 'timeFrame': 'Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).'}\n- {'measure': 'Change in Burnout', 'description': 'Maslach Burnout Inventory-Student Survey Questionnaire (MBI-SS). The MBI-SS contains 15 items grouped into 3 subscales: Emotional Exhaustion (5 items), Cynicism (4 items), and Academic Efficacy (6 items). These items are scored on a scale from 0 (never/never) to 6 (always/every day). High scores on burnout and cynicism and low scores on academic efficacy are indicative of burnout. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.', 'timeFrame': 'Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).'}\n\nPlease estimate the sample size based on the assumption: \nAlpha criterion of .05, 80% power, and an attrition rate of approximately 20%.", "answer": 174, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n G *Power (v. 3.1) was used to estimate the sample size needed to test hypotheses 1, 2, 3 and 5. A mixed model using treatment as a between-subjects factor (MBHC, MBHC-VR, and WL) and time as a within-subjects factor (pre, inter, post, and follow-up) will be tested. Interaction effect was powered. The sample size was estimated taking as a reference a small difference in perceived stress between MBHC with vs without VR-assisted meditation in university students [5]. With an alpha criterion of .05 and a small effect size (Cohen\u00e2\u0080\u0099s d2 = .08), to achieve a minimum of 80% power, a minimum sample size of 174 participants will be needed. Assuming an attrition rate, based on complete dropout of approximately 20% [5], the final sample needed will include at least 210 university students (i.e., 70 participants in each of three groups).", "id": 1876, "split": "test"} +{"trial_id": "NCT05930288", "pmid": "38754891", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Role of Short-term Preoperative Walking Exercises in Protecting Cognitive Function and Reducing the Incidence of Surgery-related Complications in the Short Term After Craniotomy in Patients With Supratentorial Brain Tumours\n\nIncluded conditions:\n- Supratentorial Brain Tumor\n- Exercise\n- Cognition\n- Postoperative Complications\n\nStudy Armgroups:\n- {'label': 'Walking exercise', 'type': 'EXPERIMENTAL', 'description': 'Patients receive routine care and exercise as required.', 'interventionNames': ['Behavioral: Walking exercise']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Patients receive only routine care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Walking exercise', 'description': 'The target physical activity level for participants is to walk 10,000 steps per day and to meet or exceed that level (but not exceed 15,000 steps) seven days a week for three to four weeks. Participants will be advised to gradually increase their daily step count in proportion to their physical condition. Exercise will be performed by brisk walking or jogging using the indoor treadmill equipped by the Neurosurgery Department of Xiangya Hospital or outdoors. Each workout will begin with a 5-minute warm-up and end with a 5-minute cool-down.', 'armGroupLabels': ['Walking exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of postoperative cardiopulmonary complications (pneumonia, thrombosis, etc. [by Japan Clinical Oncology Group postoperative complications criteria])', 'description': \"Type and number of surgery-related cardiopulmonary complications that occurred after the patient's surgery.\", 'timeFrame': '1 week post-operative/discharge (select whichever occurs first)'}\n- {'measure': 'Cognitive function change (by Montreal Cognitive Assessment [MoCA], MoCA Chinese 7.1 and MoCA Chinese 7.2 [both ranging from 0 to 30 points, with higher scores generally indicating better cognitive function])', 'description': \"The gap between patients' post-operative and pre-operative cognitive function. MoCA Chinese 7.1 for baseline and 14 days preoperatively, MoCA Chinese 7.2 for three days preoperatively and 1 week post-operative/discharge (select whichever occurs first).\", 'timeFrame': 'Baseline, 14 days preoperatively, three days preoperatively, 1 week post-operative/discharge (select whichever occurs first)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% and a two-sided type I error rate (alpha) of 2.5% are used. A 20% drop-out rate is considered.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size was calculated by using PASS 2023 software. Considering cognitive function, according to initial predictions, the disparity in MoCA scores between the two groups by the conclusion of the monitoring period was 4, with an approximate SD of 7 for their overall score. To achieve a power of 80% with a two-sided type I error rate (alpha) set at 2.5%, it is necessary to have a sample size of 128 subjects. Considering a 20% drop-out rate, 160 subjects will need to be enrolled to ensure that 128 subjects complete the trial. Considering cardiovascular complications, according to initial predictions, the incidence of cardiopulmonary complications in the intervention group is about 0.1, and in the control group, it is about 0.35. To achieve a power of 80% with a two-sided type I error rate (alpha) set at 2.5%, it is necessary to have a sample size of 98 subjects. Considering a 20% drop-out rate, 124 subjects will need to be enrolled to ensure that 98 subjects complete the trial. Considering respiratory complications, according to initial predictions, the incidence of cardiopulmonary complications in the intervention group is about 0.05, and in the control group, it is about 0.25. To achieve a power of 80% with a two-sided type I error rate (alpha) set at 2.5%, it is necessary to have a sample size of 112 subjects. Considering a 20% drop-out rate, 140 subjects will need to be enrolled to ensure that 112 subjects complete the trial. Since the required sample size calculated based on cognitive function scores is larger, to ensure the reliability of the results, this sample size will be used as the final sample size. It is anticipated that 160 patients will be recruited to complete the trial.", "id": 1877, "split": "test"} +{"trial_id": "NCT05931406", "pmid": "39384224", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Sedentary Behaviors at Work on Health in Emergency Medical Dispatchers and CODIS Operators\n\nIncluded conditions:\n- Sedentary Behavior\n- Occupational Stress\n\nStudy Armgroups:\n- {'label': 'Emergency medical dispatchers', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Control', 'Behavioral: Sit-and-stand desk', 'Behavioral: Cycloergometer']}\n- {'label': 'Firefighter', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Control', 'Behavioral: Sit-and-stand desk', 'Behavioral: Cycloergometer']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'A normal working day from of 12h', 'armGroupLabels': ['Emergency medical dispatchers', 'Firefighter']}\n- {'type': 'BEHAVIORAL', 'name': 'Sit-and-stand desk', 'description': 'a working day during which the participants have to get up at least 5 min/hour', 'armGroupLabels': ['Emergency medical dispatchers', 'Firefighter']}\n- {'type': 'BEHAVIORAL', 'name': 'Cycloergometer', 'description': 'a working day during which they can use a cycloergometer installed under the desk', 'armGroupLabels': ['Emergency medical dispatchers', 'Firefighter']}\n\nPrimary Outcomes:\n- {'measure': 'Sedentary behavior', 'description': 'Sedentary behavior measured by actimetry using Actigraph\u00ae in number of minutes per day standing/active.', 'timeFrame': '12 hours of work corresponding to the control condition'}\n- {'measure': 'Sedentary behavior', 'description': 'Sedentary behavior measured by actimetry using Actigraph\u00ae in number of minutes per day standing/active.', 'timeFrame': '12 hours of work corresponding to the sit-and-stand desk condition'}\n- {'measure': 'Sedentary behavior', 'description': 'Sedentary behavior measured by actimetry using Actigraph\u00ae in number of minutes per day standing/active.', 'timeFrame': '12 hours of work corresponding to the cycloergometer condition'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided type I error at 0.017, 80% statistical power, intraindividual correlation coefficient of 0.5, and allowance for lost to follow-up", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary endpoint will be sedentary behaviour expressed by standing/active time at work. Considering data from a pilot study conducted in our institution, number of minutes per day standing/active in control condition can be expected around 30\u00e2\u0080\u0089min, for a standard-deviation at 45\u00e2\u0080\u0089min. To highlight at least 50% relative difference (ie, absolute difference of 30\u00e2\u0080\u0089min: 30 min vs 60\u00e2\u0080\u0089min) between intervention (sit-and-stand desk and cycle ergometer) and control (usual working day) conditions, 27 participants are needed for a two-sided type I error at 0.017 (correction for multiple comparisons), a 80% statistical power and an intraindividual correlation coefficient equals 0.5 (cross-over design). It is proposed to include 36 participants for lost to follow-up and to have a satisfactory statistical power for secondary endpoints.", "id": 1878, "split": "test"} +{"trial_id": "NCT05931419", "pmid": "39871169", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)\n\nIncluded conditions:\n- Prostate Cancer\n- Prostate Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Robot assisted radical prostatectomy (RARP)', 'description': 'Robot-assisted radical prostatectomy, potentially as part of multimodality therapy with adjuvant radiotherapy or with (neo)adjuvant androgen deprivation therapy. Pelvic lymph node dissection (PLND) may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and may be followed by adjuvant treatment such as lymph node irradiation.'}\n- {'label': 'External beam radiotherapy (EBRT) combined with androgen deprivation therapy (ADT)', 'description': 'External beam radiotherapy (hypofractionated or conventionally fractionated) at a biologically effective dose converted to 2Gy fractions (\u03b1/\u03b2:1.5) of at least 76Gy. EBRT may be combined with a brachytherapy boost and PLND may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and lymph node irradiation may be performed. Patients should receive ADT for at least 6 months.'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Functional outcomes', 'description': 'Functional outcomes will be measured with the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). The EPIC-26 consists of 5 domains: urinary incontinence, urinary irritation, bowel function, sexual function and hormonal function. Domain scores range from 0-100 (the higher the score the better the function) and the minimally clinically important difference (MCID) per domain is 6-9, 5-7, 4-6, 10-12 and 4-6, respectively.', 'timeFrame': '3 years after treatment initiation'}\n- {'measure': 'Health-related quality of life (HRQoL)', 'description': 'HRQoL will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). The questionnaire includes five functional domains (physical, role, cognitive, emotional and social), three symptom domains (fatigue, pain, nausea and vomiting) and a global health/quality of life scale. In addition, there are six separate items assessing dyspnea, insomnia, appetite loss, constipation, diarrhea, and perceived financial impact. For each domain and single item measure, a score from 0 to 100 can be calculated. For the functional domains and the global score, higher scores indicate a higher level of functioning/ better quality of life. In contrast, for the symptom domains and single item measures, a higher score represents a higher level of symptomatology.', 'timeFrame': '3 years after treatment initiation'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided T-test with alpha = 0.05 and power = 80% was used. The sample size was increased by 15% to account for confounding factors. It is assumed that 75% of participants who complete the baseline questionnaire will complete subsequent measurements.", "answer": 837, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size\n Descriptive analyses will be used to provide insight in patient and clinical characteristics of the total study population and of both treatment groups. Mixed-effects models will be used to compare functional outcomes and HRQoL between the two treatment groups over time. Differences in functional outcomes and HRQoL between treatment modalities as measured by the EPIC-26 will be considered clinically meaningful if they are equivalent to or exceed the MCID and are statistically significant at the 0.05 level. The p-value maintained for statistical significance will be adjusted for multiple testing if appropriate. For the EORTC-QLQ-C30, the between-group anchor-based minimally important differences per scale as reported by Musoro et al. will be used to compare treatment groups over time. For scales for which no anchor-based estimates are available, distribution-based estimates will be used [25]. Due to the observational design of the study, we will adjust for confounding covariates associated with treatment with RARP versus EBRT (and ADT) using inverse probability of treatment weighting or the g-formula [30\u00e2\u0080\u009333]. In case of missing values in covariates, multiple imputation procedures will be used [34, 35]. Competing risk survival analyses will be used to evaluate PFS and DMFS with the competing event being a non-PCa related death.\n To evaluate incremental cost-effectiveness of EBRT combined with ADT versus RARP over a time horizon of 36 months, a cost-utility analysis (CUA) will be conducted both from a societal and a medical perspective. Costs are assessed by multiplying the voluminal with the unit prices. Utilities will be derived by means of a mapping algorithm from the EORTC QLQ-C30 at each time point. The derived utility will be used for the estimation of a quality adjusted life year (QALY) according to the trapezium rule. Incremental costs between treatments will be related to incremental QALYs in a cost-utility ratio (ICUR) to determine the additional costs that need to be spent to gain one QALY. Subsequently, a budget impact analysis (BIA) will be performed to predict the financial consequences related to the adaption and implementation of the favored strategy based on the cost-effectiveness analysis.\n Assuming that the effect of treatment on HRQoL is predominantly determined by functional outcomes, the sample size was calculated to demonstrate the mean or upper limit of the MCID-range for each domain of the EPIC-26. A two sided T-test (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, power 80%) using expected standard deviations, derived from previous research evaluating the impact of RP versus EBRT and ADT on functional outcomes, yielded a required total response of 471 patients at T36 [12]. To account for confounding factors, the sample size was increased by 15%. Based on previous experience with collecting PROs, we assume that 75% of men who are willing to participate in the study and complete the baseline questionnaire will do so again at each subsequent measurement moment. Therefore, 837 patients need to be included in the study (response at T0) for sufficient power.", "id": 1879, "split": "test"} +{"trial_id": "NCT05931913", "pmid": "39696590", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD\n\nIncluded conditions:\n- Obsessive-Compulsive Disorder\n\nStudy Armgroups:\n- {'label': 'ERP+iTBS', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive two weeks (10 sessions) of intermittent theta burst stimulation (iTBS; a form of TMS) targeting the dorsolateral prefrontal cortex (dlPFC), followed immediately by Exposure Plus Response Prevention (ERP).', 'interventionNames': ['Device: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex', 'Behavioral: Exposure with Response Prevention']}\n- {'label': 'ERP+cTBS', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive two weeks (10 sessions) of continuous theta burst stimulation (cTBS; a form of TMS) targeting the presupplementary motor area (pSMA), followed immediately by Exposure Plus Response Prevention (ERP).', 'interventionNames': ['Behavioral: Exposure with Response Prevention', 'Device: Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area']}\n- {'label': 'ERP+Sham', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive two weeks (10 sessions) of sham (\"fake\") TMS, followed immediately by Exposure Plus Response Prevention (ERP).', 'interventionNames': ['Behavioral: Exposure with Response Prevention', 'Device: Transcranial Magnetic Stimulation: Sham']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex', 'description': 'TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern', 'armGroupLabels': ['ERP+iTBS'], 'otherNames': ['TMS', 'Neuromodulation', 'iTBS']}\n- {'type': 'BEHAVIORAL', 'name': 'Exposure with Response Prevention', 'description': 'ERP will be delivered daily, immediately following TMS', 'armGroupLabels': ['ERP+Sham', 'ERP+cTBS', 'ERP+iTBS'], 'otherNames': ['ERP', 'Exposure Therapy', 'Cognitive-Behavioral Therapy', 'CBT']}\n- {'type': 'DEVICE', 'name': 'Transcranial Magnetic Stimulation: Sham', 'description': 'Sham stimulation will use the Magstim sham air-cooled coil, which produces auditory signals and appears identical to an active coil but contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (\\\\<3%) magnetic field is delivered to the cortex', 'armGroupLabels': ['ERP+Sham'], 'otherNames': ['TMS', 'Neuromodulation']}\n- {'type': 'DEVICE', 'name': 'Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area', 'description': 'TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern', 'armGroupLabels': ['ERP+cTBS'], 'otherNames': ['TMS', 'iTBS', 'Neuromodulation']}\n\nPrimary Outcomes:\n- {'measure': 'Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit', 'description': 'z-score representing change in resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)', 'timeFrame': 'change from baseline at two weeks (post-treatment)'}\n- {'measure': 'Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit', 'description': 'z-score representing change in resting connectivity between dorsolateral prefrontal cortex and dorsomedial striatum (DMS)', 'timeFrame': 'change from baseline at two weeks'}\n- {'measure': 'Observed Compulsive Behavior', 'description': 'Mean proportion of time during which compulsions are observed during ERP sessions', 'timeFrame': 'two weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 10% attrition rate.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Power analyses for our sample sizes (phase 1\u00e2\u0080\u0089=\u00e2\u0080\u008960, phase 2\u00e2\u0080\u0089=\u00e2\u0080\u008960), assuming an attrition rate of 10%, (phase 1\u00e2\u0080\u0089=\u00e2\u0080\u008954, phase 2\u00e2\u0080\u0089=\u00e2\u0080\u008954) were calculated. In Phase 1, we will have 80% power to detect medium-to-large effects for within- and between-subject changes in RSFC (Cohen\u00e2\u0080\u0099s d range 0.70 to 0.96) and for group differences in compulsion rate (\u00ce\u00b72\u00e2\u0080\u0089=\u00e2\u0080\u00890.23). In Phase 2, we will have 80% power to detect medium-to-large effects for tests of group differences in RSFC and compulsion rate (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.78) and for tests of RSFC and compulsion rate as mediators of OCD symptom change (\u00ce\u00b72 range\u00e2\u0080\u0089=\u00e2\u0080\u00890.16 to 0.20).", "id": 1880, "split": "test"} +{"trial_id": "NCT05933694", "pmid": "38950987", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial Comparing Performance of Primary Care Clinicians in the Interpretation of SPIROmetry With or Without Artificial Intelligence Decision Support Software\n\nIncluded conditions:\n- Lung Disease\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants to report 50 spirometry records alone'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants report the same 50 spirometry records provided in the control arm with an artificial intelligence-powered spirometry interpretation report', 'interventionNames': ['Other: Artificial Intelligence-powered Spirometry Interpretation Report']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Artificial Intelligence-powered Spirometry Interpretation Report', 'description': 'A report generated by artificial intelligence powered software that assessed technical quality of spirometry and estimates the diagnostic probability of six categories: COPD/Asthma/ILD/ Normal/Other obstructive/Other Unidentified', 'armGroupLabels': ['Intervention'], 'otherNames': ['ArtiQ.Spiro']}\n\nPrimary Outcomes:\n- {'measure': 'Preferred Diagnostic Performance', 'description': 'A correct case is where the preferred diagnosis matches the reference final diagnosis. Units will be percentage of total cases that are correct.', 'timeFrame': 'Six months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 5% (two-sided), Power: 85%, Missing/dropout rate: initially 15%, revised to 42%.", "answer": 228, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was informed by previous feasibility data from 30 primary care practitioners assessing five spirometry traces. The preferred diagnosis matched the reference diagnosis in a mean (SD) of 55% (19%) of spirometry records. We have assumed the same SD of 19%, which is conservative because more cases will be assessed per practitioner, leading to less variable practitioner rates. As the calculation involves conservative assumptions, the power was set below 90%, to be 85%. With 132 participants (66 per group) this allows for detection of a 10% difference (a mean of 5 extra cases in 50) in the rate of cases correctly identified to match the reference standard (mean 65% vs mean 55%) using an unpaired t-test at the two-sided 5% significance level.\n The recruitment target was originally estimated at 156 practitioners to allow for an estimated 15% drop out. However, a preliminary analysis of completion rate of the first 50 recruited participants demonstrated that 29 of the 50 participants scored all 50 spirometry records within the 8-week study period (58% completion). Based on this data, the study statistician advised increasing the recruitment target to 228 to account for 42% non-completion (see the Amendment section).\n Descriptive statistics will be performed for demographics, baseline characteristics and endpoint data: number and percentage for categorical data and mean and SD or median and interquartile range (IQR) for non-normally distributed continuous data.", "id": 1881, "split": "test"} +{"trial_id": "NCT05933850", "pmid": "38951006", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Culturally Adapted Strong Families Programme to Improve Child Behavior and Family Functioning in Families Living in Gilgit Baltistan, Pakistan\n\nIncluded conditions:\n- Mental Health\n\nStudy Armgroups:\n- {'label': 'Strong Family Programme Intervention', 'type': 'EXPERIMENTAL', 'description': 'There will be 3 weekly group sessions of the strong family programme with caregivers and children (8-12 families per group).', 'interventionNames': ['Behavioral: Strong Families Programme Intervention']}\n- {'label': 'Waitlist control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will be on the waiting list and receive SF programme training sessions once the study will be completed.', 'interventionNames': ['Behavioral: Strong Families Programme Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Strong Families Programme Intervention', 'description': 'This is a family skills programme providing an evidence-informed prevention to support caregivers to be better parents and strengthen positive age-specific and age-appropriate family functioning and interactions to help prevent drug use, violence and other negative social consequences in their children.', 'armGroupLabels': ['Strong Family Programme Intervention', 'Waitlist control group']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility and acceptability indicators', 'description': \"We will record feasibility indicators in terms of families' rates of recruitment and attendance to programme, and programme completeness. To evaluate cultural acceptability of programme by families, interviews with caregivers will be conducted to explore family members' opinions on the acceptability of the programme, any barriers or facilitators to participation.\", 'timeFrame': 'From baseline to end of intervention at 3 weeks (post randomisation)'}\n\nPlease estimate the sample size based on the assumption: \nNot expecting a large dropout rate, but accounting for a possible attrition rate by including 50% more participants.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim to recruit 90 families (N=45 in intervention, N=45 in the waitlist group) in total (30 families from each of the three study sites). The audit of sample sizes for pilot and feasibility RCTs has revealed a median sample size per arm of 30 across various studies,25 thus, requiring a sample size of N=30 per group for the current study. Based on the recruitment rates in the previous trials17 19 in similar contexts, we are not expecting a large dropout rate in this study. However, we have taken a possible attrition rate into account and aim to include 50% more participants making a sample size of 45 per group.", "id": 1882, "split": "test"} +{"trial_id": "NCT05934019", "pmid": "39118136", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)\n\nIncluded conditions:\n- Mental Health Issue\n- Transdiagnostic Mechanisms\n- Adolescent Psychology\n- Prevention\n- Online Intervention\n- Psychological Intervention\n- Mental Disorder in Adolescence, Subclinical\n\nStudy Armgroups:\n- {'label': 'EMPATIA', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will access the online prevention program EMPATIA as a self-help online program during eight weeks.', 'interventionNames': ['Device: EMPATIA 1']}\n- {'label': 'Care As Usual', 'type': 'NO_INTERVENTION', 'description': 'Participants in this group will gain access to the online prevention program EMPATIA after 12 months. All other kinds of interventions during participation are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'EMPATIA 1', 'description': 'The internet-program EMPATIA is hosted on a secure website https://selfhelp.psy.unibe.ch run by the Faculty of Human Sciences and is accessible from any regular internet browser. The software is not CE-marked as it has been developed for research purposes only. EMPATIA consists of 8 sessions and 1 booster session 3 weeks after the last session. It targets transdiagnostic mechanisms that have been identified in several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including intolerance of uncertainty, emotion, self-critical perfectionism and rejection sensitivity. The contents of EMPATIA are evidence-based and well-established cognitive-behavioral interventions dedicated to the respective transdiagnostic mechanism. The self-help program consists of psychoeducation, cognitive restructuring, relaxation and acceptance-based interventions, exposure and behavioral experiments and behavioral activation as treatment components.', 'armGroupLabels': ['EMPATIA']}\n\nPrimary Outcomes:\n- {'measure': 'Level of self-reported general psychopathology', 'description': 'Assessed by the \"Strength and Difficulties Questionnaire, self-report\" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.', 'timeFrame': 'Baseline'}\n- {'measure': 'Level of self-reported general psychopathology', 'description': 'Assessed by the \"Strength and Difficulties Questionnaire, self-report\" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.', 'timeFrame': 'Month 2'}\n- {'measure': 'Level of self-reported general psychopathology', 'description': 'Assessed by the \"Strength and Difficulties Questionnaire, self-report\" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.', 'timeFrame': 'Month 6'}\n- {'measure': 'Level of self-reported general psychopathology', 'description': 'Assessed by the \"Strength and Difficulties Questionnaire, self-report\" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.', 'timeFrame': 'Month 9'}\n- {'measure': 'Level of self-reported general psychopathology', 'description': 'Assessed by the \"Strength and Difficulties Questionnaire, self-report\" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.', 'timeFrame': 'Month 12'}\n\nPlease estimate the sample size based on the assumption: \nAn assumed power of 0.80, an alpha-level of 0.05, and an expected drop-out rate of 20%.", "answer": 152, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n To be included in this study, participants must report at least mild subclinical symptoms in any one of the assessed mental disorders (see Additional file 1). Based on previous empirical findings on Internet interventions targeting adolescent samples with subclinical symptoms [59] or adolescent and young adult samples with elevated levels of repetitive negative thinking as a transdiagnostic mechanism [98], we expect that the EMPATIA program will produce small effects on general psychopathology after the intervention compared to CAU. To detect at least a small effect size (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.10) for the interaction between time (five assessment points) and group (intervention vs. CAU), an a priori power analysis with G*Power [181] using repeated measures analyses of variance (ANOVA, within-between-interaction), an assumed power of 0.80, an alpha-level of 0.05, and an expected drop-out rate of 20% [98], revealed a required sample size of 152 participants. Based on an expected participation rate of 60% [98], at least 254 participants will have to be contacted who are eligible for the EMPATIA study.", "id": 1883, "split": "test"} +{"trial_id": "NCT05935150", "pmid": "39260835", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial\n\nIncluded conditions:\n- Breast Cancer\n- Clinically Assessed Negative Axillary Lymph Nodes\n- Sentinel Lymph Node\n\nStudy Armgroups:\n- {'label': 'OMSLNB', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Omit SLNB']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Omit SLNB', 'description': 'All patients enrolled have to receive two or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \\\\[18F\\\\]-FDG PET-MRI, axillary surgery will be omitted for eligible patients, and BCS or mastectomy (allowing breast reconstruction) will be chosen voluntarily by the patient under the premise of ensuring therapeutic efficacy, patients receiving BCS must undergo whole breast irradiation (WBI) after surgery, and the radiotherapy target area does not include the axillary region.', 'armGroupLabels': ['OMSLNB']}\n\nPrimary Outcomes:\n- {'measure': 'invasive Disease-Free Survival (iDFS)', 'description': 'Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (\u03b1) of 0.05, 95% confidence interval, and a 10% dropout rate.", "answer": 311, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In this study, we used PASS software (version 2021) to perform a sample size calculation for a one-proportion non-inferiority test. The sample size was based on the primary endpoint of iDFS. According to the literature exploration and previous research results, it is expected that the 3\u00e2\u0080\u0089year iDFS in patients undergoing SLNB is about 90%. We set the non-inferiority margin at 5%, with a power of 80%, a significance level (\u00ce\u00b1) of 0.05 and a 95% CI. Considering a 10% dropout rate, PASS software calculated the required sample size to be 311 patients.", "id": 1884, "split": "test"} +{"trial_id": "NCT05935228", "pmid": "38904139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Evaluation of an Algorithm for Vascular Access Management - ALCOV Pilot Study\n\nIncluded conditions:\n- Peripheral Venous Access\n\nStudy Armgroups:\n- {'label': 'The control group', 'type': 'OTHER', 'description': 'The control group will consist of patients included in phase 1. These are the patients from the \"before\" phase, i.e. before the implementation of the Difficult Intravenous Access Scale.', 'interventionNames': ['Other: Implementation of the A-DIVA Scale']}\n- {'label': 'The experimental group', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will consist of the patients included in phase 3. These are the patients from the \"after\" phases i.e after the implementation of the algorithm.', 'interventionNames': ['Other: Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Implementation of the A-DIVA Scale', 'description': \"Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for difficult intravenous access) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire of professionals' opinions on the use of the A-DIVA scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a tool for evaluating vascular access difficulties\", 'armGroupLabels': ['The control group']}\n- {'type': 'OTHER', 'name': 'Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers', 'description': \"The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement.\\n\\n\u2022 Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented. Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.\", 'armGroupLabels': ['The experimental group']}\n\nPrimary Outcomes:\n- {'measure': '1. Number of venipunctures performed per patient after implementation of the algorithm', 'description': 'Number of punctures performed per patient after implementation of the algorithm (collection according to a data grid filled in by the operator after the care).', 'timeFrame': '20 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, power of 80%, standard deviation (SD) of 0.85, and a two-sided hypothesis test. Additionally, a 5% exclusion rate is assumed.", "answer": 794, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Van Loon et al found a mean number of punctures per patient of 1.3.16 With an alpha risk of 5%, a power of 80%, an SD of 0.85 and a two-sided formulation of the hypotheses, 564 patients are needed to show a 15% decrease in the mean number of punctures per patient following the implementation of the algorithm (we believe that a 15% decrease would be clinically relevant). Assuming that 5% of patients could be excluded, 594 patients should be included. The two inclusion centres will divide these patients equally (50/50). This number of subjects was calculated to meet the primary objective (comparison of the mean number of punctures per patient in phase I to phase III).\n To be able to carry out phase II and meet specific descriptive secondary objectives (description of the effect of the implementation of the venous access difficulty scale on the mean number of punctures per patient), 200 other patients (100 per centre) will be included for the phase II study. This number of patients will allow sufficiently accurate estimates of the measured data.\n Overall, 794 patients will be included in the study.\n In addition, health practitioners will be included to conduct 16 individual semistructured interviews. Data saturation is achieved when concepts and subconcepts cannot be further specified with additional data. Data collection in the context of inductive thematic analyses occurs until saturation point.31 We chose to estimate sample size based on literature without assessing and reporting thematic saturation using a calculation approach such as the one proposed by Guest et al.32 A number of interviews ranging from 11 to 20 corresponds to a satisfactory sample size for qualitative studies to obtain satisfactory findings.33\u00e2\u0080\u009335 We reached thematic saturation with the inclusion of 13 participants. With narrowly defined objectives, as is the case in our study, saturation can be achieved with a relatively small sample size.", "id": 1885, "split": "test"} +{"trial_id": "NCT05936099", "pmid": "39779271", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital\n\nIncluded conditions:\n- Vaping\n- Smoking\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants will complete the baseline survey and receive an informational brochure'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey', 'interventionNames': ['Behavioral: E-cigarette & Tobacco Use Treatment Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'E-cigarette & Tobacco Use Treatment Intervention', 'description': 'The behavioral intervention includes health education on vaping health risk and outcomes, motivational interviewing, and assisted quit planning from a health educator and counseling and nicotine replacement therapy (if appropriate) provided by a physician.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Self-reported 30-day abstinence', 'description': 'Cessation verified with biochemical verification of a saliva sample', 'timeFrame': '3 month follow up'}\n\nPlease estimate the sample size based on the assumption: \nThe analysis will use a generalised linear model with a binomial distribution and logit link function for primary and secondary outcomes. Repeated measures ANOVA will be used for motivation and confidence to quit. Chi-square and Wilcoxon rank-sum tests will assess group differences. Missing data will be treated similarly to other participants with missing data.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size and data analysis\n Following recommendations for behavioural intervention pilot trials,31 32 our proposed sample size (n=144 (96 treatment, 48 control)) is based on what is feasible to recruit, capturing a representative sample of the target population and being sufficient to evaluate preliminary efficacy in a behavioural design trial. Data already collected from participants who withdraw from the study will be included in analyses to the extent possible, and their missing data will be treated in a similar fashion to data from other participants with missing data (ie, participants lost to follow-up for other reasons).\n To assess preliminary efficacy, differences between arms at the 3-month follow-up in self-reported (primary outcome) and biochemically verified (salivary cotinine level\u00e2\u0089\u00a44\u00e2\u0080\u0089ng/mL; secondary outcome) 30-day e-cigarette abstinence will be analysed using a generalised linear model assuming an underlying binomial distribution and logit link function. Motivation and confidence to quit will be analysed using a repeated measures analysis of variance. Potential differential outcomes based on sex and demographic factors will be explored. X2 (categorical variables) and Wilcoxon rank-sum (continuous variables) tests will be used to assess for differences between groups. For acceptability, we will calculate the proportion of AYA participants in the intervention arm with mean ratings of satisfaction and acceptability of \u00e2\u0089\u00a54 on the 5-point Likert scale. In addition, frequencies and percentages will be used to describe the enrolment and session completion rate. For feasibility, we will conduct a thematic analysis of field notes and conduct simple descriptive analyses (means, frequencies and percentages) of the survey items completed by the physician and health educator and session length data. Fidelity will be summarised using similar descriptive analyses of the fidelity ratings (eg, percentage of intervention steps completed; mean rating of key MI skill adherence). Missing data will be excluded from analyses.", "id": 1886, "split": "test"} +{"trial_id": "NCT05943548", "pmid": "38956628", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda\n\nIncluded conditions:\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'Omuyambi Traditional Healer (TH) Intervention', 'type': 'EXPERIMENTAL', 'description': 'The traditional healer (TH) clusters randomized to the intervention arm will refer consented people living with HIV to a predetermined government-run HIV clinic for the provision of care. The patients that are in this arm will receive, adherence support for PLWH using a TH-tailored curriculum as an adjunct to clinic-based HIV care. These participants will also receive one-on-one counselling to improve self-efficacy, be provided social support, and will work with THs to develop individualized adherence strategies.', 'interventionNames': ['Behavioral: Omuyambi']}\n- {'label': 'Control Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'The traditional healer (TH) clusters randomized to the control arm will refer consented people living with HIV to a predetermined government-run clinic for the provision of care. The patients in this arm will receive no additional linkage or psychosocial support.', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Omuyambi', 'description': 'HIV testing, referral, care linkage, and medication adherence support', 'armGroupLabels': ['Omuyambi Traditional Healer (TH) Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'HIV Testing and referral', 'armGroupLabels': ['Control Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Viral Load Suppression in People Living with HIV (PLWH) at 12 months', 'description': 'Achievement and maintenance of HIV-1 RNA \\\\<200 copies/mL', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes 85% power to detect a \u2265 20% difference in viral suppression, with a 10% loss-to-follow-up rate.", "answer": 650, "answer_type": "ESTIMATED", "explanation": "Sample size\n Study power calculations are based on the primary hypothesis that the intervention will improve viral suppression by 20% using standardized methods for cluster randomized trials [51]. Based on population-level data from the Ugandan Ministry of Health, we assume that the proportion of PLWH achieving the primary outcome of viral suppression will be 60% in the control arm versus 80% in the intervention arm [3]. The results of prior community-based and psychosocial HIV support interventions were used to inform this estimated effect size [32, 52, 53]. To ensure 85% power to detect a difference of\u00c2\u00a0\u00e2\u0089\u00a5 20% in viral suppression between arms and assuming a 10% loss-to-follow-up rate, we will enroll a minimum of 16 PLWH in each cluster. The target sample size is 650 PLWH, with 325 PLWH in each arm. Forty-four TH will be enrolled as cluster sites, with 22 in each study arm.\n As part of the implementation evaluation, we will purposively recruit 20 PLWH, 20 HIV clinicians, and 7 policymakers for participation. The sample size of 20 HIV clinicians is based on prior research showing that thematic and conceptual data saturation is obtained after 12\u00e2\u0080\u009316 interviews have been conducted within a subgroup [54, 55]. Due to the limited number of policymakers, 7 interviews will be conducted to understand local and national government priorities and implementation context.", "id": 1887, "split": "test"} +{"trial_id": "NCT05943821", "pmid": "39053954", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with High and Very High Cardiovascular Risk, Including the Presence of Long-COVID Syndrome.\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Uric Acid\n\nStudy Armgroups:\n- {'label': 'Allopurinol', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients will receive allopurinol at an initial daily dose of 200 mg. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100 mg (up to 300 mg during V2). Similarly, the dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).', 'interventionNames': ['Drug: Allopurinol 200 mg', 'Drug: Optional intervention']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The patients will receive placebo at an initial daily dose of 200 mg. The dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).', 'interventionNames': ['Drug: Allopurinol 200 mg', 'Drug: Optional intervention']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Allopurinol 200 mg', 'description': 'The intervention will occur after randomly allocating participants to the first group (G1), in which patients will receive allopurinol at an initial daily dose of 200 mg, or to the second group (G2), where they will receive a placebo. The placebo will be prepared as tablets with the same shape and appearance as the tested drug tablets, in the appropriate doses, and containing the same excipients. Participants will initially take one tablet of the medication daily in the morning. The physicians will dispense the drugs in packs of 30 tablets for the entire interval between visits (therapy 26 weeks \u00b1 2 weeks). The patients will receive the medications during visit V1. The drugs will be prepared in identical packages, appropriately sealed, with a number for drug identification.', 'armGroupLabels': ['Allopurinol', 'Placebo'], 'otherNames': ['Allopurinol']}\n- {'type': 'DRUG', 'name': 'Optional intervention', 'description': 'Approximately 26 weeks(+/-2 weeks) after the start of the intervention, the efficacy of the treatment will be evaluated at the follow-up visit V2. Efficacy is defined as achieving a serum UA level below 5.0mg/dL for those with baseline levels \\\\>5.0 to 7.0mg/dL or below 5.5mg/dL for those with baseline levels \u22657.0mg/dL. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100mg (up to 300mg during V2). The dose may be increased by another 100mg at visit 3 and by another 100mg at the visit 4(up to 500mg during V4). In the placebo group, an appropriate preparation will be added so that the number of tablets corresponds to the group with the active substance.\\n\\nThis treatment will be continued until the end of the bservation. Patients who meet their UA target concentration at visit V2 or V3, or V4, and those who fail to meet their target concentration at visit V4, will not have their dosing changed until the end of the follow-up.', 'armGroupLabels': ['Allopurinol', 'Placebo'], 'otherNames': ['Please describe in more detail']}\n\nPrimary Outcomes:\n- {'measure': 'The occurrence of a major adverse cardiovascular event (MACE)', 'description': 'The number of all causes of death, cardiac death, stroke, transient ischemic attack, acute coronary syndrome, coronary angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina or worsening heart failure', 'timeFrame': 'Baseline up to approximately 5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe test power was set to 80% and the confidence level to 0.95. The sample size was calculated based on the assumption of performing a Kaplan-Meier analysis and using log-rank power analysis. A 10% increase in sample size was included to account for potential participant withdrawal or adverse events.", "answer": 1116, "answer_type": "ESTIMATED", "explanation": "Sample size\n After evaluating the activity profiles of our partner centres and the aforementioned assumptions, it was estimated that the total CV risk for the Polish population over the 10-year observation period would be approximately 22%. Based on the findings of MacIsaac et al, the capacity of allopurinol versus placebo intervention to reduce CV events was 37%8; thus, it was planned to recruit 1116 participants. The sample size was calculated based on the assumption of performing a Kaplan-Meier analysis to assess the occurrence of the primary endpoint. The estimated risk of CV events in the recruited group over a 10-year observation period was approximately 22%. With an average planned observation period of 4.3 years, this value is projected to be 9.5%. Following drug administration, it is expected to decrease to 5.9% (based on results from retrospective studies, it was assumed that the risk of CV events in the tested group would decrease by 37%).\n The test power was set to 80% and the confidence level to 0.95 for calculations. Based on log-rank power analysis, the planned sample size was set at 507 people for each group. Since there is potential for loss of power due to participant withdrawal or not completing the study due to adverse events, the size of the groups was increased by 10% yielding a total of 1116 or 558 for each group.\n The number of participants over 60 years old was calculated separately to assess the test power accurately. It was assumed that the total CV risk in this subpopulation would be 20\u00e2\u0080\u0089percentage points higher than the general population (based on the Pol-SCORE tables), resulting in an estimated 42%.16 Similarly, with an average observation period of 4.3 years, the risk is assumed to be 18.1%, which would be reduced during the intervention studied to 11.3%. To achieve 80% test power at a 95% confidence level, the size of this group should be 314 participants. Taking into account potential losses due to withdrawal or adverse events, 345 participants over 60 years old should be recruited for each group with a total of 690 participants.17", "id": 1888, "split": "test"} +{"trial_id": "NCT05944731", "pmid": "38773658", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya: A Three-arm Pragmatic Randomized Study on the Effectiveness, Feasibility, Acceptability, and Cost.\n\nIncluded conditions:\n- Type 1 Diabetes\n\nStudy Armgroups:\n- {'label': 'Arm 1', 'type': 'EXPERIMENTAL', 'description': 'Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.', 'interventionNames': ['Device: Continuous glucose monitor']}\n- {'label': 'Arm 2', 'type': 'EXPERIMENTAL', 'description': 'Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months.', 'interventionNames': ['Device: Continuous glucose monitor']}\n- {'label': 'Arm 3', 'type': 'NO_INTERVENTION', 'description': 'Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Continuous glucose monitor', 'description': 'Continuous Glucose Monitoring (CGM) device is a small electronic tool that you put on your skin, and it tells you the amount of glucose in your body. It is different from a finger prick glucose machine in that you do not need to prick your finger to get some blood to put on the reader paper like you have to do for a finger prick glucose machine.', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['Freestyle Libre']}\n\nPrimary Outcomes:\n- {'measure': 'Impact of continuous and intermittent CGM used on blood glucose levels in comparison to standard of care in people living with type 1 diabetes', 'description': 'Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms', 'timeFrame': '15 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect within- and between-group differences at the 5% significance level using repeated measures ANOVA.", "answer": 246, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Assuming a change in HbA1c levels of 2% after continuous use of a CGM device (determined by expert consultation) and an effect size of 0.2, a sample size of 246 participants (82 in each arm) would be required to achieve 80% power to detect within- and between-group differences at the 5% significance level (using repeated measures analysis of variance [ANOVA]).\n For qualitative assessments, sample sizes will be pragmatically derived and will vary based on the number of available respondents and attainment of information/thematic saturation. In Kenya, the target populations will be 30 for focus group discussions and HRQoL surveys (10 in each arm) and 10 for semi-structured healthcare provider interviews. In South Africa, the target populations will be 45 for focus group discussions and HRQoL surveys (15 in each arm) and 10 for semi-structured healthcare provider interviews.", "id": 1889, "split": "test"} +{"trial_id": "NCT05951868", "pmid": "38769049", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial\n\nIncluded conditions:\n- Breastfeeding\n\nStudy Armgroups:\n- {'label': 'Continuum of support on breastfeeding', 'type': 'EXPERIMENTAL', 'description': 'Content of counselling intervention will be on ideal breast feeding practices,benefits of breastfeeding, weaning, myths \\\\& common problems faced during breastfeeding with their solutions,Latching techniques,feeding positions, ways to express milk \\\\& storage techniques. Discussion and Q\\\\&A session\\n\\n1. Women with her female family member of support invited for antenatal visit will be counselled by a trained doctor on breastfeeding in 2 -sessions between 32 \\\\& 40 weeks of gestation.\\n2. Readable booklet \\\\& whats app videos having same content in local Urdu language will be shared with the women during antenatal visit and at discharge from hospital.\\n3. At time of delivery skin to skin contact, early initiation, proper latching ,positioning and reemphasising on exclusive breastfeeding done by a trained nurse.\\n4. Follow up by trained community lady health workers to visit mothers home to reinforce learned information and support mothers at 0,1,2 weeks \\\\& 1,3,4,6 months', 'interventionNames': ['Behavioral: Continuum of support on breastfeeding.']}\n- {'label': 'Control group/Routine care', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive routine care in terms of routine counselling done on breastfeeding in the hospital \\\\& when mothers at home by lady health workers.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Continuum of support on breastfeeding.', 'description': 'A continuous support program for women from antenatal period till 6 months after delivery to initiate early breastfeeding, exclusively breastfeeding for 6 month and to continue breastfeeding till 2 years and beyond.', 'armGroupLabels': ['Continuum of support on breastfeeding']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of interventions', 'description': 'The feasibility of the intervention will be assessed through a semi-structured questionnaire administered to all participants and care providers after 6 months of delivery. The questionnaire will evaluate the practicality and ease of implementing the intervention.', 'timeFrame': 'At 7th months after delivery'}\n- {'measure': 'Acceptability of interventions', 'description': \"The acceptability of the intervention will be determined through a semi-structured questionnaire administered to all participants and care providers after 6 months of delivery. The questionnaire will explore the participants' and providers' satisfaction, comfort, and willingness to continue with the intervention.\", 'timeFrame': 'At 7th months after delivery'}\n- {'measure': 'Extent to which the intervention is implemented as intended', 'description': 'From enrolment till the last intervention a Performa of every activity ; showing number of participants, day, time, duration, checklist of all the components of intervention delivered and signed by intervention provider on the day of activity with a pictorial evidence sent via Whats App to central record. Feedback from participants on the same checklists of all the components of intervention delivered will also be taken at end of the intervention by an independent researcher.', 'timeFrame': 'From enrolment to 7 months'}\n\nPlease estimate the sample size based on the assumption: \nA 20% attrition rate is considered.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n There is no definitive rule or formula for calculating the optimal sample size for a pilot test, but some general principles should be taken into consideration. A sample size of minimum 12 participants in one arm for a pilot study is considered as a rule of thumb. A sample size range of 24\u00e2\u0080\u009360 participants is derived from general guidance found in the literature on pilot and feasibility studies and a practical guideline for ensuring enough participants to assess feasibility and preliminary outcomes without the expectation of statistical power for efficacy or effectiveness analyses.25\u00e2\u0080\u009327 Keeping in consideration 20% attrition rate of the pilot sample,28 50 participants in total will be considered for the study.\n \n Recruitment\n Recruitment will be done on 3\u00e2\u0080\u0089days a week of routine OPD of gynaecology and obstetrics department teaching unit of ABSTH based on inclusion and exclusion criteria. Informed consent in Urdu or Punjabi language from all participants agreed to participate in the study up till 6 months postpartum will be taken.", "id": 1890, "split": "test"} +{"trial_id": "NCT05952167", "pmid": "39953437", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Impact of Tractions Vs. Placebo Tractions in Patients with Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study\n\nIncluded conditions:\n- Radiculopathy\n- Cervical\n\nStudy Armgroups:\n- {'label': 'Placebo mechanical cervical traction', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Intensive cervical traction protocol - placebo']}\n- {'label': 'Mechanical cervical traction', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Intensive cervical traction protocol']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intensive cervical traction protocol', 'description': '2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected.', 'armGroupLabels': ['Mechanical cervical traction']}\n- {'type': 'OTHER', 'name': 'Intensive cervical traction protocol - placebo', 'description': '2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected.', 'armGroupLabels': ['Placebo mechanical cervical traction']}\n\nPrimary Outcomes:\n- {'measure': 'Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3.', 'description': 'The minimum clinically important difference (MCID) was established at 7 points out of 50 by (Cleland et al. 2006).', 'timeFrame': 'At 3 months post cervical traction protocol'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% alpha risk, and 10% additional participants to account for dropout/missing data.", "answer": 206, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on our preliminary study [8], we estimated a success rate (reduction in the Neck Disability Index by at least 7 points; MCID [11]) of 50% in the traction group. Assuming a success rate in the placebo group of 30% (based on our clinical experience because no data from similar studies are available), 93 patients per arm are required for an 80% power and 5% alpha risk. To guarantee the power, 10% more individuals will be randomised, giving a total of 206 participants to include.", "id": 1891, "split": "test"} +{"trial_id": "NCT05952661", "pmid": "38274807", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Minimal Residual Disease Guided Radical Chemoradiotherapy Combined With Immunotherapy After Neoadjuvant Immunochemotherapy Followed by Adjuvant Immunotherapy for Esophageal Squamous Cell Cancer\n\nIncluded conditions:\n- Esophageal Carcinoma\n- Minimal Residual Disease\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Correlations of minimal residual disease (MRD) and efficacy', 'description': 'The changes in MRD status before and after radical CCRT combined with immunotherapy and adjuvant immunochemotherapy in patients with inoperable resectable stage II-III ESCC, correlating with the efficacy of adjuvant immunotherapy', 'timeFrame': '2023/2/22-2027/12/31'}\n\nPlease estimate the sample size based on the assumption: \nThe specific statistical assumptions such as significance level, power, and missing/dropout rate are not detailed in the provided paragraph.", "answer": 56, "answer_type": "ESTIMATED", "explanation": "2.11.1\n Sample size calculation\n This single-arm clinical trial will assess the prognostic effect of adjuvant immunotherapy in MRD-negative versus MRD-positive patients with ESCC. This study used PASS software (version 15.05, NCSS, LLC. Kaysville, Utah, USA) to estimate the sample size. And 56 samples were finally used as the sample size for this study. The detailed elaboration and calculation process is placed in Supplementary Material 1.", "id": 1892, "split": "test"} +{"trial_id": "NCT05954117", "pmid": "39448207", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Chemotherapy on Metabolic Flexibility in the Context of Cachexia in Cancers of the Esophagus and Gastroesophageal Junction\n\nIncluded conditions:\n- Esophageal Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Interventional', 'type': 'EXPERIMENTAL', 'description': 'patients with esophageal or gastroesophageal adenocarcinoma included to evaluate the energy expenditure before and after chemotherapy and evaluate parameters of cachexia', 'interventionNames': ['Procedure: Adipose tissue biopsies']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Adipose tissue biopsies', 'description': 'During the 2 surgical time, when patient is under general anesthesia, two adipose tissue biopsies of 20cc each (one from abdominal subcutaneous adipose tissue and one from omental adipose tissue) are taken and characterize by oxygraphy (respirometry).\\n\\nBefore the 2 surgical times (before and after chemotherapy) patients will have evaluation of the muscle strength, cachexia (by scan analysis), energy expenditure, anthropometric criteria and biochemical inflammatory.', 'armGroupLabels': ['Interventional']}\n\nPrimary Outcomes:\n- {'measure': 'Evaluation of mitochondrial respiration on adipose tissue by oxygraphy', 'description': 'Evaluation of mitochondrial respiration on adipose tissue before and after chemotherapy Mitochondrial respiration measurements in oxydo-phosphorylated conditions. For each patient measurements using ADP and carbohydrate or lipid substrates of the respiratory chain complexes for both the subcutaneous and the visceral tissue.', 'timeFrame': '6 week'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided type I error at 5%, intra-individual correlation coefficient equals 0.5, 90% statistical power for the first scenario. For the second scenario, a two-sided type I error at 5% and a statistical power greater than 80%. Exploratory sequential analyses will be conducted after the inclusion of 20 and 40 patients.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Sample size estimation is based on the work of Kraunsoe et al18 and Jacques et al36 in order to highlight a minimum effect size of 0.8 in terms of mitochondrial activity pre- and post-chemotherapy which corresponds to an absolute difference of at least 6% for a SD between 7% and 8%. So, for a two-sided type I error at 5%, an intra-individual correlation coefficient equals 0.5, it is needed to include 19 patients to show such effect size for a 90% statistical power.\n In view of the data in the literature, confirmed by those of our department, two-thirds of patients included should be cachectic. Also, we plan to include 60 patients to highlight a difference in mitochondrial respiration on AT by high-resolution respirometry between cachectic patients (n=40) and non-cachectic patients (n=20). With such a sample size, an effect size of at least 0.8 can be highlighted for a two-sided type I error at 5% and a statistical power greater than 80%, considering unresectable patients following chemotherapy cannot be taken into account in the analyses.\n Exploratory sequential analyses will be conducted after the inclusion of 20 and 40\u00e2\u0080\u0089patients in order to evaluate aforementioned effect sizes and re-estimated statistical power.", "id": 1893, "split": "test"} +{"trial_id": "NCT05954741", "pmid": "38985746", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing the Effectiveness of Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial\n\nIncluded conditions:\n- Cognitive Impairment\n- Dementia\n- Comorbidities and Coexisting Conditions\n- Vascular Dementia\n- Dementia, Mixed\n\nStudy Armgroups:\n- {'label': 'Group 1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset \\\\< 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.', 'interventionNames': ['Other: Motor rehabilitation alone']}\n- {'label': 'Group 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset \\\\< 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.', 'interventionNames': ['Other: Motor rehabilitation and Cognitive rehabilitation (paper-based)']}\n- {'label': 'Group 3', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset \\\\< 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.', 'interventionNames': ['Other: Motor rehabilitation and cognitive rehabilitation (digital-based)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Motor rehabilitation alone', 'description': 'Participants will undergo motor training consisting of a walking session (20 minutes), balance exercises, postural control exercises, proprioceptive exercises, joint mobilization exercises, and muscle strengthening exercises for a total of 25 minutes. A muscle relaxation session will follow (45 minutes).', 'armGroupLabels': ['Group 1']}\n- {'type': 'OTHER', 'name': 'Motor rehabilitation and Cognitive rehabilitation (paper-based)', 'description': 'Group 2 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a standard cognitive intervention, with the execution of cognitive exercises in the domains of attention, memory, executive function, visuo-spatial abilities, space-time orientation, by paper-pencil support (45 minutes per day).', 'armGroupLabels': ['Group 2']}\n- {'type': 'OTHER', 'name': 'Motor rehabilitation and cognitive rehabilitation (digital-based)', 'description': 'Group 3 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a digital cognitive intervention, with the execution of cognitive exercises on attention, memory, executive functions, visual-spatial ability, space-time orientation, employing device support (tablet) with interactive exercises presented by specific software (VRRS Home tablet Khymeia Srl) (45 minutes).', 'armGroupLabels': ['Group 3']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in cognitive performances', 'description': 'Mini Mental State Examination (Foderaro, 2022; Carpinelli Mazzi, 2020). Evaluation of various cognitive domains by answering 30 items (spatial/temporal orientation, repetition and recall of three words, working memory - backward calculation and/or spelling -, sentence repetition, sentence writing, naming, three-step command execution, constructional praxis).', 'timeFrame': 'Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).'}\n\nPlease estimate the sample size based on the assumption: \nThe trial uses a two-sided type I error of 5%, 80% power, and accounts for a 16% dropout rate. The standard deviation is assumed to be 1.41, based on a standard error of measurement of 1 point.", "answer": 75, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated considering the MMSE score, the primary outcome of the trial. We required the sample size to be large enough to detect a difference in efficacy (measured as MMSE at the end of treatment\u00e2\u0080\u0094MMSE at enrolment) of 1.4 MMSE points between the most effective treatment and the least effective treatment. This value was selected because it is reported in literature as the lowest threshold for the minimum clinically important difference (MCID) [39,53]. To be conservative, the third treatment was assumed to be as effective as the average of the other two. The aim was to detect this difference with a two-sided type I error of 5% and 80% power. From previous studies in populations similar to ours [54], the standard error of measurement (SEM) for the MMSE is 1 point, giving an SD of 1.41 (resulting in a Cohen\u00e2\u0080\u0099s effect size close to 1). The sample size was then estimated at 63 patients (21 per group). Taking into account the possibility of losing some patients (up to 16% of drop-outs), the required sample size was set at 75 patients (25 per group). Computations were performed using the \u00e2\u0080\u0099proc power\u00e2\u0080\u0099 of the SAS statistical package with the following parameters: one-way ANOVA as statistical model, 0, 0.7 and 1.4 as group means, 1.41 as standard deviation, 0.05 as alpha and 0.8 as power (SAS/STAT, release 9.4, SA Institute Inc., Cary, NC, USA).", "id": 1894, "split": "test"} +{"trial_id": "NCT05954962", "pmid": "38577571", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Efficacy of Micronized Natural Progesterone (Seidigestan\u00ae) Vs GnRH Antagonist (Astart\u00e9\u00ae) in the Prevention of LH Peak During Controlled Ovarian Stimulation: a Randomized Clinical Trial.\n\nIncluded conditions:\n- IVF\n\nStudy Armgroups:\n- {'label': 'CONTROL GROUP', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily subcutenous injections of ganirelix (\"antagonist\") on day 5 or 6 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval.', 'interventionNames': ['Drug: Ganirelix Acetate']}\n- {'label': 'STUDY GROUP', 'type': 'EXPERIMENTAL', 'description': 'The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily oral capsules of natural micronized progesterone on day 1 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval.', 'interventionNames': ['Drug: Progesterone 200 MG']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Progesterone 200 MG', 'description': 'The patients in the study group will administer oral natural micronized progesterone capsules from day 1 of ovarian stimulation instead of \"antagonist\" (ganirelix) subcutaneaous injections from day 5-6 of stimulation.', 'armGroupLabels': ['STUDY GROUP']}\n- {'type': 'DRUG', 'name': 'Ganirelix Acetate', 'description': 'The patients in the control group will administer subcutaneaous injections of ganirelix from day 5-6 of stimulation as per currently used protocol.', 'armGroupLabels': ['CONTROL GROUP']}\n\nPrimary Outcomes:\n- {'measure': 'MII oocytes', 'description': 'number of mature (MII) oocytes in both stimulations.', 'timeFrame': 'Egg collection day (between 8 and 14 days after starting of ovarian stimulation)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.20 (80% power), one-sided test, estimated loss of 10%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n Considering an expected yield of 13.58 oocytes in the control group with a standard deviation of 6.997 (based on an internal study conducted within the clinic, encompassing all oocyte donor stimulations performed in 2021), and accepting an alpha risk of 0.05 and a beta risk of 0.20 in a one-sided test (with an 80% statistical power), a sample size of 136 patients (68 in each study group) is required to detect a minimum difference of 3 oocytes. Accounting for an estimated loss of 10%, a total sample size of 150 patients (75 per group) is needed.", "id": 1895, "split": "test"} +{"trial_id": "NCT05955300", "pmid": "38594710", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evidence Based Training Program Combined With Nutrition Therapy for Patients With Knee Osteoarthritis\n\nIncluded conditions:\n- Osteo Arthritis Knee\n\nStudy Armgroups:\n- {'label': 'Training program and nutrition therapy', 'type': 'EXPERIMENTAL', 'description': 'The intervention group receive the GLA:D\u00ae training program for 6 weeks and a nutrition therapy for 9 months.', 'interventionNames': ['Other: Training program', 'Other: Nutrition therapy']}\n- {'label': 'Training program', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group receive GLA:D\u00ae training program for 6 weeks and general information regarding a healthy life style for 9 months.', 'interventionNames': ['Other: Training program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Training program', 'description': 'The GLAD training program consists of neuromuscular exercises for the core, the knee and the hip muscles and patient education. The New Nordic Diet is a plant-based nutrition thats aims to reduce systematic low-grad inflammation.', 'armGroupLabels': ['Training program', 'Training program and nutrition therapy']}\n- {'type': 'OTHER', 'name': 'Nutrition therapy', 'description': 'Nutrition therapy based on the New Nordic Diet', 'armGroupLabels': ['Training program and nutrition therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Knee Injury and Osteoarthritis Outcome Score (Quality of Life)', 'description': 'Patient reported outcome measurement, Max: 100, Min: 0, Max is the best that can be achieved', 'timeFrame': '9 Month'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 90% power, and a 20% drop-out ratio.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n An a priori power calculation was performed using G-Power [78] and establishing an ANOVA (F-test) between two measures and two groups for the primary endpoint, the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score, demonstrating that 50 participants (25 in each group) are required to reveal differences at the 5% significance level, with 90% power, using large effect size (1.1) as reported by previous studies [79, 80]. A change of 8\u00e2\u0080\u009310 points is considered the minimally important change (MIC) and the standard deviation is set to 15 [81]. Considering a 20% drop-out ratio, we decided to include 30 participants per group (60 participants in total).", "id": 1896, "split": "test"} +{"trial_id": "NCT05957055", "pmid": "38086595", "question": "Here is the design of a clinical trial:\n\nOfficial Title: LAMAinDiab - Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial\n\nIncluded conditions:\n- Attention Deficit Disorder with Hyperactivity\n- Diabetes Mellitus, Type 1\n\nStudy Armgroups:\n- {'label': 'Methylphenidate first, lisdexamfetamine second', 'type': 'ACTIVE_COMPARATOR', 'description': 'Initial treatment after PT training - methylphenidate (prolonged-release tablet) once-daily with dose optimization for 5-7 weeks and 6 months total therapy then change to lisdexamfetamine once-daily with dose optimization for 5-7 weeks and 6 months total therapy.', 'interventionNames': ['Behavioral: parental training in behavior management', 'Drug: Methylphenidate']}\n- {'label': 'Lisdexamfetamine first, methylphenidate second', 'type': 'ACTIVE_COMPARATOR', 'description': 'Initial treatment after PT training - lisdexamfetamine once-daily with dose optimization for 5-7 weeks and 6 months total therapy then change to methylphenidate (prolonged-release tablet) once-daily with dose optimization for 5-7 weeks and 6 months total therapy.', 'interventionNames': ['Behavioral: parental training in behavior management', 'Drug: Lisdexamfetamine']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'parental training in behavior management', 'description': 'Parental training in behavior management - online group sessions (4-6 families within group) with trained specialist, 10 once-weekly sessions. To continue to pharmacotherapy, the parents/legal guardians are required to participate in at least 8 out of 10 sessions.', 'armGroupLabels': ['Lisdexamfetamine first, methylphenidate second', 'Methylphenidate first, lisdexamfetamine second'], 'otherNames': ['PT training']}\n- {'type': 'DRUG', 'name': 'Lisdexamfetamine', 'description': 'Once-daily pharmacotherapy with lisdexamfetamine (608137-32-2, SUB32146), administered orally, for a duration of 6 months with initial dose of 30mg and dose optimization for 5-7 weeks (visits after 1st, 3rd and 5th week of therapy to adjust dose, in 20mg steps).', 'armGroupLabels': ['Lisdexamfetamine first, methylphenidate second'], 'otherNames': ['LDX']}\n- {'type': 'DRUG', 'name': 'Methylphenidate', 'description': 'Once-daily pharmacotherapy with methylphenidate (prolonged-release tablet, 298-59-9, SUB03254MIG), administered orally, for a duration of 6 months with initial of 18mg dose optimization for 5-7 weeks (visits after 1st, 3rd and 5th week of therapy to adjust dose, in 18mg steps).', 'armGroupLabels': ['Methylphenidate first, lisdexamfetamine second'], 'otherNames': ['MPH']}\n\nPrimary Outcomes:\n- {'measure': 'Change in ADHD symptom scores on the \"inattention\" scale of the Conners 3 questionnaire', 'description': 'Change of ADHD symptom severity, measured as the difference in ADHD symptom score on the \"inattention\" scale of the Conners 3 questionnaire (completed by patient and parent/legal guardian), assessed by the investigator blinded to patient allocation.', 'timeFrame': 'Before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug'}\n- {'measure': 'Change in ADHD symptom scores on the \"hyperactivity/impulsivity\" scale of the Conners 3 questionnaire', 'description': 'Change of ADHD symptom severity, measured as the difference in ADHD symptom score on the \"hyperactivity/impulsivity\" scale of the Conners 3 questionnaire (completed by patient and parent/legal guardian), assessed by the investigator blinded to patient allocation.', 'timeFrame': 'Before pharmacotherapy (after completion of PT training) and the end of the 6-month course of pharmacotherapy with LDX or MPH; similar difference (before pharmacotherapy and after 6 months of therapy) for the other drug'}\n- {'measure': 'The number of adverse events - methylphenidate arm', 'description': 'The number of adverse events coded following the MedDRA dictionary.', 'timeFrame': 'Events recorded throughout treatment with MPH for 6 months after randomization or cross-over'}\n- {'measure': 'The frequency of adverse events - methylphenidate arm', 'description': 'The frequency of adverse events per patient-month coded following the MedDRA dictionary.', 'timeFrame': 'Events recorded throughout treatment with MPH for 6 months after randomization or cross-over.'}\n- {'measure': 'The number of adverse events - lisdexamphetamine arm', 'description': 'The number of adverse events coded following the MedDRA dictionary.', 'timeFrame': 'Events recorded throughout treatment with LDX for 6 months after randomization or cross-over'}\n- {'measure': 'The frequency of adverse events - lisdexamphetamine arm', 'description': 'The frequency of adverse events per patient-month coded following the MedDRA dictionary.', 'timeFrame': 'Events recorded throughout treatment with LDX for 6 months after randomization or cross-over'}\n\nPlease estimate the sample size based on the assumption: \nSignificance threshold of alpha=0.05, statistical power of 80%, no alpha adjustment for multiple tests, and a dropout rate of ~33%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n To our knowledge, at the time of planning this trial, no trial with equivalent design and outcome measures in this population was published. Thus, we calculated the sample size to allow for detection of a moderate difference (0.33 SD) difference in score changes between LDX versus MPH for the key Conners 3 measures.33 Such difference was deemed clinically impactful by the clinical team designing the trial. To estimate the sample size, we assumed significance threshold of alpha=0.05, the statistical power of 80%. The risk of applying multiple tests (each scale in each type of responder\u00e2\u0080\u0094four in total) was assessed as minimal due to high intercorrelations among those measures. As such, no alpha adjustment was planned. Such assumptions yielded the minimum number of participants of 89 (rounded to 90). The risk of drop-out during pharmacotherapy was assessed as considerable (~33%) due to the challenging population of interest (children with ADHD and T1D, with ADHD possibly present in parents) and known side effects of tested medications. Thus, the target number of pharmacologically treated children was planned at 135, and 150 recruited given that up to 10% might be disqualified from pharmacotherapy due to drug contraindications or considerable improvement after PT. Assuming recruitment success at 80% (considerable benefit for patients, access to a drug unavailable in Poland, coordinated diabetes and psychiatric care), we estimated that 190 children that should be approached. Based on the general prevalence of ADHD in the paediatric population, the number of patients with T1D to screen for ADHD would be at least 4000\u00e2\u0080\u0094which was a number of patients supervised by the four trial centres.", "id": 1897, "split": "test"} +{"trial_id": "NCT05957445", "pmid": "38754874", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Personalized Brain Functional Sector-guided Multi-target Continuous Theta Burst Stimulation Therapy for Aphasia After Stroke: a RCT\n\nIncluded conditions:\n- Stroke\n- Aphasia\n\nStudy Armgroups:\n- {'label': 'active cTBS group', 'type': 'ACTIVE_COMPARATOR', 'description': 'active cTBS combined with speech language therapy', 'interventionNames': ['Device: active continuous Theta Burst Stimulation']}\n- {'label': 'sham cTBS group', 'type': 'SHAM_COMPARATOR', 'description': 'sham cTBS combined with speech language therapy', 'interventionNames': ['Device: sham continuous Theta Burst Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'active continuous Theta Burst Stimulation', 'description': 'Each patient will receive a series of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, and subsequently a 600-pulse cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.', 'armGroupLabels': ['active cTBS group']}\n- {'type': 'DEVICE', 'name': 'sham continuous Theta Burst Stimulation', 'description': 'Each patient will receive a series of stimulation sequences\uff0cincluding a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, and subsequently a 600-pulse sham cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.', 'armGroupLabels': ['sham cTBS group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Western Aphasia Battery scores', 'description': \"The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.\", 'timeFrame': 'baseline, end of the 3-week therapy'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 0.85, alpha risk of 0.05 (two-sided), and an estimated dropout rate of approximately 20%.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n In this trial, participants in the treatment group will undergo active cTBS, while those in the control group will receive sham stimulation. The primary outcome for assessment is the difference between the pretreatment and post-treatment WAB-R AQ. Based on prior studies,31 32 we have conservatively estimated that the treatment group would produce an effect size of 0.9 compared with the control group after a 3-week intervention. To ensure a statistical power of 0.85 with an alpha risk of 0.05 (two-sided), sample size calculations conducted using PASS 21 software have indicated a sample size of 24 participants for each group. Accounting for an estimated dropout rate of approximately 20%, both the treatment and control groups will be expanded to include 30 participants for each, aggregating to a total of 60 participants.", "id": 1898, "split": "test"} +{"trial_id": "NCT05959538", "pmid": "37726821", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Building Regulation in Dual Generations (BRIDGE) 2022-2025\n\nIncluded conditions:\n- Maternal Depression\n- Self-Regulation, Emotion\n- Child Mental Disorder\n- Child Development\n\nStudy Armgroups:\n- {'label': 'Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)', 'type': 'EXPERIMENTAL', 'description': 'The BRIDGE program is a manualized therapy that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 16 weeks of 20-30 minute DBT and parenting skills training that will be delivered asynchronously via video (participants will access these by logging onto a password protected website). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions as well as DBT and parenting skills worksheets to complete between sessions.', 'interventionNames': ['Behavioral: Building Regulation in Dual Generations (BRIDGE)']}\n- {'label': 'Dialectical Behavioural Skills Training (DBT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the DBT arm will participate in 16 weeks of DBT skills training through weekly, synchronous 1.5-hour virtual group therapy sessions. Participants will also be asked to complete worksheets on the content between sessions.', 'interventionNames': ['Behavioral: Dialectical Behavioural Therapy Skill Training']}\n- {'label': 'Services-As-Usual (SAU)', 'type': 'NO_INTERVENTION', 'description': 'Participants in the SAU arm will receive a list of local mental health and parenting resources, curated by our research team. Participants can access any intervention or resource participants would like throughout the duration of the program.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Building Regulation in Dual Generations (BRIDGE)', 'description': \"The BRIDGE intervention includes 16 weeks of 20-30 minute DBT and parenting skills training videos, delivered asynchronously via an online website requiring a participant login. Video content was drawn from concepts outlined in the DBT Skills Training Manual 2nd Edition (Linehan, 2015). Parenting videos will provide mothers with parenting skills education based on best practices in evidence-based positive parenting interventions (e.g., Parent Management Training, Positive Parenting, Kazdin, 1997; Sanders et al., 2014). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions and worksheets to complete weekly (as an opportunity to practice skill use). The clinical team will consist of two Master's or PhD level clinical psychology trainees and a parent peer coach. Mood tracking will be completed using a brief weekly survey, including questions on depression, parenting stress, positive mood, and recent stressful experiences.\", 'armGroupLabels': ['Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)']}\n- {'type': 'BEHAVIORAL', 'name': 'Dialectical Behavioural Therapy Skill Training', 'description': \"Participants in the DBT arm will participate in 16 weeks of DBT skills training only led by two Master's or PhD level clinical psychology trainees. Participants in the DBT Skills condition will participate in a skills group which follows the DBT Skills Training Manual 2nd Edition (Linehan, 2015) through weekly, synchronous 1.5-hour virtual group therapy sessions. Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness skill domains will be covered. Participants will be asked to complete worksheets between sessions to practice using skills, and will be asked to complete a Diary Card to track DBT skills use each week (Linehan, 2015). Mood tracking will be completed using a brief weekly survey including questions on depression, parenting stress, positive mood, and recent stressful experiences.\", 'armGroupLabels': ['Dialectical Behavioural Skills Training (DBT)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in depression symptoms', 'description': 'Depressive symptoms will be measured using the PHQ-9. The PHQ-9 is a 9-item self-report questionnaire with possible scores ranging from 0 to 27, with higher scores indicating greater symptom severity.', 'timeFrame': 'The PHQ-9 will be assessed during eligibility screening, pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).'}\n- {'measure': 'Change in child mental illness symptoms', 'description': 'Changes in child mental illness symptoms will be assessed using the Child Behaviour Checklist (CBCL). The CBCL is a parent-report questionnaire that measures child functioning across internalizing and externalizing symptoms. The CBCL contains 113 items, with scores ranging from 0-226. Higher scores indicated greater symptom severity.', 'timeFrame': 'Assessed at pre-intervention (T1), immediately after the intervention (T2), and at 6-month follow-up (T3).'}\n\nPlease estimate the sample size based on the assumption: \nVery high power (> 99%) to compare intervention groups to SAU, and adequate power (75%) to compare BRIDGE with DBT Skills-only. Within-group SD of 13 on the CBCL and a mean improvement of 14 points.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample size of 180 participants will be sufficient to assess clinically meaningful reductions in both maternal depressive and child MI symptoms between groups. Based on the feasibility pilot data, we assume an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00891.02 in improvement on maternal depression symptoms for both intervention groups (BRIDGE and DBT Skills-Only) [36]. A sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008960 per group will provide very high power (>\u00e2\u0080\u008999%) to compare intervention groups to SAU. Based on pilot data on child MI symptoms, we assume a within-group SD of 13 on the CBCL and a mean improvement of 14 points [36]. As we anticipate little to no improvement in the SAU arm, we assume an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00891.08 between BRIDGE and SAU and an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.54 between BRIDGE and DBT-Only (i.e., an effect size 50% smaller than for BRIDGE, based on meta-analyses on the benefit of dual generation programs) [27]. A sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008960 per group will provide very high power (>\u00e2\u0080\u008999%) to compare BRIDGE with SAU and adequate power (75%) to compare BRIDGE with DBT Skills-only.", "id": 1899, "split": "test"} +{"trial_id": "NCT05960552", "pmid": "39138581", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Establishment and Verification of Clinical Thinking Flowchart of Rescue Transesophageal Echocardiography in the Diagnosis and Treatment of Perioperative Patients in Intensive and Critical Status\n\nIncluded conditions:\n- Transesophageal Echocardiography\n\nStudy Armgroups:\n- {'label': 'The PReTEE group', 'type': 'EXPERIMENTAL', 'description': 'Prior to clinical application of PReTEE, all participants designated must receive professional training. Within the given 120 seconds participants in the PreTEE group need to provide the leading cause with regard to difficult separation from cardiopulmonary bypass among high-risk cardiac surgical procedures.', 'interventionNames': ['Diagnostic Test: The PReTEE group']}\n- {'label': 'The conventional TEE group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The routine intra-operative TEE examinations are performed within the given 120 seconds before patients are separated from the cardiopulmonary bypass.', 'interventionNames': ['Diagnostic Test: The conventional TEE group']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'The PReTEE group', 'description': 'Prior to clinical application of PReTEE, all participants designated must receive professional training. They need to receive lectures focusing on the clinical thinking flowchart of rescue transesophageal echocardiography, in conjuntion with the simulator-based training. The discriminating ability of PReTEE will be further assessed in real clinical scenario, that is, within the specified 120 seconds participants in the PreTEE group need to provide the leading causes with regard to difficult separation from cardiopulmonary bypass in high-risk cardiac surgical procedures. All examinations will be supervised by a TEE expert owning to safety considerations but without help in views acquirement or interpretation. After completion of study assessments, the TEE expert will perform a standard comprehensive TEE, the results of which was reported to the attending cardiac anesthesiologist in charge of the patient and the recorders.', 'armGroupLabels': ['The PReTEE group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'The conventional TEE group', 'description': 'Before cardiopulmonary bypass separation, conventional TEE examinations will be performed within the specified 120 seconds. Then, the expert will also perform a standard comprehensive TEE; the leading cause should also be presented to the attending anesthesiologists and recorders.', 'armGroupLabels': ['The conventional TEE group']}\n\nPrimary Outcomes:\n- {'measure': 'Time taken in seconds in seeking out the leading cause of difficult CPB separation.', 'description': 'Time will be recorded in rea-time fashion from the appearance of midesophageal 4 chamber view to the diagnose of leading cause of difficult CPB separation in both the PReTEE group and the conventional group.', 'timeFrame': 'From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.'}\n- {'measure': 'The rate of successful diagnosis.', 'description': 'Following the completion of TEE assessment by operators in the PreTEE group or in the conventional TEE group, the TEE expert in our center will then perform a standard comprehensive examination. The TEE expert will also be required to provide the leading cause of difficult separation, which then be presented to the attending anesthesiologist and cardiac surgeons as the reference of therapeutic approaches. The successful diagnosis is defined as the agreement of cause between operators in the PreTEE group or in the conventional TEE group and the expert.', 'timeFrame': 'From the time of appearance of midesophageal 4 chamber view until the time of discrimination of the leading cause of difficult separation from cardiopulmonary bypass by the TEE operator, assessed up to 120 seconds.'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% significance level, 20% dropout rate", "answer": 6, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In our preliminary experiment, the time of finding out the cardiac etiologies in the PReTEE group was 36\u00c2\u00a0s, whereas in the conventional group was 100\u00c2\u00a0s. The preliminary results have never been published. Twenty PReTEE exams were performed using the available simulator employed at our center. Considering the apparent reduction of timing of diagnosis, no further PReTEE exams are planned to be conducted in cardiac surgical patients. However, one TEE scanning procedure in the conventional group was implemented for one cardiac patient in the operating room. To achieve a 90% power at a significance level of 5%, 42 TEE examinations should be conducted among eligible patients using a hazard ratio of 2.78. Considering a 20% dropout rate, a total of 46 TEEs are schemed to be consecutively performed. The sample size calculation was achieved using the gsDesign package via R software.", "id": 1900, "split": "test"} +{"trial_id": "NCT05961371", "pmid": "39909519", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Strength Training for Osteoporosis Prevention During Early Menopause\n\nIncluded conditions:\n- Bone Loss\n- Bone Loss, Age-related\n- Osteoporosis\n- Musculoskeletal Diseases\n\nStudy Armgroups:\n- {'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'In-person, supervised resistance training program', 'interventionNames': ['Other: Resistance Training']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Waitlist control group. Will be offered the exercise program following a 9-month wait.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Resistance Training', 'description': 'Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.', 'armGroupLabels': ['Exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility - Recruitment', 'description': 'Recruitment rates - number of participants recruited per month and number of eligible participants who consented.', 'timeFrame': 'Over 9 months'}\n- {'measure': 'Feasibility - Adherence', 'description': 'Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.', 'timeFrame': 'Over 9 months'}\n- {'measure': 'Feasibility - Attrition', 'description': 'Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.', 'timeFrame': 'Over 9 months'}\n\nPlease estimate the sample size based on the assumption: \nHypothesis testing of feasibility outcomes incorporates a 1-sided alpha=5% and power of 80% with a normal approximation.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n Consolidated Standards of Reporting Trials (CONSORT) guidelines23 do not recommend hypothesis testing of efficacy outcomes for pilot and feasibility studies, so we have justified sample size based on feasibility outcomes (recruitment rates, attrition and protocol adherence) and an adopted traffic light system (Stop, Modify, Continue) based on the framework by Lewis et al.24 Hypothesis testing of feasibility outcomes incorporates a 1-sided alpha=5%\u00e2\u0080\u0089and power of 80% and a normal approximation.\n For recruitment, progression criteria include>50% (continue zone) and<35% (stop zone), thus we will require n=68 total screened participants. For participant retention, progression criteria require>85% (continue zone) and<65% (stop zone); thus, we require n=34 (n=17 in each arm). For protocol adherence (sessions attended), progression criteria require>80% (continue zone) and<60% (stop zone); thus, we require n=38 (n=19 in each arm) and will use a sample size of n=40.", "id": 1901, "split": "test"} +{"trial_id": "NCT05962541", "pmid": "39397266", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection\n\nIncluded conditions:\n- Non-muscle-invasive Bladder Cancer\n- Non-Muscle Invasive Bladder Urothelial Carcinoma\n- High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma\n\nStudy Armgroups:\n- {'label': 'PPD-TURBT (no Re-TURBT)', 'type': 'EXPERIMENTAL', 'description': 'Primary PDD-TURBT, not followed by Re-TURBT', 'interventionNames': ['Drug: PDD-TURBT with hexaminolevulinate (Hexvix\u00ae)', 'Device: Power Led Saphira (TM)']}\n- {'label': 'WL TURBT plus Re-TURBT (Standard of Care)', 'type': 'NO_INTERVENTION', 'description': 'Standard of care consisting in primary WL TURBT followed by WL Re-TURBT within 2 - 6 weeks from initial WL TURBT'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'PDD-TURBT with hexaminolevulinate (Hexvix\u00ae)', 'description': \"In order to undergo PDD-TURBT, all eligible patients in the experimental arm will be administered the photosensitizer hexaminolevulinate (85 mg in 50 ml of phosphate buffered saline, Hexvix\u00ae) on an inpatient setting through a urethral catheterization of the participant's bladder. During the PDD-TURBT surgery, the bladder will be illuminated with blue light (wavelength 380-450 nm). The operating rooms of the participant institutions will therefore need to have the specialized equipment consisting in the blue-light source (POWER LED SAPHIRA \\\\[TM\\\\]).\", 'armGroupLabels': ['PPD-TURBT (no Re-TURBT)'], 'otherNames': ['Hexvix\u00ae']}\n- {'type': 'DEVICE', 'name': 'Power Led Saphira (TM)', 'description': 'This is a light source based on LED technology. It can be used for both White Light (WL) and fluorescence applications in blue light (i.e., Photodynamic diagnosis PDD) for visualizing tumor lesions during trans-urethral resection of bladder tumors (PPD- TURBT).', 'armGroupLabels': ['PPD-TURBT (no Re-TURBT)']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of EARLY Bladder Cancer (BCa) recurrences', 'description': 'The proportion of early BCa recurrences (i.e., within 4.5 months follow-up) in those non-muscle invasive bladder cancer (NMIBC) treated by standard of care (i.e., TURBT followed by Re-TURBT) compared to our novel algorithm proposal (i.e., primary PDD-TURBT followed by no Re-TURBT).', 'timeFrame': 'within 4.5 months following primary intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 80% with a 2.5% one-sided alpha. There is an assumed 15% withdrawal/loss during follow-up.", "answer": 327, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation\n The cohort of interest will be represented by intermediate\u00e2\u0080\u0090/high\u00e2\u0080\u0090risk NMIBCs who are currently those eligible for Re\u00e2\u0080\u0090TURBT according to EAU Guidelines [11]. For the primary outcome of the proportion of early BC recurrence a literature\u00e2\u0080\u0090based incidence estimates of 10% was applied [26, 27]. A margin of 10% clinical unimportance was applied, representing the acceptable risk of disease understaging for the event of early BC recurrence in a population already screened by mpMRI and VI\u00e2\u0080\u0090RADS score.\n Based on these assumptions and using 80% power and a 2.5% one\u00e2\u0080\u0090sided alpha, 142 patients per arm will be required to power the study for non\u00e2\u0080\u0090inferiority.\n To achieve this, prior to randomisation, we will screen potential eligible participants by VI\u00e2\u0080\u0090RADS score determination, and we will exclude patients suspected of MIBC (15\u00e2\u0080\u009320%) and, from the remaining NMIBCs, exclude low\u00e2\u0080\u0090risk disease (25\u00e2\u0080\u009330%). Furthermore, we predict 35\u00e2\u0080\u009340% of these patients will be recruited based on willingness to participate or missed opportunities for recruitment. Thus, total subjects required in study would be 284 equally distributed within the Experimental (n\u00e2\u0080\u0089=\u00e2\u0080\u0089142) and SoC arms (n\u00e2\u0080\u0089=\u00e2\u0080\u0089142). However, given pre\u00e2\u0080\u0090computed risk of 15% withdrawal/loss during follow\u00e2\u0080\u0090up, the total number of patients that will need to be randomised will be 327 across the Experimental (n\u00e2\u0080\u0089=\u00e2\u0080\u0089163) and SoC (n\u00e2\u0080\u0089=\u00e2\u0080\u0089164) arms.", "id": 1902, "split": "test"} +{"trial_id": "NCT05963542", "pmid": "39419615", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus\n\nIncluded conditions:\n- Tinnitus\n- Insomnia\n\nStudy Armgroups:\n- {'label': 'ACT + sound therapy group', 'type': 'EXPERIMENTAL', 'description': 'The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy.\\n\\nThe online ACT program includes 8 modules of structured self-help material over 8 weeks. Each module includes information, exercises, and homework. The self-help material covers the six core processes of ACT: acceptance, cognitive defusion, being present, self-as-context, values, and committed action, emphasizing psychological flexibility.\\n\\nCustomized sound therapy will be provided by the Fudan Tinnitus Relieving System (FTRS) app. Participants will listen to tailor-made music through the app for more than two hours per day.', 'interventionNames': ['Behavioral: ACT for tinnitus', 'Other: Customized sound therapy']}\n- {'label': 'sound therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day.', 'interventionNames': ['Other: Customized sound therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ACT for tinnitus', 'description': 'The intervention will be based on the ACT model and adjusted for tinnitus.', 'armGroupLabels': ['ACT + sound therapy group']}\n- {'type': 'OTHER', 'name': 'Customized sound therapy', 'description': 'The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.', 'armGroupLabels': ['ACT + sound therapy group', 'sound therapy group']}\n\nPrimary Outcomes:\n- {'measure': 'Tinnitus Handicap Inventory (THI)', 'description': 'The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a \"yes\" (4 points), \"sometimes\" (2 points), and \"no\" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).', 'timeFrame': '2 months from baseline'}\n- {'measure': 'Tinnitus Handicap Inventory (THI)', 'description': 'The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a \"yes\" (4 points), \"sometimes\" (2 points), and \"no\" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).', 'timeFrame': '3 months from baseline'}\n- {'measure': 'Tinnitus Handicap Inventory (THI)', 'description': 'The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a \"yes\" (4 points), \"sometimes\" (2 points), and \"no\" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).', 'timeFrame': '6 months from baseline'}\n\nPlease estimate the sample size based on the assumption: \nAn 80% statistical power with a type I error rate of 5% was targeted. A potential dropout rate of 20% was considered. Power calculations suggest over 90% power for secondary outcomes.", "answer": 164, "answer_type": "ESTIMATED", "explanation": "Sample size\n To ensure an 80% statistical power with a type I error rate of 5%, we conducted a two-sample t-test for superiority. The THI score difference after 8 weeks of intervention serves as the primary endpoint for this superiority trial. An equivalence margin of 7 points was set, reflecting the minimally clinically important difference for the THI, as identified in prior research.36 Anticipating a mean difference of 15.79 between the treatment groups, and based on previous ACT studies on patients with tinnitus,11 we established SD of 19.18 and 20.75 for the groups. This yielded a required sample size of 65 individuals per group. To compensate for a potential dropout rate of 20%, we aim to enrol 82 participants for each group, totaling 164 participants. Power calculations suggest that with this sample size there is over 90% power to detect differences in secondary outcomes, which include the ISI, HADS-A, HADS-D and TAQ. Participant enrolment will cease once the desired sample size has been achieved.", "id": 1903, "split": "test"} +{"trial_id": "NCT05963737", "pmid": "39097307", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Multicenter Clinical RCT\n\nIncluded conditions:\n- Mechanical Ventilation\n\nStudy Armgroups:\n- {'label': 'Experimental arm', 'type': 'EXPERIMENTAL', 'description': 'The initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated every 2 hours for 48 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT \\\\< 4 ml/Kg, RR \\\\> 35 breaths/min, respiratory acidosis, respiratory distress, VT \\\\> 10ml/Kg, Pplat \\\\> 30 cmH2O, respiratory alkalosis.', 'interventionNames': ['Procedure: PS setting strategy in pressure-support ventilated patients']}\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'PS setting strategy in pressure-support ventilated patients', 'description': 'Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).', 'armGroupLabels': ['Experimental arm']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of conditions in the range of normal inspiratory effort per patient', 'description': 'the time from the start of PSV mode to the successful weaning of the ventilated patients', 'timeFrame': 'up to 48 hours'}\n\nPlease estimate the sample size based on the assumption: \nPilot trial, 80% power.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Current sample size justification\n The present study is a pilot \u00e2\u0080\u0098proof-of-concept\u00e2\u0080\u0099 trial to evaluate the effect of PMI-guided pressure support setting on the proportion of inspiratory effort within the well-accepted \u00e2\u0080\u0098normal\u00e2\u0080\u0099 range during PSV. Up to now, the distribution of inspiratory effort has not been well characterised in patients undergoing PSV. Additionally, no previous studies have adjusted the pressure support to maintain the inspiratory effort within a specific range. A sample size of 60 patients (30 in each group) is considered to be suitable for pilot trials.20 This number of patients accounts for a likely small effect size between the groups and a definitive trial with 80% power.21", "id": 1904, "split": "test"} +{"trial_id": "NCT05964270", "pmid": "39186588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)\n\nIncluded conditions:\n- Multiple Myeloma\n\nStudy Armgroups:\n- {'label': 'Intervention group (IG)', 'type': 'ACTIVE_COMPARATOR', 'description': 'participants of the intervention group (IG) will get a login for the e-coach MM, and access to eight modules: medication, outpatient visit preparation, periodic assessment, messaging service, alerts, information, ad hoc complaint, personal care plan. IG participants information is collected on a web platform that automatically invites enrolled patients. The e-coach MM is available 24/7.', 'interventionNames': ['Device: e-coach multipel myeloma (MM)']}\n- {'label': 'Control group (CG)', 'type': 'NO_INTERVENTION', 'description': \"Participants in the CG (control group) will only get a login for a 'dummy version' without the modules, besides the periodic assessments (questionnaires), at the same time as the IG\"}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'e-coach multipel myeloma (MM)', 'description': 'In this study we developed a multimodal patient-centered MM e-coach between September 2019 and June 2020. The content of the intervention consist of eight modules and was tested in a pilot study between June 2020 and August 2020 (F-ITUMM) 22. The e-coach is digitally managed, following three phases of the tiers of VBHC as presented in Figure 1. The tiers are classified in health status, process of recovery and sustainability of health 30. Furthermore, all medication information plus current dose and frequency per unit time are integrated in the e-coach. Reminders are sent if a session or a medication unit time is exceeded. Feasibility was tested for patients as well as healthcare professionals. The F-ITUMM trial concluded that the MM e-coach has the potential to support both recently diagnosed MM patients and healthcare professionals during MM treatment, and is a promising application to improve adherence .', 'armGroupLabels': ['Intervention group (IG)']}\n\nPrimary Outcomes:\n- {'measure': 'blinded primary outcome by pill count', 'timeFrame': 'over a time periode of 3 months'}\n\nPlease estimate the sample size based on the assumption: \nPower 80%, 2-tailed alpha 5%, attrition rate 15%", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size/power calculation\n The sample size of this study is based on the primary outcome regard to the pill count at t = 3 months after randomization. Pill count is a continuous measure expressed in percentages and has a normal distribution. Due to the unpredictability of the disease and the vulnerability of this group of patients, we used a conservative approach to sample-size calculation, based on an unpaired t-test and was performed using SPSS SamplePower3.0. Calculation for pill count [14, 54] Vulnerability and frailty are factors that could have an impact on our inclusion rate; therefore, we calculated a conservative sample size. At t = 3 months, we hypothesized a minimal clinically relevant difference of 10%, standard deviation 20% [55], power 80%, and 2-tailed alpha 5%. This calculation results in 64 patients in each arm. Taking into account an attrition rate of 15%, yields 75 patients to be included in each arm. Therefore, in total 150 patients will be included in this study [56\u00e2\u0080\u009359]. Duration of the trial is 20 months of inclusion plus 12 months\u00e2\u0080\u0099 time per participant in the study (each month 8 participants).", "id": 1905, "split": "test"} +{"trial_id": "NCT05964959", "pmid": "37612654", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program\n\nIncluded conditions:\n- Xerostomia\n- End of Life\n- Frailty\n- Dry Mouth\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'In the intervention group, the nurse and participant will be using the Mouth Education Program (MEP) to discuss causes, consequences and interventions for dry mouth in a structured manner, ultimately leading to an appropriate, individual treatment plan.\\n\\nThe MEP is based on current clinical, national palliative care guidelines on dry mouth care.', 'interventionNames': ['Other: Mouth Educational Program']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.', 'interventionNames': ['Other: Care as Usual']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Mouth Educational Program', 'description': 'The Mouth Educational Program is a nurse-led patient education program for dry mouth in patients with a life-limiting condition or frailty.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Care as Usual', 'description': \"Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.\", 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage responders at week 4, as compared to baseline in both groups', 'description': 'A responder is defined as a participant with a clinically relevant response, i.e. at least a 2-point reduction on the 11-point Numeric Rating Score (NRS) for dry mouth severity. The NRS ranges from 0=no dry mouth to 10=worst possible dry mouth.', 'timeFrame': 'Baseline to Week 4'}\n\nPlease estimate the sample size based on the assumption: \nFor the MEP study: 25% more responders in the intervention group, power of 0.8, alpha of 0.05, intra cluster coefficient of 0.10, and a 20% dropout rate. For the pilocarpine study: based on a previous pilot study with a standard deviation of 3.8 points, and considering limited loss-to-follow-up with a less invasive administration method.", "answer": 228, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample sizes have been calculated based upon our expectation that both interventions, MEP and pilocarpine, lead to a clinically\u00c2\u00a0relevant lower dry mouth score, a minimum 2-point decrease on the 11-point numeric rating scale for dry mouth severity, as\u00c2\u00a0compared to CAU respectively placebo.\n \n MEP study\n For this study, we expect the intervention group (patients who follow the MEP) to have at least 25% more responders (patients with clinically relevant less dry mouth at 4\u00c2\u00a0weeks) than in the control group (patients who receive CAU). To test the null hypothesis (expected difference in responders at 4\u00c2\u00a0weeks of 25%) with a power of 0.8, an alpha of 0.05 and an intra cluster coefficient of 0.10, we will need to include 181 patients which is obtained in 12 clusters (six hospitals and six nursing home clusters). Taking into account a 20% dropout rate at 4\u00c2\u00a0weeks due to the frailty of our study population, 228 patients are needed. Each participating center is therefore expected to include 19 patients.\n \n \n Pilocarpine study\n The sample size in this study was based upon our previous pilot study in older people with dry mouth [21]. By using the largest observed standard deviation from the pilot data (i.e. 3.8 points), we calculated a sample size of 57 patients per group, or 114 in total. Considering the low drop-out rates from previous studies with pilocarpine and the knowledge that in our study a less invasive administration method of pilocarpine is used, we expect limited loss-to-follow-up. However, to allow for some drop-out due to the frailty of the study population, the final sample size was set at 120 patients, with 60 patients per group.", "id": 1906, "split": "test"} +{"trial_id": "NCT05968521", "pmid": "38401897", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cardiac Rehabilitation for Young People: A Single-Blind Randomised Acceptability and Feasibility Study of an Integrated Physical and Mental Health Approach\n\nIncluded conditions:\n- Congenital Heart Disease\n- Cardiomyopathies\n- Cardiac Arrythmias\n- Heart Failure\n- Cerebrovascular Event\n- Heart Valve Diseases\n\nStudy Armgroups:\n- {'label': 'Cardiac Rehabilitation (Intervention)', 'type': 'EXPERIMENTAL', 'description': 'Participants allocated to the intervention group will receive a cardiac rehabilitation (CR) programme which will involve education, exercise, and a psychological component.', 'interventionNames': ['Behavioral: Cardiac Rehabilitation (CR): Experimental']}\n- {'label': 'Treatment as usual (Control)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants allocated to the control group will receive treatment as usual.', 'interventionNames': ['Behavioral: Treatment as usual: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cardiac Rehabilitation (CR): Experimental', 'description': 'CR will consist of six sessions lasting 90 minutes of a structured exercise programme, educational and lifestyle modules, and a psychological component. Sessions include group discussions, experiential learning and homework tasks that participants are asked to complete between sessions. Participants in this treatment arm will also receive routine clinical outpatient management alongside CR.', 'armGroupLabels': ['Cardiac Rehabilitation (Intervention)']}\n- {'type': 'BEHAVIORAL', 'name': 'Treatment as usual: Control', 'description': 'Treatment as usual will include routine clinical outpatient management.', 'armGroupLabels': ['Treatment as usual (Control)']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment Rate (Feasibility Outcome)', 'description': 'Feasibility will be assessed using recruitment rate (i.e., number of patients consented and randomized, number of patients declined the study).', 'timeFrame': 'Date of Baseline Assessment to end of follow-up (24 week follow up)'}\n- {'measure': 'Retention Rate (Feasibility Outcome)', 'description': 'Feasibility will be assessed using retention rates (i.e., number of patients withdrawn from the study, lost to follow up)', 'timeFrame': 'Date of Baseline Assessment to end of follow-up (24 week follow up)'}\n- {'measure': 'Intervention Attendance (Feasibility Outcome)', 'description': 'Feasibility will be assessed using participant attendance at intervention (i.e., number of sessions attended at the intervention).', 'timeFrame': 'Date of Baseline Assessment to end of follow-up (24 week follow up)'}\n- {'measure': 'Acceptability of the Intervention', 'description': 'Acceptability of the intervention will be assessed in qualitative semi-structured interviews with children and young people, caregivers, and healthcare professionals, which will assess individuals views on the intervention, targets for improvement, and perceived acceptability of the components of the cardiac rehabilitation programme.', 'timeFrame': 'Date of Baseline Assessment to end of follow-up (24 week follow up)'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes an overall attrition rate of up to 20%, with 95% confidence. The sample size is also sufficient to estimate key clinical parameters, such as the SD of potential outcomes, with adequate precision.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Feasibility trials are not powered to provide a definitive effectiveness analysis. Therefore, the sample size is based on having sufficient patients to evaluate the acceptability/feasibility of the intervention (as measured by patient acceptability and adherence ratings, recruitment, and retention rates), and to obtain a provisional estimate of the \u00e2\u0080\u0098promise\u00e2\u0080\u0099 of the intervention (eg, an 80% CI) for powering a future definitive randomised controlled trial (RCT). We will recruit 50 patients per arm (total N=100), which would allow for an overall attrition rate of up to 20% to be determined to be within eight absolute percentage points with 95% confidence. The total sample size is in line with recommendations by Lancaster et al.58 This will also be sufficient to estimate key \u00e2\u0080\u0098clinical\u00e2\u0080\u0099 parameters, such as the SD of potential outcomes (in the larger trial), with adequate precision, for which samples of 40 are generally sufficient.59\n Our qualitative sample has been informed by prior experience and published guidance.60 Previous research suggests that a sample size of 12 can achieve data saturation.61 The exact number will be determined by data sufficiency, achieving adequate variance in recruitment and thematic saturation, however, we are confident this estimate will be sufficient to answer the relevant research questions.", "id": 1907, "split": "test"} +{"trial_id": "NCT05971160", "pmid": "39186770", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Creating Access to Resources and Economic Support\n\nIncluded conditions:\n- Psychological Distress\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Monthly financial education videos and one-time microgrant', 'interventionNames': ['Behavioral: Financial education videos', 'Other: Microgrant']}\n- {'label': 'Monthly microgrants', 'type': 'ACTIVE_COMPARATOR', 'description': 'Monthly financial education videos and monthly microgrants', 'interventionNames': ['Behavioral: Financial education videos', 'Other: Microgrant']}\n- {'label': 'Monthly microgrants plus peer mentoring', 'type': 'ACTIVE_COMPARATOR', 'description': 'Monthly financial education videos, monthly microgrants, and peer mentoring support', 'interventionNames': ['Behavioral: Financial education videos', 'Other: Microgrant', 'Behavioral: Peer mentoring']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Financial education videos', 'description': \"Brief videos providing structured information on managing one's money\", 'armGroupLabels': ['Monthly microgrants', 'Monthly microgrants plus peer mentoring', 'Usual Care']}\n- {'type': 'OTHER', 'name': 'Microgrant', 'description': '$150 stipend', 'armGroupLabels': ['Monthly microgrants', 'Monthly microgrants plus peer mentoring', 'Usual Care']}\n- {'type': 'BEHAVIORAL', 'name': 'Peer mentoring', 'description': 'One-on-one structured mentoring sessions with a trained peer', 'armGroupLabels': ['Monthly microgrants plus peer mentoring']}\n\nPrimary Outcomes:\n- {'measure': 'Change in psychological distress, as measured by Kessler 6', 'description': 'Kessler 6 is a 6-item scale with each item scored from 0-4 for a total score range from 0-24, with higher scores indicating greater psychological distress.', 'timeFrame': 'Baseline, 6 months, 12 months'}\n\nPlease estimate the sample size based on the assumption: \nBaseline mean for the K6 is 12.15 (SD 5.83) for all 3 groups, no change in the enhanced usual care arm, a 20% improvement over time in either intervention group (mean 9.72 at 6 months), \u03b1 of .05, power to detect a significant group-by-time interaction is 0.89 with 110 individuals per group, 0.92 with 120 individuals per group, and 0.94 with 130 individuals per group. A final sample size of 360 with 120 individuals per group is selected, retaining sufficient power (0.82) even with a 17% difference. A 10% attrition rate is accounted for by recruiting 400 individuals, and a sample size as small as 320 (20% attrition) will still provide statistical power exceeding 80%.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample Sizes\n \n Quantitative Sample\n Statistical power was estimated using the mean and SD from the Leading Innovation in Trans Equity (LITE) study, a longitudinal study with 1273 transfeminine individuals [44]. In this sample, the mean score on the 6-item Kessler Psychological Distress Scale (K6) was 10.67 (SD 5.68). When stratified by food insecurity (a type of material hardship), the difference in mean K6 scores between participants experiencing food insecurity and participants not experiencing food insecurity was 20%. Therefore, we considered a \u00e2\u0089\u00a520% improvement in either the extended microgrant or the peer mentoring arm compared to the enhanced usual care arm at 6 months as a clinically meaningful effect size.\n Assuming a baseline mean for the K6 of 12.15 (SD 5.83) for all 3 groups, no change in the enhanced usual care arm, a 20% improvement over time in either intervention group (mean 9.72 at 6 months), and an \u00ce\u00b1 of .05, power to detect a significant group-by-time interaction is 0.89 with 110 (33.3%) individuals per group (n=330), 0.92 with 120 (33.3%) individuals per group (n=360), and 0.94 with 130 (33.3%) individuals per group (n=390). On the basis of the power analysis, we selected a final sample size of 360, with 120 (33.3%) individuals per group. With this sample size, we will retain sufficient power (0.82) even if we observe a 17% difference. We plan to recruit 400 individuals to allow for a 10% attrition rate over the course of the study. However, a sample size as small as 320 (20% attrition) will still provide statistical power that exceeds 80%.\n \n \n Qualitative Sample\n Sample sizes for qualitative research aim to include enough participants to reach the point at which no new, relevant information is gleaned from continued data collection, a concept known as saturation [45]. Studies indicate that saturation often occurs within the first 12 interviews, although early themes can be identified with as few as 6 interviews [46,47]. To facilitate reaching saturation within each arm, we will conduct IDIs with 12 participants per arm (n=36).", "id": 1908, "split": "test"} +{"trial_id": "NCT05971875", "pmid": "38658010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.\n\nIncluded conditions:\n- Minimally Invasive Surgery\n\nStudy Armgroups:\n- {'label': 'vNOTES vs Vaginal Hysterectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES', 'interventionNames': ['Procedure: vNOTES vs Vaginal Hysterectomy']}\n- {'label': 'vNOTES vs Laparoscopic Hysterectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES', 'interventionNames': ['Procedure: vNOTES vs Laparoscopic Hysterectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'vNOTES vs Vaginal Hysterectomy', 'description': 'Comparison of vNOTES vs VH', 'armGroupLabels': ['vNOTES vs Vaginal Hysterectomy']}\n- {'type': 'PROCEDURE', 'name': 'vNOTES vs Laparoscopic Hysterectomy', 'description': 'Comparison of vNOTES vs LH', 'armGroupLabels': ['vNOTES vs Laparoscopic Hysterectomy']}\n\nPrimary Outcomes:\n- {'measure': 'proportion of women leaving the hospital within 12 hours after surgery complications.', 'description': 'Day sugery', 'timeFrame': '12 hours'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided \u03c72 test with a 5% significance level and a power >99% for the primary outcome. The power will still be >80% for smaller effect sizes.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size\n The aim of this study is to reproduce previously observed results in a larger sample. A total sample size of 1000 patients (500 in group A and 500 in group B) is considered feasible. The power was calculated for the primary outcome. In the HALON trial, 27 out of 35 (77%) patients were discharged within 12 hours in the vNOTES arm compared with 15 out of 35 (43%) in the TLH arm. With similar results, we would reach a power >99%, considering a two-sided \u00cf\u00872 test and adopting a 5% significance level. However, the power will still be >80% for much smaller effect sizes, for example, assuming 77% in the vNOTES arm versus 65% in the control arm (VH or LH), implying an effect size of 12% which would be considered clinically relevant.", "id": 1909, "split": "test"} +{"trial_id": "NCT05972655", "pmid": "39385104", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial\n\nIncluded conditions:\n- Low Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'Treatment Arm', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive 5\\\\*5Gy modified short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 4 cycles, followed by total mesorectal excision surgery.', 'interventionNames': ['Radiation: Modified short-course radiotherapy', 'Drug: PD-1 antibody', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Modified short-course radiotherapy', 'description': 'radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx', 'armGroupLabels': ['Treatment Arm']}\n- {'type': 'DRUG', 'name': 'PD-1 antibody', 'description': 'PD-1 antibody (Tislelizumab): 200mg d1 q3w', 'armGroupLabels': ['Treatment Arm']}\n- {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Capecitabine: 1000mg/m2 d1-14 q3w', 'armGroupLabels': ['Treatment Arm']}\n- {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Oxaliplatin: 130mg/m2 d1 q3w', 'armGroupLabels': ['Treatment Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Pathological complete response (pCR) rate', 'description': 'The status of pCR will be evaluated after the TME surgery.', 'timeFrame': 'within 10 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (\u03b2) = 0.2, Maximum dropout rate = 10%", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size\n As reported, the pCR rate of short-course chemoradiotherapy with surgery is approximately 10% [18]. The estimated pCR rate of our trial was 30% [19]. The sample size was calculated using PASS software (V.15). Using \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, the sample size should be 29 patients. Assuming a maximum dropout rate of 10%, the final sample size will be 32 patients.", "id": 1910, "split": "test"} +{"trial_id": "NCT05978336", "pmid": "38017467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults\n\nIncluded conditions:\n- Limitation, Mobility\n- Older Adults\n\nStudy Armgroups:\n- {'label': 'Health Coaching (HC)', 'type': 'EXPERIMENTAL', 'description': 'The health coaching program will be delivered by trained and certified kinesiologists utilizing Brief Action Planning (BAP) principals. The BAP behavior change approach utilizes the following 4 techniques: 1) goal-setting; 2 )action planning; 3) self-monitoring; and 4) feedback. Participants will utilize daily physical activity diaries to enable self-monitoring, and BAP coaches will provide feedback on progress toward individualized physical activity goals.', 'interventionNames': ['Behavioral: Health Coaching Program']}\n- {'label': 'Health Education Program (ED)', 'type': 'ACTIVE_COMPARATOR', 'description': 'This program is an attention control group, which consists of general health education. Education sessions will be delivered either by zoom or in person. The education sessions will cover the following topics: 1) falls prevention; 2) sleep; 3) healthy eating; 4) cognitive health; and 5) mental and emotional health.', 'interventionNames': ['Behavioral: Health Education Program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Health Coaching Program', 'description': 'The HC program will be delivered over 26-weeks. Participants will have an initial hour-long HC session where the BAP coach will conduct a brief physical assessment and work with the participant to establish their physical activity goals and develop a plan. After the initial consult, coaches will conduct 8 x 20-minute phone calls with participants over the 26-week trial decreasing from bi-weekly phone calls in weeks 1-12 to monthly phone calls in weeks 13-26.\\n\\nParticipants in the HC group will have an overall goal of increasing their weekly participation in moderate to vigorous physical activity by 50 minutes, via 5-, 7-, or 10-minute bouts of progressive exercises, at a rate of perceived exertion range of 13-14 (\"somewhat hard\") by week 16. Participants will have access to specific exercise sessions made available by YouTube and/or hardcopy manuals created by the research team.', 'armGroupLabels': ['Health Coaching (HC)'], 'otherNames': ['HC']}\n- {'type': 'BEHAVIORAL', 'name': 'Health Education Program', 'description': 'Participants will begin with a one-hour, group-based, interactive education session on falls prevention delivered either in-person or by Zoom. Following the initial education session, ED participants will receive additional group education sessions (in-person or by Zoom) with the same duration and schedule as the HC program covering a variety of healthy aging topics.', 'armGroupLabels': ['Health Education Program (ED)'], 'otherNames': ['ED']}\n\nPrimary Outcomes:\n- {'measure': 'Mobility', 'description': 'Measured by the Short Physical Performance Battery (SPPB)', 'timeFrame': 'Baseline, 13-weeks, 26-weeks, 52-weeks'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed test with alpha = 0.05, 80% power, and a 15% dropout rate. The design effect (DE) is considered negligible due to low ICC values.", "answer": 290, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size for this study is 290 participants, based on SPPB data published in the LIFE study that examined changes in SPPB scores based on changes in MVPA [6]. At 6 months, those in the highest quartile of MVPA change (i.e., > 43 min per week) experienced a mean improvement (calculated as 6 months minus baseline) of 1.21 in SPPB score with a SD = 0.98. A 0.5 difference in SPPB score is considered a clinically meaningful change [58]. Assuming at least 90% of our HC participants will increase their participation in MVPA by at least 50 min per week, and splitting the remaining 10% of HC participants equally among the 3rd quartile in MVPA change (mean SPPB change = 1.16) and the 2nd quartile in MVPA change (mean SPPB change = 0.89), we anticipate a mean SPPB improvement of 0.90 \u00c3\u0097 1.21 + 0.05 \u00c3\u0097 1.16 + 0.05 \u00c3\u0097 0.89 = 1.19 in the HC group. For the ED group, we assume the mean SPPB change will be similar to what was observed in the LIFE study control group [6]; we calculated this value to be 0.84 from the published data. Thus, the effect size for the SPPB outcome is (1.19 \u00e2\u0088\u0092 0.84)/0.98 = 0.36.\n Using a two-tailed test alpha = 0.05, our estimated effect size requires a sample size of 246 participants (123 per group) in order to achieve 80% power, assuming the outcomes for all participants are independent. In principle, this sample size should be adjusted by a design effect (DE) to account for the nesting of participants within coaches in the HC arm and nesting of participants within cohorts in the ED arm. However, as noted in the description of the HC intervention, the ICC in a previous study was found to be only 0.0007 [17]. Together with an expected 15 participants per coach, the DE is only 1 + (15 \u00e2\u0088\u0092 1) \u00c3\u0097 0.007 = 1.01 which implies a negligible impact on the required sample size. No data are available on the ICC within ED groups, but we expect it to be low enough to also have negligible impact. Allowing for a 15% dropout rate\u00c2\u00a0leads to the sample size of 290 participants (i.e., 145/group).", "id": 1911, "split": "test"} +{"trial_id": "NCT05978700", "pmid": "37974234", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Video-game Based Swallowing Function Training in Patients With Dysphagia: a Randomized, Single-blind, Controlled Trial\n\nIncluded conditions:\n- Deglutition Disorders\n- Rehabilitation\n- Video Game\n\nStudy Armgroups:\n- {'label': 'Video-game group', 'type': 'EXPERIMENTAL', 'description': 'Received the video-game intervention', 'interventionNames': ['Device: Video-game']}\n- {'label': 'Conventional therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Received the conventional therapy intervention', 'interventionNames': ['Behavioral: Conventional therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Video-game', 'description': 'The video-game has three games: (1) Game One - Lip Exercise; (2) Game Two - Tongue Exercises; (3) Game Three - Lower Jaw Exercise. The whole training will take about once a day for 30 min per session, 5 times a week for 4 weeks.', 'armGroupLabels': ['Video-game group']}\n- {'type': 'BEHAVIORAL', 'name': 'Conventional therapy', 'description': 'The control group used the conventional swallowing function training. The lip exercise consisted of the following specific movements: opening mouth, closing mouth, drumming cheeks, left drumming cheeks, and right drumming cheeks; the tongue exercise consisted of the following specific movements: extending the tongue, tongue up, tongue down, tongue left, and tongue right. Each specific movement in the steps lasts 2-3s, repeat 15 times and continue with the next movement. The lower jaw movement contains the following specific movements: keep the head as low as possible, and squeeze the rubber ball placed on the neck for 2-3 seconds, repeat 15 times.', 'armGroupLabels': ['Conventional therapy group']}\n\nPrimary Outcomes:\n- {'measure': 'the Toronto Bedside Swallowing Screening Test (TOR-BSST)', 'description': 'The Toronto Bedside Swallowing Screening Test (TOR-BSST) is the best performing water swallow screening tool 8 with a sensitivity of 91.3%, a negative predictive value of 93.3% in the acute phase and 89.5% in the recovery phase. TOR-BSST has shown to be more convenient and cheaper in bedside screening compared to the gold standard method of simultaneous videofluoroscopy (VFSS), which is an invasive assessment. Due to the limitations of the experimental site, the investigators chose TOR-BSST as the assessment tool for dysphagia.', 'timeFrame': 'Assessments were conducted at baseline, within 1 week post-training, and week 8.'}\n- {'measure': 'the Functional Oral Intake Scale (FOIS)', 'description': \"The Functional Oral Intake Scale consists of a 7-point scale, with level 1 indicating completely impaired oral intake and level 7 indicating complete oral intake regardless of food concentration or type. Scores range from 1 to 7, the higher point means that the participant's oral intake is better.\", 'timeFrame': 'Assessments were conducted at baseline, within 1 week post-training, and week 8.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 90%, and a 20% increase to account for potential dropout.", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was calculated from a previous study conducted by Park et al. [29] in dysphagia patients, which measured patient swallowing function on the Functional Oral Intake Scale (FOIS), with mean of 5.40 and 4.40, SDs of 1.70 and 0.80 for the intervention and control groups, respectively. For a significant level of 0.05 and power of 90%, 31 participants were estimated in each group (62 participants). Finally, to avoid loss of power due to potential dropout, the sample size was increased by 20% for each group, resulting in a total number of participants of N\u00e2\u0080\u0089=\u00e2\u0080\u008978. The sample size was estimated using G-Power 3.1 [30].", "id": 1912, "split": "test"} +{"trial_id": "NCT05980793", "pmid": "39169395", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial\n\nIncluded conditions:\n- Osteoarthritis Finger\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Surgical treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'PIP joint denervation is performed through a volar approach.', 'interventionNames': ['Procedure: PIP joint denervation']}\n- {'label': 'Non-surgical treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'An education and exercise program.', 'interventionNames': ['Procedure: Patient education plus exercise']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'PIP joint denervation', 'description': 'Surgical denervation of the PIP joint', 'armGroupLabels': ['Surgical treatment']}\n- {'type': 'PROCEDURE', 'name': 'Patient education plus exercise', 'description': 'An education plus exercise program', 'armGroupLabels': ['Non-surgical treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Pain on load (change baseline to -12 months)', 'description': 'Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)', 'timeFrame': '0-12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe power is 80% with a significance level of p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05. Adjustments will be made for non-parametric outcomes and loss to follow-up.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n SPSS version 29 was used for the sample size calculation. The reported MCID of NRS is 20 on a 100-point scale [22]. To our knowledge, the standard deviation (SD) of changes in pain scores in patients with PIP OA have not been previously reported. Hence, the SD is based on an estimation. SD will be calculated at the interim analysis, and the power calculation will be modified if necessary. To show a difference of 20 points in PNRS on load between intervention groups (estimated SD 30) after 12 months, 37 participants are required in each treatment arm. The power will be 80% (p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05). To account for non-parametric outcome and loss to follow-up, we aim to include 90 participants in total, 45 in each treatment arm. Participants who withdraw from the trial before intervention will be replaced.", "id": 1913, "split": "test"} +{"trial_id": "NCT05981534", "pmid": "39432457", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-blinded Randomized Controlled Trial Investigating the Effectiveness of Vitamin D Supplementation in Patients With End-stage Knee Osteoarthritis\n\nIncluded conditions:\n- Vitamin D Deficiency\n- Sarcopenia\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will receive vitamin D supplement for 6 months', 'interventionNames': ['Drug: Vitamin D']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will receive placebo for 6 months', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Vitamin D', 'description': '4000IU/day vitamin D supplement will be used for 6 months', 'armGroupLabels': ['Intervention group'], 'otherNames': ['SODX Co., Ltd, Osaka, Japan']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo will be used for 6 months', 'armGroupLabels': ['Control group'], 'otherNames': ['SODX Co., Ltd, Osaka, Japan']}\n\nPrimary Outcomes:\n- {'measure': 'Quadriceps and hamstring muscle strength assessment', 'description': 'Hand-held dynamometer microFET2 (Hoggan Scientific, Salt Lake City UT, USA) will be used to assess lower limb strength and power. Assessment of isometric muscle strength and power will be performed with the participants in a seated position to assess knee extensors and knee flexors. All tests will involve maximal voluntary isometric contractions. Both limbs will be assessed to record side-to-side difference. Two trials were recorded for each muscle group.', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months after the the commencement of vitamin D supplement'}\n\nPlease estimate the sample size based on the assumption: \nA repeated-measures one-way ANOVA will be used. The study aims for 80% power to detect differences at a 0.05 significance level. An additional 20% is added to account for possible attrition.", "answer": 56, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on our power calculation, we aim to recruit 28 patients for both groups, with a total of 56 participants. Quadriceps muscle strength measured by the handheld dynamometer will be the primary outcome for sample size estimation. The effect size of the isometric quadriceps muscle strength has been determined as 0.34 in patients with knee OA [36]. A repeated-measures one-way analysis of variance (ANOVA) will be used to compare knee muscle strength, muscle mass, physical functional test, biomarkers, and questionnaire score for four timepoints (before the vitamin D supplementation (Baseline), at 3months, 6 months, and 12 months after the commencement of vitamin D supplementation). When the sample size is 23 per group with 4 repeated measurements, will have 80% of the power to detect at the 0.05 significance level. An additional 20% will be added to account for possible attrition. Thus, our sample size of 28 participants per group (total n = 56) will be sufficient to achieve our objective. The sample size was calculated using G*Power 3.0 software.", "id": 1914, "split": "test"} +{"trial_id": "NCT05986604", "pmid": "39363383", "question": "Here is the design of a clinical trial:\n\nOfficial Title: NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment\n\nIncluded conditions:\n- Sleep Disorder\n- Circadian Dysregulation\n- Memory Impairment\n\nStudy Armgroups:\n- {'label': 'TranS-C+MSI', 'type': 'EXPERIMENTAL', 'description': 'Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention', 'interventionNames': ['Behavioral: Memory Support Intervention', 'Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction']}\n- {'label': 'TranS-C alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Transdiagnostic Sleep and Circadian Intervention will be delivered alone', 'interventionNames': ['Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Memory Support Intervention', 'description': \"The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.\", 'armGroupLabels': ['TranS-C+MSI'], 'otherNames': ['MSI']}\n- {'type': 'BEHAVIORAL', 'name': 'Transdiagnostic Intervention for Sleep and Circadian Dysfunction', 'description': 'TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.', 'armGroupLabels': ['TranS-C alone', 'TranS-C+MSI'], 'otherNames': ['TranS-C']}\n\nPrimary Outcomes:\n- {'measure': 'Patient-Reported Outcomes Measurement Information System - Sleep Disturbance', 'description': 'Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).', 'timeFrame': 'Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up'}\n- {'measure': 'Sheehan Disability Scale', 'description': 'Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment', 'timeFrame': 'Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up'}\n- {'measure': 'Satisfaction with Life Scale', 'description': \"5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life.\", 'timeFrame': 'Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) was set at 0.05, with 80% power. A 20% attrition rate was considered for all aims.", "answer": 178, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n For Aim 1, sample size was determined by conducting a power analysis using Optimal Design [139, 140] for person-randomized, repeated measures trials with four timepoints (pre-treatment, post-treatment, 6FU, and 12FU). Using a prior dataset comparing CT\u00e2\u0080\u0089+\u00e2\u0080\u0089MSI and CT-as-usual for depression [25] (R01MH108657), the effect size was calculated for midlife and older adults (\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years) by averaging the effect size for depression severity at post and 6FU. This approach yielded an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.50. To achieve 80% power, 146 participants are needed. Adding 20% for attrition results in a sample size of 176. For Aim 2, Fritz and MacKinnon [141] provide recommendations for mediation sample size. Using data from R01MH108657 for midlife and older adults (\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years), the path from the predictor (average constructive memory support) to the mediator (recall at mid-treatment) was small to medium (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.18) and the path from the mediator (recall at mid-treatment) to outcome (functional impairment at post-treatment) was medium (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.23). Based on these estimates, a sample size of 148 is needed. Adding an additional 20% for attrition results in a sample of 178. The powerMediation package in R [142] was used to calculate the minimum detectable indirect effect of average constructive memory support on outcomes at 6FU and 12FU via recall at mid-treatment. With the proposed sample size of 178 needed for mediation at post-treatment, a minimum standardized indirect effect of 0.56 for outcomes at 6FU and 0.66 for outcomes at 12FU can be detected. The present study focused on powering the primary timepoint of interest, post-treatment. As treatment effects tend to decline over time, we may not be adequately powered to detect statistical significance at 6FU and 12FU. Thus, effect sizes, rather than statistical significance, will be emphasized for the follow-up timepoints. For Aim 3, a minimum detectable effect size difference was calculated via PowerUp! [143]. Estimates from pre-treatment to post-treatment impairment were generated from two prior datasets: (1)\u00c2\u00a0midlife and older adults (\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years), who were randomized to CT\u00e2\u0080\u0089+\u00e2\u0080\u0089MSI and CT-as-usual [25] (R01MH108657) and (2) midlife and older adults (\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years), who participated in the pilot trial of TranS-C\u00e2\u0080\u0089+\u00e2\u0080\u0089MSI [24]. The moderator with the smallest estimates (education from the R01MH108657 trial) was used to help ensure adequate sample size. With an alpha of 0.05, 80% power, and a sample size of 178 (calculated for Aim 2 mediation), the MDES for the moderator effect was d\u00e2\u0080\u0089=\u00e2\u0080\u00890.24. Considering that this effect size is comparable to the effect size yielded by similar analyses using prior data (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 in the R01MH108657 trial), the sample size calculated for Aim 2 will be sufficient to power Aim 3. Together, a minimum sample size of 178 will be sufficient to power all three aims.", "id": 1915, "split": "test"} +{"trial_id": "NCT05988060", "pmid": "38561708", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study\n\nIncluded conditions:\n- Head and Neck Cancer\n\nStudy Armgroups:\n- {'label': 'Patients who were randomized in the PEI group and accepted the invitation', 'type': 'EXPERIMENTAL', 'description': 'The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.', 'interventionNames': ['Other: Experimental Intervention']}\n- {'label': 'Patients who were not randomized in the PEI group', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive usual care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Experimental Intervention', 'description': 'Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology.\\n\\nPatients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.', 'armGroupLabels': ['Patients who were randomized in the PEI group and accepted the invitation'], 'otherNames': ['Physical Exercise Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'physical performance', 'description': 'six minute walking test', 'timeFrame': 'M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 80% with a 0.05 two-sided significance level. A dropout rate of 24% is expected, and the participation rate is estimated at 36%.", "answer": 112, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on the primary outcome, the 6MWT. The power of the study is set on 80% (\u00c3\u009f), using differences between two independent means with a 0.05 two-sided significance level. For calculation of the sample size, G*Power 3.1.9.2. was used [31]. Means and standard deviations (SDs) of the 6MWT of the study of Samuel et al. [19] were used. The first mean (SD) [483.16 (88.24)] is of patients with HNC who received the exercise intervention during (C/B)RT and the second mean (SD) [374.52 (110.26)] is of patients with HNC who received usual exercise care during (C/B)RT. Based on this, an effect size of 1.09 was calculated, which resulted in a sample size of 15 patients needed to undergo the PEI. We expect a drop-out of 24% as stated in the study of Samuel et al. [19]. Therefore, 20 patients need to be included in the PEI group. A feasibility study for PEI for patients with HNC in a Dutch population showed that 36% of the approached patients signed IC [13]. To include enough patients, a bigger sample size is needed. Using the expected participation percentage of 36%, a sample size of 56 is needed for the PEI group. Randomisation will be done in a 1:1 ratio so also 56 patients are needed in the control group. In total, 112 patients are needed. With the TwiCs design, two subgroups will arise in the PEI group, consisting of patients who accept and patients who refuse to undergo the PEI [26]. This type of non-compliance (refusal of the assigned treatment) will not be identical between the study arms [32]. Therefore, the sample size calculation will be revised when the real acceptance rate of the PEI differs from the initially estimated acceptance rate, before the end of the study [33].", "id": 1916, "split": "test"} +{"trial_id": "NCT05989230", "pmid": "40090682", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study\n\nIncluded conditions:\n- Orthopaedic Trauma\n- Chronic Pain\n- Musculoskeletal Injury\n\nStudy Armgroups:\n- {'label': 'Emotional Awareness and Expression Therapy', 'type': 'EXPERIMENTAL', 'description': 'Emotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain.', 'interventionNames': ['Behavioral: Emotional Awareness and Expression Therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Emotional Awareness and Expression Therapy', 'description': 'The goal of EAET is to increase awareness of uncomfortable emotions that are often linked to stressful past experiences (e.g., anger, sadness, fear) and learn adaptive ways to experience and express those emotions, in a safe and controlled environment. Core treatment components include pain education, drawing associations between the experience of pain and emotion, and experiencing and expressing emotions via imaginary, in vivo, and real life exposures. EAET will be delivered via 8, 60-minute, weekly psychotherapy visits.', 'armGroupLabels': ['Emotional Awareness and Expression Therapy'], 'otherNames': ['EAET']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of Enrollment', 'description': 'Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.', 'timeFrame': '24 months'}\n- {'measure': 'Feasibility of Retention', 'description': 'Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.', 'timeFrame': '24 months'}\n- {'measure': 'Feasibility of Recruitment', 'description': 'Feasibility of Recruitment will be measured by the enrollment of a full sample within two years of the start of the enrollment period.', 'timeFrame': '24 months'}\n- {'measure': 'Percentage of patient session attendance', 'description': 'Percentage of patients who complete 6 of 8 total EAET sessions.', 'timeFrame': '8 weeks'}\n- {'measure': 'Therapist Fidelity (Questionnaire developed by study team)', 'description': 'Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team).', 'timeFrame': '8 Weeks'}\n- {'measure': 'Percentage of patients who indicate patient satisfaction and acceptability', 'description': 'Percentage of patients who indicate treatment acceptability on the Treatment Evaluation Inventory-Short Form. This is a 9-item measure and participants respond using a 1-5 point likert scale for a possible total range of 9-45. Higher scores indicate greater satisfaction and acceptability.', 'timeFrame': '8 Weeks'}\n- {'measure': 'Feasibility of Study Assessment', 'description': 'Measured by percent of pre-treatment assessments completed by participants.', 'timeFrame': '1 Week'}\n- {'measure': 'Feasibility of Study Assessment', 'description': 'Measured by percent of post-treatment assessments completed by participants.', 'timeFrame': '8 Weeks'}\n- {'measure': 'Feasibility of Study Assessment', 'description': 'Measured by percent of follow-up assessments completed by participants.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated, but implied to follow standard feasibility study guidelines.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n This study will enroll 30 participants who sustained traumatic orthopaedic injuries requiring surgery and with chronic pain 6 months after hospital discharge (five individuals receiving the pilot intervention and 25 receiving the final standardised intervention). This sample size is based on formal recommendations for feasibility studies43 44 and corresponds with recent feasibility trials of behavioural interventions for adults following orthopaedic trauma.27 45", "id": 1917, "split": "test"} +{"trial_id": "NCT05989594", "pmid": "38453208", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing Transcatheter Aortic Valve Replacement (REHAB-TAVR): a Randomized Clinical Trial\n\nIncluded conditions:\n- Cardiac Rehabilitation\n\nStudy Armgroups:\n- {'label': 'The REHAB-TAVR group', 'type': 'ACTIVE_COMPARATOR', 'description': 'For the REHAB-TAVR group, discharge preparation will involve an exercise endurance test, exercise prescription guidance, motivational interviews, instruction on telerehabilitation, and the provision of family and peer support. Following discharge, patients will be required to adhere to their personalized exercise prescription and attend scheduled onsite follow-ups after discharge. The management model employed for this group is called home-based mobile guided exercise-based cardiac rehabilitation.', 'interventionNames': ['Behavioral: Home-based mobile guided exercise-based cardiac rehabilitation']}\n- {'label': 'The Routine-TAVR group', 'type': 'OTHER', 'description': \"Preparation for discharge will only involve an exercise endurance test and the guidance of an exercise prescription for the Routine-TAVR group. Following discharge, nurses will conduct monthly telephone follow-ups to check on the patient's progress. Additionally, patients will be scheduled for onsite follow-ups at the Outpatient Department.\", 'interventionNames': ['Behavioral: Routine Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Home-based mobile guided exercise-based cardiac rehabilitation', 'description': 'Discharge preparation, telerehabilitation, scheduled onsite follow-ups, telephone follow-ups, self-reporting, health education, online communication, family and peer support, mailing letters, institutional referrals, and security management.', 'armGroupLabels': ['The REHAB-TAVR group']}\n- {'type': 'BEHAVIORAL', 'name': 'Routine Care', 'description': 'Discharge preparation, scheduled onsite follow-ups, telephone follow-ups', 'armGroupLabels': ['The Routine-TAVR group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in 6-minute Walk Distance', 'description': 'Distance walked in 6 minutes', 'timeFrame': 'Month 3'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided significance level (\u03b1) of 0.05, desired power (1\u2212\u03b2) of 0.8, and a 20% attrition rate. The final power calculation exceeded 0.95.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n Using 6MWD as the primary outcome measure and adopting a two-sided significance level (\u00ce\u00b1) of 0.05 with a desired power (1\u00e2\u0080\u0093\u00ce\u00b2) of 0.8, we calculated the sample size using the formula designed for estimating the required sample size in a statistical test for mean differences between two groups. As per findings from 29, the disparities in 6MWD between the intervention and control groups at both 3 months post intervention and baseline were as follows: intervention group (52.1\u00c2\u00b143.9 m), control group (\u00e2\u0088\u00924.3\u00c2\u00b138.8 m). Accounting for a 20% attrition rate, the initial sample size calculation yielded 11 participants per group. However, in pursuit of heightened statistical power, our study aims to recruit 45 patients in each group. This adjustment resulted in a power (1\u00e2\u0080\u0093\u00ce\u00b2) calculation exceeding 0.95, indicating that this sample size will provide increased sensitivity and specificity, thus achieving a higher level of statistical power. Consequently, this study intends to enrol 45 patients in each group, totaling 90 patients after TAVR.", "id": 1918, "split": "test"} +{"trial_id": "NCT05989776", "pmid": "38243214", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Usual care information to fertility preservation counseling'}\n- {'label': 'Intervention: informational brochure for patients and brief training for oncologists', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention is based on information provided to different target populations, using a variety of media, including brochures and videos.', 'interventionNames': ['Behavioral: Informational brochure for patients and brief training for oncologists']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Informational brochure for patients and brief training for oncologists', 'description': 'For this randomized, stepped wedge trial, the investigators planned a mixed intervention that targets both health professionals and patients. This intervention will be carried out in its entirety thanks to the working groups made up of health professionals and expert patients that took place before the randomized trial. The intervention for health professionals consists of awareness training. They will be trained (or made aware) at different times, defined by randomization. The intervention for patients consists of a pictorial information brochure and tabular patient decision aid given by trained health professionals.', 'armGroupLabels': ['Intervention: informational brochure for patients and brief training for oncologists']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of recourse to fertility preservation consultation before and after using the combined intervention', 'description': 'This information will be collected by each regional screening coordination center of the two participating regions from the medical records of patients', 'timeFrame': 'up to 18 mont post enrollment'}\n\nPlease estimate the sample size based on the assumption: \n6 clusters of about 120 patients, alpha risk of 5%, 80% power.", "answer": 750, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n We will include all eligible patients over a period of 30 months starting 7 months before randomization of the first cluster and ending 7 months after randomization of the last cluster. This will allow us to reach a total sample of 750 included patients, based on a feasibility assessment of 2/3 of eligible patients recruited in the Occitanie region and 1/3 in the Pays de la Loire region. Assuming a proportion of access to fertility consultation of 23% before the intervention, with 6 clusters of about 120 patients and for an alpha risk of 5%, the smallest detectable effect of the intervention that we will be able to identify with 80% power will be 5.5% points. By knowing the date of the intervention and the date of the PCR, we will be able to identify whether patients were treated as part of usual care or in the intervention phase.", "id": 1919, "split": "test"} +{"trial_id": "NCT05990790", "pmid": "39609026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Patients Undergoing Moderate- to High-risk Major Noncardiac Surgery - a Prospective, Observer-blinded, Randomized, Clinical Trial\n\nIncluded conditions:\n- Postoperative Delirium\n- Major Noncardiac Surgery\n- Postoperative Cognitive Dysfunction\n\nStudy Armgroups:\n- {'label': 'Desflurane Group', 'type': 'EXPERIMENTAL', 'description': 'After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50\u00b110.', 'interventionNames': ['Drug: Desflurane']}\n- {'label': 'Sevoflurane Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50\u00b110.', 'interventionNames': ['Drug: Sevoflurane']}\n- {'label': 'Propofol Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50\u00b110.', 'interventionNames': ['Drug: Propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Desflurane', 'description': 'After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50\u00b110.', 'armGroupLabels': ['Desflurane Group']}\n- {'type': 'DRUG', 'name': 'Sevoflurane', 'description': 'After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50\u00b110.', 'armGroupLabels': ['Sevoflurane Group']}\n- {'type': 'DRUG', 'name': 'Propofol', 'description': 'After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50\u00b110.', 'armGroupLabels': ['Propofol Group']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of postoperative delirium', 'description': 'Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial five postoperative days while the patients remain hospitalized according to current recommendations. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium, which will be analyzed dichotomously.', 'timeFrame': 'First five postoperative days'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided overall significance level of 0.0167 was used, with Bonferroni-correction for three comparisons. The Hwang-Shih-DeCani spending function was applied for two interim analyses, resulting in nominal alpha levels of 0.001, 0.004, and 0.015 for the first, second, and final analyses, respectively. The power was set at 0.9, and a dropout rate of 3% was assumed.", "answer": 1332, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We estimated the number of patients required for this trial based on previous studies, which showed that the incidence of postoperative delirium in older adults undergoing major abdominal surgery lies between 5% and 50%,5 31 32 whereas the largest study reported an incidence of 25%.33 Using a conservative approach, we assumed the incidence of postoperative delirium at about 25%. A reduction of 10% points was assumed to be clinically relevant (25% vs 15%).\n Two interim analyses, one after 1/3 and one after 2/3 of recruitment, are preplanned. To correct for the comparison of the three groups, Bonferroni-correction was applied, resulting in a two-sided overall significance level of 0.0167 (0.05/3 for three comparisons). To further correct for the two interim analyses (three total analyses including the final analysis), the Hwang-Shih-DeCani spending function for group sequential designs (with associated parameter\u00e2\u0080\u00944) was used, resulting in a nominal alpha level of 0.001 for the first interim analysis, 0.004 for the second interim analysis and 0.015 for the final analysis to control the overall significance level of 0.0167 for each of the three group comparisons.\n Using a group sequential z-test and assuming an OR of 0.529 (for proportions of 0.25 as compared with 0.15), we calculated a needed sample size of 431 patients per group to achieve a power of 0.9.\n We assumed a dropout rate of 3% (including patients who die within the first five postoperative days), resulting in a needed sample size of 1332 patients (444 patients per group).\n The sample size calculation was performed using NQuery 8.", "id": 1920, "split": "test"} +{"trial_id": "NCT05990946", "pmid": "39610048", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Randomized, Controlled Study to Evaluate the Impact of Remote Symptom Management Via Smartphone App Based on Electronic Patient-Reported Outcomes on Rehabilitation Exercise Adherence After Minimally Invasive Surgery in Lung Cancer Patients\n\nIncluded conditions:\n- Lung Neoplasms, Non-Small Cell Lung Cancer\n- Postoperative Complications\n- Patient Reported Outcome Measures\n- Telerehabilitation\n- Exercise Therapy\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored \u22654, prompting remote clinician feedback and guidance on symptom management.', 'interventionNames': ['Device: ePRO based Remote Symptom Management provide by a mobile phone app']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'ePRO based Remote Symptom Management provide by a mobile phone app', 'description': 'Alerts are triggered if any of 5 core symptoms scored \u22654, prompting remote clinician feedback and guidance on symptom management. This is facilitated through the \"Shuyu\" mobile application, which serves as the platform for monitoring symptoms and communication.', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['mobile phone app for Remote Symptom Management']}\n\nPrimary Outcomes:\n- {'measure': 'Rehabilitation exercise adherence rate over 1 month after discharge', 'description': 'Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen.', 'timeFrame': 'From the day of discharge to 30 days after discharge'}\n\nPlease estimate the sample size based on the assumption: \nThe calculation was based on 80% power, a 2-sided significance level of .05, and a 20% dropout rate.", "answer": 736, "answer_type": "ESTIMATED", "explanation": "Sample Size\n The primary outcome is the rehabilitation exercise adherence rate, defined as the proportion of patients completing the prescribed exercise regimen. Adherence is defined as completing the prescribed exercise regimen, calculated from self-reported app data and verified through weekly follow-ups.\n The sample size was calculated to detect a 10% difference in adherence rates between the intervention and control groups, with 80% power and a 2-sided significance level of .05. The control group adherence rate was assumed as 70% based on previous studies [27-30]. The 10% clinically important difference was determined through expert consultation, considering their practical experience and the potential impact on patient outcomes, despite limited direct literature support. The dropout rate was estimated as 20% from previous digital intervention trials (from 3.75% to 18.3%) [31-33]. Dropouts include discontinuation of app use and loss of follow-up.\n Using a z test with a 10% proportion difference, 80% power, 5% type I error, and 20% dropout rate, the required sample size is 368 per group, 736 in total.", "id": 1921, "split": "test"} +{"trial_id": "NCT05991154", "pmid": "39883939", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Increasing Access to Mental Health Support for 18-25 Year Old Indigenous Youth With the JoyPop Mobile Mental Health App: Randomized Controlled Trial\n\nIncluded conditions:\n- Emotion Regulation\n- Depression\n- Anxiety\n- Stress\n\nStudy Armgroups:\n- {'label': 'Usual Practice + JoyPop', 'type': 'EXPERIMENTAL', 'description': 'Participants will be monitored through the existing wait-list practices, which involve regular phone calls to check in and assess functioning, and will receive access to the JoyPop app for 4 weeks.', 'interventionNames': ['Behavioral: Usual Practice + JoyPop']}\n- {'label': 'Usual Practice', 'type': 'NO_INTERVENTION', 'description': 'Participants will be monitored through existing wait-list practices which involve regular phone calls to check in and assess functioning. After 4 weeks in the Usual Practice condition, participants will be offered access to the JoyPop app.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Usual Practice + JoyPop', 'description': 'Participants will be asked to use the app at least twice daily but will otherwise not be provided with requirements related to feature or total usage.', 'armGroupLabels': ['Usual Practice + JoyPop']}\n\nPrimary Outcomes:\n- {'measure': 'Change in emotion regulation (overall)', 'description': 'Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale - Short Form. Total scores range from 18 to 90 with higher scores indicating greater difficulties in emotion regulation.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (strategies)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form strategies subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (non-acceptance)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form non-acceptance subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (impulse)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form impulse subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (goals)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form goals subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (awareness)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form awareness subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n- {'measure': 'Change in emotion regulation (clarity)', 'description': 'Emotion regulation strategies will be assessed with the Difficulties in Emotion Regulation Scale - Short Form clarity subscale. Total scores range from 3 to 15 with higher scores indicating greater difficulties.', 'timeFrame': 'Difficulties in Emotion Regulation Scale - Short Form will be administered at baseline (pre), after 2 weeks (mid), and after 4 weeks (post)'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level=0.05, power=0.95, 40% attrition rate", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample Size\n We calculated the required sample size for a 2 (between subjects; treatment condition) by 3 (within subjects; time) mixed design, roughly estimating the statistical power needed for the planned linear mixed model for the primary outcome under the assumption of compound symmetry. We used parameters of f=0.2 (small to medium effect), =0.05, and power=0.95, resulting in a suggested sample size of 66 to achieve necessary power. We estimate 60% retention throughout the study (40% attrition) based on our initial research [53]; as such, an initial sample of 110 will be recruited.", "id": 1922, "split": "test"} +{"trial_id": "NCT05991310", "pmid": "39424402", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Safety and Efficacy of Telemedicine Neurology Assessments on a Mobile Stroke Unit\n\nIncluded conditions:\n- Ischemic Stroke\n- Intracerebral Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Telemedicine Assessment by Remote Neurologist', 'type': 'EXPERIMENTAL', 'description': 'Following the initial assessment, the stroke nurse will activate the telemedicine video conference call and review the patient with the telemedicine neurologist. The telemedicine neurologist will perform a NIHSS with assistance from the stroke nurse, and this will be documented on the clinical records. Imaging will be evaluated remotely by the telemedicine neurologist. If there is a decision to administer thrombolysis, the stroke neurologist and nurse will discuss treatment with the patient or next of kin, where appropriate and able, to acquire assent in a timely manner.', 'interventionNames': ['Other: Telemedicine Assessment by Remote Neurologist']}\n- {'label': 'In-Person Assessment by an Onboard Neurologist', 'type': 'ACTIVE_COMPARATOR', 'description': 'Upon arrival on-scene, the MSU stroke nurse, neurologist, and paramedic will liaise with local ambulance services to obtain initial clinical details and perform an initial assessment. The NIHSS will be performed by the neurologist, and this will be documented on standardized clinical records. Imaging will be assessed at the console available within the ambulance. If there is a decision to administer thrombolysis, the stroke neurologist and nurse will discuss treatment with the patient or next of kin, where appropriate and able, to acquire assent in a timely manner.', 'interventionNames': ['Other: In-Person Assessment by an Onboard Neurologist']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Telemedicine Assessment by Remote Neurologist', 'description': 'Use of a telemedicine platform for a neurologist, remotely located, to assess a MSU patient, review imaging, and decide on the required treatments.', 'armGroupLabels': ['Telemedicine Assessment by Remote Neurologist']}\n- {'type': 'OTHER', 'name': 'In-Person Assessment by an Onboard Neurologist', 'description': 'Traditional in-person assessment of a patient by a neurologist located onboard the MSU', 'armGroupLabels': ['In-Person Assessment by an Onboard Neurologist']}\n\nPrimary Outcomes:\n- {'measure': 'Desirability of Outcome Ranking (DOOR) of: Safety, Scene-to-decision Treatment Times, and Resource Efficiency', 'description': 'The odds that a random participant treated through a telemedicine assessment will have a more desirable DOOR scale outcome than a random participant treated by an onboard neurologist. Such a odds is referred to as the Win Ratio, as it reflects the odds of a random participant treated via telemedicine \"winning\" against a random participant treated via an onboard model in a direct one-to-one comparison.\\n\\nThe design evaluates, in order of importance: Safety, Scene-to-decision time metrics, Resource efficiency\\n\\nIf a participant in one treatment arm is achieving better safety than the comparator, this is defined as a \"win\" for that participant and a \"loss\" for the comparator. If there is no difference in safety, time to treatment decision is compared. If no clinically meaningful difference is observed, then resource utilization is compared. If there is no difference in resource utilization, the two participants are declared as tied for the overall outcome.', 'timeFrame': 'See pre-specified outcome section for details'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8, a 2-sided significance level (\u03b1) of 0.05, and a 10% potential loss due to nonevaluable data are assumed.", "answer": 270, "answer_type": "ESTIMATED", "explanation": "Sample Size\n We hypothesize that the telemedicine intervention will result in a distribution of win/tie/loss proportions of 0.5/0.2/0.3 that corresponds to the win odds (0.5\u00e2\u0080\u0089+\u00e2\u0080\u00890.2/2)/(0.3\u00e2\u0080\u0089+\u00e2\u0080\u00890.2/2)\u00e2\u0080\u0089=\u00e2\u0080\u00890.6/0.4\u00e2\u0080\u0089=\u00e2\u0080\u00891.5 when ties are split equally between treatment groups. This estimation is conservative due to efficiency likely being substantially greater in the telemedicine arm. Recruiting 242 participants (121 per arm) would yield a power of 0.8 to observe such hypothesized treatment effect against the null hypothesis of no treatment effect (win odds\u00e2\u0080\u0089=\u00e2\u0080\u00891) assuming a 2\u00e2\u0080\u0090sided \u00ce\u00b1level of 0.05.\n15\n To account for 10% of potential losses due to nonevaluable data, the final sample size for the study is set at 270 participants. Based on previous data from the Melbourne MSU, we anticipate \u00e2\u0089\u008810% of participants assessed will receive intravenous thrombolysis on the MSU, and 5% will require EVT.\n13", "id": 1923, "split": "test"} +{"trial_id": "NCT05991791", "pmid": "39532363", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adapted and Individualized Intelligent Robotic Interactions to the Ability Spectrum of Children With Autism Spectrum Disorder\n\nIncluded conditions:\n- Autism Spectrum Disorder\n\nStudy Armgroups:\n- {'label': 'Children with autism spectrum disorders', 'type': 'OTHER', 'interventionNames': ['Other: Early Start Denver Model (ESDM)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Early Start Denver Model (ESDM)', 'description': 'Phase A\\n\\n* 4 individual sessions (1 per week)\\n* Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM\\n* Satisfaction Evaluation - Parent\\n* Satisfaction Evaluation - Therapist\\n\\nPhase B :\\n\\n* 11 sessions (1 per week)\\n* Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM with the help of the robot Pepper\\n* Satisfaction Evaluation - Parent\\n* Satisfaction Evaluation - Therapist\\n\\nPhase C :\\n\\n* 4 sessions (1 per week)\\n* Additional time of 15 minutes to evaluate 3 selected tasks of the ESDM without the help of the robot Pepper\\n* Satisfaction Evaluation - Parent\\n* Satisfaction Evaluation - Therapist\\n* All sessions will also be filmed and recorded', 'armGroupLabels': ['Children with autism spectrum disorders']}\n\nPrimary Outcomes:\n- {'measure': 'Score of success on the selected task in the ESDM program', 'description': 'Measure the success score for the selected task using the ESDM scoring grid. As soon as the child successfully completes one of the different learning stages, a success score is given to the task. This score will be maximum if all the learning stages of the task considered have been reached (Task 1 = 6 learning stages (maximum score =6); Tasks 2 and 3 = 7 stages (maximum score =7)). The ESDM scoring grid will be completed by the research therapists at the end of each session.', 'timeFrame': 'From phase A (baseline) to phase C (post-intervention) = 19 weeks'}\n\nPlease estimate the sample size based on the assumption: \nOne measurement taken each week; efficacy must be demonstrated by reproducing the effects on at least three patients in a single publication.", "answer": 8, "answer_type": "ESTIMATED", "explanation": "Sample size\n On the basis of other studies using the SCED methodology, we consider that a group containing eight children of different ages and levels of severity is statistically sufficient with one measurement taken each week. A study using the SCED methodology must demonstrate its efficacy by reproducing the effects on at least three patients in a single publication17 18 (see the \u00e2\u0080\u0098Data statistical analyses\u00e2\u0080\u0099 section).", "id": 1924, "split": "test"} +{"trial_id": "NCT05994612", "pmid": "38461275", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Suicide Prevention for Substance Using Youth Experiencing Homelessness\n\nIncluded conditions:\n- Suicide Prevention\n\nStudy Armgroups:\n- {'label': 'Cognitive Therapy for Suicide Prevention + Services as Usual', 'type': 'EXPERIMENTAL', 'description': '10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with 9 optional booster sessions + services as usual (SAU) received by the community.', 'interventionNames': ['Behavioral: Cognitive Therapy for Suicide Prevention', 'Behavioral: Services as Usual']}\n- {'label': 'Services as Usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months.', 'interventionNames': ['Behavioral: Services as Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Therapy for Suicide Prevention', 'description': '10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions', 'armGroupLabels': ['Cognitive Therapy for Suicide Prevention + Services as Usual'], 'otherNames': ['CTSP']}\n- {'type': 'BEHAVIORAL', 'name': 'Services as Usual', 'description': 'Participants will receive services that they would normally receive in the community.', 'armGroupLabels': ['Cognitive Therapy for Suicide Prevention + Services as Usual', 'Services as Usual'], 'otherNames': ['SAU']}\n\nPrimary Outcomes:\n- {'measure': 'Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W)', 'description': 'Change in suicidal ideation is measured using the Scale for Suicidal Ideation-Worst Point (SSI-W). Each item consists of three options, which are rated on a 3-point scale from 0 to 2, and each item is graded according to the intensity of the suicidality. Total scores are calculated by summing the 19 ratings, and these total scores can range from 0 to 38 with higher scores indicating worse severity.', 'timeFrame': 'baseline, 3, 6, 9 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated. Power of 0.98 for detecting treatment effect on growth rate of outcomes. Power of 0.92 for detecting mediation effects. Attrition rates of 10%, 15%, 15%, and 20% at 3-, 6-, 9-, and 12-month follow-ups.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The power analyses were conducted using the Monte Carlo simulation method [59]. For the LGMs proposed under Aim 1, previous intervention work established a medium to large effect size for treatment differences on suicidal ideation, with rs ranging from 0.42 to 0.77 [60] and Cohen\u00e2\u0080\u0099s d ranging from 0.64 to 1.03 [61] from 3- to 12-month post-baseline, favoring the cognitive behavioral treatment. Similarly, treatment differences on secondary outcome, depressive symptoms, also have shown medium to large effect sizes, with d ranging from 0.39 to 1.24 for depressive symptoms across 6\u00c2\u00a0months [62]. Aim 1 analyses will compare the growth curves of CTSP\u00e2\u0080\u0089+\u00e2\u0080\u0089SAU to SAU alone. The proposed sample size is 300, assuming an attrition of 10, 15, 15, and 20% at the 3-, 6-, 9-, and 12-month follow-up (Table\u00c2\u00a02). For the LGMs, under the conditions of continuous outcome variables (e.g., suicidal ideation) and a dichotomous covariate (i.e., two intervention conditions) that has a regression coefficient of 0.20 (medium effect size) for the slope growth factor [59], a sample size of 300 can produce a power of 0.98 to detect the treatment effect on the growth rate of the outcomes. For Aim 2, mediation analyses (path models) are proposed to identify the mechanisms that underlie the treatment effects. Previous clinical trials have reported treatment differences of medium to large (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.49 to 0.88) effect sizes for the proposed mediators, such as perceived burdensomeness [61]. Following the three-path mediation model specification suggested by Thoemmes et al. [63], and assuming medium effect sizes for the path coefficients, the proposed sample size can provide sufficient power (0.92) to detect mediation effects.", "id": 1925, "split": "test"} +{"trial_id": "NCT05995847", "pmid": "39944075", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of Harmonica Playing in Improving Lung Function Among In-home Patients With Chronic Obstructive Pulmonary Disease\n\nIncluded conditions:\n- COPD\n\nStudy Armgroups:\n- {'label': 'harmonica combination group', 'type': 'EXPERIMENTAL', 'description': 'These patients will participate in a six-month harmonica playing program, in addition to receiving basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months.', 'interventionNames': ['Behavioral: Harmonica playing program plus basic PR care with routine follow-up']}\n- {'label': 'basic-PR-care group', 'type': 'ACTIVE_COMPARATOR', 'description': 'These patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for six months.', 'interventionNames': ['Behavioral: Basic PR care with routine follow-up']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Harmonica playing program plus basic PR care with routine follow-up', 'description': 'The intervention will last for a total of six months. During this period, patients are expected to play the harmonica daily for 30 minutes, five days a week. Additionally, patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for the duration of six months.', 'armGroupLabels': ['harmonica combination group']}\n- {'type': 'BEHAVIORAL', 'name': 'Basic PR care with routine follow-up', 'description': 'These patients will receive basic pulmonary rehabilitation (PR) care, which includes self-management education, exercise training, and breathing training, as well as routine follow-up. All training sessions are home-based and will take place five days per week for the duration of six months', 'armGroupLabels': ['basic-PR-care group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in FEV1 % predicted', 'description': \"The investigators will assess patients' lung function using a lung function detector to obtain the outcome of FEV1 % predicted.\", 'timeFrame': 'At baseline, after 1 month, after 3 months, and after 6 months of intervention'}\n\nPlease estimate the sample size based on the assumption: \n80% power at a 0.05 two-tailed significance level, with a 20% dropout rate.", "answer": 248, "answer_type": "ESTIMATED", "explanation": "2.3 Eligibility and sample size\n Eligible patients must have a clinical diagnosis of COPD and a post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of < 70%. Exclusion criteria include recent COPD exacerbations (within 6 weeks), resting oxygen saturation (SpO2) below 88% on room air or inadequate oxygenation despite supplementation; as well as severe dyspnea with Modified Medical Research Council (mMRC) grade 4, recent myocardial infarction, unstable angina, severe arrhythmias (e.g., ventricular arrhythmias or rapid atrial fibrillation), or pulmonary hypertension with right heart failure. Additional exclusions include comorbidities affecting physical activity (e.g., neurological disorders, cancer, significant musculoskeletal issues), cognitive impairments, and inability to communicate in Chinese. Furthermore, those with prior participation in PR within 6 months, or regular experience playing harmonica or similar wind instruments, are excluded to ensure baseline equivalence, minimize learning and behavioral biases, and avoid psychological effects, thereby enhancing the validity and reliability of the study outcomes.\n Based on an anticipated minimum clinically important difference (MCID) of a 4% increase in percent predicted FEV1 (FEV1%) and a standard deviation of 10% (16), each group will require 99 participants to achieve 80% power at a 0.05 two-tailed significance level. Considering a 20% dropout rate, the study plans to enroll 248 patients (124 per group) (17).", "id": 1926, "split": "test"} +{"trial_id": "NCT06000111", "pmid": "39163327", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study\n\nIncluded conditions:\n- Macular Holes\n\nStudy Armgroups:\n- {'label': 'Face-Down Positioning for 3-Days and Nights', 'type': 'EXPERIMENTAL', 'description': 'Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.', 'interventionNames': ['Behavioral: 3 Days of face-down positioning']}\n- {'label': 'Face-Down Positioning for 7-Days and Nights', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.', 'interventionNames': ['Behavioral: 7 Days of face-down positioning']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': '3 Days of face-down positioning', 'description': 'Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.', 'armGroupLabels': ['Face-Down Positioning for 3-Days and Nights']}\n- {'type': 'BEHAVIORAL', 'name': '7 Days of face-down positioning', 'description': 'Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.', 'armGroupLabels': ['Face-Down Positioning for 7-Days and Nights']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment Rate', 'description': \"This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.\", 'timeFrame': 'The recruitment rate will be calculated during the recruitment period.'}\n- {'measure': 'Retention Rate', 'description': \"This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.\", 'timeFrame': 'The retention rate will be calculated at 3-months post-operatively.'}\n- {'measure': 'Completion Rate', 'description': \"This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.\", 'timeFrame': 'The completion rate will be calculated at 3-months post-operatively.'}\n- {'measure': 'Recruitment Time', 'description': \"This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.\", 'timeFrame': 'The recruitment time will be calculated during the recruitment period.'}\n\nPlease estimate the sample size based on the assumption: \nA 10% attrition rate was estimated based on previous studies. The sample size of 40 patients will allow estimation of an 80% retention and completion rate within a 95% confidence interval of +/-12.4% and a 33% recruitment rate within a 95% confidence interval of +/- 14.6%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome of this investigation is to assess feasibility, as such, a power calculation to determine the sample size was not performed [15, 19, 20]. A literature review was undertaken to help inform the optimal sample size; no consensus was found with recommendations ranging from 24 to 50 described in the literature [21\u00e2\u0080\u009323]. A previous RCT evaluating different positioning following PPV for FTMHs experienced a 10.2% attrition and thus we similarly estimate a 10% attrition rate in this investigation [24]. As such accounting for this attrition rate, utilizing a sample size of 40 patients, we will be able to estimate an 80% retention and completion rate to within a 95% confidence interval of +/-12.4% and a 33% recruitment rate to within a 95% confidence interval of +/- 14.6% [23]. We estimate based on previous rates of FTMH at our institution that there will be 3 new eligible patients each week. Previous studies at our institution have experienced a recruitment rate of 25%. Thus, we estimate that it will take approximately 53 weeks to achieve our target sample size.", "id": 1927, "split": "test"} +{"trial_id": "NCT06002243", "pmid": "39424380", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)\n\nIncluded conditions:\n- Rheumatic Heart Disease\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participant receiving echocardiography screening.', 'interventionNames': ['Diagnostic Test: SPLASH echocardiography screening']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'SPLASH echocardiography screening', 'description': 'Screening echocardiogram performed by a briefly trained health worker with images reviewed off site by an expert cardiologist or cardiac sonographer to determine screening outcome. Screening outcome may include: screen positive, screen negative or uninterpretable images.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in proportion receiving secondary antibiotic prophylaxis', 'description': 'The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline', 'timeFrame': '18 months from commencement of study'}\n\nPlease estimate the sample size based on the assumption: \n95% two-sided significance level, 80% power.", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size has been calculated based on the primary outcome measure. To observe an absolute increase of 2.4% of the target population prescribed secondary prophylaxis, from a baseline prevalence of 4.4% to 6.8% (based on previous data from the Northern Territory3), with 95% two-sided significance and 80% power, the sample size required is 1421. However, if a lower proportion of the target population is prescribed secondary prophylaxis at baseline (as expected in Western Australia and Timor-Leste), then the power of the study is increased. The study will aim to enrol >1500 participants (children and pregnant women) across approximately 10 sites (~150 participants per site); five sites in Australia and five sites in Timor-Leste over 18 months.", "id": 1928, "split": "test"} +{"trial_id": "NCT06002737", "pmid": "39030560", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial\n\nIncluded conditions:\n- The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm\n\nStudy Armgroups:\n- {'label': 'Arm 1', 'type': 'EXPERIMENTAL', 'description': 'Using Experimental harmonic scalpel to dissect the vessel', 'interventionNames': ['Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel']}\n- {'label': 'Arm 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel', 'interventionNames': ['Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel', 'description': 'Screening of lung or esophageal surgery patients who meet the inclusion criteria but do not meet the exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of coagulation of blood vessels with a diameter greater than 5mm but not equal to 7mm.', 'armGroupLabels': ['Arm 1', 'Arm 2']}\n\nPrimary Outcomes:\n- {'measure': 'The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife', 'description': 'The success rate is defined as the number of subjects who successfully occluded and severed blood vessels divided by the number of subjects in the analysis dataset. Each subject should use an ultrasound knife to occlude and sever at least one target vessel', 'timeFrame': 'From the target Vascular detachment to finish of the surgery'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.025 (single-sided), a power of 80%, and a drop-out rate of about 15%.", "answer": 144, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A study was conducted to evaluate the effectiveness of an ultrasonic vascular closure device for closure of pulmonary artery branches of 7\u00c2\u00a0mm or below during the minimally invasive anatomic lung resection [10]. The immediate success rate reported in the Liberman study was 98.7%. In combination with literature reports and clinical conditions, assuming a success rate of 96% for coagulation of target blood vessels during surgery with an ultrasonic scalpel in the experimental group and control group, a non-inferiority margin of 10.00%, a significance level of 0.025 (single-sided), and a power of 80%, the calculated sample size is 61 cases for the test group and the control group respectively when subjects are assigned to the experimental group and the control group at a ratio of 1:1. Considering a drop-out rate of about 15%, the sample size for each group is 72 subjects, totally 144 subjects.", "id": 1929, "split": "test"} +{"trial_id": "NCT06003283", "pmid": "39407334", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial\n\nIncluded conditions:\n- Rheumatoid Arthritis\n\nStudy Armgroups:\n- {'label': 'Tapering of rituximab based on disease activity guided dose reduction', 'type': 'EXPERIMENTAL', 'description': 'Treatment with rituximab every 6 months (24 weeks) with dosing based on disease activity, measured by the DAS28-CRP.\\n\\nDAS28-CRP \u2264 3.2: dose reduction according to the following sequence: 1 x 1000 mg IV (maximum), 1 x 500 mg IV, 1 x 200 mg IV (minimum).\\n\\nDAS28-CRP \\\\> 3.2: administration of previously effective dose.', 'interventionNames': ['Drug: Rituximab']}\n- {'label': 'Tapering of rituximab based on interval prolongation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment with fixed dose of rituximab (1 x 1000 mg IV) if DAS28-CRP \u2265 3.2 AND interval of at least 6 months (24 weeks) since previous administration of rituximab.', 'interventionNames': ['Drug: Rituximab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'IV rituximab', 'armGroupLabels': ['Tapering of rituximab based on disease activity guided dose reduction', 'Tapering of rituximab based on interval prolongation'], 'otherNames': ['MabThera', 'Truxima', 'Ruxience', 'Rixathon']}\n\nPrimary Outcomes:\n- {'measure': 'Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire', 'description': 'RAID questionnaire score range: 0 - 10, with higher scores indicating worse status.', 'timeFrame': 'Over 2 years (104 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 5%, the power is 80% for the primary outcome, and the dropout rate is assumed to be 20%. For the secondary outcome, the power is >95%.", "answer": 134, "answer_type": "ESTIMATED", "explanation": "Sample size\n We hypothesise that administering rituximab according to a fixed interval disease activity-guided dose optimisation strategy would result in better reduction of patient-reported disease impact, compared with treat-to-target fixed dose rituximab administration. Therefore, our primary endpoint is based on the AUC of the RAID score over the full trial duration of 104\u00c2\u00a0weeks. Our null hypothesis was that both treatment strategies would result in equal RAID AUC (H0: \u00e1\u00ba\u009f\u00e2\u0080\u0089=\u00e2\u0080\u00890). The alternative hypothesis was that fixed interval disease activity-guided dose optimisation of rituximab would be superior, resulting in a lower RAID AUC (H1: \u00e1\u00ba\u009f\u00e2\u0080\u0089\u00e2\u0089\u00a0\u00e2\u0080\u00890). For the sample size calculation, we considered a difference in RAID AUC of at least 20% over 104\u00c2\u00a0weeks of treatment as an important difference of the overall disease impact. An effect size of 20% was chosen pragmatically and intuitively, taking into account the minimal clinically important difference of RAID in patients with active RA reported in the literature [37]. In the absence of a 2-year RAID AUC value in the literature, a pooled RAID score of patients in DAS28-CRP remission and low disease activity of the study by Salaffi et al. was used to estimate the two-year RAID AUC reference value [38]. In this study, data were reported of patients with RA from 13 European countries, resembling the Belgian RA population. Based on their data, a pooled mean RAID AUC of 293.26 (standard deviation (SD) 119.24) over a period of 104\u00c2\u00a0weeks was determined as reference. We assumed a drop-out rate of 20% based on data of the IMAGE trial, a rituximab-tapering trial, and the 2-year CareRA trial conducted in Belgium [39, 40]. According to the sample size calculation for a superiority trial, in order to have an 80% chance of detecting a difference in primary outcome measure from 293.26 in the usual care group to 234.60 in the experimental group with a significance level of 5% along with an estimated drop-out rate of 20%, a total of 134 patients are required to be included in the trial. Consequently, 67 patients need to be enrolled in both treatment arms. Furthermore, a sample size calculation was performed for the main secondary outcome (DAS28-CRP AUC over 104\u00c2\u00a0weeks). For this purpose, data of the SMART trial were used [41]. In this trial, one group was retreated based on loss of disease control (DAS28\u00e2\u0080\u0089>\u00e2\u0080\u00893.2) with one rituximab infusion of 1000\u00c2\u00a0mg, like the comparator arm of our study. In this group, patients had a mean DAS28-CRP AUC over 2\u00c2\u00a0years of 2761 (SD 508). Based on these numbers, a sample size of 134 participants would result in a power of\u00e2\u0080\u0089>\u00e2\u0080\u008995% for the main secondary outcome.", "id": 1930, "split": "test"} +{"trial_id": "NCT06003998", "pmid": "38238055", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab for Patients With Unresectable Colorectal Peritoneal Metastases\n\nIncluded conditions:\n- Colorectal Cancer\n- Peritoneal Metastases\n\nStudy Armgroups:\n- {'label': 'Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab', 'type': 'EXPERIMENTAL', 'description': 'Intraperitoneal irinotecan, 75 mg flat dose + systemic oxaliplatin, 5-Fluorouracil and bevacizumab (mFOLFOX+beva) (dose via standard of care)', 'interventionNames': ['Drug: Irinotecan', 'Drug: FOLFOX regimen', 'Drug: Bevacizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Irinotecan', 'description': '2 weekly IP irinotecan (max 12 cycles), dose 75 mg flat dose', 'armGroupLabels': ['Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab'], 'otherNames': ['Intraperitoneal irinotecan']}\n- {'type': 'DRUG', 'name': 'FOLFOX regimen', 'description': 'FOLFOX-4 regimens consist of 85 mg/m2 oxaliplatin plus 200 mg/m2 LV and 5-FU 400 mg/m2 bolus on day 1 followed by 1600 mg/m2 5-FU as a 46-h infusion', 'armGroupLabels': ['Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab'], 'otherNames': ['5-FU + oxaliplatin']}\n- {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Bevacizumab according to standard of care', 'armGroupLabels': ['Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab'], 'otherNames': ['Avastin']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'calculated from (a) the interval from diagnosis of peritoneal metastases until death or last follow-up; (b) the interval from the first day of the first cycle until death or last follow-up).', 'timeFrame': '3 year'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a power of 80% and a type I error rate of 0.05. Additionally, if a patient is withdrawn before completing one cycle of treatment, they will be replaced.", "answer": 85, "answer_type": "ESTIMATED", "explanation": "Sample size\n Population-based studies have described an OS of approximately 12.2 months5 for patients with isolated unresectable CPMs treated with palliative systemic chemotherapy. Based on clinical experience, expert consensus and the preliminary results of the INTERACT study, we hypothesise that the study treatment will result in a median OS of at least 16.2 months. This entails an expected increase of 4 months in the study population in comparison to the general population of patients with unresectable CPM. To render this assumption plausible, with a power of 80% and a type I error rate of 0.05, a sample size of 85 is needed.\n Given the previous experience with the trial treatment from the INTERACT study and the low expected additional toxicity of IP irinotecan, the investigators consider it reasonable and safe to expose 85 patients to trial treatment.\n \n Replacement of individual patients\n If a patient is withdrawn from the study prior to completing one cycle of IP irinotecan with concomitant systemic therapy, an additional patient is enrolled to replace the withdrawn patient.", "id": 1931, "split": "test"} +{"trial_id": "NCT06005623", "pmid": "39358699", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Motivational Feedback on Levels of Physical Activity and Quality of Life by Activity Monitoring Following Knee Arthroplasty Surgery - Randomized Controlled Trial Nested in a Prospective Cohort (KneeActivity)\n\nIncluded conditions:\n- Knee Arthropathy\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Activity tracking and motivational feed-back by gamification.', 'interventionNames': ['Device: SENS Motion + Motivational Feedback']}\n- {'label': 'Care as usual', 'type': 'NO_INTERVENTION', 'description': 'Activity tracking without motivational feed-back'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SENS Motion + Motivational Feedback', 'description': 'To weeks prior to surgery and in a 12-week period following discharge after TKA/UKA patients will be equipped with a discrete patch and built-in accelerometer (SENS Motion, Denmark, Copenhagen) attached on the thigh of the leg not undergoing surgery.\\n\\nFollowing discharge after TKA/UKA patients randomized to the intervention-group will receive the app (\"SENS motion\"). On their provided app, patients will be able to choose between two tabs. Tab 1 will allow patients to view predefined goals, all of which are locations in a self-selected city. The sensor will measure the physical activity and daily rhythm of the patient, and accelerometer counts will be converted into daily steps, which will be visible to the patients. In Tab 2, patients will be able to see graphical representations of their daily activity as well as their history during the period in which they have worn the accelerometer. The graphical representations include: Daily steps, physical active minutes, and type of activity.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Between-group change score of total daily PA (accelerometer counts)', 'description': 'PA will be evaluated by SENS Motion as described above. The primary outcome measure is the between-group change score of total daily PA (accelerometer counts) from baseline to 12 weeks following discharge. Accelerometer counts per day is a cumulative and validated variable based on raw accelerometer data in 3 planes and is a proxy for total daily PA', 'timeFrame': 'Baseline and 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power (\u03b2 = 0.80), two-tailed \u03b1 level of 0.05, standard deviation of 101,000 counts per day, and a dropout rate of 20%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and statistical procedures\n To our knowledge, there are no anchor-based minimum clinically important differences (MCID) specifically for physical activity in knee patients. As a substitute, we use an MCID for steps per day, derived from chronic obstructive pulmonary disease research, corresponding to a change of approximately 17%\u00e2\u0080\u009335% [31]. Applying a 17% threshold to total accelerometer counts per day, based on a previous study of TKA patients [9], yields an anticipated between-group difference in change score of 50,500 activity counts per day. This expected difference is further supported by findings from Van der Walt et al. (2018) [25], who demonstrated a 17% increase in daily step count in the feedback group compared to the non-feedback group after six months. To achieve 80% statistical power (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.80) and detect statistically significant differences at a two-tailed \u00ce\u00b1 level of 0.05, assuming a standard deviation of 101,000 counts per day before and after the intervention [9] a sample size of 62 participants per group is estimated. To account for potential dropouts, we use a rate of 20% based upon evidence from a systematic review showing that dropout rates in RCTs on physical activity are within this percentage [32]. Consequently, we will include a sample of 150 patients in total. When appropriate, all outcome measures will be checked for Gaussian distribution using QQ-plots and parametric statistical and/or non-parametric analyses.\n No a priori sample size calculation is made for the cohort study. However, based on a total sample of approximately 1,400 annual knee replacement procedures for OUH and Vejle hospitals, it is reasonable to expect an inclusion of 200 patients, which is acceptable for the current statistical analysis plan on predictive regression models [30].\n The main comparative analyses between groups will be performed using an intention-to-treat analysis. Between-group mean differences and 95% confidence intervals will be estimated with a linear regression model. The patient\u00e2\u0080\u0099s baseline score is entered as a covariate and adjusted for potential baseline differences (age, sex, BMI). In addition to the intention-to-treat analysis, a per-protocol analysis will be conducted on patients adhering to the intervention (using the patient app for 5 out of 7\u00c2\u00a0days in a week or\u00e2\u0080\u0089>\u00e2\u0080\u008970% of the available days.", "id": 1932, "split": "test"} +{"trial_id": "NCT06010641", "pmid": "38296589", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial\n\nIncluded conditions:\n- Stroke, Acute Ischemic\n\nStudy Armgroups:\n- {'label': 'Head-down position', 'type': 'EXPERIMENTAL', 'description': 'head-down position as an adjunct to guideline-based treatment', 'interventionNames': ['Other: head-down position']}\n- {'label': 'control', 'type': 'OTHER', 'description': 'guideline-based treatment', 'interventionNames': ['Other: head-down position']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'head-down position', 'description': '-20\u00b0 Trendelenburg as an adjunct to guideline-based treatment,', 'armGroupLabels': ['Head-down position', 'control']}\n\nPrimary Outcomes:\n- {'measure': 'proportion of favorable functional outcome', 'description': 'favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome', 'timeFrame': '90\u00b17 days'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided 0.05 level of significance, 80% power", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size estimatesBased on a two-sided 0.05 level of significance, 600 patients are expected to yield the superiority hypothesis with 80% power, stratified by age, sex, history of diabetes, baseline systolic blood pressure, location of index vessel, National Institutes of Health Stroke Scale Score at randomisation, onset to randomisation time, progression to moderate neurological deficit due to early neurological deterioration and degree of responsible vessel stenosis.", "id": 1933, "split": "test"} +{"trial_id": "NCT06010641", "pmid": "38296589", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial\n\nIncluded conditions:\n- Stroke, Acute Ischemic\n\nStudy Armgroups:\n- {'label': 'Head-down position', 'type': 'EXPERIMENTAL', 'description': 'head-down position as an adjunct to guideline-based treatment', 'interventionNames': ['Other: head-down position']}\n- {'label': 'control', 'type': 'OTHER', 'description': 'guideline-based treatment', 'interventionNames': ['Other: head-down position']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'head-down position', 'description': '-20\u00b0 Trendelenburg as an adjunct to guideline-based treatment,', 'armGroupLabels': ['Head-down position', 'control']}\n\nPrimary Outcomes:\n- {'measure': 'proportion of favorable functional outcome', 'description': 'favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome', 'timeFrame': '90\u00b17 days'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided 0.05 level of significance, 80% power", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n According to our recent HOPES 2 trial,25 the prevalence of favourable functional outcome at 90 days (mRS 0\u00e2\u0080\u00932) was 50% in the control group and 65.2% in the HDP group, with a 15.2% absolute difference. An absolute 12% increase in primary outcome in the HDP group is conservatively estimated, which translates into primary outcome of 62% in HDP group. A one-sided test with a power of 80% and \u00ce\u00b1 set at 0.025 calculated a sample size of 540 patients to test the hypothesis of superiority. The sample size is readjusted to 600 patients given a loss to follow-up rate of 10% and alpha consumption by interim analysis (O\u00e2\u0080\u0099Brien-Fleming method). This study will therefore include 600 patients, 300 in each group.", "id": 1934, "split": "test"} +{"trial_id": "NCT06014554", "pmid": "39689129", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Structured Tailored Rehabilitation After Hip Fragility Fracture: The 'STRATIFY' Feasibility Randomised Controlled Trial\n\nIncluded conditions:\n- Hip Fractures\n\nStudy Armgroups:\n- {'label': 'Stratify', 'type': 'EXPERIMENTAL', 'description': \"Patients randomised to the 'Stratify' intervention will receive usual care and an intervention based on their subgroup assignment. The intervention will start before the third postoperative day and be delivered during the inpatient stay. Intervention components will be delivered by a physiotherapist, occupational therapist, or therapy assistant depending on staffing availability.\", 'interventionNames': ['Other: Low-risk subgroup', 'Other: Medium-risk subgroup', 'Other: High-risk subgroup']}\n- {'label': 'Usual care', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients randomised to the control arm will receive usual physiotherapy and occupational therapy care.', 'interventionNames': ['Other: Control group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Low-risk subgroup', 'description': 'Self-managed exercise programme.', 'armGroupLabels': ['Stratify']}\n- {'type': 'OTHER', 'name': 'Medium-risk subgroup', 'description': 'Education, goal-orientated mobility programme, and enhanced discharge planning.', 'armGroupLabels': ['Stratify']}\n- {'type': 'OTHER', 'name': 'High-risk subgroup', 'description': 'Education, enhanced assessment, orientation, and goal-orientated activities of daily living training programme.', 'armGroupLabels': ['Stratify']}\n- {'type': 'OTHER', 'name': 'Control group', 'description': 'Usual care entails physiotherapy and occupational therapy from the day after surgery to the point of discharge, with a focus on discharge planning and sufficient recovery of activities of daily living and mobility for safe return to prefracture residence.', 'armGroupLabels': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment fidelity (supervised intervention)', 'description': 'measured through assessment of treatment logs', 'timeFrame': 'At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)'}\n- {'measure': 'Treatment fidelity (unsupervised intervention)', 'description': 'measured through assessment of patient diary', 'timeFrame': 'At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 95% confidence interval; Power: Not explicitly stated; Missing/dropout rate: 20% (retention rate of 80%).", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The recruitment target aims to have sufficient participants to provide the operational experience to plan a definitive future trial; provide reasonably robust estimates of our feasibility outcomes; and to estimate the variability of the proposed patient outcomes to inform a future sample size calculation. A recruitment target of 60 participants (30 per treatment arm) will allow overall retention rate at 12-weeks to be estimated with precision of \u00c2\u00b111%, using an exact 95% confidence interval, from previously observed retention rates of ~80% for the same population [49]. Assuming a non-differential retention rate of 80% at 12-week follow-up, this target will provide follow-up outcome data on ~24 participants per arm.", "id": 1935, "split": "test"} +{"trial_id": "NCT06016075", "pmid": "39461869", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques\n\nIncluded conditions:\n- Kidney Cancer\n\nStudy Armgroups:\n- {'label': 'Hyperpolarised MRI', 'type': 'OTHER', 'description': 'Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.', 'interventionNames': ['Device: Hyperpolarised MRI']}\n- {'label': 'Sodium MRI', 'type': 'OTHER', 'description': 'MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.', 'interventionNames': ['Device: Sodium MRI']}\n- {'label': 'Deuterium metabolic imaging (DMI) MRI', 'type': 'OTHER', 'description': 'Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.', 'interventionNames': ['Device: Deuterium metabolic imaging (DMI) MRI']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Hyperpolarised MRI', 'description': 'Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.', 'armGroupLabels': ['Hyperpolarised MRI']}\n- {'type': 'DEVICE', 'name': 'Sodium MRI', 'description': 'MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.', 'armGroupLabels': ['Sodium MRI']}\n- {'type': 'DEVICE', 'name': 'Deuterium metabolic imaging (DMI) MRI', 'description': 'Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.', 'armGroupLabels': ['Deuterium metabolic imaging (DMI) MRI']}\n\nPrimary Outcomes:\n- {'measure': 'LAC/PYR ratio', 'description': 'LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.', 'timeFrame': '1 year'}\n- {'measure': 'Total Sodium Concentration', 'description': 'Total Sodium Concentration - in renal tumours', 'timeFrame': '1 year'}\n- {'measure': 'Technical development of DMI in the abdomen', 'description': 'Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nDescriptive statistics will be used. The primary covariates to be studied include the ratio of the summed hyperpolarised 13C-lactate to the summed 13C-pyruvate (LAC/PYR), total sodium concentration, and the ratio of the summed 2H-lactate over the summed combined signal from 2H-glutamine+2H-glutamate.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "The sample size calculation and outcomes\n The study has been powered to assess changes in the 13C-pyruvate metabolism from the data we collected from nine treatment-na\u00c3\u00afve renal tumour patients.28 This work showed that the median pyruvate-to-lactate conversion constant (kPL) in ccRCCs was 0.0065 (range 0.0024\u00e2\u0080\u00930.0151), while it was 0.0043 (range 0.0028\u00e2\u0080\u00930.0076) in the normal kidney. This study also reported metabolism in a single case of renal oncocytoma, which showed both the lowest conversion constant and lactate-to-pyruvate ratio (LAC/PYR). There are currently no published studies assessing DMI and 23Na-MRI quantitative parameters in human kidney tumours.\n Based on the parameters obtained from the HP-13C-MRI, pragmatic sample sizes have been determined for priming of the study: we plan to include up to 30 participants in total: 15 with benign renal masses and 15 with malignant renal masses. These participants will be divided equally into three imaging arms (HP 13C-MRI, 23Na-MRI and DMI); therefore five benign and five malignant participants will be recruited to each imaging arm. If participants are willing to take part in the optional additional scan using a different imaging technique, these participants will be counted towards both arms of the study and therefore the total number recruited to the study will be less than 30 participants. The planned timeline for the study is as follows: start date on 1 January 2023, primary completion date on 31 August 2025, with study completion by 1 January 2026.\n Descriptive statistics will be used. The primary covariates to be studied are as follows:\n \n \n HP-13C-MRI: ratio of the summed hyperpolarised 13C-lactate to the summed 13C-pyruvate over the timecourse of the experiment as a quantitative metric of pyruvate-to-lactate exchange catalysed by the enzyme lactate dehydrogenase. This metric is termed the LAC/PYR. We have significant experience in developing quantitative methodology to analyse this data.40\n \n \n 23Na-MRI: total sodium concentration, as a metric to quantify accumulation of Na+in\u00e2\u0080\u0089the tissue of interest. This metric was used in comparison between prostate cancer and normal prostate tissue.35\n \n \n DMI: primary goal is the technical development of the abdominal DMI, which has not been extensively developed yet due to limitations in detection of metabolites within the DMI spectrum in abdomen attributed to lipid peaks and variability of tissues. However, we aim to evaluate the ratio of the summed 2H-lactate over the summed combined signal from 2H-glutamine+2H-glutamate as a measure of the ratio of glycolysis to oxidative metabolism, as previously shown in healthy human brain.41", "id": 1936, "split": "test"} +{"trial_id": "NCT06016244", "pmid": "39806594", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial\n\nIncluded conditions:\n- Bronchiolitis\n- Lower Respiratory Tract Infection\n- Bronchial Hyperreactivity\n\nStudy Armgroups:\n- {'label': '88% oxygen saturation threshold', 'type': 'EXPERIMENTAL', 'description': 'Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.', 'interventionNames': ['Other: Oxygen saturation threshold']}\n- {'label': '92% oxygen saturation threshold', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.', 'interventionNames': ['Other: Oxygen saturation threshold']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Oxygen saturation threshold', 'description': 'Oxygen saturation threshold on which supplemental oxygen is decided', 'armGroupLabels': ['88% oxygen saturation threshold', '92% oxygen saturation threshold']}\n\nPrimary Outcomes:\n- {'measure': 'Time to meeting all discharge criteria', 'description': 'Time in hours from admission to meeting all discharge criteria\\n\\nDischarge criteria include:\\n\\n* No need for supplemental oxygen for 4 hours, including a period of sleep for children aged \\\\< 2 years\\n* Clinically fit for discharge with normal or minimally increased respiratory rate AND no or mild respiratory distress, as judged by nurses and physicians using the Parshuram et al scoring system, commonly used in Dutch paediatric practice as part of the Pediatric Early Warning Scale\\\\].\\n* No need for in-hospital feeding or medication by nasogastric tube (NGT).\\n* No need for in-hospital intravenous treatment.\\n* No need for in-hospital nebulized bronchodilator treatment.\\n* No need for in-hospital treatment with metered dose inhalator inhalations more often than every 3 hours.\\n* No need for high flow delivered by high flow nasal cannula or nasal prongs.', 'timeFrame': 'Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, 80% power, and an estimated dropout rate of 10%.", "answer": 560, "answer_type": "ESTIMATED", "explanation": "Sample size and feasibility\n The sample size calculation is based on the mean time to meet all discharge criteria for the two groups. We aim to demonstrate a difference of 12 hours, determined as a relevant reduction through patient/parent interviews and supported by previous research.8 With a mean length of stay of 72 hours and an SD of 48 hours (based on 5 years of admissions data for respiratory distress at our hospital, Statistics Netherlands (Centraal Bureau voor Statistiek (CBS)) data on admission duration and previous research8 9) an alpha of 0.05 and 80% power, 251 children are to be included in both intervention and control groups. With an estimated dropout rate of 10%, the goal is to include 560 patients over the 30-month inclusion period. This is feasible, as two participating centres admit an average of 200 children aged 0\u00e2\u0080\u009312 years with respiratory disease per year. Estimating 80% eligibility, 15% not approached and 60% willingness to participate (based on parent interviews, in-hospital data and expert estimation), and with 10 participating, centres over 30 months up to 2000 children could be included.", "id": 1937, "split": "test"} +{"trial_id": "NCT06016777", "pmid": "38569709", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial\n\nIncluded conditions:\n- Uniportal Video-assisted Thoracic Surgery\n\nStudy Armgroups:\n- {'label': 'PVB+PCIA group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump', 'Procedure: Patient-controlled intravenous analgesia pump']}\n- {'label': 'ESB+PCIA group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump', 'Procedure: Patient-controlled intravenous analgesia pump']}\n- {'label': 'PCIA group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Patient-controlled intravenous analgesia pump']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump', 'description': 'Patients in this group will receive ultrasound-guided paraspinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8\u03bcg/hour, and total dosage \\\\<5\u03bcg/hour.', 'armGroupLabels': ['PVB+PCIA group']}\n- {'type': 'PROCEDURE', 'name': 'Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump', 'description': 'Patients in this group will receive ultrasound-guided erector spinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8\u03bcg/hour, and total dosage \\\\<5\u03bcg/hour.', 'armGroupLabels': ['ESB+PCIA group']}\n- {'type': 'PROCEDURE', 'name': 'Patient-controlled intravenous analgesia pump', 'description': 'Patients in this group will not receive regional block. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8\u03bcg/hour, and total dosage \\\\<5\u03bcg/hour.', 'armGroupLabels': ['ESB+PCIA group', 'PCIA group', 'PVB+PCIA group']}\n\nPrimary Outcomes:\n- {'measure': 'total opioid consumption', 'description': 'total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.', 'timeFrame': 'up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided hypothesis, power=0.8, \u03b1=0.05, G(group)=3, allocation ratio 1:1:1. Power=0.907. Permissible drop-out rate no higher than 20%.", "answer": 102, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was estimated using the PASS V.2021 software. We referred to data of the participants who received PVB with PCIA,22 ESPB with PCIA,23 or a sufentanil PCIA pump only.24 The required opioids were converted into morphine equivalents. Data were subjected to one-way analysis of variance (ANOVA) and F-tests using effect size. Variables are determined as follows: two-sided hypothesis, power=0.8, \u00ce\u00b1=0.05, G(group)=3, allocation ratio 1:1:1. Effect size is calculated as cumulative opioids (morphine equivalents) after VATS14\u00e2\u0080\u009318; f=\u00cf\u0083m/\u00cf\u0083, \u00cf\u0083m=\u00e2\u0088\u009a[\u00ce\u00a3(\u00ce\u00bci-\u00ce\u00bc)\u00c2\u00b2/G)=7.14 (\u00ce\u00bc is the mean of the group means, and \u00ce\u00bci is the mean of the ith group), \u00cf\u0083 (1.9, 7.4, 18.0). The results are as follows: power=0.907, ni=28, N=84. Considering that the permissible drop-out rate was no higher than 20%, the total sample size is 102 (n=34 in each group). We will conduct a power analysis after the study using the results collected from our participants. Power >0.8 is defined as meaningful to detect the effect size. In addition to the statistical significance of the study results, the clinical significance of the actual pain score, pain degree and dosage will also be considered, which will be discussed in the study results.", "id": 1938, "split": "test"} +{"trial_id": "NCT06018883", "pmid": "39075587", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer\n\nIncluded conditions:\n- Metastatic Pancreatic Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Ascorbate', 'type': 'EXPERIMENTAL', 'description': 'nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 900 mg/day, three times a day, orally.', 'interventionNames': ['Drug: Ascorbate', 'Drug: Nab paclitaxel', 'Drug: Gemcitabine']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.', 'interventionNames': ['Drug: Nab paclitaxel', 'Drug: Gemcitabine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ascorbate', 'description': 'Vitamin C 900 mg/day, three times a day, orally.', 'armGroupLabels': ['Ascorbate'], 'otherNames': ['Vitamin C']}\n- {'type': 'DRUG', 'name': 'Nab paclitaxel', 'description': 'Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks', 'armGroupLabels': ['Ascorbate', 'Control'], 'otherNames': ['Nab-paclitaxel']}\n- {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks', 'armGroupLabels': ['Ascorbate', 'Control'], 'otherNames': ['Gemcitabine Hydrochloride']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of anemia', 'description': 'Rate of anemia after every cycle of chemotherapy', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed with a significance level of 0.05, a power of 90%, and a 10% dropout rate.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on our center\u00e2\u0080\u0099s data, advanced pancreatic cancer patients undergoing two cycles of chemotherapy with albumin-bound paclitaxel and gemcitabine have a 69% incidence rate of anemia. We hypothesize that vitamin C supplementation could reduce this rate to 38%. To test this hypothesis, we plan a randomized control trial with a 1:1 allocation, targeting a sample size of 100 patients (50 per group), factoring in a 10% dropout rate. This size is calculated to achieve a power of 90% (1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.9) with a significance level of 0.05 (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), allowing us to detect a significant difference in anemia incidence between the groups.", "id": 1939, "split": "test"} +{"trial_id": "NCT06019195", "pmid": "39652561", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Time Restricted Eating for Prevention of Age-related Vascular Cognitive Decline in Older Adults\n\nIncluded conditions:\n- Intermittent Fasting\n- Aging\n\nStudy Armgroups:\n- {'label': 'Time restricted eating', 'type': 'EXPERIMENTAL', 'description': 'not more than 10 hrs. eating window daily goal for 6 months', 'interventionNames': ['Other: Time restricted eating']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Time restricted eating', 'description': 'not more than 10 hrs. eating window daily goal for 6 months', 'armGroupLabels': ['Time restricted eating'], 'otherNames': ['intermittent fasting']}\n\nPrimary Outcomes:\n- {'measure': 'Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)', 'description': 'Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after completion of study.', 'timeFrame': 'baseline, up to 6 months'}\n- {'measure': 'Change in neurovascular coupling using the dynamic retinal vessel analysis', 'description': 'Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after completion of study.', 'timeFrame': 'baseline, up to 6 months'}\n- {'measure': 'Change in EEG spectra', 'description': 'EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after completion of study.', 'timeFrame': 'baseline, up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nAt 80% power and 5% significance level, considering a dropout rate of 20%.", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Our primary endpoint is change in neurovascular coupling response in older adults comparing baseline and endpoint. We estimated the effect size for sample size calculation using preliminary data acquired with our pilot study on TRE (10 h free eating, 14 h fasting) in adults aged 55 years and older (N = 6). Regression coefficients (\u00ce\u00b2 values) were estimated for channels in the prefrontal and dorsolateral cortexes (see Statistical methods section for details). The mean difference between endpoint and baseline was 7.4 with a standard deviation of 13.1, representing an effect size of 0.56. At 80% power and 5% significance level, we calculated that we would need 27 participants to detect a similar effect size. Considering a dropout rate of 20%, the final sample size is 32 participants. We will conduct both intention-to-treat and per-protocol analyses.", "id": 1940, "split": "test"} +{"trial_id": "NCT06019884", "pmid": "39129017", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Tele-detection and Referral pAthways Model for Early Childhood cariEs Control- a Randomized Factorial Study: The TRACE Study\n\nIncluded conditions:\n- Early Childhood Caries\n\nStudy Armgroups:\n- {'label': 'Intraoral camera, conventional referral', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Caries detection method: Intraoral camera', 'Other: Referral pathway: Conventional referral']}\n- {'label': 'Intraoral camera, user fee removal', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Caries detection method: Intraoral camera', 'Other: Referral pathway: User fee removal']}\n- {'label': 'Smartphone camera, conventional referral', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Caries detection method: Smartphone camera', 'Other: Referral pathway: Conventional referral']}\n- {'label': 'Smartphone camera, user fee removal', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Caries detection method: Smartphone camera', 'Other: Referral pathway: User fee removal']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Caries detection method: Intraoral camera', 'description': 'A specialized intraoral camera (C50) with fluorescence signal and selective chromatic amplification will be used to record intraoral structures in the form of videos and/or photos. The camera has four modes (Daylight, Daylight+, Perio and Caries modes) which can differentiate the color of tissues to provide a reliable diagnosis. The camera will be used in a systemic sequence to video record and capture photos of intraoral conditions in both arches. The intraoral camera will be connected to a laptop screen, and the captured videos and/ or photos will be transferred to an electronic platform.', 'armGroupLabels': ['Intraoral camera, conventional referral', 'Intraoral camera, user fee removal']}\n- {'type': 'DEVICE', 'name': 'Caries detection method: Smartphone camera', 'description': 'This is a low-cost electronic system consisting of a smartphone positioned in front of the oral cavity to scan the upper and lower jaws from the cheek then the tongue sides. The smartphone camera resolution should be sensitive enough to capture the intraoral structures (at least 1000 pixels). The focus will be adjusted, and the inbuilt flash will be used to obtain clear and sharp images. The photos will be transferred to the electronic platform.', 'armGroupLabels': ['Smartphone camera, conventional referral', 'Smartphone camera, user fee removal']}\n- {'type': 'OTHER', 'name': 'Referral pathway: User fee removal', 'description': \"The child's parent/ legal guardian will receive financial incentives. These a are designed to cover the costs of treatment and transportation and are tied to attending the preventive dental visit. The child will receive complete dental care.\", 'armGroupLabels': ['Intraoral camera, user fee removal', 'Smartphone camera, user fee removal']}\n- {'type': 'OTHER', 'name': 'Referral pathway: Conventional referral', 'description': 'Children will be referred without providing financial incentives following the current standard of care in dental clinics in the public sector in Egypt. Care is planned by the receiving/ treating dentist, based on available resources, and hospital/ clinic policies. The screening/ sending dentist will inform the family about the oral health condition/s and planned treatment costs for which the child needs care and of available public and private facilities that offer the required care.', 'armGroupLabels': ['Intraoral camera, conventional referral', 'Smartphone camera, conventional referral']}\n\nPrimary Outcomes:\n- {'measure': 'The percentage of teeth receiving care', 'description': 'This will be assessed using the Caries Assessment Spectrum and Treatment (CAST) index. The CAST index hierarchically describes the full spectrum of caries from the absence of caries, passing through prevention (sealants) and treatment (restoration), to the presence of carious lesions with their complications (pulp exposure, abscess/fistula, and tooth loss). As for the condition severity, Codes 0-2 represent \"healthy\", 3 indicates \"pre-morbidity\", while 4-5 indicate \"morbidity\", 6-7 indicate \"serious morbidity\", and 8 indicates \"mortality\".', 'timeFrame': 'up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error = 5%, study power = 80%, numerator df = 1, and a total of 4 experimental conditions.", "answer": 480, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Previous research on the effectiveness of CCT on the use of oral healthcare services by <\u00e2\u0080\u00896 year old children reported an adjusted odds ratio (AOR) of 1.92 [53] with an effect size (f)\u00e2\u0080\u0089=\u00e2\u0080\u00890.18 [54]. Other studies reported AOR\u00e2\u0080\u0089=\u00e2\u0080\u00893.07, f\u00e2\u0080\u0089=\u00e2\u0080\u00890.31 for CCT on non-dental visits [55]. Studies on UFR are less common, with reported mean (SD) number of healthcare visits by children younger than 5 years of age before and after UFR\u00e2\u0080\u0089=\u00e2\u0080\u008913,203 (584.4) and 16,815 (1645.3), and calculated f\u00e2\u0080\u0089=\u00e2\u0080\u00891.62 [56]. Using the lowest values (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.18) in the G* Power 3.1.9.7 [57] calculator for linear regression to detect main effects and interaction in a factorial design, we specified alpha error\u00e2\u0080\u0089=\u00e2\u0080\u00895% and study power\u00e2\u0080\u0089=\u00e2\u0080\u008980%. For the four conditions in Table\u00c2\u00a02, we used numerator df= (2 detection levels\u00e2\u0080\u0093 1) \u00c3\u0097 (2 referral levels \u00e2\u0080\u0093 1)\u00e2\u0080\u0089=\u00e2\u0080\u00891\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00891\u00e2\u0080\u0089=\u00e2\u0080\u00891. A total sample size of 245 or 62 for each of the 4 experimental condition will be needed. This will be increased to 120 per condition, with a total of 480 children for all experimental conditions to make up for loss to follow up and allow estimation of effects on receiving different types of treatment.", "id": 1941, "split": "test"} +{"trial_id": "NCT06022107", "pmid": "37796784", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Piloting a Novel Social Support Intervention for Addiction Recovery\n\nIncluded conditions:\n- Alcohol; Harmful Use\n- Alcohol\n\nStudy Armgroups:\n- {'label': 'LDART', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to log onto the LDART website each night for a month.', 'interventionNames': ['Behavioral: LDART']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'LDART', 'description': \"LDART is a newly developed web-based social support intervention that can be accessed by smartphone or computer. Each night, the participant sets a recovery goal for the next day (e.g., drink less than usual, go to a support group meeting). The next night, they log on to LDART to indicate whether they reached their goal for the day. Depending on their response, they will be shown either a celebratory or encouraging message from someone in the addiction recovery community, along with specific information on that person's recovery organization.\", 'armGroupLabels': ['LDART']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment feasibility', 'description': 'Feasibility of recruitment is measured as the number of adults who consent to study participation divided by the number of months the trial recruits for.', 'timeFrame': 'Baseline'}\n- {'measure': 'Retention feasibility', 'description': 'Retention rate is calculated as the number of participants who complete the study divided by the number of participants who consented to participating in the study.', 'timeFrame': 'One-month post-intervention (Day 56)'}\n- {'measure': 'Intervention acceptability (engagement with intervention)', 'description': 'Acceptability is calculated as the number of nights participants login to LDART within the 28-day window.', 'timeFrame': 'Duration of intervention (Days 1-28)'}\n- {'measure': 'Intervention acceptability (subjective experience)', 'description': 'Acceptability is measured with a 9-item self-report acceptability assessment questionnaire. This comprises questions regarding the motivational and supportive properties of the content, perceptions on the frequency of engaging with the intervention, and whether they enjoyed using the intervention. Each question is rated on a 5-point Likert scale, where higher values indicate greater acceptability. There will also be two open-ended questions for participants to indicate what they liked and did not like about the intervention and ways to improve it.', 'timeFrame': 'Post-intervention (Day 28)'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated; no formal sample size calculation performed.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size\n We aim to recruit a sample size of 30 participants to use the intervention. Of them, 10 will be randomly selected for a follow-up QI. As this is a pilot study, a formal sample size calculation was not performed. Instead, sample size was inferred from other pilot studies of behavioral interventions [35]. Sample size for QIs was also derived from prior qualitative work.", "id": 1942, "split": "test"} +{"trial_id": "NCT06023615", "pmid": "39388231", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)\n\nIncluded conditions:\n- Medication Adherence\n- Medication Compliance\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Usual Care + mHealth/Telehealth', 'interventionNames': ['Other: mHealth app/dashboard']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Usual Care + Attention Control'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'mHealth app/dashboard', 'description': 'In the interventional group, the subject would receive the standard care that is provided to all post-transplant kidney recipients plus an additional remote monitoring system and follow-up by utilizing an app known as the mHealth app/dashboard. This app is integrated with home-based monitoring of blood pressures, glucoses, and pharmacist-led scheduled televisits.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Medication Adherence', 'description': 'Medication adherence will be measured by using tacrolimus trough concentration variability, which is a validated proxy measure of medication adherence. This is defined as the intrapatient tacrolimus concentration coefficient of variation (CV): standard deviation divided by the mean for each patient. All outpatient true trough tacrolimus levels drawn will be used to calculate the tacrolimus CV. This will be assessed every 3 months, which aligns with the minimum lab draw schedule for kidney transplant recipients at out center. This will be analyzed using repeated measures methodology, estimating efficacy effect size using the time\\\\*treatment interaction term and disparity using the time\\\\*treatment\\\\*race interaction term.', 'timeFrame': '2 Years'}\n- {'measure': 'Blood Pressure', 'description': 'Blood pressure control will be defined as the mean of all systolic BPs checked by patients at home and the transplant center (ambulatory measures). Patients with a mean of SBP \u2264140 mmHg will be considered controlled. We will aggregate and assess blood pressure levels every month (25 total); analyzed using repeated measures (time\\\\*treatment and disparity using the time\\\\*treatment\\\\*race interaction term).', 'timeFrame': '2 Years'}\n- {'measure': 'Glucose Control', 'description': 'Glucose control is defined as the mean measure of all glucoses (random or fasting). Those with DM and a mean random glucose \u2264160 mg/dL will be considered to controlled. We will aggregate and assess glucose levels every month (25 total); analyzed using repeated measures (time\\\\*treatment and disparity using the time\\\\*treatment\\\\*race interaction term).', 'timeFrame': '2 Years'}\n- {'measure': 'Cost-Benefit Analysis', 'description': 'Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED visit costs in the intervention arm vs the control arm and compare this to the costs needed to deliver the intervention.', 'timeFrame': '2 Years'}\n- {'measure': 'Acute Rejection', 'description': 'This is defined as the proportion of patients in each arm with a renal allograft biopsy showing at least grade 1A rejection by Banff criteria. Per usual care practices, all patients are required to have biopsy confirmation of rejection episodes within 24 hours of onset of treatment for acute rejection. It is standard care that all kidney allograft biopsies performed for transplant recipients occur at the transplant center (study institution). Biopsies will be read by a blinded local pathologist, as usual care. This will be assessed using time to event analyses..', 'timeFrame': '2 Years'}\n- {'measure': 'Graft Failure', 'description': 'This is defined as the proportion of patients in each arm with graft failure, which is a composite outcome of either return to chronic dialysis, nephrectomy, re-transplant, or death. The timing and cause of each graft loss will be recorded for comparative analysis.', 'timeFrame': '2 Years'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that achieves >0.999 power for tacrolimus variability, 0.998 power for SBP changes, 0.998 power for glucose changes, and 0.780 power for graft survival. The study is powered at 0.800 to test for reductions in racial disparities using a 3-way interaction term. The expected SDs are 8.5 for tacrolimus concentration coefficient of variation, 9 for SBP, and 10.8 for glucose. The study accounts for a dropout rate of 2-3% and inflates the sample size by approximately 10%.", "answer": 190, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power\n This study is powered to detect clinically meaningful and statistically significant improvements in medication adherence (aim 1), systolic BP (SBP) control (aim 2), diabetes mellitus (DM) control (aim 3), and graft survival (aim 4) while also demonstrating significant reductions in African American disparities for these end points (overarching aim). The analyses take full advantage of all measurements captured during the entire 2-year study using repeated measures methodology. For tacrolimus variability (aim 1), there will be 9 assessments (baseline and every 3 months), aligning with when laboratories are measured. Over the 2-year study, a 5% trajectory difference between arms for tacrolimus variability is considered clinically meaningful and is feasibly achievable given our pilot data (time\u00c3\u0097treatment). Tacrolimus concentration coefficient of variation (tac CV) has an expected SD of 8.5 with an approximate Gaussian distribution; thus, meeting normality assumptions. A sample size of 87 per group (N=174) achieves >0.999 power, assuming both arms start with a tac CV of 35% and change over the 2-year study to 32% in the control arm and 27% in the treatment arm. The study is powered at 0.800 to specifically test for reductions in racial disparities between the intervention and control arms, using a 3-way interaction term in the model (time\u00c3\u0097treatment\u00c3\u0097race). For BP and glucose control (aim 2), we will capture all home- and ambulatory-based measures aggregated into monthly assessments, totaling 25 (baseline and once monthly for 24 periods). We have 0.998 power to detect a difference in SBP changes between arms, assuming a mean SBP of 135 mm Hg in both arms at baseline and a 5 mm Hg reduction in the treatment arm, using 25 repeated measures (monthly). SBP has an expected SD of 9 with a Gaussian distribution; thus, meeting normality assumptions. We have 0.800 power to test for reductions in racial disparities between the arms for SBP, using the time\u00c3\u0097treatment\u00c3\u0097race 3-way interaction term. We have 0.998 power to detect a difference between arms for glucose changes, assuming a mean baseline glucose of 160 mg/dL in both arms, 50% (87/174) of patients having DM at the time of randomization, and a trajectory difference in glucose of 24 mg/dL between arms (25 repeated measures). We have 0.803 power to test for significant reductions in racial disparities between the 2 arms for glucose control, modeled using the time\u00c3\u0097treatment\u00c3\u0097race interaction term. Mean glucose has an expected SD of 10.8 and distribution approximates Gaussian; thus, meeting normality assumptions. To account for dropouts and censoring events, we will increase each arm sample size to 95, totaling 190 participants. This is an inflation of approximately 10%, which is significantly above the expected totals for dropouts (estimated to be between 2% and 3%), and power reductions due to censoring events.\n For aim 4, this study has adequate power to detect a statistically significant difference between the intervention arm and the national contemporary Veterans Affairs (VA) cohort for graft survival. Based on our previous research using the national VA database, we expect to identify roughly 8500 kidney transplants from the VA transplanted between 2015 and 2021, representing a contemporary cohort (33% of which are expected to be African American). Annual graft loss attrition rates are expected to be 5% in the VA cohort (with a mean of 7-year follow-up time) and 3% in the RCT treatment arm (with 2-year follow-up time). Given these, we will have 0.780 power to detect a significant difference in graft survival between the VA national cohort and our intervention patients. To assess if the intervention reduced racial disparities in graft loss, we would compare the African American persons in the RCT treatment arm to the roughly 2800 African American persons in the national VA cohort. We expect annual graft attrition rates to be 7% in the VA cohort (7-year mean follow-up) and 4% in the treatment arm (2-year follow-up). Given these estimates, we have 0.812 power to assess if the treatment intervention significantly reduced racial disparities for graft survival, as compared with the national contemporary VA cohort. These power analyses are valid across different data distribution assumptions (Gaussian and log-transformed). Power analyses were conducted using SAS 9.4 (SAS Proc GLMPower for aims 1-2; SAS Proc Power; two-sample survival test=log rank for aim 4; [SAS Institute]).", "id": 1943, "split": "test"} +{"trial_id": "NCT06023862", "pmid": "39710508", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Three-arm Randomized Phase II Study of Dostarlimab Alone or with Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07/ ENGOT-ov80 Study)\n\nIncluded conditions:\n- Ovarian Neoplasms\n- Endometrial Neoplasms\n- Uterine Cervical Neoplasms\n- Vulvar Cancer\n- Vagina Neoplasm\n- Clear Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': 'Dostarlimab monotherapy', 'interventionNames': ['Drug: Dostarlimab']}\n- {'label': 'Group B', 'type': 'EXPERIMENTAL', 'description': 'Dostarlimab + Bevacizumab combination therapy', 'interventionNames': ['Drug: Dostarlimab', 'Drug: Bevacizumab']}\n- {'label': 'Group C', 'type': 'ACTIVE_COMPARATOR', 'description': 'General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)', 'interventionNames': ['Drug: Doxorubicin', 'Drug: Gemcitabine', 'Drug: Paclitaxel', 'Drug: Pegylated liposomal doxorubicin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dostarlimab', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Group A', 'Group B'], 'otherNames': ['Jemperli']}\n- {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Group B']}\n- {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Group C']}\n- {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Group C']}\n- {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Group C']}\n- {'type': 'DRUG', 'name': 'Pegylated liposomal doxorubicin', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Group C']}\n\nPrimary Outcomes:\n- {'measure': 'Progression Free Survival', 'description': 'The time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first.', 'timeFrame': 'Up to approximately 48 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 10% (one-sided), type II error of 20% (80% power), 2-year accrual period, minimum 1-year follow-up, one interim analysis, and a 10% dropout rate.", "answer": 198, "answer_type": "ESTIMATED", "explanation": "5. Sample size\n Patients will be randomized 1:1:1 to receive dostarlimab, dostarlimab plus bevacizumab, or chemotherapy. The sample size calculation assumes a median PFS of 2 months in the standard chemotherapy arm and a hazard ratio of 0.67, translating to a median PFS of 3 months in the dostarlimab +/\u00e2\u0088\u0092 bevacizumab arms. The study plans for a type I error of 10% (one-sided), type II error of 20% (80% power), with a 2-year accrual period, a minimum 1-year follow-up, and one interim analysis. A total of 175 events and 177 patients (59 per arm) will be needed, adjusting for a 10% dropout rate, leading to the enrollment of 198 patients.", "id": 1944, "split": "test"} +{"trial_id": "NCT06024109", "pmid": "39806425", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA\u00ae Mid-term Unidirectional Barbed Suture Versus V-loc\u00ae Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy\n\nIncluded conditions:\n- Abnormal Uterine Bleeding\n- Endometriosis\n- Uterine Prolapse\n- Uterine Cancer\n- Ovarian Cancer\n- Fallopian Tube Cancer\n- Cervical Cancer\n- Endometrial Cancer\n\nStudy Armgroups:\n- {'label': 'SYMMCORA\u00ae', 'description': 'Barbed suture SYMMCORA\u00ae used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).', 'interventionNames': ['Device: Closure of the Vaginal Cuff after Total Hysterectomy']}\n- {'label': 'V-Loc\u00ae', 'description': 'Barbed suture V-Loc\u00ae used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).', 'interventionNames': ['Device: Closure of the Vaginal Cuff after Total Hysterectomy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Closure of the Vaginal Cuff after Total Hysterectomy', 'description': 'Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).', 'armGroupLabels': ['SYMMCORA\u00ae', 'V-Loc\u00ae'], 'otherNames': ['Suturing']}\n\nPrimary Outcomes:\n- {'measure': 'Suturing time to close the vaginal cuff', 'description': 'Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).', 'timeFrame': 'intraoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a one-sided significance level of 0.025 for the first hypothesis and a two-sided significance level of 0.05 for the second hypothesis, with 80% power for both. The standard deviations are assumed to be 6.3 minutes for the historical comparison and 4.45 minutes (SBS) and 5 minutes (VBS) for the randomized controlled comparison. No adjustment for drop-outs is made as the primary endpoint is measured intra-operatively.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size calculation\n \n Sample size calculation\n The sample size calculation is based on an efficacy endpoint \u00e2\u0080\u009ctime to perform the vaginal cuff closure\u00e2\u0080\u009d to demonstrate superiority of the novel unidirectional mid-term absorbable barbed suture (SBS) compared to a historical conventional control from the literature as well as the superiority of the novel unidirectional mid-term absorbable barbed suture (SBS) compared to a competitor unidirectional barbed suture (VBS). Therefore, the primary analysis consists of testing a two-step hierarchical hypothesis system, which allows for an ordered test procedure without inflating the type 1 error [63]. The step two of the procedure only takes place when step one succeeds rejecting the null hypothesis (one-sided p\u00e2\u0080\u0089<\u00e2\u0080\u00890.025), see Fig. 4.Fig. 4Hierachical hypothesis testing order within BARHYSTER study\n Several studies have been published investigating barbed suture materials versus conventional suture materials for vaginal cuff closure after hysterectomy. The weighted group means and the weighted pooled standard deviations were calculated based on the results of the sub-set of three studies providing suturing times for vaginal cuff closure using a unidirectional barbed suture versus a conventional suture material\u00c2\u00a0[30, 53, 64]. The calculation showed a mean weighted closure time of 13.9\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00896.3 min for the conventional suture material and this value was used for historical comparison. Furthermore, a mean weighted closure time of 11.8 min was calculated for the unidirectional barbed suture material based on these three studies. For the novel unidirectional barbed suture material (SBS), we expected a faster closure time of 9 min because of the different anchoring configuration compared to the control competitor unidirectional barbed suture material (VBS).Hierarchical hypothesis 1: Comparison to historical literature dataConsidering 9 minutes in the experimental novel unidirectional barbed group (SBS) for vaginal cuff closure compared to 13.9 minutes for the historical conventional control group from the literature, a sample size of 16 patients will have 80% power to reject the hypothesis described below, assuming that the standard deviation is 6.3 minutes, using an one-sided one sample t-test with a 0.025 one-sided significance level.H0: \u00c2\u00b5 \u00e2\u0089\u00a5 \u00c2\u00b50\u00c2\u00b5 (experimental novel barbed suture group (SBS) mean), \u00c2\u00b50 (historical conventional suture control group from the literature)Hierarchical hypothesis 2: Randomised controlled comparison SBS vs. VBSThe second hypothesis of the study is to show that the experimental novel mid-term unidirectional suture (SBS) is superior compared to the control competitor unidirectional mid-term absorbable suture (VBS) regarding the time to close the vaginal cuff.H0: \u00c2\u00b51\u00e2\u0089\u00a5 \u00c2\u00b52\u00c2\u00b51 (experimental novel unidirectional barbed suture group (SBS) mean), \u00c2\u00b52 (control competitor unidirectional barbed group (VBS) mean)A sample size of 132 patients will have 80%power to prove the difference between the experimental novel barbed suture group (SBS, \u00c2\u00b51= 9 min.) and VBS group (control competitor barbed suture group, \u00c2\u00b52= 11.8 min.) assuming respective standard deviations of 4.45 min. and 5 min., using a two-group t-test with a 0.05 two-sided significance level. The Satterthwaite method will be used for the test.\n \n Hierarchical hypotheses testing order (figure 4)\n If hypothesis 1 fails, hypothesis 2 is also considered failed. If hypothesis 1 is proven, hypothesis 2 will also be tested to full two-sided level of 5% without inflating the type 1 error rate.\n The sample size of the experimental novel barbed suture group (SBS) including a total of 99 patients is sufficient for testing hypothesis 1 (n=16 patients) and hypothesis 2.\n No adjustment for drop-outs is made because the primary endpoint will be measured intra-operatively and intra-operative drop-outs will be replaced to achieve the sample size.\n For sample size calculation, SAS Viya, software version 4.00, SAS Institute Inc., Cary NC, USA, was used.\n \n \n \n Statistical methods and analysis\n Secondary variables will be analysed using standard procedures as appropriate. For identification of relevant influencing factors and parameters of primary and secondary variables, multivariate regression models may be used where appropriate. Depending on the outcome variable, linear or logistic models may be implemented. In these models, patient age, sex, BMI and the respective baseline value will be used as covariates to adjust for.\n For data analysis, the intention-to-treat-principle will be applied. To graphically present the eligibility, allocation and follow-up process of the subjects, a CONSORT flow chart will be provided. Baseline and demographic data will be shown as min., max., median, means with standard deviation, or absolute and relative frequencies as appropriate. The test regarding the primary variable is considered confirmatory, all other tests are explanatory and secondary variables will be analysed descriptively. For binary data, a Chi-Square test will be performed; for non-parametric data, a U test according to Wilcoxon-Mann\u00e2\u0080\u0093Whitney or to Kruskal\u00e2\u0080\u0093Wallis and a t-test or One-Way-ANOVA for metric data, if a normal distribution is assumed.\n Missing data will be analysed as such and will not be replaced by estimates. All eligible patients who obtained the intended study treatment will be included in the analysis. Patients violating the inclusion or/and exclusion criteria will be dropped out from the study and deviations from the study protocol and judged as protocol violation. The safety analysis is performed according to the as-treated principle.\n The analysis will be performed after the completion of the 6-month follow-up. An interim analysis is not planned.\n \n \n Disseminations plan\n The outcome of the study will be published in a peer-reviewed international journal and the results will be also presented in international and national conferences.", "id": 1945, "split": "test"} +{"trial_id": "NCT06024109", "pmid": "39806425", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA\u00ae Mid-term Unidirectional Barbed Suture Versus V-loc\u00ae Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy\n\nIncluded conditions:\n- Abnormal Uterine Bleeding\n- Endometriosis\n- Uterine Prolapse\n- Uterine Cancer\n- Ovarian Cancer\n- Fallopian Tube Cancer\n- Cervical Cancer\n- Endometrial Cancer\n\nStudy Armgroups:\n- {'label': 'SYMMCORA\u00ae', 'description': 'Barbed suture SYMMCORA\u00ae used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).', 'interventionNames': ['Device: Closure of the Vaginal Cuff after Total Hysterectomy']}\n- {'label': 'V-Loc\u00ae', 'description': 'Barbed suture V-Loc\u00ae used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).', 'interventionNames': ['Device: Closure of the Vaginal Cuff after Total Hysterectomy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Closure of the Vaginal Cuff after Total Hysterectomy', 'description': 'Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).', 'armGroupLabels': ['SYMMCORA\u00ae', 'V-Loc\u00ae'], 'otherNames': ['Suturing']}\n\nPrimary Outcomes:\n- {'measure': 'Suturing time to close the vaginal cuff', 'description': 'Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).', 'timeFrame': 'intraoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a one-sided significance level of 0.025 for the first hypothesis and a two-sided significance level of 0.05 for the second hypothesis, with 80% power for both. The standard deviations are assumed to be 6.3 minutes for the historical comparison and 4.45 minutes (SBS) and 5 minutes (VBS) for the randomized controlled comparison. No adjustment for drop-outs is made as the primary endpoint is measured intra-operatively.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based on an efficacy endpoint \u00e2\u0080\u009ctime to perform the vaginal cuff closure\u00e2\u0080\u009d to demonstrate superiority of the novel unidirectional mid-term absorbable barbed suture (SBS) compared to a historical conventional control from the literature as well as the superiority of the novel unidirectional mid-term absorbable barbed suture (SBS) compared to a competitor unidirectional barbed suture (VBS). Therefore, the primary analysis consists of testing a two-step hierarchical hypothesis system, which allows for an ordered test procedure without inflating the type 1 error [63]. The step two of the procedure only takes place when step one succeeds rejecting the null hypothesis (one-sided p\u00e2\u0080\u0089<\u00e2\u0080\u00890.025), see Fig. 4.Fig. 4Hierachical hypothesis testing order within BARHYSTER study\n Several studies have been published investigating barbed suture materials versus conventional suture materials for vaginal cuff closure after hysterectomy. The weighted group means and the weighted pooled standard deviations were calculated based on the results of the sub-set of three studies providing suturing times for vaginal cuff closure using a unidirectional barbed suture versus a conventional suture material\u00c2\u00a0[30, 53, 64]. The calculation showed a mean weighted closure time of 13.9\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00896.3 min for the conventional suture material and this value was used for historical comparison. Furthermore, a mean weighted closure time of 11.8 min was calculated for the unidirectional barbed suture material based on these three studies. For the novel unidirectional barbed suture material (SBS), we expected a faster closure time of 9 min because of the different anchoring configuration compared to the control competitor unidirectional barbed suture material (VBS).Hierarchical hypothesis 1: Comparison to historical literature dataConsidering 9 minutes in the experimental novel unidirectional barbed group (SBS) for vaginal cuff closure compared to 13.9 minutes for the historical conventional control group from the literature, a sample size of 16 patients will have 80% power to reject the hypothesis described below, assuming that the standard deviation is 6.3 minutes, using an one-sided one sample t-test with a 0.025 one-sided significance level.H0: \u00c2\u00b5 \u00e2\u0089\u00a5 \u00c2\u00b50\u00c2\u00b5 (experimental novel barbed suture group (SBS) mean), \u00c2\u00b50 (historical conventional suture control group from the literature)Hierarchical hypothesis 2: Randomised controlled comparison SBS vs. VBSThe second hypothesis of the study is to show that the experimental novel mid-term unidirectional suture (SBS) is superior compared to the control competitor unidirectional mid-term absorbable suture (VBS) regarding the time to close the vaginal cuff.H0: \u00c2\u00b51\u00e2\u0089\u00a5 \u00c2\u00b52\u00c2\u00b51 (experimental novel unidirectional barbed suture group (SBS) mean), \u00c2\u00b52 (control competitor unidirectional barbed group (VBS) mean)A sample size of 132 patients will have 80%power to prove the difference between the experimental novel barbed suture group (SBS, \u00c2\u00b51= 9 min.) and VBS group (control competitor barbed suture group, \u00c2\u00b52= 11.8 min.) assuming respective standard deviations of 4.45 min. and 5 min., using a two-group t-test with a 0.05 two-sided significance level. The Satterthwaite method will be used for the test.\n \n Hierarchical hypotheses testing order (figure 4)\n If hypothesis 1 fails, hypothesis 2 is also considered failed. If hypothesis 1 is proven, hypothesis 2 will also be tested to full two-sided level of 5% without inflating the type 1 error rate.\n The sample size of the experimental novel barbed suture group (SBS) including a total of 99 patients is sufficient for testing hypothesis 1 (n=16 patients) and hypothesis 2.\n No adjustment for drop-outs is made because the primary endpoint will be measured intra-operatively and intra-operative drop-outs will be replaced to achieve the sample size.\n For sample size calculation, SAS Viya, software version 4.00, SAS Institute Inc., Cary NC, USA, was used.", "id": 1946, "split": "test"} +{"trial_id": "NCT06027736", "pmid": "38664701", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis in a Malaysian Tertiary Hospital: A Randomised Control Trial Protocol (AR-PRISE RCT)\n\nIncluded conditions:\n- Allergic Rhinitis\n- Pharmaceutical Care\n- Pharmaceutical Services\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: pharmacist-led education']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'pharmacist-led education', 'description': 'A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Allergic rhinitis symptom control', 'description': 'Patients are free from any symptoms or reduction in the severity of the symptoms of allergic rhinitis.\\n\\nTotal Nasal Symptom Score (TNSS) tool will be used for patients to self-rate their nasal symptoms, including nasal obstruction, itching, sneezing, secretion, runny nose, and sleep difficulty, on a 4-point Likert scale ranging from 0 (no symptom) to 3 (severe symptom). The scores will be summed; a higher score indicates the more severe the symptoms are. The measurement of nasal symptoms will be conducted at baseline, on Day 60 \u00b17, Day 120 \u00b17, and Day 180 \u00b17.\\n\\nThe outcomes will be generated as a mean and standard deviation. A two-way repeated measure ANOVA analysis will be employed to determine the mean difference between the scores of the control group and the interventional group to determine the overall effectiveness of the intervention.', 'timeFrame': '180 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (type I error probability) at 0.05, power at 0.8, correlation between repeated measurements at 0.5, and four measurements for repeated measures ANOVA. Predicted dropout rate of 10%.", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Knowledge level\n Based on the parameters provided and using the G-power calculator with a power of 0.8 and a type I error probability of 0.05, the study requires 70 participants in each group to determine the mean score difference in knowledge level. This calculation is based on the mean score of adult patients with adequate knowledge of allergic rhinitis treatment being 1.39, while the mean score of interventional participants is 1.70 (with a standard deviation of 0.58) [32].\n \n \n Symptom control\n The sample size is calculated based on the mean difference in symptom control between the intervention and control groups. An RCT that investigated the change in Total Nasal Symptom Score (TNSS) after an intervention vs placebo in adults in China with intermittent or persistent allergic rhinitis reported a mean score of 3.991 (SD\u00e2\u0080\u0089= 2.2145) vs 5.704 (SD\u00e2\u0080\u0089=\u00e2\u0080\u00892.2341) among 181 and 182 participants, respectively [33]. The pooled standard deviation was calculated as 2.2243, and an effect size of 0.3851 was determined. The G-power sample size calculator is used by setting the power at 0.8, the type I error probability at 0.05, two groups, four measurements, a correlation between repeated measurement at 0.5, and the function of repeated measures between factors ANOVA analysis. A sample of 18 participants is required for each group.\n \n \n Medication adherence\n A previous study suggested that the mean adherence rate to INCS among the control is 76.62 (SD\u00e2\u0080\u0089= 2.85), while the intervention group is 93.94 (SD\u00e2\u0080\u0089= 2.84) among 16 participants in each group [34]. The pooled standard deviation and effect size calculated were 2.84 and 3.0290, respectively. Using the G-power calculator, setting a probability (power) of 0.8, the type I error probability at 0.05, and we will need 4 participants in each group.\n \n \n QoL\n A study mapping the naso-ocular symptom scores to the EuroQoL 5-Dimensions, 5-Levels (EQ-5D-5L) utility values was referred to estimate the sample size required to compare patients\u00e2\u0080\u0099 QoL between two groups. The EQ-5D-5L utility values in mean and standard deviation are corresponding to the disease severity in allergic rhinitis patients, where the utility values of 1.000\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.000, 0.943\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.085, 0.909\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.095, 0.849 0.142, and 0.767\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.175 corresponding to none, mild, moderate, severe, and most severe groups were referred [35]. In this study, the intervention aims to improve the symptoms, if not totally absence of symptoms, at least the mild disease state. Assuming that the control group patients would be moderate to severe and the intervention group would achieve mild disease status, the EQ-5D-5L utility values corresponding to moderate (0.909\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.095) and mild (0.943\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.085) were selected to simulate the mean utility score of control and intervention, respectively. The pooled standard deviation and effect size calculated were 0.09014 and 0.1886, respectively. The G-Power sample size calculator is used, and by setting the function of a repeated-measure ANOVA statistical test, the probability (power) at 0.8, the type I error probability at 0.05, two groups, four measurements, a correlation between repeated measurement at 0.5, and the sample size of 70 calculated for each group are needed.\n The sample size estimation required for EQ-5D VAS was based on a similar study that evaluated general health-related QoL among allergic rhinitis patients. The mean and standard deviation score of EQ-5D VAS of the control group was 72.1\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008919.0 in 150 patients [36]. The scores of EQ-5D VAS for the intervention group were derived from a study assessing QoL in the general Malaysian population with a reported mean and standard deviation of 85.5\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008912.3 among 1137 participants, with the rationale that the intervention group would achieve QoL similar to the general population [37]. The pooled standard deviation and effect size calculated were 13.2517 and 0.3245, respectively. Using the G power calculator and setting the function of a repeated-measures ANOVA statistical test, the probability (power) at 0.8, the type I error probability at 0.05, two groups, four measurements, a correlation between repeated measurement at 0.5, and the sample size 25 are calculated for each group.\n \n \n Final sample size estimation\n Given the highest sample size requirement calculated for each specific objective, which is 70 participants for each group, and considering a predicted dropout rate of 10%, it is prudent to recruit 77 participants for each group. Therefore, a total of 154 participants will be recruited for this study to ensure adequate power and account for potential dropouts.", "id": 1947, "split": "test"} +{"trial_id": "NCT06027736", "pmid": "38664701", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis in a Malaysian Tertiary Hospital: A Randomised Control Trial Protocol (AR-PRISE RCT)\n\nIncluded conditions:\n- Allergic Rhinitis\n- Pharmaceutical Care\n- Pharmaceutical Services\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: pharmacist-led education']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'pharmacist-led education', 'description': 'A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Allergic rhinitis symptom control', 'description': 'Patients are free from any symptoms or reduction in the severity of the symptoms of allergic rhinitis.\\n\\nTotal Nasal Symptom Score (TNSS) tool will be used for patients to self-rate their nasal symptoms, including nasal obstruction, itching, sneezing, secretion, runny nose, and sleep difficulty, on a 4-point Likert scale ranging from 0 (no symptom) to 3 (severe symptom). The scores will be summed; a higher score indicates the more severe the symptoms are. The measurement of nasal symptoms will be conducted at baseline, on Day 60 \u00b17, Day 120 \u00b17, and Day 180 \u00b17.\\n\\nThe outcomes will be generated as a mean and standard deviation. A two-way repeated measure ANOVA analysis will be employed to determine the mean difference between the scores of the control group and the interventional group to determine the overall effectiveness of the intervention.', 'timeFrame': '180 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (type I error probability) at 0.05, power at 0.8, correlation between repeated measurements at 0.5, and four measurements for repeated measures ANOVA. Predicted dropout rate of 10%.", "answer": 154, "answer_type": "ESTIMATED", "explanation": "Final sample size estimation\n Given the highest sample size requirement calculated for each specific objective, which is 70 participants for each group, and considering a predicted dropout rate of 10%, it is prudent to recruit 77 participants for each group. Therefore, a total of 154 participants will be recruited for this study to ensure adequate power and account for potential dropouts.", "id": 1948, "split": "test"} +{"trial_id": "NCT06027814", "pmid": "39881397", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Patient Navigator Plus Remote MHealth Adherence Support with Incentives to Improve Linkage and Retention Among Hospitalized Patients with Opioid and Methamphetamine Use Who Initiate Buprenorphine\n\nIncluded conditions:\n- Opioid Use Disorder\n- Medication Adherence\n- Polysubstance Drug Use (Indiscriminate Drug Use)\n- Methamphetamine-dependence\n\nStudy Armgroups:\n- {'label': 'Treatment-as-usual (TAU)', 'type': 'NO_INTERVENTION', 'description': 'TAU will be usual care that the Addiction Consult Service provides. It is comprised of a multidisciplinary team of professionals, including addiction medicine and addiction psychiatry physicians, nurses specializing in the treatment of OUD, substance use disorder counselors, peer recovery supports, and program coordinators.'}\n- {'label': 'PN+mHealth', 'type': 'EXPERIMENTAL', 'description': 'The intervention is patient navigation and mHealth in addition to treatment-as-usual. The intervention consists of a patient navigator (PN) with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone for adherence and linkage to outpatient treatment within 30 days. Participants will be asked to upload medication adherence videos once a day over the 30 days post discharge from the hospital. Patients will be instructed to continue to take their medication as prescribed in any circumstance where they are unable to upload the video for any reason.', 'interventionNames': ['Behavioral: Patient Navigation and mHealth (PN+mHealth)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Patient Navigation and mHealth (PN+mHealth)', 'description': 'Intervention consists of patient navigation with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone.', 'armGroupLabels': ['PN+mHealth']}\n\nPrimary Outcomes:\n- {'measure': 'Patient linkage to an outpatient program that provides medication for opioid use disorder', 'description': 'Defined as documentation of an outpatient clinical encounter (either in-person or via telemedicine) where a medication for OUD (either buprenorphine, naltrexone, or methadone) was provided or prescribed.', 'timeFrame': '30 days post-discharge from hospital'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 80% to detect large effects. The sample size was chosen based on the feasibility of completing the study within the available funding period, not for providing a fully-powered study.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size and power\n The primary goal of this pilot trial is to develop and pilot test the MIAPP intervention. This pilot work will provide evidence of the feasibility/acceptability of the MIAPP intervention and research procedures that will be used to inform a future, larger study, as assessed by our ability to fully recruit the planned sample and deliver the intervention to the majority of those randomized to the intervention arm. The sample size of 40 for the pilot randomized controlled trial was chosen as we projected we could enroll and complete the study procedures and analyses within the available funding period. Although the sample size was not selected for the purpose of providing a fully-powered study, with our sample size of 40 we are nonetheless powered at 80% to detect some effects if they are large in size. For binary outcomes, power depends on the base rate of the outcome measured, and based on prior studies [38, 55], we anticipate that anywhere from 20 to 50% of participants in treatment as usual successfully linking to outpatient medications for OUD services post-discharge. For binary outcomes, including the primary outcome measure, our pilot study will be powered to detect intervention effect sizes of RR\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00891.89, 2.05, 2.40, or 3.10, if linkage rates for treatment as usual are 50%, 40%, 30%, or 20%, respectively. For continuous outcomes (days of buprenorphine coverage, days of opioid or methamphetamine use), we will be powered to detect standardized effect sizes of Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00890.91 with 40 participants.", "id": 1949, "split": "test"} +{"trial_id": "NCT06028048", "pmid": "39252084", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol of a Randomized Controlled Trial on the Effectiveness and Cost-effectiveness of a Supported Employment Intervention Aimed at Enhancing Work Participation of Unemployed or Work-disabled Cancer Survivors: the PLACES Study\n\nIncluded conditions:\n- Cancer Survivors\n- Return to Work\n\nStudy Armgroups:\n- {'label': 'PLACES intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will receive the PLACES intervention during 12-months after randomization.', 'interventionNames': ['Behavioral: PLACES']}\n- {'label': 'Care as usual', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will receive usual care from the SSA.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PLACES', 'description': 'The PLACES intervention is based on eight IPS principles, ensuring competitive employment, client choice, service integration, personalized benefits counseling, rapid job search, systematic development, and individualized support.\\n\\nCoaches: Certified IPS coaches receive training from Phrenos IPS knowledge center and Re-turn. Ongoing support includes video lectures, clarifications with researchers, and biannual collective sessions. Coaches, regionally specialized, implement interventions autonomously.\\n\\nIntervention Phases:\\n\\n1. Intake and Assessment: Participants meet IPS coaches within three days to discuss goals, procedures, and responsibilities, continuing until objectives are met.\\n2. Acquisition and Application: Coaches assist job search and placement, aiming for employment within 30 days.\\n3. Placement and Support: Coaches offer personalized support, adapting to needs, scheduling meetings based on preferences.\\n\\nThe intervention ends at 12 months or when goals are achieved.', 'armGroupLabels': ['PLACES intervention'], 'otherNames': ['Individual Placement and Support (IPS)', 'Supported employment']}\n\nPrimary Outcomes:\n- {'measure': 'Paid employment (yes/no)', 'description': 'The primary outcome measure is paid employment (yes/no) at any point during the 1-year-follow-up. Being in paid employment is operationalised as working in a paid job for at least one hour per week as defined by the central statistics office.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (alpha) of 0.05, and a 10% loss to follow-up.", "answer": 164, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In a previous study of unemployed patients with spinal cord injury, participants who received IPS were significantly more likely to return to paid employment than those in the CAU group (30.8%; 95% CI 21.8\u00e2\u0080\u009341.6 versus 10.5%; 95% CI 5.2\u00e2\u0080\u009319.7, respectively) [25]. Based on these data, a power of 80% and an alpha of 0.05, a total of 148 cancer survivors are required to detect the same difference of 20% between the two groups (nQuery Advisor 7.0). Accounting for a 10% loss to follow-up, we aim to include 164 cancer survivors.", "id": 1950, "split": "test"} +{"trial_id": "NCT06033092", "pmid": "39226292", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion: a Randomized Phase II Biomarker Trial in Subjects at Increased Risk\n\nIncluded conditions:\n- BRCA Mutation\n- PALB2 Gene Mutation\n- Ductal Carcinoma in Situ\n- Lobular Carcinoma in Situ\n- ATM Gene Mutation\n- CHEK2 Gene Mutation\n- CDH1 Gene Mutation\n- RAD51C Gene Mutation\n- RAD51D Gene Mutation\n\nStudy Armgroups:\n- {'label': 'Low dose tamoxifen', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tamoxifen 10 mg (1 tablet) every other day for 6 months.', 'interventionNames': ['Drug: Tamoxifen 10 mg Tablet']}\n- {'label': 'Low dose tamoxifen + Intermittent Caloric Restriction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tamoxifen 10 mg (1 tablet) every other day for 6 months + 5:2 diet (5 days/week at regular energy intake+2 days a week at an average 75% energy deficit)', 'interventionNames': ['Drug: Tamoxifen 10 mg Tablet', 'Other: Intermittent caloric restriction']}\n- {'label': 'Lifestyle intervention', 'type': 'PLACEBO_COMPARATOR', 'description': 'Step counter device', 'interventionNames': ['Behavioral: Step counter Device']}\n- {'label': 'Lifestyle Intervention + Intermittent Caloric Restriction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Step counter device + 5:2 diet (5 days/week at regular energy intake+2 days a week at an average 75% energy deficit)', 'interventionNames': ['Other: Intermittent caloric restriction', 'Behavioral: Step counter Device']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tamoxifen 10 mg Tablet', 'description': 'One tablet of Tamoxifen 10 mg every other day for 6 months', 'armGroupLabels': ['Low dose tamoxifen', 'Low dose tamoxifen + Intermittent Caloric Restriction'], 'otherNames': ['Low dose tamoxifen']}\n- {'type': 'OTHER', 'name': 'Intermittent caloric restriction', 'description': '\"5:2 diet\": 5 days a week at regular energy intake and 2 days/week at 75% energy deficit (diet will be restricted at 500-800 kcal corresponding to a 75% reduction compared to normal size)', 'armGroupLabels': ['Lifestyle Intervention + Intermittent Caloric Restriction', 'Low dose tamoxifen + Intermittent Caloric Restriction']}\n- {'type': 'BEHAVIORAL', 'name': 'Step counter Device', 'description': 'Participants will receive personal advice on healthy lifestyle and a step counter', 'armGroupLabels': ['Lifestyle Intervention + Intermittent Caloric Restriction', 'Lifestyle intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Post intervention levels of circulating binding globulin', 'description': 'Sex hormone binding globulin level after 6 months of intervention', 'timeFrame': 'Through study completion, an average of 6 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) of 5%, power of 80%, and a drop-out rate of 10%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n Given the results found in our previous studies [19, 20], we considered as main endpoint SHBG (nmol/L) post treatment levels, which has been shown to be associated with risk of first cancer or cancer recurrence. Considering a drop-out rate of 10%, we will have to enroll a total of 200 subjects. Actually, a sample size of overall 180 patients (90 per arm) achieves 80% power to detect a difference of 15 points between the null hypothesis that means of SHBG (nmol/L) post treatment are in both arms 70 and the alternative hypothesis that the mean in the tamoxifen arm is 85, with an estimated group standard deviation of 35 and with a significance level (alpha) of 5% using a two-sided two-sample t-test.", "id": 1951, "split": "test"} +{"trial_id": "NCT06034366", "pmid": "38128934", "question": "Here is the design of a clinical trial:\n\nOfficial Title: a Parallel Assignment Prospective, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression\n\nIncluded conditions:\n- Myopia\n\nStudy Armgroups:\n- {'label': 'study group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the study group will use 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,', 'interventionNames': ['Drug: 0.01% atropine']}\n- {'label': 'placebo eye drops', 'type': 'OTHER', 'description': 'participants in the control group will utilize placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks.', 'interventionNames': ['Other: 0.9% sodium chloride']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '0.01% atropine', 'description': '0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,', 'armGroupLabels': ['study group']}\n- {'type': 'OTHER', 'name': '0.9% sodium chloride', 'description': 'placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks', 'armGroupLabels': ['placebo eye drops']}\n\nPrimary Outcomes:\n- {'measure': 'Nearwork-induced transient myopia (NITM) in diopter', 'description': 'WAM-5500; Grand Seiko, Japan, will be used to assess the NITM in diopter unit.', 'timeFrame': 'At baseline, week 4, week 12, week 24, week 36, and week 48'}\n\nPlease estimate the sample size based on the assumption: \n90% power at a 0.05 significance level, with a maximum dropout rate of 20%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation is based on the primary outcome measures of initial NITM to establish the superiority of the 0.01% atropine group compared with the placebo group in terms of the changes in the mean from the baseline in the initial NITM at week 48. We took the estimated initial NITM for 0.01% atropine and placebo groups to be \u00e2\u0088\u00920.076 D and \u00e2\u0088\u00920.41 D.13 The expected SD within a group was assumed to be 0.20 D. A sample size of 16 subjects could achieve 90% power at a 0.05 significance level. According to Chinese\u00e3\u0080\u008apreparation supervision measures for the administration of medical institutions\u00e3\u0080\u008b(2005), the number of participants should be at least 60. Considering a maximum dropout rate of 20%, the sample size required is 150 (75 per group).", "id": 1952, "split": "test"} +{"trial_id": "NCT06037564", "pmid": "39578038", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Booster-free Antiretroviral Therapy for Persons Living With HIV and Multidrug Resistance: A Multicentre Multi-stage Randomized Trial\n\nIncluded conditions:\n- HIV\n- Drug Resistance\n- Drug Drug Interaction\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Doravirine 100 mg (Pifeltro\u00ae) will be administered once daily in combination with co-formulated dolutegravir/lamivudine 50/300 mg (Dovato\u00ae) for a duration of 48 weeks.', 'interventionNames': ['Drug: DOR/DTG/3TC']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants randomized to the control arm will continue to take their fully suppressive ART at baseline. The following selection of treatment combinations could be encountered in the control group (among others):\\n\\n* Once-daily co-formulated elvitegravir 150 mg, cobicistat 150 mg, tenofovir alafenamide 10 mg, emtricitabine 200 mg (Genvoya\u00ae) and darunavir 800 mg (e.g. Darunavir Mylan\u00ae)\\n* Once-daily co-formulated darunavir 800 mg, cobicistat 150 mg, tenofovir alafenamide 10 mg, emtricitabine 200 mg (Symtuza \u00ae) and DTG 50 mg (Tivicay \u00ae)\\n* Once-daily DTG 50 mg (Tivicay\u00ae), darunavir 800 mg (e.g. Darunavir Mylan\u00ae), and ritonavir 100 mg (Norvir\u00ae)\\n* Etravirine 200 mg twice daily (Intelence\u00ae), raltegravir 400 mg twice daily (Isentress\u00ae),darunavir 800 mg once daily (e.g. Darunvair Mylan\u00ae) and ritonavir 100 mg once daily (Norvir\u00ae)'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'DOR/DTG/3TC', 'description': 'Doravirine 100 mg (Pifeltro\u00ae) will be administered once daily in combination with co-formulated dolutegravir/lamivudine 50/300 mg (Dovato\u00ae) for a duration of 48 weeks.', 'armGroupLabels': ['Intervention'], 'otherNames': ['Doravirine (Pifeltro\u00ae) + Dolutegravir/Lamivudine (Dovato\u00ae)']}\n\nPrimary Outcomes:\n- {'measure': 'Loss of viral suppression', 'description': 'Difference in the proportion of individuals with an HIV-RNA \u226550 cp/mL at 48 weeks between the treatment arms.', 'timeFrame': 'Week 48'}\n\nPlease estimate the sample size based on the assumption: \n80% power, one-sided alpha level of 0.025, and an attrition rate of 10%.", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n For the first trial stage, the sample size was calculated to evaluate the non-inferiority of the primary outcome loss of virologic suppression (proportion of individuals with HIV-RNA \u00e2\u0089\u00a550\u00e2\u0080\u0089cp/mL) at week 48. The sample size was calculated using the following assumptions:\n \n \n Proportion with loss of viral suppression at48weeks: in a previous switch trial conducted within the SHCS (Simpl\u00e2\u0080\u0099HIV study), 2.2% of individuals had an HIV viral load \u00e2\u0089\u00a550\u00e2\u0080\u0089cp/mL after 1 year.15 However, individuals considered for the Simpl\u00e2\u0080\u0099HIV study generally did not have viruses with drug-resistance mutations, whereas in the present study, individuals will be required to have had a history of switching treatment due to lack of efficacy. In this second-line setting, we therefore assume the failure rate to be 4%.\n \n \n Non-inferiority margin: we set the non-inferiority margin at 8 percentage points. Given that we assume that 4% of individuals will have a detectable HIV viral load at 48 weeks, such a non-inferiority margin would consider 12% of individuals with a detectable HIV viral load to be acceptable with the new treatment. Such a threshold is clinically acceptable for a patient population with long-standing HIV infection and acquired resistance mutations, given the potentially large benefits of the new treatment (lower pill count, improved safety regarding DDIs and possibly better tolerability).\n \n \n Given the assumptions above, we need to include 190 individuals (95 in each arm) to have 80% power to show non-inferiority at a one-sided alpha level of 0.025. We accounted for an attrition of 10% of individuals during the study and therefore aim to include 210 individuals. This sample size will provide adequate power for both the intention-to-treat (ITT) and the per protocol analysis.", "id": 1953, "split": "test"} +{"trial_id": "NCT06037889", "pmid": "38858147", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Tirofiban in Patients With Acute Branch Atheromatous Disease (BAD)- Related Stroke (BRANT)\n\nIncluded conditions:\n- Branch Atheromatous Disease\n\nStudy Armgroups:\n- {'label': 'Tirofiban group', 'type': 'EXPERIMENTAL', 'description': 'Intravenous tirofiban will be administered immediately after randomization for a total duration of 48h with a loading dose of 0.4ug/kg/min\\\\*30min, followed by a maintenance dose of 0.1ug/kg/min\\\\*47.5h.', 'interventionNames': ['Drug: Tirofiban']}\n- {'label': 'Standard antiplatelet therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': \"Standard antiplatelet therapy based on Chinese stroke guideline will be administered after randomization for a total duration of 48h, as the two following types: 1) aspirin 150-300 mg qd, or 2) aspirin 100 mg qd plus clopidogrel 75 mg qd. The time for administration of antiplatelet drugs will be determined by the doctor in conjunction with the participants' use of antiplatelet or anticoagulant medication in the 24h prior to randomization, but the drug should be given as soon as possible after randomization.\", 'interventionNames': ['Drug: Aspirin tablet', 'Drug: Clopidogrel tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tirofiban', 'description': 'Tirofiban, a GPIIb/IIIa receptor inhibitor. Intravenous administration.', 'armGroupLabels': ['Tirofiban group'], 'otherNames': ['Tirofiban Hydrochloride and Sodium Chloride Injection']}\n- {'type': 'DRUG', 'name': 'Aspirin tablet', 'description': 'Aspirin. Oral administration.', 'armGroupLabels': ['Standard antiplatelet therapy group']}\n- {'type': 'DRUG', 'name': 'Clopidogrel tablet', 'description': 'Clopidogrel. Oral administration.', 'armGroupLabels': ['Standard antiplatelet therapy group']}\n\nPrimary Outcomes:\n- {'measure': 'Excellent functional outcome', 'description': 'Primary efficacy outcome: Excellent functional outcome is defined as modified Rankin Scale score: 0-1.\\n\\nModified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Death.', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided test with a significance level (alpha) of 0.05 and power of 0.8, considering a dropout rate of 10%.", "answer": 516, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n Based on the previous studies and clinical practice, we assumed the rates of the primary outcome to be 62% and 74% in the control and tirofiban groups, respectively.2 14\u00e2\u0080\u009316 18 27\u00e2\u0080\u009329 Thus, 234 participants per arm are needed for a two-sided test at alpha 0.05 and power 0.8. Considering a dropout rate of 10%, 516 patients will be required.", "id": 1954, "split": "test"} +{"trial_id": "NCT06038357", "pmid": "38898537", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of \"Cognitive Behavioral Intervention for Trauma in Schools\" (CBITS) in Child Welfare Programs in Germany: A Randomized Controlled Trial\n\nIncluded conditions:\n- Posttraumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'CBITS', 'type': 'EXPERIMENTAL', 'description': 'Cognitive Behavioral Intervention for Trauma in Schools (CBITS)', 'interventionNames': ['Behavioral: CBITS']}\n- {'label': 'Treatment as usual (TAU+)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Enhanced Treatment as Usual means regular care in child welfare program and mental health care. They also receive feedback on their assessments and a treatment recommendation.', 'interventionNames': ['Other: TAU+']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CBITS', 'description': 'The CBITS program is a skills-based group and individual intervention, which uses evidence-based cognitive-behavioral techniques (e.g. psychoeducation, relaxation, social problem solving, cognitive restructuring, and exposure) and is designed for delivery by mental health professionals. The program consists of 10 45-minute group sessions (about 6-8 students/participants per group), 1-3 individual sessions, 2 parent/caregiver psychoeducational sessions, and 1 teacher/ child welfare staff educational session. For this study, we will specifically train and supervise study therapists to deliver the intervention within child welfare programs.', 'armGroupLabels': ['CBITS'], 'otherNames': ['Cognitive Behavioral Intervention for Trauma in Schools']}\n- {'type': 'OTHER', 'name': 'TAU+', 'description': 'In the control condition (TAU+), child welfare programs will follow their usual procedures (i.e. routine care of child welfare, referral to medical practitioners and psychotherapists, handling of prescribed medication, referral to inpatient treatments in case of risk to self and others) which reflects treatment as usual in child welfare programs and the mental health care system in Germany. Additionally, participants in the control condition will receive the same baseline assessment and reporting of screening results as participants in the treatment condition after each assessment.', 'armGroupLabels': ['Treatment as usual (TAU+)']}\n\nPrimary Outcomes:\n- {'measure': 'Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report)', 'description': 'The CATS-2 is a questionnaire to screen for potentially traumatic events and assesses symptoms of PTSD/Complex-PTSD (CPTSD) (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases Version 11 (ICD-11)) in children and adolescents. The minimal score value is \"0\", the maximum score value is \"60\", while higher scores mean a worse outcome.', 'timeFrame': 'baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.80, significance level (\u03b1) of 0.05 (two-tailed), a correlation of r = 0.3 among replicated measures, and an assumed dropout rate of about 20% across both conditions.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the literature and our planned analyses on the effectiveness of CBITS for children, we expect a moderate effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.7 for the CBITS intervention. An attempt was made to estimate the likely effect size based on longitudinal studies reporting on children and adolescents living in the child welfare system: In our own trial of unaccompanied refugee minors, we found an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.15 for routine care in child welfare programs [18]. A Swiss study investigating externalizing behavior problems in institutionalized adolescents over the course of 1\u00c2\u00a0year found effects of dgirls\u00e2\u0080\u0089=\u00e2\u0080\u00890.28 and dboys\u00e2\u0080\u0089=\u00e2\u0080\u00890.24 [19]. Another study investigating emotional and behavioral symptom trajectories of children in long-term out-of-home care in an English local authority found that the largest trajectories were chronic symptom profiles, in which young people were rated in the abnormal range from their first year in care and remained in this range (based on the descriptive statistics reported we calculated d\u00e2\u0080\u0089=\u00e2\u0080\u00890.02\u00e2\u0080\u00930.1 for emotional problems [20]). Based on these studies, we assume a mean effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.1 for routine care for children in child welfare programs. As children and adolescents randomized to TAU\u00e2\u0080\u0089+\u00e2\u0080\u0089will also receive a report with a treatment indication, we assume that a small proportion in TAU\u00e2\u0080\u0089+\u00e2\u0080\u0089condition (10\u00e2\u0080\u009320%) will find their way to local service providers. For those receiving psychotherapeutic treatment from local service providers, we assume a mean effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00891.0 based on therapy as usual conditions in other trials (e.g., [21]). In sum, based on the before-mentioned literature on routine care in child welfare systems and the assumption that a small proportion will receive treatment at local service providers, we assume an overall mean effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.3 for the TAU\u00e2\u0080\u0089+\u00e2\u0080\u0089condition. Following the expected effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.7 for CBITS and d\u00e2\u0080\u0089=\u00e2\u0080\u00890.3 for TAU\u00e2\u0080\u0089+\u00e2\u0080\u0089, we assume a controlled effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.4 between conditions at 4-month follow-up (T1) in favor of CBITS on the primary measure of PTSS (CATS-2). A power analysis conducted with G*Power for the within-(time)-between-(condition)-interaction requiring a power of 0.80 and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-tailed), a correlation of r\u00e2\u0080\u0089=\u00e2\u0080\u00890.3 among replicated measures (based on our previous own RCTs [18, 22]) estimates a sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u008972 (n\u00e2\u0080\u0089=\u00e2\u0080\u008936 per condition) to detect the controlled effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.4 for the primary outcome between conditions. With an assumed dropout rate of about 20% across both conditions, an oversampling of n\u00e2\u0080\u0089=\u00e2\u0080\u008918 participants is needed, resulting in an overall sample of N\u00e2\u0080\u0089=\u00e2\u0080\u008990 participants (n\u00e2\u0080\u0089=\u00e2\u0080\u008945 per condition; n\u00e2\u0080\u0089=\u00e2\u0080\u008922\u00e2\u0080\u009323 per participating site).", "id": 1955, "split": "test"} +{"trial_id": "NCT06041607", "pmid": "39232668", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Shared Meditation Involving People With Cancer, Carers and Third Parties: Any Added Value Compared With Meditation Conducted With Patients? IMPLIC 2, a Randomised Study\n\nIncluded conditions:\n- Patients With Cancer\n\nStudy Armgroups:\n- {'label': 'Shared meditation', 'type': 'EXPERIMENTAL', 'description': 'Shared\" meditation: mixed groups of patients, carers and third parties', 'interventionNames': ['Behavioral: Shared meditation']}\n- {'label': 'Meditation \"patients\"', 'type': 'ACTIVE_COMPARATOR', 'description': 'groups of patients only', 'interventionNames': ['Behavioral: Meditation with patients oly']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Shared meditation', 'description': 'Meditation sessions between patients, carers and third parties\\n\\n* 12 weekly 2-hour sessions,\\n* 2 half-day 3-hour retreats after the 9th session and at the end of the programme\\n* 3 monthly follow-up sessions (2h) in remote format (videoconference)', 'armGroupLabels': ['Shared meditation']}\n- {'type': 'BEHAVIORAL', 'name': 'Meditation with patients oly', 'description': 'Meditation sessions between patients only\\n\\n* 12 weekly 2-hour sessions,\\n* 2 half-day 3-hour retreats after the 9th session and at the end of the programme\\n* 3 monthly follow-up sessions (2h) in remote format (videoconference)', 'armGroupLabels': ['Meditation \"patients\"']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.', 'description': 'Changes in self-efficacy scores according to the Generalized Self Efficacy Scale \\\\[min 10; max 40\\\\]', 'timeFrame': 'measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion'}\n\nPlease estimate the sample size based on the assumption: \n1-beta = 80%; 2-sided alpha = 5%; 10% potentially non-evaluable patients.", "answer": 96, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The added value of shared meditation versus patient-only meditation will be considered relevant if there is an additional post/pre-intervention improvement of at least 5% (1.5 points) on the GSES (score between 10 and 40). This change of more than 5% in the mean score has been described as clinically detectable in the assessment of quality of life [42]. The GSES was chosen because of its relevance to our research hypothesis and because of its sensitivity in the pilot study [25].\n To demonstrate a difference\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00891.5 points (SD\u00e2\u0080\u0089=\u00e2\u0080\u00892) in pre/post-programme improvement in the GSES between the two groups (ratio 1:1) for our target population, 58 evaluable patients are required (1-beta\u00e2\u0080\u0089=\u00e2\u0080\u008980%; 2-sided alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%), i.e. 64 patients (32 patients/group) to be included in order to anticipate 10% of potentially non-evaluable patients. The experimental arm will be completed by 16 health professionals and 16 third persons, for a total of 96 participants.", "id": 1956, "split": "test"} +{"trial_id": "NCT06042231", "pmid": "39361572", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation\n\nIncluded conditions:\n- Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Exercise Intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Exercise Intervention', 'Behavioral: Education Intervention']}\n- {'label': 'Standard Care', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise Intervention', 'description': \"Exercise and education intervention. Participants will be prescribed a tailored exercise program to complete before ('pre-habilitation') and after their AF ablation procedure (rehabilitation).\", 'armGroupLabels': ['Exercise Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Education Intervention', 'description': 'Education intervention. Participants will be given a 1-1 education session (up to 3 sessions) before and after their AF ablation procedure. Participants will be given behavioural strategies to improve adherence and compliancec to risk-factor modification.', 'armGroupLabels': ['Exercise Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'VO2 peak measurements', 'description': 'VO2peak measured from cardiopulmonary exercise testing (CPET) at baseline and 10 weeks (\u00b12 weeks) post AF ablation between the standard care and intervention arms.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 5%, the power is set at 90%, and a drop-out rate of 20% is assumed.", "answer": 106, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on the analysis of the change in the primary outcome (relative VO2peak) at 10-week post-ablation from baseline. Previous studies investigated VO2peak at 6 months post-ablation, which we assume to be similar at 10-week post-ablation. Based on Kato et al, we can assume that the VO2peak standard deviation is around 3ml/kg/min at baseline and 4ml/kg/min at 10-week post-ablation [23]. As the correlation between the time points is unknown, we assume a value of r = 0.5. Consequently, the standard deviation of the difference from 10-week post-ablation to baseline is around 3.6ml/kg/min. Based on Fiala et al and Mujovic et al, we can assume that the change in VO2peak will be around 2ml/kg/min due to AF ablation in both AF-types, and a further 4ml/kg/min due to cardiac rehabilitation (which comprises pre- and post-AF ablation rehabilitation) [23, 39, 40]. Therefore, the difference between the intervention arm and standard care is expected to be 4ml/kg/min at 10-week post-ablation compared with baseline. To detect a conservative difference of 2.5ml/kg/min (an increase in 2.5ml/kg/min VO2peak in the intervention arm from standard care at 10-week post-ablation compared with baseline) at 5% significance level, and 90% power, we require 88 participants. To allow a drop-out rate of 20%, we will recruit 106 people, with 53 randomly allocated to each group.", "id": 1957, "split": "test"} +{"trial_id": "NCT06042491", "pmid": "39510784", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The STRIVE Before Surgery Pilot Trial: a Vanguard Pragmatic Multicenter Randomized Trial of Structured TRaining to Improve Fitness in a Virtual Environment (STRIVE) Before Surgery\n\nIncluded conditions:\n- Surgery-Complications\n- Disability Physical\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.', 'interventionNames': ['Behavioral: Prehabilitation intervention']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': \"To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and \\\\>65) and healthy eating recommendations (Canada's Food Guide Snapshot) documents will be provided to control participants (without active or online support).\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prehabilitation intervention', 'description': 'The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) cardio and 3) stretching. Participants will be encouraged to complete self-directed and/or group sessions \\\\>= 3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is the STRIVE Trial website. The nutrition component includes: 1) protein supplementation; 2) nutrition advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing/huffing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Monthly recruitment', 'description': 'Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario.', 'timeFrame': '1 year'}\n- {'measure': 'Intervention adherence', 'description': 'The proportion of prescribed prehabilitation tasks adhered to', 'timeFrame': 'pre-surgery'}\n- {'measure': 'Retention', 'description': \"The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson's method.\", 'timeFrame': '1 month, year 1'}\n- {'measure': 'Elicitation of patient, clinician and researcher-identified barriers', 'description': 'For each target group, the frequency of domains identified as barriers will be calculated.', 'timeFrame': '1 year'}\n- {'measure': 'Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)', 'description': 'The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score', 'timeFrame': '1 month, 3 month, 1 year'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence interval, adherence rate similar to previous virtual platform (85%), retention rate >90% based on previous work.", "answer": 144, "answer_type": "ACTUAL", "explanation": "Sample size\n Our target sample size for the pilot trial is 144 patients. This sample size is adequate for each of the three feasibility outcomes: (1) Recruitment of 144 participants over 6 months at our five sites will demonstrate our ability to recruit, on average, 6 participants per site per month. With this recruitment rate, the expected full trial sample size (700\u00e2\u0080\u0093900 participants, dependent on sample level common SD for the WHODAS outcome61 will be achievable within 12\u00e2\u0080\u009318 months at the 11 sites planned for the larger trial; (2) Proportion of participants adherent to the intervention can be estimated with a 95% CI with a lower limit of 0.768 (assuming lowest demonstrated adherence similar to our virtual platform to date: 85%;62 63 and (3) Proportion retained at follow-up can be estimated with a 95% CI with a lower limit of 0.851 (assuming a rate>90% based on previous work.)27 64", "id": 1958, "split": "test"} +{"trial_id": "NCT06044623", "pmid": "39431459", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementing Geriatric Assessment for Dose Optimization of CDK 4/6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)\n\nIncluded conditions:\n- Metastatic Breast Cancer\n- Advanced Breast Cancer\n- Quality of Life\n- Toxicity\n- Older Patients\n\nStudy Armgroups:\n- {'label': 'Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort)', 'type': 'EXPERIMENTAL', 'description': '-1 level dose reduction as initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 100 mg x 1 for 21 days with 7 days off; or Ribociclib 400 mg x 1 for 21 days with 7 days off; or Abemaciclib 100 mg x 2 daily added to endocrine therapy.', 'interventionNames': ['Drug: CDK 4/6 inhibitors', 'Drug: Endocrine therapy']}\n- {'label': 'Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort)', 'type': 'ACTIVE_COMPARATOR', 'description': \"Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or Abemaciclib 150 mg x 2 daily) added to physician's choice endocrine therapy.\", 'interventionNames': ['Drug: CDK 4/6 inhibitors', 'Drug: Endocrine therapy']}\n- {'label': 'Full initial dose of CDK 4/6-inhibitor (fit patient cohort)', 'type': 'OTHER', 'description': \"Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or Abemaciclib 150 mg x 2 daily) added to physician's choice endocrine therapy.\", 'interventionNames': ['Drug: CDK 4/6 inhibitors', 'Drug: Endocrine therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'CDK 4/6 inhibitors', 'description': 'Either Palbociclib, Ribociclib or Abemaciclib', 'armGroupLabels': ['Full initial dose of CDK 4/6-inhibitor (fit patient cohort)', 'Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort)', 'Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort)']}\n- {'type': 'DRUG', 'name': 'Endocrine therapy', 'description': 'Either Letrozole, Anastrozole, Exemestane or Fulvestrant in combination with CDK 4/6-inhibitor', 'armGroupLabels': ['Full initial dose of CDK 4/6-inhibitor (fit patient cohort)', 'Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort)', 'Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort)']}\n\nPrimary Outcomes:\n- {'measure': 'Time to treatment failure', 'description': 'The time from randomization to treatment discontinuation because of any reason including disease progression, treatment toxicity, or death due to any cause.', 'timeFrame': 'Up to 5 years from treatment initiation'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided 5% significance level, 80% power, and a dropout rate of 10%.", "answer": 495, "answer_type": "ESTIMATED", "explanation": "2.6.\n Sample size\n In this study, a noninferiority study design is applied to vulnerable/frail cohort. TTF of 18\u00c2\u00a0months is assumed for the experimental arm and 16\u00c2\u00a0months for the standard arm with a small benefit of the experimental arm due to the anticipated lower rate of discontinuation due to toxicity. Considering a one-sided 5% significance and 80% power, a noninferiority hazard ratio margin of 1.19 (translating into an absolute margin of 2.5\u00c2\u00a0months in TTF) and a dropout rate of 10%, 346 patients should be randomized to prove noninferiority of treatment strategy with lower initial dose compared with full dose in terms of TTF.\n There will be no formal statistical considerations applied to the fit cohort, but the cohort will be analyzed with descriptive statistics. Considering a distribution of 30% fit and 70% vulnerable/frail patients, the study would need to screen 495 patients. Therefore, 149 patients in the fit cohort will be treated and followed, and 346 patients in the vulnerable/frail cohort will be randomized.", "id": 1959, "split": "test"} +{"trial_id": "NCT06045858", "pmid": "39306346", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)\n\nIncluded conditions:\n- Atrial Fibrillation\n- Peritoneal Dialysis Complication\n\nStudy Armgroups:\n- {'label': 'Warfarin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Warfarin (Coumadine): INR target \\\\[2.0-3.0\\\\]', 'interventionNames': ['Drug: Anticoagulation Agents']}\n- {'label': 'Apixaban', 'type': 'EXPERIMENTAL', 'description': 'Apixaban (Eliquis) at 2.5mg, per os, twice a day', 'interventionNames': ['Drug: Anticoagulation Agents']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Anticoagulation Agents', 'description': 'anticoagulation in peritoneal dialysis patients with non valvular atrial fibrillation during one year', 'armGroupLabels': ['Apixaban', 'Warfarin']}\n\nPrimary Outcomes:\n- {'measure': 'Safety primary criterion', 'description': 'at least one event for each participant ISTH major or clinically relevant non-major bleeding cumulated at 12 months', 'timeFrame': '0-12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size estimation assumes a two-sided alpha risk of 5%, 80% power, and includes two interim analyses and one final analysis. The Haybittle sequential plan with decision rule for better safety is used. Dropouts are not accounted for.", "answer": 178, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The APIDP group formulated a hypothesis that patients undergoing PD may experience fewer bleeding events compared with patients undergoing haemodialysis (without fistula and without heparin bridging). In order to estimate the effect size, we considered the population studied in an RCT that was similar to our cohort, which was the ARISTOTLE population with a CrCl ranging between 25 mL/min and 30\u00e2\u0080\u0089mL/min, with a focus on the 88 patients (64%) in the apixaban arm at the reduced dose of apixaban.5 Apixaban 2.5\u00e2\u0080\u0089mg caused less bleeding than warfarin with 17/85 (20%) vs 5/87 (6%) major bleeding or clinically relevant non-major bleeding events, respectively, in the warfarin group versus the apixaban group.\n The sample size estimation was computed with PROC SEQDESIGN (SAS software, V.9.4, Cary, North Carolina, USA). With a reference proportion of 20% (ie, in the control group), a two-sided alpha risk of 5%, 80% power, an effect size of \u00e2\u0088\u009214% in absolute proportion (ie, 6% in the experimental group), two interim and one final analyses, the required total sample size is 60 for the first interim, 118 for the second interim and 178 for the final analysis, by the Haybittle sequential plan with decision rule for better safety as described in figure 2. We did not account for dropouts.\n \n Figure 2\n \n Statistical output of PROC SEQDESIGN in SAS V.9.4 for the APIDP2 Study.", "id": 1960, "split": "test"} +{"trial_id": "NCT06046326", "pmid": "38803252", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluate the Effectiveness of a Virtual Community of Practice Via a Web-based Application Versus Individual and Self-administered Online Education to Improve the Activation of Middle-aged People with Multimorbidity.\n\nIncluded conditions:\n- Chronic Diseases\n\nStudy Armgroups:\n- {'label': 'virtual community of practice', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application.', 'interventionNames': ['Behavioral: virtual community of practice']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive individual, content-focused education through a web platform that will cover the same topics as the VCoP but will be self-administered and without social interaction within theplatform.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'virtual community of practice', 'description': 'The intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application.', 'armGroupLabels': ['virtual community of practice']}\n\nPrimary Outcomes:\n- {'measure': 'the Patient Activation Measure (PAM)', 'description': \"It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.\", 'timeFrame': 'Baseline'}\n- {'measure': 'the Patient Activation Measure (PAM)', 'description': \"It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.\", 'timeFrame': '12 months'}\n- {'measure': 'the Patient Activation Measure (PAM)', 'description': \"It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.\", 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nalpha error of 0.05, power of 80%, 20% loss", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size\n To detect a mean difference of 4 points (SD=10) in the PAM between the intervention and control groups, with individual randomisation, 100 patients per group are required. This threshold of 4 points (SD=10) was selected to capture clinically meaningful changes in patient activation.18 For this calculation, an alpha error of 0.05 and a power of 80% are assumed. This size is increased by the estimate of 20% loss, making a total of 240 patients.", "id": 1961, "split": "test"} +{"trial_id": "NCT06046547", "pmid": "38504215", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrating Palliative Care Education in Pulmonary Rehabilitation\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n- Interstitial Lung Disease\n\nStudy Armgroups:\n- {'label': 'Pulmonary rehabilitation with palliative care education', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will participate in PR with palliative care education.', 'interventionNames': ['Other: Pulmonary rehabilitation integrating education about palliative care']}\n- {'label': 'Pulmonary rehabilitation', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will participate in traditional PR.', 'interventionNames': ['Other: Pulmonary rehabilitation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pulmonary rehabilitation integrating education about palliative care', 'description': 'PR will include exercise training twice a week, and education and psychosocial support once per week during 12 weeks.\\n\\nThe intervention will include an education session on palliative care, a \"Peer-to-peer session\", a \"Get-apart session\" and online sessions.\\n\\nThe education session on palliative care will be facilitated by two specialist healthcare professionals. The main topics that will be discussed are: concept of palliative care, symptom control, disease impact, psychosocial support and planning for the future.\\n\\nParticipants will be the primary communicators in the \"Peer-to-peer session\", and the dialogue will be based on their suggestions. Those who feel more reluctant to reveal private thoughts in front of their loved ones will have the opportunity to discuss their issues in a \"Get-apart\" environment.\\n\\nIndividual cases will be referred to a specialist palliative care team or to any other health/social care professional according to the unmet needs identified.', 'armGroupLabels': ['Pulmonary rehabilitation with palliative care education']}\n- {'type': 'OTHER', 'name': 'Pulmonary rehabilitation', 'description': 'Participants will receive the same PR program as the experimental group besides the education session on palliative care, the \"Peer-to-peer session\", the \"Get-apart session\" and the online sessions (i.e. traditional pulmonary rehabilitation).', 'armGroupLabels': ['Pulmonary rehabilitation']}\n\nPrimary Outcomes:\n- {'measure': 'Knowledge about palliative care: Palliative Care Knowledge Scale (PaCKS)', 'description': 'PaCKS is a 13-item questionnaire assessing a broad range of topics, including goals, target population and timing of palliative care, as well as symptoms and problems that palliative care addresses. For each statement, \"True\", \"False\" and \"I don\\'t know\" options are provided, and a mark is given for each correct answer. Total scores range from 0 to 13 and higher scores indicate higher knowledge.\\n\\nIt will be evaluated in people with COPD or ILD and informal caregivers.', 'timeFrame': 'Assessment at baseline, at 12-weeks (i.e., end of PR) and at 6 months after PR.'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 of 0.05, a power of 0.80, a correlation among repeated measures of 0.5, a nonsphericity correction of 1, and a 40% dropout and missing data rate", "answer": 58, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was estimated for the primary outcome measure, PaCKS, in G*Power 3.1.9.4, for the time*group interaction of a mixed analysis of variance (ANOVA) with two groups (control and experimental) and two timepoints (at baseline and end of PR). We considered an \u00ce\u00b1 of 0.05, a power of 0.80, a correlation among repeated measures of 0.5, a nonsphericity correction of 1 and an expected effect size f of 0.25 [76]. The calculated sample size was 34 and considering a possible 40% dropout and missing data rate [77], the final sample size was determined to be 58 (29 in each group).", "id": 1962, "split": "test"} +{"trial_id": "NCT06049914", "pmid": "39443873", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Community-dwelling Older Adults in Primary Care: A Randomized Controlled Trial\n\nIncluded conditions:\n- Sarcopenia\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': \"1. Exercise interventions\\n\\n * Visiting the primary clinic twice a week and exercising at home once a week for a total of 6 weeks during the introductory and expanding period, and then visiting the primary clinic once a week and exercising at home twice a week for 6 weeks during the maintenance period\\n * For exercise intervention, the researcher visits the primary clinic and conducts it face-to-face\\n * Flexibility and strength Exercises: Up to 4 group exercises under the guidance of researchers, up to 40 minutes scheduled\\n2. Nutritional interventions\\n\\n * Evaluate nutritional status through Mini Nutritional Assessment(MNA) survey at the time of Visit 1\\n * Supplementary protein products are provided only for the malnourished group and at risk group with a MNA score of 23.5 or lower\\n * Supplementary protein products: 'Mediwell', healthy five-grain flavor, liquid 150 ml, 150 kcal, 20g carbohydrates, 2g sugars, 8g protein, 5g fat\", 'interventionNames': ['Behavioral: Experimental group']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': '* Control group: Providing only video and educational materials without intervention (12 weeks)\\n* Videos and educational materials are provided to both the experimental group and the control group for home exercise.\\n* Subjects write flexibility exercises, strength exercises, aerobic exercises, and meal diaries at home.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Experimental group', 'description': \"1. Exercise interventions\\n\\n * Measuring blood pressure and weight: before starting exercise\\n * Flexibility exercises: 5-10 minutes of stretching\\n * Strength exercises: Consists of 4 upper body exercises (Biceps Curl, Dips, Front raise, Chest press) and 5 lower body exercises (Leg lateral rotation, Leg extension, Hip abduction, Squat, Heel raise). The intensity of the band starts according to the subject's muscle strength.\\n * Aerobic exercise: 5 times a week, home-based, 30 minutes or more each time\\n2. Nutritional interventions\\n\\n * Well nourished: Overall diet check and correction\\n * at risk: Correction of diet and intake of up to 2 packs of supplemental protein products per day\\n * Malnourished: Correction of diet and intake of up to 3 packs of supplemental protein products per day\\n * Nutrition counseling is provided at the beginning of the intervention and high-protein diet composition education is provided\\n * Confirm compliance and provide feedback once every 2 weeks\", 'armGroupLabels': ['Experimental group']}\n\nPrimary Outcomes:\n- {'measure': '5-time chair stand test', 'description': 'a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded.', 'timeFrame': 'Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level with a group effect p-value of 0.004, 90% power, and a dropout rate of 20%.", "answer": 94, "answer_type": "ESTIMATED", "explanation": "Sample size determinations\n The target sample size for this study was determined based on a previous study that focused on improving muscle function (5-times chair stand test) through a three-month exercise\u00e2\u0080\u0093nutrition intervention among community-dwelling older adults [36]. According to previous findings, the change in the 5-times chair stand test performance over the three-month period was \u00e2\u0088\u0092\u00e2\u0080\u00893.77\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00892.94\u00c2\u00a0s and \u00e2\u0088\u0092\u00e2\u0080\u00891.49\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00893.17\u00c2\u00a0s for the exercise\u00e2\u0080\u0093nutrition and control groups, respectively, with a group effect p-value of 0.004. The effect size was 0.75. With 90% power using G*Power, 78 participants (39 participants in the intervention and control groups each) were required. Considering a dropout rate of 20%, 94 eligible participants will be recruited from primary care clinics according to the established criteria.", "id": 1963, "split": "test"} +{"trial_id": "NCT06054165", "pmid": "39142675", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial\n\nIncluded conditions:\n- Pelvic Bone Injury\n- Sacral Fracture\n- Pelvic Fracture\n- Fragility Fracture\n\nStudy Armgroups:\n- {'label': 'Standard-of-care', 'type': 'NO_INTERVENTION'}\n- {'label': 'Best-practice', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Clinical pathway']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Clinical pathway', 'description': 'Evidence-based and expert-opinion-based clinical pathway regarding the diagnostic and treatment strategy', 'armGroupLabels': ['Best-practice']}\n\nPrimary Outcomes:\n- {'measure': 'Mobility, using the Parker mobility score (PMS)', 'description': 'Since there is no validated tool to measure mobility specifically after a pelvic fracture, the investigators choose to use The Parker mobility score as a primary outcome measurement. The Parker mobility score is a valid and reliable score measuring mobility in hip fracture patients. The Parker Mobility Score answers three questions, each valued 0-3 points, and is commonly used in clinical practice to monitor the mobility of geriatric patients. A score of 0-3 is considered low, 4-6 moderate, and 7-9 reflects good mobility. Furthermore, the Parker Mobility Score is a validated assessment tool for mortality in patients with reduced mobility after hip surgery.', 'timeFrame': 'Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power.", "answer": 393, "answer_type": "ESTIMATED", "explanation": "Sample size\n The aim is a total of 393 inclusions, which provides an 80% statistical power for an improvement in mobility of 10%, measured by the PMS. An improvement in mobility is defined as an increase in the number of patients with a preinjury PMS of 9\u00e2\u0080\u00936 (\u00e2\u0080\u0098high mobility group\u00e2\u0080\u0099) who have a minimum of PMS 6 after treatment, and the patients with a preinjury PMS of 5 or lower (\u00e2\u0080\u0098low mobility group\u00e2\u0080\u0099) who regain their old PMS. This requires a sample size of 197 per group or 393 patients in total.", "id": 1964, "split": "test"} +{"trial_id": "NCT06055725", "pmid": "39819949", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity\n\nIncluded conditions:\n- Spasticity as Sequela of Stroke\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy', 'description': \"This is based on the investigator's clinical judgement and could include spasticity characterised by any of the following criteria aligned with the World Health Organization International Classification of Functioning, Disability and Health in three dimensions: Impairment, Activity limitations \\\\& Restriction on participation.\", 'timeFrame': 'At the Clinical Confirmation Visit (CCV) up to maximum 18 months'}\n\nPlease estimate the sample size based on the assumption: \nA screen failure rate of 20% and a drop-out/loss to follow-up rate of 30% are assumed. The precision for capturing the target population is \u00c2\u00b13%.", "answer": 1051, "answer_type": "ESTIMATED", "explanation": "Sample size\n It was estimated that investigators or designated site staff members will need to screen at least 1314 stroke survivors consecutively to enrol at least 1051 participants referred to their specialist sites by internal and external stroke units (assuming a screen failure rate of 20%). Allowing for a drop-out/loss to follow-up rate of 30%, this sample size is estimated to allow \u00c2\u00b13% precision for capturing stroke survivors who develop problematic spasticity that would benefit from treatment, assuming this proportion lies somewhere between 9.4% and 39.5%.9", "id": 1965, "split": "test"} +{"trial_id": "NCT06057441", "pmid": "39146010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children\n\nIncluded conditions:\n- Attention Deficit Hyperactivity Disorder\n- Neurodevelopmental Disorders\n\nStudy Armgroups:\n- {'label': 'No noise stimulation', 'type': 'NO_INTERVENTION', 'description': 'A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed without noise.'}\n- {'label': 'Auditory white noise stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in auditory white noise.', 'interventionNames': ['Device: Auditory noise stimulation']}\n- {'label': 'Visual white pixel noise, 25%', 'type': 'ACTIVE_COMPARATOR', 'description': 'A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 25%.', 'interventionNames': ['Device: Visual noise stimulation']}\n- {'label': 'Visual white pixel noise, 50%', 'type': 'ACTIVE_COMPARATOR', 'description': 'A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 50%.', 'interventionNames': ['Device: Visual noise stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Auditory noise stimulation', 'description': 'Auditory white noise stimulation delivered at 78dB through earphones', 'armGroupLabels': ['Auditory white noise stimulation']}\n- {'type': 'DEVICE', 'name': 'Visual noise stimulation', 'description': 'Visual white pixel noise stimulation, backgound pixel noise visible at computer screen', 'armGroupLabels': ['Visual white pixel noise, 25%', 'Visual white pixel noise, 50%']}\n\nPrimary Outcomes:\n- {'measure': 'Inhibitory control', 'description': 'Inhibitory control is the ability to suppress nonproductive behaviors and cognitive processing and will be measured through the eye tracking tasks (PF and MGS) in the study.', 'timeFrame': 'Six months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, significance level (P value) of .05", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample Size\n Power calculations are based on previous studies of auditive noise effects from our group [15,29] in combination with a review on oculomotor inhibition during MGS and PF [37]. To demonstrate an improvement of stimulation with sensory noise, equivalent to half an SD on intrusive saccades on PF, approximately 15 individuals per group are required to achieve a power of 0.80 with a P value of .05. The study aimed at including at least 60 participants, 30 in the ADHD group and 30 TD children.", "id": 1966, "split": "test"} +{"trial_id": "NCT06059014", "pmid": "38302933", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentric, Single Arm, Open-label, Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients with Metastatic Clear Cell Renal Cancer\n\nIncluded conditions:\n- Metastatic Clear Cell Renal Cell Carcinoma\n\nStudy Armgroups:\n- {'label': '177Lu-PSMA-1', 'type': 'EXPERIMENTAL', 'description': 'Radiopharmaceutical - injectable solution', 'interventionNames': ['Drug: 177Lu-PSMA-1 (radiopharmaceutical)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '177Lu-PSMA-1 (radiopharmaceutical)', 'description': '7.4 GBq (or 5.9 GBq in case of lower actvity) of 177Lu-PSMA-1, every 6 weeks for 4 administirations', 'armGroupLabels': ['177Lu-PSMA-1']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Severe Toxicities (ST) (for Phase1 part)', 'description': 'Incidence of Severe Toxicities (ST) defined as specific adverse events (AEs) graded using NCI-CTCAE V5.0 occurring during the ST period (i.e. the 6 first weeks) and assessed as related to study drug and considered clinically significant. The sepcific adverse events are defined in the protocol.', 'timeFrame': 'during the first 6 weeks of treatment'}\n- {'measure': 'Disease Control Rate after 24 weeks of treatment (DCR24w) (for Phase II part)', 'description': 'Disease Control Rate after 24 weeks of treatment (DCR24w) is defined as the rate of patients with a stable disease, a complete or partial response according to RECIST v1.1.after 24 weeks of treatment.', 'timeFrame': 'at 24 weeks of treatment'}\n\nPlease estimate the sample size based on the assumption: \nType I error alpha of 0.05, 90% power, and a unilateral situation. Assumes 15% of screened patients may have PSMA negative disease and 10% of positive PSMA patients may be non-evaluable for the primary endpoint.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical considerations\n The PRADR study is intented to recruit up to 48 evaluable participants and is divided in two parts:\n \n Safety run-in\n maximum sample size of 12 patients.\n Six (6) first patients will be treated at the starting dose (7.4 GBq of 177Lu-PSMA-1 for 4 cycles of treatment; every 6 weeks).\n \nIf\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00891/6 patients experience severe toxicity (i.e. related to study drug) during the first cycle of therapy (i.e. during the first 6 weeks), the safety data will be considered acceptable and the enrolment will be continued in phase II.If\u00e2\u0080\u0089>\u00e2\u0080\u00891/6 patients experience severe toxicity during the first cycle of therapy, then a lower dose of 177Lu-PSMA will be evaluated in an additional cohort of 6 patients.\n\n The 6 patients, enrolled in this safety run-in step and treated at the selected dose for phase II, will be included in the evaluation of Phase II part.\n Phase II: The sample size calculation was based on a Fleming\u00e2\u0080\u0099s single stage phase II design, with a minimum success (objective response rate at 24 weeks) considered of interest of p1\u00e2\u0080\u0089=\u00e2\u0080\u008930% and an uninteresting rate of p0\u00e2\u0080\u0089=\u00e2\u0080\u008910%. Assuming a type I error alpha of 0.05 and 90% power, 33 patients are needed to reject the null hypothesis H0: p\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u0089p0 versus the alternative hypothesis H1: p\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u0089p1 in a unilateral situation.\n Based on the assumption that 1)15% of screened patients may have a PSMA negative disease and 2) that among positive PSMA patients 10% may be non-evaluable for the primary endpoint, a maximum of 42 patients will be included in the study. At the time of analysis, results will be in favor of a clinical activity of 177Lu-PSMA-1 if the lower bound of the unilateral 95%CI of DCR24w is over 10% (this translates in at least 7 successes observed among 33 evaluable patients).", "id": 1967, "split": "test"} +{"trial_id": "NCT06061770", "pmid": "39032927", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'First APA program', 'type': 'EXPERIMENTAL', 'description': 'The evaluation of the primary endpoint to meet our main objective will be done at W13 for both groups. The addition of an APA program in autonomy following the structured program for group 1 will make it possible to answer a secondary question focusing on the comparison of the effectiveness of the self-directed program carried out alone or following a structured program.\\n\\n1st group: D0: Include S1-S12: APA program at IUR Valmante S13: Break S14-S25: APA Autoprogram\\n\\nIn addition, the patients in group 1 are maintained in the follow-up to study the maintenance of any observed effect.', 'interventionNames': ['Other: Adapted physical activity program']}\n- {'label': 'Second APA program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Our study design provides for compensatory participation in the structured program for patients in group 2, following the self-program. From an ethical point of view, this scheme allows all patients included in the structured APA program to benefit.\\n\\n2nd group: D0: Include S1-S12: APA Autoprogram S13: End of study S14-S25: APA program at IUR Valmante compensatory', 'interventionNames': ['Other: Adapted physical activity self-program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Adapted physical activity program', 'description': 'Rehabilitation', 'armGroupLabels': ['First APA program']}\n- {'type': 'OTHER', 'name': 'Adapted physical activity self-program', 'description': 'Rehabilitation', 'armGroupLabels': ['Second APA program']}\n\nPrimary Outcomes:\n- {'measure': 'Daily activity measurement', 'description': 'Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device', 'timeFrame': 'through study completion'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 80% power, 1:1 randomisation ratio", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Assuming the existence of a difference of 1000 steps between the endpoints, an SD of 1500,30 a 5% risk of the first type and a power of 80%, it would be appropriate to include 28 subjects per group, making a total number of 56 subjects. The present study will include 40 subjects, which will make it possible to specify the precision of the indicators with a power of 70%. The randomisation ratio will be 1:1 in this study.", "id": 1968, "split": "test"} +{"trial_id": "NCT06067178", "pmid": "39394167", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Health Dialogue Intervention Versus Opportunistic Screening in Primary Care for Type 2 Diabetes and Cardiovascular Disease Prevention in Low Socioeconomic Settings - The DETECT Trial\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Type 2 Diabetes\n\nStudy Armgroups:\n- {'label': 'Health Dialogue Intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Health Dialogue Intervention']}\n- {'label': 'Opportunistic Screening', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Opportunistic Screening']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Health Dialogue Intervention', 'description': '1. Lifestyle assessment: All participants fill out a questionnaire to assess behavioral risk factors for CVD and undergo blood tests for cholesterol and blood glucose.\\n2. Lifestyle health dialogue: When presenting in person at the primary care center, blood pressure, BMI, and waist-hip ratio will be measured. The results from the questionnaire, blood tests, blood pressure, and body measurements will be summarized using a visual tool, in which risk factors are graded into risk levels to estimate CVD risk. The visual tool will then be used in the health dialogue to discuss risk factors. The health dialogue is conducted by a licensed healthcare professional who has been trained in the methodology. The dialogue will be conducted in a person-centered manner and will aim to motivate and support lifestyle behavior changes when needed. If necessary, medical treatment will be provided according to existing guidelines.', 'armGroupLabels': ['Health Dialogue Intervention']}\n- {'type': 'OTHER', 'name': 'Opportunistic Screening', 'description': '1. Risk factor assessment: Opportunistic screening entails screening for risk factors (blood pressure, BMI, blood tests for cholesterol and blood glucose, and smoking) among patients visiting the primary care center for another reason. Screening is conducted by a healthcare professional at which the patient has an appointment.\\n2. Detected risk factors for CVD are treated according to the existing care programs and guidelines at the primary care center, which should always include lifestyle advice as the first intervention and medication if hypertension is established. In this intervention, there is a more limited assessment of behavioral risk factors; that is, patients are asked about smoking, but assessment of diet, physical activity, or alcohol consumption is not included in the opportunistic screening.', 'armGroupLabels': ['Opportunistic Screening']}\n\nPrimary Outcomes:\n- {'measure': 'Change in systolic blood pressure (mmHg)', 'description': 'Measured by care providers in accordance with routine guidelines', 'timeFrame': 'Baseline (defined as time of HDI/OS), 6 months post intervention, 12 months post intervention'}\n\nPlease estimate the sample size based on the assumption: \n80% power with 15 clusters per arm and 840 participants (420 per arm, 28 per cluster); 90% power with 15 clusters per arm and 1200 participants (600 per arm, 40 per cluster); 80% power with 9 clusters per arm and 69 participants per cluster; 90% power with 11 clusters per arm and 69 participants per cluster.", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations were based on change in systolic blood pressure as the main outcome measure. We considered a 5-mmHg reduction in systolic blood to be clinically relevant as meta-analyses of randomized trials show that such a reduction can reduce the risk of CVD by about 10% regardless of CVD history, including among people with normal to high-normal blood pressure [22], as well as specifically in middle-aged adults [23].\n Based on systolic blood pressure data in Stockholm Region that were obtained from electronic medical records, the estimated variance of systolic blood pressure levels between PCCs (clusters) was equal to 2, and the variance between subjects within PCCs (individuals) was equal to 256. These settings give rise to the underlying variance structure of the data, essential for sample sizes calculations, namely a difference of 5\u00c2\u00a0mmHg in systolic blood pressure between arms (VA\u00e2\u0080\u0089=\u00e2\u0080\u008912.5), variance between clusters, (VC\u00e2\u0080\u0089=\u00e2\u0080\u00892), and variance between individuals within PCCs (VE\u00e2\u0080\u0089=\u00e2\u0080\u0089256). We calculated the number of clusters, the number of individuals, and the power of the sample using various combinations of VA, VC, and VE values close to those outlined above. For each calculation, we adjusted one parameter while holding the other two constant. We used the package clusterPower version 0.7.0 [24], R Statistical Software version 4.1.3 [25], for the sample size and/or power calculations for the different variance settings.\n Accordingly, we calculated that based on 15 clusters in each arm, a minimum of 840 participants (n\u00e2\u0080\u0089=\u00e2\u0080\u0089420 in each arm and n\u00e2\u0080\u0089=\u00e2\u0080\u008928 per cluster) would yield 80% power to detect a reduction of 5\u00c2\u00a0mmHg systolic blood pressure in the HDI group as compared to OS. Rising power to 90% while keeping the number of clusters to 15 per arm would require a minimum of 1200 participants (n\u00e2\u0080\u0089=\u00e2\u0080\u0089600 in each arm and n\u00e2\u0080\u0089=\u00e2\u0080\u008940 per cluster). Additionally, anticipating difficulties with cluster recruitment and retention, we also calculated that if the size of the cluster is increased to n\u00e2\u0080\u0089=\u00e2\u0080\u008969, a power of 80% would be obtained with 9 clusters per arm, and 90% power would be obtained with 11 clusters per arm. Because we expected difficulties with recruitment of PCCs and participant recruitment within PCCs, as well as subsequent attrition of the two, the goal was to recruit at least 30 PCCs (n\u00e2\u0080\u0089=\u00e2\u0080\u008915 in each arm) in Stockholm Region, each of which will aim to recruit n\u00e2\u0080\u0089=\u00e2\u0080\u0089100 participants, yielding a maximum total study population of N\u00e2\u0080\u0089=\u00e2\u0080\u00893000.", "id": 1969, "split": "test"} +{"trial_id": "NCT06068582", "pmid": "38225561", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'Strengthening the brain', 'type': 'EXPERIMENTAL', 'description': 'Participants receive 30 minutes of 1-on-1 fitness training, dietary advice, and mental coaching, in addition to twice 20 minutes fitness at home, and 60 minutes of cognitive training each week for four months.', 'interventionNames': ['Behavioral: Strenghtening the brain']}\n- {'label': 'Strengthening the mind', 'type': 'EXPERIMENTAL', 'description': 'Partiicpants receive biweekly 1-on-1 coaching by a trained work-coach who has MS to identify challenges at work and implement solutions. It is completed when satisfactory solutions have been implemented for all challenges or after four months.', 'interventionNames': ['Behavioral: Strengthening the mind']}\n- {'label': 'Enhanced usual care', 'type': 'NO_INTERVENTION', 'description': 'Participants receiving general information about cognitive impairment in MS and following care as usual for four months.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Strenghtening the brain', 'description': 'Lifestyle intervention containing physical exercise, lifestyle coaching, and cognitive training. The programme contains weekly 30 minutes 1-on-1 fitness and lifestyle coaching with two moments of exercise at home for 20 minutes. Online computerized cognitive training will be done for 60 minutes per week.', 'armGroupLabels': ['Strengthening the brain']}\n- {'type': 'BEHAVIORAL', 'name': 'Strengthening the mind', 'description': 'Work-focused intervention combining the capability approach and the participatory approach. Together with a work-coach who has been diagnosed with MS themselves, participants will assess important work values, discover challenges participants are facing, think of solutions for these challenges, develop a plan of action and implement these solutions.', 'armGroupLabels': ['Strengthening the mind']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of Life', 'description': 'Quality of life assessed using the 36-item Short Form. Item-scores are summed and transformed into a total score that ranges 0-100. Higher score corresponds with better quality of life.', 'timeFrame': 'Baseline, Month 4, Month 10, and Month 16'}\n\nPlease estimate the sample size based on the assumption: \nStatistical significance level of 0.025, power of 0.80, correlation of 0.6 between measures, and a dropout rate of 20%.", "answer": 270, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of 270 participants is based on a power calculation. A review of earlier studies on the effects of cognitive rehabilitation in MS [14] suggests that we can expect moderate effects (effect size of 0.35) between pre- and post-intervention. Assuming statistical significance of 0.025, a power of 0.80, and an effect size of 0.35, 75 participants per group are needed. A conservative alpha of 0.025 has been chosen to take into account that we compare two interventions with a control group. A correlation of 0.6 between the measures was assumed. Based on previous experiences, a drop-out of 20% over the study period is expected. Therefore, we will include 90 subjects per group to ensure sufficient power. This study will be carried out using an intention-to-treat protocol. Therefore, subjects who withdraw from the study after inclusion will not be replaced.", "id": 1970, "split": "test"} +{"trial_id": "NCT06069206", "pmid": "39800394", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes: A Learning Healthcare Pragmatic Randomized Trial\n\nIncluded conditions:\n- Bloodstream Infection\n- Sepsis Bacterial\n- MRSA Bacteremia\n- Vancomycin\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive blood cultures and will not receive direct-from-blood testing.', 'interventionNames': ['Other: Usual Care']}\n- {'label': 'Direct-from-blood testing', 'type': 'ACTIVE_COMPARATOR', 'description': 'In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria\u00ae Panel.', 'interventionNames': ['Other: T2Bacteria\u00ae Panel (direct-from-blood testing)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'T2Bacteria\u00ae Panel (direct-from-blood testing)', 'description': 'Providers will be prompted to order the T2Bacteria\u00ae Panel (direct-from-blood testing) and accompanying communications regarding panel results will be delivered.', 'armGroupLabels': ['Direct-from-blood testing']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Standard blood cultures.', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Time to last dose of intravenous vancomycin', 'description': 'The time between randomization and the start time for the last dose of intravenous vancomycin received by the patient within 14 days of randomization.', 'timeFrame': 'Baseline to 14 days'}\n\nPlease estimate the sample size based on the assumption: \nThe power is 0.895, the significance level (type I error probability) is 0.05.", "answer": 500, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n The planned sample size for this trial is 500 patients (250 patients per group). The planned follow-up duration for each patient for the primary outcome is 14 days. Prior data indicate that the median time to the primary outcome in the control group will be approximately 48 hours.35 If the true median times to the primary outcome in the control and intervention groups are 48 and 36 hours, respectively, we will be able to reject the null hypothesis that the experimental and control survival curves are equal with probability (power) 0.895. The type I error probability associated with this test of this null hypothesis is 0.05.", "id": 1971, "split": "test"} +{"trial_id": "NCT06072898", "pmid": "38956594", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Engaging Mood Brain Circuits with Psilocybin: a Randomized Neuroimaging Trial in Depression\n\nIncluded conditions:\n- Depressive Disorder\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'Staged Active Treatment Arm (Psilocybin-Psilocybin)', 'type': 'EXPERIMENTAL', 'description': 'This group will receive psilocybin (25mg) at the first and second treatment visit, along with supportive psychotherapy.', 'interventionNames': ['Drug: Psilocybin', 'Behavioral: Supportive psychotherapy']}\n- {'label': 'Placebo to Active Delayed-Start Treatment Arm (MCC-Psilocybin)', 'type': 'EXPERIMENTAL', 'description': 'This group will receive microcrystalline cellulose (25mg) at the first treatment visit and psilocybin (25mg) at the second treatment visit, along with supportive psychotherapy.', 'interventionNames': ['Drug: Psilocybin', 'Other: Microcrystalline cellulose', 'Behavioral: Supportive psychotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Psilocybin', 'description': 'Psilocybin (\\\\[3-\\\\[2-(dimethylamino)ethyl\\\\]-1H-indol-4-yl\\\\] dihydrogen phosphate), 25mg PO.', 'armGroupLabels': ['Placebo to Active Delayed-Start Treatment Arm (MCC-Psilocybin)', 'Staged Active Treatment Arm (Psilocybin-Psilocybin)']}\n- {'type': 'OTHER', 'name': 'Microcrystalline cellulose', 'description': 'MCC (excipient), 25mg PO.', 'armGroupLabels': ['Placebo to Active Delayed-Start Treatment Arm (MCC-Psilocybin)'], 'otherNames': ['MCC']}\n- {'type': 'BEHAVIORAL', 'name': 'Supportive psychotherapy', 'description': 'Supportive psychotherapy in the form of reassurance, integration, and de-escalatory techniques (if needed). Facilitating rapport and a positive environment.', 'armGroupLabels': ['Placebo to Active Delayed-Start Treatment Arm (MCC-Psilocybin)', 'Staged Active Treatment Arm (Psilocybin-Psilocybin)']}\n\nPrimary Outcomes:\n- {'measure': 'Regional Blood Flow', 'description': 'Changes in cerebral blood flow within three a priori-defined brain regions relevant to mood regulation and depression as assessed by arterial spin labeling acutely at expected peak drug concentration during treatment visits.', 'timeFrame': 'Up to 3 weeks'}\n- {'measure': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS)', 'description': 'Changes in the MADRS relative to baseline at study follow-up visits. Higher scores with respect to the MADRS minimum (0) and maximum (60) values represent a worse treatment outcome .', 'timeFrame': 'Up to 6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, test-retest variability = \u00b13%, sensitivity analysis with test-retest variability up to 7.5% and psilocybin effect size as low as 15%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n As this study will employ a longitudinal design with multiple visits where CBF measurements in individual subjects may reasonably be expected to be highly dependent across visits, we will model use linear mixed-effects models of CBF at all visits to account for effects of psilocybin and MCC placebo independently of baseline CBF. Specifically, we will use the following model (in lme4 syntax):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}$$CBF\\sim Age+Sex+Drug+Drug\\;x\\;Visit+(\\mathit1\\;\\vert\\;ID)$$\\end{document}CBF\u00e2\u0088\u00bcAge+Sex+Drug+DrugxVisit+(1|ID)\n To assess the difference in CBF associated with psilocybin relative to placebo, marginal means of a Visit x Drug interaction will be calculated using the emmeans package in R, and contrasts between baseline and treatment visit 1 CBF under psilocybin and placebo conditions will be calculated separately, and an additional contrast composed of the difference of these two contrasts will be calculated. Sidak\u00e2\u0080\u0099s correction for multiple comparisons will be used to adjust p values. The primary endpoint will be the contrast estimating the between-group difference in within-subject differences in psilocybin- and placebo-induced CBF changes at treatment visit 1 vs baseline (i.e. [V1 psilocybin\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089V0]\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089[V1 placebo\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089V0]).\n As a power analysis, we simulate 500 datasets each for groups of size N\u00e2\u0080\u0089=\u00e2\u0080\u00895\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008950, in increments of 5. For each simulated subject, baseline CBF is sampled from a normal distribution 55\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008913 mL/100/g min. At each subsequent visit, a\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00893% test-retest variability is added to the baseline CBF. At psilocybin visits, relative to subject-specific baseline CBF, a proportional 23%\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008923% increase in CBF is added. MCC placebo has no direct psychotropic effects. For each of these 500 datasets, a model (Eq.\u00c2\u00a01) is fit to the data, and the contrasts described above are calculated. Sufficient power is achieved when evaluation of the between-group contrast of interest for a given group size produce corrected p-values below \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 at a frequency equal to or greater than a pre-specified power of 80%. This power analysis suggests two groups of N\u00e2\u0080\u0089=\u00e2\u0080\u008920 are sufficient to reject the null hypothesis in\u00e2\u0080\u0089>\u00e2\u0080\u008980% of cases. Sensitivity analyses additionally suggest that sufficient power can be achieved with N\u00e2\u0080\u0089=\u00e2\u0080\u008925 in each group if test-retest variability is as high as 7.5%, or if psilocybin effect size and variance is scaled from 23% to as low as 15% [see Additional file 3]. As these simulated datasets are likely somewhat idealized relative to real-world data, we will use a total of N\u00e2\u0080\u0089=\u00e2\u0080\u008950 subjects with 25 allocated to each arm.\n These anticipated CBF group session differences are consistent with a recently conducted acute neuroimaging clinical trial in bipolar depression [82]. Although we do not conduct a power analysis for HA,2, we provide context from the literature in support of the MADRS outcome measure. Example studies incorporating the MADRS outcome measure are provided [see Additional file 4], showing trial design, sample sizes, intervention details, and the reported changes in MADRS score [83\u00e2\u0080\u009387].\n Thus, our MADRS assessments for N\u00e2\u0080\u0089=\u00e2\u0080\u008950 is consistent with previous depression trials and support our second hypothesis (HA.2).", "id": 1972, "split": "test"} +{"trial_id": "NCT06075251", "pmid": "39365658", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control Trial\n\nIncluded conditions:\n- Congenital Heart Disease\n\nStudy Armgroups:\n- {'label': 'I-InTERACT-North', 'type': 'EXPERIMENTAL', 'description': 'Virtual stepped-care positive parenting program.', 'interventionNames': ['Behavioral: I-InTERACT-North']}\n- {'label': 'Care as Usual', 'type': 'NO_INTERVENTION', 'description': 'The CAU group will receive no direct parent treatment other than clinical care provided in cardiac follow-up (i.e., child assessment and consultation), which will be documented at each follow up. At end of trial, participants randomized to CAU will have the option to participate in I-InTERACT-North.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'I-InTERACT-North', 'description': \"I-InTERACT-North is a virtual stepped-care positive parenting program. It comprises online psychoeducational modules as well as live therapy and coaching sessions. The program lasts anywhere from 1 to 16 weeks depending on parents' progress.\", 'armGroupLabels': ['I-InTERACT-North']}\n\nPrimary Outcomes:\n- {'measure': 'Positive Parenting Skills', 'description': 'The primary proximal outcome will be positive parenting skills assessed through blinded (to allocation and follow up interval) coding of recorded parent-child interactions, using the Dyadic Parent-Child Interaction Coding System (DPICS). The DPICS will be used to rate positive parenting behaviors (e.g. praise, responsiveness, and enthusiasm). The DPICS is analyzed by independent blinded coders (to condition and time) observe and code parent-child interactions (5 minutes) for positive parenting behaviours (e.g., praise, responsiveness and enthusiasm).', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months'}\n- {'measure': 'Child Behaviour', 'description': 'The Eyberg Child Behavior Inventory (ECBI), is a parent rated 36-item checklist of concerns (e.g., noncompliance, emotional regulation).', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power >95%, adherence rate 86%, consent rate 70%, and subgroup analyses with a 50% split.", "answer": 382, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power Analysis\n Based on the size of the research registries available for recruitment and pilot estimates of consent rate (70%), we anticipate that 382 families will consent to participate in the RCT. Using pilot estimates of adherence rate (86%), we anticipate that 328, 282, and 244 families will complete the 3-month, 6-month, and 12-month follow-up measurements, respectively. Samples of 122 participants in each condition at 12 months postbaseline will provide >95% power to detect an effect size of 0.64, which is a medium to large effect size conservatively based on our pilot data. This sample size also achieves a power of 95% for subgroup analyses with subgroups with a split of 50%, which is consistent with or close to that of our pilot data.", "id": 1973, "split": "test"} +{"trial_id": "NCT06076421", "pmid": "39486820", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany\n\nIncluded conditions:\n- COVID-19\n- Influenza\n\nStudy Armgroups:\n- {'label': 'Evidence-based fact box on COVID-19 or influenza (intervention)', 'type': 'EXPERIMENTAL', 'description': 'Health educators (HE) will receive a flyer with a brief description of the study, a Quick Response-code (QR-code) and a link to an online survey, including either a fact box as tabular format or a visualization on the reverse side about COVID-19 or the flu vaccine to distribute to potential study participants. HE are free to decide if and how to use the fact boxes: whether during, before or after vaccination education, and who to target.\\n\\nParticipants who receive the flyer from their HE can decide on their own to participate in the study by using the QR-code or link on the flyer.', 'interventionNames': ['Other: Fact box']}\n- {'label': 'Usual education/care', 'type': 'NO_INTERVENTION', 'description': 'Study participants whose HE will be randomised to the control will receive the same flyer but without a fact box on the reverse side.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fact box', 'description': 'Fact boxes provide a tabular or graphical overview of the benefits and harms of the COVID-19 or influenza vaccination through transparent risk communication. The fact boxes are available for two different age groups each: COVID-19 vaccination for people aged 18 to 59 and over 60, influenza vaccination for people aged 16 to 64 and over 65 in Arabic, German, Russian and Turkish.', 'armGroupLabels': ['Evidence-based fact box on COVID-19 or influenza (intervention)']}\n\nPrimary Outcomes:\n- {'measure': 'Knowledge', 'description': '10 items: five items on basic knowledge of the disease (e.g. how is Corona or the flu contracted and what are the possible baseline risks) and uncertainty (e.g. quality of evidence), each with 4 possible answers, of which only one is correct. A further five questions that can only be answered through the fact box, including one question on the benefits of vaccination gist and three questions on the benefits and harms of vaccination verbatim. Responses will be graded according to the best available evidence in July 2023.', 'timeFrame': 'at T1 (initial survey; study period: 3-6 month)'}\n- {'measure': 'Informed vaccination intention', 'description': \"Based on vaccination knowledge, a person's attitudes and vaccination intentions.\\n\\nKnowledge will be measured as described above. Attitudes will be measured using an 11-point Likert scale that captures the personal assessment of the balance between the potential benefits and risks of the respective vaccine. Vaccination intention will be measured by asking whether participants would have themselves or their relatives vaccinated at the next opportunity, on a scale of 1-5 (Definitely yes, probably yes, probably not, definitely not, I cannot yet say / am still undecided).\", 'timeFrame': 'at T1 (initial survey; study period: 3-6 month)'}\n\nPlease estimate the sample size based on the assumption: \nCluster correlation coefficient (ICC=0.10); significance level and power details are provided in the supplementary section.", "answer": 800, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim to demonstrate moderate main effects (equal to Cohen\u00e2\u0080\u0099s d=0.50) of the study intervention on informed intentions (10% expected in usual care) and a knowledge sum score (equal to the proportion of correct responses; with an expected variance of 0.20). Taking into account a cluster correlation coefficient (ICC=0.10) common for primary care studies with patient endpoints,47 we will target three health educators (eg, doctors\u00e2\u0080\u0099 offices) per study arm with 40\u00e2\u0080\u0089patients/clients per health educator.48 So, 240 participants in each subgroup undergoing the same analysis are required (online supplemental table S3). Furthermore, to demonstrate small-to-moderate interaction effects (equal to Cohen\u00e2\u0080\u0099s d=0.375) of the study intervention in respective settings on informed intentions and knowledge, we have to target instead seven health educators per study arm with 40\u00e2\u0080\u0089patients/clients per health educator (n=560). In total, we aim at 800 participants because the proportion of subgroup members cannot be predicted, and we cannot rule out that interaction effects in the field are smaller than expected from experimental evidence (eg, d=0.20 would call for up to 20 health educators per study arm). Further details on the assumptions underlying the sample size calculations in the power calculation with respect to the critical hypotheses and outcomes are provided in online supplemental table S3 in the supplementary section.", "id": 1974, "split": "test"} +{"trial_id": "NCT06079970", "pmid": "38964802", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)\n\nIncluded conditions:\n- Lung Cancer\n- Lung Neoplasm Malignant\n- Carcinoma, Non-Small-Cell Lung\n- Neoplasm of Lung\n\nStudy Armgroups:\n- {'label': 'nCLE arm', 'type': 'EXPERIMENTAL', 'description': 'Diagnostic bronchoscopy is done according to institutional practice with the addition of nCLE', 'interventionNames': ['Device: Neelde Based Confocal Laser Endomicroscopy', 'Procedure: Conventional diagnostic bronchoscopy']}\n- {'label': 'Control arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Diagnostic bronchoscopy is done according to institutional practice without the addition of nCLE', 'interventionNames': ['Procedure: Conventional diagnostic bronchoscopy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Neelde Based Confocal Laser Endomicroscopy', 'description': 'Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)', 'armGroupLabels': ['nCLE arm']}\n- {'type': 'PROCEDURE', 'name': 'Conventional diagnostic bronchoscopy', 'description': 'Conventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN AND/OR VB AND/OR ultrathin scope', 'armGroupLabels': ['Control arm', 'nCLE arm']}\n\nPrimary Outcomes:\n- {'measure': 'Diagnostic yield (intermediate definition)', 'description': 'Diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis \\\\[either malignant, specific benign or non-specific benign confirmed as benign in follow-up\\\\], relative to the total number of patients that underwent the diagnostic bronchoscopic procedure). If patients with multiple lesions are included, the diagnostic yield will be computed per nodule.', 'timeFrame': 'After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is set at 0.05, the power is 0.80, and a 5% study drop-out rate is considered.", "answer": 208, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Based on previous studies and meta-analyses, we expect the diagnostic yield in patients with a lesion <30 mm in the conventional bronchoscopy arm to be 62%.24 25 We hypothesise that additional nCLE guidance in the intervention arm will result in a diagnostic yield of 80%. In total, 198 patients are needed to show that nCLE guidance results in a diagnostic yield that is 18% point higher than the conventional bronchoscopy arm (alpha=0.05 and power=0.80). Taking into account a 5% study drop-out, a total of 208 patients will be included. We believe an increase in the diagnostic yield (from 62% to 80%) demonstrates a clinically relevant improvement in lung cancer diagnosis.", "id": 1975, "split": "test"} +{"trial_id": "NCT06082349", "pmid": "38626967", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial\n\nIncluded conditions:\n- Lymphedema, Secondary\n- Lymphedema of Upper Limb\n- Lymphedema, Lower Limb\n- Lymphedema Arm\n- Lymphedema of Leg\n\nStudy Armgroups:\n- {'label': 'Lymphaticovenous anastomosis (LVA)', 'type': 'EXPERIMENTAL', 'description': 'Patients in this group will undergo lymphaticovenous anastomosis at one or more locations on the affected limb, and the procedure will be performed under local anesthesia. During the operation, patients will be blinded using a noise-canceling headphone and blindfolds. Incisions will be made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lympahtic system. The locations will be determined prior to the surgery using ICG lymphography. The LVA(s) will be made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVA(s) is made using a surgical microscope and the operation will take approximately 60 to 90 minutes.', 'interventionNames': ['Procedure: Lymphaticovenous anastomosis']}\n- {'label': 'Sham surgery', 'type': 'SHAM_COMPARATOR', 'description': 'Patients in this group will undergo sham surgery at one location on the affected limb, and the procedure will be performed under local anesthesia. During the operation, patients will be blinded using a noise-canceling headphone and blindfolds. The locations for LVA surgery will be determined prior to the surgery using ICG lymphography. However, the incision for the sham procedure will be made 2 centimeters medial or lateral to the predetermined site. This is done in order to avoid damage to the lymph vessels as to allow for future LVA surgery. After the incision, no LVA is made. Rather than performing the actual operation, the plastic surgeon will simulate the procedure by applying pressure in the surgical area. To mimic the approximate duration of a regular LVA procedure, the sham operation will take approximately 60 to 90 minutes.', 'interventionNames': ['Procedure: Sham surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Lymphaticovenous anastomosis', 'description': 'Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to a adjacent vein of similar size, thereby facilitating the ouflow of lymphatic fluid in patients suffering from secondary lymphedema', 'armGroupLabels': ['Lymphaticovenous anastomosis (LVA)'], 'otherNames': ['LVA', 'Lymphaticovenular anastomosis', 'Lymphovenous bypass', 'Lymphatic-venous shunt']}\n- {'type': 'PROCEDURE', 'name': 'Sham surgery', 'description': 'Sham surgery involves the process of surgery, including local anesthesia and incisions, but no LVA is made.', 'armGroupLabels': ['Sham surgery'], 'otherNames': ['Placebo surgery', 'Simulated surgery', 'Surgical placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline in the Lymph-ICF Score at 12 and 24 months', 'description': 'The Dutch version of the \\'Lymphedema Functioning, Disability, and Health\" (Lymph-ICF) questionnaire is used. There are two versions of the Lymph-ICF; one for the upper extremity and one for the lower extremity. The questionnaires assess the impairments in function, activity limitations, and participation restrictions of patients with lymphedema. It is a validated, disease-specific questionnaire, consisting of items across 5 domains. Each item is scored on a VAS, ranging from 0 to 100.', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).'}\n\nPlease estimate the sample size based on the assumption: \nUsing an alpha of 0.05 and a power of 80%, with a potential drop-out rate of 20%.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was performed to be able to detect a clinically relevant difference in the score on the Lymphedema Functioning, Disability and Health (Lymph-ICF) Questionnaire between groups at 24-month follow-up. A difference in Lymph-ICF score of 15 points for the upper limb and 20 points for the lower limb is deemed clinically relevant, with an estimated SD of 20 points.34 35 Because of the difference in cut-off point per limb, the randomisation is stratified and analysed separately based on the location of lymphoedema. Using an alpha of 0.05, the following sample size was calculated to achieve a power of 80%: for the upper limb, a minimum of 28 patients per group is required, resulting in a total of 56 patients. To account for a potential drop-out rate of 20%, a total of 70 patients is included. For the lower limb, a total of 16 patients is needed per group, totalling 32 patients. Taking a potential drop-out rate of 20% into account, 40 patients will be included. Drop-outs will not be replaced. Altogether, 110 patients will be included in this study, that is, 55 patients per treatment group with a 1:1 allocation.", "id": 1976, "split": "test"} +{"trial_id": "NCT06083818", "pmid": "39881313", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Therapeutic Exercise Protocol for the Prevention of Anterior Cruciate Ligament Injuries in Female Football Players With Dynamic Knee Valgus\n\nIncluded conditions:\n- Anterior Cruciate Ligament Injuries\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants in this group will undergo a conventional physical preparation programme.', 'interventionNames': ['Other: Placebo - Conventional fitness programme']}\n- {'label': 'ACL injury prevention protocol', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will undergo a specific 12-week prevention protocol.', 'interventionNames': ['Other: Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Application of an anterior cruciate ligament injury prevention protocol for female football players with dynamic knee valgus for 12 weeks.', 'description': '12-week ACL Injury Prevention Protocol', 'armGroupLabels': ['ACL injury prevention protocol']}\n- {'type': 'OTHER', 'name': 'Placebo - Conventional fitness programme', 'description': 'Conventional training and physical preparation programme', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'CHANGING RISK FACTORS', 'description': 'modification of risk factors such as dynamic knee valgus', 'timeFrame': '12 weeks'}\n- {'measure': 'MOTOR CONTROL', 'description': 'Changes in motor control not only of the lower limbs, but also of the lumbo-pelvic complex using software and imaging systems that measure joint alignments.', 'timeFrame': '12 weeks'}\n- {'measure': 'SPORT PERFORMANCE', 'description': 'Tactical and technical changes are expected on the pitch as well as improvements in the sporting performance of the players through dynamic evaluations with imaging and video systems as well as speed and agility tests by monitoring joint stability.', 'timeFrame': '12 weeks'}\n- {'measure': 'KNEE JOINT BIOMECHANICS', 'description': 'Changes in neuromuscular control of the knee using imaging and force plate assessments to monitor lower limb alignment and areas of increased reaction force.', 'timeFrame': '12 weeks'}\n- {'measure': 'SPORTSWOMEN SATISFACTION', 'description': 'Changes in the incidence of injuries among female football players using the SF-12 satisfaction scale.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05, a 95% confidence interval, a power of 90%, and a 10% abandonment rate", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n An analysis was performed with Epidat 4.2 software to calculate the sample size required in the present study. A comparison of independent means will be performed and a standardized mean difference of 1, a significance level of 0.05, a 95% CI, and a power of 90% will be considered, which determines a total sample size of 44 subjects, 22 in each group. It is necessary to consider an abandonment rate, so we will increase the sample by 10%. Therefore, the total sample size will be 48 women, 24 in each study group (Annex VII).", "id": 1977, "split": "test"} +{"trial_id": "NCT06083948", "pmid": "40132839", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients\n\nIncluded conditions:\n- Hypotension\n\nStudy Armgroups:\n- {'label': 'Noradrenaline', 'type': 'EXPERIMENTAL', 'description': 'Noradrenaline', 'interventionNames': ['Drug: Noradrenalin']}\n- {'label': 'Phenylephrine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Phenylephrine', 'interventionNames': ['Drug: Phenylephrine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Noradrenalin', 'description': 'Infusion of noradrenaline during anesthesia and surgery', 'armGroupLabels': ['Noradrenaline'], 'otherNames': ['Noradrenaline']}\n- {'type': 'DRUG', 'name': 'Phenylephrine', 'description': 'Infusion of phenylephrine during anesthesia and surgery', 'armGroupLabels': ['Phenylephrine'], 'otherNames': ['metaoxedrin']}\n\nPrimary Outcomes:\n- {'measure': 'Cerebral blood flow', 'description': 'Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography', 'timeFrame': 'Up to 3 hours (measured on the day of surgery prior to the surgical procedure)'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of 0.05, a power of 80%, and a possible dropout rate of 6%.", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n No previous studies have, to our knowledge, investigated the changes in CBF based on PET measurements after phenylephrine versus norepinephrine treatment in the same patient population. Therefore, we estimated our sample size based on the regional changes in CBF after phenylephrine versus ephedrine treatment in a similar patient cohort as reported by Koch et al.16 Ephedrine and norepinephrine are both combined \u00ce\u00b1-adrenergic and \u00ce\u00b2-adrenergic agonists and have similar pharmacological properties.8 11 16 The study by Koch et al reported a change in CBF of 1.7\u00c2\u00b13.5\u00e2\u0080\u0089mL/100 g/min after phenylephrine treatment and 5.5\u00c2\u00b14.0\u00e2\u0080\u0089mL/100 g/min after ephedrine treatment.16 Given a between-group difference in CBF=3.8\u00e2\u0080\u0089mL/100 g/min in favour of the norepinephrine group, a significance level of 0.05 and a power of 80%, the study requires 15 patients in each group to detect a significant difference in CBF changes between the two vasopressors. Considering a possible dropout rate of 6% and to increase the comparability of the two groups, we decided to recruit a total of 32 patients, with 16 patients in each arm.\n \n Statistical analyses\n All randomised subjects with a full dataset will be included in the statistical analyses. Standard parametric and non-parametric analyses are used for paired analyses of the physiological parameters.1619 The percentage changes in different measurements are calculated as the post-treatment value minus pretreatment value divided by the pretreatment value times 100 (ie, the relative change). The effects of vasopressor type, vasopressor dose and CO are estimated in a generalised linear model. Static autoregulation (relationship between MABP and CBF) is assessed using correlation plots and cubic penalised regression splines between norepinephrine and phenylephrine, and between normal and diseased brain regions (in addition to the global CBF). A detailed statistical analysis plan will be prepared prior to the start of the analyses.", "id": 1978, "split": "test"} +{"trial_id": "NCT06084234", "pmid": "39495136", "question": "Here is the design of a clinical trial:\n\nOfficial Title: National Liver Cancer Screening Trial\n\nIncluded conditions:\n- Carcinoma, Hepatocellular\n- Liver Cancer\n- Liver Cirrhosis\n- Hepatitis B\n\nStudy Armgroups:\n- {'label': 'Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoprotein', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.', 'interventionNames': ['Diagnostic Test: Liver Ultrasound with or without AFP']}\n- {'label': 'Arm B: Semi-annual surveillance using GALAD', 'type': 'EXPERIMENTAL', 'description': 'For participants in this arm, study team will order GALAD measurement every 6 months +/- 3 months.', 'interventionNames': ['Diagnostic Test: GALAD']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'GALAD', 'description': 'GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.', 'armGroupLabels': ['Arm B: Semi-annual surveillance using GALAD']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Liver Ultrasound with or without AFP', 'description': 'This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.', 'armGroupLabels': ['Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoprotein']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of HCC detected at late stage', 'description': 'Proportion of HCC detected at a late stage, defined as HCC beyond Milan Criteria (one tumor less than or equal to 5 cm or 2-3 tumors each less than or equal to 3 cm, in the absence of vascular invasion or extra-hepatic metastases)', 'timeFrame': '5.5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study will have 81% power to reject the null hypothesis using a one-sided test at the 5% significance level. The assumptions include 60% sensitivity, 85% specificity, and 55% adherence in the ultrasound \u00b1 AFP arm, and 70% sensitivity, 80% specificity, and 80% adherence in the GALAD arm. The study accounts for ~10% lost to follow-up by the end of 5.5 years, with power estimates robust to loss to follow-up up to 20%.", "answer": 5500, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study will enroll 5500 patients during the first 3 years, and the primary analysis will be conducted 5.5 years after study enrollment begins when the average follow-up for each patient is 2.6 years. Assuming an annual HCC incidence of 2%, we anticipate a total of 303 HCC cases over 14,500 person-years of follow-up. The expected proportion of late-stage HCC in the SOC arm is 39%. Therefore, the study will have 81% power to reject the null hypothesis using a one-sided test at the 5% significance level if the observed proportion of late-stage HCC in the GALAD arm is 24%, which corresponds to a 38% reduction in the proportion of late-stage HCC, assuming there is 5% overdiagnosis in the GALAD arm.\n The sample size was determined using a Monte Carlo simulation study (with 10,000 trials) to model the effect of screening interventions in patients with cirrhosis. The first step was to simulate outcomes for patients with cirrhosis in the absence of HCC screening. We then implemented screening with either ultrasound \u00c2\u00b1 AFP or GALAD. The sensitivity, specificity, and adherence of each screening approach were our key assumptions. The simulation assumed that in patients who would be diagnosed with late-stage HCC in the absence of any screening, screening with either ultrasound \u00c2\u00b1 AFP or GALAD may result in a stage shift, depending on test performance and adherence to screening. A patient would experience a stage shift because of screening testing if they had a positive screening test in the window 6\u00e2\u0080\u009318 months before their late-stage HCC clinical diagnosis. Therefore, both the assumed sensitivity of the test and the adherence assumption would affect if a late-stage HCC case experiences a stage shift to early-stage HCC, and the proportion of late-stage HCC is a consequence of these assumptions.\n We assumed 60% sensitivity, 85% specificity, and 55% adherence in the ultrasound \u00c2\u00b1 AFP arm based on a study that found ultrasound with AFP increases early-stage sensitivity to 63%, but this is offset by a decrease in specificity to 84%.\n14 In a study that examined receipt of screening in 629 patients diagnosed with HCC, 14% of patients received semi-annual screening, and 22% of patients received annual screening, while ~64% received less than annual screening.\n21 We have chosen to be more conservative and used a higher adherence assumption of 55% (rather than 36%) in the ultrasound \u00c2\u00b1 AFP arm since these patients are enrolled in a trial, and this can affect the behavior of both providers and patients. The same study found that the proportion of late-stage HCC under the current standard of care is ~35%. Note that the 5 sites where this was studied are part of this clinical utility trial. Given that we are enrolling more community-based sites in this clinical utility trial where the proportion of late-stage HCC can be as high as 60%,\n47 we believe 39% late-stage HCC in the ultrasound \u00c2\u00b1 AFP arm is justified.\n We assumed a sensitivity of 70%, specificity of 80%, and adherence of 80% in the GALAD arm. The sensitivity assumptions are based on results from the HEDS cohort, which found that at a cutoff of \u00e2\u0088\u00921.36, sensitivity and specificity of GALAD within 6 months before HCC diagnosis were 65% (95% CI: 52%\u00e2\u0080\u009378%) and 82% (80%\u00e2\u0080\u009384%), respectively and THCCC cohorts where the sensitivity within 6 months before the diagnosis of early-stage HCC was 73% and specificity was 74%.\n29 Note that the specificity assumption does not affect our primary endpoint of the proportion of late-stage HCC but could affect secondary endpoints about the consequences of false-positive screening tests. Adherence of 80% is justified by further analysis in the HEDS cohort, where, on average, patients completed labs at ~65% of all study visits and ~83% of study visits with some record of study contact. Therefore, we believe achieving 80% adherence in the GALAD arm is a justifiable assumption given that the trial includes the research team ordering the GALAD testing, and GALAD can be completed at local labs (ie, does not require a visit to the health system main campus).\n Enrollment is expected to be completed over 3 years. The study initially launched with 10 sites, and we assume that each site requires 6 months to ramp up enrollment from 7 patients/month to the target enrollment rate of 12 patients/mo. As of September 2024, an additional 5 sites are being launched. These sites are expected to require 6 months to reach target enrollment of 12 patients/mo. Therefore, the accrual of 5500 patients into the trial will require 35 months of enrollment. The power calculations consider multiple reasons why patients may not have an observed HCC event. We assume ~10% lost to follow-up by the end of 5.5 years, and we have also accounted for the competing risk of death from other causes, removal due to transplantation, and sporadic missed visits during the study. Note that our study will aim to continue to follow-up patients for outcomes of tumor stage and survival among patients who withdraw from the study intervention by asking them to consent to medical record review. Therefore, the estimate of 10.6% refers to patients who are alive but stop all medical visits at some point during the study, and, therefore, we believe it is a reasonable assumption that yields 81% power with our current design of 5500 patients. Our power estimates are robust to loss to follow-up. The power decreases to 80.4%, with 15% of patients lost to follow-up and 80% with 20% loss to follow-up. The reason that loss to follow-up has minimal effect on the study power is because the larger source of censoring for our primary endpoint of HCC events is death due to other causes or liver transplantation. We assume removal from the cohort for death or transplantation due to cirrhosis is based on Child-Pugh status at entry (2-y survival with Child-Pugh score A is 90%, 2-y survival with Child-Pugh score B is 60%, the probability of being Child-Pugh A at entry is assumed to be 60%). By the end of the study period, the average probability of being lost to follow-up is 11%, and the average probability of death or transplant before HCC is 45%.\n Therefore, we believe that with 5500 patients followed for an average of 2.6 years, we will observe a clinically significant reduction in the proportion of late-stage HCC.", "id": 1979, "split": "test"} +{"trial_id": "NCT06087874", "pmid": "38851232", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial\n\nIncluded conditions:\n- Neonatal Jaundice\n- Microtia\n- Pregnancy Related\n- Hyperbilirubinemia, Neonatal\n\nStudy Armgroups:\n- {'label': 'Probiotics', 'type': 'EXPERIMENTAL', 'description': 'Vivomixx\u00ae is a multi-strain probiotics product.', 'interventionNames': ['Dietary Supplement: Vivomixx\u00ae']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Maltose-containing placebo product', 'interventionNames': ['Dietary Supplement: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Vivomixx\u00ae', 'description': 'The probiotic group participants will receive 1 sachet of probiotic product daily from 36weeks of gestation up to 7th day of postpartum while placebo groups will 1 sachet placebo prepared with the same colour, taste, and packaging with Vivomixx\u00ae daily for the same duration of probiotic groups. Vivomixx\u00ae is a non-genetically modified (GMO), gluten-free, high potency microbiotic food supplement, containing eight strains (Streptococcus thermophilus DSM24731\u00ae / NCIMB 30438, Bifidobacterium breve DSM24732\u00ae / NCIMB 30441, Bifidobacterium longum DSM24736\u00ae / NCIMB 30435, Bifidobacterium infantis DSM24737\u00ae / NCIMB 30436\\\\*, Lactobacillus acidophilus DSM24735\u00ae / NCIMB 30442, Lactobacillus plantarum DSM24730\u00ae / NCIMB 30437, Lactobacillus paracasei DSM24733\u00ae / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM24734\u00ae / NCIMB 30440) of live bacteria (450 billion bacteria per sachet).', 'armGroupLabels': ['Probiotics']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'A maltose- containing product with a similar phenotype with Vivomixx\u00ae.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Hyperbilirubinemia', 'description': 'Investigators will measure the transcutaneous bilirubin level on the second and seventh day of life and plot the record on the nomograph. The record above the 95th percentile will be taken as considerable hyperbilirubinemia and then the baby will be investigated for total serum bilirubin measurement if needed to declare hyperbilirubinemia. The outcome will be classified as hyperbilirubinemia and non-hyperbilirubinemia.', 'timeFrame': '1 week since birth'}\n- {'measure': 'Transcutaneous bilirubin level', 'description': \"Infant's skin bilirubin level on the chest measured using a non-invasive devise called Drager meter. It will be measured in milligram per decilitre or micromole per liter. This outcome will be measured as a continuous outcome.\", 'timeFrame': '1 week of life (after birth)'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test, power 80%, significance level (\u03b1) 0.05, 1:1 allocation ratio, and a 20% dropout rate.", "answer": 94, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size in this protocol is calculated using the G*power V.3.1.9.4 statistical software.77 Due to the lack of previous studies on pregnant women targeting bilirubin level reduction in neonates, we used a previous study conducted to assess the effect of a probiotic on neonatal hyperbilirubinaemia by providing the lactobacillus RGG directly to neonates in Turkey to calculate our study sample size (PMID: 30968632).78 The effect size was calculated using mean, SD and sample size, which are the most common parameters to measure effect size. In the paper conducted in Turkey, the mean and SD of bilirubin level and the sample size were mentioned, and we took the third-day bilirubin measurement records. The effect size was computed as 0.663. Finally, the sample size is calculated using the following assumptions: Two tailed, power 80, effect size 0.663, \u00ce\u00b1=0.05, 1:1 allocation ratio. This yields about 74 (37 in each arm), and then we considered a 20% drop-out using the formula N=(n/1\u00e2\u0088\u0092DO). The final sample size, therefore, computed 94 (47 in each group).48 We have also calculated the sample size using a reduction of the incidence of neonatal jaundice in controls (p=46.6%) and in the probiotics group (p=14.6%) and yield (n=62; 31 in each group), which is smaller than the first sample size. To calculate this sample size, we used additional parameters (\u00ce\u00b1=0.05, power=0.8, enrolment ratio 1:1) and calculated using an online platform.79", "id": 1980, "split": "test"} +{"trial_id": "NCT06087952", "pmid": "38521524", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Leiden Thrombosis Recurrence Risk Prevention: Tailored Treatment After a First Venous Thromboembolism\n\nIncluded conditions:\n- Venous Thromboembolism\n- Venous Thromboses\n- Pulmonary Embolism\n- Deep Vein Thrombosis\n\nStudy Armgroups:\n- {'label': 'Continue anticoagulation', 'type': 'OTHER', 'description': 'Patients with high recurrent VTE risk and low major bleeding risks are advised to continue anticoagulant therapy.', 'interventionNames': ['Diagnostic Test: VTE-BLEED score', 'Diagnostic Test: L-TRRiP score', 'Other: Advise to continue anticoagulant treatment after 3 months']}\n- {'label': 'Discontinue anticoagulation', 'type': 'OTHER', 'description': 'Patients with low recurrent VTE risk are advised to discontinue anticoagulant therapy.', 'interventionNames': ['Diagnostic Test: VTE-BLEED score', 'Diagnostic Test: L-TRRiP score', 'Other: Advise to discontinue anticoagulant treatment after 3 months']}\n- {'label': 'Randomised to continue anticoagulation', 'type': 'OTHER', 'description': 'Patients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy.', 'interventionNames': ['Other: Randomised treatment advice (discontinue vs continue after 3 months)', 'Diagnostic Test: VTE-BLEED score', 'Diagnostic Test: L-TRRiP score']}\n- {'label': 'Randomised to discontinue anticoagulation', 'type': 'OTHER', 'description': 'Patients with intermediate recurrent VTE risk or high recurrent VTE risk and high major bleeding risk are randomised to continue or discontinue anticoagulant therapy.', 'interventionNames': ['Other: Randomised treatment advice (discontinue vs continue after 3 months)', 'Diagnostic Test: VTE-BLEED score', 'Diagnostic Test: L-TRRiP score']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Randomised treatment advice (discontinue vs continue after 3 months)', 'description': 'Randomisation to continue or discontinue anticoagulant therapy in 1:1 ratio stratified on risk category of L-TRRiP and VTE-BLEED score', 'armGroupLabels': ['Randomised to continue anticoagulation', 'Randomised to discontinue anticoagulation']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'VTE-BLEED score', 'description': 'Predict bleeding risk during extended anticoagulant treatment (high or low) using the VTE-BLEED score', 'armGroupLabels': ['Continue anticoagulation', 'Discontinue anticoagulation', 'Randomised to continue anticoagulation', 'Randomised to discontinue anticoagulation']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'L-TRRiP score', 'description': 'Predict VTE recurrence risk after anticoagulant discontinuation (high, intermediate or low) using the L-TRRiP score', 'armGroupLabels': ['Continue anticoagulation', 'Discontinue anticoagulation', 'Randomised to continue anticoagulation', 'Randomised to discontinue anticoagulation']}\n- {'type': 'OTHER', 'name': 'Advise to continue anticoagulant treatment after 3 months', 'description': 'Advise to continue anticoagulant treatment after 3 months for patients with high VTE recurrence and low bleeding risk', 'armGroupLabels': ['Continue anticoagulation']}\n- {'type': 'OTHER', 'name': 'Advise to discontinue anticoagulant treatment after 3 months', 'description': 'Advise to discontinue anticoagulant treatment after 3 months for patients with low VTE recurrence risk', 'armGroupLabels': ['Discontinue anticoagulation']}\n\nPrimary Outcomes:\n- {'measure': 'Recurrent VTE and major bleeding', 'description': 'Incidence of the combined endpoint recurrent VTE and major bleeding in the randomised arms', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nTo demonstrate a 7% absolute difference in the combined endpoint (10.6% vs 3.6%) with an alpha of 0.05 and a power of 90%, and accounting for a 10% drop-out rate.", "answer": 608, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size of this study is based on the randomised part of the study. Based on the estimated risks of recurrent VTE and major bleeding as observed in the derivation studies of both prediction models,17 33 we assume an overall 2-year recurrent VTE risk of 10% in the discontinuation arm of the randomised groups and a major bleeding risk of 0.6%. Assuming a reduction of the recurrent VTE risk of 85% by anticoagulant treatment, the recurrent VTE risk of the group that continues anticoagulant treatment will be 1.5%. Furthermore, we estimate this will lead to an increase in the overall risk of major bleeding to 2.1%. To demonstrate a 7% absolute difference in the combined endpoint (ie, 10.6% vs 3.6%) with an alpha of 0.05 and a power of 90%, we need a sample size of 552 subjects for the randomised part of the study. Taking into account a drop-out rate of 10%, we aim to include 608 patients in the randomised part of the study. Based on the derivation studies, we expect the randomised group to form about 38% of the total included population, in which case we expect to include approximately 1600 patients in total; 848 (53%) in the low VTE recurrence risk group and 144 (9%) in the high recurrence and low bleeding risk group.17 33 Of note, these numbers may change depending on the final proportion of the randomised group.", "id": 1981, "split": "test"} +{"trial_id": "NCT06088290", "pmid": "39932221", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma\n\nIncluded conditions:\n- Leiomyosarcoma\n\nStudy Armgroups:\n- {'label': 'Phase IIb (& Phase III if selected), Doxorubicin (dose A) + Lurbinectedin (dose B)', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive doxorubicin and lurbinectedin intravenously every three weeks (q3wk) on day 1 of each treatment cycle (treatment cycle = three weeks).', 'interventionNames': ['Drug: Lurbinectedin', 'Drug: Doxorubicin']}\n- {'label': 'Phase IIb (& Phase III if selected), Doxorubicin (dose C) + Lurbinectedin (dose D)', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive doxorubicin intravenously q3wk on day 1 of each treatment cycle (treatment cycle = three weeks).', 'interventionNames': ['Drug: Lurbinectedin', 'Drug: Doxorubicin']}\n- {'label': 'Phase IIb & Phase III, Doxorubicin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive doxorubicin intravenously q3wk on day 1 of each treatment cycle (treatment cycle = three weeks).', 'interventionNames': ['Drug: Doxorubicin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lurbinectedin', 'description': 'Intravenous Infusion', 'armGroupLabels': ['Phase IIb (& Phase III if selected), Doxorubicin (dose A) + Lurbinectedin (dose B)', 'Phase IIb (& Phase III if selected), Doxorubicin (dose C) + Lurbinectedin (dose D)']}\n- {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Short intravenous push or bolus (according to label)', 'armGroupLabels': ['Phase IIb & Phase III, Doxorubicin', 'Phase IIb (& Phase III if selected), Doxorubicin (dose A) + Lurbinectedin (dose B)', 'Phase IIb (& Phase III if selected), Doxorubicin (dose C) + Lurbinectedin (dose D)']}\n\nPrimary Outcomes:\n- {'measure': 'PFS by IRC', 'timeFrame': 'Up to approximately 28 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to show a difference in PFS in the metastatic setting with an improvement in median PFS in the order of 3-4 months or larger. A risk reduction of 40% is forecasted for the alternative hypothesis to have enough power to reject the null hypothesis.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "3.10.\n Planned sample size\n SaLuDo is a global phase IIb/III trial being conducted in more than 70 sites in the USA and Europe. Trial enrollment started in September 2023. The prospective assumption is a 40.0% decrease in the risk of progression or death to be achieved with the experimental arm (hazard ratio [HR]\u00e2\u0080\u0089=\u00e2\u0080\u00890.6). PFS for the control arm is expected to be around six months based on data from study LMS-04 (PFS by IRC of 6.2\u00e2\u0080\u0089months in the control arm, DOX alone) [9]. Lurbinectedin is a novel compound closely related to trabectedin. According to the Answers from the Committee for Medicinal Products for Human Use (CHMP) Scientific Advisory Group for Oncology for Revision of the anticancer guideline \u00e2\u0080\u009cwhen designing studies aiming to show a difference in PFS in the metastatic setting, if the prognosis is in the order of 2\u00e2\u0080\u00933\u00e2\u0080\u0089years OS or less, an improvement in median PFS in the order 3\u00e2\u0080\u00934\u00e2\u0080\u0089months or larger is considered adequate.\u00e2\u0080\u009d With a reasonable timeframe and an affordable required number of events, a risk reduction of 40% is forecasted for the alternative hypothesis to have enough power to reject the null hypothesis.\n The study is planned to enroll 360 patients overall. One of the two experimental arms will be dropped at the end of the phase IIb based on an efficacy interim analysis performed when\u00e2\u0080\u0089~\u00e2\u0080\u008963 PFS events have occurred; the IDMC recommendation will be binding. This is anticipated after approximately 192 patients have been recruited to the three treatment arms. Selection rules to choose the investigational arm at the efficacy interim analysis by the IDMC will be based on both safety and efficacy. If both experimental arms pass the futility rules, a risk-benefit measure will be calculated using a generalized pairwise comparison between experimental arms.\n Recruitment will not be put on hold during the conduct of this interim analysis and no claim for superiority in efficacy between any of the experimental arms against the control arm will be performed (Figure 1). After this interim analysis, approximately 168 additional patients will be enrolled in the second stage (phase III) and randomized to the selected experimental arm and the control arm at an equal 1:1 allocation ratio to complete the target number of 360 patients.", "id": 1982, "split": "test"} +{"trial_id": "NCT06100835", "pmid": "39067876", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enjoy Physical Activity to Battle Sedentary Behaviour and Inactivity Among Older Adults From a Socially Inclusive Perspective (JOIN4JOY).\n\nIncluded conditions:\n- Physical Inactivity\n- Sedentary Behavior\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Complex intervention involving physical activity and behaviour change techniques', 'description': \"The intervention protocol derives from a previous, extensive, co-creation phase involving end-users as well as relatives, experts, professionals working working with older adults, university students and researchers.\\n\\nIt will be based on a structured group-based PA programme supervised by trained professionals, tailored to participants' needs to include joyful components combined with self-management strategies to encourage behaviour change also beyond the sessions. All participants (including end-users but not only) will also be encouraged to join virtual communities of practice (VCoP) for further support and knowledge exchange.\"}\n\nPrimary Outcomes:\n- {'measure': 'Self-reported Physical activity', 'description': 'measured with de Physical Activity Questionnaire (IPAQ) - Short Form.', 'timeFrame': 'Before (week 0) and after (week 13)'}\n- {'measure': 'Physical activity level', 'description': 'Measured via Accelerometry . For 7 consecutive days before, and 7 consecutive days after the JOIN4JOY PA programme.', 'timeFrame': 'Before (week 0) and after (week 13)'}\n- {'measure': 'Sedentary Behavior', 'description': 'Assessed via the Sedentary Behaviour Questionnaire (SBQ),', 'timeFrame': 'Before (week 0) and after (Week 13)'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size is considered large enough to inform about the practicalities of recruitment, delivery, and assessment.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size\n A specific sample size calculation based on a primary outcome measure has not been deemed necessary. A pragmatic sample size of at least 144 end-users (72 nursing home residents and 72 living in the community) has been estimated. It is the result of two consecutive groups of 12 end-users, per each of the six intervention sites, and it has been considered as a large enough sample to inform about the practicalities of recruitment, delivery and assessment.", "id": 1983, "split": "test"} +{"trial_id": "NCT06101511", "pmid": "39456048", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial\n\nIncluded conditions:\n- Postoperative Complications\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Individualized high PEEP strategy with recruitment maneuvers', 'type': 'EXPERIMENTAL', 'description': \"The intervention is intraoperative ventilation using the available ventilator with individualized high positive end-expiratory pressure (PEEP) titrated to the lowest driving pressure (\u0394P) with recruitment maneuvers (RMs). After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial.\", 'interventionNames': ['Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest \u0394P with RMs']}\n- {'label': 'Standard low PEEP strategy without recruitment maneuvers', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized to the standard low PEEP group will receive 5 cm H2O PEEP for the complete duration of general anesthesia. They will neither receive one of the planned RMs nor a decremental PEEP trial.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Intraoperative ventilation with individualized high PEEP titrated to the lowest \u0394P with RMs', 'description': \"The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest \u0394P with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial\", 'armGroupLabels': ['Individualized high PEEP strategy with recruitment maneuvers'], 'otherNames': ['Individualized high PEEP strategy with recruitment maneuvers']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants developing one or more postoperative pulmonary complications (PPCs)', 'description': 'A composite of the following pulmonary complications: mild respiratory failure; severe respiratory failure; bronchospasm; suspected pulmonary infection; pulmonary infiltrate; aspiration pneumonitis; atelectasis; acute respiratory distress syndrome (ARDS); pleural effusion; cardiopulmonary edema; pneumothorax', 'timeFrame': 'The first 5 postoperative days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, alpha of 0.05, and a dropout rate of 5%.", "answer": 1806, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The required sample size is calculated based on an estimated effect size derived from individual patient data from previous clinical trials [6, 21, 22]. Based on a recently published randomized clinical trial [15], we conservatively estimate an incidence of PPCs of 30% in the standard low PEEP without RMs group. To have a power of 80% to detect a relative risk reduction in the incidence of PPCs of 20% (24% vs 30%), given an alpha of 0.05, 860 patients in each group are needed. Assuming a dropout rate of 5%, 903 patients per group are needed, resulting in a total sample size of 1806 patients.", "id": 1984, "split": "test"} +{"trial_id": "NCT06101992", "pmid": "39623365", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Double-blind Controlled Clinical Trial: the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease\n\nIncluded conditions:\n- Hemorrhoids\n\nStudy Armgroups:\n- {'label': 'Mesoglycan', 'type': 'ACTIVE_COMPARATOR', 'description': 'According to randomization, patients will take mesoglycan mg 50 (heparan sulphate 47.5%, dermathan sulphate 35.5%, chondroitin sulfate 8.5%,slow heparin 8.5%, excipients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine) 4 capsules/day for 5 days and 2 capsules/day for 35 days', 'interventionNames': ['Drug: Mesoglycan']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'According to randomization, patients will take placebo (lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate) 4 capsules/day for 5 days and 2 capsules/day for 35 days', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mesoglycan', 'description': 'Mesoglycan capsules 50 mg are composed by heparan sulphate 47.5%, dermathan sulphate 35.5%, chondroitin sulfate 8.5%,slow heparin 8.5%, excipients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine', 'armGroupLabels': ['Mesoglycan'], 'otherNames': ['MES']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'placebo capsules are composed by lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate', 'armGroupLabels': ['Placebo'], 'otherNames': ['PLA']}\n\nPrimary Outcomes:\n- {'measure': 'Symptoms relief', 'description': 'According to the validated Hemorrhoidal Disease Symptom Score (from 0: no symptoms to 20: symptoms occurring every day), score reduction will be evaluated', 'timeFrame': '40 days'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 0.05, a two-tailed t-test with 90% power, and an expected drop-out rate of approximately 10%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The trial aims to enroll a total of 50 patients (25 patients in each treatment group). This sample size is based on an assumed between-group difference in HDSS score of 1.8 points with a standard deviation (SD) of 1.7 (based on results of previous studies [31, 32]), an alpha of 0.05, and a two-tailed t-test with 90% power to reject the null hypothesis (i.e., the averages of the two treatment groups are equal) and an expected drop-out rate of approximately 10%.", "id": 1985, "split": "test"} +{"trial_id": "NCT06102590", "pmid": "39532348", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.\n\nIncluded conditions:\n- Blood Transfusion\n\nStudy Armgroups:\n- {'label': 'Individualized RBCT', 'type': 'EXPERIMENTAL', 'description': 'Requires daily assessment of hemoglobin (Hb) levels. Prescription of RCBT is restricted to patients who present Hb \u2264 9.0 g/dL and O2ER \u2265 30%. If O2ER \\\\< 30%, transfusion will take place only when Hb falls below 7.0 g/dL. Further O2ER measurements during the day in this group are allowed, and the clinician should not be blinded of the results. To tolerate Hb levels below 7.0 g/dL with O2ER \\\\< 30% remains a clinical decision, documented in the CRF. Transfusion with Hb below 6.0 g/dL is mandatory', 'interventionNames': ['Other: Individualized red blood cell transfusion strategy']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Requires daily assessment of hemoglobin levels. Prescription of RCBT is restricted to patients who present Hb \u2264 7.0 g/dL, despite of O2ER values. Indeed, O2ER calculation takes place at least once daily in this group but does not interfere with clinical decision to prescribe RBCT. A liberal transfusion threshold (i.e. 9.0 g/dL) is still possible in critically ill adults with acute coronary syndromes, as indicated by the European current guidelines', 'interventionNames': ['Other: European guidelines red blood cell transfusion strategy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Individualized red blood cell transfusion strategy', 'description': 'Prescription of RCBT is restricted to patients who present Hb \u2264 9.0 g/dL and O2ER \u2265 30%.', 'armGroupLabels': ['Individualized RBCT']}\n- {'type': 'OTHER', 'name': 'European guidelines red blood cell transfusion strategy', 'description': 'RBCT according to ESICM guidelines', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Acute Kidney Injury (AKI)', 'description': 'Primary outcome will be the incidence of AKI, according to KDIGO latest definitions', 'timeFrame': '7-day after study inclusion'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a statistical power of 0.8 and an overall alpha level of 0.05. It follows a group sequential design with an interim analysis planned at the midpoint of enrolment, involving 162 patients (81 per arm). The trial may be stopped early for efficacy if the interim analysis surpasses the O'Brien-Fleming boundary.", "answer": 324, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation for our upcoming study was based on the primary endpoint of the original study, which focused on differences in AKI rates between the individualised treatment group and the control group. For the study design computation, we considered a treatment effect corresponding to an absolute risk reduction of 13% of AKI. This reduction in AKI incidence was selected based on the findings of our previous observational study,11 where a comparable incidence rate was observed. The sample size calculation was based on an assumed event rate of 13% (\u00cf\u0080T) in the individualised treatment arm and 26% (\u00cf\u0080C) in the control arm. The required sample size for the trial to achieve a statistical power of 0.8 and an overall alpha level of 0.05 for detecting a difference in event rates is 324 patients (162 per arm).20\n The study follows a group sequential design, with an interim analysis planned at the midpoint of enrolment, involving 162 patients (81 per arm).21 The trial may be stopped early for efficacy if the interim analysis demonstrates an effect that surpasses the O\u00e2\u0080\u0099Brien-Fleming boundary, as outlined in the study design specifications in the Supplementary Material. The sample size was calculated using R V.4.3.122 with the pwr and gsDesign packages.", "id": 1986, "split": "test"} +{"trial_id": "NCT06102954", "pmid": "39695436", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Steps to Avoid Falls in the Elderly- A TECHnology Enhanced Intervention\n\nIncluded conditions:\n- Fall Prevention\n- Fall Injury\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': '12-weeks active intervention session includes exercise and educational components.\\n\\n9 months maintenance phase', 'interventionNames': ['Other: Falls prevention intervention including exercise and educational components']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'No intervention for 12 months during intervention period.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Falls prevention intervention including exercise and educational components', 'description': 'This includes five domains of exercise (strength, balance, flexibility, coordination, and endurance) and educational components to manage other falls risk factors (polypharmacy, nutrition, pain, orthostatic hypotension, poor vision and environmental hazard evaluations).', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Fallers', 'description': 'Evaluation of number of falls in 12 months', 'timeFrame': 'Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with a 5% level of significance, 80% power, and assumes a 20% drop-out rate.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n A nominal risk score cut-off will be selected based on the Youden\u00e2\u0080\u0099s index (i.e., finding a balance between both sensitivity and specificity values), such that approximately 50% of older adults with high fall risk are likely to fall in the next one year. The threshold for recruitment can be modified as falls outcomes are collected to maximize study power without interfering with the integrity of the randomization. We expect to find that the multi-component falls prevention program reduces the proportion of fallers by 31% after the 12-month intervention. Based on these assumptions, at 5% level of significance and 80% power, the total sample size calculated is 156 per arm. Assuming a 20% drop-out rate, a total of 390 participants is required for this study. As such, a total of 400 participants (200 in each arm) will be recruited into this study.", "id": 1987, "split": "test"} +{"trial_id": "NCT06104176", "pmid": "38937776", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study : a Multicenter Randomized Trial. Original Title in French : \u00e9tude de l'efficacit\u00e9 de la R\u00e9alit\u00e9 Virtuelle Dans le Traitement du Trouble de l'Usage d'Alcool : un Essai randomis\u00e9 Multicentrique (e-R\u00e9va)\n\nIncluded conditions:\n- Alcool Use Disorder\n\nStudy Armgroups:\n- {'label': 'CBT group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: CBT in group', 'Behavioral: individual CBT']}\n- {'label': 'VRET group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: CBT in group', 'Other: Virtual reality exposure']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CBT in group', 'description': 'All subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month.\\n\\nVRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.', 'armGroupLabels': ['CBT group', 'VRET group']}\n- {'type': 'OTHER', 'name': 'Virtual reality exposure', 'description': 'll subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month.\\n\\nVRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.', 'armGroupLabels': ['VRET group']}\n- {'type': 'BEHAVIORAL', 'name': 'individual CBT', 'description': 'll subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month.\\n\\nVRET consists on 4 weekly sessions (one per week, for 1 month) of 60 to 90 minutes duration. Each session, consists in 20 to 30 minutes exposure with 10 minutes breaks (2 to 3 exposure per session). Four environments will be used: The home environment, the metro advertising environment , the party environment, and the supermarket environment. Each session corresponds to one environment, previously ordered according to their difficulty for the patient.', 'armGroupLabels': ['CBT group']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative number of alcohol standard drinks', 'description': 'Cumulative number of alcohol standard drinks 8 months after inclusion assessed by the Timeline Follow-Back method (Sobell \\\\& Sobell, 1992).', 'timeFrame': 'monthly until 8 months after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 0.8, significance level (\u00ce\u00b1) of 0.05 with a two-sided hypothesis, and a dropout rate of 20%.", "answer": 156, "answer_type": "ESTIMATED", "explanation": "Sample size\n To determine the number of participants needed for the study, we randomly selected 15 patients with alcohol-related disorders (AUD) who were already being treated at the Albert Chenevier Day Hospital's addiction department. Their cumulative alcohol consumption was monitored at two, five and eight months after admission to estimate the average daily consumption over eight months. The target consumption was calculated on the basis of the recommendations of the European Medicines Agency [39], aiming at a reduction of at least two risk levels according to the World Health Organization. To achieve a statistical power of 0.8, considering a risk \u00ce\u00b1 of 0.05 with a two-sided hypothesis, 65 patients per group are required. Assuming a drop-out rate of 20%, 78 patients per group need to be recruited, for a total of 156 patients for both groups. See Table 2 for recruitment procedure. \nTable 2Recruitment proceduresNumber of subjectsTotal number of subjects selected156Number of centers4Inclusion period (months)24", "id": 1988, "split": "test"} +{"trial_id": "NCT06106204", "pmid": "38439076", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Parallel Cluster Randomized Trial of a Participatory Approach to Reduce Overuse of Antibiotics at Hospital Discharge: The ROAD Home Trial\n\nIncluded conditions:\n- Pneumonia\n- Urinary Tract Infection\n- Antibiotic Stewardship\n- Care Transition\n\nStudy Armgroups:\n- {'label': 'ROAD Home Intervention', 'type': 'EXPERIMENTAL', 'description': 'Hospitals randomized to receive the ROAD Home Intervention will receive an implementation intervention that includes external facilitation to support them in selecting and implementing evidence-based antibiotic stewardship strategies based on local context and the ROAD Home framework (https://academic.oup.com/cid/article/74/9/1696/6374407).', 'interventionNames': ['Other: ROAD Home Intervention']}\n- {'label': 'Stewardship as Usual', 'type': 'NO_INTERVENTION', 'description': 'Hospitals randomized to the control group will continue usual antibiotic stewardship activities. Although control hospitals are part of the HMS collaborative, during the intervention period they will not receive any of the ROAD Home Intervention components including analysis of their baseline data or needs assessment, customized suite of stewardship strategies, supported decision-making in selecting ROAD Home strategies to implement, an implementation blueprint, adaptable stewardship tools, or external facilitation from study investigators.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ROAD Home Intervention', 'description': 'Hospitals randomized to receive the ROAD Home Intervention will undergo (1) a baseline needs assessment to create a customized suite of stewardship strategies, (2) supported decision-making in selecting ROAD Home strategies to implement, and (3) external facilitation following an implementation blueprint.', 'armGroupLabels': ['ROAD Home Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Days of antibiotic overuse at hospital discharge', 'description': 'Antibiotic overuse at discharge is a composite score of unnecessary antibiotic use, excessive antibiotic duration, and avoidable fluoroquinolones. The score is number of days of antibiotic overuse at hospital discharge.', 'timeFrame': '12 months; from discharge prescription'}\n\nPlease estimate the sample size based on the assumption: \nIntraclass correlation coefficient (ICC) of 0.03 to 0.035, 400 patients per hospital per year, negative binomial regression used for power estimation, 80 to >90% power to detect MCID, and >90% power to detect minimum plausible effect size.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n Over the study period, we anticipate including ~\u00e2\u0080\u00898000 patients in the intervention arm and ~\u00e2\u0080\u00898000 patients in the \u00e2\u0080\u009cusual stewardship\u00e2\u0080\u009d control arm (~\u00e2\u0080\u0089400 patients/hospital/year). We estimated sample size and power based on the number of clusters (20 per arm) and using previously published data on antibiotic overuse at discharge, including in HMS hospitals [11, 35, 62], which found (a) baseline 2.2\u00c2\u00a0days of antibiotic overuse at discharge per patient (or 4.4\u00c2\u00a0days per patient with overuse); (b) an intraclass correlation coefficient (ICC) for our primary outcome (days of antibiotic overuse at discharge) of 0.03 to 0.035; and (c) the average number of patients included per hospital per year (400). Estimates of effect size were determined based on the minimal clinically important difference (MCID) needed to improve distal public health outcomes (20%) [63\u00e2\u0080\u009366] and plausible intervention effect size (24.8\u00e2\u0080\u009340%) [15\u00e2\u0080\u009317, 19, 67]. Given a high number of zeros (i.e., many patients with no antibiotic overuse at discharge), we used a negative binomial regression to estimate power. Under these conditions, a baseline-adjusted cluster randomized trial with 40 hospitals would have 80 to\u00e2\u0080\u0089>\u00e2\u0080\u008990% power (depending on ICC estimate) to detect the MCID (a 20% absolute difference in days of antibiotic overuse at discharge) and\u00e2\u0080\u0089>\u00e2\u0080\u008990% power to detect the minimum plausible effect size (a 24.8% difference).", "id": 1989, "split": "test"} +{"trial_id": "NCT06110312", "pmid": "39605055", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study Protocol for an International Pragmatic Randomised Controlled Trial of the NavCare-EU Intervention for Older People With Cancer and Their Family Caregivers\n\nIncluded conditions:\n- Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative\n\nStudy Armgroups:\n- {'label': 'intervention group', 'type': 'EXPERIMENTAL', 'description': 'In EU NAVIGATE, participants in the intervention group will receive a navigation intervention (also called NavCare-EU), alongside any usual care. Navcare-EU is a person- and family-centered navigation intervention, aimed at supporting older people with cancer throughout the care and illness continuum, via the involvement of a patient/family navigator. Navigators focus on connecting clients to social supports, both formal and informal, advocating for clients in meeting their quality-of-life goals, resourcing by identifying needs and negotiating access to meeting those needs, and engaging clients in what is most meaningful to them. Navigators are selected, trained, and mentored volunteers or professionals. NavCare-EU is based on the existing and successfully tested Nav-CARE(c) intervention from Canada.', 'interventionNames': ['Behavioral: NavCare-EU']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will receive what is usual care in each of the participating countries for 24 weeks (primary trial outcome). After 24 weeks, they will also receive the navigation intervention (NavCare-EU) (fast-track RCT).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'NavCare-EU', 'description': 'NavCare-EU is a person- and family-centered intervention in which navigators collaborate with older persons and their close family caregivers across the continuum of supportive, palliative, and end-of-life care,. NavCare-EU is based on the existing and successfully tested Nav-CARE intervention from Canada. Navigators focus on connecting clients to social supports, both formal and informal, advocating for clients in meeting their quality-of-life goals, resourcing by identifying needs and negotiating access to meeting those needs, and engaging clients in what is most meaningful to them. Navigators are selected, trained, and mentored volunteers or professionals. NavCare-EU is based on the existing and successfully tested Nav-CARE(c) intervention from Canada.', 'armGroupLabels': ['intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Global health status/quality of life of the older person with cancer', 'description': 'Global health status/quality of life of the older person with cancer, measured with 2-item subscale from the EORTC-QLQ-C30 (revised) measuring health-related quality of life.', 'timeFrame': 'Change from baseline at 24 weeks.'}\n- {'measure': 'Levels of social support of the older person with cancer', 'description': 'Levels of social support of the older person with cancer measured with the Medical Outcomes Study Social Support Survey (MOS)', 'timeFrame': 'Change from baseline at 24 weeks.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided 2.5% significance level, intra-cluster correlation (ICC) of 0.10, and a drop-out rate of 50% (17.5% due to mortality, 32.5% due to other reasons).", "answer": 489, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n To achieve at least 80% power to detect a mean difference between groups of 10 points in patient\u00e2\u0080\u0099s global health status/quality of life (considered the smallest clinically relevant difference in the mean score of EORTC QLQ-C30) [30] using an analysis of covariance (ANCOVA) adjusted for baseline global health status/quality of life, at the two-sided 2.5% significance level assuming a standard deviation of 25 points [30] and a correlation of 0.3 between baseline and 24\u00c2\u00a0weeks, a total sample size of 220 clients is needed with a balanced design (allocation ratio 1:1). Taking into account the partially nested study design (there is a cluster effect of navigators in the intervention group), 115 patients in the control group and 131 patients in the intervention group (246 in total) is most efficient, assuming on average 1.5 patients per navigator in Belgium (Flanders), Ireland, Italy, the Netherlands, and Portugal (recruiting 5/6 of all patients), and 10 patients per navigator in Poland (recruiting 1/6 of all patients), and an intra-cluster correlation (ICC) of 0.10. An ICC of 0.1 was chosen as a conservative estimate as there is currently no empirical data to support an exact estimate of the ICC.\n We will continue randomization until 246 patients have completed the primary endpoint at 24\u00c2\u00a0weeks, with a predetermined maximum sample size set at 489 patients (229 subjects in the control group and 260 subjects in the intervention group). This maximum sample size will allow for a drop-out rate of 50% (17.5% due to mortality, 32.5% due to other reasons) [7, 12, 13]. The sample size calculation was performed using SAS software (version 9.4) and is based on the methods of Moerbeek and Wong [31].", "id": 1990, "split": "test"} +{"trial_id": "NCT06118034", "pmid": "39266309", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial\n\nIncluded conditions:\n- Inflammatory Response\n- Cardiac Disease\n\nStudy Armgroups:\n- {'label': 'Experimental group (colchicine group)', 'type': 'EXPERIMENTAL', 'description': 'The experimental group take 0.5mg of colchicine tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.', 'interventionNames': ['Drug: Colchicine 0.5 MG']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group take 0.5mg of placebo tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Colchicine 0.5 MG', 'description': 'Take 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.', 'armGroupLabels': ['Experimental group (colchicine group)'], 'otherNames': ['Routine cardiovascular surgery and peri-operative management']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Take 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.', 'armGroupLabels': ['Control group'], 'otherNames': ['Routine cardiovascular surgery and peri-operative management']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants with POAF', 'description': 'POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery.', 'timeFrame': 'postoperative 10 days'}\n- {'measure': 'Number of Participants with PMI', 'description': \"PMI: Patient's high-sensitivity cardiac troponin T (hs-cTnT) exceeds 0.8 ng/L on the first day after surgery, and there is an increase of 10% or more on the second day compared to the first day postoperatively.\", 'timeFrame': 'postoperative 10 days'}\n- {'measure': 'Number of Participants with ARDS', 'description': 'ARDS: Acute Respiratory Distress Syndrome', 'timeFrame': 'postoperative 10 days'}\n- {'measure': 'Number of Participants with PPS', 'description': 'PPS: post-pericardiotomy syndrome', 'timeFrame': 'postoperative 10 days'}\n\nPlease estimate the sample size based on the assumption: \nBilateral effects \u03b1=0.0125, confidence level of 80%, and a 15% loss of follow-up or refusal of follow-up.", "answer": 768, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This study is a multicentre, randomised, double-blind, placebo-controlled clinical trial. The composite outcome indicators assessed in the study include POAF, ARDS, PMI and PPS. Previous literature indicates that the incidence rates of these outcomes after cardiac surgery are approximately 60% for POAF,3438 16% for ARDS,32 39 40 32% for PMI41 and 29% for PPS.42 43 Therefore, the sample size for this trial will be calculated based on the reported incidence rates from the literature. Assuming that colchicine can reduce the incidence of these outcomes by 30%, with a bilateral effects \u00ce\u00b1=0.0125\u00e2\u0080\u0089and a confidence level of 80%, the sample size for the treatment group (N1) was calculated to be 167 cases, and the sample size for the control group (N2) was calculated to be 167 cases.22 25 44 Accounting for a potential 15% loss of follow-up or refusal of follow-up, a minimum of 192 study subjects were required. Using a stratified block randomisation method, 192 cases were allocated to each group (CABG-colchicine treatment, CABG-control group, non-CABG-control treatment and non-CABG-colchicine treatment), resulting in a total of at least 768 study subjects included in the study.", "id": 1991, "split": "test"} +{"trial_id": "NCT06118775", "pmid": "39117412", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa F\u00e9 Foundation in Bogot\u00e1\n\nIncluded conditions:\n- Septic Shock\n\nStudy Armgroups:\n- {'label': 'EaDyn weaning arm', 'type': 'EXPERIMENTAL', 'description': 'In the EaDyn weaning arm of the study, dynamic arterial elastance (EaDyn) will be utilized as a specialized hemodynamic tool to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. EaDyn, a measure of the relationship between arterial pressure and stroke volume variation over the cardiac cycle, provides valuable insights into vascular tone and cardiac performance', 'interventionNames': ['Procedure: EaDyn Weaning Arm:']}\n- {'label': 'PAM weaning arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the PAM (Mean Arterial Pressure) weaning arm of the study, mean arterial pressure (MAP) will be used as the primary parameter to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. Mean arterial pressure represents the average pressure in the arteries during one cardiac cycle and is a crucial indicator of perfusion to vital organs. Participants in this group will be monitored continuously for their MAP values, allowing real-time assessment of their hemodynamic status.', 'interventionNames': ['Procedure: PAM Weaning Arm:']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'EaDyn Weaning Arm:', 'description': 'The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP \\\\>75 mmHg, a cardiac index (CI) \\\\>2.5 L/min/m\u00b2, and a lactate level \\\\<2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the experimental group, vasopressor weaning is guided by the EaDyn value. Weaning can proceed as long as the EaDyn remains at or above 0.90. However, if the value drops below 0.90, the weaning process halts, and the norepinephrine dose is reverted to the last dose where the EaDyn value was \u2265 0.90. Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study. Should the MAP range between 50 mmHg and 69 mmHg, a fluid challenge of 250 mL of isotonic crystalloid must be administered before weaning continues.', 'armGroupLabels': ['EaDyn weaning arm']}\n- {'type': 'PROCEDURE', 'name': 'PAM Weaning Arm:', 'description': \"The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP \\\\>75 mmHg, a cardiac index (CI) \\\\>2.5 L/min/m\u00b2, and a lactate level \\\\<2 mmol/L. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg/kg/min every 30 minutes. In the control group, vasopressor weaning progresses as long as the MAP remains at or above 70 mmHg. If the MAP falls between 50 and 69 mmHg, preload dependency is reassessed. Upon confirmation, a new fluid challenge is administered; vasopressor weaning halts, and the vasopressor dose reverts to its prior value. The weaning process can continue as long as the patient's MAP remains above 50 mmHg. If the MAP drops below this threshold, the patient exits the study.\", 'armGroupLabels': ['PAM weaning arm']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of vasopressor support', 'description': 'Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error of 0.05, beta error of 0.8, and a 10% loss rate.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size estimation was based on the results published by Ibarra-Estrada et al.16 They found that the mean duration of vasopressor support in septic shock patients was 97 (\u00c2\u00b169) hours. Considering a 24-hour reduction as clinically important, given an alpha error of 0.05 and a beta error of 0.8, we estimated the sample size according to the following formula:\n \n\nn0=2(Z\u00ce\u00b1+Z\u00ce\u00b2)2\u00c3\u0097S2d2\n\n\n where n0 is the sample size, Z\u00ce\u00b1 is the z value for a one-tailed alpha error of 0.05 (1.64), Z\u00ce\u00b2 is the z value for a beta error of 0.80 (0.842), S is the SD (69 hours) and d is the desired difference to detect (24 hours). By replacing these values in the formula, a total of 103 patients are required to answer the main objective. Considering a 10% loss, 114 patients will be recruited, for a total of 57 patients per group.", "id": 1992, "split": "test"} +{"trial_id": "NCT06121947", "pmid": "39384245", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparative Study of the Efficacy and Safety of Deep Brain Stimulation Versus Vagal Stimulation for Post-stroke Hemiplegia: Study Protocol for a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Stroke Sequelae\n- Deep Brain Stimulation\n- Vagus Nerve Stimulation\n- Motor Recovery\n- Stroke\n- Hemiplegia\n\nStudy Armgroups:\n- {'label': 'The DBS electrodes are implanted into MLR.', 'type': 'EXPERIMENTAL', 'description': \"The DBS electrodes are implanted into MLR.MLR-DBS#Deep brain stimulation of the mesencephalic locomotor region#The arm will be switched on one month postoperatively for electrical stimulation therapy, exercise training rehabilitation, and EMG-triggered neuromuscular stimulation. Specialist doctors will assess the patient's rehabilitation status through the telerehabilitation system every week, and provide, and guide on rehabilitation training and electrical stimulation therapy. Device: GPi-DBS devices DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China); Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).\", 'interventionNames': ['Procedure: The DBS electrodes are implanted into MLR.']}\n- {'label': \"The electrodes are implanted into the patient's vagus nerve\", 'type': 'ACTIVE_COMPARATOR', 'description': \"The electrodes are implanted into the patient's vagus nerve. A pre-surgery assessment was performed. Device implantation was done under general anesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunneled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region\", 'interventionNames': [\"Procedure: The electrodes are implanted into the patient's vagus nerve\"]}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'The DBS electrodes are implanted into MLR.', 'description': \"MLR-DBS#Deep brain stimulation of the mesencephalic locomotor region#The arm will be switched on one month postoperatively for electrical stimulation therapy,exercise training rehabilitation and EMG-triggered neuromuscular stimulation. Specialist doctors will assess the patient's rehabilitation status through the telerehabilitation system every week, and provide guidance on rehabilitation training and electrical stimulation therapy.\", 'armGroupLabels': ['The DBS electrodes are implanted into MLR.']}\n- {'type': 'PROCEDURE', 'name': \"The electrodes are implanted into the patient's vagus nerve\", 'description': 'A pre-surgery assessment was performed. Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region', 'armGroupLabels': [\"The electrodes are implanted into the patient's vagus nerve\"]}\n\nPrimary Outcomes:\n- {'measure': 'Motor function intervention effect: Fugl-Meyer Assessment Scale (FMA)', 'description': 'Fugl-Meyer Assessment Scale (FMA) was used to measure the motor function of stroke patients. FMA is widely used in clinical motor function assessment and is a quantitative stroke-specific scale used to assess motor function, balance, sensory and joint function in hemiplegic patients. Each of the five domains contains different assessment items, which are scored on a 3-point scale: 0 = unable to perform. 1 = Partially performed, 2 = Fully performed This scale has been found to have good validity and reliability in the stroke population . There are 17 items in total, and the higher the score, the better the motor function.', 'timeFrame': 'Up to 1.5 year postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided hypothesis test with a significance level of 5%, power of 90%, and an anticipated dropout rate of 20%.", "answer": 98, "answer_type": "ESTIMATED", "explanation": "Sample size\n Statistical experts recommended a 1:1 ratio for the experimental and control groups. Based on the literature review, we observed that VNS for poststroke motor dysfunction yields a higher FMA-UE score compared with the control group (VNS: 5.8\u00c2\u00b16.0, Control: 2.8\u00c2\u00b15.2; p=0.008, difference: 2.96, 95%\u00e2\u0080\u0089CI: 0.83 to 5.08). For DBS in poststroke motor dysfunction, FMA-UE scores showed no significant decrease from baseline on surgical implantation. However, combining DBS stimulation with rehabilitation training further boosted scores by 7 points (p=0.0005). As DBS effects waned, scores stabilised, indicating long-term benefits.\n In summary, the average Fugl-Meyer score improvement ranged from 2.96 to 7.00 for VNS and DBS, with a midpoint of 4.98 used for sample size estimation. This study aims to detect differences in mean scores between the experimental (u1) and control (u2) groups using a two-sided hypothesis test (H0: u1\u00e2\u0088\u0092u2=0, H1: u1\u00e2\u0088\u0092u2\u00e2\u0089\u00a00). With a significance level of 5%, power of 90%, and an anticipated dropout rate of 20%, PASS V.15 software calculated a total sample size of 48 (24 per group).5964 Furthermore, to account for potential electrode implantation bias and the need for four groups, enrolling 64 patients\u00e2\u0080\u009432 in each group\u00e2\u0080\u0094would ensure a balanced group size by the previous conclusion. Drawing from DBS-MLR, we are confident that this sample size will yield clinically meaningful results, fulfilling the objectives.65 66", "id": 1993, "split": "test"} +{"trial_id": "NCT06123169", "pmid": "39169298", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent\n\nIncluded conditions:\n- Pancreaticoduodenectomy\n- Antibiotherapy\n\nStudy Armgroups:\n- {'label': 'Broad spectrum antibioprophylaxis', 'type': 'ACTIVE_COMPARATOR', 'description': 'Antibioprophylaxis with Piperacillin-tazobactam during DPC.', 'interventionNames': ['Drug: Antibioprophylaxis (Piperacillin-tazobactam)']}\n- {'label': 'Broad spectrum antibiotherapy', 'type': 'EXPERIMENTAL', 'description': '5 days Antibiotherapy (Piperacillin-tazobactam) from surgery.', 'interventionNames': ['Drug: 5 days Antibiotherapy (Piperacillin-tazobactam)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Antibioprophylaxis (Piperacillin-tazobactam)', 'description': 'antibiotic prophylaxis during surgery', 'armGroupLabels': ['Broad spectrum antibioprophylaxis'], 'otherNames': ['Control arm']}\n- {'type': 'DRUG', 'name': '5 days Antibiotherapy (Piperacillin-tazobactam)', 'description': '5 days Antibiotherapy from surgery', 'armGroupLabels': ['Broad spectrum antibiotherapy'], 'otherNames': ['experimental arm']}\n\nPrimary Outcomes:\n- {'measure': 'presence of an organ/space SSI', 'description': \"The primary End Point is the presence of an organ/space SSI determined according to the Centers for Disease Control and Prevention's national nosocomial infections surveillance system. Organ/space SSIs include postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.\", 'timeFrame': '90 days after the surgery'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% two-sided type I error rate, rare protocol deviations and losses to follow-up", "answer": 326, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n Assuming a frequency of SSI equal to 33.9% in the 5-day ATB group vs. 51.6% in the standard group (same difference as the one found by Okamura, PMID: 28,371,248) [12], 90% power and a 5% two-sided type I error rate for a chi-square test, the sample size will be 163 patients per group (326 total). Protocol deviations and losses to follow-up may reduce the statistical power, but they are expected to be rare.\n In daily surgical practice, pancreaticoduodenectomy represents approximately 80% of pancreatic resections. For the last French clinical trial (PREFIPS, NCT03000946), 654 patients with PD were included during 24 months in 16 French referral centers for pancreatic surgery, ensuring the feasibility of the study in terms of recruitment.", "id": 1994, "split": "test"} +{"trial_id": "NCT06124716", "pmid": "38977368", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Collaboration Oriented Approach to Controlling High Blood Pressure\n\nIncluded conditions:\n- Hypertension\n- Multiple Chronic Conditions\n\nStudy Armgroups:\n- {'label': 'Enhanced COACH', 'type': 'EXPERIMENTAL', 'description': 'Enhanced blood pressure management recommendations that use cognitive and behavioral science to increase the likelihood of self-management goal setting to lower blood pressure. The CDS tool allows participant access to BP visualizations, reminders, and affectively tailored messaging about blood pressure management.', 'interventionNames': ['Other: Enhanced COACH CDS Tool']}\n- {'label': 'Usual Care COACH', 'type': 'ACTIVE_COMPARATOR', 'description': 'Equivalent of usual care delivered through the CDS tool: Blood pressure management with basic information, reduced reminders, and no affective alerts.', 'interventionNames': ['Other: Usual Care COACH CDS Tool']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Enhanced COACH CDS Tool', 'description': 'CDS tool with features to promote high blood pressure management', 'armGroupLabels': ['Enhanced COACH']}\n- {'type': 'OTHER', 'name': 'Usual Care COACH CDS Tool', 'description': 'CDS tool with limited features to promote high blood pressure management', 'armGroupLabels': ['Usual Care COACH']}\n\nPrimary Outcomes:\n- {'measure': 'Blood Pressure Control', 'description': 'Percent of participants at or below 140/90 (office BP) or 135/85 (home BP) average.', 'timeFrame': 'Up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05 (two-sided) and a power of 90% are assumed. The sample size accounts for attrition and uncertainty in projected changes.", "answer": 550, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n The number of participants we plan to enrol and randomise is 550 across all three sites. We anticipate that 40% of participants will come from OHSU (n=225), 40% from MU (n=225) and 20% (n=100) from VUMC. Actual enrolment may differ, and enrolment will continue until 550 participants are randomised.\n The total sample size was determined based on a test of two independent proportions (per cent with controlled BP at the end of the trial) assuming a level of significance equal to 0.05 (two sided) and power equal to 90%. We anticipate the intervention arm will increase from 0% controlled at baseline to 40% at 6 months while the control arm will increase from 0% to 25%. Under these assumptions, 406 evaluable participants are required, meaning those with complete data at the 6-month time point. We increased the total enrolment projection to account for attrition and/or uncertainty in projected changes.", "id": 1995, "split": "test"} +{"trial_id": "NCT06125093", "pmid": "39033111", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial\n\nIncluded conditions:\n- Genetic Syndrome\n- Language Development\n- Autism or Autistic Traits\n- Parenting\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Those in the intervention group will participate in a weekly group-based online intervention for approximately 6 months (Incredible Years-Autism Spectrum and Language Delays Parent Program, IY-ASLD\u00ae).\\n\\nFamilies allocated to the intervention group will also receive treatment as usual (TAU).', 'interventionNames': ['Behavioral: Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD\u00ae)']}\n- {'label': 'Treatment as usual (TAU) group', 'type': 'NO_INTERVENTION', 'description': \"The TAU condition involves outpatient appointments with different paediatric specialists in the hospitals of the 3 sites of the study.\\n\\nDepending on the patients' needs, some cases will be assisted in early years centers or child mental health centers based in the community.\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD\u00ae)', 'description': 'The IY-ASLD\u00ae program is a weekly group-based intervention for parents of children presenting neurodevelopmental problems (ASD symptoms, communication or language difficulties). The group is formed by 6-10 parents, and it is led by a group leader and a co-therapist, trained in the model.\\n\\nThe intervention is manualized. It includes video modelling and emphasizes the importance of practice-based learning through role-playing. The IY-ASLD\u00ae program takes into consideration the different developmental levels of each child and pairs parents according to this variable in role-play and other one-to-one discussions. Weekly home tasks will be assigned to parents, and families will be phoned each week to encourage home-based practice.\\n\\nThe intervention will be conducted online. Even though the IY-ASLD\u00ae original intervention comprises 14 sessions, the online format requires 22 weekly sessions.\\n\\nFidelity to the intervention will be assessed in accordance with the regulations of the program.', 'armGroupLabels': ['Intervention group'], 'otherNames': ['Parenting intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of parents engaging with and finishing the program', 'description': \"Parents' attendance at the sessions will be regeristered weekly with a sheet of attendance, with the aim to determine levels of compliance and engagement with the intervention. An attendance of at least 15/22 sessions is expected, with a minimum of 50% of parents finishing the program.\", 'timeFrame': 'Attendance sheet completed weekly throughout treatment (22 weeks total)'}\n- {'measure': 'Compliance and satisfaction throughout the study (Autism Program Parent Weekly Evaluation)', 'description': 'Parents\\' compliance and satisfaction with the intervention will be assessed weekly after each session with the questionnaire \"Autism Program Parent Weekly Evaluation\", which is part of the IY-ASLD\u00ae program materials.', 'timeFrame': 'Questionnaire administered to the intervention group weekly throughout treatment (22 weeks total)'}\n- {'measure': \"Parents' acceptability and satisfaction with the program (evaluated with the Autism Program Parent Final Satisfaction Questionnaire)\", 'description': \"Parents' acceptability and satisfaction with the program will be assessed with the Autism Program Parent Final Satisfaction Questionnaire (included within the IY-ASLD\u00ae program). Data will be collected after the last session of the intervention.\", 'timeFrame': 'Administered to the intervention group at treatment completion (approximately 22 weeks after baseline)'}\n- {'measure': \"Parents' overall experiences with the program (evaluated with individual interviews)\", 'description': \"Individual interviews will be conducted after the last session of the intervention to explore from a qualitative perspective: (1) parents' acceptability, satisfaction and overall experience with the intervention, and (2) parents' perceived changes in their parenting skills and parental distress after the intervention.\\n\\nOutcome measurements 3 and 4 will be combined to determine parents' experiences, acceptability and satisfaction with the program.\", 'timeFrame': 'Interviews to the participants of the intervention group at treatment completion (approximately 22 weeks after baseline)'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (\u03b1) of 0.05, and a standard deviation of 20 using a paired-samples t-test. Dropout rate not included in the sample size calculation.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Recruitment and sample size calculation\n Parents will be recruited from the specialist units in genetic neurodevelopmental syndromes at the three hospitals. Figure\u00c2\u00a01 shows the recruitment process that will be followed. Clinicians will present the study to preselected eligible families and will ask them for permission to be contacted by the research assistant, who will then explain the study further. If the family is interested, an appointment to evaluate all the inclusion criteria will be set up and the parents will be asked to sign the informed consent and to complete the pre-intervention assessment (see \u00e2\u0080\u009cEligibility criteria\u00e2\u0080\u009d section). Any children excluded from the study at that point due to scoring above diagnostic cut-off for ASD at the ADOS-2 will be referred for a specialized mental health assessment within the public system. Participants will be able to discontinue the treatment sessions or drop out from the control group at any point at their request. The participation or disengagement from the study will not affect their usual treatment.Fig.\u00c2\u00a01Recruitment and evaluation process that will be followed\n The sample size was primarily based on the recommendations for feasibility studies [29, 30], which suggest sample sizes of between 24 and 55 participants, and on similar previous studies [26, 31]. Secondarily, we did a sample size calculation based on the main secondary outcome, parental stress, measured through the Parental Stress Index Short Form (PSI-SF) questionnaire [32], as previous studies [31] have used PSI to estimate sample sizes. This is a 36-item scale, with a range of 180 points. There is data showing that a decrease of 16.5 points in the total scale stress score can be seen after attending an IY program [33]. Given that this study will be conducted with parents of children presenting neurodevelopmental difficulties, we anticipated that the decrease in the PSI-SF score would be lower. We estimated the necessary sample size considering a power of 80%, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, a difference between pre- and post-test of 10 points, and a standard deviation of 20, using a paired-samples t-test. We estimated 34 participants needed per arm of the study. Thus, we aim to recruit approximately 68 participants. The dropout rate has not been included when calculating the sample size, considering that a sample of 68 participants is similar than previous studies [26, 31] and in line with recommendations by the National Institute of Health Research [29]. Using the public registry for rare diseases (ReMin: Registre de Malalties Minorit\u00c3\u00a0ries) we have identified a minimum number of 184 patients within the age interval and confirmed genetic syndrome (see inclusion criteria above).\n Regarding the sample size for the individual interviews that will be conducted with parents after the intervention, a minimum of two parents of each intervention group will be interviewed. We will aim for a representative sample in terms of children\u00e2\u0080\u0099s diagnosis, age, and gender. Parents who drop out from the intervention will also be invited to be interviewed. Data saturation will be used to determine the final sample size.\n For the post-intervention individual interviews with clinicians, all clinicians who delivered the intervention will be interviewed after the intervention phase.", "id": 1996, "split": "test"} +{"trial_id": "NCT06126679", "pmid": "39068465", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Cost Effectiveness of a 1-year Dietary and Physical Activity Intervention of Childhood Obesity - Study Protocol for a Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Childhood Obesity\n\nStudy Armgroups:\n- {'label': 'intervention group', 'type': 'EXPERIMENTAL', 'description': 'The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. The multidisciplinary team consists of one pediatrician, one specialist nurse and a clinical nutritionist. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time.\\n\\nThe treatment is based on educational and behavioural counselling and motivating the participants to change their lifestyle and to support the parents in managing their children\u00b4s behaviour. The aim of counselling is to increase awareness of healthy dietary and physical activity habits; to achieve a suitable energy balance, to create a positive attitude to physical activity, to promote optimal sleep duration and to improve the children\u00b4s body image and body control.', 'interventionNames': ['Procedure: 1-year dietary and physical activity intervention of childhood obesity']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group continue with the standard care in primary care and do not receive any special lifestyle intervention during the study.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': '1-year dietary and physical activity intervention of childhood obesity', 'description': 'The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time.\\n\\nThe participants in the intervention group are advised and motivated to increase their regular daily physical activity and to reduce sedentary habits. They have one group session for the training in the gymnasium with physical education instructor. The physical education instructor gives a voluntary lecture for parents about increasing physical activity and reducing sedentary time.', 'armGroupLabels': ['intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'To investigate the efficacy of the intervention for the ISO-BMI', 'description': 'How much ISO-BMI change during the intervention (kg/m2)', 'timeFrame': '12 months'}\n- {'measure': 'The costs of the intervention for the health care system', 'description': 'Investigators calculate the costs (euros) of the intervention (the price of research visits, laboratory tests, the salary of emplyees and the cost of research rooms).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nStatistical significance level of 0.05 based on two-sided testing, power of 80%, and a 10% dropout rate in both groups.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Calculation of the sample size\n Power calculation was performed based on the assumption that there would be a difference of 0.4 in the change of body mass index standard deviation score (BMI-SDS) between the intervention and the control groups. Calculations on a difference of 0.4 SD in the change of BMI-SDS, at the level of statistical significance of 0.05 based on two-sided testing and with power of 80% and the assumption that 10% of participants will drop out in both groups the estimated sample size was 40 children per group.\n Thus, we aim to recruit 80 children, targeting 40 children in the intervention group and 40 children in the control group.", "id": 1997, "split": "test"} +{"trial_id": "NCT06127823", "pmid": "39961720", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Intensive Nutrition Training, Education, and Support Versus Standard Care in Reducing the Need for Insulin Therapy in Gestational Diabetes (INTENSE-GDM): A Randomised Controlled Trial\n\nIncluded conditions:\n- GDM\n- Gestational Diabetes\n- Nutritional and Metabolic Diseases\n- Nutrition Therapy\n- Medical Nutrition Therapy\n\nStudy Armgroups:\n- {'label': 'Intensive dietary care group', 'type': 'EXPERIMENTAL', 'description': 'Women randomised to the intensive dietary intervention group will receive one initial dietary counselling consultation (60 min), and two mandatory follow-up consultations (2 x 30 min) with a dietitian. In addition, participants in this group will be offered 1-2 follow-up consultations (1-2 x 15-30 min) if needed.', 'interventionNames': ['Behavioral: Dietary treatment']}\n- {'label': 'Standard dietary care group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Women randomised to the standard dietary care group will receive one dietary counselling consultation (60 min) according to the initial dietary counselling described without any follow-up consultations with a dietitian. Participants are encouraged to follow their dietary plan until delivery.', 'interventionNames': ['Behavioral: Dietary treatment']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Dietary treatment', 'description': 'Dietary counselling', 'armGroupLabels': ['Intensive dietary care group', 'Standard dietary care group']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of insulin-treated', 'description': 'Percentage of women with GDM treated with insulin therapy in the two study groups', 'timeFrame': 'From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size estimation was based on a logistic regression model with an allocation ratio of 1:1, alpha=0.05, 0.8 power, an incidence of insulin therapy of 50% in the standard therapy group and 25% in the intervention group.", "answer": 214, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on register data from Herlev Hospital from the period of 2019\u00e2\u0080\u00932022, the incidence of insulin therapy among women with GDM receiving standard care was 30% (unpublished data). By including women with GDM with a high risk of insulin therapy, the expected incidence of insulin therapy use was 50%. A 50% difference in the incidence of insulin therapy between the two study groups during the study period was defined as the minimally important difference for the primary outcome. Thus, the sample size estimation was based on a logistic regression model (outcome=group) and the following assumptions: an allocation ratio of 1:1; alpha=0.05; 0.8 power, an incidence of insulin therapy of 50% in the standard therapy group and 25% in the intervention group.\n The sample size is estimated to be 107\u00e2\u0080\u0089women for detecting a between-group difference. However, to ensure sufficient power for the ethnic subgroup analysis, a sample size of 214 is required (table 2).\n \n Table 2\n \n Sample size estimations\n \n \n \n \n N total\n Power all\n Power ethnic subgroups\n \n \n \n \n 107\n 0.80\n 0.51\n \n \n 150\n 0.92\n 0.65\n \n \n 175\n 0.95\n 0.72\n \n \n 200\n 0.97\n 0.78\n \n \n 214\n 0.98\n 0.80", "id": 1998, "split": "test"} +{"trial_id": "NCT06128421", "pmid": "39653573", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk: a Randomized Controlled Trail\n\nIncluded conditions:\n- Malnutrition\n- Hepatitis B,Chronic\n- Acute-On-Chronic Liver Failure\n- Nutrition Support\n\nStudy Armgroups:\n- {'label': 'Trail Group', 'type': 'EXPERIMENTAL', 'description': '30 patients will receive dietary counseling and individual nutrition support treatment based on Oral nutrition supplements and supplemented by parenteral nutrition.', 'interventionNames': ['Dietary Supplement: Individual nutritional support']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': '30 patients will receive standard care food provided by the hospital kitchen according to their ability and desire, standard care food provided by the hospital kitchen.'}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Individual nutritional support', 'description': 'Nutritional products and route\uff08oral, parenteral\uff09is possible to reach goals', 'armGroupLabels': ['Trail Group']}\n\nPrimary Outcomes:\n- {'measure': 'Transplant free survival at 30 days', 'timeFrame': '30 days'}\n- {'measure': 'Transplant free survival at 90 days', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nUsing a two-tailed alpha level of 0.05 and aiming for 90% power (beta=0.1), with a potential non-compliance and dropout rate of 14.6% (12.6% non-compliance + 2% dropout rate).", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size for this study was determined based on the primary outcome of liver transplant-free mortality rate. A previous study22 reported a 30-day mortality rate of 12% in the intervention group and 54.8% in the control group. Using a two-tailed alpha level of 0.05 and aiming for 90% power (beta=0.1), a sample size of 26 subjects per group is required. To account for a potential non-compliance and dropout rate of 14.6% (12.6% non-compliance+2% dropout rate) estimated from prior research,12 30 patients will be recruited for each group (total=60 patients).", "id": 1999, "split": "test"} +{"trial_id": "NCT06128785", "pmid": "39652211", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Electroacupuncture Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery: a Multicenter Randomized Controlled Study\n\nIncluded conditions:\n- Colorectal Cancer\n- Gastrointestinal Dysfunction\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture group', 'type': 'EXPERIMENTAL', 'description': \"The acupuncture will be performed within 6 hours after surgery Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal discharge or until the fourth day.\", 'interventionNames': ['Device: Electroacupuncture group']}\n- {'label': 'Sham EA group', 'type': 'SHAM_COMPARATOR', 'description': 'In order to achieve maximum patient blindness, both groups will use adhesive pads, and the sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25\u00d740mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output. All study patients will be treated independently and separately to ensure that patients will not come into contact with each other.', 'interventionNames': ['Other: Sham EA group']}\n- {'label': 'Conventional control group', 'type': 'NO_INTERVENTION', 'description': 'Routine perioperative management will be given, postoperative fluid and nutritional support, correction of acid-base imbalance, electrolyte disorders, anti-infection, hemostasis and other symptomatic management.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electroacupuncture group', 'description': \"Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal exhaust or until the fourth day.\", 'armGroupLabels': ['Electroacupuncture group'], 'otherNames': ['experimental group']}\n- {'type': 'OTHER', 'name': 'Sham EA group', 'description': 'Sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25\u00d740mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output.', 'armGroupLabels': ['Sham EA group']}\n\nPrimary Outcomes:\n- {'measure': 'Time of first postoperative exhaust', 'description': \"The time between the patient's first exhaust and the end of surgery will be recorded.\", 'timeFrame': 'up to 4 days after surgery.'}\n\nPlease estimate the sample size based on the assumption: \nA bilateral \u03b1 of 0.01, a power (1-\u03b2) of 0.8, and a dropout rate of 10% are assumed.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study utilizes a comparative design. Previous studies [39, 40] have indicated that the first passage time of flatus post three treatments averages 48 h (SD 21.6) in the electroacupuncture group, 58.9 h (SD 16.8) in the SA group, and 62.4 h (SD 26.4) in the control group. Adopting a bilateral \u00ce\u00b1 of 0.01 and a power (1-\u00ce\u00b2) of 0.8, the primary focus is the comparison between the EA and control groups. Using a 2:2:1 ratio for group allocation, sample size calculations performed with PASS15.0 software suggest a requirement of 108 cases each in the EA and SA groups, and 54 in the control group, totaling 270 cases. Given the study\u00e2\u0080\u0099s brief duration, a dropout rate of 10% is anticipated. Therefore, the final sample size was determined to be 300 cases, with 120 in the EA group, 120 in the SA group, and 60 in the control group.", "id": 2000, "split": "test"} +{"trial_id": "NCT06129474", "pmid": "39832992", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DepRescribing inapprOpriate Proton Pump InhibiTors - the DROPIT Trial: a Cluster Randomized Controlled Trial in Primary Care Setting\n\nIncluded conditions:\n- Inappropriate Prescribing\n- Reflux Disease\n- Proton Pump Inhibitors\n\nStudy Armgroups:\n- {'label': 'DROPIT Intervention', 'type': 'EXPERIMENTAL', 'description': 'The study intervention is a patient-centred PPI deprescribing intervention aiming to guide GPs and patients through the process of safely deprescribing inappropriate PPIs.', 'interventionNames': ['Other: Proton Pump Inhibitor deprescribing tool']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'The reference or control arm will receive usual care. This means that the GPs and patients in this group will conduct their clinical practice as per usual, without receiving the intervention from the study team.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Proton Pump Inhibitor deprescribing tool', 'description': 'The intervention is targeted to the Swiss Primary care practice. It involves educational material and resources to guide the safe deprescribing of inappropriate PPIs, for both general practitioners and patients.', 'armGroupLabels': ['DROPIT Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Effectiveness co-primary endpoint: prescribed PPI dose over 12 months follow-up (superiority endpoint).', 'timeFrame': '12 months'}\n- {'measure': 'Safety co-primary endpoint: upper gastrointestinal symptoms (Non-inferiority endpoint)', 'description': 'Co-primary endpoints measured by the Reflux Disease Questionnaire (RDQ), considering the worst of the subscales dyspepsia and gastroesophageal reflux disease (GERD) (i.e.,regurgitation and heartburn subscales combined).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nFor effectiveness: Pearson \u03c72 test, intracluster correlation coefficient of 0.05, two-sided alpha of 0.05. For safety: Student's t-test, intracluster correlation coefficient of 0.06, one-sided alpha of 0.025. For both endpoints: 80 clusters, power of 90%, coefficient of variation of cluster size of 0.5, and accounting for missing data.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on a sequential testing procedure in line with the two co-primary endpoints (effectiveness and safety). For the effectiveness, we based the calculations on PPI discontinuation rates from previous literature3337 (10% control group, 25% intervention group) and a Pearson \u00cf\u00872 test for superiority without continuity correction and the following assumptions: intracluster correlation coefficient of 0.0538 39 and a two-sided alpha of 0.05. Finally, we checked whether we achieved adequate power with the estimated sample size to demonstrate a low to medium effect size (Cohen\u00e2\u0080\u0099s d) of 0.4 for the effectiveness endpoint. For the safety, a Student\u00e2\u0080\u0099s t-test was used with the following assumptions: similar values in the two RDQ subscales (dyspepsia and GORD) per patient in both groups at the end of the trial, a non-inferiority margin of 0.5 points,29 a common SD of 1.3 resulting in an effect size (Cohen\u00e2\u0080\u0099s d) of 0.38, an intracluster correlation coefficient of 0.06 and a one-sided alpha of 0.025. For both co-primary endpoints, we additionally assumed a total of 80 clusters, a power of 90%, coefficient of variation of the cluster size of 0.5. We calculated a required mean cluster size of 4.0 and 4.5, and a sample size of 316 and 360 patients for the effectiveness and safety co-primary endpoints, respectively. To account for some missing data, we aim to recruit 400 patients who will be recruited in at least 80 clusters with a cluster size of between 2 and 12 participants.", "id": 2001, "split": "test"} +{"trial_id": "NCT06131788", "pmid": "39420312", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of an Educational Hand Washing Intervention with a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs\n\nIncluded conditions:\n- People Who Inject Drugs\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention among people who inject drugs (PWID) from the intervention arm consist in : i) educational hand washing training (\"fingertips first\" model), ii) supply of single use alcohol-based hand rub (called MONO-RUB).\\n\\nOnly staff from the 11 harm reduction (HR) centres in the intervention arm will be trained in the educational hand-washing intervention.', 'interventionNames': ['Behavioral: Educational hand hygiene intervention']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'The 11 control arm HR centres will be the placebo group. People who inject drugs (PWID) in this group will receive standard HR services, including to reduce abscesses if necessary. MONO-RUBs will not be made available in these HR centres during the intervention period.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Educational hand hygiene intervention', 'description': 'The intervention combines training in hand-washing with the supply of a single-use alcohol-based hand rub, called MONO-RUB', 'armGroupLabels': ['Intervention Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change in abscess prevalence', 'description': 'The primary outcome will be the change in abscess prevalence between M0 and M6, compared between the control and intervention arms, measured from observed and self-declared data, collected from the injection-site photographs and the face-to-face injection-related SSTI questionnaire, respectively', 'timeFrame': 'Month 0; Month 3; Month 6'}\n\nPlease estimate the sample size based on the assumption: \nA power of at least 90% with an alpha risk of 5% is assumed. Cluster auto-correlation and individual auto-correlation are both assumed to be 80%, with a within-period intra-cluster correlation coefficient (ICC) between 0.01 and 0.02. One third of participants in each cluster are expected to be lost over the 6-month follow-up.", "answer": 440, "answer_type": "ESTIMATED", "explanation": "Sample Size\n To calculate the required number of participants, we hypothesize that the prevalence of abscesses will reduce from 30 to 15% in the intervention arm compared with the control arm, where it shall remain at 30%. In other words, a difference in abscess prevalence of 15% between the two arms is forecast between M0 and M6: i.e., a binary outcome. In order to guarantee a power of at least 90%, with an alpha risk of 5%, we estimate that each cluster must contain at least 15 participants. This calculation is based on the following two hypotheses: a cluster auto-correlation (i.e. correlation of a given cluster\u00e2\u0080\u0099s outcome at different times) and individual auto-correlation (i.e. correlation of outcomes for a given individual at different times) of 80%, and a within-period intra-cluster correlation coefficient (ICC, \u00cf\u0081) between 0.01 and 0.02 as recommended for human studies [37]. However, this coefficient can be adapted if needed according to the data from the pilot phase. We hypothesize that one third of the participants in each cluster will be lost over the 6-month follow-up. Accordingly, to ensure a total of 300 participants (150 per arm) in the 22 clusters (i.e., 11 intervention clusters and 11 control clusters) at the end of the study (M6), at least 440 participants must be recruited for the intervention trial.", "id": 2002, "split": "test"} +{"trial_id": "NCT06133244", "pmid": "40082008", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study\n\nIncluded conditions:\n- Systemic Sclerosis\n\nStudy Armgroups:\n- {'label': 'VEDOSS', 'description': 'defined as RP, presence of SSc specific autoantibodies (ACA, ATA, ARA), puffy fingers and abnormal nailfold capillaroscopy (giant capillaries or capillary loss with or without haemorrhages), but not fulfilling the EULAR-ACR 2013 classification criteria for SSc', 'interventionNames': ['Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination']}\n- {'label': 'SSc with disease duration of < 4 years without hand contractures', 'interventionNames': ['Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination']}\n- {'label': 'SSc with hand contractures', 'interventionNames': ['Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Imaging, blood samples, fuctional tests and physical examination', 'description': 'Imaging, blood samples, fuctional tests and physical examination', 'armGroupLabels': ['SSc with disease duration of < 4 years without hand contractures', 'SSc with hand contractures', 'VEDOSS']}\n\nPrimary Outcomes:\n- {'measure': 'Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study will use multivariable regression analysis, variance inflation factors, data reduction techniques, and multiple imputations to handle missing data.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n For multivariable regression analysis with a continuous outcome, we need at least 10 patients per variable studied according to the rule of thumb. As we anticipate including 300 patients we will be able to validly study 30 variables for their association with the (progressive) hand impairment (including patient subgroup as a covariate in the analysis) with sufficient power. We will also perform more explorative subgroup analyses per patient population and calculate variance inflation factors as well as use data reduction techniques (eg, principal component analysis) and/or analysis techniques more suitable for analysing outcomes with many independent variables compared with the number of patients (like partial least squares regression or Lasso regression). Furthermore, we will explore clusters of patients developing hand function impairment using imaging and protein biomarkers to inform our multivariable analyses. Missing data will be accounted for using multiple imputations. With the above calculation and strategy, we think our cohort of 300 patients will be sufficient to obtain meaningful results.", "id": 2003, "split": "test"} +{"trial_id": "NCT06134492", "pmid": "38670599", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Acyclovir Therapy on the Outcome of Mechanically Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage\n\nIncluded conditions:\n- Pneumonia, Viral\n- Ventilator Associated Pneumonia\n- Community-acquired Pneumonia\n- Herpes Simplex\n- Hospital-acquired Pneumonia\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': 'Aciclovir therapy', 'interventionNames': ['Drug: Acyclovir']}\n- {'label': 'Comparison group', 'type': 'NO_INTERVENTION', 'description': 'No study-specific treatment measures'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Acyclovir', 'description': 'Dosage: 10mg/kg (current) body weight every 8 hours, dose adjustment to renal function according to technical information.\\n\\nMode of administration: intravenous (i.v.)', 'armGroupLabels': ['Treatment group'], 'otherNames': ['Aciclovir']}\n\nPrimary Outcomes:\n- {'measure': 'mortality (survival status)', 'description': 'survival status', 'timeFrame': 'day 30'}\n\nPlease estimate the sample size based on the assumption: \nA dropout rate of ~1%, a power of 0.8, and a two-sided significance test at the 5% significance level.", "answer": 710, "answer_type": "ESTIMATED", "explanation": "Proposed sample size/power calculations\n The sample size estimate for the primary endpoint (30-day mortality) is based on the Kaplan-Meier estimator. Based on the results of the meta-analysis,8 we assume an event rate of 0.4 in the control group and an RR of 0.75 (ie, fewer events with acyclovir therapy). This results in an event rate of 0.3 in the acyclovir group, corresponding to an absolute risk reduction (ARR) of 10%. We expect a dropout rate of ~1%. To demonstrate an ARR above 10% at 1\u00e2\u0080\u0089month with a power of 0.8, a sample of 710 (2\u00c3\u0097355) patients is needed, under these assumptions, with a two-sided significance test at the 5% significance level. The case number planning was performed with R V.4.0.3 and specifically the R package npurvSS V.1.0.1.", "id": 2004, "split": "test"} +{"trial_id": "NCT06140797", "pmid": "39663170", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prehabilitation Combined With Enhanced Recovery After Surgery (PREERAS) in the Chinese Elderly With Spine Surgery\n\nIncluded conditions:\n- Spine Degeneration\n- Spine Fusion\n- Frailty Syndrome\n\nStudy Armgroups:\n- {'label': 'PREERAS group', 'type': 'EXPERIMENTAL', 'description': 'Pre-operative risk assessment combined with targeted intervention During the planning phase of the study, we assembled a multidisciplinary team consisting of geriatrician, spine surgeons, nurses, rehabilitation specialists, anesthesiologists, neurologists, nutritionist, and social workers. Then, the multimodal prehabilitation combined with perioperative ERAS care (PREERAS) programme was conducted based on previous studies and surgical guideline.\\n\\nParticipants randomised to the intervention group will receive PREERAS management. PREERAS mainly consists of geriatric assessment, Vivifrail multicomponent exercise, nutritional intervention, cognitive prehabilitation and brain protection.', 'interventionNames': ['Combination Product: Multimodal prehabilitation combined with perioperative ERAS care\uff08PREERAS\uff09']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive standard of enhanced recovery after surgery (ERAS) care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation'}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Multimodal prehabilitation combined with perioperative ERAS care\uff08PREERAS\uff09', 'description': 'Pre-admission risk assessment and targeted intervention provided by multidisciplinary team', 'armGroupLabels': ['PREERAS group']}\n\nPrimary Outcomes:\n- {'measure': 'Comprehensive Complication Index', 'description': 'The Comprehensive Complication Index (CCI) is based on the complication grading by the Clavien-Dindo Classification and captures every complication that occurred after an intervention. Postoperative complications were recorded to 90-day after surgery (definitions provided in supplementary table 1) and scored by severity using the Clavien-Dindo classification. The CCI was derived from these scores using the CCI calculator available online (http://www.assessurgery.com). Previous studies have validated the CCI as a measure of postoperative morbidity, suggesting that it offers a more comprehensive and sensitive endpoint for surgical research compared to traditional morbidity measures, such as the overall rate of complications or the rate of severe complications.', 'timeFrame': 'up to 90 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA mean (SD) CCI of 14.0 (16.6) for elderly patients who had spine surgery, a 95% confidence level (\u03b1=0.05), a 90% statistical power, and a 5% attrition rate.", "answer": 164, "answer_type": "ESTIMATED", "explanation": "Sample size determination and recruitment\n Before patient enrolment, a sample-size calculation was performed using the Pwr package (R Project for Statistical Computing V.4.3.2, Base Package). The determination of the sample size for this trial was based on past data and assumptions. The significance of a 10-point difference in the Clavien-Dindo classification, which is deemed clinically meaningful, lies in its representation of the impact of a single grade 1 complication. Specifically, this difference correlates with the increased burden associated with a complication. Drawing from a prior investigation, the mean (SD) CCI for elderly patients who had spine surgery was found to be 14.0 (16.6).38 Therefore, a minimum of 118 participants is required. This is based on a 95% (\u00ce\u00b1=0.05) confidence level and a 90% statistical power.\n Estimations of sample size calculations were also performed for the secondary outcome. Based on a minimally clinical important difference of 10% on the ODI, an estimated SD for the ODI=20, a significance level of p=0.05, a power of 90%, an estimated 78 patients were required in each of the intervention groups.39 Considering a 5% attrition rate, the study was designed to enrol 164 patients. Our analysis led us to set a target of 78 patients per group. This is an exploratory study. The sample sizes were determined based on past research, as there is limited information available on elderly patients in the ERAS population. Recruitment for the study begins in May 2024, and the study is anticipated to be complete by December 2025.", "id": 2005, "split": "test"} +{"trial_id": "NCT06142032", "pmid": "39427163", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Support Groups in the Metaverse for Ukrainian Refugees: A Randomized Clinical Trial\n\nIncluded conditions:\n- Mental Health Wellness 1\n- Well-Being, Psychological\n\nStudy Armgroups:\n- {'label': 'Metaverse support group', 'type': 'EXPERIMENTAL', 'description': 'Online intervention', 'interventionNames': ['Behavioral: Metaverse support group']}\n- {'label': 'In-Person support group', 'type': 'ACTIVE_COMPARATOR', 'description': 'In-person intervention', 'interventionNames': ['Behavioral: In-Person support group']}\n- {'label': 'Waitlist', 'type': 'NO_INTERVENTION', 'description': 'Control'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Metaverse support group', 'description': 'Delivery method: Online, virtual platforms. Number of sessions: 5. Duration of each session: 1.5 hours. Sessions will adhere to evidence-based protocols for conducting support groups with a trauma-informed approach. Each session will cover a specific topic of interest related to the challenges faced by Ukrainian refugees (e.g., stress management, cultural adjustment, self-care, etc.).\\n\\nSupport group session structure:\\n\\n* Introduction, check-in, ground rules;\\n* Introducing the topic (topics will be chosen based on the feedback received from a previous session; the first session will cover a topic chosen by the facilitator);\\n* Encouragement of participants to share thoughts, ideas and experiences;\\n* Psychoeducation on the topics;\\n* Summary, takeaway, feedback.', 'armGroupLabels': ['Metaverse support group']}\n- {'type': 'BEHAVIORAL', 'name': 'In-Person support group', 'description': 'Delivery method: In-Person, traditional. Number of sessions: 5. Duration of each session: 1.5 hours. Sessions will adhere to evidence-based protocols for conducting support groups with a trauma-informed approach. Each session will cover a specific topic of interest related to the challenges faced by Ukrainian refugees (e.g., stress management, cultural adjustment, self-care, etc.).\\n\\nSupport group session structure:\\n\\n* Introduction, check-in, ground rules;\\n* Introducing the topic (topics will be chosen based on the feedback received from a previous session; the first session will cover a topic chosen by the facilitator);\\n* Encouragement of participants to share thoughts, ideas and experiences;\\n* Psychoeducation on the topics;\\n* Summary, takeaway, feedback.', 'armGroupLabels': ['In-Person support group']}\n\nPrimary Outcomes:\n- {'measure': 'Depressive symptomatology', 'description': 'Depressive symptomatology will be assessed with the Patient Health Questionnaire-Severity Measure for Depression, 9 item questionnaire. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0- not at all; 3 - nearly every day). The scores indicate the severity of depression, ranging from minimal depression (1-4) to mild, moderate, moderately severe, or severe depression (20-27).', 'timeFrame': 'Up to 9 months'}\n- {'measure': 'Anxiety symptomatology', 'description': 'Anxiety symptomatology will be assessed with the help of General Anxiety Disorder -7 - Severity Measure for Generalized Anxiety Disorder 7 item questionnaire.\\n\\nThe measure is a 7-question self-reported instrument designed to correspond to some of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition diagnostic criteria for GAD. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0 - not at all; 3 - nearly every day). The total score for the seven items ranges from 0 to 21(minimal anxiety, to mild, moderate and severe).', 'timeFrame': 'Up to 9 months'}\n\nPlease estimate the sample size based on the assumption: \nstatistical power = 0.95; \u03b1 error probability = 0.05; three groups; four main measurements (pre-intervention, mid-intervention, post-intervention, and follow-up)", "answer": 45, "answer_type": "ESTIMATED", "explanation": "Sample size\n An a priori power analysis based on a medium effect size estimation [37, 38] indicated that a total of 45 participants are needed (planned main statistical test is ANOVA repeated measures, within-between interaction; f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25; statistical power\u00e2\u0080\u0089=\u00e2\u0080\u00890.95; \u00ce\u00b1 error probability\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; three groups, four main measurements (pre-intervention, mid-intervention, post-intervention, and follow-up). Power analysis was computed using the G*Power 3.1 program [39].", "id": 2006, "split": "test"} +{"trial_id": "NCT06143345", "pmid": "39977858", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: A Proof-of-Concept Study\n\nIncluded conditions:\n- Isolated Impaired Fasting Glucose\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': \"Intervention participants will complete 24 supervised high-intensity interval training (HIIT) sessions over 8 weeks, with 3 sessions per week on alternate days. Each HIIT session will consist of a 5-minute warm-up, followed by an interval-based workout phase that includes steady up-tempo cadences, sprints, and climbs, interspersed with recovery periods. The session will conclude with a 5-minute cooldown. The workout sessions will initially last 20 minutes and will progressively increase in time based on participants' tolerance and instructor recommendations. Intensity will start at 75% of the estimated maximal heart rate reserve and will increase by 5% weekly, as tolerated and/or deemed necessary by the instructor, over the 8-week intervention period. Participants will receive instructions to maintain a eucaloric diet throughout the study.\", 'interventionNames': ['Behavioral: High-intensity interval training and eucaloric diet', 'Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Control participants will be instructed to refrain from engaging in intense physical activities during the study period. They will also receive instructions to maintain a eucaloric diet throughout the study.', 'interventionNames': ['Behavioral: No intense physical activity and eucaloric diet', 'Device: Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'High-intensity interval training and eucaloric diet', 'description': 'Intervention participants will complete 24 supervised high-intensity interval training (HIIT) sessions over 8 weeks, with 3 sessions per week on alternate days. Each HIIT session will consist of a 5-minute warm-up, followed by an interval-based workout phase that includes steady up-tempo cadences, sprints, and climbs, interspersed with recovery periods. The session will conclude with a 5-minute cooldown. The workout sessions will initially last 20 minutes and will progressively increase in time based on participants\\\\&#39; tolerance and instructor recommendations. Intensity will start at 75% of estimated maximal heart rate reserve and will increase by 5% weekly, as tolerated and/or deemed necessary by the instructor, over the 8-week intervention period. Participants will receive instructions to maintain a eucaloric diet throughout the study.', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['HIIT intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'No intense physical activity and eucaloric diet', 'description': 'Control participants will be instructed to refrain from engaging in intense physical activities during the study period. They will also receive instructions to maintain a eucaloric diet throughout the study.', 'armGroupLabels': ['Control Group']}\n- {'type': 'DEVICE', 'name': 'Continuous glucose monitoring (CGM) (Dexcom G6 Pro CGM sensor)', 'description': 'The continuous glucose monitoring (CGM) system comprises a sensor, a transmitter, and a receiver. The sensor measures interstitial fluid glucose levels every 5 minutes, and the transmitter wirelessly sends this glucose data to the receiver. Both intervention and control participants will wear the CGM device in a blinded mode for 10 days before starting the intervention, throughout the 8-week intervention period, and for 10 days post-intervention.', 'armGroupLabels': ['Control Group', 'Intervention Group'], 'otherNames': ['Dexcom G6 Pro CGM sensor']}\n\nPrimary Outcomes:\n- {'measure': 'Response rate in %', 'description': 'No. of individuals responded to the invitation/No. of individuals invited.', 'timeFrame': 'Baseline'}\n- {'measure': 'Screening yield in %', 'description': 'No. of individuals diagnosed with i-IFG/No. of individuals screened.', 'timeFrame': 'Baseline'}\n- {'measure': 'Enrolment rate in %', 'description': 'No. of individuals enrolled/No. of individuals diagnosed with i-IFG.', 'timeFrame': 'Baseline'}\n- {'measure': 'Time to enrollment (mins)', 'description': 'Average time taken from sending the invitation to enrolling one participant in the trial.', 'timeFrame': 'Baseline'}\n- {'measure': 'Intervention compliance in %', 'description': 'No. of HIIT sessions attended/Total no. of HIIT sessions.', 'timeFrame': '8 weeks'}\n- {'measure': 'Program costs (USD)', 'description': 'Includes screening cost, cost of procedures, intervention cost, participant incentives, and other costs.', 'timeFrame': 'From baseline to 8 weeks'}\n- {'measure': 'Staff time (mins)', 'description': 'Time spent screening and recruiting participants, time spent delivering the intervention, time spent making phone calls to participants, time spent implementing the study procedures, and time spent on baseline and follow-up assessments.', 'timeFrame': 'From baseline to 8 weeks'}\n- {'measure': 'Retention rate in %', 'description': 'No. of participants attended follow-up visits/No. of participants enrolled.', 'timeFrame': '8 weeks'}\n- {'measure': 'Feasibility of Intervention Measure (FIM) score', 'description': 'The FIM scale will evaluate the feasibility of the intervention, encompassing questions regarding its implementability, possibility, doability, and ease of use. Responses to the questions in the questionnaire will be recorded on a Likert scale of 1 to 5. The mean total score will be calculated by combining the individual Likert points. Higher scores on the FIM scale indicate greater intervention feasibility.', 'timeFrame': '8 weeks'}\n- {'measure': 'Theoretical Framework of Acceptability (TFA) score', 'description': 'The acceptability of the intervention will be assessed through the Theoretical Framework of Acceptability (TFA) questionnaire, which explores affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability.', 'timeFrame': '8 weeks'}\n- {'measure': 'Intervention Appropriate Measure (IAM) score', 'description': \"The Intervention Appropriate Measure (IAM) will evaluate the appropriateness of the intervention, including questions about its fittingness, suitability, applicability, and alignment with participants' needs.\", 'timeFrame': '8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 5%, power of 90%, 10% loss to follow-up", "answer": 34, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation\n Assuming a Cohen d of 0.3 to <0.7 (medium standardized effect size) [25,59] for FPG in the planned main trial, with an alpha of 5% and a power of 90%, a sample size of 15 participants per treatment group is deemed necessary for this pilot study. Factoring in a 10% loss to follow-up in each group, the total sample size was estimated to be 34 participants (17 per group).", "id": 2007, "split": "test"} +{"trial_id": "NCT06143462", "pmid": "39987011", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Vestibular Disorder\n\nStudy Armgroups:\n- {'label': 'Group A: usual care (UC)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Group A (UC) will receive conventional medications.', 'interventionNames': ['Drug: Usual care', 'Other: Health Education']}\n- {'label': 'Group B: vestibular rehabilitation treatment (VRT)', 'type': 'EXPERIMENTAL', 'description': 'Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.', 'interventionNames': ['Behavioral: vestibular rehabilitation']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Usual care', 'description': 'Include anti-dizziness medications, diuretics, or hormone therapy.', 'armGroupLabels': ['Group A: usual care (UC)']}\n- {'type': 'OTHER', 'name': 'Health Education', 'description': 'Include comprehensive health education, fall prevention and lifestyle adjustments.', 'armGroupLabels': ['Group A: usual care (UC)']}\n- {'type': 'BEHAVIORAL', 'name': 'vestibular rehabilitation', 'description': 'Encompass office-based sessions of vestibular rehabilitation treatment once weekly, supplemented by home-based exercises conducted two or three times daily for the remaining duration of the study.', 'armGroupLabels': ['Group B: vestibular rehabilitation treatment (VRT)']}\n\nPrimary Outcomes:\n- {'measure': 'Functional Gait Assessment (FGA)', 'description': 'FGA is a semi-quantitative measure of walking balance ability.', 'timeFrame': 'Change from baseline, at 8 weeks and 6 months post-randomization'}\n\nPlease estimate the sample size based on the assumption: \n90% power, alpha level of 0.05 (two-tailed test), beta level of 0.10, and a 20% dropout rate.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study sample size is based on the Functional Gait Assessment (FGA) measure. The minimum detectable change (MDC) for the FGA is reported to be 6 points, with an SD of 5.5, as reported by Marchetti et al.18 In this study, we assume an FGA difference of 6 will be considered clinically meaningful. Thus, to detect an MDC of 6 for the FGA with 90% power (alpha level of 0.05, two-tailed test, beta level of 0.10), 19 subjects per group will be required as calculated by Two-Sample T-Tests Assuming Equal Variance in PASS15. Allowing for a 20% dropout rate, we will assign 24 subjects to each group (48 in total).", "id": 2008, "split": "test"} +{"trial_id": "NCT06146062", "pmid": "39740941", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Intravascular Administration of Mesenchymal Stromal Cells Derived from Wharton's Jelly of the Umbilical Cord on Systemic Immunomodulation and Neuroinflammation After Traumatic Brain Injury.\n\nIncluded conditions:\n- Traumatic Brain Injury\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Final product is a MSC solution at the concentration of 2.10\\\\^6/kg in 150 mL of NaCl 0.9% and human albumin 0.5%, conditioned aseptically and identified for IV administration.\\n\\n3 injections one week apart.', 'interventionNames': ['Drug: Mesenchymal Stromal Cells (MSC)']}\n- {'label': 'control', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo will be a solution of NaCl 0.9% 3 injections one week apart.', 'interventionNames': ['Drug: placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mesenchymal Stromal Cells (MSC)', 'description': '3 injections one week apart', 'armGroupLabels': ['Intervention']}\n- {'type': 'DRUG', 'name': 'placebo', 'description': '3 injections one week apart', 'armGroupLabels': ['control']}\n\nPrimary Outcomes:\n- {'measure': 'effect of iterative IV injections of WJ-UC-MSC on post-traumatic neuroinflammation', 'description': '\\\\[18F\\\\]-DPA-714 Standard Uptake Value ratio (SUVr) in corpus callosum (Region of Interest, ROI) measured by dynamic PET-MRI', 'timeFrame': '6 months after the last injection'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, type-I error of 0.05, randomised ratio of 1:1, and an expected dropout rate of less than 10%.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on a previous prospective study using [18F]-DPA-714 SUVR in Alzheimer\u00e2\u0080\u0099s disease,36 we extrapolated a 0.20 difference of SUVR between the placebo and experimental groups. With this difference and an SD of 0.25, we need to include 31 patients per group for a power of 90% and a type-I error of 0.05 to reach significance by performing a t-test. Given a randomised ratio of 1:1, 68 patients (31+3 additional patients per group in case of low-binder or death during the follow-up for the intention-to-treat analysis) will be included. Considering the deceased patients (expected rate less than 10%), the imputation rule will set the highest value of the signal intensity [18F]-DPA-714 SUVr regardless of the randomisation arm.", "id": 2009, "split": "test"} +{"trial_id": "NCT06146530", "pmid": "38950994", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cerina- Cognitive Behavioural Therapy Based Mobile Application for Managing GAD Symptoms: A Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Treatment Adherence\n- Generalized Anxiety\n- Treatment Adherence and Compliance\n\nStudy Armgroups:\n- {'label': 'Treatment', 'type': 'EXPERIMENTAL', 'description': 'Participants in the treatment arm will have access to Cerina for 6 weeks.\\n\\nThe intervention (Cerina) consists of 7 sessions of Cognitive Behavioural Threapy (CBT) for the treatment of GAD. Each session contains a range of information and tasks/exercises to help the user understand the condition of GAD, the treatment approach, and how it will apply to them.', 'interventionNames': ['Device: Treatment']}\n- {'label': 'Wait-list', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the waiting-list control condition will have access to the campus-based well-being services offered by the Student Wellbeing team.', 'interventionNames': ['Device: Treatment']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Treatment', 'description': 'The intervention consists of 7 sessions of CBT for the treatment of GAD. Each session contains a range of information and tasks/exercises to help the user understand the condition of GAD, the treatment approach, and how it will be applicable to them. The intervention is based on an evidence-based treatment protocol; hence the sessions will flow from one to the other and the user will complete the sessions in a progressive direction. However, they can repeat a session before going on to the next session. Once all sessions have been completed, the user can go back over any of the sessions. There are anxiety management exercises, which the user can go to whenever they wish. There are also a therapy reflection journal and self-care resources including further anxiety management techniques, resources, and podcasts that the user will have access to whenever they want.', 'armGroupLabels': ['Treatment', 'Wait-list'], 'otherNames': ['Cerina']}\n\nPrimary Outcomes:\n- {'measure': 'The Generalised Anxiety Disorder Scale-7 (GAD-7)', 'description': 'GAD-7 is a 7-item self-report scale that identifies and measures the severity of GAD. Scores range from 0 to 21, with a cut-off score of 5 distinguishing between clinical and non-clinical populations. The scale has good psychometric properties', 'timeFrame': 'baseline, week 3 and week 6'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to include 50% more participants than initially intended to account for possible dropout rates.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of the study is 90 participants (N=45 in treatment, N=45 in wait-list control) in total. As this is a pilot RCT study and the objective is mostly to test the feasibility of the trial procedure, and intervention uptake and evaluate the acceptability of the intervention towards building capacity for a larger test population, no formal sample size calculation was performed.46 47 The audit of the sample sizes for the pilot and feasibility RCTs indicated that the median sample size per arm across all the types of studies was 30.48 Browne also recommended that 30 participants per condition are needed to estimate a parameter.49 Taking a possible dropout rate into account, the aim is to include 50% more participants than initially intended in both arms.", "id": 2010, "split": "test"} +{"trial_id": "NCT06146647", "pmid": "39702145", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dove Self-Esteem Project: Evaluating Effectiveness and Acceptability of Two Positive Body Image Micro-interventions on Young Children's Body Functionality Appreciation, State Body Appreciation and Anti-fat Attitudes\n\nIncluded conditions:\n- Body Image\n- Anti Fat Bias\n\nStudy Armgroups:\n- {'label': 'Intervention condition: 15 minute (approx.) show with positive body image messaging', 'type': 'EXPERIMENTAL', 'description': 'Those assigned to this arm will watch the 15 minute tv show with positive body image content.', 'interventionNames': ['Behavioral: Positive body image TV show']}\n- {'label': 'Control condition: 15 minute (approx.) show without positive body image messaging', 'type': 'ACTIVE_COMPARATOR', 'description': 'Those assigned to this condition will watch a 15 minute tv show that does not contain positive body image content.\\n\\nThe show that will be used for this condition is about a tv character visiting the dentist.', 'interventionNames': ['Behavioral: Active control TV show about a visit to the dentist']}\n- {'label': 'Intervention condition: Music video with positive body image messaging', 'type': 'EXPERIMENTAL', 'description': 'Those assigned to this condition will watch the music video containing positive body image messaging.', 'interventionNames': ['Behavioral: Positive body image music video']}\n- {'label': 'Control condition: Music video without positive body image content', 'type': 'ACTIVE_COMPARATOR', 'description': 'Those assigned to this condition will watch a music video without positive body image messaging.\\n\\nThe music video that will be used for this condition is about brushing teeth.', 'interventionNames': ['Behavioral: Active control music video about brushing teeth']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Positive body image TV show', 'description': 'This is a 15 minute (approximately) show that has positive body image content embedded in the storyline. It also showcases a diverse range of body sizes in the casting.', 'armGroupLabels': ['Intervention condition: 15 minute (approx.) show with positive body image messaging']}\n- {'type': 'BEHAVIORAL', 'name': 'Positive body image music video', 'description': 'This is a positive body image song with strong visual representation of diverse body sizes in the music video.', 'armGroupLabels': ['Intervention condition: Music video with positive body image messaging']}\n- {'type': 'BEHAVIORAL', 'name': 'Active control TV show about a visit to the dentist', 'description': '14 minute tv show following a tv character as he visits the dentist.', 'armGroupLabels': ['Control condition: 15 minute (approx.) show without positive body image messaging']}\n- {'type': 'BEHAVIORAL', 'name': 'Active control music video about brushing teeth', 'description': 'Music video of a tv character singing about brushing teeth', 'armGroupLabels': ['Control condition: Music video without positive body image content']}\n\nPrimary Outcomes:\n- {'measure': 'Change in body appreciation', 'description': \"Participants respond to two 4-point Likert scale questions, 'Do you love your body?' and 'Do you think your body is amazing?' (No, a little, bit, a medium bit, a lot)\", 'timeFrame': 'Baseline; post-intervention (immediate post); follow-up (10 days later)'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided test with alpha = 0.05, 90% power for delta = 0.3 and 80% power for delta = 0.25. Target recruitment inflated to compensate for missing data.", "answer": 440, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size\n A proposed sample of 440 children aged 4\u00e2\u0080\u00936 years and a corresponding parent will be recruited for this study. The study has been powered for immediate post intervention effects to be assessed using analysis of covariance with the commensurate baseline measure as the covariate. Caution has been exercised for assumed for effect size due to a universal non-clinical population undergoing a micro-intervention. This is offset by an assumed medium to large pre- post- correlation due to the short time interval between measures and the high degree of internal validity at data collection. For a two-sided test (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089103 per arm will have 90% power for an assumed standardised effect of Cohen\u00e2\u0080\u0099s delta\u00e2\u0080\u0089=\u00e2\u0080\u00890.3, with pre-post-correlation of 0.75. A sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008992 per arm will have 80% power for a standardised effect of Cohen\u00e2\u0080\u0099s delta\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 with pre- post- correlation of 0.8. The aim is to sample for n\u00e2\u0080\u0089=\u00e2\u0080\u0089105 per arm (90% power, r\u00e2\u0080\u0089=\u00e2\u0080\u00890.75, d\u00e2\u0080\u0089=\u00e2\u0080\u00890.3). To achieve sample size, the target recruitment will be inflated to n\u00e2\u0080\u0089=\u00e2\u0080\u0089110 per arm to compensate for any missing data.", "id": 2011, "split": "test"} +{"trial_id": "NCT06146725", "pmid": "39260848", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)\n\nIncluded conditions:\n- Glioblastoma\n- Glioblastoma, IDH-wildtype\n- Glioblastoma Multiforme\n- Glioblastoma Multiforme, Adult\n- Glioblastoma Multiforme of Brain\n\nStudy Armgroups:\n- {'label': 'Tumor resection', 'description': 'Tumor resection', 'interventionNames': ['Procedure: Tumor resection']}\n- {'label': 'Tumor biopsy', 'description': 'Tumor biopsy', 'interventionNames': ['Procedure: Tumor biopsy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Tumor resection', 'description': 'Maximal safe resection of the tumor', 'armGroupLabels': ['Tumor resection']}\n- {'type': 'PROCEDURE', 'name': 'Tumor biopsy', 'description': 'Biopsy of the tumor', 'armGroupLabels': ['Tumor biopsy']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'Time from diagnosis to death from any cause', 'timeFrame': 'Up to 5 years postoperatively'}\n- {'measure': 'Adjuvant treatment with chemotherapy and radiotherapy', 'description': 'Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery', 'timeFrame': '6 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nOverall type I error rate does not exceed 5% with Bonferroni correction. 95% power at a 1% significance level for both endpoints. Estimated 10% ineligibility and withdrawal rate. Propensity score matching with a 1:1 ratio. Distribution assumptions: patients aged <70 vs \u226570 is 1:1, preoperative KPS of \u226470 vs >70 is 1:2, lobar/unifocal tumour vs midline/multifocal tumour is 3:1.", "answer": 564, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study has two primary endpoints. In order to guarantee that the overall type I error rate does not exceed 5%, we apply a Bonferroni correction for multiple testing. The sample size calculations that follow take that into account. For the first primary endpoint, OS, we assume a median survival time of 9 months in the control group (biopsy), and 12 months in the experimental group (resection). A two-sample test for proportions with continuity correction requires 512 patients (256 per arm) in total in order to detect the above-mentioned difference of 10% with 95% power at a 1% significance level. For the second primary endpoint, the proportion of patients with adjuvant treatment with chemotherapy and radiotherapy, we assume a proportion of 50% in the control group (biopsy) and 60% in the experimental group (resection). A two-sample test for proportions with continuity correction requires 290 patients (145 per arm) in total in order to detect the above-mentioned difference of 10% with 95% power at a 1% significance level. In order to power the study for both primary endpoints, we should include the larger required number of patients, that is, 512. A total of 750 eligible and evaluable patients in two arms allow the difference of 10% in the proportion of patients with adjuvant treatment with chemotherapy and radiotherapy to be detected with 99% power. Taking into account possible ineligibility and withdrawal of consent (we estimate this at 10%), a total of 564 patients should be included (282 patients per arm). Since propensity score matching with a 1:1 ratio will be performed, 564 patients will be included after matching: 282 patients in the resection arm and 282 patients in the biopsy arm. Since we estimate that (1) the distribution of patients aged <70 vs \u00e2\u0089\u00a570 is 1:1, (2) the distribution of patients with a preoperative KPS of \u00e2\u0089\u00a470 vs >70 is 1:2 and (3) the distribution of patients with a lobar or unifocal tumour versus midline or multifocal tumour is 3:1, we will include a total of 1692 patients: 846 patients in the resection arm and 846 patients in the biopsy arm after matching.", "id": 2012, "split": "test"} +{"trial_id": "NCT06150508", "pmid": "39910545", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial of the Smart Online-to-Offline Model Development for Chronic Diseases Management Through Digital Health in Real World Setting\n\nIncluded conditions:\n- Hypertension\n- Diabete Mellitus\n\nStudy Armgroups:\n- {'label': 'Comparative group', 'type': 'NO_INTERVENTION', 'description': 'Comparators will not be provided with the O2O service, but will be treated as usual (TAU) through the 1st tier health care clinics/centers in Pyeongchang-gun county.'}\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Intervention group will use the service app \"Value Health\" for life-log recording. They regularly record life-log data such as blood pressure, blood glucose, medication, diet, exercise, and weight. (As mentioned, glucose level and blood pressure measurements will be automatically shared with the app using Bluetooth function of the provided checkers.) Interventions through application include automated message and alarm service through the app, as well as personalized intervention messages, record management, and other interventions from the Smart Healthcare Center and the primary healthcare provider.', 'interventionNames': ['Behavioral: O2O digital healthcare service']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'O2O digital healthcare service', 'description': 'The O2O service includes a mobile app and web-based portal that allows patients to monitor their blood glucose levels, track their medication use and physical activity, receive personalized feedback and education, and communicate with healthcare providers. The treatment group will receive a blood sugar checker and blood pressure checker that send the records automatically to the application through Bluetooth.', 'armGroupLabels': ['Intervention group'], 'otherNames': ['O2O digital healthcare service for patients with diabetes and hypertension']}\n\nPrimary Outcomes:\n- {'measure': 'Blood pressure', 'description': 'Diastolic blood pressure, Systolic blood pressure (mmHg)', 'timeFrame': 'Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)'}\n- {'measure': 'Fasting blood glucose level (FBG) in mg/dL', 'description': 'Glucose level', 'timeFrame': 'Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)'}\n- {'measure': 'Glucose level', 'description': 'HbA1c in percent', 'timeFrame': 'Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)'}\n- {'measure': 'Lipid profile', 'description': 'Cholesterol, Triglyceride(TG), HDL Cholesterol, LDL Cholesterol(All in \u338e/\u3397)', 'timeFrame': 'Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times)'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a statistical significance level of 5%, 80% power, and a 1:1 allocation ratio between treatment and control groups. The sample size is predetermined to be 1000 participants, divided into two main groups (diabetes and hypertension), each with 500 subjects.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size for this study was determined based on the requirements of the project sponsor, which set a target of 1000 participants. Given this constraint, we calculated the Minimum Detectable Effect Size (MDES) to ensure the study could still detect meaningful differences between the treatment and control groups with sufficient statistical power. The cohort will be divided into two main groups: participants with diabetes and those with hypertension. Each group will then be randomly allocated into treatment and control subgroups. The calculation of MDES has been carried out separately for the diabetes and hypertension groups, considering the unique characteristics and expected effect sizes for each group. Despite the sample size being predetermined, we are confident that the power analysis shows the study is adequately powered to detect significant effects.\n Blocking helps reduce the variance in the outcome variable by improving the balance between treatment and control groups within blocks. Additionally, regression adjustment further reduces the variance by accounting for covariates that explain part of the outcome variability. Both adjustments serve to reduce the standard error, which in turn lowers the Minimum Detectable Effect Size (MDES) in the formula. With a sample of 500 subjects, equally allocated between treatment and control groups (1:1 ratio), a statistical significance level of 5%, and 80% power, the MDES for this study is calculated based on the reduction in standard error through blocking and covariate adjustment. (The constant 2.8 comes from the standard critical values used to calculate the Minimum Detectable Effect Size (MDES) in a two-tailed test with a significance level (alpha) of 5% and power of 80%.):\\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}$$MDES=2.8\\left(\\sqrt{\\frac1{500}+\\frac1{500(1-0.5)}}\\right)=0.216$$\\end{document}MDES=2.81500+1500(1-0.5)=0.216\n In this study, the MDES is 0.216. If we assume that the variation in the outcome variable explained by blocked random assignment and covariates is about 25%, the MDES is 0.187. Assuming when 10% of the variation is explained, the MDES is 0.205. The MDES is the smallest change in a metric that an experiment can reliably detect. Cohen suggested that 0.20 is a small effect size, 0.50 is a medium effect size, and 0.80 is a large effect size [14]. Therefore, our study\u00e2\u0080\u0099s MDES demonstrates that we are powered to detect even small effect sizes, which can still be clinically meaningful.", "id": 2013, "split": "test"} +{"trial_id": "NCT06155630", "pmid": "38627819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: 3D Printing vs Traditional Workflow for the Fabrication of Mandibular Implant Overdentures: A Randomized Cross-over Clinical Trial\n\nIncluded conditions:\n- Edentulous Mouth\n- Edentulous Jaw\n\nStudy Armgroups:\n- {'label': '3D printed mandibular implant overdenture', 'type': 'EXPERIMENTAL', 'description': \"First appointment: The first visit will consist of scanning the patients' existing upper complete denture and lower mandibular implant overdenture by using a desktop scanner. In the lab, the .stl files will be 3D printed using a DLP 3D printer. Second clinical appointment: the interim printed dentures will be adjusted with wax for the desired lip support and VD. Secondary impressions will be taken to refine fit. Maxillary and mandibular interim printed dentures will be scanned separately and together with an intraoral scanner. Patient's face will also be scanned by a face scanner. 2nd lab session: .stl files will be superimposed for the digital pathway. Teeth and denture bases will be designed virtually. Dentures bases will be manufactured by a DLP 3D printer with Dentca Resin. Dentures will receive Dentsply Portrait 3D teeth. Dentures will be finished and polished, and sandblasted in the attachment sockets. 4th appointment: denture delivery.\", 'interventionNames': ['Other: mandibular implant-overdenture']}\n- {'label': 'traditional mandibular implant overdenture', 'type': 'ACTIVE_COMPARATOR', 'description': 'The first visit will be the same. For the conventional pathway, the 2nd lab session will consist of pouring the impressions (type 4 stone), mounting the casts in arcon semi-adjustable articulator, removing the printed teeth, and replacing it with wax rim and acrylic tooth setup (Dentsply Portrait - same shape, size and shade used for 3D printed dentures).\\n\\nA 3rd appointment will be used for wax try-in for the conventional pathway. For the digital pathway, participants will have a chance to appraise their smile on a computer screen (virtual try-in, done remotely) and request modifications.\\n\\nDenture bases will be manufactured with conventional heat-polymerized resins, and participants will return for a 4th appointment for delivery, including chairside pick-up of attachments (GC Reline resin). Two short-term adjustments will be scheduled 24-72 h and 7 days after delivery, and then weekly until the dentures are comfortable.', 'interventionNames': ['Other: mandibular implant-overdenture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'mandibular implant-overdenture', 'description': 'Mandibular overdentures fabricated over two implants will be delivered to the patients. In the first group, the 3D printed overdentures will be given for 3 months, followed by 3-month wear of traditional overdentures. The second group will wear traditional overdenture first followed by 3 months of 3D printed overdenture.', 'armGroupLabels': ['3D printed mandibular implant overdenture', 'traditional mandibular implant overdenture']}\n\nPrimary Outcomes:\n- {'measure': 'Patient general satisfaction with full dentures', 'description': 'The investigators will use the McGill Denture Satisfaction Questionnaire (MDSQ) to measure overall satisfaction (primary outcome), and satisfaction with specific aspects of the dentures - ability to chew, comfort, stability, aesthetics, ability to speak, and ability to clean', 'timeFrame': 'Baseline and after 3 months of wearing each denture'}\n\nPlease estimate the sample size based on the assumption: \nA 2-sided alpha of 0.01, a power of 90%, and an estimated dropout rate of 20% to compensate for possible dropouts.", "answer": 26, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n The planned enrollment comprises 26 participants, based on overall patient satisfaction. A minimal important difference of 10\u00c2\u00a0mm (10% of the VAS) was used for the estimation, as done in previous RCTs [41, 54]. A standard deviation of 7.5\u00c2\u00a0mm was chosen for the difference in satisfaction [55]. Considering a 2-sided alpha of 0.01 to compensate for the number of secondary outcomes and a power of 90%, the RCT requires n\u00e2\u0080\u0089=\u00e2\u0080\u008921 for superiority hypothesis testing (i.e., the confidence interval for between-treatment differences would exclude zero) [56]. The final sample size is drawn from including further 20% to the planned n to compensate for possible dropouts; although withdrawals will unlikely pass 10% [41, 55, 57], additional participants may be lost due to aging-related issues (e.g., worsening of systemic diseases, and death).", "id": 2014, "split": "test"} +{"trial_id": "NCT06155838", "pmid": "40122537", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reducing Depression and Anxiety Among Teens in Multan, Pakistan: a Cluster Randomized Controlled Trial\n\nIncluded conditions:\n- Anxiety\n- Depression\n\nStudy Armgroups:\n- {'label': 'EASE Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of four fundamental themes that have empirical support, structured across seven group sessions for adolescents and three group sessions for their parents or guardians. The sessions for teenagers will be conducted in person, spanning seven weeks with one session per week, each lasting 90 minutes. Similarly, three sessions are scheduled for parents.\\n\\nIn accordance with WHO guidelines (2016), the intervention will be administered by non-specialist co-facilitators(class teachers) who possess at least 16 years of education (undergraduate degree). These co-facilitators will undergo a ten-day training program, demonstrating mock sessions as part of this training. During the intervention delivery, they will also benefit from weekly supervision provided by a specialist, who will be a graduate psychologist or trained nurse in mental health.', 'interventionNames': ['Other: \"Early Adolescent Skills for Emotions (EASE)']}\n- {'label': 'control/ wait list', 'type': 'NO_INTERVENTION', 'description': 'Throughout the study, participants in the control group will continue to receive standard treatment. Nevertheless, following the conclusion of the trial, all control group participants will undergo the EASE intervention over a seven-week period, which will also involve three sessions for their parents and guardians. This approach ensures that the control group is not placed at a disadvantage, in alignment with ethical principles.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': '\"Early Adolescent Skills for Emotions (EASE)', 'description': \"Weekly Schedule for Teen's and their parents Sessions:\\n\\nOver the course of 7 sessions, with one session per week lasting 90 minutes, the following core components will be covered:\\n\\nWeek 1: Exploring My Feelings\\n\\nWeek 2: Learning to Calm\\n\\nWeek 3 \\\\& 4: Learning CBT- Restructuring My Thinking, Changing Feelings and My Actions \\\\& Managing My Emotions and Issues\\n\\nWeek 5 \\\\& 6: Fostering Independent Problem-Solving Skills and Seeking Help\\n\\nWeek 7: Relapse Prevention\\n\\n2.0 For parents/ guardians\\n\\nWeek 3 Psychoeducation (to develop skills to be able to identify, listen, better respond and provide comfort to teens when they are overwhelmed by anxiety and depression).\\n\\nWeek 4 Positive parenting strategies\\n\\nWeek 5 Parents/ guardians Self-care\", 'armGroupLabels': ['EASE Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Aga Khan University Anxiety and Depression Scale (AKUADS-25)', 'description': 'AKUADS will be used to assess anxiety and depression affecting the target population. Items score ranges from 0-3 (0= never, 1=sometime, 2=mostly, 3=always) for each question item hence the total score of the tool is 0-75. The higher the score the more anxiety and depression will be severe with the cut score of 19.', 'timeFrame': \"at 12 weeks' post-intervention\"}\n\nPlease estimate the sample size based on the assumption: \nThe calculation aimed for 90% power with a significance level of 0.05. The study accounted for an intracluster correlation coefficient of 0.05 and two-sided hypothesis testing. An anticipated attrition rate of 20% was also included.", "answer": 450, "answer_type": "ACTUAL", "explanation": "Study sample size\n Sample size calculation was performed using OpenEpi software V.3.01. The calculation was stratified by gender, with the school defined as the cluster unit of randomisation. A feasibility study2 informed the assumptions for the calculation. An effect size of 0.4 was assumed at a 3-month postintervention follow-up. The calculation aimed for 90% power with a significance level of 0.05. The study accounted for an intracluster correlation coefficient of 0.05 and two-sided hypothesis testing. An anticipated attrition rate of 20% was also included. The clusters of schools will be randomised in a 1:1 allocation ratio. This results in a total of 449 participants (rounded to approximately 450). Each arm will include around 56.25 participants (rounded to 56\u00e2\u0080\u009357) aged 13\u00e2\u0080\u009319 from eight schools. Stratification by gender-based schools aims to balance the groups. This approach minimises between-cluster variability and enhances the study\u00e2\u0080\u0099s statistical power.", "id": 2015, "split": "test"} +{"trial_id": "NCT06160232", "pmid": "38279085", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms\n\nIncluded conditions:\n- Severe Alcohol Use Disorder\n\nStudy Armgroups:\n- {'label': 'high dose psilocybin', 'type': 'EXPERIMENTAL', 'description': '31 participants will receive a single administration of 30mg psilocybin provided within the context of a brief standardized psychotherapeutic intervention.', 'interventionNames': ['Drug: Psilocybin (high dose)']}\n- {'label': 'low dose psilocybin (active placebo)', 'type': 'PLACEBO_COMPARATOR', 'description': '31 participants will receive a single administration of a very low dose of psilocybin (active placebo) provided within the context of a brief standardized psychotherapeutic intervention.', 'interventionNames': ['Drug: Active placebo (low dose of psilocybin)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Psilocybin (high dose)', 'description': 'Psilocybin-assisted therapy', 'armGroupLabels': ['high dose psilocybin']}\n- {'type': 'DRUG', 'name': 'Active placebo (low dose of psilocybin)', 'description': 'Placebo-assisted therapy', 'armGroupLabels': ['low dose psilocybin (active placebo)']}\n\nPrimary Outcomes:\n- {'measure': 'Primary clinical outcome: change in percentage of heavy drinking days', 'description': 'The primary clinical outcome is the difference between the two treatment arms in terms of change from baseline (going back 8 weeks pre-enrolment) to 4 weeks post-hospital discharge (week 1 to 4 post-discharge) in the percentage of heavy drinking days. A heavy drinking day is defined as a day with \u2265 5 standard drinks/60g of alcohol for males, and \u2265 4 standard drinks/48g of alcohol for females. Alcohol consumption will be measured using the Timeline Follow-Back method (Sobell \\\\& Sobell, 1992), a semi-structured interview that provides estimates of the daily quantity, frequency, and pattern of alcohol (and other drugs) use during a set time period. The method has demonstrated adequate to excellent reliability and validity over a wide range of studies and clinical contexts (Carey, 1997; Sobell et al., 1996).', 'timeFrame': 'Baseline (going back to 8 weeks pre-enrolment) to 4 weeks post-hospital discharge'}\n- {'measure': 'Feasibility: recruitment and retention rate', 'description': 'Recruitment and retention rate will be recorded and reported. A consort diagram displaying participant retention at each phase of the recruitment, screening and data collection process will be presented. We will report the numbers of individuals provided with participant information sheets who subsequently decided not to participate in the trial, number that underwent screening and number of drop-outs. For full transparency on inclusivity, information on the demographics and reason for exclusion will be reported from the screening dataset.', 'timeFrame': 'Recruitment rate: at screening and enrolment. Retention rate: at each study visit'}\n- {'measure': 'Safety: adverse events', 'description': 'Adverse events will be systematically assessed at each study visit and follow-ups. Adverse events summary tables will display the total number of participants reporting an adverse event and the percentage of participants (%) with an adverse event.', 'timeFrame': 'At each study visit'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.9, type I error set at 0.05, 25% attrition rate", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size\n In line with extant studies indicating medium to large effects of PAT on alcohol consumption in patients with AUD (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00891, [54]; Hedges\u00e2\u0080\u0099 g\u00e2\u0080\u0089=\u00e2\u0080\u00890.52 [15]), the sample size was calculated to observe a medium-size effect (Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25) with a power of 0.9 and a type I error set at 0.05. A priori power calculation based on the primary clinical hypothesis (mixed-design analysis of variance, two groups: high dose vs. active placebo; two timepoints: % heavy drinking days from 8 weeks prehospitalization to 1\u00c2\u00a0day prehospitalization vs. % heavy drinking days from hospital discharge to 4 weeks posthospital discharge) indicated a needed sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008946. Accounting for 25% attrition, we set the total sample size to n\u00e2\u0080\u0089=\u00e2\u0080\u008962. If the drop-out rate is higher, we will continue to include participants until 46 have completed visit 14 (primary clinical outcome).", "id": 2016, "split": "test"} +{"trial_id": "NCT06163781", "pmid": "38821574", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning: a Randomized Controlled Trial\n\nIncluded conditions:\n- Artificial Intelligence\n- Machine Learning\n- Microbiology\n- Emergency Service, Hospital\n- Randomized Controlled Trial\n\nStudy Armgroups:\n- {'label': 'Blood culture taken based on machine learning tool', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Blood culture prediction tool']}\n- {'label': 'Blood culture taken based on the treating physician', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Blood culture prediction tool', 'description': 'Machine learning based predicition tool', 'armGroupLabels': ['Blood culture taken based on machine learning tool']}\n\nPrimary Outcomes:\n- {'measure': '30-day mortality', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided alpha of 5%, target power of at least 80%, and a dropout rate of 20%.", "answer": 7584, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n An analysis of 5907 unique ED visits with blood culture sampling in Amsterdam UMC showed a 30-day mortality rate of 7.6%, a hospital admission rate of 67.4% and an average length of stay in the hospital of 6.7\u00e2\u0080\u0089days. Based on these numbers, the sample sizes with a relative non-inferiority margin of 1.25 for the rates and 1\u00e2\u0080\u0089day for the length of stay were calculated. The sample sizes were calculated by a statistician based on a one-sided alpha of 5% and a target power of at least 80%. For 30-day mortality, the calculated sample size was 6066 (3033 per arm) to test non-inferiority. After inflation for a dropout rate of 20%, the final sample size is 7584 (3792 per arm). For the secondary outcomes, described in table 2, fewer participants were needed for adequate power.\n \n Table 2\n \n Overview of outcome measures\n \n \n \n \n Primary outcome\n 30-day all-cause mortality\n \n \n Key secondary outcomes\n In-hospital mortality\n \n \n \n Hospital admission rates\n \n \n \n Hospital length-of-stay\n \n \n Other outcome measures\n \n \n \n Patient-related outcomes\n 90-day mortality\n \n \n \n 30-day readmission rates\n \n \n \n Emergency department length-of-stay in hours\n \n \n Diagnostics related outcomes\n Percentage of blood cultures avoided in the intervention group\n \n \n \n Number of blood cultures on each day of hospital stay (in admitted patients)\n \n \n \n Percentage of positive blood cultures in each group\n \n \n \n Total number of laboratory and microbiology tests in the ED\n \n \n \n Total number of laboratory and microbiology tests on each day of hospital stay (in admitted patients)\n \n \n Therapy-related outcomes\n Percentage of patients receiving antibiotics in the ED\n \n \n \n Duration of antibiotic therapy\n \n \n \n Types of antibiotics given in the ED\n \n \n Model-related outcomes\n Model performance (AUC) during the trial\n \n \n \n Model performance in subgroups:Immunocompromised patients (triple immunosuppressive therapy)Patients who had transplants\n\n \n \n \n \n \n AUC, area under the operating curve; ED, emergency department.", "id": 2017, "split": "test"} +{"trial_id": "NCT06164314", "pmid": "39515867", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial\n\nIncluded conditions:\n- Postoperative Delirium\n\nStudy Armgroups:\n- {'label': 'Dex group', 'type': 'EXPERIMENTAL', 'description': 'Subjects assigned to Dex group will receive a continuous dexmedetomidine infusion (0.4 ug/kg/h) after anesthesia induction until dural closure, and then received an intravenous analgesia pump with dexmedetomidine(0.08ug/kg/h), sufentanil and antiemetic until 48 hours postoperatively', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects in the Placebo group were given comparable volumes of normal saline during the surgery, and intravenous analgesia pump also contains sufentanil and antiemetic, but no dexmedetomidine used until 48 hours postoperatively.', 'interventionNames': ['Drug: Dexmedetomidine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'In Dex group, dexmedetomidine will continue to be used during and after surgery, with a infusion of 0.4ug/kg/ h from anesthesia induction to dural closure, and then 0.08ug/kg/ h to 48 hours postoperatively.In placebo group, equivalent normal saline will be injected during operation, and the intravenous analgesia pump will not contain dexmedetomidine after operation', 'armGroupLabels': ['Dex group', 'Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'the incidence of delirium postoperatively', 'description': 'Using the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessment,combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments will be only conducted in patients with RASS sedation score exceeding -4.The CAM-ICU and the 3D-CAM describes four main characteristics of delirium: acute altered mental state ,fluctuating level of consciousness, inattention, and confusion of thought. If both the first and second features are present, and both the third or fourth features are present, the patient is diagnosed with postoperative delirium.', 'timeFrame': 'the postoperative 5 days'}\n\nPlease estimate the sample size based on the assumption: \nAlpha set at a two-sided 0.05, 90% power, and about 5% loss to follow-up.", "answer": 366, "answer_type": "ESTIMATED", "explanation": "Sample size estimate and statistical analyses\n An observational study reported a postoperative delirium incidence of 31% in 154 patients recovering from surgery for temporal tumours.10 In addition, we found that the incidence of postoperative delirium after craniotomy of frontotemporal brain tumours was up to 46%.6 Meta-analyses in non-neurosurgical patients have reported that intraoperative application of dexmedetomidine reduced the incidence of postoperative delirium by approximately 40\u00e2\u0080\u009360%.25 26 To avoid underpowering, we assumed a delirium incidence of 40% after temporal tumours resections and a 40% reduction with dexmedetomidine. With alpha set at a two-sided 0.05, 348 patients would provide 90% power. Accounting for about 5% loss to follow-up, we plan to enrol 366 patients with 183 in each group.\n Independent statisticians who are unaware of group allocation will analyse all the data by SPSS V.23.0. Normally distributed continuous variables will be reported as the mean\u00c2\u00b1SD and analysed with Student\u00e2\u0080\u0099s t-tests. Non-normally distributed continuous data will be reported as median (IQR) and analysed with the Mann\u00e2\u0080\u0093Whitney U-test. Categorical data will be reported as frequency (%) and were analysed using the \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test. Time to event results will be calculated with the Kaplan\u00e2\u0080\u0093Meier estimator, with differences between groups assessed by the log-rank test.\n For the primary outcome, missing data will be imputed by using the worst-case imputation scenarios.27 Two analysis populations will be considered: the intent to treat population and the per-protocol population. The primary outcome, the incidence of postoperative delirium, will be compared between groups with a \u00cf\u00872 test. Subgroup analysis will be conducted according to age (more than 65 years or not), gender, American Society of Anesthesiologists (ASA) physical status, anaesthesia duration and tumour size. Secondary outcomes will be analysed using Student\u00e2\u0080\u0099s t-tests, Mann\u00e2\u0080\u0093Whitney tests or \u00cf\u00872 tests as appropriate. The intention-to-treat primary outcome analysis will include all randomised subjects.", "id": 2018, "split": "test"} +{"trial_id": "NCT06168474", "pmid": "38238170", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Impact of a SIMPlified LaYered Consent Process on Recruitment of Potential Participants to the Staphylococcus Aureus Network Adaptive Platform Trial: a Pragmatic Nested Randomized Clinical Trial\n\nIncluded conditions:\n- Staphylococcus Aureus Bacteremia\n\nStudy Armgroups:\n- {'label': 'Simplified layered consent process', 'type': 'EXPERIMENTAL', 'description': 'For participants randomized to the SIMPLY-SNAP experimental group, a simplified layered consent process will be used to explain information for the SNAP trial. The research staff member obtaining consent will provide a standardized explanation, providing summarized information in simple English or French contained in a 4-page concise participant information sheet. Throughout the consent process, the research staff member will answer any questions that the participant has, to reflect routine consent discussion practice.', 'interventionNames': ['Other: Simplified layered consent form']}\n- {'label': 'Full-length consent form', 'type': 'ACTIVE_COMPARATOR', 'description': 'For participants randomized to the control group, the existing consent process will be used including going through the currently approved full-length informed consent form. The research staff member will provide an explanation using the full-length informed consent form as per standard clinical trial procedures. Similarly, throughout the consent process, the research staff member will answer any participant questions as per normal procedures.', 'interventionNames': ['Other: Full-length consent form']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Simplified layered consent form', 'description': 'The simplified consent form includes all essential elements of trial consent including an explanation of the trial procedures, data and sample collection, and follow-up information. The form also outlines important ethical considerations for patients, such as confidentiality, regulatory and safety requirements, the ability to drop out, and the necessary process and contact numbers for grievances or feedback. In addition to the text, the form includes links to additional written information and videos that can be accessed on top of the simplified informed consent form (i.e., the additional layers in the layered consent process). These materials are hosted on the main SNAP trial website (https://www.snaptrial.com.au/patients) and are available in English and French. Participants will be able to access these directly through embedded hyperlinks using provided electronic tablets.', 'armGroupLabels': ['Simplified layered consent process']}\n- {'type': 'OTHER', 'name': 'Full-length consent form', 'description': 'The full-length informed consent form contains all information upfront. Links to additional information will not be provided on the form but are freely available on the Internet should the participant wish to access them.', 'armGroupLabels': ['Full-length consent form']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients recruited to SNAP', 'description': 'The number of patients who consented and were randomized in the SNAP trial, divided by the total number of patient eligible for the SNAP trial and randomized in SIMPLY-SNAP.', 'timeFrame': '1 day'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha level of 0.05, power of 90%, and a two-sided null hypothesis test were used for the primary hypothesis. For the secondary hypothesis, 90% power and a 2.5% one-sided alpha were assumed. No inflation for dropout rate was considered.", "answer": 346, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was based on both the primary superiority hypothesis and the secondary non-inferiority hypothesis, with the final sample size taken as the larger of the two calculated sample sizes. The first calculation was based on testing the null hypothesis of no difference in proportions of recruitment success (into the larger SNAP trial) between the two intervention arms. In discussion with the SNAP Global Trial Steering Committee, the minimally clinically important difference in recruitment success rates of 15\u00e2\u0080\u0089percentage points was defined. Using estimates based on the current proportion of eligible SNAP patients consented in Canada, a 70% recruitment rate for the full-length consent form was chosen as the control event rate. With an anticipated 85% recruitment rate for the simplified consent process, an alpha level of 0.05, power of 90% and a two-sided null hypothesis test, the calculated minimum sample size requirement is 161 participants per arm (total 322 participants).\n For the secondary non-inferiority hypothesis, we assumed that the simplified layered consent process would be slightly better than the full-length consent form but would not meet the criteria for superiority. Assuming an 80% success rate in the intervention group vs 70% in the control group, with a non-inferiority margin of \u00e2\u0088\u00925% (ie, excludes a difference in favour of the full-length consent process arm of more than 5\u00e2\u0080\u0089percentage points), we calculated the number of patients required at 173 participants per arm (total 346 participants; 90% power, 2.5% one-sided alpha).\n We took the larger of the two calculation results (346 patients) as the final sample size. We did not inflate sample size for a potential dropout rate since primary outcome assessment occurs immediately post-randomisation and intervention.", "id": 2019, "split": "test"} +{"trial_id": "NCT06170047", "pmid": "39390601", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Chicago Parent Program for Foster Care: A Randomized Control Trial Examining the Prevention of Behavior Problems Among Young Children in Foster Care Through Group-based Foster Caregiver Training\n\nIncluded conditions:\n- Behavior Problem\n- Parenting\n\nStudy Armgroups:\n- {'label': 'Chicago Parent Program for Foster Care', 'type': 'EXPERIMENTAL', 'description': \"The Chicago Parent Program for Foster Care (CPP-FC) is a caregiver-directed prevention program to strengthen parenting skills and confidence in foster and kinship caregivers and prevent or reduce behavior problems in children 2-8 years old. CPP-FC was designed to specifically meet the unique needs of children ages 2-8 who are placed with foster and kinship caregivers. Participants assigned to CPP-FC will receive CPP-FC and the services typically offered from the county, Cincinnati Children's Hospital Medical Center Comprehensive Health Evaluations for Cincinnati's Kids (CHECK) clinic, and for licensed caregivers, their licensing agency.\", 'interventionNames': ['Behavioral: Chicago Parent Program for Foster Care']}\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': \"Usual Care control will receive standard care offered from the county, Cincinnati Children's Hospital Medical Center Comprehensive Health Evaluations for Cincinnati's Kids (CHECK) clinic, and for licensed caregivers, their licensing agency.\", 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Chicago Parent Program for Foster Care', 'description': 'CPP-FC consists of 12 two-hour sessions delivered virtually by two trained group leaders over 16 weeks (11 concurrent weeks, 1 one-month booster) in a group-based format. Foster and kinship caregivers of young children are systematically taught parenting skills through group discussions, videotaped vignettes, structured role play and weekly homework assignments.', 'armGroupLabels': ['Chicago Parent Program for Foster Care'], 'otherNames': ['CPP-FC', 'Caregivers on Point']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'The Usual Care control will receive services from the county, CHECK clinic, and for licensed caregivers, their licensing agency per usual care. Caregivers receive training and support from their county and/or private licensing agency, children are referred to community services by the caseworker when behaviors emerge, and support from behavioral health specialists is available when caregivers request them.', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Parental Stress Scale', 'description': 'The Parental Stress Scale is an 18-item questionnaire that assesses parental stress relating to parental sensitivity to the child, child behavior, and quality of the caregiver-child relationship. Items are rated on a 5-point scale, ranging from 1 (\"Strongly disagree\") to 5 (\"Strongly agree\"). Some items are reverse scored. Items are summed to yield a total score, with higher scores indicating higher levels of parental stress.', 'timeFrame': 'Baseline, 3 months (mid-point), and 6 months (follow-up)'}\n- {'measure': 'Change in Perceived Stress Scale', 'description': 'The Perceived Stress Scale is a 14-item self-report measure of how unpredictable, uncontrollable, and overloaded individuals find their life circumstances. All items are rated on a 5-point scale, ranging from 0 (\"Never\") to 4 (\"very often\"). Some items are reverse scored. Responses are summed to yield a total score (range 0-56), with higher scores indicating greater perceived stress.', 'timeFrame': 'Baseline, 3 months (mid-point), and 6 months (follow-up)'}\n- {'measure': 'The Child Adjustment & Parent Efficacy Scale, Total Intensity subscale', 'description': 'The Child Adjustment \\\\& Parent Efficacy Scale, Total Intensity subscale is a 27-item measure of child behavior and emotional problems. Item responses are rated on a 4-point scale, ranging from 0 (\"Not true of my child at all\") to 3 (\"True of my child very much\"/\"Most of the time\"). Twenty-four items are summed to yield a Behavior Problems score (range 0-72), and three items are summed to yield an Emotional Problems score (range 0-9). Behavioral and Emotional Problems scores can be summed for a Total Intensity score (range 0-81). Higher scores indicate a higher level of problems.', 'timeFrame': 'Baseline, 3 months (mid-point), and 6 months (follow-up)'}\n- {'measure': 'The Child Adjustment & Parent Efficacy Scale, Parenting Efficacy subscale', 'description': 'The Child Adjustment \\\\& Parent Efficacy Scale, Parenting Efficacy subscale is a 19-item measure of parental self-efficacy. Item responses are rated on a 10-point scale, with responses ranging from 1 (\"Certain I can\\'t do it\") to 10 (\"Certain I can do it\"). Items are summed to yield a total efficacy score, with higher scores indicating higher self-efficacy.', 'timeFrame': 'Baseline, 3 months (mid-point), and 6 months (follow-up)'}\n- {'measure': 'Change in Parenting Sense of Competence Scale', 'description': 'The Parenting Sense of Competence Scale is a 17-item questionnaire that measures overall parenting satisfaction and competence. Items are measured on a 6-point scale, with responses ranging from 1 (\"Strongly disagree\") to 6 (\"Strongly agree\"). Some items are reverse scored. Items are summed to yield two subscales: parental satisfaction and parental self-efficacy. Higher scores indicate higher levels of parental satisfaction and parental self-efficacy.', 'timeFrame': 'Baseline, 3 months (mid-point), and 6 months (follow-up)'}\n\nPlease estimate the sample size based on the assumption: \n\u2265 80% power to detect the smallest group difference (d = -0.43) at mid-point assessment, with 20% attrition rate.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Previous research on the CPP found moderate effect size differences between treatment and control groups on reductions in child behavior outcomes, the primary outcome of this study, ranging between d\u00e2\u0080\u0089=\u00e2\u0080\u0089\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.43 and\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.46 [25]. A power analysis conducted via Monte Carlo simulation in Mplus 8.5 with N\u00e2\u0080\u0089=\u00e2\u0080\u00895000 replications indicated\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008980% power to detect the smallest group difference observed in previous research (d\u00e2\u0080\u0089=\u00e2\u0080\u0089\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.43) at our mid-point assessment with a total sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089300 (n\u00e2\u0080\u0089=\u00e2\u0080\u0089150 per group) assuming 20% attrition at the mid-point assessment.", "id": 2020, "split": "test"} +{"trial_id": "NCT06170801", "pmid": "39933819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Feasibility of a Transdiagnostic Augmentation Therapy for Improving Interpersonal Skills Using the Kiesler Circle Training (KCT)\n\nIncluded conditions:\n- Depressive Disorder\n- Anxiety Disorder\n\nStudy Armgroups:\n- {'label': 'Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)', 'type': 'EXPERIMENTAL', 'description': 'The Kiesler Circle Training (KCT) consists of 12 weekly group sessions of 100 minutes each (in a group of max. 10 patients). In addition, all patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).', 'interventionNames': ['Behavioral: Kiesler Circle Training (KCT)', 'Behavioral: Cognitive Behavioral Therapy (CBT)']}\n- {'label': 'Cognitive Behavioral Therapy (CBT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients receive weekly individual state-of-the-art CBT sessions (50 minutes each).', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Kiesler Circle Training (KCT)', 'description': \"Kiesler Circle Training is a transdiagnostic modular group treatment, which comprises a baseline module and four additional independent modules (nonverbal communication, verbal communication, conflict training and empathy and corrective interpersonal experiences). KCT is based on a heuristic model to explain and anticipate interactions developed by Donald Kiesler and other representatives of the interpersonal theory. The circumplex model arranges the variety of interpersonal behaviors in terms of a circular continuum allocated on two orthogonal axes: The vertical axis addresses interpersonal control (agency), the horizontal axis addresses interpersonal communion. The model further allows illustrating complementary action tendencies to anticipate other's reactions and to guide own behavior to achieve interpersonal goals. KCT is designed for increasing the awareness of such interpersonal action tendencies and for improving interpersonal behavioral flexibility.\", 'armGroupLabels': ['Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)']}\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioral Therapy (CBT)', 'description': 'Cognitive Behavioral Therapy is based on the interrelationships of thoughts, actions and feelings. Presumably, individual CBT will address intrapersonal therapeutic foci such as behavioral activation, identification of dysfunctional thoughts, overcoming fears by exposure, etc. Individual CBT may also include interpersonal functioning as therapeutic foci. Disorder-specific treatment manuals are available for all diagnoses included in the study. Of note, state-of-the-art CBT does not necessarily mean, that individual CBT-sessions strictly adhere to a manual. However, because both study sites are CBT training institutes, which guarantee supervision at least every four hours, it can be estimated that state-of-the-art CBT is realized.', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT)', 'Kiesler Circle Training (KCT) + Cognitive Behavioral Therapy (CBT)']}\n\nPrimary Outcomes:\n- {'measure': 'Inventory for Interpersonal Problems (IIP-32; Horowitz et al., 1988, German: Thomas et al., 2011)', 'description': \"Change in interpersonal functioning, measured with the IIP-32 from baseline (Time 1) to week 14 (Time 2), represents the primary outcome measure. The IIP-32 is a self-assessment questionnaire for interpersonal problems, i.e., difficulties in interacting with other individuals, based on Horowitz's Circumplex Model. It consists of 32 items that are answered on a 5-point scale (0= not at all, 4 = very much). For evaluation, a mean score is calculated across all items, with a higher score indicating a higher severity of interpersonal problems.\", 'timeFrame': 'Weeks 1, 14'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed two-sample t-test with equal variance is used for power analysis, achieving 80% power at a significance level (alpha) of 0.05. A baseline-adjusted ANCOVA will be used for primary efficacy analysis. Approximately 17% dropout rate is considered.", "answer": 156, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on Holgersen et al,30 who argue that a clinical significance can only be assumed with an effect size of Cohen\u00e2\u0080\u0099s d=0.5, considering the costs of implementing an additional group therapy. Our sample size calculation relies on a two-tailed two-sample t-test, while a baseline-adjusted analysis of covariance (ANCOVA) will be used for the primary efficacy analysis. This results in a higher power compared with the two-sided t-test, which ignores the influence of different baseline values. This strategy for calculating the sample size is a conservative procedure. With a two-sided t-test with equal variance, the power analysis resulted in a group sample size of 64. This sample size achieves a power of 80% for rejecting the null hypothesis of equal means at a significance level (alpha) of 0.05. Considering approximately 17% dropouts during the treatment phase based on our phase I study,26 the total number of patients to be recruited is 156 (78 per group). Consequently, approximately 250 patients will undergo eligibility screening using diagnostic tools (see figure 2).\n \n Figure 2\n \n Trial design. CBT, cognitive behavioural therapy; KCT, Kiesler Circle Training; T1, baseline; T2, mid-assessment; T3, post-assessment; T4, follow-up.", "id": 2021, "split": "test"} +{"trial_id": "NCT06176001", "pmid": "38783322", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder - a Large Scale Real-world Randomized Controlled Parallel Group Trial\n\nIncluded conditions:\n- Bipolar Disorder\n\nStudy Armgroups:\n- {'label': 'Psychoeducation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomized to this arm are offered group-based psychoeducation shortly thereafter.', 'interventionNames': ['Other: psychoeducation in groups']}\n- {'label': 'Waiting list', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants randomized to this arm are placed on a waiting list for approximately 4 months and then offered group-based psychoeducation thereafter.', 'interventionNames': ['Other: psychoeducation in groups']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'psychoeducation in groups', 'description': 'Group-based psychoeducation for relatives. Group size: 20-40 relatives. Duration of intervention: six sessions, each two hours long with a 15 minutes break, over a period of 6-10 weeks. The sessions are held by experienced clinicians from the Copenhagen Affective Disorder Clinic, one chief physician and one nurse. Each session focuses on a specific topic, which the clinicians present and discuss using a presentation viewer. The sessions are interactive, and the participants are encouraged to ask questions during the presentations. During each session the participants will have some discussions in smaller groups to reflect on a topics and issues raised during the session.', 'armGroupLabels': ['Psychoeducation', 'Waiting list']}\n\nPrimary Outcomes:\n- {'measure': 'Change in mood instability in the relatives', 'description': \"Mood instability is calculated from daily self-reported mood registration in the app Monsenso. Participating relatives score their daily mood on a 9-point scale from 0-8 where 8 is 'in a brilliant mood' and 0 is 'really sad'\\n\\nThe participant rate daily in the Monsenso app during the time the participate in the study (4-8 months depending on which group they are randomly allocated to).\\n\\nFor each participant, a mood instability measure will be estimated for each day and aggregated by applying the root mean square successive difference (rMSSD) method.\", 'timeFrame': 'daily in 4-8 months.'}\n- {'measure': 'Change in mood instability in the corresponding patients', 'description': \"Mood instability is calculated from daily self-reported mood registration via the app Monsenso. The patients score their daily mood on a scale from -3 to +3, where -3 is the worst and +3 is the best mood. Patients' data from the Monsenso app is collected from a parallel RCT, in the time frame in which the relatives are in the study.\", 'timeFrame': 'daily in 4-8 months.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, type 1 error risk of 0.05, interdependence adjustment of 30%, and expected dropout rate of 10%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n According to prior analyses [73] mood instability in patients with BD varies on a scale from close to 0 to 10 with an average of 4.1 (SD\u00e2\u0080\u0089=\u00e2\u0080\u00892.6). Our power calculation is based on the assumption that group-based psychoeducation will be associated with a minimum decrease of 0.2 in mood instability compared to the placebo arm; for a power of 80% and a type 1 error risk of 0.05, we need to randomize a total of 126 patients (www.sample-size.net). Also, we need to adjust for situations where one patient has two involved relatives, making them interdependent (estimated to be 30%), and consider expected dropout (estimated to be 10%, as in our prior study [68]) resulting in a total sample size of 180. We expect 200 relatives to agree in participating in the RCT.", "id": 2022, "split": "test"} +{"trial_id": "NCT06176833", "pmid": "39702102", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training\n\nIncluded conditions:\n- Spinal Cord Injuries\n\nStudy Armgroups:\n- {'label': 'Early Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Additional training will begin no more than 60 days following spinal cord injury', 'interventionNames': ['Procedure: Body Weight Supported Treadmill Training']}\n- {'label': 'Sub-acute Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Additional training will occur 3 months following spinal cord injury', 'interventionNames': ['Procedure: Body Weight Supported Treadmill Training']}\n- {'label': 'Chronic Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Additional training will occur 6-12 months following SCI', 'interventionNames': ['Procedure: Body Weight Supported Treadmill Training']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': 'This group only receives standard of care treatment but is assessed at the same time points as the other groups'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Body Weight Supported Treadmill Training', 'description': 'For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.', 'armGroupLabels': ['Chronic Intervention', 'Early Intervention', 'Sub-acute Intervention'], 'otherNames': ['BWSTT']}\n\nPrimary Outcomes:\n- {'measure': '10 Meter walk test', 'description': 'Used to assess walking speed, time taken to walk 10 meters at fastest pace', 'timeFrame': '1-5 days Following Intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe nominal statistical power is 80% at a significance level (\u03b1) of 0.05. The estimated statistical power for the outcome of distance is 94% for comparing the chronic intervention group to the control group. A 20% dropout rate is assumed.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our total subject enrollment target is 54 participants from SRAlab and 54 participants from BSW (i.e., n\u00e2\u0080\u0089=\u00e2\u0080\u0089108 subjects) with acute (<\u00e2\u0080\u008945 days from injury), traumatic, and incomplete SCI. These numbers reflect recruitment accounting for a potential\u00e2\u0080\u0089~\u00e2\u0080\u008920% attrition during the study (i.e., n\u00e2\u0080\u0089=\u00e2\u0080\u008988 subjects are needed to reach statistical power).\n We used gait velocity data from a study by Lucareli et al. [21] as pilot data to calculate the required sample population. The estimated gait velocity improvement from baseline was 0.4\u00c2\u00a0m/sec with the estimated standard deviation (SD) of 0.41. Based on that pilot data and the two-sample t-test comparing each intervention group with the control group, the sample sizes of 22 participants in each of the four groups are required to achieve the nominal statistical power of 80% at \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05. Assuming a 20% dropout rate, 27 participants per group with a total of 108 participants will therefore be enrolled in the beginning of the study.\n With at least 22 participants completing the protocol in each group, the estimated statistical power for the outcome of distance [21] is 94% for comparing the chronic intervention group to the control group, with a group difference estimate of 10.75 and a common SD of 9.06. When data from all groups are utilized, the statistical power is expected to be higher.", "id": 2023, "split": "test"} +{"trial_id": "NCT06177132", "pmid": "39806605", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vestibular Infant Screening - Rehabilitation (VIS-REHAB): Protocol for a Randomised Controlled Trial on Vestibular Rehabilitation Therapy (VRT) in Vestibular-impaired Children\n\nIncluded conditions:\n- Vestibular Disorder\n\nStudy Armgroups:\n- {'label': 'VIS-REHAB Protocol', 'type': 'EXPERIMENTAL', 'description': 'The VIS-REHAB protocol entails 30-minute sessions conducted twice a week over a span of 9 weeks. These sessions are structured with 20 minutes dedicated to enhancing postural stability and 10 minutes focused on improving gaze stability. In greater detail, a minimum of 5 minutes time is reserved for counselling and providing background information on the exercises, focused on the vestibular issue. Apart from the counselling part, each session consist of 3 different exercise categories ((static postural stability, dynamic postural stability, general gross motor training (focus on PS), oculomotor function, gaze stability, or general gross motor training (focus on GS)), each carried out for 5 to 10 minutes.', 'interventionNames': ['Behavioral: VIS-REHAB protocol']}\n- {'label': 'CTRL Protocol', 'type': 'NO_INTERVENTION', 'description': 'In the control (CTRL) protocol, all forms of physical therapy in the context of motor development are ceased. Occupational therapy, speech-language therapy and physical therapy for other purposes are not covered by this commitment. Additionally, the child and parents are asked to not do any home exercises on their own. However, sports activities and other recreational hobbies will not be asked to be temporary halted, since they will be continued in the active rehabilitation programme as well.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'VIS-REHAB protocol', 'description': 'The VIS-REHAB protocol entails two essential components: postural stability (PS) and gaze stability (GS). Within the postural stability component of the VIS-REHAB protocol, there are static and dynamic balance exercises, along with general gross motor activities targeting core stability, agility, and bilateral coordination. The gaze stability part includes exercises enhancing oculomotor function such as smooth pursuit and saccadic movements, as well as VOR-exercises. Additionally, a general gross motor training program emphasises gaze stability by including exercises that improve eye-foot and eye-hand coordination. Furthermore, each session includes counselling and the provision of background information on the exercises.', 'armGroupLabels': ['VIS-REHAB Protocol']}\n\nPrimary Outcomes:\n- {'measure': 'Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB)', 'description': 'The child stands barefoot with feet together as still as possible for 30 seconds. There are eight test conditions: eyes open or closed, with or without foam, and eyes open or closed while on a foam, nodding the head in yaw or pitch at 0.33 Hz. The test will be conducted on a force platform, a Wii Balance Board (Nintendo Co., Ltd.), using the Colorado University BrainBLoX software. The total test time (s), anteroposterior and mediolateral sway (mm), centre of pressure path length (cm), sway velocity (m/s), and 95% confidence ellipse area (cm2 ) are measured by a custom-made code in MATLAB (The MathWorks, Inc. Natick, Massachusetts, United States).', 'timeFrame': 'Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.'}\n- {'measure': 'Gaze stability as assessed by the Dynamic Visual Acuity (DVA) test', 'description': \"The setup of the test is similar to that of the Static Visual Acuity (SVA) test, the only difference being that the patient's head will be passively moved by the examiner in the horizontal plane at a 2Hz-frequency over an amplitude of 15\u00b0 from centre. The difference between the SVA and the DVA score will be included as output measure.\", 'timeFrame': 'Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.'}\n\nPlease estimate the sample size based on the assumption: \nThe study applies a Bonferroni correction for two primary endpoints, leading to an alpha level of 0.025. It aims for a power of 90% and accounts for a 20% dropout rate.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Given the novelty of the research, studies with an identical test design in children with confirmed vestibular dysfunction are lacking. The study of Rajendran et al36 is most similar and assessed the effectiveness of a combined (postural control and gaze stabilisation) VRT programme on motor skills and balance in children with hearing impairment, compared with a group of children with no therapy. This study indicated a significant improvement in all outcome measures (eg, Single Leg Standing, Bipedal Leg Standing, Paediatric Functional Reach) compared with the control group. The current study compares three age groups and two vestibular groups, which amounts to six subgroups per trajectory. Two primary outcome measures (ie, Modified Clinical Test of Sensory Integration on Balance and Dynamic Visual Acuity test) will be studied in these groups. To compensate for two primary endpoints, a Bonferroni correction will be applied, leading to an alpha level of 0.025. Aiming for a power of 90%, with the use of a two-sample t-test, the required sample sizes were calculated based on two conditions (foam\u00e2\u0080\u0094eyes open and foam\u00e2\u0080\u0094eyes closed) of the Bipedal Leg Standing Test, which are also part of the Modified Clinical Test of Sensory Integration on Balance. Table 1 illustrates the results of the Bipedal Leg Standing Test across the four outcome variables, with a minimum sample size of three and a maximum sample size of four. The latter was selected as the required sample size for each subgroup, leading to a sample of 24 per therapy trajectory. Taking into account a possible 20% dropout rate, a total of 30 children will be included in each therapy trajectory, leading to a total sample size of 60 children.\n \n Table 1\n \n Sample size calculation\n \n \n \n \n Mean\n SD\n \u00ce\u00b1 level\n Power\n Sample size\n \n \n \n \n \nBipedal Leg Standing Test\n\n \n \n Anteroposterior sway: eyes open\n \n \n Experimental: \u00e2\u0088\u00926.81Controls: 0.91\n 1.83\n 0.025\n 90%\n 4\n \n \n Anteroposterior sway: eyes closed\n \n \n Experimental: \u00e2\u0088\u00927.77Controls: \u00e2\u0088\u00920.13\n 1.5\n 0.025\n 90%\n 3\n \n \n Mediolateral sway: eyes open\n \n \n Experimental: \u00e2\u0088\u009210.77Controls: 0.004\n 1.83\n 0.025\n 90%\n 3\n \n \n Mediolateral sway: eyes closed\n \n \n Experimental: 35.09Controls: 1.18\n 7.17\n 0.025\n 90%\n 3", "id": 2024, "split": "test"} +{"trial_id": "NCT06181279", "pmid": "40050061", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study\n\nIncluded conditions:\n- Pulmonary Atelectasis\n- Obesity, Morbid\n\nStudy Armgroups:\n- {'label': 'Individualized PEEP group', 'type': 'EXPERIMENTAL', 'description': 'After recruitment maneuver, PEEP is titrated decreasingly using driving pressure guided individualised PEEP ventilation strategy, and the PEEP corresponding to the lowest driving pressure is the individualised PEEP.', 'interventionNames': ['Procedure: Individualized PEEP group']}\n- {'label': 'Fixed PEEP group', 'type': 'OTHER', 'description': 'After recruitment maneuver, PEEP is fixed at 8cmH2O.', 'interventionNames': ['Procedure: Fixed PEEP group']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Individualized PEEP group', 'description': 'Individualized PEEP group: Recruitment Maneuver (RM) is performed first. In pressure control mode, PEEP and airway plateau pressure are increased to 20 cmH2O and 35 cmH2O at a rate of 5 cmH2O every 30s, and driving pressure is maintained at 15 cmH2O throughout. Subsequently, in volume-controlled ventilation mode, PEEP decreases from 20 cmH2O to 4 cmH2O at gradient of 2 cmH2O, and each PEEP level is maintained for 30s. The PEEP corresponding to the lowest driving pressure is the individualized PEEP we need. If multiple PEEP levels showed the same lowest driving pressure, the lowest PEEP value as the individualized PEEP. The above procedures are performed three times during the surgery (5 minutes after intubation,5 minutes after the beginning of pneumoperitoneum, and 5 minutes after the end of pneumoperitoneum).', 'armGroupLabels': ['Individualized PEEP group']}\n- {'type': 'PROCEDURE', 'name': 'Fixed PEEP group', 'description': 'After the same RM, PEEP is fixed at 8 cmH2O.', 'armGroupLabels': ['Fixed PEEP group']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of postoperative pulmonary atelectasis', 'description': 'The primary outcome of this study is postoperative atelectasis measured by lung ultrasound. Each hemithorax is divided into 6 regions using 3 longitudinal lines (parasternal, anterior and posterior axillary)and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12 lung regions were scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region is assessed using a 2-dimen-sional view with the probe placed parallel to the ribs. It distinguishes four progressive steps of loss of aeration according to the artifacts visualized in a scan: score 0, normal aeration (A-lines or no more than two B-lines); score 1, moderate loss of aeration (three or more well-spaced B-lines); score 2, severe loss of aeration(coalescent B-lines); and score 3, complete loss of aeration(tissue-like pattern). We define atelectasis to be significant if any region had a lung consolidation score of \u22652.', 'timeFrame': 'After 30 minutes of extubation'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1=0.05, 1-\u03b2=0.9, and a dropout rate of 10%", "answer": 52, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Based on our unpublished pre-experimental data, the mean\u00c2\u00b1SD LUS 30\u00e2\u0080\u0089min after extubation was 4.79\u00c2\u00b11.46\u00e2\u0080\u0089when a fixed PEEP of 8 cmH2O was used. We hypothesised that DP-guided PEEP will lead to a 30% reduction in LUS.19 With \u00ce\u00b1=0.05, 1-\u00ce\u00b2=0.9 and a dropout rate of 10%, the sample size is calculated to be 52.", "id": 2025, "split": "test"} +{"trial_id": "NCT06188962", "pmid": "39350145", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pragmatic Randomized Multiple Baseline Trial Evaluating Knowledge Insight Tools (KIT), a Cognitive Behavioural Therapy-informed School-based Counselling Intervention for Secondary School-aged Children and Young People With Anxiety and Mood Difficulties in the UK\n\nIncluded conditions:\n- Anxiety\n- Depression\n- Internalizing Problems\n- Low Mood\n\nStudy Armgroups:\n- {'label': '3-8 week baseline wait period followed by CBT-informed school-based counselling', 'type': 'OTHER', 'description': 'All participants undergo a baseline wait period but are randomized to different baseline lengths (3-8 weeks)', 'interventionNames': ['Behavioral: CBT-informed school-based counselling']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CBT-informed school-based counselling', 'description': \"Knowledge Insight Tools (KIT) is a CBT-based model of one-to-one therapy for secondary school pupils who are struggling with low mood and/or anxiety. KIT incorporates the key features of CBT (e.g., agenda setting, formulation around maintenance cycles, inter-session work involving exposure and/or behavioural activation) but is delivered in a semi-structured way that meets the young person's needs and pace of learning. Whilst there is an emphasis on symptom reduction, the primary focus is on the young person's goals for living and co-producing an understanding of how symptoms can interfere with these goals. Practitioners are encouraged to incorporate different therapeutic tools and modalities that complement the young person's strengths and ways of learning, including non-verbal forms of expression like arts and crafts, music, and dance. By being flexible, person-led, goal-focused, and integrative, KIT was designed to suit the needs of secondary school students.\", 'armGroupLabels': ['3-8 week baseline wait period followed by CBT-informed school-based counselling']}\n\nPrimary Outcomes:\n- {'measure': \"Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)\", 'description': 'Child-reported psychological distress/coping, anxiety, and mood difficulties. Scores range from 0-40, with higher scores reflecting worse psychological distress.', 'timeFrame': \"Assessed at the beginning of each weekly baseline session throughout each participant's 3-8 week baseline wait period, and at the beginning of each weekly intervention session over the 10-week intervention period.\"}\n\nPlease estimate the sample size based on the assumption: \nWe estimated power at 90% using the following parameters: An alpha level/type 1 error rate of 0.05 (one-tailed). A minimum of three baseline measurements (and a maximum of eight). A maximum of six random baseline wait periods. An autocorrelation of r = 0.4 between measurements. Thirty per cent missing data. Four hundred permutations and 1000 simulated samples.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We will recruit 60 young people to observe a medium-to-large pre-post difference (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.7) in YP-CORE scores between the baseline and intervention phases. We estimated this sample size using Samantha Bouwmeester\u00e2\u0080\u0099s tool for a priori power analyses for randomisation tests [59, 51]. We estimated power at 90% using the following parameters:An alpha level/type 1 error rate of 0.05 (one-tailed, as the shape of the distribution for randomisation tests is unknown).A minimum of three baseline measurements (and a maximum of eight) to establish a stable baseline measurement.A maximum of six random baseline wait periods which produces 720 possible assignments within an ethical timescale. We used the Wampold and Worsham randomisation method (i.e. randomising to different wait periods) rather than alternative methods (i.e. randomising to different start dates within intervention start weeks) as the increase in power associated with alternative methods is small [52], and it would not be feasible to control for the start date within a pragmatic, school-based trial.A minimum of six intervention measurements (five excluding the first intervention start week), based on the average treatment length in weeks from Place2Be\u00e2\u0080\u0099s pilot data.An autocorrelation of r\u00e2\u0080\u0089=\u00e2\u0080\u00890.4 between measurements, as weekly measurements tend to be moderately correlated.Thirty per cent missing data\u00e2\u0080\u0094we expect some missing data given the pragmatic nature of the trial.Four hundred permutations and 1000 simulated samples.", "id": 2026, "split": "test"} +{"trial_id": "NCT06190301", "pmid": "39608989", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma: a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Primary Ocular Adnexal MALT Lymphoma\n\nStudy Armgroups:\n- {'label': 'Intralesional Rituximab Injection', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Rituximab']}\n- {'label': 'Involved Site Radiation Therapy', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Radiation: Involved Site Radiation Therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Intralesional Rituximab Injection', 'armGroupLabels': ['Intralesional Rituximab Injection']}\n- {'type': 'RADIATION', 'name': 'Involved Site Radiation Therapy', 'description': 'Involved Site Radiation Therapy', 'armGroupLabels': ['Involved Site Radiation Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'The cumulative occurrence rate of complications of grade \u22652 within 5 years after treatment commencement', 'timeFrame': 'within 5 years after treatment commencement'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 0.05, a power of 80%, and an approximate 15% dropout rate are assumed.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size is calculated based on the primary outcome, namely the cumulative incidence of \u00e2\u0089\u00a5grade 2 complications within 5 years after treatment commencement. The cumulative incidence of complications in the control group receiving ISRT over 5 years is assumed to be 30% based on the following:\n The American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Oculoplastic and Orbit Panel conducted a systematic assessment of the efficacy and safety of existing treatments for ocular adnexal lymphoma.5 They included 27 studies with 2009 patients, of which approximately 30% reported various types of \u00e2\u0089\u00a5grade 2 complications (median follow-up: 2.7\u00e2\u0080\u009311.4 years).\n This study anticipates that the cumulative incidence of \u00e2\u0089\u00a5grade 2 complications in the experimental group over 5 years will be reduced to 8%.192330 With a two-sided significant level of 0.05 and a power (1\u00e2\u0080\u0093\u00ce\u00b2) of 80%, the target sample size for each group is estimated to be 46 using the software PASS V.16.0 (NCSS, LLC, USA). Considering an approximate 15% dropout rate, the final sample size for each group is determined to be 54, for a total of 108 cases.\n The main efficacy endpoint is the overall response rate within 5 years after treatment commencement. Non-inferiority testing will be employed. Studies reported an average overall response rate of approximately 95% for ocular adnexal MALT lymphoma treated with ISRT.1 13 This study, based on the lower incidence of complications with rituximab relative to radiotherapy, establishes the clinical tolerance for the efficacy difference between these two treatment modalities, known as the non-inferiority margin (\u00e2\u0088\u0086), set at \u00e2\u0088\u009215%. Based on a two-sided alpha of 0.05 and an 80% power of the test, the required sample size per group is 46. The sample size, calculated based on safety indicators, is deemed sufficient to meet the non-inferiority hypothesis for efficacy.", "id": 2027, "split": "test"} +{"trial_id": "NCT06193499", "pmid": "39587622", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.\n\nIncluded conditions:\n- Osteoarthritis Thumb\n\nStudy Armgroups:\n- {'label': 'Platelet rich plasma (PRP)', 'type': 'ACTIVE_COMPARATOR', 'description': 'High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system.', 'interventionNames': ['Procedure: Platelet rich plasma (PRP)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'intraarticular saline injection (0,6-1ml)', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Platelet rich plasma (PRP)', 'description': 'Intra-articular injection of platelet rich plasma (PRP)', 'armGroupLabels': ['Platelet rich plasma (PRP)']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Intra-articular Saline injection (0,6-1ml)', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Pain on load in thumb', 'description': 'Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)', 'timeFrame': '6 months after the first injection.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (p) < 0.05, power of 80%, and accounting for non-parametric outcomes and loss to follow-up.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n To show a difference of 20 points (out of 100), representing the minimal clinical difference [28], in pain on load NRS score between PRP and saline injection (SD 30) (3) after 6\u00c2\u00a0months, 37 patients are required in each treatment arm. The power will be 80% (p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05). To account for non-parametric outcomes and loss to follow-up, we aim to include 90 patients in total, 45 in each treatment arm.", "id": 2028, "split": "test"} +{"trial_id": "NCT06198387", "pmid": "39180187", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer: An Open, Exploratory Pilot Clinical Trial\n\nIncluded conditions:\n- Oligo-metastatic Prostate Carcinoma\n\nStudy Armgroups:\n- {'label': 'hormone and RT', 'type': 'EXPERIMENTAL', 'description': 'Patients with de novo oligo-metastatic prostate cancer will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy.', 'interventionNames': ['Radiation: hormone and RT', 'Drug: ADT combined with abiraterone']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'hormone and RT', 'description': 'The patients will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy(RT).', 'armGroupLabels': ['hormone and RT']}\n- {'type': 'DRUG', 'name': 'ADT combined with abiraterone', 'description': 'The patients will receive a two-year course of ADT combined with abiraterone.', 'armGroupLabels': ['hormone and RT']}\n\nPrimary Outcomes:\n- {'measure': 'progression-free survival 2 (PFS2)', 'description': 'To assess the duration from the reinitiation of endocrine therapy until the identification of disease progression again.', 'timeFrame': 'through study completion, an average of 3 years'}\n\nPlease estimate the sample size based on the assumption: \nSingle-arm exploratory pilot clinical trial", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Determination of Sample Size\n According to the design of a single-arm exploratory pilot clinical trial and the limited sample size, our targeted enrollment aims to incorporate a total of 30 cases.", "id": 2029, "split": "test"} +{"trial_id": "NCT06212921", "pmid": "38961419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biomarkers In Prediction of Acute Mesenteric Ischaemia: a Prospective Multicentre Study (BIPAMI Study)\n\nIncluded conditions:\n- Acute Mesenteric Ischemia\n\nStudy Armgroups:\n- {'label': 'Patient with suspicion of acute mesenteric ischaemia', 'type': 'OTHER', 'description': 'Bolld samples is the only intervention. All patients with suspicion of AMI will be included and blood samples collected', 'interventionNames': ['Diagnostic Test: Sequential blood samples']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Sequential blood samples', 'description': 'Sequential blood samples for diagnostic tests is the only intervention in thei study', 'armGroupLabels': ['Patient with suspicion of acute mesenteric ischaemia']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of correctly predicted cases of acute mesenteric ischaemia', 'description': 'Rate of correctly predicted cases of Acute mesenteric ischaemia using different biomarkers', 'timeFrame': '10 months'}\n\nPlease estimate the sample size based on the assumption: \nStatistical analysis will be performed using R Statistical Software 4.3.2. Data will be described using number (%), median (IQR), or mean (SD). Kolmogorov-Smirnov test will be used for normality testing. Student\u2019s t-test or Wilcoxon rank-sum test will be used for comparisons. ROC analysis will be performed for biomarkers with p-value < 0.05. Sensitivity, specificity, PPV, NPV, and likelihood ratios with 95% CI will be reported. Multivariable stepwise logistic regression analysis will be used to identify the best combination of biomarkers.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n The estimated sample size is in total of 250 patients, 160 patients with confirmed AMI (including 40 patients with NOMI) and 90 patients with suspected but not confirmed AMI.\n In the AMESI study, European and West-Asian sites recruited 14 patients with confirmed AMI in average (range 3\u00e2\u0080\u009334) and 7 (range 0\u00e2\u0080\u009325) with suspected but eventually not confirmed AMI per site during 10\u00c2\u00a0months. Accordingly, 20 sites are expected to encounter 220 patients with confirmed AMI and 120 patients with suspected AMI during 8\u00c2\u00a0months. Estimating 5% of patients allocated to palliative treatment without any further diagnostics, 10% of referrals and 15% of patients being excluded for other reasons (e.g. missing informed consent, logistical reasons), 20 sites recruiting patients during 8\u00e2\u0080\u009310\u00c2\u00a0months are necessary to reach the targeted number of patients. As the number of patients with suspected AMI and confirmed NOMI is difficult to predict, the final decision regarding recruitment period will be made after the interim analysis after 4\u00c2\u00a0months of the study.\n Statistical analysis will be performed with R Statistical Software 4.3.2 (R Core Team, Vienna, Austria, 2023). Data will be described in number (%), median (interquartile range, IQR) or mean (standard deviation, SD) as appropriate. Kolmogorov\u00e2\u0080\u0093Smirnov test will be used for data distribution normality testing. Analyses for confirmed transmural AMI vs suspected but not confirmed AMI (comparison A \u00e2\u0080\u0093 primary outcome), confirmed AMI of any stage vs suspected but not confirmed AMI (comparison B \u00e2\u0080\u0093 secondary outcome) and transmural vs non-transmural AMI (comparison C \u00e2\u0080\u0093 secondary outcome) will be performed in different measurement time points. Each biomarker will be described at each measurement point for all comparisons (A, B and C), using Student\u00e2\u0080\u0099s t-test or Wilcoxon rank-sum test as appropriate. For all biomarkers showing a p-value\u00e2\u0080\u0089<\u00e2\u0080\u00890.05 in at least one measurement point in univariate analysis, the area under the receiver operating curve (ROC) calculation will be performed. We will do this separately for comparisons A, B and C and identify optimal cut-off values for each biomarker based on maximum value of the Youden index [13]. All measurement time points before any treatment of AMI (1,2,3,6,8) will be pooled and AUROC analysis will be performed to identify the best cut-offs also for pooled data for each biomarker. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (LR) with 95% CI-s will be reported. Positive likelihood ratio (LR\u00e2\u0080\u0089+)\u00e2\u0080\u0089>\u00e2\u0080\u008910 and negative likelihood ratio (LR-)\u00e2\u0080\u0089<\u00e2\u0080\u00890.1 will be considered high diagnostic accuracy and LR\u00e2\u0080\u0089+\u00e2\u0080\u0089\u00e2\u0080\u0089>\u00e2\u0080\u00895 and LR-\u00e2\u0080\u0089<\u00e2\u0080\u00890.2 as moderate diagnostic accuracy. All biomarkers with at least moderate accuracy will be entered as binary covariates (using the best cut-offs previously found in the AUROC analyses resulting in highest AUC) into the multivariable stepwise logistic regression analysis (both directions) to identify the best combination of biomarkers discriminating between transmural AMI and no AMI based on Akaike information criterion (AIC). Analogical approach will be used for comparisons B and C. The best models will be applied to subgroup analyses in different sub-types of AMI. If the best models selected as described previously, do not perform well at different measurement time points or in different subtypes of AMI, additional analyses will be undertaken testing alternative combinations. We will present the best models for each comparison and for each subtype separately and will use them to construct a practical score that can be used to distinguish between no AMI, non-transmural AMI and transmural AMI (Table\u00c2\u00a03). If the different cut-offs from different models contradict (for example cut-off for non-transmural AMI vs transmural AMI is lower than the cutoff for no AMI vs AMI) additional analyses will be performed and more appropriate cut-offs will be found considering acceptable sensitivity and specificity from previous AUROC analyses. This approach will be compared to decision tree approach and if the decision tree accuracy is higher than the score\u00e2\u0080\u0099s accuracy, a decision tree will be preferred. The accuracy of the decision tree and the score will be calculated as proportion of correct predictions.\nTable\u00c2\u00a03Hypothetical visualization of a practical score for diagnosis of AMINo AMINon-transmural AMITransmural AMIBiomarker 1<\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00890 pointsx\u00e2\u0080\u0093y\u00e2\u0080\u0089=\u00e2\u0080\u00891 point>\u00e2\u0080\u0089y\u00e2\u0080\u0089=\u00e2\u0080\u00892 pointsBiomarker 2<\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00890 points>\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00892 pointsBiomarker 3<\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00890 pointsx\u00e2\u0080\u0093y\u00e2\u0080\u0089=\u00e2\u0080\u00891 point>\u00e2\u0080\u0089y\u00e2\u0080\u0089=\u00e2\u0080\u00892 pointsBiomarker 4<\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00890 points>\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00891 pointBiomarker 5<\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00890 points>\u00e2\u0080\u0089x\u00e2\u0080\u0089=\u00e2\u0080\u00892 pointsThis visualization is hypothetical. PPV \u00e2\u0080\u0093 positive predictive valueHypothetical examples: 0\u00e2\u0080\u00931 points\u00e2\u0080\u0089=\u00e2\u0080\u0089no AMI (PPV; 2\u00e2\u0080\u00934 points\u00e2\u0080\u0089=\u00e2\u0080\u0089non-transmural AMI (PPV);\u00e2\u0080\u0089>\u00e2\u0080\u00895 points\u00e2\u0080\u0089=\u00e2\u0080\u0089transmural AMI (PPV)\n Dynamics of each biomarker will be visualized graphically in patients with confirmed AMI differentiating between patients in whom initial treatment was successful from patients in whom bowel ischaemia was ongoing after initial treatment, with the aim to explore possible differences in biomarker trajectories in case of reperfusion and ongoing bowel ischaemia.", "id": 2030, "split": "test"} +{"trial_id": "NCT06214988", "pmid": "39887540", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial\n\nIncluded conditions:\n- Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'selective approach to defunctioning stoma', 'type': 'EXPERIMENTAL', 'description': 'With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.', 'interventionNames': ['Procedure: selective approach defunctioning stoma']}\n- {'label': 'routine use of defunctioning stoma', 'type': 'NO_INTERVENTION', 'description': 'With randomisation to this control arm (systematic approach), a defunctioning stoma is constructed using the marked stoma site. A loop ileostomy is fashioned using an ileal loop close to the ileocecal valve, while a loop colostomy can be derived from either the transverse or a redundant left colon.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'selective approach defunctioning stoma', 'description': 'With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.', 'armGroupLabels': ['selective approach to defunctioning stoma']}\n\nPrimary Outcomes:\n- {'measure': 'textbook outcome; stoma-free survival at two years without major LARS', 'description': 'extant stoma, alive, and a LARS score at 30 or lesn has stabilised as well for those without a stoma in situ.\\n\\nno extant stoma, alive, and a LARS score at 30 or less at the time point two years after the anterior resection.', 'timeFrame': '2 year'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 25% loss of data due to non-adherence, 90% statistical power, and a significance level of 5%.", "answer": 212, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size for the whole study is based on power calculations for the nested randomized superiority trial. The sample size is calculated with the following assumptions:\nProportion of patients with stoma\u00e2\u0080\u0090free survival without major LARS is estimated at 65% in the experimental no stoma groupProportion of patients with stoma\u00e2\u0080\u0090free survival without major LARS is estimated at 40% in the control stoma groupThe loss of data due to, for example, non\u00e2\u0080\u0090adherence to study protocol, is anticipated to be 25%\n\n The null hypothesis states no difference in stoma\u00e2\u0080\u0090free survival and the alternative hypothesis is that there is a difference. A total of 158 randomized patients (79 in each arm) are needed to detect a difference in proportion of 25% units (65% vs. 40%) between the group with 90% statistical power and a significance level of 5%. Considering attrition and missing data, we aim to include 212 participants.\n The first 100 included patients will be regarded as a feasibility phase. After inclusion of this feasibility cohort, assumptions will be checked descriptively, without breaking the randomization code. This will then inform potential adjustments to the sample size.", "id": 2031, "split": "test"} +{"trial_id": "NCT06217744", "pmid": "38937769", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mental Health Literacy and Academic Performance - A Randomized Clinical Trial\n\nIncluded conditions:\n- Mental Health Wellness 1\n\nStudy Armgroups:\n- {'label': 'Automated Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention will last for 3 months, with two psychoeducational modules delivered per month.', 'interventionNames': ['Behavioral: Automated Intervention']}\n- {'label': 'Blended Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention will last for 3 months, with two psychoeducational modules delivered per month. In addition, regular synchronous or asynchronous psychoeducational sessions conducted by a licensed psychologist will be held with the participants.', 'interventionNames': ['Behavioral: Blended Intervention']}\n- {'label': 'Waitlist', 'type': 'NO_INTERVENTION', 'description': 'This group will undergo the evaluations on the same schedule like the active groups. No intervention will be done.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Automated Intervention', 'description': 'Participants will receive 6 psychoeducational modules design to increase mental health literacy: Module 1: The Stigma of Mental Illness, Module 2: Understanding Mental Health and Mental Illness, Module 3: Information on Specific Mental Illnesses, Module 4: Experiences of Mental Illness, Module 5: Seeking Help and Finding Support, Module 6: The Importance of Positive Mental Health.', 'armGroupLabels': ['Automated Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Blended Intervention', 'description': 'Participants will receive the same materials as the Automated Intervention, as well as the possibility to attend psychoeducational sessions held by licensed psychologists.', 'armGroupLabels': ['Blended Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Academic Performance - reading', 'description': 'Reading comprehension will be assessed with a standardized test for Romanian language, which were sourced from the pool of items from the Progress in International Reading Literacy Study (PIRLS). The test will consist of 26 items, with difficulties ranging from easy to difficult. Higher scores indicate greater academic performance.', 'timeFrame': 'up to 3 months'}\n- {'measure': 'Academic Performance - mathematics', 'description': 'Performance in mathematics will be assessed with a standardized test, sourced from the TIMSS, a platform specializing in standardized educational assessment in Romania. The test will consist of 26 items, with difficulties ranging from easy to difficult. Higher scores indicate greater academic performance.', 'timeFrame': 'up to 3 months'}\n- {'measure': 'Depressive symptomatology', 'description': 'The Patient Health Questionnaire-9 Depression Scale (PHQ-A, Johnson et al., 2002) is the adolescent-adapted version of the Patient Health Questionnaire and contains ten items. Scores range from 0 to 30 and a higher score is representative of a worse outcome.', 'timeFrame': 'up to 3 months'}\n- {'measure': 'Anxiety symptomatology', 'description': 'The Anxiety Rating scale (Spitzer et al., 2011) consists of eight items, with scores ranging from 0 to 24 and higher scores indicate a worse outcome.', 'timeFrame': 'up to 3 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation aimed to achieve 80% power at an alpha level of 0.05.", "answer": 264, "answer_type": "ESTIMATED", "explanation": "Sample size\n R version 4.2.2 for Windows (R Foundation for Statistical Computing, Vienna, Austria) was used for the sample size calculation in a linear mixed-effect model (sjstats package). The R statistical computing environment will also be used for future model fitting and evaluation.\n We used appropriate methods for two-level-designs [25] to determine sample size requirements for a cRCT with 3 experimental groups, 4 classrooms per experimental condition, 22 participants per cluster. For our linear mixed-effects model, a sample size of approximately 88 participants per experimental condition for a total sample size of 264 was sufficient to achieve 80% power to detect an effect size of Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.4 at an alpha level of 0.05. A medium effect size was assumed based on previous work on digital mental health literacy interventions [26].", "id": 2032, "split": "test"} +{"trial_id": "NCT06223854", "pmid": "39477275", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Acceptability and Nutritional Effects of Double-fortified Salt Containing Folic Acid and Iodine Among Ethiopian Women of Reproductive Age - a Household-randomized, Controlled, Community-based Trial\n\nIncluded conditions:\n- Folate Deficiency\n- Iodine Deficiency\n- Anemia Macrocytic\n- Anemia Deficiency\n- Salt Intake\n- Vitamin B 12 Deficiency\n\nStudy Armgroups:\n- {'label': 'Iodized salt', 'type': 'ACTIVE_COMPARATOR', 'description': 'Refined iodized salt containing 35 ppm iodine as potassium iodate', 'interventionNames': ['Dietary Supplement: Iodized salt']}\n- {'label': 'Iodized salt with lower-dose folic acid fortification', 'type': 'EXPERIMENTAL', 'description': 'Refined iodized salt containing 35 ppm iodine as potassium iodate and 33 ppm folic acid (to provide an estimated 200 microgram folic acid per day to women consuming the previously determined average amount of discretionary salt in the study communities)', 'interventionNames': ['Dietary Supplement: Experimental: Iodized salt with lower-dose folic acid fortification']}\n- {'label': 'Iodized salt with higher-dose folic acid fortification', 'type': 'EXPERIMENTAL', 'description': 'Refined iodized salt containing 35 ppm iodine as potassium iodate and 99 ppm folic acid (to provide an estimated 600 microgram folic acid per day to women consuming the previously average amount of discretionary salt in the study communities)', 'interventionNames': ['Dietary Supplement: Experimental: Iodized salt with higher-dose folic acid fortification']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Iodized salt', 'description': \"Masked, individually labeled 500-g containers of the study salts will be delivered to the participants' homes bi-weekly by field workers who will collect previously delivered salt containers during the same visit. Participants will be counseled to use the study salt for all food preparation and meal-time seasoning for all members of the household and not to share the salt with others or use it for non-food consumption purposes.\", 'armGroupLabels': ['Iodized salt']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Experimental: Iodized salt with lower-dose folic acid fortification', 'description': \"Masked, individually labeled 500-g containers of the study salts will be delivered to the participants' homes bi-weekly by field workers who will collect previously delivered salt containers during the same visit. Participants will be counseled to use the study salt for all food preparation and meal-time seasoning for all members of the household and not to share the salt with others or use it for non-food consumption purposes.\", 'armGroupLabels': ['Iodized salt with lower-dose folic acid fortification']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Experimental: Iodized salt with higher-dose folic acid fortification', 'description': \"Masked, individually labeled 500-g containers of the study salts will be delivered to the participants' homes bi-weekly by field workers who will collect previously delivered salt containers during the same visit. Participants will be counseled to use the study salt for all food preparation and meal-time seasoning for all members of the household and not to share the salt with others or use it for non-food consumption purposes.\", 'armGroupLabels': ['Iodized salt with higher-dose folic acid fortification']}\n\nPrimary Outcomes:\n- {'measure': 'Red blood cell folate', 'description': 'Red blood cell (RBC) folate concentration will be measured on three occasions in each participant: 1) before the start of the intervention, 2) at a randomly assigned mid-point between 4 and 20 weeks after the start of the intervention, and 3) between 24-26 weeks after the start of the intervention. RBC folate concentration will be will be determined by using a microbiological assay.', 'timeFrame': 'Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)'}\n- {'measure': 'Serum folate', 'description': 'Serum folate concentration will be measured on three occasions in each participant: 1) before the start of the intervention, 2) at a randomly assigned mid-point between 4 and 20 weeks after the start of the intervention, and 3) between 24-26 weeks after the start of the intervention, by using a microbiological assay.', 'timeFrame': 'Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)'}\n- {'measure': 'Serum homocysteine', 'description': 'Serum homocysteine concentration will be measured on three occasions in each participant: 1) before the start of the intervention, 2) at a randomly assigned mid-point between 4 and 20 weeks after the start of the intervention, and 3) between 24-26 weeks after the start of the intervention.', 'timeFrame': 'Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)'}\n- {'measure': 'Serum thyroglobulin', 'description': 'Serum thyroglobulin concentration will be measured on three occasions in each participant: 1) before the start of the intervention, 2) at a randomly assigned mid-point between 4 and 20 weeks after the start of the intervention, and 3) between 24-26 weeks after the start of the intervention.', 'timeFrame': 'Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)'}\n- {'measure': '24-hour urinary iodine excretion', 'description': '24-hour urinary iodine excretion will be measured prior to the start of the intervention and at a second time time at least 4 weeks after the start of the intervention.', 'timeFrame': 'Before and during the intervention'}\n- {'measure': 'Serious adverse events', 'description': 'Serious adverse events requiring an overnight stay in a clinical facility or resulting in disability, or death will be recorded during each bi-weekly home visit.', 'timeFrame': 'Throughout the course of the intervention, total of 26 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe calculations assume a coefficient of variation of 35%, an alpha of 0.05, a power of 0.90, and a 15% attrition rate. Additionally, the sample size will allow for detection of a 35 \u00b5g/L difference in urinary iodine concentration with the same alpha and power.", "answer": 360, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n The sample size estimation is based on the number of women required to detect a clinically significant change in their RBC folate concentration in response to the intervention. According to the 2016 Ethiopian National Micronutrient Survey,13 the estimated mean RBC folate concentration among WRA is 507 nmol/L. If we assume a coefficient of variation of 35%, as has been observed in most other studies (as summarised in table 1),285456 the corresponding SD for Ethiopian women would be 177.5 nmol/L. To detect an effect size of 0.5 SD units (ie, 89 nmol/L), which would represent the difference in the change in mean RBC folate concentration from baseline to 6 months between women in the control group and women in the group receiving salt fortified with 200 \u00ce\u00bcg folic acid per day, 85 participants per group are necessary. A difference of 89 nmol/L is equivalent to 18% of the expected mean RBC folate concentration at baseline, which is more conservative than the 27% change observed among women receiving a 100 \u00c2\u00b5g folic acid supplement in a study by Hao et al.28 This calculation assumes an alpha of 0.05 and power of 0.90. After adjusting the sample size to account for the three-cell design, and an additional 15% to account for possible attrition, the total required sample size per group is 120 participants (ie, 360 participants total). This sample size will allow for comparisons between any two of the study arms.\n \n Table 1\n \n Published data regarding population RBC folate concentration and responses to intervention trials\n \n \n \n \n Study\n Folic acid dose\n n\n Mean (or geometric mean)\n SD (or CI)\n Estimated SD\n Coefficient of variation, CV (%)\n % change from baseline\n Ref\n \n \n \n \n Ethiopia national survey\n \u00e2\u0080\u0093\n 1121\n 511\n (487, 527)\n 340\n 67.1\n \u00e2\u0080\u0093\n \n13\n\n \n \n Guatemala national survey\n \u00e2\u0080\u0093\n 1448\n 727\n (711, 738)\n 262\n 36.0\n \u00e2\u0080\u0093\n \n54\n\n \n \n Hao baseline\n \u00e2\u0080\u0093\n 339\n 594\n (572, 618)\n 216\n 36.3\n \n \n28\n\n \n \n Hao 6 months\n 100 \u00ce\u00bcg/day\n 339\n 760\n (731, 789)\n 272\n 35.6\n 27.9\n \n28\n\n \n \n Hao 6 months\n 400 \u00ce\u00bcg/day\n 338\n 1036\n (997, 1076)\n 370\n 35.8\n 74.4\n \n28\n\n \n \n Johansson baseline\n 166 \u00ce\u00bcg/day\n \n 577\n 93\n \n 16.1\n \u00e2\u0080\u0093\n \n55\n\n \n \n Johansson 3 months\n 166 \u00ce\u00bcg/day\n \n 694\n 154\n \n 22.2\n 20.3\n \n55\n\n \n \n Johansson baseline\n 355 \u00ce\u00bcg/day\n \n 784\n 238\n \n 30.3\n \u00e2\u0080\u0093\n \n55\n\n \n \n Johansson 3 months\n 355 \u00ce\u00bcg/day\n \n 987\n 167\n \n 16.9\n 25.9\n \n55\n\n \n \n Lamers baseline\n \u00e2\u0080\u0093\n 34\n 668\n (593, 752)\n 236\n 35.4\n \u00e2\u0080\u0093\n \n56\n\n \n \n Lamers 24 weeks\n 400 \u00ce\u00bcg/day\n 34\n 1290\n (1200, 1370)\n 496\n 38.4\n 93.1\n \n56\n\n \n \n \n \n \n RBCred blood cell\n \n \n \n Based on information on urinary iodine concentration among WRA published in the 2016 National Micronutrient Survey (median=96.7\u00e2\u0080\u0089\u00c2\u00b5g/L, IQR 57.6\u00e2\u0080\u0093170.5),13 this sample size will permit detection of a 35 \u00c2\u00b5g/L difference in urinary iodine concentration in either of the arms receiving folic acid-fortified salt compared with the control group (alpha=0.05; beta=0.90). Because we will obtain information on mean 24-hour urinary iodine concentration and total daily urinary iodine excretion rather than just single urine samples, we should be able to detect an even smaller effect size than would be possible with just a single sample.", "id": 2033, "split": "test"} +{"trial_id": "NCT06224426", "pmid": "39755573", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)\n\nIncluded conditions:\n- Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'Normobaric high-concentration oxygen (NBHO) group', 'type': 'EXPERIMENTAL', 'description': 'After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 \u00b5g/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBHO group will adjust the FiO2 at 80% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 \u00b5g/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.', 'interventionNames': ['Other: Normobaric high-concentration oxygen']}\n- {'label': 'Normobaric low-concentration oxygen (NBLO) group', 'type': 'EXPERIMENTAL', 'description': 'After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 \u00b5g/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBLO group will adjust the FiO2 at 30% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 \u00b5g/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed.', 'interventionNames': ['Other: Normobaric low-concentration oxygen']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Normobaric high-concentration oxygen', 'description': 'During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min.', 'armGroupLabels': ['Normobaric high-concentration oxygen (NBHO) group']}\n- {'type': 'OTHER', 'name': 'Normobaric low-concentration oxygen', 'description': 'During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.', 'armGroupLabels': ['Normobaric low-concentration oxygen (NBLO) group']}\n\nPrimary Outcomes:\n- {'measure': 'the incidence of early neurological improvement (ENI)', 'description': 'ENI is defined as an NIHSS score of \\\\<10 points at 24\u00b12 hours after EVT', 'timeFrame': '24\u00b12 hours after EVT'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05 (two-sided), power (1\u2212\u03b2) of 0.80, and a potential dropout rate of 5%. An interim analysis is planned after 100 patients with a nominal \u03b1 set at 0.003 using the O'Brien-Fleming spending function.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n The sample size was determined based on the incidence of ENI. According to a previous study, approximately 30% of patients achieved an NIHSS score<10 at 24 hours post-EVT when they underwent EVT via non-intubated nasal inhalation of ambient air (FiO2=21%).22 We hypothesise that a 20% difference may be observed when patients are inhaling high concentrations of oxygen under general anaesthesia with endotracheal intubation. Given a significance level (\u00ce\u00b1) of 0.05 (two-sided) and a power (1\u00e2\u0088\u0092\u00ce\u00b2) of 0.80 and assuming equal sample sizes for both groups, the calculated sample sizes for the experimental and control groups using PASS 11.0 software were N1=N2=95. Considering a potential dropout rate of 5%, a total of at least 200 patients are needed.\n We define our trial as exploratory in nature. Consequently, an interim analysis is planned after the follow-up of 100 patients using the O'Brien-Fleming spending function to adjust the significance level, with the nominal \u00ce\u00b1 set at 0.003. If the interim analysis indicates that the incidence of ENI is nearly identical between the two groups, we will consider terminating the trial to conserve resources and time. Conversely, if a positive effect is observed, even if not highly significant, we will proceed with the trial as originally planned. If necessary, we will recalculate the required sample size to ensure the study\u00e2\u0080\u0099s statistical power and scientific validity.", "id": 2034, "split": "test"} +{"trial_id": "NCT06224556", "pmid": "39272196", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Personalized Prevention Program (PPP) Based on the Comprehensive Geriatric Assessment (CGA) for the Prevention of Multidimensional Frailty Related to Non-communicable Chronic Diseases (NCDs) in Older People: a Practical Approach in Primary Care Setting\n\nIncluded conditions:\n- Older People\n- Non-Communicable Chronic Diseases\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'All the 608 patients will be evaluated by their General Practitioners through the Brief-MPI scale, which is based on the Comprehensive Geriatric Assessment (CGA).\\n\\nBased on the score obtained at the Brief-MPI, the patient will receive a Personalised Prevention Program (PPP) concerning the following domains: 1) motor, 2) cognitive, 3) nutritional, 4) polypharmacotherapy, 5) vaccination prevention, 6) basal and instrumental activities, 7) co-habitation. Patients will receive brochures containing practical advice and recommendations to be implemented over a 12-month period; in the case of high Brief-MPI risk scores, patients will be referred for specialist examinations and/or in-depth diagnostics.\\n\\nIn addition, saliva samples will be collected to assess biomarkers of oxidative stress and, in a subsample of 210 subjects, the composition of the oral microbiota will also be analysed.', 'interventionNames': ['Combination Product: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive the standard clinical practice by their General Practitioners, without being evaluated by the CGA or receiving the personalized prevention program (PPP). No saliva sample will be collected.'}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program', 'description': 'Patients will be evaluated at baseline and at 6 and 12 months after the baseline through the CGA, the Resilience Scale (RS-14 items) and the Psychological General Wellbeing Index short form.\\n\\nThe prevention program will be received at the baseline, so at the two follow-ups patients wiil asked the adherence to it and the level of satisfaction (Client Satisfaction Questionnaire - 8 items).\\n\\nSaliva sample will be collected and analyzed.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Hospitalization rate', 'description': 'Unplanned hospitalization rate', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nIntra-cluster correlation coefficient of 0.004, power of 80%, type I error of 5%, and a drop-out rate of 20% over the 1-year follow-up period.", "answer": 1216, "answer_type": "ESTIMATED", "explanation": "Sample size\n A recent Cochrane systematic review [22] reported a significantly lower risk of unplanned hospitalizations in community-dwelling older people treated with CGA compared to standard clinical practice (relative risk (RR)\u00e2\u0080\u0089=\u00e2\u0080\u00890.83; confidence interval (CI) 95%: 0.70\u00e2\u0080\u00930.99), with a proportion of unplanned hospitalizations at 12\u00c2\u00a0months of 47.7%.\n Based on a comparison of proportions between two samples, with a pre-determined number of clusters consisting of 33 general practitioners, assuming an intra-cluster correlation coefficient of 0.004 [23], 28 patients per cluster will be necessary to detect an improvement in the proportion of unplanned hospitalizations at 12\u00c2\u00a0months of approximately 9% in the intervention group, assuming a power of 80% and a type I error of 5%. Taking into account a drop-out rate of 20% over the 1-year of follow-up period, a total of 1216 participants, 608 in IG and 608 in CG, will be enrolled, corresponding to 34 patients per cluster.", "id": 2035, "split": "test"} +{"trial_id": "NCT06226818", "pmid": "39566954", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessing the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's or Traditional Health Centres: a Prospective, Quasi-experimental, Multicentre, National Study.\n\nIncluded conditions:\n- Domestic And/or Sexual Violence\n\nStudy Armgroups:\n- {'label': 'experimental group', 'description': \"Women cared for in a women's centre\", 'interventionNames': ['Other: completion of scales and questionnaires']}\n- {'label': 'comparator group', 'description': 'Women in a health centre or family planning centre.', 'interventionNames': ['Other: completion of scales and questionnaires']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'completion of scales and questionnaires', 'description': 'Patient questionnaires Abuse assessment Screen, Evaluation of the PCL-5 score, Measurement of insomnia severity indexes (ISI), quality of life scores (WHOQOL-BREF), anxiety and depression using the HAD scale (Hospital Anxiety and Depression), self-esteem score using the Rosenberg scale, feeling of security and well-being using five-point Likert scales.\\n\\nQuestionnaire on daily and occasional smoking, alcohol consumption using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cannabis dependence using the Cannabis Abuse Screening Test (CAST) and use of other psychoactive substances.', 'armGroupLabels': ['comparator group', 'experimental group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in mean PCL-5 score', 'description': 'measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).', 'timeFrame': 'Through study completion, an average of 6 months'}\n- {'measure': 'Change in the proportion of women with a PCL-5 score < 33 (validated threshold for absence of overt PTSD)', 'description': 'measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).', 'timeFrame': 'Through study completion, an average of 6 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% (two-tailed) significance level, and a 25% dropout rate.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our primary outcome, the PCL-5 score, had a mean score of 37.1 (SD=16.1) in the pilot study.25 Therefore, to achieve 80% power and a 5% (two-tailed) significance level to detect an average difference of 5.5 between the two groups, assuming the SD of the differences is 16, a minimum of 135\u00e2\u0080\u0089women per group is required.\n Thus, we need to recruit 180\u00e2\u0080\u0089women per group, 360 in total, with a potential dropout rate of 25%.", "id": 2036, "split": "test"} +{"trial_id": "NCT06228768", "pmid": "39841658", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer\n\nIncluded conditions:\n- Postmenopausal\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Acupressure Arm 1', 'type': 'OTHER', 'description': 'There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point with the AcuWand giving a total treatment time of 27 minutes daily. The relaxation acupoints are unlisted in order to maintain blinding.', 'interventionNames': ['Other: Acupressure']}\n- {'label': 'Acupressure Arm 2', 'type': 'OTHER', 'description': 'There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes daily. The acupoints are unlisted in order to maintain blinding.', 'interventionNames': ['Other: Acupressure']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Acupressure', 'description': '9 acupoints will be stimulated for 3 minutes per point', 'armGroupLabels': ['Acupressure Arm 1']}\n- {'type': 'OTHER', 'name': 'Acupressure', 'description': '9 areas will be stimulated for 3 minutes per point', 'armGroupLabels': ['Acupressure Arm 2']}\n\nPrimary Outcomes:\n- {'measure': 'Change in joint pain', 'description': 'Range 0-10 after 12 weeks of intervention. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Comparison of baseline and 12 week assessment.', 'timeFrame': 'baseline and 12 weeks after intervention is started'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided 5% significance level, simplified two-sample t-test, and accounting for potential dropout.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n A total of 50 patients will be enrolled. For the sample size calculation, we assumed a standard deviation of difference in worst pain score between treatment groups of 2.3 points based on data from a prior acupuncture clinical trial [41]. With a sample size of 44 evaluable participants (22 evaluable per arm), we will therefore have 80% power to detect a reduction of 2 points in worst pain on the BPI at 12 weeks, assuming a two-sided 5% significance level and a simplified two-sample t-test. A 2-point improvement in pain is considered a minimal clinically important difference [42]. To account for potential dropout, we are planning to accrue 50 participants to ensure that 44 participants are evaluable for the primary endpoint.", "id": 2037, "split": "test"} +{"trial_id": "NCT06230367", "pmid": "39762976", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States\n\nIncluded conditions:\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'SHAG (Sexual Health Advocacy for Guys)', 'type': 'EXPERIMENTAL', 'description': \"Young people assigned to the intervention arm will receive \\\\~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior.\", 'interventionNames': ['Behavioral: Sexual health advocacy for guys']}\n- {'label': 'Attention-matched control', 'type': 'PLACEBO_COMPARATOR', 'description': \"Young people assigned to the control arm will receive \\\\~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages.\", 'interventionNames': ['Behavioral: Healthy lifestyle control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Sexual health advocacy for guys', 'description': '5 month HIV prevention program delivered via text messaging', 'armGroupLabels': ['SHAG (Sexual Health Advocacy for Guys)']}\n- {'type': 'BEHAVIORAL', 'name': 'Healthy lifestyle control', 'description': '5 month control group program delivered via text messaging', 'armGroupLabels': ['Attention-matched control']}\n\nPrimary Outcomes:\n- {'measure': 'HIV Incidence', 'description': 'HIV Incidence determined by home testing kit', 'timeFrame': '12-months post-intervention and immediately post-intervention'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided alpha level was specified, with a power of 0.8, a significance level (p-value) of 0.05, and a 30% loss to follow-up.", "answer": 5000, "answer_type": "ESTIMATED", "explanation": "Sample size\n The proposed sample size for the current study is N\u00e2\u0080\u0089=\u00e2\u0080\u00895000 youth. We conducted power analyses to determine whether the proposed sample size is adequate to test the intervention\u00e2\u0080\u0099s impact on reducing self-reported HIV incidence (primary study outcome). We focused on this outcome measure because it is the least common of the main outcomes identified. As such, if we have sufficient power to detect HIV incidence, we have sufficient power for testing the effect of SHAG on all other primary study outcomes.\n Effect sizes for the power calculation were based on prior work. In a study of 450 men who have sex with men aged 16\u00e2\u0080\u009320\u00c2\u00a0years old, Garofalo et al. reported the 12-month HIV incidence rate to be between 2.0 and 6.0, with 95% confidence [51]. To be conservative, we assumed a 30% loss to follow-up, which is considerably higher than we have seen in previous studies by this research team. Given that we are interested in determining whether the intervention has a positive impact, a one-sided alpha level was specified. Results using PASS Sample Size and Power [52] suggest that using a log-rank test we will have power\u00e2\u0080\u0089=\u00e2\u0080\u00890.8 to detect a hazard ratio\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00890.5 implying a difference between the HIV incidence rates in the treatment (SHAG) and control if the population HIV incidence rate is 2% or higher, with a p-value of 0.05 or less.", "id": 2038, "split": "test"} +{"trial_id": "NCT06232824", "pmid": "38943178", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction\n\nIncluded conditions:\n- Tele-rehabilitation\n- Anterior Cruciate Ligament Reconstruction\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment.\\n\\nParticipants in the intervention group received detailed education and rehabilitation program on the mobile phone application including text, photos, and videos. On the first day of enrollment, the doctor inform the participants of the importance of rehabilitation and how to use the mobile phone application. The postoperative rehabilitation protocol includes four phases: Phase 1 (0-2 weeks), Phase 2 (3-4 weeks), Phase 3 (5-8 weeks), Phase 4 (9-12 weeks), and Phase 5 (after 13 weeks).', 'interventionNames': ['Behavioral: Tele-rehabilitation']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively.\\n\\nAt the 2, 4, 8, 12, and 24 weeks after ACLR, all participants went to the outpatient clinic for follow-up by physiotherapist to provide face-to-face guidance for exercise methods. Physiotherapist would clarify the content of the rehabilitation plan if any doubt, but will not provide information extending the prearranged scope.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Tele-rehabilitation', 'description': 'The whole program is constituted of preoperative education and postoperative rehabilitation (in hospital and out of hospital). All the participants received the same preoperative education through the mobile phone application and oral communication. Participants in the intervention group get the multicomponent supervised tele-rehabilitation, while participants in the control group get the home-based self-rehabilitation. All the postoperative rehabilitation programs are presented and executed through the mobile phone application.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'the percentage of patients who achieve a satisfactory active ROM (flexion and extension)', 'description': 'In the first 3 months after ACLR, the achievement of acceptable knee active extension and flexion was regarded as what matters most for a successful recovery. A good knee active ROM could guarantee an expectedly continue improvement.', 'timeFrame': 'at the 2, 4, 8, 12 and 24 weeks following the ACLR'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, attrition rate = 20%", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n We use PASS software to calculate the sample size. We set the percentage of patients who achieve a satisfactory active ROM at the 3 months following the ACLR as the primary outcome. It was reported that approximately 95% of patients should achieve an acceptable ROM at 3 months after ACLR [17]. Besides, An estimated 20% difference was reported to be clinically significant [6]. To achieve a power of 80% (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), a minimum of 44 subjects is required for each group. Taking a 20% attrition rate into consideration, a total of 110 patients (55 per group) will be recruited in the study.", "id": 2039, "split": "test"} +{"trial_id": "NCT06234592", "pmid": "38870103", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Vasopressor Therapy on Renal Perfusion in Patients With Septic Shock - a Mechanistically Focussed Randomized Control Study\n\nIncluded conditions:\n- Septic Shock\n- Acute Kidney Injury\n\nStudy Armgroups:\n- {'label': 'Angiotensin II Infusion', 'type': 'EXPERIMENTAL', 'description': 'Angiotensin II infusion commenced alongside standard care vasopressor therapy (norepinephrine). Angiotensin II up titrated in a protocolised manner to a target/maximum dose of 40 ng/kg/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.', 'interventionNames': ['Drug: Angiotensin II', 'Drug: Norepinephrine']}\n- {'label': 'Vasopressin Infusion', 'type': 'EXPERIMENTAL', 'description': 'Vasopressin infusion commenced alongside standard care vasopressor therapy (norepinephrine). Vasopressin up titrated in a protocolised manner to a target/maximum dose of 0.04 IU/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.', 'interventionNames': ['Drug: Vasopressin', 'Drug: Norepinephrine']}\n- {'label': 'Norepinephrine Infusion', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard care vasopressor therapy which recruited participants already receiving, titrated to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.', 'interventionNames': ['Drug: Norepinephrine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Angiotensin II', 'description': 'Angiotensin II infusion', 'armGroupLabels': ['Angiotensin II Infusion']}\n- {'type': 'DRUG', 'name': 'Vasopressin', 'description': 'Vasopressin infusion', 'armGroupLabels': ['Vasopressin Infusion']}\n- {'type': 'DRUG', 'name': 'Norepinephrine', 'description': 'Standard care vasopressor therapy, norepinephrine infusion', 'armGroupLabels': ['Angiotensin II Infusion', 'Norepinephrine Infusion', 'Vasopressin Infusion']}\n\nPrimary Outcomes:\n- {'measure': 'Cortical mean transit time (mTT) measured in seconds', 'description': 'Contrast enhanced ultrasound measure of renal cortical tissue blood flow', 'timeFrame': 'Measured at +24 hours following study vasopressor infusion starting'}\n\nPlease estimate the sample size based on the assumption: \npower of 0.8, alpha of 0.05, accounting for drop-outs", "answer": 45, "answer_type": "ESTIMATED", "explanation": "Sample size\n A power calculation based on detecting a difference in CEUS derived mTT of 5\u00c2\u00b12s (based on differences between groups with severe and mild AKI in the Microshock-Renal study [10]) and assuming a power of 0.8 and alpha of 0.05 produces a sample size of 12 per group, or 36 participants in total. Accounting for drop-outs, we will aim to recruit 15 patients per group to give a total sample size of 45.", "id": 2040, "split": "test"} +{"trial_id": "NCT06238414", "pmid": "39379877", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Attempted Suicide Intervention Treatment and Prevention: a Randomised Controlled Trial\n\nIncluded conditions:\n- Suicide, Attempted\n- Suicide Prevention\n\nStudy Armgroups:\n- {'label': 'Intervention/case participant', 'type': 'EXPERIMENTAL', 'description': 'The case group will receive an 8-session early psychological intervention', 'interventionNames': ['Other: Early psychotherapeutic intervention']}\n- {'label': 'Control case/participant', 'type': 'NO_INTERVENTION', 'description': 'The control group will be treated as usual (TAU)'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Early psychotherapeutic intervention', 'description': 'The case group will receive an 8-session early psychological intervention The intervention consists of eight face-to-face sessions that include techniques from the dialectical behavioral (DBT), mentalization based therapy orientation (MBT), and narrative approach, concretely an adaptation from the ASSIP therapy. The sessions will be conducted by a clinical psychologist with expertise in psychotherapy. There will be two 60-minutes sessions per week.', 'armGroupLabels': ['Intervention/case participant']}\n\nPrimary Outcomes:\n- {'measure': 'Number of suicide attempts (recurrence)', 'description': 'The recurrence of the suicide attempt will be monitored by two mechanisms:\\n\\n1. During follow-up evaluations at 3, 6, and 12 months through a telephone call to the patient\\n2. Reviewing the patient\\'s medical history through the hospital\\'s public health system program.\\n\\nThe variable will be recorded by a dicotomic answer: \"YES\" if the patient had an intent during the follow-up period (3, 6, and 12 months) and \"NO\" if the patient did not have an intent. In cases of reattempt, the C-SSRS, SCS, and SALSA scales will be administered. In case of consummated attempts, information will be collected through clinical history and family interviews if it\\'s required.\\n\\nWe expected that the \"case-intervention group\" would have fewer re-attempts than the control group.', 'timeFrame': '1 year'}\n- {'measure': 'Severity of suicide behaviour', 'description': 'The investigators will evaluate the suicide severity through the C-SSRS scale in the pre-treatment phase only if the patient makes a suicide attempt or has a suicide ideation during the study pre and post-treatment and follow up perios (3,6 and 12 months) .\\n\\nColumbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview with dicothomic answers (yes or no) that captures the occurrence, severity, and frequency of suicide-related behaviour and thoughts during the assessment period.', 'timeFrame': '1 year'}\n- {'measure': 'Suicide behaivour', 'description': 'The investigators evaluated the suicide attempt trought the SCS scale in pre treatment phase and only if the patient makes a suicide attempt or has a suicide ideation during the study pre and post-treatment and follow up perios (3,6 and 12 months) .\\n\\nSuicidal Crisis Syndrome (SCS): This is an interview with dichotomous responses that assess conditions linked to imminent suicidal behavior characterized by (a) affective disturbance, loss of cognitive control, hyperarousal and social withdrawal (Criterion B) and (b) a generalized sense of entrapment in which leaving an intolerable life situation is perceived as both urgent and impossible.', 'timeFrame': '1 year'}\n- {'measure': 'Lethality of suicide attempt', 'description': 'In the baseline phase, before treatment, we assess the lethality of the suicide attempt through the Scale for Assessment of the Lethality of the Suicide Attempt (SALSA). The investigators will only administer the scale again in case of re-attempt during the follow-up.\\n\\nSALSA consists of two parts: The first component has four items indicating seriousness of the attempt and its likely consequences and the second component is the global impression of lethality. All the items are scored from 1 to 5, higher scores suggestive of increased lethality', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, two-sided alpha level of 0.05", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Power calculation is based on the results of previous randomised controlled trials with a comparable design and an expected repetition risk of 30% in the control group and 15% in the treatment group. The required sample size was calculated to compare the survival curves of the two groups using a Cox proportional hazards model for clinical trials [48]. In order to obtained the desired statistical power of 80% (i.e., to detect a hazard ratio of 0.44 for time to the next suicide attempt in both groups, with a two-sided alpha level of 0.05), it is required to recruit a sample size of 120 subjects.", "id": 2041, "split": "test"} +{"trial_id": "NCT06242418", "pmid": "39753246", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Value of CtDNA in Surveillance of Adjuvant Chemosensitivity and Regimen Adjustment in Stage III Colon Cancer: a Phase II Randomized Controlled Trial (REVISE Trial)\n\nIncluded conditions:\n- Colon Cancer\n\nStudy Armgroups:\n- {'label': 'FOLFOXIRI', 'type': 'EXPERIMENTAL', 'description': 'Eight cycles of FOLFOXIRI: Oxaliplatin 85mg/m2 ivgtt over 2 hours on day 1, Irinotecan 165mg/m2 ivgtt over 90 minutes on day 1, Calcium folinate 400mg/m2 ivgtt over 2 hours on day 1, 5-Fluorouracil 2400mg/m2 civ48h; Each cycle lasts for 2 weeks.', 'interventionNames': ['Drug: FOLFOXIRI']}\n- {'label': 'XELOX', 'type': 'ACTIVE_COMPARATOR', 'description': 'Five cycles of XELOX: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 bid from day 1 to day 14; Each cycle lasts for 3 weeks.', 'interventionNames': ['Drug: XELOX']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'FOLFOXIRI', 'description': 'Eight cycles of FOLFOXIRI: Oxaliplatin 85mg/m2 ivgtt over 2 hours on day 1, Irinotecan 165mg/m2 ivgtt over 90 minutes on day 1, Calcium folinate 400mg/m2 ivgtt over 2 hours on day 1, 5-Fluorouracil 2400mg/m2 civ48h; Each cycle lasts for 2 weeks.', 'armGroupLabels': ['FOLFOXIRI']}\n- {'type': 'DRUG', 'name': 'XELOX', 'description': 'Five cycles of XELOX: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 bid from day 1 to day 14; Each cycle lasts for 3 weeks.', 'armGroupLabels': ['XELOX']}\n\nPrimary Outcomes:\n- {'measure': 'change in value of ctDNA concentration', 'description': 'Defined as the change in value of ctDNA measured after 2 cycles of XELOX (ctDNA2) and after the completion or termination of chemotherapy (ctDNA3). \u25b3ctDNA= ctDNA3 - ctDNA2.', 'timeFrame': 'six months'}\n\nPlease estimate the sample size based on the assumption: \nA dropout rate of 10% prior to randomisation due to recurrence or metastasis, and a further 5% loss to follow-up rate.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This phase II multicentre randomised controlled study plans to enrol 60 patients who exhibit positive ctDNA after two cycles of XELOX regimen chemotherapy. Patients will be randomly assigned to the experimental group and the control group, with 30 patients in each group. Previous studies have indicated that approximately 20% of stage III colon cancer patients display positive ctDNA after surgery, while the persistent positivity rate during chemotherapy ranging between 50% and 77%.13 14 29 In this study, we estimate that the positive rate of ctDNA after two cycles of XELOX regimen chemotherapy is approximately 60%. Additionally, we estimate a dropout rate of 10% prior to randomisation due to recurrence or metastasis, based on previous studies,12 30 31 and a further 5% loss to follow-up rate. Consequently, it is estimated that a total of 580 patients with stage III colon cancer will need to be screened to attain the targeted sample size for enrolment. If the sample size proves insufficient, we will increase the number of patients screened.", "id": 2042, "split": "test"} +{"trial_id": "NCT06242808", "pmid": "39753253", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Medically Tailored Groceries and Food Resource Coaching for Patients of a Safety-net Clinic\n\nIncluded conditions:\n- Nutrition, Healthy\n- Type 2 Diabetes\n- Hypertension\n- Dyslipidemias\n\nStudy Armgroups:\n- {'label': 'Usual free community food market services', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual free community food market services, no tailoring of food received.', 'interventionNames': ['Other: Free community food support']}\n- {'label': 'Medically tailored groceries and food resource coaching', 'type': 'EXPERIMENTAL', 'description': 'Medically tailored groceries and food resource coaching.', 'interventionNames': ['Behavioral: Food resource coaching', 'Other: Free community food support', 'Behavioral: Medically tailored groceries']}\n- {'label': 'Medically tailored groceries', 'type': 'EXPERIMENTAL', 'description': 'Medically tailored groceries only, no coaching.', 'interventionNames': ['Other: Free community food support', 'Behavioral: Medically tailored groceries']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Food resource coaching', 'description': 'Patients will meet with a food resource coach who will explain basic coaching principles including how to respond to financial crises, how to access various food resources, and the importance of consistent utilization of food resources. After the coaching session, the food resource coach will help patients select medically tailored groceries from the free community food market inventory.', 'armGroupLabels': ['Medically tailored groceries and food resource coaching']}\n- {'type': 'OTHER', 'name': 'Free community food support', 'description': 'Usual services include selecting up to 21 meals for each person in the household from Crossroads nutritious market once per month (e.g., approximately 100 pounds \\\\[$250 United States dollars\\\\] of food for a family of four)', 'armGroupLabels': ['Medically tailored groceries', 'Medically tailored groceries and food resource coaching', 'Usual free community food market services']}\n- {'type': 'BEHAVIORAL', 'name': 'Medically tailored groceries', 'description': 'A pantry staff member helps patients select medically tailored groceries (MTG) from the free community food market inventory by prepopulating MTG in their pantry cart.', 'armGroupLabels': ['Medically tailored groceries', 'Medically tailored groceries and food resource coaching']}\n\nPrimary Outcomes:\n- {'measure': 'Study feasibility (enrollment and retention)', 'description': 'Study administrative data recorded by the study team on the count of people enrolled in the study and the count of people that complete the study', 'timeFrame': 'Participants participate for 4-months, study lasts 1-year'}\n- {'measure': 'Adherence', 'description': 'Salesforce inventory data will be used to assess the nutritional quality of the food selected by participants in all groups. Healthy eating index-2015 (HEI-2015) will be applied to the food selected and scored according to National Cancer Institute (NCI) guidelines from 0-100, with 0 indicating no nutritious foods and 100 indicating all nutritious food.', 'timeFrame': 'Participants participate for 4-months, study lasts 1-year'}\n\nPlease estimate the sample size based on the assumption: \npowered to detect effect with measures taken at baseline and follow-up", "answer": 210, "answer_type": "ACTUAL", "explanation": "Sample size\n The current lack of information on novel intervention effects on outcomes of interest (eg, food selections from the pantry, dietary quality) serves as a challenge to conducting a power analysis. We estimated that with a sample size of 210 people (70 per group), the study is powered to detect a small interactive group by time effect (f=0.11) on measures taken at baseline and follow-up. The sample size was selected based on what the study team, clinic and community partners estimated might be feasible to recruit from the clinic and serve in the pantry within the 18-month grant timeline, and large enough to detect a small to medium size effect.", "id": 2043, "split": "test"} +{"trial_id": "NCT06243549", "pmid": "39913459", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exploring the Associations Between the Biomechanical and Psychological Mechanistic Pathways of Lower Back Pain Development Amongst Persons With Lower-Limb Amputation\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'How do gait characteristics and muscle activations influence functional outcomes post-amputation and how do these variables influence the development of lower back pain?', 'description': \"Monitoring patients gait and muscle activities of the erector spinae, latissimus dorsi, gluteus medius, and sound limb biceps femoris and rectus femoris, during walking at self-selected speed, and how these variables influence lower back pain, assessed through the Roland-Morris Disability Questionnaire (no scale, greater number of statements circled indicates a worse outcome; maximum score of 24), and patient functional outcomes, where the term 'function' refers to the comprehensive overview of each participant's everyday interactions and long-term targets, defined by the participant in terms of person-specific activities and goals.\", 'timeFrame': '12-months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) = 0.05, power (1-\u03b2) = 0.80, and a 10% drop-out rate.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of 30 participants was calculated using G*Power software (3.1.9.7). An a priori power analysis was performed based on data from a previous study examining lumbar spine kinematics and LBP amongst persons with unilateral LLA [17]. The estimated sample size was calculated to be N = 26 participants (\u00ce\u00b1 = 0.05, 1-b = 0.80), with an effect size of 1.03. However, due to possible challenges with recruiting and retaining participants from clinical practice environments, such as people with limb loss, it is important to account for a 10% drop-out rate [66]. Therefore, the recruitment of at least 30 participants in total will be attempted from the NHS Enablement Centres.\n It is important to note that the sample size calculation takes into account only the kinematic variables, and not the relationship with the psycho-social variables measured through the online questionnaires. Ideally, a much larger population would be required for powered analysis of the psycho-social variables, however, due to the time constraints and the lack of data, the estimated sample size of N = 30 patients is the most feasible for the project duration.", "id": 2044, "split": "test"} +{"trial_id": "NCT06244953", "pmid": "40147986", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'Regular screening with needs-guided palliative care treatments', 'type': 'EXPERIMENTAL', 'description': 'The patient continues to receive clinical care from the cardiologist, as well as palliative care treatments that are based upon his/her reported distress and concerns.', 'interventionNames': ['Other: TIER-HF-PC']}\n- {'label': 'Usual Care', 'type': 'OTHER', 'description': 'Patient is referred by cardiologist to palliative care.', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TIER-HF-PC', 'description': 'The patient will be assigned to one of the three levels of care which is determined by the results given by Distress Thermometer (DT) and the Integrated Palliative Care Outcome Scale (IPOS).', 'armGroupLabels': ['Regular screening with needs-guided palliative care treatments']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Patient continues on clinical care by his/her cardiologist. If the cardiologist picks up their symptoms or other concerns, he/or can be referred to a specialist palliative care physician by the cardiologist.', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Patient quality of life (QOL)', 'description': \"Patient quality of life will be measured at baseline, and again at 8 weeks, 16 weeks, and 24 weeks using KCCQ-12.\\n\\nDescriptive statistics, and measures of effect size will be used to compare the study groups at baseline, 8 weeks, 16 weeks, and 24 weeks.\\n\\nLongitudinal data analyses will be conducted to examine intervention effects using linear mixed-effects-modelling for repeated measures at baseline, 8 through 16 and 24 weeks, constraining the baseline mean to be equal between intervention and control groups with indicators for time, group, and time by group interactions. Estimate of standard deviation of residuals from the mixed-effects model will be used to compute effect size (Cohen's d) to estimate the efficacy.\\n\\nThe minimum score on KCCQ is 0 and maximum possible score is 100. A higher score indicates a better quality of life.\", 'timeFrame': 'Baseline, 8 weeks, 16 weeks, and 24 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nThe planned sample size will provide 80% power at a 5% two-sided type 1 error rate. To account for dropouts and attrition, the recruitment target is increased by 20%. The recruitment rate is estimated at 50%, with a more conservative estimate of 40%.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n For the purposes of evaluation of the primary outcome\u00e2\u0080\u0094assuming a common SD of 12 points for the KCCQ overall summary score,68 the planned sample size will be 200\u00e2\u0080\u0089subjects (100 per arm) to provide 80% power at 5% two-sided type 1 error rate, to detect a difference of 5 points at 24\u00e2\u0080\u0089weeks, which is the smallest change that is clinically significant at the individual patient level.51 To account for dropouts and attrition, we will aim to recruit 120\u00e2\u0080\u0089patients per arm (240\u00e2\u0080\u0089patients). As caregiver recruitment is based on the patient sample, we will aim to recruit up to 120 caregivers per arm (up to 240 caregivers). We estimate we will recruit 80% of the participants from NHCS campuses (192\u00e2\u0080\u0089patients and 192 caregivers) and 20% of the participants (48\u00e2\u0080\u0089patients and 48 caregivers) from KTPH. Based on screening logs from previous studies recruiting similar patients from the same settings, it is estimated that there will be 40 eligible patients per month. Assuming a recruitment rate of 50% and 20\u00e2\u0080\u0089patients recruited per month, the sample size could be achieved within 12\u00e2\u0080\u0089months. A more conservative estimation of a 40% recruitment rate (16\u00e2\u0080\u0089patients are recruited per month) would allow us to achieve the required sample size within 15\u00e2\u0080\u0089months. For the semistructured interviews, based on our prior research in the same setting,7577 we will reach data saturation by 30\u00e2\u0080\u009340\u00e2\u0080\u0089patients, 30\u00e2\u0080\u009340 caregivers and 30 staff across two sites. These will be our target sample sizes.", "id": 2045, "split": "test"} +{"trial_id": "NCT06247228", "pmid": "39885479", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Co-created Digital Intervention to Reduce Home-office Workers' Sedentary Behaviour: Protocol for the Click2Move Programme, a Cluster Randomised Controlled Trial\n\nIncluded conditions:\n- Sedentary Behaviour\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Experimental group will receive the Click2Move intervention for one year, including a wearable (provided by the research group) and mobile phone application downloaded in the participants own mobile phone. Click2Move intervention comprises elements at three levels: environmental (activity tracking and app provision, reminders, cooperative challenges, and social chat), organisational level (organisational support and motivational messages), and at individual level (educational materials, self-monitoring, feedback provision, demonstration videos and a list of strategies).', 'interventionNames': ['Behavioral: Click2Move']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control arm will be asked to complete the same study measurements as those in the intervention arms, at the same time points. The control arm participants will not receive any device, nor will they have to download the mobile phone application. After the year of the intervention, they will be able to receive the intervention if they agree.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Click2Move', 'description': 'One year multicomponent intervention including a wearable, and a mobile phone application downloaded in the own mobile phone. Participants will have activity tracking and app provision, sedentary reminders, cooperative challenges, organisational support and motivational messages, educational material, self-monitoring, feedback provision, demonstration videos and strategies.', 'armGroupLabels': ['Experimental group']}\n\nPrimary Outcomes:\n- {'measure': 'Occupational sitting time', 'description': 'The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the occupational sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.\\n\\nParticipants will wear the activPAL3TM for 7 days. Additionally, participants will be asked to record their daily wake-up time, bedtime, working hours, and any monitor removal time through a diary log.', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months.'}\n- {'measure': 'Leisure sitting time', 'description': 'The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the leisure sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months.'}\n- {'measure': 'Total sitting time', 'description': 'The activPAL3TM (PAL Technologies Ltd., Glasgow, UK) will be used to measure and quantify the leisure sedentary behaviour patterns of employees. This device is a valid measure to quantify body posture and activity patterns during free-living conditions.', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided alpha of 0.05, 20% dropout rate, low intra-cluster correlation coefficient (ICC) of 0.05 for the unit and 0.2 for the company.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was based on detecting a relevant effect on the primary outcome, sitting time during working hours. Based on an assumed mean reduction of 55.92\u00c2\u00a0min/day sitting in the intervention group and a standard deviation in both groups of 90\u00c2\u00a0min/day [36], a power of 80%, a two-sided alpha of 0.05, and a 20% dropout rate, a total of 200 participants across four companies at baseline will need to be recruited. Within each company, randomization in the intervention group or control group takes place at the unit level (clusters) through a hierarchic clustering between units in a company, assuming a low intra-cluster correlation coefficient (ICC) of 0.05 for the unit and 0.2 for the company. Per company, one control unit and one intervention unit will be included with the total number of participants being equal per company (n\u00e2\u0080\u0089=\u00e2\u0080\u008950). The total sample size will be equally distributed across both conditions (25 in the intervention group and 25 in the control group in each company in each country).", "id": 2046, "split": "test"} +{"trial_id": "NCT06248762", "pmid": "38926739", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Positive Psychology and Mindfulness Based App for Parents of Children with a Neurodevelopmental Disorder (NDD): Study Protocol of a Pragmatic Randomized Controlled Trial\n\nIncluded conditions:\n- Stress\n- Mental Health\n- Mental Well-being\n\nStudy Armgroups:\n- {'label': 'Intervention condition', 'type': 'EXPERIMENTAL', 'description': 'Participants will use the app for 4 weeks, daily for 10-15 minutes', 'interventionNames': ['Other: Adappt']}\n- {'label': 'Waitlist control condition', 'type': 'OTHER', 'description': 'Participants in the control condition will start using the app 4 months after the start (baseline)', 'interventionNames': ['Other: Adappt']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Adappt', 'description': 'An app to support parents of children with a NDD', 'armGroupLabels': ['Intervention condition', 'Waitlist control condition']}\n\nPrimary Outcomes:\n- {'measure': 'Ability to Adapt', 'description': 'Measured with the10-item Generic Sense of Ability to Adapt Scale (GSAAS). An average score will be calculated ranging from 0 to 4, with higher scores being indicative of higher perceived ability to adapt.', 'timeFrame': 'Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)'}\n\nPlease estimate the sample size based on the assumption: \nRequired power of 80%, two-sided significance level of 5%, first-order autoregressive (AR1) variance-covariance structure with \u03c1 = 0.5, and an assumed attrition of 10% between each measurement time point.", "answer": 212, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The required sample size was computed with RMASS2 software for two-group longitudinal designs with attrition [39]. Given a required power of 80% and a two-sided significance level of 5%, 106 participating parents will need to be recruited in each arm to detect a linear trend effect over the first three time points (a group by linear time interaction from T0 to T2) resulting in at least a moderate effect size difference between the groups (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5) at 4\u00c2\u00a0months after baseline. So, at least 212 parents must be included in this RCT.\n This sample size estimation is based on the assumption that the repeated measurements follow a first-order autoregressive (AR1) variance\u00e2\u0080\u0093covariance structure (starting at \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 between repeated measurements) and an assumed attrition of 10% between both the baseline (T0) and post-intervention (T1) and between the post-intervention (T1) and 4\u00c2\u00a0month follow-up (T2) measurements. Given the relatively low number of involved countries (five) in the trial and the self-help nature of the intervention, no relevant clustering between participants at the country level is anticipated in the sample size calculation.", "id": 2047, "split": "test"} +{"trial_id": "NCT06253585", "pmid": "39292459", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Precision Resuscitation With Crystalloids in Sepsis (PRECISE)\n\nIncluded conditions:\n- Sepsis\n\nStudy Armgroups:\n- {'label': 'EHR Alert', 'type': 'EXPERIMENTAL', 'description': 'Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to the intervention arm.', 'interventionNames': ['Other: Algorithm Alarm- Crystalloids']}\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to usual care.', 'interventionNames': ['Other: Standard of Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Algorithm Alarm- Crystalloids', 'description': 'The study uses an algorithm implemented within the Electronic Health Record (EHR). This algorithm identifies patients who belong to a sepsis subphenotype known as \"Group D\", in whom published data has shown a mortality benefit from balanced crystalloids compared to normal saline.\\n\\nThe intervention is an EHR alert when clinicians order normal saline on Group D patients randomized to intervention. In the intervention arm, if a clinician orders normal saline in a patient classified as Group D, there will be an EHR alert to change the order to balanced crystalloids (i.e., Lactated Ringer or Plasma-Lyte solution).', 'armGroupLabels': ['EHR Alert'], 'otherNames': ['Intervention Group']}\n- {'type': 'OTHER', 'name': 'Standard of Care', 'description': 'Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to usual care. In the usual care arm, the clinicians will not have any feedback from the algorithm and will not know the Group classification of their patient or the recommended fluid type.', 'armGroupLabels': ['Standard of Care'], 'otherNames': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Thirty-day mortality', 'description': 'Thirty-day mortality', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nTo detect a proportion difference of 0.03 with 90% power, the power was computed using the tests for 2 proportions module from PASS 2023, version 23.0.1 (NCSS LLC).", "answer": 2002, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power Considerations\n The power analysis was performed using Emory Healthcare system retrospective data, with mortality estimates based on proportion of normal saline vs balanced crystalloids received. Usual care has an expected mortality rate of 6%, and intervention has an expected mortality rate of 3%. To detect a proportion difference (P2 \u00e2\u0080\u0093 P1) of 0.03 (or P1 of 0.03) with 90% power, the number of participants needed will be 1001 in the intervention arm and 1001 in the usual care arm (Table 1). The power was computed using the tests for 2 proportions module from PASS 2023, version 23.0.1 (NCSS LLC).\n \n Table 1. \n \n Power and Sample Size for Hypothesis Tests of the 30-Day Inpatient Mortality Difference Between Usual Care and Interventiona\n \n \n \n \n \n \n \n \n \n \n \n Test\n Sample size assumptions and results\n \n \n Usual care P2\n Intervention P1\n Difference (P2 \u00e2\u0088\u0092 P1)\n No. of participants\n Statistical power, %\n \n \n Per group\n Total\n \n \n \n \n 1\n 0.06\n 0.03\n 0.03\n 748\n 1496\n 80\n \n \n 2\n 0.06\n 0.04\n 0.02\n 1863\n 3726\n 80\n \n \n 3\n 0.06\n 0.03\n 0.03\n 1001\n 2002\n 90\n \n \n 4\n 0.06\n 0.04\n 0.02\n 2493\n 4986\n 90\n \n \n \n \n \n \na\n\n The usual care group mortality rate (P2) is assumed to be 0.06. To detect a proportion difference (P2 \u00e2\u0088\u0092 P1) of 0.03 (or P1 of 0.03) with 90% power, the number of participants needed will be 1001 in the intervention arm and 1001 in the usual care arm.", "id": 2048, "split": "test"} +{"trial_id": "NCT06256757", "pmid": "39885531", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery\n\nIncluded conditions:\n- Aortic Dissection Aneurysm\n\nStudy Armgroups:\n- {'label': 'A\uff08extracorporeal fenestration\uff09', 'type': 'EXPERIMENTAL', 'description': \"Based on the preoperative CTA reconstructions, the diameter of the aorta and branch vessels, lengths, angles to the arch, clock positions, and related relationships are measured, and a preoperative design for the fenestrations is developed. The outer sheath of the stent graft is then pushed back for several centimeters under sterile conditions, allowing the proximal portion of the stent graft to be released. The length of the released segment should be one to two centimeters distal from the location of fenestration. Using a sterile ruler, the location of the fenestration is determined in accordance with the preoperative plan. The 12 o'clock position is considered to be at the front of the trigger. The position of the stent graft relative to the trigger is also referred to as the 12 o'clock position. If the fenestration must avoid stent struts, then the fenestration is deemed to be at 12 o'clock, as is the position of the trigger relative to the stent graft.\", 'interventionNames': ['Procedure: fenestration']}\n- {'label': 'B\uff08In situ fenestration\uff09', 'type': 'SHAM_COMPARATOR', 'description': 'From the left brachial artery (LBA), a 6F angle-adjustable sheath (Lifetech, Inc., Shenzhen, China) is introduced retrogradely until its tip reaches the aortic stent graft. The tip is then adjusted to be as perpendicular as possible to the larger curve of the aortic stent graft. Once the sheath gets to the ideal position, a flexible needle (21 gauge, Futhrough, Lifetech, Inc.) is employed to create the fenestration in the aortic stent graft. Following the puncture, a 0.018-inch guidewire (V-18 ControlWire; Boston Scientific, Natick, MA) is inserted through the needle aperture and into the ascending aorta.', 'interventionNames': ['Procedure: fenestration']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'fenestration', 'description': 'Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations', 'armGroupLabels': ['A\uff08extracorporeal fenestration\uff09', 'B\uff08In situ fenestration\uff09']}\n\nPrimary Outcomes:\n- {'measure': 'all-cause mortality', 'description': 'all-cause mortality', 'timeFrame': '1 month postoperative'}\n\nPlease estimate the sample size based on the assumption: \nCombined \u03b1-level of 0.05 (two-sided), \u03b2 = 0.20 (two-sided), and a potential dropout rate of 10%.", "answer": 170, "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. According to the literature, cumulative 30-day all-cause mortality was similar in both groups: 3.8% [8]. An equal (1:1) equivalence design was used, with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-sided), \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.20 (two-sided), \u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u008910%, from which the sample size n was estimated. In accordance with the design of the trial and the primary efficacy outcome measures, the sample size was estimated 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}$$n=\\frac{\\pi_t\\times\\;\\left(1-\\pi_t\\right)\\;+\\;\\pi_c\\;\\times\\;\\left(1-\\pi_c\\right)}{\\left(\\mathit\\triangle\\mathit\\;\\mathit-\\mathit\\;\\mathit{\\left|{\\pi_t-\\pi_c}\\right|}\\right)^2}\\times\\left(\\mu_{\\mathit a\\mathit/\\mathit2}\\mathit+\\mu_{\\mathit\\beta}\\right)^2$$\\end{document}n=\u00cf\u0080t\u00c3\u00971-\u00cf\u0080t+\u00cf\u0080c\u00c3\u00971-\u00cf\u0080c\u00e2\u0096\u00b5-\u00cf\u0080t-\u00cf\u0080c2\u00c3\u0097\u00ce\u00bca/2+\u00ce\u00bc\u00ce\u00b22\n A minimum of 154 patients (77 per group) will need to be recruited. However, considering a potential dropout rate of 10%, combined with the low probability of adverse events in this trial, the total sample size was expanded to 170 patients.", "id": 2049, "split": "test"} +{"trial_id": "NCT06258226", "pmid": "39395964", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of Auricular Acupressure on Reduction of Estazolam in Patients With Insomnia\n\nIncluded conditions:\n- Estazolam-dependent Insomnia\n\nStudy Armgroups:\n- {'label': 'Conventional dosage reduction group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The drug reduction method of estazolam tablets (Shanghai Xinyi Pharmaceutical Co., Ltd., Shanghai, China, State Drugs Administration License No.: H31020644, 1 mg) will be given, with a starting dose of 1 mg, that is, the dosage of estazolam will be reduced by 25% (0.25mg) every week until the dosage will be stopped completely on the premise of no aggravation of insomnia symptoms.', 'interventionNames': ['Drug: Conventional dosage reduction']}\n- {'label': 'Auricular acupressure group', 'type': 'EXPERIMENTAL', 'description': 'Auricular acupressure therapy will be added based on the estazolam reduction method in the control group. The specific auricular points to be treated are Shenmen (TF4), Sympathetic (AH6), Endocrine (CO18), Heart (CO15), Liver (CO12) and Kidney (CO10). During the treatment, the acupuncturist will use a metal probe to identify the auricular points and ask the patients if they experience \"deqi\" sensations such as heat, numbness, distension, or pain. Once the auricular points have been confirmed, the ear will be disinfected using a 75% ethanol solution and dried using a sterile dry cotton ball. The acupuncturist will then hold the ear in place with their left hand while using their right hand to manipulate a tweezer and apply tape (0.5 x 0.5 cm) with vaccaria (Suzhou Konakang Medical Instrument Co., LTD., Suzhou, China) to the selected auricular point.', 'interventionNames': ['Procedure: Auricular acupressure']}\n- {'label': 'Sham auricular acupressure group', 'type': 'SHAM_COMPARATOR', 'description': 'Based on the estazolam reduction method in the control group, the acupuncturist will place the same skin-colored adhesive tapes without vaccaria on the auricular points, but these tapes will not be pressed during treatment.', 'interventionNames': ['Procedure: Sham auricular acupressure']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Conventional dosage reduction', 'description': 'The doctor will guide patients to adjust medication dosage once a week in the outpatient clinic. When patients experience withdrawal reactions such as worsening insomnia or anxiety symptoms due to drug reduction, they will be returned to the oral dose before the current reduction, and the dosage will be reduced again after evaluation in the next reduction cycle. The treatment for 4 weeks is one course and 1 course of treatment is required totally.', 'armGroupLabels': ['Conventional dosage reduction group'], 'otherNames': ['Estazolam reduction']}\n- {'type': 'PROCEDURE', 'name': 'Auricular acupressure', 'description': 'Auricular acupressure is a non-pharmacological therapy that involves applying acupressure on the surface of points in different parts of the ear. One side of the auricular acupoints will be treated first and the tapes will be kept in place for 3 days. On the fourth day, the tapes on the ear will be removed and new tapes will be applied to the opposite side of the ear. The purpose of replacing tapes is to reduce the adverse events (AEs) that may be caused by long-term stimulation unilaterally. In addition, the participants will be informed to press the tapes by themselves for 3 to 5 minutes vertically and appropriately to achieve the sensation, with a duration of 4 to 5 times a day. The treatment will last for 4 weeks, and the follow-up will be done after 1 month.', 'armGroupLabels': ['Auricular acupressure group']}\n- {'type': 'PROCEDURE', 'name': 'Sham auricular acupressure', 'description': 'Based on the estazolam reduction method in the control group, the acupuncturist will place the same skin-colored adhesive tapes without vaccaria on the auricular points, but these tapes will not be pressed during treatment.', 'armGroupLabels': ['Sham auricular acupressure group']}\n\nPrimary Outcomes:\n- {'measure': 'Estazolam Dosing and Reduction Rates', 'description': 'The amount of drug taken by patients will be assessed.The rate of dosage reduction will be observed. Estazolam reduction rate = (pre-treatment Estazolam dose - post-treatment Estazolam dose)/pre-treatment Estazolam dose x 100%.', 'timeFrame': 'Estazolam dosing will be assessed before treatment\uff0c1, 2, 3, and 4 weeks after treatment\uff0c1 month after follow-up visiting. The rate of dosage reduction will be observed 4weeks after treatment\uff0c1 month after follow-up visiting'}\n- {'measure': 'Serum Gamma-aminobutyric acid and Cortisol Levels', 'description': 'The method of enzyme-linked immunosorbent assay (ELISA) will be used. 4 ml of venous blood will be extracted from the subjects, and will be added anticoagulant. After that, the samples will be centrifuged at 3000 r/min to separate upper serum and preserved in a refrigerator at -80\u2103, according to the kit instructions.', 'timeFrame': 'Venous blood samples will be drawn twice from each patient at 8:00-9:00 in the morning 1 day before treatment and 1 day after the end of treatment.'}\n\nPlease estimate the sample size based on the assumption: \ntest efficiency (power) of 0.8, significance level of 0.05, dropout rate of 15%", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size\n The eligible participants will be divided into three groups at a ratio of 1:1:1. The G*Power program (version 3) is used to calculate the sample size based on the anticipated estazolam reduction rate in each group at the end of the treatment course (obtained from our previous pilot trial). With a test efficiency of 1 - beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.8 and a significance level of 0.05, the results indicated that 31 cases would be required per group. Assuming a dropout rate of 15%, 36 cases were needed for each arm, for a total of 108 participants for the trial.", "id": 2050, "split": "test"} +{"trial_id": "NCT06259396", "pmid": "40147991", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial\n\nIncluded conditions:\n- Bile Acid Diarrhea\n\nStudy Armgroups:\n- {'label': 'The 8x5 Diet', 'type': 'ACTIVE_COMPARATOR', 'description': 'The 8x5 Diet is a healthy dietary pattern administered virtually by a specialist dietitian', 'interventionNames': ['Behavioral: The 8x5 Diet']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Continuation of habitual diet, no dietary changes.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'The 8x5 Diet', 'description': 'A virtual, dietitian-counselled, healthy dietary pattern defined by its fat intake, its daily eating pattern, keeping adequately hydrated, having a variety of whole grains, fruit and vegetables, and use of certain plant fibres.', 'armGroupLabels': ['The 8x5 Diet']}\n\nPrimary Outcomes:\n- {'measure': 'Consent', 'description': 'The number (%) of participants who consent to participate in the trial compared to the number (%) that were screened by the research team.', 'timeFrame': 'Recruitment period (50 weeks)'}\n- {'measure': 'Recruitment', 'description': 'The number (%) of participants randomised compared to the number (%) that were eligible (screened by the research team)', 'timeFrame': 'Recruitment period (50 weeks)'}\n- {'measure': 'Randomisation', 'description': 'The number (%) of participants who complete their first appointment compared to the number (%) that were randomised, intervention group only.', 'timeFrame': 'Recruitment period (50 weeks)'}\n- {'measure': 'Retention', 'description': 'Tthe number (%) of participants that completed the study compared to the number (%) randomised to each group.', 'timeFrame': 'Randomisation to trial completion (8 weeks)'}\n- {'measure': \"The trial's data collection instruments and procedures: Missing data\", 'description': 'The number and proportion of missing data identified by the research team from questionnaires.', 'timeFrame': 'At baseline and at Week 8'}\n- {'measure': \"The trial's data collection instruments and procedures: Participants' views and experiences\", 'description': \"Participants' views and experiences of the instruments (questionnaires and diaries) and procedures (screening, randomisation, baseline period, trial, general)\", 'timeFrame': 'Study identification to study completion (Week 8)'}\n\nPlease estimate the sample size based on the assumption: \nA 20% attrition rate for each group over the recruitment and delivery period of 12 months is estimated.", "answer": 76, "answer_type": "ESTIMATED", "explanation": "Study setting, sample size and recruitment\n The study will be conducted remotely using digital technologies (video-conferencing, websites, social media, email, text messaging using participants\u00e2\u0080\u0099 computers, laptops, smartphones, tablets) between 2 April 2024 and 30 April 2025.\n As this is a feasibility study that is not designed to detect a targeted difference in the secondary outcomes, a sample size calculation was not appropriate. For feasibility studies, good practice guidance suggests a sample of at least 30 individuals to estimate a parameter with the necessary level of precision.41 Therefore, a sample size of 30 participants was chosen for each group. A 20% attrition rate for each group over the recruitment and delivery period of 12 months is estimated, and so the total target sample size is 76 participants.\n Identification of potential participants will be from advertising of the study in the BAD UK website,42 and related national, patient and public, and research organisations; social media (Facebook: two groups from the membership of BAD UK and social media); and a database held from a previous study in BAD on the resources for this trial where participants gave consent for their details to be used in other studies. Interested potential participants will contact the researchers (YM) via telephone or email and be invited to discuss the study, access the study\u00e2\u0080\u0099s website43 and receive the Participant Information Sheet (online supplemental material S1).", "id": 2051, "split": "test"} +{"trial_id": "NCT06262464", "pmid": "38724961", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy of an OCD Prevention Programme for at Risk Adults: a Randomized Clinical Trial\n\nIncluded conditions:\n- Obsessive-Compulsive Disorder\n\nStudy Armgroups:\n- {'label': 'Prevention', 'type': 'EXPERIMENTAL', 'description': '6 group, online sessions over two weeks. A prevention program using cognitive and behavioral strategies to reduce OCD risk factors and related symptoms.', 'interventionNames': ['Behavioral: Prevention']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Treatment as Usual'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prevention', 'description': 'A cognitive-behavioural prevention programme.', 'armGroupLabels': ['Prevention']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in OCD symptoms on the OCI-R after the intervention', 'description': 'The OCI-R is a validated self-report instrument assessing OCD symptoms. Possible scores range from 0 to 72. Change = end of intervention score - baseline score', 'timeFrame': 'Baseline and Week 2'}\n- {'measure': 'Change from baseline in depressive symptoms on the PHQ-9 after the intervention', 'description': 'The PHQ-9 is a validated self-report instrument assessing depressive symptoms. Possible scores range from 0 to 27.\\n\\nChange = end of intervention score - baseline score', 'timeFrame': 'Baseline and Week 2'}\n- {'measure': 'Change from baseline in anxiety symptoms on the GAD-7 after the intervention', 'description': 'The GAD-7 is a validated self-report instrument assessing anxiety symptoms. Possible scores range from 0 to 21.\\n\\nChange = end of intervention score - baseline score', 'timeFrame': 'Baseline and Week 2'}\n\nPlease estimate the sample size based on the assumption: \nalpha level of \u00ce\u00b1 = 0.05, power of 0.95, expected drop-out rates", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n G*Power was used for the sample size calculation and, following an effect size of d=0.3 with a n alpha level of \u00ce\u00b1 = 0.05 and power of 0.95, a sample size of 175 was suggested. Based on this power analysis and expected drop-out rates, we aim for 200 participants (100 per treatment arm). The Consolidated Standards of Reporting Trials flow chart of the trial is shown in Figure 1.Fig. 1CONSORT flow diagram", "id": 2052, "split": "test"} +{"trial_id": "NCT06265623", "pmid": "38816826", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease (COPD)\n\nStudy Armgroups:\n- {'label': 'COPD patients with exertional desaturation', 'description': 'Patients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who experience a drop in arterial oxygen saturation (by pulse oximetry) to \\\\<90% or a drop by 4% or greater of the basal value during a six-minute walk test.', 'interventionNames': ['Other: No active intervention, but observational follow-up']}\n- {'label': 'COPD patients without exertional desaturation', 'description': 'Patients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who do not experience a drop in arterial oxygen saturation (by pulse oximetry) to \\\\<90% or a drop by 4% or greater of the basal value during a six-minute walk test.', 'interventionNames': ['Other: No active intervention, but observational follow-up']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'No active intervention, but observational follow-up', 'description': 'Patients remain in usual care by their pulmonary medicine specialists and are being observed during annual follow-up investigations during up to 3 years', 'armGroupLabels': ['COPD patients with exertional desaturation', 'COPD patients without exertional desaturation']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in FEV1(% of LLN) between baseline and end-of-follow-up', 'description': 'The difference in measured FEV1 assessed by spirometry and expressed as percent of the lower limit of the normal distribution based upon the Global Lung Function 2022 Equations, by comparing results of the baseline measurement with those of the last investigation during up to three years of follow-up', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 0.90, and an expected dropout rate of up to 15%.", "answer": 148, "answer_type": "ESTIMATED", "explanation": "Sample size discussion\n Sample size estimation was based on analysis with repeated-measures 2-way ANOVA (baseline \u00e2\u0080\u0093 1 year \u00e2\u0080\u0093 2 years \u00e2\u0080\u0093 3 years). We assume that one third of our study cohort will experience exertional hypoxemia as reported in previous studies [22, 23], and we estimate that a 20% difference in the primary endpoint will be of clinical significance. To prove or dismiss the primary endpoint with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a power of 0.90, a total sample size of 148 COPD patients stages 2\u00e2\u0080\u00933, groups B and E according to the current GOLD guideline [7] will be included in this study after accounting for an expected drop-out rate of up to 15%.", "id": 2053, "split": "test"} +{"trial_id": "NCT06266182", "pmid": "38890709", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of an Online Acceptance and Commitment Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation: a Randomized Controlled Trial Enhanced With a Single-case Experimental Design\n\nIncluded conditions:\n- Hematopoietic Cell Transplantation Recipient\n- Acceptance and Commitment Therapy\n\nStudy Armgroups:\n- {'label': 'ACT intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants in the ACT intervention arm will learn new adaptive ways to cope with difficulties (including difficult thoughts or feelings).', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy']}\n- {'label': 'Education', 'type': 'OTHER', 'description': 'Participants in the Education arm will become familiar with post-HCT recommendations. This will be a minimally enhanced usual care.', 'interventionNames': ['Behavioral: Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Acceptance and Commitment Therapy', 'description': 'ACT intervention will start on the second day after hospital discharge and will take 14 days (+ day 0 with organizational information). Each day, participants will receive a web-based intervention consisting of educational and practical tasks/activities. Participants will learn to recognize moments of choice (actions that lead towards values or away from them) and to use attention flexibly to free themselves from the power of thoughts, to open up and accept emotions, and to be able to determine what is important and take action in line with values. All of the tasks will be available in written form and audio. The ACT intervention is built from standard ACT exercises.', 'armGroupLabels': ['ACT intervention'], 'otherNames': ['ACT-based intervention', 'ACT']}\n- {'type': 'BEHAVIORAL', 'name': 'Education', 'description': 'Education will start on the second day after hospital discharge and will take 14 days (+ day 0 with organizational information). Each day, participants will receive information about post-transplant prescriptions along with exercises to support the implementation. Participants will learn about nutrition, personal hygiene, preventing infections, coping with fatigue, resuming activity, rest and sleep, engaging in social interactions, and sexual health. The content is prepared based on available guides for HCT recipients.', 'armGroupLabels': ['Education']}\n\nPrimary Outcomes:\n- {'measure': 'Distress (Global Meaning Violation Scale; GMVS)', 'description': 'The GMVS measures meaning-related distress. It is a 12-item questionnaire (from the original, the item \"health\" was removed due to the context of the study) that assesses belief (5 items) and goal violations (7 items) in response to stressors on a 5-point scale ranging from 1 (not at all) to 5 (very much). The overall score is calculated by summing the scores of all 12 items, with a possible range of 12-60. Higher scores indicate greater meaning-related distress (greater global meaning violation).', 'timeFrame': 'Change from baseline to immediately, 1 month and 3 months after intervention'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.80, an alpha level of 0.05, and an attrition rate of 20% were assumed.", "answer": 192, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In RCT, the sample size was calculated based on an analysis of variance with two groups (ACT versus mEUC) and four repeated measures of variance (ANOVA) with within-between interaction (group x time) using the G*Power calculator [59] and simulation study of the time course with dichotomous between-person level predictor [60]. Given the large effects of ACT on psychological well-being, including hope (Hedge\u00e2\u0080\u0099s g\u00e2\u0080\u0089=\u00e2\u0080\u00890.88\u00e2\u0080\u00932.17) and medium effects on psychological flexibility among cancer patients (Hedge\u00e2\u0080\u0099s g\u00e2\u0080\u0089=\u00e2\u0080\u00890.58) [29], the stronger effects in the population of women with breast cancer compared to patients with other types of cancer (large versus medium effect sizes) [31], and medium effect sizes of technology-supported ACT interventions (Hedges\u00e2\u0080\u0099 g\u00e2\u0080\u0089=\u00e2\u0080\u00890.44\u00e2\u0080\u00930.48) [21], moderate differences between conditions were expected. Assuming a medium effect size of f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25, a power of 0.80, and an alpha level of 0.05 in repeated measures of ANOVA, a total sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089178 is required. In turn, on the basis of a simulation study, a total sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089136 is required for multilevel modeling. Therefore, the minimum sample size was assumed of N\u00e2\u0080\u0089=\u00e2\u0080\u0089160 (80 per condition). Allowing for the potential attrition rate of 20%, this leads to a sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089192 participants, including 96 in each arm. In SCED, 6\u00e2\u0080\u00939 participants will be investigated, a minimum of 2 per condition. According to the simulation study [61], sufficient power (0.80) can be reached in SCED with six to eight participants, depending on the assumed effect size (large versus medium, respectively).", "id": 2054, "split": "test"} +{"trial_id": "NCT06273475", "pmid": "38965499", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Robot-Assisted Versus Standard Training on Motor Function Following Subacute Rehabilitation After Ischemic Stroke - a Randomised Controlled Trial Nested in a Prospective Cohort.\n\nIncluded conditions:\n- Stroke\n- Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Training facilitated through body weight unloading robotic technology yielding a dynamic unloading force applied to the body centre of mass.', 'interventionNames': ['Other: Robot-assisted Training']}\n- {'label': 'Active Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Training facilitated without the use of body weight unloading robotic technology, thereby only allowing manual assistance from physiotherapists.', 'interventionNames': ['Other: Standard Training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Robot-assisted Training', 'description': 'Gait training and functional strength training facilitated by body weight unloading robotic technology yielding a dynamic unloading force applied to the body centre of mass. Gait training will be conducted both on treadmill and overground. Functional strength training exercises include sit-to-stand, stair-walking, step-ups etc. The goal is to gradually reduce body weight unloading as participants progress through the intervention period.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Standard Training', 'description': 'Gait training and functional strength training facilitated without the use of body weight unloading robotic technology, thereby only allowing manual assistance from physiotherapists. The goal of training is the same as in the intervention group, however no body weight unloading device will be implemented in the active control group.', 'armGroupLabels': ['Active Control']}\n\nPrimary Outcomes:\n- {'measure': 'Fugl-Meyer Lower Extremity Assessment of Motor Function', 'description': 'The primary outcome measure is the between-group difference in change score of Fugl-Meyer Lower Extremity Assessment (FM-LE) from pre- (T6) to post-intervention (T12). The FM-LE assesses motor function and has been recommended as a part of a core outcome set in stroke rehabilitation studies.', 'timeFrame': 'Pre-intervention (6-18 months post-stroke) and post-intervention (12-24 months post-stroke).'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1 level of 5% and a statistical power of 80%, allowing for dropout", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A priori two-sided sample size calculation for two independent groups was performed and resulted in a required sample size of 34 study participants in total. This was based on detecting a minimally clinically important between-group difference (MCID) of 6 points on the FM-LE scale [55] and a standard deviation of 6 points [28, 30, 55] at an \u00ce\u00b1 level of 5% and with a statistical power of 80%. Allowing for dropout the aim is to include 40 participants in total.", "id": 2055, "split": "test"} +{"trial_id": "NCT06275100", "pmid": "40063583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry\n\nIncluded conditions:\n- Cardiac Disease\n- Aortic Valve Disease\n- Coronary Artery Disease\n- Endocarditis\n- Valve Heart Disease\n\nStudy Armgroups:\n- {'label': 'Prehabilitation arm', 'type': 'EXPERIMENTAL', 'description': \"Participants will be exposed to physical and psychological prehabilitation whilst waiting for surgery. The prehabilitation will not alter the surgical waiting time or any medical intervention but aims to work around patient's essential care.\\n\\nPhysical/ exercise component has a directly supervised component (aerobic exercise) and an unsupervised portion (Inspiratory muscle training and strength training) which is done via an app or leaflet depending on participant's preference. Participants will be given a guide number of exercises to do in their own time throughout the day.\\n\\nThe psychological component consist of a psychoeducation booklet, meditation audio and signposting if they require further assistance. The psychoeducation component is voluntary.\", 'interventionNames': ['Other: Prehabilitation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Prehabilitation', 'description': \"Participants will be exposed to exercise and psychoeducation. Aerobic exercise will be on a cycle ergometer tailored to their capability and will aim for a low to moderate intensity.The patients will be exercised using the intermittent protocol of alternating 1 minute moderate and 1 minute low intensity aerobic exercise. This duration can be gradually increased during subsequent sessions depending on the patient's ability. Aerobic exercise will be conducted 2- 3 times per week depending on patient's ability.\\n\\nIn addition, participants are expected to do strength and inspiratory muscle training in their own time.\\n\\nThe psychoeducation booklet and audio are designed with input from in-house clinical psychologist. The aim of the booklet is to explain the emotions they may feel whilst being in hospital, symptoms of anxiety, suggest how to manage anxiety, behavioural strategies that may help and signposting if they require further support.\", 'armGroupLabels': ['Prehabilitation arm'], 'otherNames': ['exercise', 'psychological']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery', 'description': 'We will be assessing the eligibility, recruitment rate, deliverability, logistical, practicality, completion rate, achievability and acceptability of the program. This is based on the recruitment as well as participant feedback interview.', 'timeFrame': 'We estimate from patient recruitment to day before surgery can be between 7 days and 4 weeks. Intervention will start as soon as patient is recruited and end the day before their surgery'}\n\nPlease estimate the sample size based on the assumption: \nNo power calculation performed; 20% attrition rate considered.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n We did not perform a power calculation for sample size estimation as PreP-ACe is a pilot feasibility study. Some studies have suggested sample sizes of at least 10 participants [34,35]. Local audit data indicated that approximately 100 patients per year are admitted to CHH for acute inpatient surgery. Approximately 20% undergo surgery within the week. Based on these estimates, we aimed to recruit approximately 2 patients per month over a 12-month period. Therefore, our target sample size is 20 patients to account for 20% attrition.", "id": 2056, "split": "test"} +{"trial_id": "NCT06275958", "pmid": "39142680", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients\n\nIncluded conditions:\n- Older Patients\n- Colorectal Cancer\n- Metastatic Cancer\n- Candidates for Palliative Chemotherapy\n\nStudy Armgroups:\n- {'label': 'Doublet therapy, full dose (low toxicity risk based on G8)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Low risk of toxicity: G8-score of 15 or higher', 'interventionNames': ['Drug: Doublet Chemotherapy, Standard Dose (100%)']}\n- {'label': 'Doublet therapy, dose-reduced (low toxicity risk based on G8)', 'type': 'EXPERIMENTAL', 'description': 'Low risk of toxicity: G8-score of 15 or higher', 'interventionNames': ['Drug: Doublet Chemotherapy, Dose-reduced (75%)']}\n- {'label': 'Fluoropyrimidine monotherapy, full dose (high toxicity risk based on G8)', 'type': 'ACTIVE_COMPARATOR', 'description': 'High risk of toxicity: G8-score of 14 or lower or judged as \"high toxicity risk\" by their treating oncologist', 'interventionNames': ['Drug: Monotherapy, Standard Dose (100%)']}\n- {'label': 'Fluoropyrimidine monotherapy, dose-reduced (high toxicity risk based on G8)', 'type': 'EXPERIMENTAL', 'description': 'High risk of toxicity: G8-score of 14 or lower or judged as \"high toxicity risk\" by their treating oncologist', 'interventionNames': ['Drug: Monotherapy, Dose-reduced (75%)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Doublet Chemotherapy, Standard Dose (100%)', 'description': 'Capecitabine 1000mg / m2 oral at day 1-14 (every 3 weeks) Oxaliplatin 130mg/m2 at day 1 (every 3 weeks) OR 5-FU 400mg/m2 IV bolus at day 1 followed by 2400mg/m2 in 46 hours (every 2 weeks) Leucovorin 400mg/m2 day 1 (every 2 weeks) Oxaliplatin 85mg/m2 day 1 (every 2 weeks)', 'armGroupLabels': ['Doublet therapy, full dose (low toxicity risk based on G8)']}\n- {'type': 'DRUG', 'name': 'Doublet Chemotherapy, Dose-reduced (75%)', 'description': '75% of: Capecitabine 1000mg / m2 oral at day 1-14 (every 3 weeks) Oxaliplatin 130mg/m2 at day 1 (every 3 weeks) OR 5-FU 400mg/m2 IV bolus at day 1 followed by 2400mg/m2 in 46 hours (every 2 weeks) Leucovorin 400mg/m2 day 1 (every 2 weeks) Oxaliplatin 85mg/m2 day 1 (every 2 weeks)', 'armGroupLabels': ['Doublet therapy, dose-reduced (low toxicity risk based on G8)']}\n- {'type': 'DRUG', 'name': 'Monotherapy, Standard Dose (100%)', 'description': '- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)', 'armGroupLabels': ['Fluoropyrimidine monotherapy, full dose (high toxicity risk based on G8)']}\n- {'type': 'DRUG', 'name': 'Monotherapy, Dose-reduced (75%)', 'description': '75% of:\\n\\n- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)', 'armGroupLabels': ['Fluoropyrimidine monotherapy, dose-reduced (high toxicity risk based on G8)']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-Free Survival', 'timeFrame': 'Time from randomization until either radiological or clinical progression or death, whichever occurs first, assessed up to at least one year.'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a non-inferiority logrank test with 80.0% power at a 5% significance level to detect an equivalence HR of 1.25 when the actual HR is 1. The reference group hazard rate is 0.12. The study duration is 48 time periods with uniform subject accrual over the first 36 periods. An expected dropout rate of 10% is accounted for.", "answer": 587, "answer_type": "ESTIMATED", "explanation": "Statistics: sample size and power calculations\n Based on previous studies in older adults with metastatic colorectal cancer (table 2), the study assumes non-inferiority of the intervention arm with a median PFS of 8 months. We determined a non-inferiority margin of 8 weeks based on previous trials16 17 and extensive consultation with seven primary investigators from participating hospitals and the Dutch colorectal patient foundation, who all considered this an acceptable upper margin for non-inferiority.\n \n Table 2\n \n Median PFS in previous trials with older adults\n \n \n \n \n Trial\n Patient population\n Median PFS\n \n \n \n \n MRFOCUS215\n \u00e2\u0080\u0098Non-fit\u00e2\u0080\u0099 older or frail mCRC patients receiving upfront dose reduction\n Median PFS was 3.5, 5.8, 5.2 and 5.8 months in the 5-FU monotherapy, FOLFOX, capecitabine monotherapy and CAPOX groups, respectively; a reasonable estimate for all patients is 5 months\n \n \n AVEX33\n Older mCRC patients, no candidate for oxaliplatin or irinotecan\n Median PFS 9.1 months for capecitabine+bevacizumab, 5.1 months for capecitabine monotherapy.\n \n \n NORDIC916\n \u00e2\u0080\u0098Non-fit\u00e2\u0080\u0099 older mCRC patients\n Median PFS 5.1 months for full-dose S-1, 6.2 months for reduced-dose oxaliplatin+S-1. 25% received bevacizumab.\n \n \n SALTO34\n mCRC patients with median age 73 years (not specifically older patients)\n Median PFS 8.2 months for capecitabine monotherapy, 8.4 months for S-1 monotherapy.\n \n \n \n \n \n AVEXAVastin in the Elderly with XelodaCAPOXcapecitabine plus oxaliplatinFOLFOXfolinic acid, fluorouracil, and oxaliplatin5-FUFluorouracilmCRC, metastatic colorectal cancerPFSprogression-free survival\n \n \n \n A non-inferiority logrank test with an overall sample size of 528 subjects (264 in the reference group and 264 in the treatment group) achieves 80.0% power at a 5% significance level to detect an equivalence HR of 1.25 when the actual HR is an equivalence HR of 1 and the reference group hazard rate is 0.12. The study will last for 48 time periods of which subject accrual entry occurs in the first 36 time periods. The accrual pattern across time periods is uniform (all periods equal). Accounting for an expected dropout rate of 10%, 587 patients in total are required.", "id": 2057, "split": "test"} +{"trial_id": "NCT06277401", "pmid": "39414294", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High-load Resistance Training Compared With Usual Care for Treatment of Painful Knee Joint Hypermobility in Young Adults: A Randomised Controlled Trial (the HIPEr-Knee Study)\n\nIncluded conditions:\n- Hypermobility, Joint\n- Hypermobility Syndrome\n- Knee Discomfort\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Progressive high-load resistance training program performed twice weekly for 12 weeks', 'interventionNames': ['Other: High-load strength training for the knee']}\n- {'label': 'Standard care', 'type': 'ACTIVE_COMPARATOR', 'description': 'The standard care group will receive instructions on a neuromuscular training program with focus on knee stability and function performed at low intensities to be conducted twice weekly for 12 weeks', 'interventionNames': ['Other: Neuromuscular training for the knee']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Neuromuscular training for the knee', 'description': 'The exercise programme includes exercises identified in literature to target muscles around the knee.', 'armGroupLabels': ['Standard care']}\n- {'type': 'OTHER', 'name': 'High-load strength training for the knee', 'description': 'The exercise programme includes exercises identified in literature to target muscles around the knee.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Visual Analogue Scale Nominated Activity', 'description': 'The primary outcome is the Self-reported knee pain during an activity nominated by patients to be the most aggravating for their present knee pain (VAS nominated activity - VASNA, 0-100, 100 = worse).\\n\\nThe primary endpoint is at 12-week follow-up.', 'timeFrame': 'Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an SD of 15 mm, a power of 80%, a significance level of 0.05, and anticipating 20% dropouts.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n As we compare two active interventions, we consider a difference in change between treatments of 10\u00e2\u0080\u0089mm VASNA to be clinically meaningful.50 We will need a total sample of 74 patients to detect a between-group difference in change of 10\u00e2\u0080\u0089mm in VASNA, assuming an SD of 15\u00e2\u0080\u0089mm, a power of 80% and a significance level of 0.05. Anticipating 20% dropouts, we will include a sample size of 90 patients (45 in each group). Because assessment of tendon stiffness is resource-heavy and takes time, we will assess tendon stiffness in a subgroup of patients (15 from each group).", "id": 2058, "split": "test"} +{"trial_id": "NCT06285721", "pmid": "39488424", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DELirium Treatment With Transcranial Electrical Stimulation\n\nIncluded conditions:\n- Delirium\n\nStudy Armgroups:\n- {'label': 'Standardized treatment arm', 'type': 'EXPERIMENTAL', 'description': 'Standardized tACS will be applied with 2.0 mA (peak-to-peak) intensity for 30 minutes, with a 10 Hz frequency. Two 5x5 cm saline-soaked electrodes located at the frontal and occipito-parietal part of the scalp will be utilized (corresponding to 10-20 EEG electrode locations POz-Oz and AFz), including in the stimulation field the DLPFC, precuneus and posterior cingulate cortex. At the beginning of stimulation, the intensity will ramp up for 30 seconds to 2.0 mA peak-to-peak, while at the end of stimulation, the intensity will ramp down for 30 seconds.', 'interventionNames': ['Device: transcranial alternating current stimulation (tACS)']}\n- {'label': 'Personalized treatment arm', 'type': 'EXPERIMENTAL', 'description': 'Personalized tACS will be applied with 2.0 mA (peak-to-peak) intensity for 30 minutes with a 30 second ramp up and ramp down. Treatment will be personalized based on a delirium neural mass model. After fitting the model to the individual EEG, a virtual tACS trial allows for optimization of treatment parameters for each individual patient. Treatment optimization will take place through changing stimulation location and/or frequency. After determining the optimal individual treatment strategy, settings of the personalized stimulation will remain constant during the treatment phase.', 'interventionNames': ['Device: transcranial alternating current stimulation (tACS)']}\n- {'label': 'Sham treatment arm', 'type': 'SHAM_COMPARATOR', 'description': 'At the beginning and end of this 30-minute protocol, the tACS device will ramp up to 2.0 mA peak-to-peak intensity for 30 seconds, stimulate for 60 seconds and ramp down for 30 seconds, which mimics the sensation of actual tACS stimulation and improves blinding.', 'interventionNames': ['Device: Sham transcranial alternating current stimulation (tACS)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'transcranial alternating current stimulation (tACS)', 'description': 'tACS is a non-invasive brain stimulation technique which involves the application of a low intensity electric current between two or more surface electrodes. tACS uses stimulation with a current alternating at a specific frequency that can entrain endogenous neuronal oscillations by inducing neural synchronization. The administration of tACS is proposed to phase-lock large populations of neurons in the superficial layers of the cerebral cortex causing neural synchronization in the corresponding frequency, thereby altering connectivity. tACS will be delivered via a transcranial electrical stimulation (tES) device (Nurostym tES, Brainbox Ltd, United Kingdom). This device has been CE-marked for use as a medical device for the treatment of mental and neurological disorders.', 'armGroupLabels': ['Personalized treatment arm', 'Standardized treatment arm']}\n- {'type': 'DEVICE', 'name': 'Sham transcranial alternating current stimulation (tACS)', 'description': 'Sham-tACS is a form of non-effective stimulation which can mimic the subjective sensation of active tACS treatment. During sham-tACS, the device will ramp up to 2.0 mA peak-to-peak intensity for 30 seconds, stimulate for 60 seconds and ramp down for 30 seconds, which mimics the sensation of actual tACS stimulation and improves blinding.The sham-tACS will be delivered via a transcranial electrical stimulation (tES) device (Nurostym tES, Brainbox Ltd, United Kingdom). This device has been CE-marked for use as a medical device for the treatment of mental and neurological disorders.', 'armGroupLabels': ['Sham treatment arm']}\n\nPrimary Outcomes:\n- {'measure': 'Relative delta power', 'description': 'Calculated by dividing the absolute power in the delta frequency range by the total power, assessed using 64-channel resting-state EEG directly before and after tACS.', 'timeFrame': '1 day'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes an effect size of 0.15 with a standard deviation of 0.3, an alpha significance level of 0.05, and 80% statistical power. Patients who do not complete the initial tACS session with EEG recordings or withdraw consent will be replaced.", "answer": 159, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical power\n The sample size calculation is based on data obtained from a previous study that examined EEG findings in both delirious and non-delirious patients.15 In this study, patients with delirium showed a median relative delta power of 0.59 (IQR 0.47\u00e2\u0080\u00930.71), while those without delirium had a median of 0.20 (IQR 0.17\u00e2\u0080\u00930.26), resulting in an effect size of 0.39 (0.20\u00e2\u0080\u00930.59). This study excluded patients in whom the diagnosis delirium was not certain, which may have inflated the effect size. It is therefore anticipated that both standardised and personalised tACS will lead to a more modest decrease of 0.15 in relative delta EEG power poststimulation compared with prestimulation measurements. We hypothesise that personalised tACS may be superior to standardised tACS in reducing relative delta power. However, the lack of data to support this claim necessitates assuming equal effectiveness for both arms in the sample size calculation. Based on these assumptions, a sample size of 159 participants (ie, 53 per group) was estimated using G*Power 3.1. This estimation considered an effect size of 0.15 with a SD of 0.3, an alpha of 0.05 and 80% statistical power. Patients who do not complete the initial tACS session with EEG recordings will be replaced, as well as patients who withdraw consent.", "id": 2059, "split": "test"} +{"trial_id": "NCT06286202", "pmid": "39300363", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial\n\nIncluded conditions:\n- Schizophrenia\n- Schizoaffective Disorder\n\nStudy Armgroups:\n- {'label': 'Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)', 'type': 'EXPERIMENTAL', 'description': \"NEAR consists of using carefully selected computer cognitive games to restore cognitive functioning through rehearsal and strategy learning. It will be delivered 3 times a week for 12 weeks at the center. The duration of each session within the week is as follows: 1) First session: 45 min computer-assisted cognitive exercises + 30 min bridging group; 2) Second session: 30 min computer-assisted cognitive exercises + 45 min bridging group; 3) Third session: 45 min computer-assisted cognitive exercises. Computer-assisted cognitive exercises are sessions where participants engage in cognitive games that target different cognitive domains. In addition, the Multicontext Treatment Approach to strategy learning will be carried out. The metacognitive framework of self-evaluation and activity mediation will also be utilized. Bridging groups are conducted twice a week, to aid transfer of learning from the computer game sessions to the participants' everyday life.\", 'interventionNames': ['Behavioral: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)']}\n- {'label': 'Standard Psychiatric Rehabilitation at Anglican Care Centers', 'type': 'OTHER', 'description': 'Participants in the control arm will attend their scheduled activities at their respective Anglican Care Centers. The Anglican Care Centers run a variety of activities to provide psychosocial rehabilitation for clients with serious mental illness. These may include vocational training such as training in a retail shop or caf\u00e9, instrumental activities of daily living training (eg: taking public transport, money management), psychoeducation, social skills training etc. Participants in the control arm will not be enrolled into the cognitive remediation.', 'interventionNames': ['Behavioral: Standard Psychiatric Rehabilitation at Anglican Care Centers']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)', 'description': 'NEAR consists of computer-assisted cognitive exercises to restore cognitive functioning through rehearsal and strategy learning. Based on the results of the baseline assessments, the therapist will complete the Cognitive Remediation Treatment Plan, to outline targeted cognitive domains and functional goals. During the cognitive games sessions, the Multicontext Treatment Approach will be used, where error patterns are identified. The participants will work on metacognition and use of strategies to overcome challenges faced during the computer games sessions. Bridging groups may include activities for participants to utilize strategies learnt during the computer game sessions to everyday living. Participants will also learn about cognitive impairments and how lifestyle modifications, mood regulation etc can affect cognitive performance. In addition, they will learn about metamotivation and build awareness about their motivation levels through self- reflection and self-monitoring.', 'armGroupLabels': ['Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard Psychiatric Rehabilitation at Anglican Care Centers', 'description': 'Participants in the control arm will attend their usual psychiatric rehabilitation activities. These activities may include vocational training, community living skills training, psychoeducation, social skills training and peer support etc. These activities are also undertaken by participants in the experimental arm.', 'armGroupLabels': ['Standard Psychiatric Rehabilitation at Anglican Care Centers']}\n\nPrimary Outcomes:\n- {'measure': 'Brief Assessment of Cognition in Schizophrenia (BACS)', 'description': 'The Brief Assessment of Cognition in Schizophrenia (BACS) assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. This assessment was validated and found to be sensitive and highly correlated with the standard battery composite scores in patients (r = 0.76) and healthy controls (r = 0.90) (Keefe et.al., 2004). BACS was also previously normed in English-speaking adult age Singaporeans (Eng et al., 2014), and had demonstrated good convergent validity with education (Lam et al., 2013) and discriminability between healthy controls and schizophrenia (Lam et al., 2014). BACS is now widely used as an outcome measurement for cognitive remediation for schizophrenia.', 'timeFrame': 'Baseline, post-intervention and 8-week follow-up'}\n- {'measure': 'Bell Lysaker Emotion Recognition Task (BLERT)', 'description': \"The Bell Lysaker Emotion Recognition Task (BLERT) measures the participants' ability to process and recognize seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion (Bryson, Bell and Lysaker, 1997). The participants will be presented with 21 video clips of an actor demonstrating facial, voice-tonal and upper-body movement cues, while engaging in work-related monologues. Unlike static photos, this measurement appears to simulate real-world situations better and may approximate real world functional outcomes (Pinkham et.al., 2016). Rating was done by computing the total number of correctly recognized emotions (ranging from 0 to 21).\", 'timeFrame': 'Baseline, post-intervention and 8-week follow-up'}\n- {'measure': 'Canadian Occupational Performance Measure (COPM)', 'description': 'The Canadian Occupational Performance Measure (COPM) is a person-centered tool that measures aspects of functional and personal recovery among clients whose occupational performance and participation are affected by their current psychiatric conditions. Through a semi-structured interview, the clients identify activities in self-care, productivity and leisure that are of personal importance and rate their performance and satisfaction in each activity (Law et.al., 1990). Self-perceived performance and satisfaction are rated on a 10-point Likert scale.', 'timeFrame': 'Baseline, post-intervention and 8-week follow-up'}\n- {'measure': 'Social and Occupational Functioning Assessment Scale (SOFAS)', 'description': \"The Social and Occupational Functioning Assessment Scale (SOFAS) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning (Goldman et.al., 1992). It differs from GAF scale by focusing on social and occupational functioning independent of the overall severity of the individual's psychological symptoms. SOFAS has been used as a functional outcome measurement in cognitive remediation trials (Au-Yeung et.al., 2023; Harris et.al., 2022; Hodge et.al., 2010).\", 'timeFrame': 'Baseline, post-intervention and 8-week follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is set at 5%, the power (\u03b2) is set at 85%, and a two-tailed test is used. Intent-to-treat analyses will be carried out without one-to-one replacement for dropouts.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and statistical analyses\n The randomized controlled trial by Katsumi and colleagues [59] is used to provide the effect size of NEAR versus control arm receiving standard psychiatric rehabilitation. Functional outcome of this study is measured using the Global Assessment of Functioning (GAF). The mean GAF scores of both arms at the first follow-up post-intervention are used in this sample size calculation. Using G*Power 3.1.9.7 calculator [60], with cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.48, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00895% and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u008985% on a two-tailed test, the number of participants required at each arm is 79. To round off, 80 participants will be needed at each arm, making the total number of participants in our study to be 160.\n Stata18 statistical package [61] will be used to present the demographic profile, calculate the descriptive statistics and to analyze the data. Intent-to-treat analyses will be carried out, hence one-to-one replacement for participants who drop out will not be carried out.\n First, a comparison of the demographic characteristics and baseline outcome measurement scores of the participants in both arms will be carried out, to delineate any significant differences. Second, Repeated Measures ANOVA will be carried out to test for group by time differences in neurocognition and social cognition performance (measured by BACS and BLERT), symptoms (measured by\u00c2\u00a0PANSS and BNSS), functioning and recovery (measured by SOFAS and COPM), metacognition (measured by WCPA) and metamotivation (measured by BroMS) across the three time points of baseline, post-intervention and eight-week follow-up.\n Next, regression analyses will be carried out with SOFAS and COPM separately as dependent variables, to determine factors which may predict functioning and recovery. Correlation analyses will also be conducted to test for associations among neurocognition, social cognition, negative symptoms, metacognition, metamotivation, functioning and recovery. Lastly, bootstrapping will be carried out to test for mediators for improvement in cognitive performance and functioning.\n See Fig.\u00c2\u00a01 for the flow diagram of the study procedure.\nFig. 1Study flow diagram", "id": 2060, "split": "test"} +{"trial_id": "NCT06286709", "pmid": "39762111", "question": "Here is the design of a clinical trial:\n\nOfficial Title: FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis\n\nIncluded conditions:\n- Primary Sclerosing Cholangitis\n- Inflammatory Bowel Diseases\n\nStudy Armgroups:\n- {'label': 'Faecal Microbiota Transplant (FMT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'FMT is 50mL aliquots of filtered suspension of stool (0.6g/mL). FMT for administration via colonoscopy will be made up of 150g stool in 250mL (5 aliquots). FMT for administration via enema will be made up of 30g stool in 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline', 'interventionNames': ['Biological: Faecal Microbiota Transplant']}\n- {'label': 'FMT Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'FMT Placebo is 50mL aliquots of 0.9% w/v saline and glycerol in a ratio of 9 parts saline: 1 part glycerol v/v.', 'interventionNames': ['Other: FMT Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Faecal Microbiota Transplant', 'description': 'FMT is 50mL aliquots of filtered suspension of stool (0.6g/mL). FMT for administration via colonoscopy will be made up of 150g stool in 250mL (5 aliquots). FMT for administration via enema will be made up of 30g stool in 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline', 'armGroupLabels': ['Faecal Microbiota Transplant (FMT)']}\n- {'type': 'OTHER', 'name': 'FMT Placebo', 'description': 'FMT Placebo is 50mL aliquots containing 0.9% w/v saline and glycerol in a ratio of 9 parts saline: 1 part glycerol v/v. FMT Placebo for administration via colonoscopy will be made up of 250mL (5 aliquots). FMT Placebo for administration via enema will be made up of 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline', 'armGroupLabels': ['FMT Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Serum Alkaline Phosphatase (ALP)', 'description': 'Reduction in serum ALP values from baseline, measured at 48 weeks following the first dose of FMT or FMT Placebo.', 'timeFrame': 'ALP at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48'}\n\nPlease estimate the sample size based on the assumption: \n90% power, type I error rate of 0.05, and an attrition rate of approximately 10-15%.", "answer": 58, "answer_type": "ESTIMATED", "explanation": "Sample size determinations\n The recruitment target is a total of 58 participants who will be randomised 1:1 to receive either active FMT or FMT Placebo treatment. Power calculations have been derived from post hoc analysis of the phase II clinical trial of simtuzumab in PSC,4 in which variation in serum ALP over time was calculated as part of the clinical course of PSC. As such, a sample size of 26 participants per treatment group would provide 90% power with a type I error rate of 0.05, to detect a mean difference of 30 units between active treatment and control groups, with regards per cent reduction in baseline of ALP, using a two-sample independent t-test. A pooled SD of 36.3 was used in this calculation (obtained from the simtuzumab data set).\n Prior clinical trials in PSC observe an approximately 10\u00e2\u0080\u009315% attrition rate; therefore, the current trial would require a total of 58 subjects (29 per treatment arm). Serum ALP will be collected at baseline and at multiple time points post-treatment. The proposed primary analysis would be to model post-treatment ALP using a Bayesian multilevel model that allows for nesting of the repeated measures data within the patient. The above sample size calculation is to provide insight into the magnitude of effect size that could be identified with reasonable error rates. However, the trial will aim to make more efficient use of the primary outcome data through the use of modelling and the trial will consider the totality of all data points with regard to the primary/secondary outcome evidence in making inferences.", "id": 2061, "split": "test"} +{"trial_id": "NCT06294990", "pmid": "40090688", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Klinefelter Syndrome - the Effect of Testosterone Treatment in Puberty. a Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'\n\nIncluded conditions:\n- Klinefelter Syndrome\n\nStudy Armgroups:\n- {'label': 'Testosterone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Testosterone gel applied to the skin', 'interventionNames': ['Drug: Testosterone gel']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo gel applied to the skin', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Testosterone gel', 'description': 'Two years treatment with testosterone', 'armGroupLabels': ['Testosterone'], 'otherNames': ['Testosterone']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Two years treatment with placebo', 'armGroupLabels': ['Placebo'], 'otherNames': ['Testosterone']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in body fat mass', 'description': 'Evaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan', 'timeFrame': 'Baseline and 1 and two years'}\n\nPlease estimate the sample size based on the assumption: \nThe test is at the nominal 5% significance level with a power of 90%. The expected dropout rate is approximately 20%.", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n Based on data from our previous study on 275 boys aged 8\u00e2\u0080\u009314 years who underwent whole-body DEXA scan using the same Lunar Prodigy Advance equipment, the coefficient of variation (CV) for body fat percentage (%BF) was 13.1% (max CV for inter-rater variability).53 The BF% for 10\u00e2\u0080\u009312\u00e2\u0080\u0089year-olds was approximately 20%, resulting in an estimated SD of 2.6%. To detect a 5% difference in BF% (primary outcome) between the two groups over a 2-year period, using a two-sample t-test on paired differences, 13 patients are required in each group. The test is at the nominal 5% significance level with a power of 90%. With an expected dropout rate of approximately 20%,\u00e2\u0080\u0089a total of 32 boys will be included to ensure that 13 participants in each arm will complete the study.", "id": 2062, "split": "test"} +{"trial_id": "NCT06295120", "pmid": "39334468", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial\n\nIncluded conditions:\n- Community-acquired Pneumonia\n\nStudy Armgroups:\n- {'label': '3 days', 'type': 'EXPERIMENTAL', 'description': '3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}\n- {'label': '4 days', 'type': 'EXPERIMENTAL', 'description': '4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}\n- {'label': '5 days', 'type': 'EXPERIMENTAL', 'description': '5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}\n- {'label': '6 days', 'type': 'EXPERIMENTAL', 'description': '6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}\n- {'label': '7 days', 'type': 'ACTIVE_COMPARATOR', 'description': '7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.', 'interventionNames': ['Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Phenoxymethylpenicillin 1.2 MIE 4 times daily', 'description': 'The intervention is the duration of treatment with phenoxymethylpenicillin from 3 to 7 days. Dose and frequency of the treatment is the same in the different arms.', 'armGroupLabels': ['3 days', '4 days', '5 days', '6 days', '7 days']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment failure at day 30', 'description': 'Treatment failure is defined as any hospitalisation OR change in the antibiotic strategy (i.e., prolongation of the duration, change in antibiotic type, new antibiotic prescription) due to symptoms of acute respiratory tract infection - between randomisation and day 30.', 'timeFrame': 'From randomisation to day 30'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided alpha of 0.025, 10% drop-out rate, optimal power of 0.79 (delta method) or 0.80 (bootstrapping), and acceptable power of 0.99 (delta method) or 0.98 (bootstrapping).", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We aim to randomise 600 participants in total across five treatment arms (120 participants per duration). This number is based on an assumed treatment success rate of 90% (i.e. 10% treatment failure rate) for those allocated to the 7-day duration, an absolute non-inferiority margin of 10%, and a one-sided alpha of 0.025 (i.e. we will conclude non-inferiority of a given duration if the limit of the one-sided 97.5% CI for the absolute % increase in treatment failure rate compared to 7\u00c2\u00a0days does not include 10%) and is inflated to account for 10% drop-out.\n We estimated the optimal power (i.e. the probability that the trial ends up identifying the actual optimal duration) and acceptable power (i.e. the probability that the trial ends up identifying an effective duration that is shorter that the maximum) via simulation, fixing the design (in terms of number of arms and spacing between arms, alpha, estimated treatment success rate, and non-inferiority margin). Our analytical model in our simulations assumed a binomial distribution for our event rate and a fixed-2 fractional polynomial for our \u00e2\u0080\u0098durations\u00e2\u0080\u0099 trial arm. We estimated standard errors initially using the delta method (1000 simulations) and subsequently with bootstrapping (100 simulations owing to the computational intensity of bootstrapping a high number of samples).\n Using the delta method to estimate confidence intervals, our simulations demonstrated that optimal power would be 0.79 and acceptable power would be 0.99 under these assumptions. Using bootstrapping, our simulations demonstrated optimal power at 0.80 and acceptable power at 0.98.\n To identify subgroups of patients, with a potential need for a different treatment duration, various covariates will be considered. Covariates included will be multimorbidity, age, and C-reactive protein (CRP) value. These variables will be treated as both categorical and continuous. A full description of the explicit exploratory analysis of subgroups will be stated in the statistical analysis plan (SAP).", "id": 2063, "split": "test"} +{"trial_id": "NCT06297252", "pmid": "39979054", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population\n\nIncluded conditions:\n- Pregnancy\n\nStudy Armgroups:\n- {'label': 'Pregnant adults', 'type': 'EXPERIMENTAL', 'description': 'Adults women with an ongoing pregnancy who are scheduled for a T2 ultrasound, regardless of known history or pregnancy context (normal or pathological).', 'interventionNames': ['Diagnostic Test: standardized clinical psychiatric evaluations', 'Diagnostic Test: self-administered psychiatric questionnaire assessments', 'Other: blood sampling']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'standardized clinical psychiatric evaluations', 'description': 'The intervention consists of a psychiatric consultation including :\\n\\n* assessment of psychiatric disorders using a MINI test\\n* information gathering (medical, obstetrical and family history, expected term of pregnancy).\\n* assessment of suicidal behaviour using the Columbia-Suicide Severity Rating Scale (CSSR-S)\\n* collection of negative life events over the past 12 months, assessed using the Paykel questionnaire', 'armGroupLabels': ['Pregnant adults']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'self-administered psychiatric questionnaire assessments', 'description': \"* EPICES Score: (Evaluation de la Pr\u00e9carit\u00e9 et des In\u00e9galit\u00e9s de sant\u00e9 dans les Centres d'Examens de Sant\u00e9):\\n* MIBS: (Mother to Infant Bonding Scale)\\n* PAI: (Prenatal Attachment Inventory)\\n* EDEQ: (Eating Disorder Examination Questionnaire)\\n* PCL-5: (Post-traumatic Stress Disorder Checklist for DSM-V)\\n* MARS: (Medication Adherence Rating Scale)\\n* EPDS: (Edinburgh Postnatal Depression Scale)\", 'armGroupLabels': ['Pregnant adults']}\n- {'type': 'OTHER', 'name': 'blood sampling', 'description': 'A blood sample is taken to form an optional biological collection, comprising 3 samples:\\n\\n* A tube to collect RNA from whole blood.\\n* A tube to collect serum\\n* A tube to collect native DNA', 'armGroupLabels': ['Pregnant adults']}\n\nPrimary Outcomes:\n- {'measure': 'To determine the prevalence of the presence of at least one characterized psychiatric disorder, in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.', 'description': 'Presence of at least one psychiatric disorder (evaluated by the MINI), of any kind, in remission or not, during pregnancy, at the time of the T2 ultrasound.\\n\\nThe MINI score verifies the presence or absence of criteria for the most common psychiatric illnesses and assess the 17 most common psychiatric disorders and suicidality in DSM-III-R, DSM-IV and DSM-5 and ICD-10.\\n\\n* Affective Disorders, Psychotic\\n* Agoraphobia\\n* Alcoholism\\n* Anorexia Nervosa\\n* Antisocial Personality Disorder\\n* Anxiety Disorders\\n* Bipolar and Related Disorders\\n* Bipolar Disorder\\n* Bulimia Nervosa\\n* Depressive Disorder, Major\\n* Mania\\n* Obsessive-Compulsive Disorder\\n* Panic Disorder\\n* Phobia, Social\\n* Psychotic Disorders\\n* Self-Injurious Behavior\\n* Stress Disorders, Post-Traumatic\\n* Substance-Related Disorders\\n* Suicidal Ideation', 'timeFrame': 'Baseline (T2 ultrasound)'}\n\nPlease estimate the sample size based on the assumption: \nPrecision of \u00b18% at 95% CI, 30% dropout rate", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study aims to estimate the prevalence of psychiatric disorders, anticipated to be around 20%. To achieve a precision of \u00c2\u00b18% at 95% CI, 97 evaluable participants would be needed. Considering a potential 30% dropout rate, the target will be to enrol 140 participants.", "id": 2064, "split": "test"} +{"trial_id": "NCT06297330", "pmid": "39972313", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Determining the Influence of an Intervention Program Based on Sleep Improvement and Fatigue Reduction Among Medical Students.\n\nIncluded conditions:\n- Health Behavior\n- Health-Related Behavior\n- Sleep\n- Sleep Disorder\n- Fatigue\n\nStudy Armgroups:\n- {'label': 'Sleep intervention', 'type': 'EXPERIMENTAL', 'description': 'One arm : All volunteers will receive a sleep management intervention.', 'interventionNames': ['Behavioral: Sleep']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Sleep', 'description': 'The sleep management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During these sessions, subjective and objective indicators related to the sleep and fatigue levels will be recorded to assess the progress of each student.', 'armGroupLabels': ['Sleep intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI).', 'description': 'The students level of sleep troubles will be assessed through the PSQI score ranging from 0 (none) to 21 (extreme). This score classified the presence or absence of sleep troubles. It can be divided into eight sub-scores (i.e., sleep quality, sleep latency, time spent in bed, sleep time, habitual sleep efficiency, sleep disturbance, use of sleeping medication and daytime dysfunction). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).', 'timeFrame': 'From week 5 to week 11.'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 = 5%, power = 0.80, three measurements, additional 10% for attrition or data loss", "answer": 45, "answer_type": "ESTIMATED", "explanation": "A priori-sample size\n The sample size was a priori calculated for the primary outcome (evolution of the global PSQI score during S1, S2, S3). Based on an expected medium effect size for repeated measures (i.e., f = 0.20, \u00ce\u00b1 = 5%, power = 0.80, and three measurements), the calculation resulted in a total sample size of 42 participants (G*Power v3.1.9.6). To ensure robustness against potential attrition or data loss, we will recruit an additional 10% of volunteers to result in a total sample size of 45 students.", "id": 2065, "split": "test"} +{"trial_id": "NCT06298877", "pmid": "39907536", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer (FOLERO) : A Prospective Cohort Study to Determine the Effect of Frailty on Survival and to Assess Early Reversal of Temporary Intestinal Stoma\n\nIncluded conditions:\n- Ovarian Cancer\n\nStudy Armgroups:\n- {'label': 'Frailty', 'type': 'EXPERIMENTAL', 'description': 'Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools', 'interventionNames': ['Other: Frailty and Quality of Life evaluation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Frailty and Quality of Life evaluation', 'description': 'Frailty and Quality of Life evaluation after surgery', 'armGroupLabels': ['Frailty']}\n\nPrimary Outcomes:\n- {'measure': 'Overall Survival', 'description': 'Overall survival time is calculated from the date of index surgery to the date of death (due to any cause), or for patients still alive to the date of last follow-up.', 'timeFrame': '24 months after index surgery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power varies between 79% and 92% depending on frailty prevalence and follow-up time, drop-out rate of 40%", "answer": 450, "answer_type": "ESTIMATED", "explanation": "Sample size\n Among the four participating University hospitals at least 250 women are surgically treated annually. With a realistic estimation of a drop-out rate of 40%, it is feasible that 150 women are recruited annually over 3 years to reach the target sample size that is fixed and set to 450 women. However, the follow-up time and exact power may vary depending on the actual prevalence of frailty (see Table 1).\n \n Table 1\n \n The relationship between the prevalence of frailty and power, events and study time in the FOLERO study.\n \n \n \n \n Sample size\n Accrual time\n Follow-up time\n Total study time\n Frailty prevalence %\n Hazard ratio\n No. of events*\n Power %\n \n \n \n \n \n450\n\n 3\n 2\n 5\n \n20\n\n 1.63\n 192\n 83\n \n \n \n450\n\n 3\n 1\n 4\n \n25\n\n 1.63\n 149\n 79\n \n \n \n450\n\n 3\n 2\n 5\n \n25\n\n 1.63\n 196\n 87\n \n \n \n450\n\n 3\n 1\n 4\n \n30\n\n 1.63\n 153\n 83\n \n \n \n450\n\n 3\n 2\n 5\n \n30\n\n 1.63\n 200\n 90\n \n \n \n450\n\n 3\n 1\n 4\n \n35\n\n 1.63\n 157\n 85\n \n \n \n450\n\n 3\n 2\n 5\n \n35\n\n 1.63\n 203\n 92\n \n \n \n \n \n FOLERO: Frailty, quality Of Life and Early Reversal of temporary defunctioning stoma in Ovarian Cancer.\n \n \n *\n Represents number of deaths.", "id": 2066, "split": "test"} +{"trial_id": "NCT06307340", "pmid": "39627789", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations\n\nIncluded conditions:\n- Polysubstance Abuse\n- Posttraumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'Adapted STAIR-NT Intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)']}\n- {'label': 'Treatment as Usual (TAU)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Treatment as Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)', 'description': 'Adapted version of evidence-based behavioral PTSD intervention.', 'armGroupLabels': ['Adapted STAIR-NT Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Treatment as Usual', 'description': 'Treatment as usual.', 'armGroupLabels': ['Treatment as Usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of Eligible Participants', 'description': 'Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.', 'timeFrame': 'Baseline'}\n- {'measure': 'Proportion of Eligible Participants who Enroll', 'description': '.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.', 'timeFrame': 'Baseline'}\n- {'measure': 'Number of Intervention Sessions Completed', 'timeFrame': 'Up to Month 3'}\n- {'measure': 'Clinician-Rated Feasibility of Intervention Measure (FIM) Score', 'description': '4-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.', 'timeFrame': 'Month 3'}\n- {'measure': 'Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score', 'description': '4-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.', 'timeFrame': 'Month 3'}\n- {'measure': 'Number of Days of Co-Use of Cocaine and Illicit Opioids', 'description': 'Measured using the Addiction Severity Index (ASI) questionnaire.', 'timeFrame': 'Month 3'}\n- {'measure': 'Number of Substances Used based on ASI Self-Report', 'description': \"Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.\", 'timeFrame': 'Month 3'}\n- {'measure': 'Number of Substances Used based on Urine Drug Screen', 'timeFrame': 'Month 3'}\n- {'measure': 'Number of Substances Used based on Chart Abstraction of Toxicology Results', 'timeFrame': 'Month 3'}\n- {'measure': 'PTSD Checklist for DSM-5 (PCL-5) Score', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.', 'timeFrame': 'Month 3'}\n- {'measure': 'Negative Mood Regulation Scale Score', 'description': \"30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.\", 'timeFrame': 'Month 3'}\n- {'measure': 'Inventory of Interpersonal Problems Score', 'description': 'A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.', 'timeFrame': 'Month 3'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to achieve 80% power with a significance level not explicitly stated. An attrition rate of 15-20% was considered.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Power calculations for the primary short-term outcome of change in number of days of PSU were conducted. To estimate the variability of number of days of PSU the manuscript of Kelly et. al [57] was used which studies a population of subjects in MMT, a decent equivalent of the proposed TAU intervention. The authors [57] reported a standard deviation of 6.78 and 7.85\u00c2\u00a0days of heroin and cocaine use, respectively. The mean difference of PSU between arms was then assumed to be 5, leading to a medium-large effect size of around 0.7 (5 divided by the average of 6.78 and 7.85\u00c2\u00a0days). With a sample of 30 participants per arm, the current proposed study will achieve 80% power to detect a size of 0.7. To account for a possible attrition rate of 15\u00e2\u0080\u009320% of participants, the sample size was inflated while maintaining 80% power to 40 participants per arm.", "id": 2067, "split": "test"} +{"trial_id": "NCT06307977", "pmid": "39563247", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples\n\nIncluded conditions:\n- Substance Use\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'No Intervention: CHTC as usual', 'type': 'NO_INTERVENTION', 'description': 'Participants complete the standard Couples HIV Testing and Counseling session (CHTC).'}\n- {'label': 'Behavioral: Couples Health Project', 'type': 'ACTIVE_COMPARATOR', 'description': 'A three-session intervention for couples addressing couples communication skills, substance use, sexual agreements. The intervention also includes couples HIV testing and counseling in the final session.', 'interventionNames': ['Behavioral: Couples Health Project']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Couples Health Project', 'description': 'A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention', 'armGroupLabels': ['Behavioral: Couples Health Project'], 'otherNames': ['CHP']}\n\nPrimary Outcomes:\n- {'measure': 'Drug use Frequency', 'description': 'Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments', 'timeFrame': '9 Months'}\n- {'measure': 'Urine assay for drug use', 'description': 'Positive urine screen for drug use assessed bi-annually', 'timeFrame': '9 Months'}\n- {'measure': 'CAS with casual partners', 'description': 'Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage', 'timeFrame': '9 Months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that provides power > 0.80, an 80% retention rate, and uses mixed models tests for two means in cluster randomized designs.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n Power analysis were conducted using the Power Analysis and Sample Size (PASS) software program (version 19) to determine the power to detect between-group differences in a Poisson distributed variable in a cluster randomized trial at any cross-sectional time-point. Estimating 80% retention, a baseline sample of 180 couples (360 individuals) would yield 300 observations at any follow-up point. Assuming average drug use frequency ranges between 2 and 4 instances of use in the past month in the control condition at follow-up, the study would have power\u00e2\u0080\u0089>\u00e2\u0080\u00890.80 to detect a between-condition difference of 0.5\u00e2\u0080\u00930.7 instances (approximately 25%). Assuming average DAST-10 scores decrease by 1.5 and 2.5 in the control condition, the study has power\u00e2\u0080\u0089>\u00e2\u0080\u00890.80 to detect a between-group difference of 0.4 to 0.5 points (approximately 23%). Finally, assuming the average HIV TRB frequency in the control condition ranges between 1.5 and 2, the study has power\u00e2\u0080\u0089>\u00e2\u0080\u00890.80 to detect a between-group difference of 0.4 (approximately 21%). Regarding the power to detect moderation, two-way and three-way interactions involving the treatment condition had effect sizes that ranged from d\u00e2\u0080\u0089=\u00e2\u0080\u00890.70 to 1.20. Using the mixed models test for two means in a cluster randomized designs module in PASS, the proposed sample has power\u00e2\u0080\u0089>\u00e2\u0080\u00890.80 to detect effects in this range of magnitude.", "id": 2068, "split": "test"} +{"trial_id": "NCT06308484", "pmid": "39334026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD\n\nIncluded conditions:\n- Alcohol Dependence\n\nStudy Armgroups:\n- {'label': 'Active transcutaneous vagus nerve stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'The tVNS device consisted of two titan electrodes mounted on a gel frame and connected to a wired neurostimulation device (tVNS Health GmbH, Germany). Electrodes were placed on the cymba conchae. Stimulation intensity of 0.5 mA, delivered with a pulse width of 200-300 \u03bcs at 25 Hz.', 'interventionNames': ['Device: Transcutaneous vagus nerve stimulation']}\n- {'label': 'Sham transcutaneous vagus nerve stimulation', 'type': 'SHAM_COMPARATOR', 'description': 'Stimulation parameters equivalent to active but sham stimulation was administered by positioning the electrodes on the central part of the left earlobe rather than the outer auditory canal, as the earlobe lacks vagus innervation.', 'interventionNames': ['Device: Transcutaneous vagus nerve stimulation']}\n- {'label': 'Closed-loop AM-tACS increase frontal midline theta oscillation', 'type': 'ACTIVE_COMPARATOR', 'description': 'We will deliver amplitude-modulated transcranial alternating current stimulation (AM-tACS) using two circular rubber electrodes (4 cm diameter) positioned at the Fpz and Cz locations of the international 10-20 system. The AM-tACS stimulation waveform features a carrier signal frequency of 10 kHz, an amplitude of \u00b11 mA, and a signal that is real-time synchronized with theta oscillations of the frontal midline. In the active condition target oscillations (frontal midline theta) will be increased.', 'interventionNames': ['Device: Closed-loop AM-tACS']}\n- {'label': 'Closed-loop AM-tACS decrease frontal midline theta oscillation', 'type': 'SHAM_COMPARATOR', 'description': 'Equivalent to the active comparator - except here the target oscillation will be suppressed.', 'interventionNames': ['Device: Closed-loop AM-tACS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcutaneous vagus nerve stimulation', 'description': 'Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.', 'armGroupLabels': ['Active transcutaneous vagus nerve stimulation', 'Sham transcutaneous vagus nerve stimulation']}\n- {'type': 'DEVICE', 'name': 'Closed-loop AM-tACS', 'description': 'Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.', 'armGroupLabels': ['Closed-loop AM-tACS decrease frontal midline theta oscillation', 'Closed-loop AM-tACS increase frontal midline theta oscillation']}\n\nPrimary Outcomes:\n- {'measure': 'Cognitive Control', 'description': 'Before and after the treatment, we will assess cognitive control on a behavioral (response inhibition) and neurophysiological level (electroencephalogram) using a Simon GoNogo task, which reliably triggers activation of the frontal midline regions (Swick et al., 2011).', 'timeFrame': 'Pre and post intervention after 6-8 weeks'}\n- {'measure': 'Interoception', 'description': 'Additionally, interoceptive control is intended to be measured using a heartbeat detection task (Kleckner et al., 2015).', 'timeFrame': 'Pre and post intervention after 6-8 weeks'}\n- {'measure': 'Cue-Reactivity', 'description': 'Evaluate physiological reactivity to alcohol cues through a passive viewing task developed based on the guidelines of Ekhitiari et al. (2022) and measure subjective cue-induced cravings.', 'timeFrame': 'Pre and post intervention after 6-8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, and an attrition rate of 20%.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size\n For the examination of the effect of tVNS, we based our sample calculations on a study that investigated the effect of tVNS on protracted alcohol withdrawal symptoms in abstinent AUD patients [73]. According to the changes in the craving scores, considering a 95% confidence interval, 80% power (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), and the related mean and standard deviation (SD) of the craving scores in the aforementioned study (\u00ce\u00bc1\u00e2\u0080\u0089=\u00e2\u0080\u00894.82; \u00ce\u00bc2\u00e2\u0080\u0089=\u00e2\u0080\u00893.92; SD1\u00e2\u0080\u0089=\u00e2\u0080\u00890.49; SD2\u00e2\u0080\u0089=\u00e2\u0080\u00890.39) we estimate n\u00e2\u0080\u0089=\u00e2\u0080\u008940 for each group. With an attrition rate of 20%, final estimated sample size is n\u00e2\u0080\u0089=\u00e2\u0080\u008950 per group. With regards to the application of CLAM-tACS, we performed a sample size estimation on the basis of a similar study investigating the causal role of frontal theta oscillations in a clinical population [74]. There, a medium effect size of dz\u00e2\u0080\u0089=\u00e2\u0080\u00890.577 was found, which corresponds to a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008920 per group at a power of 0.8 und an alpha level of 0.05. In total we will recruit n\u00e2\u0080\u0089=\u00e2\u0080\u0089140 AUD patients to be included in this study.", "id": 2069, "split": "test"} +{"trial_id": "NCT06308549", "pmid": "39350441", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY): A Multi-National Randomised-Controlled Trial\n\nIncluded conditions:\n- Type 1 Diabetes\n- Diabetes Distress\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': '2/3 of participants will be randomised into this arm. They will receive access to MyDiaMate in the language of their participation country for 6 months.', 'interventionNames': ['Behavioral: MyDiaMate']}\n- {'label': 'Care As Usual', 'type': 'NO_INTERVENTION', 'description': '1/3 of participants will be randomised into this arm. They will receive Care As Usual, so no intervention, for 3 months. After 3 months, they receive access to MyDiaMate, if so wished.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'MyDiaMate', 'description': 'MyDiaMate programme', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Diabetes Distress', 'description': 'Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (=PAID-20). The Problem Areas In Diabetes questionnaire measures diabetes distress on a 5-point Likert scale ranging from 1 (Not a problem) to 5 (Serious Problem). A higher score represents higher diabetes distress.', 'timeFrame': 'Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).'}\n\nPlease estimate the sample size based on the assumption: \nBaseline assessment as covariate, 2:1 randomised groups, a power of 0.90, a two-sided alpha of 0.05, and an attrition rate of 20% at 3 months.", "answer": 660, "answer_type": "ESTIMATED", "explanation": "2.6\n Sample Size\n We can expect an effect size of 0.3 as this is in line with results from meta\u00e2\u0080\u0090analytic reviews on psychological interventions for diabetes.\n4\n, \n28\n To be able to detect a small to moderate effect size of 0.3 (Cohen's d) on the Problem Areas in Diabetes questionnaire, our main outcome measure, a total sample of N\u00e2\u0080\u0089=\u00e2\u0080\u0089528 is needed. The calculations in G*Power took into account: Baseline assessment as covariate, 2:1 randomised groups, a power of 0.90 and a two\u00e2\u0080\u0090sided alpha of 0.05. Anticipating an attrition rate of 20% at 3\u00e2\u0080\u0089months, we aim to recruit N\u00e2\u0080\u0089=\u00e2\u0080\u0089660 participants, which is N\u00e2\u0080\u0089=\u00e2\u0080\u0089165 in each country.", "id": 2070, "split": "test"} +{"trial_id": "NCT06311799", "pmid": "39639285", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Obesity, Maternal\n- Diabetes\n\nStudy Armgroups:\n- {'label': 'Arm 1: Clinic Model', 'type': 'NO_INTERVENTION', 'description': 'Clinical team gives WIC information only'}\n- {'label': 'Arm 2: Clinic-WIC Model', 'type': 'ACTIVE_COMPARATOR', 'description': 'Clinical team connects patient to WIC', 'interventionNames': ['Behavioral: WIC Referral']}\n- {'label': 'Arm 3: Clinic-RDN Model', 'type': 'ACTIVE_COMPARATOR', 'description': 'Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN)', 'interventionNames': ['Behavioral: RDN Referral']}\n- {'label': 'Arm 4: Clinic-WIC-RDN', 'type': 'ACTIVE_COMPARATOR', 'description': 'Clinical team connects patient to WIC and RDN', 'interventionNames': ['Behavioral: WIC Referral', 'Behavioral: RDN Referral']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'WIC Referral', 'description': 'Clinical team will refer study participants to WIC', 'armGroupLabels': ['Arm 2: Clinic-WIC Model', 'Arm 4: Clinic-WIC-RDN']}\n- {'type': 'BEHAVIORAL', 'name': 'RDN Referral', 'description': 'Clinical team will refer study participants to a RDN', 'armGroupLabels': ['Arm 3: Clinic-RDN Model', 'Arm 4: Clinic-WIC-RDN']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in Women, Infants, and Children (WIC) enrollment', 'description': 'Difference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was determined assuming a Type I error rate of 5% and 80% power.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size and participants\n Approximately 240 low-income pregnant people will be recruited and randomized 1:1:1:1 to each arm. See Fig.\u00c2\u00a01 for CONSORT diagram with participants enrolled to date. Participants are blind to their randomized condition, and those assessing study outcomes will also be blinded. Sample size was determined assuming a Type I error rate of 5% and 80% power to assess a rate of WIC enrollment of 25% in the WIC information only group (Arm 1 and Arm 3) to 45% in the EHR referral group (Arm 2 and Arm 4). Participant eligibility criteria include the following: age 18 years or older, English speaking, confirmed pregnancy, intent to deliver at a Geisinger facility, and public or no insurance. The insurance criterion conveniently serves as a proxy for lower income status, as WIC serves families with household incomes up to 185% federal poverty level. Potential participants are excluded if they are not eligible for WIC, have pre-existing enrollment in WIC as a pregnant person, have private insurance, and/or are unwilling to participate for up to 12 months.\n \nFig.\u00c2\u00a01CONSORT Diagram\n\n Providers, including Geisinger clinical teams delivering prenatal care (e.g., nurse care coordinators, clinicians) and WIC staff, are also invited to participate in the study by completing surveys and semi-structured interviews.", "id": 2071, "split": "test"} +{"trial_id": "NCT06312904", "pmid": "39510785", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial\n\nIncluded conditions:\n- Postoperative Pain\n\nStudy Armgroups:\n- {'label': 'paravertebral block group', 'type': 'EXPERIMENTAL', 'description': 'This group of patients will undergo postoperative paravertebral block.', 'interventionNames': ['Procedure: paravertebral block']}\n- {'label': 'local infiltration group', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group of patients will undergo postoperative local infiltration anesthesia.', 'interventionNames': ['Procedure: Local infiltration anesthesia']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'paravertebral block', 'description': 'After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.', 'armGroupLabels': ['paravertebral block group']}\n- {'type': 'PROCEDURE', 'name': 'Local infiltration anesthesia', 'description': 'After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.', 'armGroupLabels': ['local infiltration group']}\n\nPrimary Outcomes:\n- {'measure': 'opioid consumption during the first 24h after surgery', 'description': 'the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight', 'timeFrame': '24 hours postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nOne-side significance level of 0.025, power level of 80%, and a maximum possible dropout rate of 10%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Sample size calculation was based on the primary outcome, the total opioid consumption within 24 hours after surgery. Based on our preliminary test results, the average total opioid consumption within 24 hours after surgery in the control group was 0.85\u00c2\u00b10.18\u00e2\u0080\u0089mg/kg MED. Based on previously published literature12 13 26 and the experience of clinical experts, we assumed that in the PVB group, total opioid consumption within 24 hours after surgery will be reduced by an average of 30%, that is, 0.255\u00e2\u0080\u0089mg/kg MED. The combined SD was conservatively estimated to be 0.425\u00e2\u0080\u0089mg/kg MED. With a one-side significance level of 0.025, and a power level of 80%, 90 participants need to be enrolled (45 participants for each group). Sample size calculation was performed using the Power Analysis and Sample Size (PASS) software. Taking into account the maximum possible dropout rate of 10% in the study, this trial will eventually enrol 100 children, 50 children in each group.", "id": 2072, "split": "test"} +{"trial_id": "NCT06318143", "pmid": "39774400", "question": "Here is the design of a clinical trial:\n\nOfficial Title: mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria\n\nIncluded conditions:\n- Sickle Cell Disease\n\nStudy Armgroups:\n- {'label': 'Education', 'type': 'NO_INTERVENTION', 'description': 'provision of information about task sharing'}\n- {'label': 'TASSH', 'type': 'EXPERIMENTAL', 'description': 'replicable evidence-based task-sharing strategy,TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH)', 'interventionNames': ['Behavioral: TASSH']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'TASSH', 'description': 'Strategy for Hemoglobinopathies (TASSH) containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management (Figure 1A describes the components of the intervention).', 'armGroupLabels': ['TASSH']}\n\nPrimary Outcomes:\n- {'measure': 'Patient numbers - screening', 'description': 'The number of patients taking HU identified through screening', 'timeFrame': '12 months'}\n- {'measure': 'Patient numbers - proportion on HU', 'description': 'The proportion of patients that on HU based on the REACH Clinical Trial algorithm tailored for aged 9 months through adulthood using SPARCO HU Guidelines', 'timeFrame': '12 months'}\n- {'measure': 'Patient numbers - dosage', 'description': 'Proportion of patients who maintained HU dosage', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power more than 80%, intra-class coefficients (ICCs) between 0.01 and 0.06, and up to 30% attrition rate.", "answer": 900, "answer_type": "ESTIMATED", "explanation": "Sample size and power analysis\n The unit of randomization for the intervention is the hospital or clinic; ten in the intervention arm and ten in the control arm (n = 20). Based on previous literature, implementing SIM to address SCD could have approximately 19% difference in the rates of composite measure of adoption between the treatment arms. Thus, we estimate sample sizes for a range of small differences (minimum detectable difference (MDD) between 7.5% to 10.5%, assuming standard deviation of 30% or Cohen\u00e2\u0080\u0099s d between 0.25 and 0.35) for this intervention, assuming an average class size (m) of about 45 participants/clinic, and intra-class coefficients (ICC)s between .01 and .06. This yields a total sample size of 20 x 45 = 900 participants, providing more than 80% power to detect a small difference of 9% with a conservative assumption of ICC = 0.02. Note that this includes adjustment for up to 30% attrition of the study sample; this estimate is conservative.", "id": 2073, "split": "test"} +{"trial_id": "NCT06322719", "pmid": "39237284", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Comparison Between the Hyperangulated vs. Macintosh Blades for First-attempt Intubation Success With Videolaryngoscopy in ICU Patients.\n\nIncluded conditions:\n- Acute Respiratory Failure\n- Intubation\n- Intubation; Difficult or Failed\n- Videolaryngoscopy\n- Intubation Complication\n\nStudy Armgroups:\n- {'label': 'Hyperangulated videolaryngoscope', 'type': 'EXPERIMENTAL', 'description': 'Tracheal intubation facilitated by a hyperangulated videolaryngoscope', 'interventionNames': ['Device: Hyperangulated blade videolaryngoscope']}\n- {'label': 'Macintosh videolaryngoscope', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade', 'interventionNames': ['Device: Macintosh blade videolaryngoscope']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Hyperangulated blade videolaryngoscope', 'description': 'For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.', 'armGroupLabels': ['Hyperangulated videolaryngoscope']}\n- {'type': 'DEVICE', 'name': 'Macintosh blade videolaryngoscope', 'description': 'For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.', 'armGroupLabels': ['Macintosh videolaryngoscope']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in the first attempt intubation success rate (percentage)', 'description': 'The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a videolaryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.', 'timeFrame': 'During intubation (minutes)'}\n\nPlease estimate the sample size based on the assumption: \nConsidering a significance level of 5.00% (\u00ce\u00b1=0.05), in order to achieve a power of 80.00% (\u00ce\u00b2=0.80) to detect significant differences. Assuming a drop-out rate of 5% (ab=5%).", "answer": 1036, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We aim to compare the efficacy of first-attempt intubation in a critically ill patient using a hyperangulated blade compared with the efficacy achieved with a Macintosh blade. The efficacy percentage for the Macintosh blade is estimated at 84.0% (p1=0.84), and for the hyperangulated blade, it is 90.0% (p2=0.90). The sample proportion in each group will be balanced at a 1:1 ratio (w=0.50). Considering a significance level of 5.00% (\u00ce\u00b1=0.05), in order to achieve a power of 80.00% (\u00ce\u00b2=0.80) to detect significant differences, it will be necessary to recruit 492 patients in the hyperangulated blade group and 492 in the Macintosh blade group. Assuming a drop-out rate of 5% (ab=5%), a total of 1036 patients need to be recruited for the study. This justification has been carried out using statistical software ene3.0 for sample size calculations.", "id": 2074, "split": "test"} +{"trial_id": "NCT06323707", "pmid": "40148001", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Exercise & Self-Management', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Self-management e-module']}\n- {'label': 'Self-Management Only', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Self-management e-module']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': 'Eight sessions of moderate intensity aerobic exercise using recumbent bike within the cancer institution.', 'armGroupLabels': ['Exercise & Self-Management']}\n- {'type': 'BEHAVIORAL', 'name': 'Self-management e-module', 'description': 'Eight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors.', 'armGroupLabels': ['Exercise & Self-Management', 'Self-Management Only']}\n\nPrimary Outcomes:\n- {'measure': 'Physical activity level', 'description': 'Godin Leisure Time Exercise Questionnaire', 'timeFrame': '16-weeks'}\n- {'measure': 'Physical activity level', 'description': 'Godin Leisure Time Exercise Questionnaire', 'timeFrame': '12-months'}\n- {'measure': 'Physical activity level', 'description': 'Godin Leisure Time Exercise Questionnaire', 'timeFrame': '6-months'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 0.05, power of 0.95, expected dropout rate of 25%", "answer": 129, "answer_type": "ESTIMATED", "explanation": "Sample size\n Power analysis for an analysis of covariance (ANCOVA) test with three groups was conducted in G*Power27 to determine a sufficient sample size. An alpha of 0.05, power of 0.95 and medium effect size (0.4) for the primary outcome of PA level,28 29 measured by the Godin Leisure-Time Exercise Questionnaire, was used. Based on these assumptions, the desired sample size is 102 participants. With an expected dropout rate of 25%,28 29 the total sample size for this study is 128 participants (rounded to 129; 43 per group).", "id": 2075, "split": "test"} +{"trial_id": "NCT06328153", "pmid": "38978119", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biomechanically Based Fu's Subcutaneous Needling Treatment for Senile Keen Osteoarthritis: Protocol For a Randomized Controlled Trial\n\nIncluded conditions:\n- Osteoarthritis, Knee\n\nStudy Armgroups:\n- {'label': 'FSN group', 'type': 'EXPERIMENTAL', 'description': \"Fu's subcutaneous needling (FSN) is a new type of acupuncture. Patients in the FSN Group only received FSN treatment, without other interventions such as oral drugs or topical drugs.\", 'interventionNames': [\"Device: Fu's Subcutaneous Needling\"]}\n- {'label': 'Drug Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Celecoxib is a member of Nonsteroidal Antiinflammatory Drugs (NSAIDs) and the most commonly used treatment for knee osteoarthritis. Patients in the drug group received only oral celecoxib, no other oral or topical drugs, and no other physical therapies.', 'interventionNames': ['Drug: Celecoxib']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': \"Fu's Subcutaneous Needling\", 'description': \"Operation of the FSN will follow the KOA's Fu's Subcutaneous Needling Treatment Code of Practice24. After routine disinfection, a disposable Fu's subcutaneous needle ( Nanjing-Paifu Medical Technology Co., Ltd., Jiangsu, China ) is inserted parallel into the subcutaneous loose connective tissue of the pathological tight muscles ( gastrocnemius muscle, tibial anterior muscle and quadriceps femoris muscle ). The FSN needle is operated in a swaying movement. The fan angle is approximately 60\u00b0; perform a total of 45 round trips in 30 seconds. Swaying is accompanied by reperfusion approach: 20 sweeps with 10 seconds of reperfusion approach as a group, 3 groups for each pathological tight muscle. The reperfusion approach requires active, short and sharp contractions of the pathological tight muscle. The muscle alternates contraction and relaxation. The FSN group is treated 3 times a week for 2 weeks.\", 'armGroupLabels': ['FSN group'], 'otherNames': ['FSN', \"Fu's Subcutaneous Needling Treatment\", 'FSN Treatment', 'Floating Needle', 'Floating Needle Treatment']}\n- {'type': 'DRUG', 'name': 'Celecoxib', 'description': 'Participants in the drug group will receive celecoxib (capsule) 200mg every day continuously for 2 weeks.', 'armGroupLabels': ['Drug Group'], 'otherNames': ['Nonsteroidal Antiinflammatory Drugs', 'NSAIDs']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment.', 'description': 'Visual analogue scale (VAS) is used to assess pain. A \"0\" indicates no pain or no limitation of function and gets worse as the value increases, and a \"10\" indicates severe pain (refractory to analgesic medication) or extreme limitation of function', 'timeFrame': 'Baseline and the 14th day after the start of treatment'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided test with a significance level (\u03b1) of 0.05 and a power (1-\u03b2) of 0.80 is applied. A possible dropout rate of 10% is considered.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The main outcome measure of this study is the decrease in VAS score from baseline during the 2-week treatment period. FSN, an emerging acupuncture method, has been studied in randomized controlled trials [22, 23]. However, both of these previous studies used superiority testing, which cannot provide an appropriate reference for the sample size calculation of our study. Therefore, we refer to a randomized controlled trial that compared electroacupuncture with an NSAID for treating KOA [26]. We assume that the effect sizes of interventions (FSN and celecoxib) in this trial were similar to those (acupuncture and diclofenac applied for interventions) in the aforementioned study. The results of the above study showed that the VAS score decreased by 48.24\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00893.59\u00c2\u00a0mm from baseline after 4\u00c2\u00a0weeks of electroacupuncture treatment, and by 32.99\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00893.94\u00c2\u00a0mm from baseline after 4\u00c2\u00a0weeks of oral administration of diclofenac. The actual difference in the VAS score between the two interventions after 4\u00c2\u00a0weeks of treatment was 15.25\u00c2\u00a0mm, with a combined standard deviation of 3.85\u00c2\u00a0mm. However, since the course of treatment in our trial is half of that in the aforementioned study, appropriate adjustments for the expected difference in the VAS score are needed. Based on our clinical experience, the efficacy and the treatment period cannot be considered to increase in full equivalence, and since the 2-weeks intervention course is relatively short, we would not expect the cumulative efficacy to be half that of the 4-weeks intervention in the aforementioned study.\n Therefore, to compare the efficacy of FSN and celecoxib, we assume that the difference in two groups\u00e2\u0080\u0099 means of the changes in the VAS score is 6.5\u00c2\u00a0mm after 2\u00c2\u00a0weeks of treatment, which is slightly less than half the difference observed in the reference trial [26] after 4\u00c2\u00a0weeks of intervention. Assuming a 1:1 ratio of participants in the 2 groups, the NIM (Non-Inferiority Margin) is defined as 10\u00c2\u00a0mm. A two-sided test with a significance level (\u00ce\u00b1) of 0.05 and a power(1-\u00ce\u00b2) of 0.80 is applied. With a possible dropout rate of 10%, using the PASS 15.0 software, 60 participants shall be included in this study.", "id": 2076, "split": "test"} +{"trial_id": "NCT06330298", "pmid": "40148852", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving Social Cognition and Social Behaviour in Various Brain Disorders.\n\nIncluded conditions:\n- Stroke\n- Multiple Sclerosis\n- Brain Tumor\n\nStudy Armgroups:\n- {'label': 'Experimental condition: Receives T-ScEmo Treatment', 'type': 'EXPERIMENTAL', 'description': 'Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1', 'interventionNames': ['Behavioral: Treatment social cognition and emotion regulation (T-ScEmo)']}\n- {'label': 'Waiting list group: Will be on waiting list instead of treatment', 'type': 'NO_INTERVENTION', 'description': 'Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Treatment social cognition and emotion regulation (T-ScEmo)', 'description': 'T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social cognition, regulation of social behaviour and social participation in everyday life (Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social cognitive skills throughout the treatment, close involvement of a significant other, and homework assignments. The treatment consists of three modules that address 1) perception of social information including facial expressions of emotions, 2) perspective taking and understanding of social information and 3) regulation of social behaviour. The treatment contains 15-one hour live treatment sessions with a neuropsychologist and 5 online practice sessions, once or twice a week. In the online sessions, the patient can practice the information at home as a neuropsychologist is available for questions. When patients find it too difficult to practice individually at home, there is a opportunity to offer these sessions as live sessions', 'armGroupLabels': ['Experimental condition: Receives T-ScEmo Treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Change in social behaviour examined by proxy', 'description': 'The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.', 'timeFrame': 'Through study completion, an average of 8 to 10 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power of 0.80, and consideration of the interaction of condition with time using repeated measures analysis.", "answer": 84, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study of Westerhof-Evers et al. [9] found that the DEX-Socproxy had an effect size of Cohen\u00e2\u0080\u0099s d 0.2 (Cohen\u00e2\u0080\u0099s f 0.10) for the comparison between T0 and T2. From this data, a small to medium effect size of Cohen\u00e2\u0080\u0099s f 0.15 was estimated for the current study. Therefore the sample size of the current study is based on a power calculation for the main outcome measure (DEX-Socproxy). This is regarding the interaction of condition with time (T0, T2) using repeated measures analysis (with Effect Size Cohen\u00e2\u0080\u0099s f) 0.15, \u00ce\u00b1 0.05 power 0.80 [29] results in a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008962. However, to guarantee the distribution between the various patient groups a total sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008984 will be used: 42 patients per condition.", "id": 2077, "split": "test"} +{"trial_id": "NCT06334627", "pmid": "39180108", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania\n\nIncluded conditions:\n- Child Development\n- Child Development Disorder\n\nStudy Armgroups:\n- {'label': 'Pre-Primary Intervention', 'type': 'EXPERIMENTAL', 'description': 'Program consisting of 9 modules focussing on early learning, play, saftey, wellbeing, reading and writing will be delivered approximately every two weeks to groups of 10 parents from the intervention arm.', 'interventionNames': ['Behavioral: Pre-Primary Intervention']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'No intervention delivered. Participants will attend any government pre-primary based programmes as standard of care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Pre-Primary Intervention', 'description': 'School readiness intervention', 'armGroupLabels': ['Pre-Primary Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Measuring Early Learning Quality and Outcomes (MELQO Tool)', 'description': 'School Readiness', 'timeFrame': 'Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)'}\n- {'measure': 'The Pediatric Evaluation of Disability Inventory', 'description': 'Child Disability', 'timeFrame': 'Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include 80% power, a 5% significance level, and an intraclass correlation (ICC) of 0.025. The study also assumes a 1:1 ratio between the intervention and control groups.", "answer": 1651, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Based on the design of our intervention and existing available cohort size, we have an expected sample size of 500 parent\u00e2\u0080\u0093child dyads in each of the sites. We have predetermined approximately 50 clusters per site, with expected cluster size varying between 8 and 12 parent/child dyads. Planning for a 1:1 ratio between the 2 groups, with 25 clusters each in the intervention and control arms of the cRCT.\n For the primary objective of school readiness, we will assess differences in overall direct assessment score of the child using the MELQO [27] between the two groups. Expected norms have not been generated; instead, we assumed a mean overall score of 46 in the non-intervention group. This is based on average item level statistics for 84 core items across the 4 domains (pre-numeracy, pre-literacy, executive functioning social-emotional) [32]. Therefore, we will be able to detect a 0.28 standard mean difference between the 2 groups at 80% power, 5% alpha, and an intraclass correlation (ICC) of 0.025 within our sample size of 50 clusters (25 intervention and 25 control) with 10 parent\u00e2\u0080\u0093child dyads in each cluster (N\u00e2\u0080\u0089=\u00e2\u0080\u0089500 in each site).\n The trial is powered to detect a minimum difference of 13% between the intervention and non-intervention group after the intervention period in pre-numeracy domain and a 12% difference in pre-literacy domain using a two-sided test in which both groups have 25 clusters of size 10, assuming 80% power, a 5% significance level, and an ICC of 0.025. This assumes that 68 and 48% of children in the non-intervention group will have average pre-numeracy and pre-literacy scores, respectively [32].\n We contacted 1651 parents of children from the EN-SMILING cohort for the EN-REACH trial study. We enrolled a total of 1445 participants from 160 clusters across three countries, with each cluster typically containing 6\u00e2\u0080\u009313 parent\u00e2\u0080\u0093child dyads. Specifically, in Bangladesh, there were 560 participants spread across 50 clusters. As a result of geographical challenges in Nepal and Tanzania, we increased the cluster count to 54 in Nepal (enrolling 482 participants) and to 56 in Tanzania (enrolling 403 participants).", "id": 2078, "split": "test"} +{"trial_id": "NCT06335862", "pmid": "39672574", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Primary pOsterioR TRacheopexy Prevents Collapse of the Trachea in Newborns With Oesophageal AtresIa and Tracheomalacia\n\nIncluded conditions:\n- Oesophageal Atresia With Tracheo-Oesophageal Fistula\n- Tracheomalacia\n- Oesophageal Atresia\n\nStudy Armgroups:\n- {'label': 'PPT-group', 'type': 'OTHER', 'description': 'Participants allocated to this study arm will undergo the primary posterior tracheopexy (PPT). This PPT is performed concurrently with the primary OA correction. Afterwards, all patients follow the (same) routine follow-up schedule. This treatment is currently used in some centres.', 'interventionNames': ['Other: Randomisation between the PPT- and no-PPT-group', 'Procedure: Primary Posterior Tracheopexy', 'Diagnostic Test: Preoperative tracheobronchoscopy', 'Diagnostic Test: Intraoperative tracheobronchoscopy', 'Diagnostic Test: Postoperative tracheobronchoscopy through the endotracheal tube during extubation', 'Diagnostic Test: Postoperative tracheobronchoscopy after 2-6 months']}\n- {'label': 'No-PPT-group', 'type': 'OTHER', 'description': 'Participants allocated to this study arm will undergo the the primary OA correction, without a PPT. Afterwards, all patients follow the (same) routine follow-up schedule. This treatment is also used in some centres.', 'interventionNames': ['Other: Randomisation between the PPT- and no-PPT-group', 'Diagnostic Test: Preoperative tracheobronchoscopy', 'Diagnostic Test: Intraoperative tracheobronchoscopy', 'Diagnostic Test: Postoperative tracheobronchoscopy through the endotracheal tube during extubation', 'Diagnostic Test: Postoperative tracheobronchoscopy after 2-6 months']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Randomisation between the PPT- and no-PPT-group', 'description': 'Randomisation is performed between two possible treatment options for tracheomalacia in OA patients; the PPT or the wait-and-see policy (no-PPT).', 'armGroupLabels': ['No-PPT-group', 'PPT-group']}\n- {'type': 'PROCEDURE', 'name': 'Primary Posterior Tracheopexy', 'description': 'The PPT involves fixating the posterior membrane of the trachea to the spinal ligament with sutures, to prevent the trachea from collapsing.', 'armGroupLabels': ['PPT-group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Preoperative tracheobronchoscopy', 'description': 'Prior to OA correction, a flexible and a rigid tracheobronchoscopy will be performed, in addition to a flexible tracheobronchoscopy through the endotracheal tube. Preoperative evaluation of TM through a tracheobronchoscopy is part of standard care for all participating centres.', 'armGroupLabels': ['No-PPT-group', 'PPT-group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Intraoperative tracheobronchoscopy', 'description': 'After the PPT is performed, or in case of the no-PPT group at the stage of the surgery when the PPT would usually be performed, a flexible tracheobronchoscopy through the endotracheal tube is carried out. This tracheobronchoscopy is routine care for all patients undergoing a PPT, and is additional for patients in the no-PPT-group.', 'armGroupLabels': ['No-PPT-group', 'PPT-group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Postoperative tracheobronchoscopy through the endotracheal tube during extubation', 'description': 'A postoperative flexible tracheobronchoscopy is performed in the neonatal or pediatric intensive care unit (ICU), through the endotracheal tube during extubation. This procedure is a study intervention.', 'armGroupLabels': ['No-PPT-group', 'PPT-group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Postoperative tracheobronchoscopy after 2-6 months', 'description': 'Two to six months after OA correction, a follow-up flexible and a rigid tracheobronchoscopy will be performed, under general anesthesia in the surgical theatre. This postoperative evaluation of TM through a tracheobronchoscopy is part of standard care for the Karolinska University Hospital and Great Ormond Street Hospital. At the University Medical Centre Utrecht and Erasmus Medical Centre Rotterdam, this tracheobronchoscopy is performed on indication in approximately half of patients. For the other half of patients, this is a study intervention.', 'armGroupLabels': ['No-PPT-group', 'PPT-group']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy', 'description': 'The difference in the degree of tracheal collapse between the PPT and the no-PPT group measured in percentage of the tracheal diameter', 'timeFrame': 'Measured by an intraoperative tracheobronchoscopy performed after freeing the trachea and oesophagus (and the PPT) but before the surgical correction of OA, through the ventilation tube'}\n\nPlease estimate the sample size based on the assumption: \nTo obtain an 80% power with a two-sided significance level of 5%, and accounting for a 20% dropout rate.", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In a previous pilot study, the average collapse of the trachea was approximately 32% before tracheopexy,23 with an SD of 14%. Postoperative evaluation of tracheal patency using TBS was not performed; only symptoms were assessed. In a retrospective study by Shieh et al,21 postoperative tracheal evaluation using TBS showed a decreased tracheal collapse of approximately 22% after PPT. However, this study involved a selected cohort of patients, predominantly featuring a high prevalence of long-gap OA, who underwent surgical OA correction between 1 and 4 months of age.21\n Based on these studies, the SD of the outcome measure was assumed to be 14% and it was decided that an absolute difference of 10% in mean intraoperative degree of tracheal collapse could be considered a clinically relevant difference. To obtain an 80% power with a two-sided significance level of 5%, 31 patients are needed in each study group.\n To account for 20% dropouts, the total number of patients planned for inclusion is set at 78 patients (39 per group). Dropouts can occur due to the inability to obtain the desired data during the intraoperative TBS (primary outcome measure), due to clinical deterioration, or if parents/caretakers withdraw consent for participation in the trial.", "id": 2079, "split": "test"} +{"trial_id": "NCT06338904", "pmid": "39334120", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Brief Poblem-solving Based Psychological Intervention Implemented in Different Formats for the Indicated Prevention of Suicide in Adults Over 50\n\nIncluded conditions:\n- Suicide\n\nStudy Armgroups:\n- {'label': 'Problem-solving-based psychological intervention delivered in a face-to-face format (PSPI-FF)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive a problem-solving intervention for suicide prevention in a face-to-face format. The intervention will consist of 6 sessions, approximately 90 minutes in duration each, once a week, in a group format, in person.', 'interventionNames': ['Behavioral: Problem-solving-based psychological intervention']}\n- {'label': 'Problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive the intervention described in a teleconference call format, with the same duration, contents, and structure.', 'interventionNames': ['Behavioral: Problem-solving-based psychological intervention']}\n- {'label': 'Problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive the intervention described adapted to be administered through a smartphone app, with equivalent duration, content, and structure (approximately 90 minutes to complete each of the 6 modules).', 'interventionNames': ['Behavioral: Problem-solving-based psychological intervention']}\n- {'label': 'Usual care (UCCG)', 'type': 'NO_INTERVENTION', 'description': 'Participants in this group will receive usual care. Usual treatment will include individual and group psychotherapy and/or psychiatric medication as determined by the health professionals they are currently consulting, whether in public or private facilities.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Problem-solving-based psychological intervention', 'description': \"The intervention will include training in the components of the problem-solving model and other behavioral and cognitive skills such as detecting warning signals, monitoring mood, relaxation techniques, self-reinforcement, strategies for acting in crisis situations, engaging in enjoyable activities, mindfulness meditation techniques, or strategies for reframing irrational thoughts. It will be developed from the problem-solving model (D'Zurilla and Nezu, 1982) and will reference the indicated prevention program for depression (V\u00e1zquez et al., 2015), which has shown efficacy in reducing depressive symptoms and preventing the onset of depression episodes (Otero et al., 2015; V\u00e1zquez et al., 2013), with results on symptomatology maintained at 8 years (L\u00f3pez et al., 2020); and the indicated prevention intervention that demonstrated efficacy in reducing suicide risk (Xavier et al., 2019).\", 'armGroupLabels': ['Problem-solving-based psychological intervention delivered in a face-to-face format (PSPI-FF)', 'Problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A)', 'Problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC)']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.', 'description': 'Suicidal ideation will be assessed using the Suicidal Ideation Scale (SSI; Beck et al., 1979), a semi-structured scale of 19 items with an internal consistency (Kuder-Richardson coefficient \\\\[KR-20\\\\]) of .89 and an inter-rater reliability (k) of .83.', 'timeFrame': 'Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months'}\n- {'measure': 'Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.', 'description': \"Aditionally, the severity of ideation and suicidal behavior over the last month will be assessed using the Columbia Scale for assessing suicide risk (C-SSRS; Posner et al., 2011). It consists of a semi-structured interview with good convergent and discriminant validity and high sensitivity (100.0%) and specificity (99.4%) for the classification of suicidal behavior; the ideation intensity subscale showed a Cronbach's alpha of .73-.95.\", 'timeFrame': 'Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test, significance level (\u03b1) of 0.05, power (1-\u03b2) of 0.80, and a sample loss/dropout rate of approximately 25%.", "answer": 212, "answer_type": "ACTUAL", "explanation": "Sample size\n Given the heterogeneity of the types of interventions and the results of existing studies, a conservative estimation of the sample size is necessary. In two previous works [22, 33], according to the procedure for interpreting the magnitude of Odds Ratios described by Chen et al. [34], moderate to large effect sizes were reported for suicidal ideation, suicidal orientation, and depressive symptoms for the problem-solving groups compared to the comparison groups. Taking a moderate effect size (Cohen's d\u00e2\u0080\u0089=\u00e2\u0080\u00890.50) as a reference, assuming a two-tailed test, an \u00ce\u00b1 of 0.05, and a power (1\u00e2\u0080\u0094\u00ce\u00b2) of 0.80, a sample size of 42 participants per group is required. Additionally, anticipating a sample loss of approximately 25%, similar to that reported by Fox et al. [35], it is necessary to recruit a minimum of 53 participants in each group, resulting in a final sample of 212 subjects.", "id": 2080, "split": "test"} +{"trial_id": "NCT06340282", "pmid": "39516806", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Immersive Virtual Reality and/or Multicomponent Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients With Severe Functional Dependency: Study Protocol for a Randomized Clinical Trial\n\nIncluded conditions:\n- Disability Physical\n- Cognition\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Control group'}\n- {'label': 'immersive virtual reality', 'type': 'EXPERIMENTAL', 'description': 'Patients use virtual reality', 'interventionNames': ['Device: Virtual reality']}\n- {'label': 'multicomponent physical exercise intervention', 'type': 'EXPERIMENTAL', 'description': 'Individualized exercise intervention', 'interventionNames': ['Behavioral: multicomponent exercise']}\n- {'label': 'Immersive virtual reality and multicomponent physical exercise intervention', 'type': 'EXPERIMENTAL', 'description': 'Both', 'interventionNames': ['Device: Virtual reality', 'Behavioral: multicomponent exercise']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Virtual reality', 'description': 'Immersive virtual reality', 'armGroupLabels': ['Immersive virtual reality and multicomponent physical exercise intervention', 'immersive virtual reality']}\n- {'type': 'BEHAVIORAL', 'name': 'multicomponent exercise', 'description': 'individualized exercise', 'armGroupLabels': ['Immersive virtual reality and multicomponent physical exercise intervention', 'multicomponent physical exercise intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Mini-Mental State Examination (MMSE)', 'description': 'Cognitive evolution', 'timeFrame': 'Baseline, day 3, at discharge and 1 month after discharge'}\n\nPlease estimate the sample size based on the assumption: \nbilateral \u03b1 = 0.05, power = 0.90, 15% losses", "answer": 212, "answer_type": "ESTIMATED", "explanation": "Sample size\n To detect a cognitive improvement, measured by the MMSE as a difference greater than 3 points at discharge between groups (bilateral \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, power\u00e2\u0080\u0089=\u00e2\u0080\u00890.90), 45 patients should be enrolled in each group. Assuming 15% losses, the final goal of each group is 53 patients, and consequently, a total sample size of 212 subjects.", "id": 2081, "split": "test"} +{"trial_id": "NCT06341920", "pmid": "39937759", "question": "Here is the design of a clinical trial:\n\nOfficial Title: BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull\n\nIncluded conditions:\n- Orthopedic Disorder\n\nStudy Armgroups:\n- {'label': 'BoneFit intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a personalised care plan comprising exercise, nutrition and psychological wellbeing based on individual need in the 8-week period prior to surgery', 'interventionNames': ['Behavioral: Experimental: BoneFit intervention']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants who are allocated to this group will receive baseline tests and will be invited to re-attend 3 months post surgery to re-do tests. This group will receive usual care (no intervention). The groups will be compared.', 'interventionNames': ['Behavioral: Placebo Comparator: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Experimental: BoneFit intervention', 'description': 'Exercise, nutrition and psychological support provided in 8 weeks prior to surgery', 'armGroupLabels': ['BoneFit intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Placebo Comparator: Control', 'description': 'Control group receive usual care (zero intervention)', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment', 'description': 'Number of people recruited and trained', 'timeFrame': '2 years'}\n- {'measure': 'Adherence and attendance', 'description': 'Record the number of sessions attended and calculate adherence to protocol (%)', 'timeFrame': '2.5 years'}\n- {'measure': 'Acceptability', 'description': 'Conduct semi-structured interviews following the intervention with sample of participants and ask them about experiences of the intervention. The post-intervention interviews will focus on how participants viewed the intervention, perceived burdens, and perceived effectiveness from initiation through to completion. A list of burdens / perceived benefits will be reported alongside percentage rates of respondents.', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nMinimum of 20 participants per group based on statistical guidance; approximately 20% dropout rate.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n An a priori power calculation to determine sample size was not included as the BoneFit trial has been configured as a feasibility study. However, we did follow statistical guidance indicating that a minimum of 20 participants per group should be included [13]. Therefore, to allow for a potential drop-out rate of approximately 20% (commonly reported in lifestyle interventions), we will attempt to recruit 25 participants to each group (intervention versus control), targeting 50 participants in total.", "id": 2082, "split": "test"} +{"trial_id": "NCT06341959", "pmid": "39833951", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit? A Randomized Controlled Trial\n\nIncluded conditions:\n- Oral Disease\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': \"The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.\", 'interventionNames': ['Procedure: Oral screening']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Oral screening', 'description': \"The participants in the intervention group will receive an oral examination. Subsequently, information about any identified problem will be given. Lastly, participants will receive a referral letter for their dentist and a report for the general practitioner. If the participants don't have a regular dentist, they will also be given a list with contact information of dentists in the area.\", 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Contacted a dentist', 'description': 'Number of participants that have contacted a dentist within 4 months.', 'timeFrame': '4 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) is set at 0.05, power (1 \u00e2\u0080\u0093 \u00ce\u00b2) is 80%, and a 33% drop-out rate is anticipated.", "answer": 194, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n G*Power (version 3.1.9.2) was used to calculate the sample size. To the best of our knowledge, this type of intervention has not yet been conducted within the target population. Therefore, expert opinions were utilized to estimate that the intervention would activate 30% of participants in the intervention group. In the control group, a maximum of 10% is expected to contact a dentist. Using logistic regression, with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 1 \u00e2\u0080\u0093 \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u008980%, to detect a mean difference of 20% with equal allocation to both groups, a sample size of 129 persons is required. To allow for 33% drop-out (due to advanced age and potential frailty of the participants or due to an incorrect phone number or not answering calls), 194 persons will be recruited.", "id": 2083, "split": "test"} +{"trial_id": "NCT06348420", "pmid": "39773838", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Gastroesophageal Reflux Disease\n\nStudy Armgroups:\n- {'label': 'ARMV (intervention group)', 'type': 'EXPERIMENTAL', 'description': 'Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV.', 'interventionNames': ['Procedure: anti-reflux mucosal valvuloplasty (ARMV)']}\n- {'label': 'PPI (control group)', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized to the PPI group will follow the PPI treatment scheme. If GERD symptoms are effectively controlled with their current PPI dosage for at least one month, the regimen is decreased by one step. Conversely, if symptoms are poorly controlled, the dosage is increased by one step based on the PPI algorithm, which aligns with best clinical practices. The use of PPI will be recorded in medication diaries using generic names listed in the table below and classified according to the daily dose and frequency. Dosage will be categorized as \"double dose\" = \u226530 or 40 mg per day, \"full dose\" = 30 or 40 mg per day, \"half dose\" = 15 or 20 mg per day, \"occasional\" or \"on demand\" = \\\\< \"full dose\" taken for \\\\< 50% of days in the follow-up period. Common medications include Nexium 20mg\u3001Prevacid 30mg\u3001Prilosec 20mg\u3001Protonix 20mg\u3001Aciphex20mg.The frequency of medication use is once a day.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'anti-reflux mucosal valvuloplasty (ARMV)', 'description': 'During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.', 'armGroupLabels': ['ARMV (intervention group)']}\n\nPrimary Outcomes:\n- {'measure': 'GERD-HRQL', 'description': 'Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores to questions 1-15 Greatest possible score (worst symptoms)= 75 Lowest possible score (no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of \u2264 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of \u2264 12 with each individual question not exceeding 2 indicate regurgitation elimination.', 'timeFrame': 'at 0, 6 months follow- up'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed test with a power of 90% and a significance level of \u03b1=0.05 was used. A 10% dropout rate was also accounted for.", "answer": 74, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size estimation for this trial was based on detecting differences in GERD-HRQL score, informed by preliminary test results, clinical expertise and a review of relevant literature on similar interventions. To ensure the ability to detect meaningful differences between the groups, we used G*Power 3.1.9.2 software, conducting a two-tailed test with a power of 90% and a significance level of \u00ce\u00b1=0.05. Participants will be randomised in a 1:1 ratio to either the ARMV (intervention group) or continued PPI therapy (control group). Based on existing data, we expect the mean GERD-HRQL score for the PPI group after 6 months to be 25.1\u00c2\u00b111.2 points, while for the ARMV group, we conservatively estimate a mean of 17.0\u00c2\u00b19.0 points, reflecting the greater efficacy anticipated from pilot studies.29 33 34 These assumptions suggest an effect size of Cohen\u00e2\u0080\u0099s d=0.80, which indicates a large clinical effect between the two groups. Accounting for a 10% dropout rate, the total sample size required is 74 participants (37 per group) to detect this effect size with 90% power. The sample size estimation was primarily conducted using G*Power 3.1.9.2 software and was further verified using two-sample t-tests in PASS 2021 software to ensure robustness.", "id": 2084, "split": "test"} +{"trial_id": "NCT06349967", "pmid": "40070819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer: A Prospective, Multicenter, Single-arm, Phase II Study\n\nIncluded conditions:\n- Gastric Cancer\n\nStudy Armgroups:\n- {'label': 'Nab-paclitaxel+Cadonilimab (AK104)', 'type': 'EXPERIMENTAL', 'description': 'Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;', 'interventionNames': ['Drug: Nab-paclitaxel Combined With Cadonilimab (AK104)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nab-paclitaxel Combined With Cadonilimab (AK104)', 'description': 'Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;', 'armGroupLabels': ['Nab-paclitaxel+Cadonilimab (AK104)']}\n\nPrimary Outcomes:\n- {'measure': 'overall response rate (ORR)', 'description': 'the proportion of patients with the best overall response of complete response (CR) or partial response (PR)', 'timeFrame': 'every 3 month postoperation up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha error of 5% and a power (1-\u03b2) of 80% were used for calculations. To account for potential patient dropout, the sample size was increased by 10%. PFS and OS will be analyzed using the Kaplan-Meier method, and differences between groups will be assessed using the log-rank test. Cox proportional hazards regression analysis may be performed. ORR, DCR, and AEs will be analyzed using descriptive statistics, and the Clopper-Pearson method will be used to calculate 95% confidence intervals for proportions.", "answer": 59, "answer_type": "ESTIMATED", "explanation": "2.9\n Sample size calculation and statistical analysis\n Sample size calculations were performed using Simon\u00e2\u0080\u0099s optimal two-stage design to balance ethical considerations and resource efficiency. This design minimizes the expected sample size under the null hypothesis while ensuring adequate power to detect a meaningful treatment effect if the alternative hypothesis is true. Simon\u00e2\u0080\u0099s two-stage design was chosen due to its widespread use in early-phase clinical trials to assess efficacy and safety efficiently.\n The minimax design parameters were set as follows: an alpha error of 5% and a power (1-\u00ce\u00b2) of 80% were used for calculations. The minimax two-stage design resulted in parameters (6/31, 15/53). Stage 1: Enroll 31 patients. If \u00e2\u0089\u00a46 patients achieve ORR, the trial is terminated due to futility. Stage 2: If >6 responses are observed, an additional 22 patients are enrolled, resulting in a total of 53 patients. Success Criteria: The treatment regimen is considered successful if \u00e2\u0089\u00a515 patients achieve ORR. To account for potential patient dropout, the sample size was increased by 10%, resulting in a final planned enrollment of 59 patients. PFS and OS will be analyzed using the Kaplan-Meier method. Median survival times and 95% confidence intervals (CI) will be reported. Differences between groups will be assessed using the log-rank test. If applicable, Cox proportional hazards regression analysis will be performed to evaluate the impact of baseline covariates on survival outcomes. ORR, DCR, and AEs will be analyzed using descriptive statistics. The Clopper-Pearson method will be used to calculate 95% confidence intervals for proportions. Subgroup analyses may be conducted based on predefined stratification factors. Sample size calculations were performed using PASS 2024 software (version 24.0.2, NCSS).\n Exploratory analyses will be conducted to identify predictive and prognostic biomarkers using advanced immunoassays and bioinformatics tools. Adverse events will be graded according to CTCAE v5.0, and comparisons between different severity grades will be performed using chi-square or Fisher\u00e2\u0080\u0099s exact tests. This statistical approach ensures rigorous evaluation of efficacy and safety while accommodating the exploratory nature of biomarker identification.", "id": 2085, "split": "test"} +{"trial_id": "NCT06353568", "pmid": "39843368", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study\n\nIncluded conditions:\n- Diabetic Foot\n\nStudy Armgroups:\n- {'label': 'Photobiomodulation Group', 'type': 'EXPERIMENTAL', 'description': 'The PBM Group will use a boot with 1344 LEDs once daily for 6 minutes, over a period of 60 days, and will receive therapeutic education.', 'interventionNames': ['Device: Photobiomodulation', 'Behavioral: Therapeutic education']}\n- {'label': 'Control Group', 'type': 'SHAM_COMPARATOR', 'description': 'The Control Group will use a non-therapeutic LED boot (placebo) for 6 minutes once daily for 60 days and will also receive therapeutic education.', 'interventionNames': ['Device: Simulation of Photobiomodulation', 'Behavioral: Therapeutic education']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Photobiomodulation', 'description': 'The PBM Group will use a boot with 1344 LEDs, including 504 LEDs of 660 nm located on the sides of the boot (28.5 mW, 10 J per LED); 504 LEDs of 850 nm also located on the sides of the boot (23 mW, 8 J per LED); 168 LEDs of 660 nm located at the base of the boot (28.5 mW, 10 J per LED); and 168 LEDs of 850 nm also located at the base of the boot (23 mW, 8 J per LED) once daily for 6 minutes, over 60 days.', 'armGroupLabels': ['Photobiomodulation Group']}\n- {'type': 'DEVICE', 'name': 'Simulation of Photobiomodulation', 'description': 'The Control Group will use a non-therapeutic LED boot (sham procedure) for 6 minutes once daily for 60 days. The boot used is identical to the active boot, but there is no light emission.', 'armGroupLabels': ['Control Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Therapeutic education', 'description': 'Participants will receive therapeutic education regarding nutrition, foot examination, self-care, and guidance on physical activity.', 'armGroupLabels': ['Control Group', 'Photobiomodulation Group']}\n\nPrimary Outcomes:\n- {'measure': 'Ulcer Incidence', 'description': 'The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.', 'timeFrame': 'Baseline (Before the intervention)'}\n- {'measure': 'Ulcer Incidence', 'description': 'The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.', 'timeFrame': 'at 30 days'}\n- {'measure': 'Ulcer Incidence', 'description': 'The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.', 'timeFrame': 'at 60 days'}\n\nPlease estimate the sample size based on the assumption: \n5% rate of error, 95% confidence level, 20% dropout rate", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Calculation of sample size\n For the calculation of the sample size, the main outcome was the incidence of foot ulcer, using data from the study conducted by Suryani et al,20 who investigated the incidence of ulcer after flexibility and resistance exercises in patients at high risk based on the IWGDF classification, observing a statistically significant difference in the experimental group (reduction in incidence compared with the control group). Considering a 5% rate of error, 95% confidence level and minimum incidence of 25% in the experimental group and 68% in the control group, the minimum sample size was determined to be n=54 (27 participants per group). To compensate for a possible 20% dropout rate, the sample will be composed of 64 participants (32 per group).", "id": 2086, "split": "test"} +{"trial_id": "NCT06361381", "pmid": "39085951", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Combined Effect of Transcutaneous Electrical Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation on Pressure and Heat Pain Thresholds in Pain-Free Subjects: A Randomized Cross-Over Trial\n\nIncluded conditions:\n- Healthy Volunteers\n\nStudy Armgroups:\n- {'label': 'Active TaVNS', 'type': 'EXPERIMENTAL', 'description': 'Active TaVNS: frequency of 25 Hz, pulse duration of 200 \u00b5s, at a strong but comfortable intensity.', 'interventionNames': ['Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)', 'Device: Transcutaneous Electrical Nerve Stimulation']}\n- {'label': 'Placebo TaVNS', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo TaVNS: the intensity will be increased to a sensory level and then decreased to 0 mA', 'interventionNames': ['Device: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)', 'Device: Transcutaneous Electrical Nerve Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)', 'description': 'Both concha will be swabbed with an alcohol wipe before applying a thin layer of conductive gel. An ear clip electrode will be placed in the concha of both ears.\\n\\nA frequency of 25 Hz will be applied with a pulse duration of 200 \u00b5s. Every 5 minutes, the subject will be asked if the intensity can be increased, decreased or remain the same to maintain the same level of intensity. Participants will also receive active TENS, 100 Hz, 200 \u00b5sec on forearm.', 'armGroupLabels': ['Active TaVNS'], 'otherNames': ['TaVNS']}\n- {'type': 'DEVICE', 'name': 'Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)', 'description': 'For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. Participants will also receive active TENS, 100 Hz, 200 \u00b5sec on forearm.', 'armGroupLabels': ['Placebo TaVNS'], 'otherNames': ['Placebo TaVNS']}\n- {'type': 'DEVICE', 'name': 'Transcutaneous Electrical Nerve Stimulation', 'description': \"TENS will be applied on subject's forearm at a strong but comfortable intensity\", 'armGroupLabels': ['Active TaVNS', 'Placebo TaVNS'], 'otherNames': ['TENS']}\n\nPrimary Outcomes:\n- {'measure': 'Pressure Pain Threshold', 'description': 'A digital pressure algometer will measure the pain threshold to deep mechanical stimuli in kPa', 'timeFrame': '2 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 80%, and allowance for attrition.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The sample size was calculated considering a difference of 100\u00c2\u00a0kPa between sessions and a standard deviation of 117\u00c2\u00a0kPa obtained from previous data on pressure pain threshold (PPT) and TENS [15]. At a significance level of 0.05 and a power of 80%, the required sample size in each group was 23 participants (Minitab, v.17, State College, PA, USA). Allowing for attrition, a total of 30 participants will therefore be recruited: 15 men and 15 women.", "id": 2087, "split": "test"} +{"trial_id": "NCT06367283", "pmid": "40139705", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial\n\nIncluded conditions:\n- Hand Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Metformin', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Metformin']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metformin', 'description': 'Metformin will be initiated at 500 mg once daily with breakfast meal. The dose will be increased with 500 mg every week until 2 g/day is reached, distributed as 1000 mg every morning and evening, together with a meal. If the subject cannot tolerate the maximum dose (2 g/day), the maximal tolerated dose will be given. The treatment period including titration is 16 weeks.', 'armGroupLabels': ['Metformin']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Participants in the placebo group will receive a placebo tablet identical to the metformin tablet', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Finger pain', 'description': 'Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment', 'timeFrame': 'Week 16'}\n\nPlease estimate the sample size based on the assumption: \nThe pooled standard deviation (SD) is assumed to be 20 mm VAS pain. The significance level is not explicitly stated, but the power is at least 80%. To account for potential loss-to-follow-up, the total sample size was increased to achieve a statistical power of 86%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size and power considerations\n In OA research, interpreting clinical findings based on Cohen\u00e2\u0080\u0099s d effect size helps standardise the assessment of treatment effects, informs clinical and research decisions, and highlights the magnitude of intervention impacts. However, it should be used in conjunction with other statistical measures and clinical judgement to fully understand the implications of the findings.36 During the design phase of the trial protocol, it was determined that a distribution-based moderate effect size in the primary outcome (VAS finger joint pain) would be the minimum clinically relevant effect for this patient group.37 38\n Based on a previous study at our institution, we assume that the pooled SD in our population is 20\u00e2\u0080\u0089mm VAS pain and, therefore, we would need 128 patients in total (ie, approximately 64 in each group) to achieve sufficient statistical power (at least 80%) to detect a group difference of 10 mm VAS pain, corresponding to a moderate effect size of 0.57. To take a potential loss-to-follow-up into account, it was decided by the METRO trial steering committee to enrol a total sample size of 150 participants in the intention-to-treat (ITT) population (ie, approximately 75 participants in each group), corresponding to a statistical power of 86% to detect a target difference of 10 mm VAS.36 As a consequence of potentially not being able to reject the null hypothesis (for the primary endpoint), the steering committee decided that a CI excluding differences greater than 5 units between groups would be interpreted as indicating the absence of a clinically meaningful difference.39", "id": 2088, "split": "test"} +{"trial_id": "NCT06367348", "pmid": "39929508", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi\n\nIncluded conditions:\n- HIV/AIDS\n- Alcohol Abuse\n\nStudy Armgroups:\n- {'label': 'Control Comparison', 'type': 'NO_INTERVENTION', 'description': 'Standard of care, e.g. regular HIV care plus brief advice on alcohol use'}\n- {'label': 'Mlambe Intervention', 'type': 'EXPERIMENTAL', 'description': 'A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.', 'interventionNames': ['Behavioral: Mlambe']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mlambe', 'description': 'A combined economic and relationship-strengthening intervention. Sessions consist of incentivized savings accounts, financial literacy training, and relationships skills building, including couple communication.', 'armGroupLabels': ['Mlambe Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test', 'description': 'The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.', 'timeFrame': '11 months'}\n- {'measure': 'Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test', 'description': 'The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.', 'timeFrame': '15 months'}\n- {'measure': 'Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test', 'description': 'The three item Alcohol Use Disorders Identification Test (AUDIT-C ) screens for alcohol use issues and has a value range between 0-12. Scores equal to 3 or more for women and 4 or more for men indicate unhealthy drinking. The Phosphatidylethanol test (PEth) is a biomarker used to validate self-reported drinking. Measured in nanograms per milliliter (ng/mL), PEth has a value range of 0 to over 400 ng/mL. Higher scores indicate unhealthy drinking.', 'timeFrame': '20 months'}\n\nPlease estimate the sample size based on the assumption: \nNo specific assumptions on significance level, power, or missing/dropout rate are provided.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study will enrol approximately 250 couples (500 individuals). Each arm will have an equal number of couples to allow assessment of differential retention rates between arms.", "id": 2089, "split": "test"} +{"trial_id": "NCT06368557", "pmid": "39396991", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders\n\nIncluded conditions:\n- Anxiety Disorders\n\nStudy Armgroups:\n- {'label': 'iCBT with planned feedback', 'type': 'EXPERIMENTAL', 'description': 'Participants in this iCBT condition will receive written feedback from their therapist on assignments weekly. The participants will also be able to contact their assigned therapist through messages within the program and receive asynchronous support if needed. Participant depression and suicidality will also be continuously monitored using weekly questionnaires.', 'interventionNames': ['Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)']}\n- {'label': 'iCBT with on-demand feedback', 'type': 'EXPERIMENTAL', 'description': \"Participants in the on-demand iCBT condition will not receive any planned contact with the therapist. However, the participants will be able to contact the therapist through messages within the program and receive asynchronous support if needed. The therapist will also be monitoring the participants' answers on questionnaires and assignments to ensure progress. Participant depression and suicidality will also be continuously monitored using weekly questionnaires.\", 'interventionNames': ['Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)']}\n- {'label': 'waitlist control', 'type': 'NO_INTERVENTION', 'description': 'A waitlist control is included to compare the treatment conditions to a no-treatment condition and serves as a control for the effects of time and assessment on efficacy. Participants in the waitlist condition will be instructed to wait 14 weeks. After the 14-week period, participants will be offered iCBT treatment with planned therapist feedback and with elective modules. If participants do not wish to receive the iCBT treatment, they will receive help in finding another relevant treatment if needed.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CoolMinds: Internet-based cognitive behavioral therapy (iCBT)', 'description': 'The intervention consists of 14 weeks of iCBT, where the main treatment components are psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program comprises eleven sessions for adolescents and ten sessions for parents to be completed simultaneously. The participants will have the opportunity to get therapist feedback during the treatment period, the therapist may spend a maximum of 15 minutes giving feedback per week per participant.', 'armGroupLabels': ['iCBT with on-demand feedback', 'iCBT with planned feedback']}\n\nPrimary Outcomes:\n- {'measure': 'The Youth Online Diagnostic Assessment - Child and Parent Versions', 'description': 'An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias based on the Anxiety and Related Disorders Interview Schedule for DSM-5, which is considered the golden standard.', 'timeFrame': 'Pre-treatment, immediately after treatment and at 3-month follow-up'}\n- {'measure': \"Spence Children's Anxiety Scale- Child and Parent Versions\", 'description': 'A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV. The responses are scored on a 4 point scale ranging from 0 to 3, with a minimum score of 0 and a maximum score of 114, higher scores mean a higher level of anxiety.', 'timeFrame': 'Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nOutcome variance \u03c3\u00b2=225 (\u03c3=15), intraclass coefficient ICC=0.6, significance level \u03b1=0.05, power=0.80, 20% attrition rate.", "answer": 168, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation is based on scenarios of difference between treatment and waitlist at end of treatment for the primary outcome SCAS, based on Stjerneklar and colleagues [32] previous study detecting a difference of 10 points between the waiting list and the (combined) treatment groups in change in SCAS score from baseline to 3 months\u00e2\u0080\u0099 follow-up. Using a linear mixed model with outcome variance \u00cf\u00832=225 (\u00cf\u0083 = 15) and intraclass coefficient ICC=0.6 [32], and with significance level a = 0.05 and power = 1\u00e2\u0088\u0092b = 0.80, allowing for unequal group sample sizes (randomized 1:2), a total sample size of 134 patients is needed [64, 65]. Allowing for 20% attrition, a total of n = 168 patients (n = 56 waiting list, n = 112 treatment) will be included.", "id": 2090, "split": "test"} +{"trial_id": "NCT06372600", "pmid": "39294797", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis: A Randomized Controlled Trial\n\nIncluded conditions:\n- Rotator Cuff Tendinitis\n- Rotator Cuff Tendinosis\n\nStudy Armgroups:\n- {'label': 'Extracorporeal shock wave therapy group', 'type': 'EXPERIMENTAL', 'description': 'In the shoulder pain points, choose 2 to 3 of them for each treatment, apply the coupling agent, which is convenient for the treatment head to stick to the skin, and complete the longitudinal treatment and horizontal treatment. The setting frequency was 4 \\\\~ 8 Hz, the length of the probe was 15 mm, and the pressure was set at 1.5 mJ/mm2. The frequency of each treatment point reached 2 000 \\\\~ 2 500 times, and the hand-held pressure was set to medium-high level. A total of 6 treatments were completed. For patients with unclear pain points or regional pain, the treatment point should be supraspinatus tendon or infraspinatus tendon, and the treatment should be completed with the most severe pain site.', 'interventionNames': ['Device: Extracorporeal shock wave therapy device']}\n- {'label': 'Platelet-rich plasma group', 'type': 'EXPERIMENTAL', 'description': 'Autologous Platelet-rich plasma injection was performed under ultrasound guidance', 'interventionNames': ['Biological: Platelet-rich plasma']}\n- {'label': 'Extracorporeal shock wave therapy+Platelet-rich plasma group', 'type': 'EXPERIMENTAL', 'description': 'Extracorporeal shock wave therapy followed by Platelet-rich plasma injection', 'interventionNames': ['Device: Extracorporeal shock wave therapy device', 'Biological: Platelet-rich plasma']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Extracorporeal shock wave therapy device', 'description': 'In the shoulder pain points, choose 2 to 3 of them for each treatment, apply the coupling agent, which is convenient for the treatment head to stick to the skin, and complete the longitudinal treatment and horizontal treatment. The setting frequency was 4 \\\\~ 8 Hz, the length of the probe was 15 mm, and the pressure was set at 1.5 mJ/mm2. The frequency of each treatment point reached 2 000 \\\\~ 2 500 times, and the hand-held pressure was set to medium-high level. A total of 6 treatments were completed. For patients with unclear pain points or regional pain, the treatment point should be supraspinatus tendon or infraspinatus tendon, and the treatment should be completed with the most severe pain site.', 'armGroupLabels': ['Extracorporeal shock wave therapy group', 'Extracorporeal shock wave therapy+Platelet-rich plasma group']}\n- {'type': 'BIOLOGICAL', 'name': 'Platelet-rich plasma', 'description': 'Autologous Platelet-rich plasma injection was performed under ultrasound guidance', 'armGroupLabels': ['Extracorporeal shock wave therapy+Platelet-rich plasma group', 'Platelet-rich plasma group']}\n\nPrimary Outcomes:\n- {'measure': 'Visual Analogue Scale,VAS', 'description': 'The full name of the Scale is Visual Analogue Scale, that is, visual analogue scale.\\n\\nMinimum value and maximum value: the minimum value of the VAS scale is 0, indicating \"completely painless\" or \"painless end\"; The maximum value is 10, which indicates \"the most severe pain imaginable\" or \"the most severe pain end.\" Score Significance: On the VAS scale, a higher score means a worse outcome, i.e. a greater degree of pain. The patient marks the corresponding position on the scale according to their pain experience, thus indicating the intensity of the pain.', 'timeFrame': 'After 1, 2, 4 and 8 weeks of intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation used a significance level of \u03b1 = 0.05 (two-tailed), power of 80%, and included 3 groups. The calculation was performed using G*power 3.1.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n According to the sample size calculation formula and combined with previous research, we estimated the effect size to be 0.5. The effect size F\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 was selected based on both clinical significance and prior research studies in similar contexts. The choice of effect size in clinical trials often balances between detecting a clinically meaningful difference and maintaining statistical power with a feasible sample size. Clinical assumption basis clinical significance: An effect size of 0.5 is generally considered to represent a moderate effect in clinical research. For the Visual Analog Scale (VAS) used to assess shoulder pain, a moderate effect would translate to a noticeable and clinically meaningful improvement in patients\u00e2\u0080\u0099 pain levels post-treatment, which is both relevant and impactful in the context of treating rotator cuff calcific tendinitis (RCCT). Reference for effect size: A systematic review by Oudelaar et al. [41] on needle aspiration of calcific deposits for RCCT demonstrated effect sizes ranging from moderate to large in terms of pain reduction and functional improvement. This supports the selection of F\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 as a reasonable estimate for our study\u00e2\u0080\u0099s effect size. Primary outcome using VAS Yes, the selected effect size of F\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 specifically pertains to the primary outcome, which is the patient\u00e2\u0080\u0099s shoulder pain assessed using the Visual Analog Scale (VAS) after treatment. The VAS is a widely recognized and validated tool for measuring pain intensity, and an effect size of 0.5 represents a moderate but clinically significant improvement in pain levels, which aligns with our study objectives.\n The sample size was calculated using G*power 3.1, the significance level was \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-tailed), the estimated effect size was F\u00e2\u0080\u0089=\u00e2\u0080\u00890.5, power (1\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089\u00ce\u00b2)\u00e2\u0080\u0089=\u00e2\u0080\u008980%, and the number of groups\u00e2\u0080\u0089=\u00e2\u0080\u00893. We calculated the total sample size to be 48 people, and considering sample attrition, we planned to recruit 60 people.", "id": 2091, "split": "test"} +{"trial_id": "NCT06377319", "pmid": "39773784", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Validation of an Artificial Intelligence Based Decision Support System for Predicting Risk, Diagnosis, and Progression of Heart Failure\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'Patients at risk of developing heart failure', 'description': 'Individuals at risk of developing HF \u226545 years of age sub-divided into two categories i.e., (i) patients with current or prior symptoms or signs of HF, but without structural, biomarker, or genetic markers of heart disease but have evidence of one of the following: hypertension, cardiovascular disease, type 2 diabetes mellitus, metabolic syndrome, known exposure to cardiotoxins and family history of cardiomyopathy and (ii) Patients with current or prior symptoms or signs of HF and have evidence of one of the following - structural heart disease (e.g. Left ventricular (LV) hypertrophy, chamber enlargement, wall motion abnormality, valvular disease), abnormal cardiac function (e.g., reduced LV or right ventricular systolic function, evidence of increased filling pressures or abnormal diastolic function), elevated natriuretic peptide or elevated cardiac troponin on exposure to a cardiotoxin. Willing to visit the clinical research facility and able to provide written informed consent.', 'interventionNames': ['Diagnostic Test: Cardiac Output Response to Stress (CORS) test']}\n- {'label': 'Patients diagnosed with heart failure', 'description': 'Patients with confirmed diagnosis of HF (heart failure reduced ejection fraction; heart failure mildly reduced ejection fraction; heart failure improved ejection fraction; and heart failure preserved ejection fraction) over the previous 24 months or hospitalisation due to HF \u226545 years of age; willingness to visit the clinical research facility and able to provide written informed consent.', 'interventionNames': ['Diagnostic Test: Cardiac Output Response to Stress (CORS) test']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Cardiac Output Response to Stress (CORS) test', 'description': 'Cardiac Output Response to Stress (CORS) is a novel, non-invasive, easy-to-use test developed by the Newcastle and Coventry Universities. CORS test measures heart function (cardiac output) at rest and in response to short step-exercise using validated electrical signal processing bioreactance technology, similar to an ECG.', 'armGroupLabels': ['Patients at risk of developing heart failure', 'Patients diagnosed with heart failure']}\n\nPrimary Outcomes:\n- {'measure': 'Diagnostic accuracy of the DSS', 'description': 'Collection of prospective data for the diagnostic accuracy (i.e., sensitivity and specificity) of the DSS to predict risk of developing HF within 12 months.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level and power are not explicitly mentioned, dropout rate of 20%", "answer": 1600, "answer_type": "ESTIMATED", "explanation": "Sample size\n Up to 1600 participants \u00e2\u0089\u00a545 years old of age will be recruited for the study. With an anticipated dropout rate of 20% during follow-up assessments, it is estimated that 1600 participants will be sufficient to achieve high specificity and sensitivity. This sample size will also be sufficient to evaluate the accuracy of prediction and diagnosis of different types of HF based on the most recent guidelines1 (ie, heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), heart failure with improved ejection fraction (HFimpEF) and heart failure with preserved ejection fraction (HFpEF)), assuming a sensitivity of at least 90%, with a margin of error of 12%, and a prevalence of HFpEF of ~50% in patients with a diagnosis of HF.", "id": 2092, "split": "test"} +{"trial_id": "NCT06379074", "pmid": "38858743", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health: A Translational, Longitudinal and Clinical Study. Maternal Outcome After THERapy for Sleep (MOTHERS)\n\nIncluded conditions:\n- Postpartum Depression\n- Insomnia\n- Stress\n\nStudy Armgroups:\n- {'label': 'Subgroup B2: CBT-I derived intervention', 'type': 'EXPERIMENTAL', 'description': 'CBT-I derived intervention: 6 weekly online sessions with psychoeducation on sleep adapted to pregnancy, introduction of CBT-I techniques, discussion of sleep diaries and of acquired skills.', 'interventionNames': ['Behavioral: Improving sleep health and resilience during pregnancy']}\n- {'label': 'Subgroup B1: psychological placebo intervention', 'type': 'PLACEBO_COMPARATOR', 'description': 'Psychoeducation placebo control intervention: 6 weekly online sessions composed of educational videos (ca. 20 minutes) on aspects related to pregnancy and sleep.', 'interventionNames': ['Behavioral: Information on pregnancy-related issues']}\n- {'label': 'Group A: control group', 'type': 'NO_INTERVENTION', 'description': 'A control group of healthy pregnant women with no insomnia complaints (ISI \\\\< 8) will be followed parallel to the intervention and control group, from the first trimester of pregnancy to 6 months post-partum to assess changes in sleep and psychological indices in pregnancy.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Improving sleep health and resilience during pregnancy', 'description': \"Weekly sessions include: a video clip (ca. 20 min) and a pdf; short questions on participants' experience related to the session's content; brief feedback questions on session's contents. Participants will have weekly opportunity for private online chats with a clinician.\\n\\nSessions' contents:\\n\\n1. Aims of the intervention; introducing the physiological regulation of sleep, sleep health and how sleep changes during pregnancy;\\n2. Psychological regulation of sleep and the impact of behaviors on sleep regulation; introducing the basics of CBT-I behavioral techniques;\\n3. Cognitive factors maintaining sleep difficulties; introducing cognitive techniques;\\n4. Emotional factors maintaining sleep difficulties and on the bidirectional association between sleep and emotions; introducing emotion regulation techniques;\\n5. Sleep in the postpartum and the development of sleep regulation in children;\\n6. Relapse prevention and focus on acquired skills and how to prioritize sleep.\", 'armGroupLabels': ['Subgroup B2: CBT-I derived intervention'], 'otherNames': ['Sleeping for\u20262. Taking care of sleep during pregnancy and the post-partum']}\n- {'type': 'BEHAVIORAL', 'name': 'Information on pregnancy-related issues', 'description': 'Each session will include: video clip (ca. 20 minutes) on aspects related to pregnancy and sleep; brief feedback questions. Participants in the placebo intervention will not be given specific indications on skills or techniques for sleep difficulties and will not have access to the weekly chat with the clinician.\\n\\nSessions will cover the following contents:\\n\\nSession 1: phases of pregnancy; Session 2: sleep disorders; Session 3: nutrition and physical activity during pregnancy; Session 4: childbirth; Session 5: psychophysical development of the child in the first three years of life; Session 6: synthesis of previous sessions.', 'armGroupLabels': ['Subgroup B1: psychological placebo intervention'], 'otherNames': ['Getting to know pregnancy ... pregnancy and postpartum information meetings']}\n\nPrimary Outcomes:\n- {'measure': 'Stress reactivity', 'description': 'Salivary cortisol level by saliva sample provided by participants through swab', 'timeFrame': 'Twice a day (morning and evening) once at baseline; after 6 weeks from baseline; 6 months post-partum'}\n- {'measure': 'Sleep efficiency', 'description': 'Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through actigraphy monitoring', 'timeFrame': 'One week at baseline; after 6 weeks from baseline; 6 months post-partum'}\n- {'measure': 'Depressive symptoms', 'description': 'Edinburgh Postnatal Depression Scale (EPDS) total score (min. = 0; max. = 30; higher scores indicate a greater probability of having depression)', 'timeFrame': 'Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum'}\n- {'measure': 'Insomnia symptoms', 'description': 'Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)', 'timeFrame': 'Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum'}\n- {'measure': 'Anxiety symptoms', 'description': 'Generalized Anxiety Disorder questionnaire total score (min. = 0; max. = 21; higher scores indicate a higher level of generalized anxiety)', 'timeFrame': 'Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum'}\n- {'measure': 'Valence of affective states', 'description': 'Valence of morning and evening affective states assessed through visual scale in sleep and emotion diaries', 'timeFrame': 'Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum'}\n- {'measure': 'Arousal of affective states', 'description': 'Arousal of morning and evening affective states assessed through visual scale in sleep and emotion diaries', 'timeFrame': 'Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum'}\n- {'measure': 'Emotion regulation', 'description': \"Cognitive Emotion Regulation Questionnaire - Italian Short-Version (each of the nine subscales' scores ranges from 2 to 10; higher scores indicate a greater use of a specific emotion regulation strategy)\", 'timeFrame': 'Baseline; after 6 weeks from baseline; 6 monhts post-partum'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: not explicitly stated; Power: at least 80%; Dropout rate: 24%.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size\n To estimate required sample size for adequate power of the clinical trial, we used as primary outcome peripartum depression (PDS) at post-treatment. A study that compared scores on the Edinburgh Postnatal Depression Scale (EPDS) in 132 women divided into two groups, cognitive-behavioral therapy for insomnia (N\u00e2\u0080\u0089=\u00e2\u0080\u008989) or control group (N\u00e2\u0080\u0089=\u00e2\u0080\u008943), before, during and after pregnancy [35] was used. The software G-Power was used to estimate sample size: 114 women in total would be needed to have an effect power of at least 80%. Drop-out rates in previous studies were around 5 to 16% for post-treatment and short follow-ups [28, 33] and around 17% for 6 months follow-up [36]. We plan to recruit 150 participants, accounting for a dropout rate of 24%.", "id": 2093, "split": "test"} +{"trial_id": "NCT06383364", "pmid": "39591420", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment (MEDCOOR) - Randomized Controlled Trial\n\nIncluded conditions:\n- Medication Review\n- Polypharmacy\n- Potentially Inappropriate Medication\n- Quality of Life\n- Medication Therapy Management\n\nStudy Armgroups:\n- {'label': 'Interventions group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Medication Coordinator facilitates the medication reviews in close collaboration with the patients by applying concepts of motivational interview in combination with My Medication Plan', 'interventionNames': ['Behavioral: Medication Coordinator']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': \"Usual treatment from a team consisting of hospital physicians, nurses, nurse assistants, and as needed occupational therapists, physiotherapist, and clinical dieticians. Medication reconciliation might be a part of the patients' usual care performed by physicians or pharmacologist present at the acute ward. Hospital physicians and/or nurses might perform patient counselling about medication treatment during hospitalization\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Medication Coordinator', 'description': 'The Medication Coordinator calls the patient app seven days after discharge in the transition of care from hospital to home', 'armGroupLabels': ['Interventions group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in potentially inappropriate medication according to Potentially Inappropriate Medication List', 'description': 'Evaluating the patients drug treatment to assess if a drug is a potentially inappropriate medication', 'timeFrame': 'Baseline and 6 months'}\n\nPlease estimate the sample size based on the assumption: \nVariance set at 0.5; Dropout rate associated with age; P(dropout)=exp(1.1*age-70)/(1.1*age-70+1); Power of 93% at an alpha level of 0.05; p-value calculated using the likelihood ratio test.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "2.4. Sample size\n To calculate power, we used a Monte Carlo simulation. We based the simulation on the beta-regression [67]. We assumed the proportion of PIMs were distributed across different time points, as highlighted in Table 1, similar to results reported by McCarthy et al. [68]. The Do-File from STATA/BE used for the calculation is found in S2 File.\n \n 10.1371/journal.pone.0314023.t001\n Table 1\n \n Data used for the power calculation.\n \n \n \n \n \n \n \n \n \n \n \n Time point\n At hospital discharge\n Six months after hospital discharge\n \n \n \n \n Proportion of PIMs in intervention group\n 15%\n 13%\n \n \n Proportion of PIMs in control group\n 10%\n 12%\n \n \n \n \n \n \n Data from McCarthy et al. [68] used to calculate the sample size. Abbreviation: PIMs = Potentially Inappropriate Medication\n \n \n \n The variance was set at 0.5, and we assumed the risk of dropout after 6 months was associated with age (see formula below)\n\nP(dropout)=exp(1.1*age-70)/(1.1*age-70+1)\n(1)\n\n We calculated the p-value using the likelihood ratio test because we have multiple time points. Under the assumption that age will be related to the dropout rate, we needed 70 patients in each group to achieve a power of 93% at an alpha level of 0.05.", "id": 2094, "split": "test"} +{"trial_id": "NCT06386003", "pmid": "39823496", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial\n\nIncluded conditions:\n- Post Traumatic Stress Disorder\n- PTSD\n- Chronic PTSD\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Single dose of psilocybin 25mg Massed cognitive processing therapy', 'interventionNames': ['Drug: Psilocybin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Psilocybin', 'description': 'Participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days.', 'armGroupLabels': ['Experimental']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility and tolerability', 'description': 'Recruitment rate, withdrawal rate, adherence rate, data completion rate, percentage of participants with adverse events and responses to intervention based on qualitative data from the exit interview.', 'timeFrame': 'Up to 16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size calculation conducted", "answer": 15, "answer_type": "ESTIMATED", "explanation": "3.8. Sample size\n Due to the unknown anticipated effect size, a formal sample size calculation cannot be conducted. However, we expect to recruit a total of 15 participants for this trial.", "id": 2095, "split": "test"} +{"trial_id": "NCT06387056", "pmid": "40065286", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)\n\nIncluded conditions:\n- Locally Advanced Prostate Cancer\n- Oligometastatic Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Queue 1', 'type': 'EXPERIMENTAL', 'description': 'Rezvilutamide plus ADT plus docetaxel.', 'interventionNames': ['Drug: Rezvilutamide', 'Drug: Goserelin Microspheres for Injection', 'Drug: Docetaxel']}\n- {'label': 'Queue 2', 'type': 'EXPERIMENTAL', 'description': 'Rezvilutamide plus ADT plus pamiparib.', 'interventionNames': ['Drug: Rezvilutamide', 'Drug: Goserelin Microspheres for Injection', 'Drug: Pamiparib']}\n- {'label': 'Queue 3', 'type': 'EXPERIMENTAL', 'description': 'Rezvilutamide plus ADT plus cisplatin.', 'interventionNames': ['Drug: Rezvilutamide', 'Drug: Goserelin Microspheres for Injection', 'Drug: Cisplatin']}\n- {'label': 'Queue 4', 'type': 'EXPERIMENTAL', 'description': 'Rezvilutamide plus ADT plus tislelizumab.', 'interventionNames': ['Drug: Rezvilutamide', 'Drug: Goserelin Microspheres for Injection', 'Drug: Tislelizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rezvilutamide', 'description': '240mg by mouth once a day for 24 weeks.', 'armGroupLabels': ['Queue 1', 'Queue 2', 'Queue 3', 'Queue 4']}\n- {'type': 'DRUG', 'name': 'Goserelin Microspheres for Injection', 'description': '3.6mg by intramuscular injection once 4 weeks for 24 weeks.', 'armGroupLabels': ['Queue 1', 'Queue 2', 'Queue 3', 'Queue 4']}\n- {'type': 'DRUG', 'name': 'Docetaxel', 'description': '70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).', 'armGroupLabels': ['Queue 1']}\n- {'type': 'DRUG', 'name': 'Pamiparib', 'description': '60mg by mouth twice a day for 20 weeks.', 'armGroupLabels': ['Queue 2']}\n- {'type': 'DRUG', 'name': 'Cisplatin', 'description': '70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).', 'armGroupLabels': ['Queue 3']}\n- {'type': 'DRUG', 'name': 'Tislelizumab', 'description': '200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).', 'armGroupLabels': ['Queue 4']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of clinical complete response (cCR)', 'description': 'The rate of clinical complete response (cCR) as assessed using PSMA PET/CT and mp-MRI following 20 weeks of neoadjuvant therapy', 'timeFrame': '20 weeks'}\n- {'measure': 'Rate of pathological minimal residual disease (pMRD)', 'description': 'The rate of pathological minimal residual disease (defined as residual tumour 5 mm or less) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy', 'timeFrame': '24 weeks'}\n- {'measure': 'Rate of complete pathologic response (pCR)', 'description': 'The rate of complete pathologic response (pCR) as assessed on prostatectomy specimens following 24 weeks of neoadjuvant therapy', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided Fisher's exact test, significance level (\u03b1) of 0.05, power of 80%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Determination of sample size\n A baseline pCR rate of 5% was estimated based on historical data from neoadjuvant ADT or ADT combined with ARSIs, which have reported pCR rates ranging from 0 to 13% [26]. We hypothesized that a genomic biomarker-guided neoadjuvant regimen would increase the overall pCR rate by an additional 15%, giving a target pCR rate of 20%. Using a one-sided Fisher\u00e2\u0080\u0099s exact test at an \u00f0\u009d\u009b\u00bc level of 0.05 and a power of 80%, we calculated a required sample size of 40 patients.", "id": 2096, "split": "test"} +{"trial_id": "NCT06391450", "pmid": "39675824", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease (EMPA-PKD)\n\nIncluded conditions:\n- Autosomal Dominant Polycystic Kidney\n\nStudy Armgroups:\n- {'label': 'Empagliflozin 10 milligram (MG)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Empagliflozin 10 MG']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Empagliflozin 10 MG', 'description': 'Oral', 'armGroupLabels': ['Empagliflozin 10 milligram (MG)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Oral', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Total kidney volume (TKV)', 'description': 'Relative change from baseline TKV (percent/year) to month 18 of treatment.', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-group one-sided 0.025 significance level t-test with 80% power, assuming a pooled SD of 6.32%/year and accounting for the use of ANCOVA to increase power.", "answer": 44, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculation is based on the study of Irazabal et al where a difference in TKV slopes between placebo and tolvaptan (\u00e2\u0088\u00922.79 (\u00e2\u0088\u00922.20; \u00e2\u0088\u00923.38)) was shown for Mayo class 1C, D, E patients.30 The same TKV slope difference is assumed for empagliflozin. When the sample size in each group is n=22 patients (n=44 overall), a two-group one-sided 0.025 significance level t-test will have 80% power to reject the null hypothesis that empagliflozin is inferior to placebo by more than 2.79%/year (the difference in TKV mean slopes, \u00ce\u00bcempagliflozin\u00e2\u0088\u0092\u00ce\u00bcplacebo, is 2.79 or farther from zero in the same direction) in favour of the alternative hypothesis that the decline in TKV mean slope with empagliflozin is non-inferior to placebo or even better. The assumed pooled SD is 6.32%/year and is derived from the upper limit of the treatment effect. The ANCOVA used in the primary analysis is assumed to increase power over a t-test.", "id": 2097, "split": "test"} +{"trial_id": "NCT06392412", "pmid": "39539569", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Fully Immersive Virtual Reality Cognitive Training Based on Instrumental Activities of Daily Living for Older Adults With Mild Cognitive Impairment\n\nIncluded conditions:\n- Mild Cognitive Impairment\n- Older Adults\n\nStudy Armgroups:\n- {'label': 'VR Group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: fi-VR Cognitive Training']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Traditional Cognitive Training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'fi-VR Cognitive Training', 'description': 'All participants will 16 sessions over eight weeks, with two sessions per week, each lasting 70 minutes. Participants in the fi-VRCT will use the virtual reality system with head-mounted display and handheld controllers. The fi-VRCT will be administered by an experienced research assistant.', 'armGroupLabels': ['VR Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Traditional Cognitive Training', 'description': 'All participants will 16 sessions over eight weeks, with two sessions per week, each lasting 70 minutes. The CT control program will include cognitive board games designed to improve various cognitive capacities. Certified community occupational therapists will lead the CT control group.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes scores of Montreal Cognitive Assessment (MoCA)', 'description': 'The MoCA comprises12 items, it assesses orientation to time and place, attention, concentration, short-term memory, \\\\\\\\working memory, visuospatial abilities, language, and executive function. Scores on the MoCA range from 0 to 30, with a higher score indicative of better global cognition. A total score of 26 or above is considered within the normal cognitive function range, while a total score of 18 to 25 indicates mild cognitive impairment', 'timeFrame': 'At baseline, at week 9, and at 3-month follow-up.'}\n- {'measure': 'Change scores of Wechsler Memory Scale (WMS)', 'description': 'The Wechsler Memory Scale is a neuropsychological test designed to assess memory in adults aged 16 to 90. Family Pictures, Spatial Span, and Word List will be used to evaluate visual, auditory, immediate, delayed, and working memory. For each subtest, higher scores indicate better performance in memory performance. Based on age ranges, raw scores will be transformed into scaled scores ranging from 1 to 19.', 'timeFrame': 'At baseline, at week 9, and at 3-month follow-up.'}\n- {'measure': 'Change scores of Amsterdam Instrumental Activities of Daily Living Questionnaire, Short Version', 'description': 'The questionnaire is informant-reported and is typically completed by a caregiver. It comprises 30 items in seven categories: household activities, household appliances, finances, work, computer use, appliances, and leisure activities. Each item is rated based on the difficulty levels in performing it, ranging from no difficulty in performing the task to no longer being able to perform it. Score ranges from 0 to 100 and lower score indicates better functional ability.', 'timeFrame': 'At baseline, at week 9, and at 3-month follow-up.'}\n- {'measure': 'Change scores of Lawton Instrumental Activities of Daily Living', 'description': \"The Lawton Instrumental Activities of Daily Living is commonly employed to assess participants' ability to perform daily tasks and identify early functional decline. In semi-structured interviews, participants describe how they currently perform the eight IADLs. Each item is rated based on the levels of competence, ranging from independence in performing the activity to not being able to perform it at all. Score ranges from 8 to 31 and higher scores indicate better functional ability.\", 'timeFrame': 'At baseline, at week 9, and at 3-month follow-up.'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power is set at 90%, significance level at 0.05 for a two-sided test, and an attrition rate of 30% is considered.", "answer": 52, "answer_type": "ESTIMATED", "explanation": "Power Analysis and Sample Size Estimate\n Drawing from fi-VRCT studies, effect sizes for cognitive performance vary from small to medium (d = 0.080\u00e2\u0080\u00931.315; after transforming, f = 0.040\u00e2\u0080\u00930.657),35\u00e2\u0080\u009338 while effect sizes for everyday functioning are large (d = 0.87; after transforming, f = 0.435).36 Using a conservative estimate of a medium effect size (f = 0.25), this study will implement repeated measures analysis of variance (ANOVA) with a within-between interaction design for two groups and three measurements to determine the required sample size. With a statistical power of 90% and a significance level of 0.05 for a two-sided test, a total of 36 participants (18 in each group) is needed. Accounting for a potential attrition rate of 30%, the anticipated number of participants is 52 (26 in each group).", "id": 2098, "split": "test"} +{"trial_id": "NCT06393725", "pmid": "39700497", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Asynchronous', 'type': 'EXPERIMENTAL', 'description': 'This arm involves a 1 year behavioral weight loss program delivered in private Facebook groups led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the group for the following year. Volunteers will receive a brief training on how to lead a private Facebook group.', 'interventionNames': ['Behavioral: Asynchronous Remote Lifestyle Intervention']}\n- {'label': 'Synchronous', 'type': 'ACTIVE_COMPARATOR', 'description': 'This arm involves a 1 year behavioral weight loss program delivered via weekly videoconference meetings led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the meetings for the following year. Volunteers will receive a brief training on how to lead videoconference meetings.', 'interventionNames': ['Behavioral: Synchronous Remote Lifestyle Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Asynchronous Remote Lifestyle Intervention', 'description': 'A 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered asynchronously via a private Facebook group led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training.', 'armGroupLabels': ['Asynchronous']}\n- {'type': 'BEHAVIORAL', 'name': 'Synchronous Remote Lifestyle Intervention', 'description': 'A 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered synchronously via weekly videoconference group meetings led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training.', 'armGroupLabels': ['Synchronous']}\n\nPrimary Outcomes:\n- {'measure': 'Percent of baseline weight loss at 6 months', 'description': 'Percent weight loss', 'timeFrame': '6 months'}\n- {'measure': 'Percent of baseline weight loss at 12 months', 'description': 'Percent weight loss', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, 90% power for primary outcome, 20% attrition rate, intraclass correlation coefficient (ICC) of 0.6, and 97.6% power for weight loss maintenance. For engagement, 80% power to detect differences of \u22650.26 SDs and \u22650.79 SDs in word count, and 90% power to detect differences in mean cost per participant of 0.36 SD.", "answer": 328, "answer_type": "ESTIMATED", "explanation": "Sample Size Estimation\n We powered this trial to detect noninferiority for the primary outcome, percent weight loss at 6 and 12 months. We determined the sample size using methods developed for noninferiority trials [33]. In this noninferiority trial, the null hypothesis is that the asynchronous condition is inferior to the synchronous condition and the alternate hypothesis is that the asynchronous condition is noninferior to the synchronous condition. \u00e2\u0080\u009cNot inferior to\u00e2\u0080\u009d is defined by the noninferiority margin, \u00ce\u00b4. Here, we set \u00ce\u00b4=2%, based on a clinically meaningful difference in mean weight loss between the two conditions. Thus, adequate power for clinical noninferiority requires a sample size such that there is a better than 90% probability that the lower limit of the CI lies above \u00e2\u0080\u0093\u00ce\u00b4, if the true effect size is zero or above. We will use an SD of 5.5% based on our previous trial [7]. With \u00ce\u00b1=.05, and \u00ce\u00b4=2%, we have 90% power to conclude that the asynchronous condition is not inferior to the synchronous condition with 131 participants per arm. Assuming 20% attrition, we will enroll 328 participants (164 per arm). Weight loss maintenance will be tested in a longitudinal design, assuming 5 time points (including pretest, 6, 12, 18, and 24 months) clustered within individuals. From the conservative perspective of the inferiority effect size, \u00ce\u00b4=2%, SD 5.5%, with \u00ce\u00b1=.05, and intraclass correlation coefficient (ICC) 0.6, this trial will have power of 97.6% to yield a statistically significant result with a sample size of 328 participants.\n For engagement, we have 80% power to detect differences of \u00e2\u0089\u00a50.26 SDs in engagement (word count) between conditions. With 164 participants available per arm (N=328) and \u00ce\u00b1=.05, we have 90% power to detect differences in mean cost per participant of 0.36 SD. For example, if the SD for cost is US $100, then we have 94% power to detect differences in mean cost per participant of US $35. In our previous noninferiority trial comparing a synchronous in-person lifestyle intervention to an asynchronous remote lifestyle intervention, the difference in cost per participant was US $82.66 [7]. We suspect the difference will be less in this trial because travel costs contributed to the difference in our previous trial which used an in-person condition.\n In terms of engagement during the Peer Led Maintenance Phase, we have 80% power to detect differences of \u00e2\u0089\u00a50.79 SDs in engagement (word count) between conditions.", "id": 2099, "split": "test"} +{"trial_id": "NCT06398561", "pmid": "39350120", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Peer-led Intervention for Individuals With Major Depression.\n\nIncluded conditions:\n- Depressive Disorder, Major\n\nStudy Armgroups:\n- {'label': 'Experimental: Active Patient Program intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of carrying out the six sessions of the Active Patient Program by peers. The sessions have a duration of 2 hours/week during 6 weeks. It is aimed at patients with a diagnosis of major depression and they will undergo 4 evaluations, one before, one at the end of the sessions and two more at 6 and 12 months after the end of the sessions.', 'interventionNames': ['Behavioral: Active Patient Program']}\n- {'label': 'Control: Use App COGITO', 'type': 'ACTIVE_COMPARATOR', 'description': 'the control consists of the regular use (30 minutes daily) of the COGITO App that will guide the participant in the performance of exercises to improve depressive symptomatology. The time of use is equivalent to the time invested in the sessions.\\n\\nThe same evaluations will be carried out as in the experimental group (previous evaluation, at the end of the sessions (6 weeks) and two more at 6 and 12 months after the end of the sessions.', 'interventionNames': ['Behavioral: Active Patient Program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Active Patient Program', 'description': 'The Active Patient Program is a peer-leader intervention that consist of training patients with a chronic disease or mental health illness for improve the symptoms of that pathology.\\n\\nTraining is carried out in groups of about 12-15 patients and usually has 2 patient trainers. These patients lead the sessions through the theoretical content they have integrated, motivation, group leadership, exchange of experiences and promotion of communication. In this way they favor problem-solving by the patients who attend the sessions, thus improving their self-management and self-efficacy.\\n\\nIn the group formed by patients who are trainers and patients who benefit from the sessions, a climate of trust is created that favors the expression of emotions on both sides, empathy and assertiveness. In addition to fostering socio-affective bonds between the participants and increasing perceived social and emotional support.', 'armGroupLabels': ['Control: Use App COGITO', 'Experimental: Active Patient Program intervention']}\n\nPrimary Outcomes:\n- {'measure': 'To evaluate the efficacy of an adjuvant intervention based on a peer-leader program (Active Patient Program)', 'description': 'To measure the efficacy of an adjuvant intervention based on a peer-leader program (Active Patient Program) for the reduction on 6 points the depressive sympthoms with the Beck Depression Inventory in a sample of 70 people with Major Depression versus an online intervention in Primary Care Mental Health Units in Mallorca.Using Beck Depression Inventory (BDI-II) we want to know if the intervention can reduce the depressive symptoms.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.2, two-sided test, and a dropout rate of 20%.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n This study aims to assess the effectiveness of the peer-led intervention compared to an m-health intervention facilitated by the COGITO app in reducing depressive symptoms, as well as in improving quality of life and adherence to treatment among participants. Accepting an alpha risk of 0.05 and a beta risk of 0.2, and employing a two-sided test, it is estimated that 35 participants in the intervention group and 35 participants in the control group will be necessary. This calculation is based on the aim to identify a clinically significant difference, remarked by Button et al. [46] of 6 units or more on the Beck Depression Inventory (BDI-II) such as previous related research [47, 48], with an anticipated common standard deviation of 8 units. Anticipating a dropout rate of 20%, as evidenced by previous research [47]. Therefore, the study will require a total sample size of 70 participants.", "id": 2100, "split": "test"} +{"trial_id": "NCT06399536", "pmid": "39753262", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Individualized Acute Normovolemic Hemodilution for Non-cardiac Surgery With Anticipated High-dose Red Cells Transfusion\n\nIncluded conditions:\n- Transfusion Related Complication\n- Hemodilution\n\nStudy Armgroups:\n- {'label': 'ANH group', 'type': 'EXPERIMENTAL', 'description': \"Participants will undergo individualized ANH based on the West China Liu's Score after anesthetic induction. The decision of autologous blood transfusion or allogeneic red cell transfusion will be made according to the West China Liu's Score.\", 'interventionNames': ['Procedure: Individualized ANH']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Participants will be treated as the routine clinical practice. The decision of blood transfusion will be guided as the transfusion guideline.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Individualized ANH', 'description': \"Participants will undergo individualized ANH based on the West China Liu's Score after anesthetic induction. The decision of autologous blood transfusion or allogeneic red cell transfusion will be made according to the West China Liu's Score.\", 'armGroupLabels': ['ANH group']}\n\nPrimary Outcomes:\n- {'measure': 'ABT requirement', 'description': 'The perioperative allogeneic red blood cells consumption (Units per person).', 'timeFrame': 'Up to 12 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 0.80, overall SD of 3, superiority margin of 1, and a 20% dropout rate.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The hypothesis of this trial is that the application of individualised ANH will reduce the requirement of allogeneic red blood cells. Based on previous findings,11 it is estimated that individualised ANH could decrease red cell transfusion requirement by 50%. That means the red cell transfusion volume is expected to decrease from an anticipated eight units to four units after application of ANH. Using a superiority test and assuming asignificance level of 5% and a power of 0.80, with an overall SD of 3, based on our preliminary data from transfused patients, and a superiority margin of 1, 16 participants in each group will be required. Considering an estimated 20% dropout rate, 20 participants in each group, and a total of 40 participants will be required in this trial.12", "id": 2101, "split": "test"} +{"trial_id": "NCT06401083", "pmid": "39804861", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate\n\nIncluded conditions:\n- Apnea of Prematurity\n- Premature Birth\n- Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'Pre-extubational caffeine-citrate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 20 mg/kg loading dose of caffeine citrate on the first day of life and after that 5-10 mg/kg maintenance dose each day. On this arm, the participants will receive 20 mg/kg caffeine dose once again before the planned extubation.', 'interventionNames': ['Drug: Caffeine citrate']}\n- {'label': 'Routine care', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive 20 mg/kg loading dose of caffeine citrate on the first day of life and after that 5-10 mg/kg maintenance dose each day, also on the day of the extubation.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Caffeine citrate', 'description': '20 mg/kg caffeine-citrate before the planned extubation.', 'armGroupLabels': ['Pre-extubational caffeine-citrate'], 'otherNames': ['CITRATE DE CAFEINE COOPER 25 mg/ml Coop\u00e9ration Pharmaceutique Fran\u00e7aise, Melun, France']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of extubation failure', 'description': 'Reintubation. The discretion of the attending physician.', 'timeFrame': '48 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size provides 80% statistical power to detect a significant difference using a 5% significance level test. The drop-out rate is expected to be minimal.", "answer": 226, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size considerations and primary efficacy analysis: The sample size of the study was calculated based on the expected extubation failure rate.\n We hypothesize that the reintubation rate in the arm receving the loading dose (Arm \u00e2\u0080\u009cA\u00e2\u0080\u009d) is expected to be 20%, calculated from cases at our unit where the pre-extubational loading dose of caffeine citrate was applied. The expected reintubation rate of the arm that did not receive the loading dose (Arm \u00e2\u0080\u009cB\") is 36.8% [27]. The calculated sample size is 226 patients (113 participants/arm). On the basis of our results, this sample size would provide 80% statistical power to detect a significant difference in chi-square using a 5% significance level test. The drop-out rate is expected to be minimal due to the specific population and the short timeframe between the enrollment, randomization, and the one-time intervention.", "id": 2102, "split": "test"} +{"trial_id": "NCT06401148", "pmid": "39890138", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exercise-based Cardiac Rehabilitation for Patients with Atrial Fibrillation Receiving Catheter Ablation\n\nIncluded conditions:\n- Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Exercise-based cardiac rehabilitation', 'type': 'EXPERIMENTAL', 'description': 'Participants will complete an 8-week-long cardiac rehabilitation programme consisting of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions.', 'interventionNames': ['Behavioral: Cardiac rehab intervention group']}\n- {'label': 'Treatment as Usual', 'type': 'NO_INTERVENTION', 'description': 'Participants randomised to usual care will not receive any intervention but continue with usual medical treatment for their AF as determined by their healthcare team.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cardiac rehab intervention group', 'description': 'Participants will complete an 8-week cardiac rehabilitation programme supported by the onsite CR service.', 'armGroupLabels': ['Exercise-based cardiac rehabilitation']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients screened, eligible and approached', 'description': 'The percentage of patients that are screened, eligible and approached\\n\\ndecline CR (including reasons for declining) agree to CR and consent to being part of the study The percentage of patients that take up standard CR and reasons for drop out; and the percentage of participants that complete outcome assessments and reasons for drop out.', 'timeFrame': 'Baseline'}\n- {'measure': 'Patient focus groups to assess intervention and testing acceptability', 'description': 'Patient Focus Groups', 'timeFrame': 'Up to 20 weeks from baseline'}\n- {'measure': 'Clinical exercise physiologist interview to assess intervention and testing acceptability', 'description': 'Clinical Exercise Physiologist Interview', 'timeFrame': 'Up to 20 weeks from baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to provide robust estimates of recruitment and retention rates and variability of outcomes to inform future power calculations.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A power calculation is not appropriate as the study does not aim to provide a definitive estimate of the treatment effect. Rather, the aim is to provide robust estimates of the likely rates of recruitment and retention and to yield estimates of the variability of the primary and secondary outcomes to inform power calculations for a future full-scale trial. Our aim is to recruit 60 participants,\u00e2\u0080\u0089and this is based on recommendations for pilot/feasibility studies and an audit reporting pilot and feasibility trials registered in the UK clinical research network.32 33", "id": 2103, "split": "test"} +{"trial_id": "NCT06403111", "pmid": "40037667", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fecal Microbiota Transplantation Combined with Platinum-based Doublet Chemotherapy and Tislelizumab As First-line Treatment for Driver-gene Negative Advanced Non-small-cell Lung Cancer (NSCLC): Study Protocol for a Prospective, Multi-center, Single-arm Exploratory Trial\n\nIncluded conditions:\n- Non-small Cell Lung Cancer\n\nStudy Armgroups:\n- {'label': 'Chemotherapy+Immunotherapy+FMT', 'type': 'EXPERIMENTAL', 'interventionNames': ['Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy', 'description': 'Participants will receive FMT combined with tislelizumab + pemetrexed + platinum-based treatment (lung adenocarcinoma) / albumin-bound paclitaxel + platinum-based treatment (lung squamous cell carcinoma) for 4-6 cycles. If there is no progression of the disease after 4-6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. Patients will receive tislelizumab maintenance treatment (lung squamous cell carcinoma), or tislelizumab + pemetrexed maintenance treatment (lung adenocarcinoma).', 'armGroupLabels': ['Chemotherapy+Immunotherapy+FMT']}\n\nPrimary Outcomes:\n- {'measure': '12-Months Progression-Free Survival Rate (12month-PFS)', 'description': 'The proportion of patients whose disease did not progress 12 months after treatment', 'timeFrame': 'up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe two-sided significance level alpha is set at 0.05, with an estimated dropout rate of 0% and a statistical power greater than 80%.", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n The parameters are set as follows: the two-sided significance level alpha is set at 0.05. Based on an estimated dropout rate of 0% and a reference 12-month PFS rate of 35% published in the RATIONALE-304 and RATIONALE-307 clinical studies, it is inferred that the 12-month PFS rate in this trial can reach 55%.2 3 Therefore, a total sample size of 62 participants is determined for this study to ensure statistical power greater than 80%.", "id": 2104, "split": "test"} +{"trial_id": "NCT06408519", "pmid": "40132833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Open -Label Placebo for Non-specific Pain in the Emergency Department: Study Protocol for a Mixed-method Randomised Control Feasibility Study\n\nIncluded conditions:\n- Pain, Acute\n\nStudy Armgroups:\n- {'label': 'Open-label Placebo', 'type': 'EXPERIMENTAL', 'description': 'Treatment with open-label placebo pills 3x/day', 'interventionNames': ['Other: Placebo (open-label)']}\n- {'label': 'Treatment as usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment as usual defined as Ibuprofen 3x/day', 'interventionNames': ['Drug: Ibuprofen 400 mg']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Placebo (open-label)', 'description': 'P-Tabletten weiss 10mm (Lichtenstein, Zentiva) pills 3x/day', 'armGroupLabels': ['Open-label Placebo']}\n- {'type': 'DRUG', 'name': 'Ibuprofen 400 mg', 'description': 'Ibuprofen pills 3x/day', 'armGroupLabels': ['Treatment as usual'], 'otherNames': ['Ibuprofen-Sandoz']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of eligible patients consenting to participate', 'description': 'Feasibility Outcome. Threshold: \u226530% of eligible patients for the target population of 50 patients within 12 months.', 'timeFrame': '12 months'}\n- {'measure': 'Rate of patients adhering to the study protocol in terms of medication intake', 'description': 'Feasibility Outcome. Threshold: \u226570% of patients with at least \u226570% medication intake according to the protocol.', 'timeFrame': '7 days'}\n- {'measure': 'Rate of patients completing their outcome (self-)assessments (i.e. questionnaires)', 'description': 'Feasibility Outcome. Threshold: \u226580% of patients with completed assessments/questionnaires..', 'timeFrame': '30 days'}\n- {'measure': \"Rate of patients' satisfaction with the intervention and study procedure\", 'description': 'Feasibility Outcome. Threshold: \u226570% of patients with a score \u22656 on a scale from 0 (absolutely not satisfied) to 10 (absolutely satisfied).', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an enrolment rate of 30% within 12 months and accounts for an approximate withdrawal rate of 30%. The significance level and power are kept at a nominal level.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n As feasibility studies do not require a sample size calculation based on power analyses, the CI approach is recommended.49 50 However, with the aim to investigate trial procedures and processes and to estimate parameters for the main trial sample, two additional approaches are taken into consideration to estimate the sample size: the non-centralised t-distribution approach (NCT) and the upper confidence limit approach (UCL).51 NCT and UCL approaches take the sample estimate of the variance into account instead of the actual population variance,52 53 allowing minimisation of the number of participants while keeping power at a nominal level.51 For this reason, we decided to do one sample size calculation for each of the three mentioned approaches and take an educated guess based on these calculations, bearing the limited resources of this pilot study in mind.\n We aim to enrol at least 30% of eligible patients within 12 months. This is a rather conservative estimate, considering differing enrolment rates in previous ED studies.145456 We calculated sample size based on the CI approach, with an 80%\u00e2\u0080\u0089CI, a margin of error of 10%, and the above-mentioned enrolment rate of 30%.49 50 This resulted in a sample size of 35 participants, which we rounded up to 36 participants, as this is a two-arm study. With the NCT approach, sample size resulted in 28 participants and 48 participants with the UCL approach.51 Attrition rates in similar studies are variable.14 55 56 Accounting for an approximate withdrawal rate of 30% resulted in 48 (CI), 38 (NCT) and 64 (UCL) participants in total. To meet all the different considerations for calculating the sample size for this feasibility trial, we have decided to take the mean of these different calculations, resulting in a total of 50 participants (25 per group) for this study.", "id": 2105, "split": "test"} +{"trial_id": "NCT06412107", "pmid": "40032405", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial\n\nIncluded conditions:\n- Breast Neoplasm Female\n- Symptom Cluster\n\nStudy Armgroups:\n- {'label': 'True acupressure group', 'type': 'EXPERIMENTAL', 'description': 'True self-acupressure plus routine methods of treatment and care.', 'interventionNames': ['Other: True acupressure', 'Other: Usual care']}\n- {'label': 'Sham acupressure group', 'type': 'SHAM_COMPARATOR', 'description': 'Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care.', 'interventionNames': ['Other: Sham acupressure', 'Other: Usual care']}\n- {'label': 'Usual care group', 'type': 'OTHER', 'description': 'Routine methods of treatment and care.', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'True acupressure', 'description': 'Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.', 'armGroupLabels': ['True acupressure group']}\n- {'type': 'OTHER', 'name': 'Sham acupressure', 'description': 'Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.', 'armGroupLabels': ['Sham acupressure group']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Routine methods of treatment and care along with an updated education booklet.', 'armGroupLabels': ['Sham acupressure group', 'True acupressure group', 'Usual care group']}\n\nPrimary Outcomes:\n- {'measure': 'Fatigue', 'description': 'The Brief Fatigue Inventory (BFI; 9 items) will be used to measure the participants\\' fatigue, with 0 = \"no fatigue\" and 10 = \"fatigue as bad as you can imagine.\" The global score for the BFI is calculated as the mean value of these 9 items. A higher score indicates greater severity of fatigue.', 'timeFrame': 'Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)'}\n- {'measure': 'Sleep disturbance', 'description': 'The Pittsburgh Sleep Quality Index (PSQI; 19 items) will be used to assess sleep disturbance. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher total score indicates poorer sleep quality.', 'timeFrame': 'Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)'}\n- {'measure': 'Depression', 'description': 'The Hospital Anxiety and Depression Scale-Depression (HADS-D; 7 items; score range 0-21) will be used for evaluating depression. A higher score indicating greater severity of depression', 'timeFrame': 'Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)'}\n- {'measure': 'Symptom cluster assessment: fatigue', 'description': \"The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.\", 'timeFrame': 'Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)'}\n- {'measure': 'Symptom cluster assessment: sleep disturbance', 'description': \"The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.\", 'timeFrame': 'Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)'}\n- {'measure': 'Symptom cluster assessment: depression', 'description': \"The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.\", 'timeFrame': 'Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, an alpha of 0.05, and a 25% dropout rate were assumed for the sample size estimation.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Participants and sample size\n The participants will be adult BC survivors who meet the inclusion and exclusion criteria (table 1). A power analysis software G*Power was used for sample size calculation.38 Due to the unsatisfactory participants\u00e2\u0080\u0099 adherence to self-administered acupressure at home, the results of effect size in the phase II RCT have been confounded.37 39 The effect size for sample size estimation in this phase III RCT was therefore inferred from existing clinical trials in the literature. Power and sample size estimation were based on evaluating the primary hypothesis of the SA intervention improving the FSDSC at individual and symptom cluster levels after intervention and follow-up. However, given the very limited studies on the use of self-acupressure for the FSDSC, fatigue (the core symptom of the FSDSC) measured by the Brief Fatigue Inventory (BFI),2 40 was selected as the basis for sample size calculation. Recent studies on self-acupressure for fatigue after intervention and follow-up have reported moderate-to-large effect sizes, ranging from 0.32 to 0.96.4143 To be conservative, the smallest effect size of at least 0.32 was presumed. The attrition rate in the phase II RCT was 11.76%. Given that other similar studies reported attrition rates ranging from 15% to 29%,4446 a 25% dropout rate would be considered.47 A power of 80% and an alpha of 0.05 were also adopted as commonly reported values, participants in each group will be 36, 108 in total.\n \n Table 1\n \n Inclusion and exclusion criteria of participants\n \n \n \n \n Inclusion criteria\n Exclusion criteria\n \n \n \n \n \nDiagnosed with early-stage female BC without distant metastases (from stages I to IIIa).Have experienced at least moderate FSDSC with a score of \u00e2\u0089\u00a54 on an 11-point NRS (0=\u00e2\u0080\u0098no symptom\u00e2\u0080\u0099,10=\u00e2\u0080\u0098worst symptom\u00e2\u0080\u0099) for fatigue, sleep disturbance and depression during the past month.Had completed chemotherapy for at least 1\u00e2\u0080\u0089month and up to 3 years (to capture persistent symptoms)Have no scheduled chemotherapy or radiotherapy during the study.Being willing to participate in this study and consenting in writing.\n\n \nCurrently using pharmaceutical drugs (eg, antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression.Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired.Have received any type of somatic acupressure interventions during the past 6\u00e2\u0080\u0089months.Currently involved in any other studies.\n\n \n \n \n \n \n BC, breast cancer; FSDSC, fatigue\u00e2\u0080\u0093sleep disturbance\u00e2\u0080\u0093depression symptom cluster; NRS, Numeric Rating Scale", "id": 2106, "split": "test"} +{"trial_id": "NCT06412341", "pmid": "39843373", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Feasibility Study to Inform an RCT to Evaluate 'Accepting Your Body After Cancer', an Online-delivered, Group-based CBT Body Image Intervention, for Women Who Have Received Treatment for Breast Cancer\n\nIncluded conditions:\n- Breast Cancer Female\n\nStudy Armgroups:\n- {'label': 'ABC + Macmillan body image booklet', 'type': 'EXPERIMENTAL', 'description': 'Accepting your Body after Cancer (ABC) + Macmillan Cancer Support psycho-educational body image booklet\\n\\nABC comprises seven 2-hour group sessions (with approximately 8 women per group) delivered online via Microsoft Teams and across 7 consecutive weeks. The intervention aims to improve body image among women treated for BC. Rooted in CBT, ABC uses strategies to alter unhelpful thoughts, reduce anxiety, and promote non-avoidant behaviours. Other topics are also explored, including sociocultural pressures for women, intimacy, physical activity, self-care, mindfulness, and relaxation. The sessions will be guided using PowerPoint slides, which will include text, images, and videos. Each session will include individual and group-based activities, and participants will be asked to complete between-session readings and activities. (Macmillan Cancer Support psycho-educational body image booklet is described below).', 'interventionNames': ['Behavioral: Accepting your Body after Cancer', 'Behavioral: Macmillan body image booklet']}\n- {'label': 'Macmillan body image booklet (usual care)', 'type': 'OTHER', 'description': \"Macmillan Cancer Support psycho-educational body image booklet (only)\\n\\nDiscussions with PPI advisors indicated that some form of body image-specific support should be provided for the control arm. Macmillan's freely available psychoeducational body image booklet was considered appropriate, given that the thorough 77-page booklet provides a substantial amount of support and guidance relating to managing body image concerns. It explains the effects of cancer on body image, and provides practical guidance (e.g., make-up) and psychoeducational guidance (e.g., managing others' reactions), in addition to some CBT strategies. Upon randomisation to the control arm, participants will be sent the Macmillan body image booklet and encouraged to work through it gradually. The booklet can be accessed via the following webpage: https://cdn.macmillan.org.uk/dfsmedia/1a6f23537f7f4519bb0cf14c45b2a629/791-source/body-image-mac14192\", 'interventionNames': ['Behavioral: Macmillan body image booklet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Accepting your Body after Cancer', 'description': \"See 'Arm Description'\", 'armGroupLabels': ['ABC + Macmillan body image booklet']}\n- {'type': 'BEHAVIORAL', 'name': 'Macmillan body image booklet', 'description': \"See 'Arm Description'\", 'armGroupLabels': ['ABC + Macmillan body image booklet', 'Macmillan body image booklet (usual care)']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rates', 'description': 'The number of women who are recruited into the study, with attention to the method by which women were recruited and their demographic diversity.', 'timeFrame': 'Baseline (T1; Week 1)'}\n- {'measure': 'Response rates - Self-report outcome measures', 'description': 'The proportion of women who complete the self-report measures at each time point.', 'timeFrame': 'Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)'}\n- {'measure': 'Response rates - Intervention arm', 'description': 'the proportion of women completing ABC (the number of sessions attended and the number of between-session activities completed)', 'timeFrame': 'Baseline to immediate post-intervention (T1; Week 1 - T2; Week 9)'}\n- {'measure': 'Response rates - Control arm', 'description': 'The proportion of participants in the control arm reading the Macmillan body image booklet (plus the percentage of booklet read)', 'timeFrame': 'Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)'}\n- {'measure': 'Quantitative assessment of acceptability - ABC', 'description': 'Rating scale relating to the acceptability of the ABC course (e.g., the group format, online nature, between-session activities). Completed by those in intervention arm only.', 'timeFrame': 'Immediate post-intervention (T2; Week 9)'}\n- {'measure': 'Quantitative assessment of acceptability - Research process', 'description': 'Rating scale to explore acceptability of the research process generally (e.g., information provided about the study, randomisation process, questionnaires) - to be completed by all participants', 'timeFrame': '6-month post-intervention (T4; Week 32)'}\n- {'measure': 'Qualitative assessment of acceptability - ABC (Open-ended questions)', 'description': 'Open-ended questions asking about the acceptability of the ABC course (e.g., the group format, online nature, between-session activities) - to be completed at immediate post-intervention (T2) by participants in the intervention group only.', 'timeFrame': 'Immediate post-intervention (T2; Week 9)'}\n- {'measure': 'Qualitative assessment of acceptability - ABC (interviews', 'description': 'Interviews of participant in the intervention group will include questions asking about the acceptability of the ABC course. Interviews will occur across the study period.', 'timeFrame': 'Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)'}\n- {'measure': 'Qualitative assessment of acceptability - Research process (Open-ended questions)', 'description': 'Open-ended questions to explore acceptability of the research process generally (e.g., information provided about the study, randomisation process, questionnaires) - to be completed by all participants in the six-month post-intervention assessment', 'timeFrame': '6-month post-intervention (T4; Week 32)'}\n- {'measure': 'Qualitative assessment of acceptability - Research process (interviews)', 'description': 'All interviews will include questions asking about the acceptability of the research process. Interviews will occur across the study period.', 'timeFrame': 'Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)'}\n- {'measure': 'Qualitative assessment of acceptability - ABC course facilitators', 'description': 'All ABC facilitators will also be interviewed following intervention delivery to explore their experience of the programme, as well as their perceived barriers to participant retention, and solutions.', 'timeFrame': 'Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)'}\n\nPlease estimate the sample size based on the assumption: \nThe study does not require a formal a priori power calculation. It aims for an 80% chance of not being underpowered at any level of power, with a maximum percentage error of 11% in the estimated sample size for a definitive trial. The study will estimate the upper one-sided 80% CI for the pooled variance of postintervention self-report outcome measures.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Proposed sample size\n We will recruit n=120 (60 per arm), with participants individually randomised to either the intervention arm (ABC programme plus Macmillan body image booklet) or control arm (Macmillan body image booklet). The objective of this feasibility study is to provide estimates of parameters to inform a subsequent RCT to evaluate intervention effectiveness. Therefore, the study does not need to achieve enough power to detect significant differences, and a formal a priori power calculation is not needed. Rather, the sample size is based on the aim of having a fully powered follow-on substantive or definitive trial, and to help quantify the degree of missing data. Data will be used to estimate the upper one-sided 80% CI for the pooled variance of postintervention self-report outcome measures. For an 80% chance of not being underpowered at any level of power, and for any minimum clinically important difference, a sample of 60 per condition would ensure that the percentage error in estimated sample size for a definitive trial would be no more than 11% (ie, potentially overpowered, but degree of excess restricted to 11%). The estimated sample size for the proposed definitive study can be refined further by estimating the strength of the pre- post-correlation and using these estimates in estimating sample size for repeated measures Analysis of Covariance (ANCOVA)-styled analyses (controlling for commensurate baseline methods), thus resulting in a cost-effective substantive RCT without compromising the reliability of conclusions.", "id": 2107, "split": "test"} +{"trial_id": "NCT06414993", "pmid": "39037768", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Leveraging Parents and Peer Recovery Supports to Increase Recovery Capital in Emerging Adults With Polysubstance Use: Feasibility, Acceptability, and Scaling up of Launch\n\nIncluded conditions:\n- Polysubstance Drug Use (Indiscriminate Drug Use)\n\nStudy Armgroups:\n- {'label': 'Contingency Management for Emerging Adults (CM-EA) Only', 'type': 'EXPERIMENTAL', 'description': 'The parents in this group will receive CM-EA delivered virtually by a parent coach approximately weekly (20-40 minute sessions) for 6 months.', 'interventionNames': ['Behavioral: Contingency Management for Emerging Adults (CM-EA)']}\n- {'label': 'Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building', 'type': 'EXPERIMENTAL', 'description': 'The EAs in this group will receive PRSS+Vocational/Educational (V/E) Skill Building delivered by peer workers in-person in the local community approximately weekly (1 hour sessions) for 6 months.', 'interventionNames': ['Behavioral: Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services']}\n- {'label': 'CM-EA and PRSS+V/E', 'type': 'EXPERIMENTAL', 'description': 'Families receive both CM-EA and PRSS + V/E as described above.', 'interventionNames': ['Behavioral: Contingency Management for Emerging Adults (CM-EA)', 'Behavioral: Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Contingency Management for Emerging Adults (CM-EA)', 'description': \"After CM-EA is introduced, a contingency contract is developed between a parent and emerging adult (EA) that provides EAs with rewards for negative drug screens and completion of developmentally appropriate goals to build recovery capital, along with disincentives for positive screens or engaging in inappropriate behaviors. Concurrently, parents are taught to conduct random urine drug screens. Additionally, parents are trained to complete functional analyses in collaboration with their EA to identify the EA's triggers for poly-substance use and negative behaviors. Individualized triggers are targeted via self-management planning and drug refusal skills training. At the end of CM-EA, plans are made with the family for sustaining abstinence and improvements in other behaviors.\", 'armGroupLabels': ['CM-EA and PRSS+V/E', 'Contingency Management for Emerging Adults (CM-EA) Only']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services', 'description': \"Standard PRSS begin by identifying clients' needs in key domains (e.g., transportation, employment). After needs are identified, a peer worker addresses needs through informational resources and community referrals and engages clients in positive recreational activities offering advice, hope and empowerment to encourage steps toward a reduction in substance use and eventual abstinence. When desired, peer workers also link clients to a broader recovery peer community. In addition, the peer worker will dedicate time to increasing recovery capital via improving skills related to V/E advancement using a workbook, Targeting Employment for Emerging Adults: A Toolkit for Mental Health Providers, for which peer workers will be trained.\", 'armGroupLabels': ['CM-EA and PRSS+V/E', 'Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building']}\n\nPrimary Outcomes:\n- {'measure': 'Levels of Emerging Adult Perceptions of Acceptability of the Launch Intervention (measured at 6 months).', 'description': 'Levels of acceptability of the Launch intervention, such as if participants like the intervention, as reported by emerging adults on the Acceptability of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Parent Perceptions of Acceptability of the Launch Intervention (measured at 6 months).', 'description': 'Levels of acceptability of the Launch intervention, such as if participants like the intervention, as reported by parents on the Acceptability of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Emerging Adult Perceptions of Launch Intervention Appropriateness (measured 6 months).', 'description': 'Levels of Launch intervention appropriateness, such as if the intervention is a good match, as reported by emerging adults on the Intervention Appropriateness Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Parent Perceptions of Launch Intervention Appropriateness (measured 6 months).', 'description': 'Levels of Launch intervention appropriateness, such as if the intervention is a good match, as reported by parents on the Intervention Appropriateness Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Emerging Adult Perceptions of Feasibility of the Launch Intervention (measured at 6 months).', 'description': 'Levels of Launch intervention feasibility, such as if the intervention is easy to use, as reported by emerging adults on the Feasibility of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Parent Perceptions of Feasibility of the Launch Intervention (measured at 6 months).', 'description': 'Levels of Launch intervention feasibility, such as if the intervention is easy to use, as reported by parents on the Feasibility of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Emerging Adult Client Satisfaction with Launch Services (measured at 6 months).', 'description': 'Levels of satisfaction with the Launch services reported by emerging adult clients on the Client Satisfaction Questionnaire 8-item scale adapted to reflect receipt of Launch services.', 'timeFrame': '6 months'}\n- {'measure': 'Levels of Parent Client Satisfaction with Launch Services (measured at 6 months).', 'description': 'Levels of satisfaction with the Launch services reported by parent clients on the Client Satisfaction Questionnaire 8-item scale (CSQ-8) adapted to reflect receipt of Launch services.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size conforms to guidelines for pilot studies (n\u226512 per group). The sample of 48 families is sufficient for accurate estimates of the focal model parameters, particularly fixed-effects estimates for between-group differences and change over time. For qualitative interviews, the estimated 10-participant sample size falls within the parameters of 6 to 12 interviews to determine saturation and variability.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample Size and Power Considerations\n Because this study is developmental work, the sample size (n=48 families) was driven by appropriateness for pilot study objectives rather than by statistical power computations for formal hypothesis testing [96,97]. Pilot studies play an important role in providing information for the planning and justification of future large-scale trials (eg, for feasibility of service protocols and refinement of recruitment and assessment strategies) [98]. The sample size conforms to guidelines for pilot studies (n\u00e2\u0089\u00a512 per group) [99,100] and provides representativeness of a diversity of participant characteristics for examining feasibility, data collection procedures, and Launch service acceptability. However, this pilot will inform power analyses and sample size planning for a subsequent larger effectiveness trial. Because of this, it is important for the measurement and research design to support accurate estimates of the focal model parameters\u00e2\u0080\u0094thus, there are important considerations regarding the precision of estimated effects. For the measurement models proposed, the sample is sufficient for stable and precise estimates of family and item parameters and SEs. Specifically, sample sizes in the range of 16 to 36 are sufficient for 95% confidence that the estimated person or item calibrations are stable within \u00e2\u0080\u00931 logit to +1 logit [101]. It is also worth noting that this estimate is conservative because repeated measurements of adherence will provide additional data for evaluating the psychometric performance of the proposed instruments. For the proposed mixed-effects regression models, the sample of 48 families is sufficient for accurate estimates of the focal model parameters, in particular fixed-effects estimates for between-group differences and change over time [102]. Although variance components could be prone to bias, this information is less important for planning the subsequent larger trial as the power estimates can straightforwardly penalize for a range of nesting effects.\n For the qualitative interviews with payers and providers of recovery support services, the estimated 10-participant sample size falls within the parameters of 6 to 12 interviews to determine saturation and variability [103]. The credibility of the results will be promoted by ensuring that the investigators have the required knowledge and skills to perform their roles of interviewing and coding, requiring the interviewer to maintain field notes that will be stored with the data, including a peer review process of coding, and using a semistructured interview guide that includes prompts that allow for elaboration of answers and the chance to ask for more information as needed, allowing for both focus and adjustability during interviews [104]. Transferability of the qualitative results will be promoted by using purposeful sampling and reaching data saturation, when no new codes are identified in the transcripts and the research team agrees that theoretical saturation has been reached through the discussion of coding and identifying any variation in key concepts [16].", "id": 2108, "split": "test"} +{"trial_id": "NCT06427005", "pmid": "40022044", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study\n\nIncluded conditions:\n- Fruquintinib\n- S-1\n- Raltitrexed\n\nStudy Armgroups:\n- {'label': 'RSF treatment arm', 'type': 'EXPERIMENTAL', 'description': 'Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m\u00b2 on day 1, with a maximum dose of 5 mg) every 3 weeks.', 'interventionNames': ['Drug: Fruquintinib', 'Drug: S-1', 'Drug: raltitrexed']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fruquintinib', 'description': 'Fruquintinib 5 mg daily for 14 days followed by a 7-day break', 'armGroupLabels': ['RSF treatment arm'], 'otherNames': ['Elunate']}\n- {'type': 'DRUG', 'name': 'S-1', 'description': 'S-1 80-120 mg daily for 14 days, followed by a 7-day break', 'armGroupLabels': ['RSF treatment arm'], 'otherNames': ['Tegafur,Gimeracil and Oteracil Potassium Capsules']}\n- {'type': 'DRUG', 'name': 'raltitrexed', 'description': 'raltitrexed 3 mg/m\u00b2 on day 1, with a maximum dose of 5 mg', 'armGroupLabels': ['RSF treatment arm'], 'otherNames': ['thymidylate synthase inhibitor']}\n\nPrimary Outcomes:\n- {'measure': 'ORR', 'description': 'Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1', 'timeFrame': 'about a year'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided alpha error of 0.10, beta error of 0.10 (power = 90%), and consideration of potential dropout rates.", "answer": 66, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was determined using Simon\u00e2\u0080\u0099s two-stage optimal design to evaluate the efficacy of the RSF regimen (Fig.\u00c2\u00a02). This design minimizes the number of patients required to test the hypothesis while ensuring statistical rigor. The null hypothesis (H0) assumes that the ORR of the RSF regimen is 4%, based on historical data from the FRESCO-2 trial [6], where fruquintinib monotherapy achieved an ORR of approximately 4%. The alternative hypothesis (H1) assumes an ORR of 15%, supported by clinical results from the RSA regimen developed by our team [20]. With a one-sided alpha error of 0.10 and a beta error of 0.10 (power\u00e2\u0080\u0089=\u00e2\u0080\u008990%), the first stage requires enrolling 28 patients, and if fewer than 1 patient achieves an objective response, the study will be terminated early for futility. If the first stage is successful, an additional 38 patients will be enrolled in the second stage, for a total of 66 patients, and if fewer than 5 patients achieve an objective response across both stages, the regimen will be deemed ineffective. This approach balances ethical considerations by minimizing patient exposure to potentially ineffective treatments while maintaining the statistical power to detect a significant improvement in ORR. The chosen sample size also accounts for potential dropout rates, ensuring sufficient evaluable patients to draw robust and meaningful conclusions.\n \nFig. 2Simon\u00e2\u0080\u0099s two-stage design", "id": 2109, "split": "test"} +{"trial_id": "NCT06430632", "pmid": "39425088", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Robotic Gait Training After Stroke\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Robotic Gait Training', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.', 'interventionNames': ['Device: Robotic Gait Training']}\n- {'label': 'Usual Care Gait Training', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.', 'interventionNames': ['Other: Usual Care Gait Training']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Robotic Gait Training', 'description': 'Participants will complete standing and walking activities while wearing a robotic exoskeleton. Participants will also be asked to complete questionnaires about their walking and function.', 'armGroupLabels': ['Robotic Gait Training'], 'otherNames': ['EksoNR Robotic Exoskeleton']}\n- {'type': 'OTHER', 'name': 'Usual Care Gait Training', 'description': 'Participants will complete standing and walking activities such as body weight-supported treadmill training and conventional overground walking. Participants will also be asked to complete questionnaires about their walking and function.', 'armGroupLabels': ['Usual Care Gait Training'], 'otherNames': ['Standard of Care Gait Training']}\n\nPrimary Outcomes:\n- {'measure': 'Gait speed via 10-Meter Walk Test (10MWT)', 'description': 'The 10MWT assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline. The 10MWT can be used to categorize individuals according to their ambulatory ability: household ambulators (\\\\<0.4 m/s), limited community ambulators (0.4 to 0.8 m/s), and community ambulators (\\\\>0.8 m/s). Score changes \\\\>0.16 m/s exceed the MCID. Normal gait speed for adults older than 50 years is \\\\>1.27 m/s.', 'timeFrame': 'within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (\u00b114 days) after discharge from inpatient rehabilitation, 3 months (\u00b114 days) after discharge from inpatient rehabilitation'}\n\nPlease estimate the sample size based on the assumption: \nAutocorrelation of 0.55, standard deviation of 0.25, 80% power, 5% significance level, 20% attrition rate", "answer": 54, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n We will enroll 54 participants in this study. Sample size calculations were performed based on a test for two means in a repeated measures design with 4 follow-up measures and an autoregression correlation structure. Assuming an autocorrelation of 0.55 and a standard deviation of 0.25,84 we will need 22 participants per group to detect a clinical meaningful difference of 0.16\u00c2\u00a0m/s with 80% power at a 5% significance level. We will plan for an attrition rate of up to 20% and enroll 27 in each group for a total of 54 participants.", "id": 2110, "split": "test"} +{"trial_id": "NCT06445764", "pmid": "39854477", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancing Trauma Cardiopulmonary Resuscitation Simulation Training with the Use of Virtual Reality (Trauma SimVR): Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Virtual Reality\n- Heart Arrest\n\nStudy Armgroups:\n- {'label': 'e-learning', 'type': 'OTHER', 'interventionNames': ['Other: e-learning']}\n- {'label': 'Virtual reality training', 'type': 'OTHER', 'interventionNames': ['Other: Virtual reality training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'e-learning', 'description': 'Participants will complete an e-learning course over a two-week period that focuses on skills and knowledge related to the management of in-hospital cardiac arrest. This course prepares participants for an in-person assessment.', 'armGroupLabels': ['e-learning']}\n- {'type': 'OTHER', 'name': 'Virtual reality training', 'description': 'Participants will complete a virtual reality training over a two-week period that focuses on skills and knowledge related to the management of in-hospital cardiac arrest. This training prepares participants for an in-person assessment.', 'armGroupLabels': ['Virtual reality training']}\n\nPrimary Outcomes:\n- {'measure': 'Time to critical action', 'description': 'Expert-based assessment of the difference in time (seconds) to the predefined primary critical action between randomized groups in video recordings of an in-person assessment simulation.', 'timeFrame': 'evaluation within 4 weeks after study completion'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed Wilcoxon (Mann-Whitney) rank-sum test with 80% power and a two-sided significance level of 0.05. An expected drop-out rate of 10% is also considered.", "answer": 67, "answer_type": "ESTIMATED", "explanation": "Sample size\n The time to critical action #2 is considered as primary outcome measure. Time values of participants who do not identify and treat the underlying condition, or who declare dead prematurely, will be set to 15 minutes and considered as censored observations. Therefore, a non-parametric test was used for sample size calculation, and the probability that an observation in one group will be less than an observation in the other group is considered as the effect size measure. With a sample size of 30 in each group the two-tailed Wilcoxon (Mann-Whitney) rank-sum test will have 80% power to detect a probability of at least 0.71, that an observation in one group is less with respect to the primary outcome variable than an observation in the other group. A two-sided significance level of 0.05 is considered. The software nQuery (nQuery 9, \u00c2\u00a9Statistical Solutions Ltd. 2024) was used for sample size calculation.\n Based on an expected drop-out rate of 10%, 67 participants will be recruited to participate in this study.", "id": 2111, "split": "test"} +{"trial_id": "NCT06445946", "pmid": "39317491", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes\n\nIncluded conditions:\n- Gestational Diabetes Mellitus\n- Pregnancy, High Risk\n\nStudy Armgroups:\n- {'label': 'Metformin', 'type': 'EXPERIMENTAL', 'description': 'Metformin as either immediate- or extended-release formulations can be utilized, and titrated to a maximum daily dose of 2,500 mg. Participants receiving metformin will have insulin added only if they have not achieved euglycemia for at least 30% of glucose values after generally receiving the maximum daily dose of metformin of 2,500 mg, or in select situations in the setting of participant intolerance due to mild gastrointestinal symptoms. Participants will be asked to continue taking metformin after treatment supplementation with insulin.', 'interventionNames': ['Drug: Metformin']}\n- {'label': 'Insulin', 'type': 'EXPERIMENTAL', 'description': \"Insulin will be initiated utilizing clinical standards using trimester-specific weight-based dosing criteria, including both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some people may be managed with a single dose of intermediate- or long-acting insulin at night to treat isolated fasting hyperglycemia, while others may require additional treatment of postprandial hyperglycemia with shorter-acting insulin. The sites' insulin formularies include rapid- (Novolog and Humalog), intermediate- (Humulin N, Novolin N, and NPH), and long-acting insulins (Detemir and Lantus).\", 'interventionNames': ['Drug: Insulin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metformin', 'description': 'Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.', 'armGroupLabels': ['Metformin']}\n- {'type': 'DRUG', 'name': 'Insulin', 'description': 'Individuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.', 'armGroupLabels': ['Insulin']}\n\nPrimary Outcomes:\n- {'measure': 'A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.', 'description': 'LGA will be defined as a birthweight \u226590th%tile for gestational age based on a US birth certificate reference adjusted for parity and/or fetal sex. Neonatal hypoglycemia will be defined as a blood glucose \\\\<35 mg/dL or treatment \\\\<24 hours after birth with either IV, PO, or gel glucose therapy. Neonatal hyperbilirubinemia will be defined as treated with phototherapy or exchange transfusion in the first postnatal week and either treatment in the first postnatal week or kernicterus. Fetal or neonatal death can be due to any indication between randomization to hospital discharge or 30 days postnatal if still hospitalized (excluding voluntary pregnancy termination).', 'timeFrame': 'LGA at birth. Hypoglycemia <24 hours after birth. Hyperbilirubinemia within the first week after birth. Death between randomization to hospital discharge or 30 days postnatal.'}\n- {'measure': 'Child body mass index (BMI) at 2 years of age', 'description': 'Child BMI measured in kg/m2 as a continuous measure standardized using U.S. CDC reference adjusted for child sex', 'timeFrame': '2 years of age.'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed with 90% power, a one-sided significance level of 0.025, a loss to follow-up at delivery of 2%, and a 20% supplementation with insulin in addition to metformin. For the 2-year follow-up, a 10% loss to follow-up rate is assumed, with 90% power to rule out an effect size of at least 0.172 SD and 80% power to rule out an effect size of at least 0.149 SD.", "answer": 1572, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n Published data suggest that upwards of 30% of individuals with GDM have an associated adverse neonatal outcome. Using data from recent meta-analyses that compared the two treatment regimens,18 19 71 and the most recent RCT (although comparing glyburide to insulin) that assessed the same primary composite outcome as in our study,23 we estimate the frequency of the primary composite perinatal outcome to be 28% with insulin. To be conservative, we have used an estimate of 25%.\n We have chosen a non-inferiority trial design because metformin\u00e2\u0080\u0099s advantages in terms of cost and ease (eg, oral, no refrigeration needed, less costly) suggest that metformin may be the preferred first-line treatment for GDM if it were found to be non-inferior to insulin in terms of efficacy and safety.41 A non-inferiority margin of 8% was selected for the primary outcome based on a survey and interviews we conducted in January to June 2021 with each of our 20 site PIs, all of whom are maternal-fetal medicine specialists, as well as interviews with 144 patients. This conservative margin is also consistent with recent non-inferiority RCTs for GDM.23 Additionally, we estimate that 20% of individuals who are randomised to metformin will require supplemental insulin,21 which is lower than prior trials because we will exclude those with fasting hyperglycaemia (>115\u00e2\u0080\u0089mg/dL for >50% in the prior week) who are at the highest risk of failing metformin.20\n Based on the above assumptions, we plan to enrol 1572 individuals to determine if metformin is non-inferior to insulin for the composite primary outcome, with 90% power, one-sided significance level of 0.025, a loss to follow-up at delivery of 2% and 20% supplementation with insulin in addition to metformin.\n For the 2-year follow-up, if outcomes are obtained on 1415 participants (ie, a loss to follow-up rate of 10%), there will be 90% power to rule out an effect size of at least 0.172 SD. This translates to a 0.31 unit difference in BMI or a 0.29\u00e2\u0080\u0089kg mean difference in child weight.25 There will be 80% power to rule out an effect size of at least 0.149 SD, or a 0.27 unit difference in BMI or a 0.25\u00e2\u0080\u0089kg mean difference.", "id": 2112, "split": "test"} +{"trial_id": "NCT06449625", "pmid": "39384243", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation\n\nIncluded conditions:\n- Intestinal Mucositis\n- Inflammation\n- Chemotherapeutic Toxicity\n\nStudy Armgroups:\n- {'label': 'Semaglutide', 'type': 'ACTIVE_COMPARATOR', 'description': 'Semaglutide active drug 0.25-0.5mg, once-weekly, injection', 'interventionNames': ['Drug: Semaglutide Pen Injector [Ozempic]']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Semaglutide placebo, once-weekly, injection', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Semaglutide Pen Injector [Ozempic]', 'description': 'Semaglutide active drug', 'armGroupLabels': ['Semaglutide']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'semaglutide placebo', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'gastrointestinal mucositis severity', 'description': 'mean severity grade (0-II)', 'timeFrame': 'from day of stem cell infusion (day 0) to week +3'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, 5% significance level, SD of 0.3641, and an expected drop-out rate of up to 20%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n We aim to be able to detect a difference of 0.4 in GI mucositis severity grade (graded 0\u00e2\u0080\u00932). To detect a difference of 0.4 in GI mucositis severity grade (graded 0\u00e2\u0080\u00932) between the two study arms, using a power of 80%, a 5% significance level, and a SD of 0.3641, randomisation of 32 patients is needed. Due to an expected drop-out rate of up to 20%, we will include a total of 40 patients. Assuming an inclusion success of 60% and a BEAM and auto-HSCT activity of 30 patients yearly at Rigshospitalet and Zealand University Hospital, it appears realistic to complete recruitment within 28 months.", "id": 2113, "split": "test"} +{"trial_id": "NCT06455384", "pmid": "39231549", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Genetics Navigator: Evaluating a Digital Platform for Genomics Health Services\n\nIncluded conditions:\n- Cardiac Conditions\n- Connective Tissue Diseases\n- Retinal Disease\n- Epilepsy in Children\n- Neurodevelopmental Disorders\n- Cancer\n- Polyposis\n\nStudy Armgroups:\n- {'label': 'Genetics Navigator', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention arm will use the Genetics Navigator to support the delivery of genetic services, including intake, education, pre- and post-test counselling, return of results, and physician-generated management recommendations. Participants in the experimental arm will also receive standard of care genetics care.', 'interventionNames': ['Behavioral: Genetics Navigator']}\n- {'label': 'Standard Care with Genetics Professionals', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control arm will receive their genetic counselling and test results through usual care, which consists of in-person/phone/video-conference consults with genetic counsellors and medical geneticists.', 'interventionNames': ['Behavioral: Standard Care with Genetics Professionals']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Genetics Navigator', 'description': 'The Genetics Navigator will be used to support patients during the delivery of genetic services, including intake, education, pre- and post-test counselling, and physician-generated management recommendations', 'armGroupLabels': ['Genetics Navigator']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard Care with Genetics Professionals', 'description': 'Standard care for the delivery of genetic services, including receiving genetic counselling and test results', 'armGroupLabels': ['Standard Care with Genetics Professionals']}\n\nPrimary Outcomes:\n- {'measure': 'Multi-Dimensional Impact of Cancer Risk Assessment (MICRA)', 'description': 'The Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) is a 25-item standardized, validated scale that measures the impact of result disclosure from genetic tests. There are three subscales: Distress (6 items), Uncertainty (9 items) and Positive Experiences (4 items). Total scores range from 0-125, with higher scores indicating worse outcome. Scores on the Distress subscale range from 0-30, with higher scores indicating worse outcome. Scores on the Uncertainty subscale range from 0-45, with higher scores indicating worse outcome. Scores on the Positive Experiences Subscale range from 0-20, with higher scores indicating worse outcomes. (PMID: 12433008)', 'timeFrame': 'At 6 months and 9 months after baseline'}\n\nPlease estimate the sample size based on the assumption: \n80% power at a two-sided significance level of 0.05, with consideration for attrition rates and participants not opting for genetic testing.", "answer": 170, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome is patient/parent distress; Cella et al reported a SD ranging 2\u00e2\u0080\u00937 on the MICRA distress subscale.50 Using a minimally clinically important difference (MCID) of 0.5 SDs results in absolute differences ranging between 1 and 3.5 depending on SD.50 Assuming this, we estimate that 65 participants/arm will be required to have 80% power at a two-sided significance level of 0.05 to detect the MCID using a standard two-sample t-test. The MICRA distress subscale has a range of 0\u00e2\u0080\u009330; based on Cella et al,50 we expect the control group to have means between 1 and 6, which leaves sufficient room for improvement on the scale. Based on previous studies attrition rates, we anticipate having to possibly oversample to account for attrition and to account for participants who are not offered or opt not to receive genetic testing, up to a total sample size of 170 participants (85 per group).63", "id": 2114, "split": "test"} +{"trial_id": "NCT06456229", "pmid": "39972354", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery (PICCS-1)\n\nIncluded conditions:\n- Colorectal Cancer\n- Ileus Postoperative\n- Flatus\n- Diet, Healthy\n\nStudy Armgroups:\n- {'label': 'Arm 1', 'type': 'NO_INTERVENTION', 'description': 'Control arm with no nutritional supplementation'}\n- {'label': 'Arm 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Control arm with nutritional supplementation but without probiotics', 'interventionNames': ['Dietary Supplement: Nestle Isocal']}\n- {'label': 'Arm 3', 'type': 'EXPERIMENTAL', 'description': 'Nutritional supplementation with probiotics', 'interventionNames': ['Dietary Supplement: Nestle Boost Optimum']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Nestle Isocal', 'description': 'Nestle Isocal', 'armGroupLabels': ['Arm 2']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Nestle Boost Optimum', 'description': 'Nestle Boost Optimum', 'armGroupLabels': ['Arm 3']}\n\nPrimary Outcomes:\n- {'measure': 'Time to bowel movement', 'description': 'This records the number of days from the day of surgery before the first bowel movement was experienced by the patient.', 'timeFrame': '0 - 14 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (\u03b1) of 0.05, and a dropout rate of 20%.", "answer": 162, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation was performed based on the primary outcome, which was the time to defecation measured in days from the day of surgery. Based on a previous study by Yang et al. [27], the difference in the mean time to defecation between treatment and control was given as 0.66\u00c2\u00a0days, with the mean time to defecation of the control having a standard deviation of 1.11\u00c2\u00a0days. With a power of 80% and an \u00ce\u00b1 level of 0.05, and assuming a dropout rate of 20%, we estimate that we would require 54 participants in each arm, therefore leading to the recruitment of 162 participants in total. Power calculation was performed using the pwr package on R with a two-sample t-test power calculation. An interim analysis will be undertaken after 20 participants have been recruited in each arm.", "id": 2115, "split": "test"} +{"trial_id": "NCT06475703", "pmid": "39289023", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)\n\nIncluded conditions:\n- Surgical Wound\n- Wound Healing Delayed\n- Heart; Surgery, Heart, Functional Disturbance as Result\n\nStudy Armgroups:\n- {'label': 'Isla digital wound monitoring + Standard follow-up', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the intervention group will be contacted via SMS text message seven days, fourteen days and twenty-one days after surgery with the link request remaining open for 6 days until the next request is sent out. The exception being the last request link which will remain open until 30 days after surgery. In the requests patients are asked to submit a photo of their wound and complete the UKHSA wound surveillance questionnaire. Participants can also submit an image during the 30 days whenever they have a concern.', 'interventionNames': ['Device: Isla wound prioritisation module', 'Other: Standard follow-up']}\n- {'label': 'Standard follow-up', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the control group will have standard post-operative wound care follow-up for 60 days.', 'interventionNames': ['Other: Standard follow-up']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Isla wound prioritisation module', 'description': 'The intervention group will use the artificial intelligence enabled platform with the new wound prioritisation module for 30 days after surgery in addition to standard post-operative wound follow-up care for 60 days after surgery.', 'armGroupLabels': ['Isla digital wound monitoring + Standard follow-up']}\n- {'type': 'OTHER', 'name': 'Standard follow-up', 'description': 'Standard care, mapped during the economic scoping exercise may include; out-patient appointments, advised to contact GP, or no follow-up.', 'armGroupLabels': ['Isla digital wound monitoring + Standard follow-up', 'Standard follow-up']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of images assessed by clinicians, in frequencies', 'description': 'A quality image is one that can be used to make a clinical decision', 'timeFrame': '30 days'}\n- {'measure': 'Quality of images assessed by clinicians, in percentages', 'description': 'A quality image is one that can be used to make a clinical decision', 'timeFrame': '30 days'}\n- {'measure': 'Clinician satisfaction using surveys', 'description': 'Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \\\\& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \\\\& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \\\\& percentages.', 'timeFrame': '30 days'}\n- {'measure': 'Clinician satisfaction using interviews', 'description': 'Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \\\\& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \\\\& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \\\\& percentages.', 'timeFrame': '30 days'}\n- {'measure': 'Patient satisfaction using surveys', 'description': 'Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \\\\& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \\\\& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \\\\& percentages.', 'timeFrame': '30 days'}\n- {'measure': 'Patient satisfaction using interviews', 'description': 'Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \\\\& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \\\\& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \\\\& percentages.', 'timeFrame': '30 days'}\n- {'measure': 'Recruitment rate (number and percentage of eligible patients recruited to the study). Patients who were consented but not randomised will not be included in the recruitment rate.', 'description': 'Recruitment rate (including access and barriers to recruitment and willingness to be randomised) will be assessed as a percentage of all eligible patients, regardless of treatment allocation.', 'timeFrame': '30 days'}\n- {'measure': 'Adherence with the module (intervention group only). Adherence will be reported as the number and percentage of adherent patients in the intervention group.', 'description': 'To be adherent a patient needs to submit 1 photo within the 30 day period.', 'timeFrame': '30 days'}\n- {'measure': 'Loss to follow-up (number and percentage of intervention patients complete the study)', 'description': 'Loss to follow-up will be assessed based on all randomised patients.', 'timeFrame': '30 days'}\n- {'measure': 'Number of wound problems/infections (in number and percentage)', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Severity of wound problems/infections', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Wound-related hospital admissions (in number and percentage)', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Prescribed antibiotics (in number and percentage)', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Time to review images in minutes (intervention only)', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Further surgery to treat wounds in number and percentage', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Prescribed wound treatments', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Number of clinic visits in number and percentage', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Number of General Practice visits in frequency and percentage', 'description': 'Analysis will be reported based on allocated treatment.', 'timeFrame': '30 days'}\n- {'measure': 'Patient travel time in minutes', 'timeFrame': '30 days'}\n- {'measure': 'Quality of life survey using SF-6D v2', 'timeFrame': 'At baseline, 30 days, and 60 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 95% CI; Power: Not specified; Missing/dropout rate: Recruitment and drop-out rates estimated with a 95% CI of within \u00b110% even if the rates were 50%. Adherence rate estimated with a 95% CI of within \u00b113%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a feasibility study, and therefore, sample size calculations cannot be calculated as there are no current data which can be used as the basis of the calculations. The feasibility outcomes for this study are all binary outcomes, for which the widest CIs will occur with a proportion of 0.5 (or 50%), therefore, calculating a sample size for the CI based on 50% gives a \u00e2\u0080\u0098worst case\u00e2\u0080\u0099 estimate.\n Recruiting 60 patients for each treatment group into the trial (ie, a total of 120 patients) will enable us to estimate the recruitment and drop-out rates with a 95% CI of within \u00c2\u00b110%\u00e2\u0080\u0089even if the rates were 50% for these two feasibility outcomes. (The 95% CI for a sample size of 120 patients and 60 successes, ie, 50% of patients recruited, or 50% of patients completing the study, is 41% to 59%). If the adherence to treatment rate is 50%, the adherence rate and 95% CI could be estimated to within \u00c2\u00b113%. (The 95% CI for 30 adherent patients out of 60, as this is only relevant for patients in the intervention group, is 37%\u00e2\u0080\u009363%). The sample size estimations were calculated using STATA V.18 with command \u00e2\u0080\u0098cii proportions\u00e2\u0080\u0099.\n In addition, national data show a wound problem rate of 21% (our data shows 15%) with a cardiac wound infection rate of 8%.19 20 A sample size of 120 patients should provide around nine patients in each group with a wound problem of which 4\u00e2\u0080\u00935 patients should have a wound infection. This is sufficient to inform feasibility, safety and acceptability data.\n With a potential sample size of 1300 patients, we plan to recruit 120 patients over 10 months, a recruitment rate of around 11%. This should be achievable as a randomised trial using patients\u00e2\u0080\u0099 smartphones to monitor surgical wounds had a 69% recruitment rate.9", "id": 2116, "split": "test"} +{"trial_id": "NCT06475716", "pmid": "39350097", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Guided Internet-based Trauma-focused CBT Intervention 'Spring' for ICD-11 Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial\n\nIncluded conditions:\n- Posttraumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'Immediate treatment group', 'type': 'EXPERIMENTAL', 'description': 'The immediate treatment group will receive the intervention immediately after randomization. The intervention includes using an online guided self-help programme Spring that is based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps. The user of the programme also receives up to 3 hours of guidance by a trained therapist.', 'interventionNames': ['Behavioral: Internet-based guided programme Spring']}\n- {'label': 'Delayed treatment control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The delayed treatment group will receive the same intervention as the immediate treatment group, but 24 weeks after randomization. The intervention includes using an online guided self-help programme Spring that is based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps. The user of the programme also receives up to 3 hours of guidance by a trained therapist.', 'interventionNames': ['Behavioral: Internet-based guided programme Spring']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Internet-based guided programme Spring', 'description': 'Spring is an online guided self-help programme based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps designed for delivery over 8 weeks. The steps cover psychoeducation, grounding techniques, management of anxiety, behavioral activation, imaginal exposure, cognitive restructuring, in vivo exposure, and prevention of relapse. The user of the programme also receives up to 3 hours of therapist guidance.', 'armGroupLabels': ['Delayed treatment control group', 'Immediate treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in International Trauma Interview (ITI) PTSD score post-treatment', 'description': 'The ITI is a semi-structured clinical interview for the assessment of symptoms of ICD-11 posttraumatic stress disorder. The total ITI score measuring symptoms of PTSD may range from 0 to 24. Higher scores indicate greater symptom severity.', 'timeFrame': 'baseline; 10 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level 0.05, power 80%, dropout rate 20%, retention rate 80%", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n A statistical power analysis was carried out in order to estimate the necessary sample size for the planned study. It is assumed that PTSD treatment response could be measured on a clinician- or self-report scale as a reduction in the symptomatology of \u00e2\u0089\u00a5\u00e2\u0080\u008930\u00e2\u0080\u009350% [47]. The sample size of 40 was found to be sufficient to detect significant differences between RCT groups (significance level 0.05, power 80%). The comparable trial to this study by Bisson et al. [11] showed that 10% of the participants dropped out of the internet-based CBT-TF. As this drop-out rate is rather low compared to other studies, we chose a more conservative number of 80% retention rates. Therefore, the sample size adjusted to the dropout rate of 20% is 50 [48]. Considering the experience of Bisson et al. [11], it is expected that around 50% of those who expressed an interest in taking part in the intervention after the clinician-administered interview may not meet the eligibility criteria (e.g., symptoms will be under-represented). Hence, a sample size of around 100 individuals assessed with the ITI at baseline is planned as the optimal minimum sample size, given the complexity of the planned trial procedures and design. The CONSORT flow chart for the planned trial is presented in Fig.\u00c2\u00a01.\n \nFig. 1Flow chart for the planned trial", "id": 2117, "split": "test"} +{"trial_id": "NCT06479200", "pmid": "39438104", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers\n\nIncluded conditions:\n- Kidney Failure, Chronic\n\nStudy Armgroups:\n- {'label': 'VR-guided mindfulness intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a 6-week home-based VR-guided mindfulness intervention using the Oculus Quest 3 (or equivalent) headset and a mindfulness application. They will be instructed to practice 10-15 minutes of VR-guided mindfulness daily. The intervention will consist of guided meditation practices, such as body scans, breath awareness, and loving-kindness meditation, delivered in immersive virtual environments designed to promote relaxation and focus.', 'interventionNames': ['Behavioral: VR-guided mindfulness']}\n- {'label': 'Sham VR control', 'type': 'SHAM_COMPARATOR', 'description': 'Participants will receive a 6-week home-based sham VR intervention. They will view relaxing nature videos without mindfulness content for 10-15 minutes daily, matched for duration and VR experience with the experimental group. The sham VR control condition will use the same VR headset as the intervention group but will not include any guided mindfulness practices or instructions.', 'interventionNames': ['Other: Sham VR']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'VR-guided mindfulness', 'description': 'The VR-guided mindfulness intervention is a 6-week home-based program delivered through an Oculus Quest 3 (or equivalent) headset. Participants practice 10-15 minutes of guided mindfulness exercises daily in immersive virtual environments. The program includes various mindfulness techniques such as body scans, breath awareness, and loving-kindness meditation, designed to reduce stress and improve well-being.', 'armGroupLabels': ['VR-guided mindfulness intervention'], 'otherNames': ['Virtual reality mindfulness', 'VR mindfulness']}\n- {'type': 'OTHER', 'name': 'Sham VR', 'description': 'The sham VR intervention is a 6-week home-based program that involves viewing relaxing nature videos without any mindfulness content. Participants use the same VR headset as the experimental group and engage with the sham content for 10-15 minutes daily, matching the duration of the experimental intervention. This sham intervention controls for the effects of using VR technology and engaging in a relaxing activity.', 'armGroupLabels': ['Sham VR control'], 'otherNames': ['Control VR', 'Placebo VR']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Caregiver Burden', 'description': 'Change in caregiver burden as measured by the Zarit Burden Interview (ZBI). The ZBI is a validated 22-item questionnaire that assesses the level of burden experienced by caregivers. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.', 'timeFrame': 'Baseline to 6 weeks (post-intervention)'}\n\nPlease estimate the sample size based on the assumption: \nThe analysis will focus on estimating effect sizes and variability to inform sample size calculations for a future definitive trial.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size of 30 participants (15 per group) was chosen for this pilot RCT based on recommendations for pilot studies aimed at estimating effect sizes and assessing feasibility.62 This sample size is considered sufficient to provide preliminary data on the intervention\u00e2\u0080\u0099s efficacy, feasibility and acceptability, as well as to inform sample size calculations for a future definitive RCT. As a pilot study, the primary focus is on generating effect size estimates and assessing feasibility rather than hypothesis testing.63 The analysis of the outcomes will focus on estimating effect sizes and variability to inform sample size calculations for a future definitive trial.", "id": 2118, "split": "test"} +{"trial_id": "NCT06482788", "pmid": "39905364", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study\n\nIncluded conditions:\n- Esophagogastric Junction Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Experimental arm', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive Immunotherapy (Adebrelimab, PD-L1 inhibitor) combined with XELOX chemotherapy (Capecitabine + Oxaliplatin) therapy in four 3-week treatment cycles with imaging assessment every 2 cycles. After treatment response evaluation, patients will receive resection within 4-8 weeks. Following surgery, patients will receive four further 3-week cycles of Adebrelimab + XELOX after 4-12 weeks of resection. Patients will then receive 10 additional 3-week treatment cycles with Adebrelimab alone.', 'interventionNames': ['Drug: Adebrelimab (anti-PD-L1) + XELOX']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Adebrelimab (anti-PD-L1) + XELOX', 'description': 'Adebrelimab: 1200mg, i.v., each infusion lasts 30-60 minutes and is administered on the first day of each cycle (3 weeks).\\n\\nCapecitabine: 1000mg/m2 , bid, orally, from day 1 to day 14 of each cycle (3 weeks).\\n\\nOxaliplatin: 130mg/m2, i.v., each infusion is administered on the first day of each cycle (3 weeks).', 'armGroupLabels': ['Experimental arm']}\n\nPrimary Outcomes:\n- {'measure': 'Pathological complete response rate (ITT)', 'description': 'The proportion of subjects with no cancer cells in the primary tumor and lymph node specimens (ypT0N0)', 'timeFrame': 'From date of enrolment until surgical resection, an average of 3 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) is 0.05, power of test (1-\u00ce\u00b2) is 0.80, and a 10% dropout rate is considered.", "answer": 26, "answer_type": "ESTIMATED", "explanation": "Power and sample size calculation\n The primary endpoint of this study is the pCR rate. Referencing the study of Toripalimab combined with SOX/XELOX [16], which showed a pCR rate of 7% for chemotherapy as neoadjuvant therapy, it is assumed that the pCR rate for Adebrelimab combined with XELOX as neoadjuvant therapy could reach 25%. With \u00ce\u00b1 of 0.05 and a power of test (1-\u00ce\u00b2) of 0.80, calculated through PASS software, 23 participants need to be enrolled. Considering a 10% dropout rate, the minimum sample size of this single-armed study is 26 patients.", "id": 2119, "split": "test"} +{"trial_id": "NCT06483477", "pmid": "40114285", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade \u22652 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)\n\nIncluded conditions:\n- Breast Cancer Female\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Standard skin care supported by a reminder app', 'interventionNames': ['Other: Standard skin care', 'Device: Reminder App']}\n- {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard skin care alone', 'interventionNames': ['Other: Standard skin care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard skin care', 'description': 'From the start of radiotherapy, standard skin care has to be performed by the patient. This may vary at the participating centers. At the site in L\u00fcbeck, it includes fatty cream with 2-10% urea (fatty cream alone, if patients do not tolerate urea) and, in case of pruritus, addition of mometasone furoate cream. In case of grade \u22652 moist desquamation or grade \u22653 radiation dermatitis, each day antiseptic agents will be administered for wound cleansing followed by administration of silicon or calcium alginate bandage. This treatment will be continued until moist desquamation radiation disappears and radiation dermatitis improves to grade 2. Fatty cream with 2-10% urea is applied to the irradiated skin four times daily. Mometasone furoate cream: In addition to the fatty cream with 2-10% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily.', 'armGroupLabels': ['Arm A', 'Arm B']}\n- {'type': 'DEVICE', 'name': 'Reminder App', 'description': \"In addition to standard skin care, patients are supported by a Reminder App. The purpose of the app is to remind the patients in an intuitive, unobtrusive and supportive way to perform skin care. By default, patients are reminded four times a day, but they will also be able to define a notification schedule that best suits their personal needs. The patients may postpone each required care procedure for up to 2 hours. With each procedure, the patients are guided through the skin care with simple and self-explanatory illustrations. To increase the patients' motivation, they will additionally earn points for regular and punctual performed care procedures. The patients receive a hand-out including instructions how to properly perform skin care, but they can also find an information page within the application that includes similar instructions.\", 'armGroupLabels': ['Arm A']}\n\nPrimary Outcomes:\n- {'measure': 'Prevention of grade \u22652 radiation dermatitis', 'description': 'Radiation dermatitis will be assessed according to CTCAE v5.0.', 'timeFrame': 'through study completion, an average of 4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nChi-square Test, two-sided significance level of 5%, power of 80%, and a 2% dropout rate.", "answer": 268, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The null hypothesis of equal rates of grade \u00e2\u0089\u00a52 skin toxicity is tested against the two-sided alternative hypothesis of different rates. Based on this hypothesis system, the sample size required for this trial is calculated considering the following assumptions:\u00e2\u0097\u008f A Chi-square Test will be applied\u00e2\u0097\u008f The two-sided significance level is set to 5%\u00e2\u0097\u008f In patients treated with hypo-fractionated radiotherapy for breast cancer, a retrospective pre-study suggested a rate of grade \u00e2\u0089\u00a52 dermatitis of 25.4% if standard skin care alone was administered [12].\u00e2\u0097\u008f Based on these retrospective data, a rate of grade \u00e2\u0089\u00a52 skin toxicity of approximately 30% was assumed in the reference group of a prospective trial, i.e. in patients receiving standard skin care alone for radiation dermatitis.\u00e2\u0097\u008f The impact of the Reminder App will be considered to be clinically relevant, if the rate of grade \u00e2\u0089\u00a52 dermatitis can be reduced to 15%.\u00e2\u0097\u008f The power to yield statistical significance if the difference in rates is in fact 15% is set to 80%.\n Based on these assumptions, 131 patients are required per study arm within the Full Analysis Set. Considering that 2% of patients will not qualify for this set, a total of 268 patients should be randomized.", "id": 2120, "split": "test"} +{"trial_id": "NCT06487741", "pmid": "40016827", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial\n\nIncluded conditions:\n- Fibromyalgia\n- Stretch\n- Adherence, Treatment\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).', 'interventionNames': ['Other: Home-based stretching exercises']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group receives usual care, and no change in treatment is made. Participants will be encouraged to maintain their daily routine but refrain from changing the current pharmacological treatment or initiating new physical exercise practices during the study.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Home-based stretching exercises', 'description': 'The intervention comprises six weeks of daily static stretching exercises (six minutes a day) in accordance with the recommendation of the American College of Sports Medicine. The intervention is self-administered and consists of two bouts of 30-second bilateral static stretches of the knee flexors, hip abductors, and shoulder elevators.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Severity of symptoms', 'description': 'The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score', 'timeFrame': 'Measured at baseline'}\n- {'measure': 'Severity of symptoms', 'description': 'The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score', 'timeFrame': 'Measured following 6 weeks of intervention (primary endpoint)'}\n- {'measure': 'Severity of symptoms', 'description': 'The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score', 'timeFrame': 'Measured 6 months after the primary endpoint (secondary endpoint)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, power of 0.9, and a 20% loss to follow-up.", "answer": 58, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size for this study was informed by data from our previous feasibility study that used a similar home-based stretching intervention [37]. The sample size was calculated using repeated-measures analysis of variance for a design with a 2-level within-subject factor and a 2-level between-subject factor. The mean baseline FIQ-R total score was set at 56.5, and the covariance matrix for repeated measurements, assumed to be constant across both groups, was set to [276,209/209,211]. With an alpha level of 0.05, assuming no change in the score in the control group and a minimal clinically relevant score change of 14% in the intervention group, 24 patients per group are required to achieve a power of 0.9. Additionally, considering a 20% loss to follow-up, the final total sample size needed is 58 (29 in each group).", "id": 2121, "split": "test"} +{"trial_id": "NCT06490367", "pmid": "40131943", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety, Feasibility, and Biomarker Effects of Time-restricted Eating for 12 Weeks in Early-stage Huntington's Disease.\n\nIncluded conditions:\n- Huntington Disease\n\nStudy Armgroups:\n- {'label': 'Time-Restricted Eating', 'type': 'EXPERIMENTAL', 'description': 'All participants are assigned to this arm.', 'interventionNames': ['Behavioral: Time-Restricted Eating Diet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Time-Restricted Eating Diet', 'description': 'Participants engage in a time-restricted eating diet, specifically maintaining a 6-8-hour eating window every day for 12 weeks. Participants are allowed to self-select the timing of the eating window, but once selected, they are asked to maintain that schedule daily. Outside of that window, for the remaining 16-18 hours of day/night, participants are asked not to consume calorie-containing food or drink. Beverages without calories are allowed.', 'armGroupLabels': ['Time-Restricted Eating']}\n\nPrimary Outcomes:\n- {'measure': 'Adherence to the TRE diet.', 'description': 'Adherence, measured as the number of days participants can successfully limit the eating window to 6-8 hours as tracked through self-reported surveys and time-stamped meal logs, is calculated for each participant during the 12 weeks of TRE.', 'timeFrame': 'Week 1 to Week 13'}\n\nPlease estimate the sample size based on the assumption: \n95% power for body weight change detection, 90% power for NfL change detection, two-sided Type I error of 0.05, and an expected attrition rate of 20%.", "answer": 25, "answer_type": "ESTIMATED", "explanation": "Sample size\n We will recruit 40 participants expecting roughly 25 participants (62.5%) to meet inclusion criteria with the goal of yielding a final sample of at least 20 in the experimental condition after a conservative expected level of attrition (~20%). Aside from a single patient case report, an examination of TRE in persons with HD has never been explored. Thus, we must rely on existing data on TRE intervention in other populations. To detect differences in the percent change in body weight from baseline to follow-up, assuming a standard deviation of 2.4% from Gabel et al., we will have 95% power to detect a difference as low as 2.5% change in body weight in n\u00e2\u0080\u0089=\u00e2\u0080\u008915 with two-sided Type I error of 0.05 [22]. To detect differences in plasma neurofilament light protein (NfL) from baseline to follow-up, assuming a standard deviation of 0.65 log pg/ml from Byrne et al., we will have 90% power to detect a difference as low as 15% in plasma NfL between baseline and follow-up in n\u00e2\u0080\u0089=\u00e2\u0080\u008920 with two-sided Type I error of 0.05 [26]. Thus, we will study 20 participants to maximize power while balancing feasibility to derive meaningful data.", "id": 2122, "split": "test"} +{"trial_id": "NCT06496139", "pmid": "39843366", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: a Randomised Controlled Trial\n\nIncluded conditions:\n- Premenstrual Dysphoric Disorder\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': 'Therapist-guided self-help internet-delivered cognitive behavioural therapy for PMDD', 'interventionNames': ['Behavioral: Therapist-guided internet-delivered cognitive behavioural therapy']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Waiting list'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Therapist-guided internet-delivered cognitive behavioural therapy', 'description': 'The intervention consists of 8 weeks of therapist-guided self-help ICBT.', 'armGroupLabels': ['Treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment', 'description': 'This primary outcome is assessed with the Daily Report of Severity of Problems. (DRSP) The DRSP assesses premenstrual symptoms included in DSM-5 diagnostic criteria for PMDD and their impact on everyday life. Items are rated on a scale from 1-6. Baseline and post-treatment data consist of prospective daily DRSP ratings over two consecutive menstrual cycles, both before and after treatment. Follow-up assessments will include daily DRSP ratings over one menstrual cycle.', 'timeFrame': 'Baseline to post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).'}\n- {'measure': 'Group differences in PMDD-related psychological and functional impairment during the luteal phase from baseline to post-treatment', 'description': 'This outcome is assessed using the PMS Impact Questionnaire (PMS-I) which includes two subscales: (1) psychological impairment and (2) functional impairment. The PMS-I consists of 18 items (9 for each subscale) rated on a scale from 1-4 scale (max score 72, higher points indicating higher levels of psychological and functional impairment).', 'timeFrame': 'Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is set at 0.05, power is set at 80% for the PMS-I outcome and 90% for the DRSP outcome, and an expected attrition rate of 25% is considered.", "answer": 164, "answer_type": "ESTIMATED", "explanation": "Sample size\n The fact that research on ICBT for premenstrual disorders is limited49 50 complicates the estimation of expected effect sizes. Also, only one study focusing on PMDD provides data on effect sizes.50 This study reported medium to large effect sizes on treatment-related change in symptom intensity (f2=0.13), impact on everyday life (f2=0.12) and PMDD-related psychological (f2=0.20) and functional impairment (f2=0.26) when compared with a waiting-list control group.50 Meta-analysis of RCTs on face-to-face CBT for PMS and PMDD indicate small to medium effect sizes (range: d+=0.24\u00e2\u0080\u00930.70) on mood, behaviour-autonomic responses, physical symptoms and functional impairment.22 Based on the limited research and heterogeneity in effect sizes among studies, the sample size calculation for the current study was based on an expected medium effect size (Cohen\u00e2\u0080\u0099s d=0.5, \u00ce\u00b1=0.05, power=80%).\n The power analysis for the first primary outcome measure (DRSP), based on analysis with LGPM, rendered a sample size of n=25 (Cohen\u00e2\u0080\u0099s d=0.5, \u00ce\u00b1=0.05, power=90%). The power analysis for the other primary outcome (PMS-I), based on LMM, rendered a sample size of n=123 (Cohen\u00e2\u0080\u0099s d=0.5, \u00ce\u00b1=0.05, power=80%). In line with relatively high attrition rates in internet-delivered interventions,73 the sample size was adjusted to account for an expected attrition rate of 25%, giving a total sample size of n=164.", "id": 2123, "split": "test"} +{"trial_id": "NCT06503991", "pmid": "39689146", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Community and Physician Perceptions of Barriers to Care for Acute Coronary Syndrome Among HIV-infected and -Uninfected Patients in Moshi, Tanzania_1\n\nIncluded conditions:\n- Hypertension\n- HIV\n\nStudy Armgroups:\n- {'label': 'COBRA and CHAMP (COACH) adapted intervention', 'type': 'EXPERIMENTAL', 'description': 'Persons living with HIV (PLWH) and receiving routine HIV care in northern Tanzania will receive an integrated COBRA (Control of Blood Pressure and Risk Attenuation) and CHAMP (Community Health Worker-delivered Hypertension Management Pilot) multi-component hypertension intervention.', 'interventionNames': ['Behavioral: Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)', 'Behavioral: Control of Blood Pressure and Risk Attenuation (COBRA)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP)', 'description': 'Clinic-based hypertension educational intervention delivered by a Community Health Worker.', 'armGroupLabels': ['COBRA and CHAMP (COACH) adapted intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Control of Blood Pressure and Risk Attenuation (COBRA)', 'description': 'Multi-component counseling program addressing patient education, provider training, coordination of care, and subsidizing care costs.', 'armGroupLabels': ['COBRA and CHAMP (COACH) adapted intervention']}\n\nPrimary Outcomes:\n- {'measure': \"Feasibility as measured by the proportion of total scheduled intervention sessions (CHW counseling sessions, doctor's visits, phone calls) attended\", 'description': \"The primary measure of feasibility for this study will the proportion of total scheduled intervention sessions (CHW counseling sessions, doctor's visits, phone calls) attended by the 100 study participants over the course of the 6-month intervention.\", 'timeFrame': '6 Months'}\n\nPlease estimate the sample size based on the assumption: \nThe pilot trial will not be powered to detect significant intervention effects or stable effect sizes. The focus is on assessing implementation outcomes such as reach, adoption, and fidelity.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n As this is a pilot feasibility trial using a pre-post analysis, our focus will be on assessing implementation outcomes. The primary outcomes of this study are implementation outcomes (see Study outcomes below), and no prior assumptions were made about effect size for secondary clinical effectiveness outcomes and the pilot trial will not be powered to detect significant intervention effects or stable effect sizes. Therefore, we will enroll 100 participants (50 from MCTC and 50 from PCTC) to assess reach, adoption, and fidelity of the COACH intervention. We will also gather preliminary clinical effectiveness data to generate parameter estimates and ranges of values and calculate eligibility, recruitment and attrition rates to inform sample size calculations, power considerations and potential effects for the design of a larger, definitive, fully powered randomized trial in the future.", "id": 2124, "split": "test"} +{"trial_id": "NCT06505135", "pmid": "39427182", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)\n\nIncluded conditions:\n- Rotator Cuff Tears\n- Rotator Cuff Injuries\n- Rotator Cuff Tear Arthropathy\n\nStudy Armgroups:\n- {'label': 'Standard Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'ROTATOR CUFF SURGERY Rotator cuff tendon suture is carried out at Hospital S\u00f8nderjylland according to inclusion criteria. Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors.', 'interventionNames': ['Other: Standard care']}\n- {'label': 'Stem-cell treatment', 'type': 'EXPERIMENTAL', 'description': 'HARVEST OF ADIPOSE TISSUE Harvest of adipose tissue from abdominal subcutis and the cell preparation will be performed in the approved lipoplasty system.This lipoaspirate will be processed in the dedicated adipose tissue-processing device. Cell clusters collected at the top of the adipose tissue-processing device undergo a second size reduction by being passed through a size reduction filter. The final product (approximately 60-100 mL) is then concentrated and collected into a 10-mL syringe for subsequent use.\\n\\nHARVEST OF MUSCLE BIOPSY FROM THE SUPRASPINATUS MUSCLE A biopsy of 0.1-0.2 g muscle is obtained from the supraspinatus muscle to estimate preoperative muscle fiber atrophy, intracellular lipid accumulation, mitochondrial dysfunction, inflammation and reduced regenerative capacity. The muscle biopsy specimens will be taken near the muscular tendinous junction during routine exposure or arthroscopy of the glenohumeral region.', 'interventionNames': ['Biological: Stem-cell treatment']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Stem-cell treatment', 'description': 'In the cell treatment group of patients, injection of the cell suspension will be performed at the end of the surgical procedure. Fluid is carefully aspirated via the anterior outflow cannula, and autologous micro-fragmented adipose tissue is injected in dry arthroscopy conditions from the lateral portal while maintaining a subacromial view from the posterior portal.\\n\\n10 mL of the stem cells suspension will be injected into the supraspinatus muscle at four predefined sites at the musculo-tendinous junction of the supraspinatus muscle. For each injection site, 1.5 mL of the suspension will be injected using an 18-gauge syringe.', 'armGroupLabels': ['Stem-cell treatment']}\n- {'type': 'OTHER', 'name': 'Standard care', 'description': 'Standard treatment also includes intravenous injection preoperatively of 2 g of Cloxacillin In case of allergy 1.5 g of Cefuroxim is chosen. Tendon suture is performed arthroscopically under regional anaesthetic blockage and light sedation with standard double row technique using suture anchors', 'armGroupLabels': ['Standard Care']}\n\nPrimary Outcomes:\n- {'measure': 'Patient reported outcome of Oxford shoulder score', 'description': 'A difference in 8 points from the oxford shoulder score questionnaire. The Oxford Shoulder Score comprises twelve items: four assessing the degree of pain and eight evaluating function. Each item is rated on a 5-point Likert scale, where 0 indicates the worst outcome, and 4 indicates the best. The scores from these 12 items are summed to produce a total score ranging from 0 to 48', 'timeFrame': 'From inclusion and until 12 months after operation'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculation assumes a significance level (alpha) of 0.05, a power of 94%, and adjustments for multiple testing through Bonferroni correction. The mean score and standard deviation for both control and intervention groups at different time points are provided.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n To calculate the sample size, we used Monte Carlo simulation. We based the simulation on a linear regression. Hence, the estimated sample size from the Monte Carlo simulation is a conservative estimate of the needed sample size, as we will utilize a mixed effect model in the primary analysis. In the simulation, we assumed the mean score and its standard deviation were distributed across different time points, as highlighted in Table\u00c2\u00a01, similar to the results reported by Cartuliares et al. (manuscript submitted for publication, 2024) derived from a prospective cohort including patients who underwent rotator cuff surgery at the Hospital of S\u00c3\u00b8nderjylland. This study, along with a clinical assessment by experts in shoulder surgery and stem cell therapy, determined that an 8-point increase in the OSS, equivalent to a 25% improvement, will be accepted as the minimal clinically significant difference, forming a background for the power calculation. The Do-File from STATA/BE used for the calculation is in Additional file 2.\nTable 1Data used for the power calculationTime pointBaseline3\u00c2\u00a0months6\u00c2\u00a0months12\u00c2\u00a0monthsMean score (SD) control group19 (4.12)28 (4.12)30 (4.12)33 (4.12)Mean score (SD) intervention group19 (4.12)40 (3)36 (3.6)41 (3.6)SD Standard deviation\n The p value was based on the difference at 12\u00c2\u00a0months, where we adjusted for multiple testing through Bonferroni correction. Under these assumptions, we needed 30 patients in total (15 in each arm) to achieve a power of 94% at an alpha level of 0.05.", "id": 2125, "split": "test"} +{"trial_id": "NCT06517589", "pmid": "39702504", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression\n\nIncluded conditions:\n- Depression\n- Anxiety Disorder\n\nStudy Armgroups:\n- {'label': 'Process-based Cognitive Behavioral Therapy', 'type': 'EXPERIMENTAL', 'description': 'In PBT (20 sessions), treatment is initiated by a collaborative interpretation of the dynamic network model using smartphone-based Ecological Momentary Assessment collected during the baseline. Based on the outcome of the dynamic network model, interventions are selected on the basis of empirical evidence for mechanisms of change matching to the central node of the individual patient, besides feedback loops and self-loops, as the key process maintaining the maladaptive pattern. Interventions are conceptualized in the evolutionary framework as variation, selection and retention of an adaptive mode of the central node related to the specific context of the problem. The change of this variable is monitored using daily judgements on the basis of EMA. Further treatment planning focuses on additional targets to establish the adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled in statistical analyses.', 'interventionNames': ['Other: Process-based Cognitive Behavioral Therapy (PBT)']}\n- {'label': 'Traditional Cognitive Behavioral Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'In r-CBT (20 sessions) a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the effects of the interventions on factors maintaining the disorder, e.g. avoidance and exposure in anxiety disorder or reduced reinforcement of activities and behavioral activation in depression. Interventions are selected on the basis of common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to taylor the techniques to the problem behaviors or dysfunctional thoughts of patients. Treatment process focuses mainly on the implementation of the manualized interventions adapted to the individual patient as recommended in the National guidelines for treatment of depression and anxiety disorders. Concomitant medication is allowed and will be controlled in statistical analyses.', 'interventionNames': ['Other: Cognitive Behavioral Therapy (CBT)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Process-based Cognitive Behavioral Therapy (PBT)', 'description': 'PBT (20 sessions), intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.', 'armGroupLabels': ['Process-based Cognitive Behavioral Therapy']}\n- {'type': 'OTHER', 'name': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT (20 sessions), intervention planning as usual based on manual.', 'armGroupLabels': ['Traditional Cognitive Behavioral Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Depression Anxiety Stress Scale (DASS-21)', 'description': 'Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome', 'timeFrame': 'Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha level (\u03b1) of 0.05, a power of 0.8, and a correlation among repeated measures estimated at r = 0.4.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size estimation is based on the expected outcome in DASS-21, with treatment condition as between-subjects factor and a within-subjects repeated measurement factor (pre, post, follow-up). Since no previous trial has examined the effects of PBT, the expected effect size is set to a moderate effect of f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25. Using an alpha level (\u00ce\u00b1) of\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a power of\u00e2\u0080\u0089=\u00e2\u0080\u00890.8 with correlation among repeated measures estimated at r\u00e2\u0080\u0089=\u00e2\u0080\u00890.4, 78 patients are needed (39 in each arm) to detect significant differences. To compensate for non-starters, a total sample of 80 patients will be randomized.", "id": 2126, "split": "test"} +{"trial_id": "NCT06528184", "pmid": "40132819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings\n\nIncluded conditions:\n- Uterine Cervical Neoplasms\n\nStudy Armgroups:\n- {'label': 'Usual care arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will only be offered clinician-sampling for HPV DNA testing to determine if they are agreeable to undergo screening.', 'interventionNames': ['Diagnostic Test: Clinician-sampled HPV DNA test']}\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Participants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality.', 'interventionNames': ['Diagnostic Test: Self-sampled HPV DNA testing', 'Diagnostic Test: Clinician-sampled HPV DNA test']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Self-sampled HPV DNA testing', 'description': 'Participants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab)', 'armGroupLabels': ['Intervention arm']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Clinician-sampled HPV DNA test', 'description': 'Participants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab)', 'armGroupLabels': ['Intervention arm', 'Usual care arm']}\n\nPrimary Outcomes:\n- {'measure': 'Detection of high-risk Human Papillomavirus (HPV) DNA', 'description': 'Difference in detection of high-risk HPV DNA between 2 arms', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an alpha level of 0.05, 80% power, a 1:1 allocation ratio, and accounting for a 10% loss to follow-up.", "answer": 650, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Based on data from the National Population Health Survey 2022,3 the cervical cancer screening uptake rate in Singapore is currently 43%. A meta-analysis by Dr Gianfranco Di Gennaro et al provided a pooled relative ratio of 1.89 (95% CI 1.76 to 2.02) for self-sampling HPV DNA screening uptake compared with clinician-sampling.11 Using this data, our study estimates an 83.0% uptake rate in the intervention arm (self-sampling or clinician-sampling). Additionally, a local study by Lim et al reported HR-HPV detection rates of 20.1% for self-sampling and 21.0% for clinician-sampling.16 This translates to an estimated HR-HPV detection rate of 16.7% in the intervention arm and 9.0% in the usual care arm (clinician-sampling only). Assuming an alpha level of 0.05, 80% power, a 1:1 allocation ratio and accounting for a 10% loss to follow-up, the required sample size is calculated to be 325 participants per arm, for a total of 650 participants.", "id": 2127, "split": "test"} +{"trial_id": "NCT06529081", "pmid": "39856583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment\n\nIncluded conditions:\n- Small Cell Lung Carcinoma\n\nStudy Armgroups:\n- {'label': 'Standard Treatment', 'type': 'NO_INTERVENTION', 'description': 'PDL1/PD1 immunotherapy (durvalumab or atezolozumab - according to the SmPC) after chemo-immunotherapy based on platinum compounds.'}\n- {'label': 'Standard Treatment with Palliative Radiotherapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Radiation: Palliative Radiotherapy']}\n- {'label': 'Standard Treatment with Radical/Ablative Radiotherapy', 'type': 'EXPERIMENTAL', 'interventionNames': ['Radiation: Radical/Ablative Radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Palliative Radiotherapy', 'description': 'Standard treatment with added consolidative radiotherapy to the chest area and possibly metastatic lesions (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each).', 'armGroupLabels': ['Standard Treatment with Palliative Radiotherapy']}\n- {'type': 'RADIATION', 'name': 'Radical/Ablative Radiotherapy', 'description': 'Standard treatment with added radical/ablative radiotherapy (total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and total dose of 24 Gy administered in single fractions of 8 Gy every 2-3 days to the metastatic lesions) to the chest area and all metastatic lesions.', 'armGroupLabels': ['Standard Treatment with Radical/Ablative Radiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival (PFS) according to RECIST 1.1 imaging criteria or patient death.', 'description': 'The assessment of the impact of consolidative (radical/palliative) radiotherapy on residual post-chemoimmunotherapy (during immunotherapy) lesions on progression-free survival (PFS).', 'timeFrame': '12 months after last patient entry'}\n\nPlease estimate the sample size based on the assumption: \nPower = 0.80, Significance level \u03b1 = 0.1, Estimated percentage of censored observations CR = 0.05, Planned follow-up period = 24 months, Equal ratio of sample sizes in the groups", "answer": 165, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size estimation\n The sample size for the study was estimated using the log-rank test under the following assumptions: power of 1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.80; statistical significance level \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.1; minimum expected hazard ratio for the study group vs. control group HR\u00e2\u0080\u0089=\u00e2\u0080\u00890.55; estimated percentage of censored observations CR\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; planned follow-up period [months] FU\u00e2\u0080\u0089=\u00e2\u0080\u008924. An equal ratio of sample sizes in the groups was assumed. The estimation was conducted in two stages. In the first stage, the number of adverse events was estimated at 99 (assuming HR\u00e2\u0080\u0089=\u00e2\u0080\u00890.55). Subsequently, based on the estimated number of adverse events, an assumed censoring rate of 0.05, and an assumed median time to progression in the control group of approximately 5.5\u00c2\u00a0months, the number of patients was estimated at N\u00e2\u0080\u0089=\u00e2\u0080\u0089165. The sample size estimation was performed in R v.4.0.2 based on Schoenfeld\u00e2\u0080\u0099s equation for estimating sample size for Cox proportional hazards models [15].", "id": 2128, "split": "test"} +{"trial_id": "NCT06534684", "pmid": "39529199", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial\n\nIncluded conditions:\n- Depression, Unipolar\n- Depression Moderate\n\nStudy Armgroups:\n- {'label': 'Intermittent Theta Burst Stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Stimulation will be performed with a Mag \\\\& More PowerMag EEG 100 system with a double PMD70 p-cool (fluid-cooled) figure-of-eight coil.', 'interventionNames': ['Device: Intermittent Theta Burst Stimulation']}\n- {'label': 'Sham Intermittent Theta Burst Stimulation', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sham stimulation will be performed by the Mag \\\\& More PowerMag EEG 100 system double PMD70 p-cool figure-of-eight coil Sham system.', 'interventionNames': ['Device: Intermittent Theta Burst Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Intermittent Theta Burst Stimulation', 'description': 'Intermittent Theta Burst Stimulation will be delivered with 120% of resting motor threshold with triplet 50 Hz bursts repeated at 5 Hz; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Treatment will be provided for 10 days for two consecutive weeks (except Saturdays and Sundays).', 'armGroupLabels': ['Intermittent Theta Burst Stimulation', 'Sham Intermittent Theta Burst Stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Data from magnetic resonance imaging - white matter integrity', 'description': 'Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of cerebral white matter integrity quantified by fractional anisotropy measured by diffusion tensor imaging (DTI) obtained from magnetic resonance imaging (MRI).', 'timeFrame': 'Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days'}\n- {'measure': 'Data from magnetic resonance imaging - cortical thickness', 'description': 'Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of thickness in cerebral gray matter thickness quantified by T1-weighted magnetic resonance imaging (MRI).', 'timeFrame': 'Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days'}\n- {'measure': 'Data from magnetic resonance imaging - cerebral activity', 'description': 'Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in cerebral activity quantified by blood-oxygen-level-dependent (BOLD) responses measured by functional resonance imaging (fMRI).', 'timeFrame': 'Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days'}\n\nPlease estimate the sample size based on the assumption: \nMedium effect size (f = 0.25), two groups, alpha = 0.05, power = 0.90, correlation between repeated measures = 0.5, sphericity correction = 1, and a total drop-out rate of 10%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n To date, only a single study has examined the relation between fractional anisotropy (FA) and iTBS [29], however, that study tested the after-effects of iTBS in the primary motor cortex and included only healthy participants. To our knowledge, there are no studies to date that have examined the change in FA after iTBS treatment. Furthermore, there are to our knowledge no previous studies that have measured the change in cortical thickness after iTBS treatment. Due to the lack of previous studies investigating changes in functional and structural cerebral measures after iTBS treatment in depressed patients, we based the sample size calculation on the expected cognitive improvement in N-back performance during fMRI. For the fMRI measures using the N-back task, we expect similar effect sizes as in previous comparable studies (summarized in [28]), where moderate to large effect sizes and significant group differences were observed with group sizes of 20\u00e2\u0080\u009330 participants when using the same N-back stimuli as we do. Based on previous data [28] for N-back changes in fMRI, in a repeated analysis (F-test), medium effect size (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25), two groups, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.90, correlation between repeated measures\u00e2\u0080\u0089=\u00e2\u0080\u00890.5, sphericity correction\u00e2\u0080\u0089=\u00e2\u0080\u00891, the required sample size is 46 for the fMRI analyses, with equivalent group sizes of iTBS and sham. There is limited information about drop-out rates for iTBS treatment, however, a meta-analysis on rTMS [30] suggested the mean drop-out rate to be between 7 and 8%. Thus, assuming a total drop-out of 10%, the present study must include a total of 50 participants.", "id": 2129, "split": "test"} +{"trial_id": "NCT06548477", "pmid": "39953562", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages: A Protocol for Randomized Controlled (Hash) Trial.\n\nIncluded conditions:\n- Aneurysmal Subarachnoid Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Intervention group (Albumin group)', 'type': 'EXPERIMENTAL', 'description': 'Intervention group will receive of intermittent boluses of human albumin plus standard fluid therapy (with crystalloids only) to maintain a euvolemic fluid balance.', 'interventionNames': ['Drug: Human albumin']}\n- {'label': 'Control (crystalloid group)', 'type': 'NO_INTERVENTION', 'description': 'Control group will receive only standard fluid therapy with crystalloid solutions with intermittent boluses crystalloid solution to maintain euvolemic balance'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Human albumin', 'description': 'Patients in intervention arm will also receive intermittent boluses of 20 percent human albumin (in addition to standard fluid therapy) that will be administered with dosage regimen of 1.25gm/kg of body weight per 24 hours. The maximum total calculated dose/volume of albumin for the patient will be infused @ 34 ml/hour (over 3 hours) and will be divided in 3 boluses, spaced at 8 hours intervals. During intervention period, duration of treatment (7-day study period) will cover the peak period of cerebral vasospasm from day 4th until 10th day. Albumin administration will be tailored according to the targeted values set for euvolemic fluid balance in each patient. Before randomization (within 72 hours post-ictus) and after day-10 (from day 11th-14th, patient will only receive standard fluid therapy.', 'armGroupLabels': ['Intervention group (Albumin group)']}\n\nPrimary Outcomes:\n- {'measure': 'Dichomatized modified Rankin Scale (mRS)', 'description': 'Primary clinical outcome will be based on dichotomized modified Rankin Scale \\\\[(Good grades (0 -2) and poor grades (3-6)\\\\]. Primary outcome measures (values of mRS) will be compared between study arms to assess difference in the effect size of the intervention.', 'timeFrame': 'Endpoints for primary outcome measures (values of mRS) will be assessed on Day-14 and at 3 month follow up.'}\n\nPlease estimate the sample size based on the assumption: \nUsing a two-tailed z-test of proportions/chi-square test with 80% power, a 5% level of significance, and factoring in a 10% drop rate.", "answer": 84, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample size of 84 patients, 42 in each group, has been calculated as sufficient to detect a clinically important effect size difference of 29% in mRS good score at 3\u00c2\u00a0months between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aSAH patients using a two-tailed z-test of proportions/chi-square test with 80% power and a 5% level of significance. This 29% difference represents a 68% mRS good score at 3\u00c2\u00a0months among patients receiving albumin and 29% among patients receiving non-albumin group in a previously conducted observational study [14]. As per our institutional admission statistics, we expect 40 patients per year and this number will be sufficient to reach our sample size in 3\u00c2\u00a0years, factoring in a 10% drop rate.", "id": 2130, "split": "test"} +{"trial_id": "NCT06549985", "pmid": "40044193", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain: the Peer Empowered Endometriosis Pain Support (PEEPS) Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Endometriosis\n- Pelvic Pain\n\nStudy Armgroups:\n- {'label': 'Peer Empowered Endometriosis Pain Support (PEEPS)', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will receive PEEPS plus usual care. PEEPS is comprised of eight weekly two-hour sessions delivered to groups of 6-10 participants. The sessions provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Participants additionally receive peer and clinician support.', 'interventionNames': ['Behavioral: PEEPS']}\n- {'label': 'Education', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this arm will receive an educational handout providing the basics of endometriosis pathophysiology, diagnosis, and treatment plus usual care', 'interventionNames': ['Behavioral: Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PEEPS', 'description': 'Participants will participate in the PEEPS program in addition to usual care.', 'armGroupLabels': ['Peer Empowered Endometriosis Pain Support (PEEPS)']}\n- {'type': 'BEHAVIORAL', 'name': 'Education', 'description': 'Participants will receive an educational handout on endometriosis in addition to usual care.', 'armGroupLabels': ['Education']}\n\nPrimary Outcomes:\n- {'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS) pain interference Short Form (SF) 8a', 'description': 'Validated, 8-question survey that assesses pain interference in daily activities', 'timeFrame': 'Baseline, immediately after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a significance level (alpha) of 0.05 and a power of 90%. The US general population has a mean T-score of 50 and SD of 10. The null hypothesis is that there is no difference in change from baseline of T-score between PEEPS and education.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome is the change from baseline of PROMIS pain inference SF8a at programme completion. A standardised score (T-score) rescaled from the raw score will be used for the change from baseline of PROMIS pain inference in the sample size calculation. The US general population has a mean T-score of 50 and SD of 10. The null hypothesis is that there is no difference in change from baseline of T-score between PEEPS and education. Here, the effect size is defined as the difference of change from baseline T-score between two groups divided by its SD. Recommendations for pilot clinical trials suggest using 12\u00e2\u0080\u009370 participants.38 Enrolling 60, with 1:1 randomisation to PEEPS versus education, will reduce imprecision around the SD estimate and allow for sufficient participants in PEEPS to assess implementation context and implementation outcomes. This sample size will provide 90% power to test a T-score difference of 8 (effect size=0.8) with an alpha of 0.05. Given the effect sizes for the evidence-based components in PEEPS (up to 0.8) and the fact that components will likely synergise, finding this effect size is anticipated.", "id": 2131, "split": "test"} +{"trial_id": "NCT06553820", "pmid": "40114123", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of MediYoga on Quality of Sleep, Blood Pressure and Quality of Life Among Older People: a Randomized Controlled Study\n\nIncluded conditions:\n- Hypertension\n- Quality of Life\n- Quality of Sleep\n- Mental Health\n\nStudy Armgroups:\n- {'label': 'Intervention group I, yoga 20 minutes x2 pr week', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Intervention group I, Yoga 20 minutes x2 pr week']}\n- {'label': 'Intervention Group II, yoga 40 minutes pr week', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Intervention Group II, Yoga 40 minutes x2 pr week']}\n- {'label': 'Control group, no intervention', 'type': 'OTHER', 'description': 'standard of care', 'interventionNames': ['Other: Control Group, No intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention group I, Yoga 20 minutes x2 pr week', 'description': 'App-based MediYoga exercises, 20 minutes per session, twice a week for a total of 10 weeks.', 'armGroupLabels': ['Intervention group I, yoga 20 minutes x2 pr week']}\n- {'type': 'BEHAVIORAL', 'name': 'Intervention Group II, Yoga 40 minutes x2 pr week', 'description': 'App-based MediYoga exercises, 40 minutes per session, twice a week for a total of 10 weeks.', 'armGroupLabels': ['Intervention Group II, yoga 40 minutes pr week']}\n- {'type': 'OTHER', 'name': 'Control Group, No intervention', 'description': 'standard of care only', 'armGroupLabels': ['Control group, no intervention']}\n\nPrimary Outcomes:\n- {'measure': 'sleep quality', 'description': 'Patient reported sleep quality measured on the PSQI (Pittsburg Sleep Quality Index). Minimum value: 0 Maximum value: 21 Higher scores: Indicate worse sleep quality The PSQI assesses sleep quality by compiling responses to questions covering various aspects of sleep, such as sleep duration, sleep problems, and daytime fatigue.\\n\\nA total score of 5 or higher generally indicates poor sleep quality.\\n\\nBetween group change in baseline versus follow-up patient-reported sleep quality as assessed by the psqi questionnaire .', 'timeFrame': '10 weeks'}\n\nPlease estimate the sample size based on the assumption: \nUsing a power of 80%, alpha < 0.05, and an attrition rate of 50%. Considering multiple outcome variables, a design effect (X2) is applied.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on prior research including older adults testing mindfulness and meditation in primary care [32] and a clinically relevant difference of 4.4 points on PSQI [33] a sample size has been calculated. Using a power of 80% ad alpha\u00e2\u0080\u0089<\u00e2\u0080\u00890.05, a total of 60 participants (20 in each arm) is needed. Since adherence has been reported to be a challenge in comparable interventions where the patient must be physically active (like exercise training or yoga), we expect an attrition rate of 50% similar to such studies [34, 35]. Considering an attrition rate of 50% it woud mean including 30 in each arm. Considering multiple outcome variables measured in the study (sleep, BP, and quality of life) we consider the design effect (X2) which will mean including 60 participants in each arm, a total sample of 180 participants.", "id": 2132, "split": "test"} +{"trial_id": "NCT06558955", "pmid": "39633367", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries: A Randomized Controlled Trial\n\nIncluded conditions:\n- Dental Caries\n- Dental Caries in Children\n- Diet Habit\n\nStudy Armgroups:\n- {'label': 'Technology-enabled anticipatory guidance and peer support', 'type': 'EXPERIMENTAL', 'description': \"Participants (mothers) will join online parent empowerment sessions for about 4 times (around 3, 6, 12, and 18 months of child's age, around 45 - 60 minutes each), and receive additional information and push notifications via a mobile phone app.\", 'interventionNames': ['Behavioral: Technology-enabled anticipatory guidance and peer support']}\n- {'label': 'Conventional oral health education', 'type': 'ACTIVE_COMPARATOR', 'description': \"Participants (mothers) will receive child oral health information for about 4 times (around 3, 6, 12, and 18 months of child's age).\", 'interventionNames': ['Behavioral: Conventional health education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Technology-enabled anticipatory guidance and peer support', 'description': 'The intervention includes 4 online sessions led by an oral health therapist (OHT) or dentist, as well as push notifications and information delivered to participants via a mobile/web app.', 'armGroupLabels': ['Technology-enabled anticipatory guidance and peer support']}\n- {'type': 'BEHAVIORAL', 'name': 'Conventional health education', 'description': 'Participants on this arm will receive conventional child oral health education materials at 4 time points.', 'armGroupLabels': ['Conventional oral health education']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of early childhood caries', 'description': 'Number of new surfaces with coronal caries', 'timeFrame': '24 and 36 months of age for children'}\n\nPlease estimate the sample size based on the assumption: \n80% power for a 2-sided test at the 5% statistical significance level, with a 35% dropout rate.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n The sample size needed for this trial was calculated by using G*Power version 3.1.9.2 (Franz Faul, University of Kiel, Germany), based on the primary outcome (ECC in 3-year-old children). By assuming that the prevalence of ECC for 3-year-olds is 25.5% in the control group [5] and a 40% reduction in the intervention group (i.e., to 15%) would be of clinical significance, a sample size of 196 mother-child dyads in each group is required to achieve 80% power for a 2-sided test at the 5% statistical significance level. Allowing for a 35% dropout rate, 300 mother-child dyads will need to be recruited into each group (i.e., 600 for two groups).", "id": 2133, "split": "test"} +{"trial_id": "NCT06562244", "pmid": "39920046", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Family-focused Intervention Program to Foster Adolescent Mental Health and Well-being: Protocol for a Multi-country Cluster Randomized Factorial Trial (FLOURISH Phase 2)\n\nIncluded conditions:\n- Adolescent - Emotional Problem\n- Parent-Child Relations\n- Family Functioning\n- Well-Being, Psychological\n\nStudy Armgroups:\n- {'label': 'HAT On, Peer Support On, High Engagement', 'type': 'EXPERIMENTAL', 'description': 'HAT component: On - Two interactive sessions using UNICEF\\'s Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.\\n\\nPeer Support: On - Half-day workshop from UNICEF\\'s \"I Support My Friends\" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.\\n\\nEngagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).', 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)', 'Behavioral: Helping Adolescents Thrive comics', 'Behavioral: I Support My Friends']}\n- {'label': 'HAT On, Peer Support Off, High Engagement', 'type': 'EXPERIMENTAL', 'description': \"HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.\\n\\nPeer Support: Off\\n\\nEngagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).\", 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)', 'Behavioral: Helping Adolescents Thrive comics']}\n- {'label': 'HAT On, Peer Support On, Low Engagement', 'type': 'EXPERIMENTAL', 'description': 'HAT component: On - Two interactive sessions using UNICEF\\'s Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.\\n\\nPeer Support: On - Half-day workshop from UNICEF\\'s \"I Support My Friends\" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.\\n\\nEngagement booster: Low - Refreshments and certificates.', 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)', 'Behavioral: Helping Adolescents Thrive comics', 'Behavioral: I Support My Friends']}\n- {'label': 'HAT On, Peer Support Off, Low Engagement', 'type': 'EXPERIMENTAL', 'description': \"HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.\\n\\nPeer Support: Off\\n\\nEngagement booster: Low - Refreshments and certificates.\", 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)', 'Behavioral: Helping Adolescents Thrive comics']}\n- {'label': 'HAT Off, Peer Support On, High Engagement', 'type': 'EXPERIMENTAL', 'description': 'HAT component: Off\\n\\nPeer Support: On - Half-day workshop from UNICEF\\'s \"I Support My Friends\" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.\\n\\nEngagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).', 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)', 'Behavioral: I Support My Friends']}\n- {'label': 'HAT Off, Peer Support Off, High Engagement', 'type': 'EXPERIMENTAL', 'description': 'HAT component: Off\\n\\nPeer Support: Off\\n\\nEngagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).', 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)']}\n- {'label': 'HAT Off, Peer Support On, Low Engagement', 'type': 'EXPERIMENTAL', 'description': 'HAT component: Off\\n\\nPeer Support: On - Half-day workshop from UNICEF\\'s \"I Support My Friends\" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.\\n\\nEngagement booster: Low - Refreshments and certificates.', 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)', 'Behavioral: I Support My Friends']}\n- {'label': 'HAT Off, Peer Support Off, Low Engagement', 'type': 'EXPERIMENTAL', 'description': 'HAT component: Off\\n\\nPeer Support: Off\\n\\nEngagement booster: Low - Refreshments and certificates', 'interventionNames': ['Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Parenting for Lifelong Health for Parents and Teens (PLH)', 'description': 'The PLH program is the core intervention and will be delivered over 6 sessions with adolescents and caregivers, focusing on building positive parent-child relationships, problem-solving skills, stress management, effective limit-setting, and emotional regulation. There will also be a pre-program visit with the facilitator and families prior to the group sessions. Sessions will include both separate and joint activities between adolescents and caregivers. Engagement boosters will be provided during the PLH sessions and are part of the PLH intervention.', 'armGroupLabels': ['HAT Off, Peer Support Off, High Engagement', 'HAT Off, Peer Support Off, Low Engagement', 'HAT Off, Peer Support On, High Engagement', 'HAT Off, Peer Support On, Low Engagement', 'HAT On, Peer Support Off, High Engagement', 'HAT On, Peer Support Off, Low Engagement', 'HAT On, Peer Support On, High Engagement', 'HAT On, Peer Support On, Low Engagement']}\n- {'type': 'BEHAVIORAL', 'name': 'Helping Adolescents Thrive comics', 'description': \"UNICEF's Helping Adolescents Thrive (HAT) comics will be used to guide adolescents through content on improving relationships, handling conflict, understanding emotions, and problem solving. These sessions will be group-based and cover the content in the HAT manual with the adolescents in an interactive format.\", 'armGroupLabels': ['HAT On, Peer Support Off, High Engagement', 'HAT On, Peer Support Off, Low Engagement', 'HAT On, Peer Support On, High Engagement', 'HAT On, Peer Support On, Low Engagement']}\n- {'type': 'BEHAVIORAL', 'name': 'I Support My Friends', 'description': 'An adapted version of UNICEF\\'s \"I Support My Friends\" program will be provided to adolescents by a facilitator in a group-based workshop format over the course of 1 day.', 'armGroupLabels': ['HAT Off, Peer Support On, High Engagement', 'HAT Off, Peer Support On, Low Engagement', 'HAT On, Peer Support On, High Engagement', 'HAT On, Peer Support On, Low Engagement']}\n\nPrimary Outcomes:\n- {'measure': 'Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, \"internalizing subscale\"', 'description': 'The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.', 'timeFrame': 'Pre-assessment and 6 - 8 weeks after pre-assessment'}\n- {'measure': 'Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), \"emotional support subscale\", and Kidscreen-52, \"peer and social support subscale\"', 'description': \"The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The emotional support scale comprises 8 items. The Kidscreen-52, peers and social support subscale, includes 6 items with a response range from 1 (never) to 5 (always). This subscale assesses the quality of the child's relationships with peers and the support they receive from their social network.\", 'timeFrame': 'Pre-assessment and 6 - 8 weeks after pre-assessment'}\n- {'measure': 'Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale \"general functioning\"', 'description': 'The general functioning subscale is one of the dimensions of the FAD and will be completed by caregivers. This scale has also been used as a single indicator to assess family functioning. The general functioning scale is made up of 12 items with six items that reflect healthy family functioning and the other six items reflecting unhealthy functioning. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scoring for the negatively worded items reversed.', 'timeFrame': 'Pre-assessment and 6 - 8 weeks after pre-assessment'}\n- {'measure': 'Attendance rate', 'description': 'Attendance will be assessed as the percentage of group PLH sessions attended out of 6 (individual attendance for adolescents and caregivers)', 'timeFrame': 'During the implementation of the intervention (6 - 8 weeks)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha of 0.10, ICC=0.01, ICC of change scores=0.10", "answer": 640, "answer_type": "ESTIMATED", "explanation": "Sample size\n A power analysis was conducted to determine the sample size required for this study, using the \u00e2\u0080\u0098FactorialPowerPlan\u00e2\u0080\u0099 function within the R-package \u00e2\u0080\u0098MOST\u00e2\u0080\u0099.34 The study is designed as a factorial experiment with 3 factors and 64 clusters (eight conditions with four groups per condition per country). To detect a small effect with an 80% power and alpha of 0.10 (as recommended for factorial trials in MOST),35 considering a small amount of intraclass correlation (ICC) in the absence of intervention (ie, ICC=0.01) and low clustering of change scores (ICC of change scores=0.10), the sample size should include approximately 7 families per cluster, corresponding to 448 families. To consider drop-out after recruitment, it is estimated to recruit approximately 10\u00e2\u0080\u009312 families per cluster (640\u00e2\u0080\u0093768 families).", "id": 2134, "split": "test"} +{"trial_id": "NCT06562725", "pmid": "40010841", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study\n\nIncluded conditions:\n- Mechanical Ventilation Complication\n- Fiberoptic Bronchoscopy\n- Critical Illness\n- Acute Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'standard ventilator settings', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized in the control group \"standard ventilator settings\" will be left on the ventilator settings previously chosen by the attending physician, except Inspired Oxygen Fraction(FiO2) increased to 100%'}\n- {'label': 'specific ventilator settings', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized in the experimental group \"special ventilator settings\" will receive ventilator settings aimed at reducing airway pressure during FOB. This includes : inspiratory flow \\\\<25 L/min, tidal volume = 5 mL/Kg, inspiratory time = 1 sec, respiratory frequency \\\\<20c/min, PEEP = 5 cmH2O, and FiO2 = 100%', 'interventionNames': ['Other: specific ventilator settings']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'specific ventilator settings', 'description': 'The special ventilator settings used in the intervention group - aimed at reducing airway pressure - include inspiratory flow \\\\<25 L/min, tidal volume = 5m L/Kg, inspiratory time = 1 sec, respiratory frequency \\\\<20 c/min, PEEP = 5 cmH2O, and FiO2 = 100%', 'armGroupLabels': ['specific ventilator settings']}\n\nPrimary Outcomes:\n- {'measure': 'Determine if the use of specific ventilator settings facilitates the performance of fiberoptic bronchoscopy (FOB) during mechanical ventilation compared to conventional ventilator settings.', 'description': 'Occurrence of a serious adverse - ventilatory, respiratory, or circulatory - event prompting the procedure to be interrupted early in the first 5 minutes.', 'timeFrame': '5 minutes after bronchoscopy initiation'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 90%, an alpha risk of 0.05, and a two-sided two-sample test of proportions (Fisher's exact test). Additionally, it considers a 10% rate of encountering technical problems.", "answer": 46, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size\n The study\u00e2\u0080\u0099s main objective is to show that using specific ventilator settings facilitates the feasibility of FOB during MV. Considering that FOB will not be safely feasible in 60% of cases with conventional ventilator settings because of the occurrence of serious adverse events, a total sample size of at least 42 patients is needed to detect an absolute risk reduction of 50% in the occurrence of a serious adverse event during FOB between the conventional ventilator settings and the specific ventilator settings with a power of 90% and an alpha risk of 0.05 using a two-sided two-sample test of proportions (Fisher\u00e2\u0080\u0099s exact test). Considering the possibility of encountering technical problems in approximately 10% of cases, the number of subjects needed to be included is therefore increased to 46 patients in total or 23 patients in each of the two groups.\n Between-group comparisons for continuous variables will be assessed using Student\u00e2\u0080\u0099s t-test or Wilcoxon rank-sum test, as appropriate. Analysis of categorical data will be performed using the \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test. Statistical analysis for the primary outcome will be performed using the \u00cf\u00872 test. The statistician will be kept blinded from the patients group allocation, which will be designated by a letter in the data spreadsheet.", "id": 2135, "split": "test"} +{"trial_id": "NCT06567145", "pmid": "39891254", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessing the Effectiveness and Feasibility of Group-based Treatment for Self-stigma in People With Mental Disorders: a Pragmatic Multisite Randomized Controlled Trial in Routine Mental Health Services in North-east Italy\n\nIncluded conditions:\n- Stigma\n- Mental Disorders\n- Self-stigma\n\nStudy Armgroups:\n- {'label': 'Narrative Enhancement and Cognitive Therapy (NECT)', 'type': 'EXPERIMENTAL', 'description': 'Patients assigned to the experimental gropu will receive the Narrative Enhancement and Cognitive Therapy (NECT), a structured psychological intervention aimed at reducing self-stigma in individuals with severe mental illness. It was developed in early 2000s in the USA by Philip Yanos, David Roe and Paul Lysaker. Patients in the experimental group will also receive routine treatment typically provided within their usual care settings.', 'interventionNames': ['Behavioral: Narrative Enhancement Cognitive Therapy (NECT)']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients in the control group will continue to receive the routine treatment typically provided within their usual care settings, which usually includes pharmacological treatment + outpatient visits (for monitoring pharmacological treatment and symptom management) + (if needed) other psychosocial treatments (e.g., individual or group therapy, family psychoeducation, cognitive rehabilitation, job placements/supported employment).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Narrative Enhancement Cognitive Therapy (NECT)', 'description': 'The Narrative Enhancement and Cognitive Therapy (NECT) consists of 20 group sessions divided into five parts: orientation (2 sessions), psychoeducation on stigma (3 sessions), cognitive restructuring (7 sessions), narrative enhancement (7 sessions), and a concluding reflection (1 session). The program helps participants challenge self-stigmatizing beliefs, develop coping skills, and create a new, positive narrative about themselves. Each session lasts about an hour, with a structured format of introduction, main discussion, and conclusion, encouraging active participation and reflection on personal experiences. The intervention ultimately fosters self-efficacy, control, and hope for the future.', 'armGroupLabels': ['Narrative Enhancement and Cognitive Therapy (NECT)']}\n\nPrimary Outcomes:\n- {'measure': 'Differences in the level of self-stigma', 'description': 'The primary outcome of the study is the differences in the level of self-stigma (or internalized stigma) between the group receiving the NECT (Narrative Enhancement and Cognitive Therapy) intervention and the control group. These differences will be assessed using the total score from the ISMI (Internalized Stigma of Mental Illness) scale. The ISMI (Internalized Stigma of Mental Illness) scale is a 29-item self-report questionnaire used to measure self-stigma in individuals with mental illness. It includes five subscales: Alienation, Stereotype Endorsement, Discrimination Experience, Social Withdrawal, and Stigma Resistance. Higher scores indicate greater internalized stigma. The measurements will be taken at two time points: at baseline (T0) and at the end of the treatment (T1). The main objective is to observe the change in the total ISMI score over time, comparing the two groups to evaluate the effectiveness of the NECT intervention in reducing self-stigma.', 'timeFrame': 'From enrollment to the end of treatment at 20 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAlpha = 0.05, Power (1-Beta) = 0.80, and a 25% attrition rate.", "answer": 416, "answer_type": "ESTIMATED", "explanation": "Sample size\n The intervention NECT will be implemented at 26 CMHCs. Each center will recruit 16 patients for randomization who meet the inclusion and exclusion criteria, have screened positive, and have consented to participate. Thus, the total sample size will be 416 patients, with 208 per arm. The power analysis, conducted using G*Power 3.1.9.7, indicates that this sample size will be enough to detect a Cohen's d effect size of 0.27 for the total ISMI score (where d\u00e2\u0080\u0089=\u00e2\u0080\u00890.20 indicates a small effect and d\u00e2\u0080\u0089=\u00e2\u0080\u00890.50 indicates a medium effect), with alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 1-Beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.80. After considering a potential 25% attrition rate in both study arms (giving 156 patients each), the sample size will be enough to detect a Cohen's d effect size of 0.32. Two previous trials [16, 19] estimated a Cohen's d effect size of 0.37 and 0.50, respectively, for the total ISMI score, so it is predicted that the target sample size will be adequately powered to detect a change in the ISMI.", "id": 2136, "split": "test"} +{"trial_id": "NCT06572423", "pmid": "39709372", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)\n\nIncluded conditions:\n- Head and Neck Carcinoma\n- Localized Head and Neck Carcinoma\n- Metastatic Head and Neck Carcinoma\n- Recurrent Head and Neck Carcinoma\n\nStudy Armgroups:\n- {'label': 'Treatment (PULSAR and HyperArc)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo standard of care CT simulation for radiation treatment planning using HyperArc software. 1 week later, patients undergo PULSAR fraction therapy once daily on days 0, 14, 28, 42, and 56. Patients may also undergo Positron Emission Tomography (PET) scan and MRI during follow-up.', 'interventionNames': ['Procedure: Personalized ultrafractionated stereotactic adaptive radiotherapy', 'Radiation: Volume Modulated Arc Therapy', 'Procedure: Computed Tomography', 'Procedure: Positron Emission Tomography', 'Procedure: Magnetic Resonance Imaging', 'Other: Best Practice', 'Behavioral: University of Washington Quality of Life Scale, Version 4', 'Behavioral: Functional Assessment of Cancer Therapy-Head & Neck']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Personalized ultrafractionated stereotactic adaptive radiotherapy', 'description': 'PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment.', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['PULSAR']}\n- {'type': 'RADIATION', 'name': 'Volume Modulated Arc Therapy', 'description': 'Use HyperArc technology', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['VMAT', 'Volumetric Modulated Arc Therapy']}\n- {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT simulation for radiation planning', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'CT', 'CT Scan']}\n- {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography', 'description': 'Undergo PET', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['Medical Imaging', 'PET', 'PET Scan', 'proton magnetic resonance spectroscopic imaging']}\n- {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['Magnetic Resonance', 'MRI']}\n- {'type': 'OTHER', 'name': 'Best Practice', 'description': 'Undergo standard of care', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['standard of care']}\n- {'type': 'BEHAVIORAL', 'name': 'University of Washington Quality of Life Scale, Version 4', 'description': 'Complete questionnaire', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['UW QOL v4']}\n- {'type': 'BEHAVIORAL', 'name': 'Functional Assessment of Cancer Therapy-Head & Neck', 'description': 'Complete questionnaire', 'armGroupLabels': ['Treatment (PULSAR and HyperArc)'], 'otherNames': ['FACT Head and Neck Questionnaire', 'FACT-H&N Questionnaire']}\n\nPrimary Outcomes:\n- {'measure': 'Time to progression of the treated tumor target', 'description': 'Progression of the treated tumor target will be determined clinically and/or radiographically as applicable. Time to progression of the treated tumor target will be reported descriptively for each patient. One-year treated tumor target progression free survival will be estimated by the Kaplan-Meier method, descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), and will consider the competing risk of death.', 'timeFrame': 'From baseline up to 1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on achieving 80% power to detect a 20% difference in the 1 year local control rate, using a two-sided one-sample exact binomial test at a 0.05 significance level. The target sample size accounts for potential ineligibility/dropout.", "answer": 43, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Prospective data of SBRT for unresectable head and neck cancer has demonstrated 1 year local control rates of 60% in the re-irradiation setting [20]. In the de novo setting, prospective data are limited and primarily consist of SBRT for early-stage glottis cancer, though in small, retrospective series predominantly for palliative purposes and/or for patients who are not candidates for standard of care definitive therapy, the reported 1 year local control rates range from 69\u00e2\u0080\u009387% [21]. However, in the palliative setting or patients unfit for definitive therapy, a variety of other radiation regimens are often used, such as the \u00e2\u0080\u009cQuad-Shot\u00e2\u0080\u009d regimen, which generally have lower and/or less durable local control rates [23\u00e2\u0080\u009325]. From these data, we estimate the historic control group 1 year local control rate to be 65%.\n For the study group, unpublished analysis of a recently closed phase II trial at UCLA of dose-escalated SBRT to 55 Gray for treatment of previously radiated, recurrent head and neck cancer demonstrated a 1 year local control rate of 85% (NCT 03892720). We therefore hypothesize that patients enrolled in this trial will have a similar 1 year local control rate. A sample size of 38 patients will achieve 80% power to detect a 20% difference in the 1 year local control rate between PULSAR (85%) and historic control (65%), using a two-sided one-sample exact binomial test, at 0.05 significance level. Considering that some patients may become ineligible/drop out after enrollment, the target sample size is determined to be at least 43 patients. The 15 patients in the safety lead-in portion will be included in the sample should the study proceed past this portion.", "id": 2137, "split": "test"} +{"trial_id": "NCT06582316", "pmid": "40132849", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Digital Solution for Salutogenic Brain Health (DiSaB): a Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation\n\nIncluded conditions:\n- Chronic Condition\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'EXPERIMENTAL', 'description': 'Participants will undergo 8 sessions of digital \"Train Your Brain\" programme lead by a trained clinical neuropsychologist over 2 months.', 'interventionNames': ['Other: Brain Health Training Programme']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'Participants will not undergo any sessions of digital \"Train Your Brain\" programme for 2 months when intervention arm\\'s brain health training programme is ongoing.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Brain Health Training Programme', 'description': '\"Train Your Brain (TYB)\" - group-based cognitive intervention programme for mild cognitive impairments. This programme equips participants with knowledge on cognition and brain health, provide cognitive coping strategies and boost their confidence and maintain independence in daily activities.', 'armGroupLabels': ['Intervention Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change in heart rate', 'description': 'Heart rate will be measured on-site', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 8/9)'}\n- {'measure': 'Change in lipid levels', 'description': 'Information will be obtained from patients\\\\' HealthHub/Health Buddy/OneNUHS or other health apps', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 8/9)'}\n- {'measure': 'Change in HbA1c levels', 'description': 'Information will be obtained from patients\\\\' HealthHub/Health Buddy/OneNUHS or other health apps', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in blood pressure', 'description': 'Blood pressure will be measured on-site', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in SDMT scores', 'description': 'Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in psychosocial health measured by DaSS-21', 'description': 'Depression, Anxiety and Stress Scale -21 item (DASS-21) Physical or online. There are 21 questions that are scored from 0 to 3, and the highest possible score is 63. Higher scores indicate poorer psychological health.', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in MoCA scores', 'description': 'Montreal Cognitive Assessment (MoCA). Total possible score is 30 (scoring is on the MoCA form itself), and a score of at least 26 indicates normal cognition. Higher scores indicate better cognition.', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in psychosocial health measured by EQ-5D-5L', 'description': 'EuroQol 5 Dimension 5 Level (EQ-5D-5L) Physical or online. Each question is scored from 1 to 5, with 1 indicating no problems in that dimension and 5 indicating total inability to perform in that dimension.', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in psychosocial health measured by AD8', 'description': \"Alzheimer's Disease-8 Component (AD8) Physical or online. There are a total of 8 questions asking about thinking ability, and each answer is coded 1 (yes, change present) or 0 (no change). 0 or 1 indicates normal cognition, and a score of at least 2 suggests that cognition issues might be present.\", 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Change in psychosocial health measured by Self-care of chronic illness inventory', 'description': 'Physical or online. 29 questions in total, answers are scored from 1 to 5. Higher scores indicate better self-care. When referencing standard scores, a standard score of 70 is the cut-off point for self-care adequacy.', 'timeFrame': 'Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 8/9)'}\n- {'measure': 'Patient satisfaction feedback questionnaire (patients)', 'description': 'Completed online', 'timeFrame': 'Weekly (right after each TYB intervention) for 2 months. Also after health education sessions: either once [individual session] OR monthly for 3 months [group session]; during months 4-6) - intervention arm non-responders only'}\n- {'measure': 'Feedback from patients using focus group interview', 'description': 'Questions are developed from RE-AIM model. Intervention arm participants will be randomly chosen (n=6) to take part in the focus group interview.', 'timeFrame': 'Final follow up (month 9-10)'}\n- {'measure': 'Barriers and facilitators questionnaire (nurses)', 'description': 'Completed online. The questionnaire will be administered multiple times throughout the study, at the specific time points as stated below.', 'timeFrame': 'Baseline (month 0), weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm OR months 4-6 for control arm), final follow up (month 8/9)'}\n- {'measure': 'Effectiveness of TYB intervention questionnaire (nurses)', 'description': 'Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.', 'timeFrame': 'Baseline (month 0), weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm OR months 4-6 for control arm), final follow up (month 8/9)'}\n- {'measure': 'Effectiveness of DiSaB intervention questionnaire (patients)', 'description': 'Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.', 'timeFrame': 'Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 8/9 for all participants)'}\n- {'measure': 'Feedback from nurses using focus group interview', 'description': 'Questions are developed from RE-AIM model', 'timeFrame': 'Month 3 for intervention arm OR 6 for control arm (immediately after completion of 2-month-long TYB intervention)'}\n\nPlease estimate the sample size based on the assumption: \nNo formal assumptions on significance level, power, or missing/dropout rate were made.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n As this is a pilot study, we did not complete a formal sample size calculation. Based on the study\u00e2\u0080\u0099s funding, resources and research sites available, this study will recruit a total of 160 participants across both the intervention and control arms.", "id": 2138, "split": "test"} +{"trial_id": "NCT06604988", "pmid": "40038736", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Video-feedback to Promote Positive Parenting in Families with Children At Risk of Autism Spectrum Disorder (ASD)\n\nIncluded conditions:\n- Autism Spectrum Disorder (ASD\n- Parental Behaviors\n\nStudy Armgroups:\n- {'label': 'Intervention group of videofeedback to promote positive parenting', 'type': 'EXPERIMENTAL', 'description': 'Biweekly sessions will be held for 6 months (a total of 12 sessions per family) via videoconference with the family at home. Each session will last approximately 1 hour to 1 hour and 30 minutes and will work with the primary caregiver. The intervention protocol mixes coaching strategies based on observation and video-feedback. This arm will provide with measurements at waves 0,1, and 2 over a time period of approximately 12 months.', 'interventionNames': ['Behavioral: Video-feedback intervention to promote positive parenting']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'This arm will only provide the measurements at the different time points (waves 0,1, and 2) over 12 months. After the follow-up planned in the study, feedback as well as recommendations concerning parenting will be provided.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Video-feedback intervention to promote positive parenting', 'description': 'Each session will focus on three parental behaviours (that support child development) that have appeared clearly, frequently and consistently in the video (PICCOLO score of 2) in any of the 4 dimensions (affection, responsiveness, encouragement, teaching). Other aspects of parental behaviours that have scored 1 or 0 on the PICCOLO will also be considered, to increase their frequency or encourage their appearance. It is to be expected that all the behaviours collected in PICCOLO appear in one or more of the recordings, even if only occasionally. Behaviours that do not appear can be introduced through linking strategies with other behaviours in which parents show strength (for example, if a caregiver tends to name objects a lot, a link can be established between naming and asking the child the name of objects, if questions are behaviour that does not appear in the logs).\\n\\nIn each session, the caregiver is shown video clips that clearly show the positive parenting behaviours.', 'armGroupLabels': ['Intervention group of videofeedback to promote positive parenting']}\n\nPrimary Outcomes:\n- {'measure': 'Parental anxiety', 'description': \"The Spanish version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms in children's caregivers. The HADS is a self-reporting screening questionnaire composed of 14 items (seven items concerning depression symptoms and seven for anxiety symptoms) scored on a Likert scale from 0 to 3 points. Scores higher than 7 points in the subscale of anxiety symptoms, would indicate a risk of suffering health problems due to the mental issue assessed.\", 'timeFrame': 'Pre-intervention, after six months of intervention, and follow-up six months later'}\n- {'measure': 'Parental depression', 'description': \"The Spanish version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess depression symptoms in children's caregivers. The HADS is a self-reporting screening questionnaire composed of 14 items (seven items concerning depression symptoms and seven for anxiety symptoms) scored on a Likert scale from 0 to 3 points. Scores higher than 7 points in the subscale of depression symptoms, would indicate a risk of suffering health problems due to the mental issue assessed.\", 'timeFrame': 'Pre-intervention, after six months of intervention, and follow-up six months later'}\n- {'measure': 'Parental stress', 'description': 'The Spanish version of the Parental Stress Scale (PSS) will be used to assess how caregivers perceive parental situations as stressful. This tool is composed of 12 items scored on a Likert scale, from 1 (total disagreement) to 5 (full agreement). The higher the score obtained, the higher the level of parental stress. Scores greater than or equal to 86 points would indicate a clinically significant parental stress score.', 'timeFrame': 'Pre-intervention, after six months of intervention, and follow-up six months later'}\n- {'measure': 'Parental behaviors ( Affection, Responsiveness, Encouragement, Teaching)', 'description': \"The Spanish version of the PICCOLO (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes) will be used to assess parental behaviors. It is a reliable and validated 29-item measure of parent-child interactions for parents with children aged between 10 and 47 months old. The items are scored according to their frequency as 0 (absent, not observed), 1 (rare, minor or emerging) and 2 (clear, definitive, strong and frequent). The items are grouped into four domains: (a) Affection (7 items), which involves the physical and verbal expression of affection; (b) Responsiveness (7 items), which includes reacting sensitively to a child's cues and expressions; (c) Encouragement (7 items), which considers the parents' support of their child's efforts; and (d) Teaching (8 items), which includes cognitive stimulation, joint attention, and shared play. This tool has a total score between 0 and 58. Scores equal to or less than 40 points would indicate a low parenting score\", 'timeFrame': 'Pre-intervention, after six months of intervention, and follow-up six months later'}\n- {'measure': 'Family Quality of Life', 'description': 'The Families in Early Intervention Quality of Life (FEIQoL) in its Spanish version will be used. The FEIQoL asks families to rate 39 FQoL features (i.e., items) on a 5-point rating scale from 1 = poor to 5 = excellent. The FEIQoL is comprised of four factors: family relationships, access to information and services, overall life situation, and child functioning. The minimum score on the scale is 39 points and the maximum score that can be obtained is 195 points. The higher the score obtained, the higher the level of Family Quality of Life. The scale shows a high internal consistency for the total score (\u03b1 = .94) and its factors ranged from \u03b1 = .74 to \u03b1 = .89.', 'timeFrame': 'Pre-intervention, after six months of intervention, and follow-up six months later'}\n- {'measure': 'Parental self-efficacy', 'description': 'The Spanish version of the Parental Sense of Competence Scale (PSOC) will be administered to assess parental self-efficacy. The PSOC is a 17-item self-report scale that measures perceived parental self-efficacy. Responses are scored on a 6 point likert scale (from strongly disagree (1) to strongly agree (6)). The minimum score on the scale is 17 points and the maximum score that can be obtained is 102 points. Scores on the PSOC are transformed into three scores, a total score and a score for value/conforting dimension and the dimension of skills/conforting. The higher the score obtained, the higher the level of parental self-efficacy. The internal consistency coefficient was 0.85 for the total scale, and 0.78 and 0.85 for the two dimensions respectively.', 'timeFrame': 'Pre-intervention, after six months of intervention, and follow-up six months later'}\n- {'measure': 'Quality of intervention with caregivers', 'description': 'To examine the quality of this highly individualized VFI process carried out with caregivers, four scales domains (relationship building with families, responsiveness to family strengths, facilitation of caregiver-child interaction, and collaboration with caregivers) of the Home Visit Rating Scale, version 3 (HOVRS-3) will be used.\\n\\nHOVRS-3 is structured in a list format, with each scale listing four to seven descriptive items, and each item followed by four quality indicators-1 (needs support), 3 (adequate), 5 (good), and 7 (excellent)-formatted similarly to multiple-choice test items. When the HOVRS-3 home-visit quality scores were higher, means a better quality of home visiting and it is related to parenting scores and children development. The scale demonstrated high values of validity and reliability (alphas between 0.69 to 0.91 depending on subscales) and adequate predictive validity.', 'timeFrame': 'Intervention period'}\n- {'measure': 'Family satisfaction with the intervention', 'description': \"To evaluate family satisfaction with the intervention, we will use the Spanish version of the Client Satisfaction Questionnaire (CSQ-8). It is a short questionnaire of 8 items with a likert-type response range from 1 to 4. It includes two open questions regarding the most valued aspects of the intervention and those that should be improved. The minimum score on the questionnaire is 8 points and the maximum score that can be obtained is 32 points. The higher the score obtained, the higher the level of satisfaction with the intervention. The original tool presented an adequate internal consistency, obtaining an alpha of 0.93. To add greater validity and to be able to obtain data on caregivers' perceptions of the quality of their working relationship with the VFI intervenor, we will use the Spanish version of the Working Alliance Inventory Adapted to Home Visiting - Short Revised (WAI -SR-HV).\", 'timeFrame': 'After six months of intervention'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 90%, alpha risk of 0.05, and a 20% loss throughout the longitudinal study.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n A power analysis has been carried out considering possible differences in the primary response variables after completing the intervention. Taking as reference the effects found in this type of interventions based on the improvement of parental relationships [9,\u00c2\u00a0123], various scenarios have been simulated, calculating the sample sizes necessary for separate contrasts. In this sense, those results obtained in intermediate situations (i.e. conservative) have been considered in relation to the effect sizes and the desired statistical power. Specifically, to detect moderate effect sizes (e.g. standardized differences between groups around 0.5 in the primary variables), with a statistical power of 90% and an alpha risk of 0.05, 25 families will be necessary in each group. Assuming a 20% loss throughout the longitudinal study, the total sample required will be 60 families.", "id": 2139, "split": "test"} +{"trial_id": "NCT06615765", "pmid": "40021194", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis\n\nIncluded conditions:\n- Ulcerative Colitis\n\nStudy Armgroups:\n- {'label': 'Acupuncture group', 'type': 'EXPERIMENTAL', 'description': 'Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm \u00d7 40 mm and 0.3 mm \u00d7 75 mm). Each session has two phases:\\n\\nSupine Position:\\n\\nNeedles (0.35 mm \u00d7 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer.\\n\\nNeedles (0.30 mm \u00d7 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA.\\n\\nProne Position:\\n\\nNeedles are inserted into BL32, BL33, and BL35 with precise angles and depths. EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.', 'interventionNames': ['Other: Acupuncture']}\n- {'label': 'Sham acupuncture group', 'type': 'SHAM_COMPARATOR', 'description': 'Sterile, disposable stainless-steel needles (0.30 mm \u00d7 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.', 'interventionNames': ['Other: Sham acupuncture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Acupuncture', 'description': 'Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm \u00d7 40 mm and 0.3 mm \u00d7 75 mm). Each session has two phases:\\n\\nSupine Position:\\n\\n* Needles (0.35 mm \u00d7 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer.\\n* Needles (0.30 mm \u00d7 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6.\\n* Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA.\\n\\nProne Position:\\n\\n* Needles are inserted into BL32, BL33, and BL35 with precise angles and depths.\\n* EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.', 'armGroupLabels': ['Acupuncture group']}\n- {'type': 'OTHER', 'name': 'Sham acupuncture', 'description': 'Sterile, disposable stainless-steel needles (0.30 mm \u00d7 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.', 'armGroupLabels': ['Sham acupuncture group']}\n\nPrimary Outcomes:\n- {'measure': 'change from baseline in the PRO2 score', 'description': 'Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). The primary outcome is the change from baseline in the PRO2 score at week 8.', 'timeFrame': 'Week 8 after randomization'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided significance level of 0.05, and an anticipated 20% loss to follow-up.", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on previous research64 65 and clinical experience, we estimate a mean difference of 1.50 in the change from baseline in PRO2 between groups, with a standard deviation (SD) of 1.85. To achieve 80% power with a two-sided significance level of 0.05, a sample size of 25 patients per group is required to detect statistically significant differences. To account for an anticipated 20% loss to follow-up, the sample size was adjusted to 32 patients per group. Thus, we plan to recruit a total of 64 patients.", "id": 2140, "split": "test"} +{"trial_id": "NCT06645587", "pmid": "40001028", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation\n\nIncluded conditions:\n- Autism Spectrum Disorder\n\nStudy Armgroups:\n- {'label': 'Arm Pre-SMA', 'type': 'ACTIVE_COMPARATOR', 'description': \"Active cathodal HD-tDCS over pre-SMA cortex. For HD-tDCS a 4 \u00d7 1 montage, small circular electrodes (diameter 1 cm) will be used with the cathode placed centrally over Fz with a current intensity of 0.5 mA for a total of 20 minutes (30 s ramp up/down).\\n\\nFor the electrodes' placement, the investigators will follow the recommended guidelines for children.\", 'interventionNames': ['Device: Active HD-tDCS over pre-SMA']}\n- {'label': 'Arm left-dlPFC', 'type': 'ACTIVE_COMPARATOR', 'description': \"Active cathodal HD-tDCS over left dlPFC cortex. For HD-tDCS a 4 \u00d7 1 montage, small circular electrodes (diameter 1 cm) will be used with the cathode placed centrally over F3 with a current intensity of 0.5 mA for a total of 20 minutes (30 s ramp up/down).\\n\\nFor the electrodes' placement, the investigators will follow the recommended guidelines for children.\", 'interventionNames': ['Device: Active HD-tDCS over left DLPFC']}\n- {'label': 'Arm Sham', 'type': 'SHAM_COMPARATOR', 'description': 'Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness.', 'interventionNames': ['Device: Sham HD-tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active HD-tDCS over pre-SMA', 'description': 'Active cathodal HD-tDCS over pre-SMA cortex will be delivered for 10 days (3 sessions per week). The 4 \u00d7 1 montage using small circular electrodes (diameter 1 cm) will be applied with the cathode placed centrally over Fz. The current intensity will be set at 0.5 mA for a total of 20 minutes (30 s ramp up/down).', 'armGroupLabels': ['Arm Pre-SMA']}\n- {'type': 'DEVICE', 'name': 'Active HD-tDCS over left DLPFC', 'description': 'Active cathodal HD-tDCS over left DLPFC cortex will be delivered for 10 days (3 sessions per week). The 4 \u00d7 1 montage using small circular electrodes (diameter 1 cm) will be applied with the cathode placed centrally over F3. The current intensity will be set at 0.5 mA for a total of 20 minutes (30 s ramp up/down).', 'armGroupLabels': ['Arm left-dlPFC']}\n- {'type': 'DEVICE', 'name': 'Sham HD-tDCS', 'description': 'Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex for 10 days (3 sessions per week). The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness. Each Sham session will last 20 minutes.', 'armGroupLabels': ['Arm Sham']}\n\nPrimary Outcomes:\n- {'measure': 'Repetitive Behavior Scale-Revised', 'description': 'The primary outcome measure will be the Total Score of the Repetitive Behavior Scale-Revised (Bodfish, 2000). It consists of a 43-item parent-report questionnaire evaluating the extent of RBs in individuals with ASD. The tool encompasses six scales: Stereotyped Behavior (6 items), Self-injurious Behavior (8 items), Compulsive Behavior (8 items), Routine Behavior (6 items), Sameness Behavior (11 items), and Restricted Behavior (4 items). The items are rated on a four-point scale (0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem); an overall total raw score and a total number of items score for each subscale are computed. Higher scores indicate greater severity of repetitive behaviors. The sum of all items provides a total raw score ranging from 0 to 129, with higher scores indicating more severe repetitive behaviors.', 'timeFrame': 'Baseline, pre-intervention; immediately after the intervention; three-month follow-up.'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value was set at 0.05 (5% probability of false positives), power was set at 80% (\u03b2 = 0.20), and a 30% dropout rate was considered.", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n The sample size was calculated by a priori analysis in G * Power, version 3.1.9.7 (The G*Power Team, D\u00c3\u00bcsseldorf, Germany). To be conservative, we calculated the expected effect size (f) to low and estimated it at 0.20 basing on previous literature [54, 66]. With an estimated f\u00e2\u0080\u0089=\u00e2\u0080\u00890.20, alpha value\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (i.e., probability of false positives of 5%), and \u00c3\u009f = 0.20 (i.e., at least 80% power), the sample size that was required for repeated-measures analysis of variance (RM ANOVA) with 2 groups (Frontal Active Group\u00e2\u0080\u0089+\u00e2\u0080\u0089Pre-Motor Active Group vs. Sham Group) and 2 measurements (Time: T0 vs. T1) was 54 (i.e., 18 per group). Considering a 30% dropout rate in the follow-ups, we will plan to recruit a total of 78 participants (i.e., 26 per group).", "id": 2141, "split": "test"} +{"trial_id": "NCT06672562", "pmid": "40010812", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Pilot Basket Trial of Discovering Our Best Selves: Narrative Enhancement and Cognitive Therapy for Self-stigma Among Youth\n\nIncluded conditions:\n- Bipolar Disorder\n- Multiple Mental Health Conditions\n\nStudy Armgroups:\n- {'label': 'NECT-Y', 'type': 'EXPERIMENTAL', 'description': 'Virtual 14-week Narrative Enhancement and Cognitive Therapy group intervention that will be co-facilitated by a clinician and peer support worker.', 'interventionNames': ['Behavioral: Narrative Enhancement and Cognitive Therapy']}\n- {'label': 'Treatment as usual', 'type': 'PLACEBO_COMPARATOR', 'description': 'No study-specific care will be provided to these participants.', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Narrative Enhancement and Cognitive Therapy', 'description': 'NECT-Y consists of 14 90-minute sessions over the course of 14 weeks. The intervention combines psychoeducation, cognitive therapy, narrative therapy, goal-setting and peer support. Each group meeting includes educational materials, reflections, and active exercises that participants are guided through to personalize the content to their experiences. Participants will be provided with a workbook which allows them to follow the activities easier.', 'armGroupLabels': ['NECT-Y']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Standard usual care. No study-specific care, but participants will be provided with information on community resources and support, and will also be encouraged to speak to their clinician if they are interested in learning about other services.', 'armGroupLabels': ['Treatment as usual']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants Providing Consent to Participate in the Study', 'description': 'Our study target is \\\\> 60% of individuals approached/contacted will consent to participate in the study.', 'timeFrame': 'Duration of the study enrollment period, up to 1 year'}\n- {'measure': 'Number of Participants Providing Consent in Two Months', 'description': 'The study target is to obtain study consent from 24 participants in two months.', 'timeFrame': 'Duration of the study enrollment period, up to 1 year'}\n- {'measure': 'Number of Sessions Attended by Participants Randomized to NECT-Y', 'description': 'The study target is that participants randomized to NECT-Y attend \\\\> 80% of the 14 sessions.', 'timeFrame': 'From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks'}\n- {'measure': 'Number of Participants Completing Study Questionnaires at Week 15', 'description': 'The study target is \\\\> 80% of the participants complete at least one questionnaire at post-treatment (week 15).', 'timeFrame': 'Week 15 (post-treatment)'}\n- {'measure': 'Number of Participants Completing Study Questionnaires at Week 28', 'description': 'The study target is \\\\> 80% of the participants complete at least one questionnaire at 3-month follow up (week 28).', 'timeFrame': 'Week 28 (3-month follow up)'}\n- {'measure': 'Number of Questionnaires Completed at Week 15', 'description': 'The study target is participants complete \\\\> 90% of the 14 questionnaires at post-treatment (week 15).', 'timeFrame': 'Week 15 (post-treatment)'}\n- {'measure': 'Number of Questionnaires Completed at Week 28', 'description': 'The study target is participants complete \\\\> 90% of the 14 questionnaires at 3-month follow up (week 28).', 'timeFrame': 'Week 28 (3-month follow up)'}\n- {'measure': 'Number of Participants With Study-Related Adverse Events as Assessed by an Institutional Adverse Event Log', 'description': 'The study target is for their to be no adverse events throughout a participants enrollment in the study, including no AEs from participating in the NECT-Y intervention. AEs will be tracked ad hoc as participants self-report any AEs.', 'timeFrame': 'From study enrollment to 3-month follow up, up to 28 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a recruitment success rate of 60%, generating a 95% CI of 0.520 to 0.677. The CI width for feasibility metrics is not expected to exceed 0.168. The significance level and power are not explicitly mentioned.", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is determined based on the desired precision of the estimated feasibility measures as the primary objective of the pilot trial, as recommended by the Consolidated Standards of Reporting Trials extension.44\nTable 2 below illustrates the sample size calculations for each feasibility metric. The sample size is n=96 across two baskets and two arms (24 per basket per arm). This equates to four rounds of NECT-Y, at about 12 participants per group, with the same number of control participants. A recruitment success of 60% means that 96 participants will be recruited out of 160 approached, which generates a 95%\u00e2\u0080\u0089CI of 0.520 to 0.677. Across all four feasibility metrics, the CI width is not expected to exceed 0.168, which is sufficiently narrow to be confident in our estimates of feasibility. This pilot/feasibility trial is intentionally not powered to detect statistically significant differences between arms on clinical outcome measures. Interpretations will therefore be secondary in nature and will focus on estimating between-group effect sizes (with 95% CIs).\n \n Table 2\n \n Estimated Clopper-Pearson 95% CIs for feasibility metrics\n \n \n \n \n Feasibility metric\n Target success rate\n Expected 95%\u00e2\u0080\u0089CI\n \n \n \n \n Recruitment success\n n=96/160 (60%)\n (52.0%, 67.7%)\n \n \n Treatment retention\n n=77/96 (80%)\n (70.8%, 87.6%)\n \n \n Study retention\n n=77/96 (80%)\n (70.8%, 87.6%)\n \n \n Study compliance\n n=86/96 (90%)\n (81.7%, 94.9%)", "id": 2142, "split": "test"}