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<\|newrecord\|> nctId: NCT06289647 id: 19-28923B id: 5UG1EY030833 type: NIH link: https://reporter.nih.gov/quickSearch/5UG1EY030833 briefTitle: Azithromycin Reduction to Reach Elimination of Trachoma B acronym: ARRET overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2029-08-31 date: 2029-08-31 date: 2024-03-04 date: 2024-03-04 name: University of California, San Francisco class: OTHER name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo name: National Eye Institute (NEI) briefSummary: The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution. conditions: Trachoma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double (Investigator, Outcomes Assessor) whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100000 type: ESTIMATED name: Azithromycin measure: Ocular chlamydia measured in a population-based sample of 0-9 year-old children measure: Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia measure: Conjunctival inflammation sex: ALL minimumAge: 1 Month maximumAge: 9 Years stdAges: CHILD facility: University of California, San Francisco city: Kindu state: Maniema country: Congo, The Democratic Republic of the lat: -2.94373 lon: 25.92237 hasResults: False
<\|newrecord\|> nctId: NCT06289634 id: Pending briefTitle: The Influence of Sound on Stress, Anxiety, and Mood overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-04 date: 2024-03-04 name: Medgar Evers College, The City University of New York class: OTHER briefSummary: Multiple studies have highlighted music's ability to evoke diverse emotional states. Past research reveals that factors like musical elements, and the environment impact how people respond emotionally to music. For instance, faster tempos tend to heighten arousal, while minor key compositions evoke more arousal compared to major key compositions. In efforts to induce specific emotions post-stress, the research found that both pleasant and sad music aided stress recovery. Similarly, other researchers noted that positively rated music was more effective in reducing stress than negatively rated music, especially low arousal compositions over high arousal ones. Several studies focused on applying music to reduce stress and anxiety. In addition to man-made musical tones, the positive impact of natural surroundings on emotional state has been widely explored. A psycho-evolutionary viewpoint was offered, suggesting that humans have evolved in natural settings, making us inherently attuned to them physically and psychologically. A non-threatening natural environment, rich in aesthetically pleasing elements like visible escape routes, greenery, and water, tends to reduce stress and generate interest. In this study, the researchers are exploring how different sounds-man-made instrumental music versus natural sounds-affect stress, anxiety, and mood among the students of Medgar Evers College. Using an experimental approach, the researchers will assess pretest stress levels (via the perceived stress scale (PSS), anxiety (generalized anxiety disorder (GAD-7), and mood (four-dimensional mood scale (4DMS) among a sample of students. After randomly dividing them into two groups, each group will listen to one of the designated sounds (man-made music or nature sounds) for 30 minutes daily over 15 days. The researchers will then have them retake the stress, anxiety, and mood scales for post-test comparison. Statistical analysis (mixed ANOVA) will help to compare scores within and between groups. Ultimately, this study aims to determine the influence of tonal input on stress and anxiety levels among students, crucial given the significant stress they often experience. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Man-made sounds name: Natural sounds measure: Stress measure: Anxiety measure: Mood sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289621 id: 2024P000420 id: K01TW012180 type: NIH link: https://reporter.nih.gov/quickSearch/K01TW012180 briefTitle: Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-31 date: 2026-12-31 date: 2024-03-04 date: 2024-03-15 name: Massachusetts General Hospital class: OTHER name: University of Stellenbosch name: Fogarty International Center of the National Institute of Health name: Harvard Medical School (HMS and HSDM) briefSummary: The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group. conditions: Anxiety Disorders conditions: Post-traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Type 1 hybrid-effectiveness implementation trial. Study participants are randomized into the brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) or an enhanced standard care control group. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: False Safety Behavioral Elimination Treatment (FSET) name: Enhanced Standard Care measure: Structured Clinical Interview for the DSM-5 (SCID-5) measure: Clinician-Administered PTSD Scale for the DSM-5 (CAPS) measure: Work Social Adjustment Scale (WSAS) measure: General Anxiety Disorder-7 (GAD-7) measure: Beck Anxiety Inventory (BAI) measure: Safety Aid Scale (SAS) measure: Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5) measure: Patient Health Questionnaire - 9 (PHQ-9) measure: Beck Depression Inventory (BDI) measure: Anxiety Sensitivity Index -3 measure: Life Events Checklist (LEC) measure: Alcohol Use Disorders Identification Test (AUDIT) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289608 id: ID_2024 briefTitle: Bruxism and Underlying Psichological Factors overallStatus: RECRUITING date: 2023-02-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-04 date: 2024-03-04 name: University of Salamanca class: OTHER briefSummary: The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory. conditions: Bruxism conditions: Muscular Disorders, Atrophic conditions: Temporomandibular Joint Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: No intervention measure: Depression Level measure: Stress Level measure: Anxiety sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Odontológica de la Universidad de Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: JAVIER MONTERO, DDS role: CONTACT phone: 619429971 email: javimont@usal.es lat: 40.96882 lon: -5.66388 hasResults: False
<\|newrecord\|> nctId: NCT06289595 id: Pro00134382 briefTitle: Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment overallStatus: COMPLETED date: 2023-10-03 date: 2024-02-20 date: 2024-02-20 date: 2024-03-04 date: 2024-03-04 name: PBM Healing International Limited class: INDUSTRY briefSummary: Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain. conditions: Orthodontic conditions: Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 32 type: ACTUAL name: PBM Ortho device measure: Level of Pain sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bio Dental Clinic Ashiya city: Ashiya country: Japan lat: 34.72807 lon: 135.30264 facility: Sawa Dental Clinic city: Kasugai country: Japan lat: 35.24762 lon: 136.97229 facility: Soejima Dental Clinic city: Kitakyushu country: Japan lat: 33.85181 lon: 130.85034 facility: Higashimachigran Dental Clinic city: Kumamoto country: Japan lat: 32.80589 lon: 130.69182 facility: Tsujimura Dental Clinic city: Tanabe country: Japan lat: 33.73333 lon: 135.36667 facility: IXI Family Dental Clinic city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Miki Dental Clinic city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 hasResults: False
<\|newrecord\|> nctId: NCT06289582 id: R24-004 briefTitle: Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-03-04 date: 2024-03-04 name: University of Alabama at Birmingham class: OTHER name: Michael J. Fox Foundation for Parkinson's Research briefSummary: The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval.
Primary Objectives
* To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers.
* To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.
Secondary Objectives
* To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes.
* To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes
* To acquire safety data following injection of \[18F\]DPA-714 conditions: Parkinson Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: [F-18]DPA714 administration IV measure: Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UAB city: Birmingham state: Alabama zip: 35294 country: United States name: Evan Hudson, BS role: CONTACT phone: 205-934-6499 email: evanhudson@uabmc.edu name: Jonathan McConathy, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06289569 id: PRO00037243 briefTitle: Home Tele Rehabilitation Therapy for Vascular Dementia overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2026-03-14 date: 2026-04-01 date: 2024-03-04 date: 2024-03-04 name: The Methodist Hospital Research Institute class: OTHER briefSummary: To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD) conditions: Dementia, Vascular conditions: Stroke Sequelae studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE maskingDescription: Self-report measures will be not blinded, assessors will be blinded to treatment phase (SOC or telerehabilitation) count: 120 type: ESTIMATED name: Home telerehabilitation therapy measure: Burden Scale for Family Caregivers measure: Adverse events measure: Fugl-Meyer Upper extremity assessment measure: Wolf Motor Function Test (WMFT) measure: Exercise log measure: Stroke Impact Scale sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289556 id: TEMP0001 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-04 date: 2024-03-20 name: [Redacted] hasResults: False
<\|newrecord\|> nctId: NCT06289543 id: BVU-ESTELOGLU briefTitle: Preoperative Oral Carbohydrate on Gastric Emptying overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-01 date: 2024-04-15 date: 2024-03-04 date: 2024-03-04 name: Bezmialem Vakif University class: OTHER briefSummary: The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa. conditions: Vomit Aspiration conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Preoperative carbohydrate solution measure: Gastric volume measure: preoperative anxiety measure: postoperative nausea and vomiting measure: thirst, hunger, fatigue, dry mouth measure: Postoperative Pain Score measure: postoperative insulin resistance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem University status: RECRUITING city: Istanbul state: Fatih country: Turkey name: Kazim Karaaslan role: CONTACT phone: +905055213865 email: kazimkaraslan@gmail.com lat: 41.01384 lon: 28.94966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-01 uploadDate: 2024-01-24T06:51 filename: Prot_SAP_000.pdf size: 439034 hasResults: False
<\|newrecord\|> nctId: NCT06289530 id: 2023XAGG0070-1 briefTitle: Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries acronym: CR-POPF overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-04 date: 2024-04-01 name: Peking Union Medical College Hospital class: OTHER briefSummary: This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:
1. What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?
2. What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries？
Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed. conditions: Postoperative Pancreatic Fistula studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Clinically relevant postoperative pancreatic fistula measure: Bile leakage measure: Chyle leak measure: Postpancreatectomy hemorrhage measure: Abdominal infection measure: Delayed gastric emptying sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: LING LAN, MD role: CONTACT email: lanling_1988@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06289517 id: 68Ga-Her2-affibody briefTitle: PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-30 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Peking University First Hospital class: OTHER briefSummary: This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors. conditions: Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 68Ga-Her2-affibody measure: The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer measure: The dosimetry of 68Ga-Her2-affibody measure: Quantitative evaluation of 68Ga-Her2-affibody measure: Correlation with pathological expression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital city: Beijing state: Beijing zip: 100034 country: China name: Lei Yin, Dr. role: CONTACT phone: +861083575252 email: jack-yin@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06289504 id: NN9838-4694 id: U1111-1295-4056 type: OTHER domain: World Health Organization (WHO) briefTitle: A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight overallStatus: RECRUITING date: 2024-02-27 date: 2024-11-16 date: 2024-11-16 date: 2024-03-04 date: 2024-03-19 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Atorvastatin name: Warfarin measure: AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state measure: AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state measure: Rac,0-168hours,Cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose measure: Rac,0-168hours,Sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose measure: AUC0-168hours, 4th dose Cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema measure: AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altasciences Company Inc. status: RECRUITING city: Mount-Royal state: Quebec zip: H3P 3P1 country: Canada lat: 45.51675 lon: -73.64918 hasResults: False
<\|newrecord\|> nctId: NCT06289491 id: 2024P000544 briefTitle: Randomized Trial of Hydrus Microstent Versus Goniotomy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2029-04 date: 2024-03-04 date: 2024-03-04 name: Massachusetts Eye and Ear Infirmary class: OTHER briefSummary: The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:
* How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
* How do the safety profiles of these three microinvasive glaucoma surgeries compare?
Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery. conditions: Glaucoma conditions: Glaucoma, Open-Angle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 243 type: ESTIMATED name: Hydrus Microstent name: Incisional goniotomy name: Excisional goniotomy measure: Intraocular pressure measure: Intraocular pressure-lowering medications measure: Surgical complications sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289478 id: 0151/67 briefTitle: Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Cementless Bipolar Hemiarthroplasty - a Randomized Controlled Trial acronym: TXA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-04 date: 2024-03-04 name: King Chulalongkorn Memorial Hospital class: OTHER briefSummary: The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:
* The efficacy in reducing blood transfusion for topical tranexamic acid administration
* The safety of tranexemic acid, topically used
As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.
Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion. conditions: Femoral Neck Fracture conditions: Bipolar Hemiarthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Topical tranexamic acid administration measure: Rate of blood transfusion measure: Volume of blood transfusion measure: Calculated blood loss measure: Any adverse events measure: In-hospital mortality sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine city: Bangkok zip: 10330 country: Thailand name: Kanyakorn Riewruja role: CONTACT phone: +66-95-864-4447 email: kanyakorn.riew@gmail.com name: Kanyakorn Riewruja, MD role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06289465 id: IstanbulBU briefTitle: Examination of Pain, Posture, Physical and Mental Status in Seasonal Hazelnut Workers overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-11-01 date: 2024-12-01 date: 2024-03-01 date: 2024-03-04 name: Istanbul Bilgi University class: OTHER briefSummary: The collection of hazelnuts grown in our country provides a great source of employment for local people and seasonal workers. However, geographical conditions in hazelnut growing areas, challenging variable weather conditions in August and insufficient number of workers create a disadvantageous environment for seasonal workers.
In this study, it was aimed to investigate the effects of working conditions on mental status, fatigue, pain severity and postures (posture disorders, developmental delays, etc.) of young adults working in Giresun during the hazelnut picking season in comparison with the group living in the same sociodemographic and cultural environment but not working as seasonal workers. conditions: Agricultural Workers' Diseases conditions: Posture conditions: Pain conditions: Depression conditions: Fatigue studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Observation measure: McGill Melzack Questionnaire measure: PhysioPrint Mobile Application measure: Checklist Individual Strength Questionnaire measure: Beck Depression Inventory sex: ALL minimumAge: 18 Years maximumAge: 34 Years stdAges: ADULT facility: Istanbul Bilgi University city: Istanbul zip: 34060 country: Turkey name: Furkan Çakır, M.Sc. role: CONTACT phone: 2123115432 phoneExt: +90 email: furkan.cakir@bilgi.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06289452 id: IVB102-101 briefTitle: Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis overallStatus: NOT_YET_RECRUITING date: 2024-03-06 date: 2025-12-31 date: 2029-12-31 date: 2024-03-01 date: 2024-03-01 name: InnoVec Biotherapeutics Inc. class: INDUSTRY name: Peking Union Medical College Hospital briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS. conditions: Retinoschisis conditions: Retinal Disease conditions: Retinal Degeneration conditions: Eye Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: IVB102 Injection name: IVB102 Injection name: IVB102 Injection measure: Incidence of DLTs measure: Incidence of AEs measure: Incidence of SAEs measure: Visual function measure: OCT imaging measure: ERG parameters sex: MALE minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100142 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06289439 id: 2024.05.25 briefTitle: Effect of Green Tea Supplementation in Older Adult Women acronym: GTAW overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-20 date: 2025-04-01 date: 2024-03-01 date: 2024-03-05 name: University of Valladolid class: OTHER name: Sanidad de Castilla y León name: Instituto de Neurociencia de Castillas y Leon briefSummary: Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea.
Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program.
Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2). conditions: Female conditions: Older Adults conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group placebo-controlled randomized clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Green tea (Camellia sinensis) 1000 mg as extract name: Placebo measure: Creatine kinase (CK) measure: Lactate dehydrogenase (LDH) measure: Myoglobin (Mb) measure: Alanine Aminotransferase (ALT) measure: Aspartate Aminotransferase (AST) measure: Interleukin 6 (IL-6) measure: C-reactive protein (PCR) measure: Testosterone measure: Cortisol measure: Miostatin (GDF8) measure: advanced oxidation protein products (AOPP) measure: lipid peroxidation (LPO) measure: Oxygen radical absorption (ORAC) measure: Total antioxidant status (TAS) measure: Total antioxidant capacity (TAC) measure: Short Physical Performance Battery (SPPB) measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF) sex: FEMALE minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences, University of Valladolid Soria Campus status: RECRUITING city: Soria zip: 42004 country: Spain name: Diego Fernández Lázaro, Vice Dean role: CONTACT phone: +34658073375 email: diego.fernandez.lazaro@uva.es lat: 41.76401 lon: -2.46883 hasResults: False
<\|newrecord\|> nctId: NCT06289426 id: KU3339 briefTitle: Online Yoga for Improving the Well-being of Desk-based Workers overallStatus: RECRUITING date: 2024-02-15 date: 2024-08-15 date: 2024-08-15 date: 2024-03-01 date: 2024-03-01 name: Kingston University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effectiveness of an 8-week online yoga intervention in improving the well-being and productivity of desk-based workers. The main questions it aims to answer are:
* How effective is an 8-week online yoga intervention in improving the well-being (mental and physical) and productivity (work engagement and job performance) of the yoga group compared with passive controls?
* Are there any differences in well-being and work-related measures between the yoga and control groups?
Participants in the yoga group will practice yoga three days a week for 8 weeks and will be compared with a wait-listed control group, which will continue with the usual routine for 8 weeks. Researchers will evaluate the impact of yoga on the well-being and productivity of desk-based workers. conditions: Perceived Stress conditions: Depression conditions: Anxiety conditions: Mindfulness conditions: Self-Compassion conditions: Compassion conditions: Work Engagement conditions: Productivity conditions: Heart Rate Variability conditions: Mental Wellbeing conditions: Musculoskeletal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Yoga measure: Perceived Stress Scale measure: PROMIS-Anxiety Short form measure: The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) measure: The Mindful Attention Awareness Scale (MAAS) measure: The Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) measure: Self-Compassion Scale Short Form (SCS-SF) measure: The Compassion Scale (CS) measure: Uterecht Work Engagment Scale-Short Form (UWES -9) measure: Work Ability Index (WAI) measure: Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10) measure: Heart Rate Variability (HRV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vipin Wadhen status: RECRUITING city: London zip: KT12EE country: United Kingdom name: VIPIN WADHEN, MPhil role: CONTACT phone: 07308468129 email: V.Wadhen@kingston.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06289413 id: KCHRRF_ADiPOSE_0027 briefTitle: Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study overallStatus: RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-03-01 date: 2024-03-01 name: Kansas City Heart Rhythm Research Foundation class: OTHER name: Kansas City Heart and Rhythm Institute, Overland Park, KS name: Bariatric and Metabolic Specialists, Overland Park, KS briefSummary: Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS. conditions: Autonomic Dysfunction conditions: Orthostatic Intolerance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 400 type: ESTIMATED name: Development of AD/OI after BS measure: To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66209 country: United States name: Donita Atkins role: CONTACT lat: 38.98223 lon: -94.67079 facility: Bariatric and Metabolic Specialists status: RECRUITING city: Overland Park state: Kansas zip: 66211 country: United States name: Nicole Fearing, MD role: CONTACT lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic status: RECRUITING city: Overland Park state: Kansas zip: 66211 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center status: RECRUITING city: Overland Park state: Kansas zip: 66215 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: datkins@kchrf.com name: Naga Venkata K. Pothineni role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center status: RECRUITING city: Independence state: Missouri zip: 64057 country: United States name: Donita Atkins role: CONTACT lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: Research Medical Center status: RECRUITING city: Kansas City state: Missouri zip: 64032 country: United States name: Donita Atkins role: CONTACT phone: 816-651-1969 email: Datkins@kchrf.com name: Naga Venkata K. Pothineni, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False
<\|newrecord\|> nctId: NCT06289400 id: KaratayUOAS briefTitle: Magnetic Field Application in Patellofemoral Pain Syndrome overallStatus: RECRUITING date: 2024-02-26 date: 2024-05-01 date: 2024-05-31 date: 2024-03-01 date: 2024-03-04 name: KTO Karatay University class: OTHER briefSummary: The purpose of this study is to examine the effect of magnetic field application used in the treatment of patellofemoral pain. conditions: Pain, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Magnetic field application name: Conventional treatment measure: Visual Analogue Scale (VAS) measure: 36-Item Short Form Survey (SF-36) measure: Manual Muscle Test measure: The Lower Extremity Functional Scale (LEFS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KTO Karatay University status: RECRUITING city: Konya country: Turkey name: Osman Karaca, PhD role: CONTACT phone: +90 444 1251 phoneExt: 7845 email: osmankaracaftr@gmail.com lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06289387 id: MMDEF001 briefTitle: Combining Gene Variants to Improve Risk Prediction for Metabolic (Dysfunction)- Associated Fatty Liver Disease and Its Progression to Cirrhosis in Indian Individuals With Type 2 Diabetes overallStatus: RECRUITING date: 2024-01-20 date: 2025-01-01 date: 2025-01-10 date: 2024-03-01 date: 2024-03-05 name: Medanta, The Medicity, India class: OTHER briefSummary: Type 2 diabetes and metabolic (dysfunction)-associated fatty liver disease (MAFLD) often exist together. The prevalence of MAFLD is about 15-30% in healthy people and around 60-70% in people with type 2 diabetes. Moreover, type 2 diabetes accelerates the progression of liver disease in MAFLD.
MAFLD is a spectrum of liver conditions, ranging from simple fatty liver (low risk for progression), progressing to steatohepatitis (MASH) with no or mild fibrosis, advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma. Although diabetes is the strongest predictor of advanced fibrosis in MAFLD, however, only a small proportion of people with type 2 diabetes and MAFLD (about 5-7%) develop a clinically significant liver disease, but the burden of MAFLD is such that even a small proportion of patients developing cirrhosis will lead to a huge strain on the health care system in India. MAFLD is predicted to be the leading indication for liver transplantation in coming years. At present, MAFLD/MASH is the second most common indication for liver transplantation in the USA as well as in India.
The question is why around 5-7% patients amongst MAFLD population develop fibrosis and cirrhosis. A growing body of evidence suggest that the disease develops because of a complex process in which several factors, including genetic susceptibility and environmental insults, are involved. There are several gene variants that have been incriminated in the development and progression of MAFLD. The most common genes associated with MAFLD are PNPLA3, TM6SF2, GCKR, and MBOAT7. The loss-of-function gene variant HSD17B13 seems to protect from NAFLD. There are a few studies from India about the role of PNPLA3 and TM6SF2 in MAFLD. However, these studies used USG for the diagnosis of MAFLD, which does not provide any information regarding fibrosis of the liver. The data regarding other three genetic variants are scarce from Indian individuals. conditions: Type2diabetes studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: Role of the PNPLA3, TM6SF2, GCKR, MBOAT7 and HSD17B13 genetic variants in the development and progression of MASLD. measure: Correlation between body fat percentage (DEXA-measured) and the genetic variants measure: Correlation between lean body mass (as measured by DEXA) and the genetic variants measure: Correlation between bone mineral content (DEXA-measured) and the genetic variants measure: Correlation between fibrosis-4 score (FIB-4) and the genetic variants measure: Correlation between MASLD fibrosis score (NFS) and the genetic variants measure: Correlation between serum creatinine levels (eGFR) and the genetic variants sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medanta Division of Endocrinology & Diabetes status: RECRUITING city: Gurgaon state: Haryana zip: 122001 country: India name: Surender, PhD role: CONTACT phone: 0124141414 phoneExt: 6596 email: yadavsurender89@gmail.com lat: 28.4601 lon: 77.02635 hasResults: False
<\|newrecord\|> nctId: NCT06289374 id: 23HH8340 briefTitle: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery acronym: LABS overallStatus: RECRUITING date: 2024-04 date: 2028-06 date: 2029-06 date: 2024-03-01 date: 2024-03-06 name: Imperial College London class: OTHER name: Cancer Research UK briefSummary: Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis. conditions: Oesophageal Adenocarcinoma conditions: Gastric Adenocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Biosample collection measure: Salivary microbial biomarkers to predict treatment response and long-term prognosis measure: Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment measure: Quality of life measure up to 2 years following cancer surgery using validated questionnaires sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Bhamini Vadhwana role: CONTACT name: Professor George Hanna, PhD FRCS role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06289361 id: IMEA 070 briefTitle: Cohort IMEA 070 -Lenacapavir Compassional overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-15 date: 2024-07-30 date: 2024-03-01 date: 2024-03-22 name: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba class: OTHER name: Saint-Louis Hospital, Paris, France name: Bichat Hospital name: Saint Antoine University Hospital name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023 conditions: HIV Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 58 type: ESTIMATED measure: proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection measure: incidence of side effects and laboratory abnormalities on LEN treatment measure: evolution of HIV-1 or HIV-2 RNA over time measure: evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time measure: Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0) measure: Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Zobda Quitman city: Fort-de-France state: Martinique zip: 97261 country: France name: Ornella OC CABRAS, PhD role: CONTACT phone: +33.5.96.55.23.01 email: ornella.cabras@chu-fort-de-france.fr name: Ornella OC CABRAS, PhD role: PRINCIPAL_INVESTIGATOR facility: Hopital Avicenne city: Bobigny zip: 93000 country: France name: Frederic FM MECHAI, MD role: CONTACT phone: +33.1.48.95.54.21 email: frederic.mechai@aphp.fr name: Frederic FM MECHAI, MD role: PRINCIPAL_INVESTIGATOR lat: 48.9 lon: 2.45 facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses city: Bordeaux zip: 33000 country: France name: Pauline PP PERREAU role: CONTACT phone: 33.5.57.82.11.03 email: pauline.perreau@chu-bordeaux.fr name: Arnaud AD DESCLAUX, MD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: Hopital Saint-Andre city: Bordeaux zip: 33075 country: France name: Sabrina SC CALDATO role: CONTACT phone: +33.5.56.79.57.33 email: sabrina.caldato@chu-bordeaux.fr name: Fabrice FB BONNET, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: Hopital Raymond Poincare city: Garches zip: 92380 country: France name: Rezak RM MAHREZ role: CONTACT phone: +33.1.47.10.46.65 email: rezak.mahrez@aphp.fr name: Pierre PT DE TRUCHIS, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.84226 lon: 2.18232 facility: C.H.D de Vendee city: La Roche Sur Yon zip: 85925 country: France name: Hélène HP PELERIN role: CONTACT phone: +33.2.51.44.65.72 email: helene.pelerin@ght85.fr name: Philippe PP PERRE, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.66667 lon: -1.43333 facility: André Mignot Hospital city: Le Chesnay zip: 78150 country: France name: Marie-Charlotte MCDC DE CARNE, MD role: CONTACT phone: +33.1.39.63.88.56 email: mcdecarne@ght78sud.fr name: Marie-Charlotte MCDC DE CARNE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.8222 lon: 2.12213 facility: Centre Hospitalier Bretagne Sud - Hôpital du Scorff city: Lorient zip: 56100 country: France name: Jérémie JP PASQUIER, MD role: CONTACT phone: +33.2.97.06.74.86 email: j.pasquier@ghbs.bzh name: Jérémie JP PASQUIER, MD role: PRINCIPAL_INVESTIGATOR lat: 47.75 lon: -3.36667 facility: CHU de Nice city: Nice zip: 06200 country: France name: Sophie SB BREAUD role: CONTACT phone: +33 4 92 03 90 90 email: breaud.s@chu-nice.fr name: David DC CHIRIO, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Hôpital Hotel Dieu city: Paris zip: 75004 country: France name: Valérie VLB LE BAUT role: CONTACT phone: +33.1.42.34.81.65 email: valerie.le-baut@aphp.fr name: Jean-Paul JPV VIARD, PHD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Saint Antoine city: Paris zip: 75012 country: France name: Rym RM MONARD role: CONTACT phone: +33 1 86 69 71 21 email: rym.monard@aphp.fr name: Karine KL LACOMBE, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales city: Paris zip: 75013 country: France name: Malikhone MC CHANSOMBAT role: CONTACT phone: +33.1.42.16.01.74 email: malikhone.chansombat@aphp.fr name: Sophie SS SEANG, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Necker city: Paris zip: 75015 country: France name: Elisabete EGP GOMES PIRES role: CONTACT phone: +33.1.44.49.2719 email: elisabete.gomes-pires@aphp.fr name: Carole CL LOUISIN role: CONTACT phone: +33.1.44.49.55.72 name: Claudine CD DUVIVIER, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Bichat Hospital city: Paris zip: 75018 country: France name: ZELIE JULIA role: CONTACT phone: 40257057 phoneExt: 331 email: zelie.julia@aphp.fr name: ROLAND LANDMAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Delafontaine city: Saint-Denis zip: 93200 country: France name: Awa AN N'DIAYE role: CONTACT phone: +33.1.42.35.61.40 phoneExt: 6809 email: awa.ndiaye2@aphp.fr name: Naomie NS SAYRE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.93326 lon: 2.36666 facility: Hopital Foch city: Suresnes zip: 92150 country: France name: Amina AF FADLI role: CONTACT phone: +33.1.46.25.11.73 email: a.fadli@hopital.foch.org name: David DZ ZUCMAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.87143 lon: 2.22929 hasResults: False
<\|newrecord\|> nctId: NCT06289348 id: APHP230240 id: 2023-A00970-45 type: REGISTRY domain: ID-RCB briefTitle: Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience. acronym: ANNPHE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-01 date: 2024-03-01 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aims of this collaborative, interdisciplinary research project are to understand and describe the psychological impact of the announcement of a rare, serious disease present since birth and detected in the context of the systematic neonatal screening (DNS), in terms of the parents' experience, but also on the part of the medical team, in order to improve its process and the support it provides for the announcement of the diagnosis. conditions: Phenylketonuria studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: socio-psychological questionnaire name: revised event impact scale (IER-S) name: Non directive interview name: Stern interview name: semi-directive interview measure: Psychological process linked to the announcement of inherited metabolic disease for the parents measure: Psychological impact of the announcement of an inherited metabolic disease on the doctors' experience measure: Measuring awareness of inherited metabolic diseases detected by midwives measure: Measure of the impact of the announcement on parents sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Pascale DELONLAY, MD, PhD role: CONTACT phone: +33 1 44 49 48 52 email: pascale.delonlay@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06289335 id: HCDrIMPrieto anaesthesia briefTitle: Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section overallStatus: COMPLETED date: 2020-08-05 date: 2021-09-05 date: 2022-01-03 date: 2024-03-01 date: 2024-03-01 name: Hospital Central "Dr. Ignacio Morones Prieto" class: OTHER briefSummary: Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia. conditions: Postanesthetic Excitement conditions: Cesarean Section studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: saline solution measure: Period of time measure: Adverse effects sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hospital Central Dr. Ignacio Morones Prieto city: San Luis Potosí zip: 78290 country: Mexico lat: 22.14982 lon: -100.97916 hasResults: False
<\|newrecord\|> nctId: NCT06289322 id: EU101136769-CLIN1 briefTitle: AI4HOPE Dementia Pain Assessment Pilot Study 1 acronym: AI4HOPE1 overallStatus: NOT_YET_RECRUITING date: 2025-07 date: 2026-12 date: 2026-12 date: 2024-03-01 date: 2024-03-05 name: University of Bonn class: OTHER name: University College Cork name: University of Leeds name: Fundacion Intras name: Universidade do Porto name: University Medical Centre Maribor briefSummary: The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia. conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Digital toolkit for assessment measure: Feasibility and acceptability of toolkit measure: Accuracy of toolkit assessments measure: Effect of pain /distress interventions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289309 id: N41/DBS/001142 briefTitle: NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-01 date: 2024-03-01 name: Marcin Barczynski class: OTHER briefSummary: The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury.
The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique.
A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each).
The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy. conditions: Thyroid Diseases conditions: Surgery conditions: Recurrent Laryngeal Nerve Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). Patients referred to the Department of Endocrine Surgery, Jagiellonian University Medical College in Krakow, for first-time thyroid surgery from March 1, 2024 onwards will be registered. Eligible patients with either benign or malignant thyroid disease will be assessed for the study. The study protocole has been approved by the Institutional Review Board (Bioethics Committee of the Jagiellonian University). primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Both participants and outcomes assessor will be blinded to the respective group assignment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Neuromonitoring of the recurrent laryngeal nerves measure: Prevalence of recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy measure: Positive predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy measure: Negative predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy measure: Prevalence of permanent recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Endocrine Surgery, Jagiellonian University College of Medicine status: RECRUITING city: Krakow zip: 31-202 country: Poland name: Marcin Barczynski, MD, PhD role: CONTACT phone: +48602375939 email: marbar@mp.pl name: Marcin Barczynski, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 hasResults: False
<\|newrecord\|> nctId: NCT06289296 id: MCT briefTitle: Medium Chain Fatty Acids and Ketones acronym: MCFA overallStatus: COMPLETED date: 2022-01-01 date: 2023-09-30 date: 2023-09-30 date: 2024-03-01 date: 2024-03-01 name: University of Copenhagen class: OTHER briefSummary: 16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period. conditions: Diet, Healthy conditions: Health studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel crossover design, in which a group of lean and a group of obese participants are allocated to complete two seven-day intervention periods with twice daily consumption of either medium-chain fatty acids or long-chain fatty acids. primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ACTUAL name: Fatty acid intake in lean and obese males measure: Ketone bodies in plasma sex: MALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06289283 id: Theodor Bilharz Research Ins. briefTitle: Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder acronym: Cancer bladder overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-12 date: 2026-04 date: 2026-12 date: 2024-03-01 date: 2024-03-01 name: Theodor Bilharz Research Institute class: OTHER briefSummary: Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer. conditions: Urinary Bladder Neoplasms conditions: Microtia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 38 type: ACTUAL name: Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera measure: To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Theodor Bilharz Research Institute city: Cairo zip: 12411 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06289270 id: Microbiota and bladder cancer briefTitle: Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Tissues From Egyptian Male Patients and Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder Cancer. acronym: Cancer bladder overallStatus: RECRUITING date: 2023-09-20 date: 2026-12 date: 2027-07 date: 2024-03-01 date: 2024-03-01 name: Theodor Bilharz Research Institute class: OTHER briefSummary: Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis, and new treatment strategies for bladder cancer. conditions: Microbiota in Patients With Urinary Bladder Carcinoma in Urine and Cancer Tissues studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 38 type: ESTIMATED measure: To characterize the microbiota in male patients with bladder cancer. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Theodor Bilharz Research Institute status: NOT_YET_RECRUITING city: Cairo state: Giza zip: 12411 country: Egypt name: Mohamed M Wishahi, MD role: CONTACT phone: +201222247437 email: wishahi@gmx.net lat: 30.06263 lon: 31.24967 facility: Theodor Bilharz Research Institute status: RECRUITING city: Cairo zip: 12411 country: Egypt name: Mohamed M Wishahi, MD role: CONTACT phone: +201222247437 email: wishahi@gmx.net lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06289257 id: VitDAndEndomet briefTitle: Association of Vitamin D Level and Its Receptor With Endometriosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-09-30 date: 2024-03-01 date: 2024-03-01 name: Khon Kaen University class: OTHER briefSummary: Endometriosis, a condition where endometrial-like tissue grows outside the uterus, often occurs due to retrograde menstruation, where menstrual blood flows backward through the fallopian tubes into the pelvic cavity. This tissue can then implant and grow within the pelvic peritoneum. The survival of these ectopic implants leads to chronic inflammation, adhesion formation, and scarring of surrounding tissues, including the ovaries and fallopian tubes. Symptoms include cyclic pelvic pain, dysmenorrhea, dyspareunia, and infertility.
Ectopic endometrial tissue survival is not attributed to mutations but rather epigenetic changes. Studies have linked this phenomenon to genes such as KRAS (Kirsten Rat Sarcoma Virus Oncogene), involved in cell proliferation and survival. Dysregulated KRAS activity can lead to increased production of MMP-2 and MMP-9 proteins, implicated in angiogenesis and tissue invasion, facilitating the spread of endometrial tissue.
Vitamin D has been shown to modulate immune function and reduce inflammation. Studies suggest that vitamin D deficiency may exacerbate endometriosis symptoms and severity. However, evidence regarding the efficacy of vitamin D supplementation in managing endometriosis symptoms is mixed.
One study found that long-term intake of vitamin D-rich foods was associated with an 18% lower risk of developing endometriosis. Additionally, vitamin D deficiency has been correlated with increased expression of mutated KRAS in colorectal cancer patients, suggesting a potential link between vitamin D status and genetic abnormalities in disease progression.
Further research is needed to fully understand the relationship between vitamin D deficiency and endometriosis severity, particularly in specific populations like the Thai population. conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: Vitamin D level name: Vitamin D receptor measure: Vitamin D level measure: rASRM measure: Vitamin D receptor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University city: Khon Kaen zip: 40000 country: Thailand name: Vitet Layanun, Doctor of Medicine role: CONTACT phone: +66850663130 email: jockvitet@hotmail.com name: Vitet Layanun, Doctor of Medicine role: PRINCIPAL_INVESTIGATOR lat: 16.44671 lon: 102.833 hasResults: False
<\|newrecord\|> nctId: NCT06289244 id: 6597 briefTitle: Correlation Between Muscle Strength and Thickness in Critically Ill Patients overallStatus: RECRUITING date: 2023-06-06 date: 2025-03-30 date: 2025-06-30 date: 2024-03-01 date: 2024-03-01 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.
The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.
The primary inquiries this study seeks to address are:
* Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV?
* How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV? conditions: Critical Illness conditions: Muscle Weakness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Ultrasound name: Muscle strength measurement measure: Correlation between quadriceps strength and thickness measure: Quadriceps strength measure: Quadriceps thickness measure: Diaphragm thickness measure: Diaphragm strength measure: Time to reach the sitting position sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Veronica Rossi, MSc role: CONTACT email: veronica.rossi@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06289231 id: AWFiS/2023_5_PE briefTitle: The Use of Artificial Intelligence (AI) for Gait Analysis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-08 date: 2024-03-01 date: 2024-03-04 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The main purpose of this study will be to assess the consistency and reliability of measurements made using the Vicon three-plane gait analysis device (Vicon Motion Capture System Ltd, Oxford, UK) and a mobile application based on image recognition technology with the help of artificial intelligence. conditions: Gait studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Gait analysis by the Vicon system measure: Gait analysis by the mobile image recognition application sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT facility: Gdansk University of Physical Education and Sport city: Gdańsk state: Pomorskie zip: 80-336 country: Poland lat: 54.35205 lon: 18.64637 hasResults: False
<\|newrecord\|> nctId: NCT06289218 id: Treating knee osteoarthritis briefTitle: Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-06-25 date: 2025-06 date: 2025-09 date: 2024-03-01 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The purpose of this study will be to compare the combined effect of using Kinesio taping versus interferential current with an exercise program on knee pain, function, knee range of motion, knee muscle strength, and functional mobility in chronic knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: interferential current name: kinesio taping name: exercise measure: knee flexion range of motion measure: knee extension range of motion measure: quadriceps muscle strength measure: The Western Ontario and McMaster Universities Osteoarthritis Index measure: Timed up and go test sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289205 id: 60/IRB/SLMC/SWL briefTitle: "Comparing Methotrexate Usage Techniques to Prevent Proliferative Vitreoretinopaty After Retinal Detachment Vitrectomy" overallStatus: RECRUITING date: 2024-03 date: 2025-02 date: 2025-05 date: 2024-03-01 date: 2024-03-01 name: University of Health Sciences Lahore class: OTHER briefSummary: This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups. conditions: Proliferative Vitreoretinopathy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Using lottery methods patients will be divided into two groups with 60 subjects in each group. Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution. Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd , 4th and 6th post operative weeks. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: This will be a single-blind study in which the subjects will be unaware of the intervention. Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they are receiving. whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Methotrexate measure: Development of Proliferative Vitreoretinopathy (PVR) measure: Recurrence of Retinal Detachment measure: Visual Acuity Improvement sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan status: RECRUITING city: Sahiwal state: Punjab zip: 57000 country: Pakistan name: Ahmad Z Jamil, FCPS,FRCS role: CONTACT phone: +923334853851 email: ahmadzeeshandr@gmail.com lat: 30.66667 lon: 73.1 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-24 uploadDate: 2024-02-24T14:05 filename: Prot_SAP_000.pdf size: 182492 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-24 uploadDate: 2024-02-24T14:06 filename: ICF_001.pdf size: 185782 hasResults: False
<\|newrecord\|> nctId: NCT06289192 id: IRB00396489 briefTitle: Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-01 date: 2024-03-15 name: Johns Hopkins University class: OTHER name: Maryland Cigarette Restitution Fund briefSummary: To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).
The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention. conditions: Tobacco Dependence studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: C-Raven Virtual Tobacco Cessation Counseling name: Nicotine Replacement Product name: Community Health Worker name: Lung Cancer Screening measure: Acceptability and Feasibility measure: Readiness to quit smoking as assessed by The Readiness Ruler measure: Number of Participants that Uptake nicotine replacement therapy measure: Continued use of nicotine replacement therapy measure: Number of quit attempts measure: Number of participants than maintain cessation measure: Number of participants that uptake Quit Line services measure: Participant engagement with community health worker as assessed by number of CHW interactions measure: Participant satisfaction as assessed by study team survey sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chase House Apartments city: Baltimore state: Maryland zip: 21201 country: United States name: Jeanne Clark, MD role: CONTACT phone: 410-614-1135 email: jmclark@jhmi.edu name: Alejandra Ellison-Barnes, MD role: CONTACT phone: 4106141135 email: aelliso6@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Monument East city: Baltimore state: Maryland zip: 21202 country: United States name: Jeanne Clark, MD role: CONTACT phone: 410-614-1135 email: jmclark@jhmi.edu name: Alejandra Ellison-Barnes, MD role: CONTACT phone: 4106141135 email: aelliso6@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Johns Hopkins University School of Medicine city: Baltimore state: Maryland zip: 21205 country: United States name: Jeanne Clark, MD role: CONTACT phone: 410-614-1135 email: jmclark@jhmi.edu name: Alejandra Ellison-Barnes, MD role: CONTACT phone: 4106141135 email: aelliso6@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06289179 id: Thyroid and cortisol in sepsis briefTitle: Thyroid and Cortisol Hormone Response to Sepsis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-02-20 date: 2026-10-25 date: 2024-03-01 date: 2024-03-01 name: Assiut University class: OTHER briefSummary: Thyroid and cortisol hormone response to sepsis conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 114 type: ESTIMATED measure: Pattern of cortisol level and thyroid function response to sepsis in ICU sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289166 id: STSP-0601-04 briefTitle: Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor overallStatus: RECRUITING date: 2024-03-18 date: 2025-02 date: 2025-02 date: 2024-03-01 date: 2024-04-03 name: Staidson (Beijing) Biopharmaceuticals Co., Ltd class: INDUSTRY briefSummary: This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor. conditions: Hemophilia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: STSP-0601 for Injection measure: Incidence of adverse events measure: Proportion of successfully treated bleeding episodes measure: Proportion of successfully treated bleeding episodes measure: Proportion of bleeding episodes received salvage treatment sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230000 country: China name: Changcheng Zheng role: CONTACT phone: 13956961162 email: zhengchch1123@163.com lat: 31.86389 lon: 117.28083 facility: The Second Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Shu Chen role: CONTACT phone: 13983420188 email: chenshu921@163.com lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Affiliated Union Medical College Hospital status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350005 country: China name: Fenge Yang role: CONTACT phone: 13635250168 email: 339694677@qq.com lat: 26.06139 lon: 119.30611 facility: Lanzhou University First Hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730000 country: China name: Yaming Xi role: CONTACT phone: 13919110815 email: ncuyfygcp2018@163.com lat: 36.05701 lon: 103.83987 facility: Southern Medical University Southern Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jing Sun role: CONTACT phone: 13316202696 email: jsun-cn@qq.com lat: 23.11667 lon: 113.25 facility: Shenzhen Second People's Hospital status: NOT_YET_RECRUITING city: Shenzhen state: Guangdong zip: 518000 country: China name: Xin Du role: CONTACT phone: 13602523722 email: duxingz@medmail.com.cn lat: 22.54554 lon: 114.0683 facility: Guizhou Medical University Affiliated Hospital status: NOT_YET_RECRUITING city: Guiyang state: Guizhou zip: 550000 country: China name: Jishi Wang role: CONTACT phone: 13312233711 email: wjiayu1399@163.com lat: 26.58333 lon: 106.71667 facility: Harbin First Hospital Hematology Tumor Research Center status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Jun Ma role: CONTACT phone: 0451-84883471 lat: 45.75 lon: 126.65 facility: Henan Cancer Hospital status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450000 country: China name: Hu Zhou role: CONTACT phone: 13939068863 email: papertigerhu@163.com lat: 34.75778 lon: 113.64861 facility: Xiangya Hospital of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410000 country: China name: Jie Peng role: CONTACT phone: 13974802938 email: pengjie-0728@csu.edu.cn lat: 28.19874 lon: 112.97087 facility: Nanjing University School of Medicine Affiliated Gulou Hospital status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Rongfu Zhou role: CONTACT phone: 13605142342 email: rfzhoucn@163.com lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanchang University status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330038 country: China name: Ruibin Huang role: CONTACT phone: 13970006820 email: rbhuang69@163.com lat: 28.68396 lon: 115.85306 facility: The first hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130000 country: China name: Sujun Gao role: CONTACT phone: 158430732085 email: sujung1963@163.com lat: 43.88 lon: 125.32278 facility: Shengjing Hospital Affiliated to China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Wei Yang role: CONTACT phone: 18940259033 email: yangw@sj-hospital.org lat: 41.79222 lon: 123.43278 facility: Affiliated Hospital of Qingdao University status: NOT_YET_RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Zhongguang Cui role: CONTACT phone: 18661809137 email: cuizhguang@163.com lat: 36.06488 lon: 120.38042 facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Xuefeng Wang role: CONTACT phone: 18917762601 email: 13641653074@139.com lat: 31.22222 lon: 121.45806 facility: Xi'an Central Hospital status: NOT_YET_RECRUITING city: Xi'an state: Shanxi zip: 710000 country: China name: Yanping Song role: CONTACT phone: 13572973308 email: xjtusyp@163.com lat: 34.25833 lon: 108.92861 facility: West China Hospital of Sichuan University status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Yuping Gong role: CONTACT phone: 15680990805 email: Liy1905@sina.com lat: 30.66667 lon: 104.06667 facility: Hospital of Hematology, Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang role: CONTACT phone: 022-23909095 email: zhanglei1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 facility: The Second Affiliated Hospital of Kunming Medical University status: NOT_YET_RECRUITING city: Kunming state: Yunnan zip: 650000 country: China name: Zeping Zhou role: CONTACT phone: 18788571605 email: zhouzeping@kmmu.edu.cn lat: 25.03889 lon: 102.71833 hasResults: False
<\|newrecord\|> nctId: NCT06289153 id: 23-01182 briefTitle: Internal Bracing Following ACL Reconstruction overallStatus: RECRUITING date: 2024-03-01 date: 2025-02-26 date: 2025-08-26 date: 2024-03-01 date: 2024-03-12 name: NYU Langone Health class: OTHER briefSummary: The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing. conditions: ACL Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Arthrex Internal Brace name: ACL Reconstruction measure: Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation measure: Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06289140 id: BIOPTERO2 briefTitle: Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2) acronym: BIOPTERO2 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-01 date: 2024-03-01 name: Fundació Eurecat class: OTHER name: Circe, S.L. briefSummary: The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:
• Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?
Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.
Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT). conditions: Biological Availability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 6 type: ESTIMATED name: Pterostilbene cocrystal (ccPT) - Gelatin capsule name: Pterostilbene free form (PT) name: Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule measure: Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels, both free and total. measure: Area under the curve (AUC 0-inf) of plasma pterostilbene levels, both free and total. measure: Relative bioavailability of plasma pterostilbene levels (Frel). measure: Maximum plasma concentration (Cmax) measure: Time for maximum plasma concentration (Tmax) measure: Half-life (T1/2). sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundació Eurecat city: Reus zip: 43204 country: Spain name: Antoni Caimari, PhD role: CONTACT phone: 0034 977 300 431 email: antoni.caimari@eurecat.org name: Anna Crescenti, PhD role: CONTACT phone: 0034 977 300 431 email: anna.crescenti@eurecat.org lat: 41.15612 lon: 1.10687 hasResults: False
<\|newrecord\|> nctId: NCT06289127 id: GO 22/595 briefTitle: Test Properties of Lower Quarter Y-Balance Test: Effect of Verbal Instructions and Focus Techniques overallStatus: COMPLETED date: 2022-07-20 date: 2023-02-02 date: 2023-11-10 date: 2024-03-01 date: 2024-03-04 name: Hacettepe University class: OTHER briefSummary: The Lower Quadrant Y-Balance Test (LQYBT) is a landmark test used in assessing lower extremity performance, determining risk factors for injury, and making return-to-sport decisions. Studies have shown that the individual's focus of attention affects balance. The literature, has shown that the use of external focus is more effective than the use of internal focus in the execution of a movement.Consistent with these findings, the use of an external focus instruction during the LQYBT may lead to achieve more realistic and a higher performance outcome than the test result with standard instructions. The primary aim of this study was to investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. The secondary aim was to investigate the reliability of the different instructions and focus tests we used for the LQYBT.
Hypothesis of the study that test performance can be further enhanced by differentiating the instructions and focus techniques. A more effective assessment of individual performance may help us to make a more realistic decision to return to sport. conditions: Healthy conditions: Attention Disturbances conditions: Physical Stress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 2 type: ACTUAL name: Lower Quarter Y Balance Test measure: Investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. measure: Investigate the reliability of the different instructions and focus tests we used for the LQYBT. sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Hacettepe University city: Ankara state: Sıhhıye zip: 06430 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06289114 id: S-20220005 briefTitle: Predictive Utility of a Short-term Improvement in Objectively Measured Physical Activity in Rheumatoid Arthritis (PUSIPA) acronym: PUSIPA overallStatus: RECRUITING date: 2023-09-01 date: 2025-09-01 date: 2025-09-01 date: 2024-03-01 date: 2024-03-01 name: Hospital of South West Jutland class: OTHER briefSummary: SUMMARY Background: Several studies have shown physical activity (PA) to be inversely correlated to disease activity in rheumatoid arthritis (RA) patients. However, it is unclear whether improved PA leads to lower disease activity or if low disease activity predicts improved PA in rheumatoid arthritis patients. Furthermore, it is unknown how fibromyalgia (FM) affects this interaction.
Objective(s): Our primary objective will be to compare the effect of an immediate improvement in physical activity after one week on the proportion of RA patients achieving low disease activity after 12 weeks of biological treatment. Furthermore, we will explore whether the presence of concomitant FM affects this clinical response (i.e., interaction between FM status and PA response).
Design: A prospective cohort study in the form of a target-trial attempting to address a causal question comparing the outcome among the participants with an immediate improvement in physical activity, relative to individuals without.
Setting and patients: Biologically naive RA patients initiating biological treatment are consecutively enrolled. PA is quantified by accelerometry one week prior to, one week after, and after 3 months of biological treatment.
Sample size: 100 RA patients starting biological therapy is planned enrolled in the study.
Measurements: RA patients will be divided into two groups depending on their improvement in physical activity after onset of biological treatment. The percentage of time spent in moderate-to-vigorously physical activity (MVPA) i.e., the percentage of time a patient is in motion \[walking, running, bicycling, or swimming\] is measured prior to, one week, and approximately 3 months after biological treatment onset, respectively. The MVPA ratio (MVPA After biological treatment/MVPA Before biological treatment) will divide patients enabling a contrast between two groups: Those with high improvement considering MVPA (after 1 week; the upper tertile of MVPA ratio of the sample) and those without. Treatment response (achieving a disease activity score \< 3.2) after approximately 3 months from baseline will be analyzed as the contrast between groups. conditions: Rheumatoid Arthritis conditions: Fibromyalgia, Secondary conditions: Fatigue conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: MVPA ratio before and after biological therapy measure: Disease activity score (DAS) measure: Fibromyalgia measure: Fatigue measure: Physical activity scores on questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Esbjerg Hospital status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Philip R Lage-Hansen, MD role: CONTACT phone: +4530114582 email: philip.rask.lage-hansen3@rsyd.dk lat: 55.47028 lon: 8.45187 hasResults: False
<\|newrecord\|> nctId: NCT06289101 id: IRB00422008 id: R21HD112617 type: NIH link: https://reporter.nih.gov/quickSearch/R21HD112617 briefTitle: text4FATHER R21: Social Media - Efficacy Trial overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-03-01 date: 2024-03-01 name: Johns Hopkins University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being. conditions: Fathers conditions: Mobile Health conditions: Nuclear Family studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention. primaryPurpose: PREVENTION masking: NONE count: 180 type: ESTIMATED name: text4FATHER measure: Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC) measure: Karitane Parenting Confidence Scale (KPCS) measure: Fathering Self-Efficacy Scale (FSES) measure: Father Engagement Scale (FES) measure: The Co-Parenting Relationship Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06289088 id: E-10840098-772.02-4659 briefTitle: The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance acronym: lumbosacral overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-04 date: 2024-05-04 date: 2024-05-04 date: 2024-03-01 date: 2024-03-19 name: Istanbul Medipol University Hospital class: OTHER briefSummary: The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. conditions: Orthosis conditions: Low Back Pain, Postural studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single group, crossover study primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: First Intervention name: Second Intervention name: Third Intervention measure: Visual Analog scale measure: Orthosis comfort score measure: Functional Reach Test (FRT) measure: Pedobarographic evaluation measure: Y balance test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06289075 id: 23-1096-retro briefTitle: PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040 acronym: PrognostICate overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-01 date: 2024-03-01 name: University Hospital of Cologne class: OTHER name: Johann Wolfgang Goethe University Hospital name: Monash University name: The Alfred name: Albert Einstein College of Medicine name: Montefiore Hospital briefSummary: The Objective of our retrospective multicenter- study is to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases. conditions: ICU Admission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10000000 type: ESTIMATED name: Intensive Care Unit (ICU) treatment measure: Length of mechanical ventilation measure: Length of ICU stay sex: ALL minimumAge: 1 Day maximumAge: 120 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06289062 id: NACI-CERV-005 briefTitle: Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-01 date: 2030-12-01 date: 2024-03-01 date: 2024-03-01 name: Tongji Hospital class: OTHER name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Women Hospital, School of Medicine, Zhejiang University name: Third Military Medical University name: Beijing Friendship Hospital name: Sichuan Cancer Hospital and Research Institute name: Tianjin Medical University name: West China Second University Hospital name: Xiangya Hospital of Central South University name: Qilu Hospital of Shandong University name: Gansu Cancer Hospital name: Zhejiang Cancer Hospital name: Shengjing Hospital name: Anhui Provincial Cancer Hospital briefSummary: This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, PFS and OS. conditions: Cervical Cancer conditions: Neoadjuvant Chemoimmunotherapy conditions: Fertility Preservation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Camrelizumab name: Cisplatin name: Nab paclitaxel name: biopsy measure: Pathologic complete response measure: The negative conversion of HPV measure: Pregnancy rate measure: Miscarriage rate measure: Live birth rate measure: Preterm birth rate measure: Adverse Event measure: Surgical complications measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score measure: Event-free survival (EFS) measure: Overall survival (OS) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Kezhen Li role: CONTACT phone: 086-027-8362 email: tjkeke@126.com name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Kezhen Li role: PRINCIPAL_INVESTIGATOR name: Gang Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06289049 id: HREBA.CC-24-0021 briefTitle: Heavy Strength Training in Head and Neck Cancer Survivors acronym: LIFTING2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-04 date: 2024-03-01 date: 2024-03-05 name: University of Alberta class: OTHER briefSummary: Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS. conditions: Head and Neck Neoplasms conditions: Head and Neck Cancer conditions: Head and Neck Squamous Cell Carcinoma conditions: Head and Neck Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: Participants and investigators will not be blinded to group assignment given the nature of the intervention. count: 60 type: ESTIMATED name: Experimental measure: Recruitment rate measure: Adherence to a heavy lifting strength training program measure: Completion of maximal strength testing measure: Followup assessment rate measure: Safety measure: Muscular Strength measure: Cancer Specific Quality of Life measure: Fear of Cancer Recurrence measure: Symptom Burden measure: Perceived Stress measure: Self-Esteem measure: Sleep Habits measure: Malnutrition Status measure: Swallowing Abilities measure: Shoulder Range of Motion measure: Body composition measure: Handgrip Strength measure: Physical Function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alberta city: Edmonton state: Alberta country: Canada name: Stephanie Ntoukas role: CONTACT email: ntoukas@ualberta.ca name: Kerry Courneya role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False
<\|newrecord\|> nctId: NCT06289036 id: H2020206632 briefTitle: Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging overallStatus: COMPLETED date: 2021-02-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-01 date: 2024-03-01 name: The First Hospital of Hebei Medical University class: OTHER briefSummary: We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL. Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale \[mRS\] ≤ 2) and poor prognosis (mRS \> 2). conditions: The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 28 type: ACTUAL measure: Modified Rankin Scale（mRS） score after 3 months of onset sex: ALL minimumAge: 18 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Hebei Medical University city: Shijia Zhuang state: Hebei country: China lat: 34.17775 lon: 109.84894 hasResults: False
<\|newrecord\|> nctId: NCT06289023 id: NCC1278 briefTitle: HA-WBRT-SIB for Brain Metastasis of Lung Cancer overallStatus: COMPLETED date: 2016-01-01 date: 2020-01-01 date: 2022-12-31 date: 2024-03-01 date: 2024-03-01 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, ﬁve times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment. conditions: Lung Neoplasm conditions: Brain Metastases conditions: Simultaneous Integrated Boost conditions: Hippocampal Avoidance conditions: Cognitive Function studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: HA-WBRT-SIB measure: OS measure: PFS measure: iPFS measure: HVLT-R learning score sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06289010 id: 7354E briefTitle: Neural Mechanisms of Family-Focused Treatment for Youth Depression overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-11 date: 2024-03-01 date: 2024-03-04 name: Boston University Charles River Campus class: OTHER name: Massachusetts Institute of Technology briefSummary: The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are:
* What are differences between depressed and non-depressed participants on baseline neural and parenting indicators?
* Do baseline neural and parenting indicators predict response to FFT-CD?
* Does change in parenting and neural functioning mediate change in depression from baseline to follow-up?
Participants will:

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