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protocolSection identificationModule nctId: NCT06321146, orgStudyIdInfo id: LY2024-029-B, briefTitle: Evaluation of EEG Power Spectrum in Patients With Traumatic Coma, acronym: EPIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Beijing Tiantan Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: The General Hospital of Eastern Theater Command, collaborators name: Anhui No.2 Provincial People's Hospital, descriptionModule briefSummary: Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery., conditionsModule conditions: Coma, conditions: Brain Injuries, Traumatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: EEG power spectrum, secondaryOutcomes measure: Coma Recovery Scale-Revised (CRS-R), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui No.2 Provincial People's Hospital, city: Hefei, state: Anhui, country: China, contacts name: Yongming Zhang, Dr., role: CONTACT, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Beijing Tiantan Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, contacts name: Guoyi Gao, Dr., role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xiangya Hospital, Central South University, city: Changsha, state: Hunan, country: China, contacts name: Jinfang Liu, Dr., role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The General Hospital of Eastern Theater Command, city: Nanjing, state: Jiangsu, country: China, contacts name: Chiyuan Ma, Dr., role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, city: Shanghai, state: Shanghai, zip: 201114, country: China, contacts name: Junfeng Feng, role: CONTACT, phone: +8613611860825, email: fengjfmail@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06321133, orgStudyIdInfo id: 5402589, briefTitle: High Flow Nasal Cannula Weaning in Acute Bronchiolitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Kuopio University Hospital, class: OTHER, collaborators name: Central Finland Hospital District, collaborators name: Mikkeli Central Hospital, collaborators name: Siun sote, descriptionModule briefSummary: The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy., conditionsModule conditions: Acute Bronchiolitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: High flow nasal cannula immediate ending, interventions name: High flow nasal cannula weaning, outcomesModule primaryOutcomes measure: Hospitalization time from randomization, secondaryOutcomes measure: Treatment failures, secondaryOutcomes measure: Readmission rate, secondaryOutcomes measure: Overall hospitalization time, eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Siun Sote, status: RECRUITING, city: Joensuu, country: Finland, contacts name: Paula Widgren, MD, PhD, role: CONTACT, phone: 0045813 330 8285, email: paula.widgren@siunsote.fi, geoPoint lat: 62.60118, lon: 29.76316, locations facility: Central Finland Hospital District, status: RECRUITING, city: Jyväskylä, country: Finland, contacts name: Milla Pitkänen, MD, role: CONTACT, phone: 0035814 2691811, email: milla.pitkanen@hyvaks.fi, geoPoint lat: 62.24147, lon: 25.72088, locations facility: Kuopio University Hospital, status: RECRUITING, city: Kuopio, country: Finland, contacts name: Ilari Kuitunen, MD, PhD, role: CONTACT, phone: +358447174910, email: ilari.kuitunen@uef.fi, contacts name: Marjo Renko, Professor, role: CONTACT, contacts name: Katri Backman, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Miika Arvonen, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 62.89238, lon: 27.67703, locations facility: Mikkeli Central Hospital, status: RECRUITING, city: Mikkeli, country: Finland, contacts name: Nicole Weisshoff, MD, role: CONTACT, phone: 0035815 3511, email: nicole.weisshoff@etelasavonha.fi, geoPoint lat: 61.68857, lon: 27.27227, hasResults: False
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protocolSection identificationModule nctId: NCT06321120, orgStudyIdInfo id: 0749-21-HMO-CTIL, briefTitle: Using Chronobiology to Improve Lenvatinib Efficacy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients, via a mobile application.Participants will use a mobile application to follow variability-based physician approved drug administration schedules., conditionsModule conditions: Lenvatinib Treatment, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: An open-labeled, prospective, single-center proof-of-concept clinical trial lasting 14 weeks was conducted to investigate the impact of an algorithm-based regimen on enhancing lenvatinib effectiveness., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: variability-based lenvatinib regimen, outcomesModule primaryOutcomes measure: disease progression/ tumor response, secondaryOutcomes measure: Adverse effects occurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hadassah Medical Organization, status: RECRUITING, city: Jerusalem, zip: 91120, country: Israel, contacts name: Hadas Lemberg, PhD, role: CONTACT, phone: +97226777572, email: lhadas@hadassah.org.il, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False
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protocolSection identificationModule nctId: NCT06321107, orgStudyIdInfo id: GenSci094-304, briefTitle: Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-08-15, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Changchun GeneScience Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Sixth Affiliated Hospital, Sun Yat-sen University, descriptionModule briefSummary: The purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Summary of Pregnancy Outcome, secondaryOutcomes measure: neonatal birth outcomes, secondaryOutcomes measure: Infant development, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06321094, orgStudyIdInfo id: VERI-ACS, briefTitle: Effect of Vericiguat on Endpoint Events in Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection \<45% between participants who take vericiguat regularly and those who donot., conditionsModule conditions: Acute Coronary Syndrome, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Vericiguat, outcomesModule primaryOutcomes measure: a composite of death from cardiovascular causes or first hospitalization for heart failure, secondaryOutcomes measure: results of echocardiogram, secondaryOutcomes measure: the numerical value of NT-proBNP, secondaryOutcomes measure: level of procalcitonin, secondaryOutcomes measure: interleukin-6 level, secondaryOutcomes measure: life quality score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, contacts name: Liansheng Wang, Doctor, role: CONTACT, phone: 85 25 68303830, email: drlswang@njmu.edu.cn, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06321081, orgStudyIdInfo id: 2023BJYYEC-428-02, briefTitle: ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-02-14, completionDateStruct date: 2026-08-14, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital, class: OTHER_GOV, collaborators name: Bethune Charitable Foundation, descriptionModule briefSummary: This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before., conditionsModule conditions: RAS Mutation, conditions: Metastatic Colorectal Cancer, conditions: MSS, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: irinotecan, cetuximab, envafolimab, outcomesModule primaryOutcomes measure: progression free survival, secondaryOutcomes measure: Overal survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Yingying Huang, role: CONTACT, phone: 86-10-85136715, email: yinghh@hotmail.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06321068, orgStudyIdInfo id: BAT-1308-003-CR, briefTitle: BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bio-Thera Solutions, class: INDUSTRY, descriptionModule briefSummary: Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma, conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: carboplatin, interventions name: Paclitaxel, interventions name: Recombinant humanized anti-PD-1 monoclonal antibody injection, outcomesModule primaryOutcomes measure: vital signs, primaryOutcomes measure: Physical examination, primaryOutcomes measure: Adverse events, primaryOutcomes measure: Clinical laboratory tests, primaryOutcomes measure: Clinical auxiliary tests, primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Initial efficacy, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Immunogenicity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Cancer Hospital of Chongqing University, status: RECRUITING, city: Chongqing, state: Chongqing, country: China, contacts name: Qi Zhou, role: CONTACT, phone: 86-13708384529, email: qizhou9128@163.com, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06321055, orgStudyIdInfo id: 22533, briefTitle: An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-04-28, completionDateStruct date: 2024-04-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which data already collected from people with advanced gastrointestinal stromal tumors are studied.In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment.Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body.The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused side effects that are too severe to continue the treatment. In addition, it is also the recommended first choice of treatment in people with GIST who had low levels of protein called succinate dehydrogenase (SDH) protein. This condition is called SDHdeficient GIST. However, doctors might sometimes give it in a different order. To better understand the treatment patterns with regorafenib for GIST, more knowledge is needed about its use in the real world.The participants in this study had started treatment with regorafenib as part of their regular care from their doctors.The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on:Duration of treatment with regorafenib (also known as duration of therapy)The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy)The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023.Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days.In this study, only available data are collected. No visits or tests are required as part of this study., conditionsModule conditions: Advanced Gastrointestinal Stromal Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Regorafenib (Stivarga, BAY73-4506), outcomesModule primaryOutcomes measure: Duration of Therapy (DOT) on regorafenib, primaryOutcomes measure: Time to Next Therapy (TTNT) therapy after regorafenib, secondaryOutcomes measure: Number of the guideline-listed medications other than regorafenib, secondaryOutcomes measure: Descriptive analysis of baseline demographic, secondaryOutcomes measure: Descriptive analysis of clinical characteristics, secondaryOutcomes measure: Number of patients with evidence of any metastasis on or after the index date during the follow-up period., secondaryOutcomes measure: Number of patients with evidence of surgery on or after the index date during the follow-up period using Current Procedural Terminology (CPT) codes and International Classification of Disease 9/10 Procedure codes (ICD-PC)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, city: Whippany, state: New Jersey, zip: 07981, country: United States, geoPoint lat: 40.82454, lon: -74.4171, hasResults: False
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protocolSection identificationModule nctId: NCT06321042, orgStudyIdInfo id: SYMPHO-EM, briefTitle: Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors, acronym: SYMPHO-EM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-13, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;, conditionsModule conditions: Prosthesis Durability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Knee arthroplasty, outcomesModule primaryOutcomes measure: Knee Society Score, primaryOutcomes measure: Knee Society Score, primaryOutcomes measure: Knee Society Score, primaryOutcomes measure: Knee Society Score, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, primaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, primaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, primaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, primaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, primaryOutcomes measure: 36-Item Short Form Health Survey, primaryOutcomes measure: 36-Item Short Form Health Survey, primaryOutcomes measure: 36-Item Short Form Health Survey, primaryOutcomes measure: 36-Item Short Form Health Survey, primaryOutcomes measure: Forgotten joint score, primaryOutcomes measure: Forgotten joint score, primaryOutcomes measure: Forgotten joint score, primaryOutcomes measure: Forgotten joint score, secondaryOutcomes measure: Radiographic evaluation of prosthetic femoral component positioning, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stefano Zaffagnini, status: RECRUITING, city: Bologna, state: Italia, country: Italy, contacts name: Stefano Zaffagnini, MD, role: CONTACT, phone: 051 6366075, email: stefano.zaffagnini@unibo.it, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06321029, orgStudyIdInfo id: 4-22-ICTSHD-44, briefTitle: Electronic Diabetes Tune-Up Group (eDTU) for African Americans, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: Indiana University Health, descriptionModule briefSummary: The primary aims of this study are:1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates).2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control.Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Diabetes Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group waitlist control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes Tune-Up Group, outcomesModule primaryOutcomes measure: Diabetes Distress Scale-17 (DDS-17), primaryOutcomes measure: HbA1c (A1c), primaryOutcomes measure: Acceptability of intervention (content and delivery modality), primaryOutcomes measure: Feasibility of intervention and delivery modality, secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Confidence in Diabetes Self-Care (CDSC), secondaryOutcomes measure: Short Form-12 (SF-12), secondaryOutcomes measure: Diabetes Therapy-Related Quality of Life Questionnaire, eligibilityModule sex: FEMALE, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indiana University School of Medicine, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Barb Myers, MS, role: CONTACT, phone: 317-278-7339, email: bamyers@iu.edu, contacts name: Mary de Groot, PhD, role: CONTACT, phone: 317-278-1965, email: mdegroot@iu.edu, contacts name: Mary de Groot, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
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protocolSection identificationModule nctId: NCT06321016, orgStudyIdInfo id: 2023111039, briefTitle: POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer, acronym: PoziKids, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Nere Mendizabal, class: OTHER_GOV, descriptionModule briefSummary: Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials., conditionsModule conditions: Exercise, conditions: Childhood Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Physical exercise program, interventions name: Type of the physical exercise program, outcomesModule primaryOutcomes measure: Quarterly recruitment rates assessed by comparing those who participate with those who do not., primaryOutcomes measure: Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol, primaryOutcomes measure: Body composition assessed by the Body Mass Index, primaryOutcomes measure: Muscle mass, primaryOutcomes measure: Bone mineral density, primaryOutcomes measure: Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer, primaryOutcomes measure: Muscular strength assessed by manual grip test with a dynamometer, primaryOutcomes measure: General Quality of life assessed by the PedsQL 4.0 questionnaire, primaryOutcomes measure: Specific Quality of life assessed by the PedsQL cancer questionnaire, primaryOutcomes measure: Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS), primaryOutcomes measure: Physical activity level assessed by accelerometers, secondaryOutcomes measure: Security assessment, secondaryOutcomes measure: Costs associated estimation, secondaryOutcomes measure: Implementation barriers and facilitators, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321003, orgStudyIdInfo id: OCT01, briefTitle: SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography, acronym: SYMILIS OCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice., conditionsModule conditions: Oral Squamous Cell Carcinoma, conditions: Oral Potentially Malignant Disorder, conditions: Oral Leukoplakia, conditions: Proliferative Verrucous Leukoplakia, conditions: Oral Lichen Planus, conditions: Oral Lichenoid Lesion, conditions: Graft-versus-host-disease, conditions: Oral Erythroplakia, conditions: Actinic Keratoses, conditions: Actinic Cheilitis, conditions: Oral Cancer, conditions: Oral Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: OCT (Optical Coherence Tomography), outcomesModule primaryOutcomes measure: Phase I: Standardization of Biopsy and OCT Imaging Techniques, primaryOutcomes measure: Phase II: Development of Standardized OCT Patterns, Creation of Comprehensive Image Repository, and Training Algorithms, primaryOutcomes measure: Phase III: Development and Large-Scale Validation of Diagnostic OCT Software, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Palermo, status: RECRUITING, city: Palermo, country: Italy, contacts role: CONTACT, phone: 091 238 93011, email: pec@cert.unipa.it, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06320990, orgStudyIdInfo id: 0074-24-CB, briefTitle: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection, acronym: MCN_Tam, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Nebraska, class: OTHER, descriptionModule briefSummary: This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks., conditionsModule conditions: Pancreatic Cyst, conditions: Pancreatic Mucinous Cystic Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Tamoxifen 20mg, outcomesModule primaryOutcomes measure: Feasibility, by adherence rate, primaryOutcomes measure: Feasibility, by retention rate, secondaryOutcomes measure: Objective response rate (ORR) of pancreatic MCN, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Nebraska Medical Center, city: Omaha, state: Nebraska, zip: 68198, country: United States, contacts name: Christina Hoy, DNP, role: CONTACT, email: choy@nebraskamed.com, contacts name: Kelsey Klute, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False
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protocolSection identificationModule nctId: NCT06320977, orgStudyIdInfo id: ESS/FSA-397/23-2, briefTitle: The Influence of Acute Static Stretching on the Ankle Joint-position Sense of Soccer Players, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-03-13, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University Fernando Pessoa, class: OTHER, descriptionModule briefSummary: The aim of this study isto investigate the influence of acute static stretching on the ankle joint position sense of soccer players., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule interventions name: Static Stretching, outcomesModule primaryOutcomes measure: Absolute angular error, primaryOutcomes measure: Relative angular error, primaryOutcomes measure: Variable angular error, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Escola Superior de Saúde Fernando Pessoa, city: Porto, zip: 4200-253, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False
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protocolSection identificationModule nctId: NCT06320964, orgStudyIdInfo id: R01HD108252_1, secondaryIdInfos id: R01HD108252, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HD108252, briefTitle: The TARANG Intervention, acronym: TARANG Pilot, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-14, primaryCompletionDateStruct date: 2024-01-21, completionDateStruct date: 2024-01-21, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Network for Engineering and Economics Research and Management, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: Vikalp Sansthan, descriptionModule briefSummary: The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial., conditionsModule conditions: Feasibility, conditions: Acceptability, conditions: Family Planning, conditions: Unintended Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ACTUAL, armsInterventionsModule interventions name: TARANG, outcomesModule primaryOutcomes measure: Feasibility of the intervention, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Usefulness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vikalp Sansthan, city: Udaipur, state: Rajasthan, country: India, geoPoint lat: 24.58584, lon: 73.71346, hasResults: False
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protocolSection identificationModule nctId: NCT06320951, orgStudyIdInfo id: 300012681, secondaryIdInfos id: Pending, type: OTHER, domain: Pending, briefTitle: VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway, acronym: VITAL-IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals., conditionsModule conditions: Cardiovascular Diseases, conditions: Insulin Sensitivity/Resistance, conditions: Metabolic Disease, conditions: Metabolism, conditions: Energy Expenditure, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Vericiguat 10 MG, interventions name: Placebo, interventions name: Insulin Sensitivity Test, interventions name: Resting Energy and Exercise Energy Expenditure Assessment, interventions name: White Adipose Tissue Biopsy, interventions name: MRI-PET Scan for Brown Adipose Tissue Volume Assessment, outcomesModule primaryOutcomes measure: Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance., primaryOutcomes measure: Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in BAT volume after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in BAT activity after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
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protocolSection identificationModule nctId: NCT06320938, orgStudyIdInfo id: 2024/18, briefTitle: Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Turkoglu Dr. Kemal Beyazit State Hospital, class: OTHER, descriptionModule briefSummary: The effectiveness of neuroscience-based pain education, myofascial induction technique, and home exercise programs will be compared in patients with chronic neck pain., conditionsModule conditions: Cervical Spine Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Neuroscience-Based Pain Education Combined with Home Exercise Program, interventions name: Myofascial Induction Techniques Combined with Home Exercise Program, interventions name: Home Exercises Group, outcomesModule primaryOutcomes measure: Short Form McGill Pain Questionnaire, primaryOutcomes measure: Algometric Digital Measurement, primaryOutcomes measure: Central Sensitization Inventory, primaryOutcomes measure: Head Posture Evaluation, primaryOutcomes measure: Neck Disability Index, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: 36-Item Short Form Health Survey Questionnaire, primaryOutcomes measure: Pain Catastrophizing Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Türkoğlu Dr. Kemal Beyazıt State Hospital, city: Kahramanmaraş, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False
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protocolSection identificationModule nctId: NCT06320925, orgStudyIdInfo id: SYK-SM-2022-02, briefTitle: SportsPro: Post-Market Clinical Follow Up Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-05, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Stryker Endoscopy, class: INDUSTRY, descriptionModule briefSummary: Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice), conditionsModule conditions: Shoulder Injuries, conditions: Knee Injuries, conditions: Hip Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Standard of Care Treatment, outcomesModule primaryOutcomes measure: ASES, primaryOutcomes measure: iHOT-12, primaryOutcomes measure: mHHS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Musculoskeletal-Orthopedic Research and Education Foundation, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85023, country: United States, contacts name: Wafa Mohsin, role: CONTACT, email: wafa.mohsin@more-foundation.org, contacts name: Michael Amini, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Steadman Hawkins Clinic Denver, status: RECRUITING, city: Englewood, state: Colorado, zip: 80112, country: United States, contacts name: Lauren Heylmun, role: CONTACT, email: LAUREN.HEYLMUN@CUANSCHUTZ.EDU, contacts name: James Genuario, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.64777, lon: -104.98776, locations facility: TSAOG Orthopaedics & Spine, status: RECRUITING, city: San Antonio, state: Texas, zip: 78258, country: United States, contacts name: Amanda Strickland, role: CONTACT, email: astrickland@brioresearch.org, contacts name: Robert Hartzler, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06320912, orgStudyIdInfo id: TIPS01, briefTitle: Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Shanghai Shenqi Medical Technology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE., conditionsModule conditions: Portal Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 258, type: ESTIMATED, armsInterventionsModule interventions name: The intraparenchymal portal vein covered stent, interventions name: TIPS Covered Stent System GORE, outcomesModule primaryOutcomes measure: Postoperative Stent Patency Rate, secondaryOutcomes measure: Immediate Postoperative Technical Success Rate, secondaryOutcomes measure: Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively, secondaryOutcomes measure: Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively, secondaryOutcomes measure: Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively, secondaryOutcomes measure: All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively, secondaryOutcomes measure: Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively, secondaryOutcomes measure: Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only), secondaryOutcomes measure: Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only), secondaryOutcomes measure: Incidence of Adverse Events/Serious Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern Medical University Nanfang Hospital, city: Guangzhou, state: Guangdong, country: China, contacts name: Jianbo Zhao, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06320899, orgStudyIdInfo id: SpineShape_CH_001, secondaryIdInfos id: BASEC 2023-D0092, type: OTHER, domain: Ethics Committee Bern, briefTitle: Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2031-08-31, completionDateStruct date: 2031-08-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: SpineSave AG, class: INDUSTRY, descriptionModule briefSummary: The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods., conditionsModule conditions: Degenerative Lumbar Spinal Stenosis, conditions: Facet Joint Arthrosis, conditions: Spondylarthritis, conditions: Discopathy, conditions: Degenerative Spondylolisthesis, conditions: Instability Lumbar Spine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: SpineShape System IV straight rod elastic, interventions name: SpineShape System IV straight rod medium, interventions name: SpineShape System IV straight rod stiff, outcomesModule primaryOutcomes measure: VAS Score lower back pain, secondaryOutcomes measure: VAS Score leg pain, secondaryOutcomes measure: walking duration, secondaryOutcomes measure: medication consumption, secondaryOutcomes measure: adverse events, secondaryOutcomes measure: segmental mobility index level, secondaryOutcomes measure: ability to work/ activity (for retirees), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320886, orgStudyIdInfo id: Soh-Med-24-02-05MS, briefTitle: Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The study aims to evaluate the role of Ultrasonography in the diagnosis of the cause of acute abdominal pain in 50 adults presenting in the ER at Sohag University Hospital and compares it to the Computed Tomography scan results of the same patients to discover the superiority of both over the other in the diagnosis of different acute abdomen cases., conditionsModule conditions: Acute Abdomen, conditions: In Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic Test, outcomesModule primaryOutcomes measure: Comparison between the role of Ultrasonography and Computed Tomography in Acute Abdomen diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, Proffesor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06320873, orgStudyIdInfo id: zselcuk1, briefTitle: The Effect of Respiratory on Sports Performance in Archers, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-26, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2022-01-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: Purpose: The physical, physiological, and functional characteristics of archers affect target shooting performance. In our study, we aimed to examine the effect of pulmonary functions and respiratory muscle strength on sports performance in archers.Methods: Our study included 46 (27 female, 19 male) professional archers registered in archery sports clubs. Sociodemographic and physical characteristics were recorded. Pulmonary function test (PFT), respiratory muscle strength, shooting performance test, Moberg-pickup collection test, Nelson hand reaction test, and Fatigue Severity Scale (FSS) were applied to all participants., conditionsModule conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: archery respiratory parameters, outcomesModule primaryOutcomes measure: FEV1 (liter), primaryOutcomes measure: FEV1 (%-percentage), primaryOutcomes measure: FVC (liter), primaryOutcomes measure: FVC (%-percentage), primaryOutcomes measure: FEV1/FVC (percentage), primaryOutcomes measure: Inspiratory muscle test, primaryOutcomes measure: Expiratory muscle test, primaryOutcomes measure: Shooting performance, primaryOutcomes measure: Nelson Hand Reaction Test, primaryOutcomes measure: Moberg-pickup collection test, primaryOutcomes measure: The Fatigue Severity Scale (FSS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Halic University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06320860, orgStudyIdInfo id: IRB231189, briefTitle: FlexStone Enabled Kidney Stone Retrieval, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-09-08, completionDateStruct date: 2024-09-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: EndoTheia, class: INDUSTRY, collaborators name: Vanderbilt University Medical Center, descriptionModule briefSummary: This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets., conditionsModule conditions: Kidney Calculi, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Kidney Stone Retrieval, outcomesModule primaryOutcomes measure: Successful retrieval of kidney stones, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
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protocolSection identificationModule nctId: NCT06320847, orgStudyIdInfo id: Predictbloodpressure, briefTitle: Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Singapore General Hospital, class: OTHER, collaborators name: Nervotec Pte. Ltd., descriptionModule briefSummary: Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied., conditionsModule conditions: Remote Photoplethysmography, Blood Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: rPPG, outcomesModule primaryOutcomes measure: To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations., primaryOutcomes measure: To develop a predictive model in using rPPG for determination of blood pressure., primaryOutcomes measure: To validate this predictive model by comparing blood pressure readings obtained using rPPG with standard procedures such as contact sensors and automated oscillometry., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Singapore General Hospital, status: RECRUITING, city: Singapore, zip: 169608, country: Singapore, contacts name: Hairil Rizal Abdullah, role: CONTACT, phone: 63265428, email: hairil.rizal.abdullah@singhealth.com.sg, contacts name: Hairil Rizal Abdullah, role: PRINCIPAL_INVESTIGATOR, contacts name: Jia Xin Chai, role: SUB_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06320834, orgStudyIdInfo id: PTL-1000294, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06320821, orgStudyIdInfo id: RAKT Version 1.0, briefTitle: RAKT OUTCOME ANALYSIS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2021-08-21, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare outcomes of robot-assisted kidney transplantation and open kidney transplantation. The main questions are- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients, conditionsModule conditions: Kidney Transplantation, conditions: Robotic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: learning curve, secondaryOutcomes measure: renal function, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 110-744, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06320808, orgStudyIdInfo id: STUDY2023_00000449, briefTitle: Evaluating FDA's Proposed Patient Medication Information Handout, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-03-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Carnegie Mellon University, class: OTHER, collaborators name: University of Pittsburgh, descriptionModule briefSummary: The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users.The main questions it aims to answer are:How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension?andHow does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information?Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension., conditionsModule conditions: Knowledge, conditions: Attitude, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information). Participants will complete the same survey questions measuring perceived usefulness and comprehension of the information., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: FDA template PMI, interventions name: Decision Critical PMI, interventions name: Standard Information, outcomesModule primaryOutcomes measure: Perceived difficulty or ease in reading information, primaryOutcomes measure: Perceived usefulness of the medication information guide in making a use decision, primaryOutcomes measure: Perceived usefulness of the medication information guide in taking the medication properly, primaryOutcomes measure: Comprehension, secondaryOutcomes measure: Strength of Evidence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Carnegie Mellon University, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
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protocolSection identificationModule nctId: NCT06320795, orgStudyIdInfo id: IT-MF-000031905, briefTitle: Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device, acronym: SOUNDI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Biocubica srl, class: INDUSTRY, descriptionModule briefSummary: This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders., conditionsModule conditions: OSA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: SOUNDI, outcomesModule primaryOutcomes measure: To evaluate the accuracy of the clinical diagnosis of OSA, primaryOutcomes measure: To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG), secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca, status: RECRUITING, city: Milan, zip: 20149, country: Italy, contacts name: Carolina Lombardi, Prof., role: CONTACT, contacts name: Carolina Lombardi, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-02-15, uploadDate: 2024-03-13T09:06, filename: Prot_000.pdf, size: 2928638, hasResults: False
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protocolSection identificationModule nctId: NCT06320782, orgStudyIdInfo id: 4659262, briefTitle: Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2021-08-23, primaryCompletionDateStruct date: 2023-12-26, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Pernambuco, class: OTHER, collaborators name: Universidade Federal de Pernambuco, descriptionModule briefSummary: The study aims to evaluate the impact of different dietary interventions on abdominal fat components and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue. The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 6 months on abdominal fat deposits and cardiometabolic parameters., conditionsModule conditions: Abdominal Obesity, conditions: Cardiac Disease, conditions: Metabolic Disease, conditions: Cardiometabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 4 interventions distributed in a randomized manner among 4 different groups, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The data analysis and interpretation stage will be carried out by the study coordinator, who will not have knowledge about the allocation of participants among the intervention groups, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Calorie restriction and balanced distribution of macronutrients, interventions name: Calorie restriction and low-carbohydrate diet, interventions name: Calorie restriction and low-fat diet, interventions name: Collective nutritional guidance, outcomesModule primaryOutcomes measure: Thickness, measured in centimeters, of visceral adipose tissue, primaryOutcomes measure: Weight loss measured in kilograms, secondaryOutcomes measure: Serum levels of fasting glucose, secondaryOutcomes measure: Serum levels of Insulin, secondaryOutcomes measure: Serum levels Triglycerides, secondaryOutcomes measure: Serum levels Lipid profile, secondaryOutcomes measure: Serum levels C-reactive protein (hs-CRP), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Isa Galvao Rodrigues, city: Recife, state: PE, zip: 51021120, country: Brazil, geoPoint lat: -8.05389, lon: -34.88111, hasResults: False
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protocolSection identificationModule nctId: NCT06320769, orgStudyIdInfo id: 24101994, briefTitle: Role of Rotational Guided Growth in Management of Increased Femoral Anteversion, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs., conditionsModule conditions: Increased Femoral Anteversion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Plate Technique, outcomesModule primaryOutcomes measure: Gait, secondaryOutcomes measure: Limb length discrepancy, secondaryOutcomes measure: Angular Deformities, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Medicine, Ainshams University, status: RECRUITING, city: Cairo, state: El-Waily, country: Egypt, contacts name: Tarek Hassan Abdelaziz, Professor, role: CONTACT, phone: +201222421760, email: drtarekibrahim@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06320756, orgStudyIdInfo id: 24-WYSA-101, briefTitle: Examining the Feasibility of Wysa in Hindi, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Wysa, class: INDUSTRY, collaborators name: Udaan, descriptionModule briefSummary: The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17)., conditionsModule conditions: Mental Health Issue, conditions: Diabetes Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial with an intervention arm and a control arm., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: Wysa in Hindi, interventions name: Individual and group sessions on topics like motivation, coping, wellbeing, outcomesModule primaryOutcomes measure: Feasibility - Recruitment rate (Proportion of participants who completed consent procedures), primaryOutcomes measure: Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration), primaryOutcomes measure: Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app), primaryOutcomes measure: Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app), primaryOutcomes measure: Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app, primaryOutcomes measure: Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app, secondaryOutcomes measure: Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17), eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Udaan, status: RECRUITING, city: Aurangabad, state: Maharashtra, zip: 431003, country: India, contacts name: Archana Sarda, M.D, role: CONTACT, phone: 9730792405, email: dr.archana.sarda@gmail.com, contacts name: Saumya Sarda, B.A, role: CONTACT, phone: 8698351351, geoPoint lat: 19.87757, lon: 75.34226, hasResults: False
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protocolSection identificationModule nctId: NCT06320743, orgStudyIdInfo id: Low Flow Anaesthesia And NIRS, briefTitle: Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-08-19, completionDateStruct date: 2024-09-19, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur., conditionsModule conditions: Child, Only, conditions: Inhalation; Vapor, conditions: Anesthesia, conditions: Cerebral Oxygenation, conditions: Cerebral Hypoxia, conditions: Peripheral Oxygenation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Cerebral NIRS probe will be attached to the right and left frontotemporal region, and a peripheral NIRS probe will be attached to the inner surface of the forearm and the values will be noted., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: NIRS ,Ventilation parameters, interventions name: Oxygen concentration, outcomesModule primaryOutcomes measure: Near infrared spectroscopy (NIRS), secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: Ventilation parameters, secondaryOutcomes measure: İntraoperative sevoflurane consumption, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, status: RECRUITING, city: Ankara, state: Çankaya, zip: 06800, country: Turkey, contacts name: Rabia Bayar, role: CONTACT, phone: 5393300403, email: rabiabtlbayar@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06320730, orgStudyIdInfo id: 2020-0675, briefTitle: Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-25, primaryCompletionDateStruct date: 2020-08-29, completionDateStruct date: 2021-03-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated., conditionsModule conditions: Acute Kidney Injury, conditions: Hyperglycemia, conditions: Hypoglycemia, conditions: End Stage Liver Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3790, type: ACTUAL, armsInterventionsModule interventions name: Observational study, records of blood glucose level after reperfusion, outcomesModule primaryOutcomes measure: incidence of acute kidney injury, secondaryOutcomes measure: incidence of severe AKI, secondaryOutcomes measure: incidence of chronic kidney disease (CKD), secondaryOutcomes measure: incidence of Major adverse cardiac event (MACE), secondaryOutcomes measure: overall mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jun-Gol Song, city: Seoul, state: Song-pa Gu, zip: 05500, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06320717, orgStudyIdInfo id: I-3574823, briefTitle: AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2026-07-02, completionDateStruct date: 2026-07-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, outcomesModule primaryOutcomes measure: Retrospective prediction of pCR in resectable patients, primaryOutcomes measure: Retrospective prediction of pCR in borderline resectable patients, secondaryOutcomes measure: Survival status, secondaryOutcomes measure: RECIST 1.1 response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Comprehensive Cancer Center, status: RECRUITING, city: Buffalo, state: New York, zip: 14263, country: United States, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
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protocolSection identificationModule nctId: NCT06320704, orgStudyIdInfo id: 01067485392, briefTitle: Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-09-21, completionDateStruct date: 2024-09-21, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Badr University, class: OTHER, descriptionModule briefSummary: Although the number of individuals who are edentulous is declining, a sizable fraction still needs a complete denture for their oral rehabilitation.Tooth loss is an issue in public health that determines quality of life since it is linked to socioeconomic, physiological, and psychological aspects. In patients who are completely edentulous, dental implants have been viewed as a favorable choice for rehabilitation., conditionsModule conditions: Bone Density, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Digital occlusal adjustment using Occulosense digital device, outcomesModule primaryOutcomes measure: Bone Density, primaryOutcomes measure: Bone Density, primaryOutcomes measure: Bone Density, primaryOutcomes measure: Bone Density, eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Badr University in Cairo, status: RECRUITING, city: Cairo, state: القاهرة, country: Egypt, contacts name: Shady Elnaggar, role: CONTACT, email: shady.mahmoud@buc.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06320691, orgStudyIdInfo id: BezmialemVU 1, briefTitle: General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2014-01-10, primaryCompletionDateStruct date: 2017-01-10, completionDateStruct date: 2017-05-25, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively, conditionsModule conditions: Arthroplasty Complications, conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 437, type: ACTUAL, armsInterventionsModule interventions name: Total Hip Arthroplasty, interventions name: General Anesthesia, interventions name: Spinal Anesthesia, outcomesModule primaryOutcomes measure: Mean intraoperative estimated blood loss, primaryOutcomes measure: mean duration of surgery, primaryOutcomes measure: length of hospital stay, primaryOutcomes measure: stem subsidence, primaryOutcomes measure: stem varus/valgus degrees, primaryOutcomes measure: acetabular abduction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezmialem Vakif University, city: Istanbul, zip: 34140, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06320678, orgStudyIdInfo id: Aysun Acun 5, briefTitle: Parenteral Drug Administration Training for Nursing Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bilecik Seyh Edebali Universitesi, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effect of blended self-directed learning with concept mapping on the level of knowledge regarding parenteral drug administration in nursing students. With out-of-class, online, interactive teaching methods, a memorable learning away from complex structure is aimed., conditionsModule conditions: Nursing Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Nursing Students Education, outcomesModule primaryOutcomes measure: Students' knowledge level after blended learning method, eligibilityModule sex: ALL, minimumAge: 17 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bilecik Şeyh Edebali University, status: RECRUITING, city: Bilecik, zip: 11000, country: Turkey, contacts name: Aysun Acun, PhD, role: CONTACT, phone: +905072104506, email: aysun.acun@bilecik.edu.tr, geoPoint lat: 40.14192, lon: 29.97932, hasResults: False
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protocolSection identificationModule nctId: NCT06320665, orgStudyIdInfo id: 2024PI003, briefTitle: Assessment of Sagittal and Vertical Pattern in Correlation With Third Molar Inclusion : A 3D CBCT Analysis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar.Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction).The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence., conditionsModule conditions: Impacted Third Molar Tooth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Radiographic measurement, outcomesModule primaryOutcomes measure: Distance between the occlusal plane and the second molar, primaryOutcomes measure: Angle of the third molar, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320652, orgStudyIdInfo id: CUHospital, briefTitle: Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Copenhagen University Hospital, Hvidovre, class: OTHER, collaborators name: Hvidovre University Hospital, descriptionModule briefSummary: The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses., conditionsModule conditions: Cardiac Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: First, all willing patients who are offered cardiac rehabilitation will comprise the control group. Following a period of implementing the adapted co-created cardiac telerehabilitation intervention. Patients in the control group have access to standard care at the cardiac outpatient clinic program comprising standard center-based cardiac rehabilitation. Patients in the intervention group will, in addition to standard care, be offered an individually tailored family-focused cardiac telerehabilitation developed through a co-creative process., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac telerehabilitation (video consultation and home monitoring), outcomesModule primaryOutcomes measure: Health Literacy Questonnaire, secondaryOutcomes measure: The European Quality of life five dimensions questionnaire, secondaryOutcomes measure: The Iceland-Family Perceived Support Questionnaire, secondaryOutcomes measure: The eHealth Literacy Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320639, orgStudyIdInfo id: UGustaveEiffel, briefTitle: DRIVing Simulator and People With NeuroCognitive Disorders, acronym: DRIVS-NCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-03, primaryCompletionDateStruct date: 2026-10-10, completionDateStruct date: 2026-10-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University Gustave Eiffel, class: OTHER, collaborators name: Hospices Civils de Lyon, descriptionModule briefSummary: The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an "awareness score of driving ability" will be calculated to determine whether the driver correctly assessed his or her performance.Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.2. to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).3. to establish a methodology to identify a driver at risk of dangerous driving.It is mainly an exploratory study however some hypotheses can be made :* The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.* Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs., conditionsModule conditions: Neurocognitive Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Awareness score of driving ability, primaryOutcomes measure: Driving performance variables measured by the driving simulator, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital des Charpennes, status: RECRUITING, city: Villeurbanne, zip: 69100, country: France, contacts name: Marion Giroux, PhD, role: CONTACT, phone: 0472432372, email: marion.giroux@chu-lyon.fr, geoPoint lat: 45.76667, lon: 4.88333, hasResults: False
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protocolSection identificationModule nctId: NCT06320626, orgStudyIdInfo id: 22-571, briefTitle: Pharmacokinetic-guided Dosing of Emicizumab, acronym: DosEmi, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-08, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Kathelijn Fischer, class: OTHER, collaborators name: Erasmus Medical Center, collaborators name: Amsterdam University Medical Center, collaborators name: Leiden University Medical Center, collaborators name: Radboud University Medical Center, collaborators name: Maastricht University Medical Center, collaborators name: University Medical Center Groningen, collaborators name: HagaZiekenhuis, collaborators name: Dutch Society of Haemophilia Patients, descriptionModule briefSummary: The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients., conditionsModule conditions: Hemophilia A With Inhibitor, conditions: Hemophilia A Without Inhibitor, conditions: Hemophilia A, Severe, conditions: Adolescent, conditions: Child, conditions: Adult, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: * PK-guided dosing - Intervention group (12M): Subjects with emicizumab concentration of ≥ 40 μg/mL will receive individualized PK-guided dose reduction of emicizumab targeted at a Ctrough of 30μg/mL. The validated population PK model is based on published population PK and PK/PD modelling studies. (9,10,15)* PK-Guided dosing - Non-intervention group (12M): Subjects with emicizumab concentration of 25-39 μg/mL will continue on their current dose regimen and will be followed according to the same assessment schedule as the Intervention Group. Only subjects with emicizumab plasma concentration \< 25 μg/mL will be adjusted in dosing regimen according to local protocol. These subjects will be followed for selective safety data only., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: Emicizumab - PK-guided dose reduction, interventions name: Emicizumab - Dosis continuation group, interventions name: Emicizumab - Dose adjustment group, outcomesModule primaryOutcomes measure: Proportion of patients without treated bleeds, secondaryOutcomes measure: Proportion of patients without treated bleeds, secondaryOutcomes measure: Proportion of patients without spontaneous joint- or muscle bleeds, secondaryOutcomes measure: Annualized bleeding rate (ABR) of treated bleeds, including joint bleeds and sport-induced bleeds, secondaryOutcomes measure: To compare cost-effectiveness between conventional dosing and individualized PK-guided dosing of emicizumab, secondaryOutcomes measure: To assess the cumulative number of coagulation factor (sc. and/or iv.) of per year., secondaryOutcomes measure: To assess the performance of the population PK model, secondaryOutcomes measure: To investigate whether direct joint health remains stable measured by physical examination when switching to lower-dosed emicizumab compared to conventional treatment, secondaryOutcomes measure: To investigate whether direct joint health remains stable measured by ultrasound when switching to lower-dosed emicizumab compared to conventional treatment, secondaryOutcomes measure: To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment., secondaryOutcomes measure: To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment., secondaryOutcomes measure: To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab., secondaryOutcomes measure: To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab., secondaryOutcomes measure: To investigate whether sports participation are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab., secondaryOutcomes measure: To investigate whether thrombin generation parameters can be used as a pharmacodynamic (PD) biomarker for emicizumab treatment efficacy., secondaryOutcomes measure: To assess and monitor pain during emicizumab administration, eligibilityModule sex: MALE, minimumAge: 1 Year, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud University Medical Center, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525 GA, country: Netherlands, contacts name: Saskia Schols, Dr, MD, role: CONTACT, phone: +310 24 361 8823, email: Saskia.Schols@radboudumc.nl, contacts name: Saskia Schols, Dr, MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Maastricht University Medical Center, status: RECRUITING, city: Maastricht, state: Limburg, country: Netherlands, contacts name: Floor Moenen, Dr, MD, role: CONTACT, phone: +31433876543, email: floor.moenen@mumc.nl, contacts name: Floor Moenen, Dr, MD, role: SUB_INVESTIGATOR, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Amsterdam University Medical Center, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105 AZ, country: Netherlands, contacts name: Michiel Coppens, Dr, MD, role: CONTACT, phone: +31(0)20 566 5964, email: m.coppens@amsterdamumc.nl, contacts name: Michiel Coppens, Dr, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: HagaZiekenhuis, status: RECRUITING, city: Den Haag, state: Zuid-Holland, zip: 2545 CH, country: Netherlands, contacts name: Paula Ypma, MD, role: CONTACT, phone: +310702102620, email: haematologie@hagaziekenhuis.nl, contacts name: Paula Ypma, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Leids Universitair Medisch Centrum, status: RECRUITING, city: Leiden, state: Zuid-Holland, zip: 2300 RC, country: Netherlands, contacts name: Paul den Exter, Dr, MD, role: CONTACT, phone: +31 (0)71 526 1850, email: p.l.den_exter@lumc.nl, contacts name: Paul den Exter, Dr, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Erasmus University Medical Center, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3000CA, country: Netherlands, contacts name: Marjon Cnossen, Dr., MD, role: CONTACT, phone: +31107040113, email: m.cnossen@erasmusmc.nl, contacts name: Marjon Cnossen, Dr. MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: University Medical Center Groningen, status: RECRUITING, city: Groningen, zip: 9700 RB, country: Netherlands, contacts name: Louise Hooimeijer, MD, role: CONTACT, phone: +310-503612740, email: h.l.hooimeijer@umcg.nl, contacts name: Louise Hooimeijer, MD, role: SUB_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, locations facility: University Medical Center Utrecht, status: RECRUITING, city: Utrecht, country: Netherlands, contacts name: Kathelijn Fischer, Dr, MD, role: CONTACT, phone: +31887558450, email: K.Fischer@umcutrecht.nl, contacts name: Konrad van der Zwet, MD, role: CONTACT, phone: +31650124691, email: dosemi@umcutrecht.nl, contacts name: Kathelijn Fischer, Dr, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Konrad van der Zwet, MD, role: SUB_INVESTIGATOR, contacts name: Lize F.D. van Vulpen, Dr, MD, role: SUB_INVESTIGATOR, contacts name: Roger E.G. Schutgens, Prof, MD, role: SUB_INVESTIGATOR, contacts name: Paul van der Valk, MD, role: SUB_INVESTIGATOR, contacts name: Karin P.M. van Galen, Dr, MD, role: SUB_INVESTIGATOR, contacts name: Nanda Uitslager, Msc, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False
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protocolSection identificationModule nctId: NCT06320613, orgStudyIdInfo id: KYLL20240117-2, briefTitle: Effect of Implementing Snap-needle Therapy Combined With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-20, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Weifang Medical University, class: OTHER, collaborators name: Weifang People's Hospital, descriptionModule briefSummary: The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy., conditionsModule conditions: Gastrointestinal Motility, conditions: Postoperative Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture therapy, interventions name: Ginger Acupuncture Point Patch, outcomesModule primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Abdominal distention, primaryOutcomes measure: Abdominal distention, primaryOutcomes measure: Abdominal distention, primaryOutcomes measure: Abdominal distention, primaryOutcomes measure: Abdominal distention, primaryOutcomes measure: Abdominal distention, primaryOutcomes measure: Time to first flatus, secondaryOutcomes measure: Postoperative pain response, secondaryOutcomes measure: Postoperative pain response, secondaryOutcomes measure: Postoperative pain response, secondaryOutcomes measure: Postoperative pain response, secondaryOutcomes measure: Postoperative pain response, secondaryOutcomes measure: Postoperative pain response, secondaryOutcomes measure: Consumption of postoperative analgesic, secondaryOutcomes measure: Consumption of postoperative rescue antiemetic, secondaryOutcomes measure: Time to first defecation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lin Cheng, status: RECRUITING, city: Weifang, state: Shandong, zip: 261000, country: China, contacts name: Lin Cheng, B.S, role: CONTACT, phone: 17667404256, email: 1318216353@qq.com, geoPoint lat: 36.71, lon: 119.10194, hasResults: False
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protocolSection identificationModule nctId: NCT06320600, orgStudyIdInfo id: PDC, briefTitle: Precision Medicine of Diabetes Program in China, acronym: PDC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Second Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients., conditionsModule conditions: Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 120000, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: The currency analysis of diabetes classification, secondaryOutcomes measure: To establish a model for predicting diabetic retinopathy, secondaryOutcomes measure: To establish a model for predicting diabetic kidney disease, secondaryOutcomes measure: To establish a model for predicting diabetic neuropathy, otherOutcomes measure: To establish a model for hypoglycemic therapy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Second Xiangya Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410010, country: China, contacts name: Shuting Yang, role: CONTACT, phone: 15200863137, email: yang_shting@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06320587, orgStudyIdInfo id: AEŞH-EK1-2023-508, briefTitle: The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby., conditionsModule conditions: Kangaroo Care, conditions: Fathers, conditions: Mother-Infant Interaction, conditions: Premature Infant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Kangaroo care practice by both mother and father, interventions name: Kangaroo care practice only mother, outcomesModule primaryOutcomes measure: Mother-To-Infant Bonding Scale, primaryOutcomes measure: Perceived Mother Parenting Self-Efficacy Scale, primaryOutcomes measure: Postnatal Paternal-Infant Attachment Questionnaire, primaryOutcomes measure: Perceived Father Parenting Self-Efficacy Form, primaryOutcomes measure: Physiological parameters of the premature infant: peak heart rate (BPM), primaryOutcomes measure: Physiological parameters of the premature infant: oxygen saturation (%), primaryOutcomes measure: Physiological parameters of the premature infant: body temperature (°C), primaryOutcomes measure: Physiological parameters of the premature infant:Respiration rate (RPM), eligibilityModule sex: ALL, minimumAge: 28 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Ankara Etlik City Hospital, status: RECRUITING, city: Ankara, zip: 06170, country: Turkey, contacts name: Gönül Kurt, Assoc.prof., role: CONTACT, phone: 90(312)304, phoneExt: 3934, email: gonul.kurt@sbu.edu.tr, contacts name: Meryem Büşra Borazan, role: CONTACT, email: busrabrzn.bb@gmail.com, contacts name: Meryem Büşra Borazan, role: SUB_INVESTIGATOR, contacts name: Gönül Kurt, Assoc.prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06320574, orgStudyIdInfo id: 2023-16880, briefTitle: Nurses' Competence in Gastric Ultrasound, acronym: SKILLS-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:• how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.Participants will follow a training involving* theoretical background using e-learning, picture library and lecture* practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer* and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers)., conditionsModule conditions: Gastric Content, conditions: Healthy Volunteers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of required training, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320561, orgStudyIdInfo id: 23485_StrIMuC12, briefTitle: Muscular Changes in the First 12 Weeks After Stroke., acronym: StrIMuC12, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Vrije Universiteit Brussel, class: OTHER, collaborators name: University Ghent, collaborators name: Research Foundation Flanders, descriptionModule briefSummary: The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Longitudinal prospective cohort study, outcomesModule primaryOutcomes measure: Functional Ambulation Categories (FAC)-score, primaryOutcomes measure: Muscle volume, primaryOutcomes measure: Cross-sectional area (CSA), primaryOutcomes measure: Physiological cross-sectional area (pCSA), primaryOutcomes measure: Muscle tickness, primaryOutcomes measure: Fascicle length, primaryOutcomes measure: Muscle length, primaryOutcomes measure: Tendon length, primaryOutcomes measure: Pennation angle, primaryOutcomes measure: Echo Intensity, primaryOutcomes measure: Dynamic muscle morphology, primaryOutcomes measure: Change in cross-sectional area, primaryOutcomes measure: Change in fascicle length, primaryOutcomes measure: Average root mean square (RMS), primaryOutcomes measure: Peak root mean square (RMS), primaryOutcomes measure: Muscle strength, primaryOutcomes measure: Spasticity, primaryOutcomes measure: Lower limb motor impairment, primaryOutcomes measure: Spatiotemporal gait parameters, primaryOutcomes measure: Gait quality, secondaryOutcomes measure: TWIST-score, secondaryOutcomes measure: Knee extension strength, secondaryOutcomes measure: Balance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320548, orgStudyIdInfo id: 0724/2018, briefTitle: The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2020-11-30, completionDateStruct date: 2020-12-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Roma La Sapienza, class: OTHER, descriptionModule briefSummary: The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups., conditionsModule conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 166, type: ACTUAL, armsInterventionsModule interventions name: Low-residue diet, interventions name: Free diet, outcomesModule primaryOutcomes measure: Number of participants who have passage of flatus within the first 24 hours after caesarean section., secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Quality of the surgical field, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sapienza University of Rome, city: Rome, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06320535, orgStudyIdInfo id: VAC096, briefTitle: A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, collaborators name: Bill and Melinda Gates Foundation, collaborators name: University Hospitals Bristol and Weston NHS Foundation Trust, descriptionModule briefSummary: This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults., conditionsModule conditions: Malaria,Falciparum, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: R21/Matrix M™ (Group 1), interventions name: R21/Matrix M™ (Group 2), interventions name: R21/Matrix M™ (Group 3), interventions name: Fine needle aspiration (FNA), outcomesModule primaryOutcomes measure: To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults, primaryOutcomes measure: To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults, primaryOutcomes measure: To compare the humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule with a standard prime-boost regimen in healthy UK adults, otherOutcomes measure: To assess the relationship between vaccination schedule and humoral immune response in participants vaccinated with R21/Matrix-M™ administered in escalating dose, multi-prime vaccination schedules compared with a standard prime-boost regimen, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford, status: RECRUITING, city: Oxford, state: Oxfordshire, zip: OX3 7LE, country: United Kingdom, contacts name: Volunteer Recruitment Co-ordinator, role: CONTACT, phone: 01865611386, email: vaccinetrials@ndm.ox.ac.uk, geoPoint lat: 51.75222, lon: -1.25596, locations facility: University Hospitals Bristol and Weston NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Bristol, zip: BS2 8HW, country: United Kingdom, contacts name: Rajeka Lazarus, DPhil FCRPath, role: CONTACT, email: rajeka.lazarus@uhbristol.nhs.uk, contacts name: Rajeka Lazarus, DPhil FRCPath, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.45523, lon: -2.59665, hasResults: False
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protocolSection identificationModule nctId: NCT06320522, orgStudyIdInfo id: R82053/RE002, briefTitle: Exogenous Ketosis in a Fed and a Fasted State, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, descriptionModule briefSummary: The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state.This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism.As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes.Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal., conditionsModule conditions: Ketosis, conditions: Exogenous Ketosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Ketone Monoester, interventions name: Placebo, outcomesModule primaryOutcomes measure: Plasma β-hydroxybutyrate (βHB) kinetics, primaryOutcomes measure: Plasma glucose kinetics, primaryOutcomes measure: Postprandial de novo lipogenesis (DNL), secondaryOutcomes measure: Plasma biochemistry, secondaryOutcomes measure: Very low-density lipoprotein-triglyceride (VLDL-TG) fatty acid composition, secondaryOutcomes measure: Breath acetone, secondaryOutcomes measure: Urine volume, secondaryOutcomes measure: Urine composition, secondaryOutcomes measure: Indirect calorimetry, secondaryOutcomes measure: Subjective measures of appetite, secondaryOutcomes measure: Subjective measures of gastrointestinal distress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM), status: RECRUITING, city: Oxford, state: Oxfordshire, zip: OX3 7LE, country: United Kingdom, contacts name: Leanne Hodson, PhD, role: CONTACT, phone: 01865 857224, email: leanne.hodson@ocdem.ox.ac.uk, contacts name: Leanne Hodson, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Adam Isherwood, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False
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protocolSection identificationModule nctId: NCT06320509, orgStudyIdInfo id: 49RC23_0417, briefTitle: Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study, acronym: OXYpi, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: Shock state is defined as an acute, life-threatening, circulatory failure with impaired tissue oxygenation (or tissue hypoxia). The cause of the shock state can be septic, anaphylactic, hypovolemic or cardiogenic. Its management is based on etiological treatment and replacement of organ failures. Acute kidney injury (AKI) may be lead by renal hypoxia. Acute kidney injury is frequent in patients admitted to intensive care unit (ICU) and associated with an increased mortality. Serum creatinine is the reference biological marker in the diagnosis of Acute kidney injury. However, its use is limited by a delayed increase in plasma creatinine level in relation to the causal renal agression, at a time when renal tissue damage may already be established. Thus, the identification of a biological marker making it possible to estimate renal hypoxia continuously during a shock could allow us to identify early a situation at risk of evolving into Acute kidney injury.The renal medulla is vulnerable to tissue hypoxia with a risk of acute tubular necrosis. As in situ measurement of mPO2 is not possible in current practice in humans, several studies have shown a positive correlation between variations in mPO2/uPO2 and occurence of Acute kidney injury. In humans, studies have shown a significant association between the reduction in uPO2 in cardiac surgeries and the occurrence of postoperative Acute kidney injury. The aim of the study is to describe the association between uPO2 values and the onset of Acute kidney injury and/or the ocurrence of early recovery of renal function after Acute kidney injury. Any patient in shock (group A) or without shock and requiring urinary catheterization as part of treatment (group B) admitted to the Medical-Intensive Care Unit of Angers University Hospital is eligible for inclusion. After inclusion, a continuous uPO2 measuring probe is introduced with the placement of the urinary probe. uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. uPO2 is also measured by a gasometry on a urine sample on a multi-daily basis. Serum creatinine is collected every 12 hours (twice a day) and diuresis every two hours for 5 days., conditionsModule conditions: Shock Circulatory, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Continuous measurement of uPO2 (both groups), outcomesModule primaryOutcomes measure: A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria, primaryOutcomes measure: B - For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury, secondaryOutcomes measure: In patients in group A, assess the association between uPO2 variation and acute kidney injury, defined by KDIGO criteria, in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock)., secondaryOutcomes measure: In patients in group A with newly occured acute kidney injury, assess the association between uPO2 variation and recovery of acute kidney injury in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock)., secondaryOutcomes measure: In patients in group A, assess the evolution of uPO2 during the first 5 days in patients with and without sepsis, secondaryOutcomes measure: Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received fluid expansion, secondaryOutcomes measure: Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received blood transfusion, secondaryOutcomes measure: In patients with need of increasing Mean Arterial Pressure by increase of norepinephrine doses, describe the evolution of uPO2 according to Mean Arterial Pressure evolution., secondaryOutcomes measure: In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution., secondaryOutcomes measure: Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry., secondaryOutcomes measure: In patients without shock, describe the evolution of uPO2 during the first 5 days., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Angers, city: Angers, zip: 49933, country: France, contacts name: Nicolas Fage, PhD, role: CONTACT, geoPoint lat: 47.46667, lon: -0.55, hasResults: False
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protocolSection identificationModule nctId: NCT06320496, orgStudyIdInfo id: IRR-FLAVIGNY-2021-2, briefTitle: Evaluation of the Effect of a Physical Activity Recovery Stay, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-22, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est, class: OTHER, descriptionModule briefSummary: A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions".In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning., conditionsModule conditions: Children With Cerebral Palsy, conditions: Children With Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnoform test score, secondaryOutcomes measure: KidScreen52 quality-of-life scale score., secondaryOutcomes measure: Impedance measurement, secondaryOutcomes measure: Exercise test on ergometer, secondaryOutcomes measure: Anamnesis, secondaryOutcomes measure: 6-minute walk test, secondaryOutcomes measure: Energy expenditure index, secondaryOutcomes measure: Gluteal bridge, secondaryOutcomes measure: Shirado test, secondaryOutcomes measure: Sorensen test, secondaryOutcomes measure: Timed Up and Down Stairs (TUDS) test, secondaryOutcomes measure: Floor survey test, secondaryOutcomes measure: Mini Bestest : Each of the 14 tests is graded from 0 to 2. "0" represents the lowest functional level and "2" the highest functional level. Maximal score : 28., secondaryOutcomes measure: The Canadian Occupational Performance Measure, secondaryOutcomes measure: A motivational questionnaire, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institut Régional de Médecine Physique et de Réadaptation, status: RECRUITING, city: Nancy, zip: 54000, country: France, contacts name: Jonathan Pierret, PhD, role: CONTACT, phone: +33 3 82 52 6761, email: jonathan.pierret@ugecam.assurance-maladie.fr, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
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protocolSection identificationModule nctId: NCT06320483, orgStudyIdInfo id: BT-01-23, briefTitle: Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bark Technology LLP, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period., conditionsModule conditions: Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 310, type: ESTIMATED, armsInterventionsModule interventions name: Vibroacoustic device BARK VibroLUNG, outcomesModule primaryOutcomes measure: Partial pressure of oxygen (PaO2), primaryOutcomes measure: Partial pressure of carbon dioxide (PaCO2), primaryOutcomes measure: Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation), primaryOutcomes measure: Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2, primaryOutcomes measure: Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2, primaryOutcomes measure: ROX Index, primaryOutcomes measure: P/F index (ratio of arterial blood PO2 to oxygen fraction), secondaryOutcomes measure: pH of blood, secondaryOutcomes measure: BE (base excess) of blood, secondaryOutcomes measure: CBC indicators (hemoglobin), secondaryOutcomes measure: CBC indicators (hematocrit), secondaryOutcomes measure: CBC indicators (platelets), secondaryOutcomes measure: Coagulogram indicators (prothrombin time), secondaryOutcomes measure: Coagulogram indicators (prothrombin index), secondaryOutcomes measure: Coagulogram indicators (international normalized ratio), secondaryOutcomes measure: Coagulogram indicators (fibrinogen), secondaryOutcomes measure: Coagulogram indicators (activated partial thromboplastin time), secondaryOutcomes measure: Number of days spent in the high dependency unit (intensive care ward in the department), secondaryOutcomes measure: Number of days in hospital, secondaryOutcomes measure: Number of days of O2 support, secondaryOutcomes measure: Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JSC "National Research Cardiac Surgery Center", status: RECRUITING, city: Astana, country: Kazakhstan, contacts name: Makhabbat Sansyzbaeva, role: CONTACT, phone: +7(7172)703158, email: cardiacsurgery@heartcenter.kz, contacts name: Timur Sayranovich, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.1801, lon: 71.44598, locations facility: State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center", status: RECRUITING, city: Atyrau, country: Kazakhstan, contacts name: Marat Konysov, role: CONTACT, phone: +7(7122)50-69-26, email: cardiocenter@atyraumed.kz, contacts name: Zhangeldy Kadirov, role: SUB_INVESTIGATOR, geoPoint lat: 47.11667, lon: 51.88333, locations facility: State-owned public enterprise with the right of economic management "Regional Cardiology Center", status: RECRUITING, city: Oral, country: Kazakhstan, contacts name: Aktilek Umirbaev, role: CONTACT, phone: + 7701 338 35 04, email: kardio-zko@mail.ru, contacts name: Daniyar Arenov, role: SUB_INVESTIGATOR, geoPoint lat: 51.23333, lon: 51.36667, locations facility: State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center", status: RECRUITING, city: Pavlodar, country: Kazakhstan, contacts name: Gulzhanat Dzhakova, role: CONTACT, phone: +7(7182)39-08-00, email: info@cardiomedical.kz, contacts name: Inna Glowacka, role: SUB_INVESTIGATOR, geoPoint lat: 52.28333, lon: 76.96667, locations facility: State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital", status: RECRUITING, city: Ust-Kamenogorsk, country: Kazakhstan, contacts name: Erlan Burkutov, role: CONTACT, phone: +7(7232)25-60-34, email: vko_obl@mail.ru, contacts name: Olesya Subbotina, role: SUB_INVESTIGATOR, geoPoint lat: 49.97143, lon: 82.60586, hasResults: False
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protocolSection identificationModule nctId: NCT06320470, orgStudyIdInfo id: HUM00231159a, secondaryIdInfos id: VMR2022-03, type: OTHER_GRANT, domain: Michigan, State of, Licensing and Regulatory Affairs, Department of 573000, briefTitle: MIVetsCan: Can-Coach Trial (Phase 1), statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-07, primaryCompletionDateStruct date: 2023-12-11, completionDateStruct date: 2023-12-11, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Michigan, State of, Licensing and Regulatory Affairs, descriptionModule briefSummary: The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Educational Session, outcomesModule primaryOutcomes measure: Patient Global Impression of Change (PGIC) score, secondaryOutcomes measure: Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction., secondaryOutcomes measure: Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06320457, orgStudyIdInfo id: 2024-00095, briefTitle: A Brief Case Management Intervention for People Involuntarily Admitted to a Psychiatric Hospital, acronym: CARP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-10-21, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Lausanne Hospitals, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:* Is the case management intervention acceptable and feasible?* What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?Participants will be asked to take part in:* the five sessions of the case management intervention;* two evaluation sessions (pre and post-intervention);* a final in-depth semi-structured interview (optional)., conditionsModule conditions: Psychiatric Disorder, conditions: Involuntary Psychiatric Hospitalization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Brief case management intervention, outcomesModule primaryOutcomes measure: Eligibility rate, primaryOutcomes measure: Participation rate, primaryOutcomes measure: Drop-out rate, primaryOutcomes measure: Intervention dosage, primaryOutcomes measure: Missing data rates, primaryOutcomes measure: Number of unexpected adverse events, primaryOutcomes measure: Participants' acceptance and degree of satisfaction, primaryOutcomes measure: Implementation barriers and facilitating factors, secondaryOutcomes measure: Recovery Assessment Scale (RAS), secondaryOutcomes measure: Empowerment Scale, secondaryOutcomes measure: Rosenberg Self-Esteem Scale (RSS), secondaryOutcomes measure: The Paradox of Self-Stigma scale (PaSS-24), secondaryOutcomes measure: Beck Hopelessness Scale (BHS), secondaryOutcomes measure: WHOQOL-BREF, secondaryOutcomes measure: International Trauma Questionnaire (ITQ), secondaryOutcomes measure: Coercion Ladder (CL), secondaryOutcomes measure: Index of fairness and Index of effectiveness, secondaryOutcomes measure: Satisfaction with hospital care, secondaryOutcomes measure: Brief INSPIRE scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lausanne University Hospital, city: Lausanne, state: Canton Of Vaud, zip: 1003, country: Switzerland, contacts name: Stéphane Morandi, role: CONTACT, phone: +41 21 3140050, email: stephane.morandi@chuv.ch, contacts name: Stéphane Morandi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
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protocolSection identificationModule nctId: NCT06320444, orgStudyIdInfo id: CRFSJ0297, briefTitle: Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, collaborators name: Motor Neurone Disease Association, UK, collaborators name: Irish Research Council, IE, collaborators name: Health Research Board, IE, collaborators name: Research Motor Neurone, IE, collaborators name: Thierry Latran Foundation, FR, collaborators name: ALS Association, USA, descriptionModule briefSummary: Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS., conditionsModule conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis, conditions: Motor Neuron Disease Progressive Spinal Muscle Atrophy, conditions: Primary Lateral Sclerosis, conditions: Multiple Sclerosis, conditions: Postpoliomyelitis Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG), outcomesModule primaryOutcomes measure: Biomarker of sensorimotor integration, primaryOutcomes measure: Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS, primaryOutcomes measure: Non-invasive recording of the SC functional neuro-electric activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, status: RECRUITING, city: Dublin, state: Leinster, zip: Dublin 2, country: Ireland, contacts name: Orla Hardiman,, BSc MB BCh BAO MD FRCPI FAAN, role: CONTACT, phone: +353 1 896 4497, email: hardimao@tcd.ie, contacts name: Prabhav Mehra, BE MSc, role: CONTACT, phone: +3530894781347, email: mehrap@tcd.ie, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False
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protocolSection identificationModule nctId: NCT06320431, orgStudyIdInfo id: ACT-WHEN-001, briefTitle: ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632, acronym: ACT-WHEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2030-09-30, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: The George Institute for Global Health, Australia, descriptionModule briefSummary: This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.This domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all.2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg).4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging., conditionsModule conditions: Acute Ischemic Stroke AIS, conditions: Stroke Acute, conditions: Stroke, Acute, Stroke Ischemic, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization will be stratified by: (1) planned emergency endovascular thrombectomy (EVT) and (2) known use or history to suggest use of a standard-dose direct oral anticoagulant (DOAC) within the last 24 hours. Randomization will be centralized, secure and concealed, using a web-based server and permuted blocks of varying sizes will be used.This will result in four pre-defined strata: (i) EVT+ / DOAC+ (ii) EVT+ / DOAC- (iii) EVT- / DOAC+ and (iv) EVT- / DOAC-.Patients in strata 1, 2 and 3 will be randomized to standard-dose IV tenecteplase (0.25 mg/kg body weight) vs. Low-dose tenecteplase (0.18 mg/kg body weight) or no IV thrombolysis (1:1:1 randomization). Patients in strata 4 will be randomized to standard-dose intravenous (IV) tenecteplase (0.25 mg/kg body weight) vs. Low-dose IV tenecteplase (0.18 mg/kg body weight) only (1:1 randomization).Emergency EVT is defined as anticipated arterial puncture time in the enrolling hospital ≤ 60 minutes from randomization., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The trial will have allocation concealment and blinded endpoint assessment, but open-label treatment. Given the time sensitive nature of acute stroke treatment, blinding the enrolling personnel to treatment assignment is not practical. Clinical site staff, including the Principal Investigator (PI), sub-investigators, clinic site staff, and the Sponsor will not be blinded to treatment allocated or received. In the event of an emergency the PI will be already unblinded.The trial will have blinded endpoint assessment on Day 90, with central blinded assessors contacting the participants., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Tenecteplase, outcomesModule primaryOutcomes measure: A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS),, secondaryOutcomes measure: 90-day mortality, secondaryOutcomes measure: Proportion of participants with a Modified Rankin Scale (mRS) of 0-1 at Day 90., secondaryOutcomes measure: Proportion of participants with a Modified Rankin Scale (mRS) of 0-2 at Day 90., secondaryOutcomes measure: Health-related quality of life, as measured by the EQ-5D-5L at Day 90., secondaryOutcomes measure: The frequencies of Serious Adverse Events (SAEs) from enrollment up to Day 4, secondaryOutcomes measure: Symptomatic intracranial hemorrhage, secondaryOutcomes measure: Large parenchymal hemorrhage (PH-2), secondaryOutcomes measure: Ordinal shift of 7 levels of mRS at 90 days, secondaryOutcomes measure: Proportion of participants achieving first pass (eTICI 2c or higher) reperfusion (when treated with EVT)., secondaryOutcomes measure: Proportion of participants achieving successful recanalization (revised arterial occlusive lesion [rAOL] score of 2b-3) at first angiographic acquisition (when treated with EVT)., secondaryOutcomes measure: Ambulatory status at discharge, secondaryOutcomes measure: Place of residence at 90 days, secondaryOutcomes measure: Imaging assessment (e.g., infarct size and edema volume), secondaryOutcomes measure: Summative total length of hospital stay in the first 90-days after stroke onset, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The George Institute for Global Health, city: Sydney, state: Barangaroo, zip: NSW 2000, country: Australia, contacts name: Xiaoying Chen, PHD, role: CONTACT, email: xchen@georgeinstitute.org.au, contacts name: Craig Anderson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.86785, lon: 151.20732, locations facility: University of Calgary, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, contacts name: Carol C Kenney, RN, role: CONTACT, phone: 4039444286, email: ckenney@ucalgary.ca, contacts name: Michael D Hill, MD, role: CONTACT, email: michael.hill@ucalgary.ca, contacts name: Michael D Hill, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
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protocolSection identificationModule nctId: NCT06320418, orgStudyIdInfo id: RHDIRB2020110301REC#196, briefTitle: The Epigenetic Regulatory Role of P-element Induced Wimpy Testis (Piwi) Interacting RNA-823 (piR-823) in Ovarian Cancer Progression, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-15, primaryCompletionDateStruct date: 2023-12-10, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Ovarian cancer (OC) has one of the highest mortality rates for female malignant tumors, attributed to advanced cancer stages upon diagnosis as well as a high recurrence rate. Piwi-interacting RNA-823 (piR-823) is a single-stranded non-protein coding RNA (ncRNA) star molecule in epigenetics research. Extensive cellular regulatory functions and aberrant expression of piR-823 have been implicated in carcinogenesis. Therefore, the findings of piwi-ncRNA dysregulated-expression in OC Egyptian female patients' cohort could be employed as a potential novel mechanism for OC precision, a step toward ncRNA-precision, conditionsModule conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Association of piR-823 expression with ovarian cancer progression, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab, city: Cairo, zip: 11566, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06320405, orgStudyIdInfo id: STUDY00025940, secondaryIdInfos id: NCI-2024-01397, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00025940, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: Incyte Corporation, descriptionModule briefSummary: This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors., conditionsModule conditions: Advanced Malignant Solid Neoplasm, conditions: Metastatic Malignant Solid Neoplasm, conditions: Recurrent Malignant Solid Neoplasm, conditions: Refractory Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Axatilimab, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Paclitaxel, interventions name: Positron Emission Tomography, interventions name: Retifanlimab, outcomesModule primaryOutcomes measure: Incidence of dose limiting toxicities (phase Ib), primaryOutcomes measure: Recommended phase 2 dose of the study drug combination (phase Ib), primaryOutcomes measure: Clinical benefit rate (phase Ib/II), secondaryOutcomes measure: Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs, secondaryOutcomes measure: Changes in immune cell composition and functionality, secondaryOutcomes measure: Change in immune cell population, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Shivaani Kummar, role: CONTACT, phone: 503-494-6594, email: kummar@ohsu.edu, contacts name: Shivaani Kummar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06320392, orgStudyIdInfo id: RHDIRB2020110301 REC#48, briefTitle: Implication of CCR4-NOT Complex Subunit 7 Expression in Natural Killer Cell Resistance in Metastatic Breast Cancer, acronym: CCR4-NOT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Being a mechanistic study, this work aims to figure out "the role of the cytoplasmic mRNA deadenylase CNOT7 expressed protein on NK cell resistance in metastatic BC". In other words, to explore, whether, "CNOT7 contributes to metastasis in Egyptian female metastatic BC patient's cohort, through NK cell resistance, or not.", conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Cytoplasmic mRNA deadenylase CNOT7 protein expression level in metastatic/advanced localized and non-metastatic BC sera using ELISA., primaryOutcomes measure: CNOT7 tissue expression level in BC tissue samples categorized as metastatic vs non-metastatic tumor alongside with adjacent non-tumor tissue margin using immunohistochemistry., primaryOutcomes measure: LAIR-1 protein expression level in BC patients peripheral blood samples using ELISA., eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab, city: Cairo, zip: 11566, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06320379, orgStudyIdInfo id: RB071522, briefTitle: Zypan Functional Dyspepsia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: National University of Natural Medicine, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia., conditionsModule conditions: Dyspepsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Zypan, interventions name: Placebo Comparator, outcomesModule primaryOutcomes measure: Protein Assimilation, primaryOutcomes measure: Protein Assimilation, secondaryOutcomes measure: Mineral concentrations in blood, secondaryOutcomes measure: Mineral concentrations in blood, secondaryOutcomes measure: Fat-soluble vitamin concentration in blood, secondaryOutcomes measure: Fat-soluble vitamins, secondaryOutcomes measure: Leeds Dyspepsia Questionnaire, secondaryOutcomes measure: Leeds Dyspepsia Questionnaire, secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale, secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale, otherOutcomes measure: Microbiota Relative Abundance and Composition, otherOutcomes measure: Microbiota Relative Abundance and Composition, otherOutcomes measure: Blood glucose, otherOutcomes measure: Blood glucose, otherOutcomes measure: Urea Nitrogen, otherOutcomes measure: Urea Nitrogen, otherOutcomes measure: Creatinine, otherOutcomes measure: Creatinine, otherOutcomes measure: Urea Nitrogen to creatinine ratio, otherOutcomes measure: Urea Nitrogen to creatinine ratio, otherOutcomes measure: Sodium, otherOutcomes measure: Sodium, otherOutcomes measure: Potassium, otherOutcomes measure: Potassium, otherOutcomes measure: Chloride, otherOutcomes measure: Chloride, otherOutcomes measure: Carbon Dioxide, otherOutcomes measure: Carbon Dioxide, otherOutcomes measure: Calcium, otherOutcomes measure: Calcium, otherOutcomes measure: Total Protein, otherOutcomes measure: Total Protein, otherOutcomes measure: Albumin, otherOutcomes measure: Albumin, otherOutcomes measure: Globulin, otherOutcomes measure: Globulin, otherOutcomes measure: Albumin to Globulin ratio, otherOutcomes measure: Albumin to Globulin ratio, otherOutcomes measure: Bilirubin, otherOutcomes measure: Bilirubin, otherOutcomes measure: Alkaline Phosphatase, otherOutcomes measure: Alkaline Phosphatase, otherOutcomes measure: aspartate aminotransferase, otherOutcomes measure: aspartate aminotransferase, otherOutcomes measure: Alanine aminotransferase, otherOutcomes measure: Alanine aminotransferase, otherOutcomes measure: Estimated glomerular filtration rate, otherOutcomes measure: Estimated glomerular filtration rate, otherOutcomes measure: White blood cell count, otherOutcomes measure: White blood cell count, otherOutcomes measure: Red blood cell count, otherOutcomes measure: Red blood cell count, otherOutcomes measure: Hemoglobin, otherOutcomes measure: Hemoglobin, otherOutcomes measure: Hematocrit, otherOutcomes measure: Hematocrit, otherOutcomes measure: Mean corpuscular volume, otherOutcomes measure: Mean corpuscular volume, otherOutcomes measure: Mean corpuscular hemoglobin, otherOutcomes measure: Mean corpuscular hemoglobin, otherOutcomes measure: Mean corpuscular hemoglobin concentration, otherOutcomes measure: Mean corpuscular hemoglobin concentration, otherOutcomes measure: Erythrocyte distribution width, otherOutcomes measure: Erythrocyte distribution width, otherOutcomes measure: Platelet count, otherOutcomes measure: Platelet count, otherOutcomes measure: Neutrophils, otherOutcomes measure: Neutrophils, otherOutcomes measure: Band Neutrophils, otherOutcomes measure: Band Neutrophils, otherOutcomes measure: Absolute band neutrophils, otherOutcomes measure: Absolute band neutrophils, otherOutcomes measure: Metamyelocytes, otherOutcomes measure: Metamyelocytes, otherOutcomes measure: Absolute Metamyelocytes, otherOutcomes measure: Absolute Metamyelocytes, otherOutcomes measure: Myelocytes, otherOutcomes measure: Myelocytes, otherOutcomes measure: Absolute Myelocytes, otherOutcomes measure: Absolute Myelocytes, otherOutcomes measure: Promyelocytes, otherOutcomes measure: Promyelocytes, otherOutcomes measure: Absolute Promyelocytes, otherOutcomes measure: Absolute Promyelocytes, otherOutcomes measure: Absolute Neutrophils, otherOutcomes measure: Absolute Neutrophils, otherOutcomes measure: Lymphocytes, otherOutcomes measure: Lymphocytes, otherOutcomes measure: Reactive Lymphocytes, otherOutcomes measure: Reactive Lymphocytes, otherOutcomes measure: Absolute Lymphocytes, otherOutcomes measure: Absolute Lymphocytes, otherOutcomes measure: Monocytes, otherOutcomes measure: Monocytes, otherOutcomes measure: Absolute monocytes, otherOutcomes measure: Absolute monocytes, otherOutcomes measure: Eosinophils, otherOutcomes measure: Eosinophils, otherOutcomes measure: Absolute Eosinophils, otherOutcomes measure: Absolute Eosinophils, otherOutcomes measure: Basophils, otherOutcomes measure: Basophils, otherOutcomes measure: Absolute Basophils, otherOutcomes measure: Absolute Basophils, otherOutcomes measure: Blasts, otherOutcomes measure: Blasts, otherOutcomes measure: Absolute Blasts, otherOutcomes measure: Absolute Blasts, otherOutcomes measure: Nucleated red blood cells, otherOutcomes measure: Absolute Nucleated red blood cells, otherOutcomes measure: Absolute Nucleated red blood cells, otherOutcomes measure: Platelet mean volume, otherOutcomes measure: Platelet mean volume, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Helfgott Research Institute, status: RECRUITING, city: Portland, state: Oregon, zip: 97201, country: United States, contacts name: Anders Gundersen, MS, role: CONTACT, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06320366, orgStudyIdInfo id: 23-1044, secondaryIdInfos id: K24DA058882, type: NIH, link: https://reporter.nih.gov/quickSearch/K24DA058882, briefTitle: Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes., conditionsModule conditions: Methamphetamine Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Sham vs. real Transcranial Magnetic Stimulation (TMS), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participant and all study personnel are blinded., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Sham TMS, interventions name: Active TMS, outcomesModule primaryOutcomes measure: Tolerability, primaryOutcomes measure: Study emergent adverse events, secondaryOutcomes measure: Weeks of continuous abstinence, secondaryOutcomes measure: Days of methamphetamine use, secondaryOutcomes measure: Methamphetamine craving, secondaryOutcomes measure: Methamphetamine craving on visual analog scale, secondaryOutcomes measure: MRI cue craving, secondaryOutcomes measure: MRI resting state, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Joseph T Sakai, MD, role: CONTACT, phone: 303-724-7402, email: joseph.sakai@cuanschutz.edu, contacts name: Kristen M Raymond, BA, role: CONTACT, phone: 303-724-3196, email: kristen.raymond@cuanschutz.edu, contacts name: Joseph T Sakai, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
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protocolSection identificationModule nctId: NCT06320353, orgStudyIdInfo id: CL01860211, briefTitle: Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: R-Pharm, class: INDUSTRY, collaborators name: Data Management 365, collaborators name: Exacte Labs LLC, collaborators name: Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor, descriptionModule briefSummary: The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen.The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy., conditionsModule conditions: Skin Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 266, type: ACTUAL, armsInterventionsModule interventions name: RPH-075, interventions name: Keytruda®, outcomesModule primaryOutcomes measure: The objective response rate (ORR), secondaryOutcomes measure: The disease control rate (DCR), secondaryOutcomes measure: The time to response (TTR), secondaryOutcomes measure: The Duration of response (DOR), secondaryOutcomes measure: The Progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, city: Obninsk, state: Kaluga Region, zip: 249036, country: Russian Federation, geoPoint lat: 55.09681, lon: 36.61006, locations facility: State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of the Krasnodar Territory, city: Krasnodar, state: Krasnodar Territory, zip: 350040, country: Russian Federation, geoPoint lat: 45.04484, lon: 38.97603, locations facility: Regional Budgetary Healthcare Institution "Kursk Oncological Research and Clinical Center named after G.E. Ostroverkhov", city: Kislino, state: Kursk Region, zip: 305524, country: Russian Federation, locations facility: State Budgetary Healthcare Institution of the city of Moscow "Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow", city: Istra, state: Moscow Region, zip: 143515, country: Russian Federation, geoPoint lat: 55.91997, lon: 36.86867, locations facility: The State budgetary healthcare Institution of the Stavropol Territory "Pyatigorsk Interdistrict Oncological Dispensary", city: Pyatigorsk, state: Stavropol Territory, zip: 357502, country: Russian Federation, geoPoint lat: 44.04861, lon: 43.05944, locations facility: The State Autonomous Healthcare Institution of the Sverdlovsk region "Sverdlovsk Regional Oncological Dispensary", city: Ekaterinburg, state: Sverdlovsk Region, zip: 620036, country: Russian Federation, geoPoint lat: 56.8519, lon: 60.6122, locations facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan, city: Ufa, state: The Republic Of Bashkortostan, zip: 450054, country: Russian Federation, geoPoint lat: 54.74306, lon: 55.96779, locations facility: State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z.Segal", city: Kazan, state: The Republic Of Tatarstan, zip: 420029, country: Russian Federation, geoPoint lat: 55.78874, lon: 49.12214, locations facility: Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary of the Ministry of Health of the Udmurt Republic", city: Izhevsk, state: Udmurt Republic, zip: 426009, country: Russian Federation, geoPoint lat: 56.84976, lon: 53.20448, locations facility: State Budgetary Healthcare Institution of the Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary", city: Arkhangelsk, zip: 163045, country: Russian Federation, geoPoint lat: 64.5401, lon: 40.5433, locations facility: State Budgetary Healthcare Institution "Regional Oncological Dispensary", city: Irkutsk, zip: 664035, country: Russian Federation, geoPoint lat: 52.29778, lon: 104.29639, locations facility: Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary", city: Ivanovo, zip: 153040, country: Russian Federation, geoPoint lat: 56.99719, lon: 40.97139, locations facility: Kaluga Region State Budgetary Healthcare Institution "Kaluga Regional Clinical Oncological Dispensary", city: Kaluga, zip: 248007, country: Russian Federation, geoPoint lat: 54.5293, lon: 36.27542, locations facility: State Budgetary healthcare Institution "Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport", city: Kemerovo, zip: 650036, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations facility: Regional State Budgetary Healthcare Institution "Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky", city: Krasnoyarsk, zip: 660133, country: Russian Federation, geoPoint lat: 56.01839, lon: 92.86717, locations facility: State Budgetary Institution of healthcare of the city of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of the City of Moscow", city: Moscow, zip: 108814, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, city: Moscow, zip: 115478, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Healthcare Institution of the city of Moscow "City Clinical Oncological Hospital No. 1 of the Department of Health of the City of Moscow", city: Moscow, zip: 117152, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Autonomous Education Insitution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of Russian Federation (Sechenov University), city: Moscow, zip: 119991, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Branch Office of "Hadassah Medical Ltd", city: Moscow, zip: 121205, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: "Moscow Center for Rehabilitation Treatment" LLC, city: Moscow, zip: 121552, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Medsi Group of Companies JSC, city: Moscow, zip: 123056, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: "Research lab" LLC, city: Moscow, zip: 127521, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Oncological Dispensary", city: Nizhny Novgorod, zip: 603126, country: Russian Federation, geoPoint lat: 56.32867, lon: 44.00205, locations facility: State Budgetary Healthcare Institution of the Novosibirsk region "Novosibirsk Regional Clinical Oncological Dispensary", city: Novosibirsk, zip: 630108, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, locations facility: Budgetary healthcare institution of the Omsk region "Clinical Oncological Dispensary", city: Omsk, zip: 644013, country: Russian Federation, geoPoint lat: 54.99244, lon: 73.36859, locations facility: State Budgetary Healthcare Institution of the Perm Territory "Perm Regional Oncological Dispensary", city: Perm, zip: 614066, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital, city: Saint Petersburg, zip: 188300, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" of the city of St. Petersburg", city: Saint Petersburg, zip: 195271, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: "Euro Cityclinic" LLC, city: Saint Petersburg, zip: 197022, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary", city: Saint Petersburg, zip: 197022, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncological Dispensary", city: Samara, zip: 443031, country: Russian Federation, geoPoint lat: 53.20007, lon: 50.15, locations facility: State Healthcare Institution "Regional Clinical Oncological Dispensary", city: Saratov, zip: 410053, country: Russian Federation, geoPoint lat: 51.54056, lon: 46.00861, locations facility: Regional State Budgetary Healthcare Institution "Smolensk Regional Oncological Clinical Dispensary", city: Smolensk, zip: 214000, country: Russian Federation, geoPoint lat: 54.7818, lon: 32.0401, locations facility: Siberian State Medical University of the Ministry of Healthcare of Russian Federation, city: Tomsk, zip: 634050, country: Russian Federation, geoPoint lat: 56.49771, lon: 84.97437, locations facility: The State Autonomous healthcare Institution of the Tyumen region "Multidisciplinary clinical Medical Center "Medical City", city: Tyumen, zip: 625041, country: Russian Federation, geoPoint lat: 57.15222, lon: 65.52722, hasResults: False
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protocolSection identificationModule nctId: NCT06320340, orgStudyIdInfo id: 07032024, briefTitle: Effectiveness of NMES on Neck Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-15, primaryCompletionDateStruct date: 2021-05-15, completionDateStruct date: 2021-09-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II)., conditionsModule conditions: Chronic Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Exercise, interventions name: Electrotherapy, outcomesModule primaryOutcomes measure: Neck disability, primaryOutcomes measure: Neck disability, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Range of Motion, secondaryOutcomes measure: Range of Motion, secondaryOutcomes measure: Static endurance of cervical deep flexor muscles, secondaryOutcomes measure: Static endurance of cervical deep flexor muscles, secondaryOutcomes measure: Fear of the movement, secondaryOutcomes measure: Fear of the movement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul Aydın University, city: İstanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06320327, orgStudyIdInfo id: 80177, briefTitle: Topical CBD's Effects on Soreness and Performance, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-23, primaryCompletionDateStruct date: 2023-04-27, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Joseph Pastina, class: OTHER, descriptionModule briefSummary: Exercise-induced muscle damage (EIMD) results from unaccustomed exercise and can lead to delayed onset muscle soreness (DOMS). Impairments associated with EIMD and DOMS can result in moderate-to-severe discomfort and hindered performance. Recently, a compound derived from the cannabis plant, cannabidiol (CBD), has been used as a recovery tool for EIMD and DOMS. Despite the rising popularity of CBD products, their effectiveness in mitigating EIMD and DOMS is unknown. Specifically, to the investigators' knowledge, no clinical trials have been completed to assess the effects of topical CBD cream application on soreness, recovery and performance.Therefore, the purpose of the present study was to investigate the effects of CBD cream on DOMS and performance after an intensive lower-body exercise protocol. Specifically, the study's aims were:Aim 1: To assess the effect of topical CBD cream administration on muscle soreness following fatiguing exercise.Hypothesis 1: CBD cream would decrease perceived muscle soreness when compared to a placebo or control (no cream) group.Aim 2: To assess the effect of topical CBD cream administration on muscular performance following fatiguing exercise.Hypothesis 2: Recovery of muscular power would be quicker when CBD cream is applied, compared to a placebo or control (no cream) group.Aim 3: To assess if topical CBD cream has a localized (if any) or systemic effect on muscle soreness.Hypothesis 3: Improvements in muscle soreness would only be observed in localized muscles around where the CBD cream was applied., conditionsModule conditions: Muscle Soreness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The research participant's and research personnel conducting the testing will be blinded to who is in the CBD and placebo groups throughout the study. Those in Group 3 (the control group) will be aware that they are in the control group, as they will be skipping the steps involving cream application. The protocols for Group 1 and Group 2 will be identical and the respective cream will be made available to the testers and participants in identical containers., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Cannabidiol cream, interventions name: Placebo cream, outcomesModule primaryOutcomes measure: Vertical Jump Test, secondaryOutcomes measure: Peak Isokinetic Torque Test, secondaryOutcomes measure: Pressure-Pain Threshold Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Seaton Center Building, city: Lexington, state: Kentucky, zip: 40502, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Multidisciplinary Science Building, city: Lexington, state: Kentucky, zip: 40536, country: United States, geoPoint lat: 37.98869, lon: -84.47772, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-08-04, uploadDate: 2024-03-13T17:59, filename: ICF_000.pdf, size: 187622, hasResults: False
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protocolSection identificationModule nctId: NCT06320314, orgStudyIdInfo id: LRP23021-E serum, briefTitle: Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-05-22, completionDateStruct date: 2024-05-22, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cosmetique Active International, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo., conditionsModule conditions: Hyperpigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: tested product (2039125 03), outcomesModule primaryOutcomes measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP), primaryOutcomes measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma, primaryOutcomes measure: Post-Acne Hyperpigmentation Index (PAHPI), secondaryOutcomes measure: colorimetry measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PhDTrials Center, status: RECRUITING, city: Lisboa, country: Portugal, contacts name: Pedro Pinto, role: CONTACT, phone: +351 216034267, phoneExt: 501, email: geral@phdtrials.com, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False
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protocolSection identificationModule nctId: NCT06320301, orgStudyIdInfo id: SYSKY-2024-027-01, briefTitle: Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, collaborators name: Suzhou Suncadia Biopharmaceuticals Co., Ltd., descriptionModule briefSummary: Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX)., conditionsModule conditions: Biliary Tract Cancer, conditions: Gemox Chemotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab + GEMOX + TKI, outcomesModule primaryOutcomes measure: the effectiveness of first-line treatment with Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX) in patients with advanced BTC, secondaryOutcomes measure: To assess the progression-free survival (PFS), secondaryOutcomes measure: To evaluate the time to progression (TTP), secondaryOutcomes measure: To evaluate the disease control rate (DCR),, secondaryOutcomes measure: To evaluate the objective response rate (ORR), secondaryOutcomes measure: To evaluate the duration of response (DoR), secondaryOutcomes measure: To evaluate the overall survival (OS)., otherOutcomes measure: To explore the correlation between biomarkers and the efficacy of the combination regimen., otherOutcomes measure: The PFS based on an immunomodified RECIST (imRECIST）, otherOutcomes measure: The TTP based on an immunomodified RECIST (imRECIST）, otherOutcomes measure: The ORR based on an immunomodified RECIST (imRECIST）, otherOutcomes measure: The DCR based on an immunomodified RECIST (imRECIST）, otherOutcomes measure: The DoR based on an immunomodified RECIST (imRECIST）, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 512000, country: China, contacts name: Junkai Ren, role: CONTACT, phone: 86-18664506517, email: rjk119234@163.com, contacts name: Wenbin Li, role: CONTACT, phone: 86-13602773101, hasResults: False
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protocolSection identificationModule nctId: NCT06320288, orgStudyIdInfo id: IRR-FLAVIGNY-2023-1, briefTitle: Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL), acronym: VERTEBRAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est, class: OTHER, descriptionModule briefSummary: During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP., conditionsModule conditions: Children With Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Trunk and center-of-mass accelerations and acceleration variability, secondaryOutcomes measure: Gait Variability Index, secondaryOutcomes measure: Trunk Control Measurement Scale score (TCMS), secondaryOutcomes measure: Early Clinical Assessment of Balance score, eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institut Régional de Médecine Physique et de Réadaptation, status: RECRUITING, city: Nancy, zip: 54000, country: France, contacts name: Jonathan Pierret, PhD, role: CONTACT, phone: +33 3 82 52 6761, email: jonathan.pierret@ugecam.assurance-maladie.fr, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
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protocolSection identificationModule nctId: NCT06320275, orgStudyIdInfo id: self-efficiency, briefTitle: Fathers' Breastfeeding Self-efficiency, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-07-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cukurova University, class: OTHER, descriptionModule briefSummary: The purpose of this study was planned to examine the effect of the education given through digital storytelling method on fathers' breastfeeding self-efficacy perception. The research is in a quasi-experimental design with no pretest-posttest control group., conditionsModule conditions: FATHER, conditions: BREASTFEEDING, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Storytelling Intervention, outcomesModule primaryOutcomes measure: Breastfeeding Self-Efficacy Scale for Fathers Short Form, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cukurova University, city: Adana, state: Balcalı, zip: 01 330, country: Turkey, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Çukurova, city: Adana, state: Balcalı, zip: 01330, country: Turkey, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Çukurova University, city: Adana, zip: 01330, country: Turkey, geoPoint lat: 37.00167, lon: 35.32889, hasResults: False
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protocolSection identificationModule nctId: NCT06320262, orgStudyIdInfo id: NRC/TDF/01/F, briefTitle: Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Rasmia Elgohary, class: OTHER, descriptionModule briefSummary: Fibromyalgia has become one of the most prevalent chronic pain conditions that impair quality of life. Wet cupping has gained increasing popularity in treating painful conditions.This study aims to investigate the effectiveness of wet cupping therapy combined with home-based exercise compared to home-based exercise alone in improving patients diagnosed with primary fibromyalgia syndrome., conditionsModule conditions: Treatment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled drugs, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Wet cupping therapy (WCT), outcomesModule primaryOutcomes measure: Change from baseline brain MRS, secondaryOutcomes measure: Change from baseline Visual Analog Scale (VAS), secondaryOutcomes measure: Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR), secondaryOutcomes measure: Change from the baseline sleep disturbance using the Jenkins sleep score (JSS), secondaryOutcomes measure: Change from baseline Fatigue- VAS., secondaryOutcomes measure: Change from baseline of Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Change from baseline of the Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Change from baseline of the Widespread pain index (WPI), secondaryOutcomes measure: Change from baseline hemoglobin, secondaryOutcomes measure: patient compliance on exercise as instructed, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320249, orgStudyIdInfo id: WJYY-XZKT-2023-05, briefTitle: Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Wangjing Hospital, China Academy of Chinese Medical Sciences, class: OTHER, collaborators name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, collaborators name: Affiliated Hospital of Changchun University of Chinese Medicine, collaborators name: Dongzhimen Hospital, Beijing University of Chinese Medicine, descriptionModule briefSummary: The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial., conditionsModule conditions: Cervical Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This study did not implement blinding for the manipulative therapists and participants. However, blinding procedures were employed for the outcome assessors and data analysts, meaning that they remained unaware of the group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: High-frequency rotation-traction manipulation, interventions name: Low-frequency rotation-traction manipulation, interventions name: Cervical traction, outcomesModule primaryOutcomes measure: The Visual Analog Scale for Pain, secondaryOutcomes measure: The Visual Analog Scale for Pain, secondaryOutcomes measure: The Visual Analog Scale for Pain, secondaryOutcomes measure: The Visual Analog Scale for Pain, secondaryOutcomes measure: The Visual Analog Scale for Pain, secondaryOutcomes measure: The Visual Analog Scale for Pain, secondaryOutcomes measure: The Visual Analog Scale for Numbness, secondaryOutcomes measure: The Visual Analog Scale for Numbness, secondaryOutcomes measure: The Visual Analog Scale for Numbness, secondaryOutcomes measure: The Visual Analog Scale for Numbness, secondaryOutcomes measure: The Visual Analog Scale for Numbness, secondaryOutcomes measure: The Visual Analog Scale for Numbness, secondaryOutcomes measure: The Neck Disability Index, secondaryOutcomes measure: The Neck Disability Index, secondaryOutcomes measure: The Neck Disability Index, secondaryOutcomes measure: The Neck Disability Index, secondaryOutcomes measure: The Neck Disability Index, secondaryOutcomes measure: The Neck Disability Index, secondaryOutcomes measure: The Short Form 12, secondaryOutcomes measure: The Short Form 12, secondaryOutcomes measure: The Short Form 12, secondaryOutcomes measure: The Short Form 12, secondaryOutcomes measure: The Short Form 12, secondaryOutcomes measure: The Short Form 12, secondaryOutcomes measure: The total cost, secondaryOutcomes measure: The recurrence rate, secondaryOutcomes measure: Expectation of Treatment and Credibility Scale, secondaryOutcomes measure: Expectation of Treatment and Credibility Scale, secondaryOutcomes measure: Adverse reactions, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wangjing Hospital, China Academy of Chinese Medical Sciences, city: Beijing, state: Beijing, zip: 100102, country: China, contacts name: Xu Wei, Ph.D, role: CONTACT, phone: 13488716557, email: weixu.007@163.com, contacts name: Tianxiao Feng, Ph.D, role: CONTACT, phone: 15733196045, email: fengtianxiao96@163.com, contacts name: Xu Wei, Ph.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Aifeng Liu, Ph.D, role: SUB_INVESTIGATOR, contacts name: Yanguo Wang, Ph.D, role: SUB_INVESTIGATOR, contacts name: Zhenhua Li, Ph.D, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06320236, orgStudyIdInfo id: 4603, briefTitle: Emergency Medicine Pulmonary Embolism Testing Multicentre Study, acronym: EMPET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Dr. Kerstin de Wit, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although positive results are low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging.We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results.Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism., conditionsModule conditions: Pulmonary Embolism, conditions: D-dimer, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Adjust-Unlikely, outcomesModule primaryOutcomes measure: Venous thrombosis, secondaryOutcomes measure: Venous thrombosis, secondaryOutcomes measure: Index presentation Adjust-Unlikely testing results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kingston Health Sciences Centre, status: RECRUITING, city: Kingston, state: Ontario, zip: K7L 2V7, country: Canada, contacts name: Natasha Clayton, CRA, RA, role: CONTACT, phone: 4165663590, email: natasha.clayton@queensu.ca, contacts name: Kerstin de Wit, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.22976, lon: -76.48101, hasResults: False
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protocolSection identificationModule nctId: NCT06320223, orgStudyIdInfo id: PROMISE PET Registry, briefTitle: PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer, acronym: PROMISE-PET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2034-03-05, completionDateStruct date: 2035-03-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, descriptionModule briefSummary: Background:PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome.Need:Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.Aim:1. To assess the prognostic value of PSMA PET2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stagesInclusion:* Adult patients with* biopsy/histo proven prostate cancer who* underwent PSMA PET (any type)* for staging or re-staging at any stage and who* have at least 3-year overall survival follow-up data available will be included consecutively.Exclusion:* Patients with neuroendocrine prostate cancer* Patients with metastasized or disseminated malignancy other than prostate cancer, conditionsModule conditions: Prostate Cancer, conditions: PET/CT, conditions: Survivorship, conditions: PSMA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Metastasis-free survival, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Essen, status: RECRUITING, city: Essen, zip: 45147, country: Germany, contacts name: Wolfgang P Fendler, M.D., role: CONTACT, phone: +492017232032, email: redcap@ikim.nrw, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False
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protocolSection identificationModule nctId: NCT06320210, orgStudyIdInfo id: IRB19-1308, briefTitle: Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence, acronym: CASCADE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-31, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level., conditionsModule conditions: Asthma in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Multicomponent program, outcomesModule primaryOutcomes measure: Asthma control, secondaryOutcomes measure: Missed work days in parents, secondaryOutcomes measure: Asthma knowledge - parents, secondaryOutcomes measure: Asthma knowledge - child, secondaryOutcomes measure: Asthma quality of life - child, secondaryOutcomes measure: Caregiver quality of life, secondaryOutcomes measure: Asthma impact - parent, secondaryOutcomes measure: Missed school days, secondaryOutcomes measure: Healthcare utilization, secondaryOutcomes measure: Asthma impact - child, eligibilityModule sex: ALL, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago Charter Schools, status: RECRUITING, city: Chicago, state: Illinois, zip: 60640, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06320197, orgStudyIdInfo id: DROWN_INSITU, briefTitle: In Situ Simulation Training in Lifeguard Organisations, acronym: DROWN_INSITU, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: This retrospective study will analyse a dataset consisting of 919 in situ simulation assessments collected between 2018 and 2023 in a Danish nationwide surf lifeguard organisation. The primary objective is to estimate the pass/fail ratio of in situ simulation assessments. The secondary objective is to analyse risk factors associated with a failed assessment. These results may guide future efforts to improve the Danish surf lifeguard training program., conditionsModule conditions: Drowning, conditions: Drowning, Near, conditions: Drowning and Nonfatal Submersion, conditions: Drowning/Submersion, conditions: Drowning and Submersion While in Natural Water, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: In situ simulation assessment, outcomesModule primaryOutcomes measure: Pass/fail ratio of in situ simulation assessments, secondaryOutcomes measure: Risk factors associated with a failed assessment, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, status: RECRUITING, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, contacts name: Niklas Breindahl, MD, role: CONTACT, phone: 004528566410, email: niklas.breindahl@regionh.dk, contacts name: Helle Collatz Christensen, MD, PhD, role: CONTACT, phone: 004521673452, email: helle.collatz.christensen.02@regionh.dk, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06320184, orgStudyIdInfo id: INT 0083/23, briefTitle: AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-30, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, class: OTHER, collaborators name: University of Milano Bicocca, descriptionModule briefSummary: Low-dose computed tomography (LDCT) lung cancer (LC) screening can reduce mortality among heavy smokers, but there is a critical need to better identify people at higher risk and to reduce harms related to management of benign nodules. The most promising strategy is to combine novel tools to optimize clinical decisions and increase the benefit of screening.In this respect, the investigators already demonstrated that the combination of baseline LDCT features with a minimal invasive microRNA blood test was able to more precisely estimate the individual risk of developing LC. The investigators posit that additional immune-related and radiologic features can be integrated with the help of artificial intelligence (AI) to further implement LDCT screening strategies. The project will answer whether the combination of (bio)markers of different origin can predict LC development at baseline and over time, indicate which screen-detected lung nodules are likely to be malignant and ultimately reduce LC and all cause mortality., conditionsModule conditions: Lung Cancer, conditions: Blood Biomarkers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 650, type: ACTUAL, armsInterventionsModule interventions name: Artificial Intelligence risk model, outcomesModule primaryOutcomes measure: Aim 1, secondaryOutcomes measure: Aim 2, secondaryOutcomes measure: Aim 3, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale dei Tumori, city: Milan, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06320171, orgStudyIdInfo id: 240118,2024-481, briefTitle: Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: The study, conducted by the Universidad Europea de Madrid, examines the immediate effects of a single session using NESA microcurrents on various circulatory system variables in healthy subjects. It divides participants into three groups based on session duration (15, 30, 45 minutes), measuring pre and post-intervention changes. The focus is on autonomic nervous system responses, aiming to understand the minimum treatment characteristics needed for significant autonomic changes. Variables studied include systolic and diastolic blood pressure, heart rate, and several ultrasound measurements of the common carotid artery (CSA), including thickness and peak systolic flow velocity., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Non-Invasive neuromodulation, outcomesModule primaryOutcomes measure: Systolic and diastolic Blood Pressure:, primaryOutcomes measure: Heart rate, secondaryOutcomes measure: Ultrasonographic variables: Cross-sectional area of the jugular vein, secondaryOutcomes measure: Ultrasonographic variables:Cross-sectional area of the common carotid, secondaryOutcomes measure: Ultrasonographic variables:Thickness of the common carotid, secondaryOutcomes measure: Ultrasonographic variables:Peak systolic velocity., secondaryOutcomes measure: Cortisol measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06320158, orgStudyIdInfo id: PNRR-MAD-2022-12376672, briefTitle: Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-22, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years., conditionsModule conditions: Sarcopenic Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1108, type: ESTIMATED, armsInterventionsModule interventions name: clinical evaluation of sarcopenic obesity, outcomesModule primaryOutcomes measure: Identifying new molecular markers in elderly patients with sarcopenic obesity, secondaryOutcomes measure: Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 99 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Raffaele, status: RECRUITING, city: Milan, zip: 20132, country: Italy, contacts name: Patrizia Rovere Querini, MD, PhD, role: CONTACT, phone: +390226433065, email: rovere.patrizia@hsr.it, contacts name: Rebecca De Lorenzo, MD, role: CONTACT, phone: +390226433065, email: delorenzo.rebecca@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06320145, orgStudyIdInfo id: P.T.REC/012/004045, briefTitle: Effect of Cryotherapy on Primary Dysmenorrhoea, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-13, primaryCompletionDateStruct date: 2023-09-13, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women.Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature., conditionsModule conditions: Dysmenorrhea Primary, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Cryotherapy, interventions name: core stability exercises, outcomesModule primaryOutcomes measure: Pain assessed by VAS, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy,Cairo University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06320132, orgStudyIdInfo id: BLANDISH, briefTitle: BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage), acronym: BLANDISH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-01-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.Participants will be treated as per standard clinical practice., conditionsModule conditions: Intracranial Hemorrhages, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Treatment of spontaneous intracranial hemorrhage, outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milano, state: MI, country: Italy, contacts name: Francesca Guzzo, MD, role: CONTACT, phone: +393470830669, phoneExt: +390226433333, email: guzzo.francesca@hsr.it, contacts name: Margherita Tozzi, MD, role: CONTACT, phone: +393343138755, phoneExt: +390226433333, email: tozzi.margherita@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06320119, orgStudyIdInfo id: 2943, briefTitle: Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study, acronym: PERSONAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed., conditionsModule conditions: Bronchial Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: PDO Group, outcomesModule primaryOutcomes measure: Primary Outcome. The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group)., secondaryOutcomes measure: Secondary Outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3., secondaryOutcomes measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6., secondaryOutcomes measure: Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1., secondaryOutcomes measure: Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1., secondaryOutcomes measure: Secondary outcome. To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST Papa Giovanni XXIII, status: RECRUITING, city: Bergamo, zip: 24127, country: Italy, contacts name: Fabiano Di Marco, Prof., role: CONTACT, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Azienda ospedaliera Spedali Civili di Brescia, status: RECRUITING, city: Brescia, zip: 25123, country: Italy, contacts name: Laura Pini, Prof., role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale San Martino di Genova, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Fulvio Braido, Prof., role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, status: RECRUITING, city: Milano, zip: 20122, country: Italy, contacts name: Francesco Blasi, Prof., role: CONTACT, phone: +390250320627, email: francesco.blasi@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Fate Bene e Fratelli Sacco, status: RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Pierachille Santus, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Grande Ospedale Metropolitano Niguarda, status: NOT_YET_RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Paolo Tarsia, Prof., role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Santi Paolo e Carlo, status: RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Stefano Centanni, Prof., role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico San Matteo, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Angelo Corsico, Prof., role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale di Rovigo, status: RECRUITING, city: Rovigo, zip: 45100, country: Italy, contacts name: Gianluca Casoni, Dott., role: CONTACT, geoPoint lat: 45.06982, lon: 11.79022, locations facility: Humanitas Hospital - UO Allergologia, status: RECRUITING, city: Rozzano, zip: 20089, country: Italy, contacts name: Enrico Heffler, role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Humanitas Hospital - UO Pneumologia, status: NOT_YET_RECRUITING, city: Rozzano, zip: 20089, country: Italy, contacts name: Stefano Aliberti, Prof., role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Istituti Clinici Scientifici Maugeri, IRCCS Tradate, status: RECRUITING, city: Tradate, zip: 21049, country: Italy, contacts name: Antonio Spanevello, Prof., role: CONTACT, geoPoint lat: 45.70843, lon: 8.90763, hasResults: False
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protocolSection identificationModule nctId: NCT06320106, orgStudyIdInfo id: GIP 1021, briefTitle: Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-07, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives., conditionsModule conditions: Cerebral Palsy, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality baseline assessment, outcomesModule primaryOutcomes measure: Navigation strategy, secondaryOutcomes measure: Learning rate, secondaryOutcomes measure: Simulator Sickness Questionnaire, secondaryOutcomes measure: System Usability Scale, secondaryOutcomes measure: Independent Television Commission-Sense of Presence Inventory, secondaryOutcomes measure: Suitability Evaluation Questionnaire - simplified version, secondaryOutcomes measure: Short-form of PANAS-Positive Affect and Negative Affect Scales, eligibilityModule sex: ALL, minimumAge: 13 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Institute, IRCCS E. Medea, status: RECRUITING, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Emilia Biffi, PhD, role: CONTACT, phone: +39 31877862, email: emilia.biffi@lanostrafamiglia.it, contacts name: Emilia Biffi, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
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protocolSection identificationModule nctId: NCT06320093, orgStudyIdInfo id: INRCA_002_2024, briefTitle: Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia, acronym: SOUND, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-03, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istituto Nazionale di Ricovero e Cura per Anziani, class: OTHER, collaborators name: European Union, descriptionModule briefSummary: The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia., conditionsModule conditions: Dementia, conditions: Older People, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: SOUND Intervention, outcomesModule primaryOutcomes measure: Change in mental wellbeing of patients with dementia, primaryOutcomes measure: Change in cognitive status of patients with dementia, primaryOutcomes measure: Change in stress of health care providers, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: INRCA Hospital, city: Ancona, zip: 60127, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Sons do Estamine Associacao, city: Trofa, country: Portugal, locations facility: Associatia Habilitas, city: Bucarest, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, hasResults: False
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protocolSection identificationModule nctId: NCT06320080, orgStudyIdInfo id: TQB2223-AK105-Ib-01, briefTitle: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: TQB2223 is a recombinant, fully human antibody that binds to lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase Ib study aimed at evaluating the safety, tolerability, and immunogenicity characteristics of TQB2223 injection combined with AK105 injection in the treatment of advanced hepatocellular carcinoma., conditionsModule conditions: Advanced Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: TQB2223 injection, interventions name: Penpulimab Injection, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Number of patients with adverse events (AEs) and/or serious adverse events (SAEs), secondaryOutcomes measure: Immunogenicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Cancer Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Zhiwei Li, Doctor, role: CONTACT, phone: 15004683651, email: lzhw0451@163.com, geoPoint lat: 45.75, lon: 126.65, locations facility: Hubei Provincial Tumor Hospital, city: Wuhan, state: Hubei, zip: 430079, country: China, contacts name: Feng Zhang, Doctor, role: CONTACT, phone: 13871410719, email: zhangfeng_329@126.com, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Provincial Tumor Hospital, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Shanzhi Gu, Master, role: CONTACT, phone: 13574865998, email: 105575191@qq.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06320067, orgStudyIdInfo id: PR12, secondaryIdInfos id: 1006437, type: OTHER, domain: IRAS, briefTitle: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer, acronym: STAMPEDE2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2031-04, completionDateStruct date: 2034-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: Cancer Research UK, collaborators name: Novartis, collaborators name: Janssen Pharmaceutica NV, descriptionModule briefSummary: STAMPEDE2 is a clinical trial comparing three new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial.Each comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care.Participants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment.Comparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR)) - Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison.Comparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617)) - Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison.Comparison N: Arm A(N) versus Arm N (Niraparib-Abiraterone Acetate+Prednisolone (Nira-AA+P)) - Tests whether giving a new drug (Nira-AA+P) slows the spread of the cancer and improves survival. Only people with certain genetic changes in their tumour sample can take part in Comparison N. 682 people will be in this comparison.Participants may be able to take part in more than one comparison.All participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments., conditionsModule conditions: Prostate Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Platform trial testing three research comparisons where patients are randomised either to experimental treatments in Arms S, P and N or their corresponding SoC control Arms A and A(N)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Ablative Body Radiotherapy (SABR), interventions name: 177Lu-PSMA-617, interventions name: Niraparib and Abiraterone Acetate Dual Action Tablet DAT, interventions name: Abiraterone Acetate, interventions name: Apalutamide, interventions name: Androgen Deprivation Therapy (ADT), interventions name: Androgen Receptor Signalling Inhibitor (ARSI), interventions name: Local Radiotherapy, interventions name: Prednisolone, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Radiographic Progression-Free-Survival (rPFS), primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Failure-Free Survival (FFS), secondaryOutcomes measure: Prostate cancer specific survival (PCSS), secondaryOutcomes measure: Safety through reporting of SAEs, secondaryOutcomes measure: Toxicity using CTCAE classification and reporting of all Adverse Events that are ≥ grade 3 or grade 1 and 2 leading to a change in trial treatment, secondaryOutcomes measure: Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development., secondaryOutcomes measure: EQ-5D-5L questionnaire for QoL and cost effectiveness assessment, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320054, orgStudyIdInfo id: PRO00049771, briefTitle: Preventing Obstetric Complications With Dietary Intervention, acronym: PLATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, collaborators name: Advancing a Healthier Wisconsin Endowment, collaborators name: Food for Health, Inc., descriptionModule briefSummary: The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?* Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.Participants in the standard of care will be asked to:* Complete surveys* Biometric screeningsParticipants in the intervention group will be asked to:* Complete surveys* Biometric screenings* Participate in weekly personal health coaching* Receive and consume provided weekly meals.Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth., conditionsModule conditions: Gestational Diabetes, conditions: Gestational Hypertension, conditions: High Risk Pregnancy, conditions: Preeclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Maternal Health Management Program, outcomesModule primaryOutcomes measure: Clinical Outcomes, primaryOutcomes measure: Clinical Outcomes, primaryOutcomes measure: Clinical Outcomes, primaryOutcomes measure: Clinical Outcomes, primaryOutcomes measure: Clinical Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320041, orgStudyIdInfo id: KY-2024-028, briefTitle: Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice.Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Low dose oxelidine group, interventions name: High dose oxelidine group, interventions name: Hydromorphone group, outcomesModule primaryOutcomes measure: Pain score at rest 0-72 hours after surgery, secondaryOutcomes measure: The total amount of opioid after operation., secondaryOutcomes measure: PCIA as a remedial analgesic press time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320028, orgStudyIdInfo id: 019782-00001, briefTitle: Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms, acronym: DMNtFUS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-27, primaryCompletionDateStruct date: 2024-01-03, completionDateStruct date: 2024-06-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Arizona, class: OTHER, collaborators name: Openwater, descriptionModule briefSummary: Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or "too connected", within itself which, in turn, is thought to promote RNT.Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision.The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention., conditionsModule conditions: Depressive Disorder, Major, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will receive the same treatment protocol., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: There is no masking., enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Non-Invasive Transcranial Focused Ultrasound, outcomesModule primaryOutcomes measure: Beck Depression Inventory - II (BDI-II), primaryOutcomes measure: Perseverative Thinking Questionnaire (PTQ), primaryOutcomes measure: Hamilton Depression Rating Scale (HDRS), primaryOutcomes measure: Default Mode Network (DMN) Connectivity, secondaryOutcomes measure: The Montgomery-Åsberg Depression Rating Scale (MADRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Arizona, city: Tucson, state: Arizona, zip: 85721, country: United States, geoPoint lat: 32.22174, lon: -110.92648, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-13, uploadDate: 2024-03-13T20:19, filename: SAP_000.pdf, size: 123058, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-12-22, uploadDate: 2024-01-17T15:37, filename: ICF_001.pdf, size: 159488, hasResults: False
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protocolSection identificationModule nctId: NCT06320015, orgStudyIdInfo id: R01CE003632-01-00, secondaryIdInfos id: R01CE003632, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CE003632, briefTitle: Emergency Medicine Peer Outreach Worker Engagement for Recovery, acronym: EMPOWER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: Rhode Island Hospital, collaborators name: The Miriam Hospital, collaborators name: Brown University, descriptionModule briefSummary: This is an observational, prospective case-control study evaluating the effects of an emergency department community health worker-peer recovery specialist program (PCHW), the Substance Misuse Assistance Response Team (SMART). Aims of this study are to 1) understand participant experiences working with a SMART PCHW and identify possible mechanisms for successful recovery linkage; 2) Evaluate SMART effectiveness on patient-centered outcomes, building recovery capital, and recovery linkage; 3) Evaluate SMART implementation and effectiveness on patient outcomes over time.Using a combination of surveys and data linkages to state administrative databases, study investigators will prospectively compare changes in addiction treatment engagement, recovery capital, health related social needs, acute care utilization, and death between people receiving a ED PCHW and those who do not. After consenting to study participation, participants will complete surveys at time of study enrollment and 3 and 6 months after their initial ED visit. Primary outcomes include engagement in addiction treatment, social services engagement, acute care utilization, and mortality will be assessed through linkages to state administrative databases., conditionsModule conditions: Substance Use Disorders, conditions: Overdose, conditions: Opioid Use Disorder, conditions: Alcohol Use Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Substance Misuse Assistance Response Team (SMART), outcomesModule primaryOutcomes measure: Treatment engagement, primaryOutcomes measure: Recovery Capital, secondaryOutcomes measure: Emergency Department Utilization, secondaryOutcomes measure: Repeat Hospitalization, secondaryOutcomes measure: Repeat Overdose, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Social Services Engagement, secondaryOutcomes measure: Housing Services Engagement, secondaryOutcomes measure: Employment, secondaryOutcomes measure: Incarceration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06320002, orgStudyIdInfo id: 2023P003564, briefTitle: Communication Intervention for Fecal Ostomy Surgery, acronym: CI-oSurg, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention., conditionsModule conditions: Surgery, conditions: Colostomy Stoma, conditions: Ileostomy - Stoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Communication Intervention for fecal ostomy surgery, outcomesModule primaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Intervention Usability, otherOutcomes measure: Emotional Distress, otherOutcomes measure: World Health Organization Brief quality of life evaluation, otherOutcomes measure: Hospital Anxiety and Depression Scale, otherOutcomes measure: Therapy Evaluation Form, otherOutcomes measure: Client Satisfaction Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Christy E Cauley, MD, role: CONTACT, phone: 617-726-8129, email: ccauley@mgb.org, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06319989, orgStudyIdInfo id: IRB202301905, briefTitle: The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-25, primaryCompletionDateStruct date: 2026-03-25, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use., conditionsModule conditions: Educational Problems, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. The procedures for patients in the control group will be guided by conventional single-plane ultrasound., enrollmentInfo count: 281, type: ESTIMATED, armsInterventionsModule interventions name: Biplane Ultrasound, interventions name: Single plane ultrasound, outcomesModule primaryOutcomes measure: First puncture success, secondaryOutcomes measure: Number of Needle redirections, secondaryOutcomes measure: Duration of epidural, secondaryOutcomes measure: Postoperative analgesic use, eligibilityModule sex: MALE, minimumAge: 4 Months, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319976, orgStudyIdInfo id: P.T.REC/012/004883, briefTitle: Effect of Rotator Cuff Training on Hand Grip in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Purpose of the study:* To investigate the effect of rotator cuff training on hand grip strength in adults with different body mass index.* To investigate the effect of rotator cuff training on hand grip static endurance in adults with different body mass index.* To investigate the effect of rotator cuff training on hand grip dynamic endurance in adults with different body mass index.* To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index., conditionsModule conditions: Hand Grasp, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: open chain exercises for rotator cuff muscles, interventions name: Advices for postural correction, outcomesModule primaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Hand grip static endurance, secondaryOutcomes measure: Hand grip dynamic endurance, secondaryOutcomes measure: Upper limb function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319963, orgStudyIdInfo id: Lenti-HPV-07-CT01, briefTitle: A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Theravectys S.A., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).The main questions aim to answer are:* Is Lenti-HPV-07 safe?* Does Lenti-HPV-07 induce an immune response?Participants will be assigned to a group based on their cancer type* either study drug group A: recurrent and/or metastatic cancer* or study drug group B: newly diagnosed with locally advanced cancerAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year., conditionsModule conditions: HPV-Related Cervical Carcinoma, conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase 1/2a, open label, multicenter, dose-escalation and dose expansion trial to assess the safety, tolerability, and preliminary efficacy of Lenti-HPV-07 to participants with HPV associated oropharyngeal squamous cell cancer or cervical cancer. Three dose strengths will be investigated: a low, midlevel, and high dose. Lenti HPV-07 will be administered as either 2 × intramuscular (IM) injections to participants in arm A (recurrent or metastatic stage, refractory to previous treatments) or as a single IM injection to participants in Arm B (newly diagnosed with locally advanced HPV+ cancer never treated). Eligible participants in Arm B will receive only 1 injection of Lenti-HPV-07 prior to the initiation of their standard of care (SoC) therapy. After 18 participants in either arm have been treated in the escalation phase and have completed the 14 day DLT period, the Safety Review Committee and Sponsor will determine the OBD for use in the dose expansion phase., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Two IM injections Lenti-HPV-07, interventions name: One IM injection Lenti-HPV-07, outcomesModule primaryOutcomes measure: Safety and Tolerability, primaryOutcomes measure: OBD, secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: PD-L1 expression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida Cancer Specialists (from Sarah Canon research Institute), city: Orlando, state: Florida, zip: 32827, country: United States, contacts name: Cesar Augusto Perez Batista, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, hasResults: False
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protocolSection identificationModule nctId: NCT06319950, orgStudyIdInfo id: 20240229, briefTitle: High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Taizhou Hospital, class: OTHER, descriptionModule briefSummary: The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis., conditionsModule conditions: Lung Cancer, Nonsmall Cell, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 255, type: ESTIMATED, armsInterventionsModule interventions name: Furmonertinib, interventions name: Osimertinib, outcomesModule primaryOutcomes measure: progression free survival(PFS), secondaryOutcomes measure: objective response rate(ORR), secondaryOutcomes measure: Intracranial objective Response Rate(iORR), secondaryOutcomes measure: Intracranial progression free survival(iPFS), secondaryOutcomes measure: overal survival time(OS), secondaryOutcomes measure: Disease control rate(DCR), secondaryOutcomes measure: Intracranial disease control rate(iDCR), secondaryOutcomes measure: Depth of response (DepOR), secondaryOutcomes measure: Depth of intracranial response(iDepOR), secondaryOutcomes measure: Time to intracranial remission(iTTR), secondaryOutcomes measure: Duration of response(DoR), secondaryOutcomes measure: Duration of intracranial response(iDoR), secondaryOutcomes measure: Rate of improvement in neural function, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Adverse events, otherOutcomes measure: Dynamic changes of ct-DNA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319937, orgStudyIdInfo id: OA2023, briefTitle: Muscle Architecture in Knee Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy)., conditionsModule conditions: Knee Osteoarthritis, conditions: Foot Deformities, conditions: Muscle Weakness, conditions: Kinesiophobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Muscle thickness, primaryOutcomes measure: Pennation angle, primaryOutcomes measure: Fat thickness, secondaryOutcomes measure: Stair climbing test, secondaryOutcomes measure: Sit-stand test, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319924, orgStudyIdInfo id: XIMEPEG-RL, briefTitle: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy, acronym: XIMEPEG-RL, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-02-01, primaryCompletionDateStruct date: 2021-05-31, completionDateStruct date: 2022-09-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hospital St. Joseph, Marseille, France, class: OTHER, descriptionModule briefSummary: Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments., conditionsModule conditions: Colorectal Cancer, conditions: Colonoscopy, conditions: Bowel Preparation Solution, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 601, type: ACTUAL, armsInterventionsModule interventions name: Simethicone combined with Macrogol 4000 (PEG), outcomesModule primaryOutcomes measure: Assess the quality of the bowel preparation assessed by Bubble scale, primaryOutcomes measure: Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS), secondaryOutcomes measure: Colonoscope removal time, secondaryOutcomes measure: The frequency of adverse events (AEs), secondaryOutcomes measure: volume of bowel preparation ingested, secondaryOutcomes measure: Caecal intubation rate, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique des Cèdres, Ramsay Santé,, city: Cornebarrieu, zip: 31700, country: France, geoPoint lat: 43.64895, lon: 1.32407, locations facility: Polyclinique Louis Pasteur,, city: Essey-les-Nancy, zip: 54280, country: France, geoPoint lat: 48.70179, lon: 6.22425, locations facility: Saint Joseph Hospital, city: Marseille, zip: 13008, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: 5. Clinique Ambroise Paré, city: Toulouse, zip: 31082, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Pole Santé des Haberges, city: Vesoul, zip: 70000, country: France, geoPoint lat: 47.63333, lon: 6.16667, hasResults: False
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protocolSection identificationModule nctId: NCT06319911, orgStudyIdInfo id: AETOS 2022.04, briefTitle: AETOS Shoulder System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-08-30, completionDateStruct date: 2030-08-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Smith & Nephew, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization, conditionsModule conditions: Shoulder Osteoarthritis, conditions: Shoulder Arthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: AETOS, outcomesModule primaryOutcomes measure: Implant Survivorship, secondaryOutcomes measure: Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years, secondaryOutcomes measure: Radiographic Assessment - Glenoid Migration/Subsidence, secondaryOutcomes measure: Radiographic Assessment - Glenoid Radiolucency, secondaryOutcomes measure: Radiographic Assessment - Humeral Radiolucency, secondaryOutcomes measure: Radiographic Assessment - Humeral Migration/Subsidence, secondaryOutcomes measure: Radiographic Assessment - Humeral Head Centeredness, secondaryOutcomes measure: Radiographic Assessment - Bone Remodeling, secondaryOutcomes measure: Radiographic Assessment - Glenohumeral Subluxation, secondaryOutcomes measure: Radiographic Assessment - Device Condition: Anatomic, secondaryOutcomes measure: Radiographic Assessment - Device Condition: Reverse, secondaryOutcomes measure: American Shoulder and Elbow Score (ASES), secondaryOutcomes measure: Constant Murley Score, secondaryOutcomes measure: Simple Shoulder Test (SST), secondaryOutcomes measure: Single Assessment Numeric Evaluation (SANE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: California Pacific Orthopedics, status: RECRUITING, city: San Francisco, state: California, zip: 94118, country: United States, contacts name: Katie Sheehi, role: CONTACT, phone: 415-668-8010, email: ksheehi@calpacortho.com, contacts name: James Kelly, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Western Orthopaedics, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80210, country: United States, contacts name: Libby Mauter, role: CONTACT, phone: 303-321-1333, email: lmauter@western-ortho.com, contacts name: Armand Hatzidakis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Hughston Foundation, status: NOT_YET_RECRUITING, city: Columbus, state: Georgia, zip: 31909, country: United States, contacts name: Cholly Minton, role: CONTACT, phone: 706-494-3330, email: cminton@hughston.com, contacts name: Brent Ponce, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Center for Orthopedics and Neurosurgical Care, status: RECRUITING, city: Bend, state: Oregon, zip: 97701, country: United States, contacts name: Cody Manriquez, role: CONTACT, phone: 541-420-0774, email: codymanriquez@gmail.com, contacts name: Scott Jacobson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.05817, lon: -121.31531, locations facility: Rothman Institute, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Brooke Olin, role: CONTACT, phone: 267-516-9393, contacts name: Matthew Ramsey, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06319898, orgStudyIdInfo id: IRB00110787, briefTitle: Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder, acronym: RELAX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, descriptionModule briefSummary: Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population.The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline., conditionsModule conditions: Anxiety, conditions: Pain, conditions: Burnout, Professional, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Lavender aromatherapy sticker, outcomesModule primaryOutcomes measure: Mean change in Visual Analog Scale (VAS) Anxiety Scores, secondaryOutcomes measure: Visual Analog Scale (VAS) Pain during the chemodenervation procedure, secondaryOutcomes measure: Procedure Staff Burnout Scores - Burnout Battery visual analog scale for healthcare worker burnout, secondaryOutcomes measure: Patient satisfaction with their procedure experience Scores, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Megan Tarr, MD, role: CONTACT, phone: 704-304-1160, email: megan.tarr@atriumhealth.org, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06319885, orgStudyIdInfo id: SDU project nr. 3110386, secondaryIdInfos id: ID: 158341, type: OTHER_GRANT, domain: Trygfonden, briefTitle: Text Messaging to Reduce High-risk Alcohol Use Among Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, collaborators name: Anette Søgaard Nielsen, PhD, collaborators name: Kjeld Andersen, PhD, collaborators name: Angelina Mellentin, PhD, collaborators name: Alexis Kuerbis, descriptionModule briefSummary: High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment., conditionsModule conditions: Hazardous Alcohol Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition)., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Text messaging, outcomesModule primaryOutcomes measure: High-risk alcohol use (yes/no), secondaryOutcomes measure: WHOQOL-Bref (The World Health Organization Quality of Life Brief Version ), secondaryOutcomes measure: OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS), secondaryOutcomes measure: Drinker Inventory of Consequences (DrInC-2R), secondaryOutcomes measure: Frequency of alcohol use, secondaryOutcomes measure: Amount of alcohol use, secondaryOutcomes measure: Heavy drinking days, secondaryOutcomes measure: User evaluation (tailor-made), secondaryOutcomes measure: PHQ-9 (Patient Health Questionnaire-9 ), eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319872, orgStudyIdInfo id: STUDY00009118, briefTitle: The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, descriptionModule briefSummary: Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder., conditionsModule conditions: Alcohol Use Disorder, conditions: Retinal Dystrophies, conditions: Age-Related Macular Degeneration, conditions: Retinitis Pigmentosa, conditions: Stargardt Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Oral disulfiram, outcomesModule primaryOutcomes measure: mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS, secondaryOutcomes measure: mean change in total contrast sensitivity score using Pelli-Robson charts, secondaryOutcomes measure: mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment, secondaryOutcomes measure: mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), secondaryOutcomes measure: mean change in fundus autofluorescence (FAF), secondaryOutcomes measure: number of participants with retinal anatomy changes assessed using fundus photos, secondaryOutcomes measure: mean change in visual field perimetry using full-field stimulus test, secondaryOutcomes measure: mean change in isopter constriction using Goldmann visual field, secondaryOutcomes measure: mean change in size of scotomas using Goldmann visual field, secondaryOutcomes measure: mean change in cone and rod latency assessed using Full field electroretinogram (ffERG), secondaryOutcomes measure: mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG), secondaryOutcomes measure: mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG), secondaryOutcomes measure: mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG), secondaryOutcomes measure: mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Flaum Eye Institute, University of Rochester Medical Center, city: Rochester, state: New York, zip: 14642, country: United States, contacts name: Gary Gagarinas, role: CONTACT, email: gary_gagarinas@urmc.rochestere.edu, contacts name: Alex Levin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06319859, orgStudyIdInfo id: N-72-2024, briefTitle: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Morphine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to first analgesic requirement, secondaryOutcomes measure: Nalbuphine consumption, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: The incidence of other adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kasr Alaini hospital, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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