data
stringlengths 358
80.8k
|
|---|
protocolSection identificationModule nctId: NCT06373172, orgStudyIdInfo id: 202005-HR-003, briefTitle: Enhancing Clinical Reasoning Competency, acronym: Reasoning, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-01, primaryCompletionDateStruct date: 2020-06-01, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tongmyong University, class: OTHER, descriptionModule briefSummary: Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education based on the Rasch modelAims: Clinical reasoning is a core nursing competency that involves analyzing patient-related data and providing appropriate nursing practices. Simulation-based education is effective in improving the clinical reasoning competencies and communication skills of nursing students. This study aimed to verify the effectiveness of virtual simulation-based education., conditionsModule conditions: Clinical Reasoning, conditions: Communication, conditions: Development, Human, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This quasi-experimental study used a single-group pretest-posttest design to verify the effectiveness of virtual simulation-based education for undergraduate nursing students., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: virtual simulation-based education program, outcomesModule primaryOutcomes measure: Nurses Clinical Reasoning Scale, primaryOutcomes measure: Communication Skills Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 28 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tongmyong Unoversity, city: Busan, zip: 48520, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, hasResults: False |
protocolSection identificationModule nctId: NCT06373159, orgStudyIdInfo id: 22643, briefTitle: An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.In this study, researchers will assess patient data from a hospital database in Japan.The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.To learn about this, researchers will collect the following information:* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis* The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)* The number of days between diagnosis of sepsis and the beginning of DICResearchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.In this study, only available data from routine care are collected., conditionsModule conditions: Sepsis, conditions: Disseminated Intravascular Coagulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5740, type: ESTIMATED, armsInterventionsModule interventions name: No study intervention, outcomesModule primaryOutcomes measure: Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up, primaryOutcomes measure: Distribution of JAAM DIC score, primaryOutcomes measure: Distribution of ISTH DIC score, primaryOutcomes measure: Distribution of MHLW DIC score, primaryOutcomes measure: Distribution of SOFA score, primaryOutcomes measure: Days from sepsis diagnosis to the onset of DIC, secondaryOutcomes measure: Number of participants per clinical characteristics, secondaryOutcomes measure: Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC, secondaryOutcomes measure: Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC, secondaryOutcomes measure: Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC, secondaryOutcomes measure: Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC, secondaryOutcomes measure: Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC, secondaryOutcomes measure: Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC, secondaryOutcomes measure: Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC, secondaryOutcomes measure: Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC, secondaryOutcomes measure: Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, city: Tokyo, zip: 100-8265, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False |
protocolSection identificationModule nctId: NCT06373146, orgStudyIdInfo id: 18750, secondaryIdInfos id: I8F-MC-GPIV, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Tirzepatide, interventions name: Mibavademab, interventions name: Tirzepatide-Placebo, interventions name: Mibavademab-Placebo, outcomesModule primaryOutcomes measure: Mean Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg), secondaryOutcomes measure: Mean Absolute Change from Baseline for Body Weight (kg), secondaryOutcomes measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction, secondaryOutcomes measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction, secondaryOutcomes measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction, secondaryOutcomes measure: Percentage of Participants Who Achieve ≥20 Body Weight Reduction, secondaryOutcomes measure: Mean Percent Change from Randomization 2 for Body Weight, secondaryOutcomes measure: Mean Change from Randomization 2 for Body Weight (kg), secondaryOutcomes measure: Mean Absolute Change from Randomization 2 for Body Weight (kg), secondaryOutcomes measure: Change from Baseline to Week 24 in CoEQ Scores, secondaryOutcomes measure: Change from Baseline to Week 24 in CoEQ Scores, secondaryOutcomes measure: Change from Baseline in FCQ-T-r Scores, secondaryOutcomes measure: Change from Baseline in FCQ-T-r Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research, Gardena, city: Gardena, state: California, zip: 90247, country: United States, contacts name: Mark T. Leibowitz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.88835, lon: -118.30896, locations facility: Irvine Clinical Research, city: Irvine, state: California, zip: 92614, country: United States, contacts name: Elly R Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.66946, lon: -117.82311, locations facility: National Research Institute - Wilshire, city: Los Angeles, state: California, zip: 90057, country: United States, contacts name: Juan Pablo Frias, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Velocity Clinical Research, North Hollywood, city: North Hollywood, state: California, zip: 91606, country: United States, contacts name: Samuel Penziner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17223, lon: -118.37897, locations facility: Velocity Clinical Research, Panorama City, city: Panorama City, state: California, zip: 91402, country: United States, contacts name: Maricor Grio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.22473, lon: -118.44981, locations facility: Velocity Clinical Research, Santa Ana, city: Santa Ana, state: California, zip: 92704, country: United States, contacts name: Julie Vu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Diablo Clinical Research, Inc., city: Walnut Creek, state: California, zip: 94598, country: United States, contacts name: Bonnie S. Kimmel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.90631, lon: -122.06496, locations facility: Solaris Clinical Research, city: Meridian, state: Idaho, zip: 83646, country: United States, contacts name: David J. Butuk, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61211, lon: -116.39151, locations facility: Tandem Clinical Research, city: Marrero, state: Louisiana, zip: 70072, country: United States, contacts name: Adil Fatakia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.89937, lon: -90.10035, locations facility: Velocity Clinical Research, Metairie, city: Metairie, state: Louisiana, zip: 70006, country: United States, contacts name: Scott P Striplin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Velocity Clinical Research, Norfolk, city: Norfolk, state: Nebraska, zip: 68701, country: United States, contacts name: Charles Harold Harper, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.02834, lon: -97.417, locations facility: Lillestol Research, city: Fargo, state: North Dakota, zip: 58104, country: United States, contacts name: Michael J Lillestol, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87719, lon: -96.7898, locations facility: South Texas Clinical Research, city: Corpus Christi, state: Texas, zip: 78404, country: United States, contacts name: Lloyd Stegemann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.80058, lon: -97.39638, locations facility: Dallas Diabetes Research Center, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Julio Rosenstock, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Northwest Clinical Research Center, city: Bellevue, state: Washington, zip: 98007, country: United States, contacts name: Nazia Rahman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.61038, lon: -122.20068, locations facility: Centro de Investigacion en Artritis y Osteoporosis SC, city: Mexicali, state: Baja California, zip: 21200, country: Mexico, contacts name: Francisco Fidencio Cons Molina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.62781, lon: -115.45446, locations facility: Clínicos Asociados BOCM, city: Mexico City, state: Distrito Federal, zip: 03300, country: Mexico, contacts name: Israel Olvera-Alvarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Unidad biomedica avanzada monterrey, city: Monterrey, state: Nuevo León, zip: 64460, country: Mexico, contacts name: Raymundo Garcia Reza, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Medical Care and Research SA de CV, city: Merida, state: Yucatán, zip: 97070, country: Mexico, contacts name: Carlos Eduardo Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.97537, lon: -89.61696, locations facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos, city: Chihuahua, zip: 31110, country: Mexico, contacts name: Luis Alejandro Nevarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.63528, lon: -106.08889, hasResults: False |
protocolSection identificationModule nctId: NCT06373133, orgStudyIdInfo id: 2024 (82), briefTitle: SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: SHR-8068, interventions name: Adebrelimab, interventions name: BP102, outcomesModule primaryOutcomes measure: Dose-limiting toxicity, primaryOutcomes measure: PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06373120, orgStudyIdInfo id: QX20231057-X-1, briefTitle: Interventional Ventricular Assist System for PCI in CHIP Patients, acronym: REC-CHIPMCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI., conditionsModule conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI), conditions: Left Ventricular Assist Devices, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of CorVad compared to VA-ECMO in complicated and high-risk patient with indications for PCI, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: CorVad, interventions name: VA-ECMO, outcomesModule primaryOutcomes measure: Major adverse event, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Revascularization, secondaryOutcomes measure: Cardiovascular hospitalization, secondaryOutcomes measure: MCS-ARC defined type 3, 4, 5 bleeding, secondaryOutcomes measure: Acute kidney injury, secondaryOutcomes measure: Serious device-related adverse events, secondaryOutcomes measure: Cardiopulmonary resuscitation, secondaryOutcomes measure: Hospitalization time, secondaryOutcomes measure: Intensive care unit (ICU/CCU) stay time, secondaryOutcomes measure: ECMO/Corvad utilization time, secondaryOutcomes measure: Hemodynamic disorder, secondaryOutcomes measure: Transfusion rate, secondaryOutcomes measure: Units of transfusion, otherOutcomes measure: Device-related composite endpoint (DoCE), otherOutcomes measure: Patient-related composite endpoint (PoCE), otherOutcomes measure: Net adverse clinical events, otherOutcomes measure: Cardiac death, otherOutcomes measure: Ischemic stroke, otherOutcomes measure: Hemorrhagic stroke, otherOutcomes measure: Transient ischemic attack, otherOutcomes measure: Target vessel myocardial infarction, otherOutcomes measure: Target lesion revascularization, otherOutcomes measure: Target vessel revascularization, otherOutcomes measure: Clinically and physiologically driven target lesion revascularization (CPI-TLR), otherOutcomes measure: Rehospitalization, otherOutcomes measure: MCS-ARC type 2 bleeding, otherOutcomes measure: Puncture complications, otherOutcomes measure: Aortic valve injury, otherOutcomes measure: Active Infection, otherOutcomes measure: ECMO/Corvad setup time, otherOutcomes measure: Complete revascularization rate, otherOutcomes measure: Change in left ventricular ejection fraction (LVEF) from baseline, otherOutcomes measure: Change in New York Heart Association (NYHA) classification from baseline, otherOutcomes measure: Change in Seattle Angina Questionnaire (SAQ) score from baseline, otherOutcomes measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline, otherOutcomes measure: Change in 5-level EQ-5D version (EQ-5D-5L) standardized health status scale score from baseline, otherOutcomes measure: Change in creatinine clearance rate from baseline, otherOutcomes measure: Stent thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ling Tao, status: RECRUITING, city: Xi'an, state: Shannxi, zip: 710032, country: China, contacts name: Chao Gao, M.D., Ph.D., role: CONTACT, phone: 86-18629551066, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06373107, orgStudyIdInfo id: 2117651-2, briefTitle: Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Alvernia University, class: OTHER, collaborators name: Lehigh Valley Health Network, descriptionModule briefSummary: The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: High intensity gait training, outcomesModule primaryOutcomes measure: 3-meter backwards walk test, primaryOutcomes measure: 6-minute walk test, primaryOutcomes measure: 10-meter walk test, primaryOutcomes measure: Surface electromyography (EMG), primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Functional Gait Assessment, primaryOutcomes measure: Borg Rating Scale of Perceived Exertion (RPE), primaryOutcomes measure: Patient Health Questionnaire (PHQ-9), primaryOutcomes measure: Rate of patient attendance (Compliance) to physical therapy, primaryOutcomes measure: Newest Vital Sign, primaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lehigh Valley Health Network Outpatient Neurologic Rehab, city: Allentown, state: Pennsylvania, zip: 18104-2310, country: United States, contacts name: Sandra M Tremblay, DPT, role: CONTACT, geoPoint lat: 40.60843, lon: -75.49018, hasResults: False |
protocolSection identificationModule nctId: NCT06373094, orgStudyIdInfo id: DON102-CTP, briefTitle: A Single Dose Escalation Study of HHT201 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Shanghai Synergy Pharmaceutical Sciences Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Donepezil Dihydroxynaphthalate for Injection, outcomesModule primaryOutcomes measure: Adverse events, primaryOutcomes measure: Number of Participants With Abnormal Laboratory Values, primaryOutcomes measure: Number of Participants With Abnormal ECG QT Interval, primaryOutcomes measure: Number of Participants With Abnormal Vital signs, primaryOutcomes measure: Number of Participants With Abnormal Physical examination, primaryOutcomes measure: VAS, secondaryOutcomes measure: Cmax of Donepezil, secondaryOutcomes measure: Tmax of Donepezil, secondaryOutcomes measure: AUC0-t of Donepezil, secondaryOutcomes measure: AUC0-∞ of Donepezil, secondaryOutcomes measure: t1/2z of Donepezil, secondaryOutcomes measure: Vz/F, secondaryOutcomes measure: CLz/F, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center), city: Taizhou, state: Zhe Jiang, zip: 318000, country: China, contacts name: Donqing Lv, role: CONTACT, phone: 86-0576-85199816, email: [email protected], contacts name: Zhanrong Ye, role: CONTACT, phone: 86-0576-85199816, email: [email protected], geoPoint lat: 32.49069, lon: 119.90812, hasResults: False |
protocolSection identificationModule nctId: NCT06373081, orgStudyIdInfo id: CD19-CD3E-CN-A1, briefTitle: Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Shanghai Changzheng Hospital, class: OTHER, descriptionModule briefSummary: This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases., conditionsModule conditions: Systemic Lupus Erythematosus (SLE), conditions: Sjogren's Syndrome, conditions: Systemic Sclerosis, conditions: Inflammatory Myopathy, conditions: ANCA Associated Vasculitis, conditions: Antiphospholipid Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Anti-CD19-CD3E-CAR-T cells, outcomesModule primaryOutcomes measure: The incidence of dose-limiting toxicities (DLTs) (Safety), primaryOutcomes measure: Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured, primaryOutcomes measure: Clinical response for relapsed/Refractory SLE, primaryOutcomes measure: Clinical response for Sjögren's Syndrome, primaryOutcomes measure: Clinical response for relapsed/refractory/progressive systemic sclerosis, primaryOutcomes measure: Clinical response for relapsed/refractory/progressive inflammatory myopathy, primaryOutcomes measure: Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis:, primaryOutcomes measure: Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai ChangZheng hospital, status: RECRUITING, city: Shanghai, zip: 200003, country: China, contacts name: Huji Xu, role: CONTACT, phone: 86021-81885514, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06373068, orgStudyIdInfo id: Resuscitation Orders ICU, briefTitle: Association Between Resuscitation Orders and Mortality in ICU Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained., conditionsModule conditions: Critical Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Resuscitation orders, outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373055, orgStudyIdInfo id: 4-2023-1232, briefTitle: Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2033-11, completionDateStruct date: 2033-11, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection., conditionsModule conditions: Muscle-invasive Bladder Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: neoadjuvant chemotherapy followed by radical cystectomy, outcomesModule primaryOutcomes measure: Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles, secondaryOutcomes measure: overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy, secondaryOutcomes measure: cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy, secondaryOutcomes measure: progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy, secondaryOutcomes measure: recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Won Sik Ham, role: CONTACT, phone: 02-2228-2310, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06373042, orgStudyIdInfo id: ADJUVANT-2, briefTitle: Tirofiban for Successful Endovascular Stroke Thrombectomy, acronym: ADJUVANT-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Zhongming Qiu, class: OTHER, collaborators name: The Second Affiliated Hospital of Chongqing Medical University, collaborators name: Mianyang Central Hospital, collaborators name: The Second Hospital of Jiaozuo, collaborators name: Chongzhou People's Hospital, collaborators name: Xihua People's Hospital, collaborators name: Xingguo People's Hospital, descriptionModule briefSummary: Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy.Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate.Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear., conditionsModule conditions: Stroke, Acute Ischemic, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 712, type: ESTIMATED, armsInterventionsModule interventions name: Intraarterial and intravenous tirofiban, interventions name: Intraarterial and intravenous placebo, outcomesModule primaryOutcomes measure: Functional independence, secondaryOutcomes measure: Recanalization on follow-up CTA or MRA, secondaryOutcomes measure: Early neurologic improvement, secondaryOutcomes measure: Level of disability, secondaryOutcomes measure: Excellent outcome, secondaryOutcomes measure: Independent ambulation, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Long-term of disability level, secondaryOutcomes measure: Health-related quality of life (long-term), secondaryOutcomes measure: Incidence of symptomatic intracranial hemorrhage (SICH), secondaryOutcomes measure: Radiologic intracranial hemorrhage rate, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Incidence of non-hemorrhagic serious adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06373029, orgStudyIdInfo id: 2023PHB211-001(2), briefTitle: Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy., conditionsModule conditions: Ultrasound, conditions: Anterior Talofibular Ligament, conditions: Deep Learning, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound examination, outcomesModule primaryOutcomes measure: classification of ATFL injury, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100032, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06373016, orgStudyIdInfo id: 2015P000652, secondaryIdInfos id: 2023005, type: OTHER_GRANT, domain: Baszucki Foundation, briefTitle: Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Stony Brook University, class: OTHER, collaborators name: Massachusetts General Hospital, collaborators name: Mclean Hospital, descriptionModule briefSummary: The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior., conditionsModule conditions: Bipolar Disorder, conditions: Bipolar Disorder Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Glucose, interventions name: Ketones, outcomesModule primaryOutcomes measure: Stabilization of brain networks (general brain functioning), primaryOutcomes measure: Relative stabilization or destabilization of brain networks in response to metabolic bolus, primaryOutcomes measure: Prefrontal-limbic circuit regulation, primaryOutcomes measure: Cortico-striatal circuit regulation, primaryOutcomes measure: Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: McLean Hospital, status: RECRUITING, city: Belmont, state: Massachusetts, zip: 02478, country: United States, contacts name: Dost Ongur, MD PhD, role: CONTACT, phone: 617-855-3922, email: [email protected], contacts name: Virginie-Anne Chouinard, MD, role: CONTACT, phone: 617-855-3034, email: [email protected], contacts name: Dost Ongur, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.39593, lon: -71.17867, locations facility: Martinos Center for Biomedical Research, Building 149, 13th Street, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Lilianne Mujica-Parodi, PhD, role: CONTACT, phone: 631-428-8461, email: [email protected], contacts name: Eva-Maria Ratai, PhD, role: CONTACT, phone: 781-521-4436, email: [email protected], contacts name: Eva-Maria Ratai, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.37787, lon: -71.062, locations facility: Laufer Center for Physical and Quantitative Biology, Stony Brook University, status: ACTIVE_NOT_RECRUITING, city: Stony Brook, state: New York, zip: 11794, country: United States, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False |
protocolSection identificationModule nctId: NCT06373003, orgStudyIdInfo id: SNAPSITA, briefTitle: Negative Antiphospholipid Syndrome: a Multicentric Study, acronym: SNAPSITA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Italian Society for Rheumatology, class: OTHER, descriptionModule briefSummary: Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.The recruited patients have the following criteria:(i)Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS) or patients with seronegative APS (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS; (ii) Age \<65 years; (iii) less than 5 years from the first event to the beginning of the study., conditionsModule conditions: Antiphospholipid Syndrome, conditions: Seronegative Antiphospholipid Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic accuracy, outcomesModule primaryOutcomes measure: Primary endpoint, secondaryOutcomes measure: Secondary endpoint_1, secondaryOutcomes measure: Secondary endpoint_2, secondaryOutcomes measure: Secondary endpoint_3, otherOutcomes measure: Exploratory Endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOC di Reumatologia - AOU Policlinico Umberto I, "Sapienza" Università di Roma, status: RECRUITING, city: Roma, state: Rome, zip: 00185, country: Italy, contacts name: Simona Truglia, MD, role: CONTACT, phone: 06 49974631, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06372990, orgStudyIdInfo id: 0015338, briefTitle: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease, acronym: BDTc, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: Duke-NUS Medical School (Singapore), descriptionModule briefSummary: Prospective, non-pharmacological, single-center, non-profit observational study.The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay., conditionsModule conditions: HBV, conditions: HBV/HDV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay, secondaryOutcomes measure: Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV, secondaryOutcomes measure: Correlate the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis), disease severity (cirrhosis vs. non-cirrhosis) and response to specific HBV and HBV-HDV therapies, secondaryOutcomes measure: Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy., city: Milano, state: MI, zip: 20122, country: Italy, contacts name: Pietro Lampertico, MD, role: CONTACT, phone: 0255035432, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06372977, orgStudyIdInfo id: kappa index in ms, briefTitle: Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To:1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis), conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: kappa index, outcomesModule primaryOutcomes measure: Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases ., primaryOutcomes measure: Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases ., secondaryOutcomes measure: Assess the role of k FLC in predicting disease activity (conversion from CIS to MS), secondaryOutcomes measure: Assess the role of OCBs in predicting disease activity (conversion from CIS to MS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372964, orgStudyIdInfo id: ITI-007-421, briefTitle: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Intra-Cellular Therapies, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)., conditionsModule conditions: Bipolar Depression, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: Lumateperone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Children's Depression Rating Scale-Revised (CDRS-R), secondaryOutcomes measure: Clinical Global Impression Scale-Severity (CGI-S), eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Anaheim, state: California, zip: 92805, country: United States, geoPoint lat: 33.83529, lon: -117.9145, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92103, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Colorado Springs, state: Colorado, zip: 80910, country: United States, geoPoint lat: 38.83388, lon: -104.82136, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Gainesville, state: Florida, zip: 32607, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Miami Lakes, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Miami Lakes, state: Florida, zip: 33016, country: United States, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Clinical Site, status: RECRUITING, city: Miami Springs, state: Florida, zip: 33166, country: United States, geoPoint lat: 25.82232, lon: -80.2895, locations facility: Clinical Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32803, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Clinical Site, status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Clinical Site, status: RECRUITING, city: Lawrenceville, state: Georgia, zip: 30046, country: United States, geoPoint lat: 33.95621, lon: -83.98796, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Savannah, state: Georgia, zip: 31405, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Baltimore, state: Maryland, zip: 21229, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Saint Charles, state: Missouri, zip: 63304, country: United States, geoPoint lat: 38.78394, lon: -90.48123, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Lincoln, state: Nebraska, zip: 68526, country: United States, geoPoint lat: 40.8, lon: -96.66696, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Kinston, state: North Carolina, zip: 28504, country: United States, geoPoint lat: 35.26266, lon: -77.58164, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Avon Lake, state: Ohio, zip: 44012, country: United States, geoPoint lat: 41.50532, lon: -82.0282, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45219, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Garfield, state: Ohio, zip: 44125, country: United States, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73116, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Frisco, state: Texas, zip: 75034, country: United States, geoPoint lat: 33.15067, lon: -96.82361, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77089, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77090, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Clinical Site, status: NOT_YET_RECRUITING, city: Bellevue, state: Washington, zip: 98007, country: United States, geoPoint lat: 47.61038, lon: -122.20068, hasResults: False |
protocolSection identificationModule nctId: NCT06372951, orgStudyIdInfo id: Lung ultrasound in neonate, briefTitle: Lung Ultrasound in Neonatal Intensive Care Units, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray ., conditionsModule conditions: Neonatal Respiratory Distress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Identifying causes of neonatal respiratory distress, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372938, orgStudyIdInfo id: AEŞH-BADEK-2024-43, briefTitle: Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ankara Etlik City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges., conditionsModule conditions: Fetal Growth Restriction, conditions: Inflammatory Response, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 240, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound measurement, interventions name: Laboratory Tests and Inflammatory Markers, outcomesModule primaryOutcomes measure: Evaluation of data, secondaryOutcomes measure: Machine learning modeling, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Etlik City Hospital, city: Ankara, state: Yenimahalle, zip: 06170, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06372925, orgStudyIdInfo id: CKJX839A1CN04, secondaryIdInfos id: CKJX839A1CN04, type: OTHER, domain: Novartis, briefTitle: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction, acronym: V-ACCELERATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-23, primaryCompletionDateStruct date: 2026-06-24, completionDateStruct date: 2026-06-24, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C)., conditionsModule conditions: Plaque, Atherosclerotic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: IVUS/OCT will be conducted in local lab and blinded analyzed to Independent Review Committee(IRC)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 318, type: ESTIMATED, armsInterventionsModule interventions name: atorvastatin, interventions name: IVUS/OCT, interventions name: inclisiran, outcomesModule primaryOutcomes measure: Change in percent atheroma volume (PAV), secondaryOutcomes measure: Change in minimum fibrous cap thickness (FCT), secondaryOutcomes measure: Change in mean minimum FCT of all images, secondaryOutcomes measure: Change in normalized total atheroma volume (NTAV), secondaryOutcomes measure: Proportion of participants with progression, regression, or no change in PAV, secondaryOutcomes measure: Change in LDL-C, secondaryOutcomes measure: Change in TC, secondaryOutcomes measure: Change in HDL-C, secondaryOutcomes measure: Change in non-HDL-C, secondaryOutcomes measure: Change in ApoB, secondaryOutcomes measure: Change in ApoA1, secondaryOutcomes measure: Change in Lp(a), secondaryOutcomes measure: Change in TG, secondaryOutcomes measure: Proportion of participants with LDL-C target attainment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372912, orgStudyIdInfo id: Complications-Bariatric-TJ, briefTitle: Early Postoperative Complications in Patients Undergoing Bariatric Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Instituto Mexicano del Seguro Social, class: OTHER_GOV, descriptionModule briefSummary: This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Complication,Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries., outcomesModule primaryOutcomes measure: Rate of Postoperative Complications, secondaryOutcomes measure: Long-term Weight Loss Efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico., status: RECRUITING, city: Tijuana, state: Baja California, zip: 22046, country: Mexico, contacts name: José a Guzmán Barba, MD, PhD, role: CONTACT, phone: 3471043237, email: • [email protected], geoPoint lat: 32.5027, lon: -117.00371, hasResults: False |
protocolSection identificationModule nctId: NCT06372899, orgStudyIdInfo id: 855140, secondaryIdInfos id: R01CA290541-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA290541-01A1, briefTitle: Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms., conditionsModule conditions: E-cigarette Use, conditions: Cigarette Smoking, conditions: Harm Reduction, conditions: Tobacco Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: E-cigarettes, interventions name: Oral nicotine pouches, outcomesModule primaryOutcomes measure: Cigarette Consumption, primaryOutcomes measure: Cigarette Smoking Across Follow-Up, secondaryOutcomes measure: Biomarkers of Exposure: Carbon Monoxide (CO), secondaryOutcomes measure: Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%), secondaryOutcomes measure: Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), secondaryOutcomes measure: Biomarkers of Exposure:1-hydroxypyrene (1-HOP), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06372886, orgStudyIdInfo id: 2402-147-1516, briefTitle: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement., conditionsModule conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 264, type: ACTUAL, armsInterventionsModule interventions name: portal/superior vein resection, outcomesModule primaryOutcomes measure: 5-year overall survival, primaryOutcomes measure: 5-year portal/superior mesenteric vein stenosis free survival, eligibilityModule sex: ALL, maximumAge: 79 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06372873, orgStudyIdInfo id: 2023PHB211-001, briefTitle: Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise., conditionsModule conditions: Deep Learning, conditions: Ultrasound, conditions: Anterior Talofibular Ligament, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: re-evaluate by two senior radiologists in our medical center, outcomesModule primaryOutcomes measure: To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100032, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06372860, orgStudyIdInfo id: RKS2018350, secondaryIdInfos id: 3P20GM144269-02S2, type: NIH, link: https://reporter.nih.gov/quickSearch/3P20GM144269-02S2, briefTitle: DPP Feasibility Study of Breastfeeding - eMOMS 2.0, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, collaborators name: Ascension Health, collaborators name: National Institute of General Medical Sciences (NIGMS), descriptionModule briefSummary: The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application., conditionsModule conditions: Overweight or Obesity, conditions: Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes Prevention Program, interventions name: Breastfeeding, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Maternal weight, primaryOutcomes measure: Maternal body mass index (BMI), primaryOutcomes measure: Initiation of Lactation, primaryOutcomes measure: Duration of Lactation, primaryOutcomes measure: Type of Infant Feeding, secondaryOutcomes measure: Recruitment Rate, secondaryOutcomes measure: Retention Rate, secondaryOutcomes measure: Research Engagement, secondaryOutcomes measure: Mobile Application Usage, secondaryOutcomes measure: Health Coach Interaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-07, uploadDate: 2024-04-09T16:15, filename: Prot_SAP_000.pdf, size: 1164859, hasResults: False |
protocolSection identificationModule nctId: NCT06372847, orgStudyIdInfo id: Project ID 6214, briefTitle: DISE-HNS Effect Study, acronym: DISE-HNS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.Furthermore, outcomes will be compared between responders and non-responders., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Before-and-after study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Hypoglossal nerve stimulation implant, interventions name: Polysomnography, interventions name: Drug-induced sleep endoscopy (DISE), outcomesModule primaryOutcomes measure: Δ%area-of-collapse at the level of the lateral walls, secondaryOutcomes measure: Δ%area-of-collapse at the level of the palate, tongue base and epiglottis, secondaryOutcomes measure: Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders, secondaryOutcomes measure: DISE-score during baseline DISE and during one-year follow-up DISE., secondaryOutcomes measure: Non-invasive site and pattern of collapse, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-29, uploadDate: 2024-04-04T04:58, filename: Prot_SAP_000.pdf, size: 425782, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-29, uploadDate: 2024-04-04T04:58, filename: ICF_001.pdf, size: 336420, hasResults: False |
protocolSection identificationModule nctId: NCT06372834, orgStudyIdInfo id: B202205178, briefTitle: Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tri-Service General Hospital, class: OTHER, descriptionModule briefSummary: In this double-blind, randomized, sham-controlled trial, we aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. We hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition., conditionsModule conditions: Major Depressive Disorder, conditions: Treatment-Resistant Depression, conditions: Suicide Ideations, 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: 100, type: ESTIMATED, armsInterventionsModule interventions name: piTBS being delivered using the Magstim Rapid2 stimulator, outcomesModule primaryOutcomes measure: The change over time in the score of Beck Scale for Suicide Ideation (BSS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Snaith-Hamilton Pleasure Scale (SHAPS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Beck Hopelessness Scale (BHS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Montgomery-Å sberg Depression Rating Scale (MADRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of 17-item Hamilton Depression Rating Scale (HDRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The change over time in the score of Young Mania Rating Scale (YMRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS)., secondaryOutcomes measure: The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of indices of heart rate variability (HRV) (from baseline to the timepoint at the end of piTBS) and the HRV indices during each piTBS session., secondaryOutcomes measure: The changes over time in EEG absolute power and lag phase synchronization in the frontal electrodes in the delta, theta, alpha, beta and gamma range (from baseline to the end of piTBS)., secondaryOutcomes measure: The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS)., secondaryOutcomes measure: The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS)., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tri-service general hospital, status: RECRUITING, city: Taipei, zip: 114, country: Taiwan, contacts name: Hsin-An Chang, M.D., role: CONTACT, phone: 011-886-2-8792-3311, phoneExt: 17389, email: [email protected], contacts name: Hsin-An Chang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06372821, orgStudyIdInfo id: 158160, briefTitle: A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK, acronym: NIO-SILK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: Washington University School of Medicine, collaborators name: University of Washington, collaborators name: Alzheimer's Association, collaborators name: Sigrid Rausing Trust, descriptionModule briefSummary: This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau., conditionsModule conditions: Alzheimer Disease, conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder), conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder), conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: NIO752, interventions name: Placebo, outcomesModule primaryOutcomes measure: Tau synthesis rate inhibition in individuals with sporadic AD and ADAD, secondaryOutcomes measure: Compare efficacy of knockdown of tau production in sporadic AD and ADAD by measuring the synthesis rate of tau by determining the ratio of labelled to unlabeled tau (tracer to tracee ratio) in serial cerebrospinal fluid samples., secondaryOutcomes measure: Number of participants with adverse events [safety and tolerability], secondaryOutcomes measure: Comparison of number of Adverse Events reported between participants receiving one dose of NIO752 versus those receiving two doses of NIO752., secondaryOutcomes measure: Compare rates of tau synthesis and clearance in sporadic AD and ADAD, secondaryOutcomes measure: Determine CSF tau concentration to tau production relationships in humans, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372808, orgStudyIdInfo id: 2022/118, briefTitle: The Effect of Plyometric Training in Freestyle Adolescent Wrestlers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-06-18, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hasan Kalyoncu University, class: OTHER, descriptionModule briefSummary: This study aims to determine the effect of plyometric exercises on physical fitness parameters in freestyle adolescent wrestlers., conditionsModule conditions: Physical Fitness, conditions: Power, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: The Plyometric Exercise, interventions name: The Regular Training, outcomesModule primaryOutcomes measure: Change from Baseline in Strength at 8 weeks, primaryOutcomes measure: Change from Baseline in Endurance at 8 weeks, primaryOutcomes measure: Change from Baseline in Agility at 8 weeks, primaryOutcomes measure: Change from Baseline in Wrestling Performance at 8 weeks, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Batipark Sports Hall, status: RECRUITING, city: Kahramanmaraş, zip: 46050, country: Turkey, contacts name: Talha Gökçe, PT, role: CONTACT, phone: +905065624802, email: [email protected], geoPoint lat: 37.5847, lon: 36.92641, hasResults: False |
protocolSection identificationModule nctId: NCT06372795, orgStudyIdInfo id: KY2023635, briefTitle: Resistance Swallowing Training in Patients With Tracheotomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?* What medical problems do participants have when taking swallowing training?Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.Participants will:-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week., conditionsModule conditions: Swallowing Training on Muscle Strength, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: pure effortful swallowing, interventions name: progressive resistance swallowing training, outcomesModule primaryOutcomes measure: Forced swallowing tongue pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06372782, orgStudyIdInfo id: 43CH2305, briefTitle: Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Galderma R&D, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects., conditionsModule conditions: Skin Aging of Dorsal Hands, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Restylane Skinboosters Vital Lidocaine, interventions name: Restylane Vital, outcomesModule primaryOutcomes measure: The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Galderma Research Site 01, city: Shanghai, state: Shanghai, country: China, contacts name: Principle Investigator, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Galderma Research Site 02, city: Hangzhou, state: Zhejiang, country: China, contacts name: Principle Investigator, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Galderma Research Site 03, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06372769, orgStudyIdInfo id: 20240304, briefTitle: Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2022-07-15, completionDateStruct date: 2023-02-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Stomatological Hospital Affiliated with Fujian Medical University, class: OTHER, descriptionModule briefSummary: This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices., conditionsModule conditions: Temporomandibular Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: electromyograph and kinesiograph, outcomesModule primaryOutcomes measure: Surface electromyography (μV), secondaryOutcomes measure: Mandibular kinematics (mm, mm/s), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Affiliated Stomatological Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, zip: 350002, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06372756, orgStudyIdInfo id: 102122, briefTitle: Deep Learning Reconstruction Algorithms in Dual Low-dose CTA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hao Tang, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA., conditionsModule conditions: Deep Learning, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Deep learning image reconstruction, outcomesModule primaryOutcomes measure: The specificity and sensitivity calculated through the optimal cutoff value of the receiver operating characteristic curve., secondaryOutcomes measure: The signal-to-noise ratio calculated from image CT values and noise, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Youfa M Tang, role: CONTACT, phone: +8613554101223, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06372743, orgStudyIdInfo id: Alex Hospital, briefTitle: Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity, acronym: INTEGREATCKD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Alexandra Hospital, class: OTHER, collaborators name: National University Hospital, Singapore, descriptionModule briefSummary: Chronic kidney disease (CKD) is a prevalent chronic disease and is often intertwined with the management of cardiovascular disease and the optimization of metabolic risk factors. In light of steeply rising rates of end-stage kidney disease (ESKD) and increased healthcare resource utilization by CKD patients, the investigators propose that the role of nurses could be expanded to support the care of CKD patients in the community.A total of 220 patients will be randomized (1:1) to the intervention or control groups (usual care). The intervention entails enrolment into a nurse-led, physician-supported programme (INTEGREAT-CKD), comprising outpatient consultations and community-based ambulatory monitoring and counselling primarily driven by CKD-trained advanced practice nurses (APNs) and healthcare professionals conducted over 6 months. Patient-reported outcomes like health-related quality of life (HRQOL), as measured by EQ-5D and KDQOL, CKD self-management score and CKD health literacy will be assessed at baseline and after 6 months. The primary outcome is CKD self-management. Other secondary outcomes to be assessed and tracked including achievement of clinical targets relevant to slowing down CKD progression, attainment of CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines 2020., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a dual-centre two-arm, open-label randomized controlled trial (RCT). Patients are randomized with a one-to-one allocation into two parallel groups., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: INTEGREAT-CKD Intervention, outcomesModule primaryOutcomes measure: Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire, secondaryOutcomes measure: Secondary outcome, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wei Zhen Hong, status: RECRUITING, city: Singapore, zip: 119228, country: Singapore, contacts name: Wei Zhen Hong, role: CONTACT, phone: 97330789, email: [email protected], contacts name: Priyanka Khatri, MBBS, role: SUB_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06372730, orgStudyIdInfo id: 29BRC23.0161, secondaryIdInfos id: 2023-A01566-39, type: OTHER, domain: IDRCB, briefTitle: Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT), acronym: PRONOSPECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence., conditionsModule conditions: Pulmonary Embolism, conditions: Venous Thromboembolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Cohort study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 665, type: ESTIMATED, armsInterventionsModule interventions name: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT), outcomesModule primaryOutcomes measure: Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study, secondaryOutcomes measure: Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period., secondaryOutcomes measure: Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study., secondaryOutcomes measure: Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age, secondaryOutcomes measure: The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old), secondaryOutcomes measure: Potential predictors of RPVO including : demographics, secondaryOutcomes measure: Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan, secondaryOutcomes measure: Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council), secondaryOutcomes measure: Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life), secondaryOutcomes measure: Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH)., secondaryOutcomes measure: Mortality of all causes., secondaryOutcomes measure: Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton., secondaryOutcomes measure: The following score will be computed : PADIS-PE score., secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens, city: Amiens, zip: 80054, country: France, contacts name: Marie-Antoinette SEVESTRE, Pr, role: CONTACT, phone: +33322087306, email: [email protected], geoPoint lat: 49.9, lon: 2.3, locations facility: CHU Angers, city: Angers, zip: 49933, country: France, contacts name: Jeanne HERSANT, Pr, role: CONTACT, phone: +33661392285, email: [email protected], geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Brest, city: Brest, zip: 29609, country: France, contacts name: Pierre-Yves LE ROUX, Pr, role: CONTACT, phone: +33298223327, email: [email protected], contacts name: Francis COUTURAUD, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Hôpital Louis MourierAP-HP, city: Colombes, zip: 92700, country: France, contacts name: Isabelle MAHE, Pr, role: CONTACT, phone: +33147606490, email: [email protected], geoPoint lat: 48.91882, lon: 2.25404, locations facility: CHD Vendée - La Roche sur Yon, city: La Roche-sur-Yon, zip: 85925, country: France, contacts name: Jean-Manuel KUBINA, Dr, role: CONTACT, phone: +33251446301, email: [email protected], geoPoint lat: 46.66667, lon: -1.43333, locations facility: Kremlin-Bicêtre AP-HP, city: Le Kremlin-Bicêtre, zip: 94270, country: France, contacts name: David MONTANI, Pr, role: CONTACT, phone: +33145217976, email: [email protected], geoPoint lat: 48.81471, lon: 2.36073, locations facility: CH Les Sables d'Olonne, city: Les Sables-d'Olonne, zip: 85340, country: France, contacts name: Nicolas BREBION, role: CONTACT, phone: +33251218824, email: [email protected], geoPoint lat: 46.5, lon: -1.78333, locations facility: Hegp Ap-Hp, city: Paris, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CH Quimper, city: Quimper, zip: 29000, country: France, contacts name: Charles ORIONE, Dr, role: CONTACT, phone: +33298526096, email: [email protected], geoPoint lat: 48.0, lon: -4.1, locations facility: CHU St-Etienne, city: Saint-Étienne, zip: 42055, country: France, contacts name: Laurent BERTOLETTI, Pr, role: CONTACT, phone: +33477127770, email: [email protected], geoPoint lat: 45.43389, lon: 4.39, locations facility: CHIC Toulon, city: Toulon, zip: 83056, country: France, contacts name: Jean-Noël POGGI, Dr, role: CONTACT, phone: +33494145787, email: [email protected], geoPoint lat: 43.12442, lon: 5.92836, locations facility: HIA Toulon, city: Toulon, zip: 83800, country: France, contacts name: Antoine-Raphaël BRONSTEIN, Dr, role: CONTACT, phone: +33483162553, email: [email protected], geoPoint lat: 43.12442, lon: 5.92836, locations facility: CHU Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Alessandra BURA-RIVIERE, Pr, role: CONTACT, phone: +33561322438, email: [email protected], geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06372717, orgStudyIdInfo id: AP30CP01, briefTitle: A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Apollo Therapeutics Ltd, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only., conditionsModule conditions: Acute Myeloid Leukemia Refractory, conditions: Myelodysplastic Syndrome Acute Myeloid Leukemia, conditions: Myelodysplastic Syndrome With Excess Blasts, conditions: Acute Myeloid Leukemia, in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: APL-4098, interventions name: Azacitidine and APL-4098, outcomesModule primaryOutcomes measure: Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1), primaryOutcomes measure: Incidence of Dose Limiting Toxicities [Tolerability] (Phase 1), primaryOutcomes measure: Estimate the Maximum Tolerated Dose (MTD) of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Determine Recommended Phase 2 Dose (RP2D) levels of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess efficacy of APL-4098 alone and/or in combination with azacitidine (Phase 2), secondaryOutcomes measure: Assess response to disease with APL-4098 alone and/or in combination with azacitidine (Phase 1), secondaryOutcomes measure: Duration of response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Time to response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Event Free Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Overall Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Incidence of Treatment Emergent Adverse Events [Further Safety] (Phase 2), secondaryOutcomes measure: Incidence of Adverse Events leading to discontinuation of APL-4098 [Further Tolerability] (Phase 2), secondaryOutcomes measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2), secondaryOutcomes measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2), secondaryOutcomes measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372704, orgStudyIdInfo id: 2024/72, briefTitle: Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence?, acronym: HIFEM for PPI, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: Urinary incontinence after radical prostatectomy surgery is a common condition that negatively affects daily life. Patients often experience discomfort due to urine leakage and the resulting need to use pads daily. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary incontinence after radical prostatectomy., conditionsModule conditions: Prostate Cancer, conditions: Incontinence, conditions: Pelvic Floor Muscle Weakness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: HIFEM, outcomesModule primaryOutcomes measure: This study demonstrated the safe and effective use of HIFEM technology to prevent PPI by strengthening the pelvic floor muscles in a variety of patients., eligibilityModule sex: MALE, minimumAge: 63 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İbrahim Üntan, city: Kirşehi̇r, country: Turkey, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06372691, orgStudyIdInfo id: PoplitealApproach SciaticBlock, briefTitle: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks., conditionsModule conditions: Adult, conditions: Regional Anesthesia Morbidity, conditions: Anesthesia Injection Site, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 809, type: ESTIMATED, armsInterventionsModule interventions name: Subparaneural Injection (Grup S), Block, interventions name: Interneural Injection (Grup I), Block, outcomesModule primaryOutcomes measure: Onset Time, secondaryOutcomes measure: Block Execution Times, secondaryOutcomes measure: Need for Multiple Injections Owing to Insufficient Anesthesia, secondaryOutcomes measure: Additional Rescue Analgesic, secondaryOutcomes measure: Adverse Effects to Anesthesia, secondaryOutcomes measure: Hemodynamic Effects Of The Block, secondaryOutcomes measure: Effects Of The Block On Heart Rate, secondaryOutcomes measure: Effects Of The Block On Peripheral Pulse Oximetry, secondaryOutcomes measure: Regression Time Of Sensory and Motor Block, secondaryOutcomes measure: Total Block Times, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372678, orgStudyIdInfo id: CM326-102102, briefTitle: Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Keymed Biosciences Co.Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)., conditionsModule conditions: Chronic Rhinosinusitis With Nasal Polyps, 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: 90, type: ESTIMATED, armsInterventionsModule interventions name: CM326, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tongren Hospital, CMU, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06372665, orgStudyIdInfo id: CDB-IV-JE-025202301, briefTitle: Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Liaoning Chengda Biotechnology CO., LTD, class: INDUSTRY, descriptionModule briefSummary: This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older., conditionsModule conditions: Japanese Encephalitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 28547, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events, eligibilityModule sex: ALL, minimumAge: 8 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiangsu Provincial Center for Disease Control and Prevention, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Zhiguo Wang, Master, role: CONTACT, email: [email protected], contacts name: Zhiguo Wang, Master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06372652, orgStudyIdInfo id: TE-8214-001, briefTitle: A Phase 1 Study of TE-8214 Solution in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-10-10, completionDateStruct date: 2024-12-26, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Immunwork, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and PK of TE-8214 in healthy volunteers. The study will assess single ascending doses (SAD) of TE-8214., conditionsModule conditions: Acromegaly, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: TE-8214 - SAD, interventions name: Placebo, outcomesModule primaryOutcomes measure: Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events, primaryOutcomes measure: Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs), primaryOutcomes measure: Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings, primaryOutcomes measure: Safety and tolerability of TE-8214 by the changes in physical examination findings, primaryOutcomes measure: Safety and tolerability of TE-8214 by the changes in ECG findings, secondaryOutcomes measure: PK Parameters: Maximum observed concentration (Cmax), secondaryOutcomes measure: PK Parameters: Time to maximum observed concentration (Tmax), secondaryOutcomes measure: PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: CMAX Clinical Research, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Jessica Gehlert, Dr, role: CONTACT, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False |
protocolSection identificationModule nctId: NCT06372639, orgStudyIdInfo id: TAU-PTSD-TMS, briefTitle: Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-23, primaryCompletionDateStruct date: 2024-11-24, completionDateStruct date: 2024-11-24, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tel Aviv University, class: OTHER, descriptionModule briefSummary: Characterization and modulation of traumatic memories in PTSD patients using TMS., conditionsModule conditions: Post Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Trans-Cranial Magnetic Stimulation, outcomesModule primaryOutcomes measure: CAPS-5 score, primaryOutcomes measure: Neurological measures of functional connectivity, primaryOutcomes measure: Intrusive memories, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tel Aviv University, status: RECRUITING, city: Tel Aviv, zip: 69978, country: Israel, contacts name: Yair Bar-Haim, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08088, lon: 34.78057, hasResults: False |
protocolSection identificationModule nctId: NCT06372626, orgStudyIdInfo id: ZG005-004, briefTitle: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment., conditionsModule conditions: Neuroendocrine Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: ZG005, interventions name: Etoposide, interventions name: Cisplatin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity (DLT), primaryOutcomes measure: Objective Response Rate (ORR), primaryOutcomes measure: Adverse Event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Jianming Xu, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06372613, orgStudyIdInfo id: LRG&UC, briefTitle: Association Between LRG and Endoscopic Remission in Ulcerative Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Showa Inan General Hospital, class: OTHER, descriptionModule briefSummary: We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which predicts endoscopic remission in ulcerative colitis patients in this study. Colonoscopy with histology is performed when endoscopic remission will be predicted based on serum LRG values, irrespective of symptoms. Serum LRG levels were analyzed by an enzyme-linked immunosorbent assay., conditionsModule conditions: Ulcerative Colitis in Remission, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Endoscopic remission of UC, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Showa Inan General Hospital, status: RECRUITING, city: Komagane, country: Japan, contacts name: Akira Horiuchi, role: CONTACT, geoPoint lat: 35.71657, lon: 137.93745, hasResults: False |
protocolSection identificationModule nctId: NCT06372600, orgStudyIdInfo id: 2023-181, briefTitle: Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-02-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Xiali Xue, class: OTHER, descriptionModule briefSummary: The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible., conditionsModule conditions: Rotator Cuff Tendinitis, conditions: Rotator Cuff Tendinosis, 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: 60, type: ESTIMATED, armsInterventionsModule interventions name: Extracorporeal shock wave therapy device, interventions name: Platelet-rich plasma, outcomesModule primaryOutcomes measure: Visual Analogue Scale,VAS, secondaryOutcomes measure: American Shoulder and Elbow Surgeon's Form,ASES, secondaryOutcomes measure: the university of California at Los Angeles shoulder rating scale, UCLA, secondaryOutcomes measure: The location and size of the calcifications were examined by ultrasound, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372587, orgStudyIdInfo id: 5502, briefTitle: Next-Generation alzheImer'S Therapeutics, acronym: ENERGISE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Is this the right time to use next-generation approaches in Alzheimer's disease (AD)? In recent years, several large clinical trials testing treatments for AD have failed, putting the entire field on a reset. AD drug trials have almost exclusively sought to use antibodies targeted toward misfolded amyloid and tau proteins. Of note, although these approaches have failed, they were designed to cover both familial and sporadic forms of AD. On the other hand, the failure in developing new effective drugs is attributed to, but not limited to, the highly heterogeneous nature of AD with multiple underlying hypotheses and multifactorial pathology. The idea underlying this project is based on the assumption that learning and memory disorders can arise when the connections between neurons do not change appropriately in response to experience. Thus, by intervening on the core mechanisms of the cellular correlate of learning and memory, i.e., synaptic plasticity, the investigators expect to preserve some of the essential brain functions in AD. By overcoming the limits of traditional AD therapeutic approaches, the investigators will use genetically encoded engineered proteins (GEEPs), which the investigators developed and tested in vitro and in murine models, to control their activity in living human neurons boosting synaptic plasticity. Indeed, outstanding and relevant progress in understanding synaptic physiology empowers the possibility to prevent or limit brain disease like never before. The investigators designed GEEPs to address some of the leading causes of synaptic plasticity failures documented in AD. Thus, GEEPs will be tested in human induced pluripotent stem cells (hiPSCs)-derived living neurons obtained from reprogrammed peripheral tissues of participants with Alzheimer's diseases. hiPSCs will be obtained from fibroblast-derived from a skin biopsy of participants with AD and controls performed in local anesthesia using a 4 mm punch. The findings will provide the first preclinical study on the effect of genetically engineered proteins to control essential pathways implicated in synaptic plasticity on AD-related cognitive decline., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: genetically encoded engineered proteins, outcomesModule primaryOutcomes measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons preventing dendritic spines loss, primaryOutcomes measure: To leverage genetically encoded engineered proteins to prevent alterations in the morphology of dendritic spines in living human neurons, primaryOutcomes measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons promoting functional synaptic plasticity, primaryOutcomes measure: To use genetically encoded engineered proteins to obtain evaluate neuronal excitability in living human neurons, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: CRISTIAN RIPOLI, role: CONTACT, phone: +390630154966, email: [email protected], contacts name: CRISTIAN RIPOLI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06372574, orgStudyIdInfo id: GO44669, briefTitle: A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2028-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Genentech, Inc., class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors., conditionsModule conditions: Refractory Cancer, conditions: Recurrent Cancer, conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: RO7617991, interventions name: Tocilizumab, outcomesModule primaryOutcomes measure: Incidence and Severity of Adverse Events, primaryOutcomes measure: Number of Participants with Abnormal Values in Targeted Vital Signs, primaryOutcomes measure: Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters, secondaryOutcomes measure: Serum Concentration of RO7617991 at Specific Timepoints, secondaryOutcomes measure: Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1, secondaryOutcomes measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372561, orgStudyIdInfo id: Melatonin- vital pulp therapy, briefTitle: Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Suez Canal University, class: OTHER, descriptionModule briefSummary: The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts., conditionsModule conditions: Dental Caries in Children, conditions: Vital Pulp Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Mineral trioxide aggregate (dressing material), interventions name: Melatonin (dressing material), outcomesModule primaryOutcomes measure: Clinically assessment (Modified visual analogue scale), primaryOutcomes measure: Clinically assessment (Millar's index), primaryOutcomes measure: Clinically assessment (presence or abscence), primaryOutcomes measure: Radiographic assessment (using Image J software program), primaryOutcomes measure: Radiographic assessment (using Image J software program), primaryOutcomes measure: Radiographic assessment (using Image J software program), primaryOutcomes measure: Radiographic assessment (using Image J software program), primaryOutcomes measure: Radiographic assessment (using Image J software program), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Medicine, Suez canal university, status: RECRUITING, city: Ismailia, zip: 41522, country: Egypt, contacts name: Ismail Dahshan, PHD, role: CONTACT, phone: 01012715799, email: [email protected], geoPoint lat: 30.60427, lon: 32.27225, hasResults: False |
protocolSection identificationModule nctId: NCT06372548, orgStudyIdInfo id: NEADS0004, briefTitle: Rehabilitation Training Games for Children With Amblyopia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Zhu Dian, class: OTHER, descriptionModule briefSummary: A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game., conditionsModule conditions: Amblyopia, conditions: Amblyopia Occlusion, conditions: Child Behavior, conditions: Adherence, Treatment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Find You! Cure My Animal Friends, interventions name: DuoBao Vision Training System, outcomesModule primaryOutcomes measure: 8-Item Morisky Medication Adherence Scale (MMAS-8):, secondaryOutcomes measure: User Experience Questionnaire (UEQ), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200240, country: China, contacts name: Zhao Liu, role: CONTACT, phone: +8618901626266, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06372535, orgStudyIdInfo id: FujianUTCM-1, briefTitle: Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Lidian Chen, class: OTHER, collaborators name: Peking University Third Hospital, descriptionModule briefSummary: To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 540, type: ESTIMATED, armsInterventionsModule interventions name: Tai Chi Chuan （dose 1）, interventions name: Tai Chi Chuan （dose 2）, interventions name: Tai Chi Chuan （dose 3）, interventions name: Tai Chi Chuan （dose 4）, interventions name: Tai Chi Chuan （dose 5）, interventions name: Tai Chi Chuan （dose 6）, interventions name: Tai Chi Chuan （dose 7）, interventions name: Tai Chi Chuan （dose 8）, interventions name: Tai Chi Chuan （dose 9）, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: Wechsler Memory Scale, secondaryOutcomes measure: Digital Symbol test, secondaryOutcomes measure: Trial Making Test part B, secondaryOutcomes measure: Stroop color word test, secondaryOutcomes measure: Boston naming test, secondaryOutcomes measure: Rey-Osterrieth complex graphics test, secondaryOutcomes measure: Rey Auditory Verbal Learning Test, otherOutcomes measure: Blood glucose metabolism index, otherOutcomes measure: Blood lipid metabolism index, otherOutcomes measure: Functional Magnetic Resonance Imaging, otherOutcomes measure: Electroencephalogram, otherOutcomes measure: Heart rate variability, otherOutcomes measure: Gut microflora, otherOutcomes measure: Sleep Quality, otherOutcomes measure: General health, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06372522, orgStudyIdInfo id: RMB-0517-23, briefTitle: Oxytocin in Multiparous Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Rambam Health Care Campus, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion., conditionsModule conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 166, type: ESTIMATED, armsInterventionsModule interventions name: Pitocin Injectable Product, outcomesModule primaryOutcomes measure: The rate of women delivering within 24 hours., secondaryOutcomes measure: Length of latent and active phases of labor., secondaryOutcomes measure: The rate of instrumental and caesarean deliveries., secondaryOutcomes measure: chorioamnionitis, secondaryOutcomes measure: obstetric anal sphincter injuries (OASIS), secondaryOutcomes measure: hyponatremia, secondaryOutcomes measure: post-partum hemorrhage (PPH), secondaryOutcomes measure: neonatal outcome - 1 and 5-minute Apgar score, secondaryOutcomes measure: umbilical artery pH, secondaryOutcomes measure: NICU admission, secondaryOutcomes measure: Women's satisfaction., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06372509, orgStudyIdInfo id: L2-070, briefTitle: A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease, acronym: PMCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centro Cardiologico Monzino, class: OTHER, collaborators name: IRCCS Policlinico S. Donato, descriptionModule briefSummary: This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and CV risk factors., conditionsModule conditions: Coronary Artery Disease, conditions: Migraine, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Correlation between migraine and proteomic profiling of plasma, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centro Cardiologico Monzino, status: RECRUITING, city: Milano, state: Milan, zip: 20131, country: Italy, contacts name: Daniela Trabattoni, MD, role: CONTACT, phone: 0258002780, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06372496, orgStudyIdInfo id: 219912, briefTitle: Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2026-03-11, completionDateStruct date: 2026-03-11, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma, conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1136, type: ESTIMATED, armsInterventionsModule interventions name: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate, interventions name: Inhaled corticosteroids/long-acting beta-2 agonists, outcomesModule primaryOutcomes measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1), secondaryOutcomes measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment, secondaryOutcomes measure: Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment, secondaryOutcomes measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment, secondaryOutcomes measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment, secondaryOutcomes measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment, secondaryOutcomes measure: Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization, secondaryOutcomes measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment, secondaryOutcomes measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization, secondaryOutcomes measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization, secondaryOutcomes measure: Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization, secondaryOutcomes measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization., secondaryOutcomes measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization., secondaryOutcomes measure: Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Little Rock, state: Arkansas, zip: 72205, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Karl V Sitz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.74648, lon: -92.28959, locations facility: GSK Investigational Site, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Ryan Mitchell Klein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.61891, lon: -117.92895, locations facility: GSK Investigational Site, city: Miami, state: Florida, zip: 33135, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Enrique Villa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: GSK Investigational Site, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Ileana C. Rodicio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: GSK Investigational Site, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Jaime Landman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: GSK Investigational Site, city: Orlando, state: Florida, zip: 32819, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Marvin Heuer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: GSK Investigational Site, city: Port Charlotte, state: Florida, zip: 33952, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Joseph Ravid, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.97617, lon: -82.09064, locations facility: GSK Investigational Site, city: Tallahassee, state: Florida, zip: 32308, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Ronald H. Saff, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.43826, lon: -84.28073, locations facility: GSK Investigational Site, city: Columbus, state: Georgia, zip: 31904, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Robert R Chrzanowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.46098, lon: -84.98771, locations facility: GSK Investigational Site, city: Normal, state: Illinois, zip: 61761, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Dareen Siri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.5142, lon: -88.99063, locations facility: GSK Investigational Site, city: Bangor, state: Maine, zip: 04401, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Paul Alan Shapero, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.80118, lon: -68.77781, locations facility: GSK Investigational Site, city: Columbia, state: Maryland, zip: 21044, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: David Nyanjom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.24038, lon: -76.83942, locations facility: GSK Investigational Site, city: Brick, state: New Jersey, zip: 08724, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Bruce DeCotiis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.05928, lon: -74.13708, locations facility: GSK Investigational Site, city: Linwood, state: New Jersey, zip: 08221, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Allen Silvey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.33984, lon: -74.57516, locations facility: GSK Investigational Site, city: New Windsor, state: New York, zip: 12553, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Sashi Makam, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.47676, lon: -74.02375, locations facility: GSK Investigational Site, city: Asheville, state: North Carolina, zip: 28801, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: David Cypcar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.60095, lon: -82.55402, locations facility: GSK Investigational Site, city: Charlotte, state: North Carolina, zip: 28273, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Emeka M Eziri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22709, lon: -80.84313, locations facility: GSK Investigational Site, city: Greenville, state: North Carolina, zip: 27834, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Bryan Dunn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.61266, lon: -77.36635, locations facility: GSK Investigational Site, city: Raleigh, state: North Carolina, zip: 27607, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Craig F LaForce, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.7721, lon: -78.63861, locations facility: GSK Investigational Site, city: Winston-Salem, state: North Carolina, zip: 27104, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Wendy C Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, locations facility: GSK Investigational Site, city: Cincinnati, state: Ohio, zip: 45231, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: David I Bernstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: GSK Investigational Site, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Sadia Benzaquen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: GSK Investigational Site, city: Philadelphia, state: Pennsylvania, zip: 19140, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Kartik Shenoy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: GSK Investigational Site, city: Pittsburgh, state: Pennsylvania, zip: 15241, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Michael J. Palumbo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: GSK Investigational Site, city: Rock Hill, state: South Carolina, zip: 29732, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Michael Denenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.92487, lon: -81.02508, locations facility: GSK Investigational Site, city: Spartanburg, state: South Carolina, zip: 29303, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Farhan Siddiqui, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.94957, lon: -81.93205, locations facility: GSK Investigational Site, city: Dallas, state: Texas, zip: 75246, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Mark W Millard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: GSK Investigational Site, city: Kerrville, state: Texas, zip: 78028, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Dale E Mohar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.04743, lon: -99.14032, locations facility: GSK Investigational Site, city: Waco, state: Texas, zip: 76712, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Niran J. Amar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.54933, lon: -97.14667, locations facility: GSK Investigational Site, city: Ciudad Autónoma de Buenos Aires, state: Buenos Aires, zip: C1192AAW, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Ana Maria Stok, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: GSK Investigational Site, city: Florencio Varela, state: Buenos Aires, zip: 1888, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Andrea Cintia Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.82722, lon: -58.39556, locations facility: GSK Investigational Site, city: Mar del Plata, state: Buenos Aires, zip: 7600, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Luis Wehbe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -38.00228, lon: -57.55754, locations facility: GSK Investigational Site, city: Cordoba, state: Córdova, zip: X5003DCE, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Victor Hugo Cambursano, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: GSK Investigational Site, city: Rosario, state: Santa Fe, zip: 2000, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Adriana M. Marcipar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: GSK Investigational Site, city: Rosario, state: Santa Fe, zip: S2000DBS, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Ledit R F Ardusso, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: GSK Investigational Site, city: Ciudad Autonoma de Buenos Aires, zip: C1425BEN, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Anahi Yanez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: GSK Investigational Site, city: Mendoza, zip: 5500, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Pablo Saez Scherbovsky, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.89084, lon: -68.82717, locations facility: GSK Investigational Site, city: Rosario, zip: 2000, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Gabriel Gattolin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: GSK Investigational Site, city: Bruce, state: Australian Capital Territory, zip: 2617, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Amber Leah, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.46667, lon: 138.2, locations facility: GSK Investigational Site, city: Blacktown, state: New South Wales, zip: 2148, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Rahul Mohan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.76667, lon: 150.91667, locations facility: GSK Investigational Site, city: Campbelltown, state: New South Wales, zip: 2560, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Belinda Cochrane, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.06667, lon: 150.81667, locations facility: GSK Investigational Site, city: Coffs Harbour, state: New South Wales, zip: 2450, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Olga O Voloshyna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -30.29626, lon: 153.11351, locations facility: GSK Investigational Site, city: Kanwal, state: New South Wales, zip: 2259, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Dominic Douglas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.253, lon: 151.4911, locations facility: GSK Investigational Site, city: Brisbane, state: Queensland, zip: 4006, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Esmond Leong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, locations facility: GSK Investigational Site, city: Spearwood, state: Western Australia, zip: 6163, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Peter R Bremner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.10534, lon: 115.77797, locations facility: GSK Investigational Site, city: Brampton, state: Ontario, zip: L6T 0G1, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Naresh K. Aggarwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.68341, lon: -79.76633, locations facility: GSK Investigational Site, city: Windsor, state: Ontario, zip: N8X 1T3, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Syed Anees, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.30008, lon: -83.01654, locations facility: GSK Investigational Site, city: Trois-Rivieres, state: Quebec, zip: G9A 4P3, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Patrice Gauthier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.34515, lon: -72.5477, locations facility: GSK Investigational Site, city: Saskatoon, state: Saskatchewan, zip: S7N OW8, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Erika Dianne Penz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.13238, lon: -106.66892, locations facility: GSK Investigational Site, city: Fukuoka, zip: 802-0083, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Shinichi Osaki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: GSK Investigational Site, city: Fukuoka, zip: 816-0813, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Yuji Kawarada, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: GSK Investigational Site, city: Gifu, zip: 509-6134, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Hiroyuki Ohbayashi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.42291, lon: 136.76039, locations facility: GSK Investigational Site, city: Hiroshima, zip: 730-0853, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Yoshinori Haruta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.4, lon: 132.45, locations facility: GSK Investigational Site, city: Hyogo, zip: 651-0053, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Hiroki Kawabata, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Kagawa, zip: 761-8073, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Tadashi Kamei, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Miyazaki, zip: 880-2112, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Rei Fujiki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.91667, lon: 131.41667, locations facility: GSK Investigational Site, city: Miyazaki, zip: 889-4304, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Kenjiro Nagai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.91667, lon: 131.41667, locations facility: GSK Investigational Site, city: Niigata, zip: 950-0088, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Yuki Nishiyama, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.88637, lon: 139.00589, locations facility: GSK Investigational Site, city: Tokyo, zip: 105-0001, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Akira Mizoo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Tokyo, zip: 157-0066, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Akiyoshi Sasamoto, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Tokyo, zip: 160-0017, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Takahiro Yokoyama, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Daegu, zip: 41404, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Han-Ki Park, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.87028, lon: 128.59111, locations facility: GSK Investigational Site, city: Seoul, zip: 02841, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Byung-Keun Kim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Hye-Ryun Kang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, city: Seoul, zip: 07061, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Min-Suk Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, city: Seoul, zip: 133-792, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Sang-Heon Kim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, city: Kaohsiung, zip: 807, country: Taiwan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Chau-Chyun Sheu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.61626, lon: 120.31333, locations facility: GSK Investigational Site, city: Taichung, zip: 40447, country: Taiwan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Chia-Hung Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, locations facility: GSK Investigational Site, city: Taichung, zip: 407219, country: Taiwan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Pin-Kuei Fu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06372483, orgStudyIdInfo id: VMX-C001-03, secondaryIdInfos id: 2023-507059-32-00, type: CTIS, briefTitle: Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: VarmX B.V., class: INDUSTRY, descriptionModule briefSummary: A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects., conditionsModule conditions: Coagulation Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Placebo controlled, single dose., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: VMX-C001, interventions name: Placebo, interventions name: Rivaroxaban 20 mg Oral Tablet, interventions name: Apixaban 5 mg Oral Tablet, interventions name: Edoxaban 60 mg Oral Tablet, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1), primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2), primaryOutcomes measure: PK of VMX-C001 in plasma - Cmax, primaryOutcomes measure: PK of VMX-C001 in plasma - tmax, primaryOutcomes measure: PK of VMX-C001 in plasma - t1/2, primaryOutcomes measure: PK of VMX-C001 in plasma - AUC0-last, primaryOutcomes measure: PK of VMX-C001 in plasma - AUC0-inf, primaryOutcomes measure: PK of VMX-C001 in plasma - Lambda z, primaryOutcomes measure: PK of VMX-C001 in plasma - CL, primaryOutcomes measure: PK of VMX-C001 in plasma - Vz, primaryOutcomes measure: DOAC plasma concentrations (Part 2), primaryOutcomes measure: Change in Prothrombin time (PT) following dosing with VMX-C001, primaryOutcomes measure: Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001, primaryOutcomes measure: Change in D-dimer following dosing with VMX-C001, primaryOutcomes measure: Change in prothrombin fragments F1 and 2 following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by lag time, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by peak height, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by time to peak, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by velocity index, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by time to tail, following dosing with VMX-C001, primaryOutcomes measure: Change in diluted prothrombin time (dPT) following dosing with VMX-C001, primaryOutcomes measure: Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001, primaryOutcomes measure: Change in real time activated clotting time (ACT) following dosing with VMX-C001, secondaryOutcomes measure: Antibodies against VMX-C001 in plasma, secondaryOutcomes measure: Antibodies against human coagulation FX in plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ICON, status: RECRUITING, city: Groningen, zip: 9728 NZ, country: Netherlands, contacts name: Salah Hadi, MD, role: CONTACT, phone: +31 50 8505 798, email: [email protected], geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06372470, orgStudyIdInfo id: CLM-HTN-005, briefTitle: Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment, acronym: OptiZest, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Closed Loop Medicine, class: INDUSTRY, collaborators name: Pharmanovia, descriptionModule briefSummary: A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation, conditionsModule conditions: Uncomplicated Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Zestril, outcomesModule primaryOutcomes measure: Achieving target Home Blood Pressure, secondaryOutcomes measure: Reduction in systolic blood pressure (SBP), secondaryOutcomes measure: Reduction in diastolic blood pressure (DBP), secondaryOutcomes measure: The time to achieve BP Control (BPC), secondaryOutcomes measure: Patient daily adherence to prescribed medication, secondaryOutcomes measure: Adherence to collecting data using the electronic BP diary, secondaryOutcomes measure: Patients' thoughts and feelings about BP/treatment, secondaryOutcomes measure: Discontinuation of Zestril due to unwanted side effects, secondaryOutcomes measure: Number and type of spontaneously reported unwanted side effects, secondaryOutcomes measure: User experience and feasibility of the blood pressure digital diary, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Norwich Health Centre, status: RECRUITING, city: Norwich, country: United Kingdom, contacts name: Serge Engamba, MD, role: CONTACT, phone: 01603987074, email: [email protected], contacts name: Marc Buckingham, role: CONTACT, email: [email protected], geoPoint lat: 52.62783, lon: 1.29834, hasResults: False |
protocolSection identificationModule nctId: NCT06372457, orgStudyIdInfo id: CV027-1107, briefTitle: COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM), acronym: COLLIGO-HCM, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice., conditionsModule conditions: Hypertrophic Cardiomyopathy (HCM), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Approved Hypertrophic Cardiomyopathy drug treatments, interventions name: Mavacamten, outcomesModule primaryOutcomes measure: Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant age at mavacamten treatment initiation, primaryOutcomes measure: Participant sex, primaryOutcomes measure: Participant race/ethnicity, primaryOutcomes measure: Participant insurance coverage, primaryOutcomes measure: Participant employment status, primaryOutcomes measure: Participant educational level, primaryOutcomes measure: Date of Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis, primaryOutcomes measure: Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant New York Heart Association (NYHA) class, primaryOutcomes measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, primaryOutcomes measure: Participant height, primaryOutcomes measure: Participant weight, primaryOutcomes measure: Participant blood pressure, primaryOutcomes measure: Participant heart rate, primaryOutcomes measure: Participant Hypertrophic Cardiomyopathy (HCM) symptoms, primaryOutcomes measure: European participant CYP2C19 genotype, primaryOutcomes measure: Participant family history of Hypertrophic Cardiomyopathy (HCM), primaryOutcomes measure: Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM), primaryOutcomes measure: Participant family history of sudden cardiac death (SCD), primaryOutcomes measure: Participant smoking status, primaryOutcomes measure: Participant alcohol use, primaryOutcomes measure: Participant recreational drug use, primaryOutcomes measure: Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT), primaryOutcomes measure: Participant cardiovascular (CV) and CV-related comorbidities, primaryOutcomes measure: Participant non-cardiovascular (CV)-related comorbidities, primaryOutcomes measure: Participant electrocardiogram (ECG) rhythm results, primaryOutcomes measure: Participant cardiac magnetic resonance imaging (MRI) results, primaryOutcomes measure: Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results, primaryOutcomes measure: Participant cardiac troponin results, primaryOutcomes measure: Participant cardiopulmonary exercise test (CPET) results, primaryOutcomes measure: Participant cardiac monitoring results, primaryOutcomes measure: Participant exercise test results, primaryOutcomes measure: Participant blood creatine levels, primaryOutcomes measure: Participant cardiovascular (CV) events, primaryOutcomes measure: Type of procedures received by participants, primaryOutcomes measure: Cardiovascular treatments prescribed to participants, primaryOutcomes measure: Date of mavacamten prescription, primaryOutcomes measure: Date of mavacamten treatment initiation, primaryOutcomes measure: Date of mavacamten dosage change, primaryOutcomes measure: Reason for mavacamten dosage change, primaryOutcomes measure: Occurrence of mavacamten stable dose (a period of 6-months with the same dose), primaryOutcomes measure: Dates of follow-up after mavacamten treatment initiation, primaryOutcomes measure: Date of mavacamten treatment interuption or discontinuation, primaryOutcomes measure: Reason for mavacamten treatment interuption or discontinuation, primaryOutcomes measure: Supportive care provided to participants, primaryOutcomes measure: Heath care resource utilization (HCRU), primaryOutcomes measure: Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation, secondaryOutcomes measure: Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms, secondaryOutcomes measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM), secondaryOutcomes measure: Participant family history of sudden cardiac death (SCD), secondaryOutcomes measure: Cardiovascular (CV) and CV-related comorbidities, secondaryOutcomes measure: Non-cardiovascular (non-CV) comorbidities, secondaryOutcomes measure: Participant electrocardiogram (ECG) rhythm results, secondaryOutcomes measure: Participant echocardiogram (ECHO) results, secondaryOutcomes measure: Participant cardiac MRI results, secondaryOutcomes measure: Participant NT-proBNP results, secondaryOutcomes measure: Participant cardiac tropin results, secondaryOutcomes measure: Participant cardiopulmonary exercise test (CPET) results, secondaryOutcomes measure: Participant cardiac monitoring results, secondaryOutcomes measure: Participant exercise test results, secondaryOutcomes measure: Hypertrophic Cardiomyopathy (HCM) subtype, secondaryOutcomes measure: Participant symptoms at Hypertrophic Cardiomyopathy (HCM), secondaryOutcomes measure: Participant New York Heart Association (NYHA) class, secondaryOutcomes measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, secondaryOutcomes measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IQVIA, city: Durham, state: North Carolina, zip: 27703, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False |
protocolSection identificationModule nctId: NCT06372444, orgStudyIdInfo id: 995725, briefTitle: Mechanisms of Acute Kidney Injury in Severe Infections, acronym: PET-AKI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-03, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Uppsala University Hospital, class: OTHER, descriptionModule briefSummary: Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations., conditionsModule conditions: Sepsis, conditions: AKI - Acute Kidney Injury, conditions: Positron Emission Tomography (PET), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Positron emission tomography (PET), outcomesModule primaryOutcomes measure: Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET), primaryOutcomes measure: Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET), eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372431, orgStudyIdInfo id: D1843R00360, briefTitle: PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia, acronym: PRIORITY-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study is a multi-centre, non-interventional, observational, prospective study with retrospective analysis. The main purpose of the study is to describe the rate of CKD diagnosis in patients with AH and CKD markers. This study will include 10 000 adult outpatients with arterial hypertension, who have one or more Chronic Kidney Disease laboratory markers (without recorded CKD diagnosis prior to enrolment) and have no diabetes mellitus or chronic heart failure, who are monitored and treated by cardiologists or internal medicine specialists in approximately 50 outpatient sites in about 20 regions in Russia.This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice., conditionsModule conditions: Arterial Hypertension, Chronic Kidney Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 10000, type: ESTIMATED, outcomesModule primaryOutcomes measure: To describe the rate of CKD diagnosis in patients with AH and CKD markers., secondaryOutcomes measure: To describe demographic and clinical characteristics of patients with AH and CKD markers, secondaryOutcomes measure: To describe clinical characteristics of patients with AH and diagnosed CKD during this study (on Visit 1 or Visit 2) and profile of routine therapy before and after CKD diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372418, orgStudyIdInfo id: KEMRI/SERU/CGMR-C/238/4326, briefTitle: Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants, acronym: IBAMI-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, descriptionModule briefSummary: The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants.Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital., conditionsModule conditions: Malnutrition, Infant, conditions: Breastfeeding, Exclusive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial:Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Fieldworkers collecting endpoint data at 6 months of age will be blinded to group allocation to avoid any bias subject to knowledge of group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Breastfeeding peer support intervention, interventions name: Standard Care, outcomesModule primaryOutcomes measure: Weight gain, secondaryOutcomes measure: Morbidity, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 4 Weeks, maximumAge: 12 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372405, orgStudyIdInfo id: PSP-501/D125/79/00000, briefTitle: Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Warsaw, Poland, class: OTHER, collaborators name: Duke University, descriptionModule briefSummary: Misophonia is a disorder causing intense reactions to specific sounds, disrupting daily life. Current treatments lack evidence-based support. The goal of this study is to explore the effectiveness of cognitive reappraisal (CR) in reducing misophonic responses. The study involves 100 participants assigned to either a 4-week CR program or Autogenic Training. Emotional regulation, symptoms of anxiety and depression, quality of life, and more will be assessed using various questionnaire-based measures; perseverations with a task-based test (Wisconsin Card Sorting Test); the presence of psychiatric and personality disorders using face-to-face interviews (The Mini-International Neuropsychiatric Interview (M.I.N.I.) and "Structured Clinical Interview for DSM-5® Personality Disorders" (SCID-5-PD), conditionsModule conditions: Misophonia Treatment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive reappraisal, interventions name: Schultz Autogenic Training, outcomesModule primaryOutcomes measure: Change in misophonia symptoms measured by S-Five - Externalizing subscale, primaryOutcomes measure: Change in misophonia symptoms measured by S-Five - Internalizing subscale, primaryOutcomes measure: Change in misophonia symptoms measured by S-Five - Threat subscale, primaryOutcomes measure: Change in misophonia symptoms measured by S-Five - Impact subscale, primaryOutcomes measure: CHange in misophonia symptoms measured by S-Five - Outburst subscale, primaryOutcomes measure: Change of aversiveness rating (valence/pleasure) on the Manikin Scales., primaryOutcomes measure: Change of arousal rating on the Manikin Scales., primaryOutcomes measure: Change in Galvanic Skin Response, primaryOutcomes measure: Change in average HR during the trigger presentation, primaryOutcomes measure: Diagnosis of personality disorders as a predictor of worse treatment outcome., primaryOutcomes measure: Working Alliance Inventory will be related to better treatment outcomes., secondaryOutcomes measure: Meeting criteria for psychiatric disorders -, secondaryOutcomes measure: Hearing test - standard and high frequency pure-tone audiometry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Psychology, University of Warsaw, status: RECRUITING, city: Warsaw, state: Masovian Voivodeship, zip: 00-183, country: Poland, contacts name: Marta Siepsiak, PhD, role: CONTACT, phone: 0048661152533, email: [email protected], contacts name: Marta Siepsiak, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06372392, orgStudyIdInfo id: 1.0, briefTitle: Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tartu University Hospital, class: OTHER, collaborators name: Estonia Research Council, descriptionModule briefSummary: Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport., conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Universal meal coefficient utilization, outcomesModule primaryOutcomes measure: Time in range (TIR), secondaryOutcomes measure: TBR, secondaryOutcomes measure: TAR, secondaryOutcomes measure: auto-corrections %, secondaryOutcomes measure: coefficient of variability, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: TartuUH, status: RECRUITING, city: Tartu, state: Tartumaa, zip: 50406, country: Estonia, contacts name: Aleksandr Peet, role: CONTACT, phone: 5532256, email: [email protected], geoPoint lat: 58.38062, lon: 26.72509, hasResults: False |
protocolSection identificationModule nctId: NCT06372379, orgStudyIdInfo id: 8780_UC2, briefTitle: Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments, acronym: eCREAM-UC2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, collaborators name: Astir S.r.l., collaborators name: Orobix Life S.r.l., collaborators name: Fondazione Bruno Kessler, descriptionModule briefSummary: An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner., conditionsModule conditions: Emergency Medicine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 162000, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Daschboards, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372366, orgStudyIdInfo id: Dental caries and vit.difiency, briefTitle: Relationship Between Vitamins Deficiency and Caries Experience Among a Group of Egyptian Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Dental caries is a worldwide condition characterized by localized destruction of dental hard tissue by acidic by-products from bacterial fermentation of dietary carbohydrates . Dental caries is considered to be the single most common chronic childhood disease, and its prevalence is thought to have increased recently., conditionsModule conditions: Dental Caries, conditions: Vitamin Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Caries prevalence, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 5 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06372353, orgStudyIdInfo id: 777, briefTitle: The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-05-24, completionDateStruct date: 2023-06-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Introduction and Objectives:IPF, characterized by shortness of breath and progressive deterioration in lung function.Baduanjin (BJ) is a mindbody health exercise that combines physical exercise with psychological properties to maximize both physical and mental health.The aim of the study is to investigate the effectiveness of these exercises in patients with IPF and to present an alternative in terms of the applicability of BJ exercises as a new treatment methodMethods: 28 volunteers were invited to the study.These patients were randomly divided into 2 groups.The subjects in the exercise group were given 24 sessions of supervised online BJ exercise training, 3 days a week, for 8 weeks. The patients included in the control group did not receive any training during the 8 week period, conditionsModule conditions: Pulmonary Fibrosis, Idiopathic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 28, type: ACTUAL, armsInterventionsModule interventions name: Baduanjin Exercise, outcomesModule primaryOutcomes measure: Functional capacity, primaryOutcomes measure: Pulmonary Function Tests, primaryOutcomes measure: Pulmonary Function Tests, primaryOutcomes measure: Pulmonary Function Tests, primaryOutcomes measure: Pulmonary Function Tests, primaryOutcomes measure: Respiratory muscle strength, primaryOutcomes measure: Respiratory muscle strength, primaryOutcomes measure: St. George's Respiratory Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul University - Cerrahpaşa, city: Istanbul, state: Fatih, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06372340, orgStudyIdInfo id: 2023BJYYEC-217-01, briefTitle: Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive., conditionsModule conditions: Pelvic Organ Prolapse, conditions: Urinary Incontinence, conditions: Diagnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be allocated to experimental group(EG) or the control group(CG). Subjects in the experimental group (EG) will receive personalized pelvic floor muscle training guidance provided by the system, whereas subjects in the control group(CG) will exercise according to the handbook or oral guidance., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Assessments regarding pelvic floor muscle strength will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program. Due to the nature of the intervention neither participants nor care providers can be blinded to allocation, but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments. An employee outside the research team will feed data into the computer in separate datasets so that the researchers can analyse data without having access to information about the allocation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system., interventions name: Standard pelvic floor muscle training(PFMT) program, outcomesModule primaryOutcomes measure: Modified Oxford Scale (MOS), primaryOutcomes measure: Surface Electromyography Data, secondaryOutcomes measure: The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), secondaryOutcomes measure: The score of the Pelvic Floor Distress Inventory (PFDI-20), secondaryOutcomes measure: Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System, eligibilityModule sex: FEMALE, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372327, orgStudyIdInfo id: 73468, briefTitle: Move Often eVery Day 2.0, acronym: MOVD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess a novel, widely-accessible intervention to both promote active breaks from work and improve cognitive and psychological performances at work in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with 1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no equipment, and simple video-based instructions. The short bouts will be referred to as "exercise snacks." In this proposed exercise snacks intervention, investigators explicitly target a population with sedentary jobs due to the generalizability., conditionsModule conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This will be a 2 (Exercise snack number) x 2 (Exercise snack length) factorial design., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Daily Exercise Snacks, outcomesModule primaryOutcomes measure: Number of self-reported exercise snack breaks at work at week 7, primaryOutcomes measure: Number of self-reported exercise snack breaks at work at week 18, primaryOutcomes measure: Number of self-reported exercise snack breaks at work at week 30 during follow-up, secondaryOutcomes measure: Liking of exercise snacks, eligibilityModule sex: FEMALE, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University School of Medicine, city: Stanford, state: California, zip: 94305-7240, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False |
protocolSection identificationModule nctId: NCT06372314, orgStudyIdInfo id: 1000081221, briefTitle: Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Hospital for Sick Children, class: OTHER, descriptionModule briefSummary: This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids.The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates., conditionsModule conditions: Stable Neonates Receiving Total Parenteral Nutrition (TPN), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Total parenteral nutrition (TPN): this is total nutrition provided by central vein., outcomesModule primaryOutcomes measure: Amino acid oxidation using a labelled amino acid., eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil, city: Santa Maria, country: Brazil, contacts name: Ivo Dr Prola, MD, PhD, role: CONTACT, phone: 6477815786, email: [email protected], contacts name: Beatriz Dr Porto, MD, role: CONTACT, phone: 6475002171, email: [email protected], geoPoint lat: -29.68417, lon: -53.80694, hasResults: False |
protocolSection identificationModule nctId: NCT06372301, orgStudyIdInfo id: 1-10-72-179-23, briefTitle: Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy, acronym: DobAttrAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Steen Hvitfeldt Poulsen, class: OTHER, descriptionModule briefSummary: The goal of this prospective clinical study is improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS This question will be tried to answer by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard).In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine., conditionsModule conditions: Transthyretin Amyloid Cardiomyopathy, conditions: Aortic Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Dobutamine stress echocardiography, outcomesModule primaryOutcomes measure: The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion., secondaryOutcomes measure: Correlation between echocardiography derived AVA and invasively assessed AVA at rest and at different dobutamine infusion levels., secondaryOutcomes measure: Increase of SVI, LV ejection fraction and LV-global longitudinal strain of 10 % during maximal dobutamine stimulation., secondaryOutcomes measure: Correlation between echo- and invasive measured SVI., secondaryOutcomes measure: Degree of myocardial fibrosis, amyloid infiltration and mitochondrial dysfunction and its relation to AS severity and hemodynamic response to dobutamine, secondaryOutcomes measure: Reduction of mean pulmonary artery wedge pressure and/or mean pulmonary artery pressure by 10 %., secondaryOutcomes measure: Complication rate and symptomatic side effects during dobutamine challenge, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, Aarhus University Hospital, status: RECRUITING, city: Aarhus, zip: 8200, country: Denmark, contacts name: Ali Hussein Jaber Mejren, MD, role: CONTACT, phone: 0045 91 65 18 48, email: [email protected], geoPoint lat: 56.15674, lon: 10.21076, hasResults: False |
protocolSection identificationModule nctId: NCT06372288, orgStudyIdInfo id: 22-1754, briefTitle: Theta Burst TMS for Treatment of Methamphetamine Use Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Carilion Clinic, class: OTHER, collaborators name: Virginia Polytechnic Institute and State University, descriptionModule briefSummary: This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm., conditionsModule conditions: Methamphetamine Abuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation, interventions name: Sham Transcranial Magnetic Stimulation, outcomesModule primaryOutcomes measure: Stimulant Craving Questionnaire (STCQ), primaryOutcomes measure: Urine Drug Screen (UDS), secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q), secondaryOutcomes measure: Hamilton Anxiety Scale (HAM-A), secondaryOutcomes measure: Montgomery Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Clinical Global Impression - Severity (CGI-S), secondaryOutcomes measure: Clinical Global Impression - Improvement (CGI-I), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Carilion Clinic, status: RECRUITING, city: Roanoke, state: Virginia, zip: 24014, country: United States, contacts name: Sooraj John, M.D., role: CONTACT, contacts name: Maryann Hollen, B.S., role: CONTACT, phone: 540-566-8081, geoPoint lat: 37.27097, lon: -79.94143, hasResults: False |
protocolSection identificationModule nctId: NCT06372275, orgStudyIdInfo id: 0000, briefTitle: Investigating Two Prototype Mobile App Interventions to Increase Physical Activity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mississippi State University, class: OTHER, collaborators name: Association for contextual behavioral science, descriptionModule briefSummary: This randomized control trial aims to investigate whether writing about personal values helps enhance motivation to engage in physical activity, relative to general self-reflective writing. This study will help to (1) assess whether values clarification leads to increased motivation to engage in physical activity, greater stability in motivation, and improvements in engagement in physical activity and valued action, relative to engaging in self-reflection, (2) determine if the impact of values clarification on these outcomes vary depending on context (e.g., positive/negative affect, psychological inflexibility, stressful events), (3) explore whether values clarification procedures that employ distinct relational frames (hierarchical, conditional, distinction, and deictic) differentially impact motivation to engage in physical activity, and daily engagement in physical activity, and (4) explore whether the impact of values clarification vary depending on baseline self-compassion and/or intrinsic/extrinsic motivation., conditionsModule conditions: Health-Related Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Values Clarification Mobile Application, interventions name: Self-Reflection Mobile Application, outcomesModule primaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) - Total physical activity, secondaryOutcomes measure: Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score, secondaryOutcomes measure: Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3), secondaryOutcomes measure: External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3), secondaryOutcomes measure: Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3), secondaryOutcomes measure: Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3), secondaryOutcomes measure: Integrated Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3), secondaryOutcomes measure: Intrinsic Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3), secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2, secondaryOutcomes measure: Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System), secondaryOutcomes measure: Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System), secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a, secondaryOutcomes measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24), secondaryOutcomes measure: Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24), secondaryOutcomes measure: Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24), secondaryOutcomes measure: Values Clarity Questionnaire (VCQ), secondaryOutcomes measure: Self-Compassion Scale Short Form (SCS-SF), secondaryOutcomes measure: Random responding question, secondaryOutcomes measure: Credibility & Expectancy Questionnaire (CEQ), secondaryOutcomes measure: System Usability Scale (SUS), secondaryOutcomes measure: Treatment Evaluation Inventory-Short Form (TEI-SF), secondaryOutcomes measure: Exercise ecological momentary assessment (EMA) questions, secondaryOutcomes measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA), secondaryOutcomes measure: Momentary Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA), secondaryOutcomes measure: Momentary Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA), secondaryOutcomes measure: Emotion ratings, secondaryOutcomes measure: Current Motivation to Exercise, secondaryOutcomes measure: Previous Day Stress Level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mindfulness and Acceptance Processes Lab, city: Starkville, state: Mississippi, zip: 39759, country: United States, geoPoint lat: 33.45049, lon: -88.81961, hasResults: False |
protocolSection identificationModule nctId: NCT06372262, orgStudyIdInfo id: Rowers2022, briefTitle: Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase, acronym: Rowers, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study., conditionsModule conditions: Endothelial Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: ergometer test, outcomesModule primaryOutcomes measure: I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury, primaryOutcomes measure: zonulin to measure tight junction leakage, primaryOutcomes measure: LBP (lipopolysaccharide binding protein) to measure endotoxin, primaryOutcomes measure: LPS (lipopolysaccharide) to measure endotoxin, primaryOutcomes measure: Lactic acid to measure fatigue after the race, secondaryOutcomes measure: energy, secondaryOutcomes measure: fiber intake, secondaryOutcomes measure: protein, secondaryOutcomes measure: carbohydrate, secondaryOutcomes measure: body mass, secondaryOutcomes measure: Body composition - water, secondaryOutcomes measure: Body composition - fat, secondaryOutcomes measure: Lean body mass, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 23 Years, stdAges: ADULT, contactsLocationsModule locations facility: Poznan University of Physical Education, city: Poznań, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False |
protocolSection identificationModule nctId: NCT06372249, orgStudyIdInfo id: 22-249, secondaryIdInfos id: 2U54MD012388-06, type: NIH, link: https://reporter.nih.gov/quickSearch/2U54MD012388-06, briefTitle: A Clinical Trial of Soluble Fiber for Asthma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Phoenix Children's Hospital, class: OTHER, collaborators name: Northern Arizona University, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet., conditionsModule conditions: Asthma in Children, 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: 105, type: ESTIMATED, armsInterventionsModule interventions name: NOVELOSETM 3490, outcomesModule primaryOutcomes measure: Alpha diversity., secondaryOutcomes measure: Asthma control., secondaryOutcomes measure: Gut microbiome composition., secondaryOutcomes measure: Nasal inflammatory response., secondaryOutcomes measure: Quantification of circulating short chain fatty acids., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Phoenix Children's, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85016, country: United States, contacts name: Destiny Ogbeama, role: CONTACT, geoPoint lat: 33.44838, lon: -112.07404, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-17, uploadDate: 2024-04-02T16:19, filename: Prot_SAP_000.pdf, size: 285020, hasResults: False |
protocolSection identificationModule nctId: NCT06372236, orgStudyIdInfo id: PG-001-025, briefTitle: UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first., conditionsModule conditions: Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: UTAA06 injection, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: UTAA06 injection for treatment of advanced malignant solid tumors, outcomesModule primaryOutcomes measure: MTD, primaryOutcomes measure: To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors, primaryOutcomes measure: To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors., secondaryOutcomes measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors., secondaryOutcomes measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors., secondaryOutcomes measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors., secondaryOutcomes measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors., secondaryOutcomes measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors., secondaryOutcomes measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors., secondaryOutcomes measure: To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PersonGen Anke Cellular Therapeutice Co.,Ltd, status: RECRUITING, city: Hefei, state: Anhui, zip: 230088, country: China, contacts name: Huimin Meng, Doctor, role: CONTACT, phone: +86-18015580390, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06372223, orgStudyIdInfo id: SPH5030-102, briefTitle: A Food Effect Study of SPH5030 Tablets., statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-03-25, completionDateStruct date: 2024-03-25, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Shanghai Pharmaceuticals Holding Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: SPH5030, interventions name: SPH5030, outcomesModule primaryOutcomes measure: Peak Plasma Concentration (Cmax), primaryOutcomes measure: Peak time（Tmax）, primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Second Hospital ,Sichuan University, city: Chengdu, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06372210, orgStudyIdInfo id: 031-201-00521, briefTitle: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-26, primaryCompletionDateStruct date: 2023-07-19, completionDateStruct date: 2023-07-19, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Otsuka Pharmaceutical Development & Commercialization, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch., conditionsModule conditions: Mental Disorder, conditions: Schizophrenia, conditions: Major Depressive Disorder, conditions: Bipolar I Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Placebo IEM tablet, interventions name: Abilify MyCite®, interventions name: D-Tect Patch, outcomesModule primaryOutcomes measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch, primaryOutcomes measure: Cohort 1 and 2: Patch Detection Latency Period, primaryOutcomes measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period, primaryOutcomes measure: Cohort 1 and 2: Total Detection Latency Period, secondaryOutcomes measure: Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research site, city: Garden Grove, state: California, zip: 92845, country: United States, geoPoint lat: 33.77391, lon: -117.94145, hasResults: False |
protocolSection identificationModule nctId: NCT06372197, orgStudyIdInfo id: LIGPATD, briefTitle: Low-Income Group Psilocybin Assisted Therapy for Depression, acronym: LIGPATD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Matthew Hicks, class: OTHER, descriptionModule briefSummary: Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population.Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview.Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment.The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: Recruitment Feasibility, primaryOutcomes measure: Retention Feasibility, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Preliminary Safety and Tolerability: incidence and severity of adverse events, otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29), otherOutcomes measure: Altered State of Consciousness rating scale (11-ASC), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372184, orgStudyIdInfo id: WMT-AR-RCT, briefTitle: Washed Microbiota Transplantation for Allergic Rhinitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-06-01, completionDateStruct date: 2029-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR., conditionsModule conditions: Rhinitis, Allergic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Washed Microbiota Transplantation, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in the reflective total nasal symptom score (rTNSS), secondaryOutcomes measure: Changes in the combined symptoms and medication score (CSMS), secondaryOutcomes measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score, secondaryOutcomes measure: Changes in the single reflective nasal symptoms score, secondaryOutcomes measure: Specific IgE, secondaryOutcomes measure: Inflammatory factors, secondaryOutcomes measure: Flow cytometric analysis of lymphocyte clusters, secondaryOutcomes measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0, secondaryOutcomes measure: Changes in the Modified Lund-Kennedy endoscopic score, secondaryOutcomes measure: The changes in composition and metabolites of gut microbiota and nasal microbiota, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210011, country: China, contacts name: Faming Zhang, MD,PhD, role: CONTACT, phone: 086-25-58509883, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06372171, orgStudyIdInfo id: NYCU112182AEF, briefTitle: Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C., conditionsModule conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Satge 1, interventions name: Stage 2, outcomesModule primaryOutcomes measure: General examination, primaryOutcomes measure: Hematology Test, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, state: Beitou Dist., zip: 112, country: Taiwan, contacts name: Tze-Fang Wang, Ph.D., role: CONTACT, phone: +886-2-28267907, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06372158, orgStudyIdInfo id: NYCU112181AE, briefTitle: Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements., conditionsModule conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Stage 1, interventions name: Stage 2, outcomesModule primaryOutcomes measure: General examination, primaryOutcomes measure: Hematology Test, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, state: Beitou Dist., zip: 112, country: Taiwan, contacts name: Tze-Fang Wang, Ph.D., role: CONTACT, phone: +886-2-28267907, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, zip: 112, country: Taiwan, contacts name: ChienYu Huang, Bachelor, role: CONTACT, phone: +886-955-879163, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06372145, orgStudyIdInfo id: LTS17043, secondaryIdInfos id: 2023-503631-18, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1287-6797, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).SUBSTUDY: ToleDYNAMIC substudy, conditionsModule conditions: Relapsing Multiple Sclerosis, conditions: Secondary Progressive Multiple Sclerosis, conditions: Progressive Relapsing Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Tolebrutinib, interventions name: Placebo, interventions name: Teriflunomide, outcomesModule primaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation, primaryOutcomes measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs), secondaryOutcomes measure: Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies, secondaryOutcomes measure: Annualized Relapse Rate (ARR) for RMS only, secondaryOutcomes measure: Number of new and/or enlarging T2-hyperintense lesions per year, secondaryOutcomes measure: Change from baseline in total volume of T2-hyperintense lesions, secondaryOutcomes measure: ToleDYNAMIC substudy Change from baseline in biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Investigational Site Number : 0560005, status: RECRUITING, city: Brugge, zip: 8000, country: Belgium, geoPoint lat: 51.20892, lon: 3.22424, hasResults: False |
protocolSection identificationModule nctId: NCT06372132, orgStudyIdInfo id: NL85305.068.23, briefTitle: G-POEM vs PEG-J in Gastroparesis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM.Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point., conditionsModule conditions: Gastroparesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: G-POEM, outcomesModule primaryOutcomes measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months., secondaryOutcomes measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months., secondaryOutcomes measure: Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention., secondaryOutcomes measure: Number and severity of (s)AEs in the treatment groups., secondaryOutcomes measure: Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score., secondaryOutcomes measure: Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, status: RECRUITING, city: Maastricht, state: Zuid-Limburg, zip: 6229 HX, country: Netherlands, contacts name: Kim Sweerts, MD, role: CONTACT, phone: 0883887298, email: [email protected], geoPoint lat: 50.84833, lon: 5.68889, hasResults: False |
protocolSection identificationModule nctId: NCT06372119, orgStudyIdInfo id: 13/23/DD-BVMD, briefTitle: Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is:• Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation?Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe Femara® 2.5 milligrams (Novartis, Switzerland) at a dose of 5 milligrams/day for 5 days to stimulate follicular development and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day for luteal phase support. In contrast, the AC group will receive Valiera® 2 milligrams (Laboratories Recalcine, Chile) starting with a dose of 6 milligrams/day, up to a maximum dose of 12 milligrams/day) and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates., conditionsModule conditions: Embryo Transfer, conditions: Irregular Menstruation, conditions: Letrozole, conditions: Hormone Replacement Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Letrozole-stimulated cycle strategy (LETS), interventions name: Artificial cycle strategy (AC), outcomesModule primaryOutcomes measure: Live birth rate after one cycle of endometrial preparation, secondaryOutcomes measure: Positive pregnancy test after one cycle of endometrial preparation, secondaryOutcomes measure: Clinical pregnancy after one cycle of endometrial preparation, secondaryOutcomes measure: Ongoing pregnancy after one cycle of endometrial preparation, secondaryOutcomes measure: Multiple pregnancy after one cycle of endometrial preparation, secondaryOutcomes measure: Implantation rate after one cycle of endometrial preparation, secondaryOutcomes measure: Cycle cancellation rate, secondaryOutcomes measure: Ectopic pregnancy rate after one cycle of endometrial preparation, secondaryOutcomes measure: Threatened miscarriage rate before 12 weeks of gestation after one cycle of endometrial preparation, secondaryOutcomes measure: Early miscarriage rate after one cycle of endometrial preparation, secondaryOutcomes measure: Late miscarriage rate after one cycle of endometrial preparation, secondaryOutcomes measure: Gestational age at birth, secondaryOutcomes measure: Onset of labor, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Very low birth weight, secondaryOutcomes measure: Low birth weight, secondaryOutcomes measure: High birth weight (macrosomia), secondaryOutcomes measure: Very high birth weight (macrosomia), secondaryOutcomes measure: Gestational diabetes (GDM), secondaryOutcomes measure: Hypertensive disorders of pregnancy, secondaryOutcomes measure: Preterm birth, secondaryOutcomes measure: Stillbirth, secondaryOutcomes measure: Antepartum hemorrhage, secondaryOutcomes measure: Postpartum hemorrhage, secondaryOutcomes measure: Small for gestational age (singleton/twins), secondaryOutcomes measure: Large for gestational age (singleton/twins), secondaryOutcomes measure: Birth weight, secondaryOutcomes measure: Congenital anomalies, secondaryOutcomes measure: NICU admission, secondaryOutcomes measure: Reason for NICU admission, secondaryOutcomes measure: Neonatal mortality rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 42 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372106, orgStudyIdInfo id: MA_PM_Mountain_2022_11496, briefTitle: Project Mountain - Comparing SpO2 and SaO2 for Accuracy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Philips Clinical & Medical Affairs Global, class: INDUSTRY, descriptionModule briefSummary: The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation., conditionsModule conditions: SpO2, conditions: Nasal Alar Collapse, Bilateral, conditions: Oxygen, conditions: Measurement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 560, type: ESTIMATED, armsInterventionsModule interventions name: SaO2 Sampling, outcomesModule primaryOutcomes measure: To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth., secondaryOutcomes measure: Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology., secondaryOutcomes measure: Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06372093, orgStudyIdInfo id: PMH 2/11AII, briefTitle: Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-16, primaryCompletionDateStruct date: 2024-02-26, completionDateStruct date: 2024-02-26, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Picterus AS, class: INDUSTRY, collaborators name: University of Copenhagen, collaborators name: University of Botswana, descriptionModule briefSummary: The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.The specific objectives for this study are:i. To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin.ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin., conditionsModule conditions: Jaundice, Neonatal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 172, type: ACTUAL, armsInterventionsModule interventions name: Picterus Jaundice Pro, outcomesModule primaryOutcomes measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP., secondaryOutcomes measure: Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB, secondaryOutcomes measure: Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 14 Days, stdAges: CHILD, contactsLocationsModule locations facility: Princess Marina Hospital, city: Gaborone, country: Botswana, geoPoint lat: -24.65451, lon: 25.90859, hasResults: False |
protocolSection identificationModule nctId: NCT06372080, orgStudyIdInfo id: 19/SPS/054, briefTitle: Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-06, primaryCompletionDateStruct date: 2021-09-29, completionDateStruct date: 2023-03-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Liverpool John Moores University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women.The main questions it aims to answer are:* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone?* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups.Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed., conditionsModule conditions: Healthy Participants, conditions: Nutrition, conditions: Exercise Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule interventions name: Resistance training with hydrolyzed collagen ingestion in healthy young men, interventions name: Resistance training with hydrolyzed collagen ingestion in healthy young women, outcomesModule primaryOutcomes measure: Maximal knee extensor (quadriceps) muscle strength, primaryOutcomes measure: Maximal knee flexor (hamstring) muscle strength, primaryOutcomes measure: Patellar tendon cross-sectional area, primaryOutcomes measure: Patellar tendon stiffness, primaryOutcomes measure: Vastus lateralis (VL) muscle size, primaryOutcomes measure: Vastus lateralis (VL) muscle fascicle length, primaryOutcomes measure: Vastus lateralis (VL) muscle fascicle pennation angle, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Institute for Sport and Exercise Sciences, city: Liverpool, state: Merseyside, zip: L3 3AF, country: United Kingdom, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False |
protocolSection identificationModule nctId: NCT06372067, orgStudyIdInfo id: 17378, briefTitle: IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures, acronym: HANDFIX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, descriptionModule briefSummary: When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work., conditionsModule conditions: Hand; Fracture, Phalanx, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, open-label, pilot randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: By nature of the interventions in this study, blinding will not be possible for the surgeon or the patient post-operatively., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Intramedullary screw, interventions name: Kirschner wire, outcomesModule primaryOutcomes measure: Percentage of Patient Eligibility - Study Feasibility, primaryOutcomes measure: Recruitment rate - Study Feasibility, primaryOutcomes measure: Crossover rate - Study Feasibility, primaryOutcomes measure: Compliance with intervention rate - Study Feasibility, primaryOutcomes measure: Patient retention rate - Study Feasibility, secondaryOutcomes measure: Disability of the Arm, Shoulder, and Hand, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: Return to work, secondaryOutcomes measure: Complications/adverse events, secondaryOutcomes measure: Postoperative pain (visual analogue scale), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06372054, orgStudyIdInfo id: TORNADO, briefTitle: TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-02-05, completionDateStruct date: 2027-02-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: University of Milan, collaborators name: Italian Air Force, collaborators name: A-Tono, collaborators name: Ministry of Defense, Italy, descriptionModule briefSummary: The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine., conditionsModule conditions: Oxidative Injury, conditions: Stress Physiological, conditions: Discogenic Pain, conditions: Cardiovascular Risk Factor, conditions: Space Maintenance, conditions: Epigenetic Changes, conditions: LONGEVITY 1, conditions: Neuroplasticity, conditions: NGS, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Biological sample collection, outcomesModule primaryOutcomes measure: Assessment of flight-related exposure data and molecular modifications, secondaryOutcomes measure: Assessment of General Health, secondaryOutcomes measure: Assessment of Sleep Quality, secondaryOutcomes measure: Assessment of eating habits, secondaryOutcomes measure: Creation of reliable AI and disease-based models for personalized medicine, eligibilityModule sex: ALL, minimumAge: 26 Years, maximumAge: 38 Years, stdAges: ADULT, contactsLocationsModule locations facility: CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy, status: RECRUITING, city: Milan, zip: 20139, country: Italy, contacts name: Stefania E Navone, PhD, role: CONTACT, phone: 0256660100, phoneExt: +39, email: [email protected], contacts name: Giovanni Marfia, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Laura Guarnaccia, PhD, role: SUB_INVESTIGATOR, contacts name: Stefania E Navone, PhD, role: SUB_INVESTIGATOR, contacts name: Monica R Miozzo, PhD, role: SUB_INVESTIGATOR, contacts name: Orazio Granato, PhD, role: SUB_INVESTIGATOR, contacts name: Silvana Pileggi, PhD, role: SUB_INVESTIGATOR, contacts name: Luisella Vigna, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Matteo Bonzini, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Fontana, PhD, role: SUB_INVESTIGATOR, contacts name: Laura Begani, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06372041, orgStudyIdInfo id: 944/B, briefTitle: Transcranial Alternating Current Stimulation in Cerebral Palsy (BOOSTTACS), acronym: BOOSTTACS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-05-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, collaborators name: IRCCS National Neurological Institute "C. Mondino" Foundation, collaborators name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, descriptionModule briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcranial alternating current stimulation (tACS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tACS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, in light of findings showing that tACS effectively improves motor learning, the investigators hypothesized that active tACS might improve in a greater and more lasting extent than sham tACS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in pediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: transcranial Alternating Current Stimulation, outcomesModule primaryOutcomes measure: Assisting Hand Assessment (AHA), primaryOutcomes measure: Box and Block Test (BBT), primaryOutcomes measure: Visuomotor task, secondaryOutcomes measure: Canadian Occupational Performance Measure (COPM), secondaryOutcomes measure: Children's Hand-Use Experience Questionnaire (CHEQ), secondaryOutcomes measure: Melbourne Assessment 2 (MA2), secondaryOutcomes measure: Gross Motor Function Measure (GMFM-66), secondaryOutcomes measure: Vineland Adaptive Behavior Scale Version 2 (VABS II), secondaryOutcomes measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL), secondaryOutcomes measure: Cortical rhythms at rest and during the Visuomotor task, otherOutcomes measure: Heart rate (HR), otherOutcomes measure: Oxygen saturation (SPO2), otherOutcomes measure: Tolerability of the stimulation, otherOutcomes measure: number of patients who accept to complete the 2-week training, otherOutcomes measure: number of sessions completed per patient, otherOutcomes measure: acceptability of the training, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Scientific Institute, IRCCS E. Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Alessandra Finisguerra, role: CONTACT, phone: +39031877652, email: [email protected], contacts name: Cosimo Urgesi, role: CONTACT, phone: +39031877652, email: [email protected], contacts name: Viola Oldrati, role: SUB_INVESTIGATOR, geoPoint lat: 45.80075, lon: 9.29, hasResults: False |
protocolSection identificationModule nctId: NCT06372028, orgStudyIdInfo id: 944/A, briefTitle: Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS), acronym: (BOOSTTVNS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-05-14, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, collaborators name: IRCCS National Neurological Institute "C. Mondino" Foundation, collaborators name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, descriptionModule briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, taking into account that tVNS has the potential to facilitate in a bottom-up way neural plasticity, particularly in chronic disease conditions, the investigators hypothesized that active tVNS might improve in a greater and more lasting extent than sham tVNS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in paediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: transcutaneous vagus nerve stimulation (tVNS), outcomesModule primaryOutcomes measure: Assisting Hand Assessment (AHA), primaryOutcomes measure: Box and Block Test (BBT), primaryOutcomes measure: Visuomotor task, secondaryOutcomes measure: Canadian Occupational Performance Measure (COPM), secondaryOutcomes measure: Children's Hand-UseExperienceQuestionnaire (CHEQ), secondaryOutcomes measure: Melbourne Assessment 2 (MA2), secondaryOutcomes measure: Gross Motor Function Measure (GMFM-66), secondaryOutcomes measure: Vineland Adaptive Behavior Scale Version 2 (VABS II), secondaryOutcomes measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL), otherOutcomes measure: Heart rate (HR)., otherOutcomes measure: Oxygen saturation (SPO2)., otherOutcomes measure: Tolerability of the stimulation, otherOutcomes measure: Number of patients who accept to complete the 2-week training, otherOutcomes measure: Number of sessions completed per patient, otherOutcomes measure: Acceptability of the training, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Scientific Institute, IRCCS E. Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Alessandra Finisguerra, role: CONTACT, phone: +39031877652, email: [email protected], contacts name: Cosimo Urgesi, role: CONTACT, email: [email protected], contacts name: Viola Oldrati, role: SUB_INVESTIGATOR, geoPoint lat: 45.80075, lon: 9.29, hasResults: False |
protocolSection identificationModule nctId: NCT06372015, orgStudyIdInfo id: RC2023-24, briefTitle: Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, class: OTHER, collaborators name: Notarnicola Maria, collaborators name: Cozzolongo Raffaele, collaborators name: Shahini Endrit, collaborators name: De Pergola Giovanni, collaborators name: Lippolis Giuseppe, descriptionModule briefSummary: Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI\>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery.Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it.Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy.The choice of the surgeon, assisted by the multidisciplinary team, is binding in the choice of the type of operation to which the patient will be subjected., conditionsModule conditions: Obesity, conditions: Liver Disease Parenchymal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional Approach, interventions name: Surgery Approach, outcomesModule primaryOutcomes measure: Variation of lipidomic parameters, primaryOutcomes measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, primaryOutcomes measure: Variation in the microRNA profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS "Saverio de Bellis", city: Castellana Grotte, state: Bari, zip: 70013, country: Italy, contacts name: Rossella Donghia, Biologyst, role: CONTACT, phone: 0804994652, email: [email protected], geoPoint lat: 40.88643, lon: 17.16549, hasResults: False |
protocolSection identificationModule nctId: NCT06372002, orgStudyIdInfo id: 05/23, briefTitle: Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Instituto de Mayores y Servicios Sociales (IMSERSO), class: OTHER_GOV, collaborators name: University of Castilla-La Mancha, collaborators name: Confederación Española de Alzheimer (CEAFA), descriptionModule briefSummary: This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia.The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group)., conditionsModule conditions: Dementia, conditions: Neurocognitive Disorders, conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A pragmatic, multicenter, randomized, controlled clinical trial is proposed to compare treatment with CST-ES followed by maintenance treatment with CST-ES with treatment as usual:* First Phase: Participants who meet the inclusion criteria will be randomized to the CST-ES intervention group or a treatment-as-usual control group. Participants assigned to the intervention group will receive two sessions of CST-ES per week for 7 weeks, also they will continue their usual treatment. Participants in the control group will receive their usual treatment during the development of the study.* Second Phase: After the first phase is completed, participants assigned to the intervention group will receive one session of maintenance CST-ES per week for 24 weeks besides continuing their usual treatment, whereas participants in the control group will continue their usual treatment during this second phase., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The technician in charge of the evaluation of those participating in the study must be blinded throughout the CST intervention, i.e., he/she will not know whether the users being evaluated belong to the intervention or the control group.The CRE Alzheimer professional responsible for randomization and data analysis will also be blinded.The participants and the technician performing the intervention cannot be blinded due to the nature of the intervention., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 683, type: ACTUAL, armsInterventionsModule interventions name: Cognitive Stimulation Therapy (CST), outcomesModule primaryOutcomes measure: Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG), primaryOutcomes measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG), primaryOutcomes measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG), primaryOutcomes measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD), primaryOutcomes measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD), primaryOutcomes measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD), secondaryOutcomes measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L), secondaryOutcomes measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L), secondaryOutcomes measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L), otherOutcomes measure: Resource utilization evaluated through Resource Utilization in Dementia (RUD), otherOutcomes measure: Change in resource utilization evaluated through Resource Utilization in Dementia (RUD), otherOutcomes measure: Sociodemographic information gathered through the sociodemographic questionnaire, otherOutcomes measure: Adherence to the intervention and dropouts evaluated through a session form, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca, city: Alcoy, state: Alicante, country: Spain, geoPoint lat: 38.70545, lon: -0.47432, locations facility: AFA Castalla y Onil, city: Castalla, state: Alicante, country: Spain, geoPoint lat: 38.59694, lon: -0.67207, locations facility: AFA Elda, Petrer y Comarca del Medio Vinalopo, city: Elda, state: Alicante, country: Spain, geoPoint lat: 38.47783, lon: -0.79157, locations facility: AFA Teulada - Moraira (Marina Alta), city: Teulada, state: Alicante, country: Spain, geoPoint lat: 38.7294, lon: 0.10383, locations facility: Asociación Familiares de Personas con Alzheimer de Villena y Comarca, city: Villena, state: Alicante, country: Spain, geoPoint lat: 38.6373, lon: -0.86568, locations facility: Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez", city: Mérida, state: Badajoz, country: Spain, geoPoint lat: 38.91611, lon: -6.34366, locations facility: Centro Alois II, city: Cornellà De Llobregat, state: Barcelona, country: Spain, geoPoint lat: 41.35, lon: 2.08333, locations facility: Asociación de familiares de personas con Alzheimer y otras demencias del Maresme, city: Mataró, state: Barcelona, country: Spain, geoPoint lat: 41.54211, lon: 2.4445, locations facility: Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI), city: Iniesta, state: Cuenca, country: Spain, geoPoint lat: 39.43333, lon: -1.75, locations facility: AFEAVA, city: Hervás, state: Cáceres, country: Spain, geoPoint lat: 40.27081, lon: -5.86721, locations facility: AFA Faro de Chipiona, city: Chipiona, state: Cádiz, country: Spain, geoPoint lat: 36.73663, lon: -6.43703, locations facility: Afa Puerto, city: El Puerto De Santa María, state: Cádiz, country: Spain, geoPoint lat: 36.59389, lon: -6.23298, locations facility: Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez, city: Fernán Núñez, state: Córdoba, country: Spain, geoPoint lat: 37.67044, lon: -4.7264, locations facility: AFAMO, city: Montilla, state: Córdoba, country: Spain, geoPoint lat: 37.58627, lon: -4.63805, locations facility: AFASUR Genil, city: Puente Genil, state: Córdoba, country: Spain, geoPoint lat: 37.38943, lon: -4.76686, locations facility: Asociación de familiares de enfermos de Alzheimer de Motril - Contigo, city: Motril, state: Granada, country: Spain, geoPoint lat: 36.75066, lon: -3.5179, locations facility: AFAMA Pollença, city: Pollença, state: Islas Baleares, country: Spain, geoPoint lat: 39.87678, lon: 3.01626, locations facility: Asociación Alzheimer Bierzo, city: Ponferrada, state: León, country: Spain, geoPoint lat: 42.54664, lon: -6.59619, locations facility: Afa Santa Marina Del Rey, city: Santa Marina del Rey, state: León, country: Spain, geoPoint lat: 42.51334, lon: -5.86065, locations facility: Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca, city: Tàrrega, state: Lleida, country: Spain, geoPoint lat: 41.64704, lon: 1.13957, locations facility: AFA Pozuelo, city: Pozuelo De Alarcón, state: Madrid, country: Spain, geoPoint lat: 40.43293, lon: -3.81338, locations facility: Asociación Alzheimer y otras Demencias Lorca, city: Lorca, state: Murcia, country: Spain, geoPoint lat: 37.67119, lon: -1.7017, locations facility: Centro de día Alzheimer Estepona, city: Estepona, state: Málaga, country: Spain, geoPoint lat: 36.42764, lon: -5.14589, locations facility: Centro de Día Nieves Barranco, city: Marbella, state: Málaga, country: Spain, geoPoint lat: 36.51543, lon: -4.88583, locations facility: AFADAX, city: Vélez-Málaga, state: Málaga, country: Spain, geoPoint lat: 36.78107, lon: -4.10266, locations facility: Asociación de Alzheimer "Virgen del Castillo", city: Lebrija, state: Sevilla, country: Spain, geoPoint lat: 36.92077, lon: -6.07529, locations facility: AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina, city: Talavera De La Reina, state: Toledo, country: Spain, geoPoint lat: 39.96348, lon: -4.83076, locations facility: ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí), city: Algemesí, state: Valencia, country: Spain, geoPoint lat: 39.19042, lon: -0.43572, locations facility: AFA Alginet, city: Alginet, state: Valencia, country: Spain, geoPoint lat: 39.26667, lon: -0.46667, locations facility: Centro de estimulación y Rehabilitación "La LLimera" de AFABALS, city: Benifayó, state: Valencia, country: Spain, geoPoint lat: 39.28439, lon: -0.42598, locations facility: AFA Benavente y Comarca, city: Benavente, state: Zamora, country: Spain, geoPoint lat: 42.00249, lon: -5.67826, locations facility: AFA Alicante, city: Alicante, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Centre de Día AFA Barcelona, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Club de la memoria - Alzhei Cáceres, city: Cáceres, country: Spain, geoPoint lat: 39.47649, lon: -6.37224, locations facility: AFA Alzhe de Cadiz, city: Cádiz, country: Spain, geoPoint lat: 36.52672, lon: -6.2891, locations facility: Asociación San Rafael de Alzheimer y Otras Demencias, city: Córdoba, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: AFA Huelva, city: Huelva, country: Spain, geoPoint lat: 37.26638, lon: -6.94004, locations facility: Alzheimer León, city: León, country: Spain, geoPoint lat: 42.60003, lon: -5.57032, locations facility: Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja), city: Logroño, country: Spain, geoPoint lat: 42.46667, lon: -2.45, locations facility: AFALU, city: Lugo, country: Spain, geoPoint lat: 43.00992, lon: -7.55602, locations facility: AFA Málaga, city: Málaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso, city: Salamanca, zip: 37008, country: Spain, geoPoint lat: 40.96882, lon: -5.66388, locations facility: AGADEA, city: Santiago de Compostela, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: AFAV (Asociación Familiares Enfermos de Alzheimer Valencia), city: Valencia, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Alzheimer Ávila, city: Ávila, country: Spain, geoPoint lat: 40.65724, lon: -4.69951, locations facility: AFARABA, city: Gasteiz / Vitoria, state: Álava, country: Spain, geoPoint lat: 42.84998, lon: -2.67268, hasResults: False |
protocolSection identificationModule nctId: NCT06371989, orgStudyIdInfo id: 19/160, briefTitle: Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL, acronym: BISUCO, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-03-11, primaryCompletionDateStruct date: 2021-03-20, completionDateStruct date: 2022-12-20, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario 12 de Octubre, class: OTHER, descriptionModule briefSummary: BACKGROUND AND CURRENT STATUS:Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative.OBJECTIVE:This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response.METHODS:A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma., conditionsModule conditions: Breast Cancer, conditions: Breast Biopsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single Group Assignment, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Image guided vacuum assisted biopsy, outcomesModule primaryOutcomes measure: The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sara Jimenez Arranz, city: Madrid, zip: 28020, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06371976, orgStudyIdInfo id: APH240230, briefTitle: Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery, acronym: VASOCORT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Vasoplegic syndrome after cardiac surgery is common and is associated with increased morbidity and mortality. It is characterized by early and prolonged arterial hypotension, with preserved cardiac output and low systemic vascular resistance. Vasoplegic syndrome therefore shares pathophysiological features with septic shock. There are no data in the literature on the function of the hypothalamic-pituitary-adrenal (HPA) axis during vasoplegic syndrome after cardiac surgery. In situations of acute stress and systemic inflammation, relative adrenal insufficiency has been reported in the most severe patients, particularly those in septic shock. The term ""CIRCI"" (Critical Illness-Related Corticosteroid Insufficiency) is currently defined as an increase in total plasma cortisol of less than 9 µg/dl after stimulation with 250 µg tetracosactide (synthetic ACTH), or a basal total plasma cortisol level of less than 10 µg/dl. However, recent studies have called into question the usefulness of the cosyntropin stimulation test for exploring the HPA axis in intensive care patients.Tandem mass spectrometry (LC-MS/MS) assays can be used to measure steroid metabolites (steroidome), enabling more precise exploration of the corticotropic axis.The aim of this study is to evaluate, on an exploratory basis, the impact of the presence of a post-cardiac surgery vasoplegic syndrome on adrenal function by steroidome mapping (LC-MS/MS)., conditionsModule conditions: Vasoplegic Syndrome in Adult Cardiac Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, interventions name: Vital status, outcomesModule primaryOutcomes measure: Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function., secondaryOutcomes measure: Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome., secondaryOutcomes measure: Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery., secondaryOutcomes measure: To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome., secondaryOutcomes measure: To assess the association between ""CIRCI"" and length of stay in intensive care., secondaryOutcomes measure: Evaluate the association between ""CIRCI"" and in-hospital mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pitié-Salpêtrière, city: Paris, state: Ile-de-France, zip: 75013, country: France, contacts name: Adrien Bouglé, MD, PhD, role: CONTACT, phone: 00 33 42 16 29 91, email: [email protected], contacts name: Jérémie Guillemin, MD, role: CONTACT, phone: 00 33 84 82 82 58, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06371963, orgStudyIdInfo id: LinnaeusU REDs, briefTitle: Relative Energy Deficiency in Sports (REDs) in Swedish Athletes, acronym: REDs-Sweden, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-10, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Linnaeus University, class: OTHER, collaborators name: Swedish Olympic Committee, collaborators name: Swedish Research Council for Sport Science, collaborators name: World Anti-Doping Agency, descriptionModule briefSummary: Background: Relative Energy Deficiency in Sport (REDs) describes impairment of health and performance due to problematic (long-term/severe) low energy availability (LEA), with or without eating disorders. LEA is frequently reported in sports with high training volumes, especially in leanness demanding sports, and 20% of female and 9% of male Norwegian national team athletes have been reported to have eating disorders. Potential trigger factors are e.g., dieting, injuries, coaching behavior, and subculture aspects e.g., focus on low body weight. The main questions that will be addressed are: 1. What is the prevalence of eating disorders and REDs among Swedish elite athletes and controls? 2. What is the impact of problematic LEA on health and performance aspects in both male and female athletes? Methods: National team athletes and gender and matched controls will be invited to an anonymous on-line survey. Elite athletes who agree to participate, will be invited to assessment of eating disorders, nutritional and physiological status (e.g., metabolic and endocrine markers, bone health, microbiota, dietary intake, energy availability, and performance)., conditionsModule conditions: RED S, conditions: Eating Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Self-reported eating disorders, secondaryOutcomes measure: Eating disorders, secondaryOutcomes measure: Self-reported reproductive function in females not using hormonal contraceptives, secondaryOutcomes measure: Reproductive function in females not using hormonal contraceptives, secondaryOutcomes measure: Self-reported reproductive function in males, secondaryOutcomes measure: Reproductive function in males, secondaryOutcomes measure: Gastrointestinal function, secondaryOutcomes measure: Injury, secondaryOutcomes measure: Self- reported symptoms of depression, secondaryOutcomes measure: Compulsive exercise, secondaryOutcomes measure: The motivation for behavioral changes, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Changes in immune markers from pre to post exercise, secondaryOutcomes measure: Microbiota, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Maximal aerobic capacity, secondaryOutcomes measure: Explosive lower body power, secondaryOutcomes measure: Whole body strength, secondaryOutcomes measure: Muscular power, secondaryOutcomes measure: Resting Metabolic Rate, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body height, secondaryOutcomes measure: Glucose levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Linnaeus University, status: RECRUITING, city: Kalmar, state: Småland, country: Sweden, contacts name: Anna Melin, PhD, role: CONTACT, phone: 0732629714, email: [email protected], geoPoint lat: 56.66157, lon: 16.36163, hasResults: False |
protocolSection identificationModule nctId: NCT06371950, orgStudyIdInfo id: 123608, briefTitle: Gut Microbiome in Orthopaedics, acronym: GUMBO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes.This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are:* to compare implant migration between groups from baseline to six weeks post-surgery* to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery* to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery, conditionsModule conditions: Total Knee Arthroplasty, conditions: Inflammation, conditions: Gastrointestinal Health, 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: ESTIMATED, armsInterventionsModule interventions name: Probiotic Formula Bacillus subtilis, interventions name: Placebo, outcomesModule primaryOutcomes measure: Implant Migration, secondaryOutcomes measure: Bone Density, secondaryOutcomes measure: Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake, otherOutcomes measure: Veterans Rand 12-Item Health Survey (VR-12), otherOutcomes measure: EuroQol-5D (EQ-5D), otherOutcomes measure: Western Ontario McMaster Osteoarthritis Index (WOMAC), otherOutcomes measure: Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP), otherOutcomes measure: Patient Global Assessment (PGA), otherOutcomes measure: University of California, Los Angeles (UCLA) Activity Score, otherOutcomes measure: Oxford Knee Score - English for Canada, otherOutcomes measure: Knee Society Score (KSS), otherOutcomes measure: Presence of MRSA, otherOutcomes measure: Microbial Diversity - Taxonomic Differences, otherOutcomes measure: Microbial Diversity - Taxonomic Correlation, otherOutcomes measure: Diet and Supplement Questionnaire, otherOutcomes measure: Histopathology, otherOutcomes measure: Immunohistochemistry, otherOutcomes measure: Inflammatory Blood Marker: C-Reactive Protein, otherOutcomes measure: Inflammatory Blood Marker: Interleukin-1B, otherOutcomes measure: Inflammatory Blood Marker: Interleukin-6, otherOutcomes measure: Inflammatory Blood Marker: Interleukin-8, otherOutcomes measure: Inflammatory Blood Marker: Tumor Necrosis Factor Alpha, otherOutcomes measure: Inflammatory Blood Marker: Erythrocyte Sedimentation Rate, otherOutcomes measure: Inflammatory Blood Marker: Alkaline Phosphatase, otherOutcomes measure: Inflammatory Blood Marker: Calcium, otherOutcomes measure: Inflammatory Blood Marker: Albumin, otherOutcomes measure: Inflammatory Blood Marker: Urate, otherOutcomes measure: Inflammatory Blood Marker: Total Protein, otherOutcomes measure: Inflammatory Blood Marker: Creatinine, otherOutcomes measure: Inflammatory Blood Marker: Vitamin D, otherOutcomes measure: Inflammatory Blood Marker: White Blood Cell Count, otherOutcomes measure: Inflammatory Blood Marker: Red Blood Cell Count, otherOutcomes measure: Inflammatory Blood Marker: Hemoglobin Concentration, otherOutcomes measure: Inflammatory Blood Marker: Hematocrit Percentage, otherOutcomes measure: Inflammatory Blood Marker: Platelet Count, eligibilityModule sex: FEMALE, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Sciences Centre, city: London, state: Ontario, zip: N6A 5A5, country: Canada, contacts name: Rachel Vander Deen, role: CONTACT, phone: 519-685-8500, phoneExt: 34269, email: [email protected], contacts name: Lyndsay Somerville, PhD, role: CONTACT, phone: 519-685-8500, phoneExt: 36645, email: [email protected], contacts name: Brent Lanting, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jeremy Burton, PhD, role: SUB_INVESTIGATOR, contacts name: Tom Appleton, PhD, role: SUB_INVESTIGATOR, contacts name: Matthew Teeter, PhD, role: SUB_INVESTIGATOR, contacts name: Jonath Thiessen, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False |
protocolSection identificationModule nctId: NCT06371937, orgStudyIdInfo id: 120687, briefTitle: iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease, acronym: INFERENCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2033-06-30, completionDateStruct date: 2033-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, collaborators name: Greenstone Biosciences, Inc., descriptionModule briefSummary: The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease., conditionsModule conditions: Cardiovascular Diseases, conditions: Arrythmia, conditions: Cardiomyopathies, conditions: Heart Failure, conditions: Cerebrovascular Accident, conditions: Congenital Heart Disease, conditions: Cardiometabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: REDCap Database, primaryOutcomes measure: Induced pluripotent stem cell (iPSC) Biobank, primaryOutcomes measure: Differentiation into Cardiovascular lineages, primaryOutcomes measure: Molecular profiling of participants, primaryOutcomes measure: Bioinformatics analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06371924, orgStudyIdInfo id: KCH23-156, briefTitle: Immunometabolism of Machine Perfusion Strategies, acronym: iMaps, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: King's College Hospital NHS Trust, class: OTHER, collaborators name: King's College London, descriptionModule briefSummary: There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI).The discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative approaches, which are more complex and expensive, but that can also improve the quality of the DCD livers, involve using machines to pump fluids through the livers ('machine perfusion' or MP).There are three MP methods being used in patients: 1) normothermic regional perfusion (NRP), which involves pumping the donor's blood through the liver after the donor has died but the liver is still in the donor's body; 2) normothermic machine perfusion (NMP), in which the liver is pumped with blood outside of the donor's body; and 3) hypothermic machine perfusion (HOPE), which is also used outside of the donor's body by pumping cold fluid into the liver. HOPE and NRP have been shown to improve how well DCD livers function after transplantation. NMP can also improve the quality of the DCD livers, but its main advantage is that it allows confirming that the donated liver functions well before proceeding with the transplant. Until now, there has not been a proper comparison of these methods, and the doctors do not understand well the mechanisms through which MP improves the quality of the DCD livers.The iInvestigators plan to conduct a study where 36 DCD human livers will be split into three groups: SCS, NRP, and HOPE. After that, they will be put in NMP to confirm that they are good enough to be transplanted and to study the mechanisms through which NRP, SCS and HOPE work., conditionsModule conditions: Liver Transplantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The investigators propose to conduct a randomised clinical trial in which 36 DCD human livers will be allocated to 1 of 3 treatment arms:i) SCS; ii)NRP; and iii) HOPE. This will be followed by a period of time in NMP in order to study the IRI response and determine if the quality of the livers is good enough to proceed to transplantation. This study will allow the doctors to decipher the mechanisms of liver IRI in humans in a much better way than what has been achieved to date., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Machine Perfusion, outcomesModule primaryOutcomes measure: To determine the effect of different preservation strategies on the development of mitochondrial damage following reperfusion during NMP., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06371911, orgStudyIdInfo id: 2023-A02762-43, briefTitle: Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment, acronym: OPTIMACURE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-08-03, completionDateStruct date: 2024-12-03, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centre Francois Baclesse, class: OTHER, collaborators name: Cureety, descriptionModule briefSummary: Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. A hospital staff member then telephones the patients and evaluates, using the tests results and other patient data (including the presence of adverse events (AEs) and Eastern Cooperative Oncology Group \[ECOG\] performance status), whether the patient is apt for treatment or whether the treatment needs to be deferred.In France, the Centre François Baclesse in Caen (France) launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital.A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse.Following the positive impact of both the OPTIMA and "Star" programs, several French healthcare centers have implemented similar programs. However, a large proportion of the data during the program are collected by telephone, particularly outgoing calls (from the hospital staff to patients). Thus, implementing these programs is expected to increase the number and/or duration of outgoing calls and consequently the workload of hospital staff.Since the deployment of the OPTIMA program (between 2014 and 2016), and other equivalent programs, more and more patients have asked for the telephone calls to be replaced by a web-based application. Indeed, patients do not always respond to the telephone calls made by hospital staff, thus forcing staff to repeat calls several times. Also, some patients with language or hearing difficulties are unable to answer the questionnaires by telephone: a web-based alternative would be more appropriate for these patients.Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment. Telemonitoring can then identify the few patients that need to be contacted by hospital staff, thus reducing the number of outgoing telephone calls.There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment. The benefits include the early detection of AEs, improved quality of life (QoL), fewer admissions to emergency rooms or hospitalization, the longer remaining on chemotherapy for patients, and extended overall survival.Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool includes questionnaires for each class of medication to monitor patients' adverse events remotely. The data collected include blood results, treatment-related data (including delays, dose reductions), as well as QoL and safety data. In terms of safety, patients respond to an electronic patient-reported outcome (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0. Depending on the responses, the Cureety TechCare algorithm classifies the patient state as "correct", "compromised", "to be monitored", or "critical". The patients are then notified of the actions to be taken according to their classification. In preparation for injectable cancer treatment, Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration. The collection and evaluation of this data is expected to decrease outgoing calls by between 30% to 50%.This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment (OPTIMA program or equivalent)., conditionsModule conditions: Adult Patients Initiating Injectable Anticancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Cureety telemonitoring, interventions name: OPTIMA or equivalent programs, outcomesModule primaryOutcomes measure: Effectiveness of adding Cureety telemonitoring to usual care, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre hospitalier de Bligny, status: NOT_YET_RECRUITING, city: Bligny, country: France, contacts name: Jean-Baptiste MERRIC, MD, role: CONTACT, email: [email protected], contacts name: Jean-Baptiste MERRIC, MD, role: PRINCIPAL_INVESTIGATOR, locations facility: Centre François Baclesse, status: RECRUITING, city: Caen, zip: 14000, country: France, contacts name: Audrey Faveyrial, MD, role: CONTACT, email: [email protected], contacts name: Jean-Michel Grellard, role: CONTACT, email: [email protected], contacts name: Audrey Faveyrial, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre de Radiothérapie et Oncologie Médicale d'Osny, status: NOT_YET_RECRUITING, city: Osny, country: France, contacts name: Abderrezak LADOUANI, MD, role: CONTACT, email: [email protected], contacts name: Abderrezak LADOUANI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.0701, lon: 2.06277, hasResults: False |
protocolSection identificationModule nctId: NCT06371898, orgStudyIdInfo id: 29BRC24.0088 - MORDIGO, briefTitle: Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO), acronym: MORDIGO, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-06-17, completionDateStruct date: 2025-06-17, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. This approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal ESD is less prone to complications fewer complications than in the colon. Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. In order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer. Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. T3 and T4 lesions with their own their own morbidity will be excluded., conditionsModule conditions: Colonic Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: 30 days severe morbidity, secondaryOutcomes measure: morbidity of ESD group, secondaryOutcomes measure: comparison of morbidity in both groups, secondaryOutcomes measure: reintervention, secondaryOutcomes measure: stomia, secondaryOutcomes measure: length of hospital stay, secondaryOutcomes measure: readmission, secondaryOutcomes measure: mortality, secondaryOutcomes measure: risk factors for morbidity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Brest, city: Brest, zip: 29609, country: France, geoPoint lat: 48.3903, lon: -4.48628, hasResults: False |
protocolSection identificationModule nctId: NCT06371885, orgStudyIdInfo id: P.T.REC/012/004646, briefTitle: Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-10, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: "In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. The incision pain typically only lasts for a few days or weeks after surgery, while the pillar pain occurs on the sides of the incision in the thicker parts of the palm, called the thenar and hypothenar eminences. This is where the transverse ligament attaches to the carpal bones, forming the carpal tunnel.So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn., conditionsModule conditions: Hand Burn, conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Interventional (clinical trial), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Double mask for both groups (participant), whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: shock wave therapy, interventions name: traditional physical therapy, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Hand held dynamometer, secondaryOutcomes measure: Michigan hand out Comes questionnaire, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shaimaa Mohamed Ahmed El Sayeh, city: Cairo, state: New Cairo, zip: 02, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.