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protocolSection identificationModule nctId: NCT06343259, orgStudyIdInfo id: 2534, briefTitle: The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-14, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sisli Hamidiye Etfal Training and Research Hospital, class: OTHER, descriptionModule briefSummary: In this prospective, randomized, single-blind study, we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery. Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery, with myocardial injury after non-cardiac surgery (MINS) being a significant concern. MINS, characterized by asymptomatic elevation of troponin levels without accompanying ECG findings, is closely associated with postoperative mortality. With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic, understanding the effects of different anesthesia types on postoperative myocardial injury is crucial., conditionsModule conditions: Myocardial Injury After Non-cardiac Surgery, conditions: Hypotension During Surgery, conditions: Anesthesia, General, conditions: Anesthesia, Spinal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: General Anesthesia, interventions name: Spinal Anesthesia, outcomesModule primaryOutcomes measure: Myocardial Injury After Non-Cardiac Surgery (MINS), secondaryOutcomes measure: The duration of intensive care unit (ICU) stay, secondaryOutcomes measure: The duration of hospital stay, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sisli Hamidiye Etfal Training and Research Hospital, city: Istanbul, zip: 34396, country: Turkey, contacts name: Mustafa Bilgehan AYIK, role: CONTACT, phone: +905377247984, email: drbilgehanayik@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06343246, orgStudyIdInfo id: MustafaKemalU, briefTitle: Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Mustafa Kemal University, class: OTHER, descriptionModule briefSummary: This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength., conditionsModule conditions: Hypertension,Essential, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective Randomized Controlled Study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Inspiratory muscle training with device, outcomesModule primaryOutcomes measure: Change of the exercise capacity from baseline to 8 week, primaryOutcomes measure: Change of the peripheral muscle strenght from baseline to 8 week, primaryOutcomes measure: change of the upper extremity exercise capacity from baseline to 8 week, secondaryOutcomes measure: change of the postural balance from baseline to 8 week, secondaryOutcomes measure: change of the physical activity from baseline to 8 week, secondaryOutcomes measure: change of the quality of life from baseline to 8 week, secondaryOutcomes measure: change of the Fev1/Fvc, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hatay Mustafa Kemal University, status: RECRUITING, city: Hatay, state: Antakya, country: Turkey, contacts name: İrem hüzmeli, role: CONTACT, email: fztirem@gmail.com, geoPoint lat: 38.40227, lon: 27.10486, hasResults: False
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protocolSection identificationModule nctId: NCT06343233, orgStudyIdInfo id: FATE, briefTitle: FAiling HearT in the Elderly (FATE) Study, acronym: FATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-11-19, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: IRCCS Multimedica, class: OTHER, descriptionModule briefSummary: In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure., conditionsModule conditions: Heart Failure, conditions: Frailty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: usual care, outcomesModule primaryOutcomes measure: Hospitalization or death at 12 months, secondaryOutcomes measure: Hospitalization or death at 6-12-18 months, secondaryOutcomes measure: hospitalizations and/or death from cardiovascular causes, secondaryOutcomes measure: association between events and patient characteristics, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT), status: RECRUITING, city: Montescano, state: Italy/Pavia, zip: 27040, country: Italy, contacts name: Maria Teresa La Rovere, MD, role: CONTACT, phone: +39 0385 247290, email: mariateresa.larovere@icsmaugeri.it, geoPoint lat: 45.03196, lon: 9.28366, locations facility: IRCCS Centro Cardiologico Monzino, status: RECRUITING, city: Milan, state: MIlano, zip: 20138, country: Italy, contacts name: PierGiuseppe Agostoni, MD, role: CONTACT, phone: +39 02 58002772, email: piergiuseppe.agostoni@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Humanitas Research Hospital, status: RECRUITING, city: Rozzano, state: Milano, zip: 20089, country: Italy, contacts name: Cristina Panico, MD, role: CONTACT, phone: +39 0282241, email: cristina.panico@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, locations facility: IRCCS MultiMedica, status: RECRUITING, city: Sesto San Giovanni, state: Milano, zip: 20099, country: Italy, contacts name: Gaia Cattadori, MD, role: CONTACT, phone: +39 02 8687 8889, email: gaia.cattadori@multimedica.it, geoPoint lat: 45.53329, lon: 9.22585, locations facility: Ospedale Policlinico San Martino IRCCS, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Pietro Ameri, MD, role: CONTACT, phone: +39 0103538928, email: pietroameri@unige.it, geoPoint lat: 44.40478, lon: 8.94438, locations facility: IRCCS Auxologico, status: RECRUITING, city: Milano, zip: 20149, country: Italy, contacts name: Gianluca Caldara, MD, role: CONTACT, phone: +39 02 61911 251, email: g.caldara@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico, status: NOT_YET_RECRUITING, city: Milan, zip: 20100, country: Italy, contacts name: Marco Vicenzi, MD, role: CONTACT, phone: +39 02 503 20512, email: marco.vicenzi@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06343220, orgStudyIdInfo id: AWARE 2.0, briefTitle: Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Huntington Study Group, class: NETWORK, collaborators name: Roche Products Limited, descriptionModule briefSummary: The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted., conditionsModule conditions: Huntington Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Examine awareness, primaryOutcomes measure: Provide the HD research community with the insight., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huntington Study Group, status: RECRUITING, city: Rochester, state: New York, zip: 14618, country: United States, contacts name: Elise Kayson, MS, role: CONTACT, phone: 800-487-7671, email: info@myhdstory.org, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06343207, orgStudyIdInfo id: 249637, briefTitle: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-22, primaryCompletionDateStruct date: 2023-02-02, completionDateStruct date: 2023-02-02, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, descriptionModule briefSummary: To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI)., conditionsModule conditions: Ankle Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Controlled Trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Percussive massage gun therapy, outcomesModule primaryOutcomes measure: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical education and sport, Charles University, city: Praha, zip: 16252, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
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protocolSection identificationModule nctId: NCT06343194, orgStudyIdInfo id: 6162, briefTitle: Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism, acronym: EMG_BRUX, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-09, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-12-22, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients., conditionsModule conditions: Sleep Bruxism, conditions: Masseter Muscle Hypertrophy, conditions: Grinding Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: bruxism patients and non-bruxism patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Bruxoff ®, outcomesModule primaryOutcomes measure: Change in potentials recorded by Bruxoff ® in bruxism patients., secondaryOutcomes measure: Change of signs and symptoms of bruxism, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: UOC Odontoiatria Generale e Ortodonzia, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore, status: RECRUITING, city: Rome, state: Lazio, zip: 00168, country: Italy, contacts name: Massimo Cordaro, professor, role: CONTACT, phone: +39 0630154286, email: massimo.cordaro@unicatt.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06343181, orgStudyIdInfo id: IEO 1824, briefTitle: A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project.", conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluation of factors influencing patients' adherence to medical therapy, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Gabriella Pravettoni, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06343168, orgStudyIdInfo id: frailty, briefTitle: Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-18, primaryCompletionDateStruct date: 2022-02-18, completionDateStruct date: 2022-02-18, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Uşak University, class: OTHER, descriptionModule briefSummary: This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.The main question it aims to answer are:What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients, conditionsModule conditions: Frailty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 96, type: ACTUAL, armsInterventionsModule interventions name: prevalence of frailty, outcomesModule primaryOutcomes measure: Prevalence of frailty, secondaryOutcomes measure: Activities of Daily Living, secondaryOutcomes measure: Nutritional Assessment, secondaryOutcomes measure: Comorbidity, secondaryOutcomes measure: Cognitive Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Usak University, city: Usak, state: Center, zip: 64200, country: Turkey, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
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protocolSection identificationModule nctId: NCT06343155, orgStudyIdInfo id: E-10840098-202.3.02-235, briefTitle: Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder", statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-05-27, completionDateStruct date: 2024-06-03, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: According to the information obtained from clinical studies, it has been stated that Temporomandibular Disorder (TMD) is associated with chronic low back pain (LBP). In this study, participants will be divided into two groups. Only Rocabado's exercise will be given to the Rocabado's group (RG), and Rocabado's and therapeutic lumbar exercises will be given to the therapeutic group (TG). Warm-up exercises will be given before starting the exercises with the therapeutic group, and cool-down exercises will be given after the exercises with the therapeutic group. At the end of the sixth week, the effect of therapeutic lumbar exercises on TMD pain and function will be evaluated., conditionsModule conditions: Temporomandibular Disorder, conditions: Chronic Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups: Therapeutic group and Rocabado's group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Group, interventions name: Rocabado's Group, outcomesModule primaryOutcomes measure: Temporomandibular Joint Range of Motion Measurement (ROM), secondaryOutcomes measure: The Jaw Functional Limitation Scale 20 (JFLS-20), secondaryOutcomes measure: Oral Health Impact Profile - 14 (OHIP-14), otherOutcomes measure: The short-form McGill Pain Questionnaire (SF-MPQ), otherOutcomes measure: Graded Chronic Pain Scale 2.0 total (GCPS 2.0), otherOutcomes measure: Visual Analog Scale, eligibilityModule sex: ALL, minimumAge: 23 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, country: Turkey, contacts name: İkra Çakıcı, role: CONTACT, phone: +90 05426696487, email: ikrabayraktar951@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06343142, orgStudyIdInfo id: 42038, briefTitle: Effects of Time of Day and Nut Intake on Cognitive Performance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Monash University, class: OTHER, descriptionModule briefSummary: This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance., conditionsModule conditions: Cognitive Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 2 x 2-factor crossover design study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Nuts, interventions name: Nut-free meal, outcomesModule primaryOutcomes measure: N-back task - accuracy, primaryOutcomes measure: N-back task - matched responses, primaryOutcomes measure: N-back task - false alarm, primaryOutcomes measure: N-back task - reaction time, primaryOutcomes measure: Stroop test - congruent, primaryOutcomes measure: Stroop test - incongruent, primaryOutcomes measure: Stroop test - interference, secondaryOutcomes measure: Multitasking - pure blocks, secondaryOutcomes measure: Multitasking - mixed blocks, secondaryOutcomes measure: Multitasking - mixing cost, secondaryOutcomes measure: Satiety - hunger, secondaryOutcomes measure: Satiety - fullness, secondaryOutcomes measure: Satiety - satisfaction, secondaryOutcomes measure: Satiety - eating capacity, secondaryOutcomes measure: Satiety index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Nutrition, Dietetics and Food - Monash University, status: RECRUITING, city: Notting Hill, state: Victoria, zip: 3168, country: Australia, contacts name: Barbara R Cardoso, PhD, role: CONTACT, phone: +61499840472, email: barbara.cardoso@monash.edu, contacts name: Maxine Bonham, PhD, role: CONTACT, phone: +61418 234 292, email: maxine.bonham@monash.edu, geoPoint lat: -37.905, lon: 145.1427, hasResults: False
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protocolSection identificationModule nctId: NCT06343129, orgStudyIdInfo id: 3817, briefTitle: Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-26, primaryCompletionDateStruct date: 2022-12-12, completionDateStruct date: 2022-12-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: Rochester Lifestyle Medicine Institute, descriptionModule briefSummary: The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: Dietary education program, outcomesModule primaryOutcomes measure: Mean change in systolic blood pressure, primaryOutcomes measure: Mean change in diastolic blood pressure, primaryOutcomes measure: Mean change in potassium levels, primaryOutcomes measure: Proportion of participants developing hyperkalemia, secondaryOutcomes measure: Mean Change in energy/day, secondaryOutcomes measure: Mean change in energy/kg of body mass, secondaryOutcomes measure: Mean change in total fat, secondaryOutcomes measure: Mean change in % calories from fat, secondaryOutcomes measure: Mean change in % calories from carbohydrates, secondaryOutcomes measure: Mean change in % calories from protein, secondaryOutcomes measure: Mean change in Animal protein, secondaryOutcomes measure: Mean change in Vegetable protein, secondaryOutcomes measure: Mean change in cholesterol, secondaryOutcomes measure: Mean change in Total dietary fiber, secondaryOutcomes measure: Mean change in Total fiber per 1000 kcal, secondaryOutcomes measure: Mean change in calcium, secondaryOutcomes measure: Mean change in phosphorous, secondaryOutcomes measure: Mean change in magnesium, secondaryOutcomes measure: Mean change in sodium, secondaryOutcomes measure: Mean change in potassium, secondaryOutcomes measure: Mean change in body mass, secondaryOutcomes measure: Mean change in body mass index, secondaryOutcomes measure: Mean change in sodium measured in blood, secondaryOutcomes measure: Mean change in chloride measured in blood, secondaryOutcomes measure: Mean change in bicarbonate measured in blood, secondaryOutcomes measure: Mean change in blood urea nitrogen (BUN) measured, secondaryOutcomes measure: Mean change in creatinine measured in blood, secondaryOutcomes measure: Mean change in glucose measured in blood, secondaryOutcomes measure: Mean change in calcium measured in blood, secondaryOutcomes measure: Mean change in phosphorous measured in blood, secondaryOutcomes measure: Mean change in parathyroid hormome (PTH) measured in blood, secondaryOutcomes measure: Mean change in albumin measured in blood, secondaryOutcomes measure: Mean change in magnesium measured in blood, secondaryOutcomes measure: Mean change in erythrocyte sedimentation rate (ESR) measured in blood, secondaryOutcomes measure: Mean change in fibroblast growth factor (FGF)-23 measured in blood, secondaryOutcomes measure: Mean change in total cholesterol measured in blood, secondaryOutcomes measure: Mean change in low density lipoprotein (LDL) measured in blood, secondaryOutcomes measure: Mean change in high density lipoprotein (HDL) measured in blood, secondaryOutcomes measure: Mean change in triglycerides measured in blood, secondaryOutcomes measure: Mean change in 8-isoprostane measured in urine, secondaryOutcomes measure: Mean change in symptoms, secondaryOutcomes measure: Mean change in effects of kidney disease, secondaryOutcomes measure: Mean change in burden of kidney disease, secondaryOutcomes measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite, secondaryOutcomes measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center of the University of Rochester Medical Center, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: University of Rochester Medical Center, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06343116, orgStudyIdInfo id: BPL-Nim-CRC-3001, briefTitle: Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer, acronym: NOTABLE-308, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Biotech Pharmaceutical Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS)., conditionsModule conditions: Refractory Metastatic Colorectal Cancer, 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: 420, type: ESTIMATED, armsInterventionsModule interventions name: Nimotuzumab injection, interventions name: Placebo, interventions name: Trifluridine/tipiracil, outcomesModule primaryOutcomes measure: overall survival (OS), primaryOutcomes measure: dose-limiting toxicity (DLT), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: time to progress (TTP), secondaryOutcomes measure: overall response rate (ORR), secondaryOutcomes measure: disease control rate (DCR), secondaryOutcomes measure: duration of response (DoR), secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29), secondaryOutcomes measure: Adverse Events, otherOutcomes measure: tumor-related markers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343103, orgStudyIdInfo id: IEO 1735, briefTitle: Study Evaluating Occupational Exposure to Antineoplastic Drugs, acronym: BRIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-02, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics., conditionsModule conditions: Cytotoxicity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Workers exposed, interventions name: Workers not exposed, outcomesModule primaryOutcomes measure: Evaluation of the difference in micronuclei frequency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, country: Italy, contacts name: Sabrina Beltramini, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Emanuela Omodeo Salè, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", status: RECRUITING, city: Napoli, country: Italy, contacts name: Piera Maiolino, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Istituto Oncologico Veneto Irccs, status: RECRUITING, city: Padova, country: Italy, contacts name: Nicoletta Rigamonti, role: CONTACT, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Fondazione Policlinico Universitario Campus Bio-Medico, status: RECRUITING, city: Roma, country: Italy, contacts name: Andrea Di Mattia, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06343090, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2023-003, briefTitle: Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2042-12-01, completionDateStruct date: 2043-09-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled., conditionsModule conditions: B-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 353, type: ESTIMATED, armsInterventionsModule interventions name: CD19 CAR T-cell, interventions name: CD22 CAR T cells, interventions name: hematopoietic stem-cell transplantation, outcomesModule primaryOutcomes measure: EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group), secondaryOutcomes measure: ORR in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: DOR in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: OS in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: Adverse events (AEs) in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: Levels of CD19 and CD22 CAR-T cells in Sequential CAR group, secondaryOutcomes measure: Levels of CD19 CAR-T cells in CAR+HSCT group, secondaryOutcomes measure: Levels of CD19 and CD22 CAR transgene in Sequential CAR group, secondaryOutcomes measure: Levels of CD19 CAR transgene in CAR+HSCT group, secondaryOutcomes measure: Quantification of B cells in Sequential CAR group and CAR+HSCT group, otherOutcomes measure: EFS in CD19 CAR T-cell infusion without consolidation therapies (Single CAR group), otherOutcomes measure: DOR in Single CAR group, otherOutcomes measure: OS in Single CAR group, otherOutcomes measure: ORR in Single CAR group, otherOutcomes measure: Adverse events (AEs) in Single CAR group, otherOutcomes measure: Levels of CD19 CAR-T cells in Single CAR group, otherOutcomes measure: Levels of CD19 CAR transgene in Single CAR group, otherOutcomes measure: Quantification of B cells in Single CAR group, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Beijing GoBroad Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102206, country: China, contacts name: Tengyu Wang, role: CONTACT, phone: 86+18333186020, email: tengyu.wang@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06343077, orgStudyIdInfo id: STUDY-22-00106, briefTitle: Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ashutosh Kumar Tewari, class: OTHER, collaborators name: Oncovir, Inc., descriptionModule briefSummary: This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance., conditionsModule conditions: Prostate Cancer Patients on Active Surveillance, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Poly-ICLC intramuscular (IM) injection, interventions name: Poly-ICLC, Intertumoral (IT) injection, outcomesModule primaryOutcomes measure: Proportion of subjects without Gleason group upgrade after treatment, primaryOutcomes measure: Proportion of subjects without Gleason group upgrade after treatment, primaryOutcomes measure: Proportion of subjects without Gleason group downgrade after treatment, primaryOutcomes measure: Proportion of subjects without Gleason group downgrade after treatment, secondaryOutcomes measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0, secondaryOutcomes measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0, secondaryOutcomes measure: Number of subjects who receive prostate cancer treatment, secondaryOutcomes measure: Number of subjects who receive prostate cancer treatment, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Icahn School of Medicine at Mount Sinai (ISMMS), status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Monali Fatterpekar, PhD, role: CONTACT, email: monali.fatterpekar@mountsinai.org, contacts name: Sujit S Nair, PhD, role: CONTACT, phone: 212-241-7005, email: sujit.nair@mountsinai.org, contacts name: Ashutosh K Tewari, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06343064, orgStudyIdInfo id: PLB1001/PLB1004-NSCLC-Ib/II-01, briefTitle: Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-13, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC, conditionsModule conditions: Non-Small-Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Vebreltinib, interventions name: PLB1004, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])., primaryOutcomes measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol., primaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max), secondaryOutcomes measure: Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Caichun Zhou, PHD, role: CONTACT, phone: +86-21-65115006, email: caicunzhoudr@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06343051, orgStudyIdInfo id: STUDY-23-01681, briefTitle: USCOM in Newly Diagnosed FGR Cases, acronym: USCOM FGR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy., conditionsModule conditions: Fetal Growth Restriction, conditions: USCOM, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: USCOM, outcomesModule primaryOutcomes measure: Systemic vascular resistance obtained from USCOM, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, city: New York, state: New York, zip: 10029, country: United States, contacts name: Nicola F Tavella, MPH, role: CONTACT, phone: 212-241-3888, email: nicola.tavella@mssm.edu, contacts name: Rachel J Meislin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06343038, orgStudyIdInfo id: 2023-01868; th23Nicolas, briefTitle: Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study, acronym: PROGNOSTICS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.The performance of different prostate cancer diagnostic methods is also in scope of the study., conditionsModule conditions: Castration-resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In Phase Ia:Radiation dosimetry driven, head-to-head in cross-over design comparison of tumour and critical organ absorbed doses after sequential non-therapeutic injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in the same mCRPC patients undergoing standard 177Lu-PSMA-I\&T RLT.In Phase Ib:Clinical and radiation dosimetry-based dose escalation study, with a classical 3+3 design, to identify the optimal biologic dose (injected activity) of 161Tb-SibuDAB for safe and effective RLT., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Injection, 161Tb-SibuDAB,1GBq, interventions name: Injection, 177Lu-PSMA-I&T, 1GBq, interventions name: Injection, 161Tb-SibuDAB, Dose Escalation, outcomesModule primaryOutcomes measure: Phase Ia: Tumour absorbed dose, primaryOutcomes measure: Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT, secondaryOutcomes measure: Phase Ia: Estimation of critical organ median absorbed doses, secondaryOutcomes measure: Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios, secondaryOutcomes measure: Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT, secondaryOutcomes measure: Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, city: Basel, zip: 4031, country: Switzerland, contacts name: Alin Chirindel, MD, role: CONTACT, phone: +41 61 328 63 75, email: alin.chirindel@usb.ch, contacts name: Guillaume Nicolas, MD, role: CONTACT, phone: +41 61 265 47 02, email: guillaume.nicolas@usb.ch, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
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protocolSection identificationModule nctId: NCT06343025, orgStudyIdInfo id: Hasan Kalyoncu University, briefTitle: The Effects of Tai Chi and Pilates for Individuals With Prediabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Nigde Omer Halisdemir University, class: OTHER, collaborators name: Hasan Kalyoncu University, descriptionModule briefSummary: The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes., conditionsModule conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and Control group. 3 groups. 3 groups will be measured at the same time and then the exercise part will begin., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes ,Assesor, who will make the evaluations in the first week and after 12 weeks, will not know which group the people are in., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Pilates Exercises Group, interventions name: Tai Chi Exercises Group, outcomesModule primaryOutcomes measure: Glisemic Control, primaryOutcomes measure: Body Composition, primaryOutcomes measure: Balance, primaryOutcomes measure: Physical Activity Level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343012, orgStudyIdInfo id: 0305900, briefTitle: Caring Leadership Intervention Program for First-Line Nurse Managers, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations., conditionsModule conditions: Intervention, conditions: Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A quasi-experimental study design utilized two groups, study and control groups, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: A quasi-experimental study design utilized two groups, study and control groups., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Caring leadership Intervention program, outcomesModule primaryOutcomes measure: Questionnaire to measure first-line nurse managers' knowledge, primaryOutcomes measure: Questionnaire to measure the managerial actions of first-line nurse managers, primaryOutcomes measure: Questionnaire to assess nurses' perceived first-line nurse managers' caring behavior, primaryOutcomes measure: questionnaire to measure nurse outcomes, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Marsa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
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protocolSection identificationModule nctId: NCT06342999, orgStudyIdInfo id: 22-012399, briefTitle: Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2035-07, completionDateStruct date: 2035-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mauro H. Schenone, class: OTHER, descriptionModule briefSummary: The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS)., conditionsModule conditions: Hypoplastic Left Heart Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Fetal Aortic Valvuloplasty Procedure, interventions name: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter, interventions name: Trek RX and Mini Trek RX Coronary Dilatation Catheter, outcomesModule primaryOutcomes measure: Number of cases in which the procedure was successful, primaryOutcomes measure: Number of cases in which a biventricular repair was achieved, primaryOutcomes measure: Number cases with pulmonary hypertension, secondaryOutcomes measure: Number of cases delivered prematurely, secondaryOutcomes measure: Number of cases with perinatal death, secondaryOutcomes measure: Number of maternal complications, eligibilityModule sex: FEMALE, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06342986, orgStudyIdInfo id: 2023LS185, secondaryIdInfos id: P01CA111412, type: NIH, link: https://reporter.nih.gov/quickSearch/P01CA111412, briefTitle: Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Masonic Cancer Center, University of Minnesota, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer., conditionsModule conditions: Gynecologic Cancer, conditions: Ovarian Cancer, conditions: Fallopian Tube Cancer, conditions: Primary Peritoneal Cavity Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A minimum of 28 days must separate each Dose Cohort. A minimum of 30 days must separate the 1st and 2nd patient. All patients are assessed for Dose Limiting Toxicity (DLT), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: FT536, interventions name: Fludarabine, interventions name: CY, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342973, orgStudyIdInfo id: 5591, briefTitle: Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Case Series, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Louisiana State University Health Sciences Center in New Orleans, class: OTHER, descriptionModule briefSummary: The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane., conditionsModule conditions: Alveolar Ridge Deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Xenograft and allograft, outcomesModule primaryOutcomes measure: Horizontal bone gain, primaryOutcomes measure: Vital bone percentage, primaryOutcomes measure: Bone shrinkage, secondaryOutcomes measure: Surgical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LSUHSC School of Dentistry, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70119, country: United States, contacts name: Eswar Kandaswamy, role: CONTACT, phone: 504-941-8272, email: ekanda@lsuhsc.edu, contacts name: Eswar Kandaswamy, BDS, MS, role: PRINCIPAL_INVESTIGATOR, contacts name: Vinayak Joshi, BDS, MS, PhD, role: SUB_INVESTIGATOR, contacts name: Jeanne St Germain, RDH, role: SUB_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, hasResults: False
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protocolSection identificationModule nctId: NCT06342960, orgStudyIdInfo id: KYV101-003, briefTitle: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Kyverna Therapeutics, class: INDUSTRY, descriptionModule briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis, conditionsModule conditions: Lupus Nephritis, conditions: Lupus Nephritis - WHO Class III, conditions: Lupus Nephritis - WHO Class IV, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: KYV-101 anti-CD19 CAR-T cell therapy, interventions name: Standard lymphodepletion regimen, outcomesModule primaryOutcomes measure: Incidence adverse events (AEs) and laboratory abnormalities, primaryOutcomes measure: Frequency of dose limiting toxicities, secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To characterize the pharmacodynamics (PD), secondaryOutcomes measure: To characterize the pharmacodynamics (PD), secondaryOutcomes measure: To evaluate disease related biomarkers, secondaryOutcomes measure: To evaluate disease related biomarkers, secondaryOutcomes measure: To evaluate efficacy, secondaryOutcomes measure: To evaluate efficacy, secondaryOutcomes measure: To evaluate efficacy, secondaryOutcomes measure: To evaluate the immunogenicity (humoral response) of KYV-101, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Carl Gustav Carus Dresden, status: RECRUITING, city: Dresden, country: Germany, contacts name: Study Coordinator, role: CONTACT, geoPoint lat: 51.05089, lon: 13.73832, locations facility: University Hospital Erlangen, status: RECRUITING, city: Erlangen, country: Germany, contacts name: Study Coordinator, role: CONTACT, geoPoint lat: 49.59099, lon: 11.00783, locations facility: University Hospital Hamburg-Eppendorf, status: RECRUITING, city: Hamburg, country: Germany, contacts name: Study Coordinator, role: CONTACT, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
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protocolSection identificationModule nctId: NCT06342947, orgStudyIdInfo id: ALG-055009-303, briefTitle: ALG-055009 in Non-cirrhotic Adults With MASH (HERALD), acronym: HERALD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2024-12-23, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Aligos Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks., conditionsModule conditions: NASH, conditions: MASH, conditions: Metabolic Dysfunction-Associated Steatohepatitis, conditions: Nonalcoholic Steatohepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: ALG-055009, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent relative change from baseline in liver fat content, secondaryOutcomes measure: Absolute change from baseline in liver fat content, secondaryOutcomes measure: Proportion of subjects with ≥30% relative reduction in liver fat content, secondaryOutcomes measure: Proportion of subjects with ≥50% relative reduction in liver fat content, secondaryOutcomes measure: Proportion of subjects with ≥70% relative reduction in liver fat content, secondaryOutcomes measure: Proportion of subjects with normalization (<5%) in liver fat content, otherOutcomes measure: Change from baseline (absolute/percent) in lipid/lipoprotein levels, otherOutcomes measure: Change from baseline (absolute/percent) in SHBG, otherOutcomes measure: Change from baseline (absolute/percent) alanine aminotransferase (ALT), otherOutcomes measure: Change from baseline (absolute/percent) aspartate aminotransferase (AST), otherOutcomes measure: Safety and tolerability will be assessed by monitoring TEAEs, otherOutcomes measure: Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs), otherOutcomes measure: PK parameters of ALG-055009 in plasma, AUCs, otherOutcomes measure: PK parameters of ALG-055009 in plasma, Tmax, otherOutcomes measure: PK parameters of ALG-055009 in plasma, Cmax, otherOutcomes measure: PK parameters of ALG-055009 in plasma, Cmin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aligos Clinical Study Site 18, status: RECRUITING, city: Chandler, state: Arizona, zip: 85224, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 33.30616, lon: -111.84125, locations facility: Aligos Clinical Study Site 15, status: RECRUITING, city: Peoria, state: Arizona, zip: 85301, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 33.5806, lon: -112.23738, locations facility: Aligos Clinical Study Site 17, status: RECRUITING, city: Tucson, state: Arizona, zip: 85641, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Aligos Clinical Study Site 35, status: RECRUITING, city: Chula Vista, state: California, zip: 91902, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.64005, lon: -117.0842, locations facility: Aligos Clinical Study Site 1, status: RECRUITING, city: Lincoln, state: California, zip: 95648, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 38.89156, lon: -121.29301, locations facility: Aligos Clinical Study Site 37, status: RECRUITING, city: Poway, state: California, zip: 92025, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.96282, lon: -117.03586, locations facility: Aligos Clinical Study Site 10, status: RECRUITING, city: Rialto, state: California, zip: 92316, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 34.1064, lon: -117.37032, locations facility: Aligos Clinical Study Site 26, status: RECRUITING, city: Bradenton, state: Florida, zip: 34205, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Aligos Clinical Study Site 25, status: RECRUITING, city: Clearwater, state: Florida, zip: 33755, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 27.96585, lon: -82.8001, locations facility: Aligos Clinical Study Site 39, status: RECRUITING, city: Fort Myers, state: Florida, zip: 33901, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 26.62168, lon: -81.84059, locations facility: Aligos Clinical Study Site 2, status: RECRUITING, city: Maitland, state: Florida, zip: 32751, 32794, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Aligos Clinical Study Site 22, status: RECRUITING, city: Ocoee, state: Florida, zip: 32703, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.56917, lon: -81.54396, locations facility: Aligos Clinical Study Site 32, status: RECRUITING, city: Port Orange, state: Florida, zip: 32119, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.13832, lon: -80.99561, locations facility: Aligos Clinical Study Site 38, status: RECRUITING, city: Sarasota, state: Florida, zip: 34230, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 27.33643, lon: -82.53065, locations facility: Aligos Clinical Study Site 31, status: RECRUITING, city: The Villages, state: Florida, zip: 32159, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.93408, lon: -81.95994, locations facility: Aligos Clinical Study Site 3, status: RECRUITING, city: Viera, state: Florida, zip: 32924, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.24696, lon: -80.737, locations facility: Aligos Clinical Study Site 30, status: RECRUITING, city: Winter Park, state: Florida, zip: 32789, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.6, lon: -81.33924, locations facility: Aligos Clinical Study Site 23, status: RECRUITING, city: Athens, state: Georgia, zip: 30601, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 33.96095, lon: -83.37794, locations facility: Aligos Clinical Study Site 12, status: RECRUITING, city: Topeka, state: Kansas, zip: 66546, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Aligos Clinical Study Site 29, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40018, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Aligos Clinical Study Site 24, status: RECRUITING, city: Bastrop, state: Louisiana, zip: 71220, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.75625, lon: -91.87235, locations facility: Aligos Clinical Study Site 5, status: RECRUITING, city: Houma, state: Louisiana, zip: 70360, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.59577, lon: -90.71953, locations facility: Aligos Clinical Study Site 4, status: RECRUITING, city: Marrero, state: Louisiana, zip: 70072, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.89937, lon: -90.10035, locations facility: Aligos Clinical Study Site 6, status: RECRUITING, city: Metairie, state: Louisiana, zip: 70001, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Aligos Clinical Study Site 14, status: RECRUITING, city: Chesterfield, state: Michigan, zip: 48047, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 42.66281, lon: -82.84242, locations facility: Aligos Clinical Study Site 7, status: RECRUITING, city: New York, state: New York, zip: 10001, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Aligos Clinical Study Site 8, status: RECRUITING, city: Morehead City, state: North Carolina, zip: 28557, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 34.72294, lon: -76.72604, locations facility: Aligos Clinical Study Site 21, status: RECRUITING, city: Columbus, state: Ohio, zip: 43004, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Aligos Clinical Study Site 16, status: RECRUITING, city: Westlake, state: Ohio, zip: 44145, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 41.45532, lon: -81.91792, locations facility: Aligos Clinical Study Site 36, status: RECRUITING, city: East Greenwich, state: Rhode Island, zip: 02818, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 41.66038, lon: -71.45589, locations facility: Aligos Clinical Study Site 9, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37011, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Aligos Clinical Study Site 19, status: RECRUITING, city: Austin, state: Texas, zip: 73301, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Aligos Clinical Study Site 33, status: RECRUITING, city: Bellaire, state: Texas, zip: 77401, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.70579, lon: -95.45883, locations facility: Aligos Clinical Study Site 27, status: RECRUITING, city: Brownsville, state: Texas, zip: 78520, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 25.90175, lon: -97.49748, locations facility: Aligos Clinical Study Site 28, status: RECRUITING, city: Edinburg, state: Texas, zip: 78504, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 26.30174, lon: -98.16334, locations facility: Aligos Clinical Study Site 40, status: RECRUITING, city: Farmers Branch, state: Texas, zip: 75006, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.92651, lon: -96.89612, locations facility: Aligos Clinical Study Site 20, status: RECRUITING, city: San Antonio, state: Texas, zip: 78015, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Aligos Clinical Study Site 11, status: RECRUITING, city: Waco, state: Texas, zip: 76633, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 31.54933, lon: -97.14667, locations facility: Aligos Clinical Study Site 13, status: RECRUITING, city: Manassas, state: Virginia, zip: 20108, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 38.75095, lon: -77.47527, locations facility: Aligos Clinical Study Site 34, status: RECRUITING, city: Seattle, state: Washington, zip: 98039, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06342934, orgStudyIdInfo id: INT157/20, briefTitle: Radiomics and Machine Learning in the Diagnosis of Ovarian Masses, acronym: Multi-AROMA, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-22, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, class: OTHER, descriptionModule briefSummary: The correct differential diagnosis between benign and malignant adnexal masses is the main goal of preoperative ultrasound diagnostics and is very important to plan the correct treatment for the patient in terms of surgical team (gynecologist oncologist or benign pathology center), surgical access (laparoscopy / laparotomy) and type of surgery (conservative / demolitive).Several ultrasound models have been developed to help gynecologists define the risk of malignancy of adnexal masses. In order to use the predictive models, the examiner had to collect certain ultrasound features of the lesion which, integrated with the patient's clinical and / or biochemical characteristics, provided a risk of malignancy of the mass.Recently radiomics is emerging as an interesting tool to be applied to diagnostic imaging (computed tomography, magnetic resonance and even ultrasound). Radiomics is the evaluation of images through complex software that allows to 'read' the intrinsic characteristics of the tissue identifying aspects that are not visible by subjective interpretation of the operator, in a fully automated and therefore reproducible way.Radiomics applied to artificial intelligence for the creation of predictive models represents an interesting tool to overcome the limitations of previous models, at least partly dependent on the operator's experience.Among the serous ovarian cancer, those with BRCA gene mutation represent an interesting subgroup and are characterized by a different pathophysiological history than wild type tumors due to greater chemosensitivity and the possibility of targeted treatment with antiangiogenic drugs and PARP-inhibitors.The application of radiomics to preoperative ultrasound images could identify BRCA mutated tumors before surgical planning (radiogenomic analysis) and allow a personalized treatment.The aim of the study is to validate a predictive model to define the risk of malignancy of adnexal masses that the investigators developed at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.The model, based on the integration of radiomics and artificial intelligence, uses complex software capable of 'reading' the ultrasound images in a completely automatic way and is able to estimate the risk of malignancy of the mass.If the patient decide to participate in the clinical study, the patient will undergo transvaginal ultrasound (eventually supplemented by transabdominal ultrasound in case of large adnexal masses, if the patients are virgo or if the patients will refuse transvaginal approach for any reason). This exam is part of the routine preoperative evaluation for adnexal pathology and therefore the patients don't have to undergo any additional clinical, biochemical or imaging examination, according to national and international guidelines.Thereafter, the images stored during the preoperative ultrasound will be exported in anonymous format from the ultrasound system, and sent to the coordinating center (Fondazione IRCCS Istituto Nazionale dei Tumori di Milano). There, images will be submet to radiomic analysis through the application of a dedicated software; that will allow to evaluate the intrinsic characteristics of the tissue according to different parameters (shape, intensity, grade of heterogeneity and many others) of the 'pixels' (gray dots) that constitute the ultrasound image.This analysis, once validated, will provide clinicians an additional tool to identify malignant adnexal masses prior to surgery.If the final histological diagnosis is of serous epithelial ovarian cancer, through the use of the same radiomics software described above the investigators will try to identify the intrinsic characteristics of the tissue associated with the presence or absence of the BRCA 1 or 2 mutation, conditionsModule conditions: Ovarian Cysts, conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Diagnosis of malignant ovarian tumor, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, city: Milano, state: Lombardia, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06342921, orgStudyIdInfo id: ADC189-2022-01, briefTitle: ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection, acronym: ADC, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-07, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Jiaxing AnDiCon Biotech Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.The main aim to answer:* Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.* Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo., conditionsModule conditions: Safety Issues, conditions: Effect of Drug, 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: 675, type: ESTIMATED, armsInterventionsModule interventions name: 15 mg ADC189, interventions name: 45 mg ADC189, interventions name: Placebo, outcomesModule primaryOutcomes measure: the severity of influenza, primaryOutcomes measure: the safety of study drug, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rui Jin Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Haili Liu, Dr, role: CONTACT, phone: +862134188900, email: rjhfbgs@rjh.com.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06342908, orgStudyIdInfo id: 23-001700, secondaryIdInfos id: NCI-2024-00210, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-03-08, completionDateStruct date: 2028-01-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Jonsson Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation., conditionsModule conditions: Diffuse Hemispheric Glioma, H3 G34-Mutant, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Dendritic Cell Therapy, interventions name: Leukapheresis, interventions name: Magnetic Resonance Imaging, interventions name: Poly ICLC, outcomesModule primaryOutcomes measure: Incidence of regimen-limiting toxicities, secondaryOutcomes measure: Significant increase in gamma-interferon (IFN) gene expression signature, secondaryOutcomes measure: Significant clonal T cell expansion, secondaryOutcomes measure: Targets of clonal cytotoxic T cell expansion, secondaryOutcomes measure: Pro-inflammatory phenotypic changes in immune cell populations, secondaryOutcomes measure: Changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations, secondaryOutcomes measure: Changes of immune cell markers profile in T cell and myeloid-derived cell populations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: UCLA / Jonsson Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Sichen C. Li, role: CONTACT, phone: 310-592-9091, email: sichenli@mednet.ucla.edu, contacts name: Anthony C. Wang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06342895, orgStudyIdInfo id: 2020_1113, secondaryIdInfos id: 2022-A00103-40, type: OTHER, domain: ID-RCB number, ANSM, briefTitle: Interpretation and Optimization of Nutrition in the Intensive Care Units, acronym: IONIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Dim3, class: INDUSTRY, collaborators name: Baxter Healthcare Corporation, collaborators name: University Hospital, Lille, descriptionModule briefSummary: Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein., conditionsModule conditions: Nutritional Support, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Usual use of standard clinical and biological information related to nutritional support as available through the ICU electronic health record (i.e. without any calculated information on recommended, prescribed, or received calories and protein, only information on prescribed products and volumes as collected by and presented in the ICU EHR) In this arm, participants, investigators, and healthcare professionals will be blinded to real-time enteral feed volumes that will be collected by the Feedim medical device and transmitted to the electronic study case report form., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional support prescription and delivery monitoring feedback, interventions name: Usual care, outcomesModule primaryOutcomes measure: Mean total daily calories delivered/prescribed ratio (percent), secondaryOutcomes measure: Mean total daily protein delivered/prescribed ratio (%), secondaryOutcomes measure: Mean total daily calories delivered/recommended ratio (percent), secondaryOutcomes measure: Mean total daily protein delivered/recommended ratio (percent), secondaryOutcomes measure: Nutritional support duration (days), secondaryOutcomes measure: Time to initiation of nutritional support (days), secondaryOutcomes measure: Weight (Kg), secondaryOutcomes measure: Day 28 mortality rate, secondaryOutcomes measure: ICU length-of-stay (days), secondaryOutcomes measure: Days on ventilator (days), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Lille, status: RECRUITING, city: Lille, zip: 59037, country: France, contacts name: Eric KIPNIS, MD, PhD, role: CONTACT, phone: +33 (0)3 20 44 59 62, email: eric.kipnis@chu-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, hasResults: False
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protocolSection identificationModule nctId: NCT06342882, orgStudyIdInfo id: GO 19/833- A, briefTitle: Dysphagia Severity and Functional Independence Level, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Atılım University, class: OTHER, descriptionModule briefSummary: Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases., conditionsModule conditions: Dysphagia, conditions: Neurologic Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: dysphagia assessment, interventions name: functional independence level, outcomesModule primaryOutcomes measure: dysphagia severity, primaryOutcomes measure: functional independence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atılım Uiveristy, city: Ankara, state: Incek, zip: 06830, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06342869, orgStudyIdInfo id: 690, briefTitle: Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2022-10-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale., conditionsModule conditions: Fist and Second Molars With ırreversible Pulpitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Anesthesia, outcomesModule primaryOutcomes measure: Assessment of complementary palatinal anesthesia with VAS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Akdeniz University, city: Antalya, zip: 07070, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
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protocolSection identificationModule nctId: NCT06342856, orgStudyIdInfo id: idiopathic infertility, briefTitle: Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia, acronym: infertility, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia, conditionsModule conditions: Infertility Unexplained, conditions: Oligospermia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: co enzyme Q10, L- Carnitine, outcomesModule primaryOutcomes measure: Changes in Semen analysis parameters compared to baseline, secondaryOutcomes measure: Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain Shams University, status: RECRUITING, city: Cairo, zip: 002, country: Egypt, contacts name: ahmed ma maher, lecturer, role: CONTACT, phone: 01013340534, email: drwaleedabdelhamid@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06342843, orgStudyIdInfo id: SPLAsH, secondaryIdInfos id: NL81395.075.22, type: OTHER, domain: CCMO, briefTitle: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH), acronym: SPLAsH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2026-08-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Isala, class: OTHER, descriptionModule briefSummary: This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique., conditionsModule conditions: Osteoarthritis, Hip, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicenter, prospective, double blinded, randomized controlled intervention study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 211, type: ESTIMATED, armsInterventionsModule interventions name: Total Hip Arthroplasty, outcomesModule primaryOutcomes measure: Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form, secondaryOutcomes measure: Numeric Rating Scale (NRS), secondaryOutcomes measure: Short Form-12 (SF-12), secondaryOutcomes measure: Hip disability and Osteoarthritis Outcome Score (HOOS), secondaryOutcomes measure: Euro Quality of Life (EQ-5D), secondaryOutcomes measure: Global Rating of Change scale, secondaryOutcomes measure: Timed Up and Go test (TUG test), secondaryOutcomes measure: 40 meter self-paced walk test for hip osteoarthritis, secondaryOutcomes measure: Stair climb test, secondaryOutcomes measure: Step count application on iPhone, secondaryOutcomes measure: Muscle atrophy by using Computer Tomography (CT) scanner, secondaryOutcomes measure: Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR), secondaryOutcomes measure: Postoperative cup position on Computer Tomography (CT) image, secondaryOutcomes measure: Comparing definite cup position with preoperative planned cup position, secondaryOutcomes measure: Comparing definite component position with surgeon's perioperative estimation of component position, secondaryOutcomes measure: overall image quality, secondaryOutcomes measure: image diagnostic confidence, secondaryOutcomes measure: metal artifacts on images, secondaryOutcomes measure: Incontinence Severity Index (ISI), secondaryOutcomes measure: Urinary Distress Inventory, Short Form (UDI-6), secondaryOutcomes measure: Patient Global Impression of Severity (PGIS), secondaryOutcomes measure: Incontinence Impact Questionnaire Short Form (IIQ-7), secondaryOutcomes measure: Incontinence after Total Hip Arthroplasty, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amphia, status: NOT_YET_RECRUITING, city: Breda, state: Brabant, zip: 4818CK, country: Netherlands, contacts name: Stefan BT Bolder, MD, role: CONTACT, geoPoint lat: 51.58656, lon: 4.77596, locations facility: Medisch Centrum Leeuwarden, status: NOT_YET_RECRUITING, city: Leeuwarden, state: Friesland, zip: 8934AD, country: Netherlands, contacts name: Wierd Zijlstra, MD/PhD, role: CONTACT, geoPoint lat: 53.20139, lon: 5.80859, locations facility: Isala, status: RECRUITING, city: Zwolle, state: Overijssel, zip: 8000 GK, country: Netherlands, contacts name: Diederik de Boer, MSc., role: CONTACT, phone: 00316248117, email: die.de.boer@isala.nl, contacts name: Roelina Munnik, PhD, role: CONTACT, phone: 00316245375, email: r.munnik@isala.nl, contacts name: Harmen Ettema, MD/PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.5125, lon: 6.09444, hasResults: False
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protocolSection identificationModule nctId: NCT06342830, orgStudyIdInfo id: End 20-05 P, briefTitle: Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:* Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:* nanocurcumin gel* curcumin gel* ciprofloxacin +ibuprofen gel* calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 6 months follow up periods, conditionsModule conditions: Periapical Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: nanocurcumin gel, interventions name: Curcumin Gel, interventions name: Ciprofloxacin 500 mg +ibuprofen 400mg, interventions name: Metapaste [calcium hydroxide paste (control group)], outcomesModule primaryOutcomes measure: healing of periapical lesion, secondaryOutcomes measure: antibacterial effect (CFU), secondaryOutcomes measure: Interappointment Pain, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of dentistry, Ain shams university, city: Cairo, zip: 11512, country: Egypt, contacts name: Rawda Baghdady, role: CONTACT, phone: 01142361074, email: RawdaBaghdady@dent.asu.edu.eg, contacts name: sarah H Fahmy, role: CONTACT, phone: 01005267999, contacts name: Rawda M Baghdady, PHD student, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2020-09-20, uploadDate: 2024-03-01T05:02, filename: Prot_SAP_000.pdf, size: 719008, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2020-09-20, uploadDate: 2024-03-01T05:04, filename: ICF_001.pdf, size: 284949, hasResults: False
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protocolSection identificationModule nctId: NCT06342817, orgStudyIdInfo id: UFFS, briefTitle: Effects of Meditation on Sleep Quality of Medical Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-18, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Universidade Federal da Fronteira Sul, class: OTHER, descriptionModule briefSummary: The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed, conditionsModule conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Those students interested in participating in the study will leave their contact details (telephone and email) to the research coordinator, to whom it will be sent an online questionnaire containing the inclusion and exclusion criteria, and the free consent form through the Google forms platform. Collection instruments will only be made available after fulfilling the inclusion criteria and absence of exclusion criteria and agreement with the consent form. Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group., enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: online mindfulness based meditation program, outcomesModule primaryOutcomes measure: Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE, secondaryOutcomes measure: Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS, secondaryOutcomes measure: Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21, secondaryOutcomes measure: Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidade Federal Da Fronteira Sul, status: RECRUITING, city: Passo Fundo, state: RS, zip: 99010200, country: Brazil, contacts name: Tiago T Simon, MD, role: CONTACT, phone: +5554991843384, email: tiago.teixeira@uffs.edu.br, geoPoint lat: -28.26278, lon: -52.40667, hasResults: False
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protocolSection identificationModule nctId: NCT06342804, orgStudyIdInfo id: GIB-01-02-2023, briefTitle: Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets)., conditionsModule conditions: Cholecystitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: 4-MUST, 2 tablets, fasted, interventions name: 4-MUST, 2 tablets, after meals, outcomesModule primaryOutcomes measure: Pharmacokinetics - Cmax, primaryOutcomes measure: Pharmacokinetics - tmax, primaryOutcomes measure: Pharmacokinetics - AUC0-t, primaryOutcomes measure: Pharmacokinetics - AUC0-inf, primaryOutcomes measure: Pharmacokinetics - AUC ratio, primaryOutcomes measure: Pharmacokinetics - t1/2, primaryOutcomes measure: Pharmacokinetics - kel, primaryOutcomes measure: Pharmacokinetics - MRT, primaryOutcomes measure: Pharmacokinetics - Vd, primaryOutcomes measure: Pharmacokinetics - Cmax/AUC0-t, primaryOutcomes measure: Pharmacokinetics - f', primaryOutcomes measure: Pharmacokinetics - f'', primaryOutcomes measure: Bioavailability - ratio of Cmax, primaryOutcomes measure: Bioavailability - ratio of AUC0-t, primaryOutcomes measure: Bioavailability - ratio of AUC0-inf, secondaryOutcomes measure: Adverse event type, secondaryOutcomes measure: Adverse event frequency, secondaryOutcomes measure: Adverse event severety, secondaryOutcomes measure: Drop-outs associated with adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health", status: RECRUITING, city: Saint Petersburg, zip: 191036, country: Russian Federation, contacts name: Elena S Shalukho, MD, role: CONTACT, phone: +7 (903) 099 57 86, email: elena.shalukho@yandex.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
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protocolSection identificationModule nctId: NCT06342791, orgStudyIdInfo id: 004349, briefTitle: Effect of Laser Acupuncture on Menstrual Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: effect of laser acupuncture on menstrual back pain, conditionsModule conditions: Laser Acupuncture, conditions: Low Back Pain, conditions: Menstruation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: laser acupuncture, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: laser acupuncture, outcomesModule primaryOutcomes measure: back Pain intensity during menstruation, primaryOutcomes measure: pain threshold, primaryOutcomes measure: Ability to perform daily activities, secondaryOutcomes measure: back Pain intensity during menstruation, secondaryOutcomes measure: pain threshold, secondaryOutcomes measure: Ability to perform daily activities, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy cairo university, status: RECRUITING, city: Cairo, zip: 37617692, country: Egypt, contacts name: Mai Ali Galal El sayed, role: CONTACT, phone: 01152457470, email: Princessmai828@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06342778, orgStudyIdInfo id: DIP-05-02-2023, briefTitle: Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals, conditionsModule conditions: Nausea, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Doxylamine + Pyridoxine, interventions name: Diclectin, outcomesModule primaryOutcomes measure: Pharmacokinetics - Cmax, primaryOutcomes measure: Pharmacokinetics - tmax, primaryOutcomes measure: Pharmacokinetics - AUC0-t, primaryOutcomes measure: Pharmacokinetics - AUC0-inf, primaryOutcomes measure: Pharmacokinetics - AUCextr, primaryOutcomes measure: Pharmacokinetics - t1/2, primaryOutcomes measure: Pharmacokinetics - kel, primaryOutcomes measure: Pharmacokinetics - MRT, primaryOutcomes measure: Bioequivalence - ratio of Cmax, primaryOutcomes measure: Bioequivalence - ratio of AUC0-t, primaryOutcomes measure: Bioequivalence - ratio of AUC0-inf, secondaryOutcomes measure: Adverse event type, secondaryOutcomes measure: Adverse event frequency, secondaryOutcomes measure: Adverse event severety, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Sergey M Noskov, Prof., role: CONTACT, phone: +7-4852-242332, email: Noskov-SM@mail.ru, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False
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protocolSection identificationModule nctId: NCT06342765, orgStudyIdInfo id: SV009, briefTitle: Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment, acronym: FixedD3, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-22, primaryCompletionDateStruct date: 2028-05-30, completionDateStruct date: 2028-05-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: SpineVision, class: INDUSTRY, collaborators name: Slb Pharma, descriptionModule briefSummary: The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis®, in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery., conditionsModule conditions: Intervertebral Disc Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Pedicle fixation surgery, outcomesModule primaryOutcomes measure: Incidence of serious and non-serious device- and/or procedure-related adverse events, primaryOutcomes measure: Change of the Oswestry Disability Index (ODI), secondaryOutcomes measure: Fusion success, secondaryOutcomes measure: Change of the Oswestry Disability Index (ODI), secondaryOutcomes measure: Change of the back and leg Visual Analogue Score (VAS), secondaryOutcomes measure: Incidence of revision surgery at implant site, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DOSCEA Pôle Rachis, status: RECRUITING, city: Bayonne, zip: 64100, country: France, contacts name: Jean Bernard, role: CONTACT, email: secretariatdoscea@outlook.fr, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Clinique du dos Bordeaux-Terrefort, status: RECRUITING, city: Bruges, zip: 33520, country: France, contacts name: Louis Boissière, Doctor, role: CONTACT, email: boissierelouis@gmail.com, geoPoint lat: 44.87981, lon: -0.61219, locations facility: Orthéo Neurochirurgie, status: RECRUITING, city: Saint-Étienne, zip: 42199, country: France, contacts name: Benjamin Pommier, Doctor, role: CONTACT, email: benjamin.pommier@neurochirurgie.fr, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06342752, orgStudyIdInfo id: 6007, briefTitle: The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia, acronym: INFANCY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, descriptionModule briefSummary: Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.Despite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways.Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored.Thirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated.The threefold aim of this study is as follows:I. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress.II. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome.III. The detection of potential alterations in airway mucin expression in BPD patients.Through this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD.In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included., conditionsModule conditions: Bronchopulmonary Dysplasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Breath test, interventions name: Throat swabs, interventions name: Placental samples, interventions name: Vaginal swab, interventions name: Endotracheal aspirates, outcomesModule primaryOutcomes measure: Exhaled breath Volatile Organic Compounds (VOCs), primaryOutcomes measure: Airway mucin profiles, primaryOutcomes measure: Airway microbial profiles, secondaryOutcomes measure: Placental headspace VOCs, secondaryOutcomes measure: Placental microbiome, secondaryOutcomes measure: Vaginal microbiome, secondaryOutcomes measure: Follow-up structural lung imaging, secondaryOutcomes measure: Hypercapnia, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 3 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342739, orgStudyIdInfo id: IEO 1595, briefTitle: Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules., conditionsModule conditions: Thyroid Nodule, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Gabriella Pravettoni, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06342726, orgStudyIdInfo id: 2024/714469, briefTitle: The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2024-06-02, completionDateStruct date: 2024-06-02, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine., conditionsModule conditions: Accidental Hypothermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.Before the start of experiment, the research participant will be cooled in an ice cave wearing wet clothing and with 2-3 m/s wind to a core temperature of 35.0 °C using the established protocol for inhibition of shivering. The maximum cooling time will be 2 hours (120 minutes). The order of interventions will be randomized.When the research subjects reach the target temperature of 35.0°C or the maximum cooling time of 2 hours, they will be subjected to one of the two scenarios listed below, with a rewarming phase of maximum 60 minutes., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: PAX Warming Blanket, interventions name: Passive insulation, outcomesModule primaryOutcomes measure: Core body temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haukeland University Hospital, status: RECRUITING, city: Bergen, zip: 5021, country: Norway, contacts name: Sigurd Mydske, MD, role: CONTACT, phone: 90659586, email: sigurd.mydske@norskluftambulanse.no, contacts name: Øyvind Thomassen, MD, PhD, role: CONTACT, phone: 977 18 721, email: oyvind.thomassen1@helse-bergen.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
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protocolSection identificationModule nctId: NCT06342713, orgStudyIdInfo id: BGB-45035-101, briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: BeiGene, class: INDUSTRY, descriptionModule briefSummary: This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.Study details include:* The study duration will be up to 16 months.* The treatment duration will be up to 14 days.* Safety follow-up 30 days after last dose of study drug., conditionsModule conditions: Healthy Participants, conditions: Healthy Subjects, conditions: Healthy Volunteers, conditions: Autoimmune Diseases, conditions: Healthy Adult Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The cohorts in Part A, B, and C will be double-blinded, while the food effect study in Part D will be open-label, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: BGB-45035, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Adverse Events (AEs), primaryOutcomes measure: Number of participants with clinically significant changes from baseline in clinical laboratory values, primaryOutcomes measure: Number of participants with clinically significant changes from baseline in vital signs, primaryOutcomes measure: Number of participants with clinically significant changes from baseline in cardiac conduction intervals, secondaryOutcomes measure: Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast), secondaryOutcomes measure: Area under the plasma concentration time curve from time zero to infinite time (AUCinf), secondaryOutcomes measure: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau), secondaryOutcomes measure: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Time to maximum plasma concentration (Tmax), secondaryOutcomes measure: Trough plasma concentration (Ctrough), secondaryOutcomes measure: Half life (t½), secondaryOutcomes measure: Apparent systemic clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution (Vz/F), secondaryOutcomes measure: Accumulation Ratios, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342700, orgStudyIdInfo id: PKM18138, secondaryIdInfos id: U1111-1299-1906, type: REGISTRY, domain: ICTRP, briefTitle: A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-29, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.The total study duration per participant is expected to be up to 36 days, including:* Screening: up to 4 weeks* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study., conditionsModule conditions: Autoimmune Disorder, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Rilzabrutinib crystalline form, interventions name: Rilzabrutinib amorphous form, outcomesModule primaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state, primaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state, primaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state, secondaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state, secondaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state, secondaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state, secondaryOutcomes measure: Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state, secondaryOutcomes measure: Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state, secondaryOutcomes measure: Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state, secondaryOutcomes measure: Number of participants with adverse events, treatment-emergent adverse events, serious adverse events and adverse events of special interest, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nucleus Network Site Number : 8400001, status: RECRUITING, city: Saint Paul, state: Minnesota, zip: 55114, country: United States, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False
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protocolSection identificationModule nctId: NCT06342687, orgStudyIdInfo id: JagiellonianU 1, briefTitle: Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection., conditionsModule conditions: Colorectal Cancer, conditions: ERAS, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 468, type: ACTUAL, armsInterventionsModule interventions name: High compliance with ERAS protocol, outcomesModule primaryOutcomes measure: Post operative 5 year survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jagiellonian University Medical College, city: Kraków, state: Małopolskie, zip: 31-008, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
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protocolSection identificationModule nctId: NCT06342674, orgStudyIdInfo id: Nejla CANBULAT ŞAHİNER, briefTitle: Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients, acronym: The, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sakarya University, class: OTHER, descriptionModule briefSummary: The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.no effect on the infant's growth parameters and nutrient absorption levels by the infant.Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk., conditionsModule conditions: Breast Feeding, conditions: Breast Milk Collection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Single (participant) blinding was used in the study. For this purpose, it was not stated which group the participating mothers were in the research, but they were informed about the procedure to be performed. Therefore, a separate informed consent form was prepared for each group. Statistician blinding will also be applied. While coding the research data, the research group will be coded as A and B, and the statistician will be prevented from knowing which letter represents which group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Giving breast milk to the newborn according to the circadian rhythm, interventions name: Usual care, outcomesModule primaryOutcomes measure: Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups, primaryOutcomes measure: Evaluation of the baby's height measurements in the study and control groups, primaryOutcomes measure: Evaluation of the baby's head circumference in the study and control groups, secondaryOutcomes measure: Evaluation of nutritional absorption of infants in the study and control groups, eligibilityModule sex: ALL, minimumAge: 32 Weeks, maximumAge: 34 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342661, orgStudyIdInfo id: 2022IIT205, briefTitle: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2028-11, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Harbin Medical University, class: OTHER, descriptionModule briefSummary: 1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years., conditionsModule conditions: Cerebrovascular Disease Small Vessel, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological testing, outcomesModule primaryOutcomes measure: Patient characteristics, primaryOutcomes measure: VISTA expression in PBMCs in the VCI and control groups, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, zip: 150010, country: China, contacts name: LiJun Chi, role: CONTACT, phone: 13895783757, email: clj3757@163.com, geoPoint lat: 45.75, lon: 126.65, hasResults: False
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protocolSection identificationModule nctId: NCT06342648, orgStudyIdInfo id: Cutaneous water in renal colic, briefTitle: Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Suez Canal University, class: OTHER, descriptionModule briefSummary: Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared., conditionsModule conditions: Renal Colic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 570, type: ESTIMATED, armsInterventionsModule interventions name: Sterile Water Injection, interventions name: Diclofenac Sodium injection, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342635, orgStudyIdInfo id: HYD/DENMARK-001/2023, briefTitle: Hydra Single-centre Experience - Copenhagen, Denmark, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sahajanand Medical Technologies Limited, class: INDUSTRY, collaborators name: Qmed Consulting A/S, descriptionModule briefSummary: The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series., conditionsModule conditions: Aortic Valve Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Hydra Transcatheter Aortic Valve (THV) Series, outcomesModule primaryOutcomes measure: Primary safety endpoint, primaryOutcomes measure: Primary performance endpoint, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: All stroke, secondaryOutcomes measure: Disabling stroke, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Major vascular complication, secondaryOutcomes measure: Acute kidney injury, secondaryOutcomes measure: New permanent pacemaker implantation due to procedure related conduction abnormalities, secondaryOutcomes measure: New-onset atrial fibrillation, secondaryOutcomes measure: Coronary artery obstruction requiring intervention, secondaryOutcomes measure: Re-hospitalization for procedure- or valve-related causes, secondaryOutcomes measure: Mean aortic valve gradient, secondaryOutcomes measure: Effective Orifice Area (EOA), secondaryOutcomes measure: Paravalvular leak, secondaryOutcomes measure: New York Heart Association (NYHA) functional class, secondaryOutcomes measure: Quality-of-life evaluation, secondaryOutcomes measure: Bioprosthetic Valve Failure (BVF), secondaryOutcomes measure: Bioprosthetic valve dysfunction (BVD), secondaryOutcomes measure: Stroke or peripheral embolism, secondaryOutcomes measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns, secondaryOutcomes measure: Rates of Hypoattenuated Leaflet Thickening (HALT), secondaryOutcomes measure: Rates of Reduced leaflet motion (RLM), secondaryOutcomes measure: Commissural alignment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital, Rigshospitalet, city: Copenhagen, country: Denmark, contacts name: Dr. Ole De Backer, role: CONTACT, contacts name: Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06342622, orgStudyIdInfo id: Weiguo Dong, briefTitle: Young-onset Colorectal Cancer Screening Based on Artificial Intelligence, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-01-10, completionDateStruct date: 2024-01-25, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Renmin Hospital of Wuhan University, class: OTHER, descriptionModule briefSummary: In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 11000, type: ACTUAL, armsInterventionsModule interventions name: Using routine clinical data and machine learning models., outcomesModule primaryOutcomes measure: The performance of machine learning screening models, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Renmin Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06342609, orgStudyIdInfo id: 32857-01-EKSTROM, briefTitle: Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease, acronym: EKSTROM, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-09-07, completionDateStruct date: 2024-09-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, class: OTHER, descriptionModule briefSummary: This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind Placebo controlled, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 84, type: ACTUAL, armsInterventionsModule interventions name: Colchicine 0.5 MG, outcomesModule primaryOutcomes measure: Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography, secondaryOutcomes measure: Effect of Colchicine on markers of inflammation using laboratory tests, secondaryOutcomes measure: Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA, secondaryOutcomes measure: Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA, secondaryOutcomes measure: Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, city: Torrance, state: California, zip: 90502, country: United States, geoPoint lat: 33.83585, lon: -118.34063, hasResults: False
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protocolSection identificationModule nctId: NCT06342596, orgStudyIdInfo id: 18597, secondaryIdInfos id: J2O-MC-EKBD, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-LY3473329, interventions name: [14C]-LY3473329, interventions name: LY3473329, outcomesModule primaryOutcomes measure: Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered, primaryOutcomes measure: Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered, primaryOutcomes measure: Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity, secondaryOutcomes measure: Part 1: PK: Maximum Concentration (Cmax) of LY3473329, secondaryOutcomes measure: Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity, secondaryOutcomes measure: Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable), secondaryOutcomes measure: Part 1: Total Number of Metabolites of LY3473329, secondaryOutcomes measure: Part 2: PK: AUC (0-∞) of LY3473329, secondaryOutcomes measure: Part 2: PK: AUC (0-∞) of [14C]-LY3473329, secondaryOutcomes measure: Part 2: PK: AUC (0-∞) of Total Radioactivity, secondaryOutcomes measure: Part 2: PK: Cmax of LY3473329, secondaryOutcomes measure: Part 2: PK: Cmax of [14C]-LY3473329, secondaryOutcomes measure: Part 2: PK: Cmax of Total Radioactivity, secondaryOutcomes measure: Part 2: Total Radioactivity Recovered in Urine and Feces, eligibilityModule sex: MALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea Clinical Research Unit, city: Holbeck, state: Leeds, zip: LS11 9EH, country: United Kingdom, geoPoint lat: 53.25, lon: -1.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06342583, orgStudyIdInfo id: CNR-IRIB-PRO-2024-004, briefTitle: Advanced Social Relations Training, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-17, completionDateStruct date: 2026-02-10, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istituto per la Ricerca e l'Innovazione Biomedica, class: OTHER, collaborators name: Messina, Italy, descriptionModule briefSummary: Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Advanced social relations training with technical device, interventions name: Advanced social relations training without technical device, outcomesModule primaryOutcomes measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form), primaryOutcomes measure: Eye contact, primaryOutcomes measure: Smile in relation to group members' expressions, primaryOutcomes measure: Greeting, primaryOutcomes measure: Asking a question, primaryOutcomes measure: Proposing an idea or activity to be carried out, primaryOutcomes measure: Answering a question, primaryOutcomes measure: Taking verbal initiative, primaryOutcomes measure: Approval/sharing gestures, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), status: RECRUITING, city: Messina, zip: 98164, country: Italy, contacts name: Flavia Marino, role: CONTACT, phone: +393395798263, email: flavia.marino@irib.cnr.it, contacts name: Maria Valeria Maiorana, role: CONTACT, phone: +393285856656, email: mariavaleria.maiorana@irib.cnr.it, contacts name: Flavia Marino, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Pioggia, role: SUB_INVESTIGATOR, contacts name: Paola Chilà, role: SUB_INVESTIGATOR, contacts name: Roberta Minutoli, role: SUB_INVESTIGATOR, contacts name: Noemi Vetrano, role: SUB_INVESTIGATOR, contacts name: Chiara Failla, role: SUB_INVESTIGATOR, contacts name: Germana Doria, role: SUB_INVESTIGATOR, contacts name: Ileana Scarcella, role: SUB_INVESTIGATOR, contacts name: Cinzia Grasso, role: SUB_INVESTIGATOR, contacts name: Mariaelena Franchina, role: SUB_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False
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protocolSection identificationModule nctId: NCT06342570, orgStudyIdInfo id: 3-2023-0462, briefTitle: Quantitative Analysis of EEG Changes in Response to Nociception, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Gangnam Severance Hospital, class: OTHER, descriptionModule briefSummary: This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception., conditionsModule conditions: Patients Undergoing Laparoscopic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 109, type: ESTIMATED, armsInterventionsModule interventions name: There is no Intervention name to describe., outcomesModule primaryOutcomes measure: Correlation between changes in ANI and EEG band power in response to surgical stimulation., secondaryOutcomes measure: Correlation between changes in ANI and EEG band power in response to tracheal intubation, secondaryOutcomes measure: Correlation between changes in ANI and EEG connectivity in response to surgical stimulation, secondaryOutcomes measure: Correlation between changes in ANI and EEG connectivity in response to tracheal intubation, secondaryOutcomes measure: Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration, secondaryOutcomes measure: Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration, secondaryOutcomes measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI, secondaryOutcomes measure: Differences in EEG connectivity during surgery between groups with large and small changes in ANI, secondaryOutcomes measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI, secondaryOutcomes measure: Differences in EEG connectivity during recovery between groups with large and small changes in ANI, secondaryOutcomes measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic, secondaryOutcomes measure: Differences in EEG connectivity depending on the type of inhaled anesthetic, secondaryOutcomes measure: Differences in ANI depending on the type of inhaled anesthetic, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GangnamSeverance Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Myung Il Bae, role: CONTACT, phone: 82-2-2019-6611, email: BMI87@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06342557, orgStudyIdInfo id: FROM, briefTitle: Transitional ePRO Diary Liver, acronym: MACROLIVER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2034-02-21, completionDateStruct date: 2034-02-21, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS, class: OTHER, descriptionModule briefSummary: The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients., conditionsModule conditions: Liver Transplant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: four-item Morisky Medication Adherence Scale (MGLS), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: ASST-Papa Giovanni XXIII, status: RECRUITING, city: Bergamo, state: Milano, zip: 24127, country: Italy, contacts name: Stefano Fagiuoli, MD, role: CONTACT, phone: 035.2674259, email: sfagiuoli@asst-pg23.it, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False
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protocolSection identificationModule nctId: NCT06342544, orgStudyIdInfo id: AGN_2023_14, briefTitle: Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial., acronym: IMCOMG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Fondation Ophtalmologique Adolphe de Rothschild, class: NETWORK, descriptionModule briefSummary: Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness.In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease.Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants.There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens.On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile.We propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis.Patients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant.The aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off., conditionsModule conditions: Ocular Myasthenia Gravis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: immediate treatment with corticosteroids, interventions name: addition of rituximab if recurrence, outcomesModule primaryOutcomes measure: proportion of patients who progressed to generalized myasthenia within 2 years of follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06342531, orgStudyIdInfo id: 210324, briefTitle: More Effective Violence Risk Management - eDASA+APP FI, acronym: eDASA+APP FI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Turku, class: OTHER, collaborators name: Helsinki University Central Hospital, descriptionModule briefSummary: The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care., conditionsModule conditions: Violence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A pre-post design (quasi-experimental), a cluster design, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: eDASA+APP FI, outcomesModule primaryOutcomes measure: Workplace violence, secondaryOutcomes measure: Coercive measures, secondaryOutcomes measure: Job satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342518, orgStudyIdInfo id: MU ESWT, briefTitle: ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-01, primaryCompletionDateStruct date: 2021-09-01, completionDateStruct date: 2021-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istanbul Medeniyet University, class: OTHER, descriptionModule briefSummary: This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound., conditionsModule conditions: Lateral Epicondylitis, conditions: Tennis Elbow, 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: 42, type: ACTUAL, armsInterventionsModule interventions name: Extracorporeal Shock Wave Therapy (ESWT), interventions name: Sham ESWT, interventions name: Resting Splint, Exercises and ice, outcomesModule primaryOutcomes measure: Hand Grip Strength, primaryOutcomes measure: Pain severity, primaryOutcomes measure: Functionality, primaryOutcomes measure: Quality of life score, primaryOutcomes measure: deep muscular tissue sensitivity, primaryOutcomes measure: thickness of the common extensor tendon (CET), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department, city: Istanbul, zip: 34732, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06342505, orgStudyIdInfo id: MEC-2022-0037, briefTitle: Tacrolimus in CD3+ T Lymphocytes, acronym: INTACT, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-30, primaryCompletionDateStruct date: 2022-10-10, completionDateStruct date: 2022-11-10, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are:(i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug?Participants will:* Receive standard clinical care;* Undergo two extra venipunctures for the collection of blood., conditionsModule conditions: Immunosuppression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 28, type: ACTUAL, armsInterventionsModule interventions name: Venipunctures, outcomesModule primaryOutcomes measure: The intracellular tacrolimus concentration in CD3+ T lymphocytes, secondaryOutcomes measure: Intracellular cytokine production, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, city: Rotterdam, zip: 3015 GD, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06342492, orgStudyIdInfo id: KCHRRF_CS Lead Failure_0025, briefTitle: Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Kansas City Heart Rhythm Research Foundation, class: OTHER, descriptionModule briefSummary: This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Coronary Sinus Lead Revision, outcomesModule primaryOutcomes measure: Need for lead revision, secondaryOutcomes measure: Electrocardiography characteristics - QRS Interval, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Menorah Medical Center, city: Overland Park, state: Kansas, zip: 66209, country: United States, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Kansas City Heart Rhythm Institute - Roe Clinic, city: Overland Park, state: Kansas, zip: 66211, country: United States, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Overland Park Regional Medical Center, city: Overland Park, state: Kansas, zip: 66215, country: United States, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Centerpoint Medical Center Clinic, city: Independence, state: Missouri, zip: 64057, country: United States, geoPoint lat: 39.09112, lon: -94.41551, locations facility: Centerpoint Medical Center, city: Independence, state: Missouri, zip: 64057, country: United States, geoPoint lat: 39.09112, lon: -94.41551, locations facility: Research Medical Center Clinic, city: Kansas City, state: Missouri, zip: 64032, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Medical Center, city: Kansas City, state: Missouri, zip: 64032, country: United States, geoPoint lat: 39.09973, lon: -94.57857, hasResults: False
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protocolSection identificationModule nctId: NCT06342479, orgStudyIdInfo id: NM: 04.20.ND:30.03.2023, briefTitle: Discharge Training for Patients With Intertrochanteric Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Erzurum Technical University, class: OTHER, descriptionModule briefSummary: This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically., conditionsModule conditions: Surgical Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Discharge Education, outcomesModule primaryOutcomes measure: Toronto Wound Symptom Assessment System, secondaryOutcomes measure: Discharge readiness scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erzurum Technical University Faculty of Health Sciences, status: RECRUITING, city: Erzurum, zip: 25000, country: Turkey, contacts name: Yasemin Erden, role: CONTACT, phone: 05303461516, email: yasemin.erden@erzurum.edu.tr, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06342466, orgStudyIdInfo id: 2023-358-02, briefTitle: Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Jin Lu, MD, class: OTHER, descriptionModule briefSummary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months., conditionsModule conditions: Systemic Amyloidosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Bortezomib, pomalidomide, dexamethasone, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bortezomib, interventions name: Pomalidomide, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Hematologic VGPR + CR rate at 6 months, secondaryOutcomes measure: Overall Hematologic response rate at 6 months, secondaryOutcomes measure: At least one organ response at 6 months, secondaryOutcomes measure: TTNT at 2 years, secondaryOutcomes measure: Estimated PFS at 2 years, secondaryOutcomes measure: Estimated OS at 2 years, secondaryOutcomes measure: TRAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100044, country: China, contacts name: Yang Liu, role: CONTACT, phone: +8613716926210, email: pkuphliuyang@bjmu.edu.cn, contacts name: Jin Lu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06342453, orgStudyIdInfo id: STUDY00026814, secondaryIdInfos id: NCI-2024-01534, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00026814, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Examining Arts as Therapy in Children With Cancer, CREATe Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer., conditionsModule conditions: Hematopoietic and Lymphatic System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Art Therapy, interventions name: Discussion, interventions name: Media Intervention, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Number of participants that complete all interventions and data collection time points, secondaryOutcomes measure: Number of eligible participants that enroll in the study (feasibility threshold of 60%), secondaryOutcomes measure: Number of participants that complete all interventions and all surveys in the study., secondaryOutcomes measure: Number of intervenor fidelity surveys that obtain at least 95% score., secondaryOutcomes measure: Comparison of scores on the PRO-CTCAE between intervention arms, secondaryOutcomes measure: Comparison of scores on the PROMIS between intervention arms, secondaryOutcomes measure: Comparison of scores on the Faces between intervention arms, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Jennifer L. Raybin, role: CONTACT, phone: 503-418-5150, email: raybin@ohsu.edu, contacts name: Jennifer L. Raybin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06342440, orgStudyIdInfo id: 23228/AACRC, briefTitle: Early Detection of Advanced Adenomas and Colorectal Cancer, acronym: AACRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-03-15, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, conditions: Colorectal Polyp, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Disorders, conditions: Colorectal Dysplasia, conditions: Colorectal Cancer Stage I, conditions: Colorectal Cancer Stage II, conditions: Colorectal Cancer Stage III, conditions: Colorectal Cancer Stage IV, conditions: Colorectal Neoplasms Malignant, conditions: Colorectal Serrated Adenocarcinoma, conditions: Colorectal Adenoma With Severe Dysplasia, conditions: Colorectal Adenoma With Mild Dysplasia, conditions: Colorectal Adenoma With Moderate Dysplasia, conditions: Colorectal Adenoma and Carcinoma 1, conditions: Colorectal Adenomatous Polyp, conditions: Colorectal Adenocarcinoma Metastatic in the Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: DENEB, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Monrovia, state: California, zip: 91016, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Caiming Xu, role: SUB_INVESTIGATOR, contacts name: Alessandro Mannucci, role: SUB_INVESTIGATOR, contacts name: James Lin, role: SUB_INVESTIGATOR, contacts name: Gregory Idos, role: SUB_INVESTIGATOR, contacts name: Trilokesh Kadambi, role: SUB_INVESTIGATOR, geoPoint lat: 34.14806, lon: -117.99895, locations facility: University of California San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92093, country: United States, contacts name: C Richard Boland, MD, PhD, role: CONTACT, contacts name: C Richard Boland, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: The First Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, country: China, contacts name: Jing Zhang, role: CONTACT, contacts name: Jing Zhang, role: SUB_INVESTIGATOR, contacts name: Caiming Xu, role: SUB_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, locations facility: IRCCS San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Giulia Martina Cavestro, MD, PhD, role: CONTACT, email: cavestro.giuliamartina@hsr.it, contacts name: Giulia Martina Cavestro, role: SUB_INVESTIGATOR, contacts name: Alessandro Mannucci, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Mie University, status: RECRUITING, city: Mie, country: Japan, contacts name: Yuji Toiyama, role: CONTACT, contacts name: Yuji Toiyama, role: SUB_INVESTIGATOR, contacts name: Yoshinaga Okugawa, role: SUB_INVESTIGATOR, contacts name: Tadanobu Shimura, role: SUB_INVESTIGATOR, locations facility: Barcelona University, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Francesc Balaguer, MD, PhD, role: CONTACT, email: fprunes@clinic.cat, contacts name: Francesc Balaguer, role: SUB_INVESTIGATOR, contacts name: Miguel Pera, role: SUB_INVESTIGATOR, contacts name: Lorena Moreno, role: SUB_INVESTIGATOR, contacts name: Luis Bujanda, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06342427, orgStudyIdInfo id: 23228/DESTINEX, briefTitle: Stomach Cancer Exosome-based Detection, acronym: DESTINEX, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer., conditionsModule conditions: Gastric Cancer, conditions: Gastric Adenocarcinoma, conditions: Gastric Cancer Stage, conditions: Gastric Neoplasm, conditions: Gastric Lesion, conditions: Gastric Cancer in Situ, conditions: Gastric Cancer Stage IV, conditions: Gastric Cancer Stage IIIB, conditions: Gastric Cancer Stage III, conditions: Gastric Cancer Stage IB, conditions: Gastric Cancer Stage IA, conditions: Gastric Cancer, Stage 0, conditions: Gastric Cancer Stage IIIA, conditions: Gastric Cancer Stage II, conditions: Gastric Cancer TNM Staging, conditions: Gastric Cancer Metastatic to Lung, conditions: Gastric Cancer Metastatic to Liver, conditions: Gastric Cancer Stage I, conditions: Gastric Cancer TNM Staging Primary Tumor (T) T2B, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: DESTINEX, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Silei Sui, role: PRINCIPAL_INVESTIGATOR, contacts name: Caiming Xu, role: SUB_INVESTIGATOR, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Nagoya University, status: RECRUITING, city: Nagoya, country: Japan, contacts name: Yasuhiro Kodera, role: CONTACT, contacts name: Yasuhiro Kodera, role: SUB_INVESTIGATOR, contacts name: Mitsuo Kanda, role: SUB_INVESTIGATOR, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Mie University, status: RECRUITING, city: Tsu, country: Japan, contacts name: Yuji Toiyama, role: CONTACT, contacts name: Yuji Toiyama, role: SUB_INVESTIGATOR, contacts name: Yoshinaga Okugawa, role: SUB_INVESTIGATOR, geoPoint lat: 34.73333, lon: 136.51667, hasResults: False
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protocolSection identificationModule nctId: NCT06342414, orgStudyIdInfo id: 23228/ELUCIDATE, briefTitle: An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer, acronym: ELUCIDATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Intrahepatic Cholangiocarcinoma, conditions: Cholangiocarcinoma, conditions: Primary Liver Cancer, conditions: Primary Liver Carcinoma, conditions: Hepatic Cancer, conditions: Hepatic Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: ELUCIDATE, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Caiming Xu, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Yoh Asahi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Graduate School of Medical Sciences, Kyushu University, status: RECRUITING, city: Fukuoka, country: Japan, contacts name: Tomoharu Yoshizumi, role: CONTACT, contacts name: Tomoharu Yoshizumi, role: SUB_INVESTIGATOR, contacts name: Takeo Toshima, role: SUB_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, locations facility: Graduate School of Medical Sciences, Kumamoto University, status: RECRUITING, city: Kumamoto, country: Japan, contacts name: Hideo Baba, role: CONTACT, contacts name: Hideo Baba, role: SUB_INVESTIGATOR, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Hokkaido University Graduate School of Medicine, status: RECRUITING, city: Sapporo, country: Japan, contacts name: Akinobu Taketomi, role: CONTACT, contacts name: Akinobu Taketomi, role: PRINCIPAL_INVESTIGATOR, contacts name: Yoh Asahi, role: PRINCIPAL_INVESTIGATOR, contacts name: Tatsuhiko Kakisaka, role: SUB_INVESTIGATOR, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tokushima University, status: RECRUITING, city: Tokushima, country: Japan, contacts name: Mitsuo Shimada, role: CONTACT, contacts name: Mitsuo Shimada, role: SUB_INVESTIGATOR, contacts name: Katsuki Miyazaki, role: SUB_INVESTIGATOR, geoPoint lat: 34.06667, lon: 134.56667, hasResults: False
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protocolSection identificationModule nctId: NCT06342401, orgStudyIdInfo id: 23228/ENCODE, briefTitle: Early Onset Colorectal Cancer Detection, acronym: ENCODE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid), conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Cancer Stage I, conditions: Colorectal Cancer Stage IV, conditions: Colorectal Cancer Stage II, conditions: Colorectal Cancer Stage III, conditions: Colorectal Neoplasms Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: ENCODE, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Alessandro Mannucci, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: IRCCS San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Giulia Martina Cavestro, MD, PhD, role: CONTACT, email: cavestro.giuliamartina@hsr.it, contacts name: Alessandro Mannucci, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giulia Martina Cavestro, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Kawasaki University, status: RECRUITING, city: Kawasaki, country: Japan, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Mie University, status: RECRUITING, city: Mie, country: Japan, locations facility: National Cancer Center Hospital, status: RECRUITING, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Tokyo Medical and Dental University, status: RECRUITING, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Yamagata University, status: RECRUITING, city: Yamagata, country: Japan, geoPoint lat: 38.23333, lon: 140.36667, locations facility: Barcelona University, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Francesc Balaguer, MD, PhD, role: CONTACT, email: fprunes@clinic.cat, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University of La Laguna, status: RECRUITING, city: La Laguna, country: Spain, geoPoint lat: 28.4853, lon: -16.32014, locations facility: Salamanca Biomedical Research Institute, status: RECRUITING, city: Madrid, country: Spain, contacts name: Jose Perea, MD, role: CONTACT, email: josepereag@hotmail.com, contacts name: Jose Perea, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06342388, orgStudyIdInfo id: 2024-0427, secondaryIdInfos id: A538500, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol Version 3/20/2024, type: OTHER, domain: UW- Madison, secondaryIdInfos id: SMPH/POP HEALTH SCI/POP HLTH, type: OTHER, domain: UW- Madison, briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: Covering Wisconsin, descriptionModule briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?2. What is the effectiveness of outreach using a live call rather than a pre-recorded call?, conditionsModule conditions: No Medicaid Coverage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call, secondaryOutcomes measure: Duration of coverage gaps, secondaryOutcomes measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call, secondaryOutcomes measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342375, orgStudyIdInfo id: 2024-0434, secondaryIdInfos id: A538500, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol Version 3/20/2024, type: OTHER, domain: UW- Madison, secondaryIdInfos id: SMPH/POP HEALTH SCI/POP HLTH, type: OTHER, domain: UW- Madison, briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: Covering Wisconsin, descriptionModule briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?2. What is the effectiveness of outreach using a live call rather than a pre-recorded call?, conditionsModule conditions: No Medicaid Coverage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 425000, type: ESTIMATED, armsInterventionsModule interventions name: Outbound phone call, outcomesModule primaryOutcomes measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call, secondaryOutcomes measure: Duration of coverage gaps, secondaryOutcomes measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call, secondaryOutcomes measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342362, orgStudyIdInfo id: SICHN/IRB-001/2024, briefTitle: Magnesium Sulfate in Neonatal HIE", statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-10-02, completionDateStruct date: 2024-12-02, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sindh Institute of Child Health and Neonatology, class: OTHER, descriptionModule briefSummary: The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management., conditionsModule conditions: Neonates With HIE, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Magnesium sulfate, interventions name: placebo or standard treatment), outcomesModule primaryOutcomes measure: Neuroprotective effects, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 30 Days, stdAges: CHILD, contactsLocationsModule locations facility: SICHN, city: Karachi, state: Sindh, zip: 74201, country: Pakistan, contacts name: Naseem Ahmed, FCPS, role: CONTACT, phone: 03003145554, email: drnaseemkubar@gmail.com, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06342349, orgStudyIdInfo id: SIBP-V03-I, briefTitle: A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Shanghai Institute Of Biological Products, class: INDUSTRY, collaborators name: Shaanxi Provincial Center for Disease Control and Prevention, descriptionModule briefSummary: To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above., conditionsModule conditions: Influenza, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a single center, randomized, double-blind, controlled phase I clinical trial., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Quadrivalent influenza virus split vaccine (MDCK cells), interventions name: Quadrivalent influenza virus split vaccine (Chicken embryo), interventions name: Phosphate buffer solution, outcomesModule primaryOutcomes measure: Solicited Adverse Events (AEs), primaryOutcomes measure: Unsolicited Adverse Events, primaryOutcomes measure: Serious Adverse Events (SAE), secondaryOutcomes measure: Seroconversion rate, secondaryOutcomes measure: Ratio of ≥1:40, secondaryOutcomes measure: Geometric mean increase (GMI), eligibilityModule sex: ALL, minimumAge: 6 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342336, orgStudyIdInfo id: HS-IT101ST01-I, briefTitle: HS-IT101 Injection in the Treatment of Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Qingdao Sino-Cell Biomedicine Co., Ltd., class: INDUSTRY, collaborators name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, collaborators name: The First Hospital of Jilin University, collaborators name: West China Hospital, descriptionModule briefSummary: Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: HS-IT101 Injection, outcomesModule primaryOutcomes measure: Adverse Events (AE), primaryOutcomes measure: Serious Adverse Events (SAE), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Time-to-response (TTR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression-Free-Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Lymphocyte subpopulation, secondaryOutcomes measure: TCR repertoire, eligibilityModule sex: ALL, minimumAge: 18 Days, maximumAge: 75 Days, stdAges: CHILD, contactsLocationsModule locations facility: Cancer Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Ning Li, MD, role: CONTACT, phone: 86-010-87788713, email: lining@cicams.ac.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06342323, orgStudyIdInfo id: IRB00006761-M2023235, secondaryIdInfos id: ONFM-SBRT, type: OTHER, domain: Peking university third hospital, briefTitle: The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy, acronym: ONFM-SBRT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-08, primaryCompletionDateStruct date: 2024-10-07, completionDateStruct date: 2025-10-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study:Study Design: Prospective, single-center, exploratory clinical study.Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases.Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved.Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol.Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process.Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment.SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration.Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy., conditionsModule conditions: Lung Cancer, conditions: Liver Cancer, conditions: Pancreatic Cancer, conditions: Renal Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: SBRT, outcomesModule primaryOutcomes measure: success rate, secondaryOutcomes measure: Treatment error, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Qiu Bin, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06342310, orgStudyIdInfo id: RE104-201-PPD, briefTitle: RE104 Safety and Efficacy Study in Postpartum Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Reunion Neuroscience Inc, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo., conditionsModule conditions: Postpartum Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: RE104 for Injection, outcomesModule primaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score, secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score, secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline), secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10), secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I), secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S), secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A), secondaryOutcomes measure: RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342297, orgStudyIdInfo id: OLL-1003043, briefTitle: Dermatoscopy Guided Resection for Skin Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-14, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2026-01-14, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Region Örebro County, class: OTHER, descriptionModule briefSummary: In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report., conditionsModule conditions: Basal Cell Carcinoma, conditions: Cutaneous Squamous Cell Carcinoma, conditions: Surgical Margin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Dermatoscopy, outcomesModule primaryOutcomes measure: Pathology resection side margin (radical/not radical), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Örebro University Hospital, status: RECRUITING, city: Örebro, zip: 70375, country: Sweden, contacts name: Örebro U Hospital, role: CONTACT, phone: 0729655663, email: fredrik.landstrom@regionorebrolan.se, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False
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protocolSection identificationModule nctId: NCT06342284, orgStudyIdInfo id: NYPC ERC# 2021-030, briefTitle: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer, acronym: PGHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-03-21, completionDateStruct date: 2031-03-21, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The New York Proton Center, class: OTHER, descriptionModule briefSummary: This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards., conditionsModule conditions: Thoracic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Proton Beam Radiation with or without concurrent chemotherapy, outcomesModule primaryOutcomes measure: Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion., secondaryOutcomes measure: Demonstrate the face validity of physical activity and vital sign data collected in this trial by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics., otherOutcomes measure: Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: New York Proton Center, status: RECRUITING, city: New York, state: New York, zip: 10035, country: United States, contacts name: Ryan Holder, BS, role: CONTACT, phone: 646-968-9055, email: rholder@nyproton.com, contacts name: Thomas Mistretta, MS, role: CONTACT, phone: 646-568-5675, email: tmistretta@nyproton.com, contacts name: Nitin Ohri, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Charles Simone, MD, role: SUB_INVESTIGATOR, contacts name: Annemarie Shepherd, MD, role: SUB_INVESTIGATOR, contacts name: Stanislav Lazarev, MD, role: SUB_INVESTIGATOR, contacts name: Alexandra Hanlon, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06342271, orgStudyIdInfo id: 24-2023, briefTitle: Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Talca, class: OTHER, descriptionModule briefSummary: People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait.Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait.This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD.The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life.People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2)., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Nordic walking training, interventions name: Free Walking training, outcomesModule primaryOutcomes measure: Change in the amplitude of arm swing, primaryOutcomes measure: Change in the arm swing asymmetry, secondaryOutcomes measure: Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m]., secondaryOutcomes measure: Change in the functional mobility will be measured through the Timed up and go (TUG)., secondaryOutcomes measure: Change in the quality of life, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342258, orgStudyIdInfo id: HS-23-00611, briefTitle: COES: Curing Order Effects on Sealants, acronym: COES, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, descriptionModule briefSummary: Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases.Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel.Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures., conditionsModule conditions: Dental Sealant, conditions: Sealant Retention, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement.Heads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after.Tails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 217, type: ESTIMATED, armsInterventionsModule interventions name: Ultradent Ultra Seal XT Plus, outcomesModule primaryOutcomes measure: Sealant Longevity, secondaryOutcomes measure: Caries, secondaryOutcomes measure: Molar hypomineralization, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Herman Ostrow School of Dentistry of USC, status: RECRUITING, city: Los Angeles, state: California, zip: 90089, country: United States, contacts name: Catherine Pham, DDS, MPH, role: CONTACT, phone: 213-740-0412, email: cmpham@usc.edu, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06342245, orgStudyIdInfo id: 2023.568, briefTitle: Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy, acronym: AT RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-11, primaryCompletionDateStruct date: 2027-06-10, completionDateStruct date: 2027-06-11, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion., conditionsModule conditions: Achilles Tendinopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a multicentre prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only).Investigators will obtain written consent from all participants before the commencement of this study., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Radiofrequency coblation micro-tenotomy, outcomesModule primaryOutcomes measure: Victorian Institute of Sports Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342232, orgStudyIdInfo id: BEH1986, secondaryIdInfos id: 423629, type: OTHER_GRANT, domain: Saskatchewan Health Research Foundation, briefTitle: The Efficacy of Neurofeedback Mindfulness in Migraine Management, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-09, primaryCompletionDateStruct date: 2022-12-24, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Saskatchewan, class: OTHER, collaborators name: Saskatchewan Health Research Foundation, descriptionModule briefSummary: This longitudinal randomized controlled trial explored how long-term practice of neurofeedback mindfulness would be helpful for migraine management when compare dot a similar controlled intervention. All the participants went through assigned 10 minutes practices on a daily basis for 8 weeks. Behavioural reports and migraine characteristics were compared before and after the intervention., conditionsModule conditions: Migraine Headaches, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 101, type: ACTUAL, armsInterventionsModule interventions name: Neurofeedback mindfulness, interventions name: Simple attention controlled task, outcomesModule primaryOutcomes measure: Migraine Disability, primaryOutcomes measure: Migraine Severity, primaryOutcomes measure: Headache Management Self-efficacy, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Saskatchewan, city: Saskatoon, state: Saskatchewan, zip: S7N5A2, country: Canada, geoPoint lat: 52.13238, lon: -106.66892, hasResults: False
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protocolSection identificationModule nctId: NCT06342219, orgStudyIdInfo id: 423629, briefTitle: Chronic Migraines and Neurofdeeback Mindfulness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Saskatchewan, class: OTHER, collaborators name: Saskatchewan Health Research Foundation, descriptionModule briefSummary: As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study., conditionsModule conditions: Chronic Migraine, Headache, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Neurofeedback Mindfulness, interventions name: Attention Task, outcomesModule primaryOutcomes measure: Migraine Disability, primaryOutcomes measure: Migraine Severity, primaryOutcomes measure: Headache management self-efficacy, primaryOutcomes measure: Dependence on medicine, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Saskatchewan, city: Saskatoon, state: Saskatchewan, zip: S7N5A2, country: Canada, geoPoint lat: 52.13238, lon: -106.66892, hasResults: False
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protocolSection identificationModule nctId: NCT06342206, orgStudyIdInfo id: CMUH111-REC2-144, briefTitle: The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-08, primaryCompletionDateStruct date: 2022-09-21, completionDateStruct date: 2024-09-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: Cerebral infarction is the second cause of death and the third cause of disability. More than 13.7 million patients worldwide are diagnosed with stroke every year, and the number of deaths is 5.5 million, of which ischemic stroke is the major type, accounting for 87%. Sequelae of stroke are problems that require long-term medical care. If we can intervene and assist with Traditional Chinese Medicine (TCM) at early stage, it will be a great boon for patients. In clinical practice, TCM collects data as the basis for diagnosis through the four diagnostic methods-look, listen, question, and feel the pulse. Among these, tongue diagnosis and pulse diagnosis belong to the categories of look and feel the pulse. At present, the objective examination instruments of TCM developed are mainly tongue diagnostic instruments and pulse diagnostic instruments. Therefore, we hope to utilize tongue and pulse diagnoses as the main reference to analyze the changes in ischemic stroke stages. The data of this study are collected from China Medical University Hospital and YuanRung Hospital-for further statistical analysis. Ischemic stroke patients (ICD-10: I63) who were hospitalized within 1 week from the date of diagnosis were eligible to join this research project. Tongue and pulse examinations were collected once per week within 1 month. A total of 4 tongue-pulse examinations were collected in each case, which were categorized into acute stage (24 hours to 1 week), subacute stage (1 to 3 weeks) and chronic stage (more than 3 weeks). \[30\] This research is to study the changes of tongue and pulse diagnoses in acute, subacute and chronic stages among ischemic patients who receive TCM diagnosis and treatment. Through utilizing objective evaluation of Chinese and Western medical examination instruments, we hope to establish clear diagnostic standards for TCM syndrome types, so as to evaluate the efficacy of clinical diagnosis and treatment. The goal is to improve the quality of TCM care and to provide Chinese and Western integrated treatment for stroke patients in the future. This research can also serve as a reference for related TCM research and development., conditionsModule conditions: Stroke, Ischemic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, outcomesModule primaryOutcomes measure: Differences between tongue diagnosis and pulse diagnosis in acute and chronic stroke patients, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: YuanRung Hospital, status: RECRUITING, city: Changhua, zip: 510, country: Taiwan, contacts name: LI-CHI TSAI, role: CONTACT, phone: 0919688481, contacts name: YEN-HUA YANG, role: CONTACT, phone: 0912587467, geoPoint lat: 24.07327, lon: 120.56276, hasResults: False
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protocolSection identificationModule nctId: NCT06342193, orgStudyIdInfo id: virtual reality, briefTitle: Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Uşak University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia., conditionsModule conditions: Cystoscopy, conditions: Virtual Reality, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: virtual reality group, outcomesModule primaryOutcomes measure: anxiety, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Usak Training and Research Hospital, status: RECRUITING, city: Uşak, state: Center, zip: 64100, country: Turkey, contacts name: Yucel Can Danisman, role: CONTACT, phone: +905532864569, email: 202201023@ogr.usak.edu.tr, contacts name: Fatma Susam, PhD, role: SUB_INVESTIGATOR, contacts name: Yucel Can Danisman, role: PRINCIPAL_INVESTIGATOR, contacts name: Ozan Ozavci, role: SUB_INVESTIGATOR, contacts name: Shahnaza Mahmudova, role: SUB_INVESTIGATOR, contacts name: Erkan Arslan, MD, role: SUB_INVESTIGATOR, contacts name: Adem Tuncekin, MD, role: SUB_INVESTIGATOR, contacts name: Bilgen Arikan, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
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protocolSection identificationModule nctId: NCT06342180, orgStudyIdInfo id: Usakupcos1, briefTitle: Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2023-07-20, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Uşak University, class: OTHER, descriptionModule briefSummary: We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls., conditionsModule conditions: Uric Acid Concentration, Serum, Quantitative Trait Locus 7, conditions: Polycystic Ovary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Serum uric acid level, outcomesModule primaryOutcomes measure: Uric acid levels in PCOS subtypes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Usak Egitim Ve Araştırma Hastanesi, city: Uşak, zip: 64100, country: Turkey, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
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protocolSection identificationModule nctId: NCT06342167, orgStudyIdInfo id: NCC4409, briefTitle: Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT., conditionsModule conditions: Locally Advanced Esophageal Squamous Cell Carcinoma, conditions: Sintilimab, conditions: Radiotherapy, conditions: Concurrent Chemoradiotherapy, conditions: Immunonutrition, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: Programmed Cell Death Protein 1 Inhibitor, interventions name: Immunonutrition support, outcomesModule primaryOutcomes measure: 1-year Progression-free survival rate (PFS), secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, city: Beijing, state: Beijing, zip: 100021, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Department of Radiation Oncology,Clinical Oncology School of Fujian Medical University,Fujian Cancer Hospital, city: Fujian, state: Fujian, country: China, locations facility: Department of Oncology, Affiliated Hospital, Hebei University of Engineering, city: Handan, state: Hebei, country: China, geoPoint lat: 36.60056, lon: 114.46778, locations facility: Department 1st of Radiation Oncology, Anyang Tumor Hospital, city: Anyang, state: Henan, country: China, geoPoint lat: 36.096, lon: 114.38278, locations facility: Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University, city: Xinxiang, state: Henan, country: China, geoPoint lat: 35.19033, lon: 113.80151, locations facility: Department of Radiation Oncology, General Hospital of Ningxia Medical University, city: Yinchuan, state: Ningxia, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Department of Radiation Oncology,Fei County People's Hospital, city: Feixian, state: Shandong, country: China, locations facility: Department of Radiation Oncology, Affiliated hospital of Jining Medical University, city: Jining, state: Shandong, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: Taizhou hospital of Wenzhou Medical University, city: Taizhou, state: Zhejiang, zip: 317000, country: China, geoPoint lat: 32.49069, lon: 119.90812, hasResults: False
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protocolSection identificationModule nctId: NCT06342154, orgStudyIdInfo id: MCBU-SBF-YC-03, briefTitle: Does Endorphin Massage Reduce the Anxiety of Pregnant Women?, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2024-10-09, completionDateStruct date: 2024-12-10, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage., conditionsModule conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized study with experimental and control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Endorphin Massage, outcomesModule primaryOutcomes measure: visual analog scale (VAS), primaryOutcomes measure: State and Trait Anxiety Scales, primaryOutcomes measure: cortisol level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi, status: RECRUITING, city: Manisa, zip: 45060, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False
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protocolSection identificationModule nctId: NCT06342141, orgStudyIdInfo id: 24-1423, briefTitle: Empagliflozin for No-reflow Phenomenon in PCI for STEMI, acronym: EMPA-PCI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Cardiologia Ignacio Chavez, class: OTHER, descriptionModule briefSummary: Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.Consequently, this double-blind, randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging., conditionsModule conditions: STEMI, conditions: No-Reflow Phenomenon, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 25 milgrams (Mg), interventions name: Empagliflozin 10 Mg, interventions name: Placebo 25 Mg, interventions name: Placebo 10 Mg, outcomesModule primaryOutcomes measure: Non-Reflow Phenomenon, secondaryOutcomes measure: Infract size, secondaryOutcomes measure: Longitudinal Strain, secondaryOutcomes measure: High-sensitivity Troponin Clearance, secondaryOutcomes measure: Creatine Kinase-myocardial band Clearance, secondaryOutcomes measure: Adverse Cardiovascular Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342128, orgStudyIdInfo id: MVI_Kidney_001, briefTitle: Molecular Landscape of Microvascular Inflammation in Kidney Allografts, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Paris Translational Research Center for Organ Transplantation, class: OTHER, descriptionModule briefSummary: Microvascular inflammation in kidney allografts has been widely reappraised in the recent update of Banff classification. There is a critical need to better understand the pathophysiological mechanisms associated with the various phenotypes of microvascular inflammation that are observed in kidney transplants, particularly in order to develop targeted therapeutic approaches., conditionsModule conditions: Kidney Rejection Transplant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: RNA-based molecular signatures assessed using bulk and spatial transcriptomics, primaryOutcomes measure: Probability of graft survival based on outcome data, primaryOutcomes measure: Probability of patient survival on outcome data, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, status: RECRUITING, city: Paris, zip: 75010, country: France, contacts name: Carmen Lefaucheur, MD PhD, role: CONTACT, email: carmen.lefaucheur@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, status: RECRUITING, city: Paris, zip: 75015, country: France, contacts name: Alexandre Loupy, MD PhD, role: CONTACT, phone: +33612491082, email: alexandreloupy@inserm.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bichat Hospital, Assistance Publique - Hôpitaux de Paris, status: RECRUITING, city: Paris, zip: 75018, country: France, contacts name: Aurélie Sannier, MD PhD, role: CONTACT, email: aurelie.sannier@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06342115, orgStudyIdInfo id: CLEMENT TRIAL, briefTitle: Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens, acronym: CLEMENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Beneficência Portuguesa de São Paulo, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes., conditionsModule conditions: Febrile Neutropenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: Ceftolozane-Tazobactam, interventions name: Meropenem, outcomesModule primaryOutcomes measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population, secondaryOutcomes measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population, secondaryOutcomes measure: Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population, secondaryOutcomes measure: Incidence of microbiologically documented infections and identification of causative organisms in culture, secondaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: Occurrence of graft versus host disease (GVHD), secondaryOutcomes measure: Frequency of multidrug resistant-pathogen infections or colonization, secondaryOutcomes measure: Faecal microbiota analysis, secondaryOutcomes measure: Percentage of Participants Who Report 1 or More Adverse Event (AE), secondaryOutcomes measure: Percentage of Participants With Any Serious Adverse Event (SAE), secondaryOutcomes measure: Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A Beneficência Portuguesa de São Paulo, city: São Paulo, country: Brazil, contacts name: João Prats, MD, role: CONTACT, phone: +55 11 3505 5031, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
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protocolSection identificationModule nctId: NCT06342102, orgStudyIdInfo id: ID 4286, briefTitle: PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF), acronym: Retro-PvF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-03-26, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Ospedale Edoardo Bassini, class: OTHER, descriptionModule briefSummary: Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study., conditionsModule conditions: Regional Anesthesia Block, conditions: Regional Anesthesia, conditions: Total Hip Replacement Surgery, conditions: Total Hip Arthroplasty \(THA\), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: PENG + LFCN block, interventions name: FIC block, outcomesModule primaryOutcomes measure: Movement of the lower limb affected by surgery, secondaryOutcomes measure: pain control, secondaryOutcomes measure: pain control, secondaryOutcomes measure: pain control, secondaryOutcomes measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses, secondaryOutcomes measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses, secondaryOutcomes measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses, otherOutcomes measure: time to first opioid request, otherOutcomes measure: time to first postoperative ambulation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342089, orgStudyIdInfo id: NCT06342089, briefTitle: Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: * Determine the association between molar incisor hypomineralization and type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .* Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth.* Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.* The severity and treatment needs of each case with MIH will be recorded in patient's chart.* The results of the study will be regularly monitored by the supervisors who will have full access to these results., conditionsModule conditions: Molar Incisor Hypomineralization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 238, type: ESTIMATED, armsInterventionsModule interventions name: Type I diabetes milletus, outcomesModule primaryOutcomes measure: Association between molar incisor Hypomineralization and type I diabetes milletus, secondaryOutcomes measure: Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus., secondaryOutcomes measure: Treatment need, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342076, orgStudyIdInfo id: 2023-596, briefTitle: Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.The main question(s) it aims to answer are:\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods., conditionsModule conditions: Postoperative Pain, conditions: Postoperative Complications, conditions: Analgesia, conditions: Regional Anesthesia Morbidity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective randomize study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Prospective randomize study, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block, interventions name: Patients undergoing rectus sheat block and posterior transversus abdominis plane block, outcomesModule primaryOutcomes measure: visuel analog scale, secondaryOutcomes measure: amount of opioid used, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Başakşehir Çam and Sakura City Hospital, city: Istanbul, state: Basaksehir, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06342063, orgStudyIdInfo id: 20-0070-E, briefTitle: The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction, acronym: BFRACL, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Women's College Hospital, class: OTHER, descriptionModule briefSummary: This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial., conditionsModule conditions: ACL Injury, conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients were recruited and randomized to one of the two treatment arms., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome measurement was blinded to participant intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Blood Flow Restriction Therapy, interventions name: Blood Flow Restriction Therapy Sham, outcomesModule primaryOutcomes measure: Biodex Strength Testing, secondaryOutcomes measure: Short Form Health Survey 12 (SF-12), secondaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score (KOOS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, city: Toronto, state: Ontario, zip: M5G 1X5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-10-28, uploadDate: 2024-03-07T20:51, filename: Prot_000.pdf, size: 303762, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-10-28, uploadDate: 2024-03-23T13:30, filename: ICF_001.pdf, size: 892575, hasResults: False
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protocolSection identificationModule nctId: NCT06342050, orgStudyIdInfo id: STU-2023-0548, secondaryIdInfos id: R01MD011686, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MD011686, briefTitle: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.The main aims / objectives of this sub-study are:* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups., conditionsModule conditions: Obesity, conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Gut Microbial Composition, primaryOutcomes measure: Blood Microbial Composition, primaryOutcomes measure: Body Weight (kg), primaryOutcomes measure: Body Height (meters), primaryOutcomes measure: Fat Mass (Kg), primaryOutcomes measure: Fat-free Mass (Kg), primaryOutcomes measure: Body water (%), primaryOutcomes measure: Skeletal Muscle Mass (kg), primaryOutcomes measure: Fasting Glucose (mg/dL), primaryOutcomes measure: Fasting Insulin (mIU/L), primaryOutcomes measure: Lipopolysaccharides (%), primaryOutcomes measure: Lipopolysaccharides binding protein (mIU/L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-19, uploadDate: 2024-03-27T14:38, filename: Prot_SAP_000.pdf, size: 316789, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-19, uploadDate: 2024-03-27T14:39, filename: ICF_001.pdf, size: 297665, hasResults: False
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protocolSection identificationModule nctId: NCT06342037, orgStudyIdInfo id: N22TON, briefTitle: NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial, acronym: TONIC-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, collaborators name: Hoffmann-La Roche, descriptionModule briefSummary: This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Tiragolumab, interventions name: Atezolizumab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: PFS-12, primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Clinical benefit rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06342024, orgStudyIdInfo id: 23-871, briefTitle: Pistachio Consumption on Inflammatory Markers and Lean Body Mass, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Virginia Polytechnic Institute and State University, class: OTHER, descriptionModule briefSummary: Pistachio nuts (Pistacia vera L.) are a nutrient- and energy-dense food, and are a significant source of 15 different micronutrients. In addition to an excellent micronutrient profile, pistachios are a good source of monounsaturated and polyunsaturated fats (linoleic acid, oleic acid, and plant sterols). Pistachios have the lowest amount of total fat, and the highest protein, fiber, and phytosterol content compared to other nuts. They possess a high antioxidant content. Specifically, pistachios have high amounts of lutein, zeaxanthin, and phenolic compounds (e.g., anthocyanins, flavonoids, and proanthocyanidins). These aforementioned compounds are known for their anti-inflammatory effects. Pistachios also have been shown to reduce the risk of cardiovascular disease, metabolic syndrome, and all-cause mortality.The purpose of this study will be to determine the effects of consuming 1.5 ounces of pistachios per day compared to consuming no pistachios per day on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week). It is hypothesized that pistachio consumption will significantly lower inflammatory response and significantly increase lean body mass.This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). Those consuming pistachios will be in addition to their usual diet.The overall goal of this study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. This study could provide a simple, healthy way for recreationally active individuals to decrease inflammation and improve body composition., conditionsModule conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible participants will be randomized to one of two groups (pistachio vs. control) using permuted block randomization with stratification to balance assignment by sex. Randomization allocation tables will be created by a biostatistician not involved in the clinical trial using SAS software, version 9.4 (SAS Institute, Cary, NC, USA). The tables will be stored within the REDCap system at Virginia Tech, in such a way that only the biostatistician will be able to view them. Study outcomes will be analyzed blind to allocation status., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Not apply, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Pistachio group, outcomesModule primaryOutcomes measure: C-reactive protein concentrations in the blood, primaryOutcomes measure: Creatine kinase concentrations in the blood, primaryOutcomes measure: Cortisol concentrations in the blood, primaryOutcomes measure: Interleukin-8 concentrations in the blood, primaryOutcomes measure: Tumor necrosis factor-alpha concentrations in the blood, primaryOutcomes measure: Copper-zinc superoxide dismutase concentrations in the blood, primaryOutcomes measure: Glutathione peroxidase concentrations in the blood, primaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Magnesium concentrations in the blood, secondaryOutcomes measure: Iron concentrations in the blood, secondaryOutcomes measure: Zinc concentrations in the blood, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Virginia Polytechnic Institute and State University, status: RECRUITING, city: Blacksburg, state: Virginia, zip: 24061, country: United States, contacts name: Stella L Volpe, PhD, role: CONTACT, phone: 540-231-3805, email: stellalv@vt.edu, contacts name: Alexandra Hanlon, PhD, role: CONTACT, phone: 540-231-5657, email: alhanlon@vt.edu, geoPoint lat: 37.22957, lon: -80.41394, hasResults: False
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protocolSection identificationModule nctId: NCT06342011, orgStudyIdInfo id: KY-2024-039, briefTitle: Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: For the first time, this study developed an anti-inflammatory diet (AID) recipe suitable for Inflammatory bowel disease(IBD) patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Anti-inflammatory diet group, outcomesModule primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Erythrocyte sedimentation rate (ESR), primaryOutcomes measure: Leukocyte, secondaryOutcomes measure: Self-Rating Anxiety Scale,SAS, secondaryOutcomes measure: Self-Rating depression scale,SDS, secondaryOutcomes measure: Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ), secondaryOutcomes measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES), secondaryOutcomes measure: Body Mass Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, city: Yiwu, state: Zhejiang, zip: 322000, country: China, contacts name: Xia Qian, BA, role: CONTACT, phone: 15968110117, email: 1632936247@qq.com, geoPoint lat: 29.31506, lon: 120.07676, hasResults: False
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protocolSection identificationModule nctId: NCT06341998, orgStudyIdInfo id: HERO2020, briefTitle: Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children, acronym: SCRRYST, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Shandong First Medical University, class: OTHER, descriptionModule briefSummary: Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST)., conditionsModule conditions: Germ Cell Tumor, conditions: Yolk Sac Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children, outcomesModule primaryOutcomes measure: Objective Response Rate Allocation 'Non-Randomized' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate, secondaryOutcomes measure: Progression-free Survival, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shandong Cancer Hospital and Institute, city: Jinan, state: Shandong, zip: 250117, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06341985, orgStudyIdInfo id: IEO 1593, briefTitle: DOsimetry and Radiation Induced NAusea in Head and Neck Cancers, acronym: DORIAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer., conditionsModule conditions: Head and Neck Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Exclusive radiotherapy, outcomesModule primaryOutcomes measure: Evaluation of nausea (acute toxicity) using CTCAE V5.0, secondaryOutcomes measure: Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire, secondaryOutcomes measure: Identification of the organs at risk most strongly correlated with the onset of nausea, secondaryOutcomes measure: Identification of dosimetric cutoffs for the onset of nausea, secondaryOutcomes measure: Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques, secondaryOutcomes measure: Development of machine-learning predictive models for the onset of nausea, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, status: RECRUITING, city: Ancona, country: Italy, contacts name: Giovanna Mantello, role: CONTACT, email: clelia.dicarlo@ospedaliriuniti.marche.it, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedale "Mons. Dimiccoli", status: RECRUITING, city: Barletta, country: Italy, contacts name: Alessia Di Rito, role: CONTACT, email: aledirito@yahoo.it, geoPoint lat: 41.31429, lon: 16.28165, locations facility: Azienda Ospedaliera S.Pio, status: RECRUITING, city: Benevento, country: Italy, contacts name: Angela Argenone, role: CONTACT, email: angela.argenone@ao-rummo.it, geoPoint lat: 41.1307, lon: 14.77816, locations facility: Ospedale MultiMedica, status: RECRUITING, city: Castellanza, country: Italy, contacts name: Gianpiero Catalano, role: CONTACT, email: gianpiero.catalano@multimedica.it, geoPoint lat: 45.61079, lon: 8.89616, locations facility: IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, country: Italy, contacts name: Liliana Belgioia, role: CONTACT, email: liliana.belgioia@unige.it, geoPoint lat: 44.40478, lon: 8.94438, locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Stefania Volpe, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Italo Dell'Oca, role: CONTACT, email: delloca.italo@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Azienda Ospedaliero-Universitaria di Modena, status: RECRUITING, city: Modena, country: Italy, contacts name: Elisa D'Angelo, role: CONTACT, email: dangelo.elisa@policlinico.mo.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara, status: RECRUITING, city: Novara, country: Italy, contacts name: Carla Pisani, role: CONTACT, email: carla.pisani@maggioreosp.novara.it, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Fondazione IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: Sara Colombo, role: CONTACT, email: s.colombo@smatteo.pv.it, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata, status: RECRUITING, city: Roma, country: Italy, contacts name: Giuseppina Apicella, role: CONTACT, email: gapicella@hsangiovanni.roma.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero Universitaria Policlinico Umberto I, status: RECRUITING, city: Roma, country: Italy, contacts name: Francesca De Felice, role: CONTACT, email: francesca.defelice@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina, status: RECRUITING, city: Roma, country: Italy, contacts name: Orietta Caspiani, role: CONTACT, email: o.caspiani@gmail.com, geoPoint lat: 41.89193, lon: 12.51133, locations facility: I.R.C.C.S. MultiMedica - Sesto San Giovanni, status: RECRUITING, city: Sesto San Giovanni, country: Italy, contacts name: Gianpiero Catalano, role: CONTACT, email: gianpiero.catalano@multimedica.it, geoPoint lat: 45.53329, lon: 9.22585, hasResults: False
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protocolSection identificationModule nctId: NCT06341972, orgStudyIdInfo id: IRB00247005, secondaryIdInfos id: K23HL155735, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL155735, briefTitle: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention, acronym: SMARA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Francis Family Foundation, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.The main question\[s\] it aims to answer are:* Is this intervention feasible and acceptable in ARF patients?* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up., conditionsModule conditions: Respiratory Failure, conditions: Anxiety, conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pilot randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive behavioral therapy based self-management for anxiety, outcomesModule primaryOutcomes measure: Treatment Satisfaction Questionnaire, primaryOutcomes measure: average accrual rate of 2 patients/month across all patients, primaryOutcomes measure: treatment feasibility as assessed by sessions completed, primaryOutcomes measure: treatment feasibility as assessed by drop out rate, secondaryOutcomes measure: Visual Analog Scale - Anxiety, secondaryOutcomes measure: State Anxiety Inventory, secondaryOutcomes measure: Hopkins Rehab Engagement Scale, secondaryOutcomes measure: Self Efficacy for Managing Chronic Disease Rating Scale, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Quality of Life as assessed by the European Quality of Life Scale (EQ-5D), secondaryOutcomes measure: Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6, secondaryOutcomes measure: Healthcare Utilization as assessed by Healthcare Utilization interview, secondaryOutcomes measure: Montreal Cognitive Assessment - Blind, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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