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protocolSection identificationModule nctId: NCT06334159, orgStudyIdInfo id: PER-ECL-2019-08, briefTitle: Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-11-05, primaryCompletionDateStruct date: 2025-07-20, completionDateStruct date: 2027-07-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Universitat Internacional de Catalunya, class: OTHER, descriptionModule briefSummary: The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months., conditionsModule conditions: Bone Resorption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane, interventions name: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane, outcomesModule primaryOutcomes measure: Horizontal Bone Gain, primaryOutcomes measure: Bone Width Gain, secondaryOutcomes measure: Horizontal Dimensional Stability, secondaryOutcomes measure: Post-surgical complications, secondaryOutcomes measure: Patient's satisfaction, secondaryOutcomes measure: Histologic examination of the augmented bone at 6 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Georgios Markantonatos, status: RECRUITING, city: Barcelona, state: Sant Cugat Del Vallès, zip: 08195, country: Spain, contacts name: Georgios Markantonatos, DDS, role: CONTACT, phone: +34666022568, email: giorgosmark@uic.es, contacts name: Cristina Vallès, DDS, MS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06334146, orgStudyIdInfo id: UNLV-2023-62, briefTitle: Tap Dance for Adults With Lower Limb Amputation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Nevada, Las Vegas, class: OTHER, descriptionModule briefSummary: The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence.There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA.Participants will be asked to:* come to 1 hour dance classes, once per week, for 8 weeks.* do mobility tests before and after the program* complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks., conditionsModule conditions: Amputation; Traumatic, Leg, Lower, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Tap dance program, outcomesModule primaryOutcomes measure: Session Adherence, primaryOutcomes measure: Physical Activities Enjoyment Scale (PACES), secondaryOutcomes measure: Change in Timed Up-and-Go test score, secondaryOutcomes measure: Change in Four Square Step Test score, secondaryOutcomes measure: Change in Berg Balance Scale score, secondaryOutcomes measure: Change in Activities-Specific Balance Confidence Scale score, secondaryOutcomes measure: Physical Activities Enjoyment Scale (PACES) score - Mid program, secondaryOutcomes measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score, secondaryOutcomes measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score, secondaryOutcomes measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score, secondaryOutcomes measure: Use of assistive devices per session, secondaryOutcomes measure: Session completion per session, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Nevada Las Vegas, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89154, country: United States, contacts name: Jenny Kent, PhD, role: CONTACT, phone: 702-895-5949, email: jenny.kent@unlv.edu, geoPoint lat: 36.17497, lon: -115.13722, hasResults: False
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protocolSection identificationModule nctId: NCT06334133, orgStudyIdInfo id: TTP399-302, briefTitle: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes, acronym: CATT1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: vTv Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Cadisegliatin 800 mg QD, interventions name: Cadisegliatin 800 mg BID, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in incidence of Level 2 or Level 3 hypoglycemia, secondaryOutcomes measure: To assess the change in HbA1c, secondaryOutcomes measure: To assess the effects of treatment on CGM-based metrics for glycemic control, secondaryOutcomes measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis, secondaryOutcomes measure: To assess the effects of treatment on insulin dosing, secondaryOutcomes measure: To assess the effects of treatment on body weight, secondaryOutcomes measure: To assess the incidence of adverse events, otherOutcomes measure: Change in incidence of Level 2 or Level 3 hypoglycemia, otherOutcomes measure: To assess the change in HbA1c, otherOutcomes measure: To assess the effects of treatment on CGM-based metrics for glycemic control, otherOutcomes measure: To assess the incidence of adverse events, otherOutcomes measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis, otherOutcomes measure: To assess the effects of treatment on insulin dosing, otherOutcomes measure: To assess the effects of treatment on body weight, otherOutcomes measure: High sensitivity C-reactive protein, otherOutcomes measure: N-terminal pro brain [or B-type] natriuretic peptide, otherOutcomes measure: Urinary albumin excretion ratio, otherOutcomes measure: Estimated glomerular filtration rate, otherOutcomes measure: Gold hypoglycemia awareness score, otherOutcomes measure: Item 7 of Clarke hypoglycemia awareness scale, otherOutcomes measure: Snyder's 1-item quality of sleep questionnaire, otherOutcomes measure: World Health Organization-5 Well-Being Index, otherOutcomes measure: 8-item Diabetes Distress Scale (participant and partner or family member), otherOutcomes measure: Hypoglycemia Confidence Scale for participant and partner or family member, otherOutcomes measure: 11-item/Short Form Hypoglycemia Fear Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334120, orgStudyIdInfo id: 20654, briefTitle: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events., conditionsModule conditions: Non-metastatic Castration-resistant Prostate Cancer, conditions: Metastatic Hormone-sensitive Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Darolutamide (Nubeqa, BAY1841788), outcomesModule primaryOutcomes measure: Number, severity of adverse events (including SAEs), primaryOutcomes measure: Number, severity of adverse drug reactions (including SADRs), primaryOutcomes measure: The outcome of (serious) adverse events, primaryOutcomes measure: The outcome of (serious) adverse drug reactions, secondaryOutcomes measure: Metastasis-free survival (MFS), secondaryOutcomes measure: Time to symptomatic skeletal event (SSE), secondaryOutcomes measure: Time to prostate-specific antigen (PSA) progression, secondaryOutcomes measure: Number of patients with metastasis of castration-resistant prostate cancer (mCRPC), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Duration of Darolutamide treatment, secondaryOutcomes measure: Reasons for ending Darolutamide, secondaryOutcomes measure: Dosage and dose modification of Darolutamide, eligibilityModule sex: MALE, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Multiple locations, city: Multiple Locations, country: Korea, Republic of, hasResults: False
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protocolSection identificationModule nctId: NCT06334107, orgStudyIdInfo id: 24AIREA1191995, briefTitle: Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Texas Tech University, class: OTHER, descriptionModule briefSummary: Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem.One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals.To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability.Questions:1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm?2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term?The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life., conditionsModule conditions: Preterm Birth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Mitochondrial DNA heteroplasmy, primaryOutcomes measure: Mitochondrial DNA sequence variants, primaryOutcomes measure: Change in maximal aerobic capacity, primaryOutcomes measure: Change in mitochondrial oxidative capacity in peripheral blood mononuclear cells, secondaryOutcomes measure: Daily sleep habits, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334094, orgStudyIdInfo id: IRB-23-486, secondaryIdInfos id: IM047-1054, type: OTHER_GRANT, domain: Bristol Myers Squibb, briefTitle: Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: The University of Texas at Dallas, class: OTHER, collaborators name: Texas Institute for Neurological Disorders, descriptionModule briefSummary: The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ozanimod, outcomesModule primaryOutcomes measure: Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance, secondaryOutcomes measure: Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging, secondaryOutcomes measure: Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Brain Health, city: Dallas, state: Texas, zip: 75228, country: United States, contacts name: Jessica Ma, BS, role: CONTACT, phone: 972-883-3414, email: jxm180043@utdallas.edu, contacts name: Ashley M Campos, MA, role: CONTACT, email: amc230006@utdallas.edu, contacts name: Bart Rypma, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06334081, orgStudyIdInfo id: A02040230S, briefTitle: Different Surgical Drilling Protocols in Posterior Maxilla, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-29, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants, conditionsModule conditions: Missing Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: undersized drilling technique, interventions name: single drilling technique, outcomesModule primaryOutcomes measure: bone density measurement, primaryOutcomes measure: marginal bone loss, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Heba Elsheikh, city: Mansoura, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06334068, orgStudyIdInfo id: MS.24.03.2725, briefTitle: SHOrt-term Glycemic Control for Reducing Post-SURGical Complications, acronym: Surg-ShoGR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality., conditionsModule conditions: Diabetes, conditions: Uncontrolled Diabtetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The patients in the preoperative anesthesia clinic are divided into one of the following groups:1. Short-term glycemic control group: Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Short-term glycemic control group, interventions name: Standard-of-care group, outcomesModule primaryOutcomes measure: Number of days at home after surgery (DAH-30)., secondaryOutcomes measure: Loss of follow-up after surgery, secondaryOutcomes measure: Loss of follow up after the clinic preoperative assessment, secondaryOutcomes measure: 30-day mortality, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: incidence of postoperative complications, secondaryOutcomes measure: Quality of Recovery15 (QoR-15), otherOutcomes measure: Time to resumption of normal diabetes therapy, otherOutcomes measure: Incidence of diabetic ketoacidosis or hypoglycemia, otherOutcomes measure: Incidence of use of intravenous insulin infusion therapy, otherOutcomes measure: Duration of use of intravenous insulin infusion therapy, otherOutcomes measure: Change in diabetic management at 30 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moataz Maher Emara, city: Mansoura, state: Aldakahlia, zip: 35516, country: Egypt, contacts name: Moataz M Emara, MD, EDAIC, role: CONTACT, phone: 01064048848, email: mm.emara@mans.edu.eg, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06334055, orgStudyIdInfo id: CIP-1091, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06334042, orgStudyIdInfo id: GO 23/488, briefTitle: Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Oguzhan Kahveci, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit., conditionsModule conditions: Chromium Deficiency, conditions: Diabetes Mellitus, conditions: Hyperlipidemias, conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Serum Chromium Level, outcomesModule primaryOutcomes measure: Serum Chromium Level, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Blood Glucose, secondaryOutcomes measure: Lipid Profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, status: RECRUITING, city: Ankara, zip: 06230, country: Turkey, contacts name: Oguzhan Kahveci, MD, role: CONTACT, phone: +903123051207, email: oguzhan.kahveci@hacettepe.edu.tr, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06334029, orgStudyIdInfo id: 12.2022, briefTitle: Observational Study of the Structural-functional Connectome in Patients With Epilepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-22, primaryCompletionDateStruct date: 2026-11-22, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains., conditionsModule conditions: Epilepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Functional and structural Connectome, outcomesModule primaryOutcomes measure: Identification of regional alteration in the value of functional connectivity, secondaryOutcomes measure: Measuring the spread of the epileptogenic network, otherOutcomes measure: Correlation between the Rey Complex figure test and the regional functional alteration, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS E.Medea, status: RECRUITING, city: Conegliano, state: Treviso, zip: 31015, country: Italy, contacts name: Duma Gian Marco, PhD, role: CONTACT, phone: +39 0438414248, email: gianmarco.duma@lanostrafamiglia.it, geoPoint lat: 45.88805, lon: 12.30201, hasResults: False
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protocolSection identificationModule nctId: NCT06334016, orgStudyIdInfo id: I-3597023, secondaryIdInfos id: NCI-2024-01556, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3597023, type: OTHER, domain: Roswell Park Cancer Institute, secondaryIdInfos id: R01DA057228, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA057228, briefTitle: Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03-27, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety., conditionsModule conditions: Cannabis Dependence, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Within-subject crossover study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: Both participants and clinical personnel will be blinded to the nicotine product sequence (active vs. placebo)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Cannabis sativa Extract, interventions name: Nicotine, interventions name: Placebo Administration, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Maximum concentration of THC in plasma (Cmax), primaryOutcomes measure: Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360), primaryOutcomes measure: Time to maximum concentration of THC in plasma (Tmax), secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Puffing behaviors, secondaryOutcomes measure: Puffing behaviors, secondaryOutcomes measure: Short-term drug effects, secondaryOutcomes measure: Marijuana Withdrawal Checklist [MWC), secondaryOutcomes measure: Digit Symbol Substitution Task (DSST), secondaryOutcomes measure: Paced Auditory Serial Addition Task (PASET), secondaryOutcomes measure: Tobacco Craving Questionnaire (Short Form), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Danielle M. Smith, role: CONTACT, phone: 716-845-8403, email: Danielle.Smith@RoswellPark.org, contacts name: Danielle M. Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
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protocolSection identificationModule nctId: NCT06334003, orgStudyIdInfo id: H-23071266, briefTitle: Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology, acronym: COMPART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Herlev Hospital, descriptionModule briefSummary: The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC., conditionsModule conditions: ART, conditions: IVF, conditions: Children, Only, conditions: Cardiovascular Disease Other, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Offspring body composition, primaryOutcomes measure: Maternal cardiometabolic profile, secondaryOutcomes measure: Epigenetic in placenta and cord blood, secondaryOutcomes measure: Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS), secondaryOutcomes measure: Telomere length in children born after FET, fresh-ET and NC children, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Dept. of Paediatric and Adolescent Medicine, Herlev Hospital, city: Copenhagen, country: Denmark, contacts name: Rikke B. Jensen, MD, Ass. Prof, role: CONTACT, contacts name: Maria L. Vestager, MD, PhD-student, role: CONTACT, email: maria.linander.vestager.01@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06333990, orgStudyIdInfo id: 20220796HU, briefTitle: Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Foundation for Advancing Veterans' Health Research, class: OTHER, collaborators name: The University of Texas Health Science Center at San Antonio, collaborators name: Biomedical Research Institute of New Mexico, descriptionModule briefSummary: A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD)., conditionsModule conditions: Mild Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Quetiapine Fumarate, interventions name: TAU, outcomesModule primaryOutcomes measure: Neurobehavioral Symptom Inventory, primaryOutcomes measure: World Health Organization Disability Assessment Scale, primaryOutcomes measure: World Health Organization Quality of Life BREF, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333977, orgStudyIdInfo id: LG-GQCL001, briefTitle: A Study of LC542019 in Healthy Subjects and Subjects With T2DM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-25, primaryCompletionDateStruct date: 2023-12-14, completionDateStruct date: 2023-12-14, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: LG Chem, class: INDUSTRY, descriptionModule briefSummary: to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM)., conditionsModule conditions: Healthy, conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: LC542019, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity of adverse events, secondaryOutcomes measure: Maximum Concentration (Cmax) in Plasma, secondaryOutcomes measure: Renal Clearance (CLR) in urine, otherOutcomes measure: Cardiodynamic evaluation, otherOutcomes measure: Fasting Plasma Glucose, otherOutcomes measure: HbA1c, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PPD Development, LP (PPD Clinical Research Unit, Las Vegas), city: Las Vegas, state: Nevada, zip: 89113, country: United States, geoPoint lat: 36.17497, lon: -115.13722, hasResults: False
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protocolSection identificationModule nctId: NCT06333964, orgStudyIdInfo id: AST-001P_P301_ASD, briefTitle: Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-29, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Astrogen, Inc., class: INDUSTRY, descriptionModule briefSummary: 1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.2. Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Main study(0\~12 weeks) Experimental: AST-001 Comparator: Placebo of AST-001Extension study(12\~24 weeks) Experimental: AST-001 Comparator: AST-001, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: AST-001, interventions name: Placebo of AST-001, outcomesModule primaryOutcomes measure: K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II), secondaryOutcomes measure: CGI (Clinical Global Impression), secondaryOutcomes measure: SRS-2 (Social Responsiveness Scale-2), secondaryOutcomes measure: K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Soon Chun Hyang University Hospital Cheonan, status: RECRUITING, city: Cheonan, state: Chungcheongnam-do, country: Korea, Republic of, geoPoint lat: 36.8065, lon: 127.1522, locations facility: Hallym University Medical Center, status: RECRUITING, city: Anyang, state: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.3925, lon: 126.92694, locations facility: Samsung Changwon Medical Center, status: RECRUITING, city: Changwon, state: Gyeongsangnam-do, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Pusan National University Yangsan Hospital, status: RECRUITING, city: Yangsan, state: Gyeongsangnam-do, country: Korea, Republic of, geoPoint lat: 35.34199, lon: 129.03358, locations facility: Jeonbuk National University Hospital, status: RECRUITING, city: Jeonju, state: Jeollabuk-do, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, locations facility: Chungnam National University Hospital, status: RECRUITING, city: Daejeon, country: Korea, Republic of, geoPoint lat: 36.32139, lon: 127.41972, locations facility: Asan Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hanyang University Seoul Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Koera University Guro Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: The Catholic University of Korea, Seoul St. Mary's Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06333951, orgStudyIdInfo id: 20230167, briefTitle: AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2026-10-08, completionDateStruct date: 2029-10-07, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors., conditionsModule conditions: Thoracic Tumors, conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: AMG 193, interventions name: Carboplatin, interventions name: Paclitaxel, interventions name: Pembrolizumab, interventions name: Pemetrexed, interventions name: Sotorasib, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT), primaryOutcomes measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE), primaryOutcomes measure: Number of Participants Experiencing Serious Adverse Events (SAE), secondaryOutcomes measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), secondaryOutcomes measure: Disease Control (DC) per RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR) per RECIST v1.1, secondaryOutcomes measure: Time to Response (TTR) per RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS) per RECIST v1.1, secondaryOutcomes measure: Progression-free Survival (PFS) per RECIST v1.1, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of AMG 193, secondaryOutcomes measure: Time to Maximum Plasma Concentration (tmax) of AMG 193, secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193, secondaryOutcomes measure: Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM ), secondaryOutcomes measure: Intracranial Disease Control (IDC) per RANO-BM, secondaryOutcomes measure: Intracranial Duration of Response (IDOR) per RANO-BM, secondaryOutcomes measure: Time to Intracranial Radiation Therapy per RANO-BM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope (COH), status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False
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protocolSection identificationModule nctId: NCT06333938, orgStudyIdInfo id: 01968, briefTitle: Veterans Enhanced Recovery Using Integrative Treatments Around Surgery, acronym: VERITAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Durham VA Medical Center, class: FED, descriptionModule briefSummary: The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA)., conditionsModule conditions: Anesthesia, conditions: Surgery, conditions: Knee Arthropathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bridge, interventions name: BFA, outcomesModule primaryOutcomes measure: Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0, primaryOutcomes measure: Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate., primaryOutcomes measure: Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures., primaryOutcomes measure: Fidelity of Treatment among Patients as assessed by a Fidelity Checklist, primaryOutcomes measure: Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures., primaryOutcomes measure: Fidelity of Treatment among Providers as assessed by a Fidelity Checklist, secondaryOutcomes measure: Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents., secondaryOutcomes measure: Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333925, orgStudyIdInfo id: Pro00114183, briefTitle: Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study, acronym: MISO-STIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Misophonia Research Fund, descriptionModule briefSummary: Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress.Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits., conditionsModule conditions: Misophonia, conditions: Emotion Dysregulation, conditions: Sensory Processing Disorder, conditions: Auditory Over Responsivity, conditions: Anxiety Disorder, conditions: Sound Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In regards to the neurostimulation used in the study, there will be two conditions, receiving either active or sham neurostimulation. Both conditions will receive behavioral training in cognitive restructuring (CR; a type of emotion regulation skill). Randomization procedures will match participants on age, gender at birth, and misophonia impairment severity., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: All participants will engage in a behavioral training session (Cognitive Restructuring).The study team member who will conduct the behavioral session will be kept blind to the type of neurostimulation the participant will receive. Participants will also be kept blinded to what neurostimulation they receive and their perception of what they received will be assessed at follow-up. The intervention provider will also be kept blind to the treatment condition to ensure non-biased administration of the intervention.Participants will only be told about the type of neurostimulation at the end of the study to protect against different expectations, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS), interventions name: Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS), interventions name: Cognitive Restructuring, outcomesModule primaryOutcomes measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and exposure to misophonic versus aversive sounds, primaryOutcomes measure: Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and downregulation of versus exposure to misophonic sounds, primaryOutcomes measure: Differential change in BOLD signal within the Anterior Insular Cortex (AIC) activation when being presented with misophonic versus non-misophonic but aversive sounds, primaryOutcomes measure: Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds, primaryOutcomes measure: Change in misophonia impairment and severity using a composite, primaryOutcomes measure: Skin conductance level (scl), primaryOutcomes measure: Change in Subjective Unites of Distress (SUDS), secondaryOutcomes measure: Changes in self-reported psychopathology, secondaryOutcomes measure: Changes in clinician-assessed psychopathology, secondaryOutcomes measure: Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS), otherOutcomes measure: Changes in self-reported cognitive flexibility, otherOutcomes measure: Changes in self-reported cognitive skills, otherOutcomes measure: Baseline emotional dysregulation, otherOutcomes measure: Baseline hyperacusis, otherOutcomes measure: Baseline Affect Intensity, otherOutcomes measure: Change in Emotional distress, otherOutcomes measure: Change in self-reported Emotion regulation, otherOutcomes measure: Change in Sensory sensitivity, otherOutcomes measure: Change in Interoceptive Awareness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Duke University Medical Center, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Jessica Choi, MA, role: CONTACT, phone: 919-684-4432, email: jessica.choi@duke.edu, contacts name: Lisalynn D Kelley, BA, CCRP, role: CONTACT, phone: 919-684-6701, email: lisalynn.kelley@duke.edu, contacts name: Andrada D Neacsiu, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06333912, orgStudyIdInfo id: ridgesplittingguided, briefTitle: Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-02, primaryCompletionDateStruct date: 2024-01-29, completionDateStruct date: 2024-02-27, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency., conditionsModule conditions: Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: dental implant placement with ridge splitting., outcomesModule primaryOutcomes measure: Assessing the accuracy of guided surgery, secondaryOutcomes measure: the bone-width increase between control and study group., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alexandria University, Faculty of dentistry, city: Alexandria, zip: 21619, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06333899, orgStudyIdInfo id: CONNECT2111, briefTitle: Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2034-09-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, collaborators name: Pfizer, descriptionModule briefSummary: The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy., conditionsModule conditions: High Grade Glioma, conditions: Diffuse Intrinsic Pontine Glioma, conditions: Anaplastic Astrocytoma, conditions: Infant Type Hemispheric Glioma, conditions: Glioblastoma, conditions: Glioblastoma Multiforme, conditions: WHO Grade III Glioma, conditions: WHO Grade IV Glioma, conditions: Diffuse Midline Glioma, H3K27-altered, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Lorlatinib, interventions name: Lorlatinib with chemotherapy1, interventions name: Lorlatinib with chemotherapy 2, interventions name: Lorlatinib post Radiation, outcomesModule primaryOutcomes measure: Disease Control Rate, primaryOutcomes measure: Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0, secondaryOutcomes measure: Objective Response Rate (ORR) in HGG, secondaryOutcomes measure: Overall Survival (OS) in HGG, secondaryOutcomes measure: Progression-Free Survival in HGG, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Kathleen Dorris, MD, role: CONTACT, email: kathleen.dorris@childrenscolorado.org, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Children's National Medical Center, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Eugene Hwang, role: CONTACT, email: ehwang@childrensnational.org, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Ann & Robert H. Lurie Children's Hospital of Chicago, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Ashley Plant, MD, role: CONTACT, email: Aplant@luriechildrens.org, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Susan Chi, role: CONTACT, email: Susan_chi@dfci.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Duke University Health System, city: Durham, state: North Carolina, zip: 27708, country: United States, contacts name: David Ashley, MD, role: CONTACT, email: david.ashley@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Peter de Blank, MD, role: CONTACT, email: Peter.deBlank@cchmc.org, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43235, country: United States, contacts name: Maryam Fouladi, MD, MSc, role: CONTACT, email: Maryam.fouladi@nationwidechildrens.org, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Michael J Fisher, MD, role: CONTACT, email: fisherm@email.chop.edu, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Texas Children's Hospital, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Patricia Baxter, MD, role: CONTACT, email: pabaxter@txch.org, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Sarah Leary, role: CONTACT, email: sarah.leary@seattlechildrens.org, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Sydney Children's Hospital, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: David Ziegler, MD, role: CONTACT, email: d.ziegler@unsw.edu.au, geoPoint lat: -33.91439, lon: 151.24895, locations facility: Queensland Children's Hospital, city: South Brisbane, state: Queensland, zip: 4101, country: Australia, contacts name: Tim Hassall, MD, role: CONTACT, email: tim.hassall@health.qld.gov.au, geoPoint lat: -27.48034, lon: 153.02049, locations facility: Perth Children's Hospital, city: Perth, state: Western Australia, zip: 6000, country: Australia, contacts name: Nicholas G Gottardo, MBChB, role: CONTACT, email: nick.gottardo@health.wa.gov.au, geoPoint lat: -31.95224, lon: 115.8614, locations facility: The Hospital for Sick Children (SickKids), city: Toronto, state: Ontario, zip: M5G1X8, country: Canada, contacts name: Eric Bouffet, role: CONTACT, email: eric.bouffet@sickkids.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Montreal Children's Hospital, city: Montréal, state: Quebec, zip: H4A3J1, country: Canada, contacts name: Genevieve Legault, MD, role: CONTACT, email: Genevieve.legault4@mcgill.ca, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), city: Heidelberg, state: Baden-Württemberg, zip: 69120, country: Germany, contacts name: Olaf Witt, MD, role: CONTACT, email: o.witt@kitz-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Princess Máxima Center, city: Utrecht, zip: 3720, country: Netherlands, contacts name: Jasper van der Lugt, role: CONTACT, email: J.vanderLugt@prinsesmaximacentrum.nl, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False
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protocolSection identificationModule nctId: NCT06333886, orgStudyIdInfo id: ciusss-nordmtl_ESG, briefTitle: Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, class: OTHER, descriptionModule briefSummary: Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery., conditionsModule conditions: Spinal Cord Injuries, conditions: Neurogenic Bowel, conditions: Neurogenic Bladder Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Sacral electromyography, outcomesModule primaryOutcomes measure: Precise assessment and evaluation of neuro-sacral dysfunction, secondaryOutcomes measure: Assessment of clinical phenotypes, secondaryOutcomes measure: Clinical prognosis assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital du Sacré-Coeur de Montréal, city: Montréal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06333873, orgStudyIdInfo id: P22-09, briefTitle: Impact of Age-related Macular Degeneration on Daily Living Activitie, acronym: AMDAY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, class: OTHER, descriptionModule briefSummary: The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA), conditionsModule conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: patient-reported outcome, outcomesModule primaryOutcomes measure: Validity of criteria, primaryOutcomes measure: Validity of content, primaryOutcomes measure: Reproducibility of results, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333860, orgStudyIdInfo id: M24-541, briefTitle: A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2025-03-24, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participantsParticipants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires., conditionsModule conditions: Moderate Plaque Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: Risankizumab, interventions name: Deucravacitinib, outcomesModule primaryOutcomes measure: Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90), primaryOutcomes measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline, primaryOutcomes measure: Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR)., secondaryOutcomes measure: Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100), secondaryOutcomes measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline, secondaryOutcomes measure: Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population, secondaryOutcomes measure: Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333847, orgStudyIdInfo id: K2023-059, briefTitle: Is Multimorbidity a Source of Non-response Bias in Patients With Spinal Pain? - A Pilot Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Jacob Christiansen Gandløse, class: OTHER, collaborators name: Aalborg Municipality, collaborators name: Aalborg University, collaborators name: Aalborg University Hospital, descriptionModule briefSummary: The purpose of this study is to investigate whether the number of chronic diseases, the treatment burden resulting from multimorbidity, and health-related quality of life contribute to non-response bias in individuals with chronic back pain. Data is collected from patients at Aalborg University Hospital's Rheumatology Department through electronic means and medical records. The statistical analyses consist of two wave analyses, where we examine differences between patients who respond to invitations to participate in the study based on their response patterns; whether they respond after the first, second, or third invitation. Based on baseline data, a one-way ANOVA is conducted to identify any between-group differences in the aforementioned factors, followed by a repeated measures ANOVA to assess if there are differences between the groups over time. Finally, statistical tests are also performed to examine differences in age and gender distribution between those who complete the questionnaires at baseline compared to those who do not respond to the invitation to participate., conditionsModule conditions: Back Pain, conditions: Low Back Pain, conditions: Neck Pain, conditions: Comorbidities and Coexisting Conditions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Multimorbidity Treatment Burden Questionnaire (MTBQ)., secondaryOutcomes measure: Health-related quality of life (EQ-5D-5L), otherOutcomes measure: Brief Pain Inventory - Short form, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Patient Health Questionnaire, otherOutcomes measure: Generalized Anxiety Disorder, otherOutcomes measure: Work ability score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aalborg University Hospital, city: Aalborg, zip: 9000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
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protocolSection identificationModule nctId: NCT06333834, orgStudyIdInfo id: Dosis Seriada de Alacramyn, briefTitle: Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Selene Guadalupe Huerta Olvera, class: OTHER, descriptionModule briefSummary: The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated., conditionsModule conditions: Centruroides Envenomation, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy in a reduced regimen. The dosing regimen based on response will be one initial intravenous vial in patients with grade III scorpion envenomation, and two initial intravenous vials as the starting dose in patients with grade IV scorpion envenomation, according to the FDA classification of scorpion envenomation. In both scenarios, an additional vial can be administered every 30 minutes if symptoms persist, with no limit on vials. Control Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy according to the traditional regimen proposed in the Mexican Clinical Practice Guideline, where, according to the severity classification of scorpion envenomation, between one and six vials of anti-scorpion venom will be administered, and equal doses can be repeated every 30 minutes if necessary., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 121, type: ESTIMATED, armsInterventionsModule interventions name: Traditional scorpion antivenom regimen, interventions name: Serial dose of scorpion antivenom regimen, outcomesModule primaryOutcomes measure: Time to resolution of signs and symptoms, primaryOutcomes measure: Serum venom concentration, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Length of intrahospital stay, secondaryOutcomes measure: Serum antivenom concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Servicios Médicos Municipales de San Pedro Tlaquepaque., city: Tlaquepaque, state: Jalisco, zip: 45560, country: Mexico, contacts name: Héctor A González-Ruiz, PhD Student, role: CONTACT, phone: +52 33 1787 9139, email: andresgonzru@gmail.com, contacts name: Selene G Huerta-Olvera, PhD, role: CONTACT, phone: +52 392 111 0753, email: selene.huerta@academicos.udg.mx, geoPoint lat: 20.64091, lon: -103.29327, hasResults: False
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protocolSection identificationModule nctId: NCT06333821, orgStudyIdInfo id: BPL-Nim-CC-3003, briefTitle: A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2030-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Biotech Pharmaceutical Co., Ltd., class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival., conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: Nimotuzumab, interventions name: Cisplatin, interventions name: External Beam Radiotherapy (EBRT), interventions name: Brachytherapy, interventions name: placebo for Nimotuzumab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR), secondaryOutcomes measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator, secondaryOutcomes measure: 3-,5-Year Overall Survival (OS), secondaryOutcomes measure: 3-,5-Year Disease Free Survival(DFS), secondaryOutcomes measure: 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS), secondaryOutcomes measure: 3-,5-Year Distant Metastasis-free Survival (DMFS), secondaryOutcomes measure: Tumor Regression Rate(TRR), secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333808, orgStudyIdInfo id: GS-US-621-6290, secondaryIdInfos id: 2023-510022-33, type: OTHER, domain: European Medicines Agency, briefTitle: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy, acronym: ARTISTRY-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Gilead Sciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH., conditionsModule conditions: HIV-1-infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 546, type: ESTIMATED, armsInterventionsModule interventions name: Bictegravir, interventions name: Lenacapavir, interventions name: B/F/TAF, interventions name: Placebo to match B/F/TAF, interventions name: Placebo to match BIC/LEN, outcomesModule primaryOutcomes measure: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48, secondaryOutcomes measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm, secondaryOutcomes measure: Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96, secondaryOutcomes measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48, secondaryOutcomes measure: Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruane Medical and Clinical Research Institute, status: RECRUITING, city: Los Angeles, state: California, zip: 90036, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Therafirst Medical Center, status: RECRUITING, city: Fort Lauderdale, state: Florida, zip: 33308, country: United States, geoPoint lat: 26.12231, lon: -80.14338, locations facility: Midway Immunology and Research Center, status: RECRUITING, city: Fort Pierce, state: Florida, zip: 34982, country: United States, geoPoint lat: 27.44671, lon: -80.32561, locations facility: Infectious Disease Specialists of Atlanta, status: RECRUITING, city: Decatur, state: Georgia, zip: 30033, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Southhampton Community Healthcare, Inc., status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63139, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: South Jersey Infectious Disease, status: RECRUITING, city: Somers Point, state: New Jersey, zip: 08244, country: United States, geoPoint lat: 39.31762, lon: -74.5946, locations facility: The Crofoot research Center, INC., status: RECRUITING, city: Houston, state: Texas, zip: 77098, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06333795, orgStudyIdInfo id: 1-10-72-131-23, briefTitle: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis, acronym: FaeMiCue, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis., conditionsModule conditions: Diarrhea, conditions: Systemic Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The study is blinded throughout the active study period, both the patient and investigator are blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Faecal Microbiota Transplantation (FMT), interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo)., secondaryOutcomes measure: Patient-reported treatment outcome on symptoms, secondaryOutcomes measure: Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention., secondaryOutcomes measure: Patient-reported outcomes from questionnaires., secondaryOutcomes measure: Patient-reported outcomes from questionnaires., secondaryOutcomes measure: Patient-reported outcomes from questionnaires., secondaryOutcomes measure: Patient-reported overall symptom burden, secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the low-dose CT scan., secondaryOutcomes measure: Breath Test, secondaryOutcomes measure: Faecal microbiota composition, secondaryOutcomes measure: Faecal-calprotectin, secondaryOutcomes measure: Blood plasma proteomics, secondaryOutcomes measure: Blood plasma Fibrosis markers, secondaryOutcomes measure: Blood parameters, secondaryOutcomes measure: Health-related Quality of life, secondaryOutcomes measure: Patient perception of FMT treatment satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus University Hospital, city: Aarhus, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06333782, orgStudyIdInfo id: 2023-EU-GEN-01, secondaryIdInfos id: 2023-A02012-43, type: OTHER, domain: ANSM, briefTitle: Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Bioscience Cosmetics SL, class: INDUSTRY, collaborators name: Eurofins, descriptionModule briefSummary: The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy.The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection, conditionsModule conditions: Vulvar Atrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Single blind, whoMasked: PARTICIPANT, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Experimental- Genefill Contour®, interventions name: Marketed comparator - Desirial®Plus, outcomesModule primaryOutcomes measure: Mean of number of occurred ADEs (Adverse device effects), secondaryOutcomes measure: Global Aesthetic Improvement Scale (GAIS) assessment by investigator, secondaryOutcomes measure: Global Aesthetic Improvement Scale (GAIS) assessment by participant, secondaryOutcomes measure: Patient (Atrophy/Hypotrophy) symptoms, secondaryOutcomes measure: Sexual function Assessment, The Female Sexual Function Index (FSFI), secondaryOutcomes measure: Patient´s satisfaction, secondaryOutcomes measure: Pain during injection-Visual Analogical Scale (VAS), secondaryOutcomes measure: Adverse Events collection (Global safety during the study period), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cabinet renaissance, city: Levallois-Perret, state: Paris, zip: 92300, country: France, contacts name: Massimo Gianfermi, MD, role: CONTACT, geoPoint lat: 48.89389, lon: 2.28864, locations facility: Palais Flore, city: Lyon, zip: 69006, country: France, contacts name: Johanna Gratadour, MD, role: CONTACT, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Medical Center "Tu sie leczy", city: Gdańsk, state: Gdansk, country: Poland, contacts name: Katarzyna Kopacz-Petranyuk, MD, role: CONTACT, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False
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protocolSection identificationModule nctId: NCT06333769, orgStudyIdInfo id: CATIMOR, briefTitle: A Phase II Multicenter Clinical Study of Improved Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Fujian Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: To explore the complete response (CR) rate of improved short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer, conditionsModule conditions: Mid-low Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: Short-course Radiotherapy, interventions name: Tislelizumab, interventions name: capecitabine, interventions name: Oxaliplatin, outcomesModule primaryOutcomes measure: complete response (CR) rate, secondaryOutcomes measure: 3y-DFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333756, orgStudyIdInfo id: YM110099E, briefTitle: Effects of Muscle Strengthening and Fatigue on Activities in Cortex and Muscle, acronym: YM110099E, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2022-04-30, completionDateStruct date: 2022-08-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: We will explored the effect of cross education training on different cortex functional connectivity, cortex and muscle functional connectivity, and maximal voluntary contraction.Healthy participants receive cross education training of the elbow flexor (12 rep./set, 3sets, 60%MVC, 180°/s, eccentric).Maximal voluntary contraction, electroencephalogram and electromyogram will record during cross education tasks to determine the effects of cross education training on cortical network and muscle functional connectivity, conditionsModule conditions: Healthy Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Parallel Assignment, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Cross education, outcomesModule primaryOutcomes measure: Corticocortical coherence, primaryOutcomes measure: Corticomuscular coherence, primaryOutcomes measure: Maximal voluntary contraction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Yang-Ming University, city: Taipei, zip: 112, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06333743, orgStudyIdInfo id: ZhuLan, briefTitle: Laser Ablation in the Treatment of High-grade Cervical Lesions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, collaborators name: Obstetrics & Gynecology Hospital of Fudan University, descriptionModule briefSummary: Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL., conditionsModule conditions: High-Grade Squamous Intraepithelial Lesions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 308, type: ESTIMATED, armsInterventionsModule interventions name: laser ablation, interventions name: LEEP or Conization, outcomesModule primaryOutcomes measure: the rate of HSIL recurrence, secondaryOutcomes measure: the satisfaction with the treatment, secondaryOutcomes measure: the length of the cervix, secondaryOutcomes measure: Psychological state change related to the treatment, eligibilityModule sex: FEMALE, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333730, orgStudyIdInfo id: PMC, briefTitle: Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Prime Foundation, class: OTHER, descriptionModule briefSummary: Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison., conditionsModule conditions: Symptomatic Irreversible Pulpitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: inferior alveolar nerve block, interventions name: mental nerve block, outcomesModule primaryOutcomes measure: COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peshawar Dental College, status: RECRUITING, city: Peshawar, state: Khyber Pakhtunkhwa, zip: 25000, country: Pakistan, contacts name: Prof. Dr. Iftikhar Akbar, FCPS, CHIPE, role: CONTACT, phone: 00923479368676, email: driftikhar156@hotmail.com, contacts name: Marghalara Noor, BDS, role: CONTACT, phone: 00923359631393, email: marghalaranoor96@gmail.com, contacts name: Saifa Rashad, BDS, role: SUB_INVESTIGATOR, geoPoint lat: 34.008, lon: 71.57849, hasResults: False
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protocolSection identificationModule nctId: NCT06333717, orgStudyIdInfo id: Dnr 2020-03709, briefTitle: Impact of Whole Grain Rye Bread on Health, acronym: FBS, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-03, primaryCompletionDateStruct date: 2021-03-03, completionDateStruct date: 2021-11-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Örebro University, Sweden, class: OTHER, descriptionModule briefSummary: This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance., conditionsModule conditions: Healthy Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: double blinding, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 33, type: ACTUAL, armsInterventionsModule interventions name: Whole grain bread, interventions name: Control bread, outcomesModule primaryOutcomes measure: Microbiota composition baseline vs after intervention using 16S RNA gene sequencing, secondaryOutcomes measure: Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing, secondaryOutcomes measure: Concentrations of circulatory short-chain fatty acids SCFA, secondaryOutcomes measure: Concentrations of faecal SCFA, secondaryOutcomes measure: Concentrations of blood glucagon like peptide-1 (GLP-1), secondaryOutcomes measure: Concentrations of blood glucagon like peptide-2 (GLP-2), secondaryOutcomes measure: Concentrations of blood peptide YY (PYY), secondaryOutcomes measure: Concentrations of blood gastric inhibitory polypeptide (GIP), secondaryOutcomes measure: Concentrations of blood neuroactive peptide Y (NPY), secondaryOutcomes measure: Concentrations of blood brain-derived neurotrophic factor (BDNF), secondaryOutcomes measure: Concentrations of blood cytokines, secondaryOutcomes measure: Concentrations of blood alkylresorcinols, secondaryOutcomes measure: Concentrations of blood lipopolysaccharide-binding protein (LBP), secondaryOutcomes measure: Concentrations of blood soluble CD-14 (sCD-14), secondaryOutcomes measure: Concentrations of sugars in urine, secondaryOutcomes measure: Concentrations of saliva cortisol during stress test, secondaryOutcomes measure: Concentrations of saliva alpha-amylase during stress test, otherOutcomes measure: Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS), otherOutcomes measure: Food habits measured by an electronic food frequency questionnaire Mealq, otherOutcomes measure: Food habits measured by a Food diary, otherOutcomes measure: Physical activity measured by the International Physical Activity Questionnaire (IPAQ), otherOutcomes measure: Quality of life measured by the Euro Quality of Life questionnaire, otherOutcomes measure: Perceived stress measured by a Visual analog scale questionnaire, otherOutcomes measure: Cognitive control using Eriksen flanker task (Flanker task), otherOutcomes measure: Working memory performance using a modified N-back task combined with recent-probes item-recognition task (Sternberg task), otherOutcomes measure: Electrocardiogram (ECG) using the Biopac system, otherOutcomes measure: Electrodermal activity (EDA) using the Biopac system, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Örebro University, city: Örebro, country: Sweden, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False
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protocolSection identificationModule nctId: NCT06333704, orgStudyIdInfo id: mRNA-1273-P924, briefTitle: Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2026-12-07, completionDateStruct date: 2026-12-07, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: ModernaTX, Inc., class: INDUSTRY, descriptionModule briefSummary: The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population., conditionsModule conditions: SARS-CoV-2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3300, type: ESTIMATED, armsInterventionsModule interventions name: SPIKEVAX Bivalent, interventions name: SPIKEVAX X, outcomesModule primaryOutcomes measure: Number of Participants With AEs, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonseimin Clinic, status: RECRUITING, city: Wonju, state: Gangwon-do, zip: 26428, country: Korea, Republic of, geoPoint lat: 37.35139, lon: 127.94528, locations facility: Hyundai Clinic, status: RECRUITING, city: Bucheon, state: Gyeonggi-do, zip: 14483, country: Korea, Republic of, geoPoint lat: 37.49889, lon: 126.78306, locations facility: Ma Hak ki Family Medicine Clinic, status: RECRUITING, city: Bucheon, state: Gyeonggi-do, zip: 14614, country: Korea, Republic of, geoPoint lat: 37.49889, lon: 126.78306, locations facility: Nalee Hospital, status: RECRUITING, city: Gimpo, state: Gyeonggi-do, zip: 10108, country: Korea, Republic of, locations facility: COA ENT Clinic, status: RECRUITING, city: Goyang, state: Gyeonggi-do, zip: 10234, country: Korea, Republic of, geoPoint lat: 37.65639, lon: 126.835, locations facility: Joon Pediatric Clinic, status: RECRUITING, city: Gwangmyeong, state: Gyeonggi-do, zip: 14250, country: Korea, Republic of, locations facility: Janghyeon Medicine Clinic, status: RECRUITING, city: Siheung, state: Gyeonggi-do, zip: 14998, country: Korea, Republic of, locations facility: Hanyang Union Rehabilitation Medicine Clinic, status: RECRUITING, city: Yangju, state: Gyeonggi-do, zip: 11404, country: Korea, Republic of, geoPoint lat: 37.83311, lon: 127.06169, locations facility: KimHyungjoo Clinic, status: RECRUITING, city: Yangju, state: Gyeonggi-do, zip: 11456, country: Korea, Republic of, geoPoint lat: 37.83311, lon: 127.06169, locations facility: Kium Children Hospital, status: RECRUITING, city: Gunsan, state: Jeollabuk-do, zip: 54072, country: Korea, Republic of, geoPoint lat: 35.97861, lon: 126.71139, locations facility: Sinsegie ENT Clinic, status: TERMINATED, city: Busan, zip: 48111, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Jeil Family Medicine Clinic, status: WITHDRAWN, city: Gwangju, zip: 61108, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, locations facility: Bupyeong Yonsei Medical Clinic, status: RECRUITING, city: Incheon, zip: 21405, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Inha University Hospital, status: RECRUITING, city: Incheon, zip: 22332, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Woori Medical Clinic, status: RECRUITING, city: Seoul, zip: 01684, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Yonsei Kids Pediatrics Clinic, status: RECRUITING, city: Seoul, zip: 01851, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Star Pediatrics Clinic, status: RECRUITING, city: Seoul, zip: 03912, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Seoul Bon Clinic, status: RECRUITING, city: Seoul, zip: 04032, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Dr Cho's Family Medical Clinic, status: RECRUITING, city: Seoul, zip: 05351, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Songpa Korea Neurosurgical Clinic, status: RECRUITING, city: Seoul, zip: 05769, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: GF Pediatrics Clinic, status: RECRUITING, city: Seoul, zip: 06568, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kim Il Joong Internal Medicine Clinic, status: RECRUITING, city: Seoul, zip: 06727, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: New Yonsei ENT Clinic, status: RECRUITING, city: Seoul, zip: 07327, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Soo Orthopedics Clinic, status: TERMINATED, city: Seoul, zip: 08701, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06333691, orgStudyIdInfo id: Aya Mohammed, briefTitle: Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Minia University, class: OTHER, descriptionModule briefSummary: Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens., conditionsModule conditions: Ovarian Hyperstimulation Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Calcium Gluconate, outcomesModule primaryOutcomes measure: the incidence rate of moderate to severe OHSS., eligibilityModule sex: FEMALE, minimumAge: 23 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Minia University, Faculty of Pharmacy, city: Minya, country: Egypt, geoPoint lat: 28.10988, lon: 30.7503, hasResults: False
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protocolSection identificationModule nctId: NCT06333678, orgStudyIdInfo id: 22-321, briefTitle: A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, collaborators name: Amgen, descriptionModule briefSummary: In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib)., conditionsModule conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase II randomized trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Durvalumab, interventions name: Sotorasib, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Incidence of dose-limiting toxicity (DLT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (All Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (All Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (All Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (All Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Narek Shaverdian, MD, role: CONTACT, phone: 631-212-6323, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False
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protocolSection identificationModule nctId: NCT06333665, orgStudyIdInfo id: Wei G, briefTitle: PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, class: OTHER, descriptionModule briefSummary: To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c\<7.0%) is associated with improved survival., conditionsModule conditions: Esophageal Squamous Cell Carcinoma, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 605, type: ACTUAL, armsInterventionsModule interventions name: Whether there is type 2 diabetes mellitus before surgery, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: postoperative adverse events, secondaryOutcomes measure: perioperative 90-day mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Army Medical Center of the People's Liberation Army, city: Chongqing, state: Chongqing, zip: 400042, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06333652, orgStudyIdInfo id: 22-009239, briefTitle: Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome., conditionsModule conditions: Preeclampsia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Ravulizumab, outcomesModule primaryOutcomes measure: Alternative Complement Pathway Biomarkers at time of delivery, secondaryOutcomes measure: Pregnancy duration, secondaryOutcomes measure: Clinical biomarkers of severe features of preeclampsia and HELLP syndrome, secondaryOutcomes measure: Hospitalization length in the postpartum period, secondaryOutcomes measure: Meningococcal infection after use of ravulizumab, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mayo Clinic Minnesota, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Maria L. Gonzalez Suarez, MD,PhD, role: CONTACT, phone: 507-284-4083, email: gonzalezsuarez.maria@mayo.edu, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06333639, orgStudyIdInfo id: 24Chirortho01, briefTitle: Implementing Virtual Reality in the Operating Room, acronym: IRVABO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: "Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour.", conditionsModule conditions: General Surgery, conditions: Orthopedic Procedures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: orthopaedic surgery, interventions name: orthopaedic surgery and fitted with a virtual reality headset, outcomesModule primaryOutcomes measure: To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset., secondaryOutcomes measure: 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset., secondaryOutcomes measure: Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU NiICE, city: Nice, state: Alpes Maritimes, zip: 0600, country: France, contacts name: GAUCI Marc-Olivier, role: CONTACT, phone: 04 92 03 69 04, phoneExt: +33, email: gauci.mo@chu-nice.fr, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
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protocolSection identificationModule nctId: NCT06333626, orgStudyIdInfo id: 2020281, briefTitle: Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound., conditionsModule conditions: Nausea and Vomiting, Aspiration, Intraoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: multi-vitamin carbohydrate, outcomesModule primaryOutcomes measure: Gastric antrum area, secondaryOutcomes measure: vomiting, secondaryOutcomes measure: The pH of vomiting fluid, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333613, orgStudyIdInfo id: CR-6565, briefTitle: Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Johnson & Johnson Vision Care, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes., conditionsModule conditions: Visual Acuity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D), outcomesModule primaryOutcomes measure: Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Scripps Poway Eyecare & Optometry, status: RECRUITING, city: San Diego, state: California, zip: 92131, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Omega Vision Center, status: RECRUITING, city: Longwood, state: Florida, zip: 32779, country: United States, geoPoint lat: 28.70305, lon: -81.3384, locations facility: Maitland Vision Center - North Orlando Ave, status: RECRUITING, city: Maitland, state: Florida, zip: 32751, country: United States, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Kannarr Eye Care, status: RECRUITING, city: Pittsburg, state: Kansas, zip: 66762, country: United States, geoPoint lat: 37.41088, lon: -94.70496, locations facility: Procare Vision Centers, status: RECRUITING, city: Granville, state: Ohio, zip: 43023, country: United States, geoPoint lat: 40.06812, lon: -82.5196, hasResults: False
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protocolSection identificationModule nctId: NCT06333600, orgStudyIdInfo id: Soh-Med-23-07-05, briefTitle: Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-20, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases, conditionsModule conditions: Dermatology, conditions: Female Pattern Baldness, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Topical minoxidil, interventions name: Topical Vitamin D, interventions name: Saline spray, outcomesModule primaryOutcomes measure: Change of Sinclaire grading of Female pattern hair loss, primaryOutcomes measure: Change of Trichoscopic parameters (Hair dermoscopy), eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Facult of Medicine, Sohag Uniiversity, status: RECRUITING, city: Sohag, zip: 82515, country: Egypt, contacts name: Doaa G Abdelbaset, MSc, role: CONTACT, phone: 01022330810, phoneExt: 002, email: dodygaber64@yahoo.com, contacts name: Doaa G Abdelbaset, Msc, role: CONTACT, phone: 01014733007, phoneExt: 002, email: dodygaber64@yahoo.com, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06333587, orgStudyIdInfo id: IEO 1810, briefTitle: Minimally Invasive Treatments of the Thyroid, acronym: MIPA-MITT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2035-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC), conditionsModule conditions: Papillary Thyroid Microcarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: image-guided thermal ablation, outcomesModule primaryOutcomes measure: The proportion of patients with major complications occurring within one month after the date of intervention, secondaryOutcomes measure: Percentage of patients with local recurrence at 10 years, secondaryOutcomes measure: Percentage of patients with distant metastasis at 10 years, secondaryOutcomes measure: Percentage of patients died at 10 years, 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: Giovanni Mauri, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06333574, orgStudyIdInfo id: CDUTCM20240313, briefTitle: Weight Management of Dialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: qinxiu zhang, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:* \[Improve the self-compliance of dialysis patients with weight management\]* \[alleviate the volume load of dialysis patients and reduce cardiovascular complications\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\'s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\' family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management., conditionsModule conditions: Hemodialysis, conditions: Life Quality, conditions: Interdialytic Weight Gain, conditions: Cardiovascular Events, conditions: Hypertension, conditions: Dry Weight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Family weight self-measurement and remote follow-up management based on wechat., interventions name: Routine care, outcomesModule primaryOutcomes measure: Adverse event rate, primaryOutcomes measure: Rate of completion, secondaryOutcomes measure: dialysis related symptoms, secondaryOutcomes measure: Laboratory index, secondaryOutcomes measure: level of Ga, secondaryOutcomes measure: level of P, secondaryOutcomes measure: level of PTH, secondaryOutcomes measure: level of K, secondaryOutcomes measure: level of Na, secondaryOutcomes measure: level of Cl, secondaryOutcomes measure: concentration of albumin and prealbumin, secondaryOutcomes measure: Laboratory index of total protein, secondaryOutcomes measure: Dialysis efficiency \ dialysis adequacy (KTV), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333561, orgStudyIdInfo id: Liver Project 7, briefTitle: HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Lenvatinib, conditions: PD-1 Inhibitor, conditions: Hepatic Arterial Infusion Chemotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Hepatic arterial infusion chemotherapy, interventions name: Lenvatinib, interventions name: Tislelizumab, interventions name: Toripalimab, interventions name: Sintilimab, interventions name: Camrelizumab, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-Free-Survival, otherOutcomes measure: Objective response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Qunfang Zhou, Md, role: CONTACT, phone: 8619868000115, email: zhouqun988509@163.com, contacts name: Feng Duan, MD, role: CONTACT, phone: 8613910984586, email: duanfeng@vip.sina.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06333548, orgStudyIdInfo id: KSH_MB_2024_1, briefTitle: Cord Blood Alarin Levels in Term Babies, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-18, primaryCompletionDateStruct date: 2023-12-23, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Konya City Hospital, class: OTHER, descriptionModule briefSummary: In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin., conditionsModule conditions: Birth Weight, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 87, type: ACTUAL, armsInterventionsModule interventions name: Appropriate for gestational age, small for gestational age, large for gestational age, Baby of mother diagnosed with GDM, outcomesModule primaryOutcomes measure: Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight., eligibilityModule sex: ALL, minimumAge: 1 Minute, maximumAge: 5 Minutes, stdAges: CHILD, contactsLocationsModule locations facility: MELEK, city: Konya, state: Sıhhiye, zip: 06100, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06333535, orgStudyIdInfo id: 2022/568, briefTitle: Foot and Abdominal Massage Applied to After Colonoscopy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-25, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale, conditionsModule conditions: Abdominal Pain, conditions: Distention, conditions: Satisfaction, Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ACTUAL, armsInterventionsModule interventions name: foot massage, interventions name: abdominal massage, interventions name: foot and abdominal massage, outcomesModule primaryOutcomes measure: abdominal pain, primaryOutcomes measure: Abdominal distension, primaryOutcomes measure: Patient Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, city: Kayseri, zip: 38000, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
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protocolSection identificationModule nctId: NCT06333522, orgStudyIdInfo id: 23-00979, briefTitle: Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm., conditionsModule conditions: Arthrofibrosis of Knee, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Losartan, outcomesModule primaryOutcomes measure: Change in range of motion, primaryOutcomes measure: Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06333509, orgStudyIdInfo id: CT071-HM-01, briefTitle: Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-06-15, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: CARsgen Therapeutics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia., conditionsModule conditions: Multiple Myeloma, conditions: Primary Plasma Cell Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each indication will be dosed at the recommended dose level from Phase 1., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: N/Ap, enrollmentInfo count: 166, type: ESTIMATED, armsInterventionsModule interventions name: CT071, outcomesModule primaryOutcomes measure: Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD)., primaryOutcomes measure: Phase 2: Objective response rate, secondaryOutcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes, secondaryOutcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes, secondaryOutcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes, secondaryOutcomes measure: Phase 1 and 2: Evaluate additional clinical efficacy outcomes, secondaryOutcomes measure: Phase 2: Evaluate additional Safety of CT071., secondaryOutcomes measure: Phase 1 and 2: Assess immunogenicity of CT071, secondaryOutcomes measure: Phase 1 and 2: Evaluate PK profile of CT071, secondaryOutcomes measure: Phase 1 and 2: Evaluate PK profile of CT071, secondaryOutcomes measure: Phase 1 and 2: Evaluate PK profile of CT071, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333496, orgStudyIdInfo id: AB20240102H, briefTitle: Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-04-08, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Alpine Biotech LLC, class: INDUSTRY, descriptionModule briefSummary: BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints., conditionsModule conditions: Blood Sugar; High, conditions: Overweight and Obesity, conditions: Fat Burn, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: GLP1 Booster (GB), outcomesModule primaryOutcomes measure: blood glucose level, primaryOutcomes measure: blood HbA1c level, primaryOutcomes measure: blood insulin level, primaryOutcomes measure: blood GLP1 level, primaryOutcomes measure: blood cholesterol level, primaryOutcomes measure: body weight, primaryOutcomes measure: body fat mass, primaryOutcomes measure: body lean mass, primaryOutcomes measure: body mass index, primaryOutcomes measure: body fat index, primaryOutcomes measure: waist hip ratio, secondaryOutcomes measure: Satiety score, secondaryOutcomes measure: Resting metabolic rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alpine Bio, city: Salt Lake City, state: Utah, zip: 84109, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06333483, orgStudyIdInfo id: AUTO1-SL1, secondaryIdInfos id: 2023-508236-60-00, type: CTIS, briefTitle: A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE), acronym: CARLYSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Autolus Limited, class: INDUSTRY, descriptionModule briefSummary: This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Obecabtagene autoleucel (obe-cel), outcomesModule primaryOutcomes measure: Dose limiting toxicities, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Remission rate according to Definition of Remission in SLE (DORIS), secondaryOutcomes measure: Response over time according to Definition of Remission in SLE (DORIS), secondaryOutcomes measure: Time to response according to Definition of Remission in SLE (DORIS), secondaryOutcomes measure: Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), secondaryOutcomes measure: Change over time in Physician's global assessment (PGA), secondaryOutcomes measure: Pharmacokinetics (maximum serum concentration [Cmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood, secondaryOutcomes measure: Pharmacokinetics (time to reaching maximum serum concentration [Tmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood, secondaryOutcomes measure: Pharmacokinetics (area under the curve [AUC]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood, secondaryOutcomes measure: Pharmacokinetics (last observed quantifiable concentration [Clast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood, secondaryOutcomes measure: Pharmacokinetics (time to reach last observed quantifiable concentration [Tlast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood, secondaryOutcomes measure: Pharmacodynamics: B cell aplasia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University College London Hospitals NHS Foundation Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Maria Leandro, role: CONTACT, email: uclh.car-ttrials@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06333470, orgStudyIdInfo id: 2024KYPJ025, briefTitle: Liwan Eye Study: the Fourth Follow-up, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Zhongshan Ophthalmic Center, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG., conditionsModule conditions: Primary Angle-Closure Glaucoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Primary angle closure diseases, outcomesModule primaryOutcomes measure: The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years, secondaryOutcomes measure: The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG), secondaryOutcomes measure: The 20-year incidence of visual impairment in Chinese population aged over 50 years, eligibilityModule sex: ALL, minimumAge: 70 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333457, orgStudyIdInfo id: EA4/024/24, briefTitle: Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality, acronym: PRE-VR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, descriptionModule briefSummary: Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET., conditionsModule conditions: Alcohol Dependence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: VR Cue-Exposure Therapy, outcomesModule primaryOutcomes measure: Craving, primaryOutcomes measure: Craving, primaryOutcomes measure: Craving, secondaryOutcomes measure: Relapse rates, secondaryOutcomes measure: Quality of Life, secondaryOutcomes measure: Motion Sickness, secondaryOutcomes measure: Presence in VR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Psychiatric University Hospital Charité at St. Hedwig Hospital, city: Berlin, zip: 10115, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False
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protocolSection identificationModule nctId: NCT06333444, orgStudyIdInfo id: n. 08, 09/03/2021, briefTitle: Counselling Intervention for College Students Experienced Psychological Distress, acronym: TRESPASS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Campania "Luigi Vanvitelli", class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.The main question it aims to answer are:* is the psychological counselling intervention useful in improving psychological distress and academic motivation* which psychological variables predict the intervention outcome, conditionsModule conditions: University Students, conditions: Psychological Intervention, conditions: Psychological Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Four weekly psychological counselling intervention, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: four weekly psychological counselling intervention, outcomesModule primaryOutcomes measure: psychological distress, primaryOutcomes measure: Academic motivation, secondaryOutcomes measure: Emotion regulation ability, secondaryOutcomes measure: perceived loneliness, secondaryOutcomes measure: drop-out intention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Campania, status: RECRUITING, city: Caserta, zip: 81100, country: Italy, contacts name: ALDA TRONCONE, role: CONTACT, email: alda.troncone@unicampania.it, geoPoint lat: 41.07262, lon: 14.33231, hasResults: False
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protocolSection identificationModule nctId: NCT06333431, orgStudyIdInfo id: WN/WF, briefTitle: Effects of WN and WF During Gastroscopy, acronym: WF/WN_GCPY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-08, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Suleyman Demirel University, class: OTHER, descriptionModule briefSummary: Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group., conditionsModule conditions: Misadventure During Endoscopic Examination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment experimental model using randomized pretest and posttest with control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Glass Waterfall group, interventions name: white noise group, outcomesModule primaryOutcomes measure: Patient Information Form, primaryOutcomes measure: Visual Analogue Scale (VAS), primaryOutcomes measure: State and Trait Anxiety Scale (STAI), primaryOutcomes measure: The Patient Observation Form, primaryOutcomes measure: Pulse rate before and after gatroscopy procedure, primaryOutcomes measure: Respiratory rate before and after gatroscopy procedure, primaryOutcomes measure: Systolic and diastolic blood pressure before and after gatroscopy procedure, primaryOutcomes measure: Oxygen saturation values before and after gatroscopy procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333418, orgStudyIdInfo id: VR/WF, briefTitle: Effects of VR and Glass WF Colonoscopy, acronym: VR/WN_colon, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-08, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Suleyman Demirel University, class: OTHER, descriptionModule briefSummary: Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 135 individuals for the three groups and at 60 individuals for each group. G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information., conditionsModule conditions: Misadventure During Endoscopic Examination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment experimental model using randomized pretest and posttest with control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Double (Participant, Investigator), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Glasses Group, interventions name: Glass waterfall, outcomesModule primaryOutcomes measure: Patient Information Form, primaryOutcomes measure: Visual Analogue Scale (VAS), primaryOutcomes measure: State and Trait Anxiety Scale (STAI), primaryOutcomes measure: The Patient Observation Form, primaryOutcomes measure: Pulse rate before colonoscopy procedure, primaryOutcomes measure: Respiratory rate before colonoscopy procedure, primaryOutcomes measure: Systolic and diastolic blood pressure before colonoscopy procedure, primaryOutcomes measure: Oxygen saturation values before colonoscopy procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333405, orgStudyIdInfo id: FMTNEC/01/2024, briefTitle: Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants.This is the first stage of a clinical trial testing the effectiveness of FMT in NEC, the aim of which is to examine the safety profile and analyze all side effects., conditionsModule conditions: Necrotizing Enterocolitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single group, open label, observational study with intervention (FMT), primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fecal Microbiota Transplantation, outcomesModule primaryOutcomes measure: Adverse reactions monitoring, eligibilityModule sex: ALL, minimumAge: 24 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Medical University of Warsaw, Pediatric Surgery Clinic, city: Warsaw, state: Mazovian Voivodeship, zip: 02-097, country: Poland, contacts name: Marek Wolski, MD, PhD, role: CONTACT, phone: 665578922, phoneExt: +48, email: marek.wolski@wum.edu.pl, contacts name: Ewa A. Biegańska, MD, role: CONTACT, phone: 692542543, phoneExt: +48, email: ewa.bieganska@wum.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
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protocolSection identificationModule nctId: NCT06333392, orgStudyIdInfo id: TotalUnderwater_REK577567, briefTitle: Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Vestre Viken Hospital Trust, class: OTHER, collaborators name: Ullevaal University Hospital, collaborators name: Sahlgrenska University Hospital, Sweden, collaborators name: Ostfold Hospital Trust, descriptionModule briefSummary: Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.3. uEMR is eased.4. Improved bowel cleansingThe goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.The project has five main hypotheses:1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.2. TUC increases the rate of complete resection of lesions \>= 10mm.3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.5. TUC reduces the carbon footprint by reduced use of single use accessories.If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.The trial can be linked to three of the Global Goals:* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced., conditionsModule conditions: Colorectal Neoplasia, conditions: Screening Colonoscopy, conditions: Colorectal Cancer, conditions: Colorectal Cancer Screening, conditions: Vasovagal Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1070, type: ESTIMATED, armsInterventionsModule interventions name: Total underwater colonoscopy, interventions name: Conventional colonoscopy, outcomesModule primaryOutcomes measure: Proximal sessile serrated lesion detection rate, secondaryOutcomes measure: Complete resection rate for lesions > 10mm, secondaryOutcomes measure: Rate of painful procedures and vasovagal reactions, secondaryOutcomes measure: Leakage after colonoscopy, secondaryOutcomes measure: Detection rate for other neoplasia than SSL, secondaryOutcomes measure: Withdrawal time, secondaryOutcomes measure: Total procedure time, secondaryOutcomes measure: Bowel cleansing quality, secondaryOutcomes measure: Complications, secondaryOutcomes measure: Number of colonoscopies to achieve polyp free colon, secondaryOutcomes measure: Single use accessories for the procedure, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333379, orgStudyIdInfo id: SichuanPPHLC04, secondaryIdInfos id: 2020LY01, type: OTHER_GRANT, domain: Sichuan Provincial People's Hospital, briefTitle: Aspergillosis Detection Via EBC-GM in Ventilated Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Lin Chen, class: OTHER, descriptionModule briefSummary: Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.Expected Outcomes:Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures., conditionsModule conditions: Bronchoalveolar Lavage Fluid, conditions: Sensitivity and Specificity, conditions: Critical Illness, conditions: Respiration Failure, conditions: Respiratory Fungal Infection, conditions: Exhaled Breath Condensate, conditions: Aspergillosis, Invasive Pulmonary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF, outcomesModule primaryOutcomes measure: Diagnostic accuracy of EBC-GM vs. BALF-GM, primaryOutcomes measure: EBC-GM levels:, secondaryOutcomes measure: Correlation between EBC-GM and BALF-GM levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, city: Chengdu, state: Sichuan, zip: 86610072, country: China, geoPoint lat: 30.66667, lon: 104.06667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-04-12, uploadDate: 2024-03-22T15:01, filename: Prot_SAP_000.pdf, size: 81579, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-12, uploadDate: 2024-03-22T15:02, filename: ICF_001.pdf, size: 133154, hasResults: False
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protocolSection identificationModule nctId: NCT06333366, orgStudyIdInfo id: 202301590A0C501, secondaryIdInfos id: Application No.2402020052, type: OTHER, domain: Chang Gung Memorial Hospital, briefTitle: First-In-Human Study of PDT to Detect IAH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2024-07-16, completionDateStruct date: 2025-09-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: DOTSPACE, descriptionModule briefSummary: PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends., conditionsModule conditions: Intra-Abdominal Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Intra-gastrointestinal monitoring device (PDT), outcomesModule primaryOutcomes measure: Incidence of device-related or sensor insertion/removal procedure-related adverse events, primaryOutcomes measure: Rate of foreign body reaction due intra-gastrointestinal insertion, primaryOutcomes measure: Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus, primaryOutcomes measure: Incidence of sensor failure, secondaryOutcomes measure: Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire, secondaryOutcomes measure: Duration of PDT insertion and explantation procedure, secondaryOutcomes measure: Incidence of side effects in Post explantation follow-up, secondaryOutcomes measure: Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days, otherOutcomes measure: Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm, otherOutcomes measure: Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dong-Ru Ho, status: RECRUITING, city: Chiayi City, zip: 60061, country: Taiwan, contacts name: Dong-Ru Ho, MD, PhD, role: CONTACT, phone: 886-975353211, email: redoxdrh@gmail.com, contacts role: CONTACT, phoneExt: Ho, email: redoxdrh@gmail.com, contacts name: Dong-Ru Ho, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.47917, lon: 120.44889, hasResults: False
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protocolSection identificationModule nctId: NCT06333353, orgStudyIdInfo id: H-06-23-9278, briefTitle: Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2027-05-20, completionDateStruct date: 2027-06-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Ottawa, class: OTHER, descriptionModule briefSummary: The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.The objectives of this trial are:1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP,2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS.5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP., conditionsModule conditions: Endometriosis, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All participants, care providers, investigators and outcome assessors will remain blinded to real/sham intervention. The outcomes assessor and the investigator will remain blinded to intervention duration., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Real RepetitiveTranscranial Magnetic Stimulation 5 sessions, interventions name: Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions, interventions name: Real RepetitiveTranscranial Magnetic Stimulation 10 sessions, interventions name: Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions, outcomesModule primaryOutcomes measure: Numeric rating scale (NRS) used to record daily pain over 30 days, primaryOutcomes measure: Numeric rating scale(NRS) used to record daily pain over 30 days, primaryOutcomes measure: Patient Global Impression of Change (PGIC) in pain, primaryOutcomes measure: Patient Global Impression of Change (PGIC) in pain, primaryOutcomes measure: Patient Global Impression of Change (PGIC) in pain, secondaryOutcomes measure: The Beck Depression Inventory (BDI-II), secondaryOutcomes measure: The Beck Depression Inventory (BDI-II), secondaryOutcomes measure: The Beck Depression Inventory (BDI-II), secondaryOutcomes measure: The State-Trait Anxiety Inventory (STAI), secondaryOutcomes measure: The Pain Catastrophizing Scale, secondaryOutcomes measure: The Central sensitization index, secondaryOutcomes measure: Female Sexual Distress Scale (FSDS), secondaryOutcomes measure: Adherence to the intervention protocol, secondaryOutcomes measure: Pressure pain threshold (PPThresh), secondaryOutcomes measure: Pressure pain threshold (PPThresh), secondaryOutcomes measure: Pressure Pain Tolerance (PPTol), secondaryOutcomes measure: Pressure Pain Tolerance (PPTol), secondaryOutcomes measure: Perceived pain intensity (PPI), secondaryOutcomes measure: Perceived pain intensity (PPI), secondaryOutcomes measure: Temporal summation (TS) of pain, secondaryOutcomes measure: Temporal summation (TS) of pain, secondaryOutcomes measure: Pain rating during the tampon test, secondaryOutcomes measure: Pain rating during the tampon test, secondaryOutcomes measure: Conditioned pain modulation (CPM), secondaryOutcomes measure: Conditioned pain modulation (CPM), secondaryOutcomes measure: The Brief Pain Inventory, secondaryOutcomes measure: The Brief Pain Inventory, secondaryOutcomes measure: The Brief Pain Inventory, secondaryOutcomes measure: The Endometriosis Health Profile Questionnaire (EPH-30), secondaryOutcomes measure: The Endometriosis Health Profile Questionnaire (EPH-30), secondaryOutcomes measure: The Endometriosis Health Profile Questionnaire (EPH-30), secondaryOutcomes measure: Patient satisfaction with treatment (PST), secondaryOutcomes measure: Patient satisfaction with treatment (PST), secondaryOutcomes measure: Patient satisfaction with treatment (PST), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: McLean Function Measurement Lab, status: RECRUITING, city: Ottawa, state: Ontario, zip: K1S1S2, country: Canada, contacts name: Anne-Marie MacDonald, MSc, role: CONTACT, phone: 613-562-5800, phoneExt: 4102, email: mfmlab@uottawa.ca, contacts name: Linda McLean, PhD, role: CONTACT, phone: 613-562-5800, phoneExt: 4102, email: lmclea2@uottawa.ca, contacts name: Linda McLean, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False
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protocolSection identificationModule nctId: NCT06333340, orgStudyIdInfo id: 24-03, briefTitle: Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors., conditionsModule conditions: Post Partum Hemorrhage, 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: 160, type: ESTIMATED, armsInterventionsModule interventions name: Oxytocin, interventions name: Carbetocin, outcomesModule primaryOutcomes measure: Proportion of parturients requiring additional uterotonic agents intraoperatively, secondaryOutcomes measure: Uterine Tone 3 minutes, secondaryOutcomes measure: Uterine Tone 5 minutes, secondaryOutcomes measure: Uterine Tone 10 minutes, secondaryOutcomes measure: Calculated blood loss (CBL), secondaryOutcomes measure: Semi-quantitative blood loss (SQBL), secondaryOutcomes measure: Presence of blood transfusion, secondaryOutcomes measure: Number of patients with ICU admission, secondaryOutcomes measure: Number of patients with conservative surgical methods to manage post partum hemorrhage, secondaryOutcomes measure: Number of patients with radiological methods used to manage post partum hemorrhage, secondaryOutcomes measure: Number of patients with surgical post partum hemorrhage management measures, secondaryOutcomes measure: Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline, secondaryOutcomes measure: Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline, secondaryOutcomes measure: Number of patients with tachycardia defined as heart rate greater than 130% of baseline, secondaryOutcomes measure: Number of patients with bradycardia defined as heart rate less than 70% of baseline, secondaryOutcomes measure: Presence of ventricular tachycardia: ECG, secondaryOutcomes measure: Presence of atrial fibrillation: ECG, secondaryOutcomes measure: Presence of atrial flutter: ECG, secondaryOutcomes measure: Presence of nausea: questionnaire, secondaryOutcomes measure: Presence of vomiting: questionnaire, secondaryOutcomes measure: Number of patients with chest pain: questionnaire, secondaryOutcomes measure: Number of patients with shortness of breath: questionnaire, secondaryOutcomes measure: Number of patients with headache: questionnaire, secondaryOutcomes measure: Number of patients with flushing: questionnaire, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Mrinalini Balki, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: mrinalini.balki@uhn.ca, contacts name: Narinder Singh, MD, role: SUB_INVESTIGATOR, contacts name: Ronald George, MD, role: SUB_INVESTIGATOR, contacts name: Kristi Downey, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06333327, orgStudyIdInfo id: 1432022000278, briefTitle: Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter, acronym: COLLABORATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2030-01-01, completionDateStruct date: 2030-12-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Universitair Ziekenhuis Brussel, class: OTHER, descriptionModule briefSummary: All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter, outcomesModule primaryOutcomes measure: Atrial arrhythmia recurrence after ablation, primaryOutcomes measure: Procedural safety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Brussel Heart Rhythm Management Center, status: RECRUITING, city: Brussels, zip: 1090, country: Belgium, contacts name: Carlo de Asmundis, MD, PhD, role: CONTACT, phone: +32024763704, email: hrmc@uzbrussel.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
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protocolSection identificationModule nctId: NCT06333314, orgStudyIdInfo id: UC-IMM-2302, briefTitle: Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI, acronym: Pan-MSI-ACSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2030-09, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: UNICANCER, class: OTHER, collaborators name: National Cancer Institute, France, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A., conditionsModule conditions: Pancreatic Adenocarcinoma, conditions: Ampulla of Vater Carcinoma, conditions: Adrenocortical Carcinoma, conditions: Neuroendocrine Carcinoma, conditions: Soft Tissue Sarcoma, conditions: Small Bowel Adenocarcinoma, conditions: Duodenum Adenocarcinoma, conditions: Gastric Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, multicenter, comparative phase II trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Dostarlimab, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-Free Survival 2, secondaryOutcomes measure: Objective response rate 2, secondaryOutcomes measure: Progression-Free Survival -crossover, secondaryOutcomes measure: Circulating tumor DNA level, secondaryOutcomes measure: Incidence of treatment-emergent adverse events, secondaryOutcomes measure: Quality of life questionnaire - Core 30 (QLQ-C30), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut de Cancérologie de l'Ouest, city: Angers, country: France, contacts name: Victor SIMMET, MD, role: CONTACT, geoPoint lat: 47.46667, lon: -0.55, locations facility: Institut du Cancer Avignon-Provence, city: Avignon, country: France, contacts name: Clémence TOULLEC, MD, role: CONTACT, geoPoint lat: 43.94834, lon: 4.80892, locations facility: CHU Jean Minjoz, city: Besançon, country: France, contacts name: Angélique VIENOT, MD, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Morvan, city: Brest, country: France, contacts name: Pierre-Guillaume POUREAU, MD, role: CONTACT, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Centre François Baclesse, city: Caen, country: France, contacts name: Elodie COQUAN, MD, role: CONTACT, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre Jean Perrin, city: Clermont-Ferrand, country: France, contacts name: Florence OSAER-POLYCARPE, MD, role: CONTACT, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU - Henri Mondor, city: Créteil, country: France, contacts name: Christophe TOURNIGAND, MD, role: CONTACT, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Centre Georges François Leclerc, city: Dijon, country: France, contacts name: François GHIRINGHELLI, MD, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Centre Léon Bérard, city: Lyon, country: France, contacts name: Clélia COUTZAC, MD, role: CONTACT, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital la Timone, city: Marseille, country: France, contacts name: Laëtitia DAHAN, MD, role: CONTACT, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut Paoli Calmettes, city: Marseille, country: France, contacts name: Christelle DE LA FOUCHARDIERE, MD, role: CONTACT, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut de Cancérologie de Lorraine, city: Nancy, country: France, contacts name: Aurélien LAMBERT, MD, role: CONTACT, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Institut Mutualiste Montsouris, city: Paris, country: France, contacts name: Raphaël COLLE, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Bordeaux - Hôpital Haut -Lèvêque, city: Pessac, country: France, contacts name: Denis SMITH, MD, role: CONTACT, geoPoint lat: 44.81011, lon: -0.64129, locations facility: CHU de Poitiers, city: Poitiers, country: France, contacts name: David TOUGERON, MD, role: CONTACT, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Institut Jean Godinot, city: Reims, country: France, contacts name: Damien BOTSEN, MD, role: CONTACT, geoPoint lat: 49.25, lon: 4.03333, locations facility: Centre Eugène Marquis, city: Rennes, country: France, contacts name: Héloïse BOURIEN, MD, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU de Rouen, city: Rouen, country: France, contacts name: Frédéric DI FIORE, MD, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Institut de Cancérologie de l'Ouest, city: Saint-Herblain, country: France, contacts name: Sandrine HIRET, MD, role: CONTACT, geoPoint lat: 47.21765, lon: -1.64841, locations facility: CHU de Toulouse Hôpital Rangueil, city: Toulouse, country: France, contacts name: Rosine GUIMBAUD, MD, role: CONTACT, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Gustave Roussy Grand Paris, city: Villejuif, country: France, contacts name: Cristina SMOLENSCHI, MD, role: CONTACT, geoPoint lat: 48.7939, lon: 2.35992, locations facility: Hôpital Saint-Antoine, city: Paris, state: Île-de-France, country: France, contacts name: Thierry ANDRE, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06333301, orgStudyIdInfo id: TIME-ZZZ, briefTitle: Translational Initiative to Map Epigenetics in Sleep, acronym: TIME-ZZZ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2034-04, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Elysium Health, class: INDUSTRY, collaborators name: University of Oxford, descriptionModule briefSummary: The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging., conditionsModule conditions: Biological Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Surveys, outcomesModule primaryOutcomes measure: Effect of being "out of phase" with chronotype on biological age, secondaryOutcomes measure: Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging, secondaryOutcomes measure: Identification of DNA methylation markers associated with chronotype, secondaryOutcomes measure: Identification of DNA methylation markers associated with depression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333288, orgStudyIdInfo id: 2024-0268, briefTitle: Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: PST-APPLE Watch group, interventions name: Education-only control group, outcomesModule primaryOutcomes measure: Alcohol abstinence, secondaryOutcomes measure: Change in AUD severity at 3 months., secondaryOutcomes measure: Change in AUD frequency status., secondaryOutcomes measure: Change in Alcohol-related negative consequences at 3 months., secondaryOutcomes measure: Change in Alcohol use at 3 months., secondaryOutcomes measure: Change in Reasons for drinking at 3 months., secondaryOutcomes measure: Change in negative affect at 3 months., secondaryOutcomes measure: Change in positive affect at 3 months., secondaryOutcomes measure: Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months., secondaryOutcomes measure: Change in the quality of life at 3 months., secondaryOutcomes measure: Percent heavy drinking days at 3 months., secondaryOutcomes measure: Percent binge drinking days at 3 months., secondaryOutcomes measure: Percent days abstinence at 3 months., otherOutcomes measure: Intervention Acceptability, otherOutcomes measure: Intervention Fidelity, otherOutcomes measure: Participant Retention, otherOutcomes measure: Protocol Acceptability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Illinois at Chicago, city: Chicago, state: Illinois, zip: 60608, country: United States, contacts name: Hagar Hallihan, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06333275, orgStudyIdInfo id: DLF-Nr: 5564, secondaryIdInfos id: BASEC-Nr: 2023-01141, type: OTHER, domain: BASEC (Business Administration System for Ethics Committees) - Switzerland, briefTitle: Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy, acronym: IMCAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:* Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens* Are current re-vaccination recommendations sufficient in restoring vaccine-protection* Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy, conditionsModule conditions: Vaccine Immunity in CAR-T Cell Therapy Recipients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles, outcomesModule primaryOutcomes measure: CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens, secondaryOutcomes measure: Rate of seroprotection against tetanus 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against measles virus 12 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Clinical predictors of vaccine elicited immune response, secondaryOutcomes measure: Immunological predictors of vaccine elicited immune response, secondaryOutcomes measure: Persistence of vaccine elicited seroprotection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bern, status: RECRUITING, city: Bern, zip: 3010, country: Switzerland, contacts name: Lukas N Baumann, MD, role: CONTACT, phone: +41 31 66 4 30 69, email: lukas.baumann2@insel.ch, contacts name: Cédric Hirzel, PD, MD, role: CONTACT, phone: +41 31 66 4 01 17, email: cedric.hirzel@insel.ch, contacts name: Christine Thurnheer Zürcher, PD, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Cédric Hirzel, PD, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lukas N Baumann, MD, role: SUB_INVESTIGATOR, contacts name: Urban Novak, Professor, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False
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protocolSection identificationModule nctId: NCT06333262, orgStudyIdInfo id: 24-017, briefTitle: Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Inhye Ahn, class: OTHER, collaborators name: Loxo Oncology, Inc., descriptionModule briefSummary: This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL)., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pirtobrutinib, interventions name: Obinutuzumab, outcomesModule primaryOutcomes measure: Rate of complete response after initial therapy, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Rate of partial response, secondaryOutcomes measure: Time to next line of therapy, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Rate of re-treatment with pirtobrutinib, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beth Israel Deaconess Medical Center, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Jon Arnason, MD, role: CONTACT, contacts name: Jon Arnason, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Brigham & Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Inhye Ahn, role: CONTACT, contacts name: Inhye Ahn, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Megan Forsyth, role: CONTACT, phone: 857-215-1405, email: megan_forsyth@dfci.harvard.edu, contacts name: Inhye Ahn, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06333249, orgStudyIdInfo id: AGTC-RPGR-001 SKYLINE, briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-04-13, primaryCompletionDateStruct date: 2023-04-11, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Beacon Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations., conditionsModule conditions: X-Linked Retinitis Pigmentosa, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The purpose of the Phase 2 study is to evaluate the efficacy, safety, and tolerability of two doses of AGTC-501 in male subjects between 8 - 50 years of age (inclusive) with XLRP genetically confirmed by at least one pathogenic variant in the RPGR gene.Approximately 12 subjects who meet the inclusion criteria, will be randomized in a 1:1 ratio to 1 of 2 treatment groups. Each subject will receive the assigned dose of AGTC-501 in the study eye; no treatment will be administered in the fellow eye. As treatment outcomes in pediatric vs. adult subjects may differ, randomization to dose groups will be stratified by age.Each subject will receive a central subretinal injection of AGTC-501 at the assigned dose in the central macula of the study eye., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The Phase 2 study is a masked study; therefore, neither the investigator nor the subject will know the dose assignment. Both the subject and the investigator will know which eye received treatment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: rAAV2tYF-GRK1-RPGR, outcomesModule primaryOutcomes measure: The difference in the proportion of responding eyes between treated and control eyes in the low dose group and high dose group at 12 months, as measured by MAIA microperimetry, where response is defined as a 7dB or more improvement in at least 5 loci., secondaryOutcomes measure: Proportion of responding eyes in treated eyes versus control eyes in the low dose group and the high dose group at Month 12 where responder is defined as an ORA-VNC mobility test score improvement of 2 or more luminance levels., secondaryOutcomes measure: Proportion of responding eyes in treated versus control eyes in the low dose group and the high dose group at Month 12, as measured by MAIA microperimetry, where responder is defined as a 7 dB or more improvement in at least 5 loci within bleb., secondaryOutcomes measure: Proportion of responding eyes in treated vs control eyes in the low dose group and the high dose group at Month 12, measured by MAIA microperimetry where responder is defined as 7 dB or more improvement in at least 5 loci within the central 16 loci, secondaryOutcomes measure: Difference in mean change from baseline in the central 36 loci (C36) mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12., secondaryOutcomes measure: Difference in mean change from baseline in "within bleb" mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12., secondaryOutcomes measure: Difference in mean change from baseline in central 10 degrees of vision on light adapted static perimetry, as measured by Octopus 900, in treated eyes versus control eyes in the low dose group and high dose group at Month 12., secondaryOutcomes measure: Difference in mean change from baseline in BCVA, as measured by ETDRS or tumbling "E" chart, in treated eyes versus control eyes in the low dose group and high dose group at Month 12., secondaryOutcomes measure: Proportion of responding eyes in treated versus control eyes in the low dose group and high dose group at Month 12 where responder is defined as a 10-letter vision gain as measured by ETDRS or tumbling "E" chart., secondaryOutcomes measure: Difference in mean change from baseline in the EZ area, as measured by SD-OCT, in treated eyes versus control eyes in the low dose group and high dose group at Month 12 Visit., secondaryOutcomes measure: Mean change from baseline in Impact of Vision Impairment (IVI) (Weih et al, 2002; Lamoureaux et al, 2007) or Impact of Vision Impairment for Children (IVI-C) (Cochrane et al, 2008) in the low dose group and high dose group at Month 12 Visit, secondaryOutcomes measure: Mean change from baseline in Patient Global Impressions of Change (PGI-C) and Patient Global Impressions of Severity (PGIS) in the low dose group and high dose group at Month 12 Visit., eligibilityModule sex: MALE, minimumAge: 8 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Florida, city: Jacksonville, state: Florida, zip: 32209, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Boston Children's Hosptial, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Cincinnati Eye Institute, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Casey Eye Institute, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Retina Foundation of the Southwest, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06333236, orgStudyIdInfo id: OCU_KRON, briefTitle: Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: ASST Santi Paolo e Carlo, class: OTHER, descriptionModule briefSummary: Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function., conditionsModule conditions: Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Food for Special Medical Purposes: Kron®, outcomesModule primaryOutcomes measure: Electrofunctional evaluation, secondaryOutcomes measure: VF and SD-OCT, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06333223, orgStudyIdInfo id: LSC 23/ 396, briefTitle: Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis, acronym: SYMPTOGUT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-12-18, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Roehampton, class: OTHER, collaborators name: King's College, descriptionModule briefSummary: Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics.To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far., conditionsModule conditions: Menopause, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo), primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Mixture of (Poly)phenols and a probiotic supplement, interventions name: Placebo comparator, outcomesModule primaryOutcomes measure: Change in blood chemistry levels, secondaryOutcomes measure: Change in BMI (body mass index) Scores, secondaryOutcomes measure: Change in the gut microbiota diversity, secondaryOutcomes measure: Change in dietary habits, secondaryOutcomes measure: Change in Quality IPAQ, secondaryOutcomes measure: Change in inflammatory biomarkes, eligibilityModule sex: FEMALE, minimumAge: 48 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton, status: RECRUITING, city: London, state: UK, zip: SW15 4JD, country: United Kingdom, contacts name: Adele Costabile, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Adele Costabile, status: RECRUITING, city: London, zip: SW145JD, country: United Kingdom, contacts name: Adele Costabile, Prof, role: CONTACT, contacts name: Zicheng Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06333210, orgStudyIdInfo id: BCD-180-3, briefTitle: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-25, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Biocad, class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs., conditionsModule conditions: Axial Spondyloarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 421, type: ESTIMATED, armsInterventionsModule interventions name: anti-TRBV9 monoclonal antibody infusions, interventions name: Placebo infusions, interventions name: Adalimumab subcutaneous injection, interventions name: Placebo subcutaneous injection, outcomesModule primaryOutcomes measure: Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects, primaryOutcomes measure: Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects, secondaryOutcomes measure: Proportion of subjects who achieved ASAS40 among subjects with r-axSpA, secondaryOutcomes measure: Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP <1.3, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5, secondaryOutcomes measure: Proportion of subjects with the ASDAS-CRP >3.5, secondaryOutcomes measure: Proportion of subjects who achieved ASDAS-CII (clinically important improvement), secondaryOutcomes measure: Proportion of subjects who achieved ASDAS-MI (Major improvement), secondaryOutcomes measure: ASDAS-CRP change from baseline, secondaryOutcomes measure: Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline, secondaryOutcomes measure: Change from baseline in BASDAI, secondaryOutcomes measure: Proportion of subjects who achieved ASAS40, secondaryOutcomes measure: Proportion of subjects who achieved ASAS20, secondaryOutcomes measure: Proportion of subjects who achieved ASAS5/6, secondaryOutcomes measure: Proportion of subjects who achieved ASAS partial remission, secondaryOutcomes measure: Change from baseline in BASMI, secondaryOutcomes measure: Change from baseline in BASFI, secondaryOutcomes measure: Change from baseline in the swollen joint count (44 joints), secondaryOutcomes measure: Change from baseline in MASES, secondaryOutcomes measure: Change from baseline in overall back pain severity (BASDAI No. 2), secondaryOutcomes measure: Change from baseline in nocturnal back pain severity, secondaryOutcomes measure: Change in the patient global assessment of disease activity from baseline, secondaryOutcomes measure: Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline, secondaryOutcomes measure: Change from baseline in SF-36 Physical Functioning compared to baseline, secondaryOutcomes measure: Change from baseline in SF-36 Mental Health compared to baseline, secondaryOutcomes measure: Change in the WPAI score from baseline, secondaryOutcomes measure: Change in the ASAS HI score from baseline, secondaryOutcomes measure: Change in the concentration of hsCRP from baseline, secondaryOutcomes measure: Change in ESR from baseline, secondaryOutcomes measure: Changes in the SPARCC score (spine, SIJ) from baseline, secondaryOutcomes measure: Changes in mSASSS scores from baseline, secondaryOutcomes measure: Proportion of subjects with adverse events, secondaryOutcomes measure: Proportion of subjects with serious adverse events, secondaryOutcomes measure: Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0, secondaryOutcomes measure: Proportion of subjects prematurely withdrawn from the study due to adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chelyabinsk Regional Clinical hospital, status: RECRUITING, city: Chelyabinsk, country: Russian Federation, contacts name: Olga Nesmeianova, PhD, role: CONTACT, phone: +73517493727, email: chelokb@mail.ru, geoPoint lat: 55.15402, lon: 61.42915, locations facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Sergey Moiseev, PhD, Doc Med Sci, role: CONTACT, phone: +7 499 248 25 44, email: clinpharm@mtu-net.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Clinical Rheumatology Hospital №25, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Inna Gaidukova, role: CONTACT, phone: +7 (812) 670 30 90, email: b25@zdrav.spb.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: North-Western State Medical University n.a. I.I.Mechnikov, status: RECRUITING, city: Saint-Petersburg, country: Russian Federation, contacts name: Vadim Mazurov, PhD, role: CONTACT, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
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protocolSection identificationModule nctId: NCT06333197, orgStudyIdInfo id: Mandibular condylar fracture, briefTitle: Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The condylar region is the most frequent anatomical site for mandibular fractures .Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ)., conditionsModule conditions: Mandibular Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: ORIF through transparotid approach, interventions name: ORIF through retroparotid approach, outcomesModule primaryOutcomes measure: Facial nerve injury, primaryOutcomes measure: Operative time, secondaryOutcomes measure: Fracture stability, secondaryOutcomes measure: Mouth opening, secondaryOutcomes measure: Other Complication related to the Approach, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333184, orgStudyIdInfo id: 3085-4215, briefTitle: Smoothies and Blood Sugars, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Bath, class: OTHER, descriptionModule briefSummary: Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations., conditionsModule conditions: Metabolic Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Food, outcomesModule primaryOutcomes measure: Glycaemic index of product with capillary vs CGM, secondaryOutcomes measure: Glycaemic index of all conditions with capillary vs CGM, otherOutcomes measure: Condition-by-sampling interaction, otherOutcomes measure: GI of products in capillary samples, otherOutcomes measure: GI of products in continuous glucose monitors, otherOutcomes measure: Peak glucose capillary vs CGM, otherOutcomes measure: Time to peak glucose capillary vs CGM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department for Health, University of Bath, status: RECRUITING, city: Bath, zip: BA2 7AY, country: United Kingdom, contacts name: Javier T Gonzalez, PhD, role: CONTACT, phone: +44 (0) 1225 38, phoneExt: 5125, email: j.t.gonzalez@bath.ac.uk, geoPoint lat: 51.3751, lon: -2.36172, hasResults: False
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protocolSection identificationModule nctId: NCT06333171, orgStudyIdInfo id: 00003872, briefTitle: 4-aminopyridine for Skin Wound Healing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: John Elfar, class: OTHER, descriptionModule briefSummary: Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing., conditionsModule conditions: Wounds, conditions: Wound of Skin, conditions: Wound Heal, conditions: Wounds and Injuries, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double-blind, randomized, placebo-controlled trial design., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Subjects in both aims will be assigned to Group A or Group B using a randomization scheme. Each study participant for each aim is randomly assigned to either treatment of placebo using permuted block randomization, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: 4-Aminopyridine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Return of skin integrity and wound closure after skin punch biopsy, secondaryOutcomes measure: The effect of 4-AP on the hair number and growth at the skin punch biopsy site., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Arizona, city: Tucson, state: Arizona, zip: 85724, country: United States, contacts name: Andrea Horne, role: CONTACT, phone: 520-626-6456, email: ahh@arizona.edu, geoPoint lat: 32.22174, lon: -110.92648, hasResults: False
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protocolSection identificationModule nctId: NCT06333158, orgStudyIdInfo id: AmWaRO Study, briefTitle: Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention, acronym: AmWaRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Nina Hermans, class: OTHER, collaborators name: University Hospital, Antwerp, descriptionModule briefSummary: The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,2. Leads to a clinically relevant reduction of blood pressure on the short term,3. Leads to a change in oxidative stress biomarkers.Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured., conditionsModule conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, 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: 36, type: ESTIMATED, armsInterventionsModule interventions name: Cholesfytol NG, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline LDL cholesterol at 8 weeks, secondaryOutcomes measure: Frequency of side effects (+ their burden) as reported in the final questionnaire, secondaryOutcomes measure: Change from baseline Blood Pressure, Systolic at 8 weeks, secondaryOutcomes measure: Change from baseline Blood Pressure, diastolic at 8 weeks, secondaryOutcomes measure: Change from baseline total cholesterol level at 8 weeks, secondaryOutcomes measure: Change from baseline HDL cholesterol level at 8 weeks, secondaryOutcomes measure: Change from baseline non-HDL cholesterol level at 8 weeks, secondaryOutcomes measure: Change from baseline Remnant Cholesterol at 8 weeks, secondaryOutcomes measure: Change from baseline triglycerides level at 8 weeks, secondaryOutcomes measure: Change from baseline Apo A1 level at 8 weeks, secondaryOutcomes measure: Change from baseline Apo B level at 8 weeks, secondaryOutcomes measure: Change from baseline lipoprotein A (LP(a)) level at 8 weeks, secondaryOutcomes measure: Change from baseline OxLDL level at 8 weeks, secondaryOutcomes measure: Change from baseline malondialdehyde (MDA) level at 8 weeks, secondaryOutcomes measure: Change from baseline glutathion (GSH) level at 8 weeks, otherOutcomes measure: Change from baseline glucose level at 8 weeks, otherOutcomes measure: Change from baseline HbA1c level at 8 weeks, otherOutcomes measure: Change from baseline insuline level at 8 weeks, otherOutcomes measure: Change from baseline Body Mass Index (BMI) at 8 weeks, otherOutcomes measure: Change from baseline waist circumference at 8 weeks, otherOutcomes measure: Change from baseline hemoglobine level at 8 weeks, otherOutcomes measure: Change from baseline creatinine level at 8 weeks, otherOutcomes measure: Change from baseline hs-CRP level at 8 weeks, otherOutcomes measure: Change from baseline homocysteine level at 8 weeks, otherOutcomes measure: Change from baseline creatine kinase (CK) level at 8 weeks, otherOutcomes measure: Change from baseline C-peptide level at 8 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 76 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UAntwerp, NatuRAPT, status: RECRUITING, city: Wilrijk, state: Antwerp, zip: 2610, country: Belgium, contacts name: Nina Hermans, Prof., role: CONTACT, phone: 003232652732, email: nina.hermans@uantwerpen.be, geoPoint lat: 51.16734, lon: 4.39513, hasResults: False
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protocolSection identificationModule nctId: NCT06333145, orgStudyIdInfo id: EDRA, briefTitle: ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups., conditionsModule conditions: Effect of Drug, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Remimazolam, outcomesModule primaryOutcomes measure: Ramsey Sedation Scale, secondaryOutcomes measure: Time records, secondaryOutcomes measure: Use of drugs, secondaryOutcomes measure: Respiratory suppression incidence, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Incidence of PACU Adverse Reactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: aijun xu, Dr., role: CONTACT, phone: 027-83663173, email: ajxu@tjh.tjmu.edu.cn, contacts name: yuan Bi, Dr., role: CONTACT, phone: 027-18972718216, email: 18972718216@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06333132, orgStudyIdInfo id: DiabEAT.it, briefTitle: Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat), acronym: DiabEATit, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero, Universitaria Pisana, class: OTHER, descriptionModule briefSummary: The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission., conditionsModule conditions: Obesity, conditions: Diabetes Mellitus Type 2 in Obese, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Weight loss-induced Diabetes Remission, outcomesModule primaryOutcomes measure: Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission, secondaryOutcomes measure: Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria Pisana, city: Pisa, state: PI, zip: 56127, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
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protocolSection identificationModule nctId: NCT06333119, orgStudyIdInfo id: 72867572-050.01.04-320, briefTitle: The Relationship Between Urinary Incontinence and Motor Symptoms, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Pinar Yasar, class: OTHER, descriptionModule briefSummary: There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke., conditionsModule conditions: Stroke, conditions: Urinary Incontinence, conditions: Motor Skills Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: modified rankin scale, outcomesModule primaryOutcomes measure: relationship with between urinary incontinence and motor symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Suleyman Demirel University, city: Isparta, country: Turkey, geoPoint lat: 37.76444, lon: 30.55222, hasResults: False
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protocolSection identificationModule nctId: NCT06333106, orgStudyIdInfo id: FICUS - 2024/16FEV/077, briefTitle: PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, collaborators name: Université de Liège, collaborators name: Grand Hôpital de Charleroi, collaborators name: Clinique Saint-Jean, Bruxelles, collaborators name: Clinique Saint Pierre Ottignies, descriptionModule briefSummary: Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations)., conditionsModule conditions: Fecal Impaction of Colon, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 247, type: ESTIMATED, armsInterventionsModule interventions name: POCUS diagnostic value, outcomesModule primaryOutcomes measure: Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room, secondaryOutcomes measure: Influence of BMI on the diagnosis of fecal impaction at PoCUS, secondaryOutcomes measure: Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS, secondaryOutcomes measure: Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS, eligibilityModule sex: ALL, minimumAge: 75 Years, maximumAge: 130 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06333093, orgStudyIdInfo id: NL82178.018.22, briefTitle: Duodenal tIssue ResEction aCquisiTion (DIRECT) Study, acronym: DIRECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-10, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies., conditionsModule conditions: Duodenum Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cold snare, outcomesModule primaryOutcomes measure: Acquiring larger pieces of tissue from the duodenum, primaryOutcomes measure: Histopatholocial assessment of larger pieces of tissue from the duodenum, primaryOutcomes measure: Checking if the tissue is of good quality enough for single cell RNA sequencing, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: North-Holland, zip: 1105 AZ, country: Netherlands, contacts name: Celine BE Busch, MD, role: CONTACT, phone: +31621357593, email: diabetes-onderzoek@amsterdamumc.nl, contacts name: Jacques JG Bergman, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Celine BE Busch, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06333080, orgStudyIdInfo id: N-20220017, briefTitle: The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin, acronym: DIACRON, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Aalborg University Hospital, class: OTHER, descriptionModule briefSummary: The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes, which are dysregulated on metformin and naïve to second line antidiabetic treatment., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Time-in-Range (TIR), secondaryOutcomes measure: Pre-dose Fasting, secondaryOutcomes measure: Post-dose Fasting, secondaryOutcomes measure: Occurrence of nausea or vomiting, secondaryOutcomes measure: Water Intake at Dosing Time, secondaryOutcomes measure: Treatment-Related Impact Measure for Diabetes (TRIM-D), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Steno Diabetes Center North Denmark, status: RECRUITING, city: Aalborg, zip: 9000, country: Denmark, contacts name: Mette Pilegaard Rasmussen, BSc, role: CONTACT, phone: 00 45 30 36 46 84, email: mpr@rn.dk, contacts name: Peter Vestergaard, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nynne S Holdt-Caspersen, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
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protocolSection identificationModule nctId: NCT06333067, orgStudyIdInfo id: Sofwave21, briefTitle: Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-11, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Sofwave Medical LTD, class: INDUSTRY, descriptionModule briefSummary: Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation., conditionsModule conditions: Lax Skin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Sofwave, outcomesModule primaryOutcomes measure: Primary Outcome Measure, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Costal Skin & Eye Institute, status: RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, contacts name: Christopher V.Crosby, MD, role: CONTACT, email: research@coastalskineye.com, contacts name: Christopher V.Crosby, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.76783, lon: -117.02308, locations facility: Skin Wellness Dermatology Associates, status: RECRUITING, city: Durham, state: North Carolina, zip: 27713, country: United States, contacts name: Talasia Smith, role: CONTACT, phone: 919-294-9440, email: cst@skinwellnessdermatology.com, contacts name: Brooke Jackson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06333054, orgStudyIdInfo id: NCLIN0091/ 14ct/mp37li, briefTitle: Safety and Efficacy of a Head Lice Shampoo, statusModule overallStatus: COMPLETED, startDateStruct date: 2014-10-13, primaryCompletionDateStruct date: 2015-06-08, completionDateStruct date: 2015-06-08, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Oystershell NV, class: INDUSTRY, descriptionModule briefSummary: This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications., conditionsModule conditions: Head Lice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 109, type: ACTUAL, armsInterventionsModule interventions name: Pyrethrum Extract, interventions name: Silcap Shampoo, outcomesModule primaryOutcomes measure: Cure Rate superior to 70% for the test product, secondaryOutcomes measure: Cure Rate superior to 70% for the reference product, secondaryOutcomes measure: Superior cure rate to the reference, secondaryOutcomes measure: Non-inferiority rate to the reference, secondaryOutcomes measure: Local tolerability, secondaryOutcomes measure: Global tolerability, secondaryOutcomes measure: Skin irritation assessment, secondaryOutcomes measure: Eye irritation assessment, secondaryOutcomes measure: Esthetical effect of the anti-lice products, secondaryOutcomes measure: Adverse Events (AEs), otherOutcomes measure: Severity of the lice infestation, eligibilityModule sex: ALL, minimumAge: 1 Year, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CardioSec Clinical Research GmbH, city: Erfurt, zip: 99084, country: Germany, geoPoint lat: 50.9787, lon: 11.03283, hasResults: False
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protocolSection identificationModule nctId: NCT06333041, orgStudyIdInfo id: 32977-01-00, briefTitle: Study of Cannabidiol in Sanfilippo Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome.Each participant's caregiver will be asked to complete surveys related to the participant's behavior, mood, sleep, stooling, pain, and caregiver stress intermittently throughout the study. All participants will be enrolled into one of two cohorts based on enrollment order:1. Sentinel Safety Cohort (first 5 participants) - all participants treated with Epidiolex (cannabidiol)2. Controlled Cohort (next 30 participants) - participants randomized 1:1 (equal chance) to start treatment with Epidiolex (cannabidiol) or placebo for 16 weeks, followed by an 8-week washout period (no treatment). Participants then switch to the opposite treatment group for 16 weeks followed by all participants treated for 52 weeks with Epidiolex (cannabidiol)., conditionsModule conditions: Sanfilippo Syndrome, conditions: Mucopolysaccharidosis III, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind, placebo-controlled, cross-over study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Epidiolex, interventions name: Placebo, outcomesModule primaryOutcomes measure: Sanfilippo Behavior Rating Scale (SBRS)- mood/anger/aggression score, eligibilityModule sex: ALL, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, city: Torrance, state: California, zip: 90502, country: United States, contacts name: Cristi Williams, role: CONTACT, email: cristi.williams@lundquist.org, contacts name: Lynda Polgreen, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.83585, lon: -118.34063, hasResults: False
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protocolSection identificationModule nctId: NCT06333028, orgStudyIdInfo id: 938, briefTitle: A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bausch & Lomb Incorporated, class: INDUSTRY, descriptionModule briefSummary: A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction, conditionsModule conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: enVista Aspire EA IOLs, outcomesModule primaryOutcomes measure: Mean binocular BCDVA (logMAR) at Visit 1, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SITE 104, city: Dover, state: New Jersey, zip: 07801, country: United States, geoPoint lat: 40.88399, lon: -74.5621, locations facility: Site 105, city: Woodland Park, state: New Jersey, zip: 07424, country: United States, geoPoint lat: 40.88982, lon: -74.19487, locations facility: Site 103, city: Garden City, state: New York, zip: 11530, country: United States, geoPoint lat: 40.72677, lon: -73.6343, locations facility: Site 106, city: Charleston, state: South Carolina, zip: 29407, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Site 101, city: Sugar Land, state: Texas, zip: 77478, country: United States, geoPoint lat: 29.61968, lon: -95.63495, locations facility: Site 102, city: Mount Pleasant, state: Wisconsin, zip: 53405, country: United States, geoPoint lat: 42.69743, lon: -87.85577, hasResults: False
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protocolSection identificationModule nctId: NCT06333015, orgStudyIdInfo id: 924, briefTitle: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bausch & Lomb Incorporated, class: INDUSTRY, descriptionModule briefSummary: This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Approximately 224 subjects (448 eyes) will be enrolled in this study with plans to bilaterally implant approximately 112 subjects with each of the test and control IOLs., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned. The Investigator implanting the IOL and designated site personnel will be unmasked to the treatment assignment for a subject., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: enVista EY Beyond IOL, interventions name: TECNIS 1-Piece monofocal IOL, outcomesModule primaryOutcomes measure: Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4., primaryOutcomes measure: Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4., secondaryOutcomes measure: Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4., eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 108, city: Northridge, state: California, zip: 91325, country: United States, geoPoint lat: 34.22834, lon: -118.53675, locations facility: Site 107, city: Bloomington, state: Minnesota, zip: 55420, country: United States, geoPoint lat: 44.8408, lon: -93.29828, locations facility: Site 101, city: Omaha, state: Nebraska, zip: 68137, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Site 109, city: Las Vegas, state: Nevada, zip: 89145, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Site 102, city: Brecksville, state: Ohio, zip: 44141, country: United States, geoPoint lat: 41.31978, lon: -81.62679, locations facility: Site 105, city: North Charleston, state: South Carolina, zip: 29406, country: United States, geoPoint lat: 32.85462, lon: -79.97481, locations facility: Site 106, city: Sioux Falls, state: South Dakota, zip: 57108, country: United States, geoPoint lat: 43.54997, lon: -96.70033, locations facility: Site 103, city: Dallas, state: Texas, zip: 75243, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Site 111, city: Mount Pleasant, state: Wisconsin, zip: 53405, country: United States, geoPoint lat: 42.69743, lon: -87.85577, locations facility: Site 110, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Site 104, city: Montréal, state: Quebec, zip: H1V 1G5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06333002, orgStudyIdInfo id: PI24/00325, briefTitle: Machine Learning Model to Predict Outcome and Duration of Mechanical Ventilation in Acute Hypoxemic Respiratory Failure, acronym: MEMORIAL, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Dr. Negrin University Hospital, class: OTHER, descriptionModule briefSummary: Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death and prolonged duration (\>7 days) of mechanical ventilation (MV) in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron., conditionsModule conditions: Acute Hypoxemic Respiratory Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1241, type: ESTIMATED, armsInterventionsModule interventions name: machine learning analysis, outcomesModule primaryOutcomes measure: ICU mortality, secondaryOutcomes measure: MV duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital General Universitario de Ciudad Real, city: Ciudad Real, zip: 13005, country: Spain, geoPoint lat: 38.98626, lon: -3.92907, locations facility: Hospital Virgen de La Luz, city: Cuenca, zip: 16002, country: Spain, geoPoint lat: 40.06667, lon: -2.13333, locations facility: Hospital Universitario La Paz, city: Madrid, zip: 28046, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Puerta de Hierro, city: Madrid, zip: 28222, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Virgen de Arrixaca, city: Murcia, zip: 3012, country: Spain, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Hospital Universitario NS de Candelaria, city: Santa Cruz De Tenerife, zip: 38010, country: Spain, geoPoint lat: 28.46824, lon: -16.25462, locations facility: Hospital Cinico de Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Hospital Universitario Rio Hortega, city: Valladolid, zip: 47012, country: Spain, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False
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protocolSection identificationModule nctId: NCT06332989, orgStudyIdInfo id: N22.129, briefTitle: Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting, acronym: STROKE-APP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: Alrijne Ziekenhuis Leiderdorp, collaborators name: Groene Hart Ziekenhuis, collaborators name: Medical Center Haaglanden, collaborators name: HagaZiekenhuis, collaborators name: Reinier de Graaf Groep, collaborators name: Regionale Ambulance Voorziening Hollands Midden, descriptionModule briefSummary: There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics, conditionsModule conditions: Stroke, Acute, conditions: Pre-hospital Triage, conditions: Stroke Treatment, conditions: Stroke Code, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: stroke-APP, outcomesModule primaryOutcomes measure: final diagnosis, primaryOutcomes measure: treated with reperfusion therapy, primaryOutcomes measure: additional investigations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leiden University medical center, status: RECRUITING, city: Leiden, country: Netherlands, contacts name: Nyika D Kruyt, MD. PhD, role: CONTACT, phone: 0031-715262139, email: n.d.kruyt@lumc.nl, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
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protocolSection identificationModule nctId: NCT06332976, orgStudyIdInfo id: IEO 1521, briefTitle: PrefeRences And ChemoTherapy In Breast Cancer patiEnts, acronym: PRACTICE, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:1. before to start the chemotherapy2. during chemotherapy3. after the end of chemotherapy, conditionsModule conditions: Female Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Completion of questionnaires, outcomesModule primaryOutcomes measure: Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile, primaryOutcomes measure: Prolonged survival time gain needed to consider CT worthwhile, secondaryOutcomes measure: Behavior assessment, secondaryOutcomes measure: Reaction to uncertain situations assessment, secondaryOutcomes measure: Regret and disappointment assessment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Emilia Montagna, MD, role: CONTACT, phone: +390257489970, email: emilia.montagna@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06332963, orgStudyIdInfo id: 2023-007, briefTitle: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Laureate Institute for Brain Research, Inc., class: OTHER, descriptionModule briefSummary: The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored., conditionsModule conditions: Anorexia Nervosa, conditions: Body Image Disturbance, conditions: Interoception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Equal groups parallel randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Floatation-REST, interventions name: IFT, interventions name: EFT, outcomesModule primaryOutcomes measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS), primaryOutcomes measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS), secondaryOutcomes measure: Cognitive/affective body image on the Body Image State Scale (BISS), secondaryOutcomes measure: Body image dissatisfaction on the Somatomap3D, secondaryOutcomes measure: Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance), secondaryOutcomes measure: Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance), secondaryOutcomes measure: Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction, secondaryOutcomes measure: Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale, secondaryOutcomes measure: Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Interoceptive attention on the Interoceptive Attention Scale (IATS), secondaryOutcomes measure: Cardiac interoceptive accuracy on the Heartbeat Tapping Task, secondaryOutcomes measure: Cardiac interoceptive intensity on the Heartbeat Tapping Task, secondaryOutcomes measure: Interoceptive intensity during experimental conditions, secondaryOutcomes measure: Perceived respiratory interoceptive intensity on the Breath Hold Task, secondaryOutcomes measure: Body image distortion on the Aperture Task, secondaryOutcomes measure: Body image distortion on the String task, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332950, orgStudyIdInfo id: MA-SCLC-II-015, briefTitle: Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Baohui Han, class: OTHER, descriptionModule briefSummary: This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s)., conditionsModule conditions: Extensive-stage Small-cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, Irinotecan Liposome (II), interventions name: Adebrelimab, Irinotecan Liposome (II), Famitinib, outcomesModule primaryOutcomes measure: 6-month progression-free survival, secondaryOutcomes measure: Safety, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Duration of response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, city: Shanghai, country: China, contacts name: Baohui Han, M.D, role: CONTACT, email: 18930858216@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06332937, orgStudyIdInfo id: H-2102-079-1197, briefTitle: Breast Reconstruction, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-02-22, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction, conditionsModule conditions: Breast Implant; Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: postmastectomy breast reconstruction, outcomesModule primaryOutcomes measure: Infection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06332924, orgStudyIdInfo id: 2023/19, briefTitle: Primipara Pregnant Women and Motivational Interview, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data., conditionsModule conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: motivational discussion group, outcomesModule primaryOutcomes measure: Primipara Pregnant Women and Traumatic Birth, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332911, orgStudyIdInfo id: RO-231129, briefTitle: Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair, acronym: TEVAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-08-30, completionDateStruct date: 2026-08-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Rede Optimus Hospitalar SA, class: NETWORK, collaborators name: Shockwave Medical, Inc., descriptionModule briefSummary: Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR., conditionsModule conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, conditions: Abdominal Aortic Aneurysm Without Rupture, conditions: Thoracic Aortic Aneurysm Without Rupture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+, outcomesModule primaryOutcomes measure: Efficacy: Technical success - defined as intention-to-treat basis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332898, orgStudyIdInfo id: AG-01-0324, briefTitle: The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-02-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Athletic Greens International, class: INDUSTRY, collaborators name: Citruslabs, descriptionModule briefSummary: This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life., conditionsModule conditions: Nutrition, Healthy, conditions: Gastrointestinal Microbiome, conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-Blind, Placebo Controlled Design, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: AG1 - Nutritional Supplement, interventions name: Placebo, outcomesModule primaryOutcomes measure: Homocysteine, primaryOutcomes measure: Vitamin B12, primaryOutcomes measure: Folate, primaryOutcomes measure: Red Blood Cell Folate, primaryOutcomes measure: Zinc, primaryOutcomes measure: Vitamin C, primaryOutcomes measure: Gut Microbiome, secondaryOutcomes measure: Dietary habits, secondaryOutcomes measure: Gastrointestinal Health, secondaryOutcomes measure: Fatigue & energy, secondaryOutcomes measure: Well-being, secondaryOutcomes measure: Complete Metabolic Blood Panel, secondaryOutcomes measure: Complete Blood Count, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332885, orgStudyIdInfo id: 630-2001-01, briefTitle: Zephyr Valve Japan Post-Marketing Surveillance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Pulmonx Corporation, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months., conditionsModule conditions: Emphysema, conditions: COPD, conditions: Severe Emphysema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Zephyr Endobronchial Valve, outcomesModule primaryOutcomes measure: Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure., otherOutcomes measure: Forced Expiratory Volume in 1 second (FEV1), otherOutcomes measure: Residual Volume (RV), otherOutcomes measure: Treated lobe volume reduction (TLVR), otherOutcomes measure: Six-Minute Walk Distance (6MWD), otherOutcomes measure: Modified Medical Research Council Dyspnea (mMRC) Scale score, otherOutcomes measure: St. George's Respiratory Questionnaire (SGRQ) Total Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gifu Prefectural Medical Center, status: RECRUITING, city: Gifu, country: Japan, contacts name: Takahiro Masami, role: CONTACT, email: chiken-center.4289@gifu-hp.jp, contacts name: Fumihiro Asano, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.42291, lon: 136.76039, locations facility: Kanagawa Cardio Chest Center, status: RECRUITING, city: Kanagawa, country: Japan, contacts name: Takashi Niwa, MD, role: CONTACT, email: wanikko0714@gmail.com, contacts name: Takashi Niwa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.58333, lon: 139.91667, locations facility: Kanazawa University Hospital, status: RECRUITING, city: Kanazawa, country: Japan, contacts name: Satoshi Watanabe, MD, role: CONTACT, email: swatanabe@staff.kanazawa-u.ac.jp, contacts name: Satoshi Watanabe, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.6, lon: 136.61667, locations facility: St Marianna University Hospital, status: RECRUITING, city: Kawasaki, country: Japan, contacts name: Masamichi Mineshita, MD, role: CONTACT, email: m-mine@marianna-u.ac.jp, contacts name: Masamichi Mineshita, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Nagasaki University Hospital, status: RECRUITING, city: Nagasaki, country: Japan, contacts name: Keitaro Matsumoto, MD, role: CONTACT, email: kmatsumo@nagasaki-u.ac.jp, contacts name: Keitaro Matsumoto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.75, lon: 129.88333, locations facility: Nagoya Medical Center, status: RECRUITING, city: Nagoya, country: Japan, contacts name: Masahide Oki, MD, role: CONTACT, email: masahideo@gmail.com, contacts name: Masahide Oki, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Okayama Medical Center, status: RECRUITING, city: Okayama, country: Japan, contacts name: Yanagihara, role: CONTACT, email: okmc-iec@nifty.com, contacts name: Ken Sato, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.65, lon: 133.93333, locations facility: Kinki Chuo Chest Medical Center, status: RECRUITING, city: Osaka, country: Japan, contacts name: Akihiro Tamiya, MD, role: CONTACT, email: tamiya.akihiro.tz@mail.hosp.go.jp, contacts name: Akihiro Tamiya, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Hokkaido University Hospital, status: RECRUITING, city: Sapporo, country: Japan, contacts name: Naofumi Shinagawa, MD, role: CONTACT, email: naop.shinagawa@nifty.ne.jp, contacts name: Naofumi Shinagawa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tohoku University Hospital, status: RECRUITING, city: Sendai, country: Japan, contacts name: Hirotsugu Notsuda, MD, role: CONTACT, email: hirotsugu.notsuda.c4@tohoku.ac.jp, contacts name: Hirotsugu Notsuda, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.26667, lon: 140.86667, locations facility: Shiga University Hospital, status: RECRUITING, city: Shiga, country: Japan, contacts name: Yasuki Uchida, MD, role: CONTACT, email: uchiy@belle.shiga-med.ac.jp, contacts name: Yasuki Uchida, MD, role: PRINCIPAL_INVESTIGATOR, locations facility: Tokyo National Hospital, status: RECRUITING, city: Tokyo, country: Japan, contacts name: Hiroyuki Tashimo, MD, role: CONTACT, contacts name: Hiroyuki Tashimo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fujita Health University Hospital, status: RECRUITING, city: Toyoake, country: Japan, contacts name: Risako Koshiyama, role: CONTACT, email: gcpjim@fujita-hu.ac.jp, contacts name: Kazuyoshi Imaizumi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.038, lon: 136.99931, locations facility: Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology), status: NOT_YET_RECRUITING, city: Utsunomiya, country: Japan, contacts name: Yasuo Shimizu, MD, role: CONTACT, email: yasuo-s@dokkyomed.ac.jp, contacts name: Yasuo Shimizu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.56667, lon: 139.88333, locations facility: Dokkyo University Hospital, status: RECRUITING, city: Utsunomiya, country: Japan, contacts name: Masayuki Chida, MD, role: CONTACT, email: chidaths@dokkyomed.ac.jp, contacts name: Masayuki Chida, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.56667, lon: 139.88333, hasResults: False
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protocolSection identificationModule nctId: NCT06332872, orgStudyIdInfo id: M046q/66, briefTitle: Comparison Effectiveness of Oral Ivermectin, 1% Permethrin Shampoo and 4% Dimeticone Liquid Gel in the Treatment of Pediculosis Capitis Among School Children in Chachoengsao Province, Thailand, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-03-18, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Phramongkutklao College of Medicine and Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to Comparison effectiveness of Oral ivermectin, 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, to assess the prevalence of lice and associated risk factors between severity groups by using questionnaire-based surveys and diagnostic tests among school children in Baan Nayao, Chachoengsao Province, Thailand.The main questions it aims to answer are* What is more effective between Oral ivermectin, 1% Permethrin shampoo and 4%Dimeticone liquid gel in the treatment of Pediculosis capitis in school children in Baan Nayao, Chachoengsao Province, Thailand?* What is Prevalence and risk factors of being infected with in head lice in school and community?* What is Side effects of Oral ivermectin, 1% Permethrin shampoo and 4%Dimeticone liquid gel?Participants will receive three different drugs are* oral ivermectin* 4% Dimeticone liquid gel* 1% Permethrin shampooParticipants voluntarily received oral ivermectin as per medical prescription, with treatment outcomes, side effects, and satisfaction levels monitored following two treatment cycles. Those exhibiting persistent lice infestations were subsequently treated with 1% permethrin shampoo, the standard treatment, while alternatives were provided for individuals allergic to permethrin. These findings will contribute to formulating tailored, effective, and safe treatment regimens for future patients., conditionsModule conditions: Pediculus Capitis Infestation, conditions: Permethrin Adverse Reaction, conditions: Dimethicone Adverse Reaction, conditions: Permethrin Allergy, conditions: Dimethicone Allergy, conditions: Ivermectin, conditions: School-age Children, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: Oral Ivermectin, interventions name: 4% dimenticone liquid gel, outcomesModule primaryOutcomes measure: Comparison effectiveness of Oral ivermectin, 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, secondaryOutcomes measure: Prevalence of head louse infestation among school children in Chachoengsao Province, Thailand, secondaryOutcomes measure: Side effects of Oral ivermectin, 1% Permethrin shampoo and 4%Dimeticone liquid gel, secondaryOutcomes measure: The association factor of head lice infestation among school children in Chachoengsao Province, Thailand, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Phramongkutklao college of medicine, city: Bangkok, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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