data
stringlengths 358
80.8k
|
|---|
protocolSection identificationModule nctId: NCT06366659, orgStudyIdInfo id: M2024049, briefTitle: Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-08-20, completionDateStruct date: 2025-08-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, collaborators name: Peking University Third Hospital, descriptionModule briefSummary: This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP., conditionsModule conditions: Intrahepatic Cholestasis of Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Progesterone metabolites (levels in plasma), primaryOutcomes measure: Itch intensity, secondaryOutcomes measure: Total bile acids (levels in plasma), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Guangyi Lan, role: CONTACT, phone: 13176881226, email: Guangyi_lan@stu.pku.edu.cn, contacts name: Yulong Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Yuan Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Sichuan University West China Second University Hospital, city: Chengdu, state: Sichuan, zip: 610001, country: China, contacts name: Guangyi Lan, role: CONTACT, phone: 13176881226, email: Guangyi_lan@stu.pku.edu.cn, contacts name: Yaoyao Zhang, role: PRINCIPAL_INVESTIGATOR, contacts name: Xue Xiao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
|
protocolSection identificationModule nctId: NCT06366646, orgStudyIdInfo id: 035901, briefTitle: Competency-based Intervention for Head Nurses, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness., conditionsModule conditions: Intervention, conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A quasi-experimental design, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Competency-based intervention, outcomesModule primaryOutcomes measure: Questionnaire to measure head nurses' knowledge of leadership competency, primaryOutcomes measure: Questionnaire to measure head nurses' ability to use leadership competency, primaryOutcomes measure: Questionnaire to measure leadership effectiveness, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Mersa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
|
protocolSection identificationModule nctId: NCT06366633, orgStudyIdInfo id: 2024P000713, secondaryIdInfos id: 1K23AT012364-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23AT012364-01, briefTitle: Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Jafar Bakhshaie, class: OTHER, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use.Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT.Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations., conditionsModule conditions: Orthopedic Disorder, conditions: Nontraumatic Injury, conditions: Substance Use, conditions: Upper Extremity Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Web-TIRELESS, outcomesModule primaryOutcomes measure: Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment, primaryOutcomes measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery, primaryOutcomes measure: The percent of patients that agree to participate to assess feasibility of recruitment, primaryOutcomes measure: Rate at which program was accepted, measured by attendance to assess acceptability of treatment, primaryOutcomes measure: Adherence to homework, primaryOutcomes measure: Rate of participant's completion of self-report measures to assess feasibility of assessments, primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Graded Chronic Pain Scale (GCPS), secondaryOutcomes measure: Disabilities of the Arm, Shoulder and Hand (DASH), secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0, secondaryOutcomes measure: PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0, secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Pain Anxiety Symptoms Scale - Short Form (PASS-20), secondaryOutcomes measure: Pain Vigilance and Awareness Questionnaire (PVAQ), secondaryOutcomes measure: Brief Experiential Avoidance Questionnaire (BEAQ), secondaryOutcomes measure: Current Opioid Misuse Measure (COMM), secondaryOutcomes measure: The Timeline Follow Back (TLFB), secondaryOutcomes measure: Numerical Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02129, country: United States, contacts name: Jafar Bakhshaie, MD, PhD, role: CONTACT, phone: 617-643-7641, email: jbakhshaie@mgh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06366620, orgStudyIdInfo id: STUDY00003416, briefTitle: Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-06-19, completionDateStruct date: 2024-06-19, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, descriptionModule briefSummary: Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports., conditionsModule conditions: Child Disruptive Behavior Disorders, conditions: Parent Child Relationship, conditions: Parent Management Training, conditions: Peer Support, conditions: Child Behavior Problems, conditions: Challenging Behavior, conditions: Positive Parenting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FAST-B PEERS, interventions name: FAST-B (First Approach Skills Training - Behavior), outcomesModule primaryOutcomes measure: Acceptability of FAST-B PEERS, primaryOutcomes measure: Acceptability of FAST-B, primaryOutcomes measure: FAST-B PEERS support calls attended, secondaryOutcomes measure: Weekly Assessment of Child Behavior - P, secondaryOutcomes measure: Coping with Child Negative Emotions Scale, secondaryOutcomes measure: Strengths and Difficulties Questionnaire, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seattle Children's, status: RECRUITING, city: Seattle, state: Washington, zip: 98115, country: United States, contacts name: Doug Mason, role: CONTACT, phone: 206-987-7000, email: doug.mason@seattlechildrens.org, contacts name: Alissa D Hemke, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
|
protocolSection identificationModule nctId: NCT06366607, orgStudyIdInfo id: 0306066, briefTitle: Managing High-alert Medication Administration and Errors, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2023-05-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff., conditionsModule conditions: Knowledge, conditions: Practice Nurse's Scope, conditions: Competence, conditions: Nurse's Role, conditions: Error Disclosure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: high-alert medication administration, outcomesModule primaryOutcomes measure: Questionnaire to measure nurses' knowledge about high-alert medication administration, primaryOutcomes measure: Questionnaire to measure medication safety climate, primaryOutcomes measure: Questionnaire to measure nurses' competency, primaryOutcomes measure: observational check list to measure nurses' practice during administration of high-alert medications, primaryOutcomes measure: Questionnaire to measure errors associated with administering high-alert medications, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Mersa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
|
protocolSection identificationModule nctId: NCT06366594, orgStudyIdInfo id: 0305897, briefTitle: First-line Nurse Manager Authentic Leadership Training Program, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes., conditionsModule conditions: Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: A quasi-experimental research design, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: Authentic leadership training program, outcomesModule primaryOutcomes measure: Questionnaire to measure first-line nurse managers' knowledge about authentic leadership, primaryOutcomes measure: questionnaire to measure authentic leadership behavior among first-line nurse managers, primaryOutcomes measure: Questionnaire to measure nursing care self-efficacy, primaryOutcomes measure: Questionnaire to measure nurses' trust in their workplace, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Mersa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
|
protocolSection identificationModule nctId: NCT06366581, orgStudyIdInfo id: HD20240307, briefTitle: Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix., conditionsModule conditions: Incisional Hernia, conditions: Extracellular Matrix Alteration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Transcriptomic analysis, outcomesModule primaryOutcomes measure: the gene expression list, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hua Dong Hospital Affiliated to Fu Dan University, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06366568, orgStudyIdInfo id: CRO-2022-10-PG-MER-MW-JG, briefTitle: Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-03-06, completionDateStruct date: 2024-03-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Colgate Palmolive, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial., conditionsModule conditions: Plaque, Dental, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ACTUAL, armsInterventionsModule interventions name: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product, interventions name: fluoride toothpaste containing 1450 ppm of MFP in a PCC base, outcomesModule primaryOutcomes measure: Turesky Modification of the Quigley & Hein Plaque Index, secondaryOutcomes measure: questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras, city: Dresden, zip: 01307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, hasResults: False
|
protocolSection identificationModule nctId: NCT06366555, orgStudyIdInfo id: 24-02-0268, briefTitle: The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-06-22, completionDateStruct date: 2024-06-22, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do, it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training, conditionsModule conditions: Muscle Soreness, conditions: Stiffness of Elbow, Not Elsewhere Classified, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This research design used a randomized controlled single-blind crossover trial method (Crossover Single Blinded Randomized Control Trial). Reasons for choosing to use the Crossover method because apart from being able to implement it, it can also provide far more output results with a smaller number of subjects.The research subjects will then receive two treatments spaced 1 week apart which is called a wash out period to eliminate the carry-over effect of the treatment given. Research subjects will undergo randomization . Subjects in group A will undergo manual twisting acupuncture followed by sham manual acupuncture. The subject in group B will receive a sham acupuncture manual followed by a round of manual acupuncture twirling, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The Participant will be randomized using a computerized table and the Outcome Assessor dont know which Subjects receive the manual acupuncture twirling or sham manual acupuncture on each period, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Manual Acupuncture Twirling,, interventions name: Manual Acupuncture Sham, outcomesModule primaryOutcomes measure: Visual Analog Scale, secondaryOutcomes measure: Pain Pressure Threshold, otherOutcomes measure: Range of Motion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower, city: Jakarta, state: DKI Jakarta, zip: 10430, country: Indonesia, contacts name: IMERI, Research Center, role: CONTACT, phone: 29189160, geoPoint lat: -6.21462, lon: 106.84513, hasResults: False
|
protocolSection identificationModule nctId: NCT06366542, orgStudyIdInfo id: 2/2024, briefTitle: Virtual Reality in People With Persistent Postural-Perceptual Dizziness: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Jordan, class: OTHER, descriptionModule briefSummary: This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD). The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation. The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks. The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life., conditionsModule conditions: Vestibular Dizziness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: Vestibular rehabilitation therapy, interventions name: Virtual reality exercises, interventions name: Optokinetic Stimulation exercises, outcomesModule primaryOutcomes measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ), primaryOutcomes measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ), primaryOutcomes measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ), primaryOutcomes measure: Dizziness Handicap Inventory (DHI), primaryOutcomes measure: Dizziness Handicap Inventory (DHI), primaryOutcomes measure: Falls Efficacy Scale International (FES-I), primaryOutcomes measure: Falls Efficacy Scale International (FES-I), primaryOutcomes measure: Dynamic Gait Index (DGI), primaryOutcomes measure: Dynamic Gait Index (DGI), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Medical Outcomes Study Short Form 12 (SF-12), secondaryOutcomes measure: Medical Outcomes Study Short Form 12 (SF-12), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Medical Services, city: Amman, country: Jordan, geoPoint lat: 31.95522, lon: 35.94503, hasResults: False
|
protocolSection identificationModule nctId: NCT06366529, orgStudyIdInfo id: TJ-IRB202308123, briefTitle: Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2030-09, completionDateStruct date: 2030-09, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Zhen Li, class: OTHER, descriptionModule briefSummary: Currently, renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis, but it is invasive and carries the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias. The lack of reliable, comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs. Therefore, the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved.With the continuous development and update of technology, imaging provides a new way to non-invasively evaluate renal fibrosis. Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis, magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes. Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status, physical properties, and molecular properties of the kidney.In recent years, in the context of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis. It can extract and learn features in images with high throughput, make greater use of information in medical images that cannot be recognized by the human eye, and achieve disease diagnosis, prognosis assessment, and efficacy prediction by building models. However, most of the current research is in the preliminary stage, and there are still few studies on the assessment of renal insufficiency and renal fibrosis. I believe that with the continuous improvement of algorithms and the optimization of models, the progress of radiomics and machine learning will be great. To a certain extent, it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis., conditionsModule conditions: Renal Insufficiency, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: ESKD, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji hospital, NO.1095 jiefang avenue, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430074, country: China, contacts name: Zhen Li, Doctor, role: CONTACT, email: zhenli@hust.edu.cn, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
|
protocolSection identificationModule nctId: NCT06366516, orgStudyIdInfo id: FUOBGY2024-23, briefTitle: Role of Methylation Test Triage in HPV Positive Women, acronym: MTTRIHPW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Obstetrics & Gynecology Hospital of Fudan University, class: OTHER, collaborators name: Peking Union Medical College Hospital, collaborators name: Chengdu Women's and Children's Central Hospital, collaborators name: Guangdong Women and Children Hospital, collaborators name: Second Hospital of Jilin University, collaborators name: First Affiliated Hospital of Xinjiang Medical University, collaborators name: Third Affiliated Hospital of Zhengzhou University, descriptionModule briefSummary: The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening., conditionsModule conditions: Precancerous Cervical Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Methylation Test, outcomesModule primaryOutcomes measure: The sensitivity and specificity of methylation test in detecting CIN2+., secondaryOutcomes measure: KAPPA value of methylation test., eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Obstetrics and Gynecology Hospital of Fudan University, city: Shanghai, state: Shanghai, zip: 200011, country: China, contacts name: Long Sui, Professor, role: CONTACT, phone: 0086-021-33189900, email: suilong@fudan.edu.cn, contacts name: Qing Cong, PHD, role: CONTACT, phone: 0086-021-33189900, email: qingcong@fudan.edu.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06366503, orgStudyIdInfo id: RS-2023-05, briefTitle: Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-03, primaryCompletionDateStruct date: 2023-12-29, completionDateStruct date: 2023-12-29, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Revision Skincare, class: INDUSTRY, descriptionModule briefSummary: This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device.A total of 22 healthy female subjects completed the study., conditionsModule conditions: Photoaging, conditions: Wrinkle, conditions: Skin Laxity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Single-Center, Double-Blinded, Split-Face, Controlled, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator anhydrous formulation on the opposite side of the face.The products were packaged in the same container and labelled post-procedure cream. This was a double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety were blinded to group during the study., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule interventions name: Fractional Ablative CO2 Laser, interventions name: Facial Cleanser, interventions name: Facial Moisturizer, interventions name: Sunscreen, interventions name: Basic Ointment, outcomesModule primaryOutcomes measure: Investigator Tolerability, primaryOutcomes measure: Incidence of Adverse Events, primaryOutcomes measure: Subject Tolerability, secondaryOutcomes measure: Self-Assessment Questionnaire, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Dermatology Group, city: Blue Ash, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.232, lon: -84.37827, hasResults: False
|
protocolSection identificationModule nctId: NCT06366490, orgStudyIdInfo id: CIP2023-001, briefTitle: Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy in Recurrent Epithelial Ovarian Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: PhotonPharma, Inc., class: INDUSTRY, descriptionModule briefSummary: Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer, conditionsModule conditions: Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study is a 2-part design. For each participant, Part 1 will involve tissue procurement and confirmation of the ability to manufacture the Innocell vaccine, followed by Part 2 which is the treatment phase, involving Innocell administration to patients., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label Phase I trial with no masking, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Innocell Autologous Cellular Immunotherapy, outcomesModule primaryOutcomes measure: Saferty and Immunogenicity of Innocell in Ovarian Cancer Patients, primaryOutcomes measure: Safety of Innocell in Ovarian Cancer Patients, primaryOutcomes measure: Immunogenicity of Innocell in Ovarian Cancer Patients, primaryOutcomes measure: Immunogemicity in Ovarian Cancer Patients, primaryOutcomes measure: Immunogenicity of Innocell Vaccine in Ovarian Cancer Patients, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06366477, orgStudyIdInfo id: B-ER-103-417, briefTitle: Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-01, primaryCompletionDateStruct date: 2019-06-15, completionDateStruct date: 2019-11-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores., conditionsModule conditions: Rehabilitation, conditions: Stroke, conditions: Hand Grasp, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ACTUAL, armsInterventionsModule interventions name: Vibration stimulation combined with task-oriented training, outcomesModule primaryOutcomes measure: Fugl-Meyer assessment - wrist and hand, primaryOutcomes measure: Box and Blocks Test, primaryOutcomes measure: Motor Activity Log, primaryOutcomes measure: Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06366464, orgStudyIdInfo id: HBS-101-CL-312, briefTitle: A Study of Pitolisant in Patients With Prader-Willi Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Harmony Biosciences, LLC, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.Secondary objectives include assessing the impact of pitolisant on:* Irritable and disruptive behaviors* Hyperphagia* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech, conditionsModule conditions: Prader-Willi Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: Pitolisant tablet, interventions name: Placebo tablet, outcomesModule primaryOutcomes measure: Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score, secondaryOutcomes measure: Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain, secondaryOutcomes measure: Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS), secondaryOutcomes measure: Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS), secondaryOutcomes measure: Change in overall severity of irritable and disruptive behaviors as measured by the Caregiver Global Impression of Severity (CaGI-S) for Irritable and/or Disruptive Behaviors, secondaryOutcomes measure: Change in severity of hyperphagia as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), in conjunction with the Food Safe Zone Questionnaire (FSZQ), secondaryOutcomes measure: Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score, secondaryOutcomes measure: Change in severity of other behavioral problems as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Hyperactivity/Noncompliance, Inappropriate Speech, Social Withdrawal, and Stereotypic Behavior Domains, secondaryOutcomes measure: Percentage of patients reporting TEAEs, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Santa Monica Clinical Trials, status: RECRUITING, city: Los Angeles, state: California, zip: 90025, country: United States, contacts name: Daniel Norman, MD, role: CONTACT, contacts name: Pooja Patel, role: CONTACT, phone: (310) 586-0843, email: ppatel@smclinicaltrials.com, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Atlanta Diabetes Associates, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, contacts name: David G. Robertson, MD, role: CONTACT, contacts name: Amanda Maxson, role: CONTACT, phone: (404) 844-7775, email: amaxson@atlantadiabetes.com, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
|
protocolSection identificationModule nctId: NCT06366451, orgStudyIdInfo id: MST01-AZN-05, secondaryIdInfos id: PBI-MST-01, type: OTHER, domain: Presage Biosciences, briefTitle: PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Presage Biosciences, class: INDUSTRY, collaborators name: AstraZeneca, descriptionModule briefSummary: This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This is a cohort substudy of a Master Protocol (PBI-MST-01, NCT04541108) framework, under which comparisons will not be made between substudy cohorts., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Rilvegostomig, interventions name: Volrustomig, interventions name: Sabestomig, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab, secondaryOutcomes measure: Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UC Davis, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Clinical Research Supervisor, role: CONTACT, contacts name: Arnaud Bewley, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: LSU Health Sciences Center - Shreveport, city: Shreveport, state: Louisiana, zip: 71115, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 32.52515, lon: -93.75018, locations facility: Montefiore Medical Center, city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 40.84985, lon: -73.86641, locations facility: University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Oregon Health & Science University (OHSU), city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 45.52345, lon: -122.67621, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Sarah Cannon Medical Center, city: Charleston, state: South Carolina, zip: 29406, country: United States, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False
|
protocolSection identificationModule nctId: NCT06366438, orgStudyIdInfo id: ABC vs Parentweb, briefTitle: A Trial of Two Universal Programs for Parents of Teenagers, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-11, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-03-24, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: Parent training programs in groups and over internet can help parents improve their interaction and communication with their children. There is however a lack knowledge of how programs work for parents of teenagers, as most studies have concerned younger children. Furthermore, most studies have been conducted on programs for selective populations with elevated risk. The aim of this study was to investigate the effectiveness of two universal preventive parenting programs for teenagers: The group-based program 'ABC-teen' and the online-based 'ParentWeb'. Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication. The programs are developed in Sweden with content based on other established parenting programs (e.g., Comet, Incredible Years, the Triple P). The aim of the present study was to evaluate the effects of the the two programs, with adolescent mental health as primary outcome. Several secondary outcome measures concerning parenting and parent-adolescent relationship were also collected. Parents were randomized to ABC-teen, ParentWeb or a 6 months Wait-List control. Parent- and adolescent ratings were collected at baseline, after 4 and after 12 months. All data collection has now been completed and the next step is to process and analyze the data., conditionsModule conditions: Mental Health Issue, conditions: Mental Disorder, conditions: Adolescent Behavior, conditions: Adolescent Development, conditions: Parent-Child Relations, conditions: Parenting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are randomized to one of the three arms upon allocation., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1247, type: ACTUAL, armsInterventionsModule interventions name: ABC-teen, interventions name: ParentWeb, outcomesModule primaryOutcomes measure: The Strength and Difficulties Questionnaire (SDQ), primaryOutcomes measure: Patient Health Questionnaire (PHQ-9), primaryOutcomes measure: Parental stress scale (PSS), primaryOutcomes measure: General Anxiety Disorder Scale (GAD-7), secondaryOutcomes measure: Conflict scale, secondaryOutcomes measure: Adult Child Relationship Scale (ACRS), secondaryOutcomes measure: Adolescents' openness scale, secondaryOutcomes measure: Brief Family Relationship Scale, secondaryOutcomes measure: Positive and Negative Parenting Behaviors, secondaryOutcomes measure: Me as a Parent, secondaryOutcomes measure: Conflict Resolution Efficacy, secondaryOutcomes measure: School Adjustment Scale, secondaryOutcomes measure: Stockholmsenkaten, secondaryOutcomes measure: Satisfaction Questionnaire, secondaryOutcomes measure: Attendance and engagement measures, otherOutcomes measure: Demographics, otherOutcomes measure: Organizational and therapist factors, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Bromma stadsdel, city: Bromma, zip: 16867, country: Sweden, geoPoint lat: 59.34, lon: 17.94, locations facility: Danderyd kommun, city: Danderyd, zip: 18231, country: Sweden, geoPoint lat: 59.3987, lon: 18.02942, locations facility: Ovanåkers kommun, city: Edsbyn, zip: 82831, country: Sweden, geoPoint lat: 61.37692, lon: 15.81747, locations facility: Farsta stadsdel, city: Farsta, zip: 12347, country: Sweden, geoPoint lat: 59.24423, lon: 18.09088, locations facility: Värmdö kommun, city: Gustavsberg, zip: 13430, country: Sweden, geoPoint lat: 59.32684, lon: 18.38975, locations facility: Göteborgs kommun, city: Göteborg, zip: 41140, country: Sweden, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Götene kommun, city: Götene, zip: 53380, country: Sweden, geoPoint lat: 58.52824, lon: 13.49458, locations facility: Hallsbergs kommun, city: Hallsberg, zip: 69480, country: Sweden, geoPoint lat: 59.06463, lon: 15.10993, locations facility: Haninge kommun, city: Handen, zip: 13640, country: Sweden, geoPoint lat: 59.16809, lon: 18.13796, locations facility: Huddinge kommun, city: Huddinge, zip: 14161, country: Sweden, geoPoint lat: 59.23705, lon: 17.98192, locations facility: Hägersten-Älvsjö stadsdel, city: Hägersten, zip: 12626, country: Sweden, geoPoint lat: 59.30586, lon: 17.98719, locations facility: Tellusborgsskolan, city: Hägersten, zip: 12649, country: Sweden, geoPoint lat: 59.30586, lon: 17.98719, locations facility: Aspuddens skola, city: Hägersten, zip: 12655, country: Sweden, geoPoint lat: 59.30586, lon: 17.98719, locations facility: Hässelby Vällingby stadsdel, city: Hässelby, zip: 16555, country: Sweden, locations facility: Höörs kommun, city: Höör, zip: 24331, country: Sweden, geoPoint lat: 55.93444, lon: 13.5385, locations facility: Järfälla kommun, city: Jakobsberg, zip: 17757, country: Sweden, geoPoint lat: 59.42268, lon: 17.83508, locations facility: Skarpnäck stadsdel, city: Johanneshov, zip: 12153, country: Sweden, geoPoint lat: 59.29999, lon: 18.07903, locations facility: Enskede Årsta Vantör stadsdel, city: Johanneshov, zip: 12162, country: Sweden, geoPoint lat: 59.29999, lon: 18.07903, locations facility: Karlsborgs kommun, city: Karlsborg, zip: 54630, country: Sweden, geoPoint lat: 58.53724, lon: 14.5047, locations facility: Upplands-Bro kommun, city: Kungsängen, zip: 19640, country: Sweden, geoPoint lat: 59.47857, lon: 17.74834, locations facility: Kungälvs kommun, city: Kungälv, zip: 44281, country: Sweden, geoPoint lat: 57.87096, lon: 11.98054, locations facility: Leksands kommun, city: Leksand, zip: 79331, country: Sweden, geoPoint lat: 60.7303, lon: 14.99994, locations facility: Lidingö kommun, city: Lidingö, zip: 18182, country: Sweden, geoPoint lat: 59.36667, lon: 18.13333, locations facility: Lidköpings kommun, city: Lidköping, zip: 53132, country: Sweden, geoPoint lat: 58.50517, lon: 13.15765, locations facility: Lilla Edets kommun, city: Lilla Edet, zip: 46330, country: Sweden, geoPoint lat: 58.13333, lon: 12.13333, locations facility: Lindesbergs kommun, city: Lindesberg, zip: 71135, country: Sweden, geoPoint lat: 59.59202, lon: 15.2304, locations facility: Linköpings kommun, city: Linköping, zip: 58232, country: Sweden, geoPoint lat: 58.41086, lon: 15.62157, locations facility: Lomma kommun, city: Lomma, zip: 23431, country: Sweden, geoPoint lat: 55.67244, lon: 13.06849, locations facility: Lunds kommun, city: Lund, zip: 22223, country: Sweden, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Mariestads kommun, city: Mariestad, zip: 54230, country: Sweden, geoPoint lat: 58.70971, lon: 13.82367, locations facility: Sigtuna kommun, city: Märsta, zip: 19547, country: Sweden, geoPoint lat: 59.62157, lon: 17.85476, locations facility: Nacka kommun, city: Nacka, zip: 13157, country: Sweden, geoPoint lat: 59.31053, lon: 18.16372, locations facility: Norrköpings kommun, city: Norrköping, zip: 60224, country: Sweden, geoPoint lat: 58.59419, lon: 16.1826, locations facility: Norrtälje kommun, city: Norrtälje, zip: 76128, country: Sweden, geoPoint lat: 59.75799, lon: 18.70496, locations facility: Nynäshamns kommun, city: Nynäshamn, zip: 14931, country: Sweden, geoPoint lat: 58.90337, lon: 17.94793, locations facility: Skellefteå kommun, city: Skellefteå, zip: 93131, country: Sweden, geoPoint lat: 64.75067, lon: 20.95279, locations facility: Skärholmen stadsdel, city: Skärholmen, zip: 12748, country: Sweden, geoPoint lat: 59.27549, lon: 17.90196, locations facility: Skövde kommun, city: Skövde, zip: 54183, country: Sweden, geoPoint lat: 58.39118, lon: 13.84506, locations facility: Sollentuna kommun, city: Sollentuna, zip: 19147, country: Sweden, geoPoint lat: 59.42804, lon: 17.95093, locations facility: Stenungsunds kommun, city: Stenungsund, zip: 44431, country: Sweden, geoPoint lat: 58.07046, lon: 11.8181, locations facility: Kungsholmen stadsdel, city: Stockholm, zip: 11218, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Norra Real, city: Stockholm, zip: 11355, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Norrmalm stadsdel, city: Stockholm, zip: 11526, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Östermalm stadsdel, city: Stockholm, zip: 11526, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Södermalm stadsdel, city: Stockholm, zip: 12030, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: MFJ Hammarby Sjöstad, city: Stockholm, zip: 12068, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Sundbybergs stad, city: Sundbyberg, zip: 17458, country: Sweden, geoPoint lat: 59.36128, lon: 17.97114, locations facility: Sundsvalls kommun, city: Sundsvall, zip: 85232, country: Sweden, geoPoint lat: 62.39129, lon: 17.3063, locations facility: Sävsjö kommun, city: Sävsjö, zip: 57631, country: Sweden, geoPoint lat: 57.40327, lon: 14.66244, locations facility: Tidaholms kommun, city: Tidaholm, zip: 52231, country: Sweden, geoPoint lat: 58.18035, lon: 13.95824, locations facility: Trelleborgs kommun, city: Trelleborg, zip: 23142, country: Sweden, geoPoint lat: 55.37514, lon: 13.15691, locations facility: Botkyrka kommun, city: Tumba, zip: 147 41, country: Sweden, geoPoint lat: 59.19858, lon: 17.83317, locations facility: Täby kommun, city: Täby, zip: 18339, country: Sweden, geoPoint lat: 59.4439, lon: 18.06872, locations facility: Töreboda kommun, city: Töreboda, zip: 54530, country: Sweden, geoPoint lat: 58.70739, lon: 14.12597, locations facility: Vallentuna kommun, city: Vallentuna, zip: 18686, country: Sweden, geoPoint lat: 59.53436, lon: 18.07758, locations facility: Gotlands kommun, city: Visby, zip: 12142, country: Sweden, geoPoint lat: 57.64089, lon: 18.29602, locations facility: Vällingbyskolan, city: Vällingby, zip: 16264, country: Sweden, geoPoint lat: 59.36441, lon: 17.87407, locations facility: Växjö kommun, city: Växjö, zip: 35230, country: Sweden, geoPoint lat: 56.87767, lon: 14.80906, hasResults: False
|
protocolSection identificationModule nctId: NCT06366425, orgStudyIdInfo id: RECHMPL23_0272, briefTitle: Screening for Chronic Liver Diseases in General Population, acronym: HEPGEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: On-call medical home (MMG) Clermont-Hérault, descriptionModule briefSummary: Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care., conditionsModule conditions: Fibrosis, Liver, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample then fibroscan, outcomesModule primaryOutcomes measure: Evaluation of the liver fibrosis screening acceptability (FIB-4), primaryOutcomes measure: Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan), secondaryOutcomes measure: Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>2.67, secondaryOutcomes measure: Prevalence of excessive consumption of alcohol, secondaryOutcomes measure: Prevalence of a history or drug use, secondaryOutcomes measure: The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders), secondaryOutcomes measure: prevalence of viral hepatitis, secondaryOutcomes measure: Description of socio-demographic characteristics of participants, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Montpellier, city: Montpellier, zip: 34295, country: France, contacts name: Magdalena MESZAROS, MD, role: CONTACT, phone: : 04 67 33 02 57, email: m-meszaros@chu-montpellier.fr, contacts name: Magdalena MESZAROS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
|
protocolSection identificationModule nctId: NCT06366412, orgStudyIdInfo id: serum Tau-217 in elderly, briefTitle: Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Minia University Hospital, class: OTHER, descriptionModule briefSummary: To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia., conditionsModule conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine Hydrochloride, interventions name: normal saline, outcomesModule primaryOutcomes measure: the effect of dexmedetomidine on serum Tau-217 protein value., secondaryOutcomes measure: to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group., otherOutcomes measure: Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours, otherOutcomes measure: Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arwa Essam, status: RECRUITING, city: Minya, zip: 61111, country: Egypt, contacts name: Arwa essam Essam, assistant lecturer, role: CONTACT, phone: +201017565658, email: arwty26@gmail.com, geoPoint lat: 28.10988, lon: 30.7503, hasResults: False
|
protocolSection identificationModule nctId: NCT06366399, orgStudyIdInfo id: 00156659, briefTitle: The Acute T-Rex (Timing of Resistance Exercise) Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \~1.5 hours after habitual wake, and PM exercise will occur \~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Insulin Resistance, conditions: Glucose Intolerance, conditions: Sleep Disturbance, conditions: Overweight or Obesity, conditions: Insulin Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Resistance Exercise Timing, outcomesModule primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Sleep Duration, otherOutcomes measure: Sleep Staging, otherOutcomes measure: Sleep Quality, otherOutcomes measure: Sleep Efficiency, otherOutcomes measure: Muscular Strength, otherOutcomes measure: Perceived Hunger, otherOutcomes measure: Perceived Fullness, otherOutcomes measure: Perceived Prospective Food Consumption, otherOutcomes measure: Glucose Area Under Curve, otherOutcomes measure: Insulin Area Under Curve, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah HPER E Buildling, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Jason V Thomas, MS, role: CONTACT, email: jason.v.thomas@utah.edu, contacts name: Tanya M Halliday, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
|
protocolSection identificationModule nctId: NCT06366386, orgStudyIdInfo id: 5K43TW011963-03, type: NIH, link: https://reporter.nih.gov/quickSearch/5K43TW011963-03, briefTitle: Integrating Hypertension Management in DSD for HIV, acronym: HTN-DSD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Infectious Diseases Research Collaboration, Uganda, class: OTHER, descriptionModule briefSummary: The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are:1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care?2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care?3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda?4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda?5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda?6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda., conditionsModule conditions: Hypertension, conditions: HIV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Screening and treatment of hypertension among PLHIV in DSD models for HIV, outcomesModule primaryOutcomes measure: Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure), primaryOutcomes measure: % of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure), secondaryOutcomes measure: Mean blood pressure (both systolic and diastolic blood pressure), secondaryOutcomes measure: Number and % of hypertensive PLHIV with suppressed Viral load, secondaryOutcomes measure: Number and % of patients retained in care, secondaryOutcomes measure: Number and % of PLHIV screened for HTN at least once in six months, secondaryOutcomes measure: Implementation costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Infectious Diseases Research Collaborations (IDRCUganda), city: Kampala, state: Central, zip: +256, country: Uganda, contacts name: Martin Muddu, MMED, role: CONTACT, phone: +256774004308, email: muddu.martin@gmail.com, geoPoint lat: 0.31628, lon: 32.58219, hasResults: False
|
protocolSection identificationModule nctId: NCT06366373, orgStudyIdInfo id: 531118232022, briefTitle: An Evaluation on a Mental Health Art Exhibition's Impact on Reducing Stigma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Hunan University, class: OTHER, collaborators name: Central South University, descriptionModule briefSummary: Mental health art exhibitions, as an intervention strategy integrating artistic expression and social contact, have the potential to positively impact the elimination of stigma and discrimination associated with mental health problems. This study will utilize a real-world quasi-randomized controlled trial design and a 6-month follow-up questionnaire survey to evaluate the intervention's impact on stigma/discrimination and related outcomes, such as mental health literacy. The evaluation will encompass four categories of people: those with lived experience of mental disorders, family members and friends of those with lived experience, health professionals, and the general public. Additionally, the cost-effectiveness of the art exhibition intervention will be analyzed., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The interventional study model for this clinical trial is a quasi-randomized controlled trial design. The intervention is the exhibition, organized by "Qixi Charity," will publicly display offline artworks reflecting the diverse dimensions of mental health and ill-health. In contrast, the control group in this study will receive either printed or online educational materials, serving as a more traditional educational intervention. The study will include a baseline survey before the interventions (T0), a follow-up survey in the first month after the interventions (T1), and a follow-up survey in the sixth month after the interventions (T2) in both the experimental group (those who attend the offline exhibition) and the control group (those who are unable to attend the exhibition but will be provided with printed/online education materials)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: A mental health art exhibition, interventions name: printed or online education materials, outcomesModule primaryOutcomes measure: Stigma/discrimination regarding mental disorders, secondaryOutcomes measure: mental health literacy, otherOutcomes measure: intervention costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06366360, orgStudyIdInfo id: Piano-Neglect, briefTitle: Immersive Virtual Reality Treatment for Unilateral Spatial Neglect, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hopitaux de Saint-Maurice, class: OTHER, descriptionModule briefSummary: Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space.The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol.To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided., conditionsModule conditions: Stroke, conditions: Unilateral Spatial Neglect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each patient was assigned to a group that received 2 rehabilitations for 4 weeks, 1) both Immersive virtual reality therapy and a conventional rehabilitation first, and then conventional rehabilitation alone, or 2) A conventional rehabilitation alone and then both Immersive virtual reality therapy, and conventional rehabilitation., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Immersive Virtual Reality Intervention, interventions name: Conventional rehabilitation, outcomesModule primaryOutcomes measure: Bells Test, primaryOutcomes measure: Mesulam cancellation Task, primaryOutcomes measure: Bisection Test, primaryOutcomes measure: Copying Test, primaryOutcomes measure: Scene description Task, primaryOutcomes measure: Ecological scale of daily life activities, primaryOutcomes measure: Piano bisection Task, primaryOutcomes measure: Identifying the keys at the ends of the piano, primaryOutcomes measure: Virtual reality Bells Test, primaryOutcomes measure: Auditory Stimuli Localization Task in virtual reality, primaryOutcomes measure: Ecological virtual reality bisection task, primaryOutcomes measure: Virtual reality Baking Tray test, secondaryOutcomes measure: Mood assessment, secondaryOutcomes measure: Situational motivation questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpitaux de Saint-Maurice, status: RECRUITING, city: Saint-Maurice, zip: 94410, country: France, contacts name: Secretary, role: CONTACT, phone: 01 43 96 68 22, phoneExt: +33, email: secretariat.ssrneuro@ght94n.fr, geoPoint lat: 48.82182, lon: 2.42716, hasResults: False
|
protocolSection identificationModule nctId: NCT06366347, orgStudyIdInfo id: 23-695, briefTitle: ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: Eli Lilly and Company, descriptionModule briefSummary: A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab.The names of the study drugs involved in this study are:* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)* Letrozole (a type of aromatase inhibitor)* Pembrolizumab (a type of monoclonal antibody), conditionsModule conditions: Endometrial Cancer, conditions: Recurrent Endometrial Cancer, conditions: TP53, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Abemaciclib, interventions name: Letrozole, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Median Progression Free Survival (PFS), secondaryOutcomes measure: Grade 3-5 Adverse Events (AE) Rate, secondaryOutcomes measure: Median Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beth Israel Deaconess Medical Center, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Meghan Shea, MD, role: CONTACT, phone: 617-667-3723, email: mshea4@bidmc.harvard.edu, contacts name: Meghan Shea, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: CONTACT, phone: 617-632-2334, email: Panagiotis_Konstantinopoulos@dfci.harvard.edu, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: CONTACT, phone: 617-632-2334, email: Panagiotis_Konstantinopoulos@dfci.harvard.edu, contacts name: Panagiotis Konstantinopoulos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute at Foxborough, city: Foxboro, state: Massachusetts, zip: 02035, country: United States, contacts name: Natalie Sinclair, MD, role: CONTACT, phone: 508-543-1700, email: natalie_sinclair@dfci.harvard.edu, contacts name: Natalie Sinclair, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.06538, lon: -71.24783, locations facility: Dana-Farber Cancer Institute at Milford, city: Milford, state: Massachusetts, zip: 01757, country: United States, contacts name: Alexandra Bailey, MD, role: CONTACT, phone: 508-488-3700, email: alexandras_bailey@dfci.harvard.edu, contacts name: Alexandra Bailey, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.13982, lon: -71.51617, locations facility: Dana-Farber Cancer Institute at South Shore Hospital, city: Weymouth, state: Massachusetts, zip: 02190, country: United States, contacts name: Meredith Faggen, MD, role: CONTACT, phone: 781-624-4800, email: meredith_faggen@dfci.harvard.edu, contacts name: Meredith Faggen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.22093, lon: -70.93977, hasResults: False
|
protocolSection identificationModule nctId: NCT06366334, orgStudyIdInfo id: 23/02E, briefTitle: Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation, acronym: KSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Eastern Ontario, class: OTHER, descriptionModule briefSummary: Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond., conditionsModule conditions: Suicidal Ideation, conditions: Suicidal Ideas, 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: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine Hydrochloride, interventions name: Normal saline, outcomesModule primaryOutcomes measure: Proportion of eligible participants who complete the study protocol, secondaryOutcomes measure: Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5), secondaryOutcomes measure: Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), secondaryOutcomes measure: Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9)., secondaryOutcomes measure: Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9)., secondaryOutcomes measure: Assessment of blinding, secondaryOutcomes measure: Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5), secondaryOutcomes measure: Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), secondaryOutcomes measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9), secondaryOutcomes measure: Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5), secondaryOutcomes measure: Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), secondaryOutcomes measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9), secondaryOutcomes measure: Admission to Hospital, secondaryOutcomes measure: Length of Stay in Hospital, secondaryOutcomes measure: ED revisits, otherOutcomes measure: Safety Outcome 1: Clinically significant tachycardia, otherOutcomes measure: Safety Outcome 2: Clinically significant hypertension, otherOutcomes measure: Safety Outcome 3: Vomiting, otherOutcomes measure: Safety Outcome 4: Dissociation, otherOutcomes measure: Safety Outcome 5: Death, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Of Eastern Ontario, status: RECRUITING, city: Ottawa, state: Ontario, zip: K1H 8L1, country: Canada, contacts name: Maala Bhatt, MD, MSc., role: CONTACT, phone: 6137377600, phoneExt: 4178, email: mbhatt@cheo.on.ca, contacts name: Tyrus Crawford, role: CONTACT, phone: 6137377600, phoneExt: 4178, email: tcrawford@cheo.on.ca, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False
|
protocolSection identificationModule nctId: NCT06366321, orgStudyIdInfo id: 23-067, briefTitle: Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-01-23, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: British University In Egypt, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues., conditionsModule conditions: Dental Diseases, conditions: Dental Trauma, conditions: Bone Remodeling Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: relining technique, interventions name: CAD/CAM milling technique, outcomesModule primaryOutcomes measure: patient satisfaction using questionnaire, primaryOutcomes measure: denture retention, primaryOutcomes measure: denture adaptation to oral tissues, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: British University in Egypt, city: El Shorouk, state: Cairo, zip: 4914085, country: Egypt, geoPoint lat: 30.13806, lon: 31.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06366308, orgStudyIdInfo id: ProBiox, briefTitle: Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations., conditionsModule conditions: Prostate Cancer, conditions: Pathology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Transperineal Prostate Biopsy, outcomesModule primaryOutcomes measure: Positive rate of prostate biopsy, eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06366295, orgStudyIdInfo id: WUM.Perio.05, briefTitle: Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: subgingival mechanotherapy with perioscopy, interventions name: classical subgingival mechanotherapy, outcomesModule primaryOutcomes measure: Probing pocket depth (PPD), primaryOutcomes measure: Clinical attachment level (CAL), primaryOutcomes measure: Bleeding on probing (BoP), primaryOutcomes measure: Plaque index (PI), secondaryOutcomes measure: Width of keratinized tissue (KTW), secondaryOutcomes measure: Gingival thickness (GT), otherOutcomes measure: Subgingival plaque pathogens (Aa, Pg, Td) levels, otherOutcomes measure: Gingival crevicular fluid levels of cytokines, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, status: RECRUITING, city: Warsaw, state: Mazowieckie, zip: 02-097, country: Poland, contacts name: Bartlomiej Gorski, DDS, PhD, role: CONTACT, phone: +48 22 502 20 99, email: bartlomiej.gorski@wum.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
|
protocolSection identificationModule nctId: NCT06366282, orgStudyIdInfo id: IRB00110030, briefTitle: Pediatric and Caregiver Traumatic Stress Intervention (PACTS), acronym: PACTS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: Childress Institute for Pediatric Trauma, descriptionModule briefSummary: The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression., conditionsModule conditions: Traumatic Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Caregiver Counseling for Childhood Traumatic Injury, interventions name: Standard of Care for Childhood Traumatic Injury, outcomesModule primaryOutcomes measure: Change in Kessler 6 Scores, primaryOutcomes measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Scores, primaryOutcomes measure: Change in Child and Adolescent Trauma Screen (CATS) Scores, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Elizabeth White, MA, LCMHCS, role: CONTACT, phone: 336-716-2801, email: ebwhite@wakehealth.edu, contacts name: Elizabeth Shilling, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
|
protocolSection identificationModule nctId: NCT06366269, orgStudyIdInfo id: STUDY20240374, briefTitle: Acupuncture First for IC/BPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: David Sheyn, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.Participants will* complete surveys about their bladder pain symptoms* make behavioral changes that have been shown to improve bladder pain symptoms* attend six (6) weekly acupuncture sessions* attend six (6) weekly physical therapy sessions after finishing acupuncture, conditionsModule conditions: Bladder Pain Syndrome, conditions: Interstitial Cystitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture, interventions name: Behavioral management, interventions name: Physical therapy, outcomesModule primaryOutcomes measure: O'Leary-Sant Interstitial Cystitis Index (OLSICI), secondaryOutcomes measure: Patient Global Impression of Improvement (PGI-I), secondaryOutcomes measure: Short Form (SF-36), secondaryOutcomes measure: Genitourinary Pain Index (GUPI), secondaryOutcomes measure: Number of additional treatments used during study period, secondaryOutcomes measure: Number of unscheduled interactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06366256, orgStudyIdInfo id: 1R01DC017301-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DC017301-01, briefTitle: Simplified Ultrasound Feedback for Speech Remediation, acronym: SUFSR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-24, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Cincinnati, class: OTHER, descriptionModule briefSummary: Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic., conditionsModule conditions: Speech Sound Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Traditional ultrasound biofeedback, interventions name: Simplified ultrasound biofeedback, outcomesModule primaryOutcomes measure: Change in percent accurate words in probe list at beginning and midpoint of study, primaryOutcomes measure: Change in percent accurate words in probe list at beginning and end of study, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Cincinnati, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45220, country: United States, contacts name: Suzanne E Boyce, PhD, role: CONTACT, phone: 513-558-8509, email: boycese@ucmail.uc.edu, contacts name: Sarah M Dugan, PhD, role: CONTACT, email: hamilsm@ucmail.uc.edu, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
|
protocolSection identificationModule nctId: NCT06366243, orgStudyIdInfo id: CVL-231-HV-1012, briefTitle: A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cerevel Therapeutics, LLC, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Emraclidine, interventions name: Esomeprazole, outcomesModule primaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of Emraclidine, primaryOutcomes measure: Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine, primaryOutcomes measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine, primaryOutcomes measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine, secondaryOutcomes measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values, secondaryOutcomes measure: Number of Participants With Clinically Significant Changes in Vital Sign Parameters, secondaryOutcomes measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments, secondaryOutcomes measure: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results, secondaryOutcomes measure: Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06366230, orgStudyIdInfo id: 24-41450, briefTitle: Adding Urea to the Final Dialysis Fluid, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, descriptionModule briefSummary: At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis., conditionsModule conditions: Dysequilibrium Syndrome, conditions: ESRD, conditions: Hyperkalemia, conditions: Metabolic Acidosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Urea in the dialysate, outcomesModule primaryOutcomes measure: Disequilibrium, primaryOutcomes measure: Serum potassium concentration, primaryOutcomes measure: Serum CO2 concentration, secondaryOutcomes measure: Serum BUN concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zuckerberg San Francisco General Hospital, city: San Francisco, state: California, zip: 94110, country: United States, contacts name: Ramin Sam, MD, role: CONTACT, phone: 628-206-6605, email: ramin.sam@ucsf.edu, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
|
protocolSection identificationModule nctId: NCT06366217, orgStudyIdInfo id: 20-32530A, briefTitle: Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, descriptionModule briefSummary: To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops., conditionsModule conditions: Dilation, conditions: Pupil Reaction Absent, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: MydCombi Device, interventions name: MydCombi Drug, outcomesModule primaryOutcomes measure: Percent change in Spherical equivalent, primaryOutcomes measure: Percent Change in maximum pupil diameter, primaryOutcomes measure: Percent Change in pupil constriction percentage, secondaryOutcomes measure: Percent Change in Intraocular Pressure, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
|
protocolSection identificationModule nctId: NCT06366204, orgStudyIdInfo id: H23-03119, briefTitle: Lysine Requirements During Lactation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations., conditionsModule conditions: Lactation, conditions: Breastfeeding, Exclusive, conditions: Breastfeeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single day interventions; Repeated measures design., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Dietary Lysine Intakes, outcomesModule primaryOutcomes measure: Carbon 13 Oxidation, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: BC Children's Hospital Research Institute, status: RECRUITING, city: Vancouver, state: British Columbia, zip: V5Z 4H4, country: Canada, contacts name: Taylor Bailey, BSc, role: CONTACT, phone: 705-698-7648, email: taylor.bailey@bcchr.ca, contacts name: Rajavel Elango, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.24966, lon: -123.11934, hasResults: False
|
protocolSection identificationModule nctId: NCT06366191, orgStudyIdInfo id: 2023/CHU/08, briefTitle: Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study, acronym: A2P, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de la Réunion, class: OTHER, descriptionModule briefSummary: A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system., conditionsModule conditions: Psychological Trauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: prevention algorithm, interventions name: Standard care, outcomesModule primaryOutcomes measure: study acceptability rate, secondaryOutcomes measure: Adherence of patient to the watch, secondaryOutcomes measure: Adherence of patient to the health watch, secondaryOutcomes measure: Patient satisfaction (quantitatif), secondaryOutcomes measure: Patient satisfaction (qualitatif), secondaryOutcomes measure: Strong points of the health watch, secondaryOutcomes measure: Evolution of the patient journey in experimental arm, secondaryOutcomes measure: Occurrence of post-traumatic stress disorder, secondaryOutcomes measure: Complications associated with post-traumatic stress disorder, secondaryOutcomes measure: Complications associated with post-traumatic stress disorder, secondaryOutcomes measure: Complications associated with post-traumatic stress disorder, secondaryOutcomes measure: Complications associated with post-traumatic stress disorder, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06366178, orgStudyIdInfo id: 2024/864, briefTitle: EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses, acronym: EPBONF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed.The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter.There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment.A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology.The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF., conditionsModule conditions: Craniosynostoses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: BONFIX system, outcomesModule primaryOutcomes measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria., primaryOutcomes measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria., primaryOutcomes measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria., eligibilityModule sex: ALL, minimumAge: 4 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06366165, orgStudyIdInfo id: ACU-Med3, briefTitle: Linking Special Care Dentistry Curriculum to Seemingly Irrelevant Comedy, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2021-10-01, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: As Special care dentistry curriculum is very complicated and has a lot of details. Upon teaching it, the investigator will include memes and videos of movies and cartoons and will test the degree of retention of the information after years of passing the subject's exam., conditionsModule conditions: Learning Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Testing the procedure of using a different mode of teaching medical content, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: seemingly irrelevant funny videos and memes in teaching, outcomesModule primaryOutcomes measure: degree of retention of information, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ahram Candian University, status: RECRUITING, city: Giza, country: Egypt, contacts name: Ayat Gamal-AbdelNaser, role: CONTACT, phone: 01001874257, email: ayat.gamal@acu.edu.eg, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
|
protocolSection identificationModule nctId: NCT06366152, orgStudyIdInfo id: 43N2US2105, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
|
protocolSection identificationModule nctId: NCT06366139, orgStudyIdInfo id: Trigeminal RFT vs max/mand PRF, briefTitle: Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-11, primaryCompletionDateStruct date: 2024-02-04, completionDateStruct date: 2024-03-07, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Diskapi Teaching and Research Hospital, class: OTHER, descriptionModule briefSummary: Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared., conditionsModule conditions: Trigeminal Neuralgia, conditions: Headache Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: Radiofrequency thermocoagulation of the trigeminal ganglion, interventions name: Maxillary/Mandibular nerve pulsed radiofrequency, outcomesModule primaryOutcomes measure: Numerical rating scale (NRS), secondaryOutcomes measure: The Medication Quantification Scale III (MQS III), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diskapi Training and Research Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06366126, orgStudyIdInfo id: Child Abuse, briefTitle: Long Term Impact of Child Abuse in University Students, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, descriptionModule briefSummary: Based on research and studies, a broad conceptualization of child abuse and neglect has progressively been constructed, defining it as all actions carried out by caregivers that significantly interfere in the child's optimum development and do not adhere to social standards. This conceptualization contemplates aspects such as neglecting physical-biological, cognitive, emotional, and social needs, and the different types of child maltreatment are also classified.This study aimed too evaluate the psychological and social long-term effects of different types of child abuse., conditionsModule conditions: Child Abuse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 242, type: ACTUAL, outcomesModule primaryOutcomes measure: tailored questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 23 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amira Hussin Mohammed, city: Gamasa, zip: 35712, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False
|
protocolSection identificationModule nctId: NCT06366113, orgStudyIdInfo id: 2023-A00363-42, briefTitle: Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD), acronym: CHRONOBIO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-01-02, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Michaël RACODON, class: OTHER, descriptionModule briefSummary: Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.The program should not be improved by introducing new subjects such as circadian rhythm., conditionsModule conditions: Respiratory Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Pulmonary rehabilitation, outcomesModule primaryOutcomes measure: 6-minute walk test (6MWT), secondaryOutcomes measure: Time limit test (Time-lim), secondaryOutcomes measure: Sit to stand test (STT), secondaryOutcomes measure: Single arm curl Test (SAC), secondaryOutcomes measure: Single-leg stance test (SLT), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HAD), secondaryOutcomes measure: Pittsburgh Sleep Quality Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique la Mitterie, status: RECRUITING, city: Lille, zip: 59130, country: France, contacts name: Michaël RACODON, PhD, role: CONTACT, phone: +33320223457, email: mracodon@clinique-mitterie.com, geoPoint lat: 50.63297, lon: 3.05858, hasResults: False
|
protocolSection identificationModule nctId: NCT06366100, orgStudyIdInfo id: 2023I060, briefTitle: Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universidad de Zaragoza, class: OTHER, collaborators name: Ministerio de Sanidad, Servicios Sociales e Igualdad, descriptionModule briefSummary: The aim of this study is to evaluate the dissemination and implementation process of two transdiagnostic psychological interventions (Dialectical Behavioral Therapy for Substance Use Disorders-DBT-SUD and Unified Protocol-UP) to treat alcohol addiction by mental health practitioners in the Spanish National Health System. The main questions this study aims to answer are:Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments (EBPTs), level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction?What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training (DBT-SUD and UP)?In what degree the implementation outcomes (adoption, reach, appropriateness, feasibility, fidelity, sustainability) will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice?What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice?What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes?The study comprises two phases. In the first phase, mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other (DBT-SUD and UP) and will be evaluated before and after each training. In the second phase, participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation. Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design., conditionsModule conditions: Implementation Science, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are assigned to two groups in parallel for the duration of the study. The specific design is an reverse counterbalanced (ABBA) intrasubject experimental study where participants will be randomly assigned to first (and then the other) receive DBT-SUD or UP online training in the phase 1 of the study, and randomly assigned to first implement DBT-SUD or UP intervention in the phase two. A balanced randomization (1:1) will be conducted in order to eliminate possible biases and ensure equivalence between groups., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD), interventions name: Unified Protocol (UP), outcomesModule primaryOutcomes measure: Acceptability and Intention to Use Survey, primaryOutcomes measure: Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM), primaryOutcomes measure: Normalization MeAsure Development Questionnaire (NoMAD), secondaryOutcomes measure: Copenhagen Burnout Inventory (CBI), secondaryOutcomes measure: Brief Scale of Understanding Substance Abuse (SUSS), secondaryOutcomes measure: Implementation Climate Scale (ICS), secondaryOutcomes measure: Organizational Readiness for Implementing Change (ORIC), secondaryOutcomes measure: Evidence-Based Practice Attitudes Scale (EBPAS), secondaryOutcomes measure: Program sustainability assessment tool (PASAT), secondaryOutcomes measure: Barriers to Implementation Inventory (BTI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zaragoza, status: RECRUITING, city: Teruel, state: Aragón, zip: C/ Ciudad Escolar S/N44003, country: Spain, contacts name: María Vicenta Navarro Haro, PhD, role: CONTACT, phoneExt: 861145, email: mvnavarro@unizar.es, geoPoint lat: 40.3456, lon: -1.10646, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-02, uploadDate: 2024-04-09T12:23, filename: ICF_000.pdf, size: 419669, hasResults: False
|
protocolSection identificationModule nctId: NCT06366087, orgStudyIdInfo id: BP-C-24-001, briefTitle: Sublingual Atropine Bioequivalence by Route of Administration (SABER), acronym: SABER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-24, completionDateStruct date: 2024-05-24, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Biomedical Advanced Research and Development Authority, class: FED, collaborators name: Rho Federal Systems Division, Inc., collaborators name: Allucent, descriptionModule briefSummary: A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers., conditionsModule conditions: Atropine Bioequivalence, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Atropine Sulfate Ophthalmic Solution USP, 1%, interventions name: Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL), outcomesModule primaryOutcomes measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf)., primaryOutcomes measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt)., secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F), secondaryOutcomes measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johnson County Clin-Trials (JCCT), city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: Carlos A Fierro, MD, role: CONTACT, phone: 913-825-4400, email: cfierro@jcct.com, contacts name: Mazen Zari, role: CONTACT, phone: 913-825-4400, email: mzari@jcct.com, contacts name: Carlos A Fierro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False
|
protocolSection identificationModule nctId: NCT06366074, orgStudyIdInfo id: HUM00252120, briefTitle: Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Transtimulation Research, Inc, descriptionModule briefSummary: This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prevalence of delayed Chemotherapy-induced nausea, emesis, and dyspeptic symptoms (CINEDS) is 75% in women vs 51% in men (60% to 40% ratio). Therefore, every effort will be made to recruit at least 60% female subjects into the clinical study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Watch-TEA group, interventions name: Tethered TEA device, outcomesModule primaryOutcomes measure: Usability of the device for both groups day 3, primaryOutcomes measure: Number of adverse events related to the device noted on the safety questionnaire, primaryOutcomes measure: Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days, primaryOutcomes measure: Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level, primaryOutcomes measure: Number of non-treatment TEA adverse events for both groups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Colin Burnett, role: CONTACT, phone: 734-647-2806, email: bucolin@umich.edu, contacts name: Jiande Chen, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
|
protocolSection identificationModule nctId: NCT06366061, orgStudyIdInfo id: 2020-02868, briefTitle: A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-14, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Eckhard Mauermann, class: OTHER, descriptionModule briefSummary: This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning., conditionsModule conditions: Cardiac Functional Disturbances During Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine, secondaryOutcomes measure: Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function?, otherOutcomes measure: Comparison of high Frame Rate (FR) vs. low FR of the following measures: [ i) S'STE AP4C supine, ii) GLS AP4C supine, iii) SR AP4C supine], otherOutcomes measure: Comparison of the measured values in the cardiological gold standard (Left lateral decubitus (LLD)) vs. supine, for the following values [ i) S'TDI AP4C, ii) S'STE AP4C, iii) GLS], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, status: RECRUITING, city: Basel, state: Basel Stadt, zip: 4000, country: Switzerland, contacts name: Michael Lampart, Prakt. med., role: CONTACT, phone: +41764006180, email: michael.lampart@usb.ch, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
|
protocolSection identificationModule nctId: NCT06366048, orgStudyIdInfo id: EHBHKY2022-K-025, briefTitle: A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF), acronym: RNLV, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: National Natural Science Foundation of China, class: OTHER_GOV, descriptionModule briefSummary: The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice., conditionsModule conditions: Liver Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1133, type: ACTUAL, armsInterventionsModule interventions name: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria, outcomesModule primaryOutcomes measure: Probability of PHLF was predicted with our individual model based on RNLV., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third Affiliated Hospital of Naval Medical University, city: Shanhai, state: Shanghai, zip: 201800, country: China, hasResults: False
|
protocolSection identificationModule nctId: NCT06366035, orgStudyIdInfo id: NMRR ID-24-00924-HPO, briefTitle: LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression, acronym: LoVE4MUM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-06-03, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: National Institutes of Health, Ministry of Health Malaysia, class: OTHER, descriptionModule briefSummary: Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions., conditionsModule conditions: Postpartum Depression, conditions: Maternal Behavior, conditions: mHealth Intervention, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single Blinded, Pilot Randomized Control Trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: LoVE4MUM mobile application, outcomesModule primaryOutcomes measure: Postpartum Depression, secondaryOutcomes measure: Postpartum Mental Health Literacy, secondaryOutcomes measure: Automatic Negative Frequency, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Tengku Ampuan Rahimah, city: Klang, state: Selangor, zip: 41586, country: Malaysia, contacts name: Noor Fadzleeyanna Mohd Yahaya, MOG, role: CONTACT, phone: 03-3375 7000, contacts name: Noor Fadzleeyanna Mohd Yahaya, MOG, role: PRINCIPAL_INVESTIGATOR, contacts name: Shalisah Sarip, PhD, role: SUB_INVESTIGATOR, contacts name: Norfazilah Ahmad, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 3.03333, lon: 101.45, locations facility: Hospital Shah Alam, city: Shah Alam, state: Selangor, zip: 40000, country: Malaysia, contacts name: Siti Sabrina Kamarudin, role: CONTACT, phone: 0355263000, phoneExt: 3305, email: saby721@gmail.com, contacts name: Siti Sabrina Kamarudin, MBBS, role: PRINCIPAL_INVESTIGATOR, contacts name: NNurul Syuhaida Abdul Razak, MOG, role: SUB_INVESTIGATOR, contacts name: Idayu Badilla Idris, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 3.08507, lon: 101.53281, hasResults: False
|
protocolSection identificationModule nctId: NCT06366022, orgStudyIdInfo id: Warsaw.06, briefTitle: Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft., conditionsModule conditions: Gingival Recession, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: The tunnel technique for root coverage with CTG with inner side of the graft, interventions name: The tunnel technique for root coverage with CTG with outer side of the graft, outcomesModule primaryOutcomes measure: Clinical attachment level (CAL), primaryOutcomes measure: Recession height (RH), primaryOutcomes measure: Recession width (RW), primaryOutcomes measure: Width of keratinized tissue (KTW), primaryOutcomes measure: Thickness of keratinized tissue (GT, primaryOutcomes measure: Average recession coverage (ARC), primaryOutcomes measure: Complete recession coverage, secondaryOutcomes measure: Probing pocket depth (PPD), secondaryOutcomes measure: Root coverage esthetic score (RES), secondaryOutcomes measure: Post surgical pain and swelling, secondaryOutcomes measure: Patient's satisfaction with treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, status: RECRUITING, city: Warsaw, state: MAzowsze, zip: 00-246, country: Poland, contacts name: Bartłomiej Górski, PhD, role: CONTACT, phone: 48225022099, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
|
protocolSection identificationModule nctId: NCT06366009, orgStudyIdInfo id: Warsaw Study, briefTitle: Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Przemyslaw Kunert, class: INDUSTRY, collaborators name: NaoX Technologies, collaborators name: Warsaw Medical University Clinical Center, collaborators name: Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk, descriptionModule briefSummary: The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE)., conditionsModule conditions: Epilepsy, conditions: Focal Epilepsy, conditions: Drug Resistant Epilepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: NaoX in-ear EEG system, outcomesModule primaryOutcomes measure: determination of the starting point of focal temporal epileptic seizures, secondaryOutcomes measure: Identification of subgroups of epileptic patterns, secondaryOutcomes measure: Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kliniki Neurochirurgii CSK UCK WUM, city: Warsaw, country: Poland, contacts name: Przemysław Kunert, Prof., role: CONTACT, contacts name: Maja Kopytek-Beuzen, Dr., role: CONTACT, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
|
protocolSection identificationModule nctId: NCT06365996, orgStudyIdInfo id: Core set geriatric ICF, briefTitle: Development and Validation of the Polish Geriatric Core Set., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Rzeszow, class: OTHER, descriptionModule briefSummary: Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people., conditionsModule conditions: Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 800, type: ESTIMATED, outcomesModule primaryOutcomes measure: ICF Geriatric core set, secondaryOutcomes measure: Sociodemographic data of the sample, secondaryOutcomes measure: Disability - WHODAS 2.0 v 36 item, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Rzeszow, city: Rzeszów, state: Podkarpacie, zip: 35-959, country: Poland, contacts name: Agnieszka Sozańska, professor, role: CONTACT, phone: 530172857, email: asozanska@ur.edu.pl, geoPoint lat: 50.04132, lon: 21.99901, hasResults: False
|
protocolSection identificationModule nctId: NCT06365983, orgStudyIdInfo id: UFRGS-Cassio, briefTitle: Comparison of Free Gingival Graft and Linear Incision for Connective Tissue, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-28, primaryCompletionDateStruct date: 2025-04-28, completionDateStruct date: 2026-04-28, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Federal University of Rio Grande do Sul, class: OTHER, descriptionModule briefSummary: A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.EXCLUSION CRITERIAIndividuals will not be considered eligible if they:* Present any form of immunological compromise;* Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;* Present active periodontitis, defined by presence of \>=10% subgingival bleeding and probing depth and clinical attachment loss proximal \>4mm (Tonetti et al. 2018);* Are current or ex-smokers;* Have allergies to ibuprofen and chlorhexidine digluconate.Research Objective:PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.SECONDARY OBJECTIVECompare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes., conditionsModule conditions: Connective Tissue, conditions: Gingiva, conditions: Gingival Recession, conditions: Humans, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: All sample randomization procedures will be carried out by a researcher not involved in treatments and clinical examinations. An external researcher not affiliated with the study will be responsible for maintaining participant allocation confidentiality. Sides will be identified by numbers stored in opaque, sealed envelopes with the randomization sequence. Outcome assessors will be blinded to the experimental group to which participants belong., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Connective Tissue with Free Gingival Graft, interventions name: Connective Tissue with Linear Incision, outcomesModule primaryOutcomes measure: Percentage of root coverage, secondaryOutcomes measure: Recession depth, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alex Nogueira Haas, status: RECRUITING, city: Porto Alegre, state: RS, zip: 95780000, country: Brazil, contacts name: Cássio Cardona Orth, role: CONTACT, phone: 11999791876, email: cassio.orth@gmail.com, geoPoint lat: -30.03306, lon: -51.23, hasResults: False
|
protocolSection identificationModule nctId: NCT06365970, orgStudyIdInfo id: HCC 23-056, briefTitle: Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ibrahim Halil Sahin, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC., conditionsModule conditions: MMR-D/MSI-H Colorectal Cancers, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Niraparib, interventions name: Dostarlimab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Adverse Events Related to Treatment, secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Hillman Cancer Center, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Debra Diecks, MSN, role: CONTACT, phone: 412-623-8364, email: diecksda@upmc.edu, contacts name: Ibrahim Sahin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
|
protocolSection identificationModule nctId: NCT06365957, orgStudyIdInfo id: BSERE24-APP001-FED, briefTitle: Acute Effects of Exercise Combined With Ketone Ester Supplement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Macau, class: OTHER, descriptionModule briefSummary: To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults., conditionsModule conditions: Overweight and Obesity, conditions: Cognitive Change, conditions: Ketoses, Metabolic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ketone monoester supplementation, interventions name: High-intensity interval exercise, interventions name: Moderate-intensity continuous exercise, interventions name: Placebo, outcomesModule primaryOutcomes measure: Maximal Oxygen Uptake, primaryOutcomes measure: Systolic Blood Pressure, primaryOutcomes measure: Diastolic Blood Pressure, primaryOutcomes measure: Concentration of Blood Lipid, primaryOutcomes measure: Concentration of Blood Glucose, primaryOutcomes measure: Concentration of Blood Beta-Hydroxybutyrate, primaryOutcomes measure: Concentration of Blood Lactic Acid, primaryOutcomes measure: Concentration of Blood Insulin, primaryOutcomes measure: Reaction Time of Stroop Task, primaryOutcomes measure: Accuracy of Stroop Task, primaryOutcomes measure: Reaction Time of N-back Task, primaryOutcomes measure: Accuracy of N-back Task, primaryOutcomes measure: Cerebral Hemoglobin Concentration, secondaryOutcomes measure: Arousal Level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365944, orgStudyIdInfo id: CHUBX 2023/73, briefTitle: Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process, acronym: PRECCOCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-04-20, completionDateStruct date: 2026-04-20, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol., conditionsModule conditions: Brain Concussion, conditions: Cerebral Concussion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bordeaux University Hospital, status: RECRUITING, city: Bordeaux, country: France, contacts name: Quentin LHUAIRE, role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, hasResults: False
|
protocolSection identificationModule nctId: NCT06365931, orgStudyIdInfo id: 160224, briefTitle: Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-02-16, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Extremadura, class: OTHER, descriptionModule briefSummary: INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot.OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients.METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle.The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed., conditionsModule conditions: Stroke/Brain Attack, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Percutaneous neuromodulation, interventions name: Transcutaneous neuromodulation, interventions name: Placebo-percutaneous, interventions name: Placebo-transcutaneous, interventions name: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional), outcomesModule primaryOutcomes measure: Muscle activity, primaryOutcomes measure: Displacement of the center of pressures (CoP), primaryOutcomes measure: Articular amplitude, primaryOutcomes measure: Balance, primaryOutcomes measure: Balance, primaryOutcomes measure: Gait, primaryOutcomes measure: Tissue oxygen in muscle, primaryOutcomes measure: Muscular strength, primaryOutcomes measure: Functionality, primaryOutcomes measure: quality of life index, primaryOutcomes measure: Spasticity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mª Dolores Apolo Arenas, city: Badajoz, country: Spain, geoPoint lat: 38.87789, lon: -6.97061, hasResults: False
|
protocolSection identificationModule nctId: NCT06365918, orgStudyIdInfo id: 2023-0836, secondaryIdInfos id: NCI-2024-03236, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2028-03-22, completionDateStruct date: 2030-03-22, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, conditions: Carcinomatosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: VG2025, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Siqing Fu, MD,PHD, role: CONTACT, phone: 713-792-4318, email: siqingfu@mdanderson.org, contacts name: Siqing Fu, MD,PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
|
protocolSection identificationModule nctId: NCT06365905, orgStudyIdInfo id: 23-011680, secondaryIdInfos id: NCI-2024-02550, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-011680, type: OTHER, domain: Mayo Clinic in Rochester, briefTitle: Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions., conditionsModule conditions: Endometrial Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS), eligibilityModule sex: FEMALE, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, status: NOT_YET_RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Kristina A. Butler, M.D., M.S., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Florida, status: NOT_YET_RECRUITING, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Christopher C. DeStephano, M.D., M.P.H., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Gretchen E. Glaser, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
|
protocolSection identificationModule nctId: NCT06365892, orgStudyIdInfo id: 22-36548, briefTitle: Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years., conditionsModule conditions: Adolescent Idiopathic Scoliosis (AIS), designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinding of patients and providers will not be feasible due to the nature of the study., enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: open-label placebo, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery, secondaryOutcomes measure: Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6., secondaryOutcomes measure: Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6., secondaryOutcomes measure: Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6., secondaryOutcomes measure: The duration of time in days following surgery until patients establish Independence with Physical Therapy, secondaryOutcomes measure: The length of time in days following surgery until discharge from the hospital, secondaryOutcomes measure: The length of time in days following surgery until participant returns to school, secondaryOutcomes measure: Whether participants experience urinary retention following surgery., secondaryOutcomes measure: Whether participants experience constipation measured by the number of days between surgery and first bowel movement, secondaryOutcomes measure: Whether participants experience an oxygen requirement and the duration of the requirement following surgery., eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94158, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
|
protocolSection identificationModule nctId: NCT06365879, orgStudyIdInfo id: CMAB007-003, briefTitle: To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Taizhou Mabtech Pharmaceutical Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria, conditionsModule conditions: Chronic Spontaneous Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 392, type: ESTIMATED, armsInterventionsModule interventions name: CMAB007, interventions name: Xolair, outcomesModule primaryOutcomes measure: Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12, secondaryOutcomes measure: Change From Baseline of Urticaria Activity Score (UAS7) At Week 12, secondaryOutcomes measure: Change From Baseline of Number of Hives Score (NHS7) At Week 12, secondaryOutcomes measure: Time to ISS7 MID Response by Week 12, secondaryOutcomes measure: Percentage of Patients With UAS7≤6 at Week 12, secondaryOutcomes measure: Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12, secondaryOutcomes measure: Change From Baseline of Urticaria Control Test (UCT) at Week 12, secondaryOutcomes measure: Percentage of Patients With UCT≥12 at Week 12, secondaryOutcomes measure: Percentage of Complete Controls (UCT=16) at Week 12, secondaryOutcomes measure: Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12, secondaryOutcomes measure: Percentage of Complete Responders (UAS7=0) at Week 12, secondaryOutcomes measure: Percentage of Angioedema-free Days From Week 4 to Week 12, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: Half time, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: Clearance Rate, secondaryOutcomes measure: Apparent Volume of Distribution, secondaryOutcomes measure: Level of Total IgE and Free IgE, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365866, orgStudyIdInfo id: 2022-06-008B, briefTitle: Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Taipei Veterans General Hospital, Taiwan, class: OTHER_GOV, descriptionModule briefSummary: The purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer., conditionsModule conditions: Esophageal Neoplasms, conditions: Head and Neck Neoplasms, conditions: Gastrointestinal Neoplasms, conditions: Digestive System Diseases, conditions: Digestive System Neoplasms, conditions: Esophageal Diseases, conditions: Neoplasms by Site, conditions: Gastrointestinal Diseases, conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: "BRAXX" Esophageal Brachytherapy Applicator., interventions name: Add-on of intraluminal brachytherapy, outcomesModule primaryOutcomes measure: To estimate the local control rate at primary tumor site., secondaryOutcomes measure: To estimate overall response rate., secondaryOutcomes measure: To estimate distant metastasis rate., secondaryOutcomes measure: To estimate progression-free survival rate., secondaryOutcomes measure: To estimate overall survival status., secondaryOutcomes measure: To estimate toxicity analysis., secondaryOutcomes measure: To estimate adverse event., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Veterans General Hospital, status: RECRUITING, city: Taipei, zip: 11217, country: Taiwan, contacts name: Pin-I Huang, Ph.D., role: CONTACT, phone: +886 955-275-822, email: pihuang@vghtpe.gov.tw, contacts name: Pin-I Huang, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
|
protocolSection identificationModule nctId: NCT06365853, orgStudyIdInfo id: IMGN853-0424, secondaryIdInfos id: 2023-505617-24-00, type: CTIS, briefTitle: A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-05-26, completionDateStruct date: 2027-05-26, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ImmunoGen, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression., conditionsModule conditions: Recurrent Ovarian Cancer, conditions: Folate Receptor-Alpha Positive, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Mirvetuximab Soravtansine, interventions name: Lubricating Eye Drops, interventions name: Prednisolone acetate ophthalmic suspension 1% eye drops, interventions name: Brimonidine tartrate ophthalmic solution eye drops, outcomesModule primaryOutcomes measure: Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants, secondaryOutcomes measure: Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis, secondaryOutcomes measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants, secondaryOutcomes measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis, secondaryOutcomes measure: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score, secondaryOutcomes measure: Area Under the Curve (AUC) of MIRV, secondaryOutcomes measure: Maximum Serum Concentration (Cmax) of MIRV, secondaryOutcomes measure: Trough Concentration (Ctrough) of MIRV, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP), city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Yale School of Medicine - Yale Gynecologic Oncology, city: New Haven, state: Connecticut, zip: 06510, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Holy Cross Hospital, city: Silver Spring, state: Maryland, zip: 20910, country: United States, geoPoint lat: 38.99067, lon: -77.02609, locations facility: Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology, city: Springfield, state: Massachusetts, zip: 01107, country: United States, geoPoint lat: 42.10148, lon: -72.58981, locations facility: New York Oncology Hematology, city: Albany, state: New York, zip: 12208, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Women's Cancer Care Associates, LLC, city: Albany, state: New York, zip: 12208, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Duke Cancer Institute (DCI) - Duke Cancer Center, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, locations facility: University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic, city: Dallas, state: Texas, zip: 75235, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Monash University - Monash Medical Centre (MMC) - Clayton, city: Clayton, state: Victoria, country: Australia, geoPoint lat: -37.91667, lon: 145.11667, locations facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek, city: Edegem, state: Antwerp, country: Belgium, geoPoint lat: 51.15662, lon: 4.44504, locations facility: AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek, city: Gent, state: East Flanders, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: Universitair Ziekenhuis Gent (UZ Gent), city: Gent, state: East Flanders, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre, city: Montreal, state: Quebec, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame, city: Montreal, state: Quebec, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud, city: Pierre Benite, country: France, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Bon Secours Hospital - Dublin, city: Dublin, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Mater Misericordiae University Hospital (MMUH) (START Dublin), city: Dublin, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Istituto Europeo di Oncologia (IEO) (European Institute of Oncology), city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location, city: Badalona, state: Barcelona, country: Spain, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Parc Taulí, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Vall d'Hebron Institut d'Oncologia, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen), city: Jaen, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False
|
protocolSection identificationModule nctId: NCT06365840, orgStudyIdInfo id: IMC-001-202, briefTitle: A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor, acronym: TMB-H, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ImmuneOncia Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients., conditionsModule conditions: TMB-H, conditions: Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: IMC-001, outcomesModule primaryOutcomes measure: ORR, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365827, orgStudyIdInfo id: AZ293/20, briefTitle: Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI), acronym: aMIKI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Giessen, class: OTHER, descriptionModule briefSummary: Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis., conditionsModule conditions: Cardiac Surgery With Cardiopulmonary Bypass, conditions: Acute Mesenteric Ischemia, conditions: Acute Kidney Injury, conditions: Non-Occlusive Mesenteric Ischaemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: observational study, outcomesModule primaryOutcomes measure: Concentration of I-FABP values with/and without acute mesenteric ischemia, secondaryOutcomes measure: Time interval to mesenteric ischemia, secondaryOutcomes measure: Overall mortality rate, secondaryOutcomes measure: Correlation of I-FABP with biomarkers of acute kidney injury, secondaryOutcomes measure: Association of mesenteric ischemia with hypercoagulable states, otherOutcomes measure: Incidence of stroke, otherOutcomes measure: Association of I-FABP level and multi-organ failure or cardiovascular mortality, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Giessen, Cardiovascular surgery, city: Giessen, state: Hessen, zip: 35392, country: Germany, geoPoint lat: 50.58727, lon: 8.67554, hasResults: False
|
protocolSection identificationModule nctId: NCT06365814, orgStudyIdInfo id: ERASforNACT, briefTitle: ERAS for Gastric Cancer Patients After NACT, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Qingdao University, class: OTHER, descriptionModule briefSummary: Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 252, type: ACTUAL, armsInterventionsModule interventions name: enhanced recovery after surgery, interventions name: conventional perioperative management, outcomesModule primaryOutcomes measure: postoperative infectious complications, secondaryOutcomes measure: postoperative recovery parameter, secondaryOutcomes measure: blood test result, secondaryOutcomes measure: 3-year overall survival, secondaryOutcomes measure: 3-years recurrence-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, city: Qingdao, state: Shandong, zip: 266000, country: China, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
|
protocolSection identificationModule nctId: NCT06365801, orgStudyIdInfo id: 2022YFC3500401-IBS, briefTitle: Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pain sensitivity, primaryOutcomes measure: Thermal radiation characteristics, primaryOutcomes measure: Microcirculation characteristics, primaryOutcomes measure: Electrical characteristics, primaryOutcomes measure: Biological ultra-weak luminescence, secondaryOutcomes measure: Intestinal flora, secondaryOutcomes measure: Tryptophan metabolites, secondaryOutcomes measure: Bristol Fecal Traits Grading Scale, secondaryOutcomes measure: Severity of IBS (IBS-SSS), secondaryOutcomes measure: IBS Quality of Life (IBS-QOL ), secondaryOutcomes measure: TCM Constitution Survey, secondaryOutcomes measure: Gastrointestinal Symptoms Rating Scale (GSRS), secondaryOutcomes measure: Self-Rating Anxiety Scale (SAS), secondaryOutcomes measure: Self-Rating Depression Scale (SDS), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365788, orgStudyIdInfo id: S66466, secondaryIdInfos id: 2022-502272-23-00, type: OTHER, domain: EU CT Number, briefTitle: Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer, acronym: ABBICAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Kom Op Tegen Kanker, collaborators name: Eli Lilly and Company, collaborators name: Teva Pharma, descriptionModule briefSummary: This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer., conditionsModule conditions: Triple Negative Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: Abemaciclib, interventions name: Bicalutamide, outcomesModule primaryOutcomes measure: Number of participants with disease control at 16 weeks, secondaryOutcomes measure: Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, secondaryOutcomes measure: HRQoL change from baseline as measured by EORTC QLQ-C30, secondaryOutcomes measure: Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells., secondaryOutcomes measure: Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate, secondaryOutcomes measure: Number of participants with disease control at 24 weeks, secondaryOutcomes measure: Number of participants with partial or complete response at 16 weeks, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Months of progression free survival, secondaryOutcomes measure: Months of overall survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antwerp University Hospital, status: NOT_YET_RECRUITING, city: Antwerp, country: Belgium, contacts name: Sevilay Altintas, MD, PhD, role: CONTACT, phone: +3238213250, email: sevilay.altintas@uza.be, contacts name: Sevilay Altintas, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.21989, lon: 4.40346, locations facility: Gasthuiszusters Antwerpen, status: NOT_YET_RECRUITING, city: Antwerp, country: Belgium, contacts name: Kevin Punie, MD, role: CONTACT, phone: +3234433737, email: kevin.punie@gza.be, contacts name: Kevin Punie, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.21989, lon: 4.40346, locations facility: University Hospital Brussels, status: NOT_YET_RECRUITING, city: Brussel, country: Belgium, contacts name: Christel Fontaine, MD, role: CONTACT, phone: +3224776040, email: christel.fontaine@uzbrussel.be, contacts name: Christel Fontaine, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Ghent University Hospital, status: NOT_YET_RECRUITING, city: Ghent, country: Belgium, contacts name: Hannelore Denys, MD, PhD, role: CONTACT, phone: +3293322692, email: hannelore.denys@uzgent.be, contacts name: Hannelore Denys, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: Jessa Ziekenhuis, status: NOT_YET_RECRUITING, city: Hasselt, country: Belgium, contacts name: Annelies Requilé, MD, role: CONTACT, phone: +3211337979, email: annelies.requile@jessazh.be, contacts name: Annelies Requilé, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.93106, lon: 5.33781, locations facility: University Hospitals Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Patrick Neven, MD, PhD, role: CONTACT, phone: +3216344750, email: patrick.neven@uzleuven.be, contacts name: Kristien Borremans, MD, role: CONTACT, phone: +3216347795, email: kristien.borremans@kuleuven.be, contacts name: Patrick Neven, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
|
protocolSection identificationModule nctId: NCT06365775, orgStudyIdInfo id: TJ-IRB20221229, briefTitle: Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-11-23, completionDateStruct date: 2026-11-23, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Dan Bing, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* to find out which factor from multi-omics data relates to outcomes of SSNHL* to develop the best prognostics model based on the multi-omics data.Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model., conditionsModule conditions: Sudden Sensorineural Hearing Loss, conditions: Hearing Loss, Sensorineural, conditions: Hearing Loss, Sudden, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pure tone audiometry (PTA), secondaryOutcomes measure: Speech reception thresholds, secondaryOutcomes measure: Speech discrimination scores, otherOutcomes measure: Variant detection efficiency, otherOutcomes measure: Exome coverage, otherOutcomes measure: Genome-wide variant distribution, otherOutcomes measure: Head MRI, otherOutcomes measure: Inner Ear MRI, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06365762, orgStudyIdInfo id: CK-0103, briefTitle: The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract, statusModule overallStatus: COMPLETED, startDateStruct date: 2006-01-01, primaryCompletionDateStruct date: 2006-12-31, completionDateStruct date: 2007-04-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Livionex Inc., class: INDUSTRY, descriptionModule briefSummary: The study objectives were:* To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;* To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and* To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s)., conditionsModule conditions: Age Related Cataracts, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 111, type: ACTUAL, armsInterventionsModule interventions name: EDTA Ophthalmic Solution 2.6%, interventions name: EDTA Ophthalmic Solution 1.3%, interventions name: Saline Solution (Placebo), outcomesModule primaryOutcomes measure: Contrast Sensitivity (Mesopic) Responder Analysis, secondaryOutcomes measure: Cumulative Improvement in Contrast Sensitivity (Mesopic), otherOutcomes measure: Mean Change in Contrast Sensitivity (Mesopic), otherOutcomes measure: Mean Change in Best-Corrected Visual Acuity (BCVA), otherOutcomes measure: Pentacam Imaging, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Mary's Eye Specialists, Inc., city: San Francisco, state: California, zip: 94117, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Hunkeler Eye Institute, city: Overland Park, state: Kansas, zip: 66210, country: United States, geoPoint lat: 38.98223, lon: -94.67079, locations facility: The Johns Hopkins Hospital & Health System, Wilmer Eye Institute, city: Lutherville, state: Maryland, zip: 21093, country: United States, geoPoint lat: 39.42122, lon: -76.62608, locations facility: Harvard Medical School, Massachusetts Eye and Ear Infirmary, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Charlotte Eye, Ear, Nose, and Throat Associates, city: Charlotte, state: North Carolina, zip: 28210, country: United States, geoPoint lat: 35.22709, lon: -80.84313, locations facility: University of Utah, John Moran Eye Center, city: Salt Lake City, state: Utah, zip: 84132, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
|
protocolSection identificationModule nctId: NCT06365749, orgStudyIdInfo id: TJ-IRB20221228, briefTitle: Genetic Feature of Congenital Hearing Loss in Chinese Population, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-11-23, completionDateStruct date: 2026-11-23, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Dan Bing, class: OTHER, descriptionModule briefSummary: Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:* to present the genetic characteristics of the infant with hearing loss in the Chinese population* to build up a prognostic model base on diverse data.Participants will be asked to receive audiological tests and collection of the peripheral blood sample., conditionsModule conditions: Congenital Hearing Loss, conditions: Congenital Deafness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Whole exome sequencing data, secondaryOutcomes measure: TEOAE-based otoacoustic emissions test outcome measure, secondaryOutcomes measure: Auditory brainstem response testing, secondaryOutcomes measure: Acoustic impedance, secondaryOutcomes measure: Audiogram, eligibilityModule sex: ALL, maximumAge: 6 Months, stdAges: CHILD, hasResults: False
|
protocolSection identificationModule nctId: NCT06365736, orgStudyIdInfo id: 240310, briefTitle: The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2024-09-04, completionDateStruct date: 2024-09-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Twente, class: OTHER, descriptionModule briefSummary: The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is:Does a 2-week contemplative nature intervention improve spiritual well-being?Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality.Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes.Participants in the active control condition will walk for 30 minutes without further instruction., conditionsModule conditions: Spiritual Well-being, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Contemplating in nature, interventions name: Walking in nature, outcomesModule primaryOutcomes measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF), primaryOutcomes measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF), primaryOutcomes measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF), primaryOutcomes measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES), primaryOutcomes measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES), primaryOutcomes measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES), otherOutcomes measure: Client satisfaction of intervention condition assessed by Client Satisfaction Questionnaire (CSQ-8), otherOutcomes measure: Client satisfaction of active control condition assessed by Client Satisfaction Questionnaire (CSQ-8), otherOutcomes measure: Client satisfaction of passive control condition assessed by Client Satisfaction Questionnaire (CSQ-8), otherOutcomes measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS), otherOutcomes measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS), otherOutcomes measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS), otherOutcomes measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS), otherOutcomes measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS), otherOutcomes measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS), otherOutcomes measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF), otherOutcomes measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF), otherOutcomes measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF), otherOutcomes measure: Psychological well-being assessed by Brief INSPIRE-O, otherOutcomes measure: Psychological well-being assessed by Brief INSPIRE-O, otherOutcomes measure: Psychological well-being assessed by Brief INSPIRE-O, otherOutcomes measure: Stress assessed by Perceived Stress Scale (PSS), otherOutcomes measure: Stress assessed by Perceived Stress Scale (PSS), otherOutcomes measure: Stress assessed by Perceived Stress Scale (PSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Twente, city: Enschede, state: Overijssel, zip: 7522NB, country: Netherlands, contacts name: TALITHA RUARUS-BLANKERT, role: CONTACT, phone: +31534891289, email: pgt@utwente.nl, contacts name: Ernst Bohlmeijer, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.21833, lon: 6.89583, hasResults: False
|
protocolSection identificationModule nctId: NCT06365723, orgStudyIdInfo id: SPH-2023-32410, briefTitle: Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-15, primaryCompletionDateStruct date: 2030-06-15, completionDateStruct date: 2032-06-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Approximately 92 million U.S. adults (\~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD., conditionsModule conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is a randomized crossover trial with a 4-week washout period., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Green Walk, interventions name: Gray Walk, outcomesModule primaryOutcomes measure: Measure of Anxiety, primaryOutcomes measure: Perceived stress assessment, primaryOutcomes measure: Mood assessment, secondaryOutcomes measure: Heart Rate variability, secondaryOutcomes measure: Salivary cortisol levels, secondaryOutcomes measure: Ambient Particulate Matter, secondaryOutcomes measure: Black Carbon levels, secondaryOutcomes measure: CMD risk, secondaryOutcomes measure: State and Trait anxiety, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365710, orgStudyIdInfo id: HUS/206/2022, briefTitle: Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-24, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Töölö Hospital, class: OTHER, descriptionModule briefSummary: Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE)., conditionsModule conditions: Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation, interventions name: Traditional physiotherapy, outcomesModule primaryOutcomes measure: Patient-Rated Wrist Evaluation (PRWE), secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: Quick Disabilities of the arm, shoulder, and hand, secondaryOutcomes measure: Pain (Visual Analogue Scale), secondaryOutcomes measure: Wrist range of motion (ROM), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Global improvement, secondaryOutcomes measure: Patient-rated Quality of Life (EQ-5D), secondaryOutcomes measure: Cost-utility analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital, status: RECRUITING, city: Helsinki, state: Uusimaa, zip: 00029, country: Finland, contacts name: Samuli Aspinen, M.D., Ph.D., role: CONTACT, phone: +358406360546, email: samuli.aspinen@hus.fi, geoPoint lat: 60.16952, lon: 24.93545, hasResults: False
|
protocolSection identificationModule nctId: NCT06365697, orgStudyIdInfo id: ZHTQ202301, briefTitle: Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Zhuhai Tonbridge Medical Tech. Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis., conditionsModule conditions: Carotid Artery Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 188, type: ESTIMATED, armsInterventionsModule interventions name: Ton-bridge carotid stent, interventions name: WALLSTENT carotid stent, outcomesModule primaryOutcomes measure: Incidence of non-MAE(major adverse events) within 30 days post-procedure, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Procedural success, secondaryOutcomes measure: Target lesion revascularization (TLR), secondaryOutcomes measure: Ipsilateral stroke between 31 days and 1 year post-procedure, secondaryOutcomes measure: In-stent restenosis, secondaryOutcomes measure: mRS score, secondaryOutcomes measure: Device deficiency, secondaryOutcomes measure: Incidence of MAE, secondaryOutcomes measure: Incidence of Adverse events (AE), secondaryOutcomes measure: Incidence of Serious adverse events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The People's Hospital of Liaoning Province, city: Shenyang, state: Liaoning, country: China, contacts name: Peizhuo Zang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Linyi People's Hospital, city: Linyi, state: Shandong, country: China, contacts name: Hongxing Han, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.06306, lon: 118.34278, locations facility: Qingdao Central Hospital, city: Qingdao, state: Shandong, country: China, contacts name: Haicheng Yuan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.06488, lon: 120.38042, locations facility: The Affiliated Hospital of Qingdao University, city: Qingdao, state: Shandong, country: China, contacts name: Yong Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Central Hospital Affiliated to Shangdong First Medical University, city: Jinan, state: Shangdong, country: China, contacts name: Liqun Jiao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Lishui Central Hospital, city: Lishui, state: Zhejiang, country: China, contacts name: Xueli Cai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.46042, lon: 119.91029, locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, country: China, contacts name: Bin Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06365684, orgStudyIdInfo id: 133548, secondaryIdInfos id: 2023-507823-52, type: EUDRACT_NUMBER, briefTitle: Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4, acronym: LIBRAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \> 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed, conditionsModule conditions: Hyperkalemia, conditions: Diet Modification, conditions: Chronic Kidney Disease, conditions: Sodium Zirconium Cyclosilicate, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single center, cross-over randomized clinical trial with non-inferiority design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Sodium zirconium cyclosilicate, outcomesModule primaryOutcomes measure: The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis., secondaryOutcomes measure: Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours), secondaryOutcomes measure: 24 hours albuminuria, secondaryOutcomes measure: urinary potassium (mmol/l), secondaryOutcomes measure: Plasma bicarbonate, secondaryOutcomes measure: Quality of life, using SF36 questionnaire, secondaryOutcomes measure: Effect on stool (assessed with Bristol Stool Chart), secondaryOutcomes measure: Difference in serum potassium one week after start of study (SCZ free period), secondaryOutcomes measure: Per protocol analysis of difference in serum potassium after six week (end of study), secondaryOutcomes measure: Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia), secondaryOutcomes measure: Incidence of hyperkalemia (serum potassium above 5.5 mmol/l), secondaryOutcomes measure: Necessity for treatment of hyperkalemia, secondaryOutcomes measure: urinary sodium (mmol/l), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365671, orgStudyIdInfo id: ASCT-CART, briefTitle: CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors, conditionsModule conditions: B-NHL, Extranodal, TP53 Alterations, Bulky Mass, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel), outcomesModule primaryOutcomes measure: Best Complete Response (CR) Rate in 3 months, secondaryOutcomes measure: Objective remission rate (ORR) in 3months, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Adverse Events rate as assessed by CTCAE version 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365658, orgStudyIdInfo id: 2024/PTPiP/1, briefTitle: Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Bartosz M. Radtke, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.The main questions it aims to answer are:1. What is the profile of memory and learning among polish adults?2. Do gender and age moderates patterns of memory and learning functioning among polish adults?3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?Researchers will compare the following groups of adults:1. general population/control group2. with neurologically recognized aphasic syndromes3. seniors (over 60 y.o.), conditionsModule conditions: Aphasia, conditions: Development, Human, conditions: Neuropathology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Psychological assessment, outcomesModule primaryOutcomes measure: Memory and learning, primaryOutcomes measure: Language, primaryOutcomes measure: Socio-demographic data, secondaryOutcomes measure: General mental state, secondaryOutcomes measure: Health related data, secondaryOutcomes measure: Education data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Laboratory of Psychological and Educational Tests, status: RECRUITING, city: Gdansk, state: Pomerania, zip: 80-239, country: Poland, contacts name: Rafał Nowicki, M.A., role: CONTACT, phone: +48509805591, email: nowicki@pracowniatestow.pl, contacts name: Urszula Sajewicz-Radtke, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Bartosz M Radtke, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Ariadna Łada-Maśko, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Beata Daniluk, Ph.D., role: SUB_INVESTIGATOR, contacts name: Piotr Markiewicz, Ph.D., role: SUB_INVESTIGATOR, contacts name: Paweł Jurek, Ph.D., role: SUB_INVESTIGATOR, contacts name: Michał Olech, Ph.D., role: SUB_INVESTIGATOR, contacts name: Artur Sawicki, M.A., role: SUB_INVESTIGATOR, contacts name: Rafał Nowicki, M.A., role: SUB_INVESTIGATOR, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False
|
protocolSection identificationModule nctId: NCT06365645, orgStudyIdInfo id: 2138752, briefTitle: Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Women and Infants Hospital of Rhode Island, class: OTHER, descriptionModule briefSummary: Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention., conditionsModule conditions: Postpartum Depression, conditions: Postpartum Anxiety, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Participants who consent will be unaware of the existence of another version of M.Bapp. Obstetric care providers will be aware of participant's enrollment in this trial but not of the study group and will be encouraged to provide standardized care. The research team and outcomes assessors will be blindd to the randomization group., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: M.Bapp, interventions name: App-based parenting education, outcomesModule primaryOutcomes measure: Feasibility, primaryOutcomes measure: Acceptability, secondaryOutcomes measure: Edinburgh Postnatal Depression Scale, secondaryOutcomes measure: General Anxiety Disorder-7, secondaryOutcomes measure: Perceived Stress-Scale 4, secondaryOutcomes measure: Dyadic Adjustment Scale, secondaryOutcomes measure: UCLA Loneliness Scale, secondaryOutcomes measure: Frequency of Mothers and Babies Skills Use, otherOutcomes measure: De novo psychiatric diagnosis, otherOutcomes measure: Screening positive on study survey, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Women & Infants Hospital of Rhode Island, city: Providence, state: Rhode Island, zip: 02905, country: United States, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False
|
protocolSection identificationModule nctId: NCT06365632, orgStudyIdInfo id: OLTOSPAN-02, briefTitle: Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis, acronym: OLTOSPAN-02, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Research Institute for Physical Chemical Problems of the Belarusian State University, class: OTHER, collaborators name: Unitary Enterprise UNITEHPROM BSU, collaborators name: City Clinical Hospital of Emergency Medical Care of Minsk, descriptionModule briefSummary: The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions., conditionsModule conditions: Abdominal Adhesions, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus, interventions name: antegrade appendectomy, outcomesModule primaryOutcomes measure: Number of patients with acute phlegmonous appendicitis cured, secondaryOutcomes measure: absence of signs of adhesions, otherOutcomes measure: increase in the sliding distance of the cecum, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk, city: Minsk, zip: 220024, country: Belarus, contacts name: Olga Svetlitskaya, role: CONTACT, phone: +375297752697, email: info@bsmp.by, contacts name: Yulia Shabalina, role: CONTACT, phone: +375 (17) 287 00 15, email: info@bsmp.by, geoPoint lat: 53.9, lon: 27.56667, locations facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk, city: Minsk, zip: 220024, country: Belarus, contacts name: Olga Svetlitskaya, role: CONTACT, phone: +375297752697, email: info@bsmp.by, contacts name: Yulia Shabalina, role: CONTACT, phone: +375 (17) 287 00 15, email: info@bsmp.by, contacts name: Stanislav Tretiak, Doctor of Medicine, role: PRINCIPAL_INVESTIGATOR, contacts name: Alexander Zhura, Doctor of Medicine, role: SUB_INVESTIGATOR, geoPoint lat: 53.9, lon: 27.56667, hasResults: False
|
protocolSection identificationModule nctId: NCT06365619, orgStudyIdInfo id: HCI168525, briefTitle: Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma, acronym: NeoRelapse, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy.Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response., conditionsModule conditions: Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Ipilimumab, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery., secondaryOutcomes measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment., secondaryOutcomes measure: Rate of adverse events that occur within 30 days post-surgery., secondaryOutcomes measure: Rate of Event Free Survival (EFS)., secondaryOutcomes measure: Rate of Overall Survival (OS)., secondaryOutcomes measure: Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR and CR as defined by RECIST 1.1 prior to surgical resection., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huntsman Cancer Institute, city: Salt Lake City, state: Utah, zip: 84112, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
|
protocolSection identificationModule nctId: NCT06365606, orgStudyIdInfo id: CLS-015A, briefTitle: Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-05-29, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at, conditionsModule conditions: Syphilis Infection, conditions: Syphilis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, maskingDescription: Participants and the healthcare providers are not aware of the syphilis status., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 4500, type: ESTIMATED, armsInterventionsModule interventions name: iStatis Syphilis Ab Test, outcomesModule primaryOutcomes measure: Sensitivity and specificity of the iStatis Syphilis Ab Test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Epicentre Health Research, status: RECRUITING, city: Hillcrest, state: KwaZulu Natal, zip: 3650, country: South Africa, contacts name: Cherie Cawood, role: CONTACT, phone: +27 828202955, email: cheriec@epicentre.org.za, hasResults: False
|
protocolSection identificationModule nctId: NCT06365593, orgStudyIdInfo id: D8450R00005, briefTitle: hATTR Polyneuropathy in Russia, acronym: PRIMER, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-29, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients., conditionsModule conditions: Hereditary Transthyretin Amyloidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Mean age at the hATTR-PN or CIAP diagnosis information will be collected, primaryOutcomes measure: In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of women and men will be collected, primaryOutcomes measure: In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with each race and ethnicity will be collected, primaryOutcomes measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIA, information on Proportion of patients from each federal district of the Russian Federation will be collected, primaryOutcomes measure: in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, tha following Anthropometric characteristics will be collected:, primaryOutcomes measure: In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with underweight will be collected, primaryOutcomes measure: in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with negative lifestyle factors will be collected:, primaryOutcomes measure: in order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with positive family history in close relatives will be collected, primaryOutcomes measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from the first symptoms of neuropathy to the diagnosis of PN will be collected, primaryOutcomes measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, Proportion of patients with different firstly suspected etiology of PN will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from first PN manifestation/diagnosis to the hATTR-PN or CIAP diagnosis will be collected, primaryOutcomes measure: To describe the baseline electrophysiological and clinical characteristics of patients, Proportion of patients with chronic sensory or sensorimotor polyneuropathy and progressive chronic polyneuropathy among patients with CIAP will be calculated, primaryOutcomes measure: To describe the baseline clinical characteristics of patients with hATTR-PN and CIAP, Proportion of patients with each result of TTR gene testing will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each clinical manifestation will be calculated:, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each PND score will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each score by each parameter of neurological examination will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by MRS will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by INCAT scale (total score, arm disability, leg disability) will be collected, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean left ventricular ejection fraction (LVEF) will be collected, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean wall thickness of the left ventricular (LV) will be collected, primaryOutcomes measure: To describe the baseline electrophysiological characteristics of patients with hATTR-PN and CIAP, information Mean variables based on the results of electrophysiological investigation, including the following (on both extremities) will be collected, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with diagnosis of HFpEF will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean NT-proBNP level will be collected, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean estimated glomerular filtration rate (eGFR) will be collected, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean urine albumin-to-creatinine ratio (UACR) in a spot urine sample will be collected, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with a positive paraprotein blood test result will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean blood pressure (BP) (systolic and diastolic) and Mean heart rate (HR), primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each concomitant disease will be calculated, primaryOutcomes measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients underwent surgery for CTS to the moment of diagnosis will be calculated, secondaryOutcomes measure: To arrange a score to select patients with axonal neuropathy who deserve screening for TTR mutation., otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP in the Russian Federation during retrospective follow-up period Mean changes in BMI at visits 2, 3 will be compared to baseline, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with newly diagnosed clinical manifestations will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period, Proportion of patients with different newly diagnosed clinical manifestations will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with each PND score at visits 2, 3 will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP, Proportion of patients with worsening of PND score at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with hospitalisations (one or more) will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of different reasons for hospitalisations will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with death for all causes will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients during follow-up period Proportion of patients with different causes of death will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients during retrospective follow-up period Proportion of patients with each score by each parameter of neurological examination at visits 2, 3 will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in MRS at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in INCAT scale at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with diagnosis of HFpEF at visits 2, 3 will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in LVEF at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in wall thickness of the LV at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in NT-proBNP at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in eGFR at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in UACR at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with a positive paraprotein blood test result at visits 2, 3 will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in BP at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in HR at visits 2, 3 compared to baseline will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with new concomitant diseases will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with different new concomitant diseases will be calculated, otherOutcomes measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with presence of CTS surgery will be calculated, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Kazan, country: Russian Federation, geoPoint lat: 55.78874, lon: 49.12214, locations facility: Research Site, status: RECRUITING, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Research Site, status: RECRUITING, city: Saint-Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
|
protocolSection identificationModule nctId: NCT06365580, orgStudyIdInfo id: Kylo-0603-I-C01, briefTitle: Dose Escalation Study of Kylo-0603 in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Kylonova (Xiamen) Biopharma co., LTD., class: INDUSTRY, descriptionModule briefSummary: This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects., conditionsModule conditions: Nonalcoholic Steatohepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: Kylo-0603 capsule, interventions name: Placebo, outcomesModule primaryOutcomes measure: incidence of adverse events, secondaryOutcomes measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax), secondaryOutcomes measure: PK parameter of time of maximum observed concentration (Tmax), secondaryOutcomes measure: PK parameter of area under the concentration time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The first affiliated hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
|
protocolSection identificationModule nctId: NCT06365567, orgStudyIdInfo id: CE209/2023, briefTitle: Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease., acronym: EO2022, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-03-05, completionDateStruct date: 2026-03-02, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, collaborators name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, descriptionModule briefSummary: The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a "Western" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week.Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition.The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children., conditionsModule conditions: Pediatric Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: assessment of fructose intake with questionnaires, primaryOutcomes measure: correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis, primaryOutcomes measure: Correlation of fructose consumption with bone metabolism, detected through QUS, secondaryOutcomes measure: Characterization of the concentration of intestinal microorganisms, secondaryOutcomes measure: Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: SCDU Pediatria, AOU Ospedale Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Flavia Prodam, MD PHD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-21, uploadDate: 2024-04-11T05:17, filename: Prot_SAP_000.pdf, size: 972421, hasResults: False
|
protocolSection identificationModule nctId: NCT06365554, orgStudyIdInfo id: 2, briefTitle: On-Premise and Remote Robotic Neurointervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Remedy Robotics, Inc., class: INDUSTRY, collaborators name: Unity Health Toronto, descriptionModule briefSummary: This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention., conditionsModule conditions: Cerebrovascular Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Remedy Robot, outcomesModule primaryOutcomes measure: Procedural safety, primaryOutcomes measure: Procedural Technical Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365541, orgStudyIdInfo id: GYLLPJ-2024006, briefTitle: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The People's Hospital of Gaozhou, class: OTHER, descriptionModule briefSummary: Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance., conditionsModule conditions: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Exploring the efficacy and safety of dapagliflozin in improving heart failure in dialysis patients by the analysis and comparison of patients' own data before and after dapagliflozin treatment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin, outcomesModule primaryOutcomes measure: N-terminal B-type natriuretic peptide precursor (NT-proBNP), primaryOutcomes measure: Left ventricular ejection fraction (LVEF), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The People's Hospital of Gaozhou, status: RECRUITING, city: Maoming, state: Guangdong, zip: 525200, country: China, contacts name: Mingsheng Zhu, role: CONTACT, phone: 15016656405, email: ms160@163.com, geoPoint lat: 21.65, lon: 110.9, hasResults: False
|
protocolSection identificationModule nctId: NCT06365528, orgStudyIdInfo id: 2023-0232, briefTitle: Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Hospital de Clinicas de Porto Alegre, class: OTHER, collaborators name: Hospital Moinhos de Vento, collaborators name: Irmandade Santa Casa de Misericórdia de Porto Alegre, descriptionModule briefSummary: The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days., conditionsModule conditions: CLABSI - Central Line Associated Bloodstream Infection, conditions: Deep Vein Thrombosis, conditions: Dislodged Catheter, conditions: Occlusion, conditions: Catheter Rupture, conditions: Catheter (Other); Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Prospective Randomized Open, Blinded End-point (PROBE Study), whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 840, type: ESTIMATED, armsInterventionsModule interventions name: Subcutaneous tunnelling, interventions name: Non-tunnelling, outcomesModule primaryOutcomes measure: End of therapy or catheter removal free from complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital de Clínicas de Porto Alegre, city: Porto Alegre, country: Brazil, contacts name: Eneida R Rabelo da Silva, ScD, role: CONTACT, geoPoint lat: -30.03306, lon: -51.23, hasResults: False
|
protocolSection identificationModule nctId: NCT06365515, orgStudyIdInfo id: TUE010_IRTG_P5, briefTitle: Dopamine, Reward Learning and Sex Hormones, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, collaborators name: German Research Foundation, collaborators name: Uppsala University, descriptionModule briefSummary: Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, we aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, we are testing the effects of hormonal status on metabolic indices and its effects on mood fluctuations in a period of a month.The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. We have exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explore if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase., conditionsModule conditions: Hormonal Changes, conditions: Menstrual Cycle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The investigators will assess the effects of Levodopa administration on reward-learning using a double-blind randomized cross-over design. In a within-subject design, participants will get both conditions (Levodopa/placebo) at different time points (a few days apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional MR imaging) during effort-based decision making task., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Neither participants nor investigators will know at which time point the participant will receive Levodopa and placebo tablets. The tablets will be prepared by independent members of the university hospital., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Levodopa administration, interventions name: Placebo administration, outcomesModule primaryOutcomes measure: Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making, primaryOutcomes measure: Reward-related brain responses in the reward network during effort-based decision-making, primaryOutcomes measure: Reward anticipation on a neural level, primaryOutcomes measure: Execution of effort on a neural level, secondaryOutcomes measure: Resting-state functional connectivity, secondaryOutcomes measure: Changes in reinforcement learning, secondaryOutcomes measure: Menstrual cycle induced changes in mood and food cravings, secondaryOutcomes measure: Changes in resting energy expenditure, secondaryOutcomes measure: Changes in metabolic hormone levels during the menstrual cycle, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Psychiatry & Psychotherapy, University of Tübingen, city: Tübingen, state: BW, zip: 72076, country: Germany, contacts name: Andrea Heberle, role: CONTACT, email: Andrea.Heberle@med.uni-tuebingen.de, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
|
protocolSection identificationModule nctId: NCT06365502, orgStudyIdInfo id: KY2023-156, briefTitle: Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, collaborators name: Shanghai Shenqi Medical Technology Co., Ltd, descriptionModule briefSummary: The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome., conditionsModule conditions: Acute Coronary Syndrome (ACS), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1860, type: ESTIMATED, armsInterventionsModule interventions name: Drug-coated balloon, interventions name: Guideline-directed medical treatment, outcomesModule primaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: Major cardiac adverse event (MACE), secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death and target lesion MI, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Target lesion myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Periprocedural and non-periprocedural myocardial infarction, secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Minimal lumen area after DCB treatment, secondaryOutcomes measure: Plaque burden after DCB treatment, secondaryOutcomes measure: FCT after DCB treatment, secondaryOutcomes measure: Lipid arc after DCB treatment, secondaryOutcomes measure: FCT <75 μm after DCB treatment, secondaryOutcomes measure: PB >65% after DCB treatment, secondaryOutcomes measure: PB >70% after DCB treatment, secondaryOutcomes measure: MLA <3.5 mm^2 after DCB treatment, secondaryOutcomes measure: Maximal lipid arc >180° after DCB treatment, secondaryOutcomes measure: Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Beijing Luhe Hospital of Capital Medical University, city: Beijin, state: Beijing, zip: 101149, country: China, contacts name: Guangyao zhai, role: CONTACT, contacts name: Guangyao zhai, role: PRINCIPAL_INVESTIGATOR, locations facility: Affiliated Hospital of Zunyi Medical University, city: Zunyi, state: Guizhou, zip: 563000, country: China, geoPoint lat: 27.68667, lon: 106.90722, locations facility: Daqing Oilfield General Hospital, city: Daqing, state: Heilongjiang, zip: 150000, country: China, geoPoint lat: 46.58333, lon: 125.0, locations facility: The Second Affiliated Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Haibo Jia, PhD, role: CONTACT, contacts name: Bo Yu, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Haibo Jia, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.75, lon: 126.65, locations facility: The First Affiliated Hospital of Jiamusi University, city: Jiamusi, state: Heilongjiang, zip: 150000, country: China, contacts name: Guangyuan Yang, role: CONTACT, contacts name: Guangyuan Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.79927, lon: 130.31633, locations facility: Mudanjiang Cardiovascular Hospital, city: Mudanjiang, state: Heilongjiang, zip: 150000, country: China, contacts name: Kai Liu, role: CONTACT, contacts name: Kai Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.58333, lon: 129.6, locations facility: Fuwai Central China Cardiovascular Hospital, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital of Zhengzhou University, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: Chunguang Qiu, role: CONTACT, contacts name: Chunguang Qiu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Tongji Hospital Tongji Medical College of HUST, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Third Second Hospital of Jilin University, city: Changchun, state: Jilin, zip: 132000, country: China, contacts name: Bin Liu, role: CONTACT, contacts name: Bin Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: Dalian Municipal Central Hospital, city: Dalian, state: Liaoning, zip: 116000, country: China, contacts name: Xiaoqun Zheng, role: CONTACT, contacts name: Xiaoqun Zheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The First Affiliated Hospital of Dalian Medical University, city: Dalian, state: Liaoning, zip: 116000, country: China, contacts name: Bo Zhang, role: CONTACT, contacts name: Bo Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, locations facility: The People's Hospital of Liaoning Province, city: Shengyang, state: Liaoning, zip: 132000, country: China, locations facility: The Affiliated Hospital of Neimenggu Medical University, city: Hohhot, state: Neimenggu, zip: 011500, country: China, contacts name: Fengying Chen, role: CONTACT, contacts name: Fengying Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.81056, lon: 111.65222, locations facility: Shandong Provincial Hospital, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Haitao Yuan, role: CONTACT, contacts name: Haitao Yuan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Affiliated Hospital of Jining Medical University, city: Jining, state: Shandong, zip: 250000, country: China, contacts name: Lijun Gan, role: CONTACT, contacts name: Lijun Gan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.405, lon: 116.58139, locations facility: The Affiliated Hospital of Qingdao University, city: Qingdao, state: Shandong, zip: 250000, country: China, contacts name: Peng Li, role: CONTACT, contacts name: Peng Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Yantai Yuhuangding Hospital, city: Yantai, state: Shandong, zip: 250000, country: China, contacts name: Lin Zhong, role: CONTACT, contacts name: Lin Zhong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.47649, lon: 121.44081, hasResults: False
|
protocolSection identificationModule nctId: NCT06365489, orgStudyIdInfo id: 113293, briefTitle: Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-11, primaryCompletionDateStruct date: 2023-02-20, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Golestan University of Medical sciences, class: OTHER, descriptionModule briefSummary: Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated., conditionsModule conditions: Vascular Access Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 78, type: ACTUAL, outcomesModule primaryOutcomes measure: Early post operative WBI changes following AVF implantation, primaryOutcomes measure: Two-week post operative WBI changes following AVF implantation, primaryOutcomes measure: Three-month post operative WBI changes following AVF implantation, secondaryOutcomes measure: Correlation between WBI changes following AVF implantation with age, secondaryOutcomes measure: Correlation between WBI changes following AVF implantation with sex, secondaryOutcomes measure: Correlation between WBI changes following AVF implantation with co-morbidities, secondaryOutcomes measure: Correlation between WBI changes following AVF implantation with steal syndrome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pezhman Kharazm, MD, city: Gorgan, state: Golestan, zip: 4917956808, country: Iran, Islamic Republic of, geoPoint lat: 36.8427, lon: 54.44391, hasResults: False
|
protocolSection identificationModule nctId: NCT06365476, orgStudyIdInfo id: 202309126RIND, briefTitle: FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity., conditionsModule conditions: Stroke, conditions: Spasticity, Muscle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: focused extracorporeal shock wave therapy (ESWT), outcomesModule primaryOutcomes measure: passive range of motion for the wrist and finger joints, primaryOutcomes measure: hand grip strength, primaryOutcomes measure: Visual Analogue Scale (VAS), primaryOutcomes measure: modified Ashworth scale (MAS), primaryOutcomes measure: modified Tardieu scale (MTS), secondaryOutcomes measure: Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), secondaryOutcomes measure: Action Research Arm Test (ARAT), secondaryOutcomes measure: Barthel index, secondaryOutcomes measure: Functional Independence Measure (FIM), secondaryOutcomes measure: ultrasound assessment, secondaryOutcomes measure: Box and Block Test, secondaryOutcomes measure: Wolf Motor Function Test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Physical Medicine & Rehabilitation, National Taiwan University Hospital, status: RECRUITING, city: Taipei, zip: 100, country: Taiwan, contacts name: Shu-mei Yang, MD, role: CONTACT, phone: 886-2- 23123456, email: b99401109@gmail.com, contacts name: Shu-mei Yang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
|
protocolSection identificationModule nctId: NCT06365463, orgStudyIdInfo id: URIS202401, briefTitle: Telerehabilitation to Improve Balance and Mobility in Patients After Stroke, acronym: TeleHome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University Rehabilitation Institute, Republic of Slovenia, class: OTHER, descriptionModule briefSummary: Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions., conditionsModule conditions: Hemorrhagic Stroke, conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation, outcomesModule primaryOutcomes measure: Change in balance, primaryOutcomes measure: Change in limits of stability, primaryOutcomes measure: Change in weight-bearing symmetry, secondaryOutcomes measure: Change in mobility, secondaryOutcomes measure: Change in walking speed, otherOutcomes measure: Satisfaction with the remote training, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Rehabilitation Institute, Republic of Slovenia, status: RECRUITING, city: Ljubljana, zip: 1000, country: Slovenia, contacts name: Urška Puh, PT, PhD, role: CONTACT, phone: +386 1 4758152, email: urska.puh@ir-rs.si, geoPoint lat: 46.05108, lon: 14.50513, hasResults: False
|
protocolSection identificationModule nctId: NCT06365450, orgStudyIdInfo id: IRB00315481, briefTitle: Breast and Cervical Cancer Education Program, acronym: OCEAP, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-22, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-04-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Older Women Embracing Life, collaborators name: The John G. Bartlett Specialty Practice, descriptionModule briefSummary: The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference., conditionsModule conditions: Cervical Cancer, conditions: Breast Cancer, conditions: Health Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Educational Intervention, outcomesModule primaryOutcomes measure: Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool., secondaryOutcomes measure: Number of participants recruited from each community partner, secondaryOutcomes measure: Number of participants who preferred virtual or in person sessions, secondaryOutcomes measure: Number of participants who were lost of follow up, secondaryOutcomes measure: Number of participants who needed help redeeming their gift codes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins University School of Nursing, city: Baltimore, state: Maryland, zip: 21205, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
|
protocolSection identificationModule nctId: NCT06365437, orgStudyIdInfo id: TCD601B101, briefTitle: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ITB-Med LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients., conditionsModule conditions: Kidney Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TCD601, interventions name: Tacrolimus (TAC), interventions name: Corticosteroids (CS), interventions name: Mycophenolate Mofetil (MMF), interventions name: ATG, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0., primaryOutcomes measure: Measure Peak Plasma Concentration (Cmax) over time., primaryOutcomes measure: Measure the Area under the plasma concentration versus time curve (AUC)., secondaryOutcomes measure: Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time., secondaryOutcomes measure: Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time., secondaryOutcomes measure: Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Innsbruck Medical University, status: RECRUITING, city: Innsbruck, zip: A-6020, country: Austria, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 47.26266, lon: 11.39454, locations facility: University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Hospital Clinic de Barcelona, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitari de Bellvitge, status: RECRUITING, city: Barcelona, zip: 08907, country: Spain, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Karolinska University Hospital, status: RECRUITING, city: Stockholm, state: Huddinge, zip: 14157, country: Sweden, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Sahlgrenska University Hospital, status: RECRUITING, city: Göteborg, zip: 41345, country: Sweden, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Skåne University Hospital, status: RECRUITING, city: Malmö, zip: 20502, country: Sweden, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 55.60587, lon: 13.00073, hasResults: False
|
protocolSection identificationModule nctId: NCT06365424, orgStudyIdInfo id: KY20151230-5-1, briefTitle: Fenofibrate in Patients With Primary Biliary Cholangitis (PBC), statusModule overallStatus: RECRUITING, startDateStruct date: 2017-04-08, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital of Digestive Diseases, class: OTHER, descriptionModule briefSummary: An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC), conditionsModule conditions: Primary Biliary Cholangitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 117, type: ESTIMATED, armsInterventionsModule interventions name: Fenofibrate, interventions name: UDCA, outcomesModule primaryOutcomes measure: Treatment emergent adverse events (TEAEs), primaryOutcomes measure: Percentage of patients with biochemical response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital, status: RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Ying Han, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
|
protocolSection identificationModule nctId: NCT06365411, orgStudyIdInfo id: GEM-KiT, briefTitle: GEnomic Medicine in Kidney Transplantation Study, acronym: GEM-KiT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2030-01-01, completionDateStruct date: 2035-01-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Western Sydney Local Health District, class: OTHER, descriptionModule briefSummary: Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction, conditionsModule conditions: Transplant Complication, conditions: Kidney Transplant Rejection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Biomarker discovery and validation - with focus on genomic biomarkers, outcomesModule primaryOutcomes measure: Death censored graft loss (DCGL), primaryOutcomes measure: Biopsy proven rejection (BPAR), secondaryOutcomes measure: All cause graft loss, secondaryOutcomes measure: Death, secondaryOutcomes measure: Treatment resistant rejection, secondaryOutcomes measure: Hospital admission or emergency attendance, secondaryOutcomes measure: Delayed Graft Function (DGF), secondaryOutcomes measure: Kidney function, secondaryOutcomes measure: Albuminuria, secondaryOutcomes measure: Surrogate end-point markers, secondaryOutcomes measure: Borderline rejeciton, secondaryOutcomes measure: chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores, secondaryOutcomes measure: Recurrent disease, secondaryOutcomes measure: BK virus complications, secondaryOutcomes measure: Major cardiovascular complications, secondaryOutcomes measure: Major infectious complications, secondaryOutcomes measure: Malignancy post transplantation, secondaryOutcomes measure: Kidney biopsy transcriptomic signature, secondaryOutcomes measure: Kidney cell type composition, secondaryOutcomes measure: Proteinomic signature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365398, orgStudyIdInfo id: SELECT, secondaryIdInfos id: XWHL-2018010, type: OTHER_GRANT, domain: Xuanwu Hospital, Capital Medical University, briefTitle: Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy, acronym: SELECT, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2021-06-01, completionDateStruct date: 2022-01-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients., conditionsModule conditions: Cerebral Angiography, conditions: Heparinization, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Heparin, interventions name: Heparin Sodium Injection, interventions name: No heparinization, outcomesModule primaryOutcomes measure: postoperative cerebral infarction, secondaryOutcomes measure: Numerical Rating Scale (NRS) for back pain, secondaryOutcomes measure: the incidence of paralysis of surgical limb, secondaryOutcomes measure: the incidence of pain of surgical limb, secondaryOutcomes measure: the incidence of postoperative urethral catheterization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xuanwu Hospital, Capital Medical University., city: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06365385, orgStudyIdInfo id: FOODSEQ-MARS, briefTitle: Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, collaborators name: Federação Portuguesa de Futebol, collaborators name: Fundação para a Ciência e a Tecnologia, descriptionModule briefSummary: Emerging evidence suggests that following a 'carbohydrate-last meal pattern', wherein foods rich in protein, fat, fiber, and/or polyphenols are consumed before sources of simple carbohydrate (CHO) in a meal, results in reduced postprandial glycaemic responses than the reverse food order or a co-ingestion pattern. This effect has been observed across the spectrum of glucose tolerance, from patients with diabetes to individuals with normal glucose tolerance (Kuwata et al., 2016; Nishino et al., 2018; Lu et al., 2019; Sun et al., 2020). Furthermore, reduced glucose excursions have been linked to decreased subsequent hunger and energy intake (Lu et al., 2019; Wyatt et al., 2021).However, to date, no studies on food intake sequence have targeted athletes, despite their increased CHO demands (Thomas et al., 2016) which could expose them to repeated episodes of hyperglycaemia and high glycaemic variability, known to increase the risk of adverse cardiovascular outcomes and all-cause mortality (Loader et al., 2015; Cavero-Redondo et al., 2017; Faerch et al., 2018). Additionally, athletes often face pressure to meet body composition standards and may benefit from strategies that enhance satiety and craving control. Finally, there is reason to believe that better glycaemic control could lead to improved performance, given that enhancements in endurance activities have been observed with a low-glycemic-index diet compared to a high-glycemic-index diet (Heung-Sang Wong et al., 2017).Therefore, this randomised crossover trial is part of a wider project which seeks to explore the impact of food intake sequence on metabolic health and performance in athletes. Specifically, this trial aims to investigate the acute, postprandial metabolic and appetite responses to consuming an identical meal in two intake sequences (CHO-last versus CHO-first) in athletes, while in the resting state., conditionsModule conditions: Healthy, conditions: Nutrition, Healthy, conditions: Postprandial Hyperglycemia, conditions: Hunger, conditions: Craving, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This study is a randomised controlled trial with a counterbalanced crossover design. Block randomisation will be performed by an external researcher, and allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: This is a non-blind trial, since both participants and the investigator delivering the test-meal will be able to see the ingredients and the order in which they are consumed. However, outcome assessors will be blinded to the intervention sequence., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Carbohydrate-last meal pattern, interventions name: Carbohydrate-first meal pattern, outcomesModule primaryOutcomes measure: Postprandial blood glucose concentrations, secondaryOutcomes measure: Postprandial subjective appetite ratings, secondaryOutcomes measure: Prospective ad libitum energy intake, secondaryOutcomes measure: Prospective ad libitum nutritional intake, secondaryOutcomes measure: Postprandial serum insulin concentrations, secondaryOutcomes measure: Postprandial plasma total GLP-1 concentrations, secondaryOutcomes measure: Postprandial plasma total GIP concentrations, secondaryOutcomes measure: Postprandial serum total ghrelin concentrations, secondaryOutcomes measure: Postprandial plasma total PYY concentrations, secondaryOutcomes measure: Postprandial serum triglyceride concentrations, secondaryOutcomes measure: Postprandial serum NEFA concentrations, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365372, orgStudyIdInfo id: MrgD and PAH, briefTitle: Circulating MrgD in Pulmonary Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-10, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension., conditionsModule conditions: Pulmonary Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Western blot, outcomesModule primaryOutcomes measure: Circulating MrgD level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Panpan Hao, MD, PHD, role: CONTACT, email: panda.how@126.com, contacts name: Hongyu Zhong, MD, role: SUB_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.