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protocolSection identificationModule nctId: NCT06358859, orgStudyIdInfo id: STUDY00004203, secondaryIdInfos id: 1R01MD018208-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MD018208-01, briefTitle: Delta GREENS Food is Medicine Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), collaborators name: Tougaloo College, Mississippi, collaborators name: Delta Health Center, Mississippi, collaborators name: Reuben V. Anderson Center for Justice at Tougaloo, descriptionModule briefSummary: Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and \~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta Growing a Resilient, Enriching, Equitable, Nourishing food System (GREENS) Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide., conditionsModule conditions: Cardiometabolic Risk Factors, conditions: Diabetes, conditions: High Blood Pressure, conditions: Obesity, conditions: Nutrition Security, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The primary objective is to test whether a multi-level, community-engaged intervention with a food-is-medicine program in the Mississippi Delta can improve metabolic disease in specific minority groups. The basic study design is a cluster randomized controlled trial (RCT), with equal numbers of participants randomized to intervention and control groups. Each participant will be enrolled in the study for 12 months. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group during their 12-month study period. The control group will receive produce boxes later, after their 12-month study participation has ended. Participants will be patients at participating Delta Health Center (DHC) clinics in Mississippi., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Food is Medicine, outcomesModule primaryOutcomes measure: Change in hemoglobin A1c (HbA1c), secondaryOutcomes measure: Change in cardiometabolic risk factor composite score, secondaryOutcomes measure: Change in BMI, secondaryOutcomes measure: Change in LDL cholesterol, secondaryOutcomes measure: Change in non-HDL cholesterol, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in nutrition security, assessed via a survey, secondaryOutcomes measure: Change in dietary intake of fruits and vegetables, assessed via a survey, secondaryOutcomes measure: Change in health care utilization, assessed via review of Electronic Health Records (EHR), secondaryOutcomes measure: Change in food insecurity, assessed via a survey, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tufts University, city: Boston, state: Massachusetts, zip: 02111, country: United States, contacts name: Daniel Schultz, MS, RDN, LD, role: CONTACT, phone: 262-627-0155, email: [email protected], contacts name: Shanti Sharma, PhD, role: CONTACT, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06358846, orgStudyIdInfo id: 00004, briefTitle: Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: SINA Health Education and Welfare Trust, class: OTHER, collaborators name: Aga Khan University, descriptionModule briefSummary: There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial., conditionsModule conditions: Diabetic Foot, conditions: Educational Intervention, conditions: Foot Care, conditions: Foot Ulcer, Diabetic, conditions: Foot Cellulitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control arm =75 Interventional arm = 75, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Self-care behavior to promote foot care through educational guidance among individual with diabetes, outcomesModule primaryOutcomes measure: Improved Foot Care Knowledge, primaryOutcomes measure: Behavior Change, secondaryOutcomes measure: Reduction in Foot Complications, secondaryOutcomes measure: Empowerment and Self-efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06358833, orgStudyIdInfo id: 24-82-03, briefTitle: Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Qassim University, class: OTHER, descriptionModule briefSummary: Summary:After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain., conditionsModule conditions: Postoperative Pain, conditions: Irreversible Pulpitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients will be masked from the procedure, whoMasked: PARTICIPANT, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: endodontic needle (EN), interventions name: Endodontic activation (EA), outcomesModule primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Irrigation time, otherOutcomes measure: Adverse event, otherOutcomes measure: Rescue medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Muhammad Zubair Ahmad, status: RECRUITING, city: Ar Rass, state: Qassim, zip: 58883, country: Saudi Arabia, contacts name: Muhammad Zubair Ahmad, BDS, FCPS, role: CONTACT, phone: 0163011111, phoneExt: 10685, email: [email protected], geoPoint lat: 25.86944, lon: 43.4973, hasResults: False
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protocolSection identificationModule nctId: NCT06358820, orgStudyIdInfo id: PHGaozhou, briefTitle: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The People's Hospital of Gaozhou, class: OTHER, descriptionModule briefSummary: This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded., conditionsModule conditions: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status of Maintenance Peritoneal Dialysis Patients, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Amino acid peritoneal dialysis solution, outcomesModule primaryOutcomes measure: blood albumin, primaryOutcomes measure: prealbumin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gaozhou People's Hospital, status: RECRUITING, city: Gaozhou, state: Guangdong, zip: 525200, country: China, contacts name: Deng shanshan, role: CONTACT, phone: 8613927596600, email: [email protected], geoPoint lat: 21.93924, lon: 110.84607, hasResults: False
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protocolSection identificationModule nctId: NCT06358807, orgStudyIdInfo id: M2023438, briefTitle: Microfracture With Platelet Rich Plasma Gel Injection for Ostechondral Lesion of the Talus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?* Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.Participants will:* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel* Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment* Take MRI preoperatively and 6, 12 and 24 months after surgery, conditionsModule conditions: Osteochondral Lesion of Talus, conditions: Microfractures, conditions: Platelet Rich Plasma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Arthroscopic microfracture with intraoperative local PRP gel injection, interventions name: Isolated microfracture, outcomesModule primaryOutcomes measure: American Orthopedic Foot and Ankle Society Score (AOFAS), secondaryOutcomes measure: Foot and Ankle Outcome Score (FAOS), secondaryOutcomes measure: Ankle Activity Score (AAS), secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART), secondaryOutcomes measure: Return-to-Sport Rate, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Guo Qinwei, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06358794, orgStudyIdInfo id: IRB00006761-M2022692, briefTitle: Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-05-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models., conditionsModule conditions: Infertility, Male, conditions: Azoospermia, Nonobstructive, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2612, type: ACTUAL, armsInterventionsModule interventions name: Machine learning-based predictive model, outcomesModule primaryOutcomes measure: SRR of micro-TESE, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06358781, orgStudyIdInfo id: xuyajun197673-002, briefTitle: A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains., conditionsModule conditions: Chronic Disease Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Whole grain wheat flour, outcomesModule primaryOutcomes measure: whole grain plasma and urine biomarkers discovery and identification, secondaryOutcomes measure: Validate the performance of the potential WG biomarkers., otherOutcomes measure: Dose-response of WG wheat biomarkers., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Nutrition and Food Hygiene, School of Public Health, Peking University, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06358768, orgStudyIdInfo id: ObGynEASC005, briefTitle: Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations, acronym: PPH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: G. d'Annunzio University, class: OTHER, collaborators name: A.O. Ospedale Papa Giovanni XXIII, descriptionModule briefSummary: Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management, conditionsModule conditions: PPH - Postpartum Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: teamwork job improvement overall, interventions name: teamwork job improvement in actor scenario vs mannequin scenario, outcomesModule primaryOutcomes measure: teamwork, primaryOutcomes measure: skills, secondaryOutcomes measure: scenario quality, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Claudio Celentano, city: Pescara, state: PE, zip: 65100, country: Italy, contacts name: Claudio Celentano, MD, role: CONTACT, phone: +393285577305, email: [email protected], geoPoint lat: 42.4584, lon: 14.20283, locations facility: Ospedale Giovanni XXIII, city: Bergamo, country: Italy, contacts name: Luisa Patanè, MD, role: CONTACT, phone: 349 3503920, phoneExt: +39, email: [email protected], geoPoint lat: 45.69601, lon: 9.66721, hasResults: False
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protocolSection identificationModule nctId: NCT06358755, orgStudyIdInfo id: 10211476, secondaryIdInfos id: P0041308, type: OTHER, domain: The Hong Kong Polytechnic University, briefTitle: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: The University of Hong Kong, descriptionModule briefSummary: The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Defocus Incorporated Multiple Segments lenses, interventions name: single vision spectacle lenses, interventions name: Low dose atropine, outcomesModule primaryOutcomes measure: Changes in cycloplegic refraction, primaryOutcomes measure: Changes in axial length, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong, city: Hong Kong, zip: No postcode, country: Hong Kong, contacts name: Rachel Ka Man Chun, PhD, role: CONTACT, phone: +852-27664224, email: [email protected], contacts name: Dennis Yan-yin Tse, PhD, role: CONTACT, phone: +852-27666096, email: [email protected], contacts name: Christopher Kai-shun Leung, MD and Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06358742, orgStudyIdInfo id: ORL-GUM-2787, briefTitle: Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-10, primaryCompletionDateStruct date: 2017-05-19, completionDateStruct date: 2017-05-19, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Unilever R&D, class: INDUSTRY, collaborators name: Intertek, descriptionModule briefSummary: This study is of a double-blind, randomised, parallel group study. Subjects will be enrolled onto the study according to the inclusion/exclusion criteria. After recruitment, subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study. Following the run-in period, baseline supragingival plaque samples will be collected 12 hours after last brushing, from the upper and lower jaws separately. Subjects will then then randomly allocated to one of two products (zinc citrate trihydrate \[ZCT\] toothpaste or control toothpaste) according to the randomization. Subjects will be instructed to use the toothpaste at home, brushing twice a day for 12-weeks. Supragingival plaque samples will be collected again from the upper and lower jaws after 2, 6 and 12 weeks. Plaque samples will then undergo metataxonomic and metatranscriptomic analyses., conditionsModule conditions: Dental Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Toothpaste packaged in white tubes with a study label which only differentiates products with a alphanumeric code., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: ZCT toothpaste, interventions name: Control toothpaste, outcomesModule primaryOutcomes measure: Plaque microbiome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358729, orgStudyIdInfo id: HUM00239775, briefTitle: Pre-Pregnancy Weight Loss and Baby Behavior Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple., conditionsModule conditions: Obesity; Familial, conditions: Pregnancy Related, conditions: Infant Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Typical Nipple, interventions name: Challenging Nipple, outcomesModule primaryOutcomes measure: Suck effect, secondaryOutcomes measure: Sucking pressure, secondaryOutcomes measure: Sucking frequency, secondaryOutcomes measure: Milk/Formula intake, secondaryOutcomes measure: Milk/Formula consumption rate, secondaryOutcomes measure: Number of Feedings Over 24 Hours, secondaryOutcomes measure: Total Hours of Sleep per 24 Hours within 24 hours of intervention, secondaryOutcomes measure: Total Night Wake-ups within 24 hours of intervention, eligibilityModule sex: ALL, minimumAge: 3 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Amanda Crandall, PhD, role: CONTACT, contacts name: Amanda Crandall, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06358716, orgStudyIdInfo id: CEIC-3037, briefTitle: Glycaemic Index Determination in Oral Nutrition Supplements, acronym: BEGINS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Universitat de Lleida, class: OTHER, collaborators name: Lactalis, descriptionModule briefSummary: The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response., conditionsModule conditions: Glucose Metabolism Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Complete Oral Nutrition Supplement 1, interventions name: Complete Oral Nutrition Supplement 2, interventions name: Complete Oral Nutrition Supplement 3, interventions name: Complete Oral Nutrition Supplement 4, interventions name: Complete Oral Nutrition Supplement 5, interventions name: Complete Oral Nutrition Supplement 6, interventions name: Complete Oral Nutrition Supplement 7, interventions name: Complete Oral Nutrition Supplement 8, interventions name: Complete Oral Nutrition Supplement 9, interventions name: Glucose, outcomesModule primaryOutcomes measure: Glycemic Index, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Lleida, status: RECRUITING, city: Lleida, zip: 25198, country: Spain, contacts name: Jose Serrano, PhD, role: CONTACT, phone: 973702408, email: [email protected], contacts name: Manuel Portero, PhD, role: CONTACT, phone: 973702408, email: [email protected], geoPoint lat: 41.61674, lon: 0.62218, hasResults: False
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protocolSection identificationModule nctId: NCT06358703, orgStudyIdInfo id: P400, briefTitle: Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors, acronym: NeST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: US Thrombotic Microangiopathy Alliance, class: OTHER, descriptionModule briefSummary: 1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI, conditionsModule conditions: Immune Thrombotic Thrombocytopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: Caplacizumab, outcomesModule primaryOutcomes measure: Silent cerebral infarction, primaryOutcomes measure: Cognitive impairment, secondaryOutcomes measure: Depression scores on BDI-II, secondaryOutcomes measure: SF-36 scores for quality of life, secondaryOutcomes measure: Patient reported cognitive performance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USTMA, city: Groveport, state: Ohio, zip: 43125, country: United States, contacts name: Clare Martin, role: CONTACT, phone: 614-999-4900, email: [email protected], geoPoint lat: 39.8784, lon: -82.88379, hasResults: False
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protocolSection identificationModule nctId: NCT06358690, orgStudyIdInfo id: HSC-MS-24-0050, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06358677, orgStudyIdInfo id: HCI171997, briefTitle: Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer, acronym: FACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2029-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment.Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact., conditionsModule conditions: Metastatic Colon Cancer, conditions: Metastatic Rectum Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blind, split-face, phase II study of topical tretinoin prophylaxis for anti-EGFR treatment-induced skin toxicity in metastatic colorectal cancer., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Patients will apply topical tretinoin to one half of the face and topical moisturizer (placebo) to the other half of the face daily starting the day that anti-EGFR treatment is initiated. The sides of the face tretinoin and moisturizer are applied to will be randomized. Standardized photographs of the face will be obtained at screening and every two weeks from Week 1 Day 1 until after six weeks of treatment. Photographs will be graded by a dermatologist who will be blinded to treatment sidedness. Facial rash severity will be graded using a modified Investigators Global Assessment (IGA) score., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Topical Tretinoin, interventions name: Placebo, outcomesModule primaryOutcomes measure: The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment., 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 and the modified IGA), seriousness, duration, and relationship to study treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huntsman Cancer Institute at University of Utah, city: Salt Lake City, state: Utah, zip: 84112, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06358664, orgStudyIdInfo id: Caffeine Vitrectomy, briefTitle: Caffeine and Cataract After Pars Plana Vitrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Vienna Institute for Research in Ocular Surgery, class: OTHER, descriptionModule briefSummary: Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Pars plana vitrectomy, outcomesModule primaryOutcomes measure: Significant cataract formation at year 1, secondaryOutcomes measure: Significant cataract formation at month 6, secondaryOutcomes measure: Distance corrected visual acuity (DCVA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, status: RECRUITING, city: Vienna, zip: 1140, country: Austria, contacts name: Andreas Schlatter, MD, role: CONTACT, phone: +4391021, phoneExt: 57564, email: [email protected], contacts name: Christoph Leisser, MMD, role: CONTACT, phone: +4391021, phoneExt: 57564, email: [email protected], geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06358651, orgStudyIdInfo id: PH94B-CL042, briefTitle: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3), acronym: PALISADE-3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: VistaGen Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study., conditionsModule conditions: Social Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 236, type: ESTIMATED, armsInterventionsModule interventions name: Fasedienol Nasal Spray, interventions name: Placebo Nasal Spray, outcomesModule primaryOutcomes measure: Subjective Units of Distress Scale (SUDS), secondaryOutcomes measure: Global Impression Scale of Improvement (CGI-I), secondaryOutcomes measure: Patient Global Impression of Change (PGI-C), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vistagen Clinical Site, status: RECRUITING, city: Oceanside, state: California, zip: 92056, country: United States, geoPoint lat: 33.19587, lon: -117.37948, locations facility: Vistagen Clinical Site, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32256, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Vistagen Clinical Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32801, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Vistagen Clinical Site, status: RECRUITING, city: New York, state: New York, zip: 10128, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Vistagen Clinical Site, status: RECRUITING, city: Memphis, state: Tennessee, zip: 38119, country: United States, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False
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protocolSection identificationModule nctId: NCT06358638, orgStudyIdInfo id: STUDY00000859, briefTitle: Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY, acronym: SUN-RAY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2044-09, completionDateStruct date: 2054-09, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Children's National Research Institute, class: OTHER, collaborators name: Alberta Children's Hospital, collaborators name: The Hospital for Sick Children, collaborators name: Levine Children's Hospital, collaborators name: Ann & Robert H Lurie Children's Hospital of Chicago, collaborators name: Nationwide Children's Hospital, collaborators name: Children's Hospital at Montefiore, collaborators name: Doris Duke Charitable Foundation, collaborators name: Janssen Pharmaceuticals, descriptionModule briefSummary: This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Sickle cell patients, who have matched sibling donors with anti-donor RBC antibodies., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Daratumumab, interventions name: Alemtuzumab, interventions name: Sirolimus, interventions name: Total Body Irradiation, outcomesModule primaryOutcomes measure: To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies., secondaryOutcomes measure: To evaluate changes in antibodies to red blood cell antigens pre and post exposure to daratumumab and HCT., secondaryOutcomes measure: To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater., otherOutcomes measure: To compare alemtuzumab levels, in mcg/mL, post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study., otherOutcomes measure: To compare immune reconstitution among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study., otherOutcomes measure: To compare donor chimerism (lymphoid vs myeloid) post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children's National Hospital, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Maryanne Odinakachukwu, role: CONTACT, phone: 202-476-2957, email: [email protected], contacts name: Robert Nickel, role: PRINCIPAL_INVESTIGATOR, contacts name: David Jacobsohn, role: SUB_INVESTIGATOR, contacts name: Anant Vatsayan, role: SUB_INVESTIGATOR, contacts name: Blachy Dávila-Saldaña, role: SUB_INVESTIGATOR, contacts name: Evelio Perez-Albuerne, role: SUB_INVESTIGATOR, contacts name: Catherine Bollard, role: SUB_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False
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protocolSection identificationModule nctId: NCT06358625, orgStudyIdInfo id: 2023-4-1-001, briefTitle: Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer, acronym: CRANIUM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2031-04-30, completionDateStruct date: 2031-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Center Eugene Marquis, class: OTHER, descriptionModule briefSummary: HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment., conditionsModule conditions: HER2-positive Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Pre-treatment biopsy, outcomesModule primaryOutcomes measure: Transcriptomic profile change of HER2+ primary breast tumours before any treatment, secondaryOutcomes measure: Transcriptomic profile change on circulating tumour DNA (ctDNA), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358612, orgStudyIdInfo id: DALNSHA2024ABR001, briefTitle: Evaluation of an Anxiety Reduction Tool During Thyroid and Prostate Biopsy Procedures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Nova Scotia Health Authority, class: OTHER, descriptionModule briefSummary: Patients undergoing either thyroid or prostate biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after a thyroid or prostate biopsy procedure that they undergo. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool., conditionsModule conditions: Anxiety State, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Stress Balls, interventions name: No Stress Balls, outcomesModule primaryOutcomes measure: Change in anxiety level of greater than 20% based on Visual Analog Score (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358599, orgStudyIdInfo id: TUO-UR-21-01, briefTitle: The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-07, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ankara Etlik City Hospital, class: OTHER_GOV, descriptionModule briefSummary: The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen., conditionsModule conditions: Bladder Cancer, conditions: Bladder Cancer Stage I, conditions: Bladder Cancer Stage II, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 221, type: ACTUAL, armsInterventionsModule interventions name: Cisplatin, outcomesModule primaryOutcomes measure: Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy., secondaryOutcomes measure: Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy., eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Etlik City Hospital, city: Ankara, zip: 06170, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06358586, orgStudyIdInfo id: 044(H)MD21176, secondaryIdInfos id: CRO-PK-21-356, type: OTHER, domain: CRO code, briefTitle: New Paediatric Formulation of Tachipirina®, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-09, primaryCompletionDateStruct date: 2022-04-25, completionDateStruct date: 2022-04-25, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Aziende Chimiche Riunite Angelini Francesco S.p.A, class: INDUSTRY, collaborators name: Cross S.A., descriptionModule briefSummary: This is a single centre, single dose, single-arm, open-label, palatability study.The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single centre, single dose, single-arm, open-label, palatability study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Tachipirina® 120 mg/5 mL oral suspension, new flavour, outcomesModule primaryOutcomes measure: Palatability of new flavour - Taste (1), primaryOutcomes measure: Palatability of new flavour - Taste (2), primaryOutcomes measure: Palatability of new flavour - Smell, primaryOutcomes measure: Palatability of new flavour - Aftertaste (1), primaryOutcomes measure: Palatability of new flavour - Aftertaste (2), primaryOutcomes measure: Palatability of new flavour - Aftertaste (3), primaryOutcomes measure: Palatability of new flavour - Texture (mouthfeel), primaryOutcomes measure: Palatability of new flavour - Overall, secondaryOutcomes measure: Treatment emergent adverse events (TEAEs), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: CROSS Research S.A. - Phase I Unit,, city: Arzo, zip: CH-6864, country: Switzerland, geoPoint lat: 45.87606, lon: 8.94103, hasResults: False
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protocolSection identificationModule nctId: NCT06358573, orgStudyIdInfo id: SAKK 66/22, briefTitle: Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Swiss Group for Clinical Cancer Research, class: OTHER, descriptionModule briefSummary: About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined., conditionsModule conditions: Triple-negative Breast Cancer, conditions: TNBC - Triple-Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, open-label multicenter phase 2 clinical study to determine the clinical activity, safety and tolerability of INT230-6 in patients with early stage, operable TNBC who undergo neoadjuvant systemic treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: INT230-6, interventions name: neoadjuvant immuno-chemotherapy, outcomesModule primaryOutcomes measure: Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0)., secondaryOutcomes measure: pCR (invasive and in-situ, only invasive, respectively) in the breast, secondaryOutcomes measure: pCR in lymph nodes, secondaryOutcomes measure: Pattern of non pCR, secondaryOutcomes measure: Overall response according to RECIST v1.1, secondaryOutcomes measure: Radiological tumor response using two perpendicular diameters, secondaryOutcomes measure: Event free survival (EFS), secondaryOutcomes measure: Rate of breast conserving surgery (BCS) at the time of definitive surgery, secondaryOutcomes measure: Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tumor Zentrum Aarau, city: Aarau, zip: 5000, country: Switzerland, contacts name: Razvan Popescu, MD, role: CONTACT, phone: +41 62 836 78 33, email: [email protected], contacts name: Razvan Popescu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.39254, lon: 8.04422, locations facility: St. Claraspital, city: Basel, zip: 4058, country: Switzerland, contacts name: Thomas Schmid, MD, role: CONTACT, phone: +41 61 685 88 65, email: [email protected], contacts name: Thomas Schmid, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, locations facility: Istituto Oncologico della Svizzera Italiana (IOSI), city: Bellinzona, zip: 6500, country: Switzerland, contacts name: Lorenzo Rossi, MD, role: CONTACT, phone: +41 91 811 85 77, email: [email protected], contacts name: Lorenzo Rossi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.19278, lon: 9.01703, locations facility: Kantonsspital Graubünden, city: Chur, zip: 7000, country: Switzerland, contacts name: Michael Schwitter, MD, role: CONTACT, phone: +41 81 256 75 68, email: [email protected], contacts name: Michael Schwitter, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.84986, lon: 9.53287, locations facility: Kantonsspital Baselland, city: Liestal, zip: 4410, country: Switzerland, contacts name: Marcus Vetter, MD, role: CONTACT, phone: +41 61 925 2715, email: [email protected], contacts name: Marcus Vetter, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.48455, lon: 7.73446, locations facility: Kantonsspital St. Gallen, city: St. Gallen, zip: 9007, country: Switzerland, contacts name: Markus Jörger, MD, role: CONTACT, phone: +41 76 559 10 70, email: [email protected], contacts name: Markus Jörger, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42391, lon: 9.37477, locations facility: TBZO - Tumor- & Brustzentrum Ostschweiz, city: St. Gallen, zip: 9016, country: Switzerland, contacts name: Markus Niemeyer, MD, role: CONTACT, phone: +41 71 243 02 57, email: [email protected], contacts name: Markus Niemeyer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42391, lon: 9.37477, locations facility: Kantonsspital Winterthur, city: Winterthur, zip: 8401, country: Switzerland, contacts name: Ursina Zürrer, MD, role: CONTACT, phone: +41 52 266 25 83, email: [email protected], contacts name: Ursina Zürrer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.50564, lon: 8.72413, locations facility: Universitätsspital Zürich - Klinik für Gynäkologie, city: Zürich, zip: 8091, country: Switzerland, contacts name: Isabell Witzel, Prof, role: CONTACT, phone: +41 43 253 64 05, email: [email protected], contacts name: Isabell Witzel, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06358560, orgStudyIdInfo id: BrainHealthClinics, briefTitle: Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Dylan Saulsbery, class: OTHER, descriptionModule briefSummary: The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study., conditionsModule conditions: Stress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic exercises, outcomesModule primaryOutcomes measure: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Brain Health Clinics, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37217, country: United States, contacts name: Tyler Hurst, DC, role: CONTACT, phone: 615-922-0977, email: [email protected], contacts name: Dylan Saulsbery, DC, role: PRINCIPAL_INVESTIGATOR, contacts name: Tyler Hurst, DC, role: SUB_INVESTIGATOR, contacts name: Dominic Fetterly, DC, role: SUB_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
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protocolSection identificationModule nctId: NCT06358547, orgStudyIdInfo id: H-23072469, briefTitle: Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 590, type: ESTIMATED, armsInterventionsModule interventions name: PGT-A, outcomesModule primaryOutcomes measure: Live birth rate per first embryo transfer, primaryOutcomes measure: Cumulative live birth rate after one complete ART treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 41 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: København Ø, zip: 2100, country: Denmark, contacts name: Nathalie F Wang, MD, role: CONTACT, phone: +4535454071, email: [email protected], contacts name: Kristine Løssl, MD, role: CONTACT, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06358534, orgStudyIdInfo id: RTEU-SBF-KB-01, briefTitle: The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Recep Tayyip Erdogan University, class: OTHER, descriptionModule briefSummary: Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease., conditionsModule conditions: Kidney Failure, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pretest-posttest, control and intervention groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: psychoeducation based on acceptance and commitment therapy, outcomesModule primaryOutcomes measure: Chronic Disease Adaptation Scale (CHAS):, primaryOutcomes measure: Acceptance and Action Questionnaire-II Scale (AAQ-II), primaryOutcomes measure: Life Satisfaction Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Recep Tayyip Erdoğan University Faculty of Health Sciences, city: Rize, state: Güneysu, zip: 53100, country: Turkey, geoPoint lat: 41.02083, lon: 40.52194, hasResults: False
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protocolSection identificationModule nctId: NCT06358521, orgStudyIdInfo id: 6040471, briefTitle: Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Queen's University, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: The Arthritis Society, Canada, descriptionModule briefSummary: This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada., conditionsModule conditions: Hip Osteoarthritis, conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual physician/nurse practitioner-led care model, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention., enrollmentInfo count: 728, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapist-led primary care model for hip and knee pain, interventions name: Usual physician-led primary care model for hip and knee pain, outcomesModule primaryOutcomes measure: Self-Reported Functioning, secondaryOutcomes measure: Self-Reported Pain Intensity, secondaryOutcomes measure: Health-Related Quality of Life, secondaryOutcomes measure: Pain Self Efficacy, secondaryOutcomes measure: Catastrophic Thinking, secondaryOutcomes measure: Fear of Movement, secondaryOutcomes measure: Depression Subscale, secondaryOutcomes measure: Global Rating of Change, secondaryOutcomes measure: Satisfaction with Health Care, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Health-Care Utilization - Consultations in Electronic Medical Record (EMR), secondaryOutcomes measure: Health-Care Utilization Survey - Visits to health professionals, secondaryOutcomes measure: Health-Care Utilization Survey - Medications, secondaryOutcomes measure: Health-Care Utilization Survey - Walk-In Clinic Visits, secondaryOutcomes measure: Health-Care Utilization Survey - Emergency Department Visits, secondaryOutcomes measure: Health-Care Utilization Survey - Inpatient Hospital Stays, secondaryOutcomes measure: Health-Care Utilization Survey - Surgeries, Procedures, Injections, secondaryOutcomes measure: Health-Care Utilization Survey - Specialist Visits, secondaryOutcomes measure: Health-Care Utilization Survey - Diagnostic Imaging, secondaryOutcomes measure: Process Outcome - Medications prescribed, secondaryOutcomes measure: Process Outcome - Diagnostic Imaging Ordered, secondaryOutcomes measure: Process Outcome - Exercises Prescribed, secondaryOutcomes measure: Process Outcome - Education Provided, secondaryOutcomes measure: Process Outcome - Referrals to other health care providers (HCPs), secondaryOutcomes measure: Process Outcome - Primary Care Visits, secondaryOutcomes measure: Process Outcome - Notes to Employers or Insurers, secondaryOutcomes measure: Self-Report Time Lost, secondaryOutcomes measure: Assistance Needed, secondaryOutcomes measure: Extra Expenses, secondaryOutcomes measure: Cost outcomes, secondaryOutcomes measure: Health Care Accessibility, otherOutcomes measure: Baseline Characteristics, otherOutcomes measure: Comorbidities, otherOutcomes measure: Chronicity of Pain, otherOutcomes measure: Participant Treatment Fidelity, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen's University, status: RECRUITING, city: Kingston, state: Ontario, zip: K7L3N6, country: Canada, contacts name: Jordan Miller, role: CONTACT, geoPoint lat: 44.22976, lon: -76.48101, hasResults: False
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protocolSection identificationModule nctId: NCT06358508, orgStudyIdInfo id: VP-0786, briefTitle: Sapphire 3 CTO Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: OrbusNeich, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention.One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first., conditionsModule conditions: Coronary Artery Disease, conditions: Coronary Disease, conditions: Myocardial Ischemia, conditions: Heart Diseases, conditions: Arteriosclerosis, conditions: Cardiovascular Diseases, conditions: Chronic Total Occlusion, conditions: Chronic Total Occlusion of Coronary Artery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Sapphire 3 Coronary Dilatation Catheter, outcomesModule primaryOutcomes measure: Number of Participants With Device Procedural Success, secondaryOutcomes measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE), secondaryOutcomes measure: Number of Deaths (Cardiac and Non-Cardiac), secondaryOutcomes measure: Number of Participants With Myocardial Infarctions (MI), secondaryOutcomes measure: Number of Participants With Target Lesion Revascularization (TLR), secondaryOutcomes measure: Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel, secondaryOutcomes measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention), secondaryOutcomes measure: Number of Participants With Absence of Sapphire 3 Study Balloon Rupture, secondaryOutcomes measure: Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA), secondaryOutcomes measure: Number of Participants With Technical Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358495, orgStudyIdInfo id: REB24-0253, briefTitle: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Hotchkiss Brain Institute, University of Calgary, descriptionModule briefSummary: Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders)., conditionsModule conditions: Insomnia, conditions: Sleep Disturbance, conditions: Depressive Symptoms, conditions: Anxiety Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to either CBT for insomnia or TAU waitlist with a psychoeducational pamphlet about sleep hygiene., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes assessor will be blinded to participants' assigned condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia, interventions name: Active Control, outcomesModule primaryOutcomes measure: Insomnia Severity Index, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Internalizing Symptoms Subscale of the Youth Self-Report, secondaryOutcomes measure: Sleep Logs - Total sleep time, secondaryOutcomes measure: Sleep Logs - Onset latency, secondaryOutcomes measure: Sleep Logs - Wake after sleep onset, secondaryOutcomes measure: Sleep Logs - Sleep efficiency, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358482, orgStudyIdInfo id: ORAL1, briefTitle: Electric Toothbrush Efficacy in Preventing Dental Plaque Development, acronym: E-TOOTH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Riccardo Polosa, class: OTHER, descriptionModule briefSummary: The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology., conditionsModule conditions: Dental Plaque, conditions: Calculus, Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: oscillating toothbrush, interventions name: standard manual toothbrush, outcomesModule primaryOutcomes measure: fluorescence intensity of at least 30% (ΔR30), primaryOutcomes measure: the fluorescence intensity of at least 120% (ΔR120), secondaryOutcomes measure: oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: ADDENDO, status: RECRUITING, city: Catania, zip: 95100, country: Italy, geoPoint lat: 37.49223, lon: 15.07041, hasResults: False
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protocolSection identificationModule nctId: NCT06358469, orgStudyIdInfo id: VU2, briefTitle: STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision, acronym: STRIVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2030-06-30, completionDateStruct date: 2031-11-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Canadian Cancer Trials Group, class: NETWORK, collaborators name: Australia New Zealand Gynaecological Oncology Group, descriptionModule briefSummary: This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?, conditionsModule conditions: Vulvar Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 249, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, interventions name: Active Surveillance, outcomesModule primaryOutcomes measure: Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Recurrence-free survival, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Disease-specific survival, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Overall-survival, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale, secondaryOutcomes measure: HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358456, orgStudyIdInfo id: 20-928, briefTitle: Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-20, primaryCompletionDateStruct date: 2022-04-22, completionDateStruct date: 2022-04-22, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University Clinic Frankfurt, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:* Do artificial tears alter the measurements of the corneal surface* Is there a difference between the devices used in this studyThis is relevant because high quality measurements improve the postoperative outcome after cataract surgery., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: one arm for each diagnostic device (three in total), primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: The investigator and patient knew which device they were tested on, enrollmentInfo count: 145, type: ACTUAL, armsInterventionsModule interventions name: Artificial tear, interventions name: No artificial tears, outcomesModule primaryOutcomes measure: Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6), secondaryOutcomes measure: Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?, secondaryOutcomes measure: Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6), secondaryOutcomes measure: If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Goethe University Hospital, city: Frankfurt, state: Hesse, zip: 60590, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, hasResults: False
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protocolSection identificationModule nctId: NCT06358443, orgStudyIdInfo id: PF-Jarlsberg/IIIB, briefTitle: The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia, acronym: PF-JB3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-10-18, completionDateStruct date: 2025-02-23, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Meddoc, class: OTHER, collaborators name: Tine, descriptionModule briefSummary: Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).Study population: Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment: Daily OED Jarlsberg cheese + vitamin D and Calcium tablets. Design: An open and one-armed observational study. Main variables: Bone Mineral Density (BMD), Bone turnover markers (BTMs), Osteocalcin and K2 vitameres.Study Procedure: Prior to inclusion in this study, all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese + vitamin D and caicium tablets. Thid is the baseline of this observational study. The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months.Sample size: At least 16 patients will be included, conditionsModule conditions: Osteoporosis, conditions: Osteopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One armed observational study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Jarlsberg cheese, outcomesModule primaryOutcomes measure: Bone Mineral Density, primaryOutcomes measure: Bone Turnover Markers, primaryOutcomes measure: Osteocalcin, secondaryOutcomes measure: Vitamin K2, eligibilityModule sex: ALL, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358430, orgStudyIdInfo id: 2023-1017, secondaryIdInfos id: NCI-2024-03107, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2027-01-18, completionDateStruct date: 2029-01-18, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Bellicum Pharmaceuticals, Inc., descriptionModule briefSummary: To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC., conditionsModule conditions: Colorectal Cancer, conditions: Minimal Residual Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Fludarabine Phosphate, interventions name: Cyclophosphamide, interventions name: Cetuximab, interventions name: TROP2-CAR-NK Cells, interventions name: Rimiducid (AP1903), interventions name: Lymphodepleting Chemotherapy, 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: Maria Pia Morelli, MD, PhD, role: CONTACT, phone: 713-745-1297, contacts name: Maria Pia Morelli, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06358417, orgStudyIdInfo id: 2024P000873, briefTitle: CHW Intervention to Improve Nutrition Security of Patients With Hypertension, acronym: HeartWell, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months., conditionsModule conditions: Hypertension, conditions: Nutrition, Healthy, conditions: Food Insecurity, conditions: Community Health Worker, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition-enhanced CHW, interventions name: Basic CHW, outcomesModule primaryOutcomes measure: Feasiblity, primaryOutcomes measure: Feasibility of CHW nutrition intervention (intervention arm only), primaryOutcomes measure: Acceptability (intervention arm only), secondaryOutcomes measure: Diet quality, secondaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358404, orgStudyIdInfo id: 2024P000615, briefTitle: Developing a Peer Support Intervention for Depression in SCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline., conditionsModule conditions: Subjective Cognitive Decline, conditions: Depression in Old Age, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: PeersCOG, outcomesModule primaryOutcomes measure: Feasibility of Intervention, primaryOutcomes measure: Acceptability of Intervention, primaryOutcomes measure: Fidelity of Intervention, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06358391, orgStudyIdInfo id: TS-RF system, briefTitle: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Starmed, class: INDUSTRY, collaborators name: Helptrial, descriptionModule briefSummary: The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device., conditionsModule conditions: Arrhythmias, Cardiac, conditions: Atrial Fibrillation, conditions: Heart Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: TS-RF Transseptal Needle, interventions name: BRK Transseptal Needle, outcomesModule primaryOutcomes measure: First-pass TSP Success Rate (percent), secondaryOutcomes measure: TSP Time (Second), secondaryOutcomes measure: Fluoroscopy Time (Second) for TSP, secondaryOutcomes measure: Needle cross-over between the study and control groups, secondaryOutcomes measure: Intra-TSP procedural device-associated complications, secondaryOutcomes measure: Changes in patient's quality of life, secondaryOutcomes measure: Complications, otherOutcomes measure: Intra-TSP procedural Adverse Events, otherOutcomes measure: Overall Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358378, orgStudyIdInfo id: 995, briefTitle: Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sligo General Hospital, class: OTHER, descriptionModule briefSummary: Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Aktiia SA Bracelet, outcomesModule primaryOutcomes measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements, secondaryOutcomes measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements taken in a resting state, secondaryOutcomes measure: Mean difference between mean 24-hour cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements on a per patient basis, secondaryOutcomes measure: Tolerability : Mean paired differences on Comfort Rating Scale (CRS) between devices, secondaryOutcomes measure: User Acceptability: Mean paired differences on System Usability Scale (SUS) between devices, otherOutcomes measure: Proportion of recruited patients who provide at least 5 daytime cuffless blood pressure readings per day, otherOutcomes measure: Proportion of total measurements taken which can be paired (i.e. taken within 1-hour of a measurement from the other device), otherOutcomes measure: Proportion of missing data from activity diaries, otherOutcomes measure: Proportion of recruited patients who provide at least 3 paired blood pressure readings for 3 consecutive days, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358365, orgStudyIdInfo id: AQP-DCL-026, briefTitle: Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2023-11-02, completionDateStruct date: 2023-11-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: AquaPass Medical Ltd., class: INDUSTRY, descriptionModule briefSummary: To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin., conditionsModule conditions: Acute Kidney Failure, conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: The AquaPass System, outcomesModule primaryOutcomes measure: Differences in weight gain over the long interdialytic period, primaryOutcomes measure: Device related Adverse Events, secondaryOutcomes measure: Changes in NT-proBNP, secondaryOutcomes measure: Changes in Blood Urea Nitrogen, secondaryOutcomes measure: Effect on Quality of Life, secondaryOutcomes measure: Affect on Ultrafiltration Rates after the long inter dialytic gap, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nazareth Hospital EMMS, city: Nazareth, state: Al Wadi Al Jawani 1611, zip: 16100, country: Israel, geoPoint lat: 32.69925, lon: 35.30483, hasResults: False
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protocolSection identificationModule nctId: NCT06358352, orgStudyIdInfo id: M18080921, briefTitle: Clinical and Radiographic Assessment of PRF Versus Lutein Placement, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.7Patients grouping: Patients will be randomly divided into three groups:Group A: Immediate implant placement with leaving the gap distance emptyGroup B: Immediate implant placement then placement of PRF around the implant in the gap distanceGroup C: Immediate implant placement then placement of lutein around the implant in the gap distanceClinical evaluation:Patients will be evaluated clinically for:1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.3. Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.4. Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.Radiographic evaluation:conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement, after 3 months and after 12 months, conditionsModule conditions: Osteogenesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Lutein / Zeaxanthin, interventions name: Platelet rich fibrin, outcomesModule primaryOutcomes measure: bone formation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of dentistry,Mansoura university, city: Mansoura, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06358339, orgStudyIdInfo id: 72374095, briefTitle: TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shenzhen Kangning Hospital, class: OTHER, descriptionModule briefSummary: Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, feasibility, and sustainability of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health., conditionsModule conditions: Suicide, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: After recruitment and the baseline survey, participants will be assigned into Group 1 to Group 16 by simple randomization in R program. The allocation ratio in randomization will be 1:1. Participants, LHSs, nurses who perform recruitment and baseline survey, and investigators who perform follow-ups will be blinded to the assignment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 640, type: ESTIMATED, armsInterventionsModule interventions name: TEEM, outcomesModule primaryOutcomes measure: Suicide ideation at three months after discharge, primaryOutcomes measure: The rate of re-visits to outpatient clinic at three months after discharge, secondaryOutcomes measure: Self-determination at at three months after discharge, secondaryOutcomes measure: Social connectedness at three month after discharge, secondaryOutcomes measure: Social support at three months after discharge, otherOutcomes measure: Times of re-hospitalization for mental disorders, otherOutcomes measure: Attitudes towards the acceptability of the intervention, otherOutcomes measure: Attitudes towards the adoption of the intervention, otherOutcomes measure: The adoption rate of the intervention in patients, otherOutcomes measure: Attitudes towards the equity of the intervention, otherOutcomes measure: Attitudes towards the feasibility of the intervention, otherOutcomes measure: Attitudes towards the patient-centeredness of the intervention, otherOutcomes measure: Cost for implementing the TEEM-GIFTS, otherOutcomes measure: Fidelity of the study, otherOutcomes measure: Efficiency of the intervention, otherOutcomes measure: Attitudes towards the safety of the intervention, otherOutcomes measure: The timeliness of the intervention, otherOutcomes measure: Patients' perceived stigma from baseline to three months after discharge, otherOutcomes measure: Patients' self-efficacy from baseline to three months after discharge, otherOutcomes measure: Patients' compliance to treatment from baseline to three months after discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shenzhen Kangning Hospital, city: Shenzhen, state: Guangdong, zip: 518020, country: China, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False
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protocolSection identificationModule nctId: NCT06358326, orgStudyIdInfo id: Karabuk-1, briefTitle: Dry Needling and Rehabilitatin Carpal Tunnel Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Karabuk University, class: OTHER, descriptionModule briefSummary: Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS., conditionsModule conditions: Dry Needling, conditions: Carpal Tunnel Syndrome, conditions: Myofacial Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dry needling, interventions name: Control group, outcomesModule primaryOutcomes measure: Pain severity, primaryOutcomes measure: Wrist range of motion, primaryOutcomes measure: Position sense, primaryOutcomes measure: Severity of symptoms, primaryOutcomes measure: Functional status, primaryOutcomes measure: Hands activity level, primaryOutcomes measure: neuropathic pain severity, primaryOutcomes measure: Nerve cross-sectional area, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pursaklar State Hospital, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Fidan Yılmaz, Msc, role: CONTACT, phone: 0551 207 2954, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06358313, orgStudyIdInfo id: 0023098816, briefTitle: Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04-10, completionDateStruct date: 2025-05-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever minor stroke or TIA patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label aspirin at a loading dose of 75 to 300 mg and then 75 mg daily till the end of the 3 months and an open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Atorvastatin 40mg, interventions name: Rosuvastatin 20mg, outcomesModule primaryOutcomes measure: the rate of new stroke at 90 days, secondaryOutcomes measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week, secondaryOutcomes measure: value of Modified Rankin Scale (mRS) at one week, secondaryOutcomes measure: value of Modified Rankin Scale(mRS) at three months, secondaryOutcomes measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events, secondaryOutcomes measure: rate of drug adverse effects, secondaryOutcomes measure: Drug adverse effects: all side effects related to the drugs of our study will be reported, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33511, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: [email protected], geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06358300, orgStudyIdInfo id: Usakpcos2, briefTitle: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2023-07-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Uşak University, class: OTHER, descriptionModule briefSummary: We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls., conditionsModule conditions: Visceral Adiposity Index, conditions: Polycystic Ovary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Usak Training and Research Hospital, city: Usak, zip: 64100, country: Turkey, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
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protocolSection identificationModule nctId: NCT06358287, orgStudyIdInfo id: STUDY19030375, briefTitle: Neural Correlates of Auriculotherapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-15, primaryCompletionDateStruct date: 2022-11-07, completionDateStruct date: 2022-11-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Keith M. Vogt, MD, PhD, class: OTHER, descriptionModule briefSummary: Chronic pain continues to be a major health issue, creating a significant societal burden, as it is an independent risk factor for opioid use disorder (OUD) and deaths. Acute pain episodes can often engender OUD due to lack of effective strategies to treat pain and prevent the transition to chronic pain. One potential non-opioid method for pain relief is auriculotherapy (AT), where acupuncture-like treatment is administered to the ear. The objective of this pilot study is to illustrate that AT-related brain effects can be found using functional connectivity MRI (fcMRI) in patients with low back pain., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: cryogenic auriculotherapy, outcomesModule primaryOutcomes measure: Default Mode Network (DMN)-to-Anterior Cingulate Cortex (ACC) connectivity, secondaryOutcomes measure: Brief Pain Inventory (BPI) Severity Scores MRI #1, secondaryOutcomes measure: BPI Pain Severity Scores MRI #2, secondaryOutcomes measure: General Anxiety Disorder-7 (GAD-7) Scoring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Montefiore, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
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protocolSection identificationModule nctId: NCT06358274, orgStudyIdInfo id: MED-2024-32848, briefTitle: Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments.The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities., conditionsModule conditions: Thru-hiking, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Thru-hiking, outcomesModule primaryOutcomes measure: blood lipid panel: total cholesterol, primaryOutcomes measure: blood lipid panel: high-density lipoprotein (HDL), primaryOutcomes measure: blood lipid panel: low-density lipoprotein (LDL), primaryOutcomes measure: blood lipid panel: triglycerides, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358261, orgStudyIdInfo id: IRB00433279, secondaryIdInfos id: R03DK135898, type: NIH, link: https://reporter.nih.gov/quickSearch/R03DK135898, briefTitle: Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation., conditionsModule conditions: PreDiabetes, conditions: Lifestyle, Healthy, conditions: Activation, Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pilot group-randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes Prevention Patient Activation Clinical Decision Support Tool, outcomesModule primaryOutcomes measure: patient activation as assessed by the Patient Activation Measure Survey (PAM), secondaryOutcomes measure: number of participants referred to Diabetes Prevention Program, secondaryOutcomes measure: number of participants prescribed metformin, secondaryOutcomes measure: percent of participants who make diet changes, secondaryOutcomes measure: change in amount and frequency of physical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358248, orgStudyIdInfo id: SPHERE, briefTitle: Standardized Physician-modified Fenestrated Endograft Registry, acronym: SPHERE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2028-10-01, completionDateStruct date: 2033-10-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital Padova, class: OTHER, descriptionModule briefSummary: Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA)., conditionsModule conditions: Aortic Aneurysm, Thoracoabdominal, conditions: Aortic Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Physician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA)., outcomesModule primaryOutcomes measure: Technical success, primaryOutcomes measure: Freedom from target vessel instability, primaryOutcomes measure: Freedom from endograft instability, secondaryOutcomes measure: Early (30-days) Major Adverse Event (MAE), secondaryOutcomes measure: Aneurysm sac dynamics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vascular and Endovascular Clinic - Padova University, status: RECRUITING, city: Padova, zip: 35020, country: Italy, contacts name: Michele Piazza, Pr, role: CONTACT, phone: 3498644688, email: [email protected], geoPoint lat: 45.40797, lon: 11.88586, hasResults: False
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protocolSection identificationModule nctId: NCT06358235, orgStudyIdInfo id: SDU-IH-HA-01, briefTitle: The Effect of Music Therapy on Dyspnea Severity and Vital Signs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-07, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Suleyman Demirel University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effect of music therapy on dyspnea severity and quality of life indicators in patients with Chronic Obstructive Pulmonary Disease (COPD) admitted to the intensive care unit. The study will be conducted at Isparta City Hospital and Kumluca State Hospital in Antalya, Turkey, using an experimental design. Patients will be divided into experimental and control groups, selected using randomization.Patients in the experimental group will receive music therapy in the Hüseyni maqam, while those in the control group will not receive any music therapy. Life indicators and Modified Borg Scale (MBS) values of patients in the experimental group will be recorded before, immediately after, and 30 minutes post-application. Music therapy will be administered to patients for only one day, once in the morning. Data for patients in the control group will be collected at the same time intervals. The results of this study aim to contribute to the literature on the impact of music therapy on dyspnea severity and quality of life indicators in COPD patients., conditionsModule conditions: Dyspnea, conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Music Therapy, interventions name: No Music therapy, outcomesModule primaryOutcomes measure: Patient Identification Form, primaryOutcomes measure: Modified Borg Scale, primaryOutcomes measure: Vital Signs Record Chart, primaryOutcomes measure: Blood Test Results Record Chart, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Suleyman Demırel University, status: RECRUITING, city: Isparta, zip: 32200, country: Turkey, contacts name: Hafize Aydemir, role: CONTACT, phone: +905078380979, email: [email protected], geoPoint lat: 37.76444, lon: 30.55222, hasResults: False
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protocolSection identificationModule nctId: NCT06358222, orgStudyIdInfo id: LUNon-invasive, briefTitle: Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shanghai Chest Hospital, class: OTHER, descriptionModule briefSummary: This is a single center, prospective and observational study conducted in three stages to predict the NSCLC lymph node metastasis based on ctDNA/specific methylation molecular features combined with PET-CT imaging features and intervention study., conditionsModule conditions: Carcinoma, conditions: Non-small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Blood ctDNA + methylation + PET-CT and Postoperative pathology, interventions name: MRD+ methylation (or combined with PET-CT) and Invasive mediastinoscopy /EBUS-TBNA, interventions name: Intraoperative lymph node dissection, outcomesModule primaryOutcomes measure: Negative prediction value (NPV) of lymph node metastasis rates, primaryOutcomes measure: Disease-free survival (DFS), primaryOutcomes measure: ctDNA-free interval (CFI), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: ShangHai, country: China, contacts name: Feng Yao, PhD, role: CONTACT, phone: 021-22200000, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06358209, orgStudyIdInfo id: LY2024-045-B, briefTitle: Safety and Efficacy of Ventricular Irrigation for Ventriculitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Southern Medical University, China, collaborators name: First Affiliated Hospital of Zhejiang University, collaborators name: 904 Hospital of the People's Liberation Army Joint Logistic Support Force, collaborators name: Shenzhen Second People's Hospital, collaborators name: First Affiliated Hospital of Wannan Medical College, collaborators name: Huashan Hospital, descriptionModule briefSummary: Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe ventriculitis., conditionsModule conditions: Central Nervous System Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Ventricular irrigation, outcomesModule primaryOutcomes measure: Mortality rate, secondaryOutcomes measure: GOSE, secondaryOutcomes measure: CRS-R, secondaryOutcomes measure: DRS, secondaryOutcomes measure: mRS, secondaryOutcomes measure: Microbial culture, secondaryOutcomes measure: CSF glucose, secondaryOutcomes measure: CSF protein, secondaryOutcomes measure: CSF WBC count, secondaryOutcomes measure: Length of stay, otherOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Wannan Medical College, city: Wuhu, state: Anhui, country: China, contacts name: Xuefei Shao, Dr, role: CONTACT, geoPoint lat: 31.33728, lon: 118.37351, locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Qinghua Wang, Dr, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Second People's Hospital, city: Shenzhen, state: Guangdong, country: China, contacts name: Xianjian Huang, Dr, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: 904 Hospital of the People's Liberation Army Joint Logistic Support Force, city: Wuxi, state: Jiangsu, country: China, contacts name: Likun Yang, Dr, role: CONTACT, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Huashan Hospital, city: Shanghai, state: Shanghai, country: China, contacts name: Jin Hu, Dr, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University, city: Shanghai, state: Shanghai, country: China, contacts name: Jiyao Jiang, Dr, role: CONTACT, phone: 021-68383729, email: [email protected], contacts name: Junfeng Feng, Dr, role: CONTACT, phone: 13611860825, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: First Affiliated Hospital of Zhejiang University, city: Hangzhou, state: Zhejiang, country: China, contacts name: Xiaofeng Yang, Dr, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06358196, orgStudyIdInfo id: CESAH, briefTitle: Complex Exploratory Study of Alcohol-Associated Hepatitis, acronym: CESAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Pavol Jozef Safarik University, class: OTHER, collaborators name: L Pasteur University Hospital, collaborators name: Hospital Agel Kosice-Saca, collaborators name: Technical University in Kosice, collaborators name: Western University, collaborators name: University of Roma La Sapienza, descriptionModule briefSummary: Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis. It is associated with high mortality and characterized by an absence of effective treatment, while corticosteroids, which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval. The proposed study is a complex exploratory study of alcohol-associated hepatitis with several epidemiology- and prognosis-related aims., conditionsModule conditions: Alcoholic Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Standardized annual incidence of (severe) alcoholic hepatitis in the Kosice Urban Area, secondaryOutcomes measure: Threshold of alcohol consumption associated with (an increased risk of) developing AH, secondaryOutcomes measure: Diagnostic accuracy of NIAAA and NIAAAm-CRP, secondaryOutcomes measure: Prognostic performance of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score, secondaryOutcomes measure: Prognostic performance of SOFA and CLIF-C, secondaryOutcomes measure: An update of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score, secondaryOutcomes measure: Alternative to Lille model, secondaryOutcomes measure: Prognostic model for 90 day survival, secondaryOutcomes measure: Uper limit of MELD or Maddrey scores beyond which patients no longer derive any therapeutic benefit from corticosteroid treatment, secondaryOutcomes measure: Natural course of nonsevere alcoholic hepatitis, secondaryOutcomes measure: Natural course of severe alcoholic hepatitis, secondaryOutcomes measure: Risk score for bacterial infection before corticosteroid treatment in patients with alcoholic hepatitis, secondaryOutcomes measure: Distinguishing sterile Inflammation from infection in alcoholic hepatitis, secondaryOutcomes measure: GUT microbiome and treatment response in alcoholic hepatitis, secondaryOutcomes measure: Hypothalamus-pituitary-adrenal axis and treatment response in alcoholic hepatitis, secondaryOutcomes measure: Adherence to outpatient psychiatric management, secondaryOutcomes measure: Nutritional status and treatment response in alcoholic hepatitis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pavol Jozef Safarik University, city: Kosice, zip: 04012, country: Slovakia, contacts name: Jakub Gazda, MD, PhD, role: CONTACT, phone: +421911115288, email: [email protected], contacts name: Martin Janicko, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: 48.71395, lon: 21.25808, hasResults: False
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protocolSection identificationModule nctId: NCT06358183, orgStudyIdInfo id: ESC001, briefTitle: Surgical Capacity in Zimbabwean Public Hospitals, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-04-24, primaryCompletionDateStruct date: 2024-02-25, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Parirenyatwa Hospital, class: OTHER, descriptionModule briefSummary: This study aimed to understand how ready Zimbabwe's public hospitals are to perform essential surgeries, which are critical for treating a wide range of health issues from emergencies like car accidents to planned procedures such as childbirth by caesarean section. The researchers looked at hospitals across Zimbabwe to see what kind of surgery facilities, equipment, and specialists were available., conditionsModule conditions: Surgery, conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Bellwether procedures, primaryOutcomes measure: Procedures, primaryOutcomes measure: SAO density, primaryOutcomes measure: Infrastructure, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Parirenyatwa Hospital, city: Harare, country: Zimbabwe, geoPoint lat: -17.82772, lon: 31.05337, hasResults: False
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protocolSection identificationModule nctId: NCT06358170, orgStudyIdInfo id: NYCU112169AF, briefTitle: Effects of Circuit Training Combine With Square-Stepping Exercise, Strength Training and Balance Training on Senior Fitness and Fall Risk in Elderly in the Community, acronym: SSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Hsin-ching, Tsai, class: OTHER, descriptionModule briefSummary: According to the cause of death statistics compiled by the Ministry of Health and Welfare in 2022, among the causes of death among the elderly, falls ranked second among the causes of death from accidental injuries over the age of 65. Exercise has been proven to prevent falls in many studies, especially Square-Stepping Exercise can not only train strength and balance, but also improve cognitive function and reduce the fear of falling in the elderly. Therefore, this study will use Square-Stepping Exercise as the core and circuit training as the structure to design a set of exercise training that combines muscle strength and balance and is easy to implement in the community. The purpose of the study is to determine whether exercise training that combines circuit training with block stepping, muscle strength, and balance exercises can reduce the risk of falls among elderly people in the community (primary results: muscle strength, flexibility, cardiorespiratory endurance, balance; secondary results: cognitive function, Fear of falling, fall rate). This study will collect participant in the community, and subjects will be randomly assigned to the experimental group and the control group on a community basis. The experimental group will receive 12 weeks of exercise training, while the control group will follow their usual lifestyle, with 48 people in each group. The experimental design is exercise intervention for 12 weeks, twice a week, 90 minutes each time (30 minutes of main exercise). The exercise is designed into two stages according to the difficulty of Square-Stepping Exercise. The training of muscle strength and dynamic/static balance will also gradually increase in difficulty over the weeks. The research look forward to seeing the effects of multi-component exercise on physical fitness, cognitive function, fear of falling and fall rate., conditionsModule conditions: Circuit-Based Exercise, conditions: Exercise Test, conditions: Community Health Nursing, conditions: Aged, conditions: Physical Fitness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Circuit Training Combine with Square-Stepping Exercise, outcomesModule primaryOutcomes measure: Senior Fitness - upper body muscle strength (Arm Curl Test), primaryOutcomes measure: Senior Fitness - lower body muscle strength (Chair Stand Test ), primaryOutcomes measure: Senior Fitness - upper body flexibility (Back Scratch Test), primaryOutcomes measure: Senior Fitness - lower body flexibility (Chair Sit and Reach Test), primaryOutcomes measure: Senior Fitness - cardio respiratory endurance ( 2 Minute Step in Place Test), primaryOutcomes measure: Senior Fitness - dynamic balance (8-Foot Up and Go Test), primaryOutcomes measure: Senior Fitness - static balance (Single-Leg Balance with Eyes Open), secondaryOutcomes measure: cognitive function, secondaryOutcomes measure: Fear of falling, secondaryOutcomes measure: fall rate, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, zip: 112, country: Taiwan, contacts name: Wei Tzu Lo, role: CONTACT, phone: 02-2823-9753, phoneExt: 66378, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06358157, orgStudyIdInfo id: CLN02001, briefTitle: The Ladera Large Bore Closure Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ladera Medical, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath., conditionsModule conditions: Vascular Closure, conditions: Femoral Arteriotomy Closure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, non-randomized, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ladera LBC System, outcomesModule primaryOutcomes measure: Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications, primaryOutcomes measure: Primary Performance Endpoint: Time to Hemostasis, secondaryOutcomes measure: Secondary Safety Endpoint: Minor Arterial Access Site Closure-related Complications, secondaryOutcomes measure: Secondary Performance Endpoint: Time-to-Ambulation, secondaryOutcomes measure: Secondary Performance Endpoint: Time-to-Discharge Eligibility, secondaryOutcomes measure: Secondary Performance Endpoint: Incidence of Procedural Success, secondaryOutcomes measure: Secondary Performance Endpoint: Incidence of Device Technical Success, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358144, orgStudyIdInfo id: IRB00111438, secondaryIdInfos id: R01DA053209, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA053209, briefTitle: Cannabis Edibles Packaging Imagery Experiment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery., conditionsModule conditions: Cannabis Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will complete a 15-minute online survey, where they will be randomized to one of five conditions: four intervention conditions with a different image on the package and one without any imagery., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1250, type: ESTIMATED, armsInterventionsModule interventions name: Packaging imagery, interventions name: No Imagery (Control), outcomesModule primaryOutcomes measure: Product Appeal Scoring, primaryOutcomes measure: Harm Perceptions (Absolute) Scoring, primaryOutcomes measure: Willingness to Try Product Scoring, secondaryOutcomes measure: Appeal to Children Scoring, secondaryOutcomes measure: Harm Perceptions (Relative) Scoring, secondaryOutcomes measure: Perception of Quality Scoring, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Alexandra Zizzi, MSPH, role: CONTACT, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06358131, orgStudyIdInfo id: R.21.10.1493, briefTitle: Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia., conditionsModule conditions: Gastrointestinal Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 656, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopy, outcomesModule primaryOutcomes measure: Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events., secondaryOutcomes measure: Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mansoura University, status: RECRUITING, city: Mansoura, state: Dakhlia, zip: 35516, country: Egypt, contacts name: Asmaa Gameel, MD, role: CONTACT, phone: 01025835429, email: [email protected], geoPoint lat: 31.03637, lon: 31.38069, locations facility: MansouraU, status: RECRUITING, city: Mansoura, country: Egypt, contacts name: Asmaa Gameel, MD, role: CONTACT, phone: 201025835429, email: [email protected], geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06358118, orgStudyIdInfo id: 2024-003-KY, briefTitle: Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Qing Ni, class: OTHER, descriptionModule briefSummary: The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.The main questions it aims to answer are:1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.Participants will:1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;4. Urine and serum samples were collected before and after treatment;, conditionsModule conditions: Diabete Mellitus, conditions: Aging, conditions: Metabolic Disorders, conditions: Traditional Chinese Medicine, conditions: Randomized Controlled Trial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Buyuan Zhixiao Formula, interventions name: Placebo, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Fasting blood glucose, secondaryOutcomes measure: 2-hour postprandial blood glucose, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: weight, secondaryOutcomes measure: waist circumference, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Total Cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: High density lipoprotein cholesterol, secondaryOutcomes measure: Low density lipoprotein cholesterol, secondaryOutcomes measure: Ankle-Brachial Index（ABI）, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: C-peptide, secondaryOutcomes measure: insulin resistance index, secondaryOutcomes measure: islet β-cell function index, secondaryOutcomes measure: lipid Lipid accumulation product, secondaryOutcomes measure: visceral adiposity index, secondaryOutcomes measure: Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points, secondaryOutcomes measure: Concentration Variation of Interleukin-10, secondaryOutcomes measure: Change in Homocysteine Levels, secondaryOutcomes measure: Average Concentration of Interleukin-6, secondaryOutcomes measure: Change in Endothelin-1 Levels, secondaryOutcomes measure: Average Concentration of Nitric Oxide, secondaryOutcomes measure: Concentration Variation of Von Willebrand Factor, secondaryOutcomes measure: Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points, secondaryOutcomes measure: Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration, secondaryOutcomes measure: Average Concentration of Soluble Intercellular Adhesion Molecule-1, secondaryOutcomes measure: Change in Serum Tau Protein Levels, secondaryOutcomes measure: Average Concentration of Aβ40, secondaryOutcomes measure: Average Concentration of Aβ42, secondaryOutcomes measure: Change in Neurofilament Light Chain Protein Levels, secondaryOutcomes measure: Carotid Ultrasound; Carotid Intima-Media Thickness., secondaryOutcomes measure: Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score., secondaryOutcomes measure: Montreal Cognitive Assessment Score, secondaryOutcomes measure: Fried Frailty Phenotype Scale, secondaryOutcomes measure: Activities of Daily Living Scale score, secondaryOutcomes measure: Mini Nutritional Rating Scale, secondaryOutcomes measure: Serum and urine metabolomics, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Academy of Chinese Medical Sciences Guang'anmen Hospital, city: Beijin, state: Beijing, zip: 100053, country: China, contacts name: Qing Ni, postgraduate, role: CONTACT, phone: 010-88001245, email: [email protected], contacts name: zhige Wen, postgraduate, role: CONTACT, phone: 15890643963, email: [email protected], locations facility: Cangzhou integrative medicine hospital, city: Hebei, country: China, contacts name: zhongyong zhang, postgraduate, role: CONTACT, phone: 18031783396, email: [email protected], locations facility: Hohhot Mongolian Traditional Chinese Medicine Hospital, city: Neimeng, country: China, locations facility: Binzhou Traditional Chinese Medicine Hospital, city: Shandong, country: China, contacts name: lijuan Du, postgraduate, role: CONTACT, phone: 18800102622, email: [email protected], locations facility: Yantai Baishi Traditional Chinese Medicine Hospital, city: Shandong, country: China, locations facility: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, city: Tianjin, country: China, contacts name: bin Wang, postgraduate, role: CONTACT, phone: 13051395068, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06358105, orgStudyIdInfo id: id. 6457, briefTitle: Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial, acronym: STARTERS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.The main questions it aims to answer are:* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?* Will major and minor procedural complications be reduced after simulator-based training?Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.They will be supervised during their cath lab period as first operators by senior interventional cardiologists.During their first 50 procedures performed as supervised first operator, specific procedural data will be collected., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Simulator-based training, interventions name: Standard training, outcomesModule primaryOutcomes measure: Mean total fluoroscopy radiation time (expressed in seconds), secondaryOutcomes measure: Mean arterial cannulation time (expressed in seconds), secondaryOutcomes measure: Total radiation dose (expressed in cGy*cm2), secondaryOutcomes measure: Total contrast dose (expressed in ml), secondaryOutcomes measure: Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant), secondaryOutcomes measure: Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant), secondaryOutcomes measure: Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant), secondaryOutcomes measure: Number of catheters used, secondaryOutcomes measure: Any major or minor procedural and clinical complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS, city: Rome, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06358092, orgStudyIdInfo id: ZSSYXHNK2401, briefTitle: Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Third Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research., conditionsModule conditions: Cirrhosis, Liver, conditions: Portal Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Hepatic venous pressure gradient, interventions name: Two-Dimensional Shear Wave Elastography, outcomesModule primaryOutcomes measure: the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension, secondaryOutcomes measure: the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension, secondaryOutcomes measure: the difference among left, middle and right hepatic venous pressure gradient, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358079, orgStudyIdInfo id: 258, briefTitle: Re-infusion of Unwashed Shed Blood During Off-pump Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Damascus University, class: OTHER, descriptionModule briefSummary: To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit., conditionsModule conditions: Coronary Artery Disease, conditions: Blood Transfusion Complication, conditions: Cardiovascular Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective study involving patients undergoing off-pump coronary artery bypass surgery. Patients will be randomized to two groups; an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group (a) and the conventional no re-infusion technique will be used in group (b)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessor will be blinded to the group type when analyzing data, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Re-infusion of unwashed shed blood, outcomesModule primaryOutcomes measure: blood transfusion requirements, primaryOutcomes measure: inflammatory response, primaryOutcomes measure: alveolar/arterial oxygen pressure gradients, primaryOutcomes measure: cost-benefit, primaryOutcomes measure: Neuro-markers, primaryOutcomes measure: myocardial marker CK-MB, primaryOutcomes measure: myocardial marker troponin-I, primaryOutcomes measure: blood loss, primaryOutcomes measure: complement response, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damascus University Cardiac Surgery Hospital, status: RECRUITING, city: Damascus, country: Syrian Arab Republic, contacts name: Mohammad Bashar Izzat, FRCS, role: CONTACT, phone: +963943240820, email: [email protected], contacts name: Albaraa Bara, MD, role: CONTACT, phone: 0934206291, email: [email protected], geoPoint lat: 33.5102, lon: 36.29128, hasResults: False
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protocolSection identificationModule nctId: NCT06358066, orgStudyIdInfo id: self assembling peptides, briefTitle: The Remineralization of Early Enamel Caries in Permanent Teeth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2024-10-06, completionDateStruct date: 2024-12-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth., conditionsModule conditions: White Spot Lesion, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: diagnodent, interventions name: ICDAS 2, outcomesModule primaryOutcomes measure: measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system, secondaryOutcomes measure: measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 14 Years, stdAges: CHILD, hasResults: False
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protocolSection identificationModule nctId: NCT06358053, orgStudyIdInfo id: CRTE7A2-2302C, briefTitle: CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Corregene Biotechnology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection., conditionsModule conditions: Cervical Cancer, conditions: Anal Cancer, conditions: Head and Neck Cancers, conditions: Other Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: CRTE7A2-01 TCR-T cell therapy, outcomesModule primaryOutcomes measure: DLT, primaryOutcomes measure: RP2D, primaryOutcomes measure: cevents (SAEs)., secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival(OS), otherOutcomes measure: Peripheral blood TCR-T cell copy number, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06358040, orgStudyIdInfo id: 2023-0328, briefTitle: Opioid Dispenser for Microdiscectomy/Laminectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Hospital for Special Surgery, New York, class: OTHER, descriptionModule briefSummary: The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles., conditionsModule conditions: Opioid Use, conditions: Pain, Postoperative, conditions: Medical Device, conditions: Laminectomy, conditions: Diskectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Opioid-Dispensing Device, interventions name: App, interventions name: Standard Opioid Pill Bottle, outcomesModule primaryOutcomes measure: Cumulative Opioid Consumption at Postoperative Day 14 (POD14), secondaryOutcomes measure: NRS pain intensity ratings, secondaryOutcomes measure: Patient satisfaction with the app and with the dispensing device, secondaryOutcomes measure: Frequency of reported difficulties using the device, secondaryOutcomes measure: Frequency of reported difficulties using the app, secondaryOutcomes measure: Opioid prescription refill rates, secondaryOutcomes measure: Concordance of app data and medication left in the device or pill bottle (medication reconciliation), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital for Special Surgery, city: New York, state: New York, zip: 10021, country: United States, contacts name: William Chan, MEng, role: CONTACT, phone: 917-260-4788, email: [email protected], contacts name: Alexandra Sideris, PhD, role: CONTACT, phone: 212-774-2602, email: [email protected], geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06358027, orgStudyIdInfo id: DokuzEU-ACC-BOtlu-01, briefTitle: Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-04-21, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis., conditionsModule conditions: Atelectasis, Postoperative Pulmonary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 278, type: ESTIMATED, armsInterventionsModule interventions name: lung ultrasound, outcomesModule primaryOutcomes measure: Modified Transthoracic Ultrasound Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06358014, orgStudyIdInfo id: YX2021-02, briefTitle: Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-12, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Xiao Wang, class: OTHER, descriptionModule briefSummary: After menopause, there is a certain tendency towards depression, with the risk of developing depression being about 3 to 4 times higher than before menopause. Additionally, postmenopausal women experience varying degrees of cognitive decline, which are closely associated with hormonal changes. Therefore, we should pay more attention to the cognitive levels of postmenopausal depression patients. Increasing evidence suggests that changes in cognitive function during menopause may be related to the effects of estrogen on cognitive function, and estrogen therapy can effectively improve cognitive decline. Estrogen is not only associated with cognitive symptoms after menopause, but estrogen intervention is also an adjunctive treatment for postmenopausal depression symptoms. There is a close relationship between cognitive levels and depression, as depression itself is accompanied by cognitive decline, and early cognitive decline can also manifest depressive symptoms. Therefore, the cognitive levels of postmenopausal depression patients are also worthy of further attention.This study is an 8-week randomized controlled trial. The subjects are patients with postmenopausal depression accompanied by cognitive decline, all of whom have undergone natural menopause for at least one year; with HAMD-17 scores ≥17 points; and MOCA scores ≤26 points. This study aims to recruit patients with postmenopausal depression accompanied by cognitive decline from the outpatient or inpatient departments of Beijing Anding Hospital, Capital Medical University. Patients who meet the inclusion criteria will be randomly assigned to the combination group and the control group using a random number method. The combination group will receive estrogen combined with SSRIs, while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention. Patients' cognitive function and depressive symptoms will be assessed using scales at baseline, 2 weeks, 4 weeks, and the end of 8 weeks of treatment, and safety evaluations will be conducted. The primary efficacy endpoint is the change in MoCA scores from baseline to the end of the study. Secondary efficacy endpoints include changes in HAMD-17, modified Kupperman Scale, ADL Scale, and hormone levels from baseline to the end of the study. The safety of the study drug will be evaluated through adverse event reporting, clinical laboratory tests, and physical examinations., conditionsModule conditions: Postmenopausal Depression, conditions: Estrogen, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The combination group will receive estrogen combined with Selective serotonin reuptake inhibitors (SSRIs), while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention.SSRIs include Citalopram (Celexa), Escitalopram (Lexapro) ,Fluoxetine (Prozac) ,Paroxetine (Paxil, Pexeva) and Sertraline (Zoloft), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs, interventions name: SSRIs, outcomesModule primaryOutcomes measure: The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week)., secondaryOutcomes measure: The average change value of HAMD-17 total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures, secondaryOutcomes measure: The average change value of HAMA total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures, secondaryOutcomes measure: The average change value of Kupperman total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures, secondaryOutcomes measure: The average change value of PSQI total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures, secondaryOutcomes measure: The average change value of ADL total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures, eligibilityModule sex: FEMALE, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anding Hospital Affiliated to Capital Medical University, status: RECRUITING, city: Beijing, country: China, contacts name: xiao wang, prof, role: CONTACT, phone: +8658303103, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06358001, orgStudyIdInfo id: 21-07, briefTitle: EchoTip AcuCore Post-Market Clinical Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cook Research Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore., conditionsModule conditions: Adenocarcinoma, conditions: Neuroendocrine Tumors, conditions: Hepatocellular Carcinoma, conditions: Cholangiocarcinoma, conditions: Malignant Lymphoma, conditions: Metastasis, conditions: Chronic Pancreatitis, conditions: Autoimmune Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 183, type: ESTIMATED, armsInterventionsModule interventions name: EchoTip AcuCore, outcomesModule primaryOutcomes measure: Technical Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357988, orgStudyIdInfo id: NCI-2024-01149, secondaryIdInfos id: NCI-2024-01149, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-T, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-T, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2016-02-24, primaryCompletionDateStruct date: 2024-11-04, completionDateStruct date: 2024-11-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well GDC-0449 (vismodegib) works for treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have a smoothened or patched 1 genetic mutation. Vismodegib is a type of medication called a hedgehog signaling pathway antagonist and works by blocks a type of protein involved in tissue growth and repair and may block the growth of cancer cells., conditionsModule conditions: Advanced Lymphoma, conditions: Advanced Malignant Solid Neoplasm, conditions: Hematopoietic and Lymphatic System Neoplasm, conditions: Refractory Lymphoma, conditions: Refractory Malignant Solid Neoplasm, conditions: Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Echocardiography, interventions name: Radionuclide Imaging, interventions name: Vismodegib, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression-free survival (PFS) rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06357975, orgStudyIdInfo id: NCI-2024-01126, secondaryIdInfos id: NCI-2024-01126, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-C1, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-C1, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2016-05-30, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have MET gene amplification. Crizotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow., conditionsModule conditions: Advanced Lymphoma, conditions: Advanced Malignant Solid Neoplasm, conditions: Refractory Lymphoma, conditions: Refractory Malignant Solid Neoplasm, conditions: Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Crizotinib, interventions name: Radiologic Examination, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression-free survival (PFS) rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06357962, orgStudyIdInfo id: CSAPG-40, briefTitle: Semi-permanent Acupuncture Effect on Cervical Ripening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de l'Alt Penedès i Garraf, class: OTHER, descriptionModule briefSummary: Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture., conditionsModule conditions: Pregnancy Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Semi-permanent acupuncture, interventions name: Sham of semi-permanent acupuncture, outcomesModule primaryOutcomes measure: Pharmacological induction, secondaryOutcomes measure: Change on score of Bishop scale, secondaryOutcomes measure: Onset of spontaneous labor, secondaryOutcomes measure: Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period, secondaryOutcomes measure: Duration of labor period, secondaryOutcomes measure: Satisfaction of pregnants, eligibilityModule sex: FEMALE, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Consorci Sanitari Alt Penedes i Garraf, city: Vilafranca Del Penedès, state: Barcelona, zip: 08720, country: Spain, contacts name: Gloria Villena, role: CONTACT, phone: +34 938180440, phoneExt: 43197, email: [email protected], contacts name: Noemí Casaponsa, role: CONTACT, phone: +34 938960025, phoneExt: 43197, email: [email protected], geoPoint lat: 41.34618, lon: 1.69713, hasResults: False
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protocolSection identificationModule nctId: NCT06357949, orgStudyIdInfo id: E2-23-3615, briefTitle: The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hitit University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: High-intensity laser, interventions name: Sham laser, outcomesModule primaryOutcomes measure: 10-Meter Walk Test, secondaryOutcomes measure: Visual analogue scale for pain (VAS- pain), secondaryOutcomes measure: Modified Ashworth Scale, secondaryOutcomes measure: Joint Range of Motion (ROM) Measurement, secondaryOutcomes measure: Ultrasonography, secondaryOutcomes measure: Timed Up and Go test, secondaryOutcomes measure: Stroke Specific Quality of Life Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Tuğba Atan, role: CONTACT, phone: +90 312 2911000, phoneExt: 1414, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06357936, orgStudyIdInfo id: CNMT002, briefTitle: Nanofat Grafting as a Method of Treating Critical Limb Ischemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Center of New Medical Technologies, class: OTHER, descriptionModule briefSummary: This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments., conditionsModule conditions: Limb Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: nano-fat grafting in chronic limb ischaemia, interventions name: sham comparator, outcomesModule primaryOutcomes measure: Percent of pain absence in experimental group, secondaryOutcomes measure: Number of any intraoperative complications, secondaryOutcomes measure: Number of any inhospital complications, secondaryOutcomes measure: Number of saved limbs, secondaryOutcomes measure: Percent change in visual analog pain score (VAS) change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, city: Novosibirsk, state: Novosibirsk Region, zip: 630090, country: Russian Federation, contacts name: Andrey V Ponomarenko, MD, role: CONTACT, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False
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protocolSection identificationModule nctId: NCT06357923, orgStudyIdInfo id: 23-PP-13, secondaryIdInfos id: 2024-A00321-46, type: OTHER, domain: ANSM, briefTitle: Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-02, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects \> 60 years of age respecting a male/female ratio = 1., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: dosage, outcomesModule primaryOutcomes measure: Expression level of LAMP2 (protein and isoform A and B mRNA), secondaryOutcomes measure: Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu de Nice, city: Nice, zip: 06003, country: France, contacts name: Andrea CICCONE, role: CONTACT, phone: 0492034702, email: [email protected], contacts name: marion causeret, role: CONTACT, phone: 0492034702, email: [email protected], contacts name: Andrea CICCONE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
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protocolSection identificationModule nctId: NCT06357910, orgStudyIdInfo id: HM-EMMA-102, briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-17, primaryCompletionDateStruct date: 2024-06-29, completionDateStruct date: 2024-06-29, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Hanmi Pharmaceutical Company Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: HCP2303, interventions name: RLD2302, interventions name: RLD2102, outcomesModule primaryOutcomes measure: AUCt, primaryOutcomes measure: Cmax, secondaryOutcomes measure: AUCinf, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vd/F, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 54 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jeonbuk University Hospital, city: Jeonju, state: Jeollabuk-do, country: Korea, Republic of, contacts name: Jin A Lee, Researcher, role: CONTACT, phone: 063-259-3550, contacts name: Min-gul Kim, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False
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protocolSection identificationModule nctId: NCT06357897, orgStudyIdInfo id: 0093/67, briefTitle: The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups., conditionsModule conditions: Functional Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group received PEG-Chula Control group received Forlax, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Local PEG4000, interventions name: Commercial PEG4000, outcomesModule primaryOutcomes measure: The frequency of stool, primaryOutcomes measure: Stool consistency assessed by Bristol stool chart, secondaryOutcomes measure: Fecal incontinence, secondaryOutcomes measure: Rectal diameter, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Palatability of medication assessed by facial Hedonic scale, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06357884, orgStudyIdInfo id: CREC2023.572, briefTitle: Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, collaborators name: Princess Margaret Hospital, Hong Kong, descriptionModule briefSummary: Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot., conditionsModule conditions: Diabetic Neuropathies, conditions: Plantar Callus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Callus debridement, outcomesModule primaryOutcomes measure: Peak plantar pressure (PPP) (unit: kPa), secondaryOutcomes measure: Pressure time integral (PTI) (unit: kPa*sec), secondaryOutcomes measure: Peak pressure gradient (PPG) (unit: kPa/cm), secondaryOutcomes measure: Forefoot to rearfoot peak pressure ratio (F/R ratio), secondaryOutcomes measure: Foot and Ankle Outcome Score (FAOS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Podiatry Department, Princess Margaret Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Joanne Tze Yan Lai, role: CONTACT, phone: 29903901, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06357871, orgStudyIdInfo id: 2023PI178, briefTitle: Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer, acronym: NEPHROTOX, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, collaborators name: University Hospital, Strasbourg, France, collaborators name: CHU de Reims, collaborators name: Centre Hospitalier Régional Metz-Thionville, collaborators name: European Georges Pompidou Hospital, descriptionModule briefSummary: Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible., conditionsModule conditions: Chemotherapeutic Toxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU de Nancy, status: RECRUITING, city: Vandoeuvre les nancy, zip: 54500, country: France, contacts name: Adrien Flahault, MD PhD, role: CONTACT, phone: 0383858585, email: [email protected], geoPoint lat: 48.65, lon: 6.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06357858, orgStudyIdInfo id: CASE6323, briefTitle: ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to see if the combination of experimental drug ASTX727 and Nivolumab enhances the antitumor immune response in participants will recurrent or metastatic squamous cell carcinoma of the head and neck.Participants will take a pill called ASTX727 for 4 or 5 days every month followed by an injection of Nivolumab one week after the first dose of study medication., conditionsModule conditions: Recurrent Squamous Cell Carcinoma of the Head and Neck, conditions: Metastatic Squamous Cell Carcinoma, conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: INQOVI (decitabine and cedazuridine), interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Pharmacodynamics Effect of ASTX727 on global DNA methylation status, primaryOutcomes measure: Immunogenicity of ASTX27 in combination with Nivolumab, primaryOutcomes measure: Maximum Tolerated Dose, primaryOutcomes measure: Safety of ASTX, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Kyunghee Burkitt, DO, PhD, role: CONTACT, phone: 216-844-0512, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06357845, orgStudyIdInfo id: CASE5Z24, secondaryIdInfos id: 1R21ES036031-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21ES036031-01, briefTitle: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute of Environmental Health Sciences (NIEHS), descriptionModule briefSummary: The goal of this study is to This research team is conducting this study to develop methods to measure the biological impact of exposure to the chemicals released following the February 3, 2023 train derailment on residents of East Palestine, Ohio, and surrounding communities. The main question it aims to answer is:* What biological impact will be measured based on DNA damage?* In participants who provide a biospecimen, how are biomarker changes related to proximity to the derailment and variations in residents' health histories and behaviors?Participants will:* Complete a brief survey asking about experiences related to the February 3, 2023 train derailment, health experiences, and concerns following the derailment, and background information regarding health history.* Possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings.* Receive communication about study updates and future research opportunities.* A total of 40 study participants will be recruited to participate in a 90-minute interview. The interviews will be video and audio recorded., conditionsModule conditions: Somatic Mutation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A cross-sectional study design will be implemented., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Survey, interventions name: Biological specimen collection, interventions name: Communications about study updates and future research opportunities, interventions name: Qualitative interview, outcomesModule primaryOutcomes measure: Geographic Association of Somatic Mutation Rates, secondaryOutcomes measure: Self-reported Symptomology Association of Somatic Mutation Rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357832, orgStudyIdInfo id: CTP-ACCiTBS-00, briefTitle: New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Brainsway, class: INDUSTRY, descriptionModule briefSummary: The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Brainsway Deep TMS System, outcomesModule primaryOutcomes measure: Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group, secondaryOutcomes measure: Response rate in the investigational group, secondaryOutcomes measure: Remission rate in the investigational group, secondaryOutcomes measure: Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group, secondaryOutcomes measure: Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novus Neurology, city: Tuscaloosa, state: Alabama, zip: 35401, country: United States, contacts name: Timothy Prestley, MD, role: CONTACT, phone: 205-523-5618, email: [email protected], geoPoint lat: 33.20984, lon: -87.56917, locations facility: DTMS Center LLC, city: Palm Beach, state: Florida, zip: 33401, country: United States, contacts name: Aron Tendler, MD, role: CONTACT, phone: 561-749-9999, email: [email protected], geoPoint lat: 26.70562, lon: -80.03643, locations facility: Fermata Health, city: Brooklyn, state: New York, zip: 11249, country: United States, contacts name: Owen Muir, MD, role: CONTACT, phone: 929-346-4317, email: [email protected], geoPoint lat: 40.6501, lon: -73.94958, locations facility: Complete Mind Care of PA, city: Abington, state: Pennsylvania, zip: 19001, country: United States, contacts name: Samson Seplow, MD, role: CONTACT, phone: 215-254-6000, email: [email protected], geoPoint lat: 40.12067, lon: -75.11795, locations facility: ClearPath Psychiatry, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Molly Davis, MD, role: CONTACT, phone: 206-486-8150, email: [email protected], geoPoint lat: 47.60621, lon: -122.33207, locations facility: PsyCare, city: South Charleston, state: West Virginia, zip: 25303, country: United States, geoPoint lat: 38.36843, lon: -81.69957, hasResults: False
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protocolSection identificationModule nctId: NCT06357819, orgStudyIdInfo id: CLS-017A, secondaryIdInfos id: HSTAR010, type: OTHER, domain: HSTAR Programme, secondaryIdInfos id: EZIMOM012, type: OTHER, domain: Ezintsha, briefTitle: INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2023-12-17, completionDateStruct date: 2023-12-17, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\]., conditionsModule conditions: Hepatitis C, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 405, type: ACTUAL, armsInterventionsModule interventions name: INSTI HCV Self Test, outcomesModule primaryOutcomes measure: Successful Interpretation of contrived devices, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: bioLytical Laboratories Inc., city: Richmond, state: British Columbia, zip: V6V 2A2, country: Canada, geoPoint lat: 49.17003, lon: -123.13683, hasResults: False
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protocolSection identificationModule nctId: NCT06357806, orgStudyIdInfo id: PIN-CHB-1, briefTitle: The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PDL-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab, interventions name: Peg-IFNα-2b, interventions name: NAs, outcomesModule primaryOutcomes measure: The rate of HBsAg loss at 24 weeks and 48 weeks., primaryOutcomes measure: Incidence of treatment-emergent adverse events/serious adverse events, secondaryOutcomes measure: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks, secondaryOutcomes measure: The rate of HBsAb positive at 24 weeks and 48 weeks., secondaryOutcomes measure: The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks., secondaryOutcomes measure: The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks., secondaryOutcomes measure: The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks., secondaryOutcomes measure: Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Fifth Medical Center, Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100039, country: China, contacts name: Junliang Fu, MD, role: CONTACT, phone: 010-66933214, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06357793, orgStudyIdInfo id: camsakuraftr, briefTitle: Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity., conditionsModule conditions: Fibromyalgia, conditions: Work Productivity, conditions: Quality of Life, conditions: Pain, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Work Productivity and Activity of Fibromyalgia Patients' Relatives, secondaryOutcomes measure: Quality of life Fibromyalgia Patients' Relatives, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357780, orgStudyIdInfo id: 240396837, briefTitle: Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients, acronym: CHESTSPAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant., conditionsModule conditions: Acute Respiratory Failure, conditions: Acute Respiratory Distress Syndrome, conditions: Chronic Respiratory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: close-loop synchronization controller with spontaneous mode, interventions name: Conventional, outcomesModule primaryOutcomes measure: Asynchrony Index, secondaryOutcomes measure: Major Asynchrony index, secondaryOutcomes measure: Minor Asynchrony index, secondaryOutcomes measure: Dyspnea Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr.Suat Seren Chest Diseasees Hospital, city: Izmir, zip: 35230, country: Turkey, contacts name: Cenk Kirakli, professor, role: CONTACT, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06357767, orgStudyIdInfo id: S06GM146079, type: NIH, link: https://reporter.nih.gov/quickSearch/S06GM146079, briefTitle: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Black Hills Center for American Indian Health, class: OTHER, collaborators name: Yale University, descriptionModule briefSummary: The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment., conditionsModule conditions: Smoking Cessation, conditions: Cigarette Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, outcomesModule primaryOutcomes measure: Trauma-Informed Practice Scales (TIPS), primaryOutcomes measure: Session Rating Scale (SRS), primaryOutcomes measure: Group Attitude Scale (GAS), secondaryOutcomes measure: Biochemical verification of smoking status, secondaryOutcomes measure: Biochemical verification of smoking status, secondaryOutcomes measure: Biochemical verification of smoking status, secondaryOutcomes measure: Quit Attempts, secondaryOutcomes measure: Quit Attempts, secondaryOutcomes measure: Quit Attempts, otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), otherOutcomes measure: NIDA ASSIST, otherOutcomes measure: NIDA ASSIST, otherOutcomes measure: NIDA ASSIST, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357754, orgStudyIdInfo id: CA082-085, briefTitle: Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2038-10-06, completionDateStruct date: 2038-10-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy., conditionsModule conditions: Non-Hodgkin Lymphoma, conditions: Chronic Lymphocytic Leukaemia, conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Idecabtagene vicleucel, interventions name: Lisocabtagene maraleucel, outcomesModule primaryOutcomes measure: Participant in situ hybridization (ISH) transgene testing results, primaryOutcomes measure: Participant insertion site (ISA) analysis testing results, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CellCarta, status: RECRUITING, city: Antwerp, country: Belgium, geoPoint lat: 51.21989, lon: 4.40346, hasResults: False
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protocolSection identificationModule nctId: NCT06357741, orgStudyIdInfo id: 202286, briefTitle: Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis, acronym: CSODITTOKO, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: As an activator of inhibiting nuclear factor kB receptor, denosumab affects osteoclast differentiation and development by inhibiting OPG/RANKL-RANK bone regulatory axis pathway. Therefore, denosumab is widely used in the treatment of bone diseases such as osteoporosis. Osteoporosis is closely related to knee osteoarthritis. RANKL-RANK pathway also plays a key role in the pathogenesis of knee osteoarthritis. Therefore, the investigators propose the hypothesis that denosumab can effectively treat knee osteoarthritis., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Denosumab, outcomesModule primaryOutcomes measure: Knee pain relief, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wuhan Union Hospital, city: Wuhan, state: Hubei, zip: 430000, country: China, geoPoint lat: 30.58333, lon: 114.26667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-03, uploadDate: 2024-04-04T11:01, filename: Prot_000.pdf, size: 398739, hasResults: False
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protocolSection identificationModule nctId: NCT06357728, orgStudyIdInfo id: 2024/2035, briefTitle: Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy, acronym: I-CHAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: KK Women's and Children's Hospital, class: OTHER_GOV, descriptionModule briefSummary: Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis., conditionsModule conditions: Gestational Diabetes, conditions: Glucose Metabolism Disorders, conditions: Metabolic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Continuous glucose monitoring, outcomesModule primaryOutcomes measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L), primaryOutcomes measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L), primaryOutcomes measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L), secondaryOutcomes measure: Maternal obstetric outcomes - Pre-eclampsia, secondaryOutcomes measure: Maternal obstetric outcomes- Pregnancy-induced hypertension, secondaryOutcomes measure: Maternal obstetric outcomes - C-section, secondaryOutcomes measure: Neonatal outcomes- Large-for-gestational-age, secondaryOutcomes measure: Neonatal outcomes-Birth weigh, secondaryOutcomes measure: Neonatal outcomes- Small-for-gestational-age, secondaryOutcomes measure: Neonatal outcomes-Pre-term birth, secondaryOutcomes measure: Neonatal outcomes-Neonatal hypoglycaemia, otherOutcomes measure: Types of treatment received for gestational diabetes diagnosis, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-02-20, uploadDate: 2024-03-18T04:35, filename: Prot_SAP_ICF_000.pdf, size: 218503, hasResults: False
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protocolSection identificationModule nctId: NCT06357715, orgStudyIdInfo id: 2021/373/HP, briefTitle: Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People, acronym: SPEAKER 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-09, completionDateStruct date: 2026-05-09, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: According to the French National Health Agency, the use of manual therapy techniques is "possible" \[grade B\] as part of a multimodal combination of treatments for low back pain. These include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. Most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. Pain reduction is observed in more areas of the body with sliding techniques than with traction techniques.In this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes, conditionsModule conditions: Voluntary, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: the second physiotherapist who evaluate the pressure pain, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: "slump"position, interventions name: no" slump" position, outcomesModule primaryOutcomes measure: Difference in pressure at the moment when the volunteer indicates that the sensation of pressure becomes pain, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357702, orgStudyIdInfo id: 81313, secondaryIdInfos id: K23DE031807, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DE031807, briefTitle: K23- Physical Self Regulation vs Placebo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ian Boggero, PhD, class: OTHER, collaborators name: National Institute of Dental and Craniofacial Research (NIDCR), descriptionModule briefSummary: This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects., conditionsModule conditions: Temporomandibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Physical Self Regulation Telehealth, interventions name: Psycho-education Telehealth, outcomesModule primaryOutcomes measure: Change in pain intensity, primaryOutcomes measure: Change in pain interference, primaryOutcomes measure: Change in quality of life, primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Interventionist Fidelity Session 1, primaryOutcomes measure: Interventionist Fidelity Session 2, primaryOutcomes measure: Treatment Acceptability, primaryOutcomes measure: Treatment Credibility, primaryOutcomes measure: Research Burden, secondaryOutcomes measure: Treatment Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40506, country: United States, contacts name: Ian Boggero, Ph.D., role: CONTACT, phone: 859-562-3291, email: [email protected], geoPoint lat: 37.98869, lon: -84.47772, hasResults: False
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protocolSection identificationModule nctId: NCT06357689, orgStudyIdInfo id: REC ID 6, briefTitle: Association of SNPs in Long Intergenic Noncoding RNA 00511 (LINC00511) With Breast Cancer Among the Egyptian Population, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-24, primaryCompletionDateStruct date: 2023-03-11, completionDateStruct date: 2023-04-29, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, collaborators name: British University In Egypt, descriptionModule briefSummary: Long non-coding RNAs (lncRNAs) play an important role in different types of cancer, including breast cancer, through regulation of gene expression and epigenetic signatures. Genetic variations such as single nucleotide polymorphisms (SNPs) in lncRNAs have been found to be associated with cancer. Our aim was to provide information about the role of LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859, rs4432291 and rs1558535) in breast cancer susceptibility in the Egyptian population., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 417, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Investigating the relationship of the genotypes of each SNP of the LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) with either increased or decreased risk of breast cancer or no effect in the Egyptian population, secondaryOutcomes measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Estrogen receptor, secondaryOutcomes measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Progesterone receptor, secondaryOutcomes measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and HER2 status, secondaryOutcomes measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor stage, secondaryOutcomes measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor grade, secondaryOutcomes measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and lymph node metastasis, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Faculty of Pharmacy, The British University in Egypt, Pharmacology and Biochemistry Research lab, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06357676, orgStudyIdInfo id: STUDY00025355, secondaryIdInfos id: NCI-2024-01208, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00025355, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: Genentech, Inc., descriptionModule briefSummary: This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL., conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Echocardiography, interventions name: FDG-Positron Emission Tomography, interventions name: Glofitamab, interventions name: Ibrutinib, interventions name: Magnetic Resonance Imaging, interventions name: Obinutuzumab, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLT), primaryOutcomes measure: Proportion of participants who achieve a complete response (CR), secondaryOutcomes measure: Incidence of grade 3 or above adverse events (AEs), secondaryOutcomes measure: Proportion of patients treated with tocilizumab (TCZ), secondaryOutcomes measure: Number of doses of TCZ per participant, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Duration of complete response (DOCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Knight Cancer Clinical Trials Hotline, role: CONTACT, phone: 503-494-1080, email: [email protected], contacts name: Stephen E. Spurgeon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06357663, orgStudyIdInfo id: Pro00071128, briefTitle: Subtle Energy Transmission and Tao Calligraphy Mindfulness in Telomere Length in Peripheral Blood Leukocytes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sha Research Foundation, class: OTHER, descriptionModule briefSummary: Effect of Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice on Telomere Length in Peripheral Blood Leukocytes A Follow-up Pilot StudyThe goal of this Pilot clinical trial is to learn if a Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice works to increase Telomere Length in Peripheral Blood Leukocytes in adults. The main questions it aims to answer are:* Does A Subtle energy transmission and Tao Calligraphy Mindfulness increase Telomere Length in Peripheral Blood Leukocytes in adults?* Will this increase of Telomere Length in Peripheral Blood Leukocytes in adults be statistically significant? Researchers will compare the length of Telomere in peripheral blood Leukocytes at beginning of the mindfulness practices to the length of Telomere in peripheral blood Leukocytes at 3 months and at 9 months of regular daily practices.Participants will:* Receive a transmission of Subtle energy at beginning of practices* Visit the Laboratory for a blood sample taken at beginning, at 3 months and at 9 months of practices.* Fill the Study Questionnaires at beginning, at 3 months and at 9 months of practices.* Practice the Mindfulness with Tao Calligraphy daily 1 hour in the morning and 1 hour in the evening., conditionsModule conditions: Telomere Length, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study will be performed as a Pilot follow-up study, should the 0 Hypothesis be successfully rejected, this study will be followed by a formal Double Blind Randomized Crossover Study.We plan subjects may enter the study as a group and will have measurements done within short time frame from each other at beginning and at the end of 3 and 9 months.As this is a pilot study, there will be no randomization into treatment and control group, as a control we will use the "Normal" values of telomere from general population. All subjects will receive a transmission and then will be practicing Tao Calligraphy mindfulness daily during the 9 months.Every subject who is accepted into the study, will have blood sample taken for analysis and will fill Rand SF 36 Questionnaire. Afterwards, will receive transmission of subtle energy by Zhi Gang Sha (or his designee) and will be instructed on how to practice mindfulness with Tao Calligraphy., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Mindfulness practice with Calligraphy, outcomesModule primaryOutcomes measure: Telomere Length in Peripheral blood leukocytes, secondaryOutcomes measure: Quality of Life by John Ware's SF-36 Quality of Life questionnaire (that produces eight scores with 0-to-100 scale, 100 being the best possible outcome)., eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sha Research Foundation (Branch), city: North Vancouver, state: British Columbia, zip: V7R 1P5, country: Canada, geoPoint lat: 49.31636, lon: -123.06934, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-04-10, uploadDate: 2024-03-28T15:14, filename: Prot_SAP_000.pdf, size: 428331, hasResults: False
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protocolSection identificationModule nctId: NCT06357650, orgStudyIdInfo id: CSQ-2024-001, briefTitle: Collaborative Open Research Initiative Study (CORIS-1), acronym: CORIS-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chisquares Incorporated, class: INDUSTRY, descriptionModule briefSummary: The Collaborative Open Research Initiative Study (CORIS) is a groundbreaking international research endeavor aimed at exploring vital topics within the field of health professions education. At its core, CORIS embodies the spirit of inclusivity by opening its doors to contributors from all corners of the globe, putting the power of research into the hands of the global community and fostering an environment of open collaboration and meaningful contribution. We invite anyone and everyone to join as collaborators and suggest questions for inclusion in the survey, ensuring that the research process is enriched by diverse perspectives. As a collaborator, you will not only have the opportunity to actively engage in survey design, question formulation, and the entire research process from start to finish, but also gain the prospect of achieving valuable publications, which may boost your professional career., conditionsModule conditions: Patient Engagement, conditions: COVID-19, conditions: Preventable Disease, Vaccine, conditions: Burnout, Professional, conditions: Emerging Infectious Disease, conditions: Artificial Intelligence, conditions: Climate Change, conditions: Online Education, conditions: Mental Health Issue, conditions: Substance Use Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 15000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention. This is an observational study, outcomesModule primaryOutcomes measure: Percentage of health professions schools implementing changes in patient care strategies before versus after the COVID-19 pandemic., primaryOutcomes measure: Percentage of personnel in health professions education with adequate epidemic preparedness and readiness., primaryOutcomes measure: Percentage of faculty and staff in health professions schools experiencing burnout., primaryOutcomes measure: Percentage of healthcare professionals who report the integration and utilization of artificial intelligence (AI) in their education and practice., primaryOutcomes measure: Percentage of participants expressing positive attitudes and perceptions towards climate change and the role of individuals and society in mitigating it., primaryOutcomes measure: Percentage of participants reporting effectiveness and challenges of remote learning and online education in health professions schools., primaryOutcomes measure: Percentage of personnel within health professions education reporting substance use behaviors and their implications., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06357637, orgStudyIdInfo id: 59/2023, briefTitle: Abdominal Circumference Measure in Caesarian Section, acronym: ACirCuS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: CHU Mohammed VI Marrakech, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate preoperative measures of abdominal circumference in patients admitted for a cesarean section. The main questions it aims to answer are:* Can preoperative abdominal circumference predict patients with difficult spinal anesthesia* Can preoperative abdominal circumference predict the occurrence of maternal hypotension during cesarean section Participants will be examined preoperatively in terms of visibility and palpation of spinous processes, abdominal circumference will be measured in the supine and sitting positions with other clinical parameters. Spinal anesthesia will be performed by the same experienced anesthesiologist with a standardized procedure. The number of skin punctures, needle reorientations, traumatic Cerebrospinal fluid, need for a paramedian approach or failure will be recorded. Maternal blood pressure and vasopressor requirements will also be monitored., conditionsModule conditions: Anesthesia, Spinal, conditions: Cesarean Section, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Measure of abdominal circumference, outcomesModule primaryOutcomes measure: Number of patients with difficult spinal anesthesia, secondaryOutcomes measure: Rate of Maternal hypotension, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Mohammed VI, status: RECRUITING, city: Marrakech, zip: 40000, country: Morocco, contacts name: MERYEM ESSAFTI, MD, role: CONTACT, phone: +212662393700, email: [email protected], contacts name: MARINA BOKOBA, MD, role: CONTACT, phone: +242065166209, email: [email protected], contacts name: MERYEM ESSAFTI, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: MARINA NDE BOKOBA, MD, role: SUB_INVESTIGATOR, geoPoint lat: 31.63416, lon: -7.99994, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-10, uploadDate: 2024-01-23T03:56, filename: Prot_000.pdf, size: 162775, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-01, uploadDate: 2024-04-06T11:11, filename: ICF_001.pdf, size: 350456, hasResults: False
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protocolSection identificationModule nctId: NCT06357624, orgStudyIdInfo id: Physiotherapy, briefTitle: Effectiveness of Mulligan Mobilization Technique, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-05-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Karabuk University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effects of the Mulligan mobilization technique (MMT) on pain intensity, joint position sense (JPS), kinesiophobia, and disability level in individuals with nonspecific neck pain. A total of 34 female individuals with nonspecific neck pain were included in the study. Pain intensity, JPS, kinesiophobia, and disability levels of all participants were evaluated before and after the 3-week intervention. Participants were randomly divided into two groups. In the first group, the participants received MMT by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. The second group was trained only self-mobilization techniques., conditionsModule conditions: Neck Pain, conditions: Disability Physical, conditions: Kinesiophobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Mulligan mobilization, interventions name: Self-Mobilization, outcomesModule primaryOutcomes measure: Disability, primaryOutcomes measure: Neck Pain Severity, primaryOutcomes measure: Joint Position Sense, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tarik Ozmen, city: Karabük, country: Turkey, geoPoint lat: 41.20488, lon: 32.62768, hasResults: False
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protocolSection identificationModule nctId: NCT06357611, orgStudyIdInfo id: OST1_015, briefTitle: Combination of Two Osteopathic Techniques for the Hamstring's Stretching Capacity in Basketball Female Players, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-09-16, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-17, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Natália Maria Oliveira Campelo, class: OTHER, descriptionModule briefSummary: It is known that there are studies that prove the effectiveness of muscle energy techniques and the fourth ventricle technique separately, however, information is scarce regarding the combination of the two and their effectiveness in the population. The aim of this randomized controlled study is to compare the immediate effects of the techniques compared to the muscle energy technique alone in female basketball players., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In order to allocate each participant to an intervention group, each voluntary participation questionnaire was assigned a number. Subsequently, all the numbers of the participants in the sample were randomly distributed among the 3 groups by the principal investigator., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Simulated technique, interventions name: Muscle energy technique, interventions name: 4th ventricle technique and muscular energy technique, outcomesModule primaryOutcomes measure: Altered range of motion of the hamstring muscles., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Escola Superior de Saúde do Porto, status: RECRUITING, city: Porto, zip: 4200-072, country: Portugal, contacts name: Natália Campelo, role: CONTACT, phone: +35122 206 1000, email: [email protected], contacts name: Natália MO Campelo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False
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protocolSection identificationModule nctId: NCT06357598, orgStudyIdInfo id: QYFYEC2023-95, briefTitle: Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer, acronym: PILOT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Qingdao University, class: OTHER, descriptionModule briefSummary: Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma., conditionsModule conditions: Non-small-cell Lung Cancer (NSCLC), designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC), interventions name: Carboplatin or Cisplatin, interventions name: Surgery, outcomesModule primaryOutcomes measure: R0 Resection Rate, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Resectability Rate, secondaryOutcomes measure: Major Pathological Response (MPR) Rate, secondaryOutcomes measure: Rate of grade 3 and higher grade treatment-related adverse events, secondaryOutcomes measure: Progression-Free Survival (PFS), otherOutcomes measure: Pathological Complete Response (pCR) Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Affiliated Hospital of Qingdao University, status: RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Zhe Wu, PhD, role: CONTACT, phone: +86 17863934867, email: [email protected], geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
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protocolSection identificationModule nctId: NCT06357585, orgStudyIdInfo id: SBUBURCUCALİK, briefTitle: Providing Web-based Training to Parents Of Children With Leukemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-24, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Following and implementing innovations and current developments in care practices for children diagnosed with leukemia and their parents will allow the quality of care to increase. The purpose of this research is to evaluate the effect of web-based education given to parents of children diagnosed with leukemia on their knowledge level, satisfaction and self-efficacy.The research is a single-blind randomized controlled experimental research type. The research will be conducted in a single center, Ankara Bilkent City Hospital MH4 Children's Hospital Hematology-Oncology Clinics and Leukemia Polyclinic. The population of the research consists of parents of children diagnosed with leukemia between the ages of 2-18 who are followed and treated in the specified places. The sample of the research consists of 72 participants, 36 in the experimental group (the group that received web-supported training) and 36 in the control group (the group that continued routine treatment).The consent of the parents who meet the research criteria and voluntarily agree to participate in the study will be obtained with the "Informed Voluntary Consent Form" and the parents in both the experimental group and the control group will be given the "Child and Parent Introductory Information Form", "Child with Leukemia Parent Information Level Pre-Test Evaluation Form". ", "Generalized Perceived Self-Efficacy Scale" will be applied. Once the sufficient number is reached, web-based training will be provided to the parents in the experimental group. "Parents of Children with Leukemia Knowledge Level Post-Test Evaluation Form", "Generalized Perceived Self-Efficacy Scale" and "Web-Based Parents of Children with Leukemia Training Satisfaction Evaluation Form" will be applied to the parents who complete the training. No intervention will be made to the parents in the control group, and the children will continue their routine care and treatment process. The "Child with Leukemia Parent Knowledge Level Posttest Evaluation Form" and the "Generalized Perceived Self-Efficacy Scale" will also be applied to the parents in the control group., conditionsModule conditions: Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Web-based training will be provided to parents in the experimental group, and parents in the control group will continue their routine treatment and care process., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Participant blinding was done because the parents who participated in the study voluntarily did not know which group they were in until the end of the study., whoMasked: PARTICIPANT, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Web based education, interventions name: inactive group, outcomesModule primaryOutcomes measure: Child with Leukemia Parent Knowledge Level Pre-Test Evaluation Form, primaryOutcomes measure: Child with Leukemia Parent Knowledge Level Post-Test Evaluation Form, primaryOutcomes measure: Web-Based Child with Leukemia Parent Education Satisfaction Evaluation Form, primaryOutcomes measure: Generalized Perceived Self-Efficacy Scale, primaryOutcomes measure: Generalized Perceived Self-Efficacy Scale, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Health Sciences, status: RECRUITING, city: Ankara, state: Keçiören, zip: 06018, country: Turkey, contacts name: Burcu ÇALIK BAĞRIYANIK, role: CONTACT, phone: 05067075349, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06357572, orgStudyIdInfo id: ENZ13-2024, briefTitle: Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-03-27, completionDateStruct date: 2024-03-27, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Enzyre B.V., class: INDUSTRY, collaborators name: Instytut Hematologii i Transfuzjologii, Warschau, Poland, descriptionModule briefSummary: The goal of this observational study is to assess if the version A of the HemA EnzySystem, a novel portable coagulation testing platform, can be used in patients with hemophilia A treated with Factor VIII Bypassing Agent (FEIBA). The main question\[s\] it aims to answer are:* Can the version A of the HemA EnzySystem can record thrombin generation within a time frame of 60 min in fresh whole blood samples of patients with hemophilia A treated with FEIBA?* Are the TGA results of the version A of the HemA EnzySystem in agreement with the TGA results obtained with conventional methods in fresh non frozen plasma?Participants are asked to fill in a questionnaire regarding their general health and hemophilia treatment. Subsequently, blood will be drawn from the patients before, and at 30, 120, and 240 minutes after FEIBA administration. Whole blood is immediately tested using the Version A HemA EnzySystem, and plasma is generated for testing with the Ceveron s100 (Technoclone). Leftover samples are frozen for later additional coagulation testing., conditionsModule conditions: Hemophilia A With Inhibitor, conditions: Hemophilia A, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Thrombin generation assay (EnzySystem HemA version A - whole blood), interventions name: Thrombin generation assay (Ceveron s100 (Technoclone) - fresh plasma), interventions name: Additional coagulation tests, outcomesModule primaryOutcomes measure: Time between venipuncture and TGA result, secondaryOutcomes measure: Agreement between TGA obtained with the EnzySystem HemA version A and conventional TGA results, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Hematology and Blood Transfusion, city: Warsaw, state: Mazowieckie Województwo, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
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