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protocolSection identificationModule nctId: NCT06270433, orgStudyIdInfo id: 2023-KY142-01, briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Jiangsu Province Nanjing Brain Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use., conditionsModule conditions: Anhedonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Toludesvenlafaxine hydrochloride sustained-release tablets, interventions name: Desvenlafaxine succinate sustained-release tablets, outcomesModule primaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate, secondaryOutcomes measure: Dimensional Anhedonia Rating Scale (DARS) Score, secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score, secondaryOutcomes measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score, secondaryOutcomes measure: Sheehan Disability Scale (SDS) Score, secondaryOutcomes measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score, otherOutcomes measure: Rating Scale for Side Effects (SERS) Score, otherOutcomes measure: Arizona Sexual Experience Scale (ASEX) Score, otherOutcomes measure: Count of red blood cell in blood, otherOutcomes measure: Count of white blood cell in blood, otherOutcomes measure: Count of platelet in blood, otherOutcomes measure: Concentration of hemoglobin in blood, otherOutcomes measure: Concentration of alanine aminotransferase in blood, otherOutcomes measure: Concentration of aspartate aminotransferase in blood, otherOutcomes measure: Concentration of gamma-glutamyltransferase in blood, otherOutcomes measure: Concentration of blood glucose in blood, otherOutcomes measure: Concentration of serum creatinine in blood, otherOutcomes measure: Concentration of urea in blood, otherOutcomes measure: Concentration of total cholesterol in blood, otherOutcomes measure: Concentration of high density lipoprotein in blood, otherOutcomes measure: Concentration of low density lipoprotein in blood, otherOutcomes measure: Concentration of triglyceride in blood, otherOutcomes measure: Concentration of thyroid-stimulating hormone in blood, otherOutcomes measure: Concentration of protein in urine, otherOutcomes measure: Concentration of sugar in urine, otherOutcomes measure: Count of white blood cell in urine, otherOutcomes measure: Count of red blood cell in urine, otherOutcomes measure: ECG QT Interval, otherOutcomes measure: Changes in weight, otherOutcomes measure: Changes in pulse, otherOutcomes measure: Changes in both systolic and diastolic blood pressure, otherOutcomes measure: Changes in respiration rate, otherOutcomes measure: Changes in armpit temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Brian Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210024, country: China, contacts name: Hao Tang, MD, role: CONTACT, phone: +8618913821366, email: tanghao997@163.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06270420, orgStudyIdInfo id: 2022.04, briefTitle: Technological Devices and Home Automation System in Neurological Rehabilitation, acronym: SMART, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-05, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: IRCCS San Camillo, Venezia, Italy, class: OTHER, descriptionModule briefSummary: The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room., conditionsModule conditions: Neurological Disease, conditions: Motor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Longitudinal Pilot study, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Technological Motor Rehabilitation, outcomesModule primaryOutcomes measure: Key performance indicator (KPI) of the room - Number of treatments, primaryOutcomes measure: Key performance indicator (KPI) ot the room - Number of sessions, primaryOutcomes measure: Room Key performance indicator (KPI) of the room - Number of minutes of therapy, primaryOutcomes measure: Key performance indicator (KPI) of the room - Number of physiotherapists involved, primaryOutcomes measure: Key performance indicator (KPI) of the room - Number of adverse events, secondaryOutcomes measure: Box and Blocks Test, secondaryOutcomes measure: Reaching Performance Scale, secondaryOutcomes measure: Nine Hole Pegboard Test, secondaryOutcomes measure: Berg balance scale (BBS), secondaryOutcomes measure: 10 Meter Walk Test (10MWT), secondaryOutcomes measure: Functional Ambulation Categories (FAC), secondaryOutcomes measure: Trunk Control Test (TCT), secondaryOutcomes measure: EuroQol questionnaire (EQ-5D), secondaryOutcomes measure: System Usability Scale (SUS), secondaryOutcomes measure: Short Form Patient Satisfaction Questionnaire (PSQ-18), secondaryOutcomes measure: User Experience Questionnaire (UEQ), secondaryOutcomes measure: Number of falls, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Camillo Hospital, status: RECRUITING, city: Venice-Lido, state: Venice, zip: 30126, country: Italy, contacts name: Giorgia Pregnolato, role: CONTACT, phone: +0412207, phoneExt: 214, email: giorgia.pregnolato@hsancamillo.it, geoPoint lat: 45.4131, lon: 12.3742, hasResults: False

protocolSection identificationModule nctId: NCT06270407, orgStudyIdInfo id: 270777, secondaryIdInfos id: 2022-001580-28, type: EUDRACT_NUMBER, secondaryIdInfos id: 2023-510381-28-00, type: REGISTRY, domain: CTIS European Clinical Trial Identification System, briefTitle: The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: St. Olavs Hospital, class: OTHER, collaborators name: Smerud Medical Research International AS, collaborators name: Sykehuset Asker og Baerum, collaborators name: Oslo universitetssykehus HF, collaborators name: Sykehuset Telemark, collaborators name: Sykehuset Innlandet HF, collaborators name: Molde Hospital, collaborators name: Haukeland University Hospital, collaborators name: Haraldsplass Deaconess Hospital, collaborators name: Helse Stavanger HF, collaborators name: University Hospital of North Norway, collaborators name: Bodø sykehus, collaborators name: Helsinki University Central Hospital, descriptionModule briefSummary: Study objective:This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.Eligible patients:Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.Study intervention:Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules., conditionsModule conditions: Surgical Complication, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Randomized controlled prospective interventional trial, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Identically shaped ampoules containing traneamic acid (Cyklokapron, Pfizer) and 0.9% NaCl (Lavoisier, France) have been identified. The ampoule top part is camouflaged with a tight-fitting black tube which preserves the breaking point on the neck of the ampoule. The ampoules will be re-labeled with study-specific labels (text will be in accordance with Regulation 546/2014, annex VI). Randomized study envelopes will be provided in packages of two, with a 1:1 TXA:Placebo randomization, enabling a within-patient randomization in bilateral procedures.Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Tranexamic Acid 100 MG/ML, interventions name: 0.9%sodium chloride, outcomesModule primaryOutcomes measure: Postoperative re-bleeding, secondaryOutcomes measure: Postoperative wound infection, secondaryOutcomes measure: Postoperative wound rupture, secondaryOutcomes measure: Postoperative thromboembolic events, secondaryOutcomes measure: Postoperative seroma, secondaryOutcomes measure: Any other postoperative complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270394, orgStudyIdInfo id: MJX, briefTitle: FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application, statusModule overallStatus: SUSPENDED, startDateStruct date: 2022-04-28, primaryCompletionDateStruct date: 2023-07-28, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Anhui Medical University, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.Investigators will screen suitable participants among patients undergoing routine FDG examination.* Participants will sign an informed consent form* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test., conditionsModule conditions: Malignant Tumors, conditions: Positron-Emission Tomography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-Fibroblast activation protein inhibitor, outcomesModule primaryOutcomes measure: 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG, secondaryOutcomes measure: Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FirstHAnhuiMU, city: Hefei, state: Anhui, zip: 230032, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False

protocolSection identificationModule nctId: NCT06270381, orgStudyIdInfo id: UIDB/05299/2020, briefTitle: Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-07, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment., conditionsModule conditions: Grief Disorder, Prolonged, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: EMPOWER, interventions name: Treatment as usual (TAU), outcomesModule primaryOutcomes measure: Prolonged Grief, secondaryOutcomes measure: Anxiety and depression, otherOutcomes measure: Sociodemographic data, otherOutcomes measure: Risk Assessment for Grief, otherOutcomes measure: Coping strategies, otherOutcomes measure: Adult attachment, otherOutcomes measure: Psychological inflexibility, otherOutcomes measure: Social Support, otherOutcomes measure: Therapeutic alliance, otherOutcomes measure: Posttraumatic Growth, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unidade Local de Saúde Santa Maria, status: RECRUITING, city: Lisboa, country: Portugal, contacts name: Alexandra Coelho, PhD, role: CONTACT, phone: 919957534, email: alexandra.moura.coelho@gmail.com, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False

protocolSection identificationModule nctId: NCT06270368, orgStudyIdInfo id: PREHMO, briefTitle: Children Born Preterm: Sustainable Health Monitoring, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-08-05, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, collaborators name: IRCCS Fondazione Stella Maris, descriptionModule briefSummary: Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data., conditionsModule conditions: Premature Birth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 650, type: ESTIMATED, outcomesModule primaryOutcomes measure: Infant development, primaryOutcomes measure: Childhood development, secondaryOutcomes measure: Presence of visual or hearing impairement, secondaryOutcomes measure: Presence of asthma, secondaryOutcomes measure: Access to care, eligibilityModule sex: ALL, minimumAge: 20 Months, maximumAge: 66 Months, stdAges: CHILD, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria Careggi (AOUC), status: RECRUITING, city: Firenze, country: Italy, contacts name: Simone Pratesi, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Vieri Lastrucci, role: CONTACT, email: vieri.lastrucci@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliero Universitaria Pisana (AOUP), status: RECRUITING, city: Pisa, country: Italy, contacts name: Rosa Scaramuzzo, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Azienda Ospedaliero Universitaria Senese (AOUS), status: RECRUITING, city: Siena, country: Italy, contacts name: Carlo Valerio Bellieni, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, hasResults: False

protocolSection identificationModule nctId: NCT06270355, orgStudyIdInfo id: 2023-06555-01, briefTitle: Stockholm Mammography Risk Stratified Trial, acronym: SMART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2028-04-08, completionDateStruct date: 2032-04-08, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 70000, type: ESTIMATED, armsInterventionsModule interventions name: Risk based screening, outcomesModule primaryOutcomes measure: Incidence of interval cancers, secondaryOutcomes measure: Number of recalled women, otherOutcomes measure: Number of biopsies, otherOutcomes measure: Breast cancer, otherOutcomes measure: Tumor characteristics - Stage, otherOutcomes measure: Tumor characteristics - Multifocality, otherOutcomes measure: Tumor characteristics - Receptor status, otherOutcomes measure: Tumor characteristics - Proliferation, otherOutcomes measure: Cancer worry, otherOutcomes measure: Cancer anxiety, otherOutcomes measure: Side effects related to contrast enhanced mammography, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: Willingness-to-pay, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270342, orgStudyIdInfo id: DTMS, briefTitle: The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: dual task assessment, outcomesModule primaryOutcomes measure: The Minnesota Manual Dexterity Test, primaryOutcomes measure: Dual Task Questionnaire, primaryOutcomes measure: Edinburgh Handedness Questionnaire, primaryOutcomes measure: Expanded Disability Status Scale, primaryOutcomes measure: Brief International Cognitive Assessment Battery for Multiple Sclerosis, primaryOutcomes measure: Beck Depression Scale, primaryOutcomes measure: Fatigue Impact Scale, primaryOutcomes measure: Multiple Sclerosis Quality of Life Questionnaire-54, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kutahya Health Sciences University, city: Kütahya, zip: 43100, country: Turkey, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False

protocolSection identificationModule nctId: NCT06270329, orgStudyIdInfo id: NMTwithKOA, briefTitle: Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis), acronym: OA, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-15, primaryCompletionDateStruct date: 2023-01-15, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA)., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled clinical trial design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Neuromuscular training program, interventions name: conventional physical therapy program, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Western Ontario and McMasterUniversities Osteoarhritis Index, primaryOutcomes measure: Time on One Leg Standing, primaryOutcomes measure: Five Times Sit to Stand Test, primaryOutcomes measure: Manual Muscle Test, primaryOutcomes measure: Short Form, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kutahya Health Science University, city: Kütahya, zip: 43100, country: Turkey, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False

protocolSection identificationModule nctId: NCT06270316, orgStudyIdInfo id: CT-AMT-191-01, briefTitle: Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-29, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: UniQure Biopharma B.V., class: INDUSTRY, descriptionModule briefSummary: This is an open-label multi-center study to evaluate safety and biomarkers of efficacy of a single dose of intravenously-administered AMT-191. The study will also include exploratory functional efficacy assessments. The plan is to investigate 2 sequential dose cohorts in 3-6 Participants per cohort. Participants will be monitored for 24 hours following AMT-191 administration then follow-up study visits will continue for 24 months, during which safety, pharmacokinetics/pharmacodynamics, biomarkers, and efficacy assessments will be performed. Participants will continue receiving their regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal., conditionsModule conditions: Fabry Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: AMT-191, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], primaryOutcomes measure: Duration of Vector deoxyribonucleic acid (DNA) shedding presented in blood, saliva, feces, semen, and urine, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270303, orgStudyIdInfo id: 2023-00383-01, briefTitle: Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2036-03-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Göteborg University, class: OTHER, collaborators name: Johann Wolfgang Goethe University Hospital, collaborators name: Charite University, Berlin, Germany, collaborators name: King's College London, collaborators name: Queen Mary University of London, collaborators name: Geistlich Pharma AG, collaborators name: Vastra Gotaland Region, descriptionModule briefSummary: The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated., conditionsModule conditions: Periodontitis, conditions: Furcation Defects, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The project will be conducted as a two-armed randomized controlled trial in multiple clinical centers. The primary outcome will be assessed at 1 year post-surgery with a subsequent follow-up of 10 years., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Clinical assessments following intervention will be conducted by assessors unaware of group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Access flap & surgical debridement, interventions name: Application of bone substitute material (BioOss Collagen), outcomesModule primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Patient satisfaction assessed by visual analogue scale., secondaryOutcomes measure: Patient satisfaction assessed by visual analogue scale., secondaryOutcomes measure: Patient discomfort as expressed on a visual analogue scale., secondaryOutcomes measure: Patient discomfort as expressed on a visual analogue scale., secondaryOutcomes measure: Esthetic appreciation as expressed on a visual analogue scale., secondaryOutcomes measure: Esthetic appreciation as expressed on a visual analogue scale., secondaryOutcomes measure: Rate of adverse events., secondaryOutcomes measure: Rate of adverse events., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Change of inflammatory markers., secondaryOutcomes measure: Change of inflammatory markers., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Periodontology, Institute of Odontology, city: Göteborg, zip: 40530, country: Sweden, contacts name: Jan Derks, PhD, role: CONTACT, phone: 0046 76 618 3124, email: jan.derks@odontologi.gu.se, contacts name: Jan Derks, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Karolina Karlsson, PhD, role: SUB_INVESTIGATOR, contacts name: Kostas Bougas, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False

protocolSection identificationModule nctId: NCT06270290, orgStudyIdInfo id: 327648, briefTitle: The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls, acronym: COSP-RBD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Guy's and St Thomas' NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).The main questions it aims to answer are:* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?* Is this proportion higher to that in control patients without a diagnosis of RBD?Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ., conditionsModule conditions: REM Sleep Behavior Disorder, conditions: Concussion, Brain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Exposure to contact sports or history of concussions, outcomesModule primaryOutcomes measure: Proportion of history of contact sports practice / concussion in RBD and control participants., secondaryOutcomes measure: Differences in concussions characteristics between RBD and control participants., secondaryOutcomes measure: Demographic or clinical differences between RBD participants with and without concussions history., eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guy's & St Thomas' NHS Foundation Trust, status: RECRUITING, city: London, zip: SE1 9RT, country: United Kingdom, contacts name: Gill Radcliffe, role: CONTACT, phone: 02071888070, email: gillian.radcliffe@gstt.nhs.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06270277, orgStudyIdInfo id: 30.01.2024-4272, briefTitle: Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-21, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Sisli Hamidiye Etfal Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Psychosocial Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Adolescents with Inflammatory bowel diseases and healthy control group in same age will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ)., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 159, type: ACTUAL, armsInterventionsModule interventions name: Pediatric Quality of Life Inventory (PedsQL), interventions name: Strengths and Difficulties Questionnaire (SDQ), outcomesModule primaryOutcomes measure: Pediatric Quality of Life Inventory (PedsQL) score, primaryOutcomes measure: Strengths and Difficulties Questionnaire (SDQ), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sisli Hamidiye Etfal Research and Training Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06270264, orgStudyIdInfo id: 111-2023, briefTitle: Nociception Monitoring in Intensive Care, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Haseki Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care., conditionsModule conditions: Unconscious State, conditions: Pressure Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, prospective and controlled, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: the Nociception level index monitoring, outcomesModule primaryOutcomes measure: total fentanyl consumption, secondaryOutcomes measure: systolic blood pressure, secondaryOutcomes measure: heart rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haseki Training and Research Hospital, city: Istanbul, state: Sultangazi, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06270251, orgStudyIdInfo id: PSYCH-2023-32292, briefTitle: Modeling Tic Change During Behavior Therapy for Tics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded., conditionsModule conditions: Chronic Tic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CBIT, outcomesModule primaryOutcomes measure: Tic Severity, primaryOutcomes measure: Sheehan Disability scale, primaryOutcomes measure: Behavior Rating Inventory of Executive Function, primaryOutcomes measure: Ask Suicide-Screening Questions (ASQ), primaryOutcomes measure: Child Attitudes Toward Illness Scale (CATIS), primaryOutcomes measure: Rosenberg Self-Esteem Scale, primaryOutcomes measure: Caregiver Strain Questionnaire, primaryOutcomes measure: Clinical Global Impressions (CGI), primaryOutcomes measure: Parent/Adult Tic Questionnaire, secondaryOutcomes measure: Premonitory Urge for Tics Scale, secondaryOutcomes measure: Tic Suppression Task, secondaryOutcomes measure: Stop signal task, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Brianna Wellen, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False

protocolSection identificationModule nctId: NCT06270238, orgStudyIdInfo id: 2023-11-164, briefTitle: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: National Research Foundation of Korea, collaborators name: Ministry of Food and Drug Safety, Korea, collaborators name: Seoul National University Hospital, collaborators name: Bucheon St. Mary's Hospital, collaborators name: Saint Vincent's Hospital, Korea, collaborators name: Severance Hospital, collaborators name: Kumoh National Institute of Technology, collaborators name: NEUROPHET, descriptionModule briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: High-Frequency1, interventions name: cTBS1, interventions name: High-Frequency2, interventions name: cTBS2, interventions name: High-Frequency3, interventions name: cTBS3, outcomesModule primaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score (FMA), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score (FMA), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score (FMA), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL), secondaryOutcomes measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL), secondaryOutcomes measure: Differences of Box and block test, secondaryOutcomes measure: Differences of Box and block test, secondaryOutcomes measure: Differences of Box and block test, secondaryOutcomes measure: Differences of Functional Ambulation Category (FAC), secondaryOutcomes measure: Differences of Functional Ambulation Category (FAC), secondaryOutcomes measure: Differences of Functional Ambulation Category (FAC), secondaryOutcomes measure: Differences of Action Research Arm Test (ARAT), secondaryOutcomes measure: Differences of Action Research Arm Test (ARAT), secondaryOutcomes measure: Differences of Action Research Arm Test (ARAT), secondaryOutcomes measure: Differences of Jebsen-Taylor hand function test, secondaryOutcomes measure: Differences of Jebsen-Taylor hand function test, secondaryOutcomes measure: Differences of Jebsen-Taylor hand function test, secondaryOutcomes measure: Differences of Hand grip strength test, secondaryOutcomes measure: Differences of Hand grip strength test, secondaryOutcomes measure: Differences of Hand grip strength test, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Won Hyuk Chang, PhD, role: CONTACT, phone: +82-2-3410-6068, email: wh.chang@samsung.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06270225, orgStudyIdInfo id: SSGJ-613-PGF-II-01, briefTitle: A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment., conditionsModule conditions: Gout Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg, interventions name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg, interventions name: Colchicine 0.5 mg, outcomesModule primaryOutcomes measure: Numbers of acute gout flares, secondaryOutcomes measure: Numbers of acute gout flares, secondaryOutcomes measure: Proportions of subjects with at least 1 acute gout flare, secondaryOutcomes measure: Proportions of subjects with at least 1 acute gout flare, secondaryOutcomes measure: Time from randomization to first acute flare., secondaryOutcomes measure: Duration of acute gout flares., secondaryOutcomes measure: Duration of acute gout flares., secondaryOutcomes measure: Subject's overall assessment of response to treatment, secondaryOutcomes measure: Investigator's overall assessment of response to treatment, secondaryOutcomes measure: 36-item Short Form Survey (SF-36), secondaryOutcomes measure: Adverse events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Huashan Hospital Fudan University-Rheumatology, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Hejian Zou, MD, role: CONTACT, phone: +86 13311881366, email: hjzou@fudan.edu.cn, contacts name: Hejian Zou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06270212, orgStudyIdInfo id: CIV-ID 23-08-043797, briefTitle: Medical Device for Airway Patency During Sedation, acronym: STAIRWAY-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Stairway Medical AB, class: INDUSTRY, collaborators name: Lund University, descriptionModule briefSummary: OVERALL SYNOPSISPART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants* of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position* of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position.PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration* of adjuvant manual airway support and ventilation* of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\])* of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and* of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients., conditionsModule conditions: Airway Obstruction, conditions: Sedation Complication, conditions: Perioperative Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective randomized unpaired, and paired crossover, evaluations of study outcome measures in healthy volunteer study participants (PART A), and prospective randomized unpaired evaluation of study outcome measures in study patients (PART B).The number of arms reported below (3) refers to unpaired comparisons (PARTS A-B)., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: For practical reasons, study participants, sedationists and study investigators on site cannot be masked to study interventions.However, procedural interventionists on site and study investigators scrutinizing study outcome data will be masked to study interventions.The number of enrolled study participants reported below (46) refers to evaluable ones., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: STAIRWAY, interventions name: NO DEVICE, outcomesModule primaryOutcomes measure: Transpharyngeal distance during moderate-to-deep steady-state sedation., primaryOutcomes measure: Duration of manual airway support during PS for clinical procedures., secondaryOutcomes measure: Transpharyngeal distance during mild steady-state sedation., secondaryOutcomes measure: Duration of interrupted capnometric monitoring during sedation., secondaryOutcomes measure: Duration of manual airway support during induction of steady-state sedation., secondaryOutcomes measure: Sedational comfort, secondaryOutcomes measure: Conditions for sedation, secondaryOutcomes measure: Conditions for procedural intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skåne University Hospital, status: RECRUITING, city: Malmö, state: Skåne, zip: 20502, country: Sweden, contacts name: Magnus Ljungvall, MD, role: CONTACT, phone: +46-705445502, email: magnus.ljungvall@med.lu.se, contacts name: Jonas Åkeson, PhD, Professor, role: CONTACT, phone: +46-708311113, email: jonas.akeson@med.lu.se, geoPoint lat: 55.60587, lon: 13.00073, hasResults: False

protocolSection identificationModule nctId: NCT06270199, orgStudyIdInfo id: PULMESCELL-2, briefTitle: Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal, class: OTHER, descriptionModule briefSummary: Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients., conditionsModule conditions: Bronchopulmonary Dysplasia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Group Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Control, interventions name: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions, interventions name: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions, outcomesModule primaryOutcomes measure: Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia, primaryOutcomes measure: feasibility variable, secondaryOutcomes measure: Incidence of BPD and PH in very low birth weight babies treated with MSC, secondaryOutcomes measure: Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen, secondaryOutcomes measure: Exitus on week 36 and 40 of post-menstrual age or at hospital discharge, secondaryOutcomes measure: Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death., secondaryOutcomes measure: Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs)., secondaryOutcomes measure: Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy., secondaryOutcomes measure: Changes in modified respirator score during therapy and up to week 36 of port-menstrual age, secondaryOutcomes measure: Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age, secondaryOutcomes measure: Date of hospital discharge and respiratory care at discharge., secondaryOutcomes measure: Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2)., secondaryOutcomes measure: Duration of invasive and non-invasive mechanical ventilation., secondaryOutcomes measure: Use of postnatal corticosteroids indicated, secondaryOutcomes measure: Respiratory readmission rates., secondaryOutcomes measure: Bayley Neurodevelopmental Scale at 24 months, secondaryOutcomes measure: Date and cause of death., eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 28 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Complejo Hospitalario La Coruña, status: RECRUITING, city: La Coruña, country: Spain, contacts name: Alejandro Dávila, role: CONTACT, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Clínico San Carlos, status: RECRUITING, city: Madrid, country: Spain, contacts name: Luis Arruza, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario La Paz, status: RECRUITING, city: Madrid, country: Spain, contacts name: Paloma Lopez, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Carlos Haya, status: RECRUITING, city: Málaga, country: Spain, contacts name: Tomás Sánchez Tamayo, role: CONTACT, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Hospital Vírgen del Rocío, status: RECRUITING, city: Sevilla, country: Spain, contacts name: Antonio Pavón Delgado, role: CONTACT, contacts name: María José Moreno Valera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Hospital Universitario y Politécnico La Fe, status: RECRUITING, city: Valencia, country: Spain, contacts name: Máximo Vento, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False

protocolSection identificationModule nctId: NCT06270186, orgStudyIdInfo id: 20-AOIP-04, briefTitle: Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach, acronym: GoodDiagNMD, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2023-11, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased muscle volume). It also affects eyes, heart, endocrine system, gastrointestinal system and central nervous system. Specific cognitive abilities are impaired in patients with MD1 such as attention, visio-spatial or visio-building abilities as well as executive dysfunctions.Currently, the cognitive assessment of MD1 patients is based on classical neuropsychological tests, which are time-consuming and require a MD1 expert neuropsychologist. Moreover, it is usually very difficult for MD1 patients to accept performing these tests, and when they agree to perform them, they usually give up before the end. This finding is more frequent in MD1 patients with high level of cognitive impairment.In order to overcome these difficulties in assessing cognitive functions of MD1 patients, the investigators decided to use innovative tools such as virtual reality, which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet, glasses and joysticks.The start-up My Cyber Royaume from Lille, in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi, have developed a software "Good Diag NMD" which uses virtual reality to assess cognitive disorders, more specifically executive functions in patients with type 1 myotonic dystrophy., conditionsModule conditions: Myotonic Dystrophy 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Type 1 myotonic dystrophy, outcomesModule primaryOutcomes measure: Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1, secondaryOutcomes measure: Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session, secondaryOutcomes measure: To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session, secondaryOutcomes measure: Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests, secondaryOutcomes measure: Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270173, orgStudyIdInfo id: TWM-C-2202, briefTitle: Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Wiltrom Co., Ltd., class: INDUSTRY, collaborators name: Maxis Medical GmbH, descriptionModule briefSummary: The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis., conditionsModule conditions: Osteoporotic Vertebral Compression Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix), outcomesModule primaryOutcomes measure: Proportion of participants with study success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinikum Friedrichshafen, status: NOT_YET_RECRUITING, city: Friedrichshafen, state: Baden-Württemberg, zip: 88048, country: Germany, contacts name: Ludwig Oberkircher, Prof Dr med, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.65689, lon: 9.47554, locations facility: University Hospital Mannheim, status: NOT_YET_RECRUITING, city: Mannheim, state: Baden-Württemberg, zip: 68167, country: Germany, contacts name: Frederic Bludau, PD Dr med, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Johann Wolfgang Goethe University Frankfurt/Main, status: NOT_YET_RECRUITING, city: Frankfurt am Main, state: Hesse, zip: 60596, country: Germany, contacts name: Thomas Vogl, Prof Dr med, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Krankenaus Mechernich, status: RECRUITING, city: Mechernich, state: North-Rhine-Westphalia, zip: 53894, country: Germany, contacts name: Robert Pflugmacher, Prof Dr med, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.59304, lon: 6.65224, hasResults: False

protocolSection identificationModule nctId: NCT06270160, orgStudyIdInfo id: KampalaLivelihoodsStudy, briefTitle: Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Toronto, class: OTHER, descriptionModule briefSummary: Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala., conditionsModule conditions: Financial Stress, conditions: Social Functioning, conditions: Social Skills, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey after the study is complete., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 432, type: ESTIMATED, armsInterventionsModule interventions name: HIVST, interventions name: mHealth, interventions name: Creating Futures Livelihoods program, outcomesModule primaryOutcomes measure: Number of participants engaged in HIV testing, secondaryOutcomes measure: Number of participants with knowledge of their HIV status, secondaryOutcomes measure: Number of participants linked to confirmatory HIV testing, secondaryOutcomes measure: Frequency of linkage to HIV care, secondaryOutcomes measure: Brief HIV Knowledge Questionnaire, secondaryOutcomes measure: Sexual Risk, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Young African Refugees for Integral Development, status: RECRUITING, city: Kampala, country: Uganda, contacts name: Robert Hakiza, role: CONTACT, phone: 256 2009 12345, email: roberthakiza2001@gmail.com, geoPoint lat: 0.31628, lon: 32.58219, hasResults: False

protocolSection identificationModule nctId: NCT06270147, orgStudyIdInfo id: 16935, briefTitle: Timing of TAP Blocks in Bariatric Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, descriptionModule briefSummary: This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs., conditionsModule conditions: Opioid Use, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine-epinephrine, outcomesModule primaryOutcomes measure: Opioid Consumption, secondaryOutcomes measure: Length of Stay, secondaryOutcomes measure: Anesthesia requirements, secondaryOutcomes measure: Sedation requirements, secondaryOutcomes measure: Nausea and vomiting, secondaryOutcomes measure: Respiratory Status, secondaryOutcomes measure: Opioid consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06270134, orgStudyIdInfo id: 14410, briefTitle: Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel., conditionsModule conditions: Hemolysis, conditions: Renal Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: Bicarbonate, outcomesModule primaryOutcomes measure: Non-elective hospitalizations or mortality, secondaryOutcomes measure: Hospitalizations and fractures, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270121, orgStudyIdInfo id: R2111483, briefTitle: Development of a Healthcare Service Platform for Successful Aging, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-21, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2030-11-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sunmi Song, class: OTHER, descriptionModule briefSummary: The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are:* Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults* Develop digital health monitoring service to inform individualized daily health status of older adults users* Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information.Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers.If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group., conditionsModule conditions: Depression in Old Age, conditions: Chronic Pain, conditions: Sleep Disorder Insomnia Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Control group was informed that they participated in the study with a repeated measure survey about digital healthcare for elderly without detailed descriptions on the living-lab intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Living-lab digital intervention group, outcomesModule primaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), primaryOutcomes measure: Sleep fragmentation index, primaryOutcomes measure: Daily steps, primaryOutcomes measure: Intensity of physical activity, primaryOutcomes measure: Heart rate variability, secondaryOutcomes measure: Geriatic depression, secondaryOutcomes measure: SF-12 Quality of life, secondaryOutcomes measure: Pain related functional limitations, secondaryOutcomes measure: Chronic pain, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Korea University, status: RECRUITING, city: Seoul, zip: 02841, country: Korea, Republic of, contacts name: Sunmi Song, PhD, role: CONTACT, phone: +821087489593, email: sunmi.song0715@gmail.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06270108, orgStudyIdInfo id: 22/SS/0040, secondaryIdInfos id: 299382, type: OTHER, domain: Integrated Research Application System, briefTitle: The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia, acronym: RESTORE, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: South London and Maudsley NHS Foundation Trust, descriptionModule briefSummary: The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology.The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia., conditionsModule conditions: Treatment-resistant Schizophrenia, conditions: Treatment-responsive Schizophrenia, conditions: Healthy Controls, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a basic science study the purpose of which is to to explore the responsivity of glutamate in treatment-resistant schizophrenia to a given challenge (riluzole)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Riluzole, outcomesModule primaryOutcomes measure: Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration, secondaryOutcomes measure: Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging), secondaryOutcomes measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging), secondaryOutcomes measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Psychiatry, Psychology and Neuroscience, status: RECRUITING, city: London, zip: SE5 8AB, country: United Kingdom, contacts name: James Scott, role: CONTACT, phone: +44 207 848 0002, email: james.1.scott@kcl.ac.uk, contacts name: Guy Gitlin-Leigh, role: CONTACT, email: guy.1.gitlin-leigh@kcl.ac.uk, contacts name: Oliver D Howes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06270095, orgStudyIdInfo id: C21-57, briefTitle: " Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft", acronym: AVISAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Institut National de la Santé Et de la Recherche Médicale, France, class: OTHER_GOV, collaborators name: Université Paris Cité, collaborators name: National Agency for Sanitary Safety of the Food of the Environment and Labor, descriptionModule briefSummary: The subject of the study focuses on commercial aircraft's cabins air quality, under conditions of both fume events and non-fume events. It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members. The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils. The epidemiological facet is geared towards the identification of potential neurological consequences., conditionsModule conditions: Neurologic Symptoms, conditions: Neurologic Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Neurocognitive, neuromuscular and neurosensitive tests., outcomesModule primaryOutcomes measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning, primaryOutcomes measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing, primaryOutcomes measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge, primaryOutcomes measure: Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies, primaryOutcomes measure: Neuromuscular test to evaluate muscle strength assessment, primaryOutcomes measure: Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight, secondaryOutcomes measure: Characteristics of plane and fume event and possible causes of fume event, secondaryOutcomes measure: Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 67 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270082, orgStudyIdInfo id: IK595-001, briefTitle: Study of IK-595 in RAS- or RAF-altered Advanced Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ikena Oncology, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit., conditionsModule conditions: Solid Tumor, Adult, conditions: Colorectal Cancer, conditions: Pancreatic Cancer, conditions: Malignant Melanoma, conditions: Ras (Kras or Nras) Gene Mutation, conditions: BRAF Gene Mutation, conditions: CRAF Gene Mutation, conditions: Non-Small Cell Lung Carcinoma, conditions: Thyroid Carcinoma, conditions: Gliomas, Malignant, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Dose Escalation: BOIN design Dose Expansion: 4 genetically/molecularly defined cohorts using Simon 2-stage adaptive design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: IK-595, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events, including treatment-related adverse events, and serious adverse events, primaryOutcomes measure: Dose Limiting Toxicities, primaryOutcomes measure: Treatment-Emergent Adverse Events, primaryOutcomes measure: Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595, secondaryOutcomes measure: Pharmacokinetics of IK-595: half-life (t1/2), secondaryOutcomes measure: Pharmacokinetics of IK-595: Area Under the Curve (AUC), secondaryOutcomes measure: Pharmacokinetics of IK-595: Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics of IK-595: Minimum Plasma Concentration (Cmin), secondaryOutcomes measure: To evaluate pERK fold change from baseline in paired tumor biopsies, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity: Median progression-free survival (PFS) of IK-595 as a single agent, otherOutcomes measure: Antitumor activity: Median overall survival (OS) of IK-595 as a single agent, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Midwest, status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, contacts name: Jacob Goldberg, BA, role: CONTACT, phone: 616-954-5554, email: jacob.goldberg@startmidwest.com, contacts name: Nehal J Lakhani, MD,PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.96336, lon: -85.66809, locations facility: University of Pittsburgh Medical Center- Hillman Cancer Center, status: NOT_YET_RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Jason Luke, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Sarah Cannon Research Institute, status: NOT_YET_RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, contacts name: Meredith McKean, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Next Oncology- San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Carmen Gonzalez, role: CONTACT, phone: 210-580-9521, email: cgonzalez@nextoncology.com, contacts name: Anthony W Tolcher, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Next Oncology- Virginia Cancer Specialists, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Blake Paterson, role: CONTACT, phone: 703-783-4505, email: mpoole@nextoncology.com, contacts name: Alexander Spira, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False

protocolSection identificationModule nctId: NCT06270069, orgStudyIdInfo id: 2024-001, briefTitle: Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: International Institute of Behavioral Medicines, class: OTHER, descriptionModule briefSummary: This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated., conditionsModule conditions: Low Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Excercise-based therapy, outcomesModule primaryOutcomes measure: NRS, primaryOutcomes measure: Gauge of pain, secondaryOutcomes measure: ODI, secondaryOutcomes measure: PCS, secondaryOutcomes measure: TSK, secondaryOutcomes measure: PSEQ, secondaryOutcomes measure: GPE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06270056, orgStudyIdInfo id: 1058, briefTitle: Evaluation of Telemedicine Medical Abortion Service in Ecuador, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Gynuity Health Projects, class: OTHER, descriptionModule briefSummary: This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant., conditionsModule conditions: Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Misoprostol, outcomesModule primaryOutcomes measure: Adverse events (safety), secondaryOutcomes measure: Feasibility of telemedicine service, secondaryOutcomes measure: Acceptability of telemedicine service, eligibilityModule sex: FEMALE, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: El Comité de Derechos Sexuales y Reproductivos de Ecuador (CODESER), city: Ambato, country: Ecuador, contacts name: Maria Fernanda Morales, role: CONTACT, phone: 593 998220369, email: mafer_moca@yahoo.es, geoPoint lat: -1.24908, lon: -78.61675, locations facility: Cemoplaf, city: Quito, country: Ecuador, contacts name: Gabriela Rivera, role: CONTACT, phone: 593 995512828, email: gabyrivera2398@hotmail.com, geoPoint lat: -0.22985, lon: -78.52495, locations facility: Federación Nacional de Obstetrices y Obstetras del Ecuador (FENOE), city: Quito, country: Ecuador, contacts name: Paola Tito, role: CONTACT, phone: 593 22951737, email: paojaime@hotmail.es, geoPoint lat: -0.22985, lon: -78.52495, hasResults: False

protocolSection identificationModule nctId: NCT06270043, orgStudyIdInfo id: 809622, briefTitle: Focal Therapy for Localized Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2034-02-01, completionDateStruct date: 2034-02-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Focal Therapy, outcomesModule primaryOutcomes measure: Oncological Response, secondaryOutcomes measure: Erectile Dysfunction, secondaryOutcomes measure: Incontinence, secondaryOutcomes measure: Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Diego, status: RECRUITING, city: La Jolla, state: California, zip: 92121, country: United States, contacts name: Juan Javier-DesLoges, MD, role: CONTACT, phone: 858-657-8786, email: jjavierdesloges@health.ucsd.edu, geoPoint lat: 32.84727, lon: -117.2742, hasResults: False

protocolSection identificationModule nctId: NCT06270030, orgStudyIdInfo id: JX07002, secondaryIdInfos id: CTR20240460, type: OTHER, domain: China Center for Drug Evaluation (CDE), NMPA, briefTitle: Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd., class: INDUSTRY, collaborators name: LENZ Therapeutics, Inc, descriptionModule briefSummary: Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia, conditionsModule conditions: Presbyopia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution, interventions name: LNZ100 (Aceclidine) ophthalmic solution, interventions name: Placebo (Vehicle) ophthalmic solution, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: Tmax, primaryOutcomes measure: AUC0-t, primaryOutcomes measure: AUC0-∞, primaryOutcomes measure: T1/2, primaryOutcomes measure: Safety: adverse event reporting, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai General Hospital, city: Shanghai, state: Shanghai, zip: 200080, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06270017, orgStudyIdInfo id: 282242, briefTitle: Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars, acronym: ZEBRA-COLON, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University Hospital, Linkoeping, class: OTHER, descriptionModule briefSummary: In order to improve and individualize cancer treatment personalized treatments developed much further. Colon cancer is treated with surgery and thereafter adjuvant oncological treatment. The selection of chemotherapy is today mainly done according to best guess. Today only a small fraction of oncological treatment may be known to be effective in a person before treatment start, most often it is trial and error. A fast reliable system for looking at response to different treatments in each unique patient is much needed and would, if successful, completely change the way we give oncological treatment today. This system would also be possible to use to evaluate new treatments and if successful, implement in the clinical setting. In this project we will implant a part of the patient's tumour tissue into a zebrafish embryo and evaluate tumour growth and frequency of metastatic disease as well as response to given oncological treatment.2.2 Objective: The objective of this project is to explore the usefulness of zebrafish (Danio Rerio) embryo models to determine tumor biology and treatment response in colon cancer. An overarching goal would be, before start of any oncological treatment in a patient, to have evaluated the response of oncological treatment in the zebrafish avatar and only treat with a combination of drugs known to have effect against the patient's own tumour.2.3 Study design: This protocol describes a series of prospective studies in different cohorts of patients with colon cancer to investigate the applicability of zebrafish embryo models. The common denominator of the sub-studies is prospective collection of tumor tissue implanted in zebrafish embryos in order to evaluate if the model is robust enough for growing colon cancer tissue and evaluate growth pattern and response to chemotherapy. This study protocol is designed according to and in adherence with the SPIRIT guidelines.2.4 Intervention: In all sub-studies the intervention is inoculation of tumor cells in zebrafish embryos followed by observation of tumor behavior and testing of treatments., conditionsModule conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Evaluation of patients derived colon cancer tumour cell growth in zebra fish embryos and response evaluation of combinations of chemotherpy, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Chemotherapy drug, outcomesModule primaryOutcomes measure: Tumour growth, secondaryOutcomes measure: response evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Per Sandström, status: RECRUITING, city: Linköping, state: Ostergotland, zip: 58185, country: Sweden, contacts name: Per Sandström, Prof, role: CONTACT, phone: +46734058581, email: per.sandstrom@liu.se, contacts name: Bergthor Bjornsson, MD PhD, role: CONTACT, phone: +46101033666, email: bergthor.bjornsson@liu.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False

protocolSection identificationModule nctId: NCT06270004, orgStudyIdInfo id: nonsurgical periodontal, briefTitle: Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Baghdad, class: OTHER, descriptionModule briefSummary: 1. To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .2. To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months), conditionsModule conditions: Non Surgical Periodontal Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: smoker and non smoker patients with unstable periodontitis, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: nonsurgical periodontal therapy, outcomesModule primaryOutcomes measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients., secondaryOutcomes measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients., secondaryOutcomes measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06269991, orgStudyIdInfo id: SBA23/083, briefTitle: Fascial Anthropometry in Archery Athletes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-06, completionDateStruct date: 2025-09-06, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: In archery, the body morphological and anthropometric characteristics of the prominent athletes change. It is important to examine facial anthropometry, especially since the athlete's equipment touches the facial area, and there are no studies on this subject. The aim of this study is to determine the relationship between facial anthropometric measurements and anthropometry-related parameters and sports performance in archery athletes., conditionsModule conditions: Sports Physical Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: evaluation of cervical region biomechanic, primaryOutcomes measure: fat tissue distribution, primaryOutcomes measure: head circumference, primaryOutcomes measure: extremity circumference, primaryOutcomes measure: extremity lengt measurement, primaryOutcomes measure: knee and elbow diameter, primaryOutcomes measure: nose width, primaryOutcomes measure: chin width, primaryOutcomes measure: face width, primaryOutcomes measure: head width, primaryOutcomes measure: nose protrusion, primaryOutcomes measure: nose lenght, primaryOutcomes measure: head lenght, primaryOutcomes measure: face lenght, primaryOutcomes measure: lip lenght, secondaryOutcomes measure: Assessment of Perıpheral Muscle Strength, secondaryOutcomes measure: postural analysis, secondaryOutcomes measure: Evaluation of shooting performance, secondaryOutcomes measure: The seated medicine ball throw (SMBT), secondaryOutcomes measure: Closed Kinetic Chain Upper Extremity Stability Test, secondaryOutcomes measure: Upper Quarter Y Balance Test, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, zip: 06100, country: Turkey, contacts name: Aynur Demirel, role: CONTACT, phone: +905545295057, phoneExt: 178, email: aynur.demirel@hacettepe.edu.tr, contacts name: Nisanur Kutay, role: CONTACT, phone: +905515549957, email: kutaynisanur@gmail.com, contacts name: Nisanur Kutay, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06269978, orgStudyIdInfo id: OSU-23195, secondaryIdInfos id: NCI-2023-10497, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: R21CA282536, type: NIH, link: https://reporter.nih.gov/quickSearch/R21CA282536, briefTitle: Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Arjun Mittra, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer., conditionsModule conditions: Metastatic Colorectal Carcinoma, conditions: Metastatic Malignant Neoplasm in the Peritoneum, conditions: Stage IV Colorectal Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Diagnostic Laparoscopy, interventions name: Fluorouracil, interventions name: Magnetic Resonance Imaging, interventions name: Oxaliplatin, interventions name: Surgical Procedure, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: Area under the curve, primaryOutcomes measure: Clearance, primaryOutcomes measure: Volume of distribution, primaryOutcomes measure: Half-life, secondaryOutcomes measure: Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin, secondaryOutcomes measure: Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin, secondaryOutcomes measure: Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin, secondaryOutcomes measure: Rate of conversion from unresectable to resectable, secondaryOutcomes measure: Overall response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Arjun Mittra, MD, role: CONTACT, phone: 614-293-6529, contacts name: Arjun Mittra, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False

protocolSection identificationModule nctId: NCT06269965, orgStudyIdInfo id: 2023-A02181-44, briefTitle: Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair, acronym: REGENECUFF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream.Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired.Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing., conditionsModule conditions: Cuff Rotator Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: Regeneten® adding, outcomesModule primaryOutcomes measure: Rotator cuff healing quality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06269952, orgStudyIdInfo id: MVarmafalk, briefTitle: Intimate Partner Violence Among People Who Inject Drugs - Prevalence, Risk Factors and Experiences, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, descriptionModule briefSummary: There are around 15,6 million people who inject drugs (PWID) worldwide, of which around 3,5 million are women who inject drugs (WWID) (1). In Sweden, estimates suggest 8000-21000 PWID (2). PWID are exposed to substantial health risks that are directly linked to injection drug use, such as blood borne viruses (hepatitis and HIV), overdoses and skin and tissue infections. Additionally psychiatric disorders are common and PWID's general health is often neglected (3,4,5).In Sweden, harm reduction units such as needle and syringe programs (NSP) have scaled-up in recent years. In Stockholm the first NSP opened in 2013 and the second in 2018. In 2022, 4600 individuals were enrolled in the program since it opened, of which approximately 25% were women. Around 2000 were active participants, defined as having visited the program at least once during the last 12 months. In 2021 54% of the participants stated amphetamine as the last drug injected, 31% heroin, 4% buprenorphine and 11% other drugs. Most participants were between 30-49 years of age. In addition to distribution of sterile needles and injection paraphernalia, the NSP staff (nurses, doctors, midwifes, counselors) provides services such as testing for blood borne viruses, vaccinations, wound care, take-home naloxone, reproductive health services, counselling, support in contact with social service and referrals for substance use disorder treatment and hepatitis C/HIV treatment.Gender-based violence (GBV) is a global health issue and WHO estimates that one in three women globally have been exposed to some sort of partner violence during their lifespan (7). Intimate partner violence (IPV) is defined as violent behavior between two people who have a close relationship, such as partners, ex-partners, siblings, relatives, friends and alike. In Sweden around 14% of women and 5% of men are exposed to physical violence in an intimate partner relationship during their lifespan however 20-25% of women and around 17% of men are exposed to psychological violence during their lifespan (8; 9). The prevalence of IPV among PWID is estimated to be significantly higher than in the general population (10). A study from USA found the risk of IPV to be three times higher and the prevalence estimated between 35-57% (7). In international studies, IPV exposure is found to be a significant risk factor for needle sharing among WWID (11, 12). There are other well-known consequences of IPV including impact on sexual and reproductive health rights, physical and psychological wellbeing, increased risk of contracting HIV and hepatitis C (13; 14). IPV exposure disproportionately affects WWID worldwide, however studies in Sweden on IPV exposure in the PWID population is scarce. To date there are studies that address this among women with substance use disorders but none with an exclusive focus on PWID or WWID. In clinical research of women diagnosed with substance use disorders (SUD) with psychiatric comorbidities and social challenges, one study indicates that the majority (91%, n=79) of women had been exposed to some form of IPV (15). Another study of women with SUD (n=52), 50% reported exposure of serious violence and the majority (96%) reported exposure to psychological violence (10). There are different types of IPV; psychological, physical, sexual, financial, latent, digital, neglect, honor related, aftermath of IPV (16). Our research team has previously carried out a qualitative interview study among WWID at the Stockholm NSP in 2019 to investigate reasons and barriers for participation among women (17). The interviews illustrated that IPV is common. In the proposed studies, for this doctoral thesis, we have chosen to focus on physical, sexual, psychological and financial violence among PWID motivated by findings in our previous research.PWID and specifically WWID are regarded as groups who are especially vulnerable for IPV exposure and should therefore be prioritized in the national efforts to prevent IPV (15). However, there are no studies estimating the prevalence and frequency of IPV among PWID in Sweden. Previous international studies suggest that PWID are exposed to IPV to a greater extent than the general population, and women with substance use disorders are exposed to an alarming degree of violence (15). In Sweden there are no tailored interventions for PWID or WWID who are exposed to IPV, it is reasonable to believe that there is a need for a multi-faceted program for PWID exposed to IPV, however this is still unexplored.The overall aim of this project is to increase knowledge about IPV among PWID and WWID as particularly vulnerable groups in regards to IPV. More specifically, the aim is to investigate the prevalence and frequency of different types of IPV among PWID at the Stockholm NSP and to explore the experiences' of IPV, needs and preferences for IPV support among WWID to facilitate tailored support and prevention programs for those exposed., conditionsModule conditions: People Who Inject Drugs, Injection Risk Behaviour, Gender-based Violence, Intimate Partner Violence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Intimate partner violence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Needle syringe program, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Malin Värmå Falk, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False

protocolSection identificationModule nctId: NCT06269939, orgStudyIdInfo id: R-1253-24, briefTitle: Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Kessler Foundation, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in an aging population., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: STEM, outcomesModule primaryOutcomes measure: Verbal Leaning task, primaryOutcomes measure: Participation in Everyday life, secondaryOutcomes measure: Functional Neuroimaging, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kessler Foundation, city: East Hanover, state: New Jersey, zip: 07936, country: United States, contacts name: Samantha Schmidt, role: CONTACT, phone: 973-323-3686, email: sschmidt@kesslerfoundation.org, geoPoint lat: 40.8201, lon: -74.36487, hasResults: False

protocolSection identificationModule nctId: NCT06269926, orgStudyIdInfo id: IRB00431182, briefTitle: Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc., class: OTHER, collaborators name: Johns Hopkins University, descriptionModule briefSummary: The purpose of this study is to understand if cognitive behavioral therapy can improve pain-related thought patterns and pain-related impairment in adults with cerebral palsy., conditionsModule conditions: Cerebral Palsy, conditions: Pain, Chronic, conditions: Pain Catastrophizing, conditions: Brain Diseases, conditions: Central Nervous System Diseases, conditions: Coping Strategies, conditions: Catastrophizing Pain, conditions: Coping Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The investigators will randomize 40 adults with cerebral palsy and pain-related impairment in daily activities into two study arms: Group 1 (Education-CBT) will receive enhanced usual care (a pain education booklet in addition to usual medical care) followed by Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a once weekly, 12-week group therapy course). Group 2 (CBT-Education) will instead receive CBT-CP first. To maintain reasonable therapy cohort sizes (n=10 per cohort), each group (n=20 participants) will consist of two separate therapy cohorts (n=10 each). Participants will be evaluated at the beginning of the study, and then once every 3 months during the 12-month duration of the study., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Chronic Pain, interventions name: Pain education, outcomesModule primaryOutcomes measure: Pain Catastrophizing, secondaryOutcomes measure: Global Impressions of Change, secondaryOutcomes measure: Pain Interference, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Anxiety/Mood symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kennedy Krieger Institute, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Paul Salib, B.S, role: CONTACT, phone: 443-923-9272, email: salib@kennedykrieger.org, contacts name: Eric Chin, M.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Paul Salib, B.S, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False

protocolSection identificationModule nctId: NCT06269913, orgStudyIdInfo id: 23-0826, briefTitle: A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Mitacs, collaborators name: Natural Sciences and Engineering Research Council, Canada, descriptionModule briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females., conditionsModule conditions: Iron Deficiencies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FeSC, outcomesModule primaryOutcomes measure: Iron Status, primaryOutcomes measure: Hemoglobin, primaryOutcomes measure: Upper Gut Microbiome, primaryOutcomes measure: Lower Gut microbiome, secondaryOutcomes measure: Exercise Capacity, secondaryOutcomes measure: Hemoglobin Mass, secondaryOutcomes measure: Gastrointestinal Symptoms 1, otherOutcomes measure: Gastrointestinal Symptoms 2, otherOutcomes measure: Sleepiness, otherOutcomes measure: Stress and Recovery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06269900, orgStudyIdInfo id: RC23_0358, briefTitle: Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, acronym: HAP-DEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-08-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial., conditionsModule conditions: Hospital Acquired Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Clinical cure rate at the test-of-cure visit (TOC visit), primaryOutcomes measure: The rate of all-cause mortality on Day 28., secondaryOutcomes measure: Rate of death, secondaryOutcomes measure: Rate of pleural empyema at Day 28., secondaryOutcomes measure: Rate of microbiological failure, secondaryOutcomes measure: Rate of pneumonia relapse, secondaryOutcomes measure: Duration of hospitalization and hospital-free days, secondaryOutcomes measure: Rates of non-respiratory hospital-acquired infection, secondaryOutcomes measure: Antibiotic-free days at Day 28, secondaryOutcomes measure: Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days, secondaryOutcomes measure: Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event), secondaryOutcomes measure: Rate of gastric ulcer, secondaryOutcomes measure: Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Changes in subjective well-being with the Satisfaction With Life Scale (SWLS), secondaryOutcomes measure: Changes in health-related quality of life measured with the Short Form (SF)-36, secondaryOutcomes measure: the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Angers, city: Angers, country: France, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Brest, city: Brest, country: France, contacts name: Xavier CHAPALAIN, role: CONTACT, email: xavier.chapalain@chu-brest.fr, geoPoint lat: 48.3903, lon: -4.48628, locations facility: CHU Caen, city: Caen, country: France, contacts name: Clément GAKUBA, role: CONTACT, email: gakuba-c@chu-caen.fr, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CHU Clermont - Ferrand, city: Clermont-Ferrand, country: France, contacts name: Russell CHABANNE, role: CONTACT, email: rchabanne@chu-clermontferrand.fr, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU Clermont-Ferrand, city: Clermont-Ferrand, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU Clermont-Ferrand, city: Clermont-Ferrand, country: France, contacts name: Pierre COUHAULT, role: CONTACT, email: couhault@chu-clermontferrand.fr, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU Beaujon, city: Clichy, country: France, contacts name: Emmanuel WEISS, role: CONTACT, email: emmanuel.weiss@aphp.fr, geoPoint lat: 48.90018, lon: 2.30952, locations facility: CHU Limoges, city: Limoges, country: France, contacts name: Bruno FRANCOIS, role: CONTACT, email: bruno.francois@chu-limoges.fr, geoPoint lat: 45.83153, lon: 1.25781, locations facility: CHU Marseille, city: Marseille, country: France, contacts name: Marc LEONE, role: CONTACT, email: marc.leone@ap-hm.fr, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Nancy, city: Nancy, country: France, contacts name: Gérard AUDIBERT, role: CONTACT, email: g.audibert@chru-nancy.fr, geoPoint lat: 48.68439, lon: 6.18496, locations facility: CHU Nantes (HGRL), city: Nantes, zip: 44000, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Nantes, city: Nantes, zip: 44000, country: France, contacts name: Antoine ROQUILLY, role: CONTACT, phone: +33253482835, email: antoine.roquilly@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Nantes (HGRL), city: Nantes, country: France, contacts name: Mickael VOURC'H, role: CONTACT, email: mickael.vourch@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Pitié Salpétrière, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Poitiers, city: Poitiers, country: France, contacts name: Claire DAHYOT FIZELIER, role: CONTACT, email: claire.dahyot-fizelier@chu-poitiers.fr, geoPoint lat: 46.58333, lon: 0.33333, locations facility: CHU Rennes, city: Rennes, country: France, contacts name: Yoann LAUNEY, role: CONTACT, email: yoann.launey@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU Rennes, city: Rennes, country: France, contacts name: Jean-Marc TADIE, role: CONTACT, email: jeanmarc.tadie@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, hasResults: False

protocolSection identificationModule nctId: NCT06269887, orgStudyIdInfo id: Karabuk-001, briefTitle: Dominant Non-Dominant Upper Extremity in Gender, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-07, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Karabuk University, class: OTHER, descriptionModule briefSummary: There are strength and functional differences between non-dominant and dominant extremities. This is important in the hand and extremity rehabilitation process. This situation also differs between genders. Comparison of the dominant and non-dominant limb can provide important clinical or rehabilitation field-related information. It is reported in the literature that manual dexterity, grip strength and joint position sense may differ between extremities. However, the relationship between this situation and the difference between genders has not been explained. It is thought that examining this difference can be extremely useful in determining achievable goals in hand rehabilitation and in customizing care for different groups., conditionsModule conditions: Upper Extremity Problem, conditions: Gender Issues, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Hand Preference, primaryOutcomes measure: Grip Strength, primaryOutcomes measure: Joint Position Sense, primaryOutcomes measure: Manual Dexterity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Karabük University, status: RECRUITING, city: Karabük, zip: 78000, country: Turkey, contacts name: Metehan YANA Phd, role: CONTACT, phone: 05072665522, email: metehanyana@karabuk.edu.tr, geoPoint lat: 41.20488, lon: 32.62768, hasResults: False

protocolSection identificationModule nctId: NCT06269874, orgStudyIdInfo id: ASPERA-ANOCA, secondaryIdInfos id: 20240124, type: OTHER, domain: JohannesGU, briefTitle: Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment, acronym: ASPERA-ANOCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Johannes Gutenberg University Mainz, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.Goals of this study are:1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).3. Time required for IMR measurements, conditionsModule conditions: Microvascular Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE)., primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, maskingDescription: Patients and outcome assessors will be blinded to the randomization group., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: microvascular function assessment, outcomesModule primaryOutcomes measure: Agreement between intravenous and intracoronary adenosine responses (IMR), secondaryOutcomes measure: Agreement between secondary parameters and reproducibility as compared with absolute, secondaryOutcomes measure: Time required for IMR measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of Cardiology, Cardiology I, university hospital Mainz, city: Mainz, state: Rheinland-Pfalz, zip: 55131, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, hasResults: False

protocolSection identificationModule nctId: NCT06269861, orgStudyIdInfo id: GaziUtipNBDundar003, briefTitle: Comparison of Body Weights Via Visual Estimation, Anthropometric Calculation, and Actual Measured in Critically Ill Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: Rapid and accurate determination of body weight in adult intensive care patients is very important for both calculating target tidal volume during invasive mechanical ventilation support and dose dependent drug administration. In this patient group, measuring actual body weight with a calibrated scale by standing the patient up is often impossible due to acute illness. Instead, estimated body weight determined by health care personnel or estimated body weights calculated according to anthropometric measurements are used. These calculations have some limitations in showing actual body weight, and there is some controversial information in current literature regarding their validity in critically ill patients. There is newly developed patient transfer scale called Marsden M-999® manufactured by Marsden Weighing Machine Group Ltd, which has the advantage of being used in patients who are unable to stand up, in rapidly and accurately measuring the current body weight in critically ill patients. This study aimed to evaluate the validity of these methods by comparing the body weights calculated by visual estimation and various anthropometric methods in critically ill Turkish patients with the actual weight measured by the mentioned scale., conditionsModule conditions: Critically Ill, conditions: Body Weight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, maskingDescription: To avoid self-calibration, all measurements will be recorded by a different doctor other than the primary care physician.The all calculations will be performed by a different doctor other than the primary care physician., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: patient transfer scale, outcomesModule primaryOutcomes measure: determining actual weight, primaryOutcomes measure: determining the ideal estimated body weight in critically ill patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gazi University, status: RECRUITING, city: Ankara, state: Yenimahalle, zip: 06560, country: Turkey, contacts name: Nazlıhan Boyacı Dündar, assist.prof., role: CONTACT, phone: +905054790794, email: nazlihan_boyaci@yahoo.com, contacts name: Kamil İnci, assist.prof., role: CONTACT, phone: +905442122545, email: kamilinci@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06269848, orgStudyIdInfo id: ITaDeBo, briefTitle: Identification of Sports Talents in Boxers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-03-11, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Dynamical Business and Science Society - DBSS International SAS, class: NETWORK, descriptionModule briefSummary: This study aims to identify sporting talents by profiling a group of young boxers residing in the State of Mexico using unsupervised machine learning methods. This study is supported by Asociación de Boxeo del Estado de México AC (ABEM) and powered by DBSS., conditionsModule conditions: Body Composition, conditions: Exercise Test, conditions: Psychological Well-Being, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 178, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Anthropometry-Based Analysis of Adiposity, primaryOutcomes measure: The acceleration of the fists in straight boxing punches, primaryOutcomes measure: Number of punches thrown within a specific timeframe, primaryOutcomes measure: Punch impact force, primaryOutcomes measure: Reactive force index, primaryOutcomes measure: Cardiorespiratory fitness, primaryOutcomes measure: Isometric Mid-Thigh Pull, primaryOutcomes measure: Load-velocity profile, secondaryOutcomes measure: Well-being profile, secondaryOutcomes measure: Ways of Coping Questionnaire, secondaryOutcomes measure: Attention and Perceptual Processes, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Centro Ceremonial Otomí, city: México, zip: 50868, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, hasResults: False

protocolSection identificationModule nctId: NCT06269835, orgStudyIdInfo id: NAOTAN-IOE, briefTitle: Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: systemic therapy, interventions name: Intermittent Oro-Esophageal Tube Feeding, interventions name: Persistent Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: The Oral Motor Assessment Scale, secondaryOutcomes measure: Pneumonia, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Total Protein, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: Prealbumin, secondaryOutcomes measure: body weight, secondaryOutcomes measure: upper arm circumference, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale for Infants, secondaryOutcomes measure: Feeding amount, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Center Rehabilitation Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Wei Liu, Master, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06269822, orgStudyIdInfo id: SSR, HRV, QEEG in TLE, briefTitle: Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-11-25, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques.Moreover, it aimed at finding any correlation between electrophysiological tests and SUDEP risk., conditionsModule conditions: Temporal Lobe Epilepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Sympathetic skin response, heart rate variability test, quantitative EEG, outcomesModule primaryOutcomes measure: Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy, primaryOutcomes measure: Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy, secondaryOutcomes measure: Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Neurophysiology unit- Kasr alainy-Cairo University, city: Cairo, state: Cairo Governorate, zip: Cairo, Egypt, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06269809, orgStudyIdInfo id: s67279, briefTitle: Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial, acronym: TACROM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-04, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Amsterdam UMC, location VUmc, collaborators name: Bichat Hospital, collaborators name: Rennes University Hospital, descriptionModule briefSummary: This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time., conditionsModule conditions: Fibroid Uterus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric non-blinded randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Temporary clipping of the uterine arteries and the utero-ovarian ligmants., interventions name: No temporary clipping of the uterine arteries and the utero-ovarian ligmants., outcomesModule primaryOutcomes measure: Peri-operative blood loss: Estimated blood loss, primaryOutcomes measure: Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL, primaryOutcomes measure: Peri-operative blood loss: Need for peri-operative blood transfusion, secondaryOutcomes measure: Hospitalisation time, secondaryOutcomes measure: Operation time in minutes, secondaryOutcomes measure: Number of patients with complications postoperatively, graded by Clavien Dindo classification, secondaryOutcomes measure: Number of patients requiring secondary hemostatic measures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Wouter Froyman, MD, PhD, role: CONTACT, phone: +3216342612, email: wouter.froyman@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, locations facility: Department of Gynecology and Obstetrics, Hopital Bichat, status: NOT_YET_RECRUITING, city: Paris, country: France, contacts name: Martin Koskas, MD, PhD, role: CONTACT, email: martin.koskas@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service de gynécologie, Centre Hospitalier Universitaire de Rennes, status: NOT_YET_RECRUITING, city: Rennes, country: France, contacts name: Vincent Lavoué, MD, PhD, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Amsterdam UMC, locatie VUmc, status: NOT_YET_RECRUITING, city: Amsterdam, country: Netherlands, contacts name: Robert De Leeuw, MD, PhD, role: CONTACT, email: r.a.deleeuw@amsterdamumc.nl, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False

protocolSection identificationModule nctId: NCT06269796, orgStudyIdInfo id: little-dcdq, briefTitle: Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-01, primaryCompletionDateStruct date: 2021-07-31, completionDateStruct date: 2021-09-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment., conditionsModule conditions: Motor Skills Disorders, conditions: Child Development, conditions: Child, Preschool, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 424, type: ACTUAL, armsInterventionsModule interventions name: Little Developmental Coordination Disorder Questionnaire (LDCDQ), interventions name: Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2), outcomesModule primaryOutcomes measure: Parent Screening Questionnaire for Motor Coordination Difficulties (DCD), primaryOutcomes measure: Screening Test for Detection of Developmental Coordination Disorder (DCD), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Human Performance & Rehabilitation Laboratory, Department of Physiotherapy, University of Thessaly, city: Lamía, state: Pthiotis, zip: 35100, country: Greece, geoPoint lat: 38.9, lon: 22.43333, hasResults: False

protocolSection identificationModule nctId: NCT06269783, orgStudyIdInfo id: STUDY00022968, briefTitle: Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Penn State University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period., conditionsModule conditions: Kidney Stone, conditions: Urolithiasis, conditions: Nephrolithiasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 155, type: ESTIMATED, armsInterventionsModule interventions name: sipIT, outcomesModule primaryOutcomes measure: Urine volume (intervention), secondaryOutcomes measure: Urine volume (maintenance), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Pennsylvania State University, status: RECRUITING, city: University Park, state: Pennsylvania, zip: 16802, country: United States, contacts name: Shiyu Li, PhD, role: CONTACT, email: shiyu.li@psu.edu, geoPoint lat: 40.80201, lon: -77.85639, hasResults: False

protocolSection identificationModule nctId: NCT06269770, orgStudyIdInfo id: Tapentadol, briefTitle: Tapentadol vs Tramadol in Total Knee Arthroplasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR)., conditionsModule conditions: Total Knee Replacement, conditions: Post-operative Pain, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Tapentadol, interventions name: Tramadol, outcomesModule primaryOutcomes measure: Post-operative pain, primaryOutcomes measure: Post-operative pain, primaryOutcomes measure: Post-operative pain, primaryOutcomes measure: Post-operative pain, primaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: Neuropathic pain, secondaryOutcomes measure: Quality of life postoperatively, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Function, secondaryOutcomes measure: Outcome, secondaryOutcomes measure: Arthritis impact, secondaryOutcomes measure: Health Status, secondaryOutcomes measure: Pain severity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Of Larissa, status: RECRUITING, city: Larissa, state: Thessaly, zip: 41110, country: Greece, geoPoint lat: 39.63689, lon: 22.41761, hasResults: False

protocolSection identificationModule nctId: NCT06269757, orgStudyIdInfo id: 23-01514, briefTitle: Exercise Program for ITB Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes., conditionsModule conditions: Iliotibial Band Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Individualized Exercise Program, interventions name: Standard Physical Therapy, outcomesModule primaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score, primaryOutcomes measure: Visual Analogue Scale (VAS) Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06269744, orgStudyIdInfo id: 23-01032, briefTitle: Proactive Outreach With FIT, acronym: PROOF, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Proactive Screening Outreach, outcomesModule primaryOutcomes measure: Proportion of Participants who Complete FIT Test by Month 6, secondaryOutcomes measure: Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: Brooklyn, state: New York, zip: 11203, country: United States, geoPoint lat: 40.6501, lon: -73.94958, locations facility: Community Health Care Network of New York, city: Brooklyn, state: New York, zip: 11206, country: United States, geoPoint lat: 40.6501, lon: -73.94958, hasResults: False

protocolSection identificationModule nctId: NCT06269731, orgStudyIdInfo id: Thyroid cancer, briefTitle: Anxiety & Depression in Thyroid Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. To identify the prevalence of both anxiety and depression in thyroid cancer patients2. To assess quality of life in thyroid cancer patients, conditionsModule conditions: Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 159, type: ESTIMATED, armsInterventionsModule interventions name: Hamilton depression Rating Scale, outcomesModule primaryOutcomes measure: the prevalence of anxiety in thyroid cancer patients, primaryOutcomes measure: the prevalence of depression in thyroid cancer patients, secondaryOutcomes measure: assess quality of life in thyroid cancer patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06269718, orgStudyIdInfo id: CMRPG8N0471, briefTitle: The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: The aims of this study are:1. Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function2. To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.3. To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: swallowing therapy, interventions name: IOPI therapy, outcomesModule primaryOutcomes measure: the change from baseline to time of swallowing muscle strength, primaryOutcomes measure: the change from baseline to time of Masster thickness, primaryOutcomes measure: the change from baseline to time of tongue muscles thickness, secondaryOutcomes measure: the change from baseline to time of general muscle mass, secondaryOutcomes measure: Measure the change in grip strength (by Jamar hand dynamometer), secondaryOutcomes measure: the change from baseline to time of swallowing functions, secondaryOutcomes measure: the change from baseline to time of clinical nutrition status, secondaryOutcomes measure: the change from baseline to time of swallowing functions 100 ml water test, secondaryOutcomes measure: the change from baseline to time of quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ChangGungMH, status: RECRUITING, city: Kaohsiung, zip: 833, country: Taiwan, contacts name: Yuchi Huang, MD, role: CONTACT, phone: 886-7-7317123, phoneExt: 6286, email: hyuchi@gmail.com, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False

protocolSection identificationModule nctId: NCT06269705, orgStudyIdInfo id: 006-C-301, briefTitle: ZILRETTA in Subjects With Glenohumeral Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Pacira Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placeboSecondary Objective:* To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo* To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR, conditionsModule conditions: Glenohumeral Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Only unblinded team (pharmacist, unblinded coordinator, drug administrator) will know the treatment assignment. A site-specific blinding plan will be developed to ensure blinding. Unblinded team will only interact with the subject at treatment and will not have any blinded roles on the study (only exception- informed consent). The subject and the assessor responsible for assessments/safety monitoring will be blinded. Site and Sponsor personnel/representatives will be blinded, with the following Sponsor/representative exceptions: unblinded monitors for performing drug accountability, unblinded clinical manager for reviewing unblinded monitoring visit reports and escalation of site unblinded issues, inventory manager for addressing product-related issues, and regulatory personnel for safety reporting. Information regarding treatment assignments will be kept securely at Sponsor., whoMasked: INVESTIGATOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ZILRETTA, interventions name: TCA-IR, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to TCA-IR, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 18 for ZILRETTA relative to TCA-IR, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 2 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 4 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 8 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to TCA-IR, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alabama Orthopaedic Center- Research, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35243, country: United States, contacts name: Robert Sorrell, MD, role: CONTACT, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False

protocolSection identificationModule nctId: NCT06269692, orgStudyIdInfo id: 2023-A01353-42, briefTitle: MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators, acronym: SMART-DEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2030-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients., conditionsModule conditions: Myocardial Infarction, conditions: Ventricular Tachycardia, conditions: Ventricular Fibrillation, conditions: Sudden Cardiac Death, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1812, type: ESTIMATED, armsInterventionsModule interventions name: MRI screening, interventions name: Implantable Loop Recorder, interventions name: Implantable Cardioverter Defibrillator, outcomesModule primaryOutcomes measure: Occurrence of Sudden Cardiac Death (SCD) during the follow-up period, secondaryOutcomes measure: Total number of deaths during the follow-up period, secondaryOutcomes measure: Total number of deaths from cardiovascular cause during the follow-up period, secondaryOutcomes measure: Total number of SCD due to ventricular arrhythmia during the follow-up period, secondaryOutcomes measure: Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period, secondaryOutcomes measure: Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period, secondaryOutcomes measure: Total number of hospitalizations due to cardiovascular causes during the follow-up period, secondaryOutcomes measure: Duration of hospitalizations due to cardiovascular causes during the follow-up period, secondaryOutcomes measure: Total number of hospitalizations from any cause during the follow-up period, secondaryOutcomes measure: Duration of hospitalizations from any cause during the follow-up period, secondaryOutcomes measure: Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period, secondaryOutcomes measure: Measurements of the estimated costs, secondaryOutcomes measure: Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences, secondaryOutcomes measure: Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences, secondaryOutcomes measure: Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar, secondaryOutcomes measure: Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU Nancy, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, contacts name: Christian de CHILLOU, MD, PhD, role: CONTACT, email: c.dechillou@chru-nancy.fr, contacts name: Guillaume DROUOT, PhD, role: CONTACT, email: g.drouot@chru-nancy.fr, geoPoint lat: 48.65, lon: 6.18333, hasResults: False

protocolSection identificationModule nctId: NCT06269679, orgStudyIdInfo id: RC23_0336, briefTitle: CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis., acronym: 3D STARS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: 1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes., conditionsModule conditions: Infective Endocarditis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: CBCT, outcomesModule primaryOutcomes measure: Superiority of CBCT, primaryOutcomes measure: Superiority of CBCT, primaryOutcomes measure: Superiority of CBCT, secondaryOutcomes measure: Diagnostic at inclusion, secondaryOutcomes measure: Incident symptomatic OIF, secondaryOutcomes measure: Incident asymptomatic OIF, secondaryOutcomes measure: Oral hygiene, secondaryOutcomes measure: Follow-up habits, secondaryOutcomes measure: Follow-up habits, secondaryOutcomes measure: Oral health quality of life, secondaryOutcomes measure: Premature end of study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Bordeaux - Site Pellegrin, city: Bordeaux, country: France, contacts name: Elise ARRIVE, role: CONTACT, phone: +33/5 56 79 56 79, email: elise.arrive@u-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Grenoble, city: Grenoble, country: France, contacts name: Cécile CHATEL, role: CONTACT, phone: +33/4 76 76 50 26, email: cchatel1@chu-grenoble.fr, geoPoint lat: 45.16667, lon: 5.71667, locations facility: CHRU Nancy, city: Nancy, country: France, contacts name: Vanessa MOBY, role: CONTACT, phone: +33/3 83 39 18 00, email: vanessa.moby@univ-lorraine.fr, geoPoint lat: 48.68439, lon: 6.18496, locations facility: CHU Nantes, city: Nantes, country: France, contacts name: Philippe LESCLOUS, role: CONTACT, phone: +33/2.40.41.29.40, email: philippe.lesclous@chu-nantes.fr, contacts name: Astrid GARREAU, role: CONTACT, email: astrid.garreau@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: AP-HP - Site Bretonneau, city: Paris, country: France, contacts name: MESSECA Clément, role: CONTACT, phone: +33/1 53 11 18 00, email: clement.messeca@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Toulouse, city: Toulouse, country: France, contacts name: Sarah COUSTY, role: CONTACT, phone: +33/5.61.32.20.30, email: cousty.s@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CHRU Tours, city: Tours, country: France, contacts name: Frédéric DENIS, role: CONTACT, phone: +33/2 47 47 47 47, email: frederic.denis@univ-tours.fr, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False

protocolSection identificationModule nctId: NCT06269666, orgStudyIdInfo id: OPT1100, briefTitle: P200TxE Diseased Eye Image Collection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Optos, PLC, class: INDUSTRY, descriptionModule briefSummary: The primary objective is to collect images on the P200TxE device in diseased eyes., conditionsModule conditions: Retinal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: P200TxE, outcomesModule primaryOutcomes measure: Number of images, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bennett and Bloom Eye Centers, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40215, country: United States, contacts name: Megan Kingdon, role: CONTACT, phone: 513-305-8654, email: megankingdon@eyecare-partners.com, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False

protocolSection identificationModule nctId: NCT06269653, orgStudyIdInfo id: 10001944, secondaryIdInfos id: 001944-AG, briefTitle: Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute on Aging (NIA), class: NIH, descriptionModule briefSummary: Background:Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover.Objective:To measure rates of protein turnover in healthy adults.Eligibility:Healthy people aged 20 years and older with a body mass index between 20 and 30.Design:Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit.Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs.Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years.Participants will have tests during study visits, including:Imaging scans of a leg.Exercise on a treadmill.Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen.Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes.Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands.D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle., conditionsModule conditions: Healthy Volunteers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Measure the turnover proteins in humans across tissues, age, and sex., secondaryOutcomes measure: Test the hypothesis that older age is associated with diminished protein turnover., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Aging, Clinical Research Unit, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Luigi Ferrucci, M.D., role: CONTACT, phone: 410-558-8110, email: ferruccilu@grc.nia.nih.gov, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False

protocolSection identificationModule nctId: NCT06269640, orgStudyIdInfo id: 10001640, secondaryIdInfos id: 001640-H, briefTitle: NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Heart, Lung, and Blood Institute (NHLBI), class: NIH, descriptionModule briefSummary: Background:Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO.Objective:To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME).Eligibility:Adults aged 21 years with LVOTO.Design:Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life.Participants will stay in the hospital 2 to 6 days for the SESAME procedure.They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart.Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum.Participants will have 3 follow-up visits within 1 year., conditionsModule conditions: Hypertrophic Cardiomyopathy, conditions: Left Ventricular Septal Hypertrophy, conditions: Mitral Valve Disease, conditions: Aortic Valve Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Septal Scoring Along Midline Endocardium, outcomesModule primaryOutcomes measure: Technical success, primaryOutcomes measure: Safety, secondaryOutcomes measure: Complete heart block requiring permanent pacemaker, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University Hospital, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Robert Lederman, M.D., role: CONTACT, phone: 301-402-6769, email: lederman@nih.gov, geoPoint lat: 33.749, lon: -84.38798, hasResults: False

protocolSection identificationModule nctId: NCT06269627, orgStudyIdInfo id: 10001644, secondaryIdInfos id: 001644-AA, briefTitle: Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), class: NIH, descriptionModule briefSummary: Background:Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.Objective:To learn more about how acamprosate affects brain function in people with AUD.Eligibility:People aged 21 to 65 years with moderate to severe AUD.Design:Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.Participants may have up to three follow-up visits for 6 months., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Acamprosate calcium, interventions name: Placebo, outcomesModule primaryOutcomes measure: Reduction of beta power, secondaryOutcomes measure: Promotion of alpha power in active group compared to placebo group., secondaryOutcomes measure: No change in slow band (delta and theta) power in active group compared to placebo group., secondaryOutcomes measure: Reduction of theta event-related synchronization in active group compared to placebo group., secondaryOutcomes measure: Amplification and hastening of P300 in active group compared to placebo group., secondaryOutcomes measure: Correlation of EEG markers of acamprosate treatment with clinical measures of anxiety and alcohol craving, secondaryOutcomes measure: Correlation of EEG markers of acamprosate treatment with polysomnography markers, secondaryOutcomes measure: Correlation of polysomnography markers of acamprosate treatment with clinical measures of anxiety and alcohol craving, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False

protocolSection identificationModule nctId: NCT06269614, orgStudyIdInfo id: QOL334829, briefTitle: Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-12, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nova Southeastern University, class: OTHER, descriptionModule briefSummary: Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group., conditionsModule conditions: Autism Spectrum Disorder, conditions: Adverse Childhood Experiences, conditions: Stress Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Enteric Microbiome abundance, primaryOutcomes measure: Enteric Microbiome diversity, secondaryOutcomes measure: Improved response to stressor, secondaryOutcomes measure: Improved physiological response to stressor, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 95 Months, stdAges: CHILD, contactsLocationsModule locations facility: Nova Southeastern University College of Nursing, status: RECRUITING, city: Davie, state: Florida, zip: 33314, country: United States, contacts name: Gesulla Cavanaugh, PhD, role: CONTACT, phone: 954-262-1980, email: gcavanaugh@nova.edu, geoPoint lat: 26.06287, lon: -80.2331, hasResults: False

protocolSection identificationModule nctId: NCT06269601, orgStudyIdInfo id: HÜ- FTR- BD- 02, briefTitle: The Reliability of the Upper Limb Rotation Test in Adolescent Male Basketball Players, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-10, primaryCompletionDateStruct date: 2023-09-15, completionDateStruct date: 2023-09-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The objective of the study is to examine the reliability of the Upper Limb Rotation Test in adolescent male basketball players aged between 14 and 16. According to the sample size calculation for the study, 51 athletes were included. The Upper Limb Rotation Test was administered to the athletes twice, with a one-week interval. The athlete was positioned in a plank stance with shoulder, elbow lateral epicondyle, greater trochanter, and ankle lateral malleolus making contact with the wall. The athletes were instructed to perform a 90° abduction and 90° external rotation of the shoulder, accompanied by trunk rotation for a duration of 15 seconds. The number of repetitions was recorded. The tested side was the upper extremity in which the closed kinetic chain position was maintained. The test was repeated three times, and the average of the results was calculated. The Upper Extremity Rotation Test is a reliable assessment tool for evaluating performance in adolescent basketball players aged 14-16, particularly in relation to shooting skills., conditionsModule conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 14-18 years basketball players, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 51, type: ACTUAL, armsInterventionsModule interventions name: Upper Limb Rotation Test, outcomesModule primaryOutcomes measure: The Reliability of the Upper Limb Rotation Test, eligibilityModule sex: MALE, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06269588, orgStudyIdInfo id: NBM-NP004, briefTitle: Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, collaborators name: Next Biomedical Co., Ltd., collaborators name: Tan Tock Seng Hospital, collaborators name: National University Hospital, Singapore, descriptionModule briefSummary: The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore, conditionsModule conditions: Gastrointestinal Hemorrhage, conditions: Hematemesis; With Ulcer, conditions: Endoscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: prospective single arm intervention cohort, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Nexpowder, outcomesModule primaryOutcomes measure: endoscopic hemostasis, secondaryOutcomes measure: recurrent bleeding rate on second-look endoscopy, secondaryOutcomes measure: hydrogel persistence rate at the bleeding site, secondaryOutcomes measure: Recurrent bleeding within 30 days after endoscopic therapy, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changi General Hospital, status: RECRUITING, city: Singapore, zip: 529889, country: Singapore, contacts name: Tiing Ang, MRCP (UK), role: CONTACT, phone: 69365737, email: ang.tiing.leong@singhealth.com.sg, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False

protocolSection identificationModule nctId: NCT06269575, orgStudyIdInfo id: Dysphagia, briefTitle: Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-05, primaryCompletionDateStruct date: 2023-08-15, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia?, conditionsModule conditions: DYSPHAGIA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: non-randomized controlled, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: SAFE NUTRITION PROGRAM, outcomesModule primaryOutcomes measure: Complications of dysphagia, primaryOutcomes measure: Complications of dysphagia, primaryOutcomes measure: Complications of dysphagia, secondaryOutcomes measure: Stroke-Specific Quality of Life Scale (SS-QOL), secondaryOutcomes measure: Swallowing Anxiety Scale (YKÖ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Universitesi-Cerrahpasa, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06269562, orgStudyIdInfo id: clavicle, briefTitle: SPSIPB and CPB on Clavicle Surgeries, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-20, primaryCompletionDateStruct date: 2023-12-20, completionDateStruct date: 2024-02-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, descriptionModule briefSummary: Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS)., conditionsModule conditions: Clavicle Fracture, conditions: Postoperative Pain, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: Serratus posterior superior intercostal plane block and clavipectoral plane block, outcomesModule primaryOutcomes measure: Numerical Rating Scale, secondaryOutcomes measure: tramadol consumption, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sivas Cumhuriyet University, city: Sivas, zip: 58050, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, hasResults: False

protocolSection identificationModule nctId: NCT06269549, orgStudyIdInfo id: KDS_KOA, briefTitle: Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis, acronym: KDSKOA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Primorska, class: OTHER, collaborators name: Community Healthcare Center dr. Adolf Drolc Maribor (HCM), descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:* Is adding a dietary supplement to exercise additionally effective in managing KOA?* Is adding exercise to the dietary supplement additionally effective in managing KOA?Participants will be given in three groups:1. Real dietary supplement alone2. Real dietary supplement with exercise3. Placebo dietary supplement with exerciseInvestigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Placebo blinding / masked for dietary supplement, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Non-training Real Dietary Supplement (G1), interventions name: Training Placebo Dietary Supplement (G2), interventions name: Training Real Dietary Supplement (G3), outcomesModule primaryOutcomes measure: Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12, primaryOutcomes measure: Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12, primaryOutcomes measure: Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12, primaryOutcomes measure: Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12, primaryOutcomes measure: Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12, primaryOutcomes measure: Change from baseline in knee pain on visual analogue scale at week 12, primaryOutcomes measure: Change from baseline in static balance time at week 12, primaryOutcomes measure: Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12, primaryOutcomes measure: Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12, primaryOutcomes measure: Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12, primaryOutcomes measure: Change from baseline in number of repetitions in Chair Stand Test at week 12, primaryOutcomes measure: Change from baseline in time for Five Times Sit to Stand Test at week 12, primaryOutcomes measure: Change from baseline in number of repetitions in Arm Curl Test at week 12, primaryOutcomes measure: Change from baseline in lower body flexibility at week 12, primaryOutcomes measure: Change from baseline in upper body flexibility at week 12, primaryOutcomes measure: Change from baseline in 6-minute walk distance at week 12, primaryOutcomes measure: Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor at week 12, primaryOutcomes measure: Change from baseline in explosive strength of knee extensor at week 12, primaryOutcomes measure: Change from baseline in 24-hour time use at week 12, primaryOutcomes measure: Change from baseline in presence of inflammatory markers in blood sample at week 12, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Primorska, Faculty of Health Sciences, city: Izola, zip: 6310, country: Slovenia, contacts name: Nejc Šarabon, PhD, role: CONTACT, phone: 05 662 64 66, phoneExt: +386, email: nejc.sarabon@fvz.upr.si, contacts name: Tina Čeh, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 45.53694, lon: 13.66194, locations facility: Community Healthcare Center dr. Adolf Drolc, city: Maribor, zip: 2000, country: Slovenia, contacts name: Jernej Završnik, PhD, role: CONTACT, phone: 02 2286 257, phoneExt: +386, email: jernej.zavrsnik@zd-mb.si, contacts name: Tina Čeh, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 46.55472, lon: 15.64667, hasResults: False

protocolSection identificationModule nctId: NCT06269536, orgStudyIdInfo id: UC-SK004, briefTitle: Stress-reducing Intervention in Urothelial Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2027-02-15, completionDateStruct date: 2029-02-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Comenius University, class: OTHER, descriptionModule briefSummary: The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: HRV biofeedback, outcomesModule primaryOutcomes measure: Primary Objective: Inflammation, primaryOutcomes measure: Primary Objective: Heart Rate Variability (HRV), primaryOutcomes measure: Primary Objective: Quality of Life (QoL), primaryOutcomes measure: Primary Objective: Working memory, primaryOutcomes measure: Primary objective: Executive function, primaryOutcomes measure: Primary objective: Salivary Cortisol Slopes, primaryOutcomes measure: Primary objective: Sleep Quality, secondaryOutcomes measure: Secondary objective: Serious Adverse Events, secondaryOutcomes measure: Secondary objective: Disease-Free Survival (DFS), secondaryOutcomes measure: Secondary objective: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Institute, status: RECRUITING, city: Bratislava, zip: 83310, country: Slovakia, contacts name: Katarina Rejlekova, role: CONTACT, email: katarina.rejlekova@nou.sk, contacts name: Patrik Palacka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.14816, lon: 17.10674, hasResults: False

protocolSection identificationModule nctId: NCT06269523, orgStudyIdInfo id: MFR032024, briefTitle: Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-21, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery., conditionsModule conditions: Axillary Web Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Kinesio taping, Lymphatic drainage, interventions name: Lymphatic drainage, outcomesModule primaryOutcomes measure: NRS Scale, primaryOutcomes measure: Joint excursion shoulder, primaryOutcomes measure: Muscular strength of the upper limbs, secondaryOutcomes measure: Constant Murley Score, secondaryOutcomes measure: upper limbs circumferenze (cyrtometry), eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone, city: Palermo, zip: 90127, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False

protocolSection identificationModule nctId: NCT06269510, orgStudyIdInfo id: HUM00242997, secondaryIdInfos id: 1R01AA030748-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01AA030748-01, briefTitle: Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions., conditionsModule conditions: Alcohol-related Liver Disease, conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Computer-generated urn randomization will ensure balanced groups based on stage of ALD (advanced ALD and non-advanced ALD) and inpatient versus outpatient status at time of recruitment. Second stage randomization to 3-month intervention conditions will be stratified based on response and non-response status. Urn randomization using stage of ALD and inpatient versus outpatient recruitment will also be used at the second stage randomization. Re-randomization of non-responders will be computerized and stratified by stage of ALD and inpatient vs outpatient status., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 268, type: ESTIMATED, armsInterventionsModule interventions name: ENGAGE-ALD Application (APP), interventions name: Treatment Facilitation bundle, interventions name: Enhanced Usual Care, outcomesModule primaryOutcomes measure: Alcohol treatment engagement, secondaryOutcomes measure: Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method, secondaryOutcomes measure: Percent heavy drinking days (PHDD), secondaryOutcomes measure: Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants, secondaryOutcomes measure: Change in Liver health based on liver laboratory values (total bilirubin) for all participants, secondaryOutcomes measure: Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Haila Asefa, role: CONTACT, phone: 734-232-0284, email: asefah@umich.edu, contacts name: Jessica Mellinger, MD, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False

protocolSection identificationModule nctId: NCT06269497, orgStudyIdInfo id: 2018/2300, briefTitle: TiO2-scaffolds for Alveolar Ridge Preservation, acronym: TIOSCAFF, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-09, primaryCompletionDateStruct date: 2022-06-20, completionDateStruct date: 2023-08-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Oslo, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction., conditionsModule conditions: Alveolar Bone Resorption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Observational study / clinical trial, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Scaffold placement, interventions name: CBCT, outcomesModule primaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Anatomy, secondaryOutcomes measure: Inflammation, secondaryOutcomes measure: Mineralization, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, University of Oslo, city: Oslo, zip: Postboks 1142 Blindern, country: Norway, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False

protocolSection identificationModule nctId: NCT06269484, orgStudyIdInfo id: D4326C00004, briefTitle: A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK, acronym: ZEAL UNLOCK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-01-17, completionDateStruct date: 2025-01-17, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis., conditionsModule conditions: Liver Cirrhosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet), interventions name: Zibotentan + placebo (placebo matching dapagliflozin tablet), interventions name: Zibotentan + dapagliflozin, outcomesModule primaryOutcomes measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE), primaryOutcomes measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE), secondaryOutcomes measure: Change in body weight (kg) over time course of study, secondaryOutcomes measure: Change in body weight (kg) over time course of study, secondaryOutcomes measure: Change in total dosage of loop-diuretic equivalents use, secondaryOutcomes measure: Change in total dosage of loop-diuretic equivalents use, secondaryOutcomes measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use, secondaryOutcomes measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use, secondaryOutcomes measure: Absolute change in systolic and diastolic blood pressure, secondaryOutcomes measure: Absolute change in systolic and diastolic blood pressure, secondaryOutcomes measure: Change from baseline in body weight, secondaryOutcomes measure: Change from baseline in total body water, secondaryOutcomes measure: Change from baseline in extracellular water volume, secondaryOutcomes measure: Change from baseline in intracellular water volume, secondaryOutcomes measure: Change from baseline in body fat mass, secondaryOutcomes measure: Change from baseline in body weight, secondaryOutcomes measure: Change from baseline in total body water, secondaryOutcomes measure: Change from baseline in extracellular water volume, secondaryOutcomes measure: Change from baseline in intracellular water volume, secondaryOutcomes measure: Change from baseline in body fat mass, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Englewood, state: Colorado, zip: 80113, country: United States, geoPoint lat: 39.64777, lon: -104.98776, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Research Site, status: RECRUITING, city: San Antonio, state: Texas, zip: 78215, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Adelaide, zip: 5000, country: Australia, geoPoint lat: -34.92866, lon: 138.59863, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kogarah, zip: 2217, country: Australia, geoPoint lat: -33.98333, lon: 151.11667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mitcham, zip: 3132, country: Australia, geoPoint lat: -37.81667, lon: 145.2, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Edegem, zip: 2650, country: Belgium, geoPoint lat: 51.15662, lon: 4.44504, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mechelen, zip: 2800, country: Belgium, geoPoint lat: 51.02574, lon: 4.47762, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Liberec, zip: 460 63, country: Czechia, geoPoint lat: 50.76711, lon: 15.05619, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mladá Boleslav, zip: 293 01, country: Czechia, geoPoint lat: 50.41135, lon: 14.90318, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Plzeň, zip: 323 00, country: Czechia, geoPoint lat: 49.74747, lon: 13.37759, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Praha 4, zip: 140 21, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aachen, zip: 52074, country: Germany, geoPoint lat: 50.77664, lon: 6.08342, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kiel, zip: 24146, country: Germany, geoPoint lat: 54.32133, lon: 10.13489, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tuebingen, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milano, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Padova, zip: 35128, country: Italy, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Roma, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gifu-shi, zip: 500-8513, country: Japan, geoPoint lat: 35.42291, lon: 136.76039, locations facility: Research Site, status: RECRUITING, city: Iizuka-shi, zip: 820-8505, country: Japan, geoPoint lat: 33.63654, lon: 130.68678, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kawasaki-shi, zip: 215-0026, country: Japan, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kitakyusyu-shi, zip: 806-8501, country: Japan, locations facility: Research Site, status: RECRUITING, city: Nagaoka-shi, zip: 940-2085, country: Japan, geoPoint lat: 37.45, lon: 138.85, locations facility: Research Site, status: RECRUITING, city: Niigata-shi, zip: 951-8520, country: Japan, geoPoint lat: 37.88637, lon: 139.00589, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sapporo-shi, zip: 006-8555, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yokohama-shi, zip: 236-0004, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bydgoszcz, zip: 85-794, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Katowice, zip: 40-081, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kraków, zip: 31-513, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mysłowice, zip: 41-400, country: Poland, geoPoint lat: 50.20745, lon: 19.16668, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Poznań, zip: 61-848, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wrocław, zip: 52-210, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bratislava, zip: 83104, country: Slovakia, geoPoint lat: 48.14816, lon: 17.10674, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nitra, zip: 950 01, country: Slovakia, geoPoint lat: 48.30763, lon: 18.08453, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Trnava, zip: 91702, country: Slovakia, geoPoint lat: 48.37741, lon: 17.58723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aberdeen, zip: AB25 2ZN, country: United Kingdom, geoPoint lat: 57.14369, lon: -2.09814, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hull, zip: HU3 2KZ, country: United Kingdom, geoPoint lat: 53.7446, lon: -0.33525, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ipswich, zip: IP4 5PD, country: United Kingdom, geoPoint lat: 52.05917, lon: 1.15545, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nottingham, zip: NG7 2UH, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False

protocolSection identificationModule nctId: NCT06269471, orgStudyIdInfo id: 2023-A02039-36, briefTitle: On the ICC's Path: a Prevalence Study, acronym: SSICC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France., conditionsModule conditions: Chronic Ankle Instability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 385, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Prevalence of chronic ankle instability in trailers, secondaryOutcomes measure: Socio-demographic data (1/4), secondaryOutcomes measure: Socio-demographic data (2/4), secondaryOutcomes measure: Socio-demographic data (3/4), secondaryOutcomes measure: Socio-demographic data (4/4), secondaryOutcomes measure: Trail running and prevalence reports (1/11), secondaryOutcomes measure: Trail running and prevalence reports (2/11), secondaryOutcomes measure: Trail running and prevalence reports (3/11), secondaryOutcomes measure: Trail running and prevalence reports (4/11), secondaryOutcomes measure: Trail running and prevalence reports (5/11), secondaryOutcomes measure: Trail running and prevalence reports (6/11), secondaryOutcomes measure: Trail running and prevalence reports (7/11), secondaryOutcomes measure: Trail running and prevalence reports (8/11), secondaryOutcomes measure: Trail running and prevalence reports (9/11), secondaryOutcomes measure: Trail running and prevalence reports (10/11), secondaryOutcomes measure: Trail running and prevalence reports (11/11), secondaryOutcomes measure: Associated pathologies (1/2), secondaryOutcomes measure: Associated pathologies (2/2), secondaryOutcomes measure: Medical care (1/3), secondaryOutcomes measure: Medical care (2/3), secondaryOutcomes measure: Medical care (3/3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Grenoble Alpes, city: Grenoble, zip: 38000, country: France, contacts name: Leo Druart, role: CONTACT, email: leo.druart@univ-grenoble-alpes.fr, contacts name: Audrey Milon, role: PRINCIPAL_INVESTIGATOR, contacts name: Massamba M'Baye, role: SUB_INVESTIGATOR, contacts name: Thomas Lathière, role: SUB_INVESTIGATOR, contacts name: Maïa Dolopogoloff, role: SUB_INVESTIGATOR, contacts name: Guillaume Néron, role: SUB_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False

protocolSection identificationModule nctId: NCT06269458, orgStudyIdInfo id: ABU-001, briefTitle: The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-11-25, completionDateStruct date: 2023-12-26, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Antalya Bilim University, class: OTHER, descriptionModule briefSummary: Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated., conditionsModule conditions: Newborn, conditions: Yoga, conditions: Mother-Infant Interaction, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Baby Massage, interventions name: Monther-Baby Yoga, outcomesModule primaryOutcomes measure: Attachment, primaryOutcomes measure: Weight and Sleep, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 5 Days, stdAges: CHILD, contactsLocationsModule locations facility: Antalya Bilim Üniversitesi, city: Antalya, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False

protocolSection identificationModule nctId: NCT06269445, orgStudyIdInfo id: 2023-942-01, briefTitle: The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sir Run Run Shaw Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Icaritin Combined With Bevacizumab and FOLFIRI, outcomesModule primaryOutcomes measure: Progression-free survival(PFS), secondaryOutcomes measure: Objective remission rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of ongoing remission (DOR), secondaryOutcomes measure: TRAEs, secondaryOutcomes measure: Quality of life of the patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Fei Wang, role: CONTACT, phone: 13732236150, email: 21418531@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06269432, orgStudyIdInfo id: 2023YFS0042, briefTitle: Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE（PATH-STROKE）, acronym: PATH-STROKE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sichuan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: Objectives of Study:To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic cerebral infarction under the guidance of platelet aggregation function., conditionsModule conditions: Ischemic Stroke, conditions: Antiplatelet Drug, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3524, type: ESTIMATED, armsInterventionsModule interventions name: Precision Antiplatelet Therapy Trial Group, interventions name: Traditional Antiplatelet Therapy Control Group, outcomesModule primaryOutcomes measure: 3-month major ischemic events and major bleeding events, secondaryOutcomes measure: disability, secondaryOutcomes measure: Cardiovascular or cerebrovascular mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610072, country: China, contacts name: Jie Yang, doctor, role: CONTACT, phone: +86 13678130516, email: yangjie1126@163.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False

protocolSection identificationModule nctId: NCT06269419, orgStudyIdInfo id: 2023-KY295, briefTitle: Study of Natural Course Progression of Diabetic Retinopathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2029-01-01, completionDateStruct date: 2029-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Jie Li, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.The contents of follow-up examinations are:History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.Urinary microalbumin/urinary creatinine ACR. Microvisual field., conditionsModule conditions: Biomarkers of Diabetic Retinopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Observation and follow-up of biomarkers of diabetic retinopathy, primaryOutcomes measure: Level of Glycosylated hemoglobin, primaryOutcomes measure: Creatinine, primaryOutcomes measure: Total cholesterol, primaryOutcomes measure: Urinary microalbumin, primaryOutcomes measure: Urea, primaryOutcomes measure: Glomerular filtration rate, primaryOutcomes measure: Triglycerides, primaryOutcomes measure: Low-density lipoprotein cholesterol, primaryOutcomes measure: High-density lipoprotein cholesterol, primaryOutcomes measure: Urinary creatinine ACR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial, status: RECRUITING, city: Chendu, state: Sichuan, zip: 610014, country: China, contacts name: Jie Li, doctor, role: CONTACT, phone: +86 13908094675, email: lijieyk@med.uestc.edu.cn, hasResults: False

protocolSection identificationModule nctId: NCT06269406, orgStudyIdInfo id: SW008, briefTitle: A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults, acronym: ICLID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-07-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: NMSI DENTMASTER, descriptionModule briefSummary: Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy., conditionsModule conditions: Dental Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg, interventions name: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg, interventions name: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure, outcomesModule primaryOutcomes measure: Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points), secondaryOutcomes measure: Total pain relief (TOTPAR) %, secondaryOutcomes measure: Time to pain half pain gone (in minutes), secondaryOutcomes measure: Duration of pain half gone (in minutes), secondaryOutcomes measure: Any adverse events (facial swelling, nausea, vomiting, headache) (%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nmsi Dentmaster, city: Novosibirsk, state: Novosibirsk Region, zip: 630090, country: Russian Federation, contacts name: Gatilova A Tatyana, MD, role: CONTACT, phone: 9529399919, phoneExt: +7, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False

protocolSection identificationModule nctId: NCT06269393, orgStudyIdInfo id: CIBI311Y101, briefTitle: A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity., conditionsModule conditions: Thyroid Associated Ophthalmopathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: IBI311, outcomesModule primaryOutcomes measure: The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye., secondaryOutcomes measure: Overall responder rate in proptosis of the study eye., secondaryOutcomes measure: Percentage of subjects with a CAS value of 0 or 1, secondaryOutcomes measure: Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia), otherOutcomes measure: Safety and tolerability of intravenous IBI311 in subjects with TAO, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100034, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06269380, orgStudyIdInfo id: 30.01.2024-4274, briefTitle: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-21, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Sisli Hamidiye Etfal Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal., conditionsModule conditions: Gastritis H Pylori, conditions: Gastritis Chronic, conditions: Intestinal Metaplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The biopsies obtained from patients who underwent esophagogastroduodenoscopy and were found to have normal endoscopic findings will be evaluated. The histopathological findings and their frequencies in these biopsies will be examined to assess the necessity of routine biopsy during esophagogastroduodenoscopy., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 671, type: ACTUAL, armsInterventionsModule interventions name: Esophagogastroduodenoscopy, interventions name: Endoscopic biopsy sampling, outcomesModule primaryOutcomes measure: Rate of abnormal histopathologic findings, secondaryOutcomes measure: Rate of intestinal metaplasia, secondaryOutcomes measure: Rates of gastritis severity and activity, secondaryOutcomes measure: Rate of Helicobacter Pylori positivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sisli Hamidiye Etfal Research and Training Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06269367, orgStudyIdInfo id: HUM00226149, secondaryIdInfos id: 1R41HD111289-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R41HD111289-01, briefTitle: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be randomly assigned to the two device interventions but will receive both interventions., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: NewGait, interventions name: Control wearable limb orthotic device, outcomesModule primaryOutcomes measure: Gait speed, primaryOutcomes measure: Ankle Muscle Activation, secondaryOutcomes measure: Changes in paretic leg propulsive force, otherOutcomes measure: Changes in paretic leg loading (i.e., vertical ground reaction force), otherOutcomes measure: Changes in other lower extremity muscle activation, otherOutcomes measure: Muscle Coordination, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48108, country: United States, contacts name: Chanramouli Krishnan, PT, PhD, role: CONTACT, phone: 734-936-4031, email: mouli@umich.edu, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False

protocolSection identificationModule nctId: NCT06269354, orgStudyIdInfo id: 20231121-71479, briefTitle: Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society., conditionsModule conditions: Bone Defects, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: 3D printed prostheses, outcomesModule primaryOutcomes measure: Evaluation of implant stability, new bone growth- limb length, primaryOutcomes measure: Evaluation of bone healing, secondaryOutcomes measure: Pain assessment, secondaryOutcomes measure: Evaluation of life quality and health status., secondaryOutcomes measure: Evaluation of knee function, secondaryOutcomes measure: Evaluation of hip function, secondaryOutcomes measure: Evaluation of ankle function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Haidian, country: China, contacts name: Bingchuan Liu, role: CONTACT, phone: +86 18310188678, email: liubc@bjmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06269341, orgStudyIdInfo id: SCCH-TS2208, briefTitle: Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy, acronym: OSinEC, statusModule overallStatus: RECRUITING, startDateStruct date: 2010-02-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sichuan Cancer Hospital and Research Institute, class: OTHER, descriptionModule briefSummary: Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank, conditionsModule conditions: Outcomes of Smoker and Drinker After Esophagectomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2957, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Cancer Hospital and Research Institute, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Lin Peng, M.D., role: CONTACT, phone: +8618908190013, email: penglinms@126.com, contacts name: Wenwu He, M.D., role: CONTACT, phone: +8613350055340, email: wenwu_he@126.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False

protocolSection identificationModule nctId: NCT06269328, orgStudyIdInfo id: 2011-KAEK-26/463, briefTitle: Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Uludag University, class: OTHER, descriptionModule briefSummary: Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort., conditionsModule conditions: Sleep Disorder, conditions: Sleep, Inadequate, conditions: Total ıntravenous Anesthesia, conditions: Inhalation Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance, interventions name: Inhalation anesthesia with sevoflurane for anesthetic maintenance, outcomesModule primaryOutcomes measure: Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale), secondaryOutcomes measure: Subjective anxiety level, secondaryOutcomes measure: Subjective pain level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elifgül Ulutaş, city: Bursa, state: Nilüfer, zip: 16240, country: Turkey, geoPoint lat: 40.19559, lon: 29.06013, hasResults: False

protocolSection identificationModule nctId: NCT06269315, orgStudyIdInfo id: SBDDCP, briefTitle: Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants, acronym: SBDDCP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Swiss Institute of Allergy and Asthma Research, class: OTHER, collaborators name: University Hospital, Zürich, descriptionModule briefSummary: The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.The main questions it aims to answer are:* How does exposure to household detergents and hand disinfectants impact skin barrier function?* Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?Participants will:Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.If there is a comparison group:Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact., conditionsModule conditions: Control Condition (PBS), conditions: Household Detergent Exposure, conditions: Hand Disinfectant Exposure, conditions: Surfactant Exposure, conditions: Other Ingredients Exposure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 1. Skin Cleansing and Testing Patch Preparation: Prepare a test set of patch testing tapes, each containing a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution. The safety dose of the tested products and agents will be defined beforehand. Before exposure, selected areas of forearm skin will be cleaned and moistened. Electrical impedance will be measured by electrical impedance spectroscopy (EIS) to assess skin barrier integrity.2. Patch Application:Apply the prepared patches on the skin of the forearm. Patches will be removed after 5 minutes of exposure.During the exposure period, subjects will be instructed not to touch, wash, or wet the exposed area to avoid interfering with the action of the testing reagents. 3. Patch Removal and Post-Exposure Monitoring:The patch will be gently removed from the skin. Exposed areas of skin will be evaluated by EIS at specific times up to 24 hours after the treatment., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cleaning product exposure, outcomesModule primaryOutcomes measure: Skin barrier evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Swiss Institute of Allergy and Asthma Research, city: Davos, state: Graubuenden, zip: 7265, country: Switzerland, contacts name: Yasutaka Mitamura, MD PhD, role: CONTACT, phone: +41 (0) 81 410 08 48, email: yasutaka.mitamura@siaf.uzh.ch, contacts name: Cezmi A Akdis, MD professor, role: CONTACT, phone: +41 (0) 81 410 08 48, email: cezmi.akdis@siaf.uzh.ch, contacts name: Manru Li, role: SUB_INVESTIGATOR, contacts name: Marie-Charlotte Brueggen, MD PhD professor, role: SUB_INVESTIGATOR, geoPoint lat: 46.80429, lon: 9.83723, hasResults: False

protocolSection identificationModule nctId: NCT06269302, orgStudyIdInfo id: 2, briefTitle: Comparison of the Effect of Warfarin and Direct Oral Anticoagulants, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Samsun Education and Research Hospital, class: OTHER, descriptionModule briefSummary: In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding, conditionsModule conditions: Anticoagulants and Bleeding Disorders, conditions: Gastrointestinal Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 346, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Change in the incidence of recurrent bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsun Education and Research Hospital, city: Samsun, state: İlkadım, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False

protocolSection identificationModule nctId: NCT06269289, orgStudyIdInfo id: SBU-KOMSERN-001, briefTitle: Effects of Web-Based Education on Patient Empowerment and Asthma Control in Asthma Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Asthma is defined as a chronic inflammatory disorder of the airways associated with an extreme increase in airway hyperresponsiveness leading to recurrent wheezing, shortness of breath, chest tightness, and coughing attacks. The World Health Organization states that approximately 339 million individuals worldwide have asthma and more than 400 thousand deaths occur due to asthma every year.With effective and sustainable asthma management, it is possible to reduce disease-related complaints, admissions to emergency units and hospitalizations, limit the physiological and psychological effects of the disease, prevent dependence on healthcare professionals and caregivers, increase the quality of life and reduce the mortality of the disease. Patient education, which is within the educational role of professional nurses, is very important in asthma management. The research was planned in a single-center, randomized control group pretest-posttest design. The sample will consist of individuals who applied to the Allergy and Immunology clinic of Sureyyapasa Chest Diseases and Surgery Training and Research Hospital between May 2024 and January 2024, who have been diagnosed with asthma for at least one year and who accept the study \[25 intervention group - 25 control group\]. Groups will be determined using the random numbers table from the simple random sampling method. A web-based asthma education module will be created in line with the literature, and participants in the intervention group will be given synchronous training in 5 modules. After meeting the individuals in the intervention and control groups and obtaining verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test prepared via Google Forms. A 30-minute training session will be given to the intervention group every week and there will be short evaluations after each training. When the 5th Module is completed, the intervention group will be asked to fill out the Patient Empowerment Scale and Asthma Control Test Scale. No intervention will be applied to the control group. 5. At the end of the module, the Patient Empowerment Scale and Asthma Control Test will be completed by individuals in the control group. It is thought that web-based asthma education that individuals will receive will positively affect their empowerment levels and increase their disease control., conditionsModule conditions: Asthma, conditions: Patient Empowerment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research was designed as a randomized controlled experimental study with a pretest-posttest design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: web based education, interventions name: Standard education brochure, outcomesModule primaryOutcomes measure: patient empowerment scale (PES), secondaryOutcomes measure: Asthma Control Test (ACT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital, city: Istanbul, zip: 34854, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06269276, orgStudyIdInfo id: CAVCU, briefTitle: Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-20, primaryCompletionDateStruct date: 2021-01-15, completionDateStruct date: 2021-01-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Namik Kemal University, class: OTHER, descriptionModule briefSummary: This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used.At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish., conditionsModule conditions: Stoma Colostomy, conditions: Stoma Ileostomy, conditions: Caregiver, conditions: Self Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 223, type: ACTUAL, armsInterventionsModule interventions name: Caregiver Contribution to Self-Care in Ostomy Patient Index, outcomesModule primaryOutcomes measure: Caregiver Contribution to Self-Care in Ostomy Patient Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tekirdag Namık Kemal University, city: Tekirdag, state: Suleymanpasa, zip: 59000, country: Turkey, geoPoint lat: 40.9781, lon: 27.51101, hasResults: False

protocolSection identificationModule nctId: NCT06269263, orgStudyIdInfo id: 339/23-ek, briefTitle: Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF), acronym: Pilot-CRHF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Leipzig, class: OTHER, descriptionModule briefSummary: The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, we will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, we will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot study of home-based cardiac rehabilitation, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Home-based cardiac rehabilitation, outcomesModule primaryOutcomes measure: Percentage of patients completing the program, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Exercise capacity, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Leipzig, city: Leipzig, state: Saxony, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, hasResults: False

protocolSection identificationModule nctId: NCT06269250, orgStudyIdInfo id: ANDI-MFA2023_10, briefTitle: Acceptance and Perceived Benefits of Digitalization by Medical Assistants, acronym: ANDI-MFA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Jacobs University Bremen gGmbH, class: OTHER, collaborators name: Mirjam Jansen; medmedia Academy, descriptionModule briefSummary: The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare., conditionsModule conditions: Health Care Providers, conditions: Patient Safety, conditions: eHealth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Policy Change, outcomesModule primaryOutcomes measure: Adoption and acceptance of information technology (IT), primaryOutcomes measure: Requests by patients regarding IT, primaryOutcomes measure: Perceived Benefits of IT, secondaryOutcomes measure: Knowledge and Digital health literacy, secondaryOutcomes measure: Preferred learning format, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Germany, status: RECRUITING, city: Bremen, zip: 28759, country: Germany, contacts name: Sonia Lippke, Prof. Dr., role: CONTACT, phone: +49 421 200 4730, email: slippke@constructor.university, contacts name: Keller Franziska, PhD, role: CONTACT, phone: +49 421 200 4730, email: fkeller@constructor.university, geoPoint lat: 53.07516, lon: 8.80777, hasResults: False

protocolSection identificationModule nctId: NCT06269237, orgStudyIdInfo id: 2023LTA, briefTitle: Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: He Eye Hospital, class: OTHER, descriptionModule briefSummary: To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment., conditionsModule conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: M22, interventions name: sham M22, outcomesModule primaryOutcomes measure: LTA, primaryOutcomes measure: Non-invasive tear break-up time (NITBUT), secondaryOutcomes measure: Fluorescein and lissamine conjunctival and cornea staining (CFS), secondaryOutcomes measure: Meibomian quality, secondaryOutcomes measure: Tear Film Lipid Layer Score(TFLL), secondaryOutcomes measure: Tear meniscus height (TMH), secondaryOutcomes measure: Conjunctival hyperemia (RS score), secondaryOutcomes measure: Ocular Surface Disease Index (OSDI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06269224, orgStudyIdInfo id: HU-FTR-KS-01, briefTitle: Examining Factors Influencing Thoracolumbar Mobility in Runners, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running., conditionsModule conditions: Runners, conditions: Mobility, conditions: Fascia, conditions: Range of Motion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners., outcomesModule primaryOutcomes measure: Myoton Assessment, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, state: Altındağ, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06269211, orgStudyIdInfo id: RTS-019, briefTitle: Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer With EGFR Mutation and PD-L1 Positive Expression, acronym: TOPLINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2030-01-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, collaborators name: Guangdong Provincial People's Hospital, descriptionModule briefSummary: The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression., conditionsModule conditions: Carcinoma, Non-Small-Cell Lung, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study has only one arm, neoadjuvant Toripalimab treatment arm. Primary endpoint is MPR. We apply the optimal design of Simon's two-stage model to calculate the sample size and set both sides α= 0.05 and power=0.8, resulting in a total sample size of 29. Among them, 10 patients will be enrolled in the first stage. If the number of MPR cases in the first stage is less than or equal to 1, the study will be terminated in the early stage; On the contrary, participants in the second stage will continue to be enrolled. If the total number of MPR cases is greater than or equal to 5 after the completion of the second stage, the study is considered positive., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ESTIMATED, armsInterventionsModule interventions name: Toripalimab, outcomesModule primaryOutcomes measure: Major Pathological Response (MPR), secondaryOutcomes measure: Pathological Complete Response (pCR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: 2-year Event Free Survival (EFS), secondaryOutcomes measure: 2-year Overall Survival (OS), secondaryOutcomes measure: Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events), secondaryOutcomes measure: Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial People's Hospital, city: Guangzhou, state: Guangdong, zip: 510180, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06269198, orgStudyIdInfo id: WARD - SX - RCT II, briefTitle: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System, acronym: WARD-SX-RCT-II, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Bispebjerg Hospital, collaborators name: Hvidovre University Hospital, descriptionModule briefSummary: The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy., conditionsModule conditions: Postoperative Complications, conditions: Cancer, Treatment-Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomisation stratified by study site, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Participants will not be given information on group allocation. Care-providers will not be blinded, due to having to carry out the intervention.Investigator will not be blinded to carrie out roles such as safety surveillance, error-solving and quality assurance.Outcome assessor will be blinded to study allocation., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 504, type: ESTIMATED, armsInterventionsModule interventions name: WARD-CSS, outcomesModule primaryOutcomes measure: Overall complication severity - 30 days, secondaryOutcomes measure: Overall complication severity - 7 days, secondaryOutcomes measure: Frequency of Serious adverse events, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Time to initiation of post-operative adjuvant chemotherapy, secondaryOutcomes measure: Completion of post-operative adjuvant chemotherapy, otherOutcomes measure: Frequency of severe clinical complications, otherOutcomes measure: ICU admission, otherOutcomes measure: Surgical reintervention of any kind, otherOutcomes measure: Post-discharge readmission, otherOutcomes measure: Health-economic cost-effectiveness., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University hospital - Rigshospitalet, status: RECRUITING, city: Copenhagen, state: Other (Non US), zip: 1665, country: Denmark, contacts name: Jesper Mølgaard, PhD, role: CONTACT, phone: +4535453545, email: jesper.moelgaard@regionh.dk, contacts name: Eske K Aasvang, DMSc, role: CONTACT, phone: +4535450802, email: eske.kvanner.aasvang.01@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Bispebjerg Hospital, status: RECRUITING, city: Copenhagen, state: Other (Non US), zip: 2400, country: Denmark, contacts name: Christian S Meyhoff, PhD, role: CONTACT, phone: +4524910542, email: christian.sylvest.meyhoff@regionh.dk, contacts name: Christian S Meyhoff, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Hvidovre Hospital, status: NOT_YET_RECRUITING, city: Hvidovre, state: Other (Non US), zip: 2650, country: Denmark, contacts name: Katja B L Glud, RN, role: CONTACT, phone: +4538625713, email: katja.balle.levring.glud@regionh.dk, contacts name: Søren Kjær, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.65719, lon: 12.47364, hasResults: False

protocolSection identificationModule nctId: NCT06269185, orgStudyIdInfo id: 2024_IFXvsADAinUC, briefTitle: Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment., conditionsModule conditions: Ulcerative Colitis, conditions: Inflammatory Bowel Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Infliximab, interventions name: Adalimumab, outcomesModule primaryOutcomes measure: Percentage of patients achieving steroid-free clinical remission, secondaryOutcomes measure: Percentage of patients achieving clinical response, secondaryOutcomes measure: Percentage of patients achieving clinical remission, secondaryOutcomes measure: Percentage of patients achieving biochemical remission, secondaryOutcomes measure: Percentage of patients achieving clinical remission, secondaryOutcomes measure: Percentage of patients achieving biochemical remission, secondaryOutcomes measure: Percentage of patients achieving endoscopic response, secondaryOutcomes measure: Percentage of patients achieving endoscopic remission, otherOutcomes measure: Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Västra Götalandsregionen, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Börje Jonefjäll, role: CONTACT, phone: +46703753933, email: borje.jonefjall@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False

protocolSection identificationModule nctId: NCT06269172, orgStudyIdInfo id: 162076, secondaryIdInfos id: 322453, type: OTHER, domain: HRA, briefTitle: Perceptions Across Ethnicities to Develop an Adapted Intervention for Breathlessness, acronym: Paint, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University Hospitals, Leicester, class: OTHER, descriptionModule briefSummary: An individual's experience of their breathlessness is influenced by multiple factors including their medical condition, psychology, sociological and situational circumstances which will include ethnicity. There is currently a lack of evidence exploring the impact of ethnicity in the experience and presentation of breathlessness.The non-medical management of breathlessness in respiratory diseases includes pulmonary rehabilitation (PR). PR is a highly evidenced exercise-based intervention to help manage breathlessness, improving health-related quality of life and improving survival. Recent audits in England and Wales showed 89% of patients attending PR were recorded as having a White British ethnicity which is in contrast to national ethnicity demographics. This may be because the cultural acceptability of PR components are not fully considered. Therefore, this study will explore how individuals with cardiorespiratory disease from different ethnicities from the Leicestershire population experience and manage their breathlessness through art workshops, focus groups and interviews. Informed by these results, the study team will work with individuals from under-represented ethnicities and key stakeholders to co-design adaptations of PR that may improve the management of breathlessness in underrepresented ethnicities that do not attend conventional PR programmes.The study is funded by the Wellcome Trust as part of the Leicestershire Health Inequalities Improvement Programme at the University of Leiceste, conditionsModule conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: intereviews, outcomesModule primaryOutcomes measure: Art Workshops, Focus Groups and Semi-Structured Interviews, secondaryOutcomes measure: : Experience Based Co-design The co-development of an intervention for breathlessness for under-represented ethnicities., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Glenfield Hospital, status: RECRUITING, city: Leicester, state: Leicestershire, zip: LE39QP, country: United Kingdom, contacts name: Holly Ms Drover, role: CONTACT, email: hd225@leicester.ac.uk, geoPoint lat: 52.6386, lon: -1.13169, hasResults: False

protocolSection identificationModule nctId: NCT06269159, orgStudyIdInfo id: ONZ-2023-0185, briefTitle: The Power of 24-hour: Co-designing Intervention Components, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients., conditionsModule conditions: Overweight and Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Concept mapping: brainstorm, interventions name: Concept mapping: clustering and rating, outcomesModule primaryOutcomes measure: Themes, primaryOutcomes measure: Score of effectiveness, primaryOutcomes measure: Score of feasibility, primaryOutcomes measure: Score of modifiability, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ghent university Hospital, status: RECRUITING, city: Ghent, zip: 9000, country: Belgium, contacts name: Bruno Lapauw, role: CONTACT, email: bruno.lapauw@uzgent.be, geoPoint lat: 51.05, lon: 3.71667, hasResults: False

protocolSection identificationModule nctId: NCT06269146, orgStudyIdInfo id: 806035, secondaryIdInfos id: 1R61MH129380-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R61MH129380-01, briefTitle: Pramipexole to Enhance Social Connections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), collaborators name: New York State Psychiatric Institute, descriptionModule briefSummary: This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention., conditionsModule conditions: Anxiety Disorders, conditions: Anxiety, conditions: Depression, conditions: Social Disconnection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The pharmacy will blind drug and placebo through identical encapsulation. Placebo will match the study drug in mode of administration, color, size, and taste., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Pramipexole Pill, interventions name: Placebo Pill, outcomesModule primaryOutcomes measure: Neural activation during social reward anticipation, secondaryOutcomes measure: Neural activation during opportunities to disclose to others, secondaryOutcomes measure: Motivation to engage in shared experiences with others, secondaryOutcomes measure: Positive affect in response to the social affiliation task, secondaryOutcomes measure: Social approach goals during the social affiliation task, secondaryOutcomes measure: Social approach behavior during the social affiliation task, secondaryOutcomes measure: Future approach motivation, secondaryOutcomes measure: Blood plasma pramipexole concentrations, otherOutcomes measure: Negative affect in response to the social affiliation task, otherOutcomes measure: Neural activation during social punishment anticipation, otherOutcomes measure: Social avoidance goals during the social affiliation task, otherOutcomes measure: Anxious behavior during the social affiliation task, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, San Diego, city: San Diego, state: California, zip: 92093, country: United States, contacts name: Margaret K Satchwell, BS, role: CONTACT, phone: 858-822-4357, email: mksatchwell@health.ucsd.edu, geoPoint lat: 32.71533, lon: -117.15726, locations facility: New York State Psychiatric Institute, city: New York, state: New York, zip: 10032, country: United States, contacts name: Liza Handler, BS, role: CONTACT, phone: 917-652-6355, email: liza.handler@nyspi.columbia.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False