[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"randomized-controlled-trial-rct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:randomized-controlled-trial-rct":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,86,128,152,183,234,268],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100645401","phase-2-sglt2i-effect-on-ptdm-development-and-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-a-randomized-doubleblind-placebo-controlled-national-multicenter-trial-100645401",false,"NCT07682350","SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM: SGLT2i Effect on PTDM Development and Kidney Allograft Function in Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM","Inclusion Criteria:\n\n* Obtained written informed consent\n* Male or female patients, age ≥ 18 years.\n* Non-diabetic KTR\n* Immunosuppressive must include Tacrolimus\n\nExclusion Criteria:\n\n* Patients who is treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization\n* eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2 (before randomization)\n* Alanine aminotransferase (ALAT) \\> 3 x upper normal limit\n* Bilirubin \\> 2 x upper normal limit\n* Pregnancy\n* Positive plasma hCG\n* Breastfeeding\n* Known allergy towards SGLT2i or the content substance\n* Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis) and structural conditions such as short bowel syndrome.","ALL","18 Years",{"count":20,"type":21},184,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation.\n\nThe main questions it aims to answer are:\n\n* Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo?\n* Does Forxiga help preserve the function of the transplanted kidney compared with placebo?\n* Is Forxiga safe for kidney transplant recipients who do not have diabetes?\n* Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo?\n\nResearchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use.\n\nAdults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements.\n\nParticipants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.",[27,28,29,30,31,32],"Kidney Transplant Recipient","Sodium Glucose Co-Transporter 2 Inhibitors","Non-Diabetic Patients","Randomized Controlled Trial (RCT)","Placebo Control Design","Post Transplant Diabetes Mellitus",[34,35,36,37,38,39,15],"SGLT2i","Kidney Transplant","Kidney Transplant Recipients","non-diabetic patients","Sodium-glucose Transporter 2 inhibitors","RCT","NOT_YET_RECRUITING","2026-06-26",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":21},"2026-09-01",{"date":48,"type":21},"2029-10-01",{"name":50,"class":51},"Odense University Hospital","OTHER",3,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":72,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100627856","efficacy-of-transcutaneous-auricular-vagus-nerve-stimulation-on-alleviating-major-depressive-disorder-in-patients-with-acute-coronary-syndrome-after-percutaneous-coronary-interventiona-prospective-double-blindrandomized-controlled-study-100627856","NCT07454070","Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Meeting the diagnostic criteria for ACS\n* 14 days to 12 months after successful PCI, with stable vital signs\n* Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)\n* HAMD-17 score ≥7 and \\\u003C24 (mild-to-moderate depression), with HAMA score \\\u003CHAMD score;\n* Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent\n* Voluntary participation in the study and signing of the informed consent form\n\nExclusion Criteria:\n\n* Severe heart failure (New York Heart Association \\[NYHA\\] class ≥III)\n* Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg)\n* Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per minute, RR interval ≥3 s) or a history of syncope unrelated to the current ACS\n* Dialysis-dependent patients\n* Previous renal sympathetic denervation or vagal ganglion ablation\n* Expected survival time \\\u003C4 months\n* Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse\n* Current use of antipsychotic medications\n* High suicide risk\n* Pregnant or lactating women\n* Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment\n* Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)",{"count":60,"type":21},120,[62],"NA","This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study.\n\nPatients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up.\n\nAll treatments were self-administered by the patients at home after they received training from the hospitals.\n\nThe primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .",[65,66,67,68,69,70,71,30],"Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate)","Acute Coronary Syndrome (ACS)","Percutaneous Coronary Intervention (PCI)","Depressive Disorder","Postoperative Psychological Distress","Heart Rate Variability (HRV)","Inflammatory Factors",[73,66,74],"Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Post-Percutaneous Coronary Intervention (PCI) Psychological Distress","RECRUITING","2026-06-14",{"date":78,"type":44},"2026-06-16",{"date":80,"type":44},"2026-01-06",{"date":82,"type":21},"2026-08-10",{"name":84,"class":51},"Jing Han",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":107,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":5},"100642980","feel-good-a-multicenter-trial-of-a-mindfulness-based-group-therapy-in-young-adults-with-early-psychosis-100642980","NCT07645443","FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis","Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)","FEEL-GOOD","Inclusion Criteria:\n\n* Age 16 to 35 years\n* Clinical diagnosis of early psychosis, defined as first psychotic episode within the last 5 years as assessed with the Structural Clinical Interview for DSM-5 Research Version (SCID-5-RV)\n* DSM-5 schizophrenia spectrum or other psychotic disorder confirmed with SCID-5-RV (DSM-5: 297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) Currently receiving inpatient\u002Fday clinic treatment with a planned stay of at least 4 weeks\n* Interested in and willing to participate in FEEL-GOOD and\u002For TAU.\n\nExclusion Criteria:\n\n* Insufficient German language abilities\n* Acute suicidality or acute threat to others","16 Years","35 Years",{"count":97,"type":21},252,[62],"FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone. The intervention consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. Outcomes are assessed at baseline, 4 weeks post-intervention, and 6 months follow-up, with the primary outcome being observer-rated total psychopathology as measured with the assessed by the total score of the Positive and Negative Syndrome Scale (PANSS) post-treatment (4 weeks post baseline).",[101,102,103,104,105,106,30],"Early Onset Psychosis","First Psychotic Episode Within the Last 5 Years","First-episode Psychosis","Schizophrenia Spectrum Disorders (SSD)","Psychosis","Psychosis NOS",[108,109,110,111,112,113,114,115,116,105,117,118],"Randomized controlled trial","Emotion regulation","Ecological momentary assessment","Early psychosis","First-episode psychosis","Mindfulness-based intervention","PANSS","EMA","Schizophrenia spectrum disorder","Mindfulness","observer-rated","2026-06-09",{"date":121,"type":44},"2026-06-12",{"date":123,"type":44},"2026-05-27",{"date":125,"type":21},"2028-12-31",{"name":127,"class":51},"Stephanie Mehl",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":134,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":85},"100641275","creating-opportunities-for-personal-empowerment-cope-in-women-with-breast-cancer-during-first-line-therapy-a-pilot-randomized-controlled-trial-100641275","NCT07610499","Creating Opportunities For Personal Empowerment (COPE) In Women With Breast Cancer During First-Line Therapy: A Pilot Randomized Controlled Trial","Eligibility Criteria\n\n* Female\n* Age 18 years and older\n* Diagnosed with stage I-III breast cancer\n* Receiving first line treatment for breast cancer\n* Receiving treatment at MD Anderson\n* Able to read, speak, and consent in English\n* Able to understand and be willing to sign a written informed consent document\n* Able to complete the study questionnaires and intervention sessions\n\nExclusion Criteria\n\n* Diagnosed with multiple tumor types\n* Diagnosed with stage IV breast cancer\n* Unable to provide consent, such as cognitively impaired individuals\n* Has a preexisting psychiatric diagnosis (e.g., bipolar depression)","FEMALE",{"count":136,"type":21},40,[62],"To learn if the Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with breast cancer who are receiving first line treatment.",[140,141,142,30],"COPE","Breast Cancer","First Line Therapy","2026-05-20",{"date":145,"type":44},"2026-05-28",{"date":147,"type":21},"2026-10-30",{"date":149,"type":21},"2029-05-01",{"name":151,"class":51},"M.D. Anderson Cancer Center",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":85},"100638496","multimodal-ai-guided-recovery-management-after-lung-cancer-surgery-100638496","NCT07588737","Multimodal AI-Guided Recovery Management After Lung Cancer Surgery","Multimodal Artificial Intelligence-Guided Symptom Monitoring and Recovery Management After Lung Cancer Surgery: A 20-Center Prospective Randomized Controlled Trial","AI-LungRecover","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Clinically or pathologically diagnosed with lung cancer.\n3. Undergoing lung cancer-related thoracic surgery.\n4. Surgical procedures may include video-assisted thoracoscopic surgery, robot-assisted thoracic surgery, or open thoracic surgery.\n5. Surgical extent may include wedge resection, segmentectomy, lobectomy, sleeve resection, combined resection, bilobectomy, or pneumonectomy.\n6. Clinically stable after surgery and able to participate in symptom assessment and postoperative recovery management.\n7. Able to use a smartphone or study device, or has a caregiver who can assist with use.\n8. Able to complete patient-reported symptom assessments and postoperative recovery information reporting.\n9. Provides written informed consent.\n\nExclusion Criteria:\n\n1. Patients receiving non-surgical treatment only.\n2. Patients undergoing bronchoscopy, percutaneous biopsy, or other non-surgical diagnostic or therapeutic procedures only.\n3. Clinically unstable after surgery and unable to participate in symptom assessment or recovery management.\n4. Requiring prolonged intensive care unit treatment, continuous advanced life support, or continuous intensive medical management.\n5. Severe cognitive impairment, psychiatric disorder, language communication disorder, or other conditions that preclude completion of study assessments.\n6. Unable to use a smartphone or study device and without a caregiver who can assist with use.\n7. Currently participating in another interventional clinical study that may affect the primary outcome of this trial.\n8. Any other condition judged by the investigator to make the patient unsuitable for participation in this study.","80 Years",{"count":162,"type":21},868,[62],"This study is a multicenter, prospective, randomized controlled trial designed to evaluate the effectiveness and safety of a multimodal artificial intelligence (AI)-guided postoperative recovery management system in patients after lung cancer surgery. Eligible patients will be enrolled after surgery when their clinical condition is stable and will be randomly assigned to either an AI-guided recovery management group or a usual postoperative care group.\n\nPatients in the AI-guided group will receive usual postoperative care plus a multimodal AI-based recovery management system. The system will collect patient-reported symptoms, vital signs, physical activity, respiratory rehabilitation information, recovery-related data, and, when needed, wound or chest-related images or short videos. Based on these data, the system will provide recovery feedback, general nursing advice, respiratory rehabilitation reminders, activity guidance, and risk stratification alerts. For red-flag symptoms or high-risk conditions, the system will advise patients to contact the clinical team or seek medical care.\n\nPatients in the usual-care group will receive standard postoperative management after lung cancer surgery and will complete symptom assessments at the same prespecified time points, but they will not receive AI-generated individualized recovery feedback or AI-generated risk alerts.\n\nThe primary outcome is the number of MDASI-LC-derived target symptom threshold events within 30 days after surgery. Target symptoms include pain, fatigue, disturbed sleep, shortness of breath, and cough. Secondary outcomes include overall target symptom burden, quality of recovery, time to recovery to a mild-symptom state, functional interference, respiratory rehabilitation adherence, physical activity adherence, unplanned healthcare utilization, pulmonary complications, and unplanned readmission.",[166,167,168,30],"Postoperative Care","Rehabilitation","Artificial Intelligence (Al)",[170,171,172,173],"Artificial Intelligence","Large Language Model","Postoperative Rehabilitation","Thoracic Surgery","2026-05-09",{"date":176,"type":44},"2026-05-15",{"date":178,"type":44},"2025-03-01",{"date":180,"type":21},"2026-12-31",{"name":182,"class":51},"The First Affiliated Hospital of Guangzhou Medical University",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":210,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":85},"100634199","time-to-healing-in-displaced-pediatric-diaphyseal-forearm-fractures-treated-with-bioabsorbable-compared-to-titanium-intramedullary-nails-100634199","NCT07536581","Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails","Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails: A Single-Center, Multi-Blinded, Randomized Parallel-Group, Non-Inferiority Study","FOREST","Inclusion Criteria:\n\n* Diagnosis of a traumatic diaphyseal forearm fracture of the radius, ulna, or both\n* Operative fixation required\n* Fractures must be complete (not unicortical or greenstick) AND displaced \\>50% of bone width (after attempted closed reduction) AND\u002FOR angulated \\>10° in any plane (after attempted closed reduction)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Conditions where internal fixation is contraindicated (e.g. active or potential infection)\n* Grossly open fractures (Gustilo Anderson grade \\> 2)\n* Fracture occurred more than 2 weeks prior\n* Fractures that are well managed conservatively (undisplaced or minimally displaced)\n* Previous ipsilateral forearm fracture (risk of closed medullary canal)\n* Fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)\n* Concurrent ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)\n* Unable to participate in follow-up\n* Existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)\n* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present study\n\nIntraoperative exclusion criteria:\n\n* Fractures suitable for closed reduction and casting (see 6.3.9)\n* Indication for treatment 1 (BIN) only\n* Indication for treatment 2 (ESIN) only\n* Intraoperative decision to use implants other than the devices under investigation","3 Years","13 Years",{"count":194,"type":21},60,[62],"This study looks at children with forearm fractures that need surgery. The standard treatment uses titanium nails, which usually need to be removed in a second operation later. This study compares titanium nails with bioabsorbable nails, which gradually dissolve in the body and may help some children avoid another operation.\n\nThe study will compare how quickly the fractures heal on X-ray, and also look at complications, recovery, function, and the family's experience. Children who need surgery will be randomly assigned to one of the two treatments so the comparison is fair.\n\nHypothesis: The researchers expect that fractures treated with bioabsorbable nails will heal almost as quickly as fractures treated with titanium nails, while reducing the need for later implant removal surgery.",[198,199,200,201,202,203,204,205,206,207,208,209,30],"Forearm Injuries","Radius Fractures","Ulna Fractures","Fractures, Bone","Child","Adolescent","Fracture Fixation, Intramedullary","Internal Fixation","Orthopedic Operations","Polymers","Fracture Healing","Radiography",[30,211,212,213,214,215,216,217,218,219,220,221,222,223,224],"pediatric forearm fracture","forearm shaft fracture in children","elastic stable intramedullary nailingelastic stable intramedullary nailing","ESIN","titanium elastic nail","bioabsorbable intramedullary nail","TEN","BIN","radiographic healing","radiographic union","modified Radiographic Union Score","mRUS","non-inferiority trial","randomized trial","2026-04-17",{"date":227,"type":44},"2026-04-22",{"date":229,"type":21},"2026-04",{"date":231,"type":21},"2031-12",{"name":233,"class":51},"Children's Fractures Interest Group, Denmark",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":254,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100632650","vdyne-transcatheter-tricuspid-valve-replacement-study-to-evaluate-safety-and-clinical-efficacy-in-patients-with-symptomatic-severe-tricuspid-valve-regurgitation-trivita-pivotal-trial-100632650","NCT07516444","VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)","VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation","TRIVITA","Inclusion Criteria:\n\n* Age ≥18 years old\n* Subject is willing and able to comply with all study evaluations and provide consent\n* Subject must agree not to participate in any other clinical trial for a period of one year following index procedure\n* New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory\n* At least severe symptomatic tricuspid regurgitation.\n* Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR\n* Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement\n* Functional and\u002For degenerative TR graded as at least severe\n\nExclusion Criteria:\n\n* Subject unable or unwilling to comply with study required testing and follow-up visits\n* Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study\n* Pregnant, lactating subjects, and \u002For those who plan pregnancy in the period up to one year following index procedure.\n* Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically\n* Life expectancy ≤12 months due to non-cardiac comorbidities\n* Current IV Drug user (must be free from drug abuse for ≥1 year)\n* Subject unable or unwilling to provide written, informed consent before study enrollment\n* Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System\n* Hypersensitivity to metals (such as nickel or titanium)\n* Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)\n* Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve\n* Known significant intracardiac shunt (e.g., septal defect).\n* Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure\n* Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids\n* Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility\n* Leukopenia, chronic anemia (Hgb \\\u003C 9 g\u002FdL), current thrombocytopenia (platelets \\\u003C70\u002FmcL), history of bleeding diathesis, or coagulopathy\n* Unwilling to receive blood products\n* Deep vein thrombosis and\u002For pulmonary embolism in the last 6-months",{"count":243,"type":21},730,[62],"Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.",[247,248,249,250,251,252,30,253],"Tricuspid Valve Regurgitation","Tricuspid Valve Disease","Cardiovascular Diseases (CVD)","Heart Valve Diseases","Tricuspid Valve Insufficiency","Severe Heart Valve Disease","Symptomatic Tricuspid Regurgitation",[255,240,256,257],"VDyne","TRIVITA Pivotal","Tricuspid Regurgitation","2026-03-31",{"date":260,"type":44},"2026-04-08",{"date":262,"type":21},"2026-06",{"date":264,"type":21},"2036-06",{"name":266,"class":267},"VDyne, Inc.","INDUSTRY",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":134,"minAge":18,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":293},"100631989","electroacupuncture-for-the-prevention-of-recurrent-lower-urinary-tract-infection-in-women-100631989","NCT07507851","Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women","A Randomized Controlled Trial of Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women","rLUTI","Inclusion Criteria:\n\n1. Female patients aged 18-75 years;\n2. Meeting the diagnostic criteria for recurrent lower urinary tract infections;\n3. No acute lower urinary tract infections at enrollment;\n4. Voluntary participation in this trial and signed informed consent. Only patients who meet all the above inclusion criteria can be enrolled in the study.\n\nExclusion Criteria:\n\n1. Currently receiving prophylactic antibiotics for lower urinary tract infection;\n2. Abnormal urinary tract anatomy (e.g., urinary calculi);\n3. Complicated or neurogenic genitourinary disorders, such as spinal cord injury, cauda equina injury, active pelvic inflammatory disease, active vaginitis, overactive bladder, interstitial cystitis;\n4. Requiring urinary catheterization;\n5. HIV infection, long-term use of immunosuppressants, infection with multidrug-resistant organisms, or uncontrolled diabetes mellitus;\n6. Pelvic organ prolapses of grade 2 or above;\n7. Post-void residual urine volume \\> 100 ml measured by B-ultrasound;\n8. Lactating, pregnant, or planning to conceive within the next 6 months;\n9. Implantation of a cardiac pacemaker;\n10. Malignant tumor; severe cardiac, pulmonary, cerebral, hepatic, renal, or hematological diseases, mental illness, or significant cognitive impairment;\n11. Previous history of electroacupuncture treatment;\n12. Subjects with potential poor compliance (e.g., living far from the hospital). Patients meeting any of the above exclusion criteria shall not be enrolled in the study.","75 Years",{"count":278,"type":21},312,[62],"The goal of this clinical trial is to evaluate if electroacupuncture works to prevent recurrent lower urinary tract infections in female patients. It will also learn about the safety of electroacupuncture. The main questions it aims to answer are:\n\n1. Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women?\n2. What medical problems do participants have when taking electroacupuncture?\n\nResearchers will compare electroacupuncture to sham electroacupuncture to assess if electroacupuncture works to prevent recurrent lower urinary tract infections.\n\nParticipants will:\n\n1. Take electroacupuncture or sham electroacupuncture for 30 minutes per session over a 6-month period. During the first month, treatment was administered 3 times weekly (once every other day); the second month, 2 times weekly (once every 2-3 days); and the 3-6 month, once monthly.\n2. Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations.\n3. Keep a diary of their symptoms and the number of times they use an antibiotic.",[282,283,284,30],"Urinary Tract Infections","Recurrent","Electroacupuncture","2026-03-30",{"date":287,"type":44},"2026-04-02",{"date":229,"type":21},{"date":290,"type":21},"2029-03",{"name":292,"class":51},"Yanjun Zhang, Baoyan Liu",2]