[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LMU Klinikum\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":404},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,58,90,111,140,161,193,203,230,265,289,313,335,356,380],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":43,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100053513","global-registry-and-natural-history-study-for-mitochondrial-disorders-100053513",false,"NCT05554835","Global Registry and Natural History Study for Mitochondrial Disorders","Global Mitochondrial Registry to Define Natural History and Outcome Measures to Achieve Definite Trial Readiness for Mitochondrial Disorders","GENOMIT","Inclusion Criteria:\n\n* suspected or confirmed mitochondrial disease\n* willingness to participate\n\nExclusion Criteria:\n\n* unwillingness to participate","ALL",{"count":19,"type":20},6000,"ESTIMATED","30 Years","OBSERVATIONAL","The main goal of the project is provision of a global registry for mitochondrial disorders to harmonize previous national registries, enable world-wide participation and facilitate natural history studies, definition of outcome measures and conduction of clinical trials.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Mitochondrial Diseases","Kearns-Sayre Syndrome","MIDD","SANDO","SCAE","NARP Syndrome","MELAS Syndrome","MERRF Syndrome","Coenzyme Q10 Deficiency","LHON","MNGIE","MIRAS","Barth Syndrome","MDS","Mitochondrial Myopathies","Leigh Syndrome","Pearson Syndrome","CPEO",[44],"Patient Registry","RECRUITING","2026-07-09",{"date":48,"type":49},"2026-07-13","ACTUAL",{"date":51,"type":49},"2009-02-01",{"date":53,"type":20},"2040-12",{"name":55,"class":56},"LMU Klinikum","OTHER",33,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100626997","tricuspid-intervention-and-invasive-hemodynamic-monitoring-in-heart-failure-100626997","NCT07442903","TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure","Heart Failure Monitoring Using Continuous Pulmonary Arterial or Central Venous Pressure Measurement in Patients Undergoing Transcatheter Tricuspid Valve Intervention: a Pilot and Feasability Study","TRIC-I-HF 2","Inclusion Criteria:\n\n* Age ≥18 years\n* Heart-failure NYHA class III despite optimal medical therapy\n* Heart failure related hospitalization in the 12 month prior to Cordella PA pressure sensor system implant\n* Planned tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR)\n* Willingness to participate and sign informed consent\n* Ability to perform PA pressure reading and telemonitoring\n\nExclusion Criteria:\n\n* Cardiogenic shock or hemodynamic instability\n* Previous tricuspid intervention or surgery with repair or replacement of tricuspid leaflets\n* Active endocarditis\n* Tricuspid valve stenosis (baseline tricuspid valve in-flow gradient \\> 5 mmHg)\n* Life expectancy of less than 12 months\n* Chronic renal failure requiring dialysis\n* Anatomic conditions impeding implantation of PA sensor\n* Acute pulmonary embolism or chronic thromboembolic pulmonary Hypertension (CTEPH)","18 Years",{"count":68,"type":20},45,"INTERVENTIONAL",[71],"NA","Tricuspid regurgitation (TR) is a severe and highly prevalent disease that leads to right-sided heart failure. The severity of TR is associated with increasing morbidity and mortality. While severe TR and right-sided heart failure have an impact on the quality of life and prognosis of the individual patient, repeat heart failure hospitalizations challenge limited hospital resources on an institutional level and stress the medical health care system on an economic level. Transcatheter valve interventions (TTVI) including transcatheter tricuspid edge-to-edge repair (T-TEER) and transcather tricuspid valve replacement (TTVR) have been established as effective techniques to safely reduce TR severity in many patients leading to significant improvements in quality-of-life and potential reduction of heart failure hospitalizations. However, the rate of heart failure hospitalizations remains elevated, despite technically successful TTVI. Accordingly, heart failure hospitalizations occur in approximately 15-20% of patients and often result in complicated and prolonged in-hospital treatments. Therefore, optimization of the heart failure management and reduction of post-procedural heart failure hospitalizations are unmet needs in patients after TTVI.\n\nImplantable pulmonary artery (PA) pressure sensing (IPAPS) is a novel strategy to improve heart failure management and to reduce heart failure hospitalizations. Continuous PA pressure monitoring provides an early indication of worsening heart failure trends and allows for the guidance of medical management to prevent unplanned hospitalizations. So far, this technology has been predominantly studied in patients with left-sided heart failure. The performance of PA pressure monitoring in right-sided heart failure is understudied. Also, the changes of PA pressure levels in response to TTVI has not yet been investigated. Heart failure hospitalizations in patients with right-sided heart failure are caused by gradual fluid overload resulting in shortness of breath, weight gain, peripheral edema, and ascites. Fluid overload will lead to a simultaneous increase of PA pressure, and therefore, may also be identified early by IPAPS in right-sided heart failure patients. The Cordella PA Sensor System has been designed for multi-parametric heart failure telemonitoring including PA pressure and other vital signs. In clinical trials, the Cordella PA Sensor System demonstrated a significantly lower heart failure hospitalization and all-cause mortality event rate in NYHA class III heart failure patients, when compared to historical PA pressure studies. IPAPS was associated with significant improvements in quality-of-life metrics, while complication rates were low. The Cordella PA Sensor System is expected to receive CE-marking in 2025. The proposed study will be initiated after CE-mark approval, so that all patients will be treated with CE-marked devices and on-label.\n\nIn this study we will assess the applicability of PA pressure monitoring using the Cordella Sensor device in patients with severe TR undergoing T-TEER or TTVR (n=30 patients). Included patients will undergo right-heart catheterization for evaluation of TR as indicated by clinical routine practice before TTVI. During right heart catheterization, patients receive implantation of the Cordella Sensor device. Thereafter, PA pressure will be monitored for approximately 4 weeks prior to TTVI. Subsequently, patients undergo T-TEER or TTVR as indicated and recommended by the heart team. PA pressure telemonitoring will be continued after TTVI. The change in PA pressure before TTVI compared to the first month after TTVI will be reported as primary endpoint in this pilot study. The performance of the Cordella PA Sensor System in right-sided heart failure patients for remote heart failure monitoring will be assessed over a 12-month follow-up period as the main secondary endpoint.\n\nThe concept of IPAPS has the potential to significantly improve the post-procedural heart failure management in patients after TTVI. The proposed pilot study will serve as base for the development of a larger clinical trial evaluating the concept of PA telemonitoring for improving outcomes in patients with severe tricuspid regurgitation and right-sided heart failure.\n\nIn an adjunct feasibility study, an implantable pulmonary artery pressure sensor (IPAPS) will be implanted off-label in the hepatic vein to evaluate a sensitive heart failure monitoring strategy in patients with right-sided heart failure (n = 15).",[74],"Heart Failure With Severe Tricuspid Regurgitation",[76,77,78,79,80],"Heart failure","Tricuspid regurgitation","Transcatheter tricuspid intervention","PA sensor","Remote hemodynamic management","2026-05-04",{"date":83,"type":49},"2026-05-08",{"date":85,"type":49},"2026-02-17",{"date":87,"type":20},"2029-03",{"name":55,"class":56},2,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":97,"targetDuration":99,"studyType":22,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":89},"100628353","assessment-of-physical-activity-and-cardiovascular-outcomes-in-patients-with-chronic-heart-failure-100628353","NCT07460531","Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure","SOPHIE","Inclusion Criteria:\n\n* Heart failure NT-proBNP \\>600 pg\u002Fml (at least once in the history) NYHA-Class II-IV HFrEF - heart failure with reduced ejection fraction; LVEF ≤40% or HFmrEF - heart failure with mildly reduced ejection fraction; LVEF 41% - 49% or HFpEF - heart failure with preserved ejection fraction; LVEF ≥50%\n* Age ≥18 years old\n* Willingness to participate in the study, confirmed by a signed informed consent form\n* Ownership of a pedometer (e.g. smartwatch, activity tracker, smartphone-app, analogical pedometer)\n\nExclusion Criteria:\n\n* Disease or disability that prevents physical activity\n* Hospitalisation due to heart failure within the last three months",{"count":98,"type":20},2000,"3 Years","SOPHIE is a prospective, multicentre, observational cohort study aiming to enrol 2,000 CHF patients. Baseline assessments include validated PA questionnaires (GPAQ, IPAQ, KCCQ) and seven-day step counts from commercially available pedometer devices. Follow-up is conducted every six months via telephone, repeating PA assessments and recording cardiovascular events, hospitalisations, and patient-reported outcomes.",[102],"Heart Failure","2026-03-09",{"date":105,"type":49},"2026-03-11",{"date":107,"type":49},"2025-02-01",{"date":109,"type":20},"2031-06-30",{"name":55,"class":56},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":89},"100605214","amino-acid-pet-based-response-assessment-in-idh-mutant-gliomas-appear-100605214","NCT07159607","Amino Acid PET-based Response Assessment in IDH-mutant Gliomas (APPEAR)","Positron Emission Tomography-based Response Assessment in Isocitrate Dehydrogenase (IDH)-Mutant Gliomas - a Bicentric, Prospective, Observational Study","APPEAR","Inclusion Criteria:\n\n* ≥ 18 years\n* Histologically verified diffuse IDH-mutant glioma (astrocytoma, oligodendroglioma) of any grade as defined in the WHO classification of tumors of the central nervous system\n* Postoperative treatment according to current standard of care at the time of study inclusion\n* Performance of amino acid PET as part of clinical routine\n\nExclusion Criteria:\n\n* Inclusion in another clinical trial\u002Finvestigational study involving an experimental therapy or study medication\n* Inclusion criteria not met",{"count":120,"type":20},100,"Background: The radiological follow-up of diffuse gliomas is challenged by the difficult distinction of true progression from treatment-related changes. To this end, the Response Assessment in Neuro-Oncology (RANO) Working Group has issued specific recommendation for the standardized evaluation of magnetic resonance imaging (MRI). In addition, positron emission tomography (PET) using radiolabeled amino acids allows for the delineation of metabolically active tumor regions in brain tumors, and guidelines for PET-based response assessment have been recently proposed (PET RANO 1.0). However, well-annotated data on longitudinal PET alterations before and during treatment and follow-up are missing in isocitrate dehydrogenase (IDH)-mutant gliomas, particularly as tumor entities defined by IDH mutations have been established only recently and data on PET imaging mainly rely on previous brain tumor classification frameworks.\n\nAims: This bicentric, prospective, observational study aims to collect data on imaging-based disease monitoring in patients with IDH-mutant gliomas. Specifically, this study aims to investigate longitudinal changes of amino acid PET tracer uptake during treatment in IDH-mutant gliomas and to evaluate the correlation between amino acid PET uptake at baseline and response to postoperative standard of care treatment.\n\nPatient cohort\u002Fmethods: Adult (age ≥ 18 years) patients diagnosed and\u002For treated at the Medical University of Vienna (Vienna, Austria) or the LMU Hospital Munich (Munich, Germany) with histologically verified diffuse IDH-mutant glioma (oligodendroglioma, astrocytoma of all grades) and PET imaging for routine follow-up before, during and after treatment will be included. Clinical and imaging data will be collected in a standardized manner and correlated with treatment response. Primary endpoint is progression-free survival (PFS) according to RANO 2.0 criteria, secondary endpoints include PFS according to PET-RANO 1.0 criteria, time to next intervention (TTNI) and overall survival (OS).\n\nOriginality\u002Frelevance: This study will generate data that will inform future response assessment frameworks and the design of future clinical trials in IDH-mutant glioma.",[123],"IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)",[117,125,126,127,128,129,130,131],"PET-basierte Beurteilung des Therapieansprechens in Isocitrat-Dehydrogenase (IDH)-mutierten Gliomen - eine prospektive Beobachtungsstudie","Isocitrate dehydrogenase mutant gliomas","Positron emission tomography","FET PET","PET RANO","Amino acid PET","glioma","2025-09-05",{"date":134,"type":49},"2025-09-08",{"date":136,"type":49},"2025-07-17",{"date":138,"type":20},"2030-07-16",{"name":55,"class":56},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100562207","intraoperative-confocal-laser-scanning-microscopy-with-use-of-ai-for-optimized-surgical-excision-of-basal-cell-carcinoma-100562207","NCT06600165","Intraoperative Confocal Laser Scanning Microscopy With Use of AI for Optimized Surgical Excision of Basal Cell Carcinoma","Intraoperative Confocal Laser Scanning Microscopy and Artificial Intelligence for Optimized Surgical Excision of Basal Cell Carcinoma","Inclusion Criteria:\n\n* Patients with Basal Cell Carcinoma\n\nExclusion Criteria:\n\n* Patient unable to consent",{"count":148,"type":20},1000,"The aim is to use AI to assist surgeons in analyzing CLSM tissue slide images obtained during BCC surgeries with the aim to integrate it in real time. We plan to use AI to analyze CLSM images of BCCs and distinguish between tumor tissue, inflammatory tissue, and non-tumor\u002Fnon-inflammatory tissue. This approach would provide surgeons with real-time feedback and automated image analysis, leading to a more targeted and efficient approach to tissue analysis. By improving the accuracy and speed of tissue analysis, our proposal could ultimately improve operative patient outcomes and benefit healthcare professionals.",[151],"Basal Cell Carcinoma","2025-09-02",{"date":154,"type":49},"2025-09-09",{"date":156,"type":49},"2025-03-01",{"date":158,"type":20},"2027-12-31",{"name":55,"class":56},1,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":169,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":170,"conditions":171,"keywords":183,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":191,"locationsCount":192},"100479391","tircon-international-nbia-registry-100479391","NCT05522374","TIRCON International NBIA Registry","TIRCON International NBIA (Neurodegeneration Associated With Brain Iron Accumulation) Patient Registry and Natural History Study","TIRCON","Inclusion Criteria:\n\n* suspected or confirmed NBIA\n* willingness to participate\n\nExclusion Criteria:\n\n* unwillingness to participate",{"count":98,"type":20},"TIRCON-reg aims to\n\n* continue the provision of a global registry and natural history study for NBIA disorders\n* harmonize and cover existing national and single site registries\n* enable participation of countries and single sites that so far have no access to an NBIA registry\n* join forces in order to recruit sufficient numbers of patients\n* define the natural history of NBIA disorders\n* define the most appropriate outcome measures\n* inform the design and facilitate the conduction of clinical trials",[172,173,174,175,176,177,178,179,180,181,182],"Neurodegeneration With Brain Iron Accumulation (NBIA)","Pantothenate Kinase-associated Neurodegeneration (PKAN)","Beta-Propeller Protein-Associated Neurodegeneration (BPAN)","Mitochondrial Membrane Protein Associated Neurodegeneration (MPAN)","Fatty Acid Hydroxylase-associated Neurodegeneration (FAHN)","Kufor Rakeb Syndrome","Neuroferritinopathy","Aceruloplasminemia","Woodhouse Sakati Syndrome","COASY Protein-associated Neurodegeneration (CoPAN)","PLA2G6-Associated Neurodegeneration (PLAN)",[184],"NBIA, PKAN, BPAN, MPAN, FAHN, KRS, CoPAN, PLAN,","2025-06-02",{"date":187,"type":49},"2025-06-05",{"date":189,"type":49},"2012-06-14",{"date":53,"type":20},{"name":55,"class":56},9,{"id":194,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":195,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":196,"keywords":197,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":201,"locationsCount":202},"100481885",{"count":19,"type":20},[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],[44],{"date":187,"type":49},{"date":51,"type":49},{"date":53,"type":20},{"name":55,"class":56},18,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":69,"phases":213,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":160},"100564818","efficacy-of-mitraclip-vs-pascal-for-the-treatment-of-mitral-regurgitation-in-an-all-comer-population-100564818","NCT06634121","Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population","Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population","LEAFLET I","Inclusion Criteria:\n\n* Age equal or above 18 years\n* Written consent\n* Heart Team recommends M-TEER\n\nExclusion Criteria:\n\n* Mitral Stenosis (MV mean PG \\> 5 mmHg)\n* Cardiogenic shock or hemodynamic instability at the time of intervention\n* Active endocarditis\n* Participant in another interventional cardiology study",{"count":212,"type":20},180,[71],"To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.",[216,217,102],"Mitral Regurgitation","Valvular Heart Disease",[216,219,220,221],"TEER","MitraClip","PASCAL","2024-10-08",{"date":224,"type":49},"2024-10-09",{"date":226,"type":49},"2024-04-01",{"date":228,"type":20},"2028-04-01",{"name":55,"class":56},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":238,"sex":17,"minAge":239,"maxAge":66,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":242,"conditions":243,"keywords":248,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100247201","pediatric-arm-of-dzl-all-age-asthma-cohort-100247201","NCT02496468","Pediatric Arm of DZL All Age Asthma Cohort","The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Pediatric Arm","ALLIANCE","Inclusion Criteria:\n\n* informed consent by parents (and by children if age \\> 8 years)\n* age 6 months to 18 years\n* term delivery (≥ 37 weeks)\n* active\u002Fpassive understanding of German\n* age 6 months - \\\u003C 6 years: preschool wheeze (more than two episodes of wheeze during 12 months prior to inclusion)\n* age at least 6 years: doctor diagnosed asthma (according to current guidelines)\n\nExclusion Criteria:\n\n* known inborn or perinatal pulmonary disease\n* airway malformation\n* oxygen therapy after birth with a duration of more than 24 hours\n* ventilator support or mechanical ventilation after birth\n* diagnoses of cystic fibrosis; primary ciliary dyskinesia\n* heart failure diagnosed after birth affecting pulmonary circulation\n* major respiratory diseases such as e.g. interstitial lung disease\n* any current non-atopic comorbidity\n* fever of at least 38.5°C during the last two weeks prior to the planned first visit",true,"6 Months",{"count":241,"type":20},1500,"Despite its common occurrence, still little is known about pathomechanisms determining different wheeze and asthma trajectories and phenotypes in children, and those beginning in adulthood. Therefore, deciphering underlying determinants for different childhood and adult asthma phenotypes is urgently needed to develop personalized treatment approaches targeting distinct underlying mechanisms. Thereby, secondary prevention early in the disease process can also be achieved. The decoding of such mechanisms and their translation to the individual patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for Lung Research' (DZL).",[244,245,246,247],"Asthma","Wheeze","Hypersensitivity","Endophenotype",[249,250,251,252,253,254,255],"childhood asthma","preschool wheeze","adult asthma","transition","phenotype","endotype","trajectory","2024-08-27",{"date":258,"type":49},"2024-08-28",{"date":260,"type":4},"2013-01",{"date":262,"type":20},"2027-12",{"name":55,"class":56},5,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":69,"phases":275,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":280,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100540371","phase-2-combining-clemastine-and-aerobic-exercise-to-treat-cognitive-dysfunction-in-schizophrenia-by-targeting-myelin-plasticity-100540371","NCT06315972","Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity","OligoTreat","Inclusion Criteria:\n\n* • Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations\n\n  * A DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview\n  * Age between 18 and 65 years EudraCT Number: 2022-000054-28 Confidential OligoTreat Study Protocol Version 2.0 06.09.2023 9 of 62\n  * Total Positive and Negative Syndrome Scale (PANSS) score ≤ 75 at V0\n  * Stable antipsychotic treatment dose for at least one week prior to inclusion\n  * Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion\n  * Female participants with reproductive potential must have a negative beta- HCG serum pregnancy test as part of the screening visit\n  * Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization\n  * Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent\n\n  * Coercive treatment at the time of study inclusion\n  * Treatment-naïve schizophrenia defined as cumulative treatment with an antipsychotic agent lifetime for \\\u003C30 days\n  * Insufficient understanding of the German language\n  * Patients with primary active (moderate or severe) substance use disorder (other than nicotine) according to MINI interview (DSM-V): patients fulfilling early (\\>3 months) or sustained (\\>12 months) remission criteria and\u002For with low severity of substance use disorder according to MINI are eligible for the study\n  * Known clinically relevant CNS disorder(s), such as epilepsy or history of seizures\n  * Concomitant use of any other putative remyelinating therapy as determined by investigator\n  * Co-occurrent unstable somatic condition\n  * Known porphyria\n  * Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion\n  * Known intolerance, allergy\u002Fcontraindications to one of the study drugs or any of the excipients or other agents with similar chemical properties as the study drugs (such as other arylalkylamine antihistamines)\n  * Clinically relevant liver and\u002For renal impairment (serum creatinine \\>1.5mg\u002Fdl or eGFR\\\u003C30 ml\u002Fmin\u002F1.73 m2 at screening, AST or ALT \\> 2-times the upper limit of normal at screening)\n  * Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics\n  * Clinically relevant cardiac comorbidities (i.e. Long QT-syndrome)\n  * Current hypokalaemia and\u002For clinically relevant hyponatraemia at screening\n  * Patient-reported hereditary galactose-intolerance and\u002For Lapp lactosedeficiency, lactose intolerance and\u002For glucose-galactose malabsorption\n  * Pregnancy or breast-feeding\n  * Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer.\n  * For the optional MRI assessments: potential MRI contraindication(s)","65 Years",{"count":274,"type":20},90,[276],"PHASE2","Schizophrenia (SZ) is a broad clinical entity characterized by different subjective symptoms,behavioural signs, and disease course. Research has pointed to numerous biological indicators tentatively associated with neurocognitive dysfunction, brain structural and neurochemical alterations. Cognitive deficits occur as early as the prodromal phase of the illness and significantly determine its outcome. Pathophysiologically, SZ is regarded as a disconnectome disorder in which frontal and temporal brain regions are functionally disconnected, which contributes substantially to the development of cognitive dysfunction.\n\nImpaired connectivity is related to synaptic (microconnectivity) and myelin (macroconnectivity) plasticity. With design-based stereology, a decreased number of oligodendrocytes (OLs) in the CA4 hippocampal subregion as the basis for disturbed myelination and impaired cognition, but also a decrease in the prefrontal cortex were observed. Animal studies demonstrated that clemastine enhances remyelination by increasing the differentiation of oligodendrocyte precursor cells (OPCs) and showed that aerobic exercise increases the rate of remyelination and proliferation of OPCs; this clinically meaningful effect of aerobic exercise is stronger in combination with clemastine. Furthermore, aerobic exercise improves everyday functioning, measured by the Global Assessment of Functioning (GAF) scale, and cognitive dysfunction in SZ and increases hippocampal volume, especially the volume in the hippocampal CA4 subregion. This regional volume change correlates negatively with global and cell-specific polygenic risk scores (PRSs), indicating that OPCs are involved in the genetic risk mechanisms and disturbed plasticity underlying SZ. In patients with multiple sclerosis, 90 days' administration of clemastine fumarate 10.72 mg\u002Fday, corresponding to clemastine 8 mg\u002Fday, significantly decreased the P100 latency delay of visual evoked potentials (VEPs) as a sign of myelin repair. In a bicentric, randomized, double-blind, controlled phase IIb clinical trial with a 2-arm parallel group design in patients with SZ, the study will compare the effects of aerobic exercise training plus clemastine vs. aerobic exercise training plus placebo over a period of 3 months on 1) everyday functioning and 2) working memory as primary outcomes.",[279],"Schizophrenia","NOT_YET_RECRUITING","2024-03-18",{"date":283,"type":49},"2024-03-20",{"date":285,"type":20},"2024-04",{"date":287,"type":20},"2028-04",{"name":55,"class":56},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":297,"targetDuration":299,"studyType":22,"phases":4,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":160},"100539701","european-registry-of-transcatheter-repair-for-tricuspid-regurgitation-100539701","NCT06307262","European Registry of Transcatheter Repair for Tricuspid Regurgitation","European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)","EuroTR","Inclusion Criteria:\n\n* Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve\n* Age ≥ 18 years",{"count":298,"type":20},3000,"5 Years","To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.",[302,217,102],"Tricuspid Regurgitation",[77,219,304],"edge-to-edge repair","2024-03-13",{"date":307,"type":49},"2024-03-15",{"date":309,"type":49},"2023-10-23",{"date":311,"type":20},"2030-12-31",{"name":55,"class":56},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":272,"enrollmentInfo":320,"targetDuration":4,"studyType":69,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":160},"100512736","insight-into-hippocampal-neuroplasticity-in-schizophrenia-by-investigating-molecular-pathways-during-physical-training-100512736","NCT05956327","Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training","BrainTrain","Inclusion Criteria:\n\n* Written informed consent for voluntary study participation.\n* Patients with schizophrenia: diagnosis of schizophrenic psychosis according to ICD10 and DSM V,\n* Positive And Negative Syndrome Scale (PANSS) total score ≤ 75 before the start of the intervention\n* Reliable contraception in women of childbearing age\n* Patients must have been treated with individualized medication according to valid treatment guidelines. All antipsychotic substances are allowed, also as depot medication. Treatment with one as well as with two antipsychotic substances is possible. The additional administration of low- and medium-potency antipsychotic substances as on-demand medication for the treatment of agitation and sleep disorders is possible, provided that the daily dosage of 150 CPZ units is not exceeded. The active substance and dose of the individualized antipsychotic medication used to achieve the inclusion criterion of psychopathological symptom remission must be constant for at least 2 weeks before inclusion in the study.\n\nExclusion Criteria:\n\n* Lack of reliability and sanity (examined by an independent psychiatrist)\n* Positive urine drug screen for illicit drugs (except benzodiazepines)\n* Acute suicide risk\n* Other relevant psychiatric axis-I disorders according to the diagnostic testing procedure (Mini International Neuropsychiatric Interview, MINI)\n* Other relevant neurological or other disorders\n* Pregnancy or lactation",{"count":321,"type":20},156,[71],"Aerobic endurance training has shown positive effects on symptoms, cognition, daily functioning, and the structure of the hippocampus in patients with schizophrenia. The study investigates genetic and epigenetic influences on neuroplastic changes following three months of endurance training. A control group performs flexibility, strength, and balance training. The main objective is to examine the association between a genetic risk score for schizophrenia and volume increase in the CA4\u002FDG region of the hippocampus. Additional goals include examining changes in synapses, brain structure, function, and metabolism, as well as clinical symptoms and cognitive performance.",[279,325,326],"Neuronal Plasticity","Exercise","2023-11-17",{"date":329,"type":49},"2023-11-21",{"date":331,"type":49},"2023-09-29",{"date":333,"type":20},"2026-09",{"name":55,"class":56},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":69,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":160},"100490545","prevention-of-pacemaker-lead-induced-tricuspid-regurgitation-by-transesophageal-echo-guided-implantation-place-100490545","NCT05667519","Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)","PLACE","Inclusion Criteria:\n\n* indication for right ventricular lead implantation according to current guidelines\n\nExclusion Criteria:\n\n* preexisting tricuspid regurgitation ≥ grade 2\n* other severe heart valve disease\n* history of tricuspid valve treatment\n* preexisting right ventricular lead\n* chronic dialysis\n* contraindication for transesophageal echocardiography",{"count":343,"type":20},324,[71],"This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.",[302,347],"Pacemaker Complication","2022-12-19",{"date":350,"type":49},"2022-12-28",{"date":352,"type":49},"2022-10-01",{"date":354,"type":20},"2027-10",{"name":55,"class":56},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":364,"targetDuration":99,"studyType":22,"phases":4,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":379},"100431457","tendyne-european-experience-registry-100431457","NCT04898335","Tendyne European Experience Registry","TENDyne European expeRience Registry","TENDER","Inclusion Criteria:\n\n* Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting\n* Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements\n\nExclusion Criteria:\n\n* Patients not providing written informed consent",{"count":365,"type":20},400,"TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.",[216],[369,370,371],"mitral regurgitation","Tendyne","transcatheter mitral valve replacement","2021-05-18",{"date":374,"type":49},"2021-05-24",{"date":376,"type":49},"2021-04-15",{"date":158,"type":20},{"name":55,"class":56},30,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":386,"targetDuration":299,"studyType":22,"phases":4,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":403,"locationsCount":160},"100412659","german-registry-for-transcatheter-tricuspid-valve-interventions-100412659","NCT04653428","German Registry for Transcatheter Tricuspid Valve Interventions","Inclusion Criteria:\n\n* Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair\n* Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.\n\nExclusion Criteria:\n\n* No agreement to participation\n* Age \\\u003C 18 years",{"count":387,"type":20},600,"Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.",[302,390,391],"Tricuspid Valve Insufficiency","Heart Valve",[393,394,395,396],"Tricuspid regurgiation","Tricuspid valve insufficiency","Interventional treatment","Heart valve diseases","2020-11-28",{"date":399,"type":49},"2020-12-04",{"date":401,"type":49},"2020-10-01",{"date":311,"type":20},{"name":55,"class":56},""]