[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Technical University of Munich\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":738},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,43,75,101,129,155,187,213,241,271,297,324,345,375,398,432,469,496,530,564,586,619,649,678,712],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100639351","comparison-of-ai-based-smartphone-derived-gait-parameters-with-the-gold-standard-100639351",false,"NCT07613957","Comparison of AI-based Smartphone-derived Gait Parameters With the Gold Standard","Biomechanical and Technical Comparison of AI-based Smartphone-derived Gait Parameters With the Gold Standard","Inclusion Criteria:\n\n* Adults aged 18 years or older. No known acute or chronic disorder or injury of the lower extremities. Ability to walk independently. Sufficient physical capacity to complete a standardized walking test. Ability to understand the study information and provide written informed consent. German-, English-, or Spanish-speaking.\n\nExclusion Criteria:\n\n* Acute injury or disease of the lower extremity. Chronic injury or disease of the lower extremity. Inability to walk independently. Relevant motor impairment or other major limitation affecting safe gait testing. Lack of capacity to provide informed consent. Inability to understand German, English, or Spanish. Insufficient physical capacity to perform the walking test. Any condition that, in the opinion of the study team, would impair participant safety or the validity of the gait measurements.",true,"ALL","18 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","This monocentric prospective cohort study evaluates the technical agreement between artificial intelligence (AI)-based smartphone-derived gait parameters and an optical motion-capture system as the current technical gold standard for gait analysis. Wearables and smartphone-based inertial measurement units (IMUs) offer a scalable and low-threshold approach to assessing human gait mechanics outside specialized gait laboratories. However, before such approaches can be used reliably in clinical research or future clinical pathways, their technical validity and agreement with established reference systems need to be systematically quantified under controlled conditions.\n\nThe study will include 40 healthy adult volunteers without acute or chronic disorders of the lower extremities. Participants will be recruited among employees and students of the TUM School of Medicine and Health. After written informed consent, each participant will undergo standardized gait testing at the TUM Campus in the Olympiapark. During testing, participants will carry an iPhone and an Android smartphone in their trouser pockets while simultaneously being assessed with a Vicon optical motion-capture system. The walking test will consist of repeated two-minute walking trials. First, participants will walk wearing their own trousers. Subsequently, the measurements will be repeated while wearing standardized trousers with defined pocket positions at thigh level. All device and Vicon data will be recorded in parallel.\n\nThe primary objective is to evaluate the level of agreement between AI-based smartphone-derived gait parameters and Vicon-based gait analysis. Primary outcome measures include the intraclass correlation coefficient (ICC), Bland-Altman limits of agreement, mean absolute error (MAE), and root mean square error (RMSE) for key spatiotemporal and kinematic gait parameters. These parameters include gait speed, step length, cadence, step time, double support time, gait asymmetry, and lower-limb kinematic angle parameters, particularly knee range of motion. Secondary objectives include comparison between Android and iOS devices, assessment of test-retest reliability, evaluation of the influence of trouser type, and analysis of potential systematic bias.\n\nThe study is exploratory and non-invasive. It does not provide direct individual benefit to participants, but it is expected to generate relevant scientific and technical evidence regarding the accuracy, reproducibility, and limitations of smartphone-based gait analysis. The risks for participants are minimal and limited to ordinary walking-related discomfort, mild fatigue, a very low risk of stumbling, and rare minor skin irritation from motion-capture markers. No vulnerable groups will be included. Data will be anonymized and processed in accordance with the General Data Protection Regulation.",[28],"Gait Analysis on Healthy Adults",[30],"gait analysis, app, vicon, gold standard","NOT_YET_RECRUITING","2026-05-21",{"date":34,"type":35},"2026-05-29","ACTUAL",{"date":37,"type":22},"2026-06-01",{"date":39,"type":22},"2026-12-31",{"name":41,"class":42},"Technical University of Munich","OTHER",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100589989","score-study-comparing-surgery-and-rigid-collar-treatment-for-odontoid-fractures-in-adults-over-70-100589989","NCT06961578","SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70","Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)","Inclusion Criteria:\n\n* At least 70 years old\n* Acute unstable OFs (types II, III as classified by Anderson and d'Alonzo, and atypical)\n* Less than two weeks post injury\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous treatment for odontoid fracture\n* Concomitant fractures of the subaxial cervical spine necessitating surgery\n* Significant comorbidity resulting in inoperability of the patient: i.e. ASA score \\> 4\n* Neurological compromise due to displaced fracture","70 Years",{"count":52,"type":22},322,[25],"The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures are common in older adults and can significantly impact mobility, independence, and quality of life. There is currently no clear evidence to determine which treatment is better for this population. The main questions it aims to answer are:\n\n* Does surgery or conservative collar treatment lead to better improvement in daily living, measured by the Barthel Index, after 12 weeks?\n* What are the differences in pain, disability, and quality of life between the two treatments?\n\nThe study team will compare patients who receive surgical stabilization with those who are treated with a rigid cervical collar to see which approach supports better functional outcomes and healing.\n\nParticipants will:\n\n* be randomly assigned to either surgery (posterior C1-C2 screw-rod fixation) or conservative collar treatment\n* attend study visits at 12 weeks and 6 months\n* complete questionnaires on daily functioning, pain, and quality of life\n* undergo CT scans and other medical assessments\n* record collar use (for conservative group) in a diary\n* be monitored for any complications or changes in treatment (including crossover to surgery if needed)\n\nThe study aims to include 322 participants to provide evidence on which treatment helps older adults recover better from odontoid fractures with fewer complications and improved quality of life.",[56,57],"Odontoid Fracture","Elderly",[59,60,61,62,63,64],"Odontoid fracture","C2 fracture","atlantoaxial instability","atlantoaxial fusion","Barthel Index","functional outcome","RECRUITING","2026-05-05",{"date":68,"type":35},"2026-05-06",{"date":70,"type":35},"2025-08-13",{"date":72,"type":22},"2028-06-01",{"name":41,"class":42},16,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100608136","iomri-in-the-surgery-of-brain-metastases-100608136","NCT07197632","ioMRI in the Surgery of Brain Metastases.","Evaluation of the Efficacy and Safety of Intraoperative MRI in the Surgery of Brain Metastases.","MET-MRI","Inclusion Criteria:\n\n* Patients for whom surgical resection of brain metastasis is indicated\n\nExclusion Criteria:\n\n* age \\\u003C 18\n* 3T MRI contraindications",{"count":84,"type":22},154,[25],"The study aims to improve the surgical treatment of brain metastases through the use of advanced imaging techniques. The investigators are examining how intraoperative MRI (iMRI) can aid surgeons in precisely locating and removing tumors, with the potential to enhance surgical outcomes and reduce the need for additional procedures. While iMRI offers the promise of better tumor visualization during surgery, it is also associated with longer surgical times and may carry the risk of increased complications. This study seeks to carefully evaluate these aspects to determine the overall benefits and challenges of iMRI in brain metastasis surgeries. The ultimate aim is to enhance treatment effectiveness and improve recovery and health outcomes for participants dealing with brain metastases.",[88],"Brain Metastases",[90,91,92],"ioMRI","Brain metastases","Neurosurgical resection","2026-05-03",{"date":66,"type":35},{"date":96,"type":35},"2025-01-17",{"date":98,"type":22},"2030-01-01",{"name":41,"class":42},1,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":100},"100626339","exercise-timing-and-postprandial-glucose-responses-100626339","NCT07434349","Exercise Timing and Postprandial Glucose Responses","Exercise Timing and Postprandial Glucose Responses in Healthy Adults","ExTime-Glu","Inclusion Criteria:\n\n* Age 18 to 35 years\n* Body mass index 18.5 to 24.9 kg per square meter\n* Able to complete 45 minutes of continuous running at an intensity corresponding to 75 to 85 percent of maximal heart rate without stopping\n* Engages in regular endurance-type physical activity\n* Habitual waking times are compatible with the fixed breakfast time of 08:00\n* Willing and able to comply with all study procedures, including standardized meals, exercise sessions, behavioral restrictions, and continuous glucose monitoring\n* For female participants: non-pregnant and using stable hormonal contraception for at least 3 months\n\nExclusion Criteria:\n\n* Acute or chronic illness\n* Metabolic disorders or conditions associated with altered glucose or lipid metabolism\n* Use of medications known to interfere with glucose metabolism or study outcomes\n* Intolerance or allergy to components of the standardized study diets\n* Pregnancy or breastfeeding\n* Body mass index greater than or equal to 25 kg per square meter\n* Current or past eating disorder, or any medical condition or medication that could affect appetite regulation, glucose regulation, or make vigorous endurance exercise unsafe\n* Current smoking or use of nicotine-containing products","35 Years",{"count":111,"type":22},30,[25],"This interventional crossover study examines the effect of exercise timing relative to meal intake on postprandial glucose responses in healthy, physically active young adults. Participants complete five experimental conditions involving endurance exercise performed before or after breakfast or dinner, as well as a non-exercise control condition, while wearing a continuous glucose monitoring device.\n\nPostprandial glucose responses are assessed for the three consecutive meals following each exercise session. Following morning exercise, outcomes are assessed after breakfast, lunch, and dinner on the same day. Following evening exercise, outcomes are assessed after dinner on the same day and after breakfast and lunch on the subsequent day. All meals are standardized and consumed at fixed clock times.",[115,116],"Exercise Timing","Postprandial Glucose",[115,116,118,119,120],"Continuous Glucose Monitoring","Endurance Exercise","Glycemic Response","2026-04-15",{"date":123,"type":35},"2026-04-20",{"date":125,"type":35},"2026-04-01",{"date":127,"type":22},"2026-08",{"name":41,"class":42},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":100},"100632909","llm-generated-plain-language-patient-synopses-to-improve-comprehension-in-hematology-and-oncology-oncopal-100632909","NCT07519811","LLM-Generated Plain-Language Patient Synopses to Improve Comprehension in Hematology and Oncology (oncOPAL)","Prospective Randomized Controlled Trial to Evaluate Locally Implemented Large Language Models (LLMs) for Simplifying Patient Communication in Hematology and Oncology","oncOPAL","Inclusion Criteria:\n\n* Age 18 years or older\n* Inpatient of the Department of Medicine III (Hematology\u002FOncology) at TUM University Hospital (Klinikum rechts der Isar), Munich, Germany\n* Receipt of a discharge letter including the sections Current Status, Medical History, Epicrisis, and Further Management as part of routine clinical care\n* Capacity to provide informed consent\n* Written informed consent following the consent procedure\n\nExclusion Criteria:\n\n* Cognitive impairment precluding independent assessment of comprehension (e.g., dementia, severe encephalopathy)\n* Participation in another study with potential influence on the study endpoints\n* Lack of capacity to provide informed consent\n* Refusal to participate in the study",{"count":138,"type":22},150,[25],"This study tests whether patients with blood cancer or other cancers better understand their medical information when it is rewritten in plain language by an artificial intelligence (AI) system.\n\nWhen patients are discharged from the hospital, they receive a medical letter summarizing their diagnosis, treatment, and next steps. These letters are often written in technical language that is difficult for patients to understand. In this study, an AI language model running on the hospital's own secure servers rewrites parts of this letter into simpler language. A physician checks the simplified version before the patient receives it.\n\nPatients are randomly assigned to one of two groups. One group receives both the standard medical letter and the AI-simplified version. The other group receives the standard letter only. A separate group of patients who do not speak German well will receive a simplified and translated version.\n\nAfter reading their letter, all participants fill out a short questionnaire about how well they understood the information. The study takes place at TUM University Hospital (Klinikum rechts der Isar) in Munich, Germany.",[142,143],"Hematologic Neoplasms","Oncologic Disorders",[145,146,147],"Patient-Provider Communication","Patient Health Literacy","Large Language Model","2026-04-13",{"date":150,"type":35},"2026-04-16",{"date":125,"type":35},{"date":153,"type":22},"2027-04-01",{"name":41,"class":42},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":172,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":100},"100609293","development-of-an-outcome-score-for-patients-with-knee-osteoarthritis-and-knee-joint-endoprosthesis-using-an-app-100609293","NCT07212699","Development of an Outcome Score for Patients With Knee Osteoarthritis and Knee Joint Endoprosthesis Using an App","Pilot Study: Development of an Outcome Score for Patients With Knee Osteoarthritis and\u002For Knee Joint Endoprosthesis Using an App Developed at the Clinic for Orthopedics","KneeApp","Inclusion criteria:\n\n* aged 18 years or older\n* german speaking\n* signed informed consent\n* using own smartphone\n\nExclusion criteria:\n\n* age below 18 years.\n* Lack of informed consent\n* no smartphone\n* non-German-speaking",{"count":164,"type":22},1250,[25],"Total knee arthroplasty (TKA) and total hip arthroplasty (THA) is one of the most frequent orthopedic procedures. Over 50% of patients report higher expectations than their surgeons, and 10-50% remain dissatisfied postoperatively. Persistent pain, functional limitations, and unmet expectations are key drivers. Identifying risks pre- and early postoperatively is essential, alongside empowering patients through self-management.\n\nExisting scoring systems integrate PROMs, demographics, and sometimes imaging but within limited timeframes. They rarely capture functional deficits or long-term trajectories. Digital health solutions for TKA (pre-)rehabilitation exist, yet most focus on physiotherapy and education rather than predictive outcome modeling.\n\nTo address this gap, the study team has developed a novel mobile application that enables the documentation and analysis of movement data up to 10 years before surgery and throughout long-term follow-up. These data are combined with PROMs and functional test results, providing a unique basis for outcome prediction and risk stratification in TKA\u002FTHA.\n\nPrimary Objective The aim of this pilot study is to develop a composite outcome score for TKA\u002FTHA patients. This score will integrate demographic variables, PROMs, and objective functional measures (knee joint angles, gait parameters, walk tests) to identify risk factors for dissatisfaction and support predictive modeling. A machine learning algorithm will be trained using the collected dataset to predict patient satisfaction after TKA\u002FTHA.\n\nEndpoints Primary endpoint: Overall patient satisfaction Secondary endpoints: Age, height, weight, step count, step length, gait asymmetry, gait speed, double support phase, knee joint ROM, walk test, KOOS, SF-36, EQ5d, satisfaction with the app, and satisfaction with app use.\n\nStudy Population App-Group: Inclusion criteria are patients ≥18 years before or after TKA\u002FTHA. Exclusion criteria include missing consent, ineligible diagnosis, lack of smartphone, age \\\u003C18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.\n\nNon-App-Group: Inclusion criteria are patients ≥18 years before or after TKA\u002FTHA. Exclusion criteria include missing consent, ineligible diagnosis, age \\\u003C18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.\n\nHealthy-group: Inclusion criteria are healthy proband ≥18 years with no lower limb conditions. The overall procedure is identical to that of the AppGroup. Exclusion criteria include missing consent, ineligible diagnosis, no smartphone, age \\\u003C18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.\n\nMethods Design: Single-center, prospective pilot study. The app collects patient-authorized movement data already stored on smartphones as well as future data. Participants choose which data to share. In addition, they are prompted to complete gait tests and knee function tests. PROMs (KOOS, SF-36, satisfaction) are administered at regular intervals.",[168,169,170,171],"Knee Osteoarthritis","Knee Arthroplasty","Hip Osteoarthritis","Hip Arthroplasty",[173,174,175,176,177,178],"knee","app","arthroplasty","detection","risk score","hip","2026-03-31",{"date":181,"type":35},"2026-04-06",{"date":183,"type":35},"2025-10-01",{"date":185,"type":22},"2028-08-31",{"name":41,"class":42},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":100},"100630419","cll-impact-a-clinical-nutrition-trial-investigating-immune-and-metabolic-changes-in-early-stage-cll-100630419","NCT07487428","CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLL","An Interventional Study of Dietary Effects on Immune Function, Metabolism and Disease Activity in Early-Stage Chronic Lymphocytic Leukemia","CLL-IMPACT","Inclusion Criteria:\n\n* Confirmed CLL diagnosis\n* No previous treatments (watch and wait)\n* Willingness to comply to a whole-food plant-based diet for 4 weeks\n* Willingness to participate in a total of 3 blood drawings\n\nExclusion Criteria:\n\n* Emergency interventions\n* Patients that already follow a WFPB or vegan diet\n* Progression of CLL that implicates need for treatment\n* Insulin-dependent diabetes\n* Taking lipid-lowering medications (e.g. statins)\n* Body mass index (BMI) \\\u003C20 And if in the opinion of the investigator there are any concerns regarding the ability of the patient to complete the study safely.",{"count":196,"type":22},50,[25],"The goal of this clinical trial is to investigate whether a short-term (4-week) whole-food, plant-based (WFPB) diet has an effect on metabolism, immune function, and disease activity in early-stage chronic lymphocytic leukemia (CLL). The main questions the study aims to answer are:\n\n* Does a WFPB diet influence disease progression?\n* How do CLL cells and other immune cell types respond to a WFPB diet in terms of metabolism and signaling?\n\nResearchers will examine whether a WFPB diet can affect absolute lymphocyte counts in participants' blood and what metabolic or functional changes occur within the CLL cells.\n\nParticipants will:\n\n* Switch to a WFPB diet for 4 weeks following an introductory session with a certified dietary instructor.\n* Visit the clinic before starting the diet and again after 14 and 28 days for blood draws and to provide stool samples.\n* Keep a diary of all foods and drinks consumed during the week prior to and throughout the study period.",[200],"CLL (Chronic Lymphocytic Leukemia)",[202,203,204],"Diet","Nutrition","Plant-based diet","2026-03-17",{"date":207,"type":35},"2026-03-23",{"date":209,"type":35},"2024-01-01",{"date":211,"type":22},"2028-06-30",{"name":41,"class":42},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":230,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100509938","improved-muscle-metabolism-by-combination-of-muscle-activation-and-protein-substitution--imempro--100509938","NCT05919940","Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )","Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)","Inclusion Criteria:\n\n* critically ill adults (≥ 18 years of age)\n* newly admitted to the ICU (\\\u003C48h)\n* mechanically ventilated, expected to remain for at least 72h\n* enteral nutrition is feasible\n\nExclusion Criteria:\n\n* a BMI \\> 30\n* expected death or withdrawal of life-sustaining treatments\n* prior neuromuscular disease (e.g. paresis, myopathies, neuropathies)\n* injury or disease preventing neuromuscular electrical stimulation or early mobilization (e.g., elevated intracranial pressure, unstable spine)\n* a pacemaker or other electronic implant\n* allergy to components of NMES adhesive\n* have been dependent during activities of daily living prior to the hospital admission\n* a language barrier",{"count":21,"type":22},[25],"Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients.\n\nThe study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline.\n\nThe study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.",[224,225,226,227,228,229],"ICU Acquired Weakness","Muscle Atrophy","Energy Malnutrition Protein","Quality of Life","Morphological and Microscopic Findings","Metabolic Disturbance",[231],"Early Mobilization and high-protein nutrition","2026-02-28",{"date":234,"type":35},"2026-03-03",{"date":236,"type":35},"2023-06-27",{"date":238,"type":22},"2027-01-31",{"name":41,"class":42},4,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":252,"conditions":253,"keywords":261,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":270},"100347976","metabolomics-study-on-postoperative-intensive-care-acquired-muscle-weakness-100347976","NCT03810768","Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness","Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)","MIRACLE I","Inclusion Criteria:\n\n* invasive mechanically ventilated critically ill patient with expected intensive care unit stay \\> 3 days\n* postoperative patient\n* ≥ 18 years old\n* American Society of Anesthesiology (ASA) classification ≥ III\n\nExclusion Criteria:\n\n* moribund patient\n* non-curative care (comfort care)",{"count":250,"type":22},20,"OBSERVATIONAL","In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing.\n\nAim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.",[254,255,256,257,258,259,260],"Metabolomics","Critical Care","Critical Illness","Critical Illness Myopathy","Critical Illness Polyneuropathy","Intensive Care (ICU) Myopathy","Muscle Weakness",[262,263,264],"pilot trial","muscle biopsy","blood metabolome",{"date":234,"type":35},{"date":267,"type":35},"2022-09-02",{"date":39,"type":22},{"name":41,"class":42},3,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":279,"studyType":251,"phases":4,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":100},"100625260","real-world-neuromodulate-investigating-non-invasive-brain-stimulation-for-neuropsychiatric-disorders-at-tum-100625260","NCT07420322","Real-World NeuroModulate: Investigating Non-Invasive Brain Stimulation for Neuropsychiatric Disorders at TUM","Inclusion Criteria:\n\nAge 18 years or older\n\nClinical indication for non-invasive brain stimulation due to a depressive episode (e.g., unipolar or bipolar depression) or predominant depression-associated symptoms (e.g., negative symptoms in schizophrenia-spectrum disorders)\n\nInsufficient response to first-line treatments and\u002For patient preference for brain stimulation treatment\n\nCapacity and willingness to provide written informed consent\n\nExclusion Criteria:\n\nAcute suicidal risk\n\nPresence of a significant neurological disorder or condition, including:\n\nIncreased intracranial pressure\n\nSpace-occupying brain lesions\n\nHistory of cerebrovascular accident within the last 12 months\n\nIncidental structural brain abnormalities on MRI requiring further diagnostic clarification\n\nFor TMS specifically:\n\nNon-removable ferromagnetic implants in or near the stimulation site (e.g., cochlear implants, implanted neurostimulators, metallic clips or nails)\n\nOther treatment-relevant ferromagnetic implants (e.g., cardiac pacemakers)",{"count":278,"type":22},100,"4 Months","In this study, patients diagnosed with a depressive syndrome and with a clinical indication for treatment will receive an acute course of transcranial magnetic stimulation (TMS). The treatment consists of 20 TMS sessions administered over a period of four weeks (five sessions per week).\n\nMagnetic resonance imaging (MRI) will be performed at four time points: prior to the start of treatment, after 10 treatment sessions, after completion of all 20 sessions, and at a three-month follow-up after the end of treatment. The MRI data will include different imaging modalities to assess treatment-related neurobiological changes.\n\nThe primary objective is to investigate changes in neuroimaging markers over the course of TMS treatment and to examine their associations with clinical response and behavioral as well as clinical outcome measures. Another key goal of the study is the identification of markers allowing for early prediction of treatment response to TMS and, additionally, for the prediction of relapse at follow-up.",[282],"Depressive Syndrom",[284,285,286,287,288],"Depressive Disorder","TMS","rTMS","iTBS","MRI","2026-02-12",{"date":291,"type":35},"2026-02-19",{"date":293,"type":35},"2024-08-15",{"date":295,"type":22},"2026-08-15",{"name":41,"class":42},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":323,"locationsCount":100},"100598862","mavacamten-enables-exercise-in-hypertrophic-obstructive-cardiomyopathy-100598862","NCT07077005","Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy","MavaEnEx-HOCM: Mavacamten Enables Exercise Training in Patients With Hypertrophic Obstructive CardioMyopathy. A Pilot Study","MavaEnEx","Inclusion Criteria:\n\n* Age ≥18 years of age\n* Diagnosis of hypertrophic obstructive cardiomyopathy\n* ≥12 weeks of unchanged dosage of mavacamten\n* Peak left ventricular outflow tract gradient ≤ 50 mmHg at rest and during stress echocardiography\n* Left ventricular ejection fraction ≥50% at study inclusion\n* New York Heart Association classes I-II\n\nExclusion Criteria:\n\n* Syncope or sustained ventricular tachycardia within 6 months prior to study inclusion\n* Corrected QT-interval (Fridericia-formula) ≥ 500 ms\n* Paroxysmal or intermittent atrial fibrillation (AF) on screening electrocardiogram\n* Persistent or permanent AF without anticoagulation for ≥4 weeks\n* Previous transcoronary ablation of septal hypertrophy or surgical myectomy\n* Ventricular tachycardia, significant ST-elevation or depression upon baseline cardiopulmonary exercise testing\n* ≥ grade II valve insufficiencies or stenoses during resting echocardiography\n* Prior implantable cardioverter defibrillator-implantation\n* Sudden Cardiac Death Risk Score ≥4%","99 Years",{"count":307,"type":22},24,[25],"Patients with hypertrophic obstructive cardiomyopathy and New York Heart Association Class I-II under stable treatment with mavacamten (at least 12 weeks without change of dosage) and a peak left ventricular outflow tract obstruction \\\u003C50mmHg undergo either 6 weeks of structured moderate intensity endurance and resistance training (supervised, 3x\u002Fweek, intervention, IT) or usual care (UC). Patients within 1 hour of travel to the training venue will be referred to IT, while those with more than 1 hour will join UC.\n\nAt baseline (visit 1, V1) and after 6 weeks of exercise intervention (visit 2, V2) all patients undergo a medical exam, resting and stress echocardiography and receive a questionnaire on the quality of life (Kansas City Cardiomyopathy Questionnaire). Cardiac biomarkers are assessed. 3 hours after stress echocardiography cardiopulmonary exercise testing is performed to measure peak oxygen consumption (VO2peak).\n\nThe primary outcome is safety. Secondary outcomes include the change of VO2peak, changes in cardiac biomarkers, resting and stress echocardiographic variables, quality of life and variables of cardiopulmonary exercise testing from V1 to V2.",[311],"Cardiomyopathy, Hypertrophic",[313,314,315,316],"exercise capacity","mavacamten","safety","exercise training","2025-12-18",{"date":319,"type":35},"2025-12-26",{"date":321,"type":35},"2025-11-01",{"date":238,"type":22},{"name":41,"class":42},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":305,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":337,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":100},"100566116","alex-dhf-ablation-and-exercise-in-diastolic-heart-failure-100566116","NCT06650995","AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure","AlEX-DHF","Inclusion Criteria:\n\n* Diagnosed heart failure with preserved ejection fraction\n* Symptomatic short-persistent atrial fibrillation (diagnosis within 1 year of study inclusion)\n\nExclusion Criteria:\n\n* Paroxysmal, long-persistent or permanent atrial fibrillation\n* Clinically unstable coronary artery disease or acute coronary syndrome\n* Physical and\u002For mental inability to perform exercise testing\n* Prior ablation therapy\n* Precapillary pulmonary hypertension at rest\n* Intracardiac shunts\n* Left ventricular ejection fraction \\\u003C50%\n* High-degree valve insufficiency or stenosis (greater than grade 1 at rest)",{"count":21,"type":22},[25],"The investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). It is hypothesized that the combination of ablation and exercise better improves peak oxygen consumption (VO2peak) through improvement of peripheral (exercise training) and central (ablation) adaptations.\n\nExercise intervention will contain a 12-week combined, video-based, supervised, endurance, resistance and respiratory training.",[335,336],"HFpEF - Heart Failure With Preserved Ejection Fraction","Atrial Fibrillation",[313,338],"ablation",{"date":319,"type":35},{"date":341,"type":22},"2026-02-01",{"date":343,"type":22},"2027-06-30",{"name":41,"class":42},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":360,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":374},"100613697","at-home-tdcs-as-maintenance-therapy-100613697","NCT07269964","At-Home tDCS as Maintenance Therapy","At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study","MaintenanceDC","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode).\n* Clear indication for maintenance therapy after successful acute treatment (esketamine, rTMS, or ECT) with remission\u002Fimprovement of symptoms.\n* Capacity to provide informed consent, confirmed in a physician-led consent discussion.\n\nExclusion Criteria:\n\n* Currently in the acute treatment phase of an affective disorder and non-response to previous treatments.\n* Currently clinically relevant Axis II disorders.\n* Suicidal risk, including suicidal ideation.\n* Contraindications for tDCS: e.g., skin disease at electrode sites, cochlear implants.\n* Neurological, somatic, or psychiatric comorbidities that could compromise validity or safety.",{"count":111,"type":22},[25],"The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment.\n\nParticipant population:\n\nAdults (18+) with depressive disorder who had already improved\u002Fstabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy).\n\nMain questions:\n\nFeasibility: Do participants reliably complete the home program and stay in the study?\n\nPreliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)?\n\nParticipants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up\u002Fdown for comfort.\n\nDuring treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks.\n\nWhere:\n\nDepartment and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich\n\nSafety \\& data privacy:\n\nThe device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.",[357,358,359],"MDD","Severe Depression","Major Depressive Episode",[361,362,363,364,365],"Non Invasive Brain Stimulation (NIBS)","tDCS","at-home treatment","tdcs at home","transcranial direct current stimulation","2025-11-25",{"date":368,"type":35},"2025-12-08",{"date":370,"type":35},"2024-10-01",{"date":372,"type":22},"2026-11-29",{"name":41,"class":42},2,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":100},"100608299","comparison-of-complication-rate-functional-outcome-and-quality-of-life-between-standard-therapy-versus-fast-track-therapy-in-patients-following-hip-replacement-surgery-100608299","NCT07199751","Comparison of Complication Rate, Functional Outcome and Quality of Life Between Standard Therapy Versus Fast-track Therapy in Patients Following Hip Replacement Surgery","Vergleich Der Komplikationsrate, Des Funktionellen Outcomes Und Der Lebensqualität Zwischen Standard Therapie Versus Fast Track Therapie Bei Patienten Und Patientinnen Nach Hüft-TEP Operationen","Inclusion Criteria:\n\n* Age ≥18 years\n* The patient will undergo surgery at Klinikum rechts der Isar, Technical University of Munich (TUM)\n* Written informed consent for participation in the study after detailed explanation of the nature, significance, risks and scope of the clinical trial\n* Written informed consent from the patient for data collection and data processing, with the patient fully informed.\n* Sufficient German language skills of the patient.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* The patient is under guardianship, legally incapacitated or has limited legal capacity\n* Only partial weight-bearing permitted",{"count":383,"type":22},90,"The fast track group vs. control group will be compared with regard to hospitalization time and the non-inferiority of the fast track group vs. control group with regard to HOOS will be assessed.\n\nThe questionnaires will only be collected in the study: Eq-5d-5l, HOOS, self-efficacy, enjoyment of movement, fear of movement, pain catastrophizing.",[386],"Coxarthrosis",[388,389],"enhanced recovery","physiotherapy","2025-09-26",{"date":392,"type":35},"2025-09-30",{"date":394,"type":35},"2025-06-01",{"date":396,"type":22},"2025-12-31",{"name":41,"class":42},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":413,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":374},"100601250","strengthening-relationships-and-mental-health-through-a-couples-based-economic-empowerment-intervention-100601250","NCT07108049","Strengthening Relationships and Mental Health Through a Couples-Based Economic Empowerment Intervention","A Randomized Controlled Trial of a Couple-Based Economic Empowerment Intervention to Improve Relationship Quality and Mental Health in Three States of India","Inclusion Criteria:\n\n* Women: 18 - 49 years, Men: 18+\n* Couples: Married and co-habitating, husband-wife pairs, who regard the selected cluster in the states Maharashtra, Andhra Pradesh, or Rajasthan of India as their primary residence for the study period.\n* Consent: Both partners provide written informed consent and agree to six sessions, baseline and endline surveys, and SMS follow-ups.\n* Education: Primary schooling (4th grade) complete\n* Comprehension: Both partners understand the local language used in sessions.\n* Availability: No plans for relocation or prolonged absence before endline.\n\nExclusion Criteria:\n\n* Either partner \\\u003C 18 years\n* Refusal of consent or unwillingness to participate in sessions or data collection by either partner.\n* Serious physical or mental condition that prevents safe, active participation (e.g., severe mental illness, debilitating disease).",{"count":406,"type":22},4500,[25],"This sub-study is part of a larger randomized controlled trial (RCT) titled Disentangling and Preventing Economic Violence against Women (ECOVI). It is conducted in rural and urban communities across Maharashtra, Andhra Pradesh, and Rajasthan, India. The sub-study evaluates the impact of a couples-based financial literacy and gender-transformative intervention on relationship strength, empathy, and mental health among married couples. Using a two-arm cluster RCT design, 150 clusters (villages or community units) are randomized to intervention or control, with \\~15 husband-wife pairs per cluster (approximately 2,250 couples in total). Outcomes are measured at baseline (pre-intervention) and endline (post-intervention) approximately six months after delivery of the intervention to assess changes in perceived relationship strength, empathy (using an adapted relationship strengths and empathy scale), and mental health (General Health Questionnaire-6, GHQ-6). The study will also explore whether improvements in relationship strength and empathy mediate the intervention's effect on mental health outcomes.",[410,411,412],"Mental Health","Empathy","Relation, Interpersonal",[414,415,416,417,411,410,418,419,420,421,422,423],"Couples Intervention","Economic Empowerment","Gender Transformation","Relationship Strength","GHQ-6","Cluster RCT","India","Family Economic Wellbeing","Marital Relationship Strength","Couple-based Empathy","2025-09-22",{"date":426,"type":35},"2025-09-24",{"date":428,"type":35},"2025-07-29",{"date":430,"type":22},"2027-06",{"name":41,"class":42},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":17,"sex":18,"minAge":438,"maxAge":279,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":468},"100550867","phase-4-anti-viral-action-against-type-1-diabetes-autoimmunity-100550867","NCT06452654","Anti-viral Action Against Type 1 Diabetes Autoimmunity","Inclusion Criteria:\n\n1. Ages between 3.00 and 4.00 months at the time of enrollment.\n2. A high genetic risk (\\>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR\u002FDQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status.\n3. Written informed consent signed by the custodial parent(s).\n\nExclusion Criteria:\n\n1. Previous hypersensitivity to the excipients of the vaccine.\n2. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study. These include immune deficiencies, and conditions or treatments that lead to immune suppression.\n3. Likely poor compliance due to expected change in residency.\n4. Diagnosis of diabetes prior to recruitment or randomisation\n5. Current use of any other investigational drug","3 Months",{"count":440,"type":22},2252,[442],"PHASE4","The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB.1.5 or new variant Comirnaty vaccines ) or placebo from age 6 months.\n\nThe study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes.\n\nThe primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood.\n\nSecondary objectives are:\n\n1. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.\n2. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and\n3. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood.\n\nFurther exploratory objectives are described in the study protocol.\n\nStudy participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (NCT03316261).\n\nEligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit).\n\nRandomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. Consent will be obtained by the custodial parents prior to enrollment.",[445],"Diabetes Mellitus, Type 1",[447,448,449,450,451,452,453,454,455,456,457,458,459,460],"Type 1 diabetes","T1D","Diabetes mellitus","Autoantigen","Prevention","at risk for developing type 1 diabetes","Juvenile diabetes","Autoimmune diabetes","Corona","COVID-19","Viral infection","Viral infection surveillance","Immune response","Metabolism",{"date":462,"type":35},"2025-09-23",{"date":464,"type":35},"2024-05-08",{"date":466,"type":22},"2027-10",{"name":41,"class":42},9,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":477,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":484,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":100},"100607047","return-to-sports-after-knee-arthroplasty-100607047","NCT07183475","Return to Sports After Knee Arthroplasty","Amendment to the Study \"Prospective, Multicenter Investigation of Clinical Rehabilitation and Everyday Recovery Following Knee Joint Endoprosthetic Replacement\" With Additional Return-to-sports-testing at One Participating Center","RTS","Inclusion Criteria:\n\n* The study includes all patients with a history of unicondylar or bicondylar knee joint replacement and engagement in sports activity.\n* All participating patients have provided their informed consent following comprehensive information and explanation.\n* All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving detailed information and clarification.\n\nExclusion Criteria:\n\n* Patients who are unable to understand the patient information and study design (e.g., due to language barriers) or whose compliance is deemed insufficient by the study team\n* No knee joint endoprosthesis implanted\n* No engagement in athletic activity","85 Years",{"count":196,"type":22},[25],"The ability to return to sports after joint arthroplasty is increasingly becoming an important factor for patients in terms of their perceived quality of life. In sports orthopaedics, standardized functional tests have already been established - particularly for anterior cruciate ligament injuries - to assess athletic performance and prevent re-injury. These tests allow a stepwise evaluation of a subject's physical readiness for sports.\n\nIn the field of arthroplasty, and despite increasing sports activity among patients with joint arthroplasty such structured assessment is still lacking. As a result, patients with arthroplasty typically resume sports activities based solely on individual recommendations from the surgeon or treating therapist. However, an objective evaluation of sports capability is currently not available.\n\nTherefore the amendment intends to expand the current testing protocol of the already registered and ongoing study (Protocol ID: UBonn\\_TKA\\_FollowUp) to include additional standardized, evidence-based return-to-sprort-tests.",[482,483],"Knee Osteoarthristis","Arthroplasty Replacement, Knee",[485,486,487],"return to sports","knee oteoarthritis","knee arthroplasty","2025-09-16",{"date":490,"type":35},"2025-09-19",{"date":492,"type":35},"2025-07-15",{"date":494,"type":22},"2027-07-31",{"name":41,"class":42},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":515,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":100},"100606208","blood-flow-restriction-training-for-the-treatment-of-lateral-epicondylopathy-100606208","NCT07172568","Blood Flow Restriction Training For The Treatment Of Lateral Epicondylopathy","Randomisierte, Kontrollierte Untersuchung Der Wirksamkeit Von Blood Flow Restriction (BFR)-Training Zur Behandlung Der Epicondylopathia Humeri Radialis","EPIC-BFR","Inclusion Criteria:\n\n* diagnosis of lateral epicondylitis\n* duration of symptoms \\> 6 weeks\n* failed physical therapy\n* absence of x-ray abnormalities\n* written and informed consent\n\nExclusion Criteria:\n\n* prior joint infiltrations\n* duration of symptoms \\> 12 months\n* concomitant rheumatoid diseases\n* concomitant elbow pathologies, including medial epicondylitis\n* concomitant radicular symptoms of the cervical spine, shoulder or hand\n* traumatic etiology of symptoms","65 Years",{"count":21,"type":22},[25],"The study aims to evaluate the effectiveness of Blood Flow Restriction Training for the treatment of lateral elbow epicondylopathy.",[509,510,511,512,513,514],"Elbow Tendinopathy","Elbow, Tennis","Lateral Epicondylitis","Epicondylitis of the Elbow","Blood Flow Restriction Therapy","BFR",[516,517,518,514,519,520,521],"Randomised controlled Trial","RCT","Interventional study","Blood-Flow-Restriction-Therapy","lateral Epicondylopathy","Epicondylitis","2025-09-11",{"date":524,"type":35},"2025-09-15",{"date":526,"type":35},"2021-08-25",{"date":528,"type":22},"2026-02",{"name":41,"class":42},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":545,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":100},"100552180","comparison-between-ureterorenoscopy-with-lithotripsy-alone-versus-combination-with-hydrogel-for-kidney-stone-removal-100552180","NCT06469736","Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal","Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal: An Open, Randomized, Monocentric Study","Inclusion Criteria:\n\n* Male or female subjects aged ≥ 18 years\n* Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months\n* Minimum size of the kidney stones defined as \\>10mm in the longest axis in the preoperative CT.\n* Ability to read, write and speak German\n* Women of childbearing age must have a negative serum pregnancy test at the start of the study.\n* Submission of a personally signed and dated informed consent form stating that the subject has been informed of all relevant aspects of the study prior to any trial-related activity and that all information has been understood\n\nExclusion Criteria:\n\n* Participation in another clinical trial for kidney stone removal in the last 6 months\n* Subjects with gastrointestinal cancer who have not been in remission for at least 2 years\n* Subjects with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject\n* Subjects with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction\u002Fureterovesical junction\n* Subjects with known impaired renal function from stage IV or known dialysis\n* Subjects with chronic hydronephrosis not associated with nephrolithiasis\n* Subjects with the following known or suspected diseases: Coagulation disorders, untreated urinary tract infections, renal disease sepsis and marked prostatic hyperplasia\n* Subjects with any other disease or condition that, in the opinion of the investigator, could interfere with the purpose of the study (e.g. bleeding that restricts vision in the kidney, problems in the renal tubular system)\n* Breastfeeding or pregnant women\n* Subjects who may be part of a vulnerable group (e.g. prisoners or developmentally delayed adults)",{"count":538,"type":22},120,[25],"The incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England. Correspondingly, the number of surgical stone removal procedures increased by 3%, 38%, and 18%, respectively. Common treatments include extracorporeal shock wave lithotripsy (ESWL), ureterorenoscopy (URS) with lithotripsy, and percutaneous nephrolithotomy (PCNL).\n\nURS, depending on stone size, has become a preferred method due to advancements in intraoperative imaging and laser technology. Despite these improvements, small fragments often remain post-intervention, leading to recurrent stones. Complete removal of all fragments is crucial to significantly reduce recurrence rates. Current literature suggests a high recurrence rate with residual fragments, impacting healthcare costs and patient quality of life.\n\nA key objective in endourological research is optimizing the stone clearance rate. Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation. These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times.\n\nRecently, a two-component hydrogel system called mediNiK® (Purenum GmbH, Germany) was developed. This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust, forming a removable conglomerate. MediNiK® has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe, showing potential for optimizing stone removal.\n\nA multicenter study has assessed the safety and tolerability of mediNiK® in standard URS (Open, randomized, multicentre study to evaluate the safety, tolerability, and performance of mediNiK® compared to standard treatment in kidney stone removal - DRKS00030532). Results indicate the gel is safe and tolerable. However, further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK®.",[542,543,544],"Nephrolithiasis","Lithotripsy, Laser","Ureteroscopy",[546,547,548,549,550,551,552,553,554,555],"Hydrogel","MediNiK","Hydrogel methode","Stone Free Rate","Zero Residual Fragments","URS","Dusting","Stone free","Thulium","Kidneystones","2025-09-02",{"date":558,"type":35},"2025-09-09",{"date":560,"type":35},"2024-07-01",{"date":562,"type":22},"2026-07-30",{"name":41,"class":42},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":572,"minAge":19,"maxAge":504,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":374},"100567740","exercise-in-triple--negative-breast-cancer-100567740","NCT06672120","Exercise in Triple- Negative Breast Cancer","Exercise in Regional Breast Cancer With Neoadjuvant Anthracycline- Based Chemotherapy and Immunotherapy With Checkpoint-Inhibition","ExACT-ICI","Inclusion Criteria:\n\n* Female patients with newly diagnosed, local triple-negative breast cancer (stage I-III) ≥ 18 to 65 years of age scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy\n\nExclusion Criteria:\n\n* Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias)\n* Orthopaedic disability to exercise","FEMALE",{"count":538,"type":22},[25],"This is a prospective, randomized, controlled mono-center study investigating the effects of a combined, supervised aerobic exercise and resistance training in female patients with newly diagnosed, therapy-naive triple-negative breast cancer (TNBC, stage I-III) between 18 and 50 years of age scheduled for anthracycline-based chemotherapy and immunotherapy with checkpoint inhibitors. All patients will receive smart watches for rhythm monitoring.\n\nPatients will be randomized (1:1) into a control group, receiving 24 weeks of standard exercise recommendations during neoadjuvant therapy, and an intervention group receiving 24 weeks of home-based, video-supervised exercise training consisting of endurance and resistance training. The primary endpoint is the change of peak oxygen consumption (VO2peak) between baseline and 24 weeks in the groups. Secondary endpoints include changes of physical function (short physical performance battery, SPPB), as well as cardiac biomarkers, quality of life, and changes of strength of the upper and lower body between baseline and 24 weeks. In addition, variables of cardiopulmonary exercise testing (CPET), resting and stress echocardiography, and burden of atrial fibrillation (AF) will be assessed. All changes in variables will be analyzed from baseline until 52 weeks as well.\n\nBoth groups will receive standard exercise recommendations after 24 weeks and will be followed-up by clinical examination after 52 weeks. Echocardiographic variables (at rest and during exercise), quality of life, CPET, SPPB, strength testing, burden of AF, and cardiac biomarkers will be assessed. Changes between the end of the intervention period 24 weeks after diagnosis and the end of follow-up after 52 weeks will be analyzed. In addition, changes in variables between baseline and 52 weeks will be analyzed.\n\nAs an exploratory endpoint the incidence of cancer therapy-related cardiac dysfunction (CTRCD) and immune-checkpoint inhibitor- associated myocarditis (ICI-myocarditis) will be assessed after 24 and 52 weeks.",[577],"Cancer, Breast","2025-05-27",{"date":580,"type":35},"2025-05-31",{"date":582,"type":35},"2025-04-03",{"date":584,"type":22},"2028-12-31",{"name":41,"class":42},{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":601,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":100},"100585826","40-hz-visual-stimulation-as-an-intervention-in-schizophrenia-100585826","NCT06907420","40 Hz Visual Stimulation as an Intervention in Schizophrenia","Effects of Multi-Session 40 Hz Visual Stimulation on Neuronal and Psychiatric Outcomes in Schizophrenia","GammaSZ","Inclusion Criteria:\n\n* Medical diagnosis of schizophrenia (F20) or schizoaffective disorder (F25)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Any history of seizures\n* Acute suicidality assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS; Brent et al., 2008)\n* Any other relevant axis 1 disorder\n* Red-green colour blindness or current ocular disease\n* Alcohol, cannabis, or illicit drug addiction within the last 3 months",{"count":250,"type":22},[25],"In schizophrenia, an abnormal reduction in neuronal gamma oscillations (30-100 Hz) is associated with negative symptoms such as cognitive dysfunction. The literature suggests that rescuing gamma oscillations through non-invasive brain stimulation may be an accessible and safe add-on strategy to mitigate negative symptoms. Here, a stimulation protocol based on gamma visual stimulation will be tested. This pilot study will follow an uncontrolled clinical trial design: A minimum of ten patients diagnosed with schizophrenia or a schizoaffective disorder and predominant negative symptoms will be recruited at Klinikum rechts der Isar. They will undergo a multisession stimulation protocol, consisting of one hour of 40 Hz visual stimulation per day over five consecutive days, during which they will be encouraged to fall asleep. An equal number of patients will be recruited for a treatment-as-usual group without intervention. Pre- and post-assessments will include EEG, a cognitive test battery (THINC-IT), a mood scale (PANAS), and a schizophrenia symptom scale (PANSS). This study's results will inform on the feasibility of gamma visual stimulation as a potential add-on intervention in schizophrenia.",[598,599,600],"Negative Symptoms in Schizophrenia","Schizophrenia Disorders","Schizoaffective Disorder",[602,603,604,605,606,607,608,609,610],"gamma","40 Hz","schizophrenia","visual stimulation","EEG","neuromodulation","flicker","sleep","negative symptoms","2025-03-26",{"date":613,"type":35},"2025-04-02",{"date":615,"type":35},"2025-03-14",{"date":617,"type":22},"2025-07",{"name":41,"class":42},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":627,"minAge":19,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":630,"conditions":631,"keywords":633,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":374},"100582122","a-prospective-bicentric-evaluation-of-fluciclovine-pet-imaging-in-patients-with-prior-negative-or-inconclusive-psma-ligand-pet-100582122","NCT06859203","A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET","Prospective Evaluation of Fluciclovine (18F) PET\u002FCT in Patients with Prior Negative PSMA PET\u002FCT","REFINE","Inclusion Criteria:\n\n* Patient is male and aged \\>18 years old.\n* Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and\u002For androgen deprivation therapy \\[ADT\\].\n* An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng\u002FmL followed by a subsequent confirmatory PSA value ≥0.2 ng\u002FmL and within the total range of 0.2 and 2 ng\u002Fml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng\u002FmL and within the total range of 2 and 4 ng\u002Fml\n\nExclusion Criteria:\n\n* Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.\n* Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist\u002Fantagonist, and first-\u002Fsecond-generation anti androgen alone or combined with LHRH agonist\u002Fantagonist.","MALE",{"count":629,"type":22},94,"The REFINE study is evaluating whether a fluciclovine (18F) PET\u002FCT scan can detect recurrent prostate cancer in patients whose previous PSMA PET\u002FCT was negative or inconclusive.",[632],"Biochemical Recurrence of Malignant Neoplasm of Prostate",[634,635,636,637,638,639,640],"prostate cancer","biochemical recurrence","PET","PSMA","fluciclovine","BCR","prostate","2025-02-27",{"date":643,"type":35},"2025-03-05",{"date":645,"type":22},"2025-03",{"date":647,"type":22},"2027-12",{"name":41,"class":42},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":656,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":658,"conditions":659,"keywords":665,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":4},"100577306","reliability-of-multiple-repetition-maximum-tests-in-patients-with-cardiovascular-disease-or-risk-factors-100577306","NCT06796582","Reliability of Multiple-Repetition-Maximum Tests in Patients with Cardiovascular Disease or Risk Factors","Agreement of the Estimated 1-Repetition-Maximum Between Two Multiple-Repetition-Maximum Tests with Different Weight in Patients with Cardiovascular Disease or Risk Factors","Inclusion Criteria:\n\n* Age ≥ 50 years\n* At least one of the following cardiovascular diseases \u002F risk factors:\n* Heart failure\n* Coronary heart disease\n* Atrial fibrillation\n* Arterial hypertension\n* Type 2 diabetes mellitus\n* Clinically stable for ≥ 4 weeks\n* Medical clearance to perform resistance training \u002F strength testing\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Acute infection\n* Chronic joint inflammation\n* Knee, hip, ankle, wrist, elbow or shoulder pain\n* Known osteoporosis (T-value ≤ -2.5)\n* Uncontrolled hypertension (≥160 mmHG systolic \u002F ≥100 mmHG diastolic)\n* Known cerebral or thoracic aneurysm","50 Years",{"count":196,"type":22},"Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important. The gold standard to prescribe resistance training intensity or monitor longitudinal changes is the 1-Repetition-Maximum (1-RM) test. However, particularly for unexperienced individuals, this test may not be recommendable due to the high load and an increased risk of injuries. Alternatively, there are several published formulas to estimate the 1-RM based on a multiple-repetition-maximum (or repetition-to-failure) test. However, these formulas have been primarily tested in healthy individuals. Moreover, the reliability of the 1-RM estimation based on two tests with different submaximal weight is unknown. Therefore, the present study evaluates the agreement of the 1-RM estimation (based on different formulas) between two Multiple-RM tests with different weight in 50 patients with cardiovascular disease (heart failure, coronary heart disease, atrial fibrillation) or cardiovascular risk factors (type 2 diabetes, arterial hypertension).",[660,661,662,663,664],"Heart Failure","Coronary Heart Disease (CHD)","Atrial Fibrillation (AF)","Diabetes Mellitus","Arterial Hypertension",[666,667,668,669],"resistance training","cardiovascular disease","cardiovascular risk factors","muscle strength","2025-01-27",{"date":672,"type":35},"2025-01-29",{"date":674,"type":22},"2025-02",{"date":676,"type":22},"2025-06",{"name":41,"class":42},{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":18,"minAge":686,"maxAge":4,"enrollmentInfo":687,"targetDuration":689,"studyType":251,"phases":4,"briefSummary":690,"conditions":691,"keywords":696,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":100},"100499034","multi-center-registry-for-mecfs-100499034","NCT05778006","Multi-Center Registry for ME\u002FCFS","Multi-Center Registry for ME\u002FCFS, Including ME\u002FCFS Following Epstein-Barr Virus-Associated Infectious Mononucleosis (EBV-IM) or Coronavirus Disease 2019 (Covid-19)","MECFS-R","Inclusion Criteria:\n\n* ME\u002FCFS diagnosis (ICD-10 G93.3) based on internationally established criteria\n* Informed consent by patients and\u002For guardian(s)\n\nExclusion Criteria:\n\n* No ME\u002FCFS (ICD-10 G93.3)\n* No informed consent","0 Years",{"count":688,"type":22},650,"30 Years","The ME\u002FCFS study (MECFS-R) aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for ME\u002FCFS at any age in Germany, which can be used for future clinical trials.",[692,693,694,695],"ME\u002FCFS","CFS\u002FME","ME\u002FCFS Following EBV-associated Infectious Mononucleosis","ME\u002FCFS Following COVID-19",[692,693,697,698,699,700,701,702,703],"SARS-CoV-2","COVID-10","Post-COVID-19 condition","Chronic fatigue syndrome","Myalgic encephalomyelitis","Epstein-Barr virus","EBV","2025-01-08",{"date":706,"type":35},"2025-01-10",{"date":708,"type":35},"2022-05-31",{"date":710,"type":22},"2052-05-31",{"name":41,"class":42},{"id":713,"slug":714,"hasResults":12,"nctId":715,"briefTitle":716,"officialTitle":716,"acronym":717,"eligibilityCriteria":718,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":719,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":721,"conditions":722,"keywords":726,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":731,"lastUpdatePostDateStruct":732,"startDateStruct":734,"completionDateStruct":736,"leadSponsor":737,"locationsCount":100},"100574389","characterizing-the-retinal-microvasculature-in-patients-with-fabry-disease-a-prospective-observational-study-100574389","NCT06758648","Characterizing the Retinal Microvasculature in Patients with Fabry Disease: a Prospective Observational Study","VASCinFABRY","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of Fabry disease by genetic testing or GB3 activity in leukocytes.\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Active infection or cancer\n* Surgery less than 2 weeks prior to inclusion in the study\n* Known glaucoma\n* Lack of capacity to give consent; lack of informed consent.\n* Known epilepsy",{"count":720,"type":22},63,"This study aims to gain a deeper understanding of endothelial dysfunction in patients with Fabry disease through a prospective study of the retinal microvasculature and to identify an objective, non-invasive marker to assess disease severity and cardiovascular risk in patients.\n\nThe main questions addressed are: Do dynamic and static retinal vessel analysis parameters differ from those in healthy individuals? Can these parameters predict cardiovascular and\u002For Fabry-related events during follow-up? Do these parameters change during follow-up in patients with a non-stable disease?",[723,724,725],"Fabry Disease","Endothelial Dysfunction","Microvasculature",[727,728,729,730],"Chronic inflammation","retinal microvasculature","retinal vessel analysis","vasculopathy","2024-12-30",{"date":733,"type":35},"2025-01-06",{"date":735,"type":35},"2020-06-25",{"date":321,"type":22},{"name":41,"class":42},""]