[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Charite University, Berlin, Germany\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":673},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,100,0,25,[9,41,79,101,126,147,170,206,234,252,272,301,328,364,402,440,468,491,516,541,561,586,606,625,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053767","exspanding-the-knowledge-about-tnpo2-associated-disorders-100053767",false,"NCT07699510","Exspanding the Knowledge About TNPO2-Associated Disorders","Development of New Therapeutic Approaches for TNPO2-Associated Disorders","Target-TNPO2","Inclusion Criteria:\n\n* TNPO2 variant\n\nExclusion Criteria:\n\n* no consent","ALL",{"count":20,"type":21},50,"ESTIMATED","10 Years","OBSERVATIONAL","The Target-TNPO2 is an international, multicenter observational registry designed to collect comprehensive clinical, genetic, neurodevelopmental, and longitudinal data from individuals with pathogenic or likely pathogenic variants in the TNPO2 gene.\n\nThis aids to improve the knowledge and clinical progression on TNPO2-associated disorders.\n\nThe investigators further aim to provide new insides into the pathomechanism of TNPO2 variants using blood samples.",[26],"TNPO2",[26],"RECRUITING","2026-07-08",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-06-01",{"date":36,"type":21},"2036-12-31",{"name":38,"class":39},"Charite University, Berlin, Germany","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":40},"100645299","clinical-study-on-high-fiber-diet-and-short-term-fasting-in-melanoma-under-immunotherapy-with-checkpoint-inhibition-100645299","NCT07680452","Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition","Exploratory Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition","Melafit","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIB-IIIC melanoma\n* Indication for immune checkpoint inhibition as monotherapy as determined by the tumor board\n* No prior systemic melanoma therapy\n* ECOG 0 or 1\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Underweight (BMI ≤19.5)\n* Pre-existing eating disorder\n* Severe internal medical conditions (e.g., renal insufficiency with creatinine \\> 2 mg\u002FdL) or secondary malignancy\n* Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months\n* Use of antibiotics within 4 weeks prior to the start of the study intervention","18 Years",{"count":51,"type":21},60,"INTERVENTIONAL",[54],"NA","The treatment of melanoma has improved significantly in recent years. A modern form of cancer treatment known as immunotherapy with checkpoint inhibitors plays a key role in this. These drugs help the immune system better recognize and fight cancer cells. Nevertheless, it remains a challenge to maximize treatment effectiveness while minimizing side effects.\n\nOne possible approach to influencing treatment efficacy and tolerability is diet. A high-fiber diet, as recommended by the German Nutrition Society, increases the effectiveness of immunotherapy, in part through its influence on gut bacteria (the gut microbiota). Initial studies also show that short-term fasting (i.e., eating nothing or very little for a limited period) reduces the side effects of immunotherapy in mouse models and improves the tolerability of chemotherapy in humans.\n\nThis study investigates the feasability of a study on short-term fasting, in addition to a high-fiber diet in patiens with melanoma undergoing immunotherapy.\n\n40 participants will follow a high-fiber diet based on the recommendations of the German Nutrition Society. Additionally, half of the participants will undergo periodic cycles of short-term fasting of 72h with each immunotherapy. Another 20 participants will not undergo any intervention and serve as a control group.\n\nThe goal is to determine whether this study concept is feasible. Exploratory outcomes include, quality of life, fatigue, tolerability of the therapy, impact on disease progression, immune system (flow cytometry) and gut bacteria (microbiome).\n\nThe results are intended to help understand whether targeted dietary measures can support the effectiveness of modern cancer treatments.",[57],"Melanoma (Skin Cancer)",[59,60,61,62,63,64,65,66,67,68,69],"fasting","diet","fiber","high-fiber","melanoma","STF","short-term fasting","microbiome","checkpoint-inhibitor","checkpoint-inhibition","immunotherapy","NOT_YET_RECRUITING","2026-06-25",{"date":73,"type":32},"2026-07-02",{"date":75,"type":21},"2026-06-30",{"date":77,"type":21},"2028-12-05",{"name":38,"class":39},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100389770","quality-contract-prevention-of-postoperative-delirium-in-the-care-of-older-patients-qv-pod-2-100389770","NCT04355195","Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)","Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)","Inclusion criteria:\n\n* Age ≥ 70 years\n* male and female patients\n* Patients who are insured with BARMER, HEK, KKH, DAK, TK or hkk Health insurances\n* Patients eligible for inclusion: by the patient, preoperatively\n* Incapacitated patients for inclusion: Written informed consent by a legal representative\n* surgery (elective and not elective)\n\nExclusion criteria:\n\n* Moribund patients\n* Not enough language skills","70 Years",{"count":88,"type":21},18100,"The project \"QV-POD-2\" is a prolongation based on \"QV-POD-1\", which was a quality contract program of the IQTIG - Institute for Quality and Transparency in Health Care. The aim is to improve inpatient care for older patients who are undergoing inpatient surgery and thus to specifically reduce the postoperative risk of delirium. This is achieved through the implementation of evidence-based and consensus-based measures to prevent postoperative delirium in a comprehensive structured concept in routine care. The transparent documentation in an electronic patient file enables the relationships between the symptoms to be depicted in accordance with the clinical circumstances and the genesis of the postoperative delirium to be recorded and treated at an early stage. The content of the additional elements from the routine data (see primary and secondary outcome measures) in QV-POD-2 is analysed internally.\n\nSubproject Retro-Pressure started in August 2022:\n\nRetrospective, exploratory cohort study using electronic anesthesia and hospital records from Jan 1, 2016 to Jan 1, 2020, including patients ≥70 years undergoing surgery with anesthesia. The objective is to quantify associations between intraoperative blood pressure dynamics-variability, rate of change, relative hypo-\u002Fhypertension versus baseline, and time-integrated BP (area under\u002Fabove reference)-and postoperative organ dysfunction Primary endpoints: Emergence delirium incidence (PACU\u002FITS) based on Nu-DESC scores and CAM-ICU scores; incidence of postoperative acute renal failure (creatinine and urea levels, as well as urine output); intraoperative blood pressure variation\\*; intraoperative blood pressure variation rate\\*; intraoperative blood pressure integral\\* Secondary endpoints: Blood count (hemoglobin and hematocrit values); intraoperative transfusions of blood reserves Addendum from the ethics amendment vote of 25\u002F07\u002F2022\n\nSubproject Delta-Scan started in August 2022:\n\nEvaluation of brain function using \"Delta Scan\" Primary objective: Evaluation of the prognostic significance of Delta Scan measurements in relation to postoperative delirium Secondary objectives: Examination of the delirium-related predictive relevance of individual influencing factors (directly but also indirectly through Delta Scan values) and examination of the effect of Delta Scan measurements on standard delirium screening methods. Study and control group's Inclusion criteria: Age \\>= 70 years and major surgery with anesthesia; additional exclusion criterion in the control group: Inclusion in the QV-POD-1 project (receipt of postoperative preventive measures) Addendum from the ethics amendment vote of 25\u002F07\u002F2022\n\nSubproject started in June,18th, 2026:\n\nFor selected patients who are scheduled to undergo a procedure in June, July or August 2026 as part of the QV-POD-2 study, a wristband called CardioWatch 287-2 (manufacturer: Corsano Health B.V., Wilhelmina van Pruisenweg 35, 2595 AN The Hague, The Netherlands, loaned by Medtronic, will be etsablished. For same-day surgery patients, monitoring begins before the operation and continues until discharge from the hospital. For pre-hospitalized patients, measurements can begin at least one day before surgery upon request. The recorded values include blood pressure, heart rate, heart rate variability, respiratory rate, oxygen saturation, body temperature, physical activity, and an electrocardiogram once a day.",[91],"Delirium in Old Age","2026-06-22",{"date":94,"type":32},"2026-06-26",{"date":96,"type":32},"2020-04-20",{"date":98,"type":21},"2029-06",{"name":38,"class":39},2,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":52,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":40},"100643943","effects-of-olfactory-stimuli-in-virtual-reality-cue-exposure-on-craving-and-attentional-bias-in-alcohol-use-disorder-100643943","NCT07667790","Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder","Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence","OLFA-VR","Inclusion Criteria:\n\n* age between 18-65 years\n* diagnosis of alcohol dependence according to ICD-10 (F10.2)\n* complete inpatient detoxification within the last three months\n* history of alcohol craving\n* capacity to provide written informed consent\n\nExclusion Criteria:\n\n* substance dependences other than alcohol or nicotine\n* current alcohol intoxication (tested by random breath-alcohol measurements)\n* alcohol abstinence less than 7 days or on-going alcohol consumption\n* severe neuropsychiatric disorder (e.g. schizophrenia-spectrum disorder, bipolar affective disorder or substantial cognitive impairment)\n* severe medical conditions affecting brain or heart function that could influence the parameters under investigation\n* acute suicidality or risk of harm to others\n* current pharmacological treatment for alcohol dependence (e.g., benzodiazepines) or for craving (e.g., acamprosate, disulfiram, naltrexone, nalmefene)\n* other medications that may have a significant influence on heart rate\n* sinusitis, self-reported problems with smell, or lack of normosmia, assessed both subjectively and objectively\n* limited ability to understand the study information, the consent form or the study procedures and principles","65 Years",{"count":51,"type":21},[54],"Alcohol use disorder (AUD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol-often accompanied by an attentional bias toward alcohol-related stimuli-which can be evoked by both real-world and virtual stimuli in immersive virtual reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory stimuli embedded in VR-based cue exposure (VR-CE) influence craving and attentional bias in patients with AUD.\n\nThe goal of this prospective experimental single-arm clinical study, with a 2 (visual stimuli: neutral vs. alcohol-related VR scenarios) × 2 (olfactory stimuli: no odor vs. alcohol-related odor) within-subjects factorial design, is to determine how visual and olfactory stimuli contribute to the outcomes during a multimodal VR-CE in patients with AUD.\n\nThe main question is whether VR-CE with concurrent visual and olfactory alcohol-related stimuli induces a greater increase in craving and attentional bias from baseline than exposure to a single modality (visual or olfactory), as assessed by subjective and psychophysiological measures in patients with AUD.",[114],"Alcohol Use Disorder",[116,117,118],"alcohol use disorder","virtual reality cue exposure","olfactory","2026-06-21",{"date":71,"type":32},{"date":122,"type":21},"2026-07-01",{"date":124,"type":21},"2027-07",{"name":38,"class":39},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":109,"enrollmentInfo":132,"targetDuration":4,"studyType":52,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":40},"100622828","feasibility-of-integrating-olfactory-stimuli-into-virtual-reality-cue-exposure-for-patients-with-alcohol-dependence-100622828","NCT07388693","Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence","Inclusion Criteria:\n\n* age: 18-65 years\n* diagnosis of alcohol dependence according to ICD-10 (F10.2)\n* history of alcohol craving\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* hyposmia\n* dependence on substances other than alcohol and nicotine\n* current alcohol intoxication (randomly tested by measurement of breath alcohol concentration)\n* unable to understand the study information, consent form or principles of the study\n* abstinence for less than 7 days or ongoing consumption of alcohol\n* severe neuropsychiatric disorder (e.g. schizophrenia spectrum disorders, bipolar affective disorder) or substantial cognitive impairment\n* serious illnesses affecting brain or heart function that influence physiological study parameters\n* acute suicidality (or acute endangerment of others)\n* concurrent pharmacological treatment targeting AUD (e.g. benzodiazepines) or craving (e.g. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart rate",{"count":133,"type":21},20,[54],"Alcohol dependence (AD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol, which can be evoked by both real-world and virtual cues in immersive Virtual Reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory stimuli embedded in VR-based Cue Exposure (VR-CE) influence cue-elicited craving. As part of the OLFA-VR (Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence) research project, the present feasibility study aims to evaluate the feasibility, tolerability and acceptability of implementing olfactory stimuli into VR-CE.\n\nIn addition, this study not only examines the general feasibility of alcohol-related olfactory stimuli in VR-CE but also explores which specific alcohol-related olfactory stimuli prove to be feasible.\n\nThe investigators hypothesize that implementing olfactory stimuli into VR-CE will be feasible and tolerable for patients with AD, with no preventable serious side effects caused by VR-CE. The investigators also hypothesize that VR-CE will induce craving in most patients.",[137],"Alcohol Dependence",[139],"Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory",{"date":141,"type":32},"2026-06-23",{"date":143,"type":32},"2026-03-07",{"date":145,"type":21},"2026-07-31",{"name":38,"class":39},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":52,"phases":156,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":40},"100642599","surgical-treatment-of-adjacent-segment-stenosis-100642599","NCT07661199","Surgical Treatment of Adjacent Segment Stenosis","STASS","Inclusion Criteria:\n\n* Age ≥18 years.\n* Oswestry Disability Index (ODI) between 30% and 80% at screening.\n* Symptomatic adjacent segment stenosis following degenerative lumbar fusion surgery.\n* Persistent symptoms despite at least 6 weeks of appropriate conservative treatment.\n* Radiological evidence of adjacent segment spinal stenosis on magnetic resonance imaging (MRI).\n* Ability to understand the study procedures and complete patient-reported outcome questionnaires.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Adjacent segment kyphosis or scoliosis greater than 10 degrees.\n* Screw loosening or pseudarthrosis of the previous fusion construct.\n* Known current pregnancy or breastfeeding.\n* Acute traumatic spinal injury or fracture.\n* Active inflammatory disease of the spine.\n* Active neoplastic disease of the spine.\n* Contraindication to spinal surgery.\n* Inability to provide informed consent or complete study questionnaires.\n* Symptoms attributable to spinal stenosis are not the predominant clinical complaint\n* Foraminal stenosis grade ≥2 according to the Lee classification.\n* Dynamic spondylolisthesis ≥3 mm on flexion-extension radiographs.\n* Persons involuntarily detained by judicial or administrative order.",{"count":155,"type":21},338,[54],"The goal of this clinical trial is to learn whether microdecompression alone is as effective as decompression with extension of fusion surgery in patients with symptomatic adjacent segment stenosis after previous lumbar fusion surgery.\n\nThe main questions it aims to answer are:\n\nIs microdecompression alone non-inferior to decompression with extension of fusion in improving disability 24 months after surgery, as measured by the Oswestry Disability Index (ODI)? Does microdecompression alone result in similar or lower rates of complications, reoperations, pain, and radiological progression compared with decompression and fusion?\n\nResearchers will compare microdecompression alone to decompression with extension of lumbar fusion to determine whether the less invasive procedure can achieve similar clinical outcomes while reducing surgical burden and preserving spinal structures.\n\nParticipants will:\n\nBe randomly assigned to one of two treatment groups: microdecompression alone or decompression with extension of lumbar fusion.\n\nUndergo the assigned surgical treatment. Attend clinical and radiological follow-up visits at 6, 12, and 24 months after surgery.\n\nComplete questionnaires assessing disability, pain, quality of life, sleep quality, and mental health.\n\nUndergo routine imaging and clinical examinations to evaluate treatment outcomes and possible complications.",[159,160],"Adjacent Segment Disease","Lumbar Spinal Stenosis",[159,162,160],"Adjacent Segment Stenosis","2026-06-18",{"date":92,"type":32},{"date":166,"type":21},"2026-10-01",{"date":168,"type":21},"2031-03-01",{"name":38,"class":39},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":52,"phases":181,"briefSummary":182,"conditions":183,"keywords":189,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":40},"100641421","preoperative-fasting-and-the-gut-microbiome-before-hip-replacement-100641421","NCT07651462","Preoperative Fasting and the Gut Microbiome Before Hip Replacement","Preoperative Metabolic Optimization: Influence of Intermittent and Buchinger-Type Fasting on the Gut Microbiome, Immune Profile, and Postoperative Complications in Patients Undergoing Primary Total Hip Arthroplasty - A Randomized Controlled Trial","PreFAST-Hip","Inclusion Criteria:\n\n* Adults aged 18-75 years (inclusive)\n* Scheduled for elective primary total hip arthroplasty (THA)\n* Able and willing to provide written informed consent\n* Able to follow the 20-day preoperative fasting protocol independently at home (if randomized to the fasting arm) or willing to be randomized to either arm\n\nExclusion Criteria:\n\n* Resorption disorder due to bowel disease (e.g. inflammatory bowel disease, short-bowel syndrome, active celiac disease)\n* Antibiotic therapy within the last 2 months before baseline (T0)\n* Probiotic, prebiotic, or symbiotic supplementation within the last 2 months before baseline (T0)\n* Inability or unwillingness to provide informed consent\n* Severe comorbidity precluding fasting (e.g. ASA ≥ IV, advanced renal\u002Fhepatic impairment, eating disorder)\n* BMI \\\u003C 18.5 kg\u002Fm² (underweight)\n* Concurrent participation in another interventional drug or device trial\n* Pregnancy or breastfeeding","75 Years",{"count":180,"type":21},130,[54],"Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters.\n\nThis single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-\u002FB-\u002FNK-cell subsets, activation\u002Fexhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay).\n\nAdults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h \u002F 24 h \u002F 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.",[184,185,186,187,188],"Hip Osteoarthritis","Arthroplasty, Replacement, Hip","Postoperative Complications","Surgical Wound Infection","Gastrointestinal Microbiome",[190,191,192,193,194,195,196,197,198],"Therapeutic fasting","Buchinger fasting","Intermittent fasting","Gut microbiome","Immunophenotyping","Continuous glucose monitoring","Total hip arthroplasty","Metabolic syndrome","Preoperative optimization","2026-06-17",{"date":92,"type":32},{"date":202,"type":32},"2025-07-01",{"date":204,"type":21},"2026-12-31",{"name":38,"class":39},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":214,"enrollmentInfo":215,"targetDuration":217,"studyType":23,"phases":4,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":40},"100464991","sex-differential-host-microbiome-cvd-risk---a-longitudinal-cohort-approach-100464991","NCT05334888","Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach","Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.","XCVD","Inclusion Criteria:\n\n* Age 18-50\n* Language requirements: German, English\n* Previous gender hormone replacement therapy (HRT).\n* Ability to give consent and written consent to participate.\n* Health insurance (for clarification of incidental findings)\n\nExclusion Criteria:\n\n* Diseases or functional disorders that, in the opinion of the study physician, preclude participation in the study.\n* Incapacity or other circumstances that do not allow study participants to fully understand the nature, significance and scope of this study.","50 Years",{"count":216,"type":21},200,"2 Years","The XCVD study investigates the influence of sex hormones on the composition of the gut microbiome and the possible emergence of cardiovascular risk factors. It will follow 200 healthy transgender individuals for five years during their hormone replacement therapy (HRT) and analyze them for the possible emergence of cardiovascular risk factors in relation to changes in the gut microbiome, metabolome, and immunome. We would also like to phenotype cardiovascular disease.",[220,221,222,223],"Transgender","Gut Microbiome","Immune System","Cardiovascular Risk Factors",[225],"Transgender Medicine","2026-06-12",{"date":228,"type":32},"2026-06-15",{"date":230,"type":32},"2022-08-29",{"date":232,"type":21},"2030-12-31",{"name":38,"class":39},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":251,"locationsCount":100},"100640121","prosevo-trial-propofol-sevoflurane-delirium-target-trial-emulation-100640121","NCT07612579","PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)","Inclusion Criteria:\n\n* Adult patients (≥18 years) at the Department of Anesthesiology and Intensive Care Medicine (CCM\u002FCVK) and the Department of Anesthesiology and Intensive Care Medicine (CBF) at Charité,\n* undergoing elective surgery under general anesthesia\n* with a planned surgery duration of ≥ 30 minutes\n\nIn addition, the following conditions must be met:\n\n* The surgery must be the patient's first surgery per hospital stay to avoid dependencies and repeated measurements of the same person within a short time frame;\n* The surgeries take place at Charité between January 1, 2011, and December 31, 2025.\n\nExclusion Criteria:\n\nPatients in any of the following situations are excluded:\n\n1. Cardiac surgery (this patient group requires specialized monitoring strategies and has postoperative delirium risk profiles that differ significantly from those of other types of surgery)\n2. preoperatively diagnosed delirium, defined as positive results on the Nursing Delirium Screening Scale (NU-DESC) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during preoperative evaluations;\n3. severe preoperative cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \\\u003C15 points, or\n4. preoperatively documented severe dementia\n5. neurosurgical procedures (neurosurgical patients require specialized monitoring protocols and differ from other surgical patients in their postoperative delirium (POD) symptoms)\n6. Patients who were already admitted to intensive care units prior to their elective surgery (these patients already have increased mortality and a different risk profile)\n7. Patients who were already intubated or sedated prior to surgery (this group cannot undergo standardized POD screening)\n8. High preoperative risk for postoperative nausea and vomiting (PONV) (specifically, patients with documented PONV grade 3 or PONV grade 4 risk are excluded, as this group is indicated for anesthesia with propofol)",{"count":241,"type":21},100000,"The results of this study have significant implications for clinical practice and guideline development. The current European guideline on postoperative Delirium prevention (ESAIC 2024) explicitly identifies a lack of large, adequately powered studies comparing different anesthetic techniques and is therefore currently unable to provide clear recommendations on the selection of an optimal technique. This study will close this knowledge gap and thus support future guideline recommendations. The results could show that a particular anesthetic technique (e.g., propofol) is associated with a significantly lower risk of postoperative delirium; if so, this would have immediate implications for modifying standard anesthesia protocols in hospitals.\n\nFurthermore, Delirium is a significant public health challenge in aging societies. With demographic aging, the number of older patients undergoing surgery is continuously increasing. The societal costs of Delirium are estimated at several billion euros per year in major industrialized nations. A reduction in the incidence of postoperative Delirium by just 10% through optimization of the anesthetic procedure would therefore have major health economic implications.",[244],"Postoperative Delirium","2026-06-03",{"date":247,"type":32},"2026-06-04",{"date":245,"type":32},{"date":250,"type":21},"2027-12",{"name":38,"class":39},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":40},"100413988","identification-of-outcome-relevant-indicators-in-routine-data-100413988","NCT04670744","Identification of Outcome Relevant Indicators in Routine Data","Retrospective Analysis for the Identification of Outcome Relevant Indicators (\"Patterns\") in Routine Data and Investigation of the Influence on Patient-centered Outcome for a Data-driven Improvement of Quality-based Treatment of Perioperative and Intensive Care Patients","Inclusion Criteria:\n\n* Age: 0 to 120 years\n* Gender: female, male, diverse\n* Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Department of Anesthesiology and Intensive Care Medicine, CCM\u002FCVK\u002FCBF) since 2016\n\nExclusion Criteria:\n\n-none","120 Years",{"count":261,"type":21},1000000,"The availability of electronic documentation systems in patient care means that large amounts of clinical routine data are available from which conclusions can be drawn for improving patient care. Compared to conventional research approaches, a data science-oriented approach offers the possibility of identifying patterns in routine data (\"pattern recognition\") that are relevant for patient-centered outcomes.\n\nNumerous projects and sub-projects can be evaluated from this data set.",[264,265],"Anesthesiological Risk Reduction","Intensive Care Risk Reduction",{"date":267,"type":32},"2026-06-05",{"date":269,"type":32},"2020-12-03",{"date":232,"type":21},{"name":38,"class":39},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100639853","prospective-mma-embolization-registry-100639853","NCT07626671","Prospective MMA Embolization Registry","Prospective Outcomes of MMA Embolization: A Prospective Single-center Registry Investigating Endovascular Therapy for Chronic Subdural Hematomas","PRO-EMMA","Inclusion Criteria:\n\n* CT- or MRI-confirmed chronic subdural hematoma (cSDH)\n* Planned or completed middle meningeal artery embolization (MMAE), either as primary treatment or as adjunct to surgical evacuation\n* Age ≥ 18 years\n* Modified Rankin Scale (mRS) ≤ 3 at baseline\n* Written informed consent including agreement to structured follow-up (follow-up CT scans and clinical assessments)\n* Willingness and ability to participate in structured follow-up assessments (telephone and\u002For in-person interviews)\n\nExclusion Criteria:\n\n* Acute subdural hematoma requiring emergency neurosurgical intervention\n* Missing or incomplete baseline clinical or radiological data\n* Unavailability for prospective follow-up (e.g., no fixed address, no telephone contact)",{"count":5,"type":21},"Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane. This membrane continuously rebleeds through fragile neovessels, driven in large part by branches of the middle meningeal artery (MMA), preventing spontaneous resolution and promoting hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%, largely because surgery does not address the underlying membrane vascularity. Middle meningeal artery embolization (MMAE) is a minimally invasive angiographic procedure that targets this root cause by occluding the arterial supply to the hematoma membrane, thereby reducing rebleeding and promoting resolution. Recent clinical trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as a standalone treatment and as an adjunct to surgery. Despite this evidence, standardized prospective data on patient selection, predictors of treatment success, and optimal follow-up are still lacking.\n\nPRO-EMMA is a prospective, single-center registry at the Charité - Universitätsmedizin Berlin, a tertiary center consisting of three separate campuses. Pro-Emma systematically collects clinical, radiological, and procedural data from patients with cSDH who undergo MMAE. In addition to routine clinical care, participants undergo a structured follow-up protocol: CT scans within 7 days and at 3 months after the procedure, and standardized assessments of neurological status, functional outcome, and quality of life - using the Glasgow Coma Scale (GCS), Markwalder score, modified Rankin Scale (mRS), Glasgow Outcome Scale Extended (GOS-E), and EQ-5D-5L- before the procedure and at days 30, 90, and 120 post-intervention.\n\nThe study tests the hypothesis that MMAE leads to good functional outcomes, rapid hematoma resolution, and low recurrence rates, and that specific clinical, interventional, and imaging features predict treatment success. Findings will help identify which patients benefit most from MMAE, optimize treatment decisions, and establish a practical, evidence-based follow-up standard. The registry aims to enroll 75-150 patients over approximately 12 months.",[283],"Chronic Subdural Hematomas",[285,286,287,288,289,290,291,292,293,294],"chronic subdural hematoma","Middle meningeal artery embolization","MMAE","cSDH","Endovascular treatment","Hematoma recurrence","Modified Rankin Scale","Functional outcome","Neuroradiology","Prospective registry","2026-05-31",{"date":247,"type":32},{"date":122,"type":21},{"date":299,"type":21},"2028-01-31",{"name":38,"class":39},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":308,"sex":18,"minAge":49,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":52,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":40},"100639299","burnout-intervention-during-war-for-hospital-staff-in-ukraine-100639299","NCT07620756","Burnout Intervention During War for Hospital Staff in Ukraine","Professional Burnout Among Socially Significant Services in Ukraine in Wartime and Its Dynamics Within the Framework of Training Intervention for Burnout Prevention","Inclusion Criteria:\n\n* Respondents must be 18 years of age or older.\n* Sufficient command of the Ukrainian language to understand the materials and complete the questionnaires.\n* Voluntary informed consent to participate in the study and data processing.\n* Permanent residence in Ukraine at the time of participation in the study.\n* Belonging to the working civilian population (medical or non-medical workers).\n* Technical ability to participate online (access to the internet and an electronic device for completing questionnaires and participating in training).\n* Skills\u002Fability to attend online sessions and use smartphone chat for communication.\n* Willingness to complete questionnaires at specified time points (T0, T1, T2).\n\nExclusion Criteria:\n\n* Inability to provide informed consent or limited legal capacity.\n* Presence at the time of inclusion of a condition that significantly complicates participation in the study or adherence to the protocol (acute psychotic episodes, manic states, severe cognitive impairment, decompensated somatic diseases, active dependence on psychoactive substances), Severe mental state or pronounced mental distress requiring urgent specialized care.\n* Current intensive psychotherapeutic or psychiatric treatment that may significantly affect the assessed indicators.\n* Lack of technical ability to participate in online training or complete questionnaires at specified times.\n* Inability to use a smartphone or significant visual, hearing, or speech impairments that prevent interaction with the application and completion of questionnaires.\n* Refusal to participate or withdrawal of informed consent at any stage of the study.",true,"99 Years",{"count":311,"type":21},80,[54],"The project endeavours to investigate the feasibility and acceptability of a psychoeducational training intervention for professional burnout and related psychological variables among both medical and non-medical workers in Ukraine during wartime. A secondary aim is to assess the outcomes of the intervention at baseline (T0), post-intervention (T1), and follow-up (single-arm feasibility design). The participants receive two days of a psychoeducational training focusing on different facets of burnout prevention.",[315],"Burnout Risk",[317,318,319],"Burnout","War","Ukraine","2026-05-29",{"date":322,"type":32},"2026-06-02",{"date":324,"type":32},"2026-03-24",{"date":326,"type":21},"2026-11",{"name":38,"class":39},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":109,"enrollmentInfo":335,"targetDuration":4,"studyType":52,"phases":337,"briefSummary":338,"conditions":339,"keywords":344,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":40},"100423436","a-transdiagnostic-self-guided-internet-intervention-velibra-for-waitlist-patients-with-anxiety-disorders-100423436","NCT04793828","A Transdiagnostic, Self-guided Internet Intervention (\"Velibra\") for Waitlist Patients With Anxiety Disorders","The Effect of a Transdiagnostic, Self-guided Internet Intervention (\"Velibra\") for Waitlist Patients With Anxiety Disorders","Inclusion Criteria:\n\n* Diagnosis of panic disorder with or without agoraphobia, social anxiety disorder, or generalized anxiety disorder\n* Knowledge of German that is sufficient for engaging with the treatment and responding to the questionnaires\n* Written informed consent\n* Internet access\n\nExclusion Criteria:\n\n* Diagnoses of severe mental comorbidities (e.g., schizophrenia, severe major depression, borderline personality disorder)\n* Acute suicidality\n* Started or changed anxiolytic pharmacotherapy recently (currently or in the past four weeks)",{"count":336,"type":21},30,[54],"The project's aim is to investigate the effect of a transdiagnostic, self-guided, internet-based cognitive behavioral therapy program in waitlist patients with anxiety disorders.",[340,341,342,343],"Panic Disorder With Agoraphobia","Panic Disorder Without Agoraphobia","Generalized Anxiety Disorder","Social Anxiety Disorder",[345,346,347,348,349,350,351,352,353,354,355],"cognitive behavioral therapy","internet intervention","administrative-supported","anxiety","panic disorder","social anxiety disorder","generalized anxiety disorder","computerized CBT","anxiety disorders","velibra","psychotherapy","2026-05-06",{"date":358,"type":32},"2026-05-07",{"date":360,"type":32},"2020-07-04",{"date":362,"type":21},"2027-12-31",{"name":38,"class":39},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":372,"maxAge":49,"enrollmentInfo":373,"targetDuration":4,"studyType":52,"phases":374,"briefSummary":377,"conditions":378,"keywords":389,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":40},"100630322","phase-1-influence-of-lung-volume-optimization-maneuver-on-cardiac-output-and-lung-compliance-in-ventilated-children-with-congenital-heart-disease-undergoing-surgical-repair-100630322","NCT07486167","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease","ILOCO-CHD","Inclusion Criteria:\n\n* Inclusion Criteria\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.","0 Days",{"count":311,"type":21},[375,376],"PHASE1","PHASE2","The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.\n\nThe primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.\n\nSecondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.",[379,380,381,382,383,384,385,386,387,388],"Congenital Heart Disease","Cardiopulmonary Bypass","Mechanical Ventilation","Peep Titration in Lung Protective Ventilation","Positive End-expiratory Pressure (PEEP)","Lung Volume","Lung Mechanics","Children","Hemodynamic Changes","Cardiac Surgery",[390,391,392,393],"cardiopulmonary interactions","end-expiratory lung volume","electrical impedance tomography","PEEP titration","2026-04-26",{"date":396,"type":32},"2026-04-30",{"date":398,"type":21},"2026-09-01",{"date":400,"type":21},"2028-12-31",{"name":38,"class":39},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":410,"targetDuration":412,"studyType":23,"phases":4,"briefSummary":413,"conditions":414,"keywords":420,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100635512","master-study-protocol-for-the-cohort-of-the-specialist-network-stroke-sn-strokestroke-core-100635512","NCT07553650","Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE)","Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke) (Stroke-CORE)","Stroke-CORE","Inclusion Criteria:\n\n* Diagnosis of AIS or ICH; the AIS diagnosis may be diagnosed clinically or radiologically (i.e., focal neurological impairment of sudden onset, lasting more than 24 hours and of presumed vascular origin, or with proof of cerebral ischaemia corresponding to the clinical symptoms in neuroimaging); for ICH diagnosis requires clinical symptoms and radiological diagnosis of ICH\n* Hospital admission \\\u003C24h after symptom onset\n* Age 18+ years for the basic Modules AIS and ICH; age \\\u003C18 years for the basic Module paediatric stroke patients\n* Informed consent: Signed IC from patients capable of giving consent and understanding all content of the IC or IC of an appropriate patient representative or deferred consent, if patients are unable to consent themselves\n* Additional inclusion criteria are defined by the individual Modules\n\nExclusion Criteria:\n\n* In-hospital stroke\n* TIA\n* SAH\n* Stroke as a complication of a medical procedure\n* Enrolment in a randomised placebo-controlled interventional trial\n* Already enrolled in the SN STROKE base cohort",{"count":411,"type":21},12750,"90 Days","The Stroke-CORE cohort aims to provide a comprehensive and up-to-date understanding of stroke care in Germany. To achieve this, patients are followed along the entire continuum of care-from initial management before hospital admission, through acute treatment, rehabilitation, and follow-up care, to the prevention of recurrent strokes. Strokes occurring in childhood are also included in this cohort study.\n\nIn addition, the study seeks to establish effective structures for the early identification and inclusion of patients in clinical research (screening). In this context, structured screening processes are being implemented across all levels of care at participating sites within the Network University Medicine (NUM), a collaboration of German university hospitals. At the same time, the cohort serves as a platform within this network to systematically address open research questions in various areas of stroke care and to support the targeted planning and conduct of future clinical studies.\n\nThe study includes patients with ischemic stroke (caused by a blocked blood vessel) or intracerebral hemorrhage (bleeding within the brain). Participation takes place in different thematic modules, each focusing on specific aspects of the disease course and its management. These modules address, among other topics, acute hospital treatment, measures to prevent recurrent strokes (secondary prevention), possible complications, pre-hospital care, rehabilitation, follow-up care, and long-term outcomes such as physical recovery, independence in daily life, and cognitive functions including memory and concentration.\n\nAs part of the study, a range of data is collected. This includes sociodemographic information (such as age and living situation) as well as medical data, for example on prior conditions, diagnoses, treatments, and comorbidities. In addition, patients' health status is assessed at multiple time points in order to better understand the course of the disease. Depending on the level of participation, data collection may be complemented by the collection of biological samples, such as blood. These are obtained either during routine clinical procedures or through simple, minimally burdensome (non-invasive) methods.\n\nThe study is structured into several levels that differ in the scope and depth of data collection. The basic level includes essential information, while higher levels involve more detailed assessments. In addition, some levels include the collection of biological samples, and there are optional supplementary modules in which patients may participate voluntarily. This tiered approach allows participation to be flexibly adapted to the individual situation while contributing to a nuanced and comprehensive understanding of stroke care.",[415,416,417,418,419],"Intracerebral Haemorrhage","Paediatric Stroke","Stroke Acute","Stroke","Ischemic Stroke",[418,421,422,416,423,424,425,426,427,428,429,430],"ischemic stroke","Intracerebral Hemorrhage","Cerebrovascular Disorders","Brain Diseases","Vascular Diseases","Cardiovascular Diseases","Brain Infarction","Embolic Stroke","Thrombotic Stroke","Acute","2026-04-23",{"date":433,"type":32},"2026-04-28",{"date":435,"type":21},"2026-05-01",{"date":437,"type":21},"2030-06-30",{"name":38,"class":39},12,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":52,"phases":450,"briefSummary":451,"conditions":452,"keywords":456,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":467},"100583282","assessing-declined-liver-grafts-with-normothermic-machine-perfusion-to-reduce-transplant-waiting-time-100583282","NCT06874296","Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time","Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation","ExTra","Inclusion Criteria:\n\n* Able to consent\n* ≥ 18 years old\n* Listed in status \"transplantable\" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion\n* ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for \\[non\\]standard exceptions\n* Medically suitable and informed for transplantation with an organ that fulfils extended donor criteria (Eurotransplant ECD criteria)\n* Patient information and written consent to participate in the Extra trial\n* No participation in another interventional study during participation\n\nExclusion Criteria:\n\n* Listed for retransplantation\n* High-Urgency Listing\n* Listed for combined organ transplantation\n* Pregnancy",{"count":449,"type":21},186,[54],"The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.\n\nThe main questions this study aims to answer are:\n\n* Does this method help patients get a transplant sooner?\n* Can this method make more livers available for transplant?\n* Does it improve survival and health after transplant?\n\nParticipants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:\n\n* Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion.\n* Control group: These participants will receive a liver through the usual transplant process.\n\nThe main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.\n\nThis study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.",[453,454,455],"Liver Transplantation","Liver Diseases","Surgery",[453,457,458,459],"Extended Criteria Donors","Normothermic Machine Perfusion","Discarded Liver Grafts","2026-04-14",{"date":462,"type":32},"2026-04-15",{"date":464,"type":32},"2025-06-02",{"date":232,"type":21},{"name":38,"class":39},10,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":109,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":490,"locationsCount":40},"100633631","observational-study-on-immunoadsorption-ia-in-patients-with-autoantibody-positive-post-infectious-mecfs-100633631","NCT07529197","Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME\u002FCFS","Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","IMPACT","Inclusion Criteria:\n\n* Patients aged 18-65 years who are able to give informed consent and have: i) ME\u002FCFS diagnosed according to the CCC, with exertion intolerance and symptom worsening (post exertional malaise = PEM) lasting at least 14 hours and ii) Significant functional impairment with a Bell Disability Score \\\u003C 60\n* Presence of autoantibodies (adrenergic or antineuronal antibodies)\n* Undergoing IA with the TheraSorb® column over 5 days\n* Written informed consent provided by the patient\n* Health insurance coverage\n\nExclusion Criteria:\n\n* Lack of willingness to store pseudonymized disease data as part of the study\n* Pregnancy\n* Presence of other conditions that prevent a definite ME\u002FCFS diagnosis (e.g., heart failure, lung disease, severe depression, cancer)\n* Acute infection (COVID, HIV, hepatitis)\n* Severe fatigue disease with bedriddenness (Bell Disability Score \\\u003C 30)",{"count":20,"type":21},"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Around 10% of patients after mild or moderate COVID-19 develop Post-COVID Syndrome (PCS), and some meet ME\u002FCFS criteria after six months. No causal treatment exists for ME\u002FCFS or PCS; current approaches are symptomatic and rehabilitative. Given the high and increasing number of affected patients, there is an urgent need for evidence-based, standardized therapies.\n\nImmunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME\u002FCFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME\u002FCFS also showed symptomatic improvement in most patients.\n\nHypothesis:\n\nAntibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME\u002FCFS and is associated with altered memory B-cell profiles before treatment.\n\nObjective:\n\nTo observe and document symptom progression in 50 ME\u002FCFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response.\n\nThe study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.",[479,480],"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","ME\u002FCFS Following COVID-19",[479,482,483,484],"Post-COVID Syndrome (PCS)","Immunoadsorption (IA)","SF-36 Physical Function (PF)","2026-04-13",{"date":460,"type":32},{"date":488,"type":32},"2026-03-11",{"date":362,"type":21},{"name":38,"class":39},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":499,"maxAge":49,"enrollmentInfo":500,"targetDuration":4,"studyType":52,"phases":501,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":40},"100607835","phase-1-influence-of-personalized-lung-volume-optimization-maneuver-on-lung-function-and-cardiac-performance-in-children-100607835","NCT07193719","Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children","Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children","ILOCO","CHD study:\n\nInclusion Criteria\n\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.\n\nECMO study Inclusion Criteria\n\n* patients with respiratory failure on ECMO or at risk for ECMO\n* invasive ventilation\n\nExclusion Criteria:\n\n\\- severe lung hypoplasia or interstitial lung disease","0 Years",{"count":311,"type":21},[375,376],"The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in\n\n1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and\n2. study) in children with severe respiratory failure at risk for or need for ECMO.\n\nThe main questions it aims to answer are:\n\nMain hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:\n\n* cardiac performance\n* lung function\n\nDoes it make a difference in:\n\n* length of ventilation\n* ventilation\u002Fperfusion mismatch of the lung\n* need for vasopressor support?\n\nMain hypotheses of ECMO study:\n\nDoes a LVOM in children\u002Finfants with severe respiratory failure \u002FARDS\n\n* improve lung compliance and gas exchange\n* facilitate lung protective ventilation according to PALICC-2 guidelines\n* improve lung aeration and V\u002FQ-matching assessed with EIT\n\nDoes it make a difference in\n\n* need for ECMO\n* duration of ECMO runs\n* hemodynamics stability",[379,380,388,381,383,384,385,387,386,504,505],"ARDS","ECMO",[390,391,393,504,505,507],"cardiopulmonary bypass","2026-04-05",{"date":510,"type":32},"2026-04-09",{"date":512,"type":32},"2025-12-05",{"date":514,"type":21},"2027-12-20",{"name":38,"class":39},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":52,"phases":525,"briefSummary":526,"conditions":527,"keywords":530,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":540},"100490398","prevention-of-sudden-cardiac-death-after-myocardial-infarction-by-defibrillator-implantation-100490398","NCT05665608","Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation","PROFID EHRA","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Naïve to implantation of any pacemaker or defibrillator\n3. Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI) at least 3 months prior to enrolment.\n4. Symptomatic heart failure with New York Heart Association (NYHA) class II or III.\n5. On OMT for at least 3 months prior to enrolment.\n6. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging \\[MRI\\] at least 3 months after MI).\n7. Signed informed consent.\n\nInclusion criterion I3 defines myocardial infarction according to the 2018 ESC\u002FACC\u002FAHA\u002FWHF Fourth Universal Definition of myocardial infarction\n\nExclusion Criteria:\n\n1. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.\n2. Ventricular tachycardia induced in an electrophysiologic study.\n3. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.\n4. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)\n5. Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).\n6. Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.\n7. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.\n8. On the waiting list for heart transplantation.\n\n   Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachy-cardia has to be assessed according to the 2022 ESC Guidelines for the management of patients with ven-tricular arrhythmias and the prevention of SCD.\n9. Any known disease that limits life expectancy to less than 1 year.\n10. Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.\n11. Previous participation in PROFID EHRA.\n\nParallel participation in sub-studies connected to this trial is permitted as well as in purely observational studies without any pre-defined intervention.",{"count":524,"type":21},3595,[54],"Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative.\n\nOBJECTIVE:\n\nTo demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.",[528,529],"Sudden Cardiac Death","Myocardial Infarction",[531,528,529],"Implantable Cardioverter Defibrillator","2026-03-31",{"date":534,"type":32},"2026-04-01",{"date":536,"type":32},"2023-11-16",{"date":538,"type":21},"2027-11-30",{"name":38,"class":39},86,{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":560,"locationsCount":40},"100631500","evaluation-of-quality-indicators-in-patients-receiving-intensive-care-and-their-influence-on-outcome-indicators-and-economic-indicators-100631500","NCT07501494","Evaluation of Quality Indicators in Patients Receiving Intensive Care and Their Influence on Outcome Indicators and Economic Indicators","Retrospective Observational Study - Evaluation of Quality Indicators in Patients Receiving Intensive Care and Their Influence on Outcome Indicators and Economic Indicators","EQUINOK","Inclusion Criteria:\n\n* Patients with complete, electronically documented intensive care treatment data, including vital sign monitor data and laboratory data from the patient documentation system.\n* Complete, electronically documented treatment data for these patients from the hospital information system.\n* Data from cost and revenue accounting from the hospital information system, §21 routine data records.\n* Age ≥ 18 years\n* Length of stay \\> 24 hours\n* Intensive care units from the Department of Anesthesiology and Intensive Care Medicie (CCM\u002FCVK) of Charité - University Medicine Berlin: \"M101I\", 'MPACU', \"WAN-S14I\", \"WAN-S8I\", \"WAN-PACU\". Since the introduction of electronic patient records, some of these intensive care units have had different names (e.g., MAN-101i, MAN-103i, W1i).\n\nExclusion Criteria:\n\n-none",{"count":550,"type":21},26000,"The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes. The objective is to correlate adherence to individual process-based quality indicators or their combination with outcome data. In addition, cost shares and case revenues are evaluated. Indices are also derived from routine data that may represent additional influencing factors (Charlson Comorbidity Index or secondary diagnoses that increase case severity based on ICD-10 coding and procedures based on the Surgery and procedure codes system).",[553],"Quality Indicators","2026-03-26",{"date":556,"type":32},"2026-03-30",{"date":558,"type":32},"2026-03-05",{"date":362,"type":21},{"name":38,"class":39},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":569,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":52,"phases":572,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":585,"locationsCount":40},"100631620","ovarian-cancer-screening-and-ai-100631620","NCT07503054","Ovarian Cancer Screening and AI","AI on Ovarian Cancer Screening Attitudes in Gynecologists","AI-OCS-Gyn","Inclusion Criteria:\n\n* gynecologists in outpatient care who provide ovarian cancer screening to asymptomatic, average-risk women (not guideline consistent)\n\nExclusion Criteria:\n\n* gynecologists in inpatient care\n* gynecologist in outpatient care who do NOT provide ovarian cancer screening to asymptomatic, average-risk women (guideline consistent)","24 Years",{"count":571,"type":21},350,[54],"Gynecologists frequently overestimate the benefits and safety of ovarian cancer screening. AI-supported discussions may help correct these misperceptions. This study tests whether an AI-guided conversation about the evidence on ovarian cancer screening can improve gynecologists' knowledge and reduce non-evidence-based screening recommendations, compared with a control AI discussion on ovarian cancer prevalence.",[575],"Ovarian Cancer Screening Recommendations by Gynecologists",[577,578,579],"ovarian cancer screening recommendations","AI-based conversational intervention","gynecologists' knowledge on ovarian cancer screening","2026-03-25",{"date":532,"type":32},{"date":583,"type":21},"2026-03-27",{"date":396,"type":21},{"name":38,"class":39},{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":86,"enrollmentInfo":593,"targetDuration":4,"studyType":52,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":40},"100539795","neuromodulation-and-mindfulness-patients-with-aud-100539795","NCT06308484","Neuromodulation and Mindfulness Patients With AUD","Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD","Inclusion Criteria:\n\n* Alcohol Dependence (ICD-10)\n* abstinence between 3 days and 12 months\n\nExclusion Criteria:\n\n* current (last 12 months) substance use disorder\u002Fdependence\n* neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis)\n* current severe major depressive disorder, manic episode or schizophreniform disorder\n* intake of anticonvulsive or high-potency antipsychotic medication",{"count":594,"type":21},140,[54],"Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2).",[137],"2026-03-18",{"date":600,"type":32},"2026-03-20",{"date":602,"type":32},"2024-03-20",{"date":604,"type":21},"2027-06-30",{"name":38,"class":39},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":259,"enrollmentInfo":612,"targetDuration":613,"studyType":23,"phases":4,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":40},"100406265","berlin-registry-of-right-heart-interventions-100406265","NCT04570163","Berlin Registry of Right Heart Interventions","Inclusion Criteria:\n\n* Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation\u002F stenosis, pulmonary regurgitation\u002F stenosis)\n* \\>18 years\n* Written, documented consent\n\nExclusion Criteria:\n\n* Patients in care or unable to consent\n* Patients who are unable to comply with follow-up examinations\n* Patients who are detained in an institution",{"count":216,"type":21},"24 Months","The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.",[616,617],"Tricuspid Regurgitation","Pulmonary Regurgitation",{"date":619,"type":32},"2026-03-19",{"date":621,"type":32},"2020-06-16",{"date":623,"type":21},"2035-12-31",{"name":38,"class":39},{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":308,"sex":18,"minAge":49,"maxAge":109,"enrollmentInfo":633,"targetDuration":4,"studyType":52,"phases":635,"briefSummary":636,"conditions":637,"keywords":639,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":40},"100509118","dopamine-modulation-of-motivation-and-motor-function-in-major-depression--inflammation-100509118","NCT05909267","Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation","Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.","MOTIVADE","Inclusion Criteria:\n\nFor patients with major depressive disorder:\n\n* diagnosis of major depressive disorder according to DSM-5\n* free of antidepressant medication\n\nFor healthy participants:\n\n* C-reactive protein (CRP): ≤ 1 mg\u002Fl\n* free of antidepressant medication\n* free of any current psychiatric disorder\n\nExclusion Criteria:\n\n* diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, dementia, and current\u002Fpast alcohol or drug dependence\n* central nervous system diseases\n* neurological diseases\n* suspicious undiagnosed skin lesions or a history of melanoma\n* narrow-angle or wide-angle glaucoma\n* bronchial asthma\n* history of peptic ulcer disease\n* history of seizures\n* any severe somatic disease\n* current infections or chronic inflammatory diseases (e.g., rheumatic diseases, inflammatory bowel disease)\n* pregnancy \u002F breast-feeding\n* class 3 obesity (body mass index of 40 or higher)\n* Use of medication containing reserpine (certain antihypertensive agents), tricyclic antidepressants, bon-selective monoamine oxidase (MAO) inhibitors, antiparkinsonian drugs, sympathomimetic drugs, tetrabenazine.",{"count":634,"type":21},165,[54],"A large body of evidence on depression heterogeneity point to an \"immunometabolic\" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. Motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. In the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. If successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.",[638],"Depressive Disorder, Major",[640,641,642,643],"depression","inflammation","anhedonia","psychomotor retardation","2026-03-16",{"date":598,"type":32},{"date":647,"type":32},"2023-07-26",{"date":649,"type":21},"2026-07",{"name":38,"class":39},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":658,"enrollmentInfo":659,"targetDuration":4,"studyType":52,"phases":661,"briefSummary":662,"conditions":663,"keywords":665,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":671,"locationsCount":672},"100331048","phase-2-international-study-for-treatment-of-high-risk-childhood-relapsed-all-2010-100331048","NCT03590171","International Study for Treatment of High Risk Childhood Relapsed ALL 2010","International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group","Inclusion Criteria:\n\n* Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL\n* Children less than 18 years of age at date of inclusion into the study\n* Meeting HR criteria any BM relapse, early\u002Fvery early isolated BM relapse, very early isolated\u002Fcombined extramedullary relapse)\n* Patient enrolled in a participating centre\n* Written informed consent\n* Start of treatment falling into the study period\n* No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL\n\nExclusion Criteria:\n\n* Breakpoint cluster region-Abelson (BCR-ABL)\u002F t(9;22) positive ALL\n* Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \\> 10 U\u002Fl)\n* Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \\\u003C1) until 12 months after end of anti-leukemic therapy\n* Breast feeding\n* Relapse post allogeneic stem-cell transplantation\n* Neuropathy \\> II°\n* The whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* Objection to the study participation by a minor patient, able to object\n* Any patient being dependent on the investigator\n* No consent is given for saving and propagation of pseudonymized medical data for study reasons\n* Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)\n* Subjects unwilling or unable to comply with the study procedures\n* Subjects who are legally detained in an official institute","17 Years",{"count":660,"type":21},250,[376],"The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.",[664],"Acute Lymphoblastic Leukemia (ALL)",[18],{"date":667,"type":32},"2026-03-17",{"date":669,"type":32},"2017-09-01",{"date":362,"type":21},{"name":38,"class":39},15,""]