[{"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:":694},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,104,0,25,[9,43,86,106,135,167,187,218,241,278,297,322,343,366,401,429,447,467,496,522,557,594,622,644,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100613330","oxytocin-augmented-group-psychotherapy-for-patients-with-schizophrenia---an-oxytocin-dose-comparison-100613330",false,"NCT07265180","Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison","Oxytocin-Augmented Mindfulness-Based Group Psychotherapy for Patients With Schizophrenia Spectrum Disorders - an Oxytocin-dose Comparison (OXYMIND2.0)","OXYMIND2","Inclusion Criteria:\n\n* Declaration of consent\n* Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients\n* Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P-PANSS)\n* German should either be the native language or spoken at a native level\n* No change in systematically recorded psychopharmacological medication in the last 2 weeks before study inclusion\n\nExclusion Criteria:\n\n* Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS)\n* Acute suicidality\n* Acute consumption phase of a substance dependence, except nicotine\n* No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage\n* Pregnancy and breastfeeding\n* Current acute electroconvulsive therapy\n\nIf one of the following criteria applies to the participants, we will conduct an individual consultation in advance to determine whether participation in the study is possible:\n\n* Overweight or underweight (body mass index (BMI) \\\u003C 17.5 or \\> 30)\n* Disease of the endocrine system\n* Impaired kidney or liver function\n* Metabolic diseases\n* Asthma\n* Change in blood potassium or sodium levels","ALL","18 Years","75 Years",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"NA","The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.",[29],"Schizophrenia Spectrum Disorders (SSD)","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2025-09-08",{"date":38,"type":23},"2026-11-30",{"name":40,"class":41},"Charite University, Berlin, Germany","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":70,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":42},"100652013","angiovac-aspiration-therapy-registry-100652013","NCT07769320","AngioVac Aspiration Therapy Registry","A Multicenter, International, Retrospective Observational Study Evaluating the Safety and Effectiveness of the AngioVac System Across Clinical Indications","AVATaR","Inclusion Criteria:\n\n1. Age ≥18 years at time of AngioVac procedure\n2. Patient underwent percutaneous AngioVac aspiration (any AngioVac model or version used clinically during study period)\n3. Procedure performed within study period (January 2018 (or site's institutional start date) - June 2026)\n4. Written informed consent OR documented waiver\u002Fexemption from ethics authority (per local regulations per GDPR)\n\nExclusion Criteria:\n\n1. Insufficient documentation to assess primary safety or effectiveness endpoints (e.g. defined as \\>20% missing data in core endpoint variables)\n2. Patient objection to retrospective data use (where required by local law; GDPR Article 21 opt-out; honored without study impact)\n3. Non-AngioVac procedures: Patients undergoing thrombus\u002Fvegetation removal by surgery or other percutaneous devices only (not AngioVac)",{"count":52,"type":23},1000,"OBSERVATIONAL","As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients that were treated with the AngioVac Aspiration System:\n\n1. Quantify Real-World Safety: Composite adverse event rates across diverse populations and indications\n2. Assess Effectiveness: Technical and clinical success rates stratified by indication\n3. Identify Predictors: Clinical, procedural, and anatomical factors predicting success versus complications\n4. Generate Publishable Cohorts: Sufficient statistical power (approx. 1000 patients across 8 indication cohorts) for:\n\n   * Indication-specific outcomes\n   * Multivariable prediction models\n   * Time-to-event analyses (30-day and 12-month mortality)\n5. Establish Best Practices: Evidence-based recommendations for patient selection, procedural technique, and follow-up",[56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Intracardiac Thrombus","Intracardiac Mass","Intravascular Thrombosis","Vegetation; Heart","Vegetation; Endocarditis","Vegetation on Catheter","Thrombus of Right Atrium","Thrombus of Right Ventricle","Thrombus Inferior Vena Cava","Thrombus of Pacemaker Electrode","Endocarditis Infective","Endocarditis, Bacterial","Thrombus of Pulmonary Artery","Thrombus on Catheter",[71,72,73,74,75,76],"Percutaneous aspiration","Intracardiac thrombus","Intravascular thrombus","Vegetation","Endocarditis","CIED lead associated vegetation","NOT_YET_RECRUITING","2026-08-12",{"date":80,"type":34},"2026-08-17",{"date":82,"type":23},"2026-10-01",{"date":84,"type":23},"2027-12-31",{"name":40,"class":41},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100647701","development-of-context-adapted-quality-indicators-for-early-sepsis-care-in-sub-saharan-africa---a-modified-delphi-consensus-procedure-100647701","NCT07711535","Development of Context-Adapted Quality Indicators for Early Sepsis Care in Sub-Saharan Africa - A Modified Delphi Consensus Procedure","Inclusion Criteria:\n\n* Professionals with proven experience in sepsis care or sepsis research in low- and middle-income countries, particularly Sub-Saharan Africa including physicians, nurses, researchers, and other healthcare professionals involved in early acute care and quality assurance\n* Minimum age of 18\n* Willingness to voluntarily participate in one or more Delphi rounds\n\nExclusion criteria:\n\n* Lack of professional expertise in the field of sepsis care\n* Refusal to consent to participation\n* Withdrawal from participation at the participant's own request",true,{"count":94,"type":23},45,"The research project is an anonymous, prospective, non-interventional consensus study in the form of a modified Delphi method, consisting of three online surveys and structured feedback meetings without recording. The goal is the structured evaluation and consolidation of expert assessments to develop context-adapted quality indicators and operationalize them for early sepsis care in Sub-Saharan Africa.",[97],"Sepsis","2026-08-03",{"date":100,"type":34},"2026-08-05",{"date":102,"type":23},"2026-08",{"date":104,"type":23},"2026-10",{"name":40,"class":41},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":132,"leadSponsor":134,"locationsCount":42},"100593282","phase-3-continuous-or-intermittent-cetuximab-plus-folfiri-as-first-line-treatment-in-rasbraf-wild-type-mcrc-patients-100593282","NCT07004413","Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS\u002FBRAF Wild-type mCRC Patients","Randomized Study to Compare First-line Treatment With Either Continuous or Intermittent Cetuximab Plus FOLFIRI in Patients With RAS\u002FBRAF-wild-type Metastatic Colorectal Cancer (mCRC): AIO-KRK-0524 \u002F FIRE-11","FIRE-11","Inclusion Criteria:\n\n1. Patient's signed informed consent\n2. Histologically confirmed, UICC stage IV unresectable adenocarcinoma of the colon or rectum\n3. Locally confirmed RAS\u002FBRAF wild-type tumor status (KRAS and NRAS exon 2, 3, 4, BRAF exon 11\u002F15)\n\n   a) Note: A maximum of two cycles FOLFIRI is allowed prior to start of induction treatment until the molecular characterization is fully reported\n4. Centrally confirmed RAS\u002FBRAF wild-type status by liquid biopsy during screening phase\n5. Age 18 or older at the time of written informed consent\n6. ECOG performance status below or equal 1\n7. Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria\n8. Archival tumor tissue available\n9. Consent to storage, molecular and genetic profiling of tumor material and blood\n10. Adequate bone marrow function:\n\n    1. Leukocytes ≥ 3.0 x 109\u002FL with neutrophils ≥ 1.5 x 109\u002FL\n    2. Thrombocytes ≥ 100 x 109\u002FL\n    3. Hemoglobin ≥ 8 g\u002FdL)\n11. Adequate hepatic function:\n\n    1. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)\n    2. ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN)\n    3. INR \\\u003C 1.5 and aPTT \\\u003C 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.\n12. Adequate renal function:\n\n    a) Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL\u002Fmin\n13. Proficient fluorouracil metabolism as defined:\n\n    1. Prior treatment with 5-FU or capecitabine without unusual toxicity OR\n    2. If tested, normal DPD deficiency test according to the standard of the study site OR\n    3. If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine dosage should be reduced by 50%\n14. Females of childbearing potential (FCBPs) and men must agree to use highly effective contraceptive measures (Pearl index \\\u003C1) or practice true abstinence from any heterosexual intercourse (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject) for the duration of the study treatment and for at least 6 months after last administration of study medication. A woman will be considered as being of childbearing potential unless she is at least 50 years old and moreover has gone through menopause for at least 2 years or has been surgically sterilized. For men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of study medication to avoid exposing the embryo.\n\nExclusion Criteria:\n\n1. Proof of a RAS or BRAF mutation (KRAS\u002FNRAS exons 2, 3, 4 or BRAF exon 15) in the tumor (proven in the primary tumor or metastasis) or liquid biopsy during screening phase.\n2. Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before written informed consent.\n3. New York Heart Association Class III or greater heart failure by clinical judgement.\n4. Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cerebral vascular accident\u002Fstroke within the past 12 months before randomization\n5. Unstable angina pectoris\n6. Unstable cardiac arrhythmia \\> grade 2 NCI CTCAE despite anti-arrhythmic therapy.\n7. Active uncontrolled infection by investigator's perspective.\n8. Pre-existing pulmonary fibrosis or immune pneumonitis\n9. Additional cancer treatment (chemotherapy, radiation, immunotherapy or hormone treatment) during the study treatment in first-line and third-line treatment (treatments that are conducted as part of an anthroposophical or homeopathic treatment approach, e.g. mistletoe therapy does not represent an exclusion criterion)\n10. Participation in a clinical study or experimental drug treatment within 30 days prior to written informed consent or within a period of 5 half-lives of the substances administered in a clinical study or during an experimental drug treatment prior to written informed consent, depending on which period is longest or simultaneous participation in another study while taking part in the study\n11. Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, cetuximab, irinotecan and chemically related substances and\u002For hypersensitivity to any of the components in the formulations of the aforementioned substances, including known hypersensitivity reactions to monoclonal antibodies NCI CTC grade ≥ 3.\n12. Known hypersensitivity to Chinese hamster ovary cell (CHO) -cellular products or other recombinant human or humanized monoclonal antibodies\n13. Patients with known brain metastases or leptomeningeal disease. In case of clinical suspicion of brain metastasis, a cranial CT or MRI must be performed to rule out brain metastasis before study inclusion.\n14. History of acute or subacute intestinal occlusion, inflammatory bowel disease, immune colitis or chronic diarrhea\n15. Symptomatic peritoneal carcinosis\n16. Severe, non-healing wounds, ulcers or bone fractures\n17. Requirement for immunization with live vaccine including attenuated live vaccine from at least 4 weeks before begin of induction treatment until 6 months after the administration of IMPs.\n18. Hemorrhagic diathesis or known thrombophilia\n19. Known glucuronidation deficiency (Gilbert's syndrome) (specific screening not required)\n20. Treatment with nucleoside analogues including sorivudine or brivudine within 28 days before begin of induction treatment or requirement for concomitant antiviral treatment with sorivudine or brivudine or analogues\n21. History of a second primary malignancy during the past 5 years before written informed consent or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively.\n22. Active alcohol or drug abuse\n23. Any significant adverse event that has not adequately resolved, severe acute or chronic concomitant disease or medical condition including psychiatric conditions (including recent i.e. within the past year or active suicidal ideation or behavior) or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n24. Absent or restricted legal capacity\n25. Patients who are institutionalized by order of court or public authority\n26. Patients who might be dependent on the sponsor\u002Finvestigator or the trial site",{"count":115,"type":23},267,[117],"PHASE3","The goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. The main question it aims to answer is, whether worsening of disease after 12 months of treatment is lower when the treatment is given with breaks or given continuously. It will also answer the question whether the quality of life is better and side effects are less if chemotherapy is given with breaks.\n\nAdditionally, the treatment breaks will be controlled by blood tests and imaging examinations. A novel blood test will be introduced to investigate, whether worsening of the disease might be detected before the imaging, and whether a quicker reaction by re-starting the therapy would help the patients.\n\nParticipants will:\n\n* receive an established chemotherapy mit FOLFIRI and cetuximab\n* Receive blood tests every 4 weeks and imaging investigations every 12 weeks\n* fill out questionnaires to report their quality of life",[120],"Colorectal Cancer Metastatic",[122,123,124,125,126,127],"Metastatic colorectal cancer","RAS","BRAF","cetuximab","ctDNA","treatment break","2026-07-28",{"date":130,"type":34},"2026-07-29",{"date":82,"type":23},{"date":133,"type":23},"2031-10-01",{"name":40,"class":41},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":166,"locationsCount":42},"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",{"count":144,"type":23},60,[26],"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.",[148],"Melanoma (Skin Cancer)",[150,151,152,153,154,155,156,157,158,159,160],"fasting","diet","fiber","high-fiber","melanoma","STF","short-term fasting","microbiome","checkpoint-inhibitor","checkpoint-inhibition","immunotherapy","2026-07-27",{"date":130,"type":34},{"date":128,"type":34},{"date":165,"type":23},"2028-12-05",{"name":40,"class":41},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"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":176,"type":23},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.\n\nSubproject started in July, 2026:\n\nEconomic analysis conducted by Cellogic as a contract research project-selected clinical trial data from the clinical trial database and selected data from the Institute for the Hospital Payment System (InEK), cost unit accounting, and OPS codes will be evaluated for patients form QV-POD-1",[179],"Delirium in Old Age",{"date":130,"type":34},{"date":182,"type":34},"2020-04-20",{"date":184,"type":23},"2029-06",{"name":40,"class":41},2,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":24,"phases":198,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":42},"100648803","phase-2-cd19-b-cell-depletion-in-pais-mecfs-patients-100648803","NCT07724834","CD19-B Cell Depletion in PAIS-ME\u002FCFS Patients","Prospective, Randomized, Double-blind, Placebo-controlled Phase 2b Trial Evaluating the Efficacy and Safety of the Anti-CD19 Monoclonal Antibody Inebilizumab Compared With Placebo in Patients With Post-acute Infection Syndromes Fulfilling ME\u002FCFS Criteria (PIONEER)","PIONEER_PAIS","Inclusion Criteria:\n\n* Male\u002Ffemale\u002Fdiverse adults who are 18-65 years old at time of enrollment\n* Subject is able and willing to give informed consent\n* Signed informed consent prior to initiation of any trial related measure\n* Diagnosis of PAIS as defined by WHO for PCS, wi th other infectious triggers\n* Diagnosis of ME\u002FCFS according to CCC criteria with PEM \\> 14 hours = PAIS\u002FCFS\n* Detection of autoantibodies (elevated ß2R adrenergic AAB) prior to immunoadsorption or prior to inclusion to PIONEER\n* Pre-treatment with immunoadsorption in the immunoadsorption studies at least 6 months before study inclusion\n* Documented clinical response to immunoadsorption (minimum increase in SF-36 PF of 10 points at week 8) followed by consecutive worsening of symptoms (minimum decrease in SF-36 PF of 10 points for at least 3 months)\n* Evidence of activated pro inflammatory immune cell status\n* Bell score at screening visit: 30-60\n* Normal thyroid function or sufficiently medicated dysfunction\n* For women of childbearing potential (WOCBP):\n\n  1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or\n  2. If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before randomization, and practicing a highly effective birth control method (failure rate of less than 1%)\n\nExclusion Criteria:\n\n* Contraindication against IMP or AMP\n* Hypersensitivity to the active substance or any of the other ingredients\n* Vaccination less or up to 4 weeks before first visit\n* Immunomodulative therapy \\\u003C 3 month before screening visit\n* Concomitant and previous use of IMP\n* Known SARS-CoV-2 or other infection related organ damage\u002Fcomorbidity\n* Pre-infection history of chronic fatigue syndrome or other fatigue syndromes that are due to associated diseases (e.g., cancer, autoimmune diseases \\[patients with a preexcisting Hashimoto thyroiditis and\u002For fibromyalgia without fatigue syndromes can be included\\])\n* Serious infections, including active or latent and chronic infections such as tuberculosis, HIV, Lues, hepatitis B and C\n* Immune- and immunoglobulin-deficiency or severely immunocompromised condition\n* Any other severe or unstable medical conditions (immune, cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, systemic) or any other condition deemed by the Investigator to pose unacceptable risk, interfere with IP evaluation, or confound study results.\n* At screening : aspartate transaminase (AST) \\> 2.5 × upper limit of normal (ULN), alanine transaminase (ALT) \\> 2.5 × ULN, total bilirubin \\> 1.5 × ULN (unless due to Gilbert's syndrome), platelet count \\\u003C 75,000\u002FµL, hemoglobin \\\u003C 8 g\u002FdL, eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m², total immunoglobulin \\\u003C 900 mg\u002FdL, absolute neutrophil count \\\u003C 1200 cells\u002FµL, CD4 T lymphocyte count \\\u003C 300 cells\u002FµL\n* Concomitant diseases or health constellations causing general physical weakness or fatigue, like: i) renal insufficiency with eGR\\\u003C 15 or diyalsis, ii) impaired liver function with elevated liver enzymes a) Aspartate aminotransferase (AST) and b) Alanin-Aminotransferase (ALT), both \\>35 U\u002Fl for women or \\> 50 U\u002Fl for men, iii) anemia with low hemoglobin-concentrations \\\u003C13,0 g\u002FdL for males and \\\u003C12,0 g\u002FdL for females, and iv) adipositas grades II or higher (BMI: ≥ 35 kg\u002Fm 2) at screening\n* Subject is pregnant or breastfeeding\n* Subject is institutionalized by order of court or public authority\n* Subject who might be dependent on the sponsor, the investigator, or the trial site\n* Participation in another clinical trial with a medical device or an investigational medicinal product within 3 Months or 5 half-lives (whichever is longer) before screening visit","65 Years",{"count":197,"type":23},38,[199],"PHASE2","Post-acute infection syndromes (PAIS) are long-lasting health problems that can develop after an infection. They include post-COVID-19 syndrome and similar illnesses following other infections. Some people with PAIS develop myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS), a serious and disabling illness that can greatly limit everyday activities. People with ME\u002FCFS may experience severe fatigue, reduced physical and mental function, pain, sleep problems, and problems with the regulation of heart rate and blood pressure. A key feature is post-exertional malaise (PEM), in which symptoms become worse after physical or mental activity. The biological causes of PAIS and ME\u002FCFS are not fully understood, and there is currently no established treatment that targets the underlying disease process.\n\nResearch suggests that changes in the immune system may contribute to PAIS and ME\u002FCFS in some patients. In particular, B cells (a type of immune cell) and autoantibodies (antibodies that react with the body's own structures) may play a role. Previous studies of immunoadsorption, a procedure that removes antibodies from the blood, have shown improvements in some patients with ME\u002FCFS. These findings support further investigation of treatments that target B cells in selected patients.\n\nThe PIONEER\\_PAIS study will investigate whether inebilizumab can improve physical function in adults with PAIS who meet the diagnostic criteria for ME\u002FCFS. The study includes a selected group of patients with evidence of autoantibodies and immune activation who previously improved after immunoadsorption but later experienced worsening of their symptoms. Inebilizumab is a monoclonal antibody that targets CD19, a protein found on B cells, and leads to the depletion of these cells.\n\nParticipants will be randomly assigned to receive either inebilizumab or placebo (saline solution) as an infusion into a vein. Inebilizumab will be given at a dose of 300 mg on Day 1, Day 15, and Week 24. The study is double-blind, meaning that neither the participants nor the study team assessing them will know which treatment they receive.\n\nThe main research question is whether treatment with inebilizumab leads to a greater improvement in physical function (PF) than placebo. PF will be measured using the PF scale of the SF-36 health questionnaire, comparing the change from the start of the study to Month 9 (Week 36).\n\nThe study will also examine other aspects of health and daily functioning, including fatigue, post-exertional malaise, pain and headache, disability, symptoms related to the autonomic nervous system, muscle strength and fatigability, heart rate and blood pressure responses during standing, daily step count, and cognitive function. Adverse events will be monitored to assess the safety of the treatment. In addition, the study includes biomarker research focusing on B cells, autoantibodies, and other markers in the blood.\n\nThis research aims to explore biological characteristics that may be associated with response to treatment and may help inform future studies of B-cell-targeted treatment in PAIS and ME\u002FCFS.",[202,203,204],"Post-acute Infectious Syndrome (PAIS)","Post-COVID 19 Condition (PCC or Long COVID)","Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)",[206,207,208,209],"PAIS","Long COVID","ME\u002FCFS","Fatigue","2026-07-21",{"date":212,"type":34},"2026-07-24",{"date":214,"type":23},"2026-12-01",{"date":216,"type":23},"2029-03-01",{"name":40,"class":41},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":226,"targetDuration":228,"studyType":53,"phases":4,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":42},"100645923","exspanding-the-knowledge-about-tnpo2-associated-disorders-100645923","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",{"count":227,"type":23},50,"10 Years","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.",[231],"TNPO2",[231],"2026-07-08",{"date":235,"type":34},"2026-07-13",{"date":237,"type":34},"2026-06-01",{"date":239,"type":23},"2036-12-31",{"name":40,"class":41},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":251,"studyType":53,"phases":4,"briefSummary":252,"conditions":253,"keywords":259,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"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":250,"type":23},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.",[254,255,256,257,258],"Intracerebral Haemorrhage","Paediatric Stroke","Stroke Acute","Stroke","Ischemic Stroke",[257,260,261,255,262,263,264,265,266,267,268,269],"ischemic stroke","Intracerebral Hemorrhage","Cerebrovascular Disorders","Brain Diseases","Vascular Diseases","Cardiovascular Diseases","Brain Infarction","Embolic Stroke","Thrombotic Stroke","Acute","2026-07-07",{"date":272,"type":34},"2026-07-09",{"date":161,"type":23},{"date":275,"type":23},"2030-06-30",{"name":40,"class":41},12,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":285,"targetDuration":228,"studyType":53,"phases":4,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":296,"locationsCount":42},"100646495","international-registry-for-trpm3-associated-disorders-100646495","NCT07690111","International Registry for TRPM3-associated Disorders","TRPM3Care","Inclusion Criteria:\n\n* Variant in the TRPM3 gene\n\nExclusion Criteria:\n\n* no consent from patient\u002Ffamiliy",{"count":286,"type":23},100,"The goal of the TRPM3Care-registry is to record the disease progression of patients with TRPM3-associated disorders. This allows us to compare the disease progression and the success of different therapies, as well as to examine their impact on quality of life.",[289],"TRPM3",[289],"2026-07-02",{"date":233,"type":34},{"date":294,"type":34},"2026-01-01",{"date":239,"type":23},{"name":40,"class":41},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":305,"targetDuration":4,"studyType":24,"phases":306,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":42},"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",{"count":144,"type":23},[26],"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.",[309],"Alcohol Use Disorder",[311,312,313],"alcohol use disorder","virtual reality cue exposure","olfactory","2026-06-21",{"date":316,"type":34},"2026-06-25",{"date":318,"type":23},"2026-07-01",{"date":320,"type":23},"2027-07",{"name":40,"class":41},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":328,"targetDuration":4,"studyType":24,"phases":330,"briefSummary":331,"conditions":332,"keywords":334,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":42},"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":329,"type":23},20,[26],"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.",[333],"Alcohol Dependence",[335],"Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory",{"date":337,"type":34},"2026-06-23",{"date":339,"type":34},"2026-03-07",{"date":341,"type":23},"2026-07-31",{"name":40,"class":41},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":24,"phases":352,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":42},"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":351,"type":23},338,[26],"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.",[355,356],"Adjacent Segment Disease","Lumbar Spinal Stenosis",[355,358,356],"Adjacent Segment Stenosis","2026-06-18",{"date":361,"type":34},"2026-06-22",{"date":82,"type":23},{"date":364,"type":23},"2031-03-01",{"name":40,"class":41},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":374,"targetDuration":4,"studyType":24,"phases":376,"briefSummary":377,"conditions":378,"keywords":384,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":42},"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",{"count":375,"type":23},130,[26],"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.",[379,380,381,382,383],"Hip Osteoarthritis","Arthroplasty, Replacement, Hip","Postoperative Complications","Surgical Wound Infection","Gastrointestinal Microbiome",[385,386,387,388,389,390,391,392,393],"Therapeutic fasting","Buchinger fasting","Intermittent fasting","Gut microbiome","Immunophenotyping","Continuous glucose monitoring","Total hip arthroplasty","Metabolic syndrome","Preoperative optimization","2026-06-17",{"date":361,"type":34},{"date":397,"type":34},"2025-07-01",{"date":399,"type":23},"2026-12-31",{"name":40,"class":41},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":409,"enrollmentInfo":410,"targetDuration":412,"studyType":53,"phases":4,"briefSummary":413,"conditions":414,"keywords":419,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":42},"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":411,"type":23},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.",[415,416,417,418],"Transgender","Gut Microbiome","Immune System","Cardiovascular Risk Factors",[420],"Transgender Medicine","2026-06-12",{"date":423,"type":34},"2026-06-15",{"date":425,"type":34},"2022-08-29",{"date":427,"type":23},"2030-12-31",{"name":40,"class":41},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":444,"leadSponsor":446,"locationsCount":186},"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":436,"type":23},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.",[439],"Postoperative Delirium","2026-06-03",{"date":442,"type":34},"2026-06-04",{"date":440,"type":34},{"date":445,"type":23},"2027-12",{"name":40,"class":41},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":454,"enrollmentInfo":455,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":42},"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":456,"type":23},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.",[459,460],"Anesthesiological Risk Reduction","Intensive Care Risk Reduction",{"date":462,"type":34},"2026-06-05",{"date":464,"type":34},"2020-12-03",{"date":427,"type":23},{"name":40,"class":41},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":476,"conditions":477,"keywords":479,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"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":286,"type":23},"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.",[478],"Chronic Subdural Hematomas",[480,481,482,483,484,485,486,487,488,489],"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":442,"type":34},{"date":318,"type":23},{"date":494,"type":23},"2028-01-31",{"name":40,"class":41},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":24,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":42},"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.","99 Years",{"count":505,"type":23},80,[26],"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.",[509],"Burnout Risk",[511,512,513],"Burnout","War","Ukraine","2026-05-29",{"date":516,"type":34},"2026-06-02",{"date":518,"type":34},"2026-03-24",{"date":520,"type":23},"2026-11",{"name":40,"class":41},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":531,"briefSummary":532,"conditions":533,"keywords":538,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":42},"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":530,"type":23},30,[26],"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.",[534,535,536,537],"Panic Disorder With Agoraphobia","Panic Disorder Without Agoraphobia","Generalized Anxiety Disorder","Social Anxiety Disorder",[539,540,541,542,543,544,545,546,547,548,549],"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":552,"type":34},"2026-05-07",{"date":554,"type":34},"2020-07-04",{"date":84,"type":23},{"name":40,"class":41},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":565,"maxAge":19,"enrollmentInfo":566,"targetDuration":4,"studyType":24,"phases":567,"briefSummary":569,"conditions":570,"keywords":581,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":42},"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":505,"type":23},[568,199],"PHASE1","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.",[571,572,573,574,575,576,577,578,579,580],"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",[582,583,584,585],"cardiopulmonary interactions","end-expiratory lung volume","electrical impedance tomography","PEEP titration","2026-04-26",{"date":588,"type":34},"2026-04-30",{"date":590,"type":23},"2026-09-01",{"date":592,"type":23},"2028-12-31",{"name":40,"class":41},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":24,"phases":604,"briefSummary":605,"conditions":606,"keywords":610,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":621},"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":603,"type":23},186,[26],"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.",[607,608,609],"Liver Transplantation","Liver Diseases","Surgery",[607,611,612,613],"Extended Criteria Donors","Normothermic Machine Perfusion","Discarded Liver Grafts","2026-04-14",{"date":616,"type":34},"2026-04-15",{"date":618,"type":34},"2025-06-02",{"date":427,"type":23},{"name":40,"class":41},10,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":630,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":643,"locationsCount":42},"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":227,"type":23},"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.",[204,633],"ME\u002FCFS Following COVID-19",[204,635,636,637],"Post-COVID Syndrome (PCS)","Immunoadsorption (IA)","SF-36 Physical Function (PF)","2026-04-13",{"date":614,"type":34},{"date":641,"type":34},"2026-03-11",{"date":84,"type":23},{"name":40,"class":41},{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":18,"minAge":652,"maxAge":19,"enrollmentInfo":653,"targetDuration":4,"studyType":24,"phases":654,"briefSummary":655,"conditions":656,"keywords":659,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":42},"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":505,"type":23},[568,199],"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",[571,572,580,573,575,576,577,579,578,657,658],"ARDS","ECMO",[582,583,585,657,658,660],"cardiopulmonary bypass","2026-04-05",{"date":663,"type":34},"2026-04-09",{"date":665,"type":34},"2025-12-05",{"date":667,"type":23},"2027-12-20",{"name":40,"class":41},{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":676,"targetDuration":4,"studyType":24,"phases":678,"briefSummary":679,"conditions":680,"keywords":683,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":693},"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":677,"type":23},3595,[26],"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.",[681,682],"Sudden Cardiac Death","Myocardial Infarction",[684,681,682],"Implantable Cardioverter Defibrillator","2026-03-31",{"date":687,"type":34},"2026-04-01",{"date":689,"type":34},"2023-11-16",{"date":691,"type":23},"2027-11-30",{"name":40,"class":41},86,""]