[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Johann Wolfgang Goethe University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100315242","phase-1-intracranial-injection-of-nk-92528z-cells-in-combination-with-intravenous-ezabenlimab-in-patients-with-recurrent-her2-positive-glioblastoma-100315242",false,"NCT03383978","Intracranial Injection of NK-92\u002F5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma","Multicenter, Open Label, Phase I Study of Intracranial Injection of NK-92\u002F5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma","CAR2BRAIN","Inclusion Criteria:\n\n1. Recurrent or refractory HER2-positive glioblastoma or its variant gliosarcoma in which relapse surgery (partial or total) or a biopsy (biopsy only for the \"CAR2BRAIN-CheckR\" cohort) is being planned. Those patients with planned biopsy may be included into the \"CAR2BRAIN-CheckR\" cohort, if all of the following conditions apply:\n\n   * Biopsy is necessary (as determined by the treating physician) to rule out the differential diagnosis of pseudoprogression prior to relapse surgery.\n   * Patients must be candidates for relapse surgery, which must be postponable for four weeks.\n2. Prior therapy must include the standard of care for glioblastoma (radiotherapy and alkylating chemotherapy, or at least a part thereof if the therapy was terminated prematurely due to therapy failure or poor tolerance). For patients with non-methylated MGMT-Promotor, prior alkylating chemotherapy is dispensable.\n3. Age ≥ 18 years\n4. Life expectancy ≥ 3 months\n5. Bilirubin ≤ 3x normal, AST ≤ 5x normal, ALT ≤ 5x normal, serum creatinine ≤ 2x upper limit of normal for age, leukocyte count ≥ 3\u002Fnl, thrombocyte count ≥ 100\u002Fnl and Hb ≥ 8.0 g\u002Fdl\n6. Blood oxygenation of ≥ 90% as measured by pulse oximetry on room air\n7. Women must have a negative serum pregnancy test within 72h prior to the start of the first NK-92\u002F5.28.z cell injection.\n8. Sexually active patients must be willing to utilize effective birth control methods throughout the study and for 24 weeks after the last NK-92\u002F5.28.z cell injection. This includes two different forms of effective contraception (e.g. hormonal contraceptive and condom, IUD\u002FIUS and condom) or sterilization.\n9. Patients should have been off other antineoplastic therapy for two weeks prior to entry in this study. Temozolomide will be allowed up to 48h preinjection. At the time of inclusion, dexamethasone up to a total dose of 4 mg per day will be allowed if medically indicated.\n10. Informed consent explained to and signed by patient; patient given copy of informed consent.\n11. Karnofsky performance score of ≥ 70%\n\nExclusion criteria:\n\n1. Anti-angiogenic therapy e.g. with bevacizumab in the last four weeks prior to study entry\n2. Previous anti-PD-1 or anti-PD-L1 directed checkpoint inhibitor therapy (only \"CAR2BRAIN-Check\" cohort)\n3. Coagulation disorder (INR\\>1.4 or PTT\\>50sec) or anticoagulation in therapeutic dosage\n4. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. However, patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n5. Patients with Type I diabetes mellitus not on a stable dose of insulin regimen\n6. Psoriatic arthritis (however, patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are permitted provided that they meet all of the following conditions:\n\n   * Rash must cover less than 10% of body surface area\n   * Disease is well controlled at baseline and only requiring low potency topical steroids\n   * No acute exacerbations of underlying condition within the previous 12 months (not requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids))\n7. Patients with clinical or laboratory signs for immunodeficiency or under immunosuppressive medication other than corticosteroids\n8. Severe intercurrent infection\n9. Known HIV, HBV (defined by detection of HBsAg) or HCV positivity (defined by detection of HCV-IgG)\n10. Chronic heart failure NYHA ≥III\n11. Patients with a prior solid organ transplantation or allogenic haematopoietic stem cell transplantation\n12. Patients unable to undergo MRI\n13. Pregnancy or breastfeeding\n14. Drug or alcohol abuse\n15. Severe psychiatric disorder which might interfere with the study treatment or examination\n16. Simultaneous participation in another interventional clinical trial. If a subject participated in a trial testing another IMP, such IMP should have been terminated at least 30 days before inclusion of the subject.","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The main objective of this clinical study is to evaluate the safety and tolerability of NK-92\u002F5.28.z and to determine the maximum tolerated dose or maximum feasible dose (MFD). Recommended phase 2 doses both for intraoperative injections only (RP2Diio) and repetitive injections (RP2Dri) will be determined. Frequent side effects and target organs of toxicity and their severity, duration and reversibility will be determined. Furthermore, pharmacokinetics and pharmacodynamics will be examined. In addition, potential signs of anti-tumor activity of NK-92\u002F5.28.z cells will be analyzed. In the separate \"CAR2BRAIN-Check\" and \"CAR2BRAIN-CheckR\" cohorts, combination therapy of NK-92\u002F5.28.z with the anti-PD-1 antibody Ezabenlimab (BI 754091) will be tested.",[27],"Glioblastoma","RECRUITING","2026-04-19",{"date":31,"type":32},"2026-04-23","ACTUAL",{"date":34,"type":32},"2017-12-01",{"date":36,"type":21},"2028-06-30",{"name":38,"class":39},"Johann Wolfgang Goethe University Hospital","OTHER",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100619572","spontaneous-dislocation-and-adverse-events-of-a-prophylactic-pancreatic-stent-100619572","NCT07346365","Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent","Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)","SAFE PANCREAS","Inclusion Criteria:\n\n* prophylactic pancreatic stent (5Fr 4cm length)\n* informed consent\n\nExclusion Criteria:\n\n* necrotising post-ercp-pancreatitis\n* pregnancy\u002Fbreastfeeding\n* Billroth II",{"count":50,"type":21},358,[52],"NA","A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP).\n\nThe primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.",[55,56,57,58,59],"Stent Dislodgement","ERCP","Pancreas Stent","Post-ERCP Pancreatitis","Prophylactic Pancreatic Stent",[61,62,63,64,65,66],"ercp","prophylactic pancreatic stent","post-ercp-pancreatitis","pancreatic stent","post-ercp pancreatitis","PEP","NOT_YET_RECRUITING","2026-01-14",{"date":70,"type":32},"2026-01-16",{"date":72,"type":21},"2026-01-01",{"date":74,"type":21},"2032-06",{"name":38,"class":39},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":87,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":76},"100396593","improving-cardiovascular-risk-stratification-using-t1-mapping-in-general-population-100396593","NCT04444128","IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION","IMPReSSION","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. 18 years of age and over\n3. Absence of a valid clinical indication for CMR, and\u002For known or clinically relevant cardiac disease\n\nExclusion Criteria:\n\n* accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)",true,{"count":86,"type":21},6000,"5 Years","OBSERVATIONAL","Magnetic properties of myocardial tissue change in the presence of disease. This is detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable imaging measures for myocardial tissue characterisation. Despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. A further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. Examples include patients with possible inflammation, such as in patients with a recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).",[91,92,93,94,95],"Myocarditis","Heart Failure","Myocardial Fibrosis","Vascular Inflammation","Long COVID Syndrome",[97,98,99],"Inflammation","Remodeling","vascular inflammation","2026-01-02",{"date":102,"type":32},"2026-01-06",{"date":104,"type":32},"2016-11-15",{"date":106,"type":21},"2030-06-30",{"name":38,"class":39},""]