[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jena University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":415},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,70,104,131,162,194,217,245,276,308,333,362,388],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100543375","ultrahypofractionated-adaptive-radiation-therapy-of-prostate-cancer-100543375",false,"NCT06355050","Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer","Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART","ultraHART","Inclusion Criteria:\n\n* no androgen deprivation therapy within the last 2 months prior to RT\n* good performance status (Eastern Cooperative Oncology Group, ECOG, 0\u002F1)\n* no secondary malignancy","MALE","18 Years","120 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.",[26,27,28],"Prostate Cancer","Adaptive Radiotherapy","Quality of Life",[27,28,30],"Ultra-hypofractionation","RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-11","ACTUAL",{"date":37,"type":35},"2026-04-01",{"date":39,"type":22},"2032-09-30",{"name":41,"class":42},"Jena University Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100625868","serum-bile-acid-profiles-in-patients-with-intrahepatic-cholestasis-of-pregnancy-100625868","NCT07428226","Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy","BAPP","Inclusion Criteria Group I:\n\n* Minimum age of 18 years\n* Written informed consent\n* Pregnant patients with suspected ICP\n* Pregnant patients with confirmed ICP\n* Pregnant patients with elevated total bile acids (\\>14 µmol\u002Fml)\n* Pregnant patients with elevated liver enzymes\n* Pregnant patients that suffer from itching with elevated transaminases\n\nInclusion Criteria Group II:\n\n* Minimum age of 18 years\n* Confirmed pregnancy\n* Written informed consent\n* Generally considered healthy in common usage (corresponding to ASA II of the American Society of Anesthesiologists classification)\n\nInclusion Criteria Group III:\n\n* Minimum age of 18 years\n* Female gender\n* Pregnancy excluded\n* Written informed consent\n* Generally considered healthy in common usage (corresponding to ASA II of the American Society of Anesthesiologists classification)\n\nExclusion Criteria Group II and III:\n\n* Age \\\u003C18 years\n* Inability to provide informed consent\n* Signs of an acute illness (for control groups II and III)\n* Known liver, biliary, or pancreatic diseases (for control groups II and III)\n* ICP in personal or family medical history (for control groups II and III)",true,"FEMALE","45 Years",{"count":55,"type":22},74,"The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the baby. The main questions it aims to answer are:\n\n* Can measuring specific types of bile acids (particularly taurine-conjugated versus glycine-conjugated bile acids) in the mother's and baby's blood help predict the risk of stillbirth and other complications?\n* Do these bile acid patterns activate specific receptors (TGR5) that might contribute to immune problems or heart rhythm abnormalities in the baby?\n* How do bile acid patterns in the mother's stool relate to her gut bacteria and the severity of ICP?\n* Can heart rate monitoring (CTG) combined with bile acid measurements better identify high-risk pregnancies? ICP is a pregnancy-related liver condition that causes bile acids to build up in the mother's bloodstream. This can lead to serious risks for the baby, including an increased chance of stillbirth, premature birth, and heart rhythm problems. Current monitoring methods (such as heart rate monitoring and ultrasound) often don't show warning signs before complications occur.\n\nParticipants will:\n\n* Provide blood samples at each routine bile acid check during pregnancy and at delivery\n* Provide stool samples for analyzing gut bacteria and bile acids\n* Have their baby's umbilical cord blood collected at birth for bile acid analysis\n* Undergo standard heart rate monitoring (CTG) of the baby\n* Have ultrasound examination of the baby's heart (echocardiography) The study will compare three groups: pregnant women with ICP, healthy pregnant women, and healthy non-pregnant women. The researchers hope this information will help doctors better predict which pregnancies need more intensive monitoring and potentially prevent stillbirths and other complications in women with ICP.",[58],"Intrahepatic Cholestasis of Pregnancy",[60,61],"Intrahepatic Cholestasis of pregnancy","Bile acid profile","2026-02-17",{"date":64,"type":35},"2026-02-23",{"date":66,"type":35},"2024-07-01",{"date":68,"type":22},"2027-12-31",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100526419","phase-3-acyclovir-in-ventilated-patients-with-pneumonia-and-hsv-1-in-bal-100526419","NCT06134492","Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL","Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage","HerpMV","Inclusion Criteria:\n\n1. ≥ 18 years\n2. need for invasive or non-invasive respiratory support\n3. PCR HSV-1 detection in BAL (≥ 10\\^3 copies\u002Fml)\n4. Pneumonia (community or healthcare acquired, incl. ventilator-associated pneumonia)\n5. declaration of consent by the patient or legal representative\n\nExclusion Criteria:\n\n1. History of hypersensitivity to acyclovir or valacyclovir or other components of the investigational product.\n2. Pregnancy\u002FLactation\n3. Simultaneous participation in another interventional clinical trial\n4. Decision to withhold life-sustaining therapies\n5. Use of a virostatic agent (i.v. or p. os) with activity against herpes simplex (acyclovir, valacyclovir, famciclovir\u002Fpenciclovir, brivudine, cidofovir, foscarnet) for therapeutic or prophylactic reasons at the time of randomization.\n6. Solid organ transplantation, stem cell transplantation\n7. Neutropenia (absolute neutrophil count \\\u003C1500\u002Fμl (\\\u003C1.5 × 109 \u002Fl)\n8. Previous study participation in HerpMV","ALL",{"count":80,"type":22},616,"INTERVENTIONAL",[83],"PHASE3","Almost 90 out of 100 people carry herpes simplex viruses (HSV). Once a person has been infected with the herpes viruses, he or she can't get rid of them for the rest of her\u002Fhis life. For the most part, the viruses are in a dormant state. Only when the immune system is weakened, for example in the case of a serious illness or stress, are the viruses reactivated. They then mainly cause cold sores, which are harmless for healthy people and usually heal without therapy. However, especially in people with a weakened immune system, HSV can also cause serious infections, such as meningitis. In almost every second mechanically ventilated patient in intensive care who has pneumonia, HSV can be detected in the respiratory tract. This is caused by reactivation of the viruses as a result of the severe underlying disease and stress during intensive care therapy. Whether treatment of the herpes viruses (e.g. with acyclovir) is necessary in this situation and helps the patients to cure has not been clarified, especially as acyclovir can also cause side effects such as a deterioration in kidney function. Currently, the physicians decide to treat the herpes viruses in about half of the patients. Several studies have shown that patients for whom the physician decided to treat the viruses survived more often. However, all of these studies looked at the course of the disease only retrospectively and thus are subject to many biases (including physician selection of who receives treatment, missing data). A definitive conclusion as to whether herpesvirus therapy can be recommended cannot be drawn without doubt from these studies. Therefore, the investigators would like to investigate in a randomized controlled trial, i.e. patients are randomly assigned to the experimental (therapy of herpesviruses) or control group (no therapy of herpesviruses), the effect of therapy with acyclovir on survival in ventilated intensive care patients with lower respiratory tract infection (pneumonia) in whom a large amount of HSV was found in the respiratory tract. The goal of the study is to provide clarity on whether therapy will help patients recover.",[86,87,88,89,90],"Pneumonia, Viral","Ventilator Associated Pneumonia","Community-acquired Pneumonia","Herpes Simplex","Hospital-acquired Pneumonia",[92,89,93,94],"Pneumonia","Mechanical Ventilation","Aciclovir","2025-11-18",{"date":97,"type":35},"2025-11-21",{"date":99,"type":35},"2024-02-20",{"date":101,"type":22},"2026-12",{"name":41,"class":42},28,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100521236","cardiac-biomarkers-for-the-quantification-of-myocardial-damage-after-cardiac-surgery-100521236","NCT06066970","Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery","RORSCHACH","Inclusion Criteria:\n\n* Indication for isolated aortic or mitral valve surgery\n* Written informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Presence of coronary artery disease (excluded within the last 6 months)\n* Allergy to gadolinium\n* Cochlear implant\n* Deep brain stimulation\n* Individual factors excluding the performance of an MRI (e.g. claustrophobia of the patient)\n* Significantly reduced renal function (GFR \\< 30ml\u002Fmin)\n* Perioperative complications that may lead to myocardial damage (discontinuation of the study for the patient and exclusion from the analysis after primary study inclusion)\n* Need for extension of surgery (additional procedures on other heart valves, aorta, myocardium, or similar; exclusion after primary study inclusion possible)\n* Pregnancy or lactation",{"count":112,"type":22},100,"The aim of the study is to clarify whether the perioperative release of the cardiac biomarkers troponin I, troponin T and CK-MB consistently correlate with visualizable myocardial damage, and to what extent these biomarkers are comparable by means of their kinetics and dynamics.\n\nDue to the uncertainty regarding the validity of cardiac biomarkers in the diagnosis of myocardial infarction, the answer to these questions could have a considerable influence on internationally valid guidelines and definitions. International studies, especially in the field of coronary surgery and coronary artery disease treatment refer to these definitions, in particular, the adequate treatment of affected patients is directly dependent on them.",[115],"Cardiac Valve Disease",[117,118,119,120,121],"Biomarker","Troponin","CK-MB","Perioperative Myocardial Infarction","LGE-cMRI","2025-09-23",{"date":124,"type":35},"2025-09-26",{"date":126,"type":35},"2023-09-05",{"date":128,"type":22},"2025-12-31",{"name":41,"class":42},5,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":81,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100361984","phase-2-trial-to-evaluate-efficacy-and-safety-of-bortezomib-in-patients-with-severe-autoimmune-encephalitis-100361984","NCT03993262","Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis","A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis","Generate-Boost","Inclusion Criteria:\n\n* Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and \u002F or serum\n* Pretreatment with rituximab\n* Age ≥18 years\n* signed informed consent\n* Women of childbearing potential (up to 2 years after menopause): negative pregnancy test\n\nExclusion Criteria:\n\n* pregnancy\u002Fbreast-feeding\n* acute infiltrative pulmonary and pericardial disease\n* malignant tumor under current chemotherapy\n* Simultaneous participation in another intervention study\n* Previous participation in this study\n* Known hypersensitivity to an ingredient of the investigational product\n* Continued therapy with glucocorticoids \u002F rituximab during the study duration (last dose must be administered before the first dose of the investigational product)",{"count":140,"type":22},50,[142],"PHASE2","Autoimmune Encephalitis is a disorder of the central nervous system caused by bodily substances, called antibodies. Antibodies normally help the body to prevent infections. However, in this disorder, the antibodies turn against the body itself and especially against cells in the brain and disturb the normal brain function. They are therefore called autoantibodies.\n\nThere is no specific therapy for patients with autoimmune encephalitis so far. At the moment, the symptoms are treated with approved medications such as cortisone and immunotherapies also used in oncology. These therapies are unspecified and aim to reduce the number of autoantibodies and to contain the autoimmune process. In this trial we aim to test a new therapy option: in this therapy the body cells producing autoantibodies will be specifically targeted by a substance called bortezomib.\n\nThe trial addresses patients with severe autoimmune encephalitis. The aim of the trial is to evaluate the efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.",[145],"Autoimmune Encephalitis",[147,148,149,150,151,152],"autoimmune disease","autoimmune encephalitis","bortezomib","NMDAR","LGI1","encephalitis","2025-08-27",{"date":155,"type":35},"2025-09-04",{"date":157,"type":35},"2020-05-13",{"date":159,"type":22},"2026-12-31",{"name":41,"class":42},17,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":81,"phases":172,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100385439","comparison-of-laa-closure-vs-oral-anticoagulation-in-patients-with-nvaf-and-status-post-intracranial-bleeding-100385439","NCT04298723","Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.","Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.","CLEARANCE","Inclusion Criteria:\n\n* Signed written informed consent\n* Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)\n* CHA2DS2VASc-Score ≥2\n* Status post intracranial bleeding \\>6 weeks\n* Favorable LAA anatomy\n* Subject eligible for a LAA occluder device\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis\n* Symptomatic carotid disease (if not treated)\n* Thrombus in the left atrium or left atrial appendage\n* Active infection or active endocarditis or other infections resulting in bacteremia\n* Functional Impairment (modified ranking scale ≥4 )\n* Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)\n* Pregnancy or breastfeeding\n* Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.\n* Known terminating disease with life expectancy \\\u003C1 year (including those with end-stage heart failure)\n* Subjects, who are committed to an institution due to binding official or court order\n* Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention \u002F surgery",{"count":171,"type":22},530,[173],"NA","Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.",[176,177,178],"Intracranial Hemorrhages","Atrial Fibrillation (AF)","Atrial Flutter",[180,181,182,183,184],"Intracranial Hemorrhage","Intracranial Bleeding","Atrial Fibrillation","Anticoagulation","LAA Occlusion","2025-08-25",{"date":187,"type":35},"2025-09-02",{"date":189,"type":35},"2020-06-16",{"date":191,"type":22},"2029-12",{"name":41,"class":42},33,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":204,"studyType":23,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100450956","itp-registry-and-accompanying-biospecimen-collection-100450956","NCT05152238","ITP Registry and Accompanying Biospecimen Collection","Multicenter National ITP Registry and Accompanying Biospecimen Collection","ITP-Registry","Inclusion Criteria:\n\n* Primary or secondary Immune Thrombocytopenia (ITP)\n* Age ≥18 years\n* signed declaration of consent\n\nExclusion Criteria:\n\n* diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)\n* no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)",{"count":203,"type":22},1100,"5 Years","The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.",[207],"Immune Thrombocytopenia","2025-07-10",{"date":210,"type":35},"2025-07-15",{"date":212,"type":35},"2021-11-29",{"date":214,"type":22},"2027-04",{"name":41,"class":42},64,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":51,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":43},"100574920","ai-based-muscular-ultrasound-to-assess-intensive-care-unit-acquired-weakness-100574920","NCT06765551","AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness","Artificial IntelligenCe Based UlTrasonographic Assessment of IntensiVe CAre UniT-acquired WEakness (ACTIVATE)","ACTIVATE","Inclusion Criteria:\n\n* Patients aged 18 years or above\n* Major elective surgery, e.g. cardiothoracic or abdominal surgery\n* Expected ICU stay \\>1 day postoperatively\n* Healthy, age-machted subjects without ICUAW (recruited from staff of the department of anesthesiology and intensive care medicine)\n\nExclusion Criteria:\n\n* No informed consent\n* Emergency surgery\n* Previous participation in the same study\n* Preexisting neuromuscular disease\n* Preexisting central nervous system disease with residual neuromuscular impairment (e.g. cerebral haemorrhage, stroke, brain tumor)\n* High-dose glucocorticoid therapy (\\>300 mg hydrocortisone or equivalent per day) before or during particiation in the study",{"count":140,"type":22},"The aim of this observational case-control study is to investigate, whether artificial intelligence can detect ultrasound-derived imaging characteristics typical for intensive care unit-acquired weakness. The main questions it aims to answer are:\n\n1. Is the evaluation of specific parameters of neuromuscular ultrasound using AI-based image analysis suitable for detecting and monitoring critically ill ICU patients with ICUAW?\n2. Do the results of AI-based ultrasound image analysis correlate with:\n\n(A) the severity of ICUAW (B) the visual grading of muscle echogenicity (C) the 30- and 90-day-outcome?",[228,229,230],"Intensive Care Unit-acquired Weakness","Artifical Intelligence","Ultrasound",[232,233,234,235,236],"weakness","neuromuscular","critical illness polyneuropathy","critical illness myopathy","neuromuscular impairment","2025-01-03",{"date":239,"type":35},"2025-01-09",{"date":241,"type":35},"2024-10-01",{"date":243,"type":22},"2026-06-30",{"name":41,"class":42},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":254,"conditions":255,"keywords":262,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":275,"locationsCount":43},"100573684","the-gut-microbiome---source-of-sepsis-and-novel-target-in-intensive-care-units-100573684","NCT06749483","The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units?","The Gut Microbiome - Source of Sepsis and Novel Target in Intensive Care Units? Research on Human Tissue, Body Fluids, Neuropsychological Assessment and Brain Imaging","MS-ICU","Inclusion Criteria:\n\n* Age ≥ 18 years\n* One of the following criteria\n\n  1. Critically ill patients treated with meropenem or piperacillin\u002Ftazobactam started within the last 72 h\n  2. Critically ill patients without systemic antimicrobial therapy within the last 72 hours and an expected ICU length of stay of more than 3 days\n  3. Long-term survivors of sepsis, e.g. from pre-existing sepsis cohorts\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Major bowel resection\n* Selective decontamination of the oral and digestive tract\n* Oral vancomycin therapy\n* Immunocompromised patients\n* History of chemotherapy during the last 6 months.\n* Known travel history to countries to areas of high antimicrobial resistance (\\>5% according to the report of the European Centre for Disease Prevention and Control and all countries except USA and Canada) within the last 4 weeks\n* Acute neurological diseases (e.g., brain ischemia, hemorrhage, meningoencephalitis, tumor)\n* Manifest dementia, pre-existing psychiatric diseases (schizophrenia, psychosis)\n* Acute brain surgery\n* MRI contraindications: pacemakers, hearing aids, neurostimulation, insulin pumps, other potentially ferromagnetic implants, screws, clips, prostheses, metal splinters, etc., pregnancy, claustrophobia, extensive tattoos.",{"count":112,"type":22},"Here, the investigators propose to study host responses to reduced microbiome complexity driven by treatment with broad spectrum antibiotics in patients with severe infections or sepsis. The proposal aims to combine holistic approaches with emerging experimental technologies to investigate the complex interactions between the gut microbiota and its host and assess the impact of specific bacterial communities on longevity and stress responses. A strong focus of this study will also be placed on microbiome dysbiosis and secondary impacts on short- and long-term brain dysfunction using clinical, laboratory and imaging procedures.",[256,257,258,259,260,261],"Critical Illness","Intensive Care Unit Delirium","Neurocognitive Deficit","Microbiome,immune Function, Critically Ill","Infection in ICU","Sepsis",[263,264,265,266,267,268,269],"sepsis","broad-spectrum antibiotics","stool","neuropsychological assessment","delirium","neurocognitive impairment","microbiome","2024-12-27",{"date":272,"type":35},"2024-12-30",{"date":270,"type":35},{"date":159,"type":22},{"name":41,"class":42},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":81,"phases":287,"briefSummary":288,"conditions":289,"keywords":294,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":5},"100465874","hrs-aki-treatment-with-tips-in-patients-with-cirrhosis-100465874","NCT05346393","HRS-AKI Treatment With TIPS in Patients With Cirrhosis","Hepatorenal Syndrome-acute Kidney Injury (HRS-AKI) Treatment With Transjugular Intrahepatic Portosystemic Shunt in Patients With Cirrhosis. A Randomized Controlled Trial","Liver-HERO","Inclusion Criteria:\n\n1. Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and\u002For blood tests\n2. Clinically evident ascites due to portal hypertension\n3. HRS-AKI\n4. Age: ≥ 18 to ≤ 80 years old at the time of consent\n5. ECOG \\\u003C 4 prior to hospital admission\n6. Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.\n7. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses). A contraceptive method with a pearl index below 1% is assumed to be effective.\n\nExclusion Criteria:\n\n1. Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosed iodinated contrast medium) in the previous 72 hours before AKI diagnosis\n2. Improvement of renal function after 1 day of diuretic removal and plasma volume expansion with albumin 1-1.5 gr\u002Fkg\n3. Uncontrolled shock within the last 48 hours prior to randomization\n4. Patients with uncontrolled infection (defined by a 20 % increase in inflam-matory parameters (CRP, leucocytes or insufficient decrease of PMN in ascitic fluid \\\u003C 25 % from baseline in the case of a SBP) despite 48 hours of antibiotic treatment.\n5. Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (is-chemic cardiomyopathy, hypertensive cardiomyopathy, etc.)\n6. Patients with contraindications to TIPS placement (e.g. Bilirubin \\> 85.5 µmol\u002FL (≙ 5 mg\u002FdL), recurrent hepatic encephalopathy, clinically relevant pulmonary hypertension, aortic stenosis)\n7. Patients with cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis\n8. Patients with clinically significant cardiac disease (NYHA ≥ II)\n9. Patients with diastolic dysfunction grade 3.\n10. Patients with a reduced systolic function with an ejection fraction ≤ 50 %\n11. Patients with ACLF grade 3\n12. Patients with creatinine value \\> 442 µmol\u002FL (≙ 5 mg\u002FdL)\n13. Patients with an acute variceal bleeding at the time of screening who have indication for pre-emptive TIPS and\u002For terlipressin.\n14. Patients with refractory ascites as defined by the International Ascites Club (\\\u003C 800 gr weight loss over 4 days in patients on low salt diet and high dose diuretics (spironolactone 400 mg \u002Fday and furosemide \\* 160 mg \u002Fday), or lower dose of diuretics with complications secondary to the use of diuretics such as hyponatremia, renal failure, hepatic encephalopathy. \\*equivalent dose of torasemide 40 mg\u002Fday\n15. Patients with hepatocellular carcinoma outside of the Milan criteria\n16. Patients with hepatocellular carcinoma within the Milan criteria in whom the tumor is located in the puncture tract.\n17. Patients with benign liver tumors (except regenerative nodules) which are located in the puncture tract.\n18. Patients who already have a TIPS placed\n19. Patients who already had a liver transplantation\n20. Patients with other comorbidities that lead to an estimated life expectancy under 1 year.\n21. Patients with respiratory insufficiency which requires mechanical ventila-tion\n22. Patients with circulatory failure which requires administration of other vas-opressors (catecholamines)\n23. Patients receiving renal replacement therapy\n24. The subject is currently enrolled in another investigational device or drug trial.\n25. Patients with pregnancy or lactation\n26. Patients which are suspected to be incompliant for study participation.","80 Years",{"count":286,"type":22},124,[173],"The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage1, 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).",[290,291,292,293],"Cirrhosis, Liver","Hepatorenal Syndrome","Acute Kidney Injury","Ascites Hepatic",[295,292,296,291,297,298,299],"Ascites","Cirrhosis","TIPS","transjugular intrahepatic portosystemic shunt","Terlipressin","2024-11-14",{"date":302,"type":35},"2024-11-18",{"date":304,"type":35},"2022-11-29",{"date":306,"type":22},"2026-06",{"name":41,"class":42},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":78,"minAge":316,"maxAge":18,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100557145","long-term-follow-up-of-children-born-in-the-petn-studies-100557145","NCT06534307","Long-term Follow-up of Children Born in the PETN Studies","Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien","LOOP","Inclusion Criteria:\n\n* mothers participation in one of the PETN studies\n* age above 5 years\n* completion of questionnaires for self reported data\n* written consent for physical examination\n\nExclusion Criteria - only physical examination:\n\n* physical and mental states preventing physical examination","6 Years",{"count":318,"type":22},228,"In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention).\n\nFrom 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany.\n\nIn this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.",[321,322,323],"Intrauterine Growth Restriction","Pentaerithrityl Teratnitrate in Pregnancy","Long-Term Effects to Children","2024-08-01",{"date":326,"type":35},"2024-08-02",{"date":328,"type":35},"2024-06-01",{"date":330,"type":22},"2028-03-31",{"name":41,"class":42},13,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":81,"phases":343,"briefSummary":344,"conditions":345,"keywords":349,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100557535","living-donor-liver-transplantation-for-intrahepatic-cholangiocarcinoma-100557535","NCT06539377","Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma","Living Donor Liver Transplantation for Neoadjuvant Treated, Unresectable Intrahepatic Cholangiocarcinoma","LIVINCA","Inclusion Criteria:\n\n* non-resectable intrahepatic cholangiocarcinoma (either for localization \u002F distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis \u002F cirrhosis)\n* biopsy proven grading G1 \u002F G2\n* in case of mixed hepatocellular carcinoma \u002F cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 \u002F G2\n* response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory\n* peritoneal carcinosis \u002F extrahepatic spread ruled out in PET-CT and\u002For MRT\u002FCT and, at latest, during exploration\n* age ≥ 18\n* blood-group compatible living donor available\n* in female patients: negative pregnancy test\n* written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)\n\nExclusion Criteria:\n\n* extrahepatic tumor\u002Fmetastases\n* G3 tumors\n* progress under neoadjuvant treatment according to the RECIST-criteria\n* pregnancy or breastfeeding\n* patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons\n* general contraindications for liver transplantation",{"count":342,"type":22},6,[173],"This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication \"non-resectable intrahepatic cholangiocarcinoma\" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).",[346,347,348],"Living Donor Liver Transplantation","Liver Transplantation","Neoadjuvant Therapy",[350,351,352,353],"intrahepatic cholangiocarcinoma","living donor liver transplantation","neoadjuvant therapy","SIRT","NOT_YET_RECRUITING",{"date":356,"type":35},"2024-08-06",{"date":358,"type":22},"2024-09-01",{"date":360,"type":22},"2031-10-01",{"name":41,"class":42},{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":81,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":386,"locationsCount":387},"100323284","living-donor-liver-transplantation-with-two-stage-hepatectomy-for-patients-with-isolated-irresectable-colorectal-liver-metastases-100323284","NCT03488953","Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases","LIVERT(W)OHEAL","Inclusion Criteria:\n\n* Patients with irresectable colorectal liver metastases without extrahepatic tumor burden, except resectable pulmonary metastases\n* stable disease or regression after at least eight weeks of systemic chemotherapy\n\nExclusion Criteria:\n\n* comorbidities precluding liver transplantation\n* extrahepatic tumor spread, except resectable pulmonary metastases\n* progression during chemotherapy",{"count":370,"type":22},40,[173],"Nearly one third of patients with colorectal cancer develop liver metastases. It is well known that the achievement of a R0-situation is one of the most important factors for a positive long-term outcome. Despite further advantages in multimodal treatment concepts, only 20 - 30 % of the patients with metastases can be resected in curative intention.\n\nRecent studies, especially from Norway, have shown that liver transplantation might be a feasible option in well selected patients since the complete hepatectomy with subsequent liver transplantation can be an option for the achievement of a R0 situation.\n\nIn this study, we pursue the strategy of two-stage hepatectomy combined with a left-lateral living donor liver transplantation.\n\nInclusion criteria are as follows: non-resectable liver metastases of a primary colorectal carcinoma with an assumed portal-venous drainage of the tumor and at least a \"stable disease\" after a period of eight weeks systemic chemotherapy. Patients are excluded from the study if there is an extrahepatic tumor burden (with the exception of resectable lung metastases) or if the patient is not suitable for liver transplantation due to co-morbidities.\n\nThe transplantation itself will be undertaken as a living donor liver transplantation where the left lateral liver lobe (liver segments 2 \\& 3) from a healthy volunteer donor will serve as graft. Prior transplantation, a left hemihepatectomy in the recipient is performed and the left lateral graft will be transplanted in this position. At the end of the transplantation procedure, the right portal vein will be closed to induce a rapid growth of the graft. The second step, and therefore the completion of the operation is performed after a growth period of the transplanted left-lateral lobe: in this procedure, the right hemi-liver of the recipient will be removed and the patient is supposed to be free of tumor at this point in time.",[374,375],"Colorectal Cancer Metastatic","Liver Metastases",[377,378,379],"Liver transplantation","Two-stage hepatectomy","Living donor liver transplantation","2024-07-30",{"date":382,"type":35},"2024-07-31",{"date":384,"type":35},"2018-04-10",{"date":68,"type":22},{"name":41,"class":42},2,{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":78,"minAge":18,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":81,"phases":399,"briefSummary":400,"conditions":401,"keywords":405,"overallStatus":354,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":414},"100484406","intensive-lipid-lowering-in-patients-with-stemi-and-nstemi-germany-on-target-100484406","NCT05587621","Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)","\"Intensive Lipid-Lowering Therapy Guided by a Cloud-based Software System (CLIMEDO GmbH) in Patients With ST-Elevation and Non-ST-Elevation Myocardial Infarctions\" (Germany on Target)","GoT","Inclusion Criteria:\n\n* patients with ST- and Non-ST-elevation myocardial infarctions\n\nExclusion Criteria:\n\n* patient without informed concent\n* patients in cardiogenic shock\n* patients with contraindication to lipid-lowering therapy\n* patients on lipid-lowering medications on admission","75 Years",{"count":398,"type":22},300,[173],"Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy\u002FEuropean Atherosclerosis Society) ESC\u002FEAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).",[402,403,404],"ST Elevation Myocardial Infarction","Non-ST Elevation Myocardial Infarction","LDL-cholesterol",[406],"STEMI, NSTEMI; LDL-C; target attainment","2024-03-05",{"date":409,"type":35},"2024-03-07",{"date":411,"type":22},"2024-04-01",{"date":159,"type":22},{"name":41,"class":42},10,""]