[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital of Cologne\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":377},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,73,97,138,162,189,217,242,268,297,318,344],{"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":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641466","rapid-microaxial-flow-pump-support-and-escalation-in-patients-with-myocardial-infarction-associated-cardiogenic-shock-and-persistent-need-of-hemodynamic-support-100641466",false,"NCT07655479","Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support","Rapid Impella Support and Escalation Trial","RISE","Inclusion Criteria:\n\n1. Age ≥18 years and ≤77 years\n2. Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation\n3. The following additional parameters must be met at the time of initial revascularisation procedure:\n\n   1. Hypotension or need for inotropes AND\n   2. Lactate \\> 2.5 mM AND\n   3. Left ventricular ejection fraction (EF) \\\u003C 45%\n4. Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:\n\n   1. Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure\n   2. Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure\n5. Need for inotropes and\u002For vasopressors with VIS \\> 5 but ≤ 50 at Impella CP™ support at level P7 or above at 6+1 hours after completion of initial revascularisation procedure\n6. Prospective Informed Consent obtained from the patient or deferred consent according to \"Cologne Model\" applied.\n\nExclusion Criteria:\n\n1. Implanted VA-ECMOwithin 6 ± 1 hours after initial revascularisation Note: If VA-ECMO support is needed between 6 ± 1 hours after initial revascularisation and escalation to Impella 5.5, patients will be included forlimited data collection per Table 2 only. In this case the same Informed Consent Process as for regular trial participants applies.\n2. Elevated risk of hypoxic brain injury indicated by MIRACLE2 score \\>3 (Aldous et al., 2023)\n3. Platelet count \\\u003C75,000 cells\u002Fmm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions\n4. Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation\n5. Any contraindication listed in the Impella 5.5 IFU if known to be present\n6. Chronic haemodialysis and\u002For chronic kidney disease stage G5 according to KDIGO\n7. Pregnancy or lactation, if known\n8. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint, if known","ALL","18 Years","77 Years",{"count":21,"type":22},115,"ESTIMATED","6 Months","OBSERVATIONAL","The aim of this trial is to evaluate whether a structured and time-optimized escalation strategy from a transfemoral microaxial flow-pump (Impella CP™) to the Impella 5.5™ microaxial flow-pump is associated with improved clinical outcomes and fewer adverse events in patients with cardiogenic shock due to acute myocardial infarction",[27],"Cardiogenic Shock Post Myocardial Infarction",[29,30,31,32],"Impella","Microaxial Flow-pump","cardiogenic shock","myocardial infarction","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-04-23",{"date":41,"type":22},"2028-10",{"name":43,"class":44},"University Hospital of Cologne","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":24,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100634760","mitraclip-generation-5-mitral-valve-transcatheter-edge-to-edge-repair-registry-100634760","NCT07543874","MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry","MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry (MITRAGEN5 Registry)","MITRAGEN5","Inclusion Criteria:\n\n* Age 18 years or older at the time of M-TEER\n* Treatment using the MitraClip G5 system\n\nExclusion Criteria:\n\n\\- None",{"count":55,"type":22},1000,"30 Days","The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.",[59],"Mitral Regurgitation",[61,62,63,64],"MitraClip","Mitral Valve Transcatheter Edge-to-Edge Repair","M-TEER","MitraClip G5","NOT_YET_RECRUITING","2026-04-27",{"date":68,"type":37},"2026-05-01",{"date":68,"type":22},{"date":71,"type":22},"2030-12-31",{"name":43,"class":44},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100572159","external-beam-radiotherapy-combined-with-endorectal-high-dose-rate-brachytherapy-in-elderly-and-frail-patients-with-rectal-cancer-100572159","NCT06729645","External Beam Radiotherapy Combined With Endorectal High-dose-rate Brachytherapy in Elderly and Frail Patients With Rectal Cancer","ACO\u002FARO\u002FAIO-22 - External Beam Radiotherapy Combined With Endorectal High-dose-ratebrachytherapy in Elderly and Frail Patients With Rectal Cancer. A Prospective Multicentre Trial of the German Rectal Cancer Study Group","ACO\u002FARO\u002FAIO-22","Inclusion Criteria:\n\n* Elderly patients (age ≥70 years) with a G8-frailty score ≤ 14 based on the G8 geriatric assessment tool of frailty and\u002For elderly patients (age ≥70 years) with American Society of Anesthesiologists Physical Status (ASA PS) ≥ 3 and\u002F elderly patients (age ≥70 years) unsuitable to tolerate radical surgery as judged by the surgeon and\u002For elderly patients (age ≥70 years) that refuse radical surgery\n* Life expectancy ≥ 6 months\n* Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0-16 cm from the anocutaneous line as measured by rigid rectoscopy\n* MRI-defined cT1-3d N0\u002F+ M0, mrCRM - \u002F +, \\\u003C\u002F= 2\u002F3 involvement of the rectal wall circumference\n* Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.\n* Spiral-CT of the abdomen and chest to exclude distant metastases.\n\nExclusion Criteria:\n\n* Previous or current drug abuse\n* Other concomitant antineoplastic therapy\n* Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-\n\n  1), unless the patient is continuously disease-free\n* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).","70 Years",{"count":83,"type":22},80,"INTERVENTIONAL",[86],"NA","ACO\u002FARO\u002FAIO-22 - External beam radiotherapy combined with endorectal high-dose-ratebrachytherapy in elderly and frail patients with rectal cancer.\n\nA prospective multicentre trial of the German Rectal Cancer Study Group.",[89],"Rectal Cancer",{"date":68,"type":37},{"date":92,"type":22},"2026-09-30",{"date":94,"type":22},"2031-12-30",{"name":43,"class":44},4,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":105,"targetDuration":18,"studyType":24,"phases":4,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":45},"100630687","neonatal-data-and-biobank-to-study-factors-influencing-development-in-preterm-infants-born-at-32-weeks-gestation-andor-1500-g-birth-weight-100630687","NCT07490912","Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at \u003C32 Weeks' Gestation and\u002For \u003C1500 g Birth Weight","Establishing a Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at \u003C32 Weeks' Gestation and\u002For \u003C1500 g Birth Weight","Neo-Life","Inclusion Criteria:\n\n* Preterm infants born \\\u003C32 weeks' gestational age and\u002For with a birth weight \\\u003C 1500 g\n* Informed consent of parents\u002F legal guardians\n\nExclusion Criteria:\n\n* none",{"count":106,"type":22},1300,"The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and\u002For a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions.\n\nThe primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems.\n\nThe study population includes infants born with a gestational age of less than 32 weeks and\u002For a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants.\n\nBy combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.",[109,110,111,112],"Preterm Infant Development","Preterm Infant Health","Prematurity Complications","Premature Birth",[114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"prematurity","preterm infants","very low birth weight infants","very preterm infants","gestational age \u003C32 weeks","Premature birth","\u003C32 weeks gestational age","very low birth weight","\u003C1500 g birth weight","database","biobank","preterm infant development","preterm infant health","preterm infant long-term outcome","prematurity complications","risk and protective factors of preterm infant development","2026-03-18",{"date":132,"type":37},"2026-03-24",{"date":134,"type":22},"2026-03-13",{"date":136,"type":22},"2056-03-13",{"name":43,"class":44},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":84,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":45},"100622909","preoperative-physical-exercise-nutritional-support-and-psychological-intervention-multimodal-prehabilitation-to-strengthen-patients-overall-health-and-reduce-postoperative-complications-100622909","NCT07389746","Preoperative Physical Exercise, Nutritional Support, and Psychological Intervention (Multimodal Prehabilitation) to Strengthen Patients' Overall Health and Reduce Postoperative Complications","Multimodal Prehabilitation Reduces Postoperative Complications in High Risk Patients Undergoing Major Gastrointestinal Cancer Surgery","PREHAB","Inclusion Criteria:\n\n* Candidate to elective major gastrointestinal cancer surgery (pelvic exenteration, cytoreductive surgery, oesophagectomy, transhiatal gastrectomy, hepatectomy, pancreatectomy, rectum resection)\n* High risk for surgical complications defined by presence of comorbid disease such as deconditioning, heart disease, diabetes, renal impairment or morbid obesity\n* Duke Activity Status Index score (DASI) \\\u003C402\n* Schedule allowing for at least 4 weeks for intervention with multimodal prehabilitation prior to surgery \u002F willingness to exercise\n\nExclusion Criteria:\n\n* Non-elective surgery\n* Unstable cardiac or respiratory disease\n* Locomotor limitations precluding exercise training\n* Cognitive deterioration impeding adherence to the programme\n* Enrolment in other research studies affecting study endpoint","80 Years",{"count":148,"type":22},400,[86],"In this prospective, randomized, controlled trial patients undergoing major gastrointestinal cancer surgery will be exercised (intervention group) 4 weeks before surgery with a high-intensity interval training (HIIT). They will also receive a specialized nutrition therapy and psychological support (multimodal prehabilitation). Aim of this study is to find out if the prehabilitation group is more resilient to postoperative complications when compared to the control group that will receive standard of care. Another goal is to unravel the underlying mechanisms that are stimulated by exercise like enhancing vascular function, improving immune system response, strengthen cellular tumor defense and optimizing neurological outcome.",[152,153],"Cancer Surgery","Prehabilitation","2026-02-10",{"date":156,"type":37},"2026-02-13",{"date":158,"type":22},"2026-07-01",{"date":160,"type":22},"2029-01-01",{"name":43,"class":44},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100586109","assessment-of-transcatheter-edge-to-edge-repair-in-atrial-functional-mitral-regurgitation-atrial-mr-100586109","NCT06911099","Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)","Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation","Inclusion Criteria:\n\n* functional mitral regurgitation\n* left ventricular ejection fraction ≥50%\n\nExclusion Criteria:\n\n* age under 18 years\n* known regional wall movement disorders",{"count":55,"type":22},"This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.",[172,173],"Atrial Functional Mitral Regurgitation","Mitral Insufficiency",[175,176,177,178,179,63],"atrial functional mitral regurgitation","AFMR","atrial secondary mitral regurgitation","ASMR","mitral valve transcatheter edge-to-edge repair","2025-04-03",{"date":182,"type":37},"2025-04-06",{"date":184,"type":37},"2010-01-01",{"date":186,"type":22},"2035-12-31",{"name":43,"class":44},22,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":84,"phases":199,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":45},"100557261","ketonifast-cyclic-enteral-daytime-feeding-with-ketogenic-nighttime-fasting-100557261","NCT06535815","KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting","KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.","KetoNiFast","Inclusion Criteria:\n\n* written informed consent to participate in this study\n* admission to ICU\n* enteral nutrition\n\nExclusion Criteria:\n\n* Severe liver dysfunction \u002F liver failure (Child Pugh \\>7 points \u002F category B)\n* Severe kidney dysfunction (KDIGO stage 3)\n* Total pancreatectomy \u002F insulin dependent diabetes mellitus (IDDM)\n* Pregnancy \u002F lactation\n* Hemoglobin concentration \\\u003C 80g\u002Fl\n* Severe metabolic disorders \u002F severe autoimmune diseases\n* Refractory metabolic or respiratory acidosis\n* Dysfunction of mitochondrial transport of fatty acids\n* Dysfunction of oxidation of fatty acids\n* Dysfunction of gluconeogenesis, production and reduction of ketones\n* Intermittent Porphyria\n* Severe cardiac arrhythmias \u002F cardiomyopathy\n* Contraindication against enteral nutrition\n* Lack of informed consent",{"count":198,"type":22},130,[86],"A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.",[202,203,204],"Nutrition","Muscle Loss","Inflammatory Response",[206,207,208],"Ketogenic diet","ketogenic fasting","cyclic enteral nutrition","2024-08-04",{"date":211,"type":37},"2024-08-06",{"date":213,"type":37},"2023-09-01",{"date":215,"type":22},"2026-03-01",{"name":43,"class":44},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":84,"phases":227,"briefSummary":228,"conditions":229,"keywords":233,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":241,"locationsCount":4},"100557200","deliket-substudy-of-ketonifast-study-id-22-13981-100557200","NCT06535022","DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)","Impact of Cyclic, Daytime Enteral Nutrition and Ketogenic Nighttime Fasting on the Incidence of Postoperative Delirium in Critically Ill Patients","DeliKet","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to an ICU\n* Start of enteral nutrition\n\nExclusion Criteria:\n\n* Severe liver insufficiency \u002F liver disease (Child Pugh \\> B or 7-9 points)\n* Post total Pancreatectomy \u002F Insulin-depending diabetes mellitus (IDDM)\n* Pregnancy \u002F Lactation\n* Hemoglobin-concentration \\\u003C 80g\u002Fl\n* Severe metabolic disorder \u002F severe autoimmune disease\n* Refractory respiratory or metabolic acidosis\n* Disorder of mitochondrial transportation of fatty acids\n* Disorder of the oxidation of fatty acids\n* Disorder of gluconeogenesis, der ketone body production or ketone body degradation\n* Intermittent porphyria\n* Severe arrhythmia \u002F cardiomyopathy\n* Contraindications against enteral nutrition\n* Missing informed consent",{"count":226,"type":22},90,[86],"Postoperative delirium is a common problem of the critically ill patient and associated with an increased mortality. Intermittent fasting and ketogenesis have been shown to be beneficial for maintaining a circadian rhythm and initiating anti-inflammatory repair mechanisms which could potentially be neuroprotective. However, so far there is little data if cyclic enteral feeding with ketogenic nighttime fasting might be beneficial for reducing the rate of postoperative delirium. The study hypothesis is that equicaloric cyclic enteral feeding (12 hrs) during daytime with ketogenic fasting and exogenous ketone supplementation at nighttime compared to continuous standard enteral nutrition (24 hours) decreases the incidence of postoperative delirium in critically ill patients.",[230,231,232],"Delirium","Ketogenic Dieting","Nutrition, Healthy",[234,235,236],"ketogenic diet","cyclic nutrition","postoperative delirium",{"date":211,"type":37},{"date":239,"type":22},"2024-09-01",{"date":215,"type":22},{"name":43,"class":44},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":45},"100538303","prognosticate--studyprognostication-of-icu--and-ventilator--days-over-the-next-years-until-2040-100538303","NCT06289075","PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040","Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040 Using Statistical Projection Models and Retrospective Data From International Databases From 2005-2023 (PrognostICate- Study).","PrognostICate","Inclusion Criteria:\n\n* All patients admitted to an ICU between the years 2005-2023\n\nExclusion Criteria:\n\n* Patients without ICU admission or ICU admission \\\u003C 4 hours","1 Day","120 Years",{"count":253,"type":22},10000000,"The Objective of this retrospective multicenter- study is to forecast Intensive Care Unit (ICU) length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases.",[256],"ICU Admission",[258,259],"Length of ICU stay","Length of mechanical ventilation","2024-07-19",{"date":262,"type":37},"2024-07-23",{"date":264,"type":37},"2024-03-01",{"date":266,"type":22},"2025-06-01",{"name":43,"class":44},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":275,"minAge":18,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":84,"phases":279,"briefSummary":280,"conditions":281,"keywords":284,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":45},"100554302","exercise-intervention-in-women-diagnosed-with-triple-negative-breast-cancer-receiving-oncologic-treatment-100554302","NCT06497322","Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment","Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer","Inclusion Criteria:\n\n* Primary diagnosis of histologically verified triple-negative breast cancer (TNBC) measurable by ultrasound imaging\n* Stage of disease: T1c and nodal status N1-2 or Stage T2-4 and nodal status N0-2\n* Deemed eligible for intended treatment with Paclitaxel 80mg\u002Fm2 q1w x12, Carboplatin 1,5 AUC q1w x12, Pembrolizumab 200mg q3w x4 followed by Epirubicin 90mg\u002F m2 q3w x 4, Cyclophosphamid 600mg m2 q3w x 4, Pembrolizumab 200mg q3w x 4; by the treating physician\n* Treatment in curative intent with life expectancy ≥ 3 months\n* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.\n* Sufficient German language skills;\n\nExclusion Criteria:\n\n* History of invasive malignancy ≤2 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* Any history of previous systemic treatment for TNBC;\n* Any diseases that do not allow sports activity, such as:\n\n  * Clinically-manifest heart failure (NYHA III-IV);\n  * Respiratory partial or global insufficiency;\n  * Permanent thrombocytopenia \\\u003C10,000\u002Fµl, e.g., refractory autoimmune thrombocytopenia;\n  * Congenital or acquired thrombocytopathies or coagulation disorders.\n  * Symptomatic CHD (clearance certificate required, stress ECG and cardiac ultrasound recommended if necessary);\n* Participation in another exercise study;","FEMALE","85 Years",{"count":278,"type":22},60,[86],"In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide. Among the different subtypes, triple-negative breast cancer accounts for about 15-20% of all breast cancer cases and is characterized by a more aggressive clinical course. Recent results indicate that the percentage of patients with a pathologic complete response was 13% higher in the chemotherapy-immunotherapy group (by 64.8%) than in the placebo-chemotherapy group (51.2). High-intensity interval training has a positive effect on the immune system, suggesting that it may improve the efficacy of chemo-immunotherapy, leading to a higher rate of pathologic complete response (pCR) in patients with newly diagnosed triple-negative breast cancer. In addition to the immunomodulatory effects, this exercise model could boost microvascular perfusion, thereby improving tumor perfusion, enhancing chemo-immunotherapy and leading to better outcomes.",[282,283],"Breast Cancer","Triple Negative Breast Cancer",[285,286,287,288,289],"Exercise","Immunotherapy","Oxygen uptake","CT scan","Blood markers","2024-07-04",{"date":292,"type":37},"2024-07-11",{"date":239,"type":22},{"date":295,"type":22},"2027-12-31",{"name":43,"class":44},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":304,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":45},"100416261","characterization-of-antibacterial-antibodies-in-patients-with-cystic-fibrosis-100416261","NCT04700358","Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis","Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to give consent\n* Normal vital signs including:\n* Blood pressure systolic value 150 - 100 mmHg, diastolic value \\\u003C 90 mmHg\n* Respiratory rate \\\u003C 20\u002Fmin\n* Oxygen saturation \\>92%\n* Heart rate 50 - 110\u002Fmin\n* Body temperature \\\u003C38°C\n\nExclusion Criteria:\n\n* Cytopenia (leukocytes \\\u003C 1.500\u002Fµl, thrombocytes \\\u003C 50.000\u002Fµl, Hemoglobin \\\u003C 12 g\u002Fdl)\n* Heart disease or pulmonary hypertension\n* Body weight \\\u003C50 kg (exclusion of blood sampling for B cell isolation)\n* Blood donation, larger blood loss and\u002For major surgery in the last 8 (male) or 12 (female) weeks\n* Any decline of the general state of health in the last 3 month including weight loss \\> 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 \\\u003C 50%)",true,{"count":306,"type":22},75,"Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization\u002Fchronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.",[309,310],"Pulmonary Cystic Fibrosis","Neutralizing Antibodies","2024-05-07",{"date":313,"type":37},"2024-05-08",{"date":315,"type":37},"2020-10-01",{"date":295,"type":22},{"name":43,"class":44},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":304,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":45},"100220587","german-centre-for-infection-research-hiv-translational-platform-100220587","NCT02149004","German Centre for Infection Research HIV Translational Platform","Translational Research Platform of the TTU HIV of the German Center for Infection Research (DZIF)","Inclusion Criteria:\n\n* HIV positive\n\nExclusion Criteria:\n\n* None",{"count":326,"type":22},10000,"Despite major advances in therapy and management, HIV\u002FAIDS continues to be a major cause of infectious disease morbidity and mortality on a global scale. The discovery of effective antiretroviral treatment has turned HIV infection into a manageable chronic disease in most patients with access to care. However, the different economic and epidemiologic situation in developing and developed countries requires different research priorities, so that three main challanges are universal and in focus of research of the DZIF HIV Translational Platform:\n\n* Prevention of HIV infection\n* Long-term life with HIV\n* HIV cure\n\nThe \"Translation Reserach HIV\" will bring together clinical researchers in HIV infection in order to develop new treatment options to the above mentioned main challanges. It will take advantage of existing expertise (e.g. basic science, novel targets for treatment and HIV eradiation) of the partner sites. This platform is necessary because Germany's HIV research has suffered in the past from a lack of integration between its excellent basic science and clinical research. In addition, there was too little integration into networks that address the main international challenges. There is an urgent need to link these research strands through dedicated structures emphasising the translation of preclinical results into new therapies.",[329],"HIV",[331,332,333,334,335],"Human immunodeficiency virus (HIV)","Prevention","Long-term life","Cure","Cohort","2017-10-26",{"date":338,"type":37},"2017-10-27",{"date":340,"type":4},"2015-04",{"date":342,"type":22},"2035-01",{"name":43,"class":44},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":304,"sex":17,"minAge":352,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":355,"conditions":356,"keywords":362,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":45},"100195543","cologne-cohort-of-neutropenic-patients-coconut-100195543","NCT01821456","Cologne Cohort of Neutropenic Patients (CoCoNut)","The Cologne Cohort of Neutropenic Patients (CoCoNut) - a Non-interventional Cohort Study Assessing Risk Factors, Interventions, and Outcome of Immunosuppressed Patients With or Without Opportunistic Infections","CoCoNut","Inclusion Criteria:\n\n* immunosuppressed patients\n\nExclusion Criteria:\n\n* none","1 Year",{"count":354,"type":22},100000,"The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.",[357,358,359,360,361],"Hematological Malignancies","Cancer","Chemotherapy","Neutropenia","Immunosuppression",[363,364,365,366,367,368],"hematological malignancies","cancer","chemotherapy","anti-infectives","treatment","outcome","2013-03-26",{"date":371,"type":22},"2013-04-01",{"date":373,"type":4},"1995-01",{"date":375,"type":22},"2050-12",{"name":43,"class":44},""]