[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Leipzig\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":582},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,38,66,89,117,153,174,206,233,263,292,337,367,395,424,455,484,507,534,560],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100638417","impact-of-iridotomyiridectomy-size-on-postoperative-pupillary-block-and-dysphotopsia-following-dmek-100638417",false,"NCT07577635","Impact of Iridotomy\u002FIridectomy Size on Postoperative Pupillary Block and Dysphotopsia Following DMEK","Inclusion Criteria:\n\n* Adults aged ≥ 18 years\n* Patients undergoing Descemet membrane endothelial keratoplasty (DMEK) at the Department of Ophthalmology, University Hospital Leipzig\n* Preoperative Nd:YAG laser iridotomy or intraoperative surgical iridectomy performed as part of standard care\n* Ability to provide written informed consent\n* Willingness to complete the postoperative dysphotopsia questionnaire\n\nExclusion Criteria:\n\n* Inability to provide informed consent or refusal to participate\n* Pre-existing surgical iridectomy\n* Missing or incomplete preoperative or postoperative anterior segment OCT data\n* Active anterior uveitis or panuveitis at the time of surgery","ALL",{"count":17,"type":18},100,"ESTIMATED","OBSERVATIONAL","Descemet membrane endothelial keratoplasty (DMEK) is the standard surgical treatment for corneal endothelial disorders. A postoperative pupillary block may occur despite routine preoperative laser iridotomy or intraoperative surgical iridectomy. Insufficient size or incomplete patency of the iridotomy\u002Firidectomy (IT) may contribute to this complication, while excessively large openings may be associated with postoperative dysphotopsia. This prospective observational study investigates the association between IT size measured by anterior segment optical coherence tomography (AS-OCT) and the occurrence of postoperative pupillary block and dysphotopsia after DMEK.",[22,23,24,25],"Pupillary Block After DMEK","Laser Iridotomy \u002F Surgical Iridectomy","Dysphotopsia","Descemet Membrane Endothelial Keratoplasty (DMEK)","NOT_YET_RECRUITING","2026-07-01",{"date":29,"type":30},"2026-07-02","ACTUAL",{"date":32,"type":18},"2026-06-01",{"date":34,"type":18},"2027-07-01",{"name":36,"class":37},"University of Leipzig","OTHER",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100566565","peripheral-drivers-of-heart-failure-progression---the-prospective-pedal-hf-study-100566565","NCT06656832","Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study","PEDAL-HF","Inclusion Criteria:\n\n* Patients admitted to the participating study centres with acute decompensated heart failure (ADHF), defined as clinical signs and\u002For symptoms of heart failure\n* objective structural cardiac abnormalitites according to the ESC criteria.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* pregnancy\n* any condition interfering with the informed consent process\n* patients placed in an institution by official or court order","18 Years",{"count":47,"type":18},1000,"INTERVENTIONAL",[50],"NA","PEDAL-HF is a registry-based randomized prospective multicenter study. The investigators plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up.\n\nAll patients (randomized or not) will be followed for two years.",[53],"Heart Failure - NYHA II - IV",[55],"Heart Failure Network Care","RECRUITING","2026-04-30",{"date":59,"type":30},"2026-05-06",{"date":61,"type":30},"2024-11-28",{"date":63,"type":18},"2028-12-31",{"name":36,"class":37},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":48,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":65},"100524702","comparison-of-a-lithotripsy-vs-standard-preparation-followed-by-stenting-with-supera-stent-in-femoropopliteal-lesions-100524702","NCT06112171","Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions","Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD","CRACK-IT","Inclusion Criteria:\n\n* Subject age ≥ 18\n* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form\n* Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing\n* Rutherford Classification 2-5\n* Subject has a de novo or restenotic lesion in SFA and\u002For PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically\n* No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart\n* Target lesion length is ≥ 10cm, no maximum lesion length limit\n* Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length\n* Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion\n* Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation\n* Patency of at least one infrapopliteal artery to the ankle (\\\u003C 50% diameter stenosis) in continuity with the native femoropopliteal artery\n* A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)\n\nExclusion Criteria:\n\n* Failure to successfully cross the target lesion\n* Presence of fresh thrombus in the lesion\n* Presence of aneurysm in the target vessel\u002Fs\n* Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel\n* Prior vascular surgery of the target lesion\n* Stroke or heart attack within 3 months prior to enrollment\n* Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint\n* Life expectancy of less than one year\n* Known allergies or sensitivity to heparin, aspirin, other anticoagulant\u002F antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure\n* Rutherford Classification of 0, 1, or 6\n* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy\n* Receiving immunosuppressant therapy\n* Pregnant or breast-feeding females\n* History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion",{"count":75,"type":18},120,[50],"This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study.\n\nThe trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and\u002For high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion.\n\nPatients will be stratified for total occlusions.",[79],"Peripheral Arterial Disease",[81,82],"Calcification","Lithotripsy",{"date":59,"type":30},{"date":85,"type":30},"2024-02-13",{"date":87,"type":18},"2032-12-31",{"name":36,"class":37},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":65},"100604903","validation-of-energy-expenditure-measures-study-100604903","NCT07155564","Validation of Energy Expenditure Measures Study","Energy Balance Within a Whole-Room Indirect Calorimeter and Its Relevance for Energy Expenditure Measures","ValEE","Inclusion Criteria:\n\n* Abilty to provide informed consent\n* Written declaration of consent\n* Healthy study participants\n* Able to perform moderate physical exercise using a bike ergometer\n* Women: continuous contraception\u002Ffullicular phase of menstrual cycle\n\nExclusion Criteria:\n\n* Weight change \\> 5 kg or 5% of body weight in the last 3 months\n* Nicotine abuse, Alcohol\u002Fdrug abuse\n* Strenuous physical activity in everyday life \\> 1 h per day\n* Body mass index \\\u003C 18.5 kg\u002Fm² or ≥ 40 kg\u002Fm²\n* Chronic diseases with an impact on energy expenditure\n* Food allergy\u002Fintolerance, vegan diet\n* Circumstances that speak against the application of wearable accelerometers (e.g. silicone contact allergy)\n* Impaired fasting glucose, diabetes mellitus and prediabetes\n* Pregnancy\u002Fbreastfeeding\n* Claustrophobia\n* Refusal to communicate incidental findings","40 Years",{"count":99,"type":18},34,"The energy that the human body burns and the amount of food consumed determine a person's body weight. If food intake covers the amount of energy burned, body weight remains constant - a state known as energy balance. Achieving an energy balance is not easy in everyday life. This is reflected in the increasing number of people suffering from morbid obesity. To counteract this development, it is important to have a better understanding of how much food a person should eat.\n\nIn this study, the investigators will investigate the amount of food needed to meet a person's energy needs and bring them into energy balance.\n\nPrimary aims of the study are i) to technically and biologically validate two whole-room indirect calorimeters (WRICs) and ii) by using whole-room indirect calorimetry, to achieve a more accurate estimate of a person's emergy balance compared to common approximation formulas.\n\nSecondary study aims:\n\n1. To investigate whether the transfer of a person into energy balance using WRIC has an influence on energy expenditure measures compared to the transfer into energy balance using the usual approximation formula.\n2. To investigate whether the transfer of a person into energy balance using WRIC has an influence on activity-dependent energy expenditure measures compared to the transfer into energy balance using the usual approximation formula.\n3. To investigate whether differences in energy expenditure during energy balance during moderate and strenuous physical activity influence food intake.\n4. To investigate whether energy intake in relation to energy expenditure during energy balance is related to weight development",[102,103],"Obesity Prevention","Healthy",[105,106,107,108,109],"Energy balance","Energy expenditure","Weight change","Energy intake","Indirect calorimetry","2026-04-29",{"date":57,"type":30},{"date":113,"type":30},"2025-08-26",{"date":115,"type":18},"2029-01-31",{"name":36,"class":37},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":48,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100321802","mucous-fistula-refeeding-reduces-the-time-from-enterostomy-closure-to-full-enteral-feeds-muc-fire-trial-100321802","NCT03469609","Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (\"MUC-FIRE\" Trial)","A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding (\"MUC-FIRE\") Trial)","MUC-FIRE","Inclusion Criteria:\n\n1. Infants \\\u003C 366 days,\n2. Ileostomy \u002F Jejunostomy,\n3. double loop enterostomies and split enterostomies (with mucous fistula)\n4. Signed written informed consent obtained by parents\u002Flegal guardians and willingness of parents\u002Flegal guardians to comply with treatment and follow-up procedures of their child\n\nExclusion Criteria:\n\n1. resection of ileocecal valve,\n2. colostomy,\n3. small bowel atresia,\n4. multiple ostomies (more than just an enterostomy and a mucous fistula),\n5. chromosomal abnormalities (if known at the time of randomization),\n6. Hirschsprung's disease,\n7. participation in another drug-intervention study\n8. Intestinal perforation due to a hemodynamic heart defect","12 Months",{"count":75,"type":18},[50],"The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.",[130],"Enterostomy",[132,133,134,135,136,137,138,139,140,141,142,143],"infants","necrotizing enterocolitis (NEC)","focal intestinal perforation (FIP)","enterostomy creation","bowel reanastomosis","enteral feeding","caloric intake","parenteral nutrition","complication rate","reduction of hospital expenses","length of hospital stay","refeeding","2026-04-27",{"date":146,"type":30},"2026-05-01",{"date":148,"type":30},"2018-06-18",{"date":150,"type":18},"2027-12",{"name":36,"class":37},17,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":160,"targetDuration":161,"studyType":19,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100635201","clinical-characterization-of-patients-with-primary-biliary-cirrhosis-treated-with-seladelpar-in-the-real-life-setting-100635201","NCT07549607","Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting","SENSE registry","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Diagnosis of PBC according to EASL criteria\n3. Treatment with seladelpar\n4. Written informed consent\n\nExclusion Criteria:\n\n1. current or previous participation in a phase I to IV interventional clinical trial for seladelpar treatment of PBC\n2. Pregnancy and breastfeeding",{"count":17,"type":18},"48 Weeks","The seladelpar registry will collect real-world data of patients with PBC diagnosis treated with seladelpar in the real-life scenario in Germany and Switzerland.",[164],"Primary Bilary Cirrhosis (PBC)","2026-04-17",{"date":167,"type":30},"2026-04-24",{"date":169,"type":18},"2026-04-01",{"date":171,"type":18},"2028-10-01",{"name":36,"class":37},21,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":48,"phases":184,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100566577","phase-3-a-contrast-medium-sparing-strategy-using-automated-co2-injection-during-pvi-for-prevention-of-major-adverse-kidney-events-make-100566577","NCT06656988","A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)","A Contrast Medium Sparing Strategy Using Automated Carbon Dioxide Injection During PERIpheral Vascular Interventions for PREVENTion of Major Adverse Kidney Events (MAKE): the PeriPREVENT Randomized Controlled Trial","PeriPREVENT","Inclusion Criteria:\n\n1. Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) or chronic symptoms (Fontaine stages IIb-IV or Rutherford clinical categories 2-6)\n2. Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and\u002For infrapopliteal lesions\n3. Increased risk of CA-AKI identified by a baseline risk score of ≥ 5 points based on a published dedicated PVI risk score and a pre-angiographic estimated glomerular filtration rate (eGFR) \\< 60 ml\u002Fmin\u002F1.73 m²\n4. Both angiographic strategies seem feasible at the investigator's discretion\n5. Age 18 years or older\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Very agitated patients\n2. Patients with planned full anaesthesia during procedure\n3. Patients with a life-expectancy less than one year\n4. Patients confined to bed that are completely non-ambulatory\n5. Known acute renal failure or known unstable renal function as evidenced by a recent increase in serum creatinine (SCr) of \\> 0.5 mg\u002Fdl or \\> 25% within 7 days\n6. Iodinated contrast medium exposure within 7 days prior to procedure with change in SCr ≥ 0.1 mg\u002Fdl on two SCr measures ≥ 24 h apart\n7. Advanced chronic kidney disease (CKD) with an eGFR \\< 30 ml\u002Fmin\u002F1.73m² and\u002For dialysis\n8. Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent\n9. Acute or chronic pulmonary disease requiring oxygen therapy\n10. Patients with known patent foramen ovale or atrial septal defect\n11. Patients with planned nitrous oxide anaesthesia during intervention\n12. Patients with manifest hyperthyroidism or manifest thyrotoxicosis\n13. Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure\n14. Patients with decompensated heart failure\n15. Patients with manifest tetany\n16. Planned further procedure with a need for \\> 10 ml of iodinated contrast medium (CM) in any location (e.g., CT scan, coronary angiography) within a period of 90 days\n17. Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure\n18. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI.\n19. Participation in other interventional trials. Exceptions are described in the trial protocol.\n20. Suspected lack of compliance\n21. Pregnant or nursing women",{"count":183,"type":18},1960,[185],"PHASE3","The primary objective of the trial is to evaluate if an iodinated contrast medium sparing strategy using automated Carbon Dioxide (CO2) Injection prevents Major Adverse Kidney Events up to 90 days (MAKE90) in patients at moderately elevated risk for contrast-associated acute kidney injury (CA-AKI) undergoing infrainguinal peripheral vascular interventions (PVI).",[188,189],"Peripheral Vascular Diseases","Kidney Diseases",[191,192,193,194,195,196],"carbon dioxide","contrast medium","iodinated contrast medium","CA-AKI","angiography","angioplasty","2026-03-18",{"date":199,"type":30},"2026-03-23",{"date":201,"type":30},"2025-04-14",{"date":203,"type":18},"2029-02",{"name":36,"class":37},11,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":48,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100520582","phase-3-the-pancreatic-enzymes-after-gastrectomy-trial-100520582","NCT06058442","The Pancreatic Enzymes After Gastrectomy Trial","Inclusion Criteria:\n\n1. Gastrectomy (total and partial); at least \\> 50 % of the stomach must be resected\n2. Age 18 or older\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Indication for pancreas enzyme therapy\n2. Gastrectomy with palliative intention\n3. UICC (Union for International Cancer Control) Stage IV gastric malignancy\n4. Malnutrition of other aetiology\n5. Life expectancy \\\u003C 12 months\n6. Known lactose intolerance\n7. Known hereditary galactose intolerance\n8. Patients on alpha-glucosidase inhibitors (AGIs)\n9. Acute pancreatitis\n10. Acute episode of chronic pancreatitis\n11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®\n12. Participation in competing interventional trials may be allowed under circumstances\n13. Patients under legal supervision or guardianship\n14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor\n15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial\n16. Pregnant or nursing women\n17. Suspected lack of compliance\n18. Patients who were already enrolled in the trial",{"count":213,"type":18},188,[185],"This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.",[217],"Gastrectomy",[219,220,221,222,223],"enzyme supplementation","lipase","elastase","gastrointestinal","quality of life","2026-01-19",{"date":226,"type":30},"2026-01-22",{"date":228,"type":30},"2024-01-24",{"date":230,"type":18},"2027-06",{"name":36,"class":37},9,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":241,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":244,"conditions":245,"keywords":252,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":65},"100426841","effects-of-cross-sex-hormone-therapy-on-eating-behavior-metabolism-energy-balance-and-cardiovascular-system-100426841","NCT04838249","Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System","Investigation of the Effects of Testosterone and Estrogen on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System in Transsexual Patients Undergoing Cross-sex Hormone Therapy","HHS","Inclusion Criteria:\n\n* transsexual patients undergoing cross-sex hormone therapy versus controls\n* able to give informed consent, if \\\u003C18 years from all legal guardians\n* only for part B (patients will participate in all other study parts): weight stable (± 5%) for last 3 months, BMI ≤ 30 kg\u002Fm2\n\nExclusion Criteria:\n\n* severe medical impairments (e.g., uncontrolled cardiovascular disease, severe heart failure, uncontrolled hypertension, cerebral insult, active malign disease, etc.)\n* self-initiated cross-sex hormone therapy before study start only for part B (patients will participate in all other study parts): Insufficiently controlled endocrine disorders (Cushing's disease, other uncontrolled pituitary disorders, uncontrolled hypothyroidism, hyperthyroidism, etc.)\n* Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only will be allowed to enter the study (provided use of these agents is not required for 1 week before\n* Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study entry).\n* History of HIV infection or ongoing chronic infection (such as tuberculosis)\n* only for part D (patients will participate in all other study parts): Contraindication against performance of an MRI scan (i.e., presence of metal in body, tattoos in head\u002Fneck region, claustrophobia etc.)",true,{"count":243,"type":18},80,"Current study aims to characterize five highly interconnected physiological systems in patients undergoing cross-sex hormone therapy - namely glucose and lipid metabolism, energy balance, eating behavior, functional brain networks involved in the regulation of eating behavior and the cardiovascular system - to gain novel insights into the effects of sex hormones on the human body. Gathered information will help to identify pathophysiological mechanisms for the development of overeating\u002Fobesity, insulin resistance, and cardiovascular disease. Secondarily, the relationships between the gut and oral microbiomes and metabolomes and circulating bacterial signatures will be investigated in relation to the other pervasive physiological systems.\n\nCurrent study is an observational study. The decision if the patient's request for cross-sex hormone therapy can complied with (i.e., if cross-sex hormone therapy is medically indicated) is made prior to the first contact with the study center and with the outpatients clinic for Endocrinology at the University Hospital in Leipzig. Decision ifor treatment is made according to national and international guidelines. Treatment of study participants with testosterone and estradiol\u002Fantiandrogens is not affected by the study. During the course of the study no invasive interventions are being performed.",[246,247,248,249,250,251],"Transsexualism","Transgenderism","Adiposity","Eating Behavior","Arterial Stiffness","Microangiopathy",[246,106,105,253,248,254],"Eating behavior","Cardiovascular disease","2025-11-27",{"date":257,"type":30},"2025-12-05",{"date":259,"type":30},"2021-05-05",{"date":261,"type":18},"2026-05",{"name":36,"class":37},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":48,"phases":273,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":5},"100481614","phase-4-treatment-of-non-resectable-bile-duct-cancer-with-radiofrequency-ablation-or-photodynamic-therapy-100481614","NCT05551299","Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy","Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial","CARP","Inclusion Criteria:\n\n1. Hilar cholangiocarcinoma (cytological or histological confirmation)\n2. Surgery is not planned\n3. Age ≥ 18 years\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumour not accessible endoscopically\n2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen\n3. Leukopenia (\\\u003C 2000\u002Fmm3)\n4. Thrombocytopenia (\\\u003C 100,000 \u002F mm³)\n5. Severe, uncorrected coagulopathy (at the discretion of the physician)\n6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists\n7. Porphyria (clinician's assessment) or other light-exacerbated diseases\n8. Severely impaired liver and or kidney function (at the discretion of the physician)\n9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)\n10. Planned surgical procedure within the next 30 days\n11. Concurrent eye disease that will require a slit lamp examination within the next 30 days\n12. Prior radiotherapy within the last four weeks\n13. Previous PDT or RFA\n14. Planned liver transplantation\n15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)\n16. Participation in other interventional trials\n17. Patients under legal supervision or guardianship\n18. Pregnant or nursing women",{"count":272,"type":18},258,[274],"PHASE4","Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.",[277],"Hilar Cholangiocarcinoma",[277,279,280,281,282,283],"Radiofrequency ablation (RFA)","Photodynamic therapy (PDT)","Photosensitizer","Klatskin Tumor","Bile Duct Cancer","2025-03-24",{"date":286,"type":30},"2025-03-27",{"date":288,"type":30},"2023-02-10",{"date":290,"type":18},"2028-04",{"name":36,"class":37},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":48,"phases":303,"briefSummary":305,"conditions":306,"keywords":319,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":232},"100526640","phase-2-european-larynx-organ-preservation-study-elos-mk-3475-c44-100526640","NCT06137378","European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]","ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal\u002FHypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation","ELOS","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for total laryngectomy can be enrolled in this study.\n2. Stage III, IVA or IVB, whenever clear resection margins R0 \\>5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes are present.\n3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n4. PD-L1-expression\\* within the tumor biopsy, CPS ≥1\n5. Male participants:\n\n   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. Female participants:\n\n   A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n8. Have adequate organ function as defined in the (Table 4) of the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents.\n4. Has received prior radiotherapy.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n9. Has known distant metastases including active CNS metastases and\u002For carcinomatous meningitis.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. Has a known intolerance to one of the substances administered during treatment including e.g. antibiotics, antiemetics, etc. or any other component of concurrent auxiliary medication.","70 Years",{"count":302,"type":18},140,[304],"PHASE2","ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA\u002FB head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \\\u003C 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.",[307,308,309,310,311,312,313,314,315,316,317,318],"Squamous Cell Carcinoma of Head and Neck","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma Stage III","Laryngeal Squamous Cell Carcinoma Stage IV","Squamous Cell Carcinoma of Larynx","Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Larynx Stage III","Squamous Cell Carcinoma of the Larynx Stage IV","Laryngeal Squamous Cell Carcinoma","Laryngectomy; Status","Laryngeal Cancer","Laryngeal Neoplasms",[320,321,322,323,324,325,326,327,328],"induction chemotherapy","neoadjuvant treatment","immune checkpoint inhibitor","pembrolizumab","KEYNOTE","larynx organ preservation","laryngectomy-free survival","overall survival","event-free survival","2024-09-18",{"date":331,"type":30},"2024-09-20",{"date":333,"type":30},"2024-04-17",{"date":335,"type":18},"2030-12",{"name":36,"class":37},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":48,"phases":348,"briefSummary":349,"conditions":350,"keywords":353,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":366},"100465101","peer2me-a-peer-supported-program-for-adolescent-and-young-adult-cancer-patients-100465101","NCT05336318","Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients","Evaluation of a Peer Supported Program for Adolescent and Young Adult Cancer Patients","Peer2Me","Inclusion Criteria:\n\n* Cancer disease between the ages of 18 and 39 (all tumor entities)\n* completion of acute treatment at least 2 years ago (mentors)\n* curative prognosis\n* Native language German or fluent German speaker\n* first cancer diagnosis in the last 6 months (mentees, all tumor entities)\n* curative prognosis\n\nExclusion Criteria:\n\n* existing and already diagnosed psychiatric disease, ongoing psychotherapy and\u002For existing suicidal tendency\n* palliative treatment approach","39 Years",{"count":347,"type":18},180,[50],"The present bicentric study has the aim to investigate the effectiveness of the peer supported mentoring program 'Peer2Me' with regard to psychosocial parameters using a prospective Comprehensive Cohort Design. Over a period of three months, acutely ill patients in the intervention group are accompanied by a mentor with the same disease and of similar age. Patients in the control group receive a one-time consultation. Before and after the intervention, mentors and mentees are interviewed about their psychosocial distress and quality of life.",[351,352],"Cancer","Psychosocial Problem",[354,355,356,357],"adolescents and young adulthood","AYA","psychooncology","peer-support","2024-08-22",{"date":360,"type":30},"2024-08-23",{"date":362,"type":30},"2021-01-01",{"date":364,"type":18},"2024-09-30",{"name":36,"class":37},2,{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":48,"phases":376,"briefSummary":377,"conditions":378,"keywords":383,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":65},"100556508","cholesterol-self-testing-in-patients-post-acute-coronary-syndrome-100556508","NCT06526013","Cholesterol Self-testing in Patients Post Acute Coronary Syndrome","C-Check","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with acute coronary syndrome in the last 6 months and not having reached the LDL target value\n* Signed informed consent\n\nExclusion Criteria:\n\n* Persons unable to understand the study\n* Persons unable or unwilling to perform self-measurements\n* Persons unable or unwilling to undergo additional cholesterol-lowering therapy to reach the LDL target\n* Pre-menopausal women without contraception\n* Use of experimental drugs or investigational products within 30 days prior to screening\n* Employees or contractors of the institution conducting the study or family members of the Principal Investigator, Co-Investigator, or financial supporter",{"count":375,"type":18},200,[50],"The pharmacological reduction of LDL-C lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. The achievement of LDL-C target levels in Germany, Europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. Only a small proportion of post-myocardial infarction patients reach their LDL-C target range within a year. There is a significant need for new strategies to improve LDL-C target achievement and thereby reduce the occurrence of secondary cardiovascular events.\n\nThe aim of the study is to establish a basis for improving prevention by achieving the target LDL level effectively and quickly in patients with high and very high cardiovascular risk profiles.",[379,380,381,382],"Acute Coronary Syndrome","Prevention","LDL Hyperlipoproteinemia","Therapeutic Adherence",[379,384,385,386,254],"Dyslipidemia","Statin","Lipid lowering therapy","2024-07-30",{"date":389,"type":30},"2024-08-01",{"date":391,"type":30},"2024-06-01",{"date":393,"type":18},"2025-09-30",{"name":36,"class":37},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":48,"phases":406,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100441639","renal-denervation-to-treat-heart-failure-with-preserved-ejection-fraction-100441639","NCT05030987","Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction","Renal Denervation to Treat Heart Failure With Preserved Ejection Fraction - A Pilot Trial","UNLOAD-HFpEF","Inclusion Criteria:\n\n1. confirmed arterial hypertension (1-5 antihypertensive drugs without any dosage change in the preceding 4 weeks) and average systolic BP between \\>125 and ≤170 mmHg and diastolic BP ≤110 mmHg in 24h ambulatory blood pressure measurement (ABPM)\n2. HFpEF (defined by clinical signs and\u002For symptoms of heart failure, objective structural cardiac abnormalities according to the ESC (European Society of Cardiology) criteria \\[1\\], elevated NT-proBNP ≥125 pg\u002FmL and left-ventricular ejection fraction ≥55%)\n3. NYHA-Class II or III\n4. Confirmation of an elevated cardiac filling pressures (either LVEDP \\>= 16 mmHg or PCWP \\>= 15 mmHg at rest or \\>=25 mmHg during exercise) by catheterization\n5. Age 18-80 years\n6. Written informed consent\n\nExclusion Criteria:\n\n1. ≥1 main renal artery diameter \\\u003C3.0 mm\n2. main renal artery length \\\u003C 20 mm\n3. a single functioning kidney\n4. presence of abnormal kidney tumors\n5. renal artery aneurysm\n6. pre-existing renal stent or history of renal artery angioplasty\n7. fibromuscular disease of the renal arteries\n8. presence of renal artery stenosis of any origin ≥50%\n9. iliac\u002Ffemoral artery stenosis precluding femoral access for RDN\n10. fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial device on contraception).\n11. participation in other interventional trials\n12. patients under legal supervision or guardianship\n13. suspected lack of compliance\n14. pregnant women\n15. Presence of intracardiac pacemakers or implantable cardioverter\u002Fdefibrillators","80 Years",{"count":405,"type":18},68,[50],"Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of renal denervation as a treatment option for heart failure with preserved ejection fraction.",[409,410],"Heart Failure With Preserved Ejection Fraction","Hypertension, Renal",[412,413,414],"Renal Denervation","Hypertension","Heart Failure with Preserved Ejection Fraction","2024-07-15",{"date":417,"type":30},"2024-07-17",{"date":419,"type":30},"2021-11-30",{"date":421,"type":18},"2026-03-31",{"name":36,"class":37},5,{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":241,"sex":15,"minAge":431,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":65},"100251316","life-child-life-leipzig-research-centre-for-civilization-diseases-100251316","NCT02550236","LIFE Child (LIFE Leipzig Research Centre for Civilization Diseases)","Prospective Population-based Childhood Cohort Study in the Leipzig Area Investigating Genetic, Environmental, and Metabolic Factors and Their Association With the Development of Civilization Diseases","Inclusion Criteria:\n\n* children with their families and pregnant women of the area of Leipzig\n\nExclusion Criteria:\n\n* severe diseases","0 Years","20 Years",{"count":434,"type":18},7000,"The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease.\n\nThe LIFE Child Study focuses on two main research objectives:\n\n* What are premises of normal growth, development and health in children?\n* Which factors contribute to the development of non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems?\n\nDetailed assessments will be conducted alongside long-term storage of biological samples in 1,000 pregnant women and more than 5,000 children and their families.",[437],"Child Development",[439,440,441,442,443,444,445,446],"Children","Pregnancy","Growth","Lifestyle","Metabolic and cardiovascular health","Birth","Development","Reference Values","2024-02-29",{"date":449,"type":30},"2024-03-04",{"date":451,"type":4},"2010-10",{"date":453,"type":18},"2026-12",{"name":36,"class":37},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":48,"phases":465,"briefSummary":466,"conditions":467,"keywords":470,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},"100468815","phase-2-efficacy-of-luspatercept-in-esa-naive-lr-mds-patients-with-or-without-ring-sideroblasts-who-do-not-require-transfusions-100468815","NCT05384691","Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions","A Phase II, Open-label, Single Arm Study to Evaluate the Efficacy of Luspatercept in Erythropoiesis-stimulating Agent Naive Lower-risk MDS Patients With or Without Ring Sideroblasts Who do Not Require RBC Transfusions","LENNON","Inclusion Criteria:\n\n* Diagnosis of myelodysplastic syndrome (MDS) according to WHO classification\n* Very low-, low-, or intermediate-risk disease MDS with up to 3.5 according to revised International Prognostic Scoring System (IPSS-R)\n* Less than 5% blasts in bone marrow\n* Peripheral blood white blood cell (WBC) count \\\u003C 13,000\u002FμL\n* sEPO levels ≤ 500 mU\u002FmL\n* Non-transfusion dependence (NTD) according to IWG 2018 criteria\n* Symptomatic anemia\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient does not accept bone marrow sampling during screening and during treatment\n* Patient does not accept regular peripheral blood sampling for screening and during treatment.\n* Patient does not accept subcutaneous application of LUS every three weeks\n* Prior treatment for anemia associated with MDS (i.e. ESA, luspatercept), except previously treated with G-CSF\u002Fgranulocyte-macrophage colony-stimulating factor (GM-CSF), both agents must be discontinued at least 4 weeks before registration\n* Secondary MDS, i.e. MDS arising as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.\n* Prior allogeneic or autologous stem cell transplant\n* Prior history of AML\n* Prior history of malignancies, other than MDS, unless the subject is free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥ 5 years.\n* Major surgery within 8 weeks prior to registration.\n* Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥160 mmHg or of diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment\n* Platelet count \\\u003C 30,000\u002FμL (30 × 10\\^9\u002FL)\n* Estimated glomerular filtration rate or creatinine clearance \\\u003C 40 mL\u002Fmin\n* Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase (SGOT) ≥ 3.0 × upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≥ 3.0 × ULN\n* Total bilirubin ≥ 2.0 × ULN\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 2\n* Stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to registration\n* Myocardial infarction, uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months prior to registration.\n* Subjects with a known ejection fraction of ˂ 35%, confirmed by a local echocardiography or multigated acquisition scan (MUGA) performed within 6 months prior to registration, are excluded\n* Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and\u002For known evidence of active hepatitis C.\n* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the IMP\n* Subject has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (e.g., imprisoned or institutionalized) that would prevent the subject from participating in the study.\n* Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe participates in the study\n* Subject has any condition or concomitant medication that confounds the ability to interpret data from the study.\n* Use of any of the following within five weeks prior to registration are prohibited: Anticancer cytotoxic chemotherapeutic agent or treatment, Corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to inclusion for medical conditions other than MDS, Iron chelation therapy, except for subjects on a stable or decreasing dose for at least 8 weeks prior to registration, Other RBC hematopoietic growth factors (e.g. interleukin \\[IL\\]-3)\n* Pregnant or breastfeeding females\n* Positive pregnancy test in women of childbearing potential.\n* Female subjects of childbearing potential unwilling to use a highly effective method of contraception for the course of the study through 90 days after the last dose of study medication.\n* Male subjects with procreative capacity not willing to use a highly effective method of contraception, starting with the first dose of study therapy through 90 days after the last dose of study therapy.\n* Participation in other interventional trials.\n* Patients under legal supervision or guardianship.",{"count":464,"type":18},213,[304],"Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent",[468,469],"Myelodysplastic Syndromes","Anemia",[471,469,472,473,474],"MDS","Ring sideroblast","Low risk","non-transfusion dependence (NTD)","2024-01-30",{"date":477,"type":30},"2024-01-31",{"date":479,"type":30},"2022-09-27",{"date":481,"type":18},"2027-07-31",{"name":36,"class":37},22,{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":490,"targetDuration":432,"studyType":19,"phases":4,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":65},"100526047","cardiac-amyloidosis-registry-of-university-hospital-leipzig-100526047","NCT06129656","Cardiac Amyloidosis Registry of University Hospital Leipzig","Inclusion Criteria:\n\n* Confirmed cardiac amyloidosis according to current standards\n\nExclusion Criteria:\n\n* refusal to participate",{"count":491,"type":18},500,"This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.",[494],"Cardiac Amyloidosis",[496,497,498],"heart failure","cardiac amyloidosis","restrictive cardiomyopathy","2023-11-08",{"date":501,"type":30},"2023-11-13",{"date":503,"type":30},"2023-05-01",{"date":505,"type":18},"2033-05",{"name":36,"class":37},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":241,"sex":15,"minAge":514,"maxAge":45,"enrollmentInfo":515,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":65},"100400216","leipzig-childhood-obesity-study-100400216","NCT04491344","Leipzig Childhood Obesity Study","Extended Geno- and Phenotyping of Overweight and Obese Children and Adolescents","Inclusion Criteria:\n\n* all pediatric patients seen in the adiposity outpatient clinic\n* informed patient consent\n\nExclusion Criteria:\n\n* none","1 Month",{"count":516,"type":18},3000,"The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.",[519],"Childhood Obesity",[521,522,523,524,525],"Single nucleotide polymorphisms","Obesity","Insulin resistance","Metabolic syndrome","Oral glucose tolerance test","2023-11-03",{"date":528,"type":30},"2023-11-07",{"date":530,"type":4},"2002-01",{"date":532,"type":18},"2030-01",{"name":36,"class":37},{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":241,"sex":15,"minAge":4,"maxAge":45,"enrollmentInfo":542,"targetDuration":45,"studyType":19,"phases":4,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":65},"100291343","crescnet---growth-monitoring-network-100291343","NCT03072537","CrescNet - Growth Monitoring Network","CrescNet - Computer-guided, Population-based Surveillance System for Growth Disorders","CrescNet","Inclusion Criteria: Population based sample with inclusion of any patient seen by primary care or institutional physician\u002Fpediatrician, regardless of the objective for the visit (well child visits, acute visits or special requests)\n\nExclusion Criteria: none",{"count":543,"type":18},1000000,"CrescNet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in Leipzig in 1998, whose aim is to improve the early detection of growth disorders. Secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.",[522,437,546],"Growth Disorders",[548,549,550,551,552,553],"growth","BMI","obesity","childhood","adolescence","development",{"date":528,"type":30},{"date":556,"type":30},"1998-01-01",{"date":558,"type":18},"2028-01-01",{"name":36,"class":37},{"id":561,"slug":562,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":241,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":580,"leadSponsor":581,"locationsCount":65},"100225115","leipzig-adipose-tissue-childhood-cohort-100225115","NCT02208141","Leipzig Adipose Tissue Childhood Cohort","Determinants of Adipose Tissue Development and Obesity in Children and Adolescents","Inclusion Criteria:\n\n* body weight: 3000 g - 180 kg\n* suitable surgical procedure\n* signed informed consent by the guardians and the study participant, if older 12 years\n\nExclusion Criteria:\n\n* severe chronic and inflammatory diseases\n* acute or chronic infections\n* oncological diseases\n* clotting disorders\n* complications during surgical procedure\n* drug treatment\n* nil by mouth",{"count":47,"type":18},"In this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. The investigators aim to identify and characterize mechanisms and molecular targets that affect the development of adipose tissue and ensuing obesity in childhood and adolescence.",[519,570],"Insulin Resistance",[572,550,573,574,575,576,577],"children","adipose tissue dysfunction","inflammation","macrophage infiltration","insulin resistance","dyslipidemia",{"date":528,"type":30},{"date":451,"type":4},{"date":335,"type":18},{"name":36,"class":37},""]