[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute for Clinical and Experimental Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":431},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,46,75,106,134,161,185,210,235,267,291,319,348,373,401],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637848","evaluate-the-performance-of-the-dexcom-g7-continuous-glucose-monitoring-cgm-system-in-critically-ill-patients-undergoing-major-abdominal-surgery-and-solid-organ-transplantation-which-require-blood-glucose-monitoring-for-intensive-insulin-therapy-100637848",false,"NCT07611721","Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.","Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU","DREAM-ICU","Inclusion Criteria:\n\n* Age 18 years or over\n* Intensive care unit admission\n* Requiring blood glucose monitoring for insulin therapy\n\nExclusion Criteria:\n\n* High-dose ascorbic acid or acetaminophen \\> 4g\u002Fday\n* Physical or mental health condition precluding continuous wear of the continuous glucose monitor, as judged by the physician","ALL","18 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"NA","Main objective:\n\nThe goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit.\n\nOn admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position.\n\nSensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels.\n\nSensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose.\n\nPatients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows.\n\nCalibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter.\n\nCalibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol\u002FL).\n\nCalibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol\u002FL) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol\u002FL).\n\nHypothesis:\n\n* Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors.\n* Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%).\n\nFurther objectives:\n\nTo evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety.\n\nTo identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.",[27,28,29,30,31,32],"CGM","Intensive Care (ICU)","Liver Transplant Surgery","Solid Organ Transplantation","Major Abdominal Surgeries","Diabetes (Insulin-requiring, Type 1 or Type 2)","RECRUITING","2026-05-20",{"date":36,"type":37},"2026-05-28","ACTUAL",{"date":39,"type":37},"2026-01-14",{"date":41,"type":21},"2027-04",{"name":43,"class":44},"Institute for Clinical and Experimental Medicine","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100634161","endoscopic-ultrasound-guided-radiofrequency-ablation-for-pancreatic-cystic-neoplasms-and-pancreatic-neuroendocrine-tumors-100634161","NCT07536087","Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors","Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Neuroendocrine Tumors","Inclusion Criteria:\n\n* Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team\n* Capability of giving informed consent PCN Inoperability or refusal of surgery\n* Branch duct IPMN (BD-IPMN) with worrisome features:\n* Jaundice\n* High grade dysplasia or cancer\n* Solid mass\u002Fnodule \\> 5mm\n* Main pancreatic duct dilation \\> 10mm Or at least one (patients without comorbidities) or at least two (patient with comorbidities) of the following risk features:\n* CA 19-9\\> 37 U\u002Fml\n* Increase in size \\> 5mm\u002Fyear\n* Dilation of the main pancreatic duct between 5-10mm\n* Size ≥ 40mm\n* Symptoms (new onset of diabetes, acute pancreatitis)\n* Nodule \\\u003C 5mm Pancreatic NET\n* Size \\\u003C 2 cm\n* Histological proof in non-functional lesions\u002Fhistological proof or clinical proof in functional lesions\n* 68Ga-DOTATATE PET\u002FCT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases\n* G1 or G2 (\\\u003C5 %) histology\n\nExclusion Criteria:\n\n* Known bleeding disorder that cannot be sufficiently corrected with medication\n* Use of anticoagulants that cannot be discontinued\n* Physical and\u002For psychological inability to understand the aims of the research and to adequately cooperate\n* Pregnancy\n* Inability to sign the informed consent",{"count":54,"type":21},50,[24],"The primary aim of this study is to evaluate the technical feasibility and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) in the treatment of pancreatic cystic neoplasms (PCNs) and pancreatic neuroendocrine tumors (pNETs) in patients who are not suitable candidates for surgical treatment or who refuse surgery.\n\nEUS-RFA, as a minimally invasive therapeutic option, may potentially reduce the need for intensive imaging surveillance, prevent further progression of these lesions, and serve as a bridging therapy in selected patients for whom surgical intervention may be considered in the future. At the same time, EUS-RFA could contribute to reducing overtreatment, thereby lowering the risk of complications associated with surgical procedures and leading to an overall reduction in healthcare costs.\n\nThe secondary objectives of the study are to evaluate the safety profile of EUS-RFA, including the incidence and severity of adverse events both in the early postoperative period and during the first year of follow-up, as well as to assess the long-term efficacy of EUS-RFA, including disease progression.",[58,59,60],"Endoscopic Ultrasound-Guided Radiofrequency Ablation","Pancreatic Neuroendocrine Tumors (pNET)","Pancreatic Cystic Neoplasms",[62,63,64,65,66,67],"Pancreatic Cystic Neoplasm","Intraductal papillary mucinous neoplasm","EUS-guided RFA","Pancreas","Neuroendocrine tumor","Radiofrequency ablation","2026-04-11",{"date":70,"type":37},"2026-04-17",{"date":68,"type":37},{"date":73,"type":21},"2029-12-31",{"name":43,"class":44},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":45},"100633474","phase-4-prolonged-nasogastric-administration-of-ketones-in-decompensated-heart-failure-100633474","NCT07527156","Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure","Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure","KADHEF-2","Inclusion Criteria:\n\n* LVEF \\\u003C35%\n* Acute heart failure with low cardiac output syndrome or cardiogenic shock\n\nExclusion Criteria:\n\n* Severe liver failure\n* Severe acidosis\n* Inability to insert nasogastric tube\n* Gastric paralysis \u002F ileus\n* Repeated vomiting\n* Severe hypokalemia",{"count":84,"type":21},12,[86],"PHASE4","This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.",[89,90,91,92,93],"Acute Heart Failure (AHF)","Cardiogenic Shock","Heart Failure","Ketones","Ketone Body Metabolism",[95,96,97],"acute heart failure","ketones","ketone body","2026-04-07",{"date":100,"type":37},"2026-04-14",{"date":102,"type":37},"2026-04-04",{"date":104,"type":21},"2027-03-31",{"name":43,"class":44},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":45},"100620692","pericoronary-adipocyte-size-gradient-100620692","NCT07360925","Pericoronary Adipocyte Size Gradient","Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue","AdipoCor","Inclusion Criteria:\n\n* Age 30-90 years\n* Diagnosis of dilatational or ischemic cardiomyopathy\n* Patients undergoing heart transplantation in IKEM\n\nExclusion Criteria:\n\n* Known combined diagnosis of dilatational and ischemic cardiomyopathy\n* Arrhythmogenic cardiomyopathy\n* Congenital heart defects\n* Non-eligibility due to the absence of informed consent","30 Years","90 Years",{"count":117,"type":21},60,"OBSERVATIONAL","Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.",[91,121],"Heart Transplantation",[123,124,125,126],"Pericoronary adipose tissue","adipocyte size","inflammatory changes","macrophages",{"date":128,"type":37},"2026-01-22",{"date":130,"type":37},"2023-06-01",{"date":132,"type":21},"2029-07-01",{"name":43,"class":44},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":143,"studyType":118,"phases":4,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100618069","hernia-repair-using-rectus-fascia-allograft-100618069","NCT07326826","Hernia Repair Using Rectus Fascia Allograft","Abdominal Wall Hernia Repair With Implantation of an Allogeneic Non-vascularised Rectus Abdominis Fascial Graft: A Pilot Prospective Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Solid organ transplant recipients (liver, kidney, pancreas, heart, or combined transplantation) ≥ 6 months post-transplantation with a primary ventral or incisional hernia.\n* Non-transplant patients with a complex abdominal wall defect not amenable to currently established reconstructive methods (e.g., mesh repair, flap transposition, component separation).\n* ECOG performance status 0-2.\n* Written informed consent.\n\nExclusion Criteria:\n\n* ECOG performance status 3-4.\n* Pregnancy.\n* High-dose corticosteroid therapy.",{"count":142,"type":21},20,"12 Months","Abdominal wall closure in highly complex patients is one of the most difficult tasks in abdominal surgery. Repeated laparotomies, enterocutaneous fistulas, loss of the fascial layer and contaminated operative fields may prevent safe fascial approximation, and closure under high tension can lead to serious complications such as abdominal compartment syndrome. These problems are frequently encountered after intestinal or multivisceral transplantation and are not uncommon after liver transplantation. While component separation, flap techniques and mesh reinforcement are available, standard approaches may be insufficient or inappropriate in extensive or contaminated defects, and synthetic mesh may be contraindicated due to infection risk.\n\nAn allogeneic non-vascularized rectus abdominis fascial graft (NVRF) offers a practical alternative for isolated fascial defects with preserved skin coverage. The technique is relatively simple, reproducible, and does not require vascular reconstruction, potentially filling a gap where synthetic mesh is unsuitable. However, current evidence is limited, heterogeneous and largely retrospective.\n\nThis pilot prospective observational study will assess the feasibility and outcomes of elective incisional or primary ventral hernia repair using NVRF in (1) solid organ transplant recipients and (2) highly selected patients with exhausted standard abdominal wall reconstruction options and contraindications to synthetic mesh. Key outcomes include 12-month hernia recurrence, 90-day surgical site infection, immunologic response measured by donor-specific anti-HLA antibodies, direct healthcare costs over 12 months, and patient-reported quality of life using the EuraHS-QoL questionnaire.",[146],"Abdominal Wall Hernia",[148,149,150,151],"hernia repair","fascia","transplant","abdominal wall reconstruction","NOT_YET_RECRUITING","2026-01-08",{"date":155,"type":37},"2026-01-12",{"date":157,"type":21},"2026-02-01",{"date":159,"type":21},"2029-02-10",{"name":43,"class":44},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":45},"100618239","alss---dpmas-and-therapeutic-plasma-exchange-tpe-its-effect-on-primary-coagulation-inflammation-and-the-function-of-vital-organs-in-alf-or-aclf-100618239","NCT07329036","ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF","The Artificial Liver Support System (ALSS) in Patients With Acute on Chronic Liver Failure - the Use of Combined Molecular Adsorption System With Double Plasma (DPMAS) and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation and the Function of Vital Organs.","Inclusion Criteria:\n\n* Adult patient, age ≥18 years\n* Expressed consent to the inclusion\n* Patient hospitalized on ICU with ALF or ACLF diagnosis\n* Recently meeting the inclusion to liver transplantation\n* Present on a waiting list to liver transplant\n* Unsuitable for inclusion to liver transplantation - indicated for support therapy only, but not indented to palliative care\n\nExclusion Criteria:\n\n* Disagreement with the study\n* Infaust prognosis with expected survival less than 24 hours\n* Physiologically\u002Fbiologically very advanced stage patients condition, severe lung disease (Gold criteria 3 or 4), heart failure (functional class NYHA III or IV) or neurological disease, as well as ACLF-3.\n* Advanced oncological disease (expected life expectancy below 6 months)\n* Severe degree of Frailty syndrome in secondary severe sarcopenia (muscle and malnutrition) or reduced performance state according","75 Years",{"count":170,"type":21},25,[24],"The artificial liver support system (ALSS) in patients with acute on chronic liver failure - the use of combined molecular adsorption system with double plasma (DPMAS) and therapeutic plasma exchange (TPE), its effect on primary coagulation, inflammation and the function of vital organs.",[174],"Acute Liver Failure",[176],"acute liver failure","2025-12-28",{"date":179,"type":37},"2026-01-09",{"date":181,"type":37},"2024-04-01",{"date":183,"type":21},"2026-12-31",{"name":43,"class":44},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":192,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":45},"100604739","chronic-kidney-disease-screening-100604739","NCT07153432","Chronic Kidney Disease Screening","Chronic Kidney Disease Screening in Patients Followed at a Tertiary Care Center","Inclusion Criteria:\n\n* age \\> 50 or age \\>18 + one of these conditions (history of diabetes, arterial hypertension, ischemic heart disease, stroke, perpheral artery disease, atrial fibrillation, heart failure)\n* agree to participate\n* followed at the Institute for Clinical and Experimental Medicine\n\nExclusion Criteria:\n\n* unwilling to participate\n* kidney transplant recipient\u002Fprevious kidney transplantation",true,{"count":194,"type":21},3000,"The goal of this observational study is to assess epidemiology of chronic kidney disease in patients followed at a tertiary care center. The main question it aims to answer is: What is the proportion of patients with chronic kidney disease overall and how many are previously undiagnosed.",[197],"Chronic Kidney Diseases",[199,200,201],"chronic kidney disease","screening","epidemiology","2025-08-29",{"date":204,"type":37},"2025-09-04",{"date":206,"type":37},"2025-02-24",{"date":208,"type":21},"2026-01-31",{"name":43,"class":44},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100583125","per-oral-endoscopic-myotomy-poem-in-patients-with-postfundplication-dysphagia-100583125","NCT06872255","Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia","A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)","VADYSMA","Inclusion Criteria:\n\n1. Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.\n2. Refractory (\\> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.\n3. X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial\u002Ftotal stagnation of the contrast solution above the GEJ\n4. Endoluminal planimetry: EGJ-DI \\\u003C 3 mm2\u002FmmHg (with 40ml)\n5. Age above 18 years\n6. Signed informed consent form\n\nExclusion Criteria:\n\n1. No previous attempt with at least one prokinetic drug\n2. Previous esophageal myotomy (open, laparoscopic or endoscopic)\n3. Primary esophageal motility disorder (achalasia etc.)\n4. Active erosive esophagitis\n5. Active peptic ulcer disease\n6. Esophageal stricture (peptic, malignant, other)\n7. Partial or complete supradiaphragmatic migration of the wrap and\u002For stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm\n8. Known eosinophilic esophagitis\n9. Severe coagulopathy\n10. Esophageal or gastric varices\n11. Advanced liver cirrhosis (Child B or Child C)\n12. Pregnancy or puerperium\n13. Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment\n14. Any other condition, which in the opinion of the investigator would interfere with study requirements\n15. Known gastroparesis",{"count":219,"type":21},30,[24],"Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.",[223,224,225],"Dysphagia","Dysphagia, Esophageal","Healthy","2025-03-06",{"date":228,"type":37},"2025-03-12",{"date":230,"type":21},"2025-04-01",{"date":232,"type":21},"2027-06-01",{"name":43,"class":44},2,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":192,"sex":243,"minAge":18,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":45},"100573867","the-role-of-sugars-in-fat-accumulation-in-the-liver-100573867","NCT06751862","The Role of Sugars in Fat Accumulation in the Liver","The Effect of Simple Carbohydrates on the Development of Non-alcoholic Fatty Liver Disease (FROGLOSA)","FROGLOSA","Part A\n\nInclusion Criteria:\n\n* male volunteers - 15 nonobese subjects (Body Mass Index (BMI) \\\u003C 30 kg\u002Fm2) and 15 obese subjects (BMI ˃ 30 kg\u002Fm2)\n* 18 - 70 years old\n\nExclusion Criteria:\n\n* diabetes mellitus (fasting glucose above 7 mmol\u002Fl, 2-hour glucose after oGTT above 11.1 mmol\u002Fl, or antidiabetic treatment)\n* other serious illnesses (cardiovascular disease, cancer, etc.)\n* alcohol consumption ˃ 30 g\u002Fday\n* fructose intolerance\n* use of drugs affecting lipid metabolism\n\nPart B\n\nInclusion Criteria:\n\n* male volunteers with hepatic fat content higher than 6.2% and less than 16.5%, which corresponds to steatosis grade 2 (S2)\n* 18 - 70 years old\n\nExclusion Criteria:\n\n* diabetes mellitus (fasting glucose above 7 mmol\u002Fl, 2-hour glucose after oGTT above 11.1 mmol\u002Fl, or antidiabetic treatment)\n* other serious illnesses (cardiovascular disease, cancer, etc.)\n* alcohol consumption ˃ 30 g\u002Fday\n* use of drugs affecting lipid metabolism\n* intolerance of MR examination (claustrophobia, metal implants, etc.).","MALE","70 Years",{"count":246,"type":21},40,[24],"This interventional study has 2 parts. In the part A of the project, we will determine how the acute changes in hepatic fat content (HFC) after high-fat load (150 g of fat) are affected by co-administration with three doses of glucose, fructose, and sucrose. HFC in non-obese and obese male volunteers will be measured by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) before and at the end of 6-hour intervention. The changes in triglycerides (TG), non-esterified fatty acids (NEFA), insulin and glucose will be also measured throughout the experiments. It can be expected that most of the obese subjects will also have a non-alcoholic fatty liver disease (NAFLD) and we will be therefore able to compare the HFC response between subjects with normal liver fat content and those with steatosis.\n\nOur previous results (doi: 10.26402\u002Fjpp.2021.1.05) clearly pointed out that glucose, contrary to fructose, prevents the storage of fat in the liver and that such an effect could be observed even after six hours. In the part B, we will therefore eliminate fructose from the diet of subjects with NAFLD of steatosis grade 2 for seven days - such an intervention will be isocaloric and fructose\u002Fsucrose will be replaced by starch or by glucose. The HFC content will be measured again by MRS and MRI after 168 hours. Very low density lipoprotein (VLDL), that transport TG out from the liver, will be isolated before and after intervention from the plasma obtained after overnight fasting. The analysis of lipid profile of the liver fat by MRS and fatty acid profile of TG in VLDL should provide an information on the role of de novo lipogenesis (DNL) in changes of HFC.\n\nIn the part A of the project we will aim\n\n* to compare the response of HFC after high-fat load to repeated doses of glucose, fructose, and sucrose (3 x 50 g in two-hour intervals)\n* to compare such a response between non-obese and obese-subjects\n\nIn the part B of the project we will aim\n\n* to find out whether short-term (7 days) restriction of fructose from the diet will decrease HFC in subjects with NAFLD\n* to find out whether such an intervention affects fatty acid profile of hepatic TG evaluated by MRS and by fatty acid profile of TG in VLDL - in this way we can estimate whether DNL is suppressed after fructose withdrawal\n* to further corroborate such an aim, we will also compare the fatty acid profile of plasma NEFA and that of TG in VLDL",[250],"Fatty Liver Disease",[252,253,254,255,256,257,258],"hepatic fat content","magnetic resonance","fatty liver disease","diet intervention","fructosa","glucosa","sucrosa","2024-12-18",{"date":261,"type":37},"2024-12-30",{"date":263,"type":37},"2024-06-20",{"date":265,"type":21},"2027-03",{"name":43,"class":44},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":45},"100571153","biodegradable-stents-in-liver-transplant-recipients-for-treatment-of-biliary-anastomotic-strictures-100571153","NCT06716541","Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures","Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant RecipIents","BRILLIANT","Inclusion Criteria:\n\n* Age ≥18 years\n* Liver transplant recipients\n* Duct-to-duct biliary anastomosis\n* Anastomotic biliary stricture (cholestasis unexplained by other causes and\u002For liver biopsy showing altered biliary drainage and\u002For anastomotic stricture on MRCP)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Hepaticojejunoanastomosis\n* Physical and\u002For psychological inability to understand the aims of the research and to adequately cooperate\n* Pregnancy",{"count":276,"type":21},70,[24],"Biliary complications after liver transplantation (LT) remain common and are associated with higher morbidity in liver transplant recipients and liver graft failure. Anastomotic biliary strictures are the most common biliary strictures after LT. Today, the gold standard for treatment remains endoscopic retrograde cholangiopancreatography (ERCP) with either multiple plastic stenting (MPS) or fully covered metal stents. These methods have disadvantages such as the need for repeated ERCP procedures, high costs or the risk of migration.\n\nBiodegradable stents (BDS) are a novel type of stents made from various synthetic polymers or their copolymers, which are now being used in a variety of medical fields, including the pancreatobiliary tract.The use of biodegradable stents has shown good potential in the treatment of benign biliary strictures. However, overall data on their endoscopic use in liver transplant recipients, particularly in the treatment of anastomotic biliary strictures, are scarce. Most studies have either been in animal models, using percutaneously implanted stents, or in non-transplanted patients. There are no randomised controlled trials investigating their use in LT patients. Based on the available evidence, the use of BDS in the treatment of anastomotic biliary strictures in liver transplant recipients appears to be a promising technique that may be as effective as the standard treatment with MPS, but may reduce the number of ERCP procedures and eliminate the risk of migration.\n\nThe aim of this randomised prospective study is to compare the difference in rates of anastomotic stricture resolution between the active (BDS) and control (MPS) groups to demonstrate non-inferiority of the biodegradable stents. Outcomes will be classified as complete resolution (no significant stricture at the anastomotic site on imaging and resolution of cholestasis), significant response (relative stricture and resolution of cholestasis) or failure (persistent stricture and\u002For persistent cholestasis). Secondary outcomes are technical feasibility, immediate and late complications.",[280,281,282],"Liver Transplant, Complications","Biliary Anastomotic Stenosis","Endoscopic Retrograde Cholangiopancreatography","2024-12-03",{"date":285,"type":37},"2024-12-04",{"date":287,"type":37},"2024-11-01",{"date":289,"type":21},"2027-12-31",{"name":43,"class":44},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":45},"100569194","cavo-tricuspid-isthmus-block-durability-after-pulsed-electric-field-ablation-100569194","NCT06691074","Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation","Systematic Assessment of the Acute Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation","SECTION","Inclusion Criteria:\n\n* patients with paroxysmal AF undergoing PVI by PEF energy with documented typical atrial flutter or patients with persistent AF in whom catheter ablation of CTI is planned as a part of a complex procedure\n* Age ≥ 18 years at the time of study enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* \\- LA diameter \\> 65 mm (measured in the parasternal long-axis view)\n* History of CTI ablation in the past\n* History of cardiac valve surgery\n* Significant valvular defect\n* Age below 18 years\n* Pregnancy, breastfeeding\n* Any disease with a life expectancy \\<1 year\n* Uncorrected congenital heart disease or valvular obstruction\n* Active myocarditis\n* Untreated hypothyroidism or hyperthyroidism\n* Recipient of any major organ transplant (e.g., lung, liver, heart)\n* HIV positivity with a survival expectancy of less than five years due to HIV\n* Chronic dialysis treatment\n* Unwillingness to participate.",{"count":300,"type":21},150,[24],"This study seeks to assess the acute durability of the CTI block when PEF energy is used. Second goal is to establish the optimal waiting time for the conduction recovery after PEF CTI ablation and to assess the utility of routine adenosine testing for dormant conduction. Moreover, this study aims to investigate the differences in acute efficacy and adverse events (hemolysis, coronary vasospasm) between the two available configurations (basket or flower) of the pentaspline Farawave catheter (Farapulse-Boston Scientific Inc, USA).",[304,305,306],"Flutter, Atrial","Cavotricuspid Isthmus Dependent Right Atrial Flutter","Catheter Ablation",[308,309,310],"Pulsed Electric Field","Cavo-tricuspid Isthmus","Biderectional Block","2024-11-14",{"date":313,"type":37},"2024-11-15",{"date":315,"type":37},"2024-09-16",{"date":317,"type":21},"2025-12-31",{"name":43,"class":44},{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":328,"conditions":329,"keywords":332,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":347,"locationsCount":45},"100541541","mechanisms-of-pulmonary-vascular-dysfunction-in-heart-failure-100541541","NCT06331208","Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure","LUNG-HF","A) Inclusion Criteria\n\nHF group:\n\n* age\\>18y\n* signed informed consent,\n* left ventricular (LV) ejection fraction \\\u003C50%\n* duration of HF\\>6 months,\n* loop diuretic use,\n* clinical indication to right heart catheterisation\n\nControl group:\n\n* Age \\>18years\n* Signed informed consent\n* Non-HF subjects referred to Institute for Clinical and Experimental Medicine (IKEM) in Prague for an invasive procedure (PFO closure, arrhythmia ablation, for subjects undergoing RHC) or non-invasive diagnostic evaluation (controls without invasive sampling)\n\nB) Exclusion Criteria:\n\nHeart Failure group:\n\n* Patients with hemodynamic instability requiring inotropic support\n* Severe renal insufficiency (estimated glomerular filtration rate \\\u003C0.6 ml\u002Fs)\n* Acute coronary syndrome\n* High cardiac output (cardiac index \\>4 l\u002Fm2)\n* Known pulmonary hypertension of other type than II (type I, III, IV)\n* Active infection\n* Respiration insufficiency\n* Large pleural effusion\n* Severe intrinsic lung disease (treated chronic obstructive pulmonary disease (COPD)\n\n  * asthma, known interstitial lung disease)\n\nControl group:\n\n* Pulmonary hypertension (RV systolic pressure estimate on screening \\> 45 mmHg)\n* History of recent pulmonary embolism \\\u003C 1 year\n* Echocardiographic evidence of reduced function of right or left ventricle\n* Treated asthma\u002FCOPD, known intersticial lung disease\n* Significant exercise intolerance (NYHA \\> II)",{"count":327,"type":21},230,"Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis.\n\nThere are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD.\n\nUntargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling.\n\nPart A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug\u002Fdiet on pulmonary vasculature in experimental HF-related PVD. The \"gold standard\" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late.\n\nThere is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data.",[91,330,331],"Pulmonary Hypertension","Pulmonary Vascular Resistance Abnormality",[333,334,335,336,337,338,339,340],"heart failure","pulmonary Hypertension","pulmonary Vasculopathy","Type 2 pulmonary Hypertension","right heart catheterisation","metabolomics","computed tomography of the lungs","AI-assisted quantitative lung CT","2024-08-23",{"date":343,"type":37},"2024-08-27",{"date":341,"type":37},{"date":346,"type":21},"2026-12-30",{"name":43,"class":44},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":192,"sex":17,"minAge":18,"maxAge":244,"enrollmentInfo":356,"targetDuration":143,"studyType":118,"phases":4,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100521324","gastric-pathophysiology-in-diabetes-100521324","NCT06068114","Gastric Pathophysiology in Diabetes","Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus","DiaFLIP","Inclusion Criteria (diabetic group):\n\n* Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years\n\nExclusion Criteria (diabetic group):\n\n* Diabetes mellitus type II being treated with a diet only\n* Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization\n* Concomitant treatment with more than one prokinetic agent\n* Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment\n* Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation)\n* Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)\n* Severe coagulopathy\n* Esophageal or gastric varices and \u002For portal gastropathy\n* Advanced liver cirrhosis\n* Pregnancy or puerperium\n* Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment\n* The presence of a rumination syndrome or eating disorders (anorexia nervosa, bulimia). In case of doubts, a psychiatric examination will be performed.\n* Systemic connective tissue disorder\n* Inability to obtain informed consent\n* Any other condition, which in the opinion of the investigator would interfere with study requirements",{"count":357,"type":21},120,"This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated.\n\nFor example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.",[360,361,362,363,225],"Diabetes Mellitus, Type 1","Diabetes Mellitus, Type 2","Functional Dyspepsia","Gastroparesis","2024-05-16",{"date":366,"type":37},"2024-05-17",{"date":368,"type":37},"2022-10-05",{"date":370,"type":21},"2027-06-30",{"name":43,"class":44},5,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":45},"100544110","use-of-wearables-to-detect-infections-in-kidney-transplant-recipients-100544110","NCT06364618","Use of Wearables to Detect Infections in Kidney Transplant Recipients","Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients","RENALERT","Inclusion Criteria:\n\n* kidney transplant recipient\n* age 18 years or more\n* kidney allograft function (eGFR based on CKD-EPI more than 15ml\u002Fmin\u002F1.73m2)\n\nExclusion Criteria:\n\n* recipient of another transplanted organ\n* terminal failure of another organ (heart, liver, lung)\n* diabetes mellitus type 1\n* pregnant or breastfeeding woman\n* refusal to give informed consent",{"count":382,"type":21},200,"The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.\n\nThe main questions it aims to answer are:\n\n1. What are the biometric data pattern changes in impending infections?\n2. What accuracy the machine learning algorithm can achieve?\n\nParticipants will be given\u002Fuse their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection.",[385],"Kidney Transplant Infection",[387,388,389,390,391,392],"biometric data","continuous monitoring","machine learning","early alert system","infection","kidney transplantation","2024-04-09",{"date":395,"type":37},"2024-04-15",{"date":397,"type":21},"2024-09-01",{"date":399,"type":21},"2027-12",{"name":43,"class":44},{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":17,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":411,"conditions":412,"keywords":416,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":45},"100524129","comprehensive-geriatric-assessment-in-kidney-transplantation-100524129","NCT06104696","Comprehensive Geriatric Assessment in Kidney Transplantation","CoGeriaTx","Inclusion Criteria:\n\n* kidney transplant candidates aged 60+ years\n* kidney transplant recipients aged 60+ years\n\nExclusion Criteria:\n\n* kidney transplant candidates aged below 60 years\n* kidney transplant recipients aged below 60 years","60 Years",{"count":410,"type":21},1000,"This observational study aims to analyze the results of comprehensive geriatric assessment and to monitor the development of functional status in geriatric kidney transplant candidates and recipients.",[413,414,415],"Kidney Transplant; Complications","Frailty Syndrome","Depressive Syndrome",[392,417,418,419,420,421,422],"geriatric","frailty","depression","pretransplant evaluation","comprehensive geriatric assessment","posttransplant","2023-10-23",{"date":425,"type":37},"2023-10-27",{"date":427,"type":37},"2020-01-02",{"date":429,"type":21},"2040-01-02",{"name":43,"class":44},""]