[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Medical Centre Ljubljana\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":718},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,45,76,114,145,168,204,235,260,281,298,326,345,376,402,427,460,489,520,546,571,597,630,665,691],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644103","prediction-of-pancreatogenic-diabetes-after-partial-resection-of-the-pancreas-100644103",false,"NCT07665710","Prediction of Pancreatogenic Diabetes After Partial Resection of the Pancreas","Inclusion Criteria:\n\n* age ≥ 18 years\n* planned partial resection of the pancreas\n* absence of known diabetes before the procedure\n* absence of known borderline basal glycemia before the procedure\n* absence of impaired glucose tolerance before the procedure\n* signed written informed consent\n\nExclusion Criteria:\n\n* known diabetes mellitus before the procedure\n* known borderline basal glycemia before the procedure\n* impaired glucose tolerance before the procedure\n* inability to provide informed consent\n* withdrawal of consent during the course of the study\n* incomplete key data\n* total resection of the pancreas\n* a subsequent decision for conservative treatment (based on clinical characteristics at the time of the surgical procedure)","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","The primary aim of the study is to identify clinical, laboratory, imaging, and pathohistological risk factors for the development of pancreatogenic diabetes after partial resection of the pancreas (PRP) and, based on these, to build a predictive model that would enable reliable and accurate identification of patients who will develop pancreatogenic diabetes. A review of the literature shows that there is currently no validated tool available in clinical practice for identifying patients at risk of this type of diabetes after PRP. Etiological differences between type 2 diabetes and pancreatogenic diabetes often lead to late diagnosis, limiting opportunities for timely intervention. The development of a comprehensive predictive model would contribute to a better understanding of the pathophysiology of pancreatogenic diabetes, enable the identification of patients at risk, facilitate tailored clinical monitoring, and allow the implementation of targeted preventive or therapeutic measures in the perioperative period.\n\nBased on a review of the literature and clinical observations, the investigators formulated the following hypotheses:\n\nH1: Clinical, laboratory, imaging, and pathohistological variables are independently associated with the development of pancreatogenic diabetes after partial pancreatic resection.\n\nH2: A predictive model that allows reliable and accurate identification of patients who will develop pancreatogenic diabetes can be build based on the identified variables (H1).\n\nH3: A comprehensive predictive model in the perioperative period allows more precise identification of patients who will develop pancreatogenic diabetes, and thus more effective risk stratification compared to the use of individual risk factors (variables).\n\nBased on the reviewed literature and our own clinical observations, this constitutes an original contribution to science. The investigators expect that the research will identify key clinical, laboratory, imaging, and pathohistological factors associated with the development of pancreatogenic diabetes after partial pancreatic resection. The development of a clinically useful predictive model that will allow individual risk assessment for the development of pancreatogenic diabetes in patients after partial pancreatic resection is anticipated. A similar comprehensive model has not yet been described in the accessible literature. The research will contribute to a better understanding of metabolic changes and will enable the identification of patients who will develop pancreatogenic diabetes after partial pancreatic resection. The results of the study could provide a basis for improved perioperative monitoring of these patients in the field of pancreatogenic diabetes.",[24],"Pancreatogenic Diabetes Mellitus",[26,27,28,29,30,31],"Partial Pancreatectomy","Pancreatogenic Diabetes","Prediction Model","Pancreas Volume","C-peptide","HOMA-IR","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2026-04-01",{"date":40,"type":20},"2029-04-01",{"name":42,"class":43},"University Medical Centre Ljubljana","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100637372","phase-4-dual-pcsk9-inhibition-with-inclisiran-and-alirocumab-in-secondary-prevention-100637372","NCT07581808","Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention","PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention","PCSK9-DUO","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease).\n* Eligible for PCSK9 inhibitor therapy according to national clinical criteria\n* Fasting LDL cholesterol ≥2.5 mmol\u002FL and ≤5.0 mmol\u002FL at screening\n* Documented statin intolerance or contraindication to statin therapy\n* On stable background lipid-lowering therapy (including ezetimibe if applicable) for at least 4 weeks prior to enrollment\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) \\>1000 mg\u002FL with LDL-C below inclusion threshold\n* Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment\n* Planned initiation or modification of lipid-lowering therapy during the study period\n* Known homozygous familial hypercholesterolemia\n* Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3× upper limit of normal\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Active malignancy or life expectancy \\\u003C1 year\n* Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception\n* Known hypersensitivity to inclisiran, alirocumab, or any of their excipients\n* Participation in another interventional clinical trial within 30 days prior to enrollment\n* Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results",{"count":54,"type":20},60,"INTERVENTIONAL",[57],"PHASE4","This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.\n\nLowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins.\n\nInclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels.\n\nIn this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments.\n\nThe main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.",[60,61],"Hypercholesterolemia","Atherosclerotic Cardiovascular Disease (ASCVD)",[63,64,65,66,67],"Alirocumab","Inclisiran","LDL cholesterol","Secondary prevention","Statin intolerance","2026-05-28",{"date":70,"type":36},"2026-06-02",{"date":72,"type":36},"2026-05-18",{"date":74,"type":20},"2027-06",{"name":42,"class":43},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":55,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":44},"100639360","comparison-of-citrate-and-heparin-anticoagulation-during-postdilution-hemodiafiltration-100639360","NCT07618858","Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration","Efficiency and Biocompatibility of Postdilution Hemodiafiltration Using Different Anticoagulation Methods: A Randomized Crossover Clinical Trial","CITRA-HDF","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* End-stage kidney disease requiring maintenance postdilution hemodiafiltration\n* Stable chronic hemodialysis treatment three times weekly\n* Functional arteriovenous fistula\n\nExclusion Criteria:\n\n* Therapeutic anticoagulation therapy\n* Dual antiplatelet therapy\n* Significant coagulopathy\n* Active bleeding\n* Acute kidney injury",{"count":85,"type":20},20,[87],"NA","This randomized crossover clinical trial will compare regional citrate anticoagulation (RCA) and standard heparin anticoagulation (HA) during postdilution hemodiafiltration (HDF) in chronic dialysis patients with end-stage kidney disease.\n\nThe primary aim of the study is to evaluate biocompatibility during HDF by measuring markers of complement activation (C3a), platelet activation (PF4), and coagulation activation (thrombin-antithrombin complex, TAT).\n\nSecondary aims include comparison of solute removal efficiency, including beta-2 microglobulin, phosphate, and urea removal, as well as assessment of citrate, calcium, and magnesium kinetics during citrate anticoagulation.\n\nTwenty adult chronic dialysis patients will undergo two study HDF procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation with a one-week interval between procedures.\n\nThe study aims to improve understanding of the effects of anticoagulation methods on hemodiafiltration biocompatibility and dialysis efficiency and may contribute to optimization of citrate anticoagulation protocols in chronic hemodiafiltration patients.",[90,91,92,93],"End-Stage Kidney Disease","Hemodiafiltration","Chronic Hemodialysis","Renal Failure",[95,96,91,97,98,99,100,101,102,103,104],"Citrate anticoagulation","Heparin anticoagulation","Dialysis","Biocompatibility","Beta-2 microglobulin","Complement activation","Regional citrate anticoagulation","Chronic dialysis","Thrombin-antithrombin complex","Platelet factor 4","NOT_YET_RECRUITING","2026-05-27",{"date":108,"type":36},"2026-06-01",{"date":110,"type":20},"2026-06-05",{"date":112,"type":20},"2027-04-01",{"name":42,"class":43},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":124,"conditions":125,"keywords":131,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":44},"100639718","the-role-of-cd34-stem-cells-in-the-pathogenesis-of-takotsubo-syndrome-100639718","NCT07604467","The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome","Effects of CD34+ Stem Cells on Left Ventricular Dysfunction Among Patients With Takotsubo Syndrome","STRESS","Inclusion Criteria:\n\n* Minimum age 18 years\n* Established TTS per InterTak registry criteria\n* Signed consent form\n\nExclusion Criteria:\n\n* Patients under the age of 18 years\n* Ischemic heart disease with at least one complete total occlusion\n* Other concurrent cardiomyopathies\n* Active infectious myocarditis\n* obstructive coronary artery disease\n* Previous hospital stay due to acute coronary syndrome (myocardial infarction) in the last 6 months before TTS acute event\n* Previous interventional coronary artery procedure in the last 6 months before TTS acute event\n* Significant valvular heart disease\n* Significant peripheral artery occlusive disease\n* Active or remitted hematologic malignancy\n* Patients receiving immunosuppressive therapy\n* Significant comorbiditeis affecting patients survival (malignancy)\n* Failure to obtain freely given, informed consent form.",{"count":123,"type":20},40,"The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.",[126,127,128,129,130],"Tako Tsubo Cardiomyopathy","Microvascular Dysfunction","CD34+ Stem Cells","Heart Failure","Cardiac Contractility Recovery",[132,133,134,135,136],"Takotsubo syndrome","CD34+ stem cells","heart failure","microvascular dysfunction","cardiac contractility recovery","2026-05-17",{"date":139,"type":36},"2026-05-22",{"date":141,"type":36},"2021-09-06",{"date":143,"type":20},"2026-12-31",{"name":42,"class":43},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":55,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":44},"100638089","phase-3-dexamethasone-in-tick-borne-encephalitis-100638089","NCT07584525","Dexamethasone in Tick-borne Encephalitis","Treatment With Dexamethasone in Patients With Tick-borne Encephalitis: Randomized Clinical Trial","Inclusion Criteria:\n\n* age 18 years or older and\n* clinical signs and symptoms of meningoencephalitis or meningomyelitis and\n* cerebrospinal pleocytosis and\n* serological confirfmation of tick-borne encephalitis virus infection\n\nExclusion Criteria:\n\n* pregnancy or\n* severe neurological impairment befor tick-borne encephalitis or\n* systemic corticosteroid treatment in the past 30 days or\n* allergy to corticosteroids or\n* immunosuppresive condition or therapy such as HIV with CD4 \\\u003C 200\u002Fml, organ or bone marrow transplant, receiving chemotherapy, radiotherapy or any other immunosuppresive therapy, primary immunodeficiency, hematological maliganncy or\n* ventricular shunt or\n* endoscopically documented peptic gastric ulcer in the past six months or gastrointestinal bleeding with hemoglobin drop ≥ 20 units or\n* uncontrolled diabetes with hyperglicemia or\n* antiviral therapy with rilpivirin",true,{"count":154,"type":20},200,[156],"PHASE3","The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.",[159],"Tick-Borne Encephalitis","2026-05-07",{"date":162,"type":36},"2026-05-13",{"date":164,"type":36},"2024-05-03",{"date":166,"type":20},"2030-09-30",{"name":42,"class":43},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":55,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":44},"100563260","phase-4-effect-of-early-combination-antihyperglycemic-treatment-on-metabolic-control-in-individuals-with-type-2-diabetes-100563260","NCT06613854","Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes","Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs. Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes","E-SEMPA","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes for up to 2 years (prior to randomization);\n* Aged between 18 and 70 years, both sexes, of any race or ethnicity;\n* HbA1c ≤8.0% at randomization;\n* Baseline treatment with metformin at a steady daily dose of ≥1500 mg;\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Treatment at any time in the past with SGLT2i, GLP-1RA, or DPP-4 inhibitors;\n* Insulin treatment for longer than 2 weeks in the past;\n* Body Mass Index below 22 kg\u002Fm2 or BMI above 40 kg\u002Fm2;\n* Chronic kidney disease stages 3-5 (eGFR below 60 ml\u002Fmin or the presence of albuminuria (urine albumin-to-creatinine ratio above 34 g\u002Fmmol);\n* Known cardiovascular disease (angina pectoris, history of myocardial infarction, ischemic heart disease, heart failure, known carotid atherosclerosis, objectively proven peripheral arterial disease, or other known atherosclerotic disease at other locations);\n* Moderate or severe liver disease (Child-Pugh stage B or C);\n* Personal history of pancreatitis;\n* Advanced heart failure (NYHA III-IV);\n* Retinopathy or maculopathy or their active treatment;\n* Pregnancy, expected pregnancy, or breastfeeding;\n* Presence of active malignancy or personal history of malignancy within 5 years of study enrollment;\n* Personal history of thyroid cancer; personal or family history of multiple endocrine neoplasia type 2 or family history of medullary thyroid carcinoma;\n* Chronic inflammatory bowel disease;\n* History of bariatric surgery or other gastrointestinal surgery that could affect drug or nutrient absorption;\n* Frequent or severe urinary tract infections;\n* Presence of a urinary catheter;\n* Troublesome and recurrent genital fungal infections;\n* Personal history of ketoacidosis;\n* Symptomatic hypotension or predisposition to hypovolemia;\n* History of organ transplantation;\n* Allergy to any component in the semaglutide or empagliflozin oral tablet;\n* Any medical or social circumstance that may limit participation in the study (e.g., inability to attend regular study visits);\n* Any other condition that, in the opinion of the principal and responsible investigators, may affect the safety or efficacy of the treatment.","70 Years",{"count":178,"type":20},90,[57],"The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion from pancreas, together with its safety profile. The main questions it aims to answer are:\n\n* Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system?\n* Is early combination treatment as safe as treatment with a single antidiabetic drug?\n* Does early combination treatment reduces the need for rescue therapy?\n* Does early combination treatment reduces body weight and improves body composition?\n* Does early combination treatment improves blood lipid parameters, oxidative stress and inflammation?\n* Does early combination treatment improves metabolic parameters?\n* Does early combination treatment improves insulin resistance and insulin secretion?\n\nResearchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes.\n\nParticipants will:\n\n* Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks.\n* Visit the clinic four times during the study duration for checkups and tests.\n* Carry a continuous glucose monitoring sensor for 14 days prior to study visits.",[182],"Type 2 Diabetes Mellitus (T2DM)",[174,184,185,186,187,188,189,190,191,192,193,194,195],"Early Combination Antihyperglycemic Treatment","Metformin","Semaglutide","Empagliflozin","Glycemic Control","Metabolic Control","Type 2 Diabetes","Insulin Resistance","Time in Range","CGM","Continuous Glucose Monitoring","UMC Ljubljana","2026-04-29",{"date":198,"type":36},"2026-04-30",{"date":200,"type":36},"2024-10-01",{"date":202,"type":20},"2027-12",{"name":42,"class":43},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":212,"targetDuration":214,"studyType":21,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":44},"100517900","complicated-infections-in-otorhinolaryngology-100517900","NCT06023550","Complicated Infections in Otorhinolaryngology","Analysis of Complicated Infections in Pediatric and Adult Populations Treated by Otorhinolaryngologist","ENT_infect","Inclusion Criteria:\n\n* Diagnoses: rhinitis AND\u002FOR sinusitis AND\u002FOR facial cellulitis AND\u002FOR facial abscess AND\u002FOR nasal furuncle AND\u002FOR infection of the outer AND\u002FOR middle AND\u002FOR inner ear AND\u002FOR temporal bone AND\u002FOR infection of the soft tissues of the neck with\u002Fwithout bone and cartilage involvement AND\u002FOR laryngitis AND\u002FOR epiglottitis (or supraglottitis) AND\u002FOR\n* complication of inflammation of the nose and paranasal cavities AND\u002FOR ear AND\u002FOR temporal bone AND\u002FOR:\n* treated at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Center Ljubljana.\n\nExclusion Criteria:\n\n* disagreement of the patient and\u002For parents (or legal guardians) with inclusion in the research,\n* failure to meet the inclusion criteria.",{"count":213,"type":20},2550,"1 Year","This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are:\n\n* What is the management of complicated sinonasal infections in Ljubljana, Slovenia,\n* What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia,\n* What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia,\n* What is the management of complicated laryngeal infections in Ljubljana, Slovenia\n\nParticipants will receive standard treatment according to the established evidence-based clinical practice.",[217,218,219,220,221,222,223,224,225,226,227],"Sinusitis","Otitis","Laryngitis","Lymphadenitis","Quinsy","Peritonsillar Abscess","Parapharyngeal Abscess","Preseptal Cellulitis","Subperiosteal Abscess","Orbital Abscess","Epiglottitis","2026-04-27",{"date":196,"type":36},{"date":231,"type":36},"2024-09-01",{"date":233,"type":20},"2028-09",{"name":42,"class":43},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":243,"targetDuration":245,"studyType":21,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":44},"100485962","prospective-study-of-sinonasal-and-skull-base-tumours-management-100485962","NCT05607888","Prospective Study of Sinonasal and Skull-base Tumours Management","Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service","Sinonasal_Tu","Inclusion Criteria:\n\n* sinonasal and\u002For skull-base cancer\n* sinonasal disease expanding through the skull-base\n* the patient's written informed consent\n\nExclusion Criteria:\n\n* lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement",{"count":244,"type":20},120,"5 Years","This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are:\n\n* what is the caseload of patients with the included pathology in our centre\n* what are the results of management of these cases\n* what are the epidemiological characteristics of included patients\n* what is the quality of life of included patients.",[248,249,250,251,252,253],"Nasal Neoplasm","Nasal Neoplasm Benign","Skull Base Neoplasms","Skull Base Osteomyelitis","Sinonasal Disorder","Sinus Disease",{"date":196,"type":36},{"date":256,"type":36},"2022-01-01",{"date":258,"type":20},"2027-12-31",{"name":42,"class":43},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":152,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":55,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":44},"100321243","patients-pretreatment-expectations-about-post-lyme-symptoms-100321243","NCT03462329","Patient's Pretreatment Expectations About Post-Lyme Symptoms","Impact of Patient's Pretreatment Expectations on Treatment Outcome of Early Lyme Borreliosis","Inclusion Criteria:\n\n* erythema migrans\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* immunocompromised\n* taking antibiotic with antiborrelial activity within 10 days",{"count":154,"type":20},[87],"The investigators will focus on pretreatment expectations of patients with early Lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a questionnaire and treatment outcome quantified with the presence of post-Lyme symptoms. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.",[271],"Erythema Migrans",[273,274],"Post-Lyme symptoms","Pretreatment expectations",{"date":196,"type":36},{"date":277,"type":36},"2018-06-01",{"date":279,"type":20},"2028-12-01",{"name":42,"class":43},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":152,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":55,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":297,"locationsCount":44},"100311707","duration-of-doxycycline-treatment-in-mem-patients-100311707","NCT03337932","Duration of Doxycycline Treatment in MEM Patients","Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial","Inclusion Criteria:\n\n• multiple erythema migrans\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* immunocompromised\n* serious adverse event to doxycycline\n* taking antibiotic with antiborrelial activity within 10 days\n* extracutaneous manifestations of lyme borreliosis",{"count":154,"type":20},[87],"The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.",[292],"Erythema Chronicum Migrans",{"date":196,"type":36},{"date":295,"type":36},"2018-05-01",{"date":258,"type":20},{"name":42,"class":43},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":16,"minAge":306,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":55,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":44},"100601329","effect-of-immediate-skin-to-skin-contact-on-neonatal-heart-rate-variability-after-cesarean-secton-100601329","NCT07109076","Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton","Effect of Immediate Skin-to-Skin Contact With the Mother on Heart Rate Variability in Newborns After Cesarean Secton","HRV-SCENE","Inclusion Criteria:\n\n* planned cesarean section\n* gestational age 39 weeks 0\u002F7 or more\n\nExclusion Criteria:\n\n* Pregnancy complications (e.g. hypertensive disorders in pregnancy, fetal growth restriction, etc.)\n* neonatal resuscitation at birth","0 Years",{"count":308,"type":20},80,[87],"At birth, both the newborn and the mother experience adaptive stress, which can be measured using objective physiological methods. One of the possible methods is monitoring heart rate variability, which is an indirect indicator of the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. The proposed study will monitor the effect of early skin-to-skin contact on heart rate variability in newborns delivered by cesarean section and their mothers.\n\nThe researchers hypothesize that newborns and mothers who are provided with immediate direct skin-to-skin contact, compared to the control group receiving standard care, will exhibit higher heart beat-to-beat interval variability in the first hours after birth. This is expected to result from reduced stress and activation of the parasympathetic nervous system.\n\nThe study will include 80 newborn-mother pairs with a gestational age of 39 weeks or more, delivered via planned cesarean section. Participants will be randomly assigned to a study group (skin-to-skin contact lasting at least 15 minutes after cesarean birth) and a control group (standard care), with 40 newborns in each group. Maternal and neonatal ECG will be monitored for 15 minutes following cesarean birth in both groups. In addition, neonatal ECG will be monitored at 6, 12 and 24 hours postpartum. Time-domain analyses of hearth rate variability will be performed.",[312],"Neonatal Adaptation",[314,315,316,317],"heart rate variability","cesarean section","cesarean birth","skin-to-skin contact","2026-03-23",{"date":320,"type":36},"2026-03-27",{"date":322,"type":36},"2026-03-01",{"date":324,"type":20},"2026-12-02",{"name":42,"class":43},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":152,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":55,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":343,"locationsCount":344},"100359893","phase-3-different-amoxicillin-treatment-regimens-in-erythema-migrans-patients-100359893","NCT03966014","Different Amoxicillin Treatment Regimens in Erythema Migrans Patients","Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.","Inclusion Criteria:\n\n* erythema migrans\n\nExclusion Criteria:\n\n* pregnancy\n* extracutaneous manifestations of Lyme borreliosis\n* immunocompromising state\n* serious adverse event to beta lactam antibiotic\n* receiving antibiotic with antiborrelial activity within 10 days",{"count":154,"type":20},[156],"The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.",[271],"2026-03-22",{"date":339,"type":36},"2026-03-25",{"date":341,"type":36},"2019-06-01",{"date":258,"type":20},{"name":42,"class":43},2,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":16,"minAge":353,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":44},"100630309","orthostatic-and-postprandial-hypotension-in-hospitalized-older-adults-hope65-100630309","NCT07485998","Orthostatic And Postprandial Hypotension In Hospitalized Older Adults (HOPE65)","Orthostatic And Postprandial Hypotension In Hospitalized Older Adults: Prevalence And Association With Medications, Comorbidities, And Adverse Clinical Outcomes","HOPE65","Inclusion Criteria:\n\n* Age 65 years or older\n* Hospitalization in internal medicine departments at the University Medical Centre Ljubljana\n* Duration of hospitalization ≥48 hours\n* Hemodynamic stability confirmed by the treating physician\n* Ability to participate in study procedures\n* Ability to stand (with or without assistive devices for walking)\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Medical condition preventing study procedures (e.g., need for continuous supine position)\n* Inability to provide informed consent\n* Refusal to participate\n* Severe cognitive impairment or delirium\n* Acute critical illness requiring intensive treatment\n* Participation in another clinical study that could affect safety or study outcomes","65 Years",{"count":355,"type":20},500,"The goal of this observational study is to determine how often orthostatic hypotension and postprandial hypotension occur in adults aged 65 years and older who are hospitalized in internal medicine departments.\n\nOrthostatic hypotension is defined as an excessive drop in blood pressure after standing up from a lying or sitting position. Postprandial hypotension is an excessive drop in blood pressure that occurs after eating a meal. These conditions can increase the risk of falls, fainting, loss of independence, and other health problems in older adults.\n\nThe main questions this study aims to answer are:\n\n* How common orthostatic hypotension and postprandial hypotension are in hospitalized adults aged 65 years and older.\n* Whether these conditions are associated with medication use, chronic diseases, and geriatric syndromes (such as frailty, cognitive impairment, and functional decline).\n\nParticipants will:\n\n* have blood pressure measured while lying down and standing\n* have blood pressure measured after a meal\n* undergo a comprehensive geriatric assessment, including evaluation of functional status, cognitive function, frailty, mobility, and nutritional status\n* provide information about medications and medical history\n* be followed for up to 12 months to record outcomes such as falls, syncope, hospitalization, and death",[358,359],"Orthostatic Hypotension","Postprandial Hypotension",[361,362,363,364,365,366,367],"Older Adults","Hospitalized Patients","Blood Pressure Regulation","Falls","Geriatric Syndromes","Comprehensive Geriatric Assessment","Antihypertensive Medication","2026-03-17",{"date":370,"type":36},"2026-03-20",{"date":372,"type":20},"2026-04",{"date":374,"type":20},"2030-06",{"name":42,"class":43},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":152,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":384,"conditions":385,"keywords":388,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":44},"100630037","autonomic-regulation-of-blood-pressure-and-heart-rate-during-orthostasis-and-exercise-in-healthy-and-hypertensive-individuals-100630037","NCT07482462","Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals","Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise","Inclusion Criteria:\n\n* Healthy volunteers aged 18-35 years without known acute or chronic disease, non-smokers, body mass index (BMI) 20-24.9 kg\u002Fm², and negative orthostatic test\n* Participants aged ≥60 years with arterial hypertension followed at the Department of Hypertension\n* Hypertension group: controlled arterial hypertension, negative orthostatic test, without diabetes mellitus\n* Hypertension with orthostatic hypotension group: controlled arterial hypertension and positive orthostatic test indicating orthostatic hypotension\n* Hypertension with orthostatic hypertension group: controlled arterial hypertension and positive orthostatic test indicating a rise in blood pressure during orthostatic testing\n* Hypertension with diabetes mellitus group: controlled arterial hypertension and diabetes mellitus without previously diagnosed autonomic dysfunction\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Dementia, neurodegenerative disease, or cognitive impairment preventing understanding of study procedures\n* Known cardiovascular disease including heart failure (NYHA II-IV), myocardial infarction within the previous 6 months, clinically significant arrhythmias, or peripheral arterial occlusive disease\n* Uncontrolled arterial hypertension\n* Change in antihypertensive therapy within the previous 4 weeks\n* Presence of a cardiac pacemaker\n* Treatment with antiarrhythmic drugs (class I, III, or IV), digoxin, alpha-receptor blockers, or other medications known to significantly affect heart rate variability or autonomic function\n* Advanced renal failure (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²) or advanced liver failure\n* Active malignancy\n* Body mass index ≥35 kg\u002Fm²\n* Acute illness within the previous 4 weeks\n* Current smoking\n* Inability to safely perform exercise testing on a cycle ergometer\n* Severe psychiatric disorders without stable treatment\n* Pregnancy or breastfeeding\n* Participation in another clinical study\n* Refusal or inability to provide written informed consent",{"count":244,"type":20},"The goal of this observational study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy adults and people with arterial hypertension during orthostatic stress and graded physical exercise. The main objective is to analyze cardiovascular responses to exercise on a cycle ergometer in different subgroups of participants with hypertension.\n\nThe study includes healthy young adults and older adults with hypertension. Participants undergo standardized assessments including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity, as well as other vascular and hemodynamic parameters.\n\nThe results of this study are expected to improve understanding of cardiovascular physiology and autonomic regulation in people with hypertension and may contribute to earlier recognition of autonomic dysfunction and improved clinical management.",[386,387,358],"Hypertension","Autonomic Dysfunction",[389,390,391,392,393],"Orthostatic Test","Arterial Stiffness","Exercise Testing","Heart Rate Variability","Pulse Wave Velocity","2026-03-14",{"date":396,"type":36},"2026-03-19",{"date":398,"type":36},"2025-10-15",{"date":400,"type":20},"2027-03",{"name":42,"class":43},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":410,"conditions":411,"keywords":414,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":426,"locationsCount":4},"100628809","image-guided-central-catheter-insertion-with-concurrent-assessment-of-vascular-wall-integrity-100628809","NCT07466472","Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity","Assessment of the Impact of a Peripherally Inserted Central Catheter on Vascular Wall Integrity","Inclusion Criteria:\n\n* sinus rhythm\n* medical indication\n* suitable upper-extremity venous anatomy confirmed by ultrasound examination\n* ability to provide written informed consent\n\nExclusion Criteria:\n\n* Implanted cardiac pacing device\n* Palliative care\n* \\\u003C18years old\n* Local infection, skin lesion, or burn at the intended insertion site\n* Severe coagulopathy contraindicating vascular access procedures\n* Known allergy to catheter materials or local anesthetics used during the procedure\n* Presenceof an implanted cardiac pacemaker or non-sinus cardiac rhythm preventing reliable intracavitary ECG guidance\n* Anatomical abnormalities preventing safe PICC insertion\n* Previous lymphadenectomy on the intended side\n* Pre-existing venous thrombosis or significant venous wall pathology detected on baseline ultrasound",{"count":308,"type":20},"The insertion of peripherally inserted central catheters (PICCs) represents a minimally invasive and safe method for establishing long-term central venous access in patients requiring prolonged intravenous therapy, including chemotherapy, parenteral nutrition, and long-term antibiotic treatment. Ultrasound-guided cannulation of peripheral arm veins improves procedural success, reduces complications, and increases patient comfort compared with centrally inserted central catheters.Accurate positioning of the catheter tip at the cavo-atrial junction is essential for optimal catheter function and safety. The Sherlock 3CG Tip Confirmation System combines electromagnetic tracking with intracavitary electrocardiography (ECG) to enable real-time catheter tip navigation and positioning.The aim of this prospective clinical study is to evaluate the accuracy and safety of ultrasound-guided PICC insertion using the Sherlock 3CG system, as well as to assess the impact of PICC placement on venous wall integrity. Ultrasound examination of the target vein will be performed before catheter insertion and after catheter removal to evaluate potential vascular wall changes associated with catheter use. A chest X-ray examination will be performed after each catheter insertion to confirm final catheter tip position and to assess the accuracy of the navigation system.Fluoroscopic guidance will be used only in selected cases, such as patients with anatomical anomalies, previously known difficult vascular access, or unsuccessful standard catheter advancement.A total of 80 adult patients with a clinical indication for PICC placement will be enrolled over a three-year study period.",[412,413],"PICC Line Placement","Vessels; Anomaly",[415,416,417,418,419],"PICC","Sherlock 3CG","Vessels Anomaly","Vessel Wall","Intracavitary Electrocardiogram","2026-03-09",{"date":422,"type":36},"2026-03-12",{"date":38,"type":20},{"date":425,"type":20},"2029-08-01",{"name":42,"class":43},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":55,"phases":436,"briefSummary":437,"conditions":438,"keywords":441,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":44},"100624154","phase-4-vericiguat-and-reverse-remodeling-indices-in-heart-failure-100624154","NCT07405944","Vericiguat and Reverse Remodeling Indices in Heart Failure","Vericiguat's Effects on Reverse Remodeling Indices: Pathophysiologic Approach to Treatment of Heart Failure With Reduced Ejection Fraction","VERI-PATH","Inclusion Criteria:\n\n* Written informed consent from an adult patient (≥ 18 years old) to participate in the clinical study,\n* Stable HFrEF defined as no heart failure worsening in the 6 months before randomization that required hospitalization or outpatient diuretic treatment,\n* Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF ≤ 40%, confirmed by echocardiography) within 12 months before randomization,\n* Stable GDMT for HFrEF for at least 3 months prior to randomisation.\n\nExclusion Criteria:\n\n* Systolic blood pressure \\\u003C 100 mmHg or symptomatic hypotension,\n* Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors,\n* Known allergy\u002Fhypersensitivity to soluble guanylate cyclase stimulators,\n* Awaiting heart transplantation or dependence on continuous inotropic therapy\n* Cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy,\n* Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention in the past three months before randomisation,\n* Long-term mechanical circulatory support of the left ventricle,\n* Active infection,\n* Chronic kidney disease stage 4 or 5, and\n* Advanced liver failure classified as Child-Pugh B or C.",{"count":54,"type":20},[57],"The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy.\n\nThe main questions are:\n\n* Does vericiguat improve right ventricular systolic function, measured by tricuspid annular plane systolic excursion (TAPSE)?\n* Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance?\n* Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months.\n\nParticipants will:\n\n* Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing\n* Perform oral glucose tolerance tests (OGTT) to assess insulin resistance\n* Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion\n* Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.",[439,440],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Chronic Heart Failure",[442,443,444,445,446,447,448,449,450,451,452,191],"Vericiguat","Soluble Guanylate Cyclase","Cyclic GMP","Reverse Remodeling","Cardiac Magnetic Resonance Imaging","Myocardial Perfusion Imaging","Fibrosis","Inflammation","Angiogenesis","Oxidative Stress","Immunomodulation","2026-02-08",{"date":455,"type":36},"2026-02-12",{"date":457,"type":36},"2025-11-01",{"date":258,"type":20},{"name":42,"class":43},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":466,"minAge":17,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":4},"100622654","the-association-between-deep-endometriosis-and-the-occurrence-of-colorectal-carcinoma-100622654","NCT07386431","The Association Between Deep Endometriosis and the Occurrence of Colorectal Carcinoma","Inclusion Criteria:\n\nFemale patients aged 18 and over, treated at the Department of Reproduction for diagnosed deep endometriosis, including bowel endometriosis, for whom surgical treatment is indicated.\n\nExclusion Criteria:\n\n* Patients with known inflammatory bowel disease (IBD), patients with a personal history of gynecological or gastrointestinal malignancy","FEMALE",{"count":468,"type":20},30,"The goal of this study is to identify the molecular or genetic mechanisms that may predispose patients with bowel endometriosis to an increased risk of colorectal carcinoma. The study will include patients for whom surgical treatment of bowel endometriosis is clinically indicated.\n\nThis research would represent a significant advancement in evaluating the necessity of surgical intervention in asymptomatic patients or those with mild symptoms. Furthermore, it would provide a broader insight into the systemic impact of endometriosis on other organ systems, ultimately improving risk assessment and preventive measures.",[471,472,473,474,475,476,477,478,479,480],"Endometriosis","Deep Endometriosis","Bowel Endometriosis","Colorectal Carcinoma","Colon Resection","Endometriosis Pelvic","Endometriosis Rectum","Carcinogenesis","Genetic Change","Infertility","2026-02-05",{"date":483,"type":36},"2026-02-06",{"date":485,"type":20},"2026-02",{"date":487,"type":20},"2029-05",{"name":42,"class":43},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":466,"minAge":17,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":55,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":519,"locationsCount":44},"100621685","tirzepatide-and-muscle-outcomes-in-obesity-100621685","NCT07373834","Tirzepatide and Muscle Outcomes in Obesity","Effects of Tirzepatide on Skeletal Muscle in Obesity","TIRMO","Inclusion Criteria:\n\n* Female sex\n* Age between 18 and 50 years\n* BMI between 30 kg\u002Fm² and 40 kg\u002Fm²\n* Stable body weight within the three months preceding study enrolment (defined as ≤ 5% change)\n* No prior pharmacological or surgical interventions for obesity treatment\n* Commitment to use barrier contraception and absence of plans for pregnancy within 8 months following enrolment\n\nExclusion Criteria:\n\n* Sarcopenic obesity\n* Pregnancy or lactation\n* Postmenopausal status\n* Diabetes\n* Immobility\n* Personal history of malignancy\n* Personal history of pancreatitis\n* Personal history of major depressive episodes\n* Personal history of myopathy\n* Personal or family history of medullary thyroid carcinoma\n* Current treatment with metformin or systemic corticosteroids","50 Years",{"count":468,"type":20},[87],"This study is evaluating whether a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, can affect the function, structure and metabolism of skeletal muscles in adults with obesity. Participants, premenopausal females with obesity, will receive either tirzepatide or placebo over 24 weeks. Researchers will assess body weight, body composition, muscle strength and functional performance, neuromuscular function and will perform muscle biopsies before and after treatment to study molecular and histological changes following treatment. The goal of this study is to investigate the effects of tirzepatide on skeletal muscle function, quantity, quality and metabolism in adults with obesity as well as clarify the molecular and structural adaptations in skeletal muscle during tirzepatide-induced weight loss, addressing an important gap in understanding the impact of incretin-based therapies on muscle health.",[502],"Obesity (Disorder)",[504,505,506,507,508,509,510,511,512],"Obesity","Tirzepatide","Skeletal muscle","Muscle quality","Muscle mass","Muscle strength","Muscle function","Myosteatosis","Muscle transcriptomics","2026-01-23",{"date":515,"type":36},"2026-01-28",{"date":517,"type":20},"2026-01",{"date":400,"type":20},{"name":42,"class":43},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":353,"enrollmentInfo":528,"targetDuration":4,"studyType":55,"phases":530,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":44},"100527921","phase-2-cell-therapy-and-myocardial-recovery-in-heart-failure-patients-undergoing-left-ventricular-assist-device-support-100527921","NCT06154044","Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support","The Effects of Cell Therapy on Myocardial Recovery in Chronic Heart Failure Patients Undergoing Left Ventricular Assist Device Support: A Pilot Trial (CELL-VAD Pilot)","CELL-VAD","Patient inclusion criteria will consist of all of the following:\n\n1. non-ischemic dilated cardiomyopathy\n2. patient accepted for LVAD support\n3. optimal (or maximal tolerable therapy) heart failure ≥ 2 months\n4. age 18-65 years\n5. ability to provide informed consent\n\nPatient exclusion criteria will consist of any of the following:\n\n1. ischemic cardiomyopathy\n2. Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \\& chronic uncontrolled tachycardia.\n3. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.\n4. ongoing or recent (less than 1 month) infection\n5. acute multi-organ failure\n6. clinically significant anemia (Hb \\\u003C 10 g\u002FdL)\n7. clinically significant leukopenia (L \\\u003C 2 x 109\u002FL) or leukocytosis (L \\> 14 x 109\u002FL)\n8. clinically significant thrombocytopenia (TRC \\\u003C 50 x 109\u002FL)\n9. known disorders of hemostasis that can not be corrected\n10. history of any thromboembolic complications\n11. chronic kidney disease (higher than stage III)\n12. chronic liver disease (Child B or C)\n13. diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI \\> 35 kg\u002Fm2)\n14. aortic stenosis (AVA \\\u003C 1.3 cm2) or ocluded aortic valve\n15. artificial (mechanical or biological) aortic valve\n16. patients with reduced immune response\n17. history of limphoprolipherative disorders or malignancy within 5 years\n18. left ventricular thrombus\n19. participation in another interventional clinical trial\n20. life expectancy less than 12 months\n21. known hypersensitivity to DMSO, penicillin or streptomycin",{"count":529,"type":20},10,[531],"PHASE2","The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.",[129,534],"Mechanical Circulatory Support",[134,536,537],"mechanical circulatory support","stem cells","2026-01-22",{"date":540,"type":36},"2026-01-26",{"date":542,"type":36},"2022-05-01",{"date":544,"type":20},"2029-03-01",{"name":42,"class":43},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":176,"enrollmentInfo":553,"targetDuration":4,"studyType":55,"phases":554,"briefSummary":555,"conditions":556,"keywords":559,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":4},"100620227","phase-4-effect-of-tirzepatide-on-cardiovascular-and-metabolic-parameters-in-obese-adult-patients-with-congenital-heart-disease-100620227","NCT07354880","Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease","TEACH","Inclusion Criteria:\n\n* Obese or overweight adult patients with congenital heart disease\n* BMI between 30 kg\u002Fm² and 40 kg\u002Fm²\n* Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%\n* Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)\n* No prior pharmacological or surgical interventions for obesity\n* Euthyroid state\n* Eumenorrhea or oligomenorrhea\n* Ability to comprehend the study objectives and procedures\n* Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate\n* Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment.\n\nExclusion Criteria:\n\n* Down syndrome\n* Type 2 diabetes\n* Severe heart failure (NYHA IV), EF of systemic or subpulmonary ventricle \\\u003C 30%, malignant arrhythmias, severe heart valve disease\n* Personal history of malignancy, personal or family history of medullary thyroid carcinoma\n* Personal history of pancreatitis or cholelithiasis\n* Personal history of acute coronary events or hemodynamically significant coronary artery disease\n* Current treatment with sympathomimetics or sympatholytic\n* Psychiatric disorders, personal history of depressive disorders or suicidal ideation\n* Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods\n* Excessive alcohol consumption\n* Smoking",{"count":468,"type":20},[57],"Several drugs have been shown effective in the treatment of obesity, with concomitant favourable cardiovascular effects. Today, there are no studies on novel anti-obesity drugs in patients with adult congenital heart disease (ACHD). Therefore, the investigators aim to study the effects of the anti-obesity drug tirzepatide (Munjaro) on cardiovascular and metabolic factors in obese patients with ACHD.\n\nIn a 24-week, randomized, open-label, placebo-controlled clinical trial the investigators will compare the effects of tirzepatide versus placebo in ACHD patients diagnosed with obesity. Patients will be randomized in a 1:1 ratio to either the intervention or placebo group. Participants will have monthly visits to monitor progress. At the beginning and end of the study, a full investigation protocol will be performed.",[557,558],"Obesity & Overweight","Adult Congenital Heart Disease",[504,560,561,562,563],"adult congenital heart disease","tirzepatide","cardiovascular factors","metabolic factors","2026-01-18",{"date":566,"type":36},"2026-01-21",{"date":568,"type":20},"2026-01-20",{"date":258,"type":20},{"name":42,"class":43},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":466,"minAge":17,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":55,"phases":581,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":44},"100620190","resistance-training-added-to-aerobic-interval-training-to-improve-aerobic-capacity-and-muscle-mass-in-women-with-coronary-artery-disease-100620190","NCT07354399","Resistance Training Added to Aerobic Interval Training to Improve Aerobic Capacity and Muscle Mass in Women With Coronary Artery Disease","Resistance Training Among Women With Coronary Artery Disease","VAKAR","Inclusion Criteria:\n\n* documented CAD,\n* stable clinical status (at least 1 month since myocardial infarction and\u002For elective percutaneous coronary intervention, at least 3 months since cardiac surgery).\n\nExclusion Criteria:\n\n* based on the American Heart Association guidelines for resistance training in patients with CAD,\n* pregnancy.",{"count":580,"type":20},50,[87],"The goal of this clinical trial is to find out whether partly replacing aerobic interval training (AIT) with resistance training (RT) leads to greater improvements in physical fitness and muscle mass in women with coronary artery disease (CAD) during cardiac rehabilitation.\n\nThe main questions this study aims to answer are:\n\n* Does combining RT (squats and pulling exercises with weights) with a reduced amount of AIT (cycling) improve aerobic fitness in the same way as AIT alone?\n* Does the combined training lead to greater improvements in muscle mass compared with AIT alone?\n* Does slow-speed RT (slower lowering phase) result in lower heart rate and blood pressure during exercise compared with normal-speed RT?\n\nResearchers will compare three exercise programs:\n\n* AIT only (control group),\n* AIT combined with normal-speed RT (1-second lifting, 2-second lowering),\n* AIT combined with slow-speed RT (1-second lifting, 5-second lowering).\n\nParticipants will take part in a 12-week cardiac rehabilitation program and will train three times per week.\n\nAt the start and end of the program, participants will complete a cycling fitness test, body composition assessment, blood sampling, two strength tests, and quality-of-life questionnaire.",[584],"Coronary Artery Disease With Myocardial Infarction",[586,587,588,589],"Coronary Artery Disease","Resistance Training","Cardiac Rehabilitation","Women","2026-01-14",{"date":566,"type":36},{"date":593,"type":36},"2025-09-26",{"date":595,"type":20},"2026-11",{"name":42,"class":43},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":16,"minAge":605,"maxAge":606,"enrollmentInfo":607,"targetDuration":4,"studyType":55,"phases":608,"briefSummary":609,"conditions":610,"keywords":614,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":44},"100619083","analgosedation-with-ketamine-nalbuphine-or-dexmedetomidine-for-suture-removal-in-children-after-cleft-surgery-100619083","NCT07340008","Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery","Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Analgosedation in Children Undergoing Suture Removal After Surgery for Congenital Clefts of the Palate, Alveolar Ridge, and Lip","KID-CLEFT","Inclusion criteria:\n\n* Age 6 months to 3 years\n* Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Written informed consent obtained from parents or legal guardians\n* Slovene-speaking family to ensure understanding and compliance\n* No contraindications to the use of study medications\n\nExclusion criteria:\n\n* Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine\n* ASA physical status greater than II\n* Significant neurological, psychiatric, or respiratory disorder\n* Active or recent upper respiratory tract infection\n* Refusal of parental or guardian consent\n* Developmental disorder affecting communication or cooperation","6 Months","3 Years",{"count":54,"type":20},[87],"This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups.\n\nThe primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs.\n\nAll study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.",[611,612,613],"Orofacial Clefts","Cleft Lip and Palate","Alveolar Ridge Defect",[615,616,617,618,619,620,621,622],"pediatric sedation","Cleft surgery","Ketamine","Dexmedetomidine","Nalbuphine","Intranasal sedation","Intramuscular injection","Sedation in children","2026-01-05",{"date":590,"type":36},{"date":626,"type":36},"2025-09-01",{"date":628,"type":20},"2029-01",{"name":42,"class":43},{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":55,"phases":639,"briefSummary":640,"conditions":641,"keywords":645,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":44},"100611783","phase-2-use-of-dapagliflozin-in-primary-prevention-of-cardiotoxicity-of-anthracycline-chemotherapy-in-breast-cancer-patients-100611783","NCT07245069","Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients","Alpaca","Inclusion Criteria:\n\n* Adults ≥18 years.\n* Histologically confirmed breast cancer with planned (neo)adjuvant anthracycline-based chemotherapy (4 cycles of epirubicin + cyclophosphamide or doxorubicin + cyclophosphamide).\n* Eligible to start dapagliflozin or placebo prior to or at initiation of chemotherapy.\n* Able to perform baseline echocardiography, vascular ultrasound (FMD and carotid stiffness), 6-minute walk test, and biomarker sampling.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known heart failure (any prior diagnosis of HF).\n* Clinically significant valvular heart disease.\n* Prior exposure to chemotherapy or radiotherapy to the left chest.\n* Type 1 diabetes mellitus.\n* Symptomatic hypotension.\n* History of recurrent urinary tract infections.\n* History of diabetic ketoacidosis or ketonemia.\n* Severe hepatic impairment (ALT, AST, ALP \\>3× upper limit of normal).\n* Severe renal impairment (eGFR \\\u003C20 mL\u002Fmin\u002F1.73 m²).\n* Known allergy or intolerance to SGLT-2 inhibitors.\n* Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, could interfere with study participation, safety, or completion.",{"count":638,"type":20},100,[531],"The goal of this randomized, double-blind, placebo-controlled clinical trial is to determine whether dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, can help prevent anthracycline-induced cardiotoxicity caused by anthracycline chemotherapy in adult women with breast cancer receiving (neo)adjuvant treatment.\n\nThe main questions the study aims to answer are:\n\ni) Does dapagliflozin reduce the decline in left ventricular function (measured by LVEF, GLS, and myocardial work) during and after anthracycline therapy? ii) Does dapagliflozin lessen the deteriorating effect of chemotherapy on endothelial function and arterial stiffness? iii) Does dapagliflozin effect levels of cardiac injury and inflammation biomarkers (e.g., hs-troponin T, NT-proBNP, ST-2, GDF-15, galectin-3, IL-6, MPO)?\n\nResearchers will compare dapagliflozin 10 mg daily with placebo to see whether those receiving dapagliflozin experience less heart and vascular impairment during treatment.\n\nParticipants will:\n\n* Take either dapagliflozin or placebo once daily during anthracycline chemotherapy.\n* Undergo heart and vascular ultrasound, and a 6-minute walk test before chemotherapy and again at 24 and 52 weeks.\n* Provide blood samples before, during and after chemotherapy to measure cardiac biomarkers.\n* Complete multiple questionnaires on quality of life.",[129,642,643,390,644],"Anthracycline-induced Cardiac Toxicity","Endothelial Function (FMD)","Breast Cancer",[646,647,644,648,649,650,651,652,653,393,654,655,129,449,656],"Anthracycline-induced cardiac toxicity","Dapagliflozin","Cardio-Oncology","Primary Prevention","Global Longitudinal Strain","Myocardial Work","Endothelial Function","Flow-Mediated Dilation","Troponin","NT-proBNP","Sodium-Glucose Transporter 2 Inhibitors","2025-11-17",{"date":659,"type":36},"2025-11-24",{"date":661,"type":36},"2025-02-01",{"date":663,"type":20},"2029-02",{"name":42,"class":43},{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":16,"minAge":671,"maxAge":672,"enrollmentInfo":673,"targetDuration":4,"studyType":55,"phases":675,"briefSummary":676,"conditions":677,"keywords":680,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":44},"100606701","psychoeducation-for-parents-of-adolescents-with-anorexia-nervosa-as-a-supportive-treatment-approach-100606701","NCT07178977","Psychoeducation for Parents of Adolescents With Anorexia Nervosa as a Supportive Treatment Approach","Inclusion Criteria:\n\n* Adolescents aged 11-19 years\n* Clinical diagnosis of anorexia nervosa (AN) according to DSM-5 criteria\n* Referred for treatment at the Child Psychiatry Department, Pediatric Clinic, University Medical Centre Ljubljana\n* At least one parent\u002Flegal guardian willing to participate in the psychoeducation program\n* Signed informed consent by parent(s) and assent from adolescent\n\nExclusion Criteria:\n\n* Adolescents with severe comorbid psychiatric conditions requiring alternative treatment (e.g., psychosis, severe intellectual disability, active substance dependence)\n* Adolescents or parents unable to understand Slovenian language sufficiently to participate in group sessions or complete questionnaires\n* Families already engaged in a structured psychoeducation or similar parent-support program at the time of recruitment","11 Years","19 Years",{"count":674,"type":20},70,[87],"This randomized controlled trial will evaluate the effectiveness of a structured four-week psychoeducation program for parents of adolescents diagnosed with anorexia nervosa (AN). The program aims to improve parental coping and improve adolescent treatment outcomes.\n\nSeventy adolescents with AN (ages 11-19) and their parents will be recruited at the University Medical Centre Ljubljana, Slovenia. Families will be randomly assigned to either an intervention group, receiving immediate psychoeducation, or a waitlist control group, receiving the program after one month. The psychoeducation program consists of four weekly 90-minute sessions covering eating disorder characteristics, maintaining factors, strategies for normal eating, and approaches for supporting change.\n\nPrimary outcomes include change in adolescent body mass index (BMI) from baseline to post-intervention and three-month follow-up. Secondary outcomes include adolescent symptoms of eating disorders, anxiety, and depression, as well as parental anxiety, depression, stress, social support, and self-efficacy. The study will test whether early, structured parental involvement through psychoeducation improves both adolescent clinical outcomes and parental coping.",[678,679],"Eating Disorders","Anorexia Nervosa",[681,679,682,683],"eating disorders","Parental Stress","Parental Coping","2025-09-22",{"date":593,"type":36},{"date":687,"type":20},"2025-10-01",{"date":689,"type":20},"2028-06-01",{"name":42,"class":43},{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":697,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":699,"targetDuration":245,"studyType":21,"phases":4,"briefSummary":701,"conditions":702,"keywords":704,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":344},"100605838","ctnnb1-neurodevelopmental-syndrome---natural-history-study-100605838","NCT07167732","CTNNB1 Neurodevelopmental Syndrome - Natural History Study","Dragonfly Study: An International, Prospective, Longitudinal, Observational Natural History Study of Children and Adults Living With CTNNB1 Neurodevelopmental Syndrome","Dragonfly","Inclusion Criteria:\n\n* Clinically and genetically confirmed diagnosis of CTNNB1 syndrome.\n* Age 0-99 years.\n* Written informed consent\u002Fonline consent to participate in study from a primary carer (parent or legal guardian).\n\nExclusion Criteria:\n\n* Child\u002Fadult with CTNNB1 syndrome participating in a clinical trial of a potential treatment for the syndrome.",{"count":700,"type":20},250,"The aim of the Dragonfly study is to characterise and monitor the neurodevelopment of children and adults diagnosed with CTNNB1 syndrome through an international collaborative effort. Gaining comprehensive understanding of the mental, physical and social development of people with CTNNB1 neurodevelopmental syndrome and how their symptoms and abilities change over time will help improve and standardize care for these patients, as well as facilitate future research and clinical trials design.",[703],"CTNNB1 Neurodevelopmental Syndrome",[705,706,707,708,709,710],"CTNNB1 neurodevelopmental syndrome","Natural History Study","CTNNB1 gene mutation","Autism Spectrum Disorder","Beta-catenin","Developmental Delay","2025-09-16",{"date":684,"type":36},{"date":714,"type":36},"2024-06-14",{"date":716,"type":20},"2030-01",{"name":42,"class":43},""]