[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grigore T. Popa University of Medicine and Pharmacy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":194},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,83,111,137,166],{"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":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100053768","atrial-cardiomyopathy-in-patients-with-cardiovascular-kidney-metabolic-syndrome-non-invasive-characterization-100053768",false,"NCT07697469","Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization","Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)","ATRIO-CKM","Inclusion Criteria:\n\n* Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements\n\nExclusion Criteria:\n\n* Missing key data for ACM or CKM classification Hemodynamically significant valvular heart disease (greater than moderate severity) Mechanical or biological valve prostheses Temporary or permanent cardiac pacing Psychiatric pathology Thyroid pathology (active or untreated) Known cardiomyopathies (hypertrophic, dilated, restrictive, or infiltrative) Refusal to participate or inability to comply with protocol requirements","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group.\n\nCKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate.\n\nThis prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI.\n\nAdults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking.\n\nPrimary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel.\n\nStatistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.",[25,26,27,28,29],"Cardiovascular-Kidney-Metabolic Syndrome","Atrial Cardiomyopathy","Atrial Fibrillation","Chronic Kidney Disease","Metabolic Syndrome",[31,32,33,34,35,36,37,38,39,27,28],"atrial cardiomyopathy","CKM syndrome","on-invasive evaluation","atrial remodeling","Bayés interatrial block","speckle tracking","Fetuin-A","MR-proANP","FGF23","NOT_YET_RECRUITING","2026-07-05",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":21},"2026-07-10",{"date":48,"type":21},"2028-04",{"name":50,"class":51},"Grigore T. Popa University of Medicine and Pharmacy","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":52},"100626601","thrombelastometry-guided-blood-component-administration-versus-standard-of-care-in-patients-with-decompensated-liver-cirrhosis-undergoing-invasive-procedures-100626601","NCT07437755","Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures","Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing High Risk of Bleeding Invasive Procedures","PROTECT-CIRR","Inclusion Criteria:\n\n* diagnosed with decompensated liver cirrhosis of any etiology\n* planned for a high risk of bleeding invasive procedure\n* coagulopathic based on conventional coagulation tests and considered for pre-procedural blood component prophylaxis\n* able and willing to provide informed consent\n\nExclusion Criteria:\n\n* acute liver failure\n* current use of anticoagulant treatment\n* patients on antiplatelet aggregation agents\n* patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior to the procedure\n* patients with stage 4 or 5 chronic kidney disease or patients receiving renal replacement therapy\n* sepsis",{"count":62,"type":21},116,"INTERVENTIONAL",[65],"NA","Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific data to warrant empirical transfusion. In many surgical and trauma-related contexts, viscoelastic tests, like Rotational Thromboelastometry (ROTEM), offer a comprehensive assessment of hemostasis, and it has been demonstrated to predict bleeding risk more accurately than traditional coagulation tests. The aim of this project is to evaluate the efficacy of a ROTEM-based algorithm in managing the administration of prophylactic blood components to patients diagnosed with decompensated liver cirrhosis undergoing invasive high risk of bleeding procedures. The investigators hypothesized that ROTEM-based decision-making will lead to a reduction in pre-procedural blood component usage, particularly fresh frozen plasma (FFP), compared with standard of care, whilst maintaining optimal clinical outcomes. The investigators will perform a prospective, single-center, randomized controlled clinical trial in a tertiary university hospital in Romania, comparing ROTEM-guided prophylactic blood component administration to standard of care in patients with decompensated cirrhosis and coagulopathy undergoing invasive procedures. Inclusion criteria: adults (aged 18 years or older) admitted with cirrhosis and an indication for high risk of bleeding invasive procedure defined as: transjugular liver biopsy, transjugular intrahepatic portosystemic shunt, endoscopic retrograde cholangio-pancreatography with sphincterotomy, endoscopic polypectomy of polyps more than 1 cm, variceal banding and complex dental extraction. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of blood products transfusion, hospital length of stay, in-hospital and 28-day mortality, incidence of minor bleeding, transfusion related adverse reactions, and cost analysis.",[68],"Liver Cirrhosis With Acute Decompensation",[70,71,72,73],"ROTEM","decompensated liver cirrhosis","bleeding risk","blood product transfusion","RECRUITING","2026-02-24",{"date":77,"type":44},"2026-02-27",{"date":79,"type":44},"2025-06-01",{"date":81,"type":21},"2026-10-31",{"name":50,"class":51},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":63,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":52},"100611196","tiva-versus-balanced-anesthesia-on-muscle-mass-in-crc-surgery-100611196","NCT07237438","TIVA Versus Balanced Anesthesia on Muscle Mass in CRC Surgery","Total Intravenous Anesthesia Versus Balanced Anesthesia on Loss of Muscle Mass After Colorectal Cancer Surgery","TIVABAL-CRC","Inclusion Criteria:\n\n• adult patients diagnosed with colorectal cancer and scheduled for open colorectal surgery at the Regional Institute of Oncology, Iaşi, Romania\n\nExclusion Criteria:\n\n* lack the capacity to consent\n* extremity amputation\n* paraplegia\n* diseases affecting the muscles (such as stroke, lower-limb immobilization from a plaster, neurodegenerative diseases, peripheral neuropathy or muscle dystrophy)\n* terminal cancer",{"count":92,"type":21},40,[65],"This study is aimed at clarifying changes in body composition during the perioperative period and identifying risk factors for skeletal muscle mass loss in patients with colorectal cancer. The investigators will asess the impact of the type of anaesthesia (total intravenous anaesthesia\u002Fsevoflurane anaesthesia) for colorectal surgery on the muscle function and mass, which will be evaluated using ultrasound, dynamometry and bioimpedance.",[96,97],"Colorectal Cancer (CRC)","Sarcopenia",[99,100,101,102],"colorectal cancer","sarcopenia","ultrasound","bioimpedance","2025-11-16",{"date":105,"type":44},"2025-11-19",{"date":107,"type":44},"2025-09-20",{"date":109,"type":21},"2026-06",{"name":50,"class":51},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":52},"100611197","cardiovascular-and-renal-endpoints-with-flozins---an-observational-prospective-study-in-ckd-hfpef-patients-100611197","NCT07237451","Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients","CARE FOR CKD H","Inclusion Criteria:\n\n* age\\>18 years;\n* ejection fraction \\> 40;\n* patients with CKD stage 3-4 (eGFR between 15-60 mL\u002Fmin\u002F1.73m2), with iSGLT2 recommendation, diabetic and non-diabetic;\n* age, sex and CKD stage 3 and 4 matched patients without iSGLT2 administration.\n\nExclusion Criteria:\n\n* eGFR\\\u003C 15 mL\u002Fmin\u002F1.73m2 or patients undergoing dialysis;\n* presence of congenital heart disease, decompensated cirrhosis, pregnancy and active malignancies;\n* coronary artery disease (including those with a history of acute coronary syndrome, angina pectoris, or prior coronary angiography or CT angiography demonstrating significant coronary artery lesions);\n* cardiac medical devices, namely metallic joint prostheses, cardiac stent or pacemakers;\n* active systemic infections (due to interference with biomarkers that can give false rise values).",{"count":20,"type":21},"The main aim of this study is to holistically assess the cardiovascular and renal outcomes in HFpEF CKD patients with and without SGLT2 inhibition, with focus on the endothelial disfunction, MACE and mortality using clinical evaluation, flow mediated dilatation, carotid-femoral pulse wave velocity, intima-media thickness, echocardiographic parameters, NMR metabolomics and a series of novel biomarkers.",[121,122,123,124],"CKD - Chronic Kidney Disease","Heart Failure Preserved Ejection Fraction","SGLT2 Inhibitors","Diabetes (DM)",[126,127,128,129,130],"CKD","HFpEF","SGTL2 inhibitors","Biomarkers","PWV",{"date":105,"type":44},{"date":133,"type":44},"2025-01-08",{"date":135,"type":21},"2027-12-31",{"name":50,"class":51},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":17,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":149,"conditions":150,"keywords":155,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":52},"100603786","assessment-of-mineral-and-bone-disorders-in-kidney-transplant-recipients-100603786","NCT07141043","Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients","New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients","Inclusion Criteria:\n\n1. HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.\n2. KTR group: Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor.\n3. GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.\n\nExclusion Criteria:\n\n1. HD group: Treatment with active bone therapies (excluding calcium and vitamin D); ongoing cancer treatment or recent history of malignancy, cirrhosis, recent major fractures, patients who have received transplants other than kidney, secondary causes of osteoporosis (other than CKD or transplant-related: primary hyperparathyroidism, hyperthyroidism, congenital bone disorders, sarcoidosis, severe bone trauma, malignant tumors, inflammatory bowel disease, endogenous Cushing syndrome, anti-estrogen\u002Fanti-androgen therapy, and anorexia nervosa), pregnancy and breast-feeding.\n2. KTR group: The same as for HD + return to dialysis + acute graft rejection.\n3. GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (\\>7.5 mg Prednisone or equivalent for at least 3 months).",true,"20 Years","70 Years",{"count":148,"type":21},180,"This study aims to integrate bone measurements (including bone turnover markers (BTM), bone mineral density (BMD) measurement, vertebral fracture assessment (VFA), trabecular bone score (TBS) ) commonly used in the general population for primary osteoporosis evaluation to enhance the assessment of CKD-MBD.",[151,152,153,154],"Hemodyalysis","Kidney Tansplant","Osteoporosis","CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder",[156,153,157],"CKD-MBD","bone turnover markers","2025-08-18",{"date":160,"type":44},"2025-08-26",{"date":162,"type":44},"2025-03-19",{"date":164,"type":21},"2027-06",{"name":50,"class":51},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":173,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":63,"phases":176,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100566999","cognitive-impairment-in-treated-breast-cancer-survivors-possible-approaches-100566999","NCT06662474","Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches","Evaluation of Cognitive Dysfunction in Patients with Breast Cancer Undergoing Systemic Therapy","Inclusion Criteria:\n\n* female patients aged 18 years or older\n* histologically confirmed treated invasive non-metastatic HR positive\n* provided written informed consent\n* (ECOG) performance status 0 -2\n* adequate hematologic functions\n* the patients must have completed the treatment (surgery or chemotherapy) for a minimum of 6 months and a maximum of 3 years before enrolling in the study\n* patients who received chemotherapy for at least 3 months, including both dose-dense regimens and those administered every 3 weeks, as part of their disease treatment.\n* patients are considered eligible for study continuation if, in 1 month of screening procedures, the tests to identify depression and severe anxiety do not indicate a severe status for them.\n\nExclusion Criteria:\n\n* history of neoplasia other than breast cancer\n* brain metastases\n* acute neurological diseases, neuro-degenerative or major psychiatric conditions such as stroke, autism, ADHD, Alzheimer's disease, Parkinson's disease, dementia, obsessive-compulsive disorder, post-traumatic stress disorder, schizophrenia, and those with a history of craniocerebral trauma\n* associated pathologies who may receive any form of treatment\n* the administration of psychotropic or pain medications in the II and III categories\n* (ECOG) ≧3\n* laboratory tests that contraindicate the administration of active oncological treatment","FEMALE",{"count":175,"type":21},120,[65],"The investigators aim is to conduct a prospective study with three arms, involving non-metastatic breast cancer patients who underwent chemotherapy as part of their treatment and were on a form of hormone therapy at the time of study inclusion. The trial consists of identifying the presence of cognitive decline and following up on methods of preventing its accentuation. The goal of this clinical trial is to assess if psychoeducation and cognitive stimulation work to decrease the intensity of cognitive impairment. It aims to answer the following main questions:\n\n* The implementation of such interventions improves both the dysfunction quantified by objective tests but also the individual's perception of it.\n* The implementation changes the patients' quality of life. Researchers will compare three study groups, each with instructions to complete one of the related 12-week programs, to see if there are any changes.\n\nDepending on the group in which the patient was randomly assigned, the interventions are :\n\n* First group - will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks\n* the second group will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks and also hold open group meetings for psychoeducation (1 meeting every 2 weeks, 6 meetings in total).\n* Group 3 is considered a control group, consisting of people who maintained their lifestyle up until their inclusion in the study without following additional measures",[179,180],"Cognitive Impairment","Chemobrain",[182,183,184,185],"breast cancer","cognitive impairment","quality of life","intervention","2024-10-28",{"date":188,"type":44},"2024-10-30",{"date":190,"type":21},"2024-11-01",{"date":192,"type":21},"2026-12-31",{"name":50,"class":51},""]