[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":628},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,49,0,25,[9,43,72,98,140,166,193,216,245,266,287,308,329,353,379,406,432,460,480,499,522,544,564,585,605],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100644203","efficacy-and-tolerability-of-treatment-with-alfalitic-plus-serenoa-repens-compared-to-alfalitic-plus-antimuscarinic-for-moderate-severe-lower-urinary-tract-symptoms-100644203",false,"NCT07665749","Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Lower Urinary Tract Symptoms","Efficacy and Tolerability of Treatment With Alfalitic Plus Serenoa Repens Compared to Alfalitic Plus Antimuscarinic for Moderate-severe Mixed Lower Urinary Tract Symptoms: Results of a Cross-sectional Clinical Study","FINAL","Inclusion Criteria:\n\n* Age 40-80 inclusive\n* Male\n* With moderate-to-severe LUTS from BPH according to IPSS score\n* Placed on AB+Serenoa repens or AB+antimuscarinics for 6 months\n\nExclusion Criteria:\n\n* Prostate or bladder cancer\n* History of neurogenic bladder\n* Urinary tract abnormalities (including urethral strictures)","MALE","40 Years","80 Years",{"count":22,"type":23},50,"ESTIMATED","OBSERVATIONAL","The study aims to investigate, through the International Prostatic Symptoms Score (IPSS) questionnaire, the non-inferiority of the therapy with the alpha-blockers+Serenoa repens combination compared to the alpha-blockers+antimuscarinic combination on storage lower urinary tract syndrome (LUTS) in patients with moderate-severe symptomatic benign prostatic hyperplasia (BPH).",[27],"Benign Prostate Hypertrophy(BPH)",[29,30],"BPH","LUTS","NOT_YET_RECRUITING","2026-06-24",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":23},"2026-06-01",{"date":39,"type":23},"2026-11-01",{"name":41,"class":42},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100643546","digital-twin-and-ml-based-model-of-tevar-interventions-100643546","NCT07640828","Digital Twin and Ml-basEd MOdel of TEVAR Interventions","MEMO","Inclusion Criteria:\n\n* ≥18 Years and older (Adult, Older Adult)\n* Female and male\n* Received TEVAR for: Chronic or acute dissection, Aneurysm, Penetrating aortic ulcer, aortic thrombus, intramural hematoma or traumatic injury\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Received TEVAR in surgical graft that replaced native aorta\n* Poor CT image quality that leads to failure in generating a high-fidelity 3D FE model of patient anatomy (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CTscan slice thickness greater than 1mm, preoperative CT-scan with artifacts, motion artifacts due to the presence of other implanted devices affecting the region of interest)","ALL","18 Years",{"count":53,"type":23},5000,"The study aims to collect clinical data and pseudonymized CT images of patients undergoing TEVAR in order to create an anatomical digital twin capable of simulating procedural outcomes and training machine learning (ML) algorithms. This approach will support predictive models that may assist physicians in selecting the optimal medical device, improving pre-TEVAR planning, and predicting post-TEVAR complications.",[56,57],"Aorta Disease","Aorta, Thoracic Pathologies",[59,60,61],"machine learning","thoracic aorta","Finite Element Analysis","RECRUITING","2026-06-05",{"date":65,"type":35},"2026-06-11",{"date":67,"type":35},"2026-02-11",{"date":69,"type":23},"2026-09-30",{"name":41,"class":42},1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":80,"minAge":51,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":71},"100640907","effect-of-fodmap-diet-on-pain-quality-of-life-and-sexual-function-in-women-with-pelvic-endometriosis-and-gastrointestinal-symptoms-100640907","NCT07590895","Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms","Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms: a Randomized Controlled Trial","FODMAPendo","Inclusion Criteria:\n\n* Age between 18 and 45 years\n* BMI between 18.5 and 24.9,\n* Surgical, clinical or instrumental diagnosis of endometriosis\n* Presence of bowel symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) referable to irritable bowel syndrome, on estro-progestin or progestin treatment or in the absence of hormonal treatment\n\nExclusion Criteria:\n\n* Associated conditions that may cause pelvic pain independent of the presence of endometriosis (e.g., pelvic varices and salpingitis outcomes)\n* chronic inflammatory bowel disease (Crohn's disease or ulcerative rectocolitis).\n* patients with obstructive uropathy, subocclusive intestinal stenosis\n* complex adnexal masses or typical endometriomas greater than 5 cm in diameter.\n* women who are obese (BMI ≥ 30) or underweight (BMI \\\u003C 18)\n* women on vegetarian-vegan dietary regimens,\n* women with metabolic diseases that require specific dietary indications such as in the case of diabetes and celiac disease.","FEMALE","45 Years",{"count":83,"type":23},150,"INTERVENTIONAL",[86],"NA","The main objective of the study is to assess whether a dietary regimen based on the principles of the FODMAP diet, compared with the current treatment programme which does not include specific dietary recommendations, can improve pain symptoms in patients with symptomatic endometriosis and intestinal symptoms (i.e. bloating, nausea, constipation, diarrhoea and vomiting) attributable to irritable bowel syndrome, compared with a control group",[89],"Endometriosis","2026-05-12",{"date":92,"type":35},"2026-05-15",{"date":94,"type":35},"2024-03-01",{"date":96,"type":23},"2026-12-15",{"name":41,"class":42},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":84,"phases":108,"briefSummary":109,"conditions":110,"keywords":117,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":71},"100635881","extracellular-vesicles-and-chemotherapy-induced-peripheral-neuropathy-100635881","NCT07558447","Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy","Extracellular Vesicles as Predictive Biomarkers for Chemotherapy-Induced Peripheral Neuropathy","CHEMOVES","Inclusion Criteria:\n\n* Has signed the informed consent form\n* Is 18 years of age or older\n* Is male or female\n* Has breast cancer and is scheduled to receive paclitaxel, docetaxel, eribulin, capecitabine, or carboplatin as part of standard care\n* Has gastrointestinal cancer and is scheduled to receive oxaliplatin or capecitabine as part of standard care\n* Has lung cancer and is scheduled to receive cisplatin, carboplatin, or docetaxel as part of standard care\n* Has urologic cancer and is scheduled to receive carboplatin, cisplatin, paclitaxel, docetaxel, or enfortumab vedotin as part of standard care\n* Has head and neck cancer and is scheduled to receive carboplatin, paclitaxel, or cisplatin as part of standard care\n\nExclusion Criteria:\n\n* Has already been diagnosed with CIPN\n* Has a neurodegenerative disease",{"count":107,"type":23},120,[86],"The goal of this clinical trial is to learn whether extracellular vesicles (EVs) in the blood can be used as biomarkers to predict chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients receiving chemotherapy with taxanes, platinum compounds, or antimitotic drugs. The main questions the study aims to answer are whether blood levels of EVs change in patients who develop CIPN during and after chemotherapy and whether specific features of EVs, including lipids and microRNAs, are associated with the development and severity of CIPN. Participants will be followed from before the start of chemotherapy until six months after treatment ends to evaluate how changes in EVs relate to nerve damage caused by chemotherapy. During the study, participants will provide blood samples before chemotherapy, at the end of treatment, and six months later for measurement and molecular analysis of EVs, will complete questionnaires about neuropathy symptoms, and will undergo simple, non-invasive nerve function tests using a tuning fork (diapason) and a Neuropen device. This study does not test cancer drugs; instead, it aims to identify biological markers in blood that may help predict which patients are at higher risk of developing CIPN, with the goal of improving monitoring and care during cancer treatment.",[111,112,113,114,115,116],"Chemotherapy-Induced Peripheral Neuropathy","Breast Cancer","Gastrointestinal Cancer","Lung Cancer","Urologic Cancer","Head and Neck Cancer",[111,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Neurotoxicity","Extracellular Vesicles","Biomarkers","Liquid Biopsy","Paclitaxel","Docetaxel","Eribulin","Capecitabine","Carboplatin","Oxaliplatin","Cisplatin","Enfortumab Vedotin","Neuropathy","Cancer","2026-04-23",{"date":134,"type":35},"2026-04-30",{"date":136,"type":35},"2025-01-01",{"date":138,"type":23},"2026-09",{"name":41,"class":42},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":71},"100632458","daratumumab-in-immune-mediated-thrombotic-thrombocytopenic-purpura-100632458","NCT07513948","Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura","DarTTP: an Observational, International, Multicentric Study on Daratumumab in Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)","DarTTP","Inclusion Criteria:\n\n* patients with a confirmed diagnosis of iTTP (i.e., ADAMTS13 activity \\\u003C10% with anti-ADAMTS13 antibodies detected);\n* aged ≥ 18 years;\n* male and female patients;\n* treated with daratumumab for iTTP.\n\nExclusion Criteria:\n\n* patients unwilling or unable to provide their informed consent;\n* follow-up \\\u003C 6 months after daratumumab administration.","99 Years",{"count":150,"type":23},40,"Data about efficacy and safety of daratumumab in iTTP refractory or intolerant to standard immunosuppressive treatments are scarce. Therefore, the investigators aim at collecting evidence on a larger number of patients through a collaborative, international study.",[153],"Thrombotic Thrombocytopenic Purpura, Acquired",[155,156,157],"daratumumab","thrombotic thrombocytopenic purpura","ADAMTS13","2026-04-13",{"date":160,"type":35},"2026-04-14",{"date":162,"type":35},"2025-10-01",{"date":164,"type":23},"2026-08",{"name":41,"class":42},{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":50,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":84,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":71},"100587426","association-of-tnfaip3-with-immune-mediated-ttp-100587426","NCT06928233","Association of TNFAIP3 With Immune-mediated TTP","Association of the TNFAIP3 Genomic Locus With Immune-mediated TTP","A20iTTP","Patients:\n\nInclusion Criteria:\n\n* Diagnosis of iTTP\n* Above 12 years of age\n* Caucasian, Italian origin\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who do not meet the above-listed criteria will be excluded from participation in the study.\n\nControls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.",true,"12 Years",{"count":177,"type":23},400,[86],"This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.",[153],[182,183,184],"A20","iTTP","TNFAIP3","2026-03-26",{"date":187,"type":35},"2026-03-27",{"date":189,"type":35},"2025-04-07",{"date":191,"type":23},"2026-04",{"name":41,"class":42},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":174,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":84,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100571333","multitarget-strategy-for-primary-podocytopathies-100571333","NCT06718894","Multitarget Strategy for Primary Podocytopathies","PODO-TARGET","Inclusion Criteria:\n\n* Signature of informed consent for study participation\n* One of the following conditions:\n\n  1. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and\u002For histological evidence of post-transplant recurrence.\n  2. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and\u002For histological evidence of post-transplant recurrence.\n  3. Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.\n  4. Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.\n  5. Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).\n  6. Patients with no history of renal diseases\n\nExclusion Criteria:\n\n* Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR \\\u003C 15 ml\u002Fmin) and\u002For on renal replacement therapy\n* Individuals unable to understand and consent to the study procedures\n* Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation",{"count":83,"type":23},[86],"The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder.\n\nResearchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.\n\nParticipants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).",[204],"Nephrotic Syndrome",[206,207],"podocytopathy","transplant","2026-03-25",{"date":187,"type":35},{"date":211,"type":35},"2025-06-19",{"date":213,"type":23},"2032-11",{"name":41,"class":42},2,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":174,"sex":50,"minAge":51,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":226,"conditions":227,"keywords":230,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100564926","impact-of-kidney-failure-on-the-regulation-of-humoral-response-to-vaccination-100564926","NCT06635525","Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination","Tfh-CKD","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Patients undergoing thrice-weekly hemodialysis \u002F peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency\n* Subjects eligible to receive a seasonal influenza vaccine\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* Recent influenza infection (clinically resolved less than 3 months ago).\n* Administration of immunosuppressive drugs in the two weeks prior to vaccination.\n* Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).\n* Systemic infection clinically resolved less than two weeks before enrollment.","70 Years",{"count":225,"type":23},146,"The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.\n\nResearchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.\n\nParticipants will:\n\n* Be enrolled at the time of influenza vaccination\n* Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination\n* Be asked to provide relevant clinical information and a blood sample at each visit",[228,229],"Chronic Kidney Disease Requiring Chronic Dialysis","Vaccine Response",[231,232,233,234,235,236],"Vaccine","Influenza","Chronic Kidney Disease","Hemodialysis","Peritoneal dialysis","Humoral Response",{"date":238,"type":35},"2026-03-30",{"date":240,"type":35},"2024-10-16",{"date":242,"type":23},"2026-07",{"name":41,"class":42},3,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":174,"sex":80,"minAge":253,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":71},"100630460","assess-abdominal-aortic-diameter-in-females-100630460","NCT07487961","Assess Abdominal Aortic Diameter in Females","Studio Osservazionale Prospettico Multicentrico nazionAle Nel Sesso Femminile peR la valutaziOne Del DIametro Dell'aorTa addominalE - A National, Multicenter, Prospective Observational Study in Females to Assess Abdominal Aortic Diameter","AFRODITE","Inclusion Criteria:\n\n* female sex\n* ≥ 50 YO\n\nExclusion Criteria:\n\n* \\\u003C 50 years\n* Previous diagnosis of abdominal\u002Fthoracic aneurysm disease\n* Subjects who have previously undergone surgery (both open and endovascular) on the thoracic and\u002For abdominal aorta\n* Presence of mental disability and\u002For inability to sign informed consent","50 Years",{"count":255,"type":23},652,"Female subjects aged 50 years or older will be enrolled. Biometric data (measurements) of the aorta and iliac vessels, demographic data, pathophysiological history, and data relating to menarche, pregnancy\u002Finfertility, and menopause will be collected.\n\nThe aortic diameter measurement protocol will follow standard clinical practice. Measurements will be performed by placing the probe on an axis perpendicular to the aortic axis, manually positioning the calipers in the antero-posterior and lateral-lateral directions, recording both the outer-to-outer (OTO) and inner-to-inner (ITI) diameters. Additionally, the presence of thrombus and\u002For calcifications and the outer-to-outer (OTO) measurement of the common iliac arteries will be detected.\n\nPrimary objective: Definition of the ultrasound diameter of the abdominal aorta in the female population. Secondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (aneurysm) in the female population.\n\nSecondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (atherosclerosis) in the female population.",[56,258],"Aorta Aneurysm","2026-03-23",{"date":187,"type":35},{"date":262,"type":35},"2025-09-29",{"date":264,"type":23},"2027-07-30",{"name":41,"class":42},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":174,"sex":50,"minAge":51,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":84,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":71},"100617328","defining-the-genetic-drivers-of-adult-onset-cholestatic-liver-disease-100617328","NCT07317193","DEFINING THE GENETIC DRIVERS OF ADULT-ONSET CHOLESTATIC LIVER DISEASE","FIRST","Inclusion Criteria:\n\nCases:\n\n* Adults, aged \\> 18 years with:\n\n  1. persistent or intermittent elevations in serum alkaline phosphatase (ALP) or gamma-glutamyltransferase (GGT) for at least six months not explained following standard diagnostic assessment adhering to the guidelines of the European Association for the Study of the Liver (EASL), or with a positive family history of unexplained cholestasis or hepato-biliary cancer, negative to previous genetic tests (targeted panel for PFIC genes or WES);\n  2. primary sclerosing cholangitis (PSC) with unusual features: small-duct PSC, non-typical radiological findings according to radiological guidelines on PSC, absence of concomitant inflammatory bowel disease, negative to previous genetic tests (targeted panel for PFIC genes or WES) or who didn't perform previous genetic test;\n  3. primary biliary cholangitis (PBC) without specific anti-mitochondrial antibodies, negative to previous genetic tests (targeted panel for PFIC genes or WES) or who didn't perform previous genetic test.\n* Signature of informed consent\n\nControls:\n\n-Blood donors (age 18-65 years) without clinical signs of liver diseases based on the collected clinical parameters: anthropometric (BMI\\>18 and \\\u003C25), haematological (Hb, white blood cells, platelets within the reference range), biochemical traits (albumin, bilirubin, AST, ALT, GGT, ALP within the reference range), medical history (negative for chronic or concomitant diseases, including immunological diseases)\n\nExclusion Criteria:\n\nCases:\n\n* Patients who do not possess the above inclusion criteria or have at least one of the following exclusion criteria:\n* an already known genetic diagnosis explaining the clinical phenotype\n* affected by other causes of liver disease such as viral or autoimmune hepatitis\n\nControls:\n\n-Blood donors with clinical signs of liver diseases","65 Years",{"count":275,"type":23},60,[86],"Cholestatic disease in adults comprises a heterogeneous group of conditions characterized by intra- or extrahepatic alterations of bile flow that can lead to fibrosis or hepatic decompensation. Due to the heterogeneity of clinical manifestation, which is sometimes very subtle, diagnosis based on clinical, histological, and radiological evaluation is often very complicated. Genetic testing can be helpful in identifying the cause of the clinical phenotype, thereby allowing for targeted follow-up adequate to the patient's specific characteristics and risk factors. Although the utility of genetic analysis has been well documented for other liver diseases or in pediatric cohorts of children with cholestatic disease, the use and benefits of genetic testing in adults with cholestatic disease are still little explored and investigated. In this context, through the use of whole-genome sequencing (WGS), the FIRST project aims to evaluate the role of rare genetic variants in the pathogenesis of cholestatic disease and the utility of WGS in defining a genetic diagnosis.",[279,280],"Cholestatic Liver Disease","Progressive Familial Intrahepatic Cholestasis",{"date":187,"type":35},{"date":283,"type":35},"2025-11-01",{"date":285,"type":23},"2026-10-31",{"name":41,"class":42},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":84,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":71},"100582639","colangioids-to-define-the-genetic-factors-involved-in-atypical-primary-sclerosing-cholangitis-100582639","NCT06865924","Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis","CILIA","Inclusion Criteria:\n\n* Between 18 and 90 years of age\n* Of both sexes\n* willingness to sign informed consent for the study; Additional criteria group 1\n* Patients with a confirmed aPSC diagnosis Additional criteria group 2\n* patients with suspected PSC liver biopsy candidates Additional criteria group 3\n* Patients not affected by aPSC listed for the following procedures:\n* Liver resection for hepatocellular or other hepatic lesions (including secondary effects from other cancers and benign focal lesions, which will result in healthy liver tissue);\n* Post-transplant biopsies of healthy liver;\n* cholecystectomies. Additional criteria group 4\n* Patients previously genotyped in the study \"Impact of complete exoma sequencing on clinical management of patient with non-alcoholic liver steatosis and cryptogenic liver disease project code RF-2016-02364358\" results carrying gene variants associated with ciliopathies\n\nExclusion Criteria:\n\n-Positive for chronic viral hepatitis (HCV-RNA and HBsAg).","90 Years",{"count":296,"type":23},80,[86],"Primary sclerosing cholangitis (PSC) is a rare, progressive and often fatal disease of the intrahepatic or extrahepatic bile ducts, with an estimated prevalence in Western countries of 1\u002F10,000. Biliary disease in PSC is represented by cholestasis, chronic inflammation of the bile ducts, the small tubes through which bile passes, progressive concentric fibrosis around the bile ducts2. This results in an obstruction to the passage of bile, which can lead to the development of cirrhosis with complications related to portal hypertension, cholangitis and often progress to bile duct cancer (cholangiocarcinoma). The only curative therapy in patients with PSC is liver transplantation, since no drug has been shown to be effective in preventing disease progression. The etiology is most likely multifactorial immune-mediated, where the onset of PSC is triggered by environmental factors in a genetically susceptible host2Genome-wide association studies (GWAS) have identified variations at the human leukocyte antigen (HLA) complex on chromosome 6 and several other loci, but these explain only a small part of the heritability of PSC. In most cases, PSC occurs in men in their 30s and 40s who have inflammatory bowel disease (IBD) suggesting a key role of altered intestinal permeability and inflammation. However, approximately 30% of patients do not present colonic inflammation, which is consistent with the heterogeneity of the disease. Preliminary data obtained in our laboratory analyzing a cohort of Italian individuals with atypical PSC (aPSC), identified a suggestive enrichment of rare variants in genes involved in cilia morphogenesis (CEP120 and AHI1). These data are consistent with previous findings, showing the correlation between gene variants involved in ciliopathies, including the DCDC26 gene, and chronic cholestatic disorders that can mimic PSC. Primary cilia are organelles present on the outer membrane of ductal cells, called cholangiocytes. These organelles function as antennas that detect stimuli from bile and transmit information to cells by regulating various signaling pathways involved in secretion, proliferation and apoptosis. Therefore, the alteration of primary cilia plays an important role in the de-differentiation of cholangiocytes and therefore in the development of cholangiopathies, in the invasion of inflammatory cells and in the fibrotic process. However, to date little is known about the contribution of genetic variants to the severity and progression of PSC, perhaps also due to the lack of a reliable model of bile duct. Recently, three-dimensional cell cultures, called organoids, have been proposed as a revolutionary tool in the field of cell biology, as they are able to mimic the corresponding organ in vivo.Organoids can be derived from either induced pluripotent stem cells (iPSCs) or tissue-resident adult stem cells. Compared to conventional 2D cultures and animal models, organoids allow to reproduce the genetic background of the patient in the model, recapitulating in vitro structures and functions similar to in vivo tissues. For this reason, organoids have been exploited in different applications, including drug discovery and testing, precision medicine and cell therapy 9311. However, organoids still show several limitations to model liver diseases. Indeed, they are only able to recapitulate the hepatic epithelial component, cholangiocytes and\u002For hepatocytes and above all they lack the 3D hepatic microenvironment, such as stromal and immune cells, which play an important role in the pathogenesis of several liver diseases. The present study is part of a project funded by the Regional Foundation for Biomedical Research (FRRB) whose general objective is to generate three-dimensional models of primary sclerosing cholangitis (PSC), called assemblyloids, and to study the cellular and molecular mechanisms through which genetic variants associated with genes involved in ciliopathies accelerate the progression of PSC. Our hypothesis is that the loss of function of cilia in cholangiocytes may represent a link between cellular senescence, development of inflammation, fibrosis and finally liver cancer. The variants related to ciliopathies could lead to an incomplete maturation of cholangiocytes with consequent malfunction that can therefore lead to a chronic inflammation of ductal cells and therefore to a persistent and uncontrolled activation of stromal cells and infiltration of immune cells. Furthermore, the generation of assemblyloids capable of reproducing native tissue as faithfully as possible will provide a new in vitro model for testing new pharmacological approaches aimed at correcting genetic mutations for improved precision medicine.",[300],"PSC",{"date":302,"type":35},"2026-03-24",{"date":304,"type":35},"2024-12-01",{"date":306,"type":23},"2027-12-31",{"name":41,"class":42},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":84,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":71},"100541654","target-of-suv420h12-in-hepatocytes-100541654","NCT06332677","Target of Suv420h1\u002F2 in Hepatocytes","Targeting the Epigenetic Regulators Suv420h1\u002F2 in Hepatocytes to Treat Nonalcoholic Fatty Liver Disease","Inclusion Criteria:\n\nWe will analyse data and samples from subjects with the following criteria:\n\n* Subjects aged\\>18;\n* Subjects who have already given their consent to genetic analysis and whose samples and data have already been collected as part of the SERENA, REASON and MAFALDA studies;\n* Subjects who have given their consent to participate in this study.\n\nIn particular, subjects with the following characteristics were included respectively:\n\n* in the SERENA study:\n\n  1. Diagnosis of NAFLD\n  2. Age between 45 and 75 years old\n  3. Any of the following criteria:\n\n     1. F3-F4 fibrosis, determined histologically, or by non-invasive techniques, or evidence of cirrhosis deriving from biochemical tests or imaging methods;\n     2. Family history of related first-degree primary liver cancer, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT)\n     3. Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.\n* in the REASON study:\n\nPatients aged\\>18, who have given their consent to participate in the study, who underwent the fol- lowing procedures:\n\n* liver biopsy for suspected non-alcoholic steatohepatitis (NASH) at the time of diagnosis;\n* liver resection for hepatocarcinoma, other liver lesions (including secondaries from other neo- plasms and benign focal lesions, which will allow obtaining healthy starting liver tissue), biopsies of whole liver explants obtained at the time of liver transplantation AND cholecystectomies.\n* In the MAFALDA study:\n\nPatients undergoing bariatric surgery for grade 3 obesity (BMI ≥40 Kg\u002Fm2) or grade 2 obesity plus:\n\n* metabolic comorbidities (uncontrolled hypertension, diabetes, dyslipidemia);\n* lack of contraindication to surgery (e.g. advanced liver disease with portal hypertension);\n* willingness to sign an informed consent.\n\nExclusion Criteria:\n\n* Individuals not reporting one of the inclusion criteria listed above or reporting at-risk alcohol intake (\\>30\u002F20 g\u002Fday in M\u002FF), viral and autoimmune hepatitis or other causes of liver disease will be ex- cluded.",{"count":316,"type":23},260,[86],"Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1\u002F2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1\u002F2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1\u002F2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1\u002F2 in human liver organoids\u002Fassembloids.",[320],"NAFLD",[322],"epigenetic",{"date":187,"type":35},{"date":325,"type":35},"2023-03-01",{"date":327,"type":23},"2027-04-30",{"name":41,"class":42},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":339,"conditions":340,"keywords":344,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":71},"100630804","risk-factors-incidence-and-clinical-impact-of-intraluminal-thrombosis-following-fet-and-tevar-100630804","NCT07492433","Risk Factors, Incidence, and Clinical Impact of Intraluminal Thrombosis Following FET and TEVAR","Risk Factors, Incidence, and Clinical Impact of Intraluminal Thrombosis Following the FRozen ElephAnt Trunk (FET) ProCedure and Thoracic Endovascular Repair (TEVAR): A Multicenter rEtrospective Cohort Study","TRACE","Inclusion Criteria:\n\n* age ≥18 years\n* males and females\n* presence of pre- and post-operative CT imaging\n\nExclusion Criteria:\n\n* Patients previously treated with TEVAR or FET",{"count":338,"type":23},800,"Intraluminal thrombosis (ILT) is a significant but underexplored complication in aortic interventions. It is defined as the formation of thrombosis, partially or totally obstructing the lumen, in the surgically treated, stented, or native aorta. In cases of Frozen Elephant Trunk interventions for which are performed regulary for type A dissections, or pathologies such as penetrating aorting ulcers or aneurysm of the distal arch or proximal descending, an ILT can occur early in the postoperative traject and have severe consequences. A recent systematic review and meta-analysis from our group (abstract attached as Annex 1; manuscript pending) analyzed data from 825 patients. and estimated a pooled incidence of ILT of 8.6% \\[95% CI: 5.7-12.9\\]. The included studies reported ILT rates ranging from 6.2% to 16.8% (1-4). Patients with ILT had significantly higher risks of dialysis (43% vs. 16%) and mortality (25% vs. 8%). Risk factors included female gender, older age, and concomitant aortic valve replacement. Despite these findings, the underlying pathophysiology and management strategies for ILT in FET remain poorly defined Intraluminal thrombosis (ILT) is a recognized but poorly studied complication following endovascular thoracic aortic repair (TEVAR). Case reports have described its occurrence, particularly in patients with blunt aortic trauma (5-14), and one study suggested a higher risk of intraluminal narrowing among female patients, associated with increased reoperation rates (15). However, no reliable data exist regarding the overall incidence, risk factors, or clinical outcomes of ILT following TEVAR.\n\nA recent systematic review conducted by our group (abstract attached as Annex 2; manuscript pending) identified 10 case reports and three retrospective studies reporting highly variable ILT rates (5-14, 16-18). A study, focusing on blunt aortic trauma patients, found an ILT incidence of 20.6% in a cohort of 34 patients, while another study observed 2 cases in 97 patients (2.06%), and a third study reported 0 cases in 11 patients (0%). The lack of consistent epidemiological data highlights the necessity of a multicenter cohort study to establish a reliable incidence estimate and investigate potential risk factors and clinical outcomes.\n\nThis study aims to fill the knowledge gap through a multicenter analysis involving patients treated with FET and TEVAR. By identifying risk factors for ILT, describing related outcomes, and evaluating management strategies, the ultimate goal is to improve clinical care and outcomes for patients undergoing these procedures.",[341,342,343],"Intraluminal Thrombosis","Tevar","FET",[345,343,346],"Intraluminal thrombosis","TEVAR","2026-03-19",{"date":208,"type":35},{"date":350,"type":23},"2026-04-01",{"date":69,"type":23},{"name":41,"class":42},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":80,"minAge":51,"maxAge":19,"enrollmentInfo":361,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":71},"100626600","reproductive-prognosis-in-women-seeking-offspring-after-medical-or-surgical-therapy-for-endometriosis-100626600","NCT07437742","Reproductive Prognosis in Women Seeking Offspring After Medical or Surgical Therapy for Endometriosis","La Prognosi Riproduttiva Nelle Donne Che Ricercano Prole Dopo Terapia Medica o Chirurgica Per Endometriosi: Studio Multicentrico Italiano","SURGENDO","Inclusion Criteria:\n\n* age \\\u003C40 years at the time of offspring research\n* previous ultrasound or surgical diagnosis of endometriosis made in one of the endometriosis referral centres participating in the study\n* search for offspring after diagnosis\n* consent to the use of pseudonymised data for research purposes.\n\nExclusion Criteria:\n\n* women without endometriosis\n* age \\>=40 years at the time of the search for offspring\n* women who have undergone demolition surgery\n* women who do not wish to have offspring\n* women who have not given consent for their pseudonymised data to be used for research purposes\n* severe male infertility factor (testicular sperm retrieval)",{"count":362,"type":23},650,"The study aims to compare the percentage of women with endometriosis who undergo PMA after medical vs surgical treatment and to describe conception patterns, pregnancy rates, and number of live vessels in women seeking offspring with endometriosis.",[89,365],"Fertility",[367,368,369,370],"fertility","endometriosis","surgery","PMA","2026-02-24",{"date":373,"type":35},"2026-02-27",{"date":375,"type":35},"2024-10-01",{"date":377,"type":23},"2026-12-31",{"name":41,"class":42},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":50,"minAge":387,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":403,"leadSponsor":405,"locationsCount":215},"100625838","integrated-multimodal-assessment-to-optimize-diagnosis-and-surgical-selection-in-idiopathic-normal-pressure-hydrocephalus-100625838","NCT07427836","Integrated Multimodal Assessment to Optimize Diagnosis and Surgical Selection in Idiopathic Normal Pressure Hydrocephalus","Integrated Multimodal Approach for Diagnostic Optimization and Surgical Candidate Selection in Idiopathic Normal Pressure Hydrocephalus: The Role of CSF Biomarkers, Cognitive-Motor Assessment, and Neuroimaging","NPH-OPTIMIZE","Inclusion Criteria:\n\n* Age 60 years or older.\n* Patients with suspected idiopathic normal pressure hydrocephalus referred to the institutional diagnostic, therapeutic, and care pathway.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.","60 Years","85 Years",{"count":390,"type":23},116,"Idiopathic normal pressure hydrocephalus (iNPH) is a neurological condition that can cause walking difficulties, cognitive impairment, and urinary incontinence. Although iNPH can be treated with cerebrospinal fluid (CSF) shunt surgery, diagnosis is often challenging because its symptoms and brain imaging findings may overlap with those of other neurodegenerative disorders, such as Alzheimer's disease or vascular parkinsonism. As a result, some patients may experience delayed diagnosis or may not be referred for potentially beneficial surgical treatment.\n\nThis observational study aims to evaluate whether combining different types of clinical information can improve the diagnosis of iNPH and help identify patients who are more likely to benefit from surgery. The study integrates cognitive testing, motor performance assessment, CSF biomarker analysis, and brain magnetic resonance imaging.\n\nPatients aged over 60 years with suspected iNPH who are evaluated within a standardized diagnostic care pathway will be included. Cognitive and motor performance will be assessed before and after a cerebrospinal fluid tap test, which is part of routine clinical practice. Results will be compared between patients who receive a confirmed diagnosis of iNPH and undergo CSF shunt surgery and patients who receive an alternative diagnosis and do not undergo surgical treatment.\n\nThe results of this study may help improve diagnostic accuracy, reduce false-negative test results, and support better clinical decision-making in patients with suspected idiopathic normal pressure hydrocephalus.",[393],"Idiopathic Normal Pressure Hydrocephalus",[395,396,397,398],"Cognition","CSF biomarkers","CSF tap test","Gait assessment","2026-02-16",{"date":401,"type":35},"2026-02-23",{"date":67,"type":23},{"date":404,"type":23},"2035-01",{"name":41,"class":42},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":50,"minAge":414,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":84,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":215},"100623864","eit--guided-lung-recruitment-in-pards-100623864","NCT07402174","EIT- Guided Lung Recruitment in pARDS","EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome","REMAV-EIT","Inclusion Criteria:\n\n* Children aged between 1 month and 10 years\n* Diagnosis of pediatric Acute Respiratory Distress Syndrome (pARDS) according to PALICC-2 criteria\n* Invasive mechanical ventilation for less than 48 hours at the time of enrollment\n\nExclusion Criteria:\n\n* Evidence or history of barotrauma (e.g., pneumothorax, pneumomediastinum)\n* Presence of congenital heart disease with hemodynamic significance\n* Known or suspected intracranial hypertension\n* Presence of an implantable cardioverter-defibrillator (ICD)\n* Parental o legal guardian refuse","1 Month","10 Years",{"count":417,"type":23},8,[86],"Study Title:\n\nEIT-Guided Lung Recruitment Maneuvers in Pediatric ARDS: Effects on Ventilation Distribution and Respiratory Mechanics\n\nStudy Objective:\n\nThe primary goal of this clinical trial is to determine whether lung recruitment maneuvers guided by Electrical Impedance Tomography (EIT) result in a more homogeneous ventilation distribution and less injurious ventilation in children with pediatric Acute Respiratory Distress Syndrome (pARDS). The study will assess changes in intrapulmonary gas distribution and respiratory mechanics during recruitment maneuvers using both EIT and partitioned respiratory mechanics.\n\nThis is a prospective cohort study involving children diagnosed with pARDS. Eligible participants will be consecutively enrolled over time and will undergo a standardized series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be individualized and titrated based on the EIT-derived response to recruitment.\n\nMain Research Questions:\n\nHow can lung recruitment maneuvers be performed safely in children with pARDS? How can we monitor the physiological effects of recruitment on respiratory mechanics? How does recruitment influence the distribution of ventilation within the lungs?\n\nEligible participants will undergo a series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be titrated and individualized based on the EIT-derived response to recruitment.",[421],"Acute Respiratory Distress Syndrome",[421,423,424],"EIT","Children","2026-02-03",{"date":67,"type":35},{"date":428,"type":23},"2026-03-01",{"date":430,"type":23},"2027-06-01",{"name":41,"class":42},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":174,"sex":50,"minAge":440,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":443,"conditions":444,"keywords":447,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":71},"100620468","endothelial-colony-forming-cells-in-patients-with-vwd-avws-and-healthy-subjects-100620468","NCT07358013","Endothelial Colony-Forming Cells in Patients With VWD, AVWS and Healthy Subjects","Isolation and Characterization of Endothelial Colony Forming Cells (ECFCs) in Patients Diagnosed With Von Willebrand Disease, Acquired Von Willebrand Syndrome and Healthy Subjects","ECFCs\u002F2022","Inclusion Criteria for patients:\n\nPatients with von Willebrand disease (VWD) or acquired von Willebrand syndrome (AVWS)\n\nAge ≥ 16 years.\n\nPrevious diagnosis of von Willebrand disease or acquired von Willebrand syndrome, defined as one of the following:\n\nGroup A - Type 1 VWD:\n\nVWF levels ≤ 30 IU\u002FdL, regardless of bleeding history, or\n\nVWF levels ≤ 0.50 IU\u002FmL in the presence of abnormal bleeding.\n\nGroup B - Congenital or acquired VWD (VWD or AVWS):\n\nDiagnosis of congenital or acquired VWD, with or without gastrointestinal bleeding.\n\nGroup C - Subgroup study (Type 2A VWD):\n\nOne patient with type 2A VWD selected for a dedicated sub-study involving allele-specific siRNA silencing of the mutant allele.\n\nAbility and willingness to provide written informed consent.\n\nFor patients without prior molecular characterization: willingness to undergo VWF gene sequencing and to sign the related informed consent.\n\nInclusion criteria for healthy volunteers\n\n* No prior diagnosis of VWD, bleeding disorders, or thrombotic disorders.\n* Willingness to donate blood for study procedures.\n* Ability and willingness to provide written informed consent.\n* Age ≥ 18 years.\n\nExclusion criteria for both patients and healthy volunteers:\n\n* Pregnancy.\n* Anemia, as determined at screening or based on medical history.","16 Years",{"count":442,"type":23},48,"The goal of this observational study is to learn how endothelial colony-forming cells (ECFCs) behave in people with von Willebrand disease (VWD), acquired von Willebrand syndrome (AVWS), and in healthy individuals.",[445,446],"Von Willebrand Disease (VWD)","Acquired Von Willebrand Disease",[448,449,450,451],"von Willebrand disease","von Willebrand factor","ex vivo","endothelial colony forming cells (ECFCs)","2026-01-13",{"date":454,"type":35},"2026-01-22",{"date":456,"type":35},"2023-11-11",{"date":458,"type":23},"2028-05-31",{"name":41,"class":42},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":71},"100554853","immunological-and-virological-characterization-of-patients-with-chronic-hbv-hdv-infection-outcomes-and-response-to-bulevirtide-treatment-100554853","NCT06504485","Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment","Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Association With Disease Outcomes and Response to Bulevirtide Treatment","MPR_BD","Inclusion Criteria:\n\n* 18 years of age or older\n* Ability to understand and sign the informed consent\n* Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.\n\nExclusion Criteria:\n\n* Co-infection with other viruses (HCV, HIV)\n* Treatment with immunosuppressive\u002Fimmunomodulatory drugs\n* Other congenital and\u002For acquired immunodeficiency conditions",{"count":469,"type":23},192,"Pharmacological, single-center, non-profit observational study.\n\nThe present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).\n\nHepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV\u002FHDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.\n\nThe study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).",[472],"Hepatitis D",{"date":474,"type":35},"2026-01-15",{"date":476,"type":35},"2024-09-01",{"date":478,"type":23},"2026-02-28",{"name":41,"class":42},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":71},"100544753","rapid-t-cell-analysis-test-in-patients-with-chronic-hbv-and-hbvhdv-disease-100544753","NCT06372990","Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV\u002FHDV Disease","Development of a Rapid T-cell Analysis Test to Guide the Management of Patients With Chronic HBV and HBV\u002FHDV Disease","BDTc","Inclusion Criteria:\n\n* 18 years of age or older\n* ability to understand and sign the informed consent\n* chronic HBV infection or HBV-HDV co-infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months\n\nExclusion Criteria:\n\n* Co-infection with other hepatotropic viruses (HCV, HIV)\n* Treatment with immunosuppressive\u002Fimmunomodulatory drugs\n* Other congenital and\u002For acquired immunodeficiency conditions",{"count":489,"type":23},300,"Prospective, non-pharmacological, single-center, non-profit observational study.\n\nThe study design allows longitudinal evaluation of the immune response during the natural history of the infection and\u002For treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.\n\nThe study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.\n\nThe present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:\n\n* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)\n* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)\n\nThe primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay.",[492,493],"HBV","HBV\u002FHDV",{"date":474,"type":35},{"date":496,"type":35},"2024-04-15",{"date":69,"type":23},{"name":41,"class":42},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":50,"minAge":81,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":84,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":71},"100613869","understanding-gene-environment-interaction-in-alcohol-related-hepatocellular-carcinoma-100613869","NCT07272200","Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma","GENIAL","Inclusion Criteria:\n\nPatients from the EPIDEMIC (approval no. 1822 of 27 August 2013) and SERENA (last amendment no. 1151\\_2021 of 9 November 2021), already approved by the CE Milano Area 2 will be included.\n\n* Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\\\u003C60\u002F40 g\u002Fday in M\u002FF), so that subjects with a moderate alcoholic component of the hepatopathy are also included, Important factor given the high epidemiological weight of this group\n* Any of the following:\n* Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.\n* Willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Alcohol intake \\>60\u002F40 g\u002Fday in M\u002FF\n* Chronic viral or autoimmune hepatitis\n* Any previously diagnosed liver genetic disease associated with increased risk of HCC (such as hereditary hemochromatosis, Wilson's disease, Alpha-1 antitrypsin deficiency)\n* Use of drugs known to induce steatosis and liver disease\n* HCC previously diagnosed the study start date.\n* Other pathological conditions with prognosis less than two years.","75 Years",{"count":508,"type":23},1000,[86],"It has been estimated that alcohol causes around 40% of premature liver deaths in Europe each year, although this number is probably underestimated. Alcohol-related liver disease (ALD) is the most common cause of liver cirrhosis and liver death in Europe with a peak age of deaths occurring among individuals aged 40 to 50. Despite these findings, ALD is little studied with only 5% of all clinical trials in the field of liver disease recorded on ClinicalTrials.gov and only 5% of all publications in the same research area.\n\nLiver cancer is the second most common cause of cancer-related death (15-20% survival at 5 years) and the second most common cause of alcohol-related cancers worldwide.\n\nLike other complex diseases, ALD-HCC results from the interaction between environmental determinants and genetic variations but knowledge of gene-environment interactions is currently lacking in this area. The GENIAL project will address these needs through a comprehensive evaluation of gene-environment interactions concerning ALD-HCC.",[512,513],"HCC","Genetic Predisposition","2025-11-26",{"date":516,"type":35},"2025-12-09",{"date":518,"type":35},"2023-12-01",{"date":520,"type":23},"2028-12-31",{"name":41,"class":42},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":174,"sex":50,"minAge":51,"maxAge":294,"enrollmentInfo":529,"targetDuration":4,"studyType":84,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":71},"100612094","definition-of-the-genomic-landscape-of-masld-100612094","NCT07249112","DEFINITION OF THE GENOMIC LANDSCAPE OF MASLD","DEFINIZIONE DEL PANORAMA GENOMICO DELLA MASLD (DEFINING THE GENOMIC LANDSCAPE OF METABOLIC STEATOTIC LIVER DISEASE)","Inclusion Criteria:\n\nSpecific Inclusion Criteria for Patients with Advanced MASLD:\n\n* Patients with advanced MASLD defined as liver fibrosis ≥2 and\u002For the development of HCC (Hepatocellular Carcinoma);\n* Patients enrolled in the context of the SERENA study and, where applicable, also in the context of the REASON study;\n* Liver biopsy for suspected Non-Alcoholic Steatohepatitis (NASH) at the time of diagnosis;\n* Cholecystectomies;\n* Age \\[40-70 years\\];\n* Patients who have signed the informed consent form.\n\nSpecific Inclusion Criteria for the Control Group:\n\nBlood donors participating in the Liver Bible study aged between 40 and 70 years who are overweight or obese and have at least two of the following risk factors:\n\n* Impaired fasting glucose or Diabetes Mellitus\n* Dyslipidemia\n* Arterial hypertension.\n\nExclusion Criteria:\n\nSpecific exclusion Criteria for Patients with Advanced MASLD:\n\n* Positivity for chronic viral hepatitis (HCV-RNA and\u002For HBsAg);\n* Positivity for other liver diseases such as autoimmune and viral hepatitis (Hepatitis B and C), hereditary hemochromatosis, alpha-1-antitrypsin deficiency, or Wilson's disease.\n\nSpecific Exclusion Criteria for the Control Group:\n\nSubjects with chronic degenerative diseases will be excluded, with the exception of well-controlled hypertension and Type 2 Diabetes Mellitus that does not require pharmacological therapy (as is already standard practice for blood donation eligibility). Also excluded are donors aged \\> 65 and \\\u003C 40 years.",{"count":530,"type":23},2880,[86],"The Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a leading cause of chronic liver disease globally, with a prevalence exceeding 30% in the population. MASLD is strictly associated with insulin resistance and cardiometabolic conditions, and in 20-30% of cases, it can progress to steatohepatitis (MASH), which is characterized by progressive liver damage and inflammation. In patients at higher risk, the disease can lead to the onset of advanced fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). One of the main problems in the clinical management of MASLD is the absence of specific risk biomarkers and the lack of effective treatments, especially for patients with advanced-stage disease.\n\nMASLD has a well-documented and enormous genetic component, with studies having identified several common variants associated with this pathology, such as those in the PNPLA3, TM6SF2, and MBOAT7 genes. However, these variants identified so far only explain a small part of MASLD's heritability, suggesting the contribution of rare loss-of-function (LoF) variants as well. Furthermore, scientific evidence indicates that the accumulation of somatic variants, both in hepatocytes and myeloid cells, could also play a key role in MASLD progression. In particular, clonal hematopoiesis of indeterminate potential (CHIP), which is a condition characterized by the presence of hematopoietic clones with somatic mutations often associated with leukemia and cardiovascular diseases, might favor the onset of hepatocellular carcinoma. However, the evidence available to date is still limited and requires further investigation and studies on larger cohorts.\n\nThe current study therefore aims to deepen this aspect through the analysis of the genetic profile using a Whole-Genome Sequencing (WGS) approach. DNA samples from peripheral blood from patients with advanced MASLD and peripheral blood DNA samples from controls presenting various associated metabolic risk factors will be sequenced.\n\nIn addition, 80 liver tissue samples from patients with advanced MASLD will also be sequenced to identify specific somatic mutations. The expected results from this study include the identification of new genetic variants associated with MASLD progression, the improvement of risk stratification through the development of polygenic risk scores, and the identification of potential therapeutic targets. This study represents a fundamental step for understanding the biology of MASLD and could have important clinical implications for disease management.",[534,535],"Cirrhosis","MASLD","2025-11-21",{"date":538,"type":35},"2025-11-25",{"date":540,"type":35},"2025-09-01",{"date":542,"type":23},"2026-08-31",{"name":41,"class":42},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":84,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":71},"100581895","human-liver-organoids-as-a-model-to-study-the-development-of-non-alcoholic-steatohepatitis-nash-100581895","NCT06856252","Human Liver ORganoids as a Model to Study the Development of Non-Alcoholic SteatOhepatitis (NASH)","Human Liver ORganoids as a Model to Study the Role of the I148M Variant of the PNPLA3 Gene in the Development of Non-Alcoholic SteatOhepatitis (NASH)","REASON","Adult patients who have given consent to participate in the study and listed for the following procedures will be included:\n\n* liver biopsy for suspected non-alcoholic steatohepatitis (NASH) at the time of diagnosis;\n* liver resection for hepatocarcinoma or other liver lesions (including secondaries from other neoplasms and benign focal lesions, which will allow obtaining healthy starting liver tissue);\n* post-transplant healthy liver biopsies;\n* cholecystectomies.\n\nIt will also be required:\n\n* availability to sign informed consent for the study\n* availability of DNA sample for genetic analysis and clinical data,\n* blood sampling for genetic and epigenetic analyzes and analysis of non-coding RNAs (lncRNAs, miRNAs and circRNAs).\n\nPatients will be excluded who present:\n\n* positivity for chronic viral hepatitis (HCV-RNA and\u002For HBsAg);\n* positivity to other liver diseases such as autoimmune and viral hepatitis (hepatitis B and C), hereditary hemochromatosis, alpha-1-antitrypsin deficiency, Wilson's disease.",{"count":275,"type":23},[86],"The primary objective of the study is to generate and characterize three-dimensional models, called \"assembloids\", composed of the main liver cell populations (in particular from the co-culture of organoids with stellate cells, responsible for fibrogenesis, deriving from clinical samples). These models will be used in order to imitate the first phases of the onset of steatohepatitis, in conditions of altered lipid metabolism (induced through exposure to the main environmental determinants of this condition: excess fatty acids, fructose, cholesterol) in the presence or absence of the mutation I148M of PNPLA3. Other genetic variants will also be analyzed, such as TM6SF2, MBOAT7 and GCKR, which have previously been correlated with the development of non-alcoholic steatohepatitis.\n\nFurther objectives will be: 1) identify new biomarkers of pathological activation of human stellate cells and progression of liver damage, to be subsequently validated in clinical case series for future use in clinical management for individual risk stratification; 2) study the epigenetic factors that underlie the onset of non-alcoholic steatohepatitis and its progression to fibrosis, cirrhosis and HCC; 3) evaluate the impact of antisense oligonucleotides directed against PNPLA3 on the severity of the \"steatohepatitic\" phenotype (lipid accumulation, lipotoxicity and inflammation and fibrogenesis) in assembloids",[320],"2025-11-17",{"date":558,"type":35},"2025-11-20",{"date":560,"type":35},"2021-07-01",{"date":562,"type":23},"2032-07-31",{"name":41,"class":42},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":174,"sex":50,"minAge":19,"maxAge":387,"enrollmentInfo":571,"targetDuration":4,"studyType":84,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":71},"100559590","the-liver-biobank-lombardia-of-fatty-liver-100559590","NCT06566105","The Liver BIoBank Lombardia of Fatty Liver","The Liver BIoBank Lombardia Genomic Cohort Study (LIVER-BIBLE): Personalized Medicine for the Management of Hepatic and Cardiovascular Thrombotic Complications of Fatty Liver","Inclusion Criteria:\n\n* Blood donors aged between 40 and 65 years presence of clinical diagnosis of overweight or obesity (body mass index-BMI \\> 25 kg\u002Fm2),\n* increased fasting blood glucose or T2D (fasting blood glucose ≥100mg\u002Fdl) or dyslipidemia (triglycerides≥150mg\u002Fdl, HDL\\\u003C45\u002F55 in M\u002FF) or arterial hypertension (n = 2,452, 11.8% of the entire cohort).\n\nExclusion Criteria:\n\n* subjects suffering from chronic degenerative diseases, except hypertension in good compensation and diabetes type 2 mellitus which does not require pharmacological therapy (as is already common practice for eligibility for donation of blood)\n* donors aged \\> 65 and \\\u003C 40 to avoid the introduction of bias",{"count":572,"type":23},2500,[86],"NAFLD is most frequently linked to excess adiposity, insulin resistance and cardiometabolic risk factors, it has become the leading cause of liver disease worldwide, and is associated with increased mortality due to multiple causes. HFC has a strong genetic component and the investigators recently showed that it plays a causal role in determining progressive liver disease and insulin resistance.\n\nThe genetic risk score predicting liver fat content (HFC-GRS) improves the stratification of liver related events, and the investigators have preliminary data on new common and rare variants that contribute to NAFLD susceptibility, and on a new non-invasive circulating biomarker associated with hepatic fat and lipotoxicity (Interleukin-32). However, no data are yet available on the causal role of hepatic fat on the procoagulant state associated with NAFLD, which could participate to liver damage and is a causal factor in atherothrombotic complications. The aim of the study is to examine the potential application of a precision medicine approach to the improvement of stratification of the risk of liver-related and cardiovascular thrombotic complications of hepatic fat accumulation (HFC) and non-alcoholic fatty liver disease (NAFLD), with a special focus on the role of procoagulant imbalance in mediating the at-risk phenotypes.",[320,576,577],"Precision Medicine","Cardiovascular Diseases",{"date":579,"type":35},"2025-11-18",{"date":581,"type":35},"2020-06-01",{"date":583,"type":23},"2037-12-31",{"name":41,"class":42},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":50,"minAge":81,"maxAge":506,"enrollmentInfo":593,"targetDuration":4,"studyType":84,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":71},"100556290","evaluation-of-risk-of-hepatocellular-carcinoma-100556290","NCT06523179","Evaluation of Risk of hEpatocellular Carcinoma","Study for the Evaluation of Risk of hEpatocellular Carcinoma in NonAlcoholic Fatty Liver","PERSPECTIVE","Inclusion Criteria:\n\n* Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\\\u003C60\u002F40 g\u002Fday in M\u002FF), so as to also include subjects with a moderate alcoholic component of liver disease, an important factor given the high epidemiological burden of this group\n* Age between 45 and 75 years\n* Any of the following criteria:\n* F3-F4 fibrosis, determined histologically, or by non-invasive techniques (stiffness \\> 7.9 kPa at Fibroscan and positivity at the NAFLD fibrosis score or at APRI or at FIB4), or evidence of cirrhosis deriving from biochemical tests or imaging methods;\n* Family history of primary liver cancer in first degree parentage, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT)\n* Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.\n* Willingness to sign the informed consent.\n\nExclusion Criteria:\n\n* Alcohol intake \\>60\u002F40 g\u002Fday in M\u002FF\n* Chronic viral or autoimmune hepatitis\n* Any previously diagnosed genetic liver disease associated with increased risk of HCC (such as hereditary hemochromatosis, Wilson's disease, Alpha-1 Antitrypsin deficiency)\n* Use of drugs known to induce steatosis and liver disease\n* HCC diagnosed before the study start date.\n* Other pathological conditions with a prognosis of less than two years.",{"count":594,"type":23},500,[86],"Hepatocellular carcinoma (HCC) is the fifth most common solid cancer and the second cause of cancer-related mortality worldwide. Nonalcoholic fatty liver disease (NAFLD), that is hepatic accumulation of fat in excess of 5% not explained by at risk alcohol intake, is projected to become the leading cause of HCC in Western countries within 2025.NAFLD is most frequently caused by insulin resistance due to unhealthy lifestyle. Due to the epidemics of obesity and type 2 diabetes, NAFLD now affects one in three individuals worldwide.\n\nNAFLD-HCC frequently develops without overt cirrhosis suggesting that steatosis directly promotes hepatic carcinogenesis.",[598,512,513],"NASH",{"date":558,"type":35},{"date":601,"type":35},"2018-01-01",{"date":603,"type":23},"2035-12-31",{"name":41,"class":42},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":253,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":84,"phases":614,"briefSummary":615,"conditions":616,"keywords":619,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":4},"100610939","the-influence-of-music-on-perceived-pain-and-levels-of-anxiety-while-undergoing-transperineal-prostate-biopsy-the-vivaldi-trial-100610939","NCT07234097","The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial","VIVALDI","Inclusion Criteria:\n\n* Suspected prostate cancer eligible for transperineal prostate biopsy\n* Patients who have signed informed consent\n* Age \\> 50 years\n* Male\n\nExclusion Criteria:\n\n* patients who have had prostate biopsies in the past",{"count":613,"type":23},78,[86],"Prostate biopsy is the key examination for the histological diagnosis of prostate cancer. This procedure can be performed via the transrectal (TR) or transperineal (TP) approach. Current Guidelines recommend the transperineal route because it is associated with fewer infectious complications compared to the transrectal approach. However, when the same type of anesthesia is used, the transperineal approach is more painful.\n\nSeveral strategies have been developed to improve pain management during TR biopsy. Some studies have shown that allowing patients to listen to music during the procedure can reduce perceived pain and stress. However, this effect has never been investigated in TP biopsies, which are now the gold standard and generally more painful than TR biopsies.\n\nPrimary Objective:\n\nTo evaluate the reduction in pain levels in patients undergoing transperineal prostate biopsy with the aid of music compared to patients undergoing the same procedure without music.\n\nSecondary Objectives:\n\nTo evaluate the reduction in stress levels related to the procedure in patients undergoing transperineal prostate biopsy with music compared to those without music.\n\nTo evaluate the reduction in the use of painkillers and sedatives during the procedure in patients undergoing transperineal biopsy with music compared to those without.\n\nTo assess pain management and procedure tolerability in both groups.",[617,618],"Prostate Cancer","Pain Management",[620,621],"pain management","prostate biopsy","2025-11-14",{"date":579,"type":35},{"date":625,"type":23},"2025-12-01",{"date":134,"type":23},{"name":41,"class":42},""]