[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Ospedaliera Universitaria Integrata Verona\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":399},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,47,75,111,140,164,186,215,243,275,306,333,353,376],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100617996","supra-papillary-versus-trans-papillary-biliary-stenting-in-malignant-peri-hilar-stenosis-100617996",false,"NCT07325877","Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis","Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial","SupraBilS","Inclusion Criteria:\n\n1. Radiological\u002F biochemical\u002Fpathological diagnosis of malignant OJ.\n2. Stenosis maximum extent may be 2 cm after biliary confluence.\n3. Documented obstructive jaundice (serum bilirubin \\> 3 mg\u002FdL).\n4. Indication for biliary drainage (preoperative or palliative).\n5. Age ≥ 18 years.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).\n2. Previous sphincterotomy or drainage.\n3. Involvement of the papilla of Vater by the tumour.\n4. Uncontrolled coagulopathy (INR \\> 1.5 uncorrectable or \\\u003C50.000 PLTs).\n5. Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.",[27,28,29],"Biliary Disease Tract","Biliary Stenosis","Biliary Stents",[31,32,33,34],"ERCP","Malignant Biliary Stenosis","Supra-papillary","Trans-Papillary","NOT_YET_RECRUITING","2026-01-03",{"date":38,"type":39},"2026-01-08","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2029-03-01",{"name":45,"class":46},"Azienda Ospedaliera Universitaria Integrata Verona","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100615163","phase-2-early-study-on-tamoxifen-safetytolerability-in-cystic-fibrosis-patients-unable-to-use-cftr-modulators-100615163","NCT07289035","Early Study on Tamoxifen Safety\u002FTolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.","Exploratory Study to Evaluate the Safety and Tolerability of Tamoxifen Citrate in the Treatment of Cystic Fibrosis in Patients Without Mutations Currently Eligible for Therapy With CFTR Modulator Drugs","TMX","Inclusion Criteria:\n\nPatients will be included if they meet all the following inclusion criteria at Visit 1:\n\n1. Subjects of both sexes, affected by cystic fibrosis, attending the CF Center in Verona\n2. Patients who do not have mutations currently eligible for therapy with CFTR modulator drugs\n3. Age 18 years or older\n4. Predicted forced expiratory volume in 1 second (ppFEV1) ≥ 40% and ≤ 90% (of the predicted value for people of their age, sex, and height) before bronchodilator administration\n5. Stable routine CF therapy in terms of dose and medication (inhaled antibiotic cycles, bronchodilator, anti-inflammatory, inhaled corticosteroid, physiotherapy technique\u002Fschedule) within 28 days prior to Day 1\n6. Clinically stable respiratory disease within 3 weeks before Day 1 (first dose of study drug)\n7. Subjects able to perform reliable and reproducible pulmonary function test maneuvers\n8. Subjects able to communicate well with the investigator, understand, and comply with the study requirements\n9. Female subjects must have a negative serum pregnancy test\n10. Sexually active subjects able to follow the contraceptive methods defined within the protocol (non-hormonal contraception) during the study and for 2 months after study discontinuation\n11. Signed informed consent for participation in the study and for the processing of personal data.\n\nExclusion Criteria:\n\nPatients will be excluded if one or more of the following criteria are met at Visit 1:\n\n1. Patients on any CFTR modulator therapy\n2. Pulmonary exacerbations within 3 weeks before Day 1 (first dose of study drug)\n3. Changes in therapy for lung disease within 3 weeks before Day 1 (first dose of study drug)\n4. Family and\u002For personal history of thromboembolism and thromboembolic conditions up to 1st-degree relatives\n5. Documented hereditary thrombophilia (hypercoagulability), e.g., protein C, protein S, and antithrombin deficiency; factor V G169A Leiden, prothrombin G20210A (PT20210A), elevated factor VIII levels, hereditary dysfibrinogenemia\n6. History of solid organ or hematopoietic transplant\n7. History of hypersensitivity to the study drug or drugs of similar chemical classes or any excipients\n8. History or presence of prolonged QT interval (QTcB \\> 450 msec)\n9. History of malignancy in any organ system (other than localized basal cell carcinoma of the skin) in the last 5 years\n10. Hemoglobin levels \\\u003C 9.0 g\u002Fdl\n11. Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or that may jeopardize the subject in case of participation in the study\n12. History of immunodeficiency diseases\n13. History of drug or alcohol abuse\n14. History of any disease or condition that, in the investigator's opinion, could confound the study results\n15. Abnormal liver function, defined as ≥ 3 times the upper limit of normal (ULN) for any of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), total bilirubin.\n16. Presence at baseline visit of endometrial polyps or vaginal symptoms (e.g., blood discharge, spotting, staining)\n17. Participation in a clinical study where an investigational drug was administered within 30 days prior to enrollment in the study or 5 half-lives of the study drug, whichever is longer\n18. Female patients who are pregnant or breastfeeding or who wish to become pregnant during the clinical study period and within one month after the end of the study\n19. Female patients of childbearing potential who do not use adequate contraception. A woman is considered of childbearing potential (WOCBP), i.e., fertile, after menarche and until reaching post-menopause, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as the absence of menstruation for 12 months without an alternative medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of menstrual cycle, a single FSH measurement is not sufficient.\\* \\*Low failure rate contraceptive methods (less than 1% per year) if used consistently, including: some intrauterine devices, abstinence, or vasectomized partner. Contraception must be maintained until 1 month after the last visit.",{"count":56,"type":21},35,[58],"PHASE2","The goal of this clinical trial is to evaluate the safety and tolerability of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.\n\nThe main questions it aims to answer is:\n\n. What medical problems do participants have when taking drug TMX?\n\nParticipants will:\n\n* Take drug TMX every day for 6 months\n* Visit the clinic once every 28 days for checkups and tests",[61],"Cystic Fibrosis - Complete",[63,64,65],"Cystic Fibrosis","Tamoxifen","CaCC","2025-12-04",{"date":68,"type":39},"2025-12-17",{"date":70,"type":21},"2026-01-15",{"date":72,"type":21},"2027-02-01",{"name":45,"class":46},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":74},"100598002","tumor-rupture-during-robotic-partial-nephrectomy-100598002","NCT07065825","Tumor Rupture During Robotic Partial Nephrectomy","A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis","RUPTURE","Inclusion Criteria:\n\n* Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection)\n* Patients who provide informed consent to participate\n* Patients from 18 to 80 years of age.\n\nExclusion Criteria:\n\n* Patients undergoing radical nephrectomy or other nephron-sparing procedures.\n* Patients undergoing partial nephrectomy with other approaches (open, pure laparoscopic)\n* Patients with multiple ipsilateral tumors\n* Patients diagnosed with genetic abnormalities that increase the likelihood of developing renal cell carcinoma.\n* Patients who deny consent.","80 Years",{"count":85,"type":21},100,"5 Years","OBSERVATIONAL","The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear.\n\nThe study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed.\n\nBy analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.",[90,91],"Kidney Cancer","Renal Neoplasms",[93,94,95,96,97,98,99,100,101,102],"robotic","robotic surgery","partial nephrectomy","tumor rupture","tumour rupture","tumor resection","kidney cancer","small renal mass","robotic partial nephrectomy","robot-assisted partial nephrectomy","2025-07-11",{"date":105,"type":39},"2025-07-15",{"date":107,"type":21},"2025-09",{"date":109,"type":21},"2030-12",{"name":45,"class":46},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":119,"minAge":120,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":74},"100598421","non-inferiority-study-of-contrast-enhanced-digital-mammography-cedm-vs-magnetic-resonance-imaging-mri-in-terms-of-diagnostic-accuracy-in-patients-undergoing-preoperative-staging-of-established-invasive-breast-cancer-100598421","NCT07071272","Non-inferiority Study of Contrast-enhanced Digital Mammography (CEDM) vs Magnetic Resonance Imaging (MRI) in Terms of Diagnostic Accuracy in Patients Undergoing Preoperative Staging of Established Invasive Breast Cancer","Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)","CEDM-VR","Inclusion Criteria:\n\n* women in pre-hospitalization with already established invasive breast cancer (T1-2)\n* over the age of 30\n* with BI-RADS mammography pattern\\> 1\n* Written and signed informed consent for research\n* Negative history of adverse events to the use of iodinated and chelated contrast media of gadolinium\n* No significant renal impairment (EGFR\\> 30 mL \u002F min within three months before administration of the iodinated contrast medium)\n\nExclusion Criteria:\n\n* women with breast implants\n* women under the age of 30\n* Any contraindication to performing the MRI exam\n* Women with known BRCA 1 and BRCA 2 mutation","FEMALE","30 Years",{"count":122,"type":21},216,[24],"The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy.\n\nIn addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned.\n\nIn patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment.\n\nThe study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.",[126],"Breast Cancer",[128,129,130],"CEM","breast cancer","breast MR","RECRUITING","2025-07-08",{"date":134,"type":39},"2025-07-17",{"date":136,"type":39},"2020-09-01",{"date":138,"type":21},"2026-12-31",{"name":45,"class":46},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":74},"100462595","phase-3-pipac-in-multimodal-therapy-for-patients-with-oligometastatic-peritoneal-gastric-cancer-100462595","NCT05303714","PIPAC in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer","Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Multimodal Therapy for Patients with Oligometastatic Peritoneal Gastric Cancer: a Randomized Multicenter Phase III Trial: PIPAC_VEROne","PIPAC_VEROne","Inclusion Criteria:\n\n* Primary resectable gastric cancer with positive peritoneal cytology and\u002For low burden peritoneal metastases (PCI ≤6) confirmed by laparoscopy\n* Signature of written informed consent\n* ECOG PS 0-1\n\nExclusion Criteria:\n\n* Extraperitoneal metastases\n* PCI \\>6\n* Gastro-esophageal junction tumor of esophageal relevance (Siewert I-II)\n* Previous allergic reactions to cisplatin or doxorubicin\n* Hemorrhagic or occlusive manifestation of the primary tumor with palliative surgery needed\n* ASA IV\n* Positivity for EBV, MSI and HER2 on diagnostic biopsies\n* Pregnancy and breastfeeding\n* Contraindication to any drug contained in the chemotherapy regimen\n* Hepatic impairment (AST\u002FALT\\> 3 times normal values, ALT\\>3 times normal values, Bilirubin\\>1.5 normal values)\n* Ischemic\u002Fhemorrhagic stroke in the last 6 months\n* Acute myocardial infarction in the last 6 months\n* Moderate\u002Fsevere heart failure (NYHA III-IV)\n* Leukopenia\\\u003C 2,000\u002Fμl\n* Thrombocytopenia \\\u003C 100,000\u002Fμl\n* Active hepatitis B or C\n* HIV infection\n* Creatinine clearance less than 30 ml\u002Fmin","75 Years",{"count":150,"type":21},98,[152],"PHASE3","Peritoneal Carcinomatosis is the most frequent site of metastases observed in patients with gastric cancer. Current standard treatment for these patients is palliative systemic chemotherapy, but the prognosis is very poor. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) resulted in long-term benefits in selected patients with limited peritoneal involvement. Indeed, among patients with Peritoneal Carcinomatosis, a distinctive subset is oligometastatic disease which is characterized by low metastatic burden. PIPAC is a recent technique of intraperitoneal chemotherapy that can be used in combination with systemic chemotherapy with promising results for patients with PM from gastric cancer. The role of PIPAC in multimodal treatment path for oligometastatic gastric cancer should be investigated in clinical trials. PIPAC VER-One is a prospective, randomized, multicenter phase III clinical trial with two arms that aims to evaluate the effectiveness of the use of PIPAC in combination with systemic chemotherapy in patients with Gastric Cancer and synchronous positive peritoneal cytology and\u002For limited peritoneal metastases (PCI ≤ 6). Patients will be randomized into two arms: arm A (control) treated with the current standard that is systemic chemotherapy only and Arm B (experimental) treated with a bidirectional scheme including PIPAC and systemic chemotherapy (1 PIPAC every 2 systemic chemotherapy cycles). Primary endpoint is the Secondary Resectability Rate. Secondary endpoints are: Overall Survival, Progression Free Survival, Disease Free Survival, histological response assessed both on primary tumor and peritoneal lesions, Quality of Life, complication rate (CTCAE v5), incremental cost-effectiveness ratios (ICER).",[155],"Oligometastatic Gastric Adenocarcinoma","2025-02-19",{"date":158,"type":39},"2025-02-21",{"date":160,"type":39},"2022-03-31",{"date":162,"type":21},"2028-09-30",{"name":45,"class":46},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":74},"100579149","gallbladder-stenting-in-fc-sems-100579149","NCT06820541","Gallbladder Stenting in FC-SEMS","Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study","Inclusion Criteria:\n\n* Adult patients\n* Signed informed consent\n* Patients requiring covered metal stent placement for managing MBO\n* High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:\n* tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;\n* presence of at least 2 of the following:\n\n  1. gallbladder stones;\n  2. CBD diameter ≤ 10 mm;\n  3. intraprocedural gallbladder opacification;\n  4. cystic duct orifice at risk of being covered by the fully-covered stent\n\nExclusion Criteria:\n\n* History of cholecystectomy\n* Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation\n* Patients with previous gallbladder drainage\n* Acute cholecystitis is already present based on the Tokyo guidelines",{"count":172,"type":21},80,[24],"The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.\n\nThe main question it aims to answer is:\n\nDoes prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.\n\nParticipants will:\n\n1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement\n2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis",[176,177],"Biliary Obstruction","Acute Cholecystitis","2025-02-06",{"date":180,"type":39},"2025-02-11",{"date":182,"type":21},"2025-03-01",{"date":184,"type":21},"2026-10-01",{"name":45,"class":46},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":74},"100538407","comparison-of-outcomes-of-multiple-platforms-for-assisted-robotic-kidney-compar-k-100538407","NCT06290427","Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)","Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney","COMPAR-K","Inclusion Criteria:\n\n* patient aged between 18 and 90 years old;\n* patient with localized kidney tumor suitable for partial nephrectomy;\n* patient able to understand and sign the informed consent;\n* patient compliance with the follow-up program.\n\nExclusion Criteria:\n\n* patient who do not fall within the inclusion age range;\n* patient not suitable for partial nephrectomy;\n* patient unable to understand and sign the informed consent;\n* patient unable to follow the monitoring program;\n* patient refusal to participate to the study.","90 Years",{"count":196,"type":21},30,[24],"The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:\n\n* DaVinci®;\n* Hugo®.\n\nThe questions it aims to answer are:\n\nDoes the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?\n\nParticipants will be invited to join one of these two experimental group:\n\n1. surgery with the DaVinci platform;\n2. surgery with the Hugo platform.",[200],"Renal Carcinoma",[202,203,204,205,206],"Robotic-assisted surgery","Partial Nephrectomy","Multiple surgical platforms","Postoperative complications","Operative outcomes","2025-01-02",{"date":209,"type":39},"2025-01-03",{"date":211,"type":39},"2024-02-01",{"date":213,"type":21},"2025-06",{"name":45,"class":46},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":230,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":74},"100562029","insulin-resistance-and-coronary-microvascular-dysfunction-in-patients-with-myocardial-ischemia-and-non-obstructive-coronary-artery-disease-100562029","NCT06597851","Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease","IRIN","Inclusion Criteria:\n\n* Aged over 18 years.\n* Cardiac chest pain with evidence of myocardial ischemia at noninvasive myocardial stress imaging and clinical indication to diagnostic coronary angiography\n* Willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Obstructive CAD (defined as more than 70% luminal stenosis and\u002For FFR ≤0.80 in 1 or more epicardial vessels).\n* History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery.\n* Diagnosis of type II diabetes.\n* BMI ≥ 35 kg\u002Fm2.\n* Stage IV and V of chronic kidney disease (eGFR ≤ 30 ml\u002Fmin, estimated through CKD - EPI Creatinine Equation).\n* Allergy or other contraindication to iodinated contrast and\u002For gadolinium and\u002For adenosine.\n* Chronic resting O2 saturation ≤ 85%.\n* Pregnancy or suspected pregnancy.",{"count":223,"type":21},40,[24],"The goal of this prospective study is to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.\n\nPatients with ANOCA and without diabetes will undergo invasive coronary microvascular assessment through coronary angiography and insulin resistance assessment through hyperinsulinemic-euglycemic clamp test.\n\nPatients enrolled in the study will be followed for a period of 2 years to monitor their clinical status.",[227,228,229],"Coronary Microvascular Dysfunction","Coronary Microvascular Disease","Insulin Resistance",[227,228,229,231,232,233,234],"INOCA","ANOCA","CMD","hyperinsulinemic-euglycemic clamp test","2024-09-12",{"date":237,"type":39},"2024-09-19",{"date":239,"type":39},"2024-06-24",{"date":241,"type":21},"2026-06-30",{"name":45,"class":46},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":251,"sex":17,"minAge":252,"maxAge":83,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},"100526711","telepsychiatry-for-social-isolation-in-youths-100526711","NCT06138301","Telepsychiatry for Social Isolation in Youths","Digital Interventions for Social isOLation In youThs And theIR familiEs","SOLITAIRE","Inclusion Criteria:\n\nPatients with SI:\n\n* age11-17 years (adolescents) 18-45 years (adults)\n* moderate-to-high levels of SI as detected by clinical evaluation and confirmed by the HQ-25 score\n* stable pharmacotherapy and symptomatology in the last 3 months\n* not being in psychotherapy or being willing to interrupt it during the study\n* have an internet connection\n\nCaregivers:\n\n* Age ≤ 80\n* no history of psychotic spectrum disorders\n* have a first-degree relative with moderate-to-severe SI\n* have an internet connection\n\nExclusion Criteria:\n\nAll participants:\n\n* primary medical conditions or vision\u002Fhearing deficits that interfere with the ability to participate in the project\n* suicidal Ideation\n* IQ \\\u003C 70",true,"11 Years",{"count":172,"type":21},[24],"This clinical trial aims to implement multimodal digital interventions for adolescents and young adults with social isolation (SI) and their family members. Furthermore, the neurobiological basis of SI will be explored by analyzing blood neuroinflammation biomarkers in socially isolated participants.\n\nThe main questions that this project aims to answer are:\n\n* What is the general feasibility and applicability of the proposed digital interventions?\n* What is the effect of the proposed digital interventions on the SI-related clinical symptoms and the cognitive and global functioning of participants with SI?\n\nParticipants will be asked to undergo:\n\n* A detailed clinical and neuropsychological evaluation (pre-post treatment)\n* A blood sample (pre-post treatment)\n* A telepsychiatry intervention (cognitive behavioural therapy (CBT) and\u002For cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members)\n\nThe researchers will compare SI participants treated with CBT+CR (experimental group) with SI patients treated only with CBT (control group) to see if the combined intervention of the experimental group leads to more durable and generalizable effects.\n\nThe same PE intervention will be offered to the family members of all recruited SI participants.",[257,258],"Social Isolation","Psychosocial Problem",[257,260,261,262,263,264,265],"Telepsychiatry","Digital health","Cognitive remediation","CBT","Psychotherapy","Loneliness","2024-07-29",{"date":268,"type":39},"2024-07-30",{"date":270,"type":39},"2023-09-01",{"date":272,"type":21},"2025-05",{"name":45,"class":46},2,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":292,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100543504","microvascular-dysfunction-assessment-to-predict-left-ventricular-reverse-remodeling-100543504","NCT06356727","Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling","Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy","MICROREV","Inclusion Criteria:\n\n* Male or female, aged \\>18 years\n* First diagnosis of idiopathic DCM (defined according to the most recent ESC Guidelines) with LVEF ≤ 40% and clinical indication to diagnostic coronary angiography\n* Willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Obstructive CAD (defined as angiographically intermediate disease \\[50%-70%\\] with impaired FFR or as angiographically severe disease \\[\\>70%\\] in 1 or more epicardial vessels)\n* History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery\n* Valvular heart disease (rheumatic heart disease, severe aortic stenosis, severe aortic regurgitation, severe primary mitral regurgitation)\n* Infective endocarditis\n* Congenital heart disease\n* Peripartum cardiomyopathy\n* Acute myocarditis (detected by endomyocardial biopsy - histological criteria - or by CMR - Lake Louis criteria) and pericarditis\n* Persistent tachyarrhythmias (documented persistent high-rate supraventricular arrhythmias)\n* Excessive alcohol intake (\\>80 g\u002Fdie for at least five years)\n* History of chemotherapy (anthracycline therapy, cumulative dosages \\>250 mg\u002Fm2)\n* History of uncontrolled arterial hypertension (blood pressure \\>160\u002F100 mmHg)\n* Stage IV and V of chronic kidney disease (eGFR \\\u003C 30 ml\u002Fmin, estimated through CKD - EPI Creatinine Equation)\n* Allergy or other contraindication to iodinated contrast and\u002For adenosine\n* Chronic resting O2 saturation \\\u003C85%\n* Pregnancy or suspected pregnancy","85 Years",{"count":285,"type":21},190,[24],"Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \\\u003C40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance.",[289,290,291],"Heart Failure","Left Ventricular Dysfunction","Idiopathic Dilated Cardiomyopathy",[293,294,295,296],"coronary microvascular dysfunction","heart failure","left ventricular reverse remodeling","optimal medical therapy","2024-04-09",{"date":299,"type":39},"2024-04-10",{"date":301,"type":39},"2024-01-03",{"date":303,"type":21},"2030-01-31",{"name":45,"class":46},9,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":251,"sex":17,"minAge":4,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":4},"100529744","targeted-approach-to-prevent-early-obesity-100529744","NCT06177756","Targeted Approach to Prevent Early Obesity","TAPEObesity","Inclusion Criteria:\n\n* New-borns\n* Parent\u002FGuardian's informed consent\n\nExclusion Criteria:\n\n* Severe prematurity or congenital disease or anomaly or perinatal complication likely to imply long-term consequences on the child possibility to be fed and to grow physiologically (COBRISC is intended to be used to predict childhood obesity in healthy infants and the TAPE-Obesity trial does not provide specific programmes for children with impaired capacity to thrive physiologically)\n* Family unavailability to plan a regular follow-up at the local Paediatric Obesity Centre","5 Days",{"count":315,"type":21},3000,[24],"Lead: UNIVR, Partners involved: UNIME, CHU Lille, INSERM-Lille\n\nThis is a multi-center (UNIVR, UNIME, CHU Lille) randomized controlled trial aiming at evaluating the effect of a selective intervention directed to parents of newborns. 1500 subjects will be recruited in both arms and evaluated with the \"Childhood Obesity Risk Score\" (COBRISC), thanks to anamnestic\u002Fclinical evaluations and molecular profiling (polygenic risk score) made at the child's birth. Participants of the intervention arm at the top tertile (33%) of the COBRISC, will access an intensive follow-up program (four visits\u002Fyear on average, with anthropometric monitoring) at the local Obesity Tertiary Center. This will include educating parents on the appropriate diet, active lifestyle from the first year of life, regular self-monitoring of their child's anthropometry, appropriate dietary composition and portion control, as well as tailor-made nutritional suggestions. To ensure a patient-centred approach, the parents participating in the intensive follow-up program will annually give their feedback and suggestions by an anonymous online survey, whose results will be used to adapt interventions according to parents' requests, as possible and appropriate. The children of the intervention arm classified as not-at-risk will benefit from a \"soft\" intervention, consisting in the access to an educational website specially implemented with interactive tools for growth self-monitoring and diverse lifestyle suggestions. The children of the whole comparator arm will benefit from routine well visits from their general practitioner\u002Fpaediatrician.\n\nThis is based on the following rationale that: (i) targeted approaches imply higher motivation and commitment for parents, more intense care for families and more effectiveness and cost-effectiveness, compared to traditional population-based interventions; and (ii) early preventive trials have not demonstrated durable effects after the end of the intervention (no cascade effect), while uninterrupted intervention and follow-up from infancy to late childhood have proved long lasting results.\n\nThe following end-points will be evaluated: Primary: overall percentage of children growing on an obesity trajectory at three years of age in the intervention compared to the comparator arm. Secondary: percentage of children growing on an obesity trajectory at three years of age in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm; physical activity and sedentary behavior at 1.5 years of age (EY-PAQ questionnaire), responsive feeding (Infant Feeding Styles Questionnaire (IFSQ) at 1.5 years of age, and dietary composition at three years of age (dietary diary and food frequency questionnaire) in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm. All the children will be measured at the tertiary centre, at one, two and three years of age, and afterwards at six and ten years of age.\n\nAll the intervention components will comply with the ESPGHAN Guidelines about infant feeding and complementary feeding, the Italian Consensus on Prevention and Treatment of Childhood Obesity, the Italian Reference Levels of Assumption of Nutrients and Energy, and the French Ministerial Recommendations about Nutrition and Physical Activity for infants and children.\n\nWho does what: UNIVR will be in charge of the study protocol writing. UNIVR will also provide Italian and French centers with educational and monitoring materials, including the web-based tool for parents. UNIVR will provide monitoring to all centers and will be in charge of deliverables, data analyses, and results publication. INSERM-Lille will perform DNA microarrays and risk assessments in all recruited newborns.",[319],"Obesity, Pediatric",[321,322,323,324],"Obesity","Pediatric","Prevention","Nutrition","2023-12-11",{"date":327,"type":39},"2023-12-20",{"date":329,"type":21},"2024-05-01",{"date":331,"type":21},"2028-05-01",{"name":45,"class":46},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":340,"enrollmentInfo":341,"targetDuration":120,"studyType":87,"phases":4,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":74},"100504246","prospective-registry-of-young-adult-patients-diagnosed-with-pancreatic-cancer-100504246","NCT05845801","Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer","PanC-YOUNG","Inclusion Criteria:\n\n* Age ≤55 years old at the time of diagnosis of pancreatic cancer\n* Age ≥ 18 years\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Any pancreatic neoplasm other than pancreatic cancer (e.g. cholangiocarcinoma, ampullary cancer,duodenal cancer, non-invasive mucinous cystic neoplasm, pancreatic intra-epithelial neoplasia 1 and 2, non-invasive intraductal papillary mucinous neoplasm, serous cystic neoplasm, pseudo papillary solid tumor, neuroendocrine tumor)\n* Absence of informed consent.\n* Age \\\u003C 18 years or \\> 55 years old at the time of diagnosis of pancreatic cancer","55 Years",{"count":315,"type":21},"The objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.",[344],"PDAC - Pancreatic Ductal Adenocarcinoma","2023-05-03",{"date":347,"type":39},"2023-05-06",{"date":349,"type":39},"2022-12-07",{"date":351,"type":21},"2052-09-30",{"name":45,"class":46},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":74},"100496143","trial-to-compare-different-strategies-of-mean-arterial-pressure-management-during-cardiopulmonary-by-pass-100496143","NCT05740397","Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass","Mean Arterial Pressure (MAP) Trial: Study Protocol for a Multicenter, Randomized, Controlled Trial to Compare Three Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass","MAP","Inclusion Criteria:\n\n* Elective surgery\n* Index of surgical risk Euroscore II \\\u003C 9%\n* The following procedures will be considered: Isolated or combined with aortic or mitral valve surgery coronary artery bypass graft surgery for acute or chronic coronary artery disease isolated aortic valve replacement for aortic stenosis and\u002For aortic regurgitation ; isolated mitral valve repair or replacement for mitral stenosis and\u002For mitral regurgitation; isolated ascending aorta surgery with or without aortic valve replacement\n* Surgical approach through complete and\u002For mini-sternotomy\n* Preserved or mildly reduced left ventricular ejection fraction (LVEF ≥ 40%) at preoperative echocardiography\n* Patients with an estimated Glomerular filtration rate (eGFR) ≥ 40 ml\u002Fmin\u002Fmq calculated using the Modification of Diet in Renal Disease formula (MDRD)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years and \\>80 years\n* Reoperation\n* Emergent, urgent and salvage procedures\n* Euroscore II \\> 9%\n* Right toracothomy procedures\n* Any surgical procedure not listed above (i.e. tricuspid valve surgery, aortic root surgery, congenital heart diseases, surgery necessitating hypotermic circulation arrest, surgical ablation of atrial fibrillation etc.)\n* More than mild left ventricular dysfunction at preoperative echocardiogram (LVEF \\\u003C 40%)\n* Patients with critical preoperative state: any ventricular fibrillation or ventricular tachycardia, preoperative cardiac massage, preoperative ventilation before anaesthetic room, preoperative inotropes or mechanical circulatory support planned before cardiac intervention (i.e. during coronary angiography) and other conditions according to Euroscore II definition.\n* Patients with an estimated eGFR \\\u003C 40 ml\u002Fmin\u002Fmq calculated using the MDRD or patients on dialysis.\n* Patients with chronic obstructive pulmonary disease \\> 3 stage according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 classification.\n* Patients with severe preoperative epatic failure (CHILD-PUGH ≥ B)\n* Patient with severe symptomatic carotid atheromasia",{"count":362,"type":21},900,[24],"* Background: One of the main goals of the Cardiopulmonary By-Pass (CPB) is targeting an adequate Mean Arterial Pressure (MAP), in order to maintain appropriate perfusion pressures in all end-organs during heart surgery. As inheritance of early studies, a value of 50-60 mmHg has been historically accepted as the \"gold standard\" MAP. However, in the last decades, the CPB management has remarkably changed, thanks to the evolution of technology and the availability of new biomaterials. Therefore, as already highlighted by the latest European Guidelines, the current management of CPB can no longer refer to those pioneering studies. To date, only few single-centre studies have compared different strategies of MAP management during CPB, but with contradictory findings and without achieving a real consensus. Therefore, what should be the ideal strategy of MAP management during CPB is still on debate. This trial will be the first multicentre, randomized, controlled study to compare three different strategies of MAP management during the CPB.\n* Methods: We described herein the methodology of a multicenter, randomized, controlled trial comparing three different approaches to MAP targeting during CPB in patients undergoing elective cardiac surgery: the historically accepted \"standard MAP\" (50-60 mmHg), the \"high MAP\" (70-80 mmHg) and the \"patient-tailored MAP\" (comparable to the patient's preoperative MAP). It is the aim of the study to find the most suitable management in order to obtain the most adequate perfusion of end-organs during cardiac surgery. For this purpose, the primary endpoint will be the peak of serum lactate (Lmax) released during CPB, as index of tissue hypoxia. The secondary outcomes will include all the intraoperative parameters of tissues oxygenation and major post-operative complications related to organ malperfusion.\n* Discussion: This trial will assess the best strategy to target the MAP during CPB to further improve the outcomes of cardiac surgery.",[366],"Heart; Surgery, Heart, Functional Disturbance as Result",[368],"Cardiopulmonary by-pass","2023-02-13",{"date":371,"type":39},"2023-02-23",{"date":373,"type":39},"2021-05-03",{"date":138,"type":21},{"name":45,"class":46},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":385,"studyType":87,"phases":4,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":74},"100347740","registry-of-pancreatic-disease-100347740","NCT03807687","Registry of Pancreatic Disease","Registry of Subjects Affected by Pancreatic Disease and Evaluated at the Pancreas Institute of Verona","PAD-R","Inclusion Criteria:\n\n* any type of pancreatic disease: inflammatory and neoplastic (including solid and cystic lesions)\n\nExclusion Criteria:\n\n* physically or mentally inability to provide consent",{"count":315,"type":21},"27 Years","This clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. All data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and\u002For video recording from operative room are collected in order to be used for prospective or retrospective studies.",[388,389,390],"Pancreatic Diseases","Pancreatic Neoplasms","Pancreatitis","2019-01-15",{"date":393,"type":39},"2019-01-17",{"date":395,"type":39},"2016-12-01",{"date":397,"type":21},"2046-12-01",{"name":45,"class":46},""]