[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100644712","new-biomarkers-for-organ-viability-assessment-during-hypothermic-machine-perfusion-in-liver-transplantation-the-role-of-extemporaneous-histological-examination-100644712",false,"NCT07674394","New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.","LOVE","Inclusion Criteria:\n\n1. Adult liver transplant recipients (≥18 years of age).\n2. Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD).\n3. Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation.\n4. Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion.\n5. Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution.\n6. Informed consent obtained from the recipient (or legal representative, where applicable) for the use of clinical and histological data for research purposes.\n\nExclusion Criteria:\n\n1. Inadequate or fragmented biopsy samples, preventing proper histological evaluation.\n2. Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis).\n3. Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques.\n4. Organs undergoing experimental or non-standard perfusion protocols.\n5. Grafts from donors \\\u003C18 years of age.\n6. Recipient refusal or inability to provide informed consent.\n7. Technical failure during perfusion (e.g., incomplete perfusion due to device malfunction or vascular anomalies).\n8. Known malignancy in the donor with potential liver involvement, excluding donors with small incidentalomas as per standard guidelines.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. To improve the quality of these organs before transplantation, many centers use hypothermic oxygenated machine perfusion (HOPE or D-HOPE), a technique that preserves the liver under cold, oxygenated conditions. However, there are currently no widely accepted methods to determine whether a liver is functioning well enough during this preservation process.\n\nThe purpose of this study is to investigate whether changes observed in liver tissue during hypothermic machine perfusion can help predict how well the transplanted liver will function after surgery. The study will compare liver biopsy samples collected before and after one hour of perfusion and will analyze biological markers released into the perfusion fluid, including markers of mitochondrial injury and inflammation.\n\nThe main question this study aims to answer is whether histological changes occurring during hypothermic perfusion, alone or in combination with biochemical biomarkers, can accurately predict liver graft viability and post-transplant outcomes. Researchers will also evaluate whether these data can be used to develop an artificial intelligence-based model to support clinical decision-making during organ preservation.\n\nA total of 150 adult liver transplant recipients receiving donor livers treated with HOPE or D-HOPE will be enrolled at three Italian liver transplant centers. Participants will be followed for 90 days after transplantation to assess liver graft function, graft survival, patient survival, and post-transplant complications.\n\nThe results of this study may improve the assessment of donor liver quality before transplantation and help clinicians make more informed decisions about organ use, ultimately increasing the safety and effectiveness of liver transplantation.",[26,27,28,29],"Liver Transplantation (LT)","Early Allograft Dysfunction","Primary Non-function","Ischemia-Reperfusion Injury",[31,32,33,29,34],"liver transplantation","Early Allograft Dysfunction (EAD)","Primary Non-Function (PNF)","Liver Graft Viability Assessment","NOT_YET_RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":20},"2026-07",{"date":43,"type":20},"2029-06",{"name":45,"class":46},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100578694","phase-3-role-of-nutritional-intervention-for-the-treatment-of-sarcopenia-in-cirrhotic-patients-with-refractory-ascites-candidate-to-transjugular-intrahepatic-portosystemic-shunt-placement-and-identification-of-prognostic-factors-related-to-clinical-outcome-100578694","NCT06814626","Role of Nutritional Intervention for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome","Role of Nutritional Intervention with Friliver for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome","NS-TIPS","Inclusion Criteria:\n\n* men and women with an age ≥ 18 and ≤ 80 years\n* clinical, radiological or histological diagnosis of liver cirrhosis\n* diagnosis of RA\n* confirmation of sarcopenia defined in CT scan as the sum of the psoas muscle areas measured at the level of the 3rd lumbar vertebra (PMA) ≤16 cm2\n* informed consent signed\n\nExclusion Criteria:\n\n* severe hepatic insufficiency (bilirubin\\> 5 mg\u002Fdl, MELD score\\> 18, Child-Pugh score\\> 9)\n* Congestive heart failure class ≥2 according to New York Heart Association criteria (NYHA)\n* Active coronary heart disease (myocardial infarction within 6 months of the study)\n* Severe pulmonary hypertension suspected on echocardiogram (systolic pulmonary arterial pressure \\[PAPs\\]\\> 35 mmHg) and confirmed with right cardiac catheterization (PAPs\\> 45mmHg)\n* Chronic renal failure (creatinine\\> 3 mg\u002Fdl)\n* Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG)\n* History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months\n* Uncontrolled systemic sepsis\n* Presence of Hepatocellular carcinoma\n* Complete portal vein thrombosis\n* Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy)\n* Diagnosis of extra hepatic neoplasia\n* Transplant recipients\n* Patients unable or unwilling to comply with the protocol requirements\n* Pregnant or lactating women\n* Patients unable to autonomously express their consent (incapable patients)\n* any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study","80 Years",{"count":57,"type":20},72,[59],"PHASE3","The hypothesis is that in patients with cirrhosis and refractory ascites candidate to TIPS, and sarcopenia (identified by a PMA ≤16 cm² at the level of L3), who are at high-risk of 6-month mortality after TIPS placement, a post-TIPS 12 weeks nutritional intervention is associated with improved post-TIPS prognosis.\n\nThe primary objective is to evaluate the effect of a post-TIPS 12 weeks nutritional intervention on liver transplant-free six-month survival in sarcopenic candidates to TIPS for refractory ascites in cirrhosis.",[62,63,64],"Liver Cirrhosis","Refractory Ascites in Patients with Cirrhosis","Sarcopenia in Liver Cirrhosis",[66,67,68,69,70,71],"nutritional treatment","sarcopenia","liver cirrhosis","refractory ascites","transjugular intrahepatic portosystemic shunt placement","TIPS","RECRUITING","2025-02-07",{"date":75,"type":39},"2025-02-11",{"date":77,"type":39},"2022-10-13",{"date":79,"type":20},"2025-12",{"name":45,"class":46},2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100578695","the-aims-of-the-study-are-to-translate-the-index-of-professional-governance-ipg-30-into-italian-and-validate-it-and-to-assess-the-state-of-professional-governance-in-an-italian-hospital-ismett-100578695","NCT06814639","The Aims of the Study Are to Translate the Index of Professional Governance (IPG 3.0) Into Italian and Validate It and to Assess the State of Professional Governance in an Italian Hospital (ISMETT)","\"Index of Professional Governance\" Tool: a Multicentric Validation and Measuring Professional Governance in an Italian Hospital Setting","Inclusion Criteria:\n\n* 1 year of professional seniority\n* possess adequate linguistic skills certified by passing an English test (prepared by the linguistic services of the promoting center).",{"count":90,"type":20},75,"OBSERVATIONAL","Professional Governance (PG) is a way to actualize better work environments and structural empowerment. PG has a history over many years in the healthcare industry and has been defined as multidimensional organizational characteristics that encompass the structure and processes through which professionals direct, control and regulate one another's goal-oriented efforts. Multiple studies over the years have shown that PG can lead to empowered personnel and quality of care delivered.\n\nIn many organizations, governance is primarily controlled by management. The responsibility for managing professional practice should, however, be shared by staff and leaders, and in order to empower staff, they should be engaged in identifying areas for improvement. In addition, evidence-based practice should be enabled by allocating sufficient time, research and access to evidence sources.\n\nThe participation element refers to who creates and participates in governance activities on different levels. Successful professional governance structures have been linked to a positive professional practice environment. An effective structure with true sharing of decision-making between management and personnel will also contribute to optimal patient outcomes.\n\nTo evaluate whether an organization's governance is empowering and professional, it must be measured. Thus, various instruments to measure nurses' participation in professional governance have been presented. The Index of Professional Nursing Governance (IPNG) has been used in more than 250 international healthcare organizations during the last 20 years to evaluate implementation of their management models.\n\nHess created the IPNG for measuring professional governance along a conceptual continuum from traditional, through shared to self-governance models. Hess has since continued to advance the questionnaire. At the same time, an extended tool was created with all professional figures involved, the so called \"Index of Professional Governance\" (IPG). Several revisions have been made over time up to the current version of the IPG 3.0 The IPG measures the governance of hospital-based professional, based on a model of governance derived from the literature, in 5 dimensions: personnel, information, resources, participation and practice. Those five dimensions are covered by 50 items. Respondents use a 5-point scale to identify the group that dominates certain areas of governance stated in the items, ranging from 'management\u002Fadministration only' (1p), through 'equally shared by staff and management\u002Fadministration' (3p) to 'staff only' (5p). The points for each dimension, and overall governance, are then organized together, analyzed and used to place the organization's governance on the continuum from traditional to self-governance.\n\nPreviously translated from its original language, English-American into Arabic, British, Finnish, French, German, Korean, Portuguese, it is structured in five dimensions: staff, information, resources, participation and practice. These 5 dimensions are analyzed in 50 items.\n\nAims of the study:\n\n1. To translate the Index of Professional Governance (IPG 3.0) into Italian and validate it;\n2. To assess the state of professional governance in an Italian hospital (ISMETT).",[94],"Validation Study",[96,97,98,99],"IPG tool","professional governance","translation","validation","2025-02-03",{"date":73,"type":39},{"date":103,"type":20},"2025-02-06",{"date":105,"type":20},"2025-10-31",{"name":45,"class":46},""]