Clinical Research Directory

A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function

The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants. The study will last up to approximately 9 weeks, excluding screening.

Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation

INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

Prevalence of Liver Dysfunction in Pediatric Patients With Congenital Heart Disease at Assiut.

Liver dysfunction is a well-documented complication in patients with congenital heart disease (CHD). The mechanisms leading to hepatic dysfunction may be multifactorial. Key risk factors for liver dysfunction in CHD include prolonged hypoxemia, high venous pressure, and prolonged duration of heart disease. While global studies have extensively explored this association, the prevalence of liver dysfunction in CHD varies, with studies reporting hepatic fibrosis in 30-40% of Fontan patients, while regional data, particularly from Egypt, remain limited. In this research we aim to determine the prevalence of biochemical and radiological hepatic abnormalities in pediatric CHD patients attending Assiut University Children's Hospital.

Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers

Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in France, 12.9% of patients on the waitlist either died or were delisted for worsening of their condition. However a substantial number of perfectly viable organs are wrongly discarded based on a highly subjective assessment as the level of acceptance varies widely depending on the physician's judgement. The idea of using Normothermic Machine Perfusion (NMP) not only to preserve the liver graft but also for selection purposes is a concept that has been already investigated. A few trials have analyzed the value of normothermic perfusion to assess rejected liver grafts. Several teams demonstrated that NMP provides a tool to assess organ viability pre-transplantation as the liver is able to maintain an almost physiological metabolism. These preliminary results came from small samples, 45% of which originated from donation after circulatory death (DCD). They need confirmation in a larger sample of organs from donors with brainstem death (DBD), adapted to the French liver allocation system. This trial will reproduce and confirm the results of the previous studies in order to establish viability testing as the de facto method for high-risk or rejected grafts. It will also validate existing viability markers so as to define a new standard for viability testing using NMP.

SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

In this study, a single non-invasive tool, spleen stiffness measurement (SSM), was used to monitor the disease regression of inpatients with chronic liver disease (CLD) and acute liver injury. The present study aimed to establish an early diagnosis warning model for acute-on-chronic liver failure (ACLF) by SSM and investigate the effect of dynamic changes in SSM on the short-term prognosis (28-day, 90-day morbidity and mortality) of inpatients with CLD and acute liver injury.

Global Utilization And Registry Database for Improved preservAtion of doNor Livers

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients

DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice

Background: Clinical trials often include patients from large hospitals or university clinics. Information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps. Aims/Objectives: The present study has three aims: First, to systematically describe the patient population of a large group practice for internal medicine. Second, to identify high-risk patients using established risk scores. And third, to include routine imaging data to optimize patient management. Methods/Facility Enrolling Participants: This is a prospective, observational study assessing patients' baseline characteristics, risk evaluation and integrating data from imaging test. The setting of the present study is a large group practice for internal medicine which consists of statutory health insurance-accredited physicians. Study participants will be included during daily routine, real-world clinical care and therefore represent all-comers fulfilling the inclusion criteria: 1. Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules. 2. Routine laboratory results available within the last 3 months. 3. Available imaging data within the last 3 months performed on site. Perspective: The study is designed to evaluate the current situation and quality of health care in defined patient populations in the routine clinical setting of a large-scale public office. These data will provide a profound rationale to identify quality issues and limitations in our performance of guideline-conform treatment in routine patient care.

Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration

The primary objective of this interventional study is determine if the future liver remnant can be optimized by improving liver function pre-operatively in patients who are scheduled for major hepatectomy. The main questions it aims to answer are: 1. Does high-dose insulin therapy improve liver function in the pre-operative setting? 2. What is the effect of high-dose insulin therapy on liver function and liver regeneration after a liver venous deprivation (LVD) procedure? 3. What is the relationship between volume hypertrophy and function in the regenerating liver? Participants will receive a 6-hour infusion of insulin and dextrose to maintain a hyperinsulinemic-normoglycemic state in the weeks prior to planned liver surgery to assess its effect on liver function measured by 99m-Tc-Mebrofenin hepatobiliary scintigraphy.

Cisplatin Combined with Oral TS-1 in Patients with Advanced Solid Tumors with Different Degrees of Liver Dysfunction

The purpose of this study is to formally characterize the pharmacokinetics (PK), safety, and tolerability of TS-1 in combination with cisplatin in adult patients with advanced solid tumors who have mild, moderate or severe hepatic impairment relative to patients with normal hepatic function, as categorized by the United States National Cancer Institute organ dysfunction working group \[NCI-ODWG\] criteria for hepatic dysfunction.

Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy

Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Complications following hepatectomy include liver failure, hepatic vascular thrombosis, wound infection at the hepatic incision, and bile leakage, among others. These complications pose a serious threat to patients' health and life, and also increase the waste of medical resources and the cost of treatment. Currently, research on postoperative complications of hepatectomy mainly focuses on small sample studies from a single center, and most studies only focus on a specific complication, lacking comprehensive and systematic analysis. Therefore, it is necessary to conduct a retrospective study analysis of complications related to hepatectomy to more comprehensively and objectively understand the incidence, risk factors, prevention, and treatment of postoperative complications, providing clinical doctors with more scientific treatment plans and guidance.

Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients

A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD. The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.