Ischemic Preconditioning of Liver in Cadaver Donors
Liver CirrhosisLiver DiseaseThe long-term goals of this proposal are to develop clinical protocols of donor preconditioning to improve liver graft function and ameliorate complications of poor graft function after liver transplantation. Achievement of these objectives would improve liver recipient outcomes, increase utilization of livers and alleviate the current critical shortage of livers for transplantation. More stringent liver donor selection intended to decrease the complications of poor graft function conflicts directly with efforts to maximize the use of donor livers. Ischemic preconditioning (IPC) of liver attenuates hepatic ischemia reperfusion injury (IRI) in animals. Preliminary data show hepatic IPC effectively decreases IRI following hepatic resection in humans. The specific aims of this project are: AIM 1: To test the hypothesis that 10 minutes of hepatic ischemic preconditioning in deceased donors would improve liver graft function and decrease injury in the early post transplant period. AIM 2: To test the hypothesis that ischemic preconditioning of deceased donor livers would decrease systemic inflammatory response in liver recipients in the early post transplant period. AIM 3: To examine whether ischemic preconditioning of deceased donor livers decreases early post transplant pulmonary edema and acute rejection and shortens hospital stay.
Oxaliplatin to Treat Advanced Cancers With Liver Dysfunction
Liver DiseaseThis is a phase I study of the experimental anticancer drug oxaliplatin. It is designed to establish the maximum dose of the drug that can be given safely to patients with cancer who have impaired liver function and to determine the drug's side effects. It will also examine how liver function affects the drug's elimination from the body. The liver plays an important role in the elimination of many anticancer drugs, and patients with impaired liver function should not take certain drugs or should take them in reduced doses. Patients 18 years of age and older with cancer that has metastasized (spread from the original tumor site) and for whom standard treatment is not available or is no longer effective may be eligible for this study. Candidates will be screened with various tests and procedures that may include physical examination, computerized tomography (CT) or magnetic resonance imaging (MRI) scans, chest X-rays, and blood and urine tests. Participants will be given oxaliplatin in doses determined according to their level of liver function. Patients may have normal liver function or mildly, moderately or severely impaired liver function, or may have had a liver transplant. Oxaliplatin will be infused intravenously (through a vein) over two hours on the first day of 21-day treatment cycles-that is, once every 3 weeks. Treatment will continue as long as the cancer is under control and side effects do not require stopping the drug. Urine will be collected over 48 hours after the infusion to determine how much of the drug is eliminated in urine. Blood tests will be done to monitor safety of the treatment, and imaging studies, such as X-rays, CT and MRI scans, will be done periodically to evaluate the tumor's response to treatment. Special blood tests will also be done to study how oxaliplatin is eliminated from the body. With the first dose of the drug, blood samples will be collected just before the infusion begins, just before it ends, 15 minutes, 30 minutes, 1, 2, 4, 6, 24, 48, and 72 hours after the infusion, and again 1 week and 3 weeks later. Additional blood samples may be collected at the third treatment cycle.
Gabapentin to Treat Itch in Patients With Liver Disease
Liver DiseaseCholestasis3 moreIn this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied. There are some funds to cover travel expenses for patients who are not from New York (NY). Gabapentin is approved to treat seizures in human beings. In this study, patients with liver disease who meet inclusion criteria are admitted to the research hospital of the New York Presbyterian Hospital to record scratching behavior by the use of a machine designed for that purpose. Blood work will be obtained. After completion of recording, patients are assigned by chance to receive active medication or placebo (a capsule that does not contain active medication). The patients will come to the outpatient office of the research hospital 2 weeks into the study for an interview and blood work. After 4 weeks, patients are readmitted to the hospital to record scratching behavior. After data are collected, the code is broken, if patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks. Blood work will be obtained. If patient had been randomized to active medication, the study will provide one week supply of drug. After that, the referring physician, with whom the study was previously discussed, could prescribe the medication as it is available.
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and...
Hepatic ImpairmentThe main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose. In addition, safety and tolerability of siremadlin after a single oral dose will be evaluated. The results of this study will inform the decision whether a dose adjustment may be recommended when treating patients with various degrees of impaired hepatic function.
Febuxostat Versus Allopurinol on Hepatic Steatosis in MAFLD Patients
Non-Alcoholic Fatty Liver DiseaseHyperuricemiaMetabolic associated fatty liver disease (MAFLD) is the most common and harmful chronic liver disease, and it is increasingly diagnosed in many developed and developing countries. Previous studies suggested a significant association between hyperuricemia and MAFLD and that hyperuricemia plays a causal role in the development of MAFLD. Xanthine oxidase is a key enzyme in uric acid metabolism, and It thus can be considered as is a therapeutic target for MAFLD, so long-term urate-lowering therapy may play a role in amelioration of MAFLD by controlling uric acid levels. So, this study is conducted to assess the effect of controlling hyperuricemia using different xanthine oxidase inhibitors on amelioration of MAFLD.
Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)
DiabetesChronic Kidney Diseases26 moreThis research programme seeks to combine the resources of NHS primary care, with the leading spectroscopic work in low-magnetic fields of the Wilson Group (Nottingham Trent University) to demonstrate the potential for benchtop Nuclear Magnetic Resonance (NMR) spectroscopy in human clinical pathology. This is an instrument assessment study for point of care viability which will also result in enhanced patient care (pending their consent) in blood screenings and metabolic health data.
Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
Chronic Hepatitis BNonalcoholic Fatty Liver DiseaseThe changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.
Non-alcoholic Fatty Liver Disease and Its Treatment
NAFLDDipeptidyl peptidase-4 inhibitors (DPP-4I), key regulators of the actions of incretin hormones, exert anti-hyperglycemic effects in type 2 diabetes mellitus (T2DM) patients. A major unanswered question concerns the potential ability of DPP-4I to improve intrahepatic lipid (IHL) content in nonalcoholic fatty liver disease (NAFLD) patients. The aim of this study was to evaluate the effects of sitagliptin on IHL in NAFLD patients.
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)...
Hepatic ImpairmentThe purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.
Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF
Fatty Liver DiseaseNonalcoholicUltrasound Derived Fat Fraction (UDFF) Evaluation of Metabolic Related Fatty Liver Disease (MAFLD) in obesity Patients Metabolic fatty liver disease (MAFLD), formerly known as Nonalcoholic Fatty Liver Disease (NAFLD), is the most common chronic liver disease in the world at present, with a incidence rate of about 30%. In the United States, NAFLD is the third leading cause of hepatocellular carcinoma, and early assessment and diagnosis of liver steatosis characteristics are crucial for timely treatment or intervention to reduce the risk of liver fibrosis and inhibit disease progression. Liver biopsy is considered as the "gold standard" for evaluating, grading, and determining inflammatory activity of liver steatosis and fibrosis. However, liver biopsy are invasive and pathological evaluation differences among observers, which makes it difficult to widely use and repeat, especially for dynamic evaluation of patients during the treatment process. Ultrasound Derviced Fat Fraction (UDFF) is a unique technology for non-invasive quantification of liver fat content, which is equipped on the Siemens ACUSON Sequoia ultrasound system. UDFF is calculated from two parameter values: attenuation coefficient (AC) and backscatter coefficient (BSC). SWE (shear wave elastography) is becoming widely used, and is recommended for the evaluation of liver fibrosis by some guidelines in patients with chronic liver diseases, such as viral hepatitis. These two technologies (UDFF+SWE) can be achieved on the same probe, and this detection technology is non-invasive, painless, simple, and reliable. Bariatric surgery (BS), also known as metabolic weight loss surgery, is currently recognized as the most significant and long-lasting method for treating obesity. It can significantly improve obesity related comorbidities, as well as long-term improvement in postoperative quality of life and mental state. This study will aim on analysis of the liver ultrasound characteristics of patients who plan to undergo bariatric surgery. By using UDFF and elastic shear wave technology (UDFF+SWE), a new non-invasive ultrasound evaluation method for MAFLD grading diagnosis of simple fatty liver, fatty hepatitis, liver fibrosis, and related cirrhosis will be proposed, and the incidence and risk factors of MAFLD in overweight and obese patients will be explored, The reversal effect of weight loss therapy on MAFLD in obese patients.