Integrating Care for Patients With Alcohol Liver Disease and Alcohol Use Disorders
Alcohol; LiverAlcohol related liver disease (ALD) contributes to 50% cases of cirrhosis worldwide and is the leading indication for liver transplant in North America. The treatment for ALD is achieving total alcohol abstinence and preventing relapse as medical and surgical options are limited when drinking continues. Patient care has been hindered by the isolation of Addiction Medical Services from Internal Medicine, Family Medicine, and Hepatology. Patients with ALD would benefit from multidisciplinary approach as it combines medical care of liver disease and management of addiction and mental health. The investigators aim to develop a patient-centered integrated care pathway supported by expertise from Hepatology, Addiction Medicine and Psychiatry to improve access to addiction services for patients with ALD. By participating in the services, patients will experience decreased substance use, psychological symptoms, and improved health-related quality of life, with greater patient and provider satisfaction.
Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease...
Alcoholic Liver DiseaseAlcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.
MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
PharmacokineticsHepatic ImpairmentThis study is an open-label, single dose study evaluating the effect of moderate hepatic impairment in the pharmacokinetics of MDMA and its active metabolite, 3,4-methylene-dioxyamphetamine (MDA) in order to decide whether an adjustment to the dosage would be need for individuals with moderate hepatic function in comparison to individuals with normal liver function. Eight participants with moderate hepatic impairment and eight matched participants with normal hepatic function will take part in this study. All patients will be evaluated to see if they meet criteria for study participation, with screening including a physical examination including a 12-lead electrocardiogram (ECG) and questions about mental and physical health. Participants who meet study criteria will stay at the study site for three days. On Day 1, they will receive a single dose of 80 mg MDMA. For the next seven to eight hours, participants will have blood collected and will rate their mood and other experiences. They will stay at the study sight for two more days. Blood will be drawn twice on the second day and once on the third day, and they will have their heart function measured with ECG. Blood will be collected periodically during a 12-hour interval on the day of drug administration. Blood will also be drawn 24, 36, 48, 72 and 96 hours after MDMA administration. Participant mood and feelings or experiences on-drug (subjective effects) will be measured a half-hour, one, two, four, six, and seven hours after receiving MDMA. ECG will be performed every day at the same time upon enrollment (Day -4 or -3) and from the Day 1 (day of drug administration) to Day 5. Blood pressure, heart rate and body temperature on Day 1 through 5. Blood samples will be used to compute the peak or maximum amount of MDMA and MDA in blood (Cmax), the time until reaching peak MDMA or MDA (Tmax) and the area under curve (AUC), or actual degree of exposure to drug. The primary outcome measure will be AUC for MDMA. Finding out if there are differences in drug metabolism between people with normally functioning livers and people whose livers do not function normally will help researchers performing MDMA-assisted psychotherapy.
Quantifying Steatosis in Liver Transplant Donors
Non-alcoholic Fatty Liver DiseaseEvidence of Liver TransplantationNon-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its presence among donors of living donor liver transplants could affect the outcomes of recipients of liver transplantation. By using controlled attenuation parameter (CAP) measurements, the investigators aim to investigate the association of CAP measurements and severity of fatty liver among liver donors in the recipient outcomes of living donor liver transplantation.
Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease
Chronic Liver DiseasePrimary objectives: To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation. To assess the safety and tolerability of GRI-0621 at these two doses. Secondary objectives: To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation. To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from baseline measured at the different trial time points. To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis. To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo. To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver disease. Exploratory objectives: To assess the effect, if any, that the investigational product may have on serum triglyceride levels.
Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome
Non-alcoholic Fatty Liver DiseaseThe study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with non-alcoholic fatty liver disease and metabolic syndrome.
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects...
Non-alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisThis clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like biomarker phenotype.
Gemcabene for the Treatment of Pediatric NAFLD
Non-Alcoholic Fatty Liver DiseaseThis is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcabene once a day for 12 weeks will reduce alanine aminotransferase (ALT), hepatic steatosis, dyslipidemia and down regulate de novo lipogenesis in children with NAFLD.
Bariatric Surgery on NASH
Non-Alcoholic Fatty Liver DiseaseObesityThe study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, RYGB or SG.
Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease
COVID-19To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients. To compare the hepatic manifestations in post COVID -19 patients with and without liver disease