Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement.

Autor: Lee BP; Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA., Witkiewitz K; Center on Alcohol, Substance use and Addictions, University of New Mexico, Albuquerque, NM, USA., Mellinger J; Department of Internal Medicine, Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA., Anania FA; Division of Hepatology and Nutrition, US Food and Drug Administration, Silver Spring, MD, USA., Bataller R; Liver Unit, Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain., Cotter TG; Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA., Curtis B; Technology and Translational Research Unit, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program, Baltimore, MD, USA., Dasarathy S; Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA., DeMartini KS; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Diamond I; Amygdala Neurosciences, Palo Alto, CA, USA., Diazgranados N; Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., DiMartini AF; Departments of Psychiatry and Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA., Falk DE; Medications Development Branch, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., Fernandez AC; Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA., German MN; Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA., Kamath PS; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA., Kidwell KM; Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA., Leggio L; Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore, MD, USA., Litten R; Division of Treatment and Recovery, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., Louvet A; Service des maladies de l'appareil digestif, University Hospital of Lille, Lille, France.; Unité INSERM INFINITE, Lille, France., Lucey MR; Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA., McCaul ME; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA., Sanyal AJ; Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, VA, USA., Singal AK; Department of Medicine, Division of Gastroenterology Hepatology and Nutrition, University of Louisville School of Medicine, Louisville, KY, USA.; Department of Medicine, Robley Rex VA Medical Center, Louisville, KY, USA., Sussman NL; DURECT Corporation, Cupertino, CA, USA.; Baylor College of Medicine, Houston, TX, USA., Terrault NA; Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA., Thursz MR; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Verna EC; Division of Digestive and Liver Diseases, Columbia University, New York, NY, USA., Radaeva S; Svetlana Radaeva, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., Nagy LE; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. nagyL3@ccf.org., Mitchell MC; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA. mack.mitchell@utsouthwestern.edu.

Publikováno v: Nature reviews. Gastroenterology & hepatology [Nat Rev Gastroenterol Hepatol] 2024 Sep; Vol. 21 (9), pp. 626-645. Date of Electronic Publication: 2024 Jun 07.

Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the AlcHep Network.

Autor: Dasarathy S; Department of Gastroenterology & Hepatology and Inflammation and Immunity, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: dasaras@ccf.org., Tu W; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, United States of America., Bellar A; Department of Gastroenterology & Hepatology and Inflammation and Immunity, Cleveland Clinic, Cleveland, OH, United States of America., Welch N; Department of Gastroenterology & Hepatology and Inflammation and Immunity, Cleveland Clinic, Cleveland, OH, United States of America., Kettler C; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, United States of America., Tang Q; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, United States of America., Liangpunsakul S; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States of America., Gawrieh S; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States of America., Radaeva S; National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, United States of America., Mitchell M; Department of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, United States of America.

Publikováno v: Contemporary clinical trials [Contemp Clin Trials] 2024 Mar; Vol. 138, pp. 107437. Date of Electronic Publication: 2024 Jan 11.

A novel score of IL-13 and age predicts 90-day mortality in severe alcohol-associated hepatitis: A multicenter plasma biomarker analysis.

Autor: Tornai D; Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.; Department of Internal Medicine, Division of Gastroenterology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary., Mitchell M; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA., McClain CJ; Department of Medicine, University of Louisville, Louisville, Kentucky, USA., Dasarathy S; Center for Microbiome and Human Health, Lerner Research Institute of the Cleveland Clinic, Cleveland, Ohio, USA.; Department of Inflammation and Immunity, Lerner Research Institute of the Cleveland Clinic, Cleveland, Ohio, USA., McCullough A; Center for Microbiome and Human Health, Lerner Research Institute of the Cleveland Clinic, Cleveland, Ohio, USA.; Department of Inflammation and Immunity, Lerner Research Institute of the Cleveland Clinic, Cleveland, Ohio, USA., Radaeva S; National Institute on Alcohol Abuse and Alcoholism, Bethesda, Marylansd, USA., Kroll-Desrosiers A; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.; VA Central Western Massachusetts Healthcare System, Leeds, Massachusetts, USA., Lee J; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA., Barton B; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA., Szabo G; Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.

Publikováno v: Hepatology communications [Hepatol Commun] 2023 Nov 22; Vol. 7 (12). Date of Electronic Publication: 2023 Nov 22 (Print Publication: 2023).

The Beneficial Effects of Lactobacillus GG Therapy on Liver and Drinking Assessments in Patients with Moderate Alcohol-Associated Hepatitis.

Autor: Vatsalya V; Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Louisville, Louisville, Kentucky, USA.; Robley Rex VA Medical Center, Louisville, Kentucky, USA.; University of Louisville Alcohol Research Center, Louisville, Kentucky, USA., Feng W; Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Louisville, Louisville, Kentucky, USA.; University of Louisville Alcohol Research Center, Louisville, Kentucky, USA.; Hepatobiology & Toxicology Program, University of Louisville, Louisville, Kentucky, USA.; Department of Pharmacology & Toxicology, University of Louisville, Louisville, Kentucky, USA., Kong M; Department of Biostatistics and Bioinformatics, School of Public Health and Information Sciences, University of Louisville, Louisville, Kentucky, USA., Hu H; Department of Biostatistics and Bioinformatics, School of Public Health and Information Sciences, University of Louisville, Louisville, Kentucky, USA., Szabo G; University of Massachusetts Medical School, Worcester, Massachusetts, USA.; Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA., McCullough A; Cleveland Clinic, Cleveland, Ohio, USA., Dasarathy S; Cleveland Clinic, Cleveland, Ohio, USA., Nagy LE; Cleveland Clinic, Cleveland, Ohio, USA., Radaeva S; NIAAA, Bethesda, Maryland, USA., Barton B; University of Massachusetts Medical School, Worcester, Massachusetts, USA., Mitchell M; University of Texas Southwestern Medical Center, Dallas, Texas, USA., McClain CJ; Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Louisville, Louisville, Kentucky, USA.; Robley Rex VA Medical Center, Louisville, Kentucky, USA.; University of Louisville Alcohol Research Center, Louisville, Kentucky, USA.; Hepatobiology & Toxicology Program, University of Louisville, Louisville, Kentucky, USA.; Department of Pharmacology & Toxicology, University of Louisville, Louisville, Kentucky, USA.

Publikováno v: The American journal of gastroenterology [Am J Gastroenterol] 2023 Aug 01; Vol. 118 (8), pp. 1457-1460. Date of Electronic Publication: 2023 Apr 11.

Design of a multicenter randomized clinical trial for treatment of Alcohol-Associated Hepatitis.

Autor: Tu W; Indiana University School of Medicine, USA., Gawrieh S; Indiana University School of Medicine, USA., Dasarathy S; Cleveland Clinic, USA., Mitchell MC; University of Texas Southwestern Medical Center, USA., Simonetto DA; Mayo Clinic, USA., Patidar KR; Indiana University School of Medicine, USA., McClain CJ; University of Louisville Medical Center, USA., Bataller R; University of Pittsburgh, USA., Szabo G; Harvard Medical School, USA., Tang Q; Indiana University School of Medicine, USA., Barton BA; University of Massachusetts Chan Medical School, USA., Radaeva S; National Institute of Alcohol Abuse and Alcoholism, USA., Sanyal AJ; Virginia Commonwealth University, USA., Shah V; Mayo Clinic, USA.

Publikováno v: Contemporary clinical trials communications [Contemp Clin Trials Commun] 2023 Jan 18; Vol. 32, pp. 101074. Date of Electronic Publication: 2023 Jan 18 (Print Publication: 2023).