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Displaying 1 - 70 of 70

TReatment for ImmUne Mediated PathopHysiology (TRIUMPH)

Condition: Liver Disease / Liver Failure
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-…
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Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of…
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Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)

Condition: Liver Disease / Liver Failure
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of…
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Maralixibat for Treatment of Cholestatic Pruritus (MRX-802 EXPAND)

Condition: Liver Disease
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
The purpose of this study is to determine whether the investigational drug (maralixibat) is safe and effective in children and participants who have cholestatic liver disease with pruritus (itch) that has been responding to other therapies, and who have no other treatment options.If you have any questions regarding this study, please contact the Transplant…
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Omics Prospective Tissue Collection

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Currently Recruiting
The purpose of this study is to learn about the causes of non-alcoholic fatty liver disease (NAFLD). This is the most common type of liver disease, affecting millions of people in the United States alone. The incidence of Nonalcoholic Fatty Liver Disease (NAFLD) is very similar to that of obesity, type-2 diabetes, and the metabolic syndrome, suggesting a…
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Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

Condition: Liver Disease
Investigator: Giuseppe Cullaro, MD
Status: Currently Recruiting
Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) is a type of kidney failure that progresses very quickly and is due to severe liver disease. Terlipressin is approved in the United States for treatment of HRS-AKI. This study will test the safety and effectiveness of terlipressin alone compared to a combination of an investigational (experimental) drug…
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AXONICS: a study of Sacral Neuromodulation (SNM) therapy for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI).

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety and effectiveness of a device called the Axonics SNM System in reducing symptoms for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI). The study will enroll up to 130 participants at up to 20 sites in the United States and Western Europe. The Axonics System delivers mild electric…
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BOOM-IBD2: A study of sacral neuromodulation (SNM) for the treatment of Inflammatory Bowel Disease (IBD)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and…
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Using Gene Silencing to Treat Chronic Liver Disease Non-Alcoholic Steatohepatitis (NASH) in Adults at Increased Genetic Risk (NASHGEN-2)

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Currently Recruiting
The purpose of this study is to determine if an experimental drug, ALN-HSD, is safe and effective in patients diagnosed with non-alcoholic steatohepatitis (NASH), or metabolic dysfunction associated steatohepatitis (MASH) by improving liver function and lessening liver inflammation. This is a double-blind study, so the study doctors and participants will…
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FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to determine if an experimental drug, INT-787, is safe and effective in patients who are hospitalized due to severe alcohol-associated hepatitis. This is a double-blind study, so the study doctors and participants will not know if they are receiving INT-787 or a placebo. Participation will last approximately 3 months. If you…
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Biometrics in Liver Disease

Condition: Liver Disease
Investigator: Avesh Thuluvath, MD
Status: Currently Recruiting
The purpose of this study is to learn whether wearable technology and the biometric data (e.g. heart rate, activity level, sleep) collected from it can be useful to detect clinical changes in those with liver disease, so that in the future it may help to prevent complications. The wearable technology that will be utilized in this study is the Oura Ring.…
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Assessment of Pruritis (Itch) in Children with Primary Sclerosing Cholangitis

Condition: Liver Disease
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
The purpose of this study is to better understand how common and how severe pruritis (itching) is in children and adults under 21 years of age with Primary Sclerosing Cholangitis (PSC). The study involves the completion of two short online surveys. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
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An Observational Study of Patients with Chronic Liver Disease

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
TARGET-Liver Disease (TARGET-LD) is an observational research study to learn more about adult patients who have been diagnosed with a chronic liver disease (CLD). This includes collecting information about their health and the medications they take to manage their disease. Participation in this study will be approximately 15 years. If you have any questions…
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Liver Cirrhosis Network (LCN) Cohort Study

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
LCN Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months for a total of 3 years. Some of the visit…
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Real World Evidence Study in Subjects With Wilson's Disease

Condition: Liver Disease
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
The purpose of this study is to find out if a new laboratory blood test for patients with Wilson's disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Participation will last about 12 months. If you have any questions regarding this study, please contact the Transplant Clinical Research…
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VISTAS - A Clinical Research Study for Primary Sclerosing Cholangitis (PSC)

Condition: Liver Disease
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
The purpose of this clinical research study is to learn more about the use of the investigational study drug, volixibat, for the treatment of pruritus (itching) associated with primary sclerosing cholangitis or PSC. Volixibat is a drug that is designed to lower circulating bile acid levels may lead to the itching in patients with PSC. Eligible patients will…
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Study of C2 CryoBalloon Focal Ablation System for Patients with Barrett's Esophagus

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Currently Recruiting
This research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
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Advancing Liver Therapeutic Approaches (ALTA) in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Closed
The main purpose of this study is to collect information on patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the long-term outcomes and complications over a 5-year period. Subjects will be asked to complete four…
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An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of…
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Study of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Condition: Liver Disease
Investigator: Dana Goldner, MD
Status: Closed
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over…
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The Redwood Study for Alpha-1 Antitrypsin Deficiency Associated Liver Disease

Condition: Liver Disease
Investigator: Dana Goldner, MD
Status: Closed
The main purpose of this study is to determine how safe and effective fazirsiran is in patients with alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD) compared to placebo. Eligible participants will receive either fazirsiran or placebo for about 4 years. This is a double-blind study, so the study doctors and participants will not know…
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Boomerang: Study of InterStim Neurostimulator (InterStim) for Patients with Crohns Disease (CD) or Ulcerative Colitis

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Closed
The purpose of this study is to evaluate the safety and performance of sacral nerve stimulation (SNS) using an FDA-approved device called InterStim Neurostimulator (InterStim) in study participants with active moderate to severe ulcerative colitis. The goal of the study team is to reduce inflammation and symptoms associated with these conditions. This…
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Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU)

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this research study is to determine whether rosuvastatin is safe and can help people living with cirrhosis lead longer, healthier lives. The study drug, rosuvastatin, is investigational, meaning it has not yet been approved for market use for this disease condition by the United States Food and Drug Administration (FDA). Participants will…
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Registry Study of Adult Patients with Primary Sclerosing Cholangitis (PSC)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Closed
This is a 20-year study of adult patients with Primary Sclerosing Cholangitis (PSC). The purpose of this research study is to evaluate PSC throughout North America, as PSC is a rare disease, and not enough information is available for patients, clinicians, and researchers to help guide medical decisions and to help find new treatment options. Participants…
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Red-C 3131: Study of Rifaximin in Preventing Hepatic Encephalopathy (HE) in Patients with Advanced Liver Cirrhosis

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Elizabeth Verna, MD
Status: Closed
The Red-C 3131 Study is a phase 3 study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE in adults who have been diagnosed with advanced liver cirrhosis. Adults who have been diagnosed with advanced liver cirrhosis, but who don't yet have HE may be eligible to join. About 466 patients will be enrolled across 200 sites.…
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Registry for Patients with Short Bowel Syndrome

Condition: Gastrointestinal and Digestive Diseases
Investigator: Shilpa Ravella, MD
Status: Closed
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide…
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A study for patients with ulcerative colitis using study drug tofacitinib as an induction therapy

Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
The purpose of this study is to find out if a new investigational drug, called tofacitinib (also known as tofacitinib citrate or CP-690,550), can help people with Ulcer Colitis (UC). The purpose of this research study is to compare the effects of tofacitinib to a placebo in patients with Ulcer Colitis (UC). A placebo looks like the study drug but does not…
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A study for patients with Chronic HCV Infection who have not received an NS5A Inhibitor using study drugs Sofosbuvir/Velpatasvir/GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that…
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Study of Emricasan in subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis

Condition: Liver Disease / NASH
Investigator: Elizabeth Verna, MD
Status: Closed
Patients who have been diagnosed with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis may be eligible to participate in this clinical trial. NASH is liver inflammation and damage caused by a buildup of fat in the liver. The main purpose of the study is to test the safety and efficacy of a drug called Emricasan (IDN-6556) in reducing the risk…
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Study for subjects with Chronic HCV with advanced liver disease using study drug combination (Sofosbuvir/Ledipasvir + Ribavirn)

Condition: Liver Disease / Hepatitis
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to see if study drug Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin (SOF/LDV FDC + RBV) are effective in treating people infected with the hepatitis C virus with genotypes 1 and 4, who have advanced liver disease with permanent liver damage (cirrhosis) and may be showing signs of liver failure or who have undergone…
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A study for patients with moderate to severe Ulcerative Colitis using study drug ustekinumab

Condition: Gastrointestinal and Digestive Diseases
Investigator: Garrett Lawlor, MD
Status: Closed
The main purpose of this study is to see if ustekinumab is useful for treating patients with moderately to severely active ulcerative colitis. The safety of ustekinumab will also be studied.
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Linaclotide study for children with Irritable Bowel Syndrome- Constipation (IBS-C)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Julie Khlevner, MD
Status: Closed
We are currently recruiting pediatric patients ages 7-17 who suffer from Irritable Bowel Syndrome with Constipation (IBS-C) for our Linaclotide clinical trial. Study will involve 6 visits and will last anywhere from 10-12 weeks after the patient qualifies.
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Study of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)

Condition: Liver Disease / NASH
Investigator: Julia Wattacheril, MD, MPH
Status: Closed
The Sponsor is conducting this study to find out how safe and effective the investigational drug (alsocalled a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH. Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several…
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An open-label study of trial drug (Peg-IFN & RBV) for pediatric subjects infected with Hepatitis C virus

Condition: Liver Disease / Hepatitis
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of this study is to learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-…
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A study for patients with Barrett's esophagus using a Wide Area Transepithelial Sample Esophageal Biopsy (WATS) kits for analysis

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
The purpose of this study is to evaluate a new technique called Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) with computer assisted method of analysis of brush biopsy. This study will assess whether performing standard biopsies in addition to the WATS brush biopsies identifies more patients with dysplasia than does performing…
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A study for patients with Non-Alcoholic Steatohepatitis (NASH using study drug armachol

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Closed
This study is for patients with Nonalcoholic Steatohepatitis (NASH) and also suffer from obesity and Type 2 diabetes Mellitus type II or prediabetes. The purpose of this study is to determine the effect of Aramchol on liver inflammation, in addition to fat reduction in the liver. NASH (Nonalcoholic Steatohepatitis) is a common, often silent liver disease.…
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A study for patients with chronic hepatitis C and advanced heart failure or lung disease using study drug Harvoni

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This research trial is being conducted to determine the safety and efficacy of HARVONI (an FDA-approved Hepatitis C Virus medication) in HCV (genotype 1, 4, 5, an 6) infected patients who also have advanced heart failure or chronic lung disease. HARVONI has not been tested in patients with HCV and heart failure or chronic lunch disease. Subjects will take…
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Study for patients with Hepatopulmonary syndrome (SHPS) using trial drug (Sorafenib)

Condition: Liver Disease
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to determine the safety and effects of a drug, sorafenib in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood and the function of the lung vessels. Participants will be randomly assigned to receive either sorafenib or a…
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A study for patients with untreated dysplastic Barrett's Epithelium using the Coldplay CryoBallon Focal Ablation System

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
C2 Therapeutics is currently enrolling patients to participate in the Coldplay 3 clinical trial. Coldplay 3 is evaluating the effectiveness of the Coldplay CryoBalloon Focal Ablation System in patients with Barrett's esophagus who have not yet received treatment. Participants will undergo treatment with the Coldplay CryoBalloon Focal Ablation System…
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Mapping of Auricular Acupoints in Pediatric Patients with Abdominal Pain

Condition: Gastrointestinal and Digestive Diseases
Investigator: Melanie Gold, MD
Status: Closed
Auriculotherapy is a type of Eastern medicine that has been used for thousands of years involving the ear. The ear has nerve connections to the whole body, and therefore using non-invasive techniques can be used to treat a wide variety of problems. This study is looking to see if auriculotherapy might be used to treat abdominal pain and find areas on the…
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Study of Drug VK2809 in Patients with Primary Hypercholesterolemia and Non-Alcoholic Fatty Livery Disease

Condition: Liver Disease
Investigator: Ali Mencin, MD
Status: Closed
This study is a multicenter study to assess the efficacy, safety, and tolerability of vk2809 administered for12 weeks followed by a 4-week off-drug Phase in subjects with primary hypercholesterolemia and nonalcoholic Fatty liver disease. This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in…
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A Study of Subjects with Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatits (NASH) Study

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Julia Wattacheril, MD, MPH
Status: Closed
The purpose of this study is to evaluate whether cirrhosis occurs as a result of NASH. NASH is a disease that results when fat accumulates in the liver. GS-6624 is an experimental medication designed to help reverse the scarring process, and the purpose of this study is to see if GS-6624 can reverse the scarring in the liver and heal cirrhosis.
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Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV (Liver)

Condition: Liver Disease / Hepatitis
Investigator: Jennifer Elliott, PhD
Status: Closed
NOTE: YOU MUST HAVE HIV AND HAVE EVER HAD HEPATITIS C TO BE ELIGIBLE FOR THIS STUDY!! ............... For individuals who have both HIV and Hepatitis C virus (HCV), heavy drinking poses serious risks to their health. We do not yet know which interventions are effective at helping individuals with HIV and HCV drink less. The goal of the study is to compare…
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A study for patients with Chronic Genotype 3 HCV Infection and Cirrhosis using study drugs Sofosbuvir, Velpatasvir and GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL) FDC for the treatment ofchronic genotype 3 hepatitis C virus (HCV) infection in patients who have cirrhosis, or scarring of the liver. The purpose of this study is to determine the efficacy,…
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A study for patients with moderate to severe Ulcerative Colitis using study drug GS-5745

Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
The purpose of this study is to see how safe and effective study drug GS-5745 is in treating people with moderate to severe Ulcerative Colitis. This is a randomized, double-blind, placebo-controlled study. Placebo-controlled means that you may receive an injection with no medicine in it, but looks like GS-5745. Randomized means you will be selected by…
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Study of New Medical Therapy for Pediatric Crohn's Disease or Pediatric Ulcerative Colitis

Condition: Gastrointestinal and Digestive Diseases
Investigator: Joseph Picoraro, MD
Status: Closed
New medical therapy for pediatric Crohn's disease (CD) or pediatric ulcerative colitis (UC). We are currently recruiting pediatric participants (aged 2 to 17 years) who have received a diagnosis of UC or CD but who do not tolerate or respond to standard treatments, including corticosteroids, immunomodulators and TNF-alpha antagonists. The hubble study…
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THE PRIORITIZE STUDY: Study of Oral Regimens for Hepatitis C

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
This study will compare the effectiveness of three different FDA approved medicines for Hepatitis C Genotype 1 patients: HARVONI , Viekira Pak and Zepatier and will observe subject experiences before, during, and after HCV treatment. Subjects will be asked to respond to several survey questionnaires and if they would allow their leftover blood collected for…
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Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD) using trial drugs

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to determine how safe and effective using three medications (pegylated-interferon, ribavirin and boceprevir) are in curing HCV in patients with end stage kidney disease on hemodialysis. Participants will be prescribed these three medications and will be followed closely through treatment, then for 6 months afterwards. During…
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A study for patients with Crohn's Disease using study drug Mongersen

Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
The purpose of this clinical research study is to test the effects of an investigational (being tested) study medication, GED-0301, in order to find out if GED-0301 can or cannot improve the symptoms of Crohns disease. The study will test 2 doses of GED-0301 compared to placebo. The placebo is a dummy pill that contains no study medication (or GED-0301),…
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A study for patients with Chronic HCV Infection using study drug combination Sofosbuvir/Velpatasvir/GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of study drugs Sofosbuvir, Velpatasvir and GS-9857 in comparison to Sofosbuvir and Velpatasvir in patients infected with HCV. Information about any side effects that may occur will also be collected.
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A study for patients with moderately to severely active Crohn's Disease using study drug GS-5745

Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
This study is for patients that have been diagnosed with Crohn's Disease, which is an inflammatory disease of the gastrointestinal tract (stomach and intestines). The purpose of this study is to see if study drug GS-5745 is effective in treating people with Crohn's Disease.
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Study of Drug in Patients 1-16 Years of Age with Gastroesophageal Reflux Disease (GERD)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Joseph Picoraro, MD
Status: Closed
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
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TARGET-NASH: Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepatitis

Condition: Liver Disease / NASH
Investigator: Elizabeth Verna, MD
Status: Closed
This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. The main purpose of this research study is to collect and study information on patients with NAFLD/NASH.The goal of this study is to observe any treatment…
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Study for subjects with alcohol-induced liver failure using ELAD (Extracorporeal Liver Assist System)

Condition: Liver Disease
Investigator: Robert Brown, MD, MPH
Status: Closed
The primary objective of the study is to evaluate safety and effectiveness of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (ALID). Subjects will be randomly assigned to receive either standard of care treatment for ALID plus treatment with the ELAD system or standard of care treatment…
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A study for patients with moderate to severe ulcerative colitis using study drug LY3074828

Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
This study is being done to see how safe and effective this investigational drug is and how well it is tolerated in subjects with ulcerative colitis. This study will study the safety of LY3074828 and any side effects one might have when they take it and how much LY3074828 should be given to subjects.
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Study of seladelpar in subjects with primary biliary cholangitis (PBC)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Closed
If you have primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, you may qualify for a clinical research study. In this study, doctors are trying to learn more about the effectiveness and safety of an investigational drug called seladelpar for patients with PBC. The ENHANCE clinical research study is enrolling patients who…
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A study for patients with Chronic HCV Infection using study drugs Sofosbuvir, Velpatasvir and GS-9857

Condition: Liver Disease / Hepatitis
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to evaluate the efficacy, safety, and tolerability of SOF/VEL/GS- 9857 FDC in patients infected with Hepatitis C (HCV), and previously treated unsuccessfully. Information about any side effects that may occur will also be collected.
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A study for patients with active moderate Crohn's Disease using study drug Rifaximin

Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
The purpose of the study is to determine if the experimental use of an antibiotic called rifaximin for upto one year can improve the symptoms of Crohns disease (like abdominalpain and liquid/very soft stools), and if rifaximin can improve the inflammation in the intestines causedby Crohns disease. The study is trying to determine if rifaximin, unlike other…
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Study of Drug in Patients with Primary Biliary Cholangitis (PBC)

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Closed
This is a randomized, double-blinded, placebo-controlled phase 2 study. The purpose of this study is to evaluate the safety and efficacy of Saroglitazar magnesium 2 mg and 4mg versus placebo in the treatment of subjects with Primary Biliary Cholangitis. The research study consists of a Screening Phase (Visits 1 and 2) that lasts up to 42 days, a Treatment…
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Study for patients with with hepatic encephalopathy using drug, rifaximin

Condition: Liver Disease / Hepatic Encephalopathy
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to compare the time to onset of an episode of overt HE, in subjects with previously demonstrated overt HE after treatment with rifaximin 550 mg BID and lactulose, or rifaximin 550 mg BID. Subjects will be screened to confirm eligibility into the study. Once confirmed, subjects will begin the treatment phase and will be randomly…
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A study for patients with heartburn (GERD) using a "pacemaker" to stimulate the stomach

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marc Bessler, MD
Status: Closed
This study is for patients with Gastroesophageal Reflux Disease or GERD which may cause reflux or heartburn. Symptoms are often caused by a weak valve, or sphincter, between the esophagus (the swallowing tube that leads from your mouth to your stomach) and the stomach. This structure is called the lower esophageal sphincter (LES). Normally, when liquid and…
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Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
The purpose of the study is to compare two types of endoscopic treatments in patients with Barretts esophagus (BE) with abnormal cells (dysplasia); radiofrequency ablation (RFA) and hybrid argon plasma coagulation (H-APC). H-APC is a newer technique in the treatment of BE and has not been adequately studied and is not approved by the FDA for routine use.…
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A study to assess the documentation of Hepatic Encephalopathy in clinical practice

Condition: Liver Disease / Hepatic Encephalopathy
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to find out how doctors describe hepatic encephalopathy episodes in patients medical records in the course of their regular practice. The aim of the study is simply to collect information from their medical records about how their episodes of overt hepatic encephalopathy are described. There is nothing that will be required of…
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A study to collect data on patients undergoing an endoscopic evaluation of their esophagus by EGD

Condition: Gastrointestinal and Digestive Diseases
Investigator: Francis Gress, MD
Status: Closed
The purpose of this Registry is to develop a database to store information from subjects who haveundergone an examination of the esophagus with the NvisionVLE Imaging System. This is done bythe collection and analysis of the medical record information, imaging data, and physicianquestionnaires. The information is then stored in a database and may be used at…
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A study for patients with non-alcoholic steatohepatitis (NASH) fibrosis using study drug Emricasan

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Closed
This study is for patients with non-alcoholic steatohepatitis (NASH) fibrosis in which there is too much fat in the liver causing inflammation and fibrosis. This condition is similar to the type of liver damage that occurs from too much alcohol use, but is not primarily caused by alcohol use. The main purpose of the study is to test whether a drug called…
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GLIMMER: Study of Drug in Treatment of Pruritus (Itching) in Patients with Primary Biliary Cholangitis

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to test a drug called GSK2330672 that is not yet approved for doctors to prescribe for patients who have a condition called primary biliary cholangitis (PBC) which has caused moderate to severe pruritus, or itching, in parts or all of the body. The objective is to find out if the drug can help to decrease the itchiness that…
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Study for treating patients with Hepatic Encephalopathy using drug, OCR-002

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to evaluate the efficacy of the drug OCR-002 for the treatment of an acute hepatic encephalopathy episode in cirrhotic patients requiring hospitalization. Subjects who have been recently hospitalized will potentially receive OCR-002 via infusion on top of their standard care for 5 days. Patients will be assessed 24-hours after…
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A study for patients with Celiac disease using study drug AMG 714

Condition: Gastrointestinal and Digestive Diseases
Investigator: Peter Green, MD
Status: Closed
This research study is testing an investigational medication called AMG 714 for people with refractory celiac disease Type II. If youre at least 18 years of age, diagnosed with celiac disease, and you are still experiencing persistent or recurrent intestinal atrophy and gastrointestinal symptoms despite following a strict gluten-free diet for at least 6 12…
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A Study of Elafibranor in Patients with NASH and Fibrosis

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Closed
NASH is a liver disease associated with inflammation and liver cell injury visible under a microscope with a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Once cirrhosis has developed, the serious complications of liver disease may occur, including liver failure. NASH might also lead to…
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A study for adults with liver disease using study drug Avatrombopag for treatment prior to an elective procedure

Condition: Liver Disease
Investigator: Carl Bazil, MD, PhD
Status: Closed
The main purpose of this research study is to investigate the effectiveness of avatrombopag (the study drug under investigation) in increasing the amount of platelets (a type of cell found in the blood) in patients with chronic liver disease who need to have an elective procedure but have thrombocytopenia (low platelet counts) related to the chronic liver…
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