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  • Show all (49)
  • (-) Currently Recruiting (5)
  • (-) Closed (44)

Medical Condition

  • Addiction (1)
  • Cancer (9)
  • Infectious Disease (2)
  • Liver Disease (26)
  • Neurological Disorders (1)
  • Pediatrics (1)
  • Transplant (8)
  • Vascular Conditions (1)
Displaying 1 - 49 of 49

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…
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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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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…
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A Trial of Transplanting Hepatitis C-Viremic Kidneys into Hepatitis C-Negative Kidney Recipients

Condition: Transplant / Kidney Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
Kidney transplant extends life, improves quality of life, and reduces healthcare costs. Unfortunately, there are not enough donated kidneys, so many people who need a transplant spend years on the waiting list. Kidneys from organ donors who have hepatitis C virus (HCV) are often thrown away, but these kidneys work well, and…
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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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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…
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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…
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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…
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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…
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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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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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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…
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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 Steato…
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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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Observational Study for Patients with Cirrhosis and Hepatocellular Carcinoma (HCC) Undergoing a Liver Transplant

Condition: Transplant
Investigator: Julia Wattacheril, MD, MPH
Status: Closed
The purpose of this research is to study the effects of liver transplantation and standard immunosuppression on body composition in patients with compensated cirrhosis and hepatocellular carcinoma (HCC). Patients with a diagnosis of HCC and cirrhosis who are listed for a liver transplant will be enrolled in this study. If you agree to participate, you will…
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A Study of Atezolizumab Plus Bevacizumab Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence

Condition: Cancer / Liver Cancer
Investigator: Gulam Manji, MD, PhD
Status: Closed
The purpose of this study is to compare the effects, good or bad, of atezolizumab plus bevacizumab versus observation (not receiving any treatment) on patients with completely resected (surgically removed) or ablated (removed using heat) hepatocellular carcinoma (the most common type of liver cancer) who are at high risk for disease recurrence.…
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A study for patients with advanced hepatocellular carcinoma using study drug pembrolizumab

Condition: Cancer / Liver Cancer
Investigator: Gulam Manji, MD, PhD
Status: Closed
The purpose of this study is to test the safety, tolerability, and anti-tumor activity of the research study drug, Pembrolizumab (also known as MK-3475) in subjects with advanced hepatocellular carcinoma (a type of liver cancer also referred to as HCC) who have taken sorafenib.
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Study for adult liver transplant recipients with chronic Hepatitis C infection using study drug (ABT-450/r/ABT-267)

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to see if study drugs ABT-450/r/ABT-267, and ABT-333 taken with RBV are safe and able to reduce the amount of Hepatitis C Virus (HCV) in subjects' blood over a 24-week treatment period. These drugs are intended to prevent the HCV from multiplying in the human body. Subjects who participate in this…
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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…
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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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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…
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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…
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Study of Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to determine if the administration of non-absorbable antibiotics (rifaximin) for the first three months after liver transplant period will reduce the amount of fibrosis (scarring of the liver) in liver transplant patients with hepatitis C virus (HCV) by lowering serum LPS (a protein in the blood…
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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 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…
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A 5-Year Study of the Natural History and Management of Patients with Hepatocellular Carcioma (A Type of Liver Cancer)

Condition: Cancer / Liver Cancer
Investigator: Elizabeth Verna, MD
Status: Closed
Patients will be asked to participate in this research study because they have been diagnosed with hepatocellular carcinoma (HCC) which is a type of liver cancer. By doing this study, researchers hope to: Find out more about patients that have HCC including their age, race/ethnicity, and other medical conditions they may have; learn more about how…
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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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Study of Glecaprevir/Pibrentasvir in Pediatric Subjects with Chronic Hepatitis C Virus (HCV) Infection

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
Open-labeled hepatitis C pediatric treatment trial with a two drug direct acting viral oral combination (already approved in adults) across all genotypes for naive or treatment experienced subjects.
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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 (…
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Prevention of Hepatitis C with Antiviral HCV Therapy After Liver and/or Kidney Transplant

Condition: Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
In this study, patients who are listed for a kidney or a liver transplant may be eligible for enrollment, asdetermined by their transplant doctors. The study is looking at patients who do not have hepatitis C virus (HCV) and provide their informed consent to receive a liver or kidney from a HCV positive donor. FDA approved…
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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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Study of Atezolizumab and Bevacizumab Alone or in Combination with Tiragolumab in Patients with Hepatocellular Carcinoma (HCC)

Condition: Cancer / Liver Cancer
Investigator: Linda Wu, MD
Status: Closed
The purpose of this study is to compare the effects, good or bad, of tiragolumab plus atezolizumab plus bevacizumab versus placebo plus atezolizumab plus bevacizumab on patients with HCC. In this study, participants will be randomized you will get either tiragolumab plus atezolizumab plus bevacizumab or placebo plus atezolizumab plus bevacizumab. A placebo…
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Study of Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Condition: Cancer
Investigator: Susan Bates, MD
Status: Closed
This study is being done to answer the following question: Is M3814 in combination with radiation therapy and avelumab safe and tolerable in patients with advanced or metastatic cancers? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced or metastatic cancer. The usual approach…
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Study for liver transplant recipients using drug (IgG) to prevent Hepatitis C virus (HCV) recurrence

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to test the safety of different doses of HCIG when given to patients with HCV who receive a liver transplant. It will also provide information about whether HCIG can prevent HCV infection. Participation in the study is expected to last about 10 months. Participants will be randomly assigned to either receive HCIG or not. Your…
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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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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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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 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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Liquid biopsy and radiomics for liver cancer surveillance

Condition: Cancer / Liver Cancer
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
This study aims to use new technology involving molecular and imaging tests to help detect liver cancer early in patients. Participants enrolled will participate in it for approximately 5 years. 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…
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SET-SAIL (Siplizumab in patients with AIH undergoing LT)

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with primary sclerosing cholangitis or autoimmune hepatitis undergoing liver transplantation. Induction immunosuppression drugs are very potent anti-rejection drugs that are given immediately after…
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Study of HBV Vaccination (HEPLISAV-B) in Patients with HIV

Condition: Infectious Disease / HIV
Investigator: Michael Yin, MD
Status: Closed
This study is looking at hepatitis B virus (HBV) vaccination in adults 18 to 70 years of age living with HIV around the world. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. A vaccine (a shot of medicine given through a needle)…
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Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV (HIV)

Condition: Infectious Disease / HIV
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…
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Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV (Alcohol)

Condition: Addiction / Alcohol
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…
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A Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

Condition: Cancer
Investigator: Fabio Iwamoto, MD
Status: Closed
This clinical trial will investigate an experimental drug called FT-2102. FT-2102 targets tumor cells that have an abnormal gene (code that tells your body what proteins to make), called isocitrate dehydrogenase 1 (IDH1). Research subjects with either a Hepatobiliary Cancer (HBC), a Chondrosarcoma, an Intrahepatic cholangiocarcinoma (IHCC), a Glioma, or…
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A study for liver transplant patients with Chronic HCV using study drug Harvoni

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to see if the study drug Harvoni given for 4 weeks immediately after liver transplantation is safe and able to clear the Hepatitis C virus (HCV) from the body. This study will test a drug named Harvoni for the treatment of chronic genotype 1 or 4 Hepatitis C Virus (…
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Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
You are being considered to participate in this research study because you have type I or II diabetes with current treatment control and, you are experiencing painful diabetic peripheral neuropathy (DPN) in both lower extremities legs.The specific events that result in painful diabetic peripheral neuropathy are not well understood, but high blood sugar,…
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A study for patients with liver cancer using study drug RO7070179

Condition: Cancer / Liver Cancer
Investigator: Gulam Manji, MD, PhD
Status: Closed
The purpose of this study is to assess the safety, tolerability, and effectiveness of RO7070179 given to patients with Hepatocellular Carcinoma (HCC), a primary type of liver cancer, with normal to moderately impaired liver function. RO7070179 is given intravenously to study its effects in the treatment of liver cancer. RO7070179 is an investigational anti-…
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A study for patients with solid tumors using study drug ASP5878

Condition: Cancer / Solid Tumors
Investigator: Emerson Lim, MD
Status: Closed
The purpose of this research study is to confirm the safety of ASP5878. It is also intended to assess how the body reacts to ASP5878 after administration, how ASP5878 functions in the body, and the antitumor effect of the ASP5878. Participants in this study will have been diagnosed with urothelial carcinoma, hepatocellular carcinoma, or squamous cell lung…
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A study for people with leg pain or/and non-healing wounds who have no surgical solution for their vascular problems

Condition: Vascular Conditions
Investigator: Roman Nowygrod, MD
Status: Closed
The purpose of this study is see if an experimental gene product, the Hepatocyte Growth Factor (HGF) Plasmid (AMG0001) which will be injected into the affected leg's muscles is effective in treating the blockages in your leg without causing adverse effects. Affected leg means the leg that has the severest disease relating to the blockage or narrowing…
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