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Displaying 1 - 84 of 84

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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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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Study of ONC-392 in Combination with PLUVICTO in Male Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO alone. ONC-392 has not yet been approved by the…
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Study of JNJ-87189401 in Combination with JNJ 78278343 in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The purpose of this study is to find out the side effects of JNJ-87189401 given in combination with JNJ-78278343 to patients with metastatic castration-resistant prostate cancer, and to find which doses of the two study drugs when given in combination cause the least side effects. The study will also look at how long JNJ-87189401 and JNJ-78278343 stay in…
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Study of JNJ-78278343 in Patients with Advanced Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
You are being invited to take part in a research study that includes studying JNJ-78278343 in subjects with prostate cancer. This is an investigational drug which means that this is a new approach for the treatment of people who have prostate cancer. The main purpose of this study is to find a safe dose of JNJ-78278343 that can be used in the treatment of…
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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 REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA-approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain…
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IRONMAN: International Registry for Men with Advanced Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The main goal of a research study is to learn things to help patients in the future. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, your doctor will continue to treat you. The purpose of this study is to learn more about prostate cancer and: to describe the…
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Study of Whole-Food Plant-Based Diet (WFPBD) to Control Weight in Overweight/Obese Men with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The purpose of this study is to assess the efficacy of a home-delivered whole-food plant-based diet (WFPBD) intervention in promoting weight loss in overweight or obese men with prostate cancer receiving androgen deprivation therapy (ADT), as compared to general nutritional counseling only. Another purpose is to assess how easy or difficult it is for…
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Study of Apalutamide Alone or in Combination with ADT in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
The purpose of this study is to help researchers understand more about the possible effectiveness and safety of apalutamide when given to patients with or without intermittent Androgen Deprivation Therapy (ADT) to treat metastatic Castration-Sensitive Prostate Cancer (mCSPC). Apalutamide is a type of drug that blocks the action of testosterone. By blocking…
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Study of CC-94676 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
You are being asked to take part in this study because you have been diagnosed with advanced prostate cancer and the standard drugs to treat your disease (metastatic castration-resistant prostate cancer mCRPC) are no longer effective or no effective treatment is known for your type of cancer. This research study will test an investigational drug called CC-…
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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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Study of XmAb20717 Alone or in Combination with Chemotherapy in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this research study is to determine the safety and tolerability of XmAb20717 by itself and in combination with other anticancer therapies (Olaparib, Cabazitaxel, Docetaxel, and Carboplatin). XmAb20717 has not been studied in a significant number of humans, therefore, some of its effects are unknown. XmAb20717 is an investigational antibody-…
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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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Study of VTP-850 in Male Patients with Prostate Cancer Whose Prostate-Specific Antigen (PSA) Levels Have Risen

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to determine how safe the study drug, VTP-850, is in people with prostate cancer who have had initial treatment but whose prostate-specific antigen (PSA) levels have started to rise again. This study also aims to find the appropriate dose regimen of VTP-850 that can be given safely to people with prostate cancer. In addition, we…
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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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Study of HB-302/HB-301 in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to determine whether HB-302/HB-301 therapy is safe and well tolerated. This will be the first time HB-302/HB-301 will be tested in humans. HB-302/HB-301 has not yet been approved by the Food and Drug Administration (FDA).
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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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Study of Cabozantinib in Patients with Prostate Cancer who Previously Received Anti-Androgen Therapy

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to determine what effects (good and bad) cabozantinib has in treatment of prostate cancer. Cabozantinib (Cometriq, Cabometyx) is an oral medication that blocks activity of specific proteins in the body. It is approved by the Food and Drug Administration (FDA) for use in patients with medullary thyroid carcinoma and advanced…
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Study of ADXS-504 in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This study aims to investigate ADXS-504 as a possible treatment for biochemically recurrent prostate cancer. ADXS-504 is a type of cancer treatment that is designed to stimulate your immune system to attack prostate cancer cells. ADXS-504 is made of bacteria that have been weakened to remove their ability to cause an infection. The bacteria have also been…
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Study of Lutetium-177 PSMA I&T in Patients with Castration-Resistant Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This study is being done to learn if the study drug called Lutetium-177 PSMA I&T is safe and effective in patients with castration-resistant metastatic prostate cancer. The study drug contains radioactive Lutetium-177, which is targeted to treat certain prostate cancers cells that have a protein called the prostate-specific membrane antigen (PSMA) on…
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Study of Abiraterone Acetate, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to find out whether delivering SBRT to the prostate, combined with the study drug atezolizumab, is a safe and effective treatment when given in combination with abiraterone, prednisone, and Lupron (the standard treatment for this disease). In addition, the researchers want to find out whether the study treatment works better…
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Study of JNJ-75229414 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to see if a new, experimental drug called JNJ-75229414 is safe and useful for treating patients with metastatic castration-resistant prostate cancer. JNJ-75229414 is a Chimeric Antigen Receptor T Cell (CAR-T) cell therapy. This is the first time that JNJ75229414 will be used in humans. In this type of treatment, your white blood…
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Study of BMS-986218 Alone or in Combination with Nivolumab for Male Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
The purpose of this study is to assess the effectiveness and safety of combining an investigational drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody), or BMS-986218 plus nivolumab, with standard of care docetaxel (chemotherapy), in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after a second-…
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Study of androgen deprivation therapy followed by chemoimmunotherpy for newly metastatic hormone-sensitive prostate cancer (mHSPC)

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to determine if the addition of immunotherapy to the current standard of care for metastatic prostate cancer, chemotherapy, and hormonal therapy, is safe and improves your response to therapy. People who usually have metastatic prostate cancer to their bones and organs are usually treated with combination of chemotherapy (…
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Study of BMS-986218 + Degarelix Acetate vs. Degarelix Acetate Alone in Men with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
The purpose of this study is to see whether immunotherapy with BMS-986218 added to degarelix (which suppresses your testosterone) given prior to surgery can decrease the chance that your cancer will come back compared to degarelix alone. People who usually have this type of prostate cancer usually do not receive any additional therapy prior to surgery.
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PLX2853 with Abiraterone Acetate, Prednisone, and Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
In Phase 1b, the purpose is to learn how well patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) tolerate the treatment when PLX2853 is added to ongoing treatment with abiraterone acetate and prednisone. We are looking for the highest dose of PLX2853 that can be given safely to patients with your type of disease who are already on…
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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 HPN424 in Patients With Advanced Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to test the effectiveness and safety of an experimental drug known as HPN424 (also known as study drug) in patients with advanced prostate cancer. This drug has been tested in animals but not yet in people. This study tests different doses of HPN424. We want to find out how good the drug is at treating prostate cancer. We also…
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Study of Immunotherapy with Nivolumab or BMS-986253 Added to Degarelix in Patients with Prostate Cancer (MAGIC-8)

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This study is for patients with prostate cancer and that require treatment because their disease is now growing. The purpose of this study is to see whether immunotherapy with nivolumab added to degarelix or nivolumab and BMS-986253 added to degarelix is safe and can decrease the chance that the cancer will come back. Degarelix is a standard of care drug…
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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 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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Study of AZD4635 in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Emerson Lim, MD
Status: Closed
The purpose of this study is to find a more effective treatment as well as to gain a better understanding of prostate cancer. This study includes investigational study drugs which are specific for your prostate cancer (module). Treatment in each module will include an investigational medication called AZD4635 as well as another module-specific study drug(s…
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Study of Diagnostic Tests for Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Sven Wenske, MD
Status: Closed
This study is being conducted to evaluate the performance of the ConfirmMDx and SelectMDx tests for Prostate Cancer to identify patients with increased risk for clinically significant disease, to ultimately lower the rate of repeat biopsies. Approximately 1000 people are expected to take part in this study.
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A study for men with non-metastatic prostate cancer using study drugs enzalutamide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide

Condition: Cancer / Prostate Cancer
Investigator: Richard Carvajal, MD
Status: Closed
This study will enroll participants with prostate cancer that were treated by removing the prostate or by giving radiation (or both), but whose blood prostate specific antigen (PSA) level is going up. PSA is produced by the prostate and other tissues, and when it goes up, it means that the prostate cancer is coming back. In this study, participants will…
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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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18F-DCFPyL PET/CT in Men with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to see if 18FDCFPyL (PyL) PET/CT scans are able to find prostate cancer tumors. PyL is a radioactive drug (tracer) that targets prostate specific membrane antigen (PSMA). Because PSMA is a protein found mostly on the surface of prostate cancer cells, we are testing to see if PyL will be able to correctly identify prostate cancer…
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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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Evaluation of the ExoIntelliScore Prostate (Urine Test)

Condition: Cancer / Prostate Cancer
Investigator: Sven Wenske, MD
Status: Closed
The goal of this study is to evaluate how the results of a novel laboratory developed and validated urine test which predicts the likelihood of high grade prostate cancer will impact the decision on whether you will have a prostate biopsy to rule out prostate cancer. Approximately 1,000 subjects will be enrolled in this study. The study is expected to last…
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A study for patients with Metastatic Castration-resistant Prostate Cancer (mCRPC) using study drug JNJ-56021927

Condition: Cancer / Prostate Cancer
Investigator: Edward Gelmann, MD
Status: Closed
The purpose of this study is to compare the clinical benefit (i.e., does it help to improve or slow down the cancer) of adding study drug JNJ-56021927 to combined treatment of abiraterone acetate plus prednisone to treat patients with metastatic Castration-resistant Prostate Cancer (mCRPC). This study will also evaluate the possible side effects of 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 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 PSMA Targeted Genetically Modified Chimeric Antigen Receptor T Cells in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This research study is investigating a new treatment for cancer that uses your immune system (a type of white blood cell called T cells or T lymphocytes) to try to attack your cancerous cells. T cells fight infections, and may attack cancer cells, in some cases. Currently, your T cells may not able to attack your cancerous cells. The use of these modified T…
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Study of Drug in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Emerson Lim, MD
Status: Closed
The purpose of this study is to find out if ODM-201 is effective at keeping hormone-sensitive prostatecancer under control when given in addition to standard treatment which includes androgen deprivation therapy (ADT) and docetaxel chemotherapy for six cycles. A total of approximately 1,300 men will take part in this study at a number of different locations…
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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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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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Study of Study Drug MGD009 in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Charles Drake, MD
Status: Closed
We are doing this study to test a drug called MGD009. MGD009 is like an antibody, which is a protein in your blood that helps get rid of germs in your body. MGD009 is made to attach to cancer cells and to T-cells, which are a part of your immune system. Certain T cells have the ability to kill other cells, including cancer cells. By attaching to cancer…
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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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Study of Prostate Cancer Monitoring Using PyL and Blood-Based Biomarkers

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
You are being asked to participate in this research study because you have been diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment. The purpose of this study is to see if changes in 18FDCFPyL (PyL) PET/CT scans before starting your new treatment and after 6 weeks on treatment is associated with…
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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 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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Diffuse Optical Tomography in Prostate Cancer Detection and Risk Stratification - A Pilot Study

Condition: Cancer / Prostate Cancer
Investigator: Emerson Lim, MD
Status: Closed
You are being asked to join this study because you have either been diagnosed with prostate cancer and will be having surgery to remove your prostate or you will be having a prostate biopsy to look for prostate cancer. This study is looking to see if a new imaging device, diffuse optical tomography (DOT), can detect prostate cancer. We will also see if DOT…
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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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Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called nivolumab when combined with rucaparib, docetaxel or enzalutamide in participants with late stage prostate cancer that was unable to be surgically removed. These three combinations: nivolumab plus rucaparib, nivolumab…
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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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Study of Pembrolizumab (MK-3475) in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Condition: Cancer / Prostate Cancer
Investigator: Charles Drake, MD
Status: Closed
The purpose of this clinical trial to find out if the investigational medication pembrolizumab in combination with enzalutamide + Androgen Deprivation Therapy (ADT) is safe and works to slow down or stop the growth of metastatic prostate cancer compared to enzalutamide + ADT alone. Pembrolizumab is a type of immunotherapy, which may help the bodys immune…
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Testing Computer Tools to Improve Prostate Cancer Decisions

Condition: Cancer / Prostate Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
This research study will look at whether computer tools (also called decision aids) help prostate cancer patients better understand their treatment options and help patients talk about their treatment preferences with their doctors
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