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Displaying 1 - 21 of 21

OptimICE-PCR: Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Currently Recruiting
This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at…
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DROP-AKI Trial: DROxidopa for mean arterial Pressure in decompensated cirrhosis Acute Kidney Injury

Condition: Liver Disease
Investigator: Giuseppe Cullaro, MD
Status: Currently Recruiting
The DROP-AKI Trial is studying whether droxidopa, an FDA-approved medication for low blood pressure, can help patients with liver cirrhosis who develop kidney problems during hospitalization. Although droxidopa is FDA-approved for certain types of low blood pressure, it is not approved to treat patients with cirrhosis of the liver who develop kidney injury…
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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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Impact of Aromatase Inhibitors on Daily Activities for Individuals with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Rochelle Mendonca, PhD
Status: Currently Recruiting
The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
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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 Predict Your Therapeutic Response (I-SPY 2 Trial)

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Currently Recruiting
The primary purpose of this trial is to determine whether adding new drugs to the standard initial cancer treatments for breast cancer increases the probability there will be no residual disease (cancer cells left after many attempts to remove the cancer), compared to the initial cancer treatment alone. The intervention includes different drugs to determine…
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Study of GLSI-100 in Female Patients with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a…
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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 Comparing Survival of Patients Monitored with Serum Tumor Marker Directed Disease Versus Usual Care in Metastatic Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Currently Recruiting
The purpose of this study is to determine if overall survival of patients monitored with serum tumor marker direct disease monitoring (STMDDM) is as good as the overall survival of patients monitored with the usual care.
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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 RLY-2608 in Patients with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA.…
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Addinex-Opioid Dispenser for Post-Op Pain in Cancer Patients

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the use of the Addinex device, a time-release medication dispenser designed to assist with medication adherence, in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery.
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