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Displaying 1 - 36 of 36

LT Inflammation and Immunosuppression Biomarkers

Condition: Transplant / Liver Transplant
Investigator: Yael Nobel, MD, MS
Status: Currently Recruiting
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. Tacrolimus is the primary medication used in most patients to suppress the immune system and prevent this complication after LT. The main purpose of this study is to determine if bacteria in the intestine (gut…
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INTEGRATE Cohort Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this observational research study is to identify things that contribute to outcomes in patients with alcohol-associated liver disease who are being considered for liver transplant and who have less than 6 months of sobriety. We will look at many things including images of the liver and heart, blood tests, urine tests, stool tests and liver…
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Cognitive Impairment (Problems with Thinking and Memory) in Liver Disease

Condition: Transplant / Liver Transplant
Investigator: Sloane Heller, MD
Status: Currently Recruiting
The purpose of this study is to understand how liver disease affects thinking and memory, both before and after transplant. Participants will take a cognitive test, which will be a series of tasks and questions similar to a video game, at home on their own computers, tablets, or phones. This will take approximately 45 minutes, and participants will do this…
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Study of ASP2138 in Patients with Stomach or Pancreatic Cancer

Condition: Cancer / Gastrointestinal
Investigator: Ryan Moy, MD
Status: Currently Recruiting
The goal of this study is to see if a study drug called ASP2138 is safe and effective for people diagnosed with tumors known to have Claudin (CLDN) 18.2 expression. CLDN is a group of proteins seen in gastric-specific, gastroesophageal junction (GEJ) or pancreatic cancer types. The study will also see how ASP2138 is processed in the blood. Each participant…
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The Janus Rectal Cancer Trial

Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Currently Recruiting
This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard chemotherapy regimens known as FOLFOX or CAPOX, given following long-course chemoradiation for patients with locally advanced rectal cancer? We are…
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Characterizing Alzheimer's Disease & Related Dementias (ADRD) and risk for ADRD among liver transplant recipients with cognitive impairment

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The main purpose of this study is to deeply characterize cognitive function in liver transplant recipients, differentiate among different causes of cognitive impairment, and identify contributors to cognitive impairment. Participants will receive a comprehensive neurological exam, cognitive assessment, neuropsychological testing, MRI of the brain, and blood…
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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 transplantation to prevent rejection.…
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Functional Assessment in Liver Transplantation (FrAILT) Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to learn more about the effects of functional status (also known as "frailty") using a physical test in patients with liver disease on their health outcomes. We are enrolling patients prior to liver transplantation, and will continue to assess their functional status post transplant. If you have any questions regarding…
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Study of Defactinib & Avutometinib in Patients with Stomach Cancer

Condition: Cancer / Gastrointestinal
Investigator: Ryan Moy, MD
Status: Currently Recruiting
There are two main types of stomach cancer based on the appearance under the microscope: intestinal-type and diffuse-type. Some stomach cancers also have a mix of intestinal-type and diffuse-type (mixed type). You are being invited to take part in this research study because you have been diagnosed with stomach cancer that has spread to other parts of the…
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Liver Transplant from Donors with HIV for Recipients with HIV: Long Term Follow-up Study (HOPE)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Currently Recruiting
The primary objective is to evaluate long-term outcomes in transplant recipients with HIV who receive livers from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
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Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
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Organ Care System (OCS) Liver Perfusion (OLP-II) Registry

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Currently Recruiting
The purpose of this sponsor-initiated multi-center registry is to collect additional data on the performance of the FDA Approved OCS Liver System and post-transplant clinical outcomes for patients who are transplanted with an OCS Liver perfused donor liver in the real-world setting. If you have any questions regarding this study, please contact the…
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Study of LBL-007 & Tislelizumab in Patients with Colon Cancer

Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The purpose of this study is safety, tolerability and efficacy of a combined treatment of LBL-007 and tislelizumab in combination with bevacizumab and capecitabine. LBL-007 and tislelizumab has not yet been approved by the Food and Drug Administration (FDA). Bevacizumab and capecitabine are approved for use in colorectal cancer, but their use in combination…
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
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Study of Domvanalimab and Zimberelimab Alone or in Combination with Chemotherapy in Patients with Upper Gastrointestinal Cancers (UGI)

Condition: Cancer / Gastrointestinal
Investigator: Ryan Moy, MD
Status: Closed
The purpose of this study is to help Arcus Biosciences, Inc. (the Sponsor) understand whether study drugs domvanalimab (also called AB154) plus zimberelimab (also called AB122) are safe and effective when given together with and without standard-of-care chemotherapy (FOLFOX) to patients with the type of cancer you have. Domvanalimab and zimberelimab are…
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Study of DKN-01 in Combination with Tislelizumab & Chemotherapy in Patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Cancer

Condition: Cancer / Gastrointestinal
Investigator: Ryan Moy, MD
Status: Closed
You are being invited to take part in a research study that includes studying DKN-01 combined with another investigational drug called tislelizumab and your physicians choice of a combination of drugs generally used to treat your type of cancer, either capecitabine and oxaliplatin (referred to as CAPOX) OR leucovorin calcium, fluorouracil, and oxaliplatin (…
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A Study of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients (Liver Transplant)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Closed
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related…
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Study of Pembrolizumab Alone or in Combination with Encorafenib and Cetuximab in Patients with Colon Cancer

Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The purpose of this study is to determine if the study drugs, encorafenib, and cetuximab, taken in combination with pembrolizumab would improve compared to the outcome of pembrolizumab alone in study patients. Encorafenib and cetuximab target cancerous BRAF proteins and potentially slow down the growth of cancer cells. Pembrolizumab may help your immune…
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Study of RO7198457 for Patients Who Have Had Surgery for Stage II and Stage III Colon Cancer

Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The BNT122-01 research study is testing an investigational medication (RO7198457) for patients who have had surgery for Stage II and Stage III colorectal cancer. The study will look at the safety and effectiveness of an investigational medication for patients who have had surgery for Stage II (high risk) and Stage III colorectal cancer. It will study…
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Solutions for Celiac Study

Condition: Cancer / Gastrointestinal
Investigator: Peter Green, MD
Status: Closed
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this…
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Study of Standard Chemotherapy Alone or Combined with Atezolizumab for Patients with Stage III Colon Cancer

Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
This study evaluates whether the addition of immune therapy to usual FOLFOX chemotherapy in patients with deficient DNA mismatch repair stage III colon cancer can improve your outcome compared to FOLFOX alone. The immune therapy drug, atezolizumab, may allow your body's immune system to more effectively kill cancer cells in your body. One of the…
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Study of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Colorectal Cancer (MORPHEUS - CRC)

Condition: Cancer / Gastrointestinal
Investigator: Yoanna Pumpalova, MD
Status: Closed
The purpose of this study is to compare the effects, good or bad, of the cancer immunotherapy combination treatments (CIT) combinations versus standard treatment on you and your colorectal cancer to find out which is better.
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Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer

Condition: Cancer / Gastrointestinal
Investigator: Rachael Safyan, MD
Status: Closed
This study is being done to answer the following question: Does duloxetine (either 30 mg or 60 mg) prevent numbness, tingling, and/or pain caused by your colorectal cancer treatment with oxaliplatin? We are doing this study because we want to find out if duloxetine can prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN).
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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 that comes from the bacteria in…
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INVICTUS Study of Drug in Advanced Gastrointestinal Stromal Tumors

Condition: Cancer / Gastrointestinal
Investigator: Matthew Ingham, MD
Status: Closed
Deciphera Pharmaceuticals, LLC., the Sponsor of this study, is developing a drug called DCC-2618 to treat Gastrointestinal Stromal Tumors (GIST) that are growing because of changes in specific genes. Genes are the instructions that tell a part of your body called a cell what to do. Cancer changes the genes so that the instructions are no longer correct. DCC…
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Study to evaluate the safety and effectiveness of Fibrin sealant during open surgeries

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during parenchyomous tissue open surgical procedures. Baseline assessments will be performed within 24 hours prior to the scheduled surgery. There will be a physical assessment and a blood draw at the first study visit. Subjects will be randomly…
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Study to Evaluate Performance of LifePort Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT)

Condition: Transplant / Liver Transplant
Investigator: Adam Griesemer, MD
Status: Closed
This is a prospective, randomized, multi-center, controlled study for subjects with end stage liver disease who require a liver transplant, comparing whole liver preservation via hypothermic machine perfusion (HMP) using the LLT System with Vasosol with livers preserved via static cold storage (which is standard of care). During Hypothermic Machine…
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Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer

Condition: Cancer / Gastrointestinal
Investigator: Alfred Neugut, MD, PhD
Status: Closed
Studies have shown that cancer patients may be at high risk for financial problems because of the cost of treatment. These financial problems can be stressful and sometimes might cause patients to avoid or refuse treatment. This study will measure how often financial problems happen in patients with colorectal cancer, using questionnaires that collect…
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A study for subjects with liver cancer using a drug to prevent recurrence of liver cancer following liver transplantation

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to determine if Nexavar (sorafenib), the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. The purpose of this study is to determine if sorafenib is a safe and effective treatment option for preventing the recurrence of liver cancer in high risk subjects…
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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 (HCV) in peri-operative liver transplant patients. Harvoni (LDV/…
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A study of liver transplant recipients to evaluate renal function, effectiveness and safety of a study drug, everolimus

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to investigate a new therapeutic regimen with or without steroids in the pediatric population. The aim is to find out whether everolimus is safe and has beneficial effects in children who receive a liver transplant. All children will receive a study drug called everolimus twice a day plus a reduced dose of cyclosporine or…
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A study for kidney transplant subjects using study drug eculizumab to prevent delayed graft function

Condition: Transplant / Liver Transplant
Investigator: Lloyd Ratner, MD, MPH, FACS
Status: Closed
The purpose of this study is to determine if eculizumab is safe and could be used to prevent Delayed Graft Function (DGF) following kidney transplantation. DGF is an early complication of kidney transplantation. This condition occurs when the transplanted kidney does not recover instantly after transplantation and can take days to weeks before recovering…
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Study of Cibisatamab in Combination with Atezolizumab in Patients with Colorectal Cancer

Condition: Cancer / Gastrointestinal
Investigator: Gulam Manji, MD, PhD
Status: Closed
The purpose of this study is to explore the effects, good or bad, of Cibisatamab, atezolizumab, obinutuzumab, and tocilizumab on patients with Colorectal cancer (CRC). In this study, you will first get treated with obinutuzumab (hereafter referred to as pretreatment with obinutuzumab). About 2 weeks later, you will then get treated with Cibisatamab and…
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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 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 study will be expected to…
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Study of Treatment Combinations in Patients with Gastric or Gastroesophageal Junction Cancer (Morpheus-Gastric Cancer)

Condition: Cancer / Gastrointestinal
Investigator: Gulam Manji, MD, PhD
Status: Closed
This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with gastric or gastroesophageal junction cancer. To evaluate the efficacy of immunotherapy-based treatment combinations in all arms during Stage 1 and stage 2.
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