This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys 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).
The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for perianal fistulizing Crohns disease. The study will enroll up to 36 participants across multiple sites. Your participation in this study will be…
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…
The Takeda study drug used in this study is vedolizumab, a monoclonal antibody. Monoclonal antibodies are proteins made in laboratories that act like proteins in our bodies called antibodies. Vedolizumab acts specifically in the gut and works by preventing certain immune cells from going to the gut and helps reduce inflammation that can cause the symptoms (…
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. This complication can be prevented with immunosuppressant medications, which are routinely used after LT. The main purpose of this study is to determine if bacteria in the intestine (gut microbiome) may affect the…
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…
If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and…
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…
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.…
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…
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).
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…
The purpose of this study is to compare the efficacy and safety of two standard-of-care drugs, Risankizumab (Skyrizi) versus Vedolizumab (Entyvio), over 48 weeks to compare how well these drugs work in patients with moderate to severe Ulcerative Colitis (UC). This study is being conducted at approximately 285 research centers worldwide and is expected to…
The purpose of this study is to assess the safety and effectiveness of GIE Medical's ProTractX3 TTS drug coated balloon (DCB) for the treatment of benign stricture in the bowel. This study is conducted to see whether this new drug coated balloon dilation device can treat strictures and reduce the rate of recurrence. Up to 215 subjects will participate…
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…
The purpose of this study is to compare the effects, good or bad, of RO7790121 versus placebo inpatients with ulcerative colitis. In this study, you will get either RO7790121 or placebo. You will have the opportunity to participate in an open-label extension phase (getting the active drug - RO7790121), if your condition has not improved. RO7790121 is an…
This research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the study drug), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study…
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…
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…
The purpose of this study is to evaluate the safety and performance of sacral nerve stimulation (SNS) using an FDA-approved device called InterStim Neurostimulator (InterStim) in study participants with active moderate to severe ulcerative colitis. The goal of the study team is to reduce inflammation and symptoms associated with these conditions. This…
The purpose of this study is to test the good and bad effects of the drugs called belinostat and SGI-110 (guadecitabine). These drugs could shrink your cancer, but they could also cause side effects. The study doctors hope to learn if the study drugs will shrink the cancer more often than observed with other standard treatment options. We dont know if…
The purpose of this study is to evaluate the effectiveness and safety of an investigational drug, unesbulin. This investigational drug is being studied in unresectable or metastatic, relapsed, or refractory leiomyosarcoma along with Dacarbazine. Dacarbazine is a drug that is FDA-approved for the treatment of other types of cancer and recommended by the…
The study drug, CFT8634, is an investigational therapy that has been shown in animal studies to help break down the BRD9 protein, an important protein in the body that helps SMARCB-null tumors, such as your own, to grow. CFT8634 is able to do so by using the body's own protein-recycling equipment. (In short, your cells are capable of breaking down…
The purpose of this research study is to determine the effectiveness and safety of envafolimab, an experimental drug that is not approved for use, when given alone or in combination with ipilimumab to stimulate your immune system to attack cancer cells. Envafolimab is an experimental (investigational) cancer drug that overrides the PD-1/PD-L1 checkpoint,…
The experimental drug called INBRX 109 has been developed as a treatment for unresectable or metastatic conventional chondrosarcoma. The purpose of this study is to learn about the effects of the study drug, INBRX-109 on you, your immune system, and your cancer. This study is being done to understand if INBRX-109 is effective against your chondrosarcoma and…
The purpose of this study is to evaluate the effectiveness of a new investigational drug, ATX-101, for the treatment of dedifferentiated liposarcoma and leiomyosarcoma. ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA with a number of stress response proteins. These interactions are thought to be important for cancer…
The purpose of this study is to learn about the safety, tolerability, and effectiveness of an investigational drug called milademetan as compared to the use of trabectedin. In this study, subjects will be randomly assigned (like flipping a coin) to receive one of two study drugs: milademetan or trabectedin. This is an open-label study, meaning you will know…
The purpose of this study is to: 1. Compare treatment with chemotherapy (paclitaxel) alone to using a combination of nivolumab plus chemotherapy (paclitaxel) treatment in patients with angiosarcoma who have not been treated with paclitaxel chemotherapy alone. 2. Evaluate the effect of nivolumab in combination with cabozantinib on angiosarcoma (cancer) in…
The purpose of this study is to test the study drug, BI 907828 for safety, effectiveness, and side effects when compared to receiving the standard treatment, doxorubicin, in subjects with dedifferentiated liposarcoma (DDLPS). BI 907828 has proven to minimize a critical protein interaction between MDM2 and p53, two proteins in your body, which when their…
The purpose of this study is to evaluate the effectiveness of a new investigational drug, PTC596, used in combination with dacarbazine, for the treatment of locally recurrent, unresectable, or metastatic relapsed/refractory leiomyosarcoma, a type of soft tissue sarcoma. The purpose of this study is to evaluate whether adding PTC596 to dacarbazine is safe…
The purpose of this study is to find out if an investigational drug, called ADP-A2M4, is safe and how well it works in attacking Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) cancer cells. The study involves taking certain types of immune cells from the blood, called T cells, and changing them in a laboratory before putting them back into the…
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide…
The purpose of this study is to test the safety of a study drug called AMG 232 given with radiation in patients with soft tissue sarcoma (STS) prior to surgery. The AMG 232 is investigational. It has been tested in other cancers but not yet in sarcoma. AMG 232 has not been tested using the dosing schedule in this study and it has not been tested with…
You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the study drug), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study…
The purpose of this Registry is to develop a database to store information from subjects who haveundergone an examination of the esophagus with the NvisionVLE Imaging System. This is done bythe collection and analysis of the medical record information, imaging data, and physicianquestionnaires. The information is then stored in a database and may be used at…
Auriculotherapy is a type of Eastern medicine that has been used for thousands of years involving the ear. The ear has nerve connections to the whole body, and therefore using non-invasive techniques can be used to treat a wide variety of problems. This study is looking to see if auriculotherapy might be used to treat abdominal pain and find areas on the…
The purpose of this study is to learn about the effects, safety, and proper dosage of tazemetostat in combination with doxorubicin for the treatment of soft tissue sarcoma. Doxorubicin is a common therapy for soft tissue sarcoma, but is not FDA approved in combination with tazemetostat. This study treatment combination may suppress or prevent tumor growth…
This research study is testing an investigational medication called AMG 714 for people with refractory celiac disease Type II. If youre at least 18 years of age, diagnosed with celiac disease, and you are still experiencing persistent or recurrent intestinal atrophy and gastrointestinal symptoms despite following a strict gluten-free diet for at least 6 12…
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…
The researchers hope to study the effectiveness of an investigational drug called AL3818 in people who have metastatic (meaning their disease has spread) or advanced ), specifically alveolar soft partsarcoma (ASPS), leiomyosarcoma (LMS) and synovial sarcoma (SS). The main purpose of the study isto learn the percentage of patients that respond to treatment…
The purpose of this study is to find out if a new investigational drug, called tofacitinib (also known as tofacitinib citrate or CP-690,550), can help people with Ulcer Colitis (UC). The purpose of this research study is to compare the effects of tofacitinib to a placebo in patients with Ulcer Colitis (UC). A placebo looks like the study drug but does not…
New medical therapy for pediatric Crohn's disease (CD) or pediatric ulcerative colitis (UC). We are currently recruiting pediatric participants (aged 2 to 17 years) who have received a diagnosis of UC or CD but who do not tolerate or respond to standard treatments, including corticosteroids, immunomodulators and TNF-alpha antagonists. The hubble study…
The main purpose of this study is to see if ustekinumab is useful for treating patients with moderately to severely active ulcerative colitis. The safety of ustekinumab will also be studied.
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…
The purpose of this study is to establish the safety profile of the study drug HuMax-AXL-ADC in a mixed population of patients with specified solid tumors. HuMax-AXL-ADC binds to a specific antigen called Axl, which is expressed on the tumor cells in the cancer types treated in this trial. When the trial drug binds to the antigen on the tumor cell, the…
The purpose of this study is to evaluate a new technique called Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) with computer assisted method of analysis of brush biopsy. This study will assess whether performing standard biopsies in addition to the WATS brush biopsies identifies more patients with dysplasia than does performing…
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
C2 Therapeutics is currently enrolling patients to participate in the Coldplay 3 clinical trial. Coldplay 3 is evaluating the effectiveness of the Coldplay CryoBalloon Focal Ablation System in patients with Barrett's esophagus who have not yet received treatment. Participants will undergo treatment with the Coldplay CryoBalloon Focal Ablation System…
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…
The main purpose of this research study is to test different doses of INCB059872 and see which doses are safe and tolerable in participants that have Ewing sarcoma. This study will research the effect that INCB059872 has on your cancer. Researchers will study the way INCB059872 come into and leave your body over time (pharmacokinetics). INCB059872 is a…
The purpose of this study is to determine if the study drug toripalimab is safe, to determine future doses to give to patients with cancer, and to measure the amount of toripalimab in the blood. Up to approximately 240 subjects will be enrolled in Part B. The dose given in Part B will be 240 mg. The dose was chosen based upon safety data obtained from…
The purpose of this study is to see how safe and effective study drug GS-5745 is in treating people with moderate to severe Ulcerative Colitis. This is a randomized, double-blind, placebo-controlled study. Placebo-controlled means that you may receive an injection with no medicine in it, but looks like GS-5745. Randomized means you will be selected by…
The purpose of the study is to compare two types of endoscopic treatments in patients with Barretts esophagus (BE) with abnormal cells (dysplasia); radiofrequency ablation (RFA) and hybrid argon plasma coagulation (H-APC). H-APC is a newer technique in the treatment of BE and has not been adequately studied and is not approved by the FDA for routine use.…
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…
The purpose of this clinical research study is to test the effects of an investigational (being tested) study medication, GED-0301, in order to find out if GED-0301 can or cannot improve the symptoms of Crohns disease. The study will test 2 doses of GED-0301 compared to placebo. The placebo is a dummy pill that contains no study medication (or GED-0301),…
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…
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/…
The purpose of this study is to evaluate the effectiveness of preoperative radiation therapy used in combination with the immunostimulatory agent talimogene laherparepvec (T-VEC) to improve outcomes for patients with resectable soft tissue sarcomas, including soft tissue sarcoma (liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and…
This study is for patients that have been diagnosed with Crohn's Disease, which is an inflammatory disease of the gastrointestinal tract (stomach and intestines). The purpose of this study is to see if study drug GS-5745 is effective in treating people with Crohn's Disease.
The purpose of this research study is to learn more about adding the drug ADI-PEG 20 to a standard treatment regimen called gem-tax (the chemotherapy drugs gemcitabine and docetaxel) for subjects with bone and soft tissue sarcoma, and how the addition of ADI-PEG 20 affects the tumors response to treatment and the side effects you experience.
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…
This study is being done to see how safe and effective this investigational drug is and how well it is tolerated in subjects with ulcerative colitis. This study will study the safety of LY3074828 and any side effects one might have when they take it and how much LY3074828 should be given to subjects.
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…
The purpose of this study is to evaluate the safety and effectiveness of a new combination treatment involving two drugs: selinexor and ixazomib, for the treatment of dedifferentiated liposarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma and Ewing sarcoma. The primary objective of the study is to determine the maximum tolerated…
The purpose of the study is to determine if the experimental use of an antibiotic called rifaximin for upto one year can improve the symptoms of Crohns disease (like abdominalpain and liquid/very soft stools), and if rifaximin can improve the inflammation in the intestines causedby Crohns disease. The study is trying to determine if rifaximin, unlike other…
We are currently recruiting pediatric patients ages 7-17 who suffer from Irritable Bowel Syndrome with Constipation (IBS-C) for our Linaclotide clinical trial. Study will involve 6 visits and will last anywhere from 10-12 weeks after the patient qualifies.
The purpose of this study is to determine the safety and effectiveness of the study drug nirogacestat for the treatment of desmoid tumors/aggressive fibromatosis (DT/AF). One group will receive the study medication, the other group will receive a placebo. After the initial phase of the study, participants may elect to participate in another phase of the…
This study is for patients with Gastroesophageal Reflux Disease or GERD which may cause reflux or heartburn. Symptoms are often caused by a weak valve, or sphincter, between the esophagus (the swallowing tube that leads from your mouth to your stomach) and the stomach. This structure is called the lower esophageal sphincter (LES). Normally, when liquid and…
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…