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…
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…
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…
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 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…
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 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).
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…
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…
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-…
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 (…
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.
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…
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 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…
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…
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 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 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
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 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…
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…
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…
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.
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…
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.
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…
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…
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 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…
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…
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 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…
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…
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 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…
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…
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 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…
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…
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…
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…
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…
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…
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 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),…
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…
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…
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…
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/…
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.
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…