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Displaying 1 - 58 of 58
Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety and effectiveness of a device called the Axonics SNM System in reducing symptoms for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI). The study will enroll up to 130 participants at up to 20 sites in the United States and Western Europe. The Axonics System delivers mild electric…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
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…
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…
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…
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…
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…
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…
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…
Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Currently Recruiting
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…
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…
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-…
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-…
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Closed
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…
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).
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…
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…
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…
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…
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…
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-…
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 (…
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.
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Shilpa Ravella, MD
Status: Closed
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…
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…
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…
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
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.
Condition: Gastrointestinal and Digestive Diseases
Investigator: Joseph Picoraro, MD
Status: Closed
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.
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
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.
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…
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
Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Marc Bessler, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
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.…
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…
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.
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Francis Gress, MD
Status: Closed
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…
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Peter Green, MD
Status: Closed
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…
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…
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Garrett Lawlor, MD
Status: Closed
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.
Condition: Gastrointestinal and Digestive Diseases
Investigator: Julie Khlevner, MD
Status: Closed
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.
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…
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…
Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Melanie Gold, MD
Status: Closed
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…
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…
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Joseph Picoraro, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Simon Lichtiger, MD
Status: Closed
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),…
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