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Displaying 1 - 35 of 35

Evaluating the Efficacy & Safety of Autogene Cevumeran + Nivolumab VS Nivolumab Alone for High-Risk Muscle-Invasive Urothelial Carcinoma

Condition: Cancer / Bladder Cancer
Investigator: Alexander Wei, MD
Status: Currently Recruiting
This study is testing a drug called autogene cevumeran in combination with nivolumab, a cancertreatment drug known for treating bladder cancer. The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus nivolumab versus nivolumab on patients with Muscle Invasive Urothelial Carcinoma (MIUC.) In this study, you will get…
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AXONICS: a study of Sacral Neuromodulation (SNM) therapy for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI).

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…
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BOOM-IBD2: A study of sacral neuromodulation (SNM) for the treatment of Inflammatory Bowel Disease (IBD)

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…
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Study of C2 CryoBalloon Focal Ablation System for Patients with Barrett's Esophagus

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…
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Study of Gemcitabine and Docetaxel Treatment in Patients with Bladder Cancer (BRIDGE)

Condition: Cancer / Bladder Cancer
Investigator: Andrew Lenis, MD
Status: Closed
This study is being done to answer the following question: Can we lower the chance of your bladder cancer growing or spreading by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual therapy? The usual approach for patients who are not in a study is treatment with Transurethral surgery of bladder tumor (…
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Boomerang: Study of InterStim Neurostimulator (InterStim) for Patients with Crohns Disease (CD) or Ulcerative Colitis

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…
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ADAPT-BLADDER: Modern Immunotherpy in BCG-Relapsing Urothelial Carcinoma of the Bladder

Condition: Cancer / Bladder Cancer
Investigator: Christopher Anderson, MD
Status: Closed
This study is for patients who have bladder cancer that has not invaded muscle tissue and who have been treated with one or more surgical resections and Bacillus Calmette-Guerin or BCG, which was directly given into the bladder before. The main purpose of this trial is to show that durvalumab is safe when given alone, in combination with BCG treatments, and…
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Study of Intravesical Cabazitaxel, Gemcitabine and Cisplatin (CGC) in the Treatment of Urothelial Carcinoma (Bladder Cancer)

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
We are doing this research to find out the safety, toxicity, and efficacy of intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of non-muscle-invasive urothelial carcinoma of the bladder that has recurred despite BCG use. The purpose of finding the maximum tolerable dose is important for future use of the drug, so as to provide the…
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First-in-Human Study of PF-07225570 Alone or in Combination with Sasanlimab for Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
This is a Phase 1 study (the first time this treatment is being tested in humans) of an anti-cancer study drug called as PF-07225570. This study drug works on stimulating certain cells in the immune system. The study will test different doses that increase (dose escalation) and at the appropriate time, additional patients will be enrolled to evaluate this…
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Registry for Patients with Short Bowel Syndrome

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…
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Study of NanoDoce Injection and as Fluid Inserted in Bladder in Subjects with Bladder Cancer

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
This research study will investigate an experimental, unapproved drug that will be given two different ways; as an injection in the bladder wall after bladder tumor resection surgery (or TURBT) and then as an intravesical instillation (fluid inserted in the bladder by catheter) right after the injection. The purpose of this study is to find the dose which…
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Study of Drug in Patients 1-16 Years of Age with Gastroesophageal Reflux Disease (GERD)

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.
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A study for patients with moderate to severe ulcerative colitis using study drug LY3074828

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.
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A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)

Condition: Cancer / Bladder Cancer
Investigator: Mark Stein, MD
Status: Closed
This clinical trial is for patients who have cancer of the urinary system (urothelial cancer, including cancer of the bladder, renal pelvis, ureter or urethra) that has spread to nearby tissues or to other areas of the body who have already been treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). This clinical trial uses an…
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A study for patients with active moderate Crohn's Disease using study drug Rifaximin

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…
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A study for patients with heartburn (GERD) using a "pacemaker" to stimulate the stomach

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…
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Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)

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.…
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Study of New Treatment for Non-Muscle-Invasive Bladder Cancer

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
The purpose of this study is to look at a new treatment for non-muscle-invasive bladder cancer. This new form of paclitaxel, a drug currently used by injection into a vein to treat various types of cancer, is designed to be instilled (injected) into the urinary bladder with a catheter (tube) placed into your bladder through your urethra (the opening where…
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A study to collect data on patients undergoing an endoscopic evaluation of their esophagus by EGD

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…
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A study for patients with Celiac disease using study drug AMG 714

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…
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MdxHealth: Study of Urine Samples in Patients with Hematuria (Blood in Urine)

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
This study is being conducted to evaluate the performance of the AssureMDx test for the detection of bladder cancer in patients presenting with hematuria.
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A study for patients with ulcerative colitis using study drug tofacitinib as an induction therapy

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…
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A study for patients with moderate to severe Ulcerative Colitis using study drug ustekinumab

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.
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Linaclotide study for children with Irritable Bowel Syndrome- Constipation (IBS-C)

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.
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Study of Multidrug Treatment in Patients with Muscle-Invasive Bladder Cancer

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
The purposes of this clinical study are: To evaluate the safety and tolerability of up to 2 drug release periods of GemRIS for up to 7 days per drug release period To evaluate the pharmacokinetics (the study of the bodily absorption, distribution, metabolism, and excretion of the drug) of gemcitabine and a gemcitabine-related metabolite (product after…
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A study for patients with Barrett's esophagus using a Wide Area Transepithelial Sample Esophageal Biopsy (WATS) kits for analysis

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…
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A study for patients with untreated dysplastic Barrett's Epithelium using the Coldplay CryoBallon Focal Ablation System

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…
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Mapping of Auricular Acupoints in Pediatric Patients with Abdominal Pain

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…
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nab-Rapamycin Treatment for BCG Refractory Bladder Cancer

Condition: Cancer / Bladder Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
The study is part of a research program to assess the efficacy of the drug nab-rapamycin, a biologic mTOR inhibitor. The purpose of the study is to assess the response rate, as well as, the safety of administering nab-rapamycin in combination with gemcitabine directly into the bladder in an effort to treat bladder cancer. The study seeks to determine if…
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Neoadjuvant Nivolumab With and Without Urelumab in Patients With Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder

Condition: Cancer / Bladder Cancer
Investigator: Christopher Anderson, MD
Status: Closed
This research is being done to study the effects, safety, and tolerability of the study drugs Nivolumab and Urelumab when given to people with advanced bladder cancer that has spread into the muscle tissue, also called Muscle-Invasive Urothelial Carcinoma of the Bladder (MIBC). Specifically, this research study will have participants either take Nivolumab…
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A study for patients with moderate to severe Ulcerative Colitis using study drug GS-5745

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…
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Study of New Medical Therapy for Pediatric Crohn's Disease or Pediatric Ulcerative Colitis

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…
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A study for patients with Crohn's Disease using study drug Mongersen

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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Study of Chemotherapy alone, Chemotherapy plus Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer

Condition: Cancer / Bladder Cancer
Investigator: Emerson Lim, MD
Status: Closed
The purpose of this study is to test how well the drug works, safety, and side effects of the experimental drug called BMS-986205. BMS-986205 will be added to another cancer medicine called nivolumab plus chemotherapy for participants who have bladder cancer that has grown into the muscle wall of the bladder. These drugs will be compared to just…
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A study for patients with moderately to severely active Crohn's Disease using study drug GS-5745

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.
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