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Displaying 1 - 31 of 31
Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Currently Recruiting
Are you suffering from persistent symptoms that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new research study aims to test a new form of treatment for people with persistent symptoms despite antibiotic treatment for Lyme disease. This treatment involves stimulating a nerve on the surface of your ear. This is called…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Bo Shen, MD
Status: Currently Recruiting
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 (…
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: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Currently Recruiting
Have you been treated for Lyme Disease but continue to have brain fog or other cognitive problems? This research study will assess a non-medication non-invasive intervention to improve cognitive functioning in people with persistent cognitive problems despite prior antibiotic treatment for Lyme Disease. Participants will complete this 4 week intervention at…
Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Currently Recruiting
This patient case registry for Lyme and other Tick-borne Diseases is a component of the Clinical Trials Network that was launched in 2021 by a grant from the Steven and Alexandra Cohen Foundation. The registry will gather general information such as demographics, medical history, and current functional status. This information will help researchers to…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Le-Chu Su, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Bo Shen, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases
Investigator: Bo Shen, MD
Status: Closed
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…
Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
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: 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: 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: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Closed
Are you suffering from chronic fatigue that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new treatment research study investigates whether disulfiram, commonly known as "Antabuse", has the potential to be used as a treatment option for patients experiencing chronic post-treatment Lyme symptoms. This well-known…
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: 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: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Closed
The CDC estimates that 10-20% of patients with Lyme disease will go on to have chronic symptoms despite having had appropriate treatment, a condition known as Post-Treatment Lyme Disease Syndrome (PTLDS). While there is currently no known cure, various therapies are being investigated. One promising approach is the practice of meditation and yoga which have…
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 / 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: 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),…
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: 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: 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: 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: 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
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: 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: 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: 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: 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: 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 / 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…