| TITLE |
BODY LOCATION |
DISEASE TYPE |
COORDINATOR |
| A Phase 2b, Multicenter, Randomized, Double-blind, Placebo–controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy (CERTIFI)
|
Large Intestine,Other,
|
Crohns Disease
|
|
|
|
| A Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)-Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis
|
Pancreas,
|
Pancreatitis
|
|
|
|
| A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis--Rollover Study
|
Large Intestine,
|
Ulcerative Colitis
|
Rebekah Whichard,
|
| The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis.
|
| A Study of The Safety and Effictiveness of CNTO 148 (Golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis
|
Large Intestine,
|
Ulcerative Colitis
|
Rebekah Whichard,
|
| The purpose of this clinical study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with Ulcerative Colitis.
|
| A Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (GEMINI II)
|
Large Intestine,
|
Crohns Disease
|
Rebekah Whichard,
|
| This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active CD comprises two phases:
The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission; and the Maintenance Phase, designed to establish the efficacy and safety of vedolizumab(MLN0002) for the maintenance of clinical response and remission.
|
| An Open-Label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (GEMINI III)
|
Large Intestine,
|
Crohns Disease
|
Rebekah Whichard,
|
| This multicenter, 2-year open-label study will collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
|
| Cimzia Registry
|
Large Intestine,Other,
|
Crohns Disease
|
|
|
|
| Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)
|
|
S.O.D.
|
Rebekah Whichard,
|
| SOD is a disorder that involves the circular muscle that surrounds the drainage hole through which bile and pancreatic juices flow from the liver and pancreas into the duodenum (small intestine). Some patients who have had their gall bladders removed (cholecystectomy) develop increased pressure in the sphincter muscle. This causes back up of bile and/or pancreatic juices, which results in attacks of abdominal pain.
ERCP (Endoscopic retrograde cholangio-pancreatography) is a standard (non-research) procedure commonly used to diagnose problems in the liver, gallbladder, bile ducts, and pancreas including SOD.
During ERCP, the doctor can also measure the pressure (squeeze) of the sphincter muscle. This is called sphincter of Oddi manometry (SOM). Patients with abnormal SOM pressure results are usually treated at the same time by cutting the sphincter muscle (sphincterotomy), so that it cannot go into spasm, in the hope of preventing further attacks of pain. As part of the procedure, a small plastic drainage tube (stent) is usually placed (temporarily) to improve drainage and prevent complications.
The main purpose of the EPISOD trial is to study whether sphincterotomy is effective and how well patients respond. Although ERCP, SOM, and sphincterotomy are all standard clinical procedures routinely performed in patients with SOD, there is no clear scientific data showing the effectiveness of sphincterotomy (how well it works in particular patients) or whether the pressure measurements (SOM) can predict how well patients will respond to the sphincterotomy.
|
| PRESEPT Study: Prospective Evaluation of SEPT9 Performance for Colorectal Screening
|
Large Intestine,
|
Other
|
Rebekah Whichard,
|
| The purpose of this study is to collect blood specimens and clinical data from screening guideline eligible individuals designated by their physician to receive a screening colonoscopy, and to evaluate the performance of a colorectal cancer-specific DNA methylation biomarker for detection of colorectal cancer in this cohort. Based on the outcome of the colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of Septin 9 as colorectal cancer screening test will be evaluated.
|