Thomas Jefferson UniversitySidney Kimmel Medical College

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Research & Publications

Current Clinical Trials

The Division conducts a number of clinical trials in various of aspects of digestive and liver diseases. For more information on any of these trials, please contact Cynthia Miller, RN at (215) 955.8108.

Gastroenterology Trials

A Retrospective Chart Review of Subjects with Inflammatory Bowel Disease to Compare Phenotypic Differences between Different Races
PI: Cuckoo Choudhary, MD

Functional antimuscarinic antibodies: a possible etiology for anorectal dysmotility in scleroderma - a pilot study.
PI: Sidney Cohen, MD

Incomplete Capsule Endoscopy in an Inpatient Population
PI: Mitchell Conn, MD

The Use of Spiral Enteroscopy in the Evaluation of Suspected Small Bowel Pathology
PI: Mitchell Conn, MD

A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects during a Gluten Challenge.  (CLIN1001-006 /Amendment 01)
PI: Anthony J DiMarino, Jr, MD

A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Study for the Treatment of Active Celiac Disease with AT-1001
PI: Anthony J DiMarino, Jr, MD

Sleep Disturbances and Hypnotic Medication Use in Relation to Risk of Barrett's Esophagus and Esophageal Adenocarcinoma
PI: Anthony J DiMarino, Jr, MD

The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux
PI: Anthony J DiMarino, Jr, MD

Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia Trial): A Multi-center, Randomized, Sham-Controlled Trial
PI: Anthony Infantolino, MD

A Prospective, Multi-Center, Longitudinal Cohort Study of Cryo Spray AblationTM of Low Grade or High Grade Dysplasia within Barrett’s Esophagus (LCS Dysplasia)
PI: Anthony Infantolino, MD

Evaluating the Role of Endoclips in Prevention of Postpolypectomy Hemorrhage After Endoscopic Mucosal Resection of Large Sessile Polyps and Laterally Spreading Tumors
PI: Anthony Infantolino, MD

Evaluation of Capsule Endoscopy in Patients with Suspected Crohn’s Disease.
PI: Anthony Infantolino, MD

HALO PATIENT REGISTRY
PI: Anthony Infantolino, MD

A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn’s Disease (DC).
PI: David Kastenberg, MD

Comparison of MiroCam Capsule Endoscope with PillCam SB2 Capsule Endoscope in
Small Bowel Disease
PI: David Kastenberg, MD

Efficacy of a low volume PEG purgative (MoviPrep®) administered entirely in the morning compared to split dose (PM/AM) administration.
PI: David Kastenberg, MD

Efficacy of low volume polyethylene glycol (MoviPrep) plus simethicone (PEG-s) as a small bowel purgatie prior to capsule endoscopy
PI: David Kastenberg, MD

The Incidence of Hyponatremia with Two Commonly Prescribed Purgatives for Colonoscopy-Polyethylene Glycol 3350 with a Sports Drink (PEG-SD) Compared to Polyethylene Glycol 3350 with Electrolyte Solution (PEG-ELS)
PI: David Kastenberg, MD

An Assessment of the Long Term Outcomes of Patients Undergoing Pancreaticoduodenectomy (Whipple) Procedures for Non-Malignant Indications
PI: Thomas Kowalski, MD

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis
PI: Patricia Kozuch, MD

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
PI: Patricia Kozuch, MD

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
PI: Patricia Kozuch, MD

A Phase 2B, Multi-center, Randomized, Double − blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT − 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease.  
PI: Patricia Kozuch, MD

Comparison of Influenza and Pneumococcus Vaccination Rates in Immunosupressed IBD Patient Before and After Health Care Provider Education
PI: Patricia Kozuch, MD

A Randomized Study of the Efficacy and Safety of OncoGel Treatment as an Adjunctive Therapy to Systemic Chemotherapy and Concurrent External Beam Radiation Prior to Surgery in Subjects With Localized or Loco-regional Esophageal Cancer
PI: David Loren, MD

Determining the incremental diagnostic yield of pancreatic cyst wall sampling durign endoscopic ultrasound fine needle aspiration
PI: David Loren, MD

To Evaluate the Efficacy of Endosonography (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) For the Diagnosis of Pancreatic Lesions Missed on Radiological Imaging
PI: Ali Siddiqui, MD

Hepatology Trials

A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumurate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects with Chronic Hepatitis B (HBV) who are Resistant to Lamivudine
PI: Hie-Won Hann, MD

Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV Infection: the REALM study
PI: Hie-Won Hann, MD

Retrospective chart review of patients with chronic hepatitis B (CHB): To investigate the changes of hepatitis B Viral Polymerase Genotypes in patients whith CHB who have developed lamivudine resistance and subsequently failed adefovir treatment
PI: Hie-Won Hann, MD

Retrospective Chart Review of Patients with Chronic Hepatitis C (CHC): To Investigate the Efficacy of Reduced Doseof Pegylated Interferon and Ribavirin in Patients with CHC
PI: Hie-Won Hann, MD

Retrospective chart review of patients with Hepatocellular Carcinoma (HCC) associated with chronic Hepatitis B (CHB): Assessment of recurrence/new development of HCC between patients who received antiviral therapy and those who did not
PI: Hie-Won Hann, MD

A Single-Arm Study to Provide Boceprevir Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Non-Responders to Peginterferon / Ribavirin in Previous Schering-Plough Boceprevir Studies
PI: Steven K. Herrine, MD

Boceprevir and Peginterferon/ribavirin for the treatment of chronic hepatitis C in Treatment-naive subjects: a comparison of erythopoietin use versus ribavirin dose reduction for the management of anemia
PI: Steven K. Herrine, MD

Long Term Follow-up of Subjects in a Phase 1, 2 or 3 Clinical Trial for the Treatment of Chronic Hepatitis C in which Boceprevir or Narlaprevir was Administered for the Treatment of Chronic Hepatitis C
PI: Steven K. Herrine, MD

MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003)
PI: Steven K. Herrine, MD

P03523-A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects with Chronic Hepatitis C Infected with Genotype 1.
PI: Steven K. Herrine, MD

Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85 kg.
PI: Steven K. Herrine, MD

An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant.
PI: Jonathan M. Fenkel, MD

Non-Interventional, Prospective, Cohort Study of the Effectiveness, Safety, and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA (PEG-BASE USA)
PI: Jonathan M. Fenkel, MD