Perioperative intravenous administration of high volume Lactated Ringers solution and the risk of post-ERCP pancreatitis
Aims:
 Pancreatitis is the most frequent serious complication of ERCP (endoscopic retrograde cholangiopancreatography) resulting in prolonged hospitalizations and in rare cases, death.  ERCP or is a procedure where  a long tube is inserted down the esophagus, through the stomach, and into the duodenum (small intestine).  Pancreatitis is inflammation (pain and swelling) of the pancreas.  The purpose of the study is to examine whether or not giving large amounts of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP).  Typically, a small amount of IV fluids are given during this procedure (approximately 1 liter).  We are testing whether using a larger amount of fluids (between 2 – 3 liters) will reduce the risk of PEP.   
Diagnosis:
Pancreatitis
Principal Investigator:
Mick S. Meiselman, MD
IRB Approval Number:
EH13-130
Sponsor:
  NorthShore University HealthSystem
Contact:
  Interested patients should contact study coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
  Yes

The role of genotypic clarithromycin resistance testing using PCR detection of 23S mutations in predicting failure of eradication of Helicobacter pylori infection with standardized clarithromycin proton pump inhibitor (PPI) based triple therapy
Aims:
 Helicobacter pylori (H. pylori) is a bacteria that infects the stomach and can cause peptic ulcers and stomach cancer.  Normally, H. pylori is tested for using a CLO test, a urease breath test, a stool antigen test, or tissue biopsy.  In addition, the treatment for the bacteria typically consists of clarithromycin triple therapy, however, there is data that suggests the clarithromycin triple therapy may not cure H. pylori infections in up to 30% of cases in the United States.  The purpose of this study is to determine whether molecular tests done on H. pylori bacteria taken from stomach tissue can predict clarithromycin treatment failure.  H. pylori can have genes that make it resistant to specific drugs.  By testing stomach tissues (taken during an esophagogastroduodenoscopy or EGD), we will be able to determine whether H. pylori will respond to certain types of drugs. 
Diagnosis:
H. pylori infection
Principal Investigator:
Jay Goldstein, MD
IRB Approval Number:
EH13-101
Sponsor:
  NorthShore University HealthSystem Department of Medicine and Department of Pathology
Contact:
 Interested patients should contact Boris Jancan, CCRP Clinical Research Associate at 847.570.1583 or Asantewaa Ture, Study Coordinator at 847.570.3708
Open to Enrollment:
  Yes

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Aims:
 Celiac disease is an inherited, life-long disease affecting children and adults.  There is no drug treatment or cure for celiac disease.  When people with celiac disease eat gluten (a plant protein found in foods like wheat, rye, barley, and many everyday products), there is a reaction that damages their small intestine and interferes with the ability of their intestine to take in nutrients.  ALV003 is an investigational drug under development by Alvine Pharmaceuticals that can break down gluten into smaller pieces of protein.  The smaller protein fragments are expected to be less damaging to the small intestine.  The purpose of the study is to determine whether ALV003 is able to improve the damage in the lining of the intestine caused by gluten.  In addition, the study will determine whether ALV0003 improves any of the symptoms related to celiac disease.    
Diagnosis:
Celiac Disease
Principal Investigator:
Jay Goldstein, MD
IRB Approval Number:
EH13-212
Sponsor:
  Alvine Pharmaceuticals, Incorporated
Contact:
  Interested patients should contact study coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
  Pending

A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pego (Cimzia) for Crohn’s Disease
Aims:
The purpose of this registry study is to collect information on the long-term use and safety of Cizmia as compared to other Crohn’s disease medications.
Diagnosis:  Crohn’s Disease
Principal Investigator:  Eugene Yen, MD
IRB Approval Number:  EH09-191
Sponsor: UCB Pharmaceuticals
Contact: Interested patients should contact Emily Borushko, MPH CCRP at 847.570.2686
Open to Enrollment:  Yes

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy
Aims: The purpose of this study is to determine whether or not Ustekinumab improves the symptom of Crohn’s in those patients who have failed or are intolerant to TNF antagonist therapy.
Diagnosis: Crohn’s Disease
Principal Investigator:  Eugene Yen, MD
IRB Approval Number: EH11-225
Sponsor: Janssen Research and Development
Contact: For more information contact Emily Borushko, MPH CCRP at 847.570.2686
Open to Enrollment:  No

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease
Aims: The purpose of this study is to determine whether or not Ustekinumab improves the symptom of Crohn’s in those patients who have failed or are intolerant to TNF antagonist therapy.
Principal Investigator:  Eugene Yen, MD
IRB Approval Number:  EH11-346
Sponsor: Janssen Research and Development
Contact: For more information contact Emily Borushko, MPH CCRP at 847.570.2686
Open to Enrollment:  No

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn’s Disease who are Anti-TNF Inadequate Responders (ANDANTE)
Aims: The purpose of this research study is to determine whether or not PF-04236921 improves the symptom of Crohn’s.
Diagnosis:  Crohn’s Disease
Principal Investigator:  Eugene Yen, MD
IRB Approval Number:  EH11-106
Sponsor: Pfizer
Contact: Interested patients should contact Emily Borushko, MPH CCRP at 847.570.2686
Open to Enrollment:  Yes

A multi-centered open label extension study for subjects who participated in study B0151003 (ANDANTE II)
Aims: The purpose of this research study is to learn about the long-term effects of the study drug, PF-04236921 and to determine whether or not PF-04236921 improves the symptom of Crohn’s.
Diagnosis:  Crohn’s Disease
Principal Investigator:  Eugene Yen, MD
IRB Approval Number:  EH11-278
Sponsor: Pfizer
Contact: Interested patients should contact Emily Borushko, MPH CCRP at 847.570.2686
Open to Enrollment:  Yes

A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) – RFIB3053
Aims: The purpose of this study is to determine if rifaximin is safe and helpful in treating IBS-D symptoms in patients who previously were helped by rifaximin treatment.
Diagnosis:  IBS-D
Principal Investigator:  Eugene Yen, MD
IRB Approval Number:  EH13-381
Sponsor: Salix Pharmaceuticals
Contact: Interested patients should contact Emily Borushko, MPH CCRP at 847.570.268
Open to Enrollment:  Yes

A double-blind, randomized, placebo-controlled, parallel, dose-ranging study to evaluate the efficacy and safety of PF-00547659 in subjects with moderate to severe ulcerative colitis (TURANDOT)
Aims:  The main purpose of this research study is to compare the study drug, PF-00547659, and a placebo to find out if PF-00547659 for treating ulcerative colitis.
Diagnosis:  Ulcerative Colitis
Principal Investigator:  Eugene Yen, MD
IRB Approval Number:  EH13-075
Sponsor: Pfizer
Contact: Interested patients should contact Emily Borushko, MPH CCRP at 847.570.2686
Open to Enrollment:  Yes

Optical Nanoscale Analysis of Buccal Cells: Transforming Lung Cancer Screening
Aims:
  The purpose of this study is to develop a new method for the early detection of lung cancer. This will be done by collecting samples with a brush from the cheek area inside the mouth (buccal mucosa), then testing these samples with Partial Wave Spectroscopy (PWS). PWS is a method that scatters light (when the light hits the cell, the structure of the cell causes the light to scatter in different ways). The purpose of this test is to look for changes in the buccal mucosa. We hope to identify cell changes in the samples which may be useful in the early detection of lung cancer.
Diagnosis: Lung Cancer, Lung Solitary Nodule, Smokers, Esophageal, Pancreatic or head and neck Cancer, Breast Cancer or Colon Cancer that have spread to the lung, Chronic obstructive pulmonary disease (COPD) or Pulmonary fibrosis
Principal Investigator:
Roy K. Hemant, MD
Other Investigator:
Michael J. Goldberg, MD and Laura Bianchi, MD
IRB Approval Number:
EH10-137
Sponsor:
NIH
Contact:
Interested patients should contact Boris Jancan, CCRP Clinical Research Associate at 847.570.1583
Open to Enrollment:
  Yes

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