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The purpose of the research institute is the development of a participant-based research program which will allow patients the opportunity to voluntarily participate in clinically sponsored and investigator-initiated research, with special focus on the most current drug and device technologies in the treatment of gastrointestinal disease.
Our mission is to advance medical knowledge and practice through ethical, clinical research projects involving diagnosis and treatment of digestive diseases utilizing leading edge medicines and technologies.
Our vision is to strive for excellence in gastrointestinal medicine to improve the lives of individuals in the local and greater community.
Our values are to respect and treat, with integrity, those who participate in research projects for the betterment of healthcare for the individual and society as a whole.
INVESTIGATORS
Dr. Dan G. Luba is the managing partner of Gastroenterology Consultants and the Monterey Bay Endoscopy Center. He completed his medical education at Boston University, and did his Internship and Residency in Internal Medicine at Boston VA Medical Center in Boston, MA. Following that, Dr. Luba moved to California to do a fellowship in Gastroenterology at Stanford University Medical Center. He is Board Certified in Internal Medicine and Gastroenterology.
Dr. James A. Disario received his medical degree at Georgetown University School of Medicine in Washington, D.C. He also participated in extracurricular studies at University of Oxford in England. He completed an Internship in Internal Medicine at the Medical College of Virginia and a Residency in Internal Medicine at Georgetown University Medical Center. He completed a Fellowship in Gastroenterology at the University of Arizona and other post-doctoral training in Advanced Therapeutic Biliary an Pancreatic Endoscopy at the University of Amsterdam, The Netherlands. Dr. Disario has been a Medical officer for the U.S. Public Health Service and a Professor of Medicine at the University of Utah where he practiced Gastroenterology for sixteen years. Dr. Disario is Board Certified in both Internal Medicine and Gastroenterology and he has edited numerous medical journals, books and has been awarded many research grants and honors in the field of Gastroenterology. He has been a teacher and mentor for many graduate medical students and faculty and has presented medical education programs internationally.
Ms. Maydeen M. Ogara, CCRP is a clinical research specialist and general sciences associate. She earned her degree in 1998. She is a nationally certified member of the Society of Clinical Research Associates and joins the practice with nearly a decade of experience in clinical research protocol management.
CURRENT PROTOCOLS
All research projects that are currently active here can be accessed on the web at www.clinicaltrials.gov
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.
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BARRX Halo Registry:
HALO Patient Registry: Ablation of Barrett’s Esophagus
Clinical Protocol #B-500-052
PI: James A. DiSario
Co-Investigator: Daniel G. Luba
Start date: August 14, 2008
Status: Currently enrolling
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Proctor and Gamble Company
A Phase III Multi-Center, Investigator-blinded, Randomized 12-month, Parallel group, Non-inferiority Study
to Compare the efficacy of 1.6 to 2.4g Asacol Therapy QD Versus Divided Dose (BID) in the Maintenance
of Remission of Ulcerative Colitis
Clinical Study Protocol: #2007021-PGP029
PI: James A. DiSario
Co-Investigator: Daniel G. Luba
Start Date: May 3, 2007
End Date: September 2, 2009
Status: Closed to enrollment
(Active treatment phase ongoing)
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AstraZeneca Pharmaceuticals
Validation of patient-reported outcome measures for the assessment of GERD symptoms and their subsequent
impact on patients with a partial response to PPI treatment in a two part multi-center phase IIA study including a
four week randomized, double-blind, placebo-controlled parallel-group treatment period with AZD3355, 65mg
bid as add-on treatment to a PPI
Clinical Study Protocol # D9120C00027- AZD3355
PI: James A. DiSario
Co-Investigator: Daniel G. Luba
Start Date: June 19, 2008
Status: Closed to enrollment (site closeout visit December 30, 2008)
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Given Imaging NEWPS (Negative Endoscopy with Persistent Symptoms) Program
Post- Market Research Study
PI: Lloyd Garren
Co-Investigators: James A. DiSario, Daniel G. Luba, Toby Katz, Isabelle Barnard, Richard Hell
Kathryn Swanson, Mary Garren, Isabelle Barnard
Start Date: August 28, 2008
End Date: December 20, 2008
Status: Closed to enrollment
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Salix Pharmaceuticals, Inc.
A Phase III, Randomized Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety
Of Rifaximin 550mg TID in the Treatment of Subjects with Non-Constipation Irritable Bowel Syndrome
Clinical Research protocol #RFIB3008
PI: Daniel G. Luba
Co-Investigators: James A. DiSario, Kathryn Swanson
Start Date: November 6, 2008
End Date: November 17, 2009
Status: Closed to enrollment
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Abbott HUMIRA Adalimumab International
A 5-Year Non- interventional Registry Study of HUMIRA (Adalimumab) in Subjects with Moderately to Severely Active Crohn’s Disease (CD)
PI: James A. DiSario, M.D.
Co-Investigators: Richard Hell, M.D, Daniel Luba, M.D. Kathryn Swanson, M.D.
Start Date: December 27, 2007
Activation date: June 5, 2009
Status: Active. Currently enrolling
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Shire Pharmaceutical Development, Ltd.
A Phase III Randomized, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo over 104 weeks in the Prevention of Recurrent Diverticulitis
Clinical Research Protocol: SPD476-313
PI: Daniel G. Luba
Co-Investigators: James A. DiSario, Richard W. Hell, Kathryn A. Swanson
Start Date: September 23, 2009
Activation Date: October 8, 2009
Status: Active. Currently enrolling
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Outcomes of Cholangioscopy in a Community Hospital
Clinical Research Protocol: JADDGL: Cholangio 1
CHOMP IRB Registration #00004326
PI: James A. DiSario/Daniel G. Luba
Co-Investigators: None
Approval Date: May 5, 2009
Status: Active. Currently enrolling
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Outcomes of Enteroscopy in a Community Hospital
CHOMP IRB Registration # 00004326
Clinical Research Protocol: JADDGL: Entero2
PI: James A. DiSario/Daniel G. Luba
Co-Investigators: None
Approval Date: August 4, 2009
Status: Active. Currently enrolling
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Sanofi-Aventis
A Randomized, double-blind, placebo-controlled study of the effect of a single injection of SAR164877
(REGN475) on reduction of pain from chronic pancreatitis
Clinical Research Protocol: ACT11286
PI: James A. DiSario
Co-Investigators: Richard W. Hell, Daniel G. Luba, Kathryn A. Swanson
Start Date: November 2009
Status: Active. Currently enrolling
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