A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:February 2011
End Date:February 2015

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Trial Summary
Trial Overview
Inclusion Criteria

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)

This is a proof of concept study to determine the efficacy and safety of a monoclonal
antibody with three doses versus placebo. Subjects will be randomized to a treatment and the
dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate
to severe refractory Crohn's Disease.


Inclusion Criteria:

- Subjects must have failed or are intolerant to anti TNFs

- hsCRP greater or equal to 5.0 mg/L

- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
within 8 weeks of study entry (screening) and able to retrospectively complete the
SES-CD or colonoscopy performed during screening

Exclusion Criteria:

- Pregnant or breastfeeding women

- Crohn's Disease with active fistulae or abscess

- History of diverticulitis or symptomatic diverticulosis

- Abnormality in hematology or chemistry profiles at screening
We found this trial at
98
sites
Disgestive Disorders Associates
Annapolis, Maryland 21401
2309
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from 91732
Annapolis, MD
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
1777
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
1730
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Chicago, IL
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Clinical Research of West Florida
2147 Northeast Coachman Road
Clearwater, Florida 33765
2119
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University of Texas Health Science Center at Houston
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
1352
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Houston, TX
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
1762
mi
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Nashville, TN
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Omega Medical Research
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
2559
mi
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Warwick, RI
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Central Indiana Gastroenterology Group
Anderson, Indiana 46016
1818
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Anderson, IN
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Saint John's Research Institute
Anderson, Indiana 46016
1819
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Anderson, IN
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St. Joseph Mercy Hospital
Ann Arbor, Michigan 48197
1936
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Digestive Disorders Associates
Annapolis, Maryland 21401
2309
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Investigative Clinical Research
Annapolis, Maryland 21401
2309
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Maryland Diagnostics & Therapeutic Endo Center
Annapolis, Maryland 21401
2309
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Illinois Gastroenterology Group, LLC
Arlington Heights, Illinois 60005
1713
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Arlington Heights, IL
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Professional Quality Research, Inc.
Austin, Texas 78705
1212
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Austin, TX
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UAB Hospital
Birmingham, Alabama 35249
1777
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
2581
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Brockton, MA
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The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
1728
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Chicago, IL
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
1730
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Chicago, IL
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University of Chicago Medical
Chicago, Illinois 60637
1729
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Chicago, IL
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Concord Repatriation General Hospital
Concord, New South Wales
7518
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Concord,
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Gastroenterology Associates
Crystal River, Florida 34429
2106
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Crystal River, FL
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
1924
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Decatur, GA
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Atlanta Endoscopy Center
Decatur, Georgia 30033
1924
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Decatur, GA
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Decatur Health Imaging
Decatur, Georgia 30033
1924
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Decatur, GA
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Rocky Mountain Clinical Research, LLC
Denver, Colorado 80229
822
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Denver, CO
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Pharma Resource
East Providence, Rhode Island 02915
2564
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East Providence, RI
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NorthShore University Health System
Evanston, Illinois 60201
1728
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Evanston, IL
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Prima CARE
Fall River, Massachusetts 02720
2578
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Fall River, MA
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Gastro One
Germantown, Tennessee 38138
1600
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Glenbrook Hospital Outpatient Pharmacy
Glenview, Illinois 60025
1722
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Glenbrook Hospital
Glenview, Illinois 60026
1720
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East Valley Endoscopy
Grand Rapids, Michigan 49546
1847
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Endoscopy Center of Connecticut, LLC
Guilford, Connecticut 06437
2499
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Endoscopy Center of Connecticut, LLC
Hamden, Connecticut 06518
2486
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Hamden, CT
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Gastroenterology Center of Connecticut
Hamden, Connecticut 06518
2487
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Hamden, CT
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
2487
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Hamden, CT
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Diagnostic Clinic of Houston
Houston, Texas 77003
1357
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Houston, TX
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Houston Hospital for Specialized Surgery (Endoscopy only)
Houston, Texas 77030
1358
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Houston, TX
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Baylor Clinic (Drug Storage)
Houston, Texas 77030
1357
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Baylor College of Medicine - Baylor Medical Center
Houston, Texas 77030
1357
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Ertan Digestive Disease Center
Houston, Texas 77030
1358
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Houston, TX
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Memorial Hermann Hospital
Houston, Texas 77030
1357
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University of Texas Medical School in Houston
Houston, Texas 77030
1357
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Houston, TX
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Physicians Endoscopy Center (Colonoscopy)
Houston, Texas 77036
1358
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Houston, TX
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Nature Coast Clinical Research
Inverness, Florida 34452
2122
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Inverness, FL
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Suncoast Endoscopy Center
Inverness, Florida 34453
2123
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Inverness, FL
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Rocky Mountain Gastroenterology Associates
Lakewood, Colorado 80215
812
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Lakewood, CO
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Rocky Mountain Gastroenterology
Lakewood, Colorado 80214
812
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University of Kentucky
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
1881
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Lexington, KY
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Arapahoe Gastroenterology
Littleton, Colorado 80120
813
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Littleton, CO
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University of Louisville Healthcare Outpatient Center
Louisville, Kentucky 40202
1812
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University of Louisville Research Foundation, Inc.
Louisville, Kentucky 40202
1813
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Louisville, KY
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
1812
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Louisville, KY
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
1908
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Marietta, GA
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GI Diagnostics
Marietta, Georgia 30067
1912
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Marietta, GA
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Advanced Research Institute, Inc
New Port Richey, Florida
2118
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New Port Richey, FL
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Weill Cornell Medical College of Cornell University-Greenberg
New York, New York 10065
2434
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Weill Cornell Medical College of Cornell University
New York, New York 10021
2435
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Present, Chapman, Steinlauf and Marion
New York, New York 10028
2435
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Mount Sinai School of Medicine
New York, New York 10029
2435
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New York, NY
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New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
New York, New York 10065
2434
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New York-Presbyterian Hospital
New York, New York 10032
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Weill Cornell Imaging at New York Presbyterian Hospital
New York, New York 10065
2351
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Arthur Asher Kornbluth
New York, New York 10128
2351
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Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma 73104
1165
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Oklahoma City, OK
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Pharmacy: Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma 73103
1164
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Oklahoma City, OK
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Colonoscopy and X-rays: OU Physicians Building
Oklahoma City, Oklahoma 73104
1165
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Oklahoma City, OK
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Pittsburgh Gastroenterology Associates
Pittsburgh, Pennsylvania 15241
2119
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Research Protocol Management Specialists
Pittsburgh, Pennsylvania 15243
2115
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Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
1501
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Plymouth, MN
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VCU Medical Investigational Drug Service (IDS)
Richmond, Virginia 93298
2267
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Richmond, VA
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Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
2269
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Richmond, VA
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University of Utah HSC
Salt Lake City, Utah 84132
573
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Salt Lake City, UT
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UCSF Endoscopy Unit at Mount Zion
San Francisco, California 94115
356
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San Francisco, CA
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University of California at San Francisco
San Francisco, California 94143
356
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San Francisco, CA
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University of California, San Francisco - Mount Zion
San Francisco, California 94115
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International Clinical Research - US, LLC
Sanford, Florida 32771
2183
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Sanford, FL
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Simon Medical Imaging
Scottsdale, Arizona 85258
353
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Scottsdale, AZ
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Digestive Health Research Unit
Scottsdale, Arizona 85260
353
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Scottsdale, AZ
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Texas Digestive Disease Consultants
Southlake, Texas 76092
1203
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Southlake, TX
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One Step Diagnostic (X-Ray)
Sugar Land, Texas 77478
1345
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Sugar Land, TX
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Pioneer Research Solutions, Inc. (Admin. Office)
Sugar Land, Texas 77479
1345
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Sugar Land, TX
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Pioneer Research Solutions , Inc
Sugarland, Texas 77479
1347
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Sugarland, TX
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Adobe Clinical Research, LLC
Tucson, Arizona 85712
430
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Tucson, AZ
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Radiology Ltd
Tucson, Arizona 85712
429
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Tucson, AZ
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Hillcrest Medical Center Endoscopy
Tulsa, Oklahoma 74104
1252
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Tulsa, OK
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Hillcrest Medical Center
Tulsa, Oklahoma 74101
1250
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Options Health Research
Tulsa, Oklahoma 74137
1253
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Tulsa, OK
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Utica Park Clinic X-Ray
Tulsa, Oklahoma 74104
1252
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Advanced Imaging
Tulsa, Oklahoma 74137
1250
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Tulsa, OK
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
1316
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Tyler, TX
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PMG Research of Winston-Salem
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
2126
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Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
1837
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Wyoming, MI
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Metro Health Hospital Endoscopy Unit
Wyoming, Michigan 49519
1836
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Metro Health Hospital
5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
1837
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Huron Gastroenterology Associates
Ypsilanti, Michigan 48197
1937
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Ypsilanti, MI
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St Joseph Mercy Hospital
Ypsilanti, Michigan 48197
1937
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