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
Pioneer Research Solutions, Inc. (Admin. Office)
Sugar Land, Texas 77479
1620
mi
from 02139
Sugar Land, TX
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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...
1052
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Birmingham, AL
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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...
845
mi
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Chicago, IL
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Clinical Research of West Florida
2147 Northeast Coachman Road
Clearwater, Florida 33765
1189
mi
from 02139
Clearwater, FL
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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...
1601
mi
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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...
940
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
48
mi
from 02139
Warwick, RI
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Central Indiana Gastroenterology Group
Anderson, Indiana 46016
773
mi
from 02139
Anderson, IN
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Saint John's Research Institute
Anderson, Indiana 46016
772
mi
from 02139
Anderson, IN
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St. Joseph Mercy Hospital
Ann Arbor, Michigan 48197
639
mi
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Ann Arbor, MI
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Digestive Disorders Associates
Annapolis, Maryland 21401
365
mi
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Annapolis, MD
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Disgestive Disorders Associates
Annapolis, Maryland 21401
366
mi
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Annapolis, MD
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Investigative Clinical Research
Annapolis, Maryland 21401
365
mi
from 02139
Annapolis, MD
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Maryland Diagnostics & Therapeutic Endo Center
Annapolis, Maryland 21401
366
mi
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Annapolis, MD
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Illinois Gastroenterology Group, LLC
Arlington Heights, Illinois 60005
862
mi
from 02139
Arlington Heights, IL
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Professional Quality Research, Inc.
Austin, Texas 78705
1691
mi
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Austin, TX
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UAB Hospital
Birmingham, Alabama 35249
1052
mi
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Birmingham, AL
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
19
mi
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Brockton, MA
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The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
847
mi
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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...
845
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Chicago, IL
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University of Chicago Medical
Chicago, Illinois 60637
846
mi
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Chicago, IL
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Concord Repatriation General Hospital
Concord, New South Wales
10093
mi
from 02139
Concord,
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Gastroenterology Associates
Crystal River, Florida 34429
1129
mi
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Crystal River, FL
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
927
mi
from 02139
Decatur, GA
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Atlanta Endoscopy Center
Decatur, Georgia 30033
926
mi
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Decatur, GA
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Decatur Health Imaging
Decatur, Georgia 30033
926
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Decatur, GA
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Rocky Mountain Clinical Research, LLC
Denver, Colorado 80229
1759
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Denver, CO
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Pharma Resource
East Providence, Rhode Island 02915
40
mi
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East Providence, RI
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NorthShore University Health System
Evanston, Illinois 60201
848
mi
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Evanston, IL
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Prima CARE
Fall River, Massachusetts 02720
43
mi
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Fall River, MA
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Gastro One
Germantown, Tennessee 38138
1123
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Germantown, TN
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Glenbrook Hospital Outpatient Pharmacy
Glenview, Illinois 60025
854
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Glenview, IL
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Glenbrook Hospital
Glenview, Illinois 60026
855
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Glenview, IL
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East Valley Endoscopy
Grand Rapids, Michigan 49546
732
mi
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Grand Rapids, MI
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Endoscopy Center of Connecticut, LLC
Guilford, Connecticut 06437
109
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Guilford, CT
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Endoscopy Center of Connecticut, LLC
Hamden, Connecticut 06518
113
mi
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Hamden, CT
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Gastroenterology Center of Connecticut
Hamden, Connecticut 06518
114
mi
from 02139
Hamden, CT
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
114
mi
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Hamden, CT
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Diagnostic Clinic of Houston
Houston, Texas 77003
1601
mi
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Houston, TX
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Houston Hospital for Specialized Surgery (Endoscopy only)
Houston, Texas 77030
1601
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Houston, TX
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Baylor Clinic (Drug Storage)
Houston, Texas 77030
1605
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Houston, TX
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Baylor College of Medicine - Baylor Medical Center
Houston, Texas 77030
1605
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Houston, TX
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Ertan Digestive Disease Center
Houston, Texas 77030
1601
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Houston, TX
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Memorial Hermann Hospital
Houston, Texas 77030
1606
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Houston, TX
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University of Texas Medical School in Houston
Houston, Texas 77030
1606
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Houston, TX
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Physicians Endoscopy Center (Colonoscopy)
Houston, Texas 77036
1601
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Houston, TX
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Nature Coast Clinical Research
Inverness, Florida 34452
1128
mi
from 02139
Inverness, FL
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Suncoast Endoscopy Center
Inverness, Florida 34453
1125
mi
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Inverness, FL
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Rocky Mountain Gastroenterology Associates
Lakewood, Colorado 80215
1768
mi
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Lakewood, CO
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Rocky Mountain Gastroenterology
Lakewood, Colorado 80214
1768
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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...
766
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Lexington, KY
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Arapahoe Gastroenterology
Littleton, Colorado 80120
1766
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Littleton, CO
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University of Louisville Healthcare Outpatient Center
Louisville, Kentucky 40202
821
mi
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Louisville, KY
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University of Louisville Research Foundation, Inc.
Louisville, Kentucky 40202
821
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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...
821
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Louisville, KY
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
932
mi
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Marietta, GA
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GI Diagnostics
Marietta, Georgia 30067
929
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Marietta, GA
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Advanced Research Institute, Inc
New Port Richey, Florida
1175
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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
184
mi
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New York, NY
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Weill Cornell Medical College of Cornell University
New York, New York 10021
184
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Present, Chapman, Steinlauf and Marion
New York, New York 10028
183
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New York, NY
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Mount Sinai School of Medicine
New York, New York 10029
182
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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
184
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New York-Presbyterian Hospital
New York, New York 10032
180
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Weill Cornell Imaging at New York Presbyterian Hospital
New York, New York 10065
227
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Arthur Asher Kornbluth
New York, New York 10128
227
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Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma 73104
1489
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Pharmacy: Wheeler and Stuckey, Inc.
Oklahoma City, Oklahoma 73103
1490
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Colonoscopy and X-rays: OU Physicians Building
Oklahoma City, Oklahoma 73104
1490
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Pittsburgh Gastroenterology Associates
Pittsburgh, Pennsylvania 15241
479
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Research Protocol Management Specialists
Pittsburgh, Pennsylvania 15243
484
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Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
1129
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Plymouth, MN
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VCU Medical Investigational Drug Service (IDS)
Richmond, Virginia 93298
472
mi
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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...
472
mi
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Richmond, VA
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University of Utah HSC
Salt Lake City, Utah 84132
2088
mi
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Salt Lake City, UT
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UCSF Endoscopy Unit at Mount Zion
San Francisco, California 94115
2691
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University of California at San Francisco
San Francisco, California 94143
2692
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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
1095
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Sanford, FL
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Simon Medical Imaging
Scottsdale, Arizona 85258
2281
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Scottsdale, AZ
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Digestive Health Research Unit
Scottsdale, Arizona 85260
2278
mi
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Scottsdale, AZ
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Texas Digestive Disease Consultants
Southlake, Texas 76092
1557
mi
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Southlake, TX
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One Step Diagnostic (X-Ray)
Sugar Land, Texas 77478
1620
mi
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Sugar Land, TX
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Pioneer Research Solutions , Inc
Sugarland, Texas 77479
1618
mi
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Sugarland, TX
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Adobe Clinical Research, LLC
Tucson, Arizona 85712
2272
mi
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Tucson, AZ
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Radiology Ltd
Tucson, Arizona 85712
2274
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Tucson, AZ
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Hillcrest Medical Center Endoscopy
Tulsa, Oklahoma 74104
1391
mi
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Tulsa, OK
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Hillcrest Medical Center
Tulsa, Oklahoma 74101
1393
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Options Health Research
Tulsa, Oklahoma 74137
1393
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Tulsa, OK
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Utica Park Clinic X-Ray
Tulsa, Oklahoma 74104
1391
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Tulsa, OK
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Advanced Imaging
Tulsa, Oklahoma 74137
1393
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Tulsa, OK
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
1491
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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...
652
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Winston-Salem, NC
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Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
741
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Wyoming, MI
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Metro Health Hospital Endoscopy Unit
Wyoming, Michigan 49519
743
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Wyoming, MI
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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
741
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Huron Gastroenterology Associates
Ypsilanti, Michigan 48197
638
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Ypsilanti, MI
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St Joseph Mercy Hospital
Ypsilanti, Michigan 48197
638
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