Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:June 8, 2015
End Date:April 19, 2024
Contact:Reference Study ID Number: GA29145 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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Trial Summary
Trial Overview
Inclusion Criteria

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

This two-part, open-label extension and safety monitoring study will examine the safety and
efficacy of continued etrolizumab treatment in patients with moderate to severely active
Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.


Inclusion Criteria:

Part 1 Open-label Extension:

- Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the
eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

- Patients who participated in etrolizumab Phase III study GA29144 and are not eligible
or choose not to enter Part 1

- Patients who transfer from Part 1

- Completion of the 12-week safety follow-up period prior to entering

Exclusion Criteria:

Part 1 Open-label Extension:

- Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

- No exclusion criteria
We found this trial at
131
sites
Great Lakes Gastroenterology Research
Mentor, Ohio 44060
146
mi
from 43215
Mentor, OH
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
344
mi
from 43215
Chapel Hill, NC
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
991
mi
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Houston, TX
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Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
167
mi
from 43215
Indianapolis, IN
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
660
mi
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Jackson, MS
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Borland-Groover Clinic
4800 Belfort Rd # 2
Jacksonville, Florida 32256
676
mi
from 43215
Jacksonville, FL
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Kinston Medical Specialists
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
438
mi
from 43215
Kinston, NC
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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
155
mi
from 43215
Lexington, KY
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Gastroenterology Associates of Central Georgia
610 3rd St # 206
Macon, Georgia 31201
493
mi
from 43215
Macon, GA
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Center for Advanced Gastroenterology
260 Lookout Pl # 201
Maitland, Florida 32751
788
mi
from 43215
Maitland, FL
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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...
333
mi
from 43215
Nashville, TN
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Internal Medicine Specialists
Orlando, Florida 32806
796
mi
from 43215
Orlando, FL
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International Clinical Research
819 E 1st St # 6
Sanford, Florida 32771
777
mi
from 43215
Sanford, FL
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
822
mi
from 43215
Tampa, FL
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Shafran Gastroenterology Center
701 West Morse Boulevard
Winter Park, Florida 32789
791
mi
from 43215
Winter Park, FL
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
164
mi
from 43215
Ann Arbor, MI
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Valley Gastroenterology Consultants
Arcadia, California 91006
1958
mi
from 43215
Arcadia, CA
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Texas Physicians Medical Research Group
Arlington, Texas 76015
927
mi
from 43215
Arlington, TX
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Asheville Gastroenterology Associates, P.A.; Gastroenterology
191 Biltmore Avenue
Asheville, North Carolina 28801
303
mi
from 43215
Asheville, NC
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Agile Clinical Research Trials,LLC
750 Hammond Drive Northeast
Atlanta, Georgia 30342
424
mi
from 43215
Atlanta, GA
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
432
mi
from 43215
Atlanta, GA
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Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
427
mi
from 43215
Atlanta, GA
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Innovative Medical Research of South Florida Inc.
Aventura, Florida 33180
981
mi
from 43215
Aventura, FL
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Gastroenterology Associates
Baton Rouge, Louisiana 70809
801
mi
from 43215
Baton Rouge, LA
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Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
619
mi
from 43215
Belton, MO
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Massachusetts General Hospital - Crohn's & Colitis Center
Boston, Massachusetts 02114
643
mi
from 43215
Boston, MA
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
642
mi
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Brockton, MA
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Investigator's Research Group
Brownsburg, Indiana
178
mi
from 43215
Brownsburg, IN
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Hospital Italiano
Caba,
?
mi
from 43215
Caba,
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Ventura County Gastroenterology
Camarillo, California 93012
2010
mi
from 43215
Camarillo, CA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
524
mi
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Charleston, SC
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Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
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University of Virginia; Gastroenterology and Hepatology
1215 Lee Street
Charlottesville, Virginia 22908
277
mi
from 43215
Charlottesville, VA
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Clin. Rsrch Inst. of Michigan
30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
187
mi
from 43215
Chesterfield, MI
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Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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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...
270
mi
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Chicago, IL
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Northwestern Uni-Feinberg School of Medicine
Chicago, Illinois 60611
?
mi
from 43215
Chicago, IL
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Consultants for Clinical Research Inc.
Cincinnati, Ohio 45219
98
mi
from 43215
Cincinnati, OH
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UC Health Clinical Trials Office
Cincinnati, Ohio 45206
94
mi
from 43215
Cincinnati, OH
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West Central Gastroenterology d/b/a Gastro Florida
3001 Executive Drive
Clearwater, Florida 33762
834
mi
from 43215
Clearwater, FL
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
138
mi
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Cleveland, OH
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Ericksen Research And Development
Clinton, Utah 84015
1518
mi
from 43215
Clinton, UT
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Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado 80907
1163
mi
from 43215
Colorado Springs, CO
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Columbus Regional Research Institute
Columbus, Georgia 31904
523
mi
from 43215
Columbus, GA
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GastroCare; Digestive Care Research
3001 Coral Hills Drive
Coral Springs, Florida 33065
959
mi
from 43215
Coral Springs, FL
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Texas Digestive Disease Consultants - Dallas
3409 Worth Street
Dallas, Texas 75231
910
mi
from 43215
Dallas, TX
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
910
mi
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Dallas, TX
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
430
mi
from 43215
Decatur, GA
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Rocky Mountain Gastroenterology Associates
Denver, Colorado 80222
1161
mi
from 43215
Denver, CO
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Iowa Digestive Disease Center
1378 Northwest 124th Street
Des Moines, Iowa 50312
574
mi
from 43215
Des Moines, IA
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Jesscan Medical Research
10200 Northwest 25th Street
Doral, Florida 33172
990
mi
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Doral, FL
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University of Louisville
301 East Muhammad Ali Boulevard
Elizabethtown, Kentucky 42791
188
mi
from 43215
Elizabethtown, KY
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Cumberland Research Associates
Fayetteville, North Carolina 28304
406
mi
from 43215
Fayetteville, NC
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University of Florida College of Medicine
3450 Hull Road
Gainesville, Florida 32610
714
mi
from 43215
Gainesville, FL
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Valley View Internal Medicine
Garden Grove, California 92843
1963
mi
from 43215
Garden Grove, CA
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Gastro One
Germantown, Tennessee 38138
501
mi
from 43215
Germantown, TN
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Valley Gastroenterology Cnslts
Glendora, California 91741
1949
mi
from 43215
Glendora, CA
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Gastroenterology Associates of Western Michigan, P.L.C.
2093 Health Drive Southwest
Grand Rapids, Michigan 49506
243
mi
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Grand Rapids, MI
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Long Island Clin Rsch Asc, LLP
Great Neck, New York 11021
491
mi
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Great Neck, NY
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Innovative Clinical Research
7021 Augusta Road
Greenville, South Carolina 29604
361
mi
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Greenville, SC
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
539
mi
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Hamden, CT
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Center for Gastrointestinal Disorders
Hollywood, Florida 33021
976
mi
from 43215
Hollywood, FL
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The Methodist Hospital Research Institute
Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Grand Teton Research Group
Idaho Falls, Idaho 83404
1506
mi
from 43215
Idaho Falls, ID
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Atlantic Medical Group
Kinston, North Carolina 28501
440
mi
from 43215
Kinston, NC
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University of California, San Diego Medical Center
La Jolla, California 92093
1926
mi
from 43215
La Jolla, CA
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Therapeutic Research Institute of Orange County
Laguna Hills, California 92653
1955
mi
from 43215
Laguna Hills, CA
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Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
7000 West Colfax Avenue
Lakewood, Colorado 80215
1166
mi
from 43215
Lakewood, CO
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Florida Center for Gastroenterology
Largo, Florida 33777
832
mi
from 43215
Largo, FL
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VA Long Beach Healthcare System
Long Beach, California 90822
1972
mi
from 43215
Long Beach, CA
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University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
394
mi
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Madison, WI
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
425
mi
from 43215
Marietta, GA
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Community Clinical Research Network
Marlborough, Massachusetts 01752
618
mi
from 43215
Marlborough, MA
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Advanced Medical Research
4730 West Bancroft Street
Maumee, Ohio 43537
121
mi
from 43215
Maumee, OH
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City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
992
mi
from 43215
Miami, FL
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Advanced Clinical Research of Miami
Miami, Florida 33155
995
mi
from 43215
Miami, FL
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Regenerate Clinical Trials
Miami, Florida 33155
993
mi
from 43215
Miami, FL
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IMIC, Inc
Miami Beach, Florida 33140
993
mi
from 43215
Miami Beach, FL
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FQL Research, LLC
Miramar, Florida 33025
978
mi
from 43215
Miramar, FL
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Gastroenterology Group of Naples
Naples, Florida 34102
957
mi
from 43215
Naples, FL
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Aquiant Research
2630 Grant Line Road
New Albany, Indiana 47150
188
mi
from 43215
New Albany, IN
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North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation
1999 Marcus Avenue
New Hyde Park, New York 11042
494
mi
from 43215
New Hyde Park, NY
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Advanced Research Institute, Inc
New Port Richey, Florida
814
mi
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New Port Richey, FL
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Concorde Medical Group
New York, New York 10016
479
mi
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New York, NY
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Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York 10021
480
mi
from 43215
New York, NY
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Mount Sinai - PRIME
New York, New York 10029
481
mi
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New York, NY
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Lenox Hill Hospital
New York, New York 10021
480
mi
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New York, NY
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Digestive and Liver Disease Specialists
Norfolk, Virginia 23502
426
mi
from 43215
Norfolk, VA
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Central Sooner Research
Norman, Oklahoma 73069
853
mi
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Norman, OK
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Clinical Trials of South Carolina
North Charleston, South Carolina 29406
514
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North Charleston, SC
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Med-Care Research
North Miami Beach, Florida 33162
983
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North Miami Beach, FL
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California Medical Research Associates Inc.
Northridge, California 91324
1983
mi
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Northridge, CA
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Southwest Gastroenterology
Oak Lawn, Illinois 60453
275
mi
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Oak Lawn, IL
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Advanced Research Institute
Ogden, Utah 84405
1514
mi
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Ogden, UT
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University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
848
mi
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Oklahoma City, OK
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
850
mi
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Oklahoma City, OK
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Quality Clinical Research, Inc.
10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
688
mi
from 43215
Omaha, NE
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University of California, Irvine Medical Center
101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
1958
mi
from 43215
Orange, CA
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Medical Research Group of Central Florida
Orange City, Florida 32763
767
mi
from 43215
Orange City, FL
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Premier Medical Group of the Hudson Valley
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
490
mi
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Poughkeepsie, NY
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McGuire Research Institute; Gastroenterology
Richmond, Virginia 23249
342
mi
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Richmond, VA
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