Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 3/8/2019 |
| Start Date: | August 15, 2017 |
| End Date: | December 2021 |
| Contact: | David B Yehle, RPh |
| Email: | dyehle@unither.com |
| Phone: | 919 485-8350 |
An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
This is an open-label study to evaluate the safety of continued therapy with oral
treprostinil in subjects who have completed Study TDE-HF-301. This study will provide
long-term, open-label data regarding the effect of continued long-term oral treprostinil
therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with
preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,
24, and every 12 weeks thereafter until either oral treprostinil becomes commercially
available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.
treprostinil in subjects who have completed Study TDE-HF-301. This study will provide
long-term, open-label data regarding the effect of continued long-term oral treprostinil
therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with
preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,
24, and every 12 weeks thereafter until either oral treprostinil becomes commercially
available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.
Inclusion Criteria:
- The subject participated in Study TDE-HF-301, remained on study drug, was compliant
with study procedures and assessments during Study TDE-HF-301, and completed through
Week 24 of that study.
Exclusion Criteria
- The subject is pregnant or lactating.
- The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
- The subject developed a concurrent illness or condition during Study TDE HF 301,
which, in the opinion of the Investigator, would represent a risk to the subject's
overall health if they enrolled in this study.
We found this trial at
82
sites
Washington, District of Columbia 20007
Principal Investigator: Tunay Kuru, MD
Phone: 202-444-1224
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Indranee Rajapreyar, MD
Phone: 205-975-9426
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Aaron Waxman, MD
Phone: 617-525-9731
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Ioana Preston, MD
Phone: 617-636-1334
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Sandhya Murthy, MD
Phone: 718-920-8780
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Miriam Jacob
Phone: 216-445-1630
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3500 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Yolanda Mageto, MD
Phone: 214-820-5829
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Bela Patel, MD
Phone: 713-500-6851
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Principal Investigator: David Booth, MD
Phone: 859-218-2880
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Antoine Hage, MD
Phone: 310-248-7141
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Thenappan Thenappan, MD
Phone: 612-626-6237
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ivan Robbins, MD
Phone: 615-322-3412
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Sean Pinney, MD
Phone: 212-241-7403
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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326 North Mills Avenue
Orlando, Florida 32803
Orlando, Florida 32803
Principal Investigator: Hadi Chohan, MD
Phone: 407-426-9299
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
Weston, Florida 33331
866.293.7866
Principal Investigator: Jinesh Mehta, MD
Phone: 954-659-6213
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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47 New Scotland Ave
Albany, New York 12208
Albany, New York 12208
(518) 262-3125
Principal Investigator: Boris Medarov, MD
Phone: 518-262-0355
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Anderson, South Carolina 29621
Principal Investigator: Abhijit Raval, MD
Phone: 864-512-8519
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55 East Camperdown Way
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Principal Investigator: Charles Thompson, MD
Phone: 864-965-0190
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Asheville, North Carolina 28802
Principal Investigator: Benjamin Trichon, MD
Phone: 828-274-6000
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1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Micah Fisher
Phone: 404-727-2011
Emory University Hospital As the largest health care system in Georgia and the only health...
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Augusta, Georgia 30912
Principal Investigator: Clark McDonough, DO
Phone: 706-721-5636
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13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Todd Bull, MD
Phone: 303-724-7466
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, Colorado 80012
Principal Investigator: Nampalli Vijay, MD
Phone: 303-839-7789
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275 Collier Road Northwest
Austell, Georgia 30309
Austell, Georgia 30309
Principal Investigator: Amy Case, MD
Phone: 770-745-1404
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Brandon, Florida 33511
Principal Investigator: Robert Dewhurst, MD
Phone: 813-684-6000
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Rahul Argula, MD
Phone: 843-792-8092
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chesterfield, Missouri 63017
Principal Investigator: Neil Ettinger, MD
Phone: 314-682-3653
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Chicago, Illinois 60612
Principal Investigator: Dustin Fraidenburg, MD
Phone: 312-355-5895
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Cincinnati, Ohio 45219
Principal Investigator: Peter Engel, MD
Phone: 513-585-1777
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2110 North Beltline Boulevard
Columbia, South Carolina 29204
Columbia, South Carolina 29204
Principal Investigator: Carlton (Greg) Cauthen, MD
Phone: 803-254-4295
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410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Veronica Franco, MD
Phone: 614-292-4084
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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3625 Braselton Highway
Dacula, Georgia 30019
Dacula, Georgia 30019
Principal Investigator: Rachel Nisbet, MD
Phone: 470-297-6789
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Detroit, Michigan 48202
Principal Investigator: Rana Awdish, M.D.
Phone: 313-916-1254
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Sudarshan Rajagopal, MD
Phone: 919-668-2642
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Falls Church, Virginia 22042
Principal Investigator: Mitchell Psotka, MD
Phone: 703-776-2018
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Germantown, Tennessee 38138
Principal Investigator: Frank McGrew, MD
Phone: 901-271-4164
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Grand Rapids, Michigan 69546
Principal Investigator: Renzo Loyaga-Rendon
Phone: 616-391-5067
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Houston, Texas 77030
Principal Investigator: Zeenat Safdar, MD
Phone: 713-363-7536
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2001 W 86th St
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
(317) 338-2345
Principal Investigator: Ashwin Ravichandran, MD
Phone: 317-338-6252
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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Indianapolis, Indiana 46202
Principal Investigator: Michael Duncan, MD
Phone: 317-962-9978
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Indianapolis, Indiana 46250
Principal Investigator: Muhamad Safiia, MD
Phone: 317-621-8629
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200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Linda Cadaret, M.D.
Phone: 319-353-5245
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32216
Principal Investigator: Charles Burger, MD
Phone: 904-953-7625
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Jacksonville, Florida 33204
Principal Investigator: Abubakr Bajwa, MD
Phone: 904-450-8255
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Lewis Satterwhite
Phone: 913-588-4022
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4401 Wornall Rd
Kansas City, Missouri 64111
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Mark Yagan, MD
Phone: 816-932-5987
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Knoxville, Tennessee 37909
Principal Investigator: John Swisher, MD
Phone: 865-934-2676
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555 N Duke St
Lancaster, Pennsylvania 17602
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Justin Roberts, MD
Phone: 717-544-1777
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Principal Investigator: Bruce Andrus, MD
Phone: 603-650-7803
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Littleton, Colorado 80120
Principal Investigator: Ira Dauber, MD
Phone: 303-703-2124
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Los Angeles, California 90073
Principal Investigator: Alberta Warner, MD
Phone: 323-479-4328
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Los Angeles, California 90024
Principal Investigator: Rajan Saggar, MD
Phone: 310-794-3299
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Louisville, Kentucky 40202
Principal Investigator: John McConnell, M.D.
Phone: 502-587-8000
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Louisville, Kentucky 40202
Principal Investigator: El-Kersh Karim, MD
Phone: 502-852-8739
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Lubbock, Texas 79430
Principal Investigator: Alejandro Marmol-Velez
Phone: 915-215-4190
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55 Whitcher Street
Marietta, Georgia 30060
Marietta, Georgia 30060
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Phone: 470-793-4046
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: James Gagermeier, MD
Phone: 708-216-5744
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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17760 Northwest 2nd Avenue
Miami Gardens, Florida 33169
Miami Gardens, Florida 33169
Principal Investigator: Javier Jimenez
Phone: 305-999-3301
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Dianne Zwicke, MD
Phone: 414-649-5664
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: David Ishizawar, MD
Phone: 414-955-7036
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1700 SpringHill Avenue
Mobile, Alabama 36604
Mobile, Alabama 36604
Principal Investigator: Adrian Divittorio, MD
Phone: 251-435-1651
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Morgantown, West Virginia
Principal Investigator: George Sokos, MD
Phone: 304-598-6424
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201 Lyons Avenue
Newark, New Jersey 07112
Newark, New Jersey 07112
Principal Investigator: Christina Migliore, MD
Phone: 973-926-8578
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Norfolk, Virginia 23507
Principal Investigator: Michael Eggert, MD
Phone: 757-388-4024
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4440 West 95th Street
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Muhyaldeen Dia, MD
Phone: 708-684-4690
Advocate Christ Medical Center Advocate Health Care, named among the nation
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601 E Rollins St
Orlando, Florida 32803
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: James Tarver III, MD
Phone: 407-303-9984
Florida Hospital Florida Hospital is one of the country
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Pensacola, Florida 32504
Principal Investigator: Rohit Amin, MD
Phone: 850-477-7900
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Phoenix, Arizona 85006
Principal Investigator: Radha Gopalan, MD
Phone: 602-828-2431
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Pinehurst, North Carolina 28734
Principal Investigator: Michael Pritchett, MD
Phone: 910-235-3144
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320 E North Ave
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Raymond Benza, MD
Phone: 412-359-3293
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Portland, Oregon 97210
Principal Investigator: Hataya (Kristy) Poonyagariyagorn, MD
Phone: 503-297-3778
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Melissa Smallfield, MD
Phone: 804-828-7966
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Roblee Allen, MD
Phone: 916-734-1554
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Santa Barbara, California 93105
Principal Investigator: Jeffrey Sager, MD
Phone: 805-569-7461
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100 Foden Road
South Portland, Maine 04106
South Portland, Maine 04106
Principal Investigator: Joel Wirth
Phone: 207-828-1122
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Spokane, Washington 99204
Principal Investigator: Bryan Fuhs, MD
Phone: 509-474-2041
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Syracuse, New York 13210
Principal Investigator: Sherif El Bayadi, MD
Phone: 315-234-0816
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Tampa, Florida 33606
Principal Investigator: Ricardo Restrepo-Jaramillo, MD
Phone: 813-844-4306
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3000 Arlington Avenue
Toledo, Ohio 43614
Toledo, Ohio 43614
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Franz Rischard, MD
Phone: 520-626-8305
University of Arizona The University of Arizona is a premier, public research university. Established in...
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West Des Moines, Iowa 50266
Principal Investigator: Randy Rough, MD
Phone: 515-633-3845
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