Sleep for Stroke Management and Recovery Trial



Status:Not yet recruiting
Conditions:Insomnia Sleep Studies, Neurology, Pulmonary, Pulmonary
Therapuetic Areas:Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:May 2019
End Date:November 2023
Contact:Kayla Gosselin, MPH, CCRP
Email:kcgossel@med.umich.edu
Phone:734-615-2006

Use our guide to learn which trials are right for you!

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes at 3 months in patients who experienced an
ischemic stroke.

Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is
a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to
usual care. The study includes two trials: a prevention study with an embedded recovery
trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded
StrokeNet clinical trials network.

Inclusion Criteria:

1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.

Exclusion Criteria:

1. pre-event inability to perform all of own basic ADLs

2. unable to obtain informed consent from subject or legally authorized representative

3. incarcerated

4. known pregnancy

5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy

6. current use of positive airway pressure, or use within one month prior to stroke

7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible

8. severe bullous lung disease

9. history of prior spontaneous pneumothorax or current pneumothorax

10. hypotension requiring current treatment with pressors (can enroll later if this
resolves)

11. other specific medical circumstances that conceivably, in the opinion of the site PI,
could render the patient at risk of harm from use of CPAP

12. massive epistaxis or previous history of massive epistaxis

13. cranial surgery or head trauma within the past 6 months, with known or possible CSF
leak or pneumocephalus

14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet
been replaced), or any other recent bone removal procedure for relief of intracranial
pressure

15. current receipt of oxygen supplementation >4 liters per minute
We found this trial at
106
sites
Columbus, Ohio 43210
Principal Investigator: Vivien Lee, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: M. Edip Gurol, MD
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Lester Y Young, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Sandeep Kumar, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Kathryn Kirchoff-Torres, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Elisheva Coleman, MD
University of Cincinnati Medical Center Opening in 1823 as the country
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Ken Uchino, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Dani Choufani, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Mark Goetting, MD
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Oana Dumitrascu, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Rohan Arora, MD
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Principal Investigator: Jose Romano, MD
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Miami, FL
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Steven Messe, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: William Scott Burgin, MD
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Dan Gzesh, MD
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Asheville, North Carolina 28801
Principal Investigator: Alex Schneider, MD
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Asheville, NC
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Michael Frankel, MD
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Gillian Gordon-Perue, MD
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bangor, ME
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Bethlehem, Pennsylvania 18015
Principal Investigator: Daniel Ackerman, MD
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Birmingham, Alabama 35294
Principal Investigator: Soo Young Kwon, MD
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Boston, Massachusetts 02118
Principal Investigator: Jose Rafael Romero, MD
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Steven Rudolph, MD
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Buffalo, New York 14203
Principal Investigator: Amit Kandal, MD
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Burlington, Vermont 05401
Principal Investigator: Ajay Tunguturi, MD
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Burlington, VT
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Carmichael, California 95608
Principal Investigator: Lucian Maidan, MD
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Carmichael, CA
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Cedar Rapids, Iowa 52402
Principal Investigator: Laurence Krain, MD
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Cedar Rapids, IA
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Charleston, South Carolina 29425
Principal Investigator: Christine Holmstedt, DO
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Charlotte, North Carolina 28204
Principal Investigator: Rob Buechler, MD
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Charlotte, NC
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57 Ray C Hunt Drive
Charlottesville, Virginia 22908
Principal Investigator: Nina Solenski, MD
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Chicago, Illinois 60612
Principal Investigator: Fernando Testai, MD
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Chicago, IL
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Shyam Prabhakaran, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nicholas Osteraas, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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4777 East Galbraith Road
Cincinnati, Ohio 45236
Principal Investigator: Elisheva Coleman, MD
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Elisheva Coleman, MD
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Sophia Sundararajan, MD
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Souvik Sen, MD
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Concord, California 94520
Principal Investigator: Ok-Kyung Kim, MD
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Concord, CA
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Mehari Gebreyohanns, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Davenport, Iowa 52803
Principal Investigator: Rodney Short, MD
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Detroit, Michigan 48202
Principal Investigator: Kumar Rajamani, MD
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Detroit, MI
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Angelos Katramados, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Edgewood, Kentucky 41017
Principal Investigator: Elisheva Coleman, MD
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Edgewood, KY
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Elk Grove Village, Illinois 60007
Principal Investigator: Franklin Marden, MD
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Elk Grove Village, IL
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Fairfield, Ohio 45014
Principal Investigator: Elisheva Coleman, MD
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Fairfield, OH
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Fresno, California 93721
Principal Investigator: Stuart Glassner, MD
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Fresno, CA
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Gainesville, Florida 32610
Principal Investigator: Anna Khanna, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Nabil Wees, MD
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Grand Rapids, MI
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Grand Rapids, Michigan 49503
Principal Investigator: Muhammad Farooq, MD
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Principal Investigator: Sanjeev Sivakumar, MD
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
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Harlingen, Texas 78550
Principal Investigator: Ameer Hassan, MD
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Harlingen, TX
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Francoise Roux, MD
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Houston, Texas 77030
Principal Investigator: Sudha Tallavajhula, MD
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Sami Al Kasab, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Jacksonville, Florida 32216
Principal Investigator: Kenneth Ngo, MD
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Suzanne Crandall, DO
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Kirkland, Washington 98034
Principal Investigator: Raymond Park, MD
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La Jolla, California 92037
Principal Investigator: Mary Kalafut, MD
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La Jolla, CA
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9300 Campus Point Drive
La Jolla, California 92037
Principal Investigator: Dawn Meyer, PhD
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Lexington, Kentucky 40536
Principal Investigator: Luther Creed, MD
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Los Angeles, California 90095
Principal Investigator: Jeffrey Saver, MD
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Los Angeles, California 90027
Principal Investigator: Prasanth Manthena, MD
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
Principal Investigator: Tracy Anders, MD
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Madison, Wisconsin 53792
Principal Investigator: Robert Dempsey, MD
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Michael Schneck, MD
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Jose Romano, MD
University of Miami Hospital The University of Miami changed the face of modern health care...
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Principal Investigator: Felipe De Los Rios La Rosa, MD
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Minneapolis, Minnesota 55415
Principal Investigator: Muna Irfan, MD
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Minneapolis, Minnesota 55455
Principal Investigator: Kamakshi Lakshimarayan, MD
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Morgantown, West Virginia 26506
Principal Investigator: Mouhannad Azzouz, MD
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Megan Donohue, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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New Brunswick, New Jersey 08903
Principal Investigator: Deviyani Mehta, MD
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Klar Yaggi, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Orleans, Louisiana 70121
Principal Investigator: Richard Zweifler, MD
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New York, New York 10016
Principal Investigator: Koto Ishida, MD
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New York, New York 10032
Principal Investigator: Joshua Willey, MD, MS
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Newport Beach, California 92658
Principal Investigator: David Brown, MD
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Pierre Fayad, MD
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Pasadena, California 91105
Principal Investigator: Arbi Ohanian, MD
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Peoria, Illinois 61637
Principal Investigator: David Wang, MD
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Syeda Imama Naqvi, MD
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Phoenix, Arizona 85013
Principal Investigator: Joni Clark, MD
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Sherry Chou, MD
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Portland, Oregon 97239
Principal Investigator: Wayne Clark, MD
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Rochester, Minnesota 55905
Principal Investigator: Eugene Scharf, MD
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Saint Louis, Missouri 63110
Principal Investigator: Eric Landsness, MD
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1755 South Grand Boulevard
Saint Louis, Missouri 63110
Principal Investigator: Joanna Ramiro, MD
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Saint Paul, Minnesota 55130
Principal Investigator: Haitham Hussein, MD
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333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
Principal Investigator: Dimitrios Giannakidis
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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Salt Lake City, Utah 84132
Principal Investigator: Jana Wold, MD
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200 West Arbor Drive
San Diego, California 92103
Principal Investigator: Dawn Meyer, PhD
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San Francisco, California 94143
Principal Investigator: Wade Smith, MD, PhD
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Principal Investigator: Mauricio Concha, MD
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Fatima Milfred, MD
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Sandeep Khot, MD
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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1541 Kings Highway
Shreveport, Louisiana 71103
Principal Investigator: Oleg Chernyshev, MD, PhD
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801 5th St
Sioux City, Iowa 51104
(712) 279-2010
Principal Investigator: Elizabeth Hartman, MD
Mercy Medical Center - Sioux City Living the traditions, visions and values of the Sisters...
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701 N 1st St
Springfield, Illinois 62781
(217) 788-3000
Principal Investigator: Fazeel Siddiqui, MD
Memorial Medical Center Memorial Medical Center is a Magnet-designated, acute care hospital in Springfield that...
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Julius Gene Latorre, MD
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Toledo, Ohio
Principal Investigator: Osama Zaidat, MD
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Tucson, Arizona 85721
Principal Investigator: Chelsea Kidwell, MD
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Walnut Creek, California 94598
Principal Investigator: Ok-Kyung Kim, MD
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