Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - 90
Updated:4/17/2018
Start Date:May 2002
End Date:August 2016

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The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) prevention trial
is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a
prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E
supplements can help to prevent memory loss and dementia such as Alzheimer's disease.

Studies show that increased oxidative stress (from excess free radicals) may damage brain
cells and is linked with Alzheimer's disease (AD). Many studies show increased oxidation of
brain lipids (fats), proteins, carbohydrates (sugars) and DNA in AD. Although the causes of
AD are not known, it is believed that oxidative stress is part of what damages brain cells in
AD and probably other brain diseases. Animal and tissue culture studies of vitamin E and
selenium suggest that they can protect brain cells from damage. This research study is being
done to see how safe and effective vitamin E and selenium may be in preventing AD and other
brain illnesses. These illnesses are more common in people over the age of 60 to 65. A
potential benefit of participating in the PREADVISE study is that early detection of memory
changes can lead to early diagnosis and treatment. Also, some participants may decrease their
risk of getting AD if the supplements are effective. The findings of this study may also help
in the research and understanding of AD.

Only participants who are taking part in the SELECT study (a study that looks at the use of
vitamin E and selenium for preventing prostate cancer) may apply to participate in the
PREADVISE study about how useful vitamin E and selenium might be for preventing memory
changes with age (including Alzheimer's disease and other disease that can affect the brain).
African American and Hispanic men who are age 60 or older may take part. Men of other ethnic
groups aged 62 or older may take part. The SELECT doctors or staff will review the
applicant's medical history and drugs to verify that they have no conditions that would
exclude them from this study. About 10,000 men will take part in this study.

The PREADVISE study examinations will be done during the participant's annual SELECT visit at
the clinic where the SELECT studies are being conducted. There will be one study visit for
each year the participants are in SELECT (7 to 12 visits). Each visit for PREADVISE will
consist of a brief screening of the participant's memory, and an update (if any) of the
participant's family history of dementia and medications. If memory changes are suggested by
the brief memory screen, the participant will be asked to take a longer memory screen to
further evaluate the potential for memory changes. If the longer memory screen also suggests
problems with the participant's memory, the participant will be asked to see his family
doctor or a PREADVISE doctor for a more complete medical exam to find the possible causes of
the memory change. Results of the doctor's medical exam, with the consent of the participant,
will be sent to the PREADVISE doctors for their review to help with the diagnosis. Results of
the memory checks will not be given to the participants. However, if the participant does
have a medical workup for memory changes, this information will be given to the family doctor
after the medical workup is completed. A portion of the blood sample that was taken when the
participant entered SELECT might be analyzed and tested for a genetic risk factor associated
with Alzheimer's disease, called Apolipoprotein E (ApoE). The results of this test will be
used for research purposes only.

Inclusion Criteria:

- Participating in SELECT Prevention study;

- 62 years or older if other ethnic origin, or 60 years or older if African-American or
Hispanic;

- General good health with no neurological or psychiatric illness.

Exclusion Criteria:

The SELECT doctors or staff will review the PREADVISE applicants' medical history and drugs
to verify that they have no condition(s) that would exclude them from this study. The
participant must not have any of the following neurological conditions based on self report
(were told by a physician):

- Alzheimer's disease, or any other form of dementia such as Pick's disease, dementia
with Lewy bodies, frontotemporal dementia, vascular dementia, significant cognitive
and motor impairment from a stroke or corticobasal degeneration;

- Huntington's disease, epilepsy, Parkinson's disease, brain tumor, multiple sclerosis,
manic-depressive disorder, or schizophrenia;

- The participant must not have had a head injury with prolonged loss of consciousness
(over 30 minutes) within the past five years;

- The participant must not have a current alcohol or substance abuse diagnosis, or must
have been treatment free for the past 24 months;

- The participant must not have had a diagnosis of depression or anxiety disorder in the
past 4 months and must not currently be under treatment for depression or anxiety
disorder. [A participant who was previously diagnosed with depression or anxiety
disorder but completed treatment more than four months ago is eligible.];

- The participant must not currently use of any of the following medications: Aricept,
Cognex, Exelon, Reminyl, or Hydergine;

- The participant must not have blindness, deafness, language difficulties or any other
disability that may prevent completion of the memory screen.
We found this trial at
85
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1307
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Albany, NY
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Jacksonville, Florida 32207
1058
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Jacksonville, FL
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740 South Limestone Street
Lexington, Kentucky 40536
725
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Lexington, KY
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
1227
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Abington, PA
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Adrian, Michigan 49221
784
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Adrian, MI
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
1209
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Allentown, PA
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370
mi
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Ames, IA
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Anchorage, Alaska 99508
2734
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Anchorage, AK
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Anchorage, Alaska 99508
2732
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Anchorage, AK
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Annapolis, Maryland 21401
1155
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Annapolis, MD
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Ashland, Kentucky 41101
825
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Ashland, KY
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2901 Squalicum Parkway
Bellingham, Washington 98225
1445
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Bellingham, WA
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
1214
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Bethlehem, PA
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90 Poly Drive, Suite 2
Billings, Montana 59101
(406) 237-5460
Montana Cancer Consortium CCOP The Montana Cancer Consortium is a nonprofit organization whose mission is...
780
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Billings, MT
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683
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Birmingham, AL
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1400 Iowa 13
Cedar Rapids, Iowa 52403
441
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Cedar Rapids, IA
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1140
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Chula Vista, CA
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Cincinnati, Ohio 45220
725
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Cincinnati, OH
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100 Michigan Street, NE, MC012
Columbus, Ohio 43215
(614) 488-2118
Columbus CCOP As one of the original 20 CCOPs, the Columbus Community Clinical Oncology Program...
810
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Columbus, OH
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1 Atwell Road
Cooperstown, New York 13326
1250
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Cooperstown, NY
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1441 North Beckley Avenue
Dallas, Texas 75203
349
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Dallas, TX
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Davenport, Iowa 52803
466
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Davenport, IA
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Des Moines, Iowa 50309
346
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Des Moines, IA
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
841
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Detroit, MI
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Doylestown, Pennsylvania 18901
1227
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Doylestown, PA
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Duluth, Minnesota 55805
688
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Duluth, MN
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385 Tremont Avenue
East Orange, New Jersey 07018
1274
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East Orange, NJ
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Fort Collins, Colorado 80524
434
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Fort Collins, CO
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Fremont, Ohio 43420
819
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Glendale, California 91204
1167
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Glendale, CA
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Glens Falls, New York 12801
1321
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Glens Falls, NY
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25 Michigan Street Northeast
Grand Rapids, Michigan 49503
733
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Grand Rapids, MI
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2621 15th Avenue South
Great Falls, Montana 59405
956
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Great Falls, MT
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Joplin, Missouri 64804
188
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Joplin, MO
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
190
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10 East 31st Street
Kearney, Nebraska 68847
215
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Kearney, NE
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
777
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Knoxville, TN
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
1145
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La Jolla, CA
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4600 Valley Road
Lincoln, Nebraska 68510
219
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Lincoln, NE
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11201 Benton Street
Loma Linda, California 92354
1114
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Long Beach, California 90822
1172
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Louisville, Kentucky 40206
657
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Marshfield, Wisconsin 54449
621
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5805 Monclova Road
Maumee, Ohio 43537
795
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Memphis, Tennessee 38120
477
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Milwaukee, Wisconsin 53233
636
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Milwaukee, WI
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718 North Macomb Street
Monroe, Michigan 48162
816
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Monroe, MI
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Muskogee, Oklahoma 74401
193
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Muskogee, OK
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Nashville, Tennessee 37208
617
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Northridge, California 91325
1180
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Oak Ridge, Tennessee 37830
757
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Oak Ridge, TN
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267
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Omaha, NE
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7500 Mercy Rd
Omaha, Nebraska 68124
(402) 398-6060
Alegent Health Bergan Mercy Medical Center Alegent Creighton Health is now CHI Health, giving you...
258
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Omaha, NE
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261
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Oregon, Ohio 43616
806
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501 Smyth Road
Ottawa, Ontario K1H 8L6
1256
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Phillipsburg, New Jersey 08865
1225
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1333
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Pittsfield, MA
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44405 Woodward Ave
Pontiac, Michigan 48341
(248) 858-3000
St. Joseph Mercy Oakland St. Joseph Mercy Oakland (SJMO) is a 443-bed comprehensive, community and...
835
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Pontiac, MI
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Red Bank, New Jersey 07701
1283
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1155 Mill Street
Reno, Nevada 89520
1189
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Reno, NV
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Santa Rosa, California 95403
1293
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Santa Rosa, CA
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Seattle, Washington 98101
1410
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Seattle, WA
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
1409
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Seattle, WA
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Seattle, Washington 98133
1410
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336
mi
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Sioux City, IA
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1000 East 23rd Street
Sioux Falls, South Dakota 57105
403
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Sioux Falls, SD
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1235 East Cherokee Street
Springfield, Missouri 65804
252
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Springfield, MO
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Springfield, Missouri 65804
253
mi
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5200 Harroun Rd
Sylvania, Ohio 43560
(419) 824-1444
Flower Hospital ProMedica's Mission is to improve your health and well-being. And ProMedica Flower Hospital...
797
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Sylvania, OH
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Temple, Texas 76508
460
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Temple, TX
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
801
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Toledo, OH
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Toledo, Ohio 43608
803
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Toledo, OH
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Toledo, Ohio 43623
803
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Toledo, OH
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Toledo, Ohio 43623
800
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Toledo, OH
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145
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Topeka, KS
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1178
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Torrance, CA
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
793
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Traverse City, MI
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2142 West Broad Street
Tucker, Georgia 30084
847
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Tucker, GA
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Upland, California 91786
1135
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Upland, CA
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5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
1127
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Washington,
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Washington, District of Columbia
1127
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Washington,
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1711 First Street Southwest
Washington, District of Columbia 20060
1128
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Washington,
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929 N St Francis Street
Wichita, Kansas 67214
(316) 262-4467
Wichita CCOP The Wichita Community Clinical Oncology Program (CCOP), which first received funding by NCI...
27
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Wichita, KS
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York, Pennsylvania 17403
1142
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York, PA
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