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UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency department visits.
The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as "Pharmacogenomics."
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Meaningful Change in Drug Regimen | The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined for each subject as:
| 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in target drug regimen over the 90-day period preceding receipt of PGx results, compared to the changes made in the 90-day period thereafter | 90 days | |
| Number of Target Drug-Related Adverse events (TDAE) over the 90-day period preceding receipt of PGx test results compared with the number over the 90-day period after the test |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects over the age of 18, receiving at least one medication with metabolism known to depend on genetic allelic variation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | upgrade@companiondxlab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Cardiovascular Center | Recruiting | Scottsdale | Arizona | 85251 | United States |
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| 90 days |
| Target-drug related outpatient clinic visits, emergency department visits, and hospitalizations over the 90-day period prior to the receipt of PGx test results, compared to the number of visits over the 90-day period following testing. | 90 Days |
| ARcare | Recruiting | Augusta | Arkansas | 72006 | United States |
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| Retina Institute of California | Recruiting | Arcadia | California | 91007 | United States |
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| John Allen, M.D. | Recruiting | El Cajon | California | 92020 | United States |
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| Delaware Electrophysiology & Cardiology | Recruiting | Newark | Delaware | 19711 | United States |
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| Boca Raton Clinical Research | Recruiting | Boca Raton | Florida | 33432 | United States |
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| St. Francis Sleep, Allergy & Lung Institute | Recruiting | Clearwater | Florida | 33765 | United States |
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| First Coast Cardiovascular Institute | Recruiting | Jacksonville | Florida | 32216 | United States |
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| Israel Machin M.D., PA | Recruiting | Lake Clarke Shores | Florida | 33406 | United States |
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| Shaw Research Specialists, Inc. | Recruiting | Miami | Florida | 33137 | United States |
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| Angel E. Rico, M.D. PA | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| Advanced Behavioral Care, LLC | Recruiting | Palm Bay | Florida | 32905 | United States |
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| Diverse Clinical Research Center of Chicago, LLC | Recruiting | Chicago | Illinois | 60611 | United States |
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| Aida Mihajlovic M.D. Inc. | Recruiting | Olympia Fields | Illinois | 60461 | United States |
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| Northshore Allergy & Immunology, LLC | Recruiting | Covington | Louisiana | 70433 | United States |
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| Centex Studies Inc | Recruiting | Lake Charles | Louisiana | 70601 | United States |
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| B. John Hynes, M.D. | Completed | Elkton | Maryland | 21921 | United States |
| Premier Psychiatric Research Institute, LLC | Recruiting | Lincoln | Nebraska | 68526 | United States |
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| Pain Medicine Physicians | Recruiting | Millburn | New Jersey | 07041 | United States |
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| Vanguard Medical Group | Recruiting | Montville | New Jersey | 07045 | United States |
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| Virtua Medical Group, P.A. | Recruiting | Moorestown | New Jersey | 08057 | United States |
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| Coventry Cardiology Associates | Recruiting | Phillipsburg | New Jersey | 08865 | United States |
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| Pennington Infectious Disease Associates | Recruiting | Trenton | New Jersey | 08638 | United States |
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| White Oak Family Physicians, PA | Recruiting | Asheboro | North Carolina | 27203 | United States |
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| Allergy Partners, P.A. | Recruiting | Asheville | North Carolina | 28803 | United States |
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| Buckeye Health and Research LLC | Recruiting | Hilliard | Ohio | 43026 | United States |
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| Kettering Medical Center | Recruiting | Kettering | Ohio | 45429 | United States |
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| Family Medicine and Occupational Health, Inc | Recruiting | Shaker Heights | Ohio | 44120 | United States |
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| Lehigh Valley Hospital's Network Office of Research and innovation | Recruiting | Allentown | Pennsylvania | 18101 | United States |
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| Wound Institute & Research Center | Recruiting | Dunmore | Pennsylvania | 18512 | United States |
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| Guthrie Foundation for Education and Research | Recruiting | Sayre | Pennsylvania | 18840 | United States |
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| Wellmon Family Practice | Recruiting | Shippensburg | Pennsylvania | 17257 | United States |
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| Abington Neurological Associates, LTD. | Recruiting | Willow Grove | Pennsylvania | 19090 | United States |
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| Recruiting | Austin | Texas | 78735 | United States |
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| Withdrawn | Harlingen | Texas | 78550 | United States |
| South Shore Medical Center | Recruiting | League City | Texas | 77573 | United States |
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| Renaissance Psychiatry | Recruiting | McAllen | Texas | 78501 | United States |
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| Centex Studies Inc | Recruiting | Pharr | Texas | 78577 | United States |
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| Hillcrest Family Health Center | Recruiting | Waco | Texas | 76710 | United States |
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| Millennium Clinical Trials LLC | Recruiting | Arlington | Virginia | 22203 | United States |
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| Ettrick Health Center, LLC | Recruiting | South Chesterfield | Virginia | 23803 | United States |
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