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| Name | Class |
|---|---|
| Syntactx | NETWORK |
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The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.
The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual'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 in each subject when:
| 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results | 90 days | |
| Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects aged 65 and above or subjects aged 18 and above who have a disability will be eligible for inclusion in the study if they are receiving or are planned to receive at least one medication with a metabolic pathway linked to genetic variations ("target drug").
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| Name | Affiliation | Role |
|---|---|---|
| Bill Massey, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Core Insitute | Recruiting | Phoenix | Arizona | 85023 | United States |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| 90 days |
| Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test | Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion | 90 days |
| Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs | 90 days |
| Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results | 90 days |
| Number of target drug-related adverse events over the 90-day period prior to and following PGx testing | 90 days |
| Emergency department visits over the 90-day periods prior to and following PGx testing | 90 days |
| Hospitalizations over the 90-day period prior to and following receipt of PGx test results | 90 days |
| LifeSpan Institute | Recruiting | La Jolla | California | 92037 | United States |
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| The International Heart & Lung Institute Center for Restorative Medicine | Recruiting | Palm Springs | California | 92262 | United States |
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| Research Physicians Network Alliance | Recruiting | Pembroke Pines | Florida | 33026 | United States |
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| Tallahassee Neurological Institute | Recruiting | Tallahassee | Florida | 32308 | United States |
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| Hypertension Institute | Recruiting | Nashville | Tennessee | 37205 | United States |
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| Diagnostic Clinic of Houston | Recruiting | Houston | Texas | 77004 | United States |
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| Research & Cardiovascular Corp. | Recruiting | Ponce | PR | 00717 | Puerto Rico |
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