Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02191358
Eligibility Criteria:
INCLUSION CRITERIA: Prospectively enrolled study participants (i.e. "tested" patients) must fulfill all of the following criteria to be eligible for enrollment into the study:
* Age 65 or older
* Willing and able to provide informed consent for study participation either directly or by a legally authorized representative (LAR)
* Undergoing testing through the YouScript Personalized Prescribing System as recommended during the course of routine care, and ordering all of the following tests: CYP2D6, CYP2C19, CYP2C9, VKORC1, CYP3A4, CYP3A5
* Currently taking at least 3 prescription medications (any route of administration)
* Initiated treatment with, or changed the dose of, at least 1 of the following oral forms of medication (excluding medications taken PRN) within the previous 120 days (generic name given with major U.S. brand name given in parentheses). These medications are subject to significant drug---gene interactions as defined by FDA boxed warning, FDA cautionary labeling, clinical literature or a YouScript algorithm---predicted significant effect:
Amitriptyline (Elavil), Aripiprazole (Abilify), Atomoxetine (Strattera), Carvedilol (Coreg), Celecoxib (Celebrex), Citalopram (Celexa), Clobazam (Onfi), Clomipramine (Anafranil), Clopidogrel (Plavix), Clozapine (Clozaril), Codeine \[Tylenol #3 (combo)\], Desipramine (Norpramin), Dextromethorphan (Delsym), Diazepam (Valium), Doxepin (Sinequan), Escitalopram (Lexapro), Esomeprazole (Nexium), Fesoterodine (Toviaz), Flecainide (Tambocor), Fluoxetine (Prozac), Flurbiprofen (Ansaid), Fluvoxamine (Luvox), Haloperidol (Haldol), Hydrocodone (Zohydro), Ibuprofen (Motrin), Iloperidone (Fanapt), Imipramine (Tofranil), Indomethacin (Indocin), Meloxicam (Mobic), Metoprolol (Toprol-XL), Mexiletine (Mexitil), Nortriptyline (Pamelor), Omeprazole (Prilosec), Oxycodone (Oxycontin), Paroxetine (Paxil), Perphenazine (Trilafon), Phenobarbital (Luminal), Phenytoin (Dilantin), Pimozide (Orap), Piroxicam (Feldene), Proguanil \[(Malarone (combo)\], Propafenone (Rythmol), Propranolol (Inderal), Risperidone (Risperdal), Sertraline (Zoloft), Tetrabenazine (Xenazine), Thioridazine (Mellaril), Timolol (Apotimol), Tolterodine (Detrol), Torsemide (Demadex), Tramadol (Ultram), Trimipramine (Surmontil), Venlafaxine (Effexor), Voriconazole (Vfend), Vortioxetine (Brintellix)
For a list of the inclusion criteria adapted to the "untested" patients (retrospective cohort), see the protocol.
EXCLUSION CRITERIA: Patients (prospective and retrospective) meeting any of the following criteria will not be eligible for enrollment/inclusion in the study (ICD9 codes are included for retrospective database patients):
* Previous CYP testing (CPT codes 81225, 81226, 81227)
* History of organ transplant (199.2; 238.77; 414.06; 414.07; 996.80---996.89; E878.0; V42.0---V42.7; V42.81---V42.84; V42.89; V42.9; V45.87; V49.83; V58.44)
* Patient currently receiving intravenous antibiotics
* Currently taking immunosuppressants (azathioprine, cyclosporine, monoclonal antibodies, corticosteroids)
* Current malabsorption syndrome (579.0), including the following: Intestinal malabsorption (579.8, 579.9), Postoperative malabsorption (579.3), Short bowel syndrome (579.3)
* Current hospitalization
* Treatment of invasive solid tumors or hematologic malignancies in the last year, excluding in situ cancers or non-melanoma skin cancer (basal cell carcinoma)
* Currently malnourished, as determined by treating provider
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02191358
Study Brief:
Protocol Section:
NCT02191358