Liver Cirrhosis
Item
1. targeted at least 20% enrollment of patients with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Adult | Age
Item
2. adults >/= age 18 years.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C Genotype
Item
3. active infection with hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Health Insurance | sofosbuvir | Ribavirin
Item
4. must have health insurance that covers therapy with sof+rbv
boolean
C0021682 (UMLS CUI [1])
C2976303 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests
Item
5. female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Patients Ineligible Interferon | Etiology Mental disorders | Etiology Autoimmune Diseases | Etiology Nervous system disorder
Item
6. patients must be either ifn-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the pi; or,
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C3652465 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0004364 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0027765 (UMLS CUI [4,2])
Intolerance to Interferon | Etiology Influenza-like symptoms | Etiology Psychiatric problem | Etiology Cytopenia
Item
7. ifn-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the pi.
boolean
C1744706 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0392171 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1306597 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0010828 (UMLS CUI [4,2])
HIV coinfection
Item
1. presence of hiv co-infection
boolean
C4062778 (UMLS CUI [1])
Liver carcinoma
Item
2. presence of hcc
boolean
C2239176 (UMLS CUI [1])
Organ Transplantation
Item
3. prior organ transplantation
boolean
C0029216 (UMLS CUI [1])
Hepatic decompensation
Item
4. any history of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Intake Pharmaceutical Preparations
Item
5. patients taking any of the following medications:
boolean
C1512806 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Anticonvulsants | Carbamazepine | oxcarbazepine | Phenobarbital | Phenytoin
Item
anticonvulsants- carbamazepine, oxcarbazepine, phenobarbital, or phenytoin.
boolean
C0003286 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
C0069751 (UMLS CUI [3])
C0031412 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
Anti-Infective Agents | Erythromycin | Clarithromycin | telithromycin
Item
anti-infectives-erythromycin, clarithromycin, or telithromycin.
boolean
C0003204 (UMLS CUI [1])
C0014806 (UMLS CUI [2])
C0055856 (UMLS CUI [3])
C0907410 (UMLS CUI [4])
Antifungal Agents | Itraconazole Systemic | Ketoconazole | posaconazole | Fluconazole | voriconazole
Item
antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole.
boolean
C0003308 (UMLS CUI [1])
C0064113 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0022625 (UMLS CUI [3])
C0936148 (UMLS CUI [4])
C0016277 (UMLS CUI [5])
C0393080 (UMLS CUI [6])
Antimycobacterial agent | Rifampin | Rifabutin | rifapentine
Item
antimycobacterials- rifampin, rifabutin or rifapentine.
boolean
C0360390 (UMLS CUI [1])
C0035608 (UMLS CUI [2])
C0140575 (UMLS CUI [3])
C0073372 (UMLS CUI [4])
Adrenal Cortex Hormones | Dexamethasone Systemic
Item
corticosteroids- systemic dexamethasone.
boolean
C0001617 (UMLS CUI [1])
C0011777 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
PROPULSIVES | Cisapride
Item
propulsives- cisapride.
boolean
C3653283 (UMLS CUI [1])
C0072916 (UMLS CUI [2])
Herbal Drugs | Milk thistle extract | Hypericum perforatum
Item
herbals- milk thistle or st. john's wart.
boolean
C1360419 (UMLS CUI [1])
C0937640 (UMLS CUI [2])
C0936242 (UMLS CUI [3])
Exposure to DIRECT ACTING ANTIVIRALS
Item
6. patients that have been exposed to direct acting anti-viral agents
boolean
C0332157 (UMLS CUI [1,1])
C3653501 (UMLS CUI [1,2])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Kidney Failure, Chronic
Item
7. patients with severe renal impairment (estimated glomerular filtration rate (egfr) <50 ml/min/1.73m2) or with end stage renal disease (esrd).
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
Platelet Count measurement | Hemoglobin measurement | Neutrophil count
Item
8. patients with platelet count <50 x109/l, hemoglobin <10 g/dl, or neutrophils <0.5 x109/l.
boolean
C0032181 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
Pregnancy
Item
9. women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Gender Partner Pregnancy | Gender Partner Planned Pregnancy
Item
10. men whose partners are pregnant or plan on becoming pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0032992 (UMLS CUI [2,3])