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ID
39684
Beschrijving
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01838590
Link
https://clinicaltrials.gov/show/NCT01838590
Trefwoorden
Versies (1)
- 10-02-20 10-02-20 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
10 februari 2020
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01838590
Eligibility Hepatitis C Virus NCT01838590
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C Virus NCT01838590
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Therapy Experience | Therapy naive
Item
treatment experienced and naïve subjects
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
C0596545 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
Chronic Hepatitis C Genotype
Item
chronic genotype 4 hcv-infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1533728 (UMLS CUI [1,2])
HIV coinfection Absent
Item
not co-infected with hiv
boolean
C4062778 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Laboratory Results Within Threshold
Item
screening laboratory values within defined thresholds
boolean
C1254595 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,3])
C0332285 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,3])
Use of Contraceptive methods
Item
use of highly effective contraception methods
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
boolean
C0525058 (UMLS CUI [1])
Chronic liver disease Other
Item
history of any other clinically significant chronic liver disease
boolean
C0341439 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or nursing female or male with pregnant female partner
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Illness Interferes with Therapeutic procedure | Illness Interferes with Assessment | Illness Interferes with Protocol Compliance
Item
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Alcohol intake above recommended sensible limits | Drug abuse
Item
excessive alcohol ingestion or significant drug abuse
boolean
C0560219 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
C0013146 (UMLS CUI [2])