ID

39683

Descripción

Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01713283

Link

https://clinicaltrials.gov/show/NCT01713283

Palabras clave

Versiones (1)
  1. 10/2/20 10/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C Virus NCT01713283

Inglés

Eligibility Hepatitis C Virus NCT01713283

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
first generation egyptian; must have been born in egypt and can trace both maternal and paternal egyptian ancestry
Descripción

Egyptian Generation First

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0337801
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205435
treatment-experienced or treatment-naive
Descripción

Therapy Experience | Therapy naive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [2]
C0919936
chronic genotype 4 hcv infection
Descripción

Chronic Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
not co-infected with hiv
Descripción

HIV coinfection Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4062778
UMLS CUI [1,2]
C0332197
screening laboratory values within defined thresholds
Descripción

Laboratory Results Within Threshold

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0449864
use of highly effective contraception methods
Descripción

Use of Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any other clinically significant chronic liver disease
Descripción

Chronic liver disease Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0205394
pregnant or nursing female or male with pregnant female partner
Descripción

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
history of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
Descripción

Illness Interferes with Therapeutic procedure | Illness Interferes with Assessment | Illness Interferes with Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
excessive alcohol ingestion or significant drug abuse
Descripción

Alcohol intake above recommended sensible limits | Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2]
C0013146
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Similar models

Eligibility Hepatitis C Virus NCT01713283

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Egyptian Generation First
Item
first generation egyptian; must have been born in egypt and can trace both maternal and paternal egyptian ancestry
boolean
C0337801 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Therapy Experience | Therapy naive
Item
treatment-experienced or treatment-naive
boolean
C0087111 (UMLS CUI [1,1])
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])
HIV coinfection Absent
Item
not co-infected with hiv
boolean
C4062778 (UMLS CUI [1,1])
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])
Use of Contraceptive methods
Item
use of highly effective contraception methods
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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 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])
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])
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