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Eligibility Chronic Hepatitis C NCT00656006

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a clinical diagnosis of chronic hepatitis c on the basis of detectable serum hcv rna during the screening period and at least a 6-month history of exposure to risk factors for hcv.
Description

Chronic Hepatitis C | Hepatitis C RNA Detectable | Exposure to risk factors Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0855840
UMLS CUI [2,2]
C3830527
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0035648
UMLS CUI [3,3]
C0220847
have never received treatment with an interferon alfa product or an interferon alfa combination product.
Description

Interferon-alpha | Interferon-alpha Combination Product

Data type

boolean

Alias
UMLS CUI [1]
C0002199
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C1880146
have hcv genotype 2 or 3.
Description

Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C1148363
have compensated liver disease with the following minimum criteria: white blood cell count (wbc) >3,000/mm3, absolute neutrophil count (anc) > 1,800/mm3, platelets >100,000/mm3, hemoglobin (hb) > 13 g/dl for males and > 12 g/dl for females.
Description

Compensated liver disease | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of decompensated liver disease.
Description

Decompensated liver disease Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0332120
pregnant or lactating female.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
Description

Disease Study Subject Participation Status Inappropriate | Medical condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
a current drug or alcohol addiction.
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Chronic Hepatitis C NCT00656006

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C | Hepatitis C RNA Detectable | Exposure to risk factors Hepatitis C virus
Item
have a clinical diagnosis of chronic hepatitis c on the basis of detectable serum hcv rna during the screening period and at least a 6-month history of exposure to risk factors for hcv.
boolean
C0524910 (UMLS CUI [1])
C0855840 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0035648 (UMLS CUI [3,2])
C0220847 (UMLS CUI [3,3])
Interferon-alpha | Interferon-alpha Combination Product
Item
have never received treatment with an interferon alfa product or an interferon alfa combination product.
boolean
C0002199 (UMLS CUI [1])
C0002199 (UMLS CUI [2,1])
C1880146 (UMLS CUI [2,2])
Hepatitis C virus genotype
Item
have hcv genotype 2 or 3.
boolean
C1148363 (UMLS CUI [1])
Compensated liver disease | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Gender
Item
have compensated liver disease with the following minimum criteria: white blood cell count (wbc) >3,000/mm3, absolute neutrophil count (anc) > 1,800/mm3, platelets >100,000/mm3, hemoglobin (hb) > 13 g/dl for males and > 12 g/dl for females.
boolean
C3839044 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease Evidence of
Item
evidence of decompensated liver disease.
boolean
C4075847 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Study Subject Participation Status Inappropriate | Medical condition Study Subject Participation Status Inappropriate
Item
history of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Substance Dependence
Item
a current drug or alcohol addiction.
boolean
C0038580 (UMLS CUI [1])
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