ID

13116

Description

Genetics of Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00005657

Link

https://clinicaltrials.gov/show/NCT00005657

Keywords

Versions (1)
  1. 1/17/16 1/17/16 -
Uploaded on

January 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00005657

English

Eligibility Hepatitis C NCT00005657

1 forms  
Criteria
Description

Criteria

patients who have recovered from past hcv exposure (positive anti-hcv but negative hcv viremia and absent liver disease).
Description

anti-hcv, viral load

Data type

boolean

Alias
UMLS CUI [1]
C0201487
UMLS CUI [2]
C1868902
patients with asymptomatic hcv infection (positive anti-hcv and hcv viremia, but persistently normal or minimally elevated alt and normal or mild disease on liver biopsy).
Description

asymptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0231221
UMLS CUI [2]
C0201487
UMLS CUI [3]
C1868902
patients with active liver disease (positive anti-hcv and hcv viremia, persistently elevated alt and/or moderate disease on liver biopsy).
Description

active disease

Data type

boolean

Alias
UMLS CUI [1]
C2707252
patients with active extrahepatic manifestations of hcv infection (cryoglobulinemia, glomerulonephritis, vasculitis, etc.).
Description

extrahepatic manifestations

Data type

boolean

Alias
UMLS CUI [1,1]
C1280464
UMLS CUI [1,2]
C0019196
patients with rapidly progressive, severe liver disease and/or hepatocellular carcinoma.
Description

liver disease, carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2239176
patients who have undergone or are undergoing treatment.
Description

treatment

Data type

boolean

Alias
UMLS CUI [1]
C0087111
patients from a single-source outbreak of hcv infections (in which the viral factors should be identical and the patients are often from a homogeneous population with less genetic variability).
Description

outbreak

Data type

boolean

Alias
UMLS CUI [1]
C0012652
hcv infected family members and twins.
Description

family

Data type

boolean

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C0439663
patients with other forms of liver disease including hbv infection, primary biliary cirrhosis, autoimmune hepatitis, nonalcoholic steatohepatitis, hemochromatosis, and wilson's disease, as well as normal volunteers.
Description

liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
adult subjects with a hct of less than 30 or pediatric subjects less than 25 will be excluded.
Description

age, hct

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0518014
children with hcv infection younger than 2 years of age will be excluded.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
unaffected healthy volunteers who are minors are not eligible for this study.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Hepatitis C NCT00005657

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
anti-hcv, viral load
Item
patients who have recovered from past hcv exposure (positive anti-hcv but negative hcv viremia and absent liver disease).
boolean
C0201487 (UMLS CUI [1])
C1868902 (UMLS CUI [2])
asymptomatic
Item
patients with asymptomatic hcv infection (positive anti-hcv and hcv viremia, but persistently normal or minimally elevated alt and normal or mild disease on liver biopsy).
boolean
C0231221 (UMLS CUI [1])
C0201487 (UMLS CUI [2])
C1868902 (UMLS CUI [3])
active disease
Item
patients with active liver disease (positive anti-hcv and hcv viremia, persistently elevated alt and/or moderate disease on liver biopsy).
boolean
C2707252 (UMLS CUI [1])
extrahepatic manifestations
Item
patients with active extrahepatic manifestations of hcv infection (cryoglobulinemia, glomerulonephritis, vasculitis, etc.).
boolean
C1280464 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
liver disease, carcinoma
Item
patients with rapidly progressive, severe liver disease and/or hepatocellular carcinoma.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2])
treatment
Item
patients who have undergone or are undergoing treatment.
boolean
C0087111 (UMLS CUI [1])
outbreak
Item
patients from a single-source outbreak of hcv infections (in which the viral factors should be identical and the patients are often from a homogeneous population with less genetic variability).
boolean
C0012652 (UMLS CUI [1])
family
Item
hcv infected family members and twins.
boolean
C0015576 (UMLS CUI [1,1])
C0439663 (UMLS CUI [1,2])
liver disease
Item
patients with other forms of liver disease including hbv infection, primary biliary cirrhosis, autoimmune hepatitis, nonalcoholic steatohepatitis, hemochromatosis, and wilson's disease, as well as normal volunteers.
boolean
C0023895 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age, hct
Item
adult subjects with a hct of less than 30 or pediatric subjects less than 25 will be excluded.
boolean
C0001779 (UMLS CUI [1])
C0518014 (UMLS CUI [2])
age
Item
children with hcv infection younger than 2 years of age will be excluded.
boolean
C0001779 (UMLS CUI [1])
age
Item
unaffected healthy volunteers who are minors are not eligible for this study.
boolean
C0001779 (UMLS CUI [1])
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