ID

39552

Description

Hepatitis B Research Network Adult Cohort Study; ODM derived from: https://clinicaltrials.gov/show/NCT01263587

Link

https://clinicaltrials.gov/show/NCT01263587

Keywords

Versions (1)
  1. 1/27/20 1/27/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 27, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01263587

English

Eligibility Hepatitis B NCT01263587

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hepatitis b surface antigen (hbsag) positive and either:
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
anti-hepatitis d positive
Description

Hepatitis D antibody Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0312635
UMLS CUI [1,2]
C1514241
diagnosed with acute hepatitis b infection or experiencing a hepatitis flare
Description

Hepatitis B | Hepatitis flare

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C3160951
immune tolerant or immune active phenotype
Description

Immune Tolerance Phenotype | Active Immune Response Phenotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0020963
UMLS CUI [1,2]
C0031437
UMLS CUI [2,1]
C2936721
UMLS CUI [2,2]
C0031437
potentially eligible for the immune regulation and costimulation in natural history of chronic hepatitis b ancillary study (nct01298037).
Description

Eligibility Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatic decompensation
Description

Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
hepatocellular carcinoma (hcc)
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
liver transplantation
Description

Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C0023911
current hepatitis b antiviral treatment (except pregnant women and patients who are anti-hdv positive)
Description

Antiviral treatment Hepatitis B | Exception Pregnancy | Exception Hepatitis D antibody Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2363964
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032961
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0312635
UMLS CUI [3,3]
C1514241
known human immunodeficiency virus (hiv) co-infection (patients with hepatitis d (hdv) or hepatitis c (hcv) co-infection are not excluded).
Description

HIV coinfection | Coinfection HDV allowed | HCV coinfection allowed

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C1698259
UMLS CUI [3,2]
C0683607
medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
Description

Medical condition Interferes with Follow-up | Social Condition Interferes with Follow-up | Medical condition Preventing Follow-up | Social Condition Preventing Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C0037403
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C3274571
unable or unwilling to return for follow-up visits
Description

Follow-up visit Unable | Follow-up visit Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Hepatitis B NCT01263587

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
hepatitis b surface antigen (hbsag) positive and either:
boolean
C0149709 (UMLS CUI [1])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
Hepatitis D antibody Positive
Item
anti-hepatitis d positive
boolean
C0312635 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Hepatitis B | Hepatitis flare
Item
diagnosed with acute hepatitis b infection or experiencing a hepatitis flare
boolean
C0019163 (UMLS CUI [1])
C3160951 (UMLS CUI [2])
Immune Tolerance Phenotype | Active Immune Response Phenotype
Item
immune tolerant or immune active phenotype
boolean
C0020963 (UMLS CUI [1,1])
C0031437 (UMLS CUI [1,2])
C2936721 (UMLS CUI [2,1])
C0031437 (UMLS CUI [2,2])
Eligibility Clinical Trial Specified
Item
potentially eligible for the immune regulation and costimulation in natural history of chronic hepatitis b ancillary study (nct01298037).
boolean
C1548635 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatic decompensation
Item
hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Liver carcinoma
Item
hepatocellular carcinoma (hcc)
boolean
C2239176 (UMLS CUI [1])
Transplantation of liver
Item
liver transplantation
boolean
C0023911 (UMLS CUI [1])
Antiviral treatment Hepatitis B | Exception Pregnancy | Exception Hepatitis D antibody Positive
Item
current hepatitis b antiviral treatment (except pregnant women and patients who are anti-hdv positive)
boolean
C2363964 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0312635 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
HIV coinfection | Coinfection HDV allowed | HCV coinfection allowed
Item
known human immunodeficiency virus (hiv) co-infection (patients with hepatitis d (hdv) or hepatitis c (hcv) co-infection are not excluded).
boolean
C4062778 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C1698259 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Medical condition Interferes with Follow-up | Social Condition Interferes with Follow-up | Medical condition Preventing Follow-up | Social Condition Preventing Follow-up
Item
medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0037403 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Follow-up visit Unable | Follow-up visit Unwilling
Item
unable or unwilling to return for follow-up visits
boolean
C0589121 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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