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Eligibility Chronic Hepatitis B NCT00895596

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
compensated chronic hepatitis b patient
Description

compensated chronic hepatitis b

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0205432
presence of serum hbsag for more than 6 months.
Description

serum hbsag

Data type

boolean

Alias
UMLS CUI [1]
C0019168
presence of hbeag for more than 1 month with compensated liver disease
Description

hbeag with compensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0019167
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205432
confirmation of ymdd mutants (m552v, m552i and its related double mutant at l528m) by genotyping of the ymdd motif using line probe assay (inno-lipa hbv dr assay)
Description

ymdd mutants

Data type

boolean

Alias
UMLS CUI [1]
C1717884
screening hbv dna value higher than or equal to 1,000,000 copies/ml (measured by the cobas amplicor hbv monitor™ assay)
Description

hbv dna

Data type

boolean

Alias
UMLS CUI [1]
C3641250
screening alt value between 1.5 and 10 x uln
Description

alt

Data type

boolean

Alias
UMLS CUI [1]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis c or d virus (hcv or hdv) or hiv
Description

co-infection with hepatitis c or d virus (hcv or hdv) or hiv

Data type

boolean

Alias
UMLS CUI [1]
C0275524
UMLS CUI [2]
C0220847
UMLS CUI [3]
C0011220
UMLS CUI [4]
C0019682
pregnancy or breast-feeding
Description

pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous treatment with nucleoside analogue or any other treatment for hbv except for lamivudine within 6 months prior to study entry
Description

treatment with nucleoside analogue or any other treatment for hbv

Data type

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0013227
treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
Description

immunomodulatory agent or corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0005525
UMLS CUI [2]
C0001617
de-compensated liver disease
Description

decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
screening alpha-fetoprotein (afp) value > 20 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc.
Description

screening alpha-fetoprotein (afp), ultrasonography, indicative of hcc

Data type

boolean

Alias
UMLS CUI [1]
C0201539
UMLS CUI [2]
C0041618
UMLS CUI [3]
C2239176
presence of anti-hbs at screening
Description

anti-hbs

Data type

boolean

Alias
UMLS CUI [1]
C0201478
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Similar models

Eligibility Chronic Hepatitis B NCT00895596

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
compensated chronic hepatitis b
Item
compensated chronic hepatitis b patient
boolean
C0524909 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
serum hbsag
Item
presence of serum hbsag for more than 6 months.
boolean
C0019168 (UMLS CUI [1])
hbeag with compensated liver disease
Item
presence of hbeag for more than 1 month with compensated liver disease
boolean
C0019167 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205432 (UMLS CUI [2,2])
ymdd mutants
Item
confirmation of ymdd mutants (m552v, m552i and its related double mutant at l528m) by genotyping of the ymdd motif using line probe assay (inno-lipa hbv dr assay)
boolean
C1717884 (UMLS CUI [1])
hbv dna
Item
screening hbv dna value higher than or equal to 1,000,000 copies/ml (measured by the cobas amplicor hbv monitor™ assay)
boolean
C3641250 (UMLS CUI [1])
alt
Item
screening alt value between 1.5 and 10 x uln
boolean
C0201836 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
co-infection with hepatitis c or d virus (hcv or hdv) or hiv
Item
co-infection with hepatitis c or d virus (hcv or hdv) or hiv
boolean
C0275524 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
C0011220 (UMLS CUI [3])
C0019682 (UMLS CUI [4])
pregnancy or breastfeeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
treatment with nucleoside analogue or any other treatment for hbv
Item
previous treatment with nucleoside analogue or any other treatment for hbv except for lamivudine within 6 months prior to study entry
boolean
C1579410 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
immunomodulatory agent or corticosteroids
Item
treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
boolean
C0005525 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
decompensated liver disease
Item
de-compensated liver disease
boolean
C4075847 (UMLS CUI [1])
screening alpha-fetoprotein (afp), ultrasonography, indicative of hcc
Item
screening alpha-fetoprotein (afp) value > 20 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc.
boolean
C0201539 (UMLS CUI [1])
C0041618 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
anti-hbs
Item
presence of anti-hbs at screening
boolean
C0201478 (UMLS CUI [1])
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