ID

20568

Description

PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327); ODM derived from: https://clinicaltrials.gov/show/NCT00536263

Link

https://clinicaltrials.gov/show/NCT00536263

Keywords

Versions (1)
  1. 3/3/17 3/3/17 -
Uploaded on

March 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT00536263

English

Eligibility Hepatitis B, Chronic NCT00536263

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults with chronic hepatitis b:
Description

adults with chronic hepatitis b

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0524909
serum hepatitis b surface antigen positive for at least 6 months
Description

hbsag

Data type

boolean

Alias
UMLS CUI [1]
C0019168
serum hepatitis b e antigen positive
Description

hbeag

Data type

boolean

Alias
UMLS CUI [1]
C0019167
serum negative for hepatitis b surface and e antibodies
Description

anti hbs, anti hbe

Data type

boolean

Alias
UMLS CUI [1]
C0201478
UMLS CUI [2]
C0948252
plasma hepatitis b virus deoxyribonucleic acid (dna) level greater than 20,000 iu/ml
Description

hepatitis b virus dna

Data type

boolean

Alias
UMLS CUI [1]
C3641250
alanine aminotransferase (alt) 2- to 10-times the upper limit of normal
Description

alt

Data type

boolean

Alias
UMLS CUI [1]
C0201836
compensated liver disease with certain minimum hematological and serum biochemical criteria
Description

compensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C3839044
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant hepatic disease from an etiology other than hepatitis b virus
Description

significant liver disease, etiology other than hepatitis b virus

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0019163
antiviral treatment for hepatitis within previous 6 months
Description

antiviral treatment hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C2363964
UMLS CUI [1,2]
C0019163
history of severe psychiatric disease, especially depression
Description

history of mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0455498
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0011581
unstable or significant cardiovascular disease
Description

unstable or significant cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0750502
prolonged exposure to known hepatotoxins such as alcohol or drugs
Description

prolonged exposure to known hepatotoxins such as alcohol or drugs

Data type

boolean

Alias
UMLS CUI [1]
C0596691
UMLS CUI [2]
C0038586
any condition that could interfere with the subject participating in and completing the study
Description

comorbidity, limited protocol compliance

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0439801
UMLS CUI [2,2]
C0525058
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Similar models

Eligibility Hepatitis B, Chronic NCT00536263

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
adults with chronic hepatitis b
Item
adults with chronic hepatitis b:
boolean
C0001675 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
hbsag
Item
serum hepatitis b surface antigen positive for at least 6 months
boolean
C0019168 (UMLS CUI [1])
hbeag
Item
serum hepatitis b e antigen positive
boolean
C0019167 (UMLS CUI [1])
anti hbs, anti hbe
Item
serum negative for hepatitis b surface and e antibodies
boolean
C0201478 (UMLS CUI [1])
C0948252 (UMLS CUI [2])
hepatitis b virus dna
Item
plasma hepatitis b virus deoxyribonucleic acid (dna) level greater than 20,000 iu/ml
boolean
C3641250 (UMLS CUI [1])
alt
Item
alanine aminotransferase (alt) 2- to 10-times the upper limit of normal
boolean
C0201836 (UMLS CUI [1])
compensated liver disease
Item
compensated liver disease with certain minimum hematological and serum biochemical criteria
boolean
C3839044 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
significant liver disease, etiology other than hepatitis b virus
Item
significant hepatic disease from an etiology other than hepatitis b virus
boolean
C0023895 (UMLS CUI [1])
C1298908 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
antiviral treatment hepatitis
Item
antiviral treatment for hepatitis within previous 6 months
boolean
C2363964 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
history of mental disorder
Item
history of severe psychiatric disease, especially depression
boolean
C0455498 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
unstable or significant cardiovascular disease
Item
unstable or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
prolonged exposure to known hepatotoxins such as alcohol or drugs
Item
prolonged exposure to known hepatotoxins such as alcohol or drugs
boolean
C0596691 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
comorbidity, limited protocol compliance
Item
any condition that could interfere with the subject participating in and completing the study
boolean
C0009488 (UMLS CUI [1])
C0439801 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
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