ID

33807

Description

The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01083251

Link

https://clinicaltrials.gov/show/NCT01083251

Keywords

Versions (1)
  1. 12/28/18 12/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B Virus NCT01083251

English

Eligibility Hepatitis B Virus NCT01083251

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients were eligible if they had been hbsag positive for at least 6 months,
Description

Hepatitis B surface antigen positive Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0449238
patients were hbeag positive or negative,
Description

Hepatitis B e antigen positive | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
patients had increased serum alt levels between 1 and 10 times the upper limit of normal (uln),
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
patients had serum hbv-dna levels greater than 1.0 x 10e5 copies/ml (2.0 x 10e4 iuml), and
Description

Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C3641250
patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis b.
Description

Signs and Symptoms Biopsy of liver | Consistent with Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0332290
UMLS CUI [2,2]
C0524909
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated liver disease,
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
antiviral therapy within 6 months before randomization,
Description

Antiviral Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
viral co-infections (hepatitis c virus, hepatitis delta virus, or human immunodeficiency virus), or
Description

Coinfection Viral | HCV coinfection | Hepatitis Delta Virus Coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0521026
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
UMLS CUI [4]
C4062778
pre-existent neutropenia or thrombocytopenia.
Description

Neutropenia Pre-existing | Thrombocytopenia Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0027947
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0040034
UMLS CUI [2,2]
C2347662
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Similar models

Eligibility Hepatitis B Virus NCT01083251

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B surface antigen positive Duration
Item
patients were eligible if they had been hbsag positive for at least 6 months,
boolean
C0149709 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
patients were hbeag positive or negative,
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Alanine aminotransferase increased
Item
patients had increased serum alt levels between 1 and 10 times the upper limit of normal (uln),
boolean
C0151905 (UMLS CUI [1])
Hepatitis B DNA Measurement
Item
patients had serum hbv-dna levels greater than 1.0 x 10e5 copies/ml (2.0 x 10e4 iuml), and
boolean
C3641250 (UMLS CUI [1])
Signs and Symptoms Biopsy of liver | Consistent with Chronic Hepatitis B
Item
patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis b.
boolean
C0037088 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0332290 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease
Item
decompensated liver disease,
boolean
C4075847 (UMLS CUI [1])
Antiviral Therapy
Item
antiviral therapy within 6 months before randomization,
boolean
C0280274 (UMLS CUI [1])
Coinfection Viral | HCV coinfection | Hepatitis Delta Virus Coinfection | HIV coinfection
Item
viral co-infections (hepatitis c virus, hepatitis delta virus, or human immunodeficiency virus), or
boolean
C0275524 (UMLS CUI [1,1])
C0521026 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
C4062778 (UMLS CUI [4])
Neutropenia Pre-existing | Thrombocytopenia Pre-existing
Item
pre-existent neutropenia or thrombocytopenia.
boolean
C0027947 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0040034 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
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