ID

40872

Description

Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand; ODM derived from: https://clinicaltrials.gov/show/NCT01745822

Link

https://clinicaltrials.gov/show/NCT01745822

Keywords

  1. 5/29/20 5/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 29, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B Chronic Infection NCT01745822

Eligibility Hepatitis B Chronic Infection NCT01745822

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
negative human immunodeficiency virus (hiv) serology
Description

HIV Serology negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0919674
positive hbsag and hepatitis b e antigen (hbeag) tests
Description

Hepatitis B surface antigen positive | Hepatitis B e antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0392390
gestational age of 28 weeks (+ or - 10 days) as determined by obstetrician
Description

Gestational Age Weeks

Data type

boolean

Alias
UMLS CUI [1,1]
C0017504
UMLS CUI [1,2]
C0439230
alanine aminotransferase (alt)≤30 u/l, confirmed ≤60 u/l on a subsequent blood draw
Description

Alanine aminotransferase measurement | Alanine aminotransferase measurement Confirmed by Blood draw

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C0521093
UMLS CUI [2,3]
C0005834
agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic.
Description

Infants Present Study Site

Data type

boolean

Alias
UMLS CUI [1,1]
C0021270
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2825164
understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis.
Description

Infant Immunization | Blood draw Infants | Follow-up Needed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021270
UMLS CUI [1,2]
C0020971
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0021270
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C0027552
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of tenofovir treatment at any time, or any other anti-hbv treatment during the current pregnancy
Description

Tenofovir | Other treatment Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0384228
UMLS CUI [2,1]
C2015819
UMLS CUI [2,2]
C0019163
creatinine clearance <50 ml/min, calculated using the cockcroft-gault formula
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
dipstick proteinuria>1+ (>30 mg/dl) or normoglycemic glucosuria confirmed on two separate occasions
Description

Dipstick Proteinuria | Glycosuria normoglycemic

Data type

boolean

Alias
UMLS CUI [1,1]
C1553114
UMLS CUI [1,2]
C0033687
UMLS CUI [2,1]
C0017979
UMLS CUI [2,2]
C0580545
positive serology for hepatitis c infection less than 12 months prior to enrollment
Description

Serology positive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019196
evidence of pre-existing fetal anomalies incompatible with life
Description

Fetal anomaly Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2347662
any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study.
Description

Comorbidity Participation Contraindicated | Other treatment Participation Contraindicated | Comorbidity Follow-up Contraindicated | Other treatment Follow-up Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C2015819
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C1444657
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C1444657
UMLS CUI [4,1]
C2015819
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C1444657
concurrent participation in any other clinical trial without written agreement of the two study teams
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976

Similar models

Eligibility Hepatitis B Chronic Infection NCT01745822

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
HIV Serology negative
Item
negative human immunodeficiency virus (hiv) serology
boolean
C0019682 (UMLS CUI [1,1])
C0919674 (UMLS CUI [1,2])
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
positive hbsag and hepatitis b e antigen (hbeag) tests
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Gestational Age Weeks
Item
gestational age of 28 weeks (+ or - 10 days) as determined by obstetrician
boolean
C0017504 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Alanine aminotransferase measurement Confirmed by Blood draw
Item
alanine aminotransferase (alt)≤30 u/l, confirmed ≤60 u/l on a subsequent blood draw
boolean
C0201836 (UMLS CUI [1])
C0201836 (UMLS CUI [2,1])
C0521093 (UMLS CUI [2,2])
C0005834 (UMLS CUI [2,3])
Infants Present Study Site
Item
agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic.
boolean
C0021270 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Infant Immunization | Blood draw Infants | Follow-up Needed
Item
understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis.
boolean
C0021270 (UMLS CUI [1,1])
C0020971 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0021270 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3,1])
C0027552 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Tenofovir | Other treatment Hepatitis B
Item
history of tenofovir treatment at any time, or any other anti-hbv treatment during the current pregnancy
boolean
C0384228 (UMLS CUI [1])
C2015819 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance <50 ml/min, calculated using the cockcroft-gault formula
boolean
C2711451 (UMLS CUI [1])
Dipstick Proteinuria | Glycosuria normoglycemic
Item
dipstick proteinuria>1+ (>30 mg/dl) or normoglycemic glucosuria confirmed on two separate occasions
boolean
C1553114 (UMLS CUI [1,1])
C0033687 (UMLS CUI [1,2])
C0017979 (UMLS CUI [2,1])
C0580545 (UMLS CUI [2,2])
Serology positive Hepatitis C
Item
positive serology for hepatitis c infection less than 12 months prior to enrollment
boolean
C0242089 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Fetal anomaly Pre-existing
Item
evidence of pre-existing fetal anomalies incompatible with life
boolean
C0000768 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Comorbidity Participation Contraindicated | Other treatment Participation Contraindicated | Comorbidity Follow-up Contraindicated | Other treatment Follow-up Contraindicated
Item
any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C2015819 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
C2015819 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C1444657 (UMLS CUI [4,3])
Study Subject Participation Status | Clinical Trial
Item
concurrent participation in any other clinical trial without written agreement of the two study teams
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])

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