ID

43555

Description

Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths; ODM derived from: https://clinicaltrials.gov/show/NCT00107042

Link

https://clinicaltrials.gov/show/NCT00107042

Keywords

Versions (2)
  1. 9/17/16 9/17/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00107042

English

Eligibility Hepatitis B NCT00107042

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hiv negative youth age 12-17 years (no serologic evidence of hiv infection).
Description

Youth | Age | HIV negative | HIV Seropositivity Evidence

Data type

boolean

Alias
UMLS CUI [1]
C0087178
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0481430
UMLS CUI [4,1]
C0019699
UMLS CUI [4,2]
C3887511
negative hepatitis b serology. (no serologic evidence of hepatitis b surface antigen (hbsag), hepatitis b surface antibody (hbsab or anti-hbs) and hepatitis b core antibody (hbcab or anti-hbc)).
Description

Hepatitis B test negative | Hepatitis B Surface Antigens Evidence | Hepatitis B Virus Surface Antibody Evidence | Anti-HBs antibody Evidence | Antibody to hepatitis B core antigen Evidence | Anti-HBc antibody Evidence

Data type

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C3887511
UMLS CUI [3,1]
C0369334
UMLS CUI [3,2]
C3887511
UMLS CUI [4,1]
C0201478
UMLS CUI [4,2]
C3887511
UMLS CUI [5,1]
C0312631
UMLS CUI [5,2]
C3887511
UMLS CUI [6,1]
C0948759
UMLS CUI [6,2]
C3887511
either no prior hepatitis b immunizations or unknown or incomplete hepatitis b immunization status.
Description

Hepatitis B vaccination | Hepatitis B vaccination Unknown | Hepatitis B vaccination Incomplete

Data type

boolean

Alias
UMLS CUI [1]
C0474232
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C0439673
UMLS CUI [3,1]
C0474232
UMLS CUI [3,2]
C0205257
willing to participate in hiv risk-reduction counseling and computer assisted measurement of behaviors.
Description

HIV risk Reduction Counseling participation Willing | behavior measurement Computer assisted participation Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0744979
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0010210
UMLS CUI [1,4]
C0679823
UMLS CUI [1,5]
C0600109
UMLS CUI [2,1]
C0597975
UMLS CUI [2,2]
C2362103
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C0600109
parent or legal guardian willing to provide written permission
Description

Informed Consent parent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
females of childbearing potential must have a negative pregnancy test at screening and should agree to avoid pregnancy through the end of the vaccine phase of the study. females who are engaging in sexual intercourse must be willing to practice a reliable method of birth control through the end of the vaccine-phase of the study (approximately 6 months). the decision of what is "reliable" is at the discretion of the site investigator.
Description

Childbearing Potential Pregnancy test negative | Gender Coitus Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0009253
UMLS CUI [2,3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of any serious illness requiring treatment with systemic medications, excluding treatment for asthma.
Description

Illness Serious Requirement systemic therapy | Therapeutic procedure Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C1515119
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0004096
previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
Description

Allergic Reaction Vaccines | Allergic Reaction Vaccines Constituents | Allergic Reaction Yeast | Allergic Reaction Thimerosal | Allergic Reaction Aluminum

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0042210
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C0729650
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0043393
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0039867
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0002367
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
current immunomodulator therapy
Description

Biological Response Modifiers

Data type

boolean

Alias
UMLS CUI [1]
C0005525
receipt of immunosuppressor therapy (more than 10 mg/day of prednisone or equivalent for >1 week) in the 6 months preceding entry or anticipated long-term corticosteroid therapy in the above dose and duration. short term (< 7 days) steroid use for the treatment of asthma is not an exclusion.
Description

Therapeutic immunosuppression | Prednisone | Prednisone Equivalent | Steroid therapy Long-term Anticipated | steroid use short-term Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0032952
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C0149783
UMLS CUI [4,2]
C0443252
UMLS CUI [4,3]
C3840775
UMLS CUI [5,1]
C0281991
UMLS CUI [5,2]
C0443303
UMLS CUI [5,3]
C0004096
receipt of any vaccine within 2 weeks preceding study entry.
Description

Vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0042210
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Similar models

Eligibility Hepatitis B NCT00107042

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Youth | Age | HIV negative | HIV Seropositivity Evidence
Item
hiv negative youth age 12-17 years (no serologic evidence of hiv infection).
boolean
C0087178 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0481430 (UMLS CUI [3])
C0019699 (UMLS CUI [4,1])
C3887511 (UMLS CUI [4,2])
Hepatitis B test negative | Hepatitis B Surface Antigens Evidence | Hepatitis B Virus Surface Antibody Evidence | Anti-HBs antibody Evidence | Antibody to hepatitis B core antigen Evidence | Anti-HBc antibody Evidence
Item
negative hepatitis b serology. (no serologic evidence of hepatitis b surface antigen (hbsag), hepatitis b surface antibody (hbsab or anti-hbs) and hepatitis b core antibody (hbcab or anti-hbc)).
boolean
C1611173 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0369334 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0201478 (UMLS CUI [4,1])
C3887511 (UMLS CUI [4,2])
C0312631 (UMLS CUI [5,1])
C3887511 (UMLS CUI [5,2])
C0948759 (UMLS CUI [6,1])
C3887511 (UMLS CUI [6,2])
Hepatitis B vaccination | Hepatitis B vaccination Unknown | Hepatitis B vaccination Incomplete
Item
either no prior hepatitis b immunizations or unknown or incomplete hepatitis b immunization status.
boolean
C0474232 (UMLS CUI [1])
C0474232 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C0474232 (UMLS CUI [3,1])
C0205257 (UMLS CUI [3,2])
HIV risk Reduction Counseling participation Willing | behavior measurement Computer assisted participation Willing
Item
willing to participate in hiv risk-reduction counseling and computer assisted measurement of behaviors.
boolean
C0744979 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0010210 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0600109 (UMLS CUI [1,5])
C0597975 (UMLS CUI [2,1])
C2362103 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0600109 (UMLS CUI [2,4])
Informed Consent parent | Informed Consent Legal Guardian
Item
parent or legal guardian willing to provide written permission
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Gender Coitus Contraceptive methods
Item
females of childbearing potential must have a negative pregnancy test at screening and should agree to avoid pregnancy through the end of the vaccine phase of the study. females who are engaging in sexual intercourse must be willing to practice a reliable method of birth control through the end of the vaccine-phase of the study (approximately 6 months). the decision of what is "reliable" is at the discretion of the site investigator.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0009253 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Illness Serious Requirement systemic therapy | Therapeutic procedure Asthma
Item
presence of any serious illness requiring treatment with systemic medications, excluding treatment for asthma.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1515119 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Allergic Reaction Vaccines | Allergic Reaction Vaccines Constituents | Allergic Reaction Yeast | Allergic Reaction Thimerosal | Allergic Reaction Aluminum
Item
previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
boolean
C1527304 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0043393 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0039867 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0002367 (UMLS CUI [5,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Biological Response Modifiers
Item
current immunomodulator therapy
boolean
C0005525 (UMLS CUI [1])
Therapeutic immunosuppression | Prednisone | Prednisone Equivalent | Steroid therapy Long-term Anticipated | steroid use short-term Asthma
Item
receipt of immunosuppressor therapy (more than 10 mg/day of prednisone or equivalent for >1 week) in the 6 months preceding entry or anticipated long-term corticosteroid therapy in the above dose and duration. short term (< 7 days) steroid use for the treatment of asthma is not an exclusion.
boolean
C0021079 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0149783 (UMLS CUI [4,1])
C0443252 (UMLS CUI [4,2])
C3840775 (UMLS CUI [4,3])
C0281991 (UMLS CUI [5,1])
C0443303 (UMLS CUI [5,2])
C0004096 (UMLS CUI [5,3])
Vaccine
Item
receipt of any vaccine within 2 weeks preceding study entry.
boolean
C0042210 (UMLS CUI [1])
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