ID

43555

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00107042

Palavras-chave

Versões (2)
  1. 17/09/2016 17/09/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hepatitis B NCT00107042

Inglês

Eligibility Hepatitis B NCT00107042

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Youth | Age | HIV negative | HIV Seropositivity Evidence

Tipo de dados

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)).
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Informed Consent parent | Informed Consent Legal Guardian

Tipo de dados

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.
Descrição

Childbearing Potential Pregnancy test negative | Gender Coitus Contraceptive methods

Tipo de dados

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
Descrição

Exclusion Criteria

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

Illness Serious Requirement systemic therapy | Therapeutic procedure Asthma

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
current immunomodulator therapy
Descrição

Biological Response Modifiers

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042210
Voltar ao início da página

Similar models

Eligibility Hepatitis B NCT00107042

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial