Informações:
Falhas:
ID
43015
Descrição
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060); ODM derived from: https://clinicaltrials.gov/show/NCT00440297
Link
https://clinicaltrials.gov/show/NCT00440297
Palavras-chave
Versões (2)
- 12/04/2017 12/04/2017 -
- 17/09/2021 17/09/2021 -
Transferido a
17 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B Virus Infection NCT00440297
Eligibility Hepatitis B Virus Infection NCT00440297
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B Virus Infection NCT00440297
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender and age
Item
male and female subjects at least 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
HBsAG, anti-HBs, anti-HBc
Item
laboratory confirmed negative serology result to hbsag (hepatitis b virus), anti-hbs (antibody to hepatitis b surface antigen), and anti hbc (antibody to hepatitis b core antigen) within 6 weeks of the initial dose of study vaccine
boolean
C0019168 (UMLS CUI [1])
C0201478 (UMLS CUI [2])
C0312631 (UMLS CUI [3])
C0201478 (UMLS CUI [2])
C0312631 (UMLS CUI [3])
Renal dialysis and creatinine clearance measurement
Item
patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min
boolean
C0011946 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0373595 (UMLS CUI [2])
Previous hepatitis B infection and vaccination
Item
previous hepatitis b infection, vaccination with any hepatitis b vaccine
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0474232 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205156 (UMLS CUI [1,2])
C0474232 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Febrile illness, hypersensitivity to hepatitis B vaccine
Item
recent febrile illness; hypersensitivity to any component of licensed hepatitis b vaccines
boolean
C0743841 (UMLS CUI [1])
C0571556 (UMLS CUI [2])
C0571556 (UMLS CUI [2])
Immune globulin administration, inactivated vaccine, live vaccine
Item
recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
boolean
C0085297 (UMLS CUI [1])
C0042212 (UMLS CUI [2])
C0042211 (UMLS CUI [3])
C0042212 (UMLS CUI [2])
C0042211 (UMLS CUI [3])
Experimental drugs
Item
receipt of investigational drugs or investigational vaccines within 3 months prior
boolean
C0304229 (UMLS CUI [1])
Immunologic function
Item
impairment of immunologic function
boolean
C1817756 (UMLS CUI [1])
Systemic immunomodulatory medications
Item
recent use of systemic immunomodulatory medications
boolean
C1963758 (UMLS CUI [1])
Gynaecological status
Item
pregnant women, nursing mothers or women planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])