ID

43015

Descripción

Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060); ODM derived from: https://clinicaltrials.gov/show/NCT00440297

Link

https://clinicaltrials.gov/show/NCT00440297

Palabras clave

Versiones (2)
  1. 12/4/17 12/4/17 -
  2. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis B Virus Infection NCT00440297

Inglés

Eligibility Hepatitis B Virus Infection NCT00440297

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects at least 18 years of age
Descripción

Gender and age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
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
Descripción

HBsAG, anti-HBs, anti-HBc

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0201478
UMLS CUI [3]
C0312631
patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min
Descripción

Renal dialysis and creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0373595
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous hepatitis b infection, vaccination with any hepatitis b vaccine
Descripción

Previous hepatitis B infection and vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C0205156
recent febrile illness; hypersensitivity to any component of licensed hepatitis b vaccines
Descripción

Febrile illness, hypersensitivity to hepatitis B vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743841
UMLS CUI [2]
C0571556
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
Descripción

Immune globulin administration, inactivated vaccine, live vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085297
UMLS CUI [2]
C0042212
UMLS CUI [3]
C0042211
receipt of investigational drugs or investigational vaccines within 3 months prior
Descripción

Experimental drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304229
impairment of immunologic function
Descripción

Immunologic function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1817756
recent use of systemic immunomodulatory medications
Descripción

Systemic immunomodulatory medications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1963758
pregnant women, nursing mothers or women planning to become pregnant
Descripción

Gynaecological status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
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Similar models

Eligibility Hepatitis B Virus Infection NCT00440297

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender and age
Item
male and female subjects at least 18 years of age
boolean
C0079399 (UMLS CUI [1])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
Volver a la parte superior de la página 

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