ID

39561

Beschrijving

Hepatitis B Booster Study in Adolescence; ODM derived from: https://clinicaltrials.gov/show/NCT02169674

Link

https://clinicaltrials.gov/show/NCT02169674

Trefwoorden

Versies (1)
  1. 28-01-20 28-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT02169674

Engels

Eligibility Hepatitis B NCT02169674

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 10-11 or 15-16 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written informed assent provided by 10-11 year old participants and consent by their parent or legal guardian or written informed consent provided by a 15-16 year old participant.
Beschrijving

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
subjects whom the investigator believes can and will comply with the requirements of the protocol.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
general good health
Beschrijving

General health good

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
immunized in bc on the regular schedule with hepatitis b vaccine at approximately 2, 4, 6 months of age, based on an available immunization record.
Beschrijving

Immunization Hepatitis B vaccine | Age

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020971
UMLS CUI [1,2]
C2066344
UMLS CUI [2]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatitis b vaccination regimen for infants born to a mother with hepatitis b infection (e.g. doses at birth and ages 1 and 6 months, with or without hb immune globulin at birth).
Beschrijving

Hepatitis B vaccination Infant | Mother Hepatitis B | Hepatitis B immune globulin at birth | Hepatitis B immune globulin Absent at birth

Datatype

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0021270
UMLS CUI [2,1]
C0026591
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C0062525
UMLS CUI [3,2]
C2599577
UMLS CUI [4,1]
C0062525
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C2599577
receipt of any additional dose(s) of hepatitis b vaccine beyond infancy.
Beschrijving

Hepatitis B vaccine Dose Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C2066344
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1524062
systemic hypersensitivity to hepatitis b vaccine or severe reaction to any previous dose of hepatitis b vaccine.
Beschrijving

Hypersensitivity Systemic Hepatitis B vaccine | Severe reaction Hepatitis B vaccine Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C2066344
UMLS CUI [2,1]
C3242604
UMLS CUI [2,2]
C2066344
UMLS CUI [2,3]
C0178602
receipt of blood or blood product within 3 months prior to visit 1.
Beschrijving

Blood Received | Blood product Received

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005767
UMLS CUI [1,2]
C1514756
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C1514756
immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to visit 1.
Beschrijving

Immunocompromised patient Due to Disease | Immunocompromised patient Due to Immunosuppressive Agent Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085393
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C0085393
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0021081
UMLS CUI [2,4]
C0205373
chronic health condition requiring ongoing medical supervision e.g. cystic fibrosis.
Beschrijving

Chronic disease Medical Supervision Required | Cystic Fibrosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1546852
UMLS CUI [2]
C0010674
incapacity to provide fully informed assent, resulting from cognitive impairment.
Beschrijving

Informed Consent Unable | Etiology Impaired cognition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0338656
inadequate participant or parental (when the parent will provide consent) fluency in english to provide fully informed consent.
Beschrijving

Lacking Able to speak fluently English Language | Parent Lacking Able to speak fluently English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564241
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0564241
UMLS CUI [2,4]
C0376245
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Similar models

Eligibility Hepatitis B NCT02169674

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 10-11 or 15-16 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
written informed assent provided by 10-11 year old participants and consent by their parent or legal guardian or written informed consent provided by a 15-16 year old participant.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Protocol Compliance
Item
subjects whom the investigator believes can and will comply with the requirements of the protocol.
boolean
C0525058 (UMLS CUI [1])
General health good
Item
general good health
boolean
C1277245 (UMLS CUI [1])
Immunization Hepatitis B vaccine | Age
Item
immunized in bc on the regular schedule with hepatitis b vaccine at approximately 2, 4, 6 months of age, based on an available immunization record.
boolean
C0020971 (UMLS CUI [1,1])
C2066344 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B vaccination Infant | Mother Hepatitis B | Hepatitis B immune globulin at birth | Hepatitis B immune globulin Absent at birth
Item
hepatitis b vaccination regimen for infants born to a mother with hepatitis b infection (e.g. doses at birth and ages 1 and 6 months, with or without hb immune globulin at birth).
boolean
C0474232 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0026591 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0062525 (UMLS CUI [3,1])
C2599577 (UMLS CUI [3,2])
C0062525 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2599577 (UMLS CUI [4,3])
Hepatitis B vaccine Dose Additional
Item
receipt of any additional dose(s) of hepatitis b vaccine beyond infancy.
boolean
C2066344 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
Hypersensitivity Systemic Hepatitis B vaccine | Severe reaction Hepatitis B vaccine Dose
Item
systemic hypersensitivity to hepatitis b vaccine or severe reaction to any previous dose of hepatitis b vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2066344 (UMLS CUI [1,3])
C3242604 (UMLS CUI [2,1])
C2066344 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Blood Received | Blood product Received
Item
receipt of blood or blood product within 3 months prior to visit 1.
boolean
C0005767 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Immunocompromised patient Due to Disease | Immunocompromised patient Due to Immunosuppressive Agent Systemic
Item
immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to visit 1.
boolean
C0085393 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0085393 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
Chronic disease Medical Supervision Required | Cystic Fibrosis
Item
chronic health condition requiring ongoing medical supervision e.g. cystic fibrosis.
boolean
C0008679 (UMLS CUI [1,1])
C1546852 (UMLS CUI [1,2])
C0010674 (UMLS CUI [2])
Informed Consent Unable | Etiology Impaired cognition
Item
incapacity to provide fully informed assent, resulting from cognitive impairment.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0338656 (UMLS CUI [2,2])
Lacking Able to speak fluently English Language | Parent Lacking Able to speak fluently English Language
Item
inadequate participant or parental (when the parent will provide consent) fluency in english to provide fully informed consent.
boolean
C0332268 (UMLS CUI [1,1])
C0564241 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0030551 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0564241 (UMLS CUI [2,3])
C0376245 (UMLS CUI [2,4])
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