ID

29619

Beskrivning

Hepatitis B Acceptability and Vaccination Incentive Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00744289

Länk

https://clinicaltrials.gov/show/NCT00744289

Nyckelord

Versioner (1)
  1. 2018-04-10 2018-04-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00744289

Engelsk

Eligibility Hepatitis B NCT00744289

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 16 years and above.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
injected drugs at least once in the preceding six months, or (i) use of any illegal/non-prescription drug apart from cannabis (e.g., speed, coke, ice, heroin) in the last three months, and (ii) spent time with 2 or more people who inject drugs on a weekly or more frequent basis in the last three months.
Beskrivning

Injected drugs | Illicit drug use | Use of Non-Prescription Drugs | Exception Marihuana | Amphetamine | Cocaine | Methamphetamine | Heroin

Datatyp

boolean

Alias
UMLS CUI [1]
C0683092
UMLS CUI [2]
C0281875
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0013231
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0024808
UMLS CUI [5]
C0002658
UMLS CUI [6]
C0009170
UMLS CUI [7]
C0025611
UMLS CUI [8]
C0011892
no previous hepatitis b infection, and a maximum of one previous dose of hepatitis b vaccination, or unknown infection and vaccination status, based on self-report and, where available, medical records
Beskrivning

Hepatitis B Previous Absent | Hepatitis B vaccination Dose Quantity Maximum | Infection status Unknown | Vaccination status Unknown

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0806909
UMLS CUI [3,1]
C0517627
UMLS CUI [3,2]
C0439673
UMLS CUI [4,1]
C1443394
UMLS CUI [4,2]
C0439673
ability to provide informed consent, to be randomized and attend vaccinations over a period of three weeks and to attend follow-up at 12 weeks post-randomisation.
Beskrivning

Informed Consent | Protocol Compliance | Vaccination Attend | Follow-up Attend

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C0042196
UMLS CUI [3,2]
C1999232
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C1999232
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of natural or vaccine-induced immunity.
Beskrivning

Immunity, Innate | Immunity Vaccine Induced

Datatyp

boolean

Alias
UMLS CUI [1]
C0020969
UMLS CUI [2,1]
C0020965
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C0205263
previous exposure or two+ vaccinations (as identified by self-report), where hbv surface antibody >= 10 miu/ml
Beskrivning

Exposure to Vaccination | Hepatitis B surface antibody measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0042196
UMLS CUI [2]
C0201478
serious mental or physical illness or disability likely to impact on capacity to complete the study procedures
Beskrivning

Mental disorders Impact Protocol Compliance | Physical illness Impact Protocol Compliance | Disability Impact Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0231170
UMLS CUI [3,2]
C4049986
UMLS CUI [3,3]
C0525058
insufficient english language skills that will impair ability to give informed consent or provide reliable responses to study interviews /questionnaires
Beskrivning

English Language skills Insufficient | Informed Consent Limited | Patient interview Completion Limited | Clinical Trial Subject Questionnaire Completion Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C1145677
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C0683518
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C3890411
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0439801
human immunodeficiency virus infection
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
refusal to be vaccinated against hepatitis b virus (hbv)
Beskrivning

Hepatitis B vaccination Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C1705116
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Similar models

Eligibility Hepatitis B NCT00744289

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 16 years and above.
boolean
C0001779 (UMLS CUI [1])
Injected drugs | Illicit drug use | Use of Non-Prescription Drugs | Exception Marihuana | Amphetamine | Cocaine | Methamphetamine | Heroin
Item
injected drugs at least once in the preceding six months, or (i) use of any illegal/non-prescription drug apart from cannabis (e.g., speed, coke, ice, heroin) in the last three months, and (ii) spent time with 2 or more people who inject drugs on a weekly or more frequent basis in the last three months.
boolean
C0683092 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C1524063 (UMLS CUI [3,1])
C0013231 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0024808 (UMLS CUI [4,2])
C0002658 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0025611 (UMLS CUI [7])
C0011892 (UMLS CUI [8])
Hepatitis B Previous Absent | Hepatitis B vaccination Dose Quantity Maximum | Infection status Unknown | Vaccination status Unknown
Item
no previous hepatitis b infection, and a maximum of one previous dose of hepatitis b vaccination, or unknown infection and vaccination status, based on self-report and, where available, medical records
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0474232 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0806909 (UMLS CUI [2,4])
C0517627 (UMLS CUI [3,1])
C0439673 (UMLS CUI [3,2])
C1443394 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
Informed Consent | Protocol Compliance | Vaccination Attend | Follow-up Attend
Item
ability to provide informed consent, to be randomized and attend vaccinations over a period of three weeks and to attend follow-up at 12 weeks post-randomisation.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0042196 (UMLS CUI [3,1])
C1999232 (UMLS CUI [3,2])
C3274571 (UMLS CUI [4,1])
C1999232 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Immunity, Innate | Immunity Vaccine Induced
Item
evidence of natural or vaccine-induced immunity.
boolean
C0020969 (UMLS CUI [1])
C0020965 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0205263 (UMLS CUI [2,3])
Exposure to Vaccination | Hepatitis B surface antibody measurement
Item
previous exposure or two+ vaccinations (as identified by self-report), where hbv surface antibody >= 10 miu/ml
boolean
C0332157 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0201478 (UMLS CUI [2])
Mental disorders Impact Protocol Compliance | Physical illness Impact Protocol Compliance | Disability Impact Protocol Compliance
Item
serious mental or physical illness or disability likely to impact on capacity to complete the study procedures
boolean
C0004936 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0683323 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0231170 (UMLS CUI [3,1])
C4049986 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
English Language skills Insufficient | Informed Consent Limited | Patient interview Completion Limited | Clinical Trial Subject Questionnaire Completion Limited
Item
insufficient english language skills that will impair ability to give informed consent or provide reliable responses to study interviews /questionnaires
boolean
C0376245 (UMLS CUI [1,1])
C1145677 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0683518 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C3890411 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
HIV Infection
Item
human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
Hepatitis B vaccination Refused
Item
refusal to be vaccinated against hepatitis b virus (hbv)
boolean
C0474232 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
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