ID

35968

Description

This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age; ODM derived from: https://clinicaltrials.gov/show/NCT02324218

Link

https://clinicaltrials.gov/show/NCT02324218

Keywords

  1. 4/7/19 4/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 7, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT02324218

Eligibility Hepatitis B NCT02324218

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects, 0 to 80 years of age during the study period.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects acceptable for research as per cprd definition:
Description

Study Subject Acceptable Research

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C0035168
acceptable flag for research.
Description

Flag Acceptable Research

Data type

boolean

Alias
UMLS CUI [1,1]
C1708067
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C0035168
subjects with at least 12 months of observation time at the time of inclusion in the study:
Description

Observation Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0700325
UMLS CUI [1,2]
C0872291
subjects have to be registered in the cprd database for at least 12 months at the date of inclusion in the study.
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
subjects have to be registered in a general practitioner practice classified as
Description

Patient registered General Practitioner

Data type

boolean

Alias
UMLS CUI [1,1]
C0585825
UMLS CUI [1,2]
C0017319
'up to standard' for at least 12 months at the date of inclusion in the study.
Description

Standard

Data type

boolean

Alias
UMLS CUI [1]
C1442989
particular case of new born children.
Description

Infant, Newborn

Data type

boolean

Alias
UMLS CUI [1]
C0021289
to ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in cprd.
Description

Age | Study Subject Participation Status Included | Independent of Observation Timespan

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332257
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0700325
UMLS CUI [3,3]
C0872291
inclusion date
Description

Enrollment Date in time

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0011008
inclusion criteria will be assessed for each calendar year between the years 2000 and 2012.
Description

Inclusion criteria Assessment Calendar year

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0456586
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• for the analyses requiring the inclusion of hes data, hes records linked with more than one cprd patient will be excluded from the analyses.
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158

Similar models

Eligibility Hepatitis B NCT02324218

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects, 0 to 80 years of age during the study period.
boolean
C0001779 (UMLS CUI [1])
Study Subject Acceptable Research
Item
subjects acceptable for research as per cprd definition:
boolean
C0681850 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Flag Acceptable Research
Item
acceptable flag for research.
boolean
C1708067 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Observation Timespan
Item
subjects with at least 12 months of observation time at the time of inclusion in the study:
boolean
C0700325 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
Other Coding
Item
subjects have to be registered in the cprd database for at least 12 months at the date of inclusion in the study.
boolean
C3846158 (UMLS CUI [1])
Patient registered General Practitioner
Item
subjects have to be registered in a general practitioner practice classified as
boolean
C0585825 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])
Standard
Item
'up to standard' for at least 12 months at the date of inclusion in the study.
boolean
C1442989 (UMLS CUI [1])
Infant, Newborn
Item
particular case of new born children.
boolean
C0021289 (UMLS CUI [1])
Age | Study Subject Participation Status Included | Independent of Observation Timespan
Item
to ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in cprd.
boolean
C0001779 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0700325 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Enrollment Date in time
Item
inclusion date
boolean
C1516879 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Inclusion criteria Assessment Calendar year
Item
inclusion criteria will be assessed for each calendar year between the years 2000 and 2012.
boolean
C1512693 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0456586 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Other Coding
Item
• for the analyses requiring the inclusion of hes data, hes records linked with more than one cprd patient will be excluded from the analyses.
boolean
C3846158 (UMLS CUI [1])

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