ID

38968

Description

Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period; ODM derived from: https://clinicaltrials.gov/show/NCT01900834

Link

https://clinicaltrials.gov/show/NCT01900834

Keywords

Versions (1)
  1. 11/16/19 11/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 16, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes NCT01900834

English

Eligibility Diabetes NCT01900834

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01900834
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
t1d
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
male or female subjects diagnosed within the last 3 years and with good general health based on medical history
Description

Gender Diagnosed | General health good Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0262926
age above or equal to 14 years and below or equal to 40 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body weight above 45 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
t2d
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
male or female subjects diagnosed within the last 15 years with good general health based on medical history
Description

Gender Diagnosed | General health good Medical History

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0262926
hba1c between 6.5% and 10%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below 45 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
age above or equal to 18 and below 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
on insulin treatment
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
hs
Description

Healthy Subjects

Data type

boolean

Alias
UMLS CUI [1]
C1708335
male or female subjects with good general heath based on medical history
Description

Gender | General health good Medical History

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0262926
age above or equal to 18 years and below or equal to 40 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any chronic disorder (besides t1d or t2d) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
Description

Chronic disease At risk Patient safety | Exception Insulin-Dependent Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011854
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011860
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C1113679
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0525058
UMLS CUI [6,4]
C1444641
female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy intended

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032961
UMLS CUI [3,3]
C1283828
Back to the top of the page

Similar models

Eligibility Diabetes NCT01900834

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01900834
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
t1d
boolean
C0011854 (UMLS CUI [1])
Gender Diagnosed | General health good Medical History
Item
male or female subjects diagnosed within the last 3 years and with good general health based on medical history
boolean
C0079399 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Age
Item
age above or equal to 14 years and below or equal to 40 years
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight above 45 kg
boolean
C0005910 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
t2d
boolean
C0011860 (UMLS CUI [1])
Gender Diagnosed | General health good Medical History
Item
male or female subjects diagnosed within the last 15 years with good general health based on medical history
boolean
C0079399 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
hba1c between 6.5% and 10%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Age
Item
age above or equal to 18 and below 65 years
boolean
C0001779 (UMLS CUI [1])
Insulin regime
Item
on insulin treatment
boolean
C0557978 (UMLS CUI [1])
Healthy Subjects
Item
hs
boolean
C1708335 (UMLS CUI [1])
Gender | General health good Medical History
Item
male or female subjects with good general heath based on medical history
boolean
C0079399 (UMLS CUI [1])
C1277245 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Age
Item
age above or equal to 18 years and below or equal to 40 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic disease At risk Patient safety | Exception Insulin-Dependent Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus | Disease Severe At risk Patient safety | Chronic disease Protocol Compliance At risk | Disease Severe Protocol Compliance At risk
Item
any chronic disorder (besides t1d or t2d) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011860 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0008679 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C1444641 (UMLS CUI [6,4])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy intended
Item
female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
C1283828 (UMLS CUI [3,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial