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Eligibility Diabetes Type 1 Prevention NCT01030861

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
between ages of 8-45 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have a relative with type 1 diabetes
Description

- if first degree relative must be 8-45 years old (brother, sister, parent, offspring) - if second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle, grandchild, cousin)

Data type

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0080103
abnormal glucose tolerance by ogtt confirmed with 7 weeks of baseline visit [fasting blood glucose greater than 110mg/dl or and less than 126 mg/dl or 2 hour glucose greater or equal to 140 mg/dl and less than 200 mg/dl or 30, 60, or 90 minute value on ogtt greater than or equal to 200 mg/dl]
Description

Abnormal glucose tolerance confirmed by ogtt, with fasting blood glucose or 2 hour glucose

Data type

boolean

Alias
UMLS CUI [1,1]
C0235401
UMLS CUI [1,2]
C0029161
UMLS CUI [2,1]
C0235401
UMLS CUI [2,2]
C0428568
UMLS CUI [3,1]
C0235401
UMLS CUI [3,2]
C2238058
presence of at least two confirmed diabetes autoantibodies
Description

Presence of diabetes autoantibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0004358
UMLS CUI [1,2]
C0011854
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater or equal to 126 mg/dl or 2 hour glucose greater or equal to 200 mg/dl]
Description

Current type 1 diabetes (fasting glucose, 2 hour glucose)

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0583513
UMLS CUI [3]
C2238058
abnormalities in blood counts, liver enzymes, inr, positive ppd Test
Description

Abnormalities in blood counts, liver enzymes, inr or positive ppd test

Data type

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0041290
UMLS CUI [3]
C0009555
UMLS CUI [4]
C1287351
vaccination with live virus within 6 weeks of randomization
Description

Recent vaccination with live virus

Data type

boolean

Alias
UMLS CUI [1,1]
C1516086
UMLS CUI [1,2]
C0332185
evidence of acute infection based on laboratory testing or clinical evidence
Description

Acute infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205210
serological evidence of past current or past hiv , hepatitis b, or hepatitis c infection
Description

Past HIV, Hepatitis B or Hepatitis C infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0036743
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0036743
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0036743
be currently pregnant or lactating
Description

Pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior treatment with study drug
Description

Prior treatment with study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1521826
prior treatment with other monoclonal antibody in past one year
Description

Prior treatment with monoclonal antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003250
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Similar models

Eligibility Diabetes Type 1 Prevention NCT01030861

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between ages of 8-45 years
boolean
C0001779 (UMLS CUI [1])
Relatives with Type 1 diabetes between 8-45 years old
Item
have a relative with type 1 diabetes
boolean
C0080103 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C0080103 (UMLS CUI [2,2])
Abnormal glucose tolerance confirmed by ogtt, with fasting blood glucose or 2 hour glucose
Item
abnormal glucose tolerance by ogtt confirmed with 7 weeks of baseline visit [fasting blood glucose greater than 110mg/dl or and less than 126 mg/dl or 2 hour glucose greater or equal to 140 mg/dl and less than 200 mg/dl or 30, 60, or 90 minute value on ogtt greater than or equal to 200 mg/dl]
boolean
C0235401 (UMLS CUI [1,1])
C0029161 (UMLS CUI [1,2])
C0235401 (UMLS CUI [2,1])
C0428568 (UMLS CUI [2,2])
C0235401 (UMLS CUI [3,1])
C2238058 (UMLS CUI [3,2])
Presence of diabetes autoantibodies
Item
presence of at least two confirmed diabetes autoantibodies
boolean
C0004358 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Current type 1 diabetes (fasting glucose, 2 hour glucose)
Item
type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater or equal to 126 mg/dl or 2 hour glucose greater or equal to 200 mg/dl]
boolean
C0011854 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2])
C2238058 (UMLS CUI [3])
Abnormalities in blood counts, liver enzymes, inr or positive ppd test
Item
abnormalities in blood counts, liver enzymes, inr, positive ppd Test
boolean
C0525032 (UMLS CUI [1])
C0041290 (UMLS CUI [2])
C0009555 (UMLS CUI [3])
C1287351 (UMLS CUI [4])
Recent vaccination with live virus
Item
vaccination with live virus within 6 weeks of randomization
boolean
C1516086 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Acute infection
Item
evidence of acute infection based on laboratory testing or clinical evidence
boolean
C0009450 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Past HIV, Hepatitis B or Hepatitis C infection
Item
serological evidence of past current or past hiv , hepatitis b, or hepatitis c infection
boolean
C0019693 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
Pregnant or lactating
Item
be currently pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior treatment with study drug
Item
prior treatment with study drug
boolean
C1514463 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Prior treatment with monoclonal antibody
Item
prior treatment with other monoclonal antibody in past one year
boolean
C1514463 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
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