ID

17736

Description

Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00057499

Link

https://clinicaltrials.gov/show/NCT00057499

Keywords

Versions (1)
  1. 9/30/16 9/30/16 -
Uploaded on

September 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Insulin-dependent Diabetes Mellitus NCT00057499

English

Eligibility Insulin-dependent Diabetes Mellitus NCT00057499

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
positive for iaa, gad65, or ia2 antibodies or positive for gad65 or ia2 antibodies after 2 weeks of starting insulin treatment
Description

Anti-insulin autoantibody Positive | Serum Gad65 Auto Antibodies Test Positive | IA-2 antibody Positive | Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C1275890
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C1255118
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0528414
UMLS CUI [3,2]
C1514241
UMLS CUI [4]
C0557978
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of treatment with any oral hypoglycemic agent for more than 3 months
Description

Oral hypoglycemic

Data type

boolean

Alias
UMLS CUI [1]
C0359086
ongoing use of medications known to influence glucose tolerance
Description

Pharmaceutical Preparations Affecting glucose tolerance

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0178665
history of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
Description

Therapeutic immunosuppression | Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0149783
severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
Description

Liver disease Severe Limiting Life Expectancy | Heart Disease Severe Limiting Life Expectancy | Kidney Disease Severe Limiting Life Expectancy | Immunologic Deficiency Syndrome Severe Limiting Life Expectancy | Liver disease Severe Requirement Therapeutic immunosuppression | Heart Disease Severe Requirement Therapeutic immunosuppression | Kidney Disease Severe Requirement Therapeutic immunosuppression | Immunologic Deficiency Syndrome Severe Requirement Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0023671
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0023671
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0023671
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0439801
UMLS CUI [4,4]
C0023671
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C1514873
UMLS CUI [5,4]
C0021079
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0021079
UMLS CUI [7,1]
C0022658
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C1514873
UMLS CUI [7,4]
C0021079
UMLS CUI [8,1]
C0021051
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C1514873
UMLS CUI [8,4]
C0021079
prior complications related to routine vaccinations
Description

Complication of vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0274430
prior participation in a trial for prevention of type 1 diabetes mellitus. individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded.
Description

Study Subject Participation Status | Insulin-Dependent Diabetes Mellitus Prevention

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0199176
any condition that may interfere with a participant's ability to comply with the study
Description

Condition Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
pregnancy or planned pregnancy within the time frame of the study
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Insulin-dependent Diabetes Mellitus NCT00057499

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
boolean
C0011854 (UMLS CUI [1])
Anti-insulin autoantibody Positive | Serum Gad65 Auto Antibodies Test Positive | IA-2 antibody Positive | Insulin regime
Item
positive for iaa, gad65, or ia2 antibodies or positive for gad65 or ia2 antibodies after 2 weeks of starting insulin treatment
boolean
C1275890 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1255118 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0528414 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0557978 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Oral hypoglycemic
Item
history of treatment with any oral hypoglycemic agent for more than 3 months
boolean
C0359086 (UMLS CUI [1])
Pharmaceutical Preparations Affecting glucose tolerance
Item
ongoing use of medications known to influence glucose tolerance
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
Therapeutic immunosuppression | Steroid therapy
Item
history of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
boolean
C0021079 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
Liver disease Severe Limiting Life Expectancy | Heart Disease Severe Limiting Life Expectancy | Kidney Disease Severe Limiting Life Expectancy | Immunologic Deficiency Syndrome Severe Limiting Life Expectancy | Liver disease Severe Requirement Therapeutic immunosuppression | Heart Disease Severe Requirement Therapeutic immunosuppression | Kidney Disease Severe Requirement Therapeutic immunosuppression | Immunologic Deficiency Syndrome Severe Requirement Therapeutic immunosuppression
Item
severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0023671 (UMLS CUI [2,4])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0023671 (UMLS CUI [3,4])
C0021051 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0023671 (UMLS CUI [4,4])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
C0021079 (UMLS CUI [5,4])
C0018799 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0021079 (UMLS CUI [6,4])
C0022658 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1514873 (UMLS CUI [7,3])
C0021079 (UMLS CUI [7,4])
C0021051 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C1514873 (UMLS CUI [8,3])
C0021079 (UMLS CUI [8,4])
Complication of vaccination
Item
prior complications related to routine vaccinations
boolean
C0274430 (UMLS CUI [1])
Study Subject Participation Status | Insulin-Dependent Diabetes Mellitus Prevention
Item
prior participation in a trial for prevention of type 1 diabetes mellitus. individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded.
boolean
C2348568 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Condition Interferes with Protocol Compliance
Item
any condition that may interfere with a participant's ability to comply with the study
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planned pregnancy within the time frame of the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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