Eligibility Type 1 Diabetes Mellitus NCT00385697

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StudyEvent: Eligibility
1. Eligibility Type 1 Diabetes Mellitus NCT00385697

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Criteria Fulfill

Item

subjects must meet all of the following criteria:

boolean

C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])

Diabetes Mellitus Sign or Symptom

Item

1. enrollment (segment #1) or randomization (segment #2) on study day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. study day 0 is the first day of study drug dosing.

boolean

C0011849 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])

Diabetes Mellitus, Insulin-Dependent

Item

2. diagnosis of type 1 diabetes mellitus, according to the american diabetes association (ada) criteria

boolean

C0011854 (UMLS CUI [1])

Insulin injection Therapy Patient need for

Item

3. requirement for injected insulin therapy

boolean

C0199782 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])

Fasting C-peptide level Detectable | C-peptide stimulation test Positive

Item

4. have a detectable fasting or stimulated c-peptide level (above the lower limit of detection of the assay)

boolean

C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0430183 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])

Antibody test Positive

Item

5. one positive result on testing for any of the following antibodies:

boolean

C0580327 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])

autoantibodies to islet cells | ICA512

Item

1. islet-cell autoantibodies (ica512/ia-2),

boolean

C2097865 (UMLS CUI [1])
C0380315 (UMLS CUI [2])

Glutamic Acid Decarboxylase Autoantibodies

Item

2. glutamic acid decarboxylase autoantibodies, or

boolean

C0017785 (UMLS CUI [1,1])
C0004358 (UMLS CUI [1,2])

Insulin autoantibody | Insulin regime

Item

3. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)

boolean

C1275890 (UMLS CUI [1])
C0557978 (UMLS CUI [2])

Gender

Item

6. male or female

boolean

C0079399 (UMLS CUI [1])

Age Group

Item

7. subject must be in one of the following age groups:

boolean

C0001779 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])

Age

Item

age 18-35 years

boolean

C0001779 (UMLS CUI [1])

Age

Item

age 12-17 years pending approval by data monitoring committee

boolean

C0001779 (UMLS CUI [1])

Age

Item

age 8-11 years pending approval by data monitoring committee

boolean

C0001779 (UMLS CUI [1])

Body Weight

Item

8. body weight ≥ 36 kg

boolean

C0005910 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Criteria None

Item

subjects must have none of the following:

boolean

C0243161 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])

Monoclonal Antibody Therapy Preventing Disease Response | Monoclonal Antibody Therapy Interferes with Disease Response | MGA031

Item

1. prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at study day 0 -- that could potentially prevent or confound a therapeutic response to mga031

boolean

C0279694 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0279694 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C2987612 (UMLS CUI [3])

Study Subject Participation Status | Investigational New Drugs | Vaccines

Item

2. participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0042210 (UMLS CUI [3])

Medical condition Interferes with Completion of clinical trial

Item

3. any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial

boolean

C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])

Pregnancy | Breast Feeding

Item

4. pregnant or lactating females

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Muromonab-CD3

Item

5. prior murine okt®3 treatment at any time before enrollment or randomization

boolean

C0085379 (UMLS CUI [1])

Exenatide | Exenatide Planned | Pharmaceutical Preparations Stimulating Pancreatic beta cell Regeneration | Pharmaceutical Preparations Stimulating Insulin secretion

Item

6. current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion

boolean

C0167117 (UMLS CUI [1])
C0167117 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1948023 (UMLS CUI [3,2])
C0030281 (UMLS CUI [3,3])
C0034963 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C1948023 (UMLS CUI [4,2])
C1256369 (UMLS CUI [4,3])

Insulin Inhaled | Insulin Inhaled Planned

Item

7. current or planned therapy with inhaled insulin

boolean

C0021641 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0001559 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])

Heart failure Uncompensated | Fluid overload | Myocardial Infarction | Myocardial Ischemia | Heart Disease Serious

Item

8. uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization

boolean

C0018801 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
C0546817 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])

Item

9. history of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease

boolean

C0014544 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0002895 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0085096 (UMLS CUI [6])
C0007820 (UMLS CUI [7])

Hypothyroidism Treatment required for | Graves Disease

Item

10. newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active graves' disease

boolean

C0020676 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0018213 (UMLS CUI [2])

Eczema Treatment required for | Asthma Treatment required for | Atopic disorders Severe Treatment required for

Item

11. eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization

boolean

C0013595 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0947961 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332121 (UMLS CUI [3,3])

Communicable Disease | Fever

Item

12. evidence of active infection, such as fever ≥ 38.0 degrees celsius (100.5 degrees fahrenheit)

boolean

C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])

HIV Infection | HIV Infection Suspected

Item

13. known or suspected infection with human immunodeficiency virus (hiv)

boolean

C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])

Hepatitis B | Hepatitis C

Item

14. evidence of active hepatitis b (hbv) or hepatitis c virus (hcv)

boolean

C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])

Tuberculosis | Latent Tuberculosis

Item

15. evidence of active or latent tuberculosis

boolean

C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])

Live Vaccines | Live Vaccines Planned | Vaccine Antigen | Vaccines, Inactivated

Item

16. vaccination with a live virus within the 12 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. vaccination with an antigen or killed organism must not be given within 12 weeks before or planned within 8 weeks after each dosing cycle.

boolean

C0042211 (UMLS CUI [1])
C0042211 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1519887 (UMLS CUI [3])
C0042212 (UMLS CUI [4])

Illness Infectious Mononucleosis Similar

Item

17. any infectious mononucleosis-like illness within the 6 months before enrollment or randomization

boolean

C0221423 (UMLS CUI [1,1])
C0021345 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])

Epstein-Barr Virus Infection Evidence Serologic | Epstein-Barr Virus Infection Evidence Clinical

Item

18. serologic and clinical evidence of acute infection with epstein-barr virus (ebv)

boolean

C0149678 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0149678 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])

Cytomegalovirus Infection Evidence Serologic

Item

19. serologic evidence of acute infection with cytomegalovirus (cmv)

boolean

C0010823 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])

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Eligibility Type 1 Diabetes Mellitus NCT00385697