0 Ratings
ID

13093

Description

Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00190502

Link

https://clinicaltrials.gov/show/NCT00190502

Keywords

Versions (1)
  1. 1/15/16 1/15/16 -
Uploaded on

January 15, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Diabetes Mellitus, Type 1 NCT00190502

    English

    Eligibility Diabetes Mellitus, Type 1 NCT00190502

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 1 diabetes
    Description

    type 1 diabetes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    body mass index up to 32 kg/m2
    Description

    bmi

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    exclusion of gravidity in women
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    known diagnosis of diabetes of less than 6 weeks
    Description

    diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011900
    insulin dose of up to 40 iu per day for no longer than 1 month
    Description

    insulin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021641
    positive for at least one autoantibody (gad, ia2, ica)
    Description

    autoantibodies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1167896
    UMLS CUI [2]
    C3495754
    UMLS CUI [3]
    C0877212
    c-peptide level ≥ 0.3 pmol/ml 4 min. following intravenous (iv) administration of 1 ml glucagon
    Description

    c-peptide

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0202100
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0017687
    no concurrent severe infection
    Description

    infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205082
    granulocyte count ≥ 2 x 10^9/l
    Description

    granulocyte count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    platelet count ≥ 120 x 10^9/l
    Description

    platelet count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    other non-diabetes related autoimmune disease
    Description

    autoimmune disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    previous immunosuppressive therapy
    Description

    immunosuppressive therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021079
    any clinical impairment precluding immunosuppressive therapy
    Description

    clinical impairment precluding immunosuppressive therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0021079
    leucopenia or thrombocytopenia
    Description

    leucopenia thrombocytopenia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023530
    UMLS CUI [2]
    C0040034
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    Similar models

    Eligibility Diabetes Mellitus, Type 1 NCT00190502

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    type 1 diabetes
    Item
    type 1 diabetes
    boolean
    C0011854 (UMLS CUI [1])
    bmi
    Item
    body mass index up to 32 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    pregnancy
    Item
    exclusion of gravidity in women
    boolean
    C0032961 (UMLS CUI [1])
    diagnosis
    Item
    known diagnosis of diabetes of less than 6 weeks
    boolean
    C0011900 (UMLS CUI [1])
    insulin
    Item
    insulin dose of up to 40 iu per day for no longer than 1 month
    boolean
    C0021641 (UMLS CUI [1])
    autoantibodies
    Item
    positive for at least one autoantibody (gad, ia2, ica)
    boolean
    C1167896 (UMLS CUI [1])
    C3495754 (UMLS CUI [2])
    C0877212 (UMLS CUI [3])
    c-peptide
    Item
    c-peptide level ≥ 0.3 pmol/ml 4 min. following intravenous (iv) administration of 1 ml glucagon
    boolean
    C0202100 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0017687 (UMLS CUI [1,3])
    infection
    Item
    no concurrent severe infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    granulocyte count
    Item
    granulocyte count ≥ 2 x 10^9/l
    boolean
    C0857490 (UMLS CUI [1])
    platelet count
    Item
    platelet count ≥ 120 x 10^9/l
    boolean
    C0032181 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    autoimmune disease
    Item
    other non-diabetes related autoimmune disease
    boolean
    C0004364 (UMLS CUI [1])
    immunosuppressive therapy
    Item
    previous immunosuppressive therapy
    boolean
    C0021079 (UMLS CUI [1])
    clinical impairment precluding immunosuppressive therapy
    Item
    any clinical impairment precluding immunosuppressive therapy
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0021079 (UMLS CUI [1,3])
    leucopenia thrombocytopenia
    Item
    leucopenia or thrombocytopenia
    boolean
    C0023530 (UMLS CUI [1])
    C0040034 (UMLS CUI [2])
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