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ID

5088

Description

ODM derived from http://clinicaltrials.gov/show/NCT01144338

Link

http://clinicaltrials.gov/show/NCT01144338

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
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April 17, 2014

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Creative Commons BY 4.0
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    Eligibility NCT01144338 Type 2 Diabetes Mellitus

    German English

    Eligibility

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

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 18 Years
    Description

    age at least 18 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Patient has type 2 diabetes mellitus
    Description

    Patient has type 2 diabetes mellitus

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011860
    Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
    Description

    Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0019018
    SNOMED CT 2011_0131
    33601001
    LOINC Version 232
    MTHU018890
    UMLS CUI 2011AA
    C0205360
    SNOMED CT 2011_0131
    58158008
    LOINC Version 232
    MTHU015276
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    C0359086
    SNOMED CT 2011_0131
    346597008
    LOINC Version 232
    MTHU003326
    Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
    Description

    Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0015780
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C2826207
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
    Description

    Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0011854
    SNOMED CT 2011_0131
    46635009
    MedDRA 14.1
    10067584
    LOINC Version 232
    MTHU020217
    ICD-10-CM Version 2010
    E10
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0220982
    SNOMED CT 2011_0131
    56051008
    MedDRA 14.1
    10023379
    Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.
    Description

    Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1512806
    UMLS CUI 2011AA
    C0021641
    SNOMED CT 2011_0131
    67866001
    LOINC Version 232
    MTHU019392
    UMLS CUI 2011AA
    C0205448
    SNOMED CT 2011_0131
    19338005
    UMLS CUI 2011AA
    C0439230
    SNOMED CT 2011_0131
    258705008
    HL7 V3 2006_05
    WK
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C1554196
    HL7 V3 2006_05
    ENC
    Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
    Description

    Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0332293
    SNOMED CT 2011_0131
    28995006
    UMLS CUI 2011AA
    C2917359
    UMLS CUI 2011AA
    C0167117
    SNOMED CT 2011_0131
    416859008
    UMLS CUI 2011AA
    C0558293
    SNOMED CT 2011_0131
    225769003
    UMLS CUI 2011AA
    C1456408
    SNOMED CT 2011_0131
    444907006
    UMLS CUI 2011AA
    C2716826
    Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
    Description

    Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1516879
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0681814
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C2346570
    UMLS CUI 2011AA
    C1948041
    SNOMED CT 2011_0131
    71388002
    MedDRA 14.1
    10042613
    LOINC Version 232
    MTHU006237
    ICD-9-CM Version 2011
    00-99.99
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0681872
    Patient has a planned or anticipated revascularization procedure.
    Description

    Patient has a planned or anticipated revascularization procedure.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1301732
    SNOMED CT 2011_0131
    397943006
    UMLS CUI 2011AA
    C0679106
    UMLS CUI 2011AA
    C0581603
    SNOMED CT 2011_0131
    297183000
    Pregnancy or planned pregnancy during the trial period.
    Description

    Pregnancy or planned pregnancy during the trial period.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C0032992
    SNOMED CT 2011_0131
    169565003
    UMLS CUI 2011AA
    C0489652
    LOINC Version 232
    MTHU024501
    Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
    Description

    Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C1516879
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0167117
    SNOMED CT 2011_0131
    416859008
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Patient has type 2 diabetes mellitus
    Item
    Patient has type 2 diabetes mellitus
    boolean
    C0011860 (UMLS CUI 2011AA)
    Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
    Item
    Patient has an HbA1c of >= 7.0 % and <= 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
    boolean
    C0019018 (UMLS CUI 2011AA)
    33601001 (SNOMED CT 2011_0131)
    MTHU018890 (LOINC Version 232)
    C0205360 (UMLS CUI 2011AA)
    58158008 (SNOMED CT 2011_0131)
    MTHU015276 (LOINC Version 232)
    C0178602 (UMLS CUI 2011AA)
    260911001 (SNOMED CT 2011_0131)
    C0359086 (UMLS CUI 2011AA)
    346597008 (SNOMED CT 2011_0131)
    MTHU003326 (LOINC Version 232)
    Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
    Item
    Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
    boolean
    C0015780 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C2826207 (UMLS CUI 2011AA)
    C0680240 (UMLS CUI 2011AA)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
    Item
    Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0011854 (UMLS CUI 2011AA)
    46635009 (SNOMED CT 2011_0131)
    10067584 (MedDRA 14.1)
    MTHU020217 (LOINC Version 232)
    E10 (ICD-10-CM Version 2010)
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0220982 (UMLS CUI 2011AA)
    56051008 (SNOMED CT 2011_0131)
    10023379 (MedDRA 14.1)
    Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.
    Item
    Patient has taken insulin within 2 weeks of screening visit or for > 1 week within 3 months of screening visit.
    boolean
    C1512806 (UMLS CUI 2011AA)
    C0021641 (UMLS CUI 2011AA)
    67866001 (SNOMED CT 2011_0131)
    MTHU019392 (LOINC Version 232)
    C0205448 (UMLS CUI 2011AA)
    19338005 (SNOMED CT 2011_0131)
    C0439230 (UMLS CUI 2011AA)
    258705008 (SNOMED CT 2011_0131)
    WK (HL7 V3 2006_05)
    C1409616 (UMLS CUI 2011AA)
    C1554196 (UMLS CUI 2011AA)
    ENC (HL7 V3 2006_05)
    Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
    Item
    Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
    boolean
    C0332293 (UMLS CUI 2011AA)
    28995006 (SNOMED CT 2011_0131)
    C2917359 (UMLS CUI 2011AA)
    C0167117 (UMLS CUI 2011AA)
    416859008 (SNOMED CT 2011_0131)
    C0558293 (UMLS CUI 2011AA)
    225769003 (SNOMED CT 2011_0131)
    C1456408 (UMLS CUI 2011AA)
    444907006 (SNOMED CT 2011_0131)
    C2716826 (UMLS CUI 2011AA)
    Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
    Item
    Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
    boolean
    C1516879 (UMLS CUI 2011AA)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0681814 (UMLS CUI 2011AA)
    C1314939 (UMLS CUI 2011AA)
    248448006 (SNOMED CT 2011_0131)
    C0013230 (UMLS CUI 2011AA)
    C2346570 (UMLS CUI 2011AA)
    C1948041 (UMLS CUI 2011AA)
    71388002 (SNOMED CT 2011_0131)
    10042613 (MedDRA 14.1)
    MTHU006237 (LOINC Version 232)
    00-99.99 (ICD-9-CM Version 2011)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0681872 (UMLS CUI 2011AA)
    Patient has a planned or anticipated revascularization procedure.
    Item
    Patient has a planned or anticipated revascularization procedure.
    boolean
    C1301732 (UMLS CUI 2011AA)
    397943006 (SNOMED CT 2011_0131)
    C0679106 (UMLS CUI 2011AA)
    C0581603 (UMLS CUI 2011AA)
    297183000 (SNOMED CT 2011_0131)
    Pregnancy or planned pregnancy during the trial period.
    Item
    Pregnancy or planned pregnancy during the trial period.
    boolean
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C0032992 (UMLS CUI 2011AA)
    169565003 (SNOMED CT 2011_0131)
    C0489652 (UMLS CUI 2011AA)
    MTHU024501 (LOINC Version 232)
    Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
    Item
    Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
    boolean
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    C1516879 (UMLS CUI 2011AA)
    C0150312 (UMLS CUI 2011AA)
    52101004 (SNOMED CT 2011_0131)
    C0167117 (UMLS CUI 2011AA)
    416859008 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
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