0 Avaliações

ID

5042

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00909597

Link

http://clinicaltrials.gov/show/NCT00909597

Palavras-chave

  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 17/04/2014 17/04/2014 - Julian Varghese
  3. 17/04/2014 17/04/2014 - Julian Varghese
Transferido a

17 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility NCT00909597 Diabetes Mellitus, Type 2

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrição

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter 18 bis 75 Jahre
    Descrição

    age 18 Years to 75 Years

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    type 2 diabetes mellitus
    Descrição

    type 2 diabetes mellitus

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0011860
    treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening
    Descrição

    treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    CL415147
    UMLS CUI 2011AA
    C0205360
    SNOMED CT 2011_0131
    58158008
    LOINC Version 232
    MTHU015276
    UMLS CUI 2011AA
    C0038766
    UMLS CUI 2011AA
    CL414906
    UMLS CUI 2011AA
    C0025598
    SNOMED CT 2011_0131
    372567009
    LOINC Version 232
    MTHU016062
    UMLS CUI 2011AA
    C0038766
    HbA1c >=7.0% and <=10% at screening
    Descrição

    HbA1c >=7.0% and <=10% at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0019018
    stable weight +/-5% for >=12 weeks prior to screening.
    Descrição

    stable weight +/-5% for >=12 weeks prior to screening.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0005910
    Ausschlusskriterien
    Descrição

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
    Descrição

    type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

    Tipo de dados

    boolean

    Alias
    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
    C0011849
    SNOMED CT 2011_0131
    191044006
    UMLS CUI 2011AA
    C1314792
    SNOMED CT 2011_0131
    134198009
    UMLS CUI 2011AA
    C0273163
    SNOMED CT 2011_0131
    61823004
    MedDRA 14.1
    10033627
    ICD-10-CM Version 2010
    S36.2
    UMLS CUI 2011AA
    C0271640
    SNOMED CT 2011_0131
    8801005
    ICD-9-CM Version 2011
    249
    clinically significant diabetic complications
    Descrição

    clinically significant diabetic complications

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0750502
    SNOMED CT 2011_0131
    386134007
    UMLS CUI 2011AA
    C0342257
    SNOMED CT 2011_0131
    74627003
    MedDRA 14.1
    10061104
    ICD-9-CM Version 2011
    250.9
    clinically symptomatic gastrointestinal disease
    Descrição

    clinically symptomatic gastrointestinal disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0231220
    SNOMED CT 2011_0131
    264931009
    UMLS CUI 2011AA
    C0017178
    SNOMED CT 2011_0131
    119292006
    MedDRA 14.1
    10017944
    >3 episodes of severe hypoglycemia within 6 months before screening.
    Descrição

    >3 episodes of severe hypoglycemia within 6 months before screening.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0439093
    SNOMED CT 2011_0131
    276140008
    HL7 V3 2006_05
    GT
    UMLS CUI 2011AA
    C0205449
    SNOMED CT 2011_0131
    421291004
    UMLS CUI 2011AA
    C0332189
    SNOMED CT 2011_0131
    272128006
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0020615
    SNOMED CT 2011_0131
    302866003
    MedDRA 14.1
    10020993
    ICD-10-CM Version 2010
    E16.2
    ICD-9-CM Version 2011
    251.2
    CTCAE 1105E
    E12322

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age 18 Years to 75 Years
    Item
    Alter 18 bis 75 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    type 2 diabetes mellitus
    Item
    type 2 diabetes mellitus
    boolean
    C0011860 (UMLS CUI 2011AA)
    treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening
    Item
    treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening
    boolean
    CL415147 (UMLS CUI 2011AA)
    C0205360 (UMLS CUI 2011AA)
    58158008 (SNOMED CT 2011_0131)
    MTHU015276 (LOINC Version 232)
    C0038766 (UMLS CUI 2011AA)
    CL414906 (UMLS CUI 2011AA)
    C0025598 (UMLS CUI 2011AA)
    372567009 (SNOMED CT 2011_0131)
    MTHU016062 (LOINC Version 232)
    C0038766 (UMLS CUI 2011AA)
    HbA1c >=7.0% and <=10% at screening
    Item
    HbA1c >=7.0% and <=10% at screening
    boolean
    C0019018 (UMLS CUI 2011AA)
    stable weight +/-5% for >=12 weeks prior to screening.
    Item
    stable weight +/-5% for >=12 weeks prior to screening.
    boolean
    C0005910 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
    Item
    type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
    boolean
    C0011854 (UMLS CUI 2011AA)
    46635009 (SNOMED CT 2011_0131)
    10067584 (MedDRA 14.1)
    MTHU020217 (LOINC Version 232)
    E10 (ICD-10-CM Version 2010)
    C0011849 (UMLS CUI 2011AA)
    191044006 (SNOMED CT 2011_0131)
    C1314792 (UMLS CUI 2011AA)
    134198009 (SNOMED CT 2011_0131)
    C0273163 (UMLS CUI 2011AA)
    61823004 (SNOMED CT 2011_0131)
    10033627 (MedDRA 14.1)
    S36.2 (ICD-10-CM Version 2010)
    C0271640 (UMLS CUI 2011AA)
    8801005 (SNOMED CT 2011_0131)
    249 (ICD-9-CM Version 2011)
    clinically significant diabetic complications
    Item
    clinically significant diabetic complications
    boolean
    C0750502 (UMLS CUI 2011AA)
    386134007 (SNOMED CT 2011_0131)
    C0342257 (UMLS CUI 2011AA)
    74627003 (SNOMED CT 2011_0131)
    10061104 (MedDRA 14.1)
    250.9 (ICD-9-CM Version 2011)
    clinically symptomatic gastrointestinal disease
    Item
    clinically symptomatic gastrointestinal disease
    boolean
    C0231220 (UMLS CUI 2011AA)
    264931009 (SNOMED CT 2011_0131)
    C0017178 (UMLS CUI 2011AA)
    119292006 (SNOMED CT 2011_0131)
    10017944 (MedDRA 14.1)
    >3 episodes of severe hypoglycemia within 6 months before screening.
    Item
    >3 episodes of severe hypoglycemia within 6 months before screening.
    boolean
    C0439093 (UMLS CUI 2011AA)
    276140008 (SNOMED CT 2011_0131)
    GT (HL7 V3 2006_05)
    C0205449 (UMLS CUI 2011AA)
    421291004 (SNOMED CT 2011_0131)
    C0332189 (UMLS CUI 2011AA)
    272128006 (SNOMED CT 2011_0131)
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0020615 (UMLS CUI 2011AA)
    302866003 (SNOMED CT 2011_0131)
    10020993 (MedDRA 14.1)
    E16.2 (ICD-10-CM Version 2010)
    251.2 (ICD-9-CM Version 2011)
    E12322 (CTCAE 1105E)

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