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ID

4313

Description

ODM derived from http://clinicaltrials.gov/show/NCT01131585

Link

http://clinicaltrials.gov/show/NCT01131585

Keywords

Versions (1)
  1. 12/6/13 12/6/13 - Martin Dugas
Uploaded on

December 6, 2013

DOI

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Creative Commons BY 4.0
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    Eligibility NCT01131585 Diabetic Macular Edema

    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
    Reduced visual acuity
    Description

    Visual Acuity impairment

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0234632
    SNOMED CT 2011_0131
    13164000
    MedDRA 14.1
    10047531
    Macular Edema in at least one eye
    Description

    Macular Edema in at least one eye

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0271051
    SNOMED CT 2011_0131
    37231002
    MedDRA 14.1
    10025415
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0439091
    SNOMED CT 2011_0131
    276138003
    HL7 V3 2006_05
    GE
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    Type 1 or Type 2 Diabetes Mellitus
    Description

    Type 1 or Type 2 Diabetes Mellitus

    Data type

    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
    C0011860
    SNOMED CT 2011_0131
    44054006
    MedDRA 14.1
    10012613
    ICD-10-CM Version 2010
    E08-E13
    Stable medication of diabetes in past 3 month
    Description

    Stable medication of diabetes in past 3 month

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205360
    SNOMED CT 2011_0131
    58158008
    LOINC Version 232
    MTHU015276
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0011849
    SNOMED CT 2011_0131
    191044006
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Patients with uncontrolled systemic or ocular diseases
    Description

    Patients with uncontrolled systemic or ocular diseases

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    UMLS CUI 2011AA
    C0442893
    SNOMED CT 2011_0131
    56019007, 264578000
    UMLS CUI 2011AA
    C0015397
    SNOMED CT 2011_0131
    371405004
    MedDRA 14.1
    10015916
    ICD-10-CM Version 2010
    H44
    ICD-9-CM Version 2011
    379.90
    Laser photocoagulation in the study eye for the last 3 months
    Description

    Laser photocoagulation in the study eye for the last 3 months

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0441510
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    Any history of any intraocular surgery in the study eye within the past 3 months
    Description

    Any history of any intraocular surgery in the study eye within the past 3 months

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    CL429484
    UMLS CUI 2011AA
    C0038895
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    Blood pressure (BP)
    Description

    Blood pressure > 160/100 mmHg

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0005823
    SNOMED CT 2011_0131
    75367002
    LOINC Version 232
    MTHU008342
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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)
    Visual Acuity impairment
    Item
    Reduced visual acuity
    boolean
    C0234632 (UMLS CUI 2011AA)
    13164000 (SNOMED CT 2011_0131)
    10047531 (MedDRA 14.1)
    Macular Edema in at least one eye
    Item
    Macular Edema in at least one eye
    boolean
    C0271051 (UMLS CUI 2011AA)
    37231002 (SNOMED CT 2011_0131)
    10025415 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0439091 (UMLS CUI 2011AA)
    276138003 (SNOMED CT 2011_0131)
    GE (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    Type 1 or Type 2 Diabetes Mellitus
    Item
    Type 1 or Type 2 Diabetes Mellitus
    boolean
    C0011854 (UMLS CUI 2011AA)
    46635009 (SNOMED CT 2011_0131)
    10067584 (MedDRA 14.1)
    MTHU020217 (LOINC Version 232)
    E10 (ICD-10-CM Version 2010)
    C0011860 (UMLS CUI 2011AA)
    44054006 (SNOMED CT 2011_0131)
    10012613 (MedDRA 14.1)
    E08-E13 (ICD-10-CM Version 2010)
    Stable medication of diabetes in past 3 month
    Item
    Stable medication of diabetes in past 3 month
    boolean
    C0205360 (UMLS CUI 2011AA)
    58158008 (SNOMED CT 2011_0131)
    MTHU015276 (LOINC Version 232)
    C0013227 (UMLS CUI 2011AA)
    C0011849 (UMLS CUI 2011AA)
    191044006 (SNOMED CT 2011_0131)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Patients with uncontrolled systemic or ocular diseases
    Item
    Patients with uncontrolled systemic or ocular diseases
    boolean
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    C0442893 (UMLS CUI 2011AA)
    56019007, 264578000 (SNOMED CT 2011_0131)
    C0015397 (UMLS CUI 2011AA)
    371405004 (SNOMED CT 2011_0131)
    10015916 (MedDRA 14.1)
    H44 (ICD-10-CM Version 2010)
    379.90 (ICD-9-CM Version 2011)
    Laser photocoagulation in the study eye for the last 3 months
    Item
    Laser photocoagulation in the study eye for the last 3 months
    boolean
    C0441510 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    Any history of any intraocular surgery in the study eye within the past 3 months
    Item
    Any history of any intraocular surgery in the study eye within the past 3 months
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    CL429484 (UMLS CUI 2011AA)
    C0038895 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    Blood pressure > 160/100 mmHg
    Item
    Blood pressure (BP)
    boolean
    C0005823 (UMLS CUI 2011AA)
    75367002 (SNOMED CT 2011_0131)
    MTHU008342 (LOINC Version 232)
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