0 Evaluaciones

ID

4459

Descripción

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.

Palabras clave

  1. 9/12/13 9/12/13 - Martin Dugas
Subido en

9 de diciembre de 2013

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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    Eligibility NCT00133952 # Diabetes Mellitus

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descripción

    Einschlusskriterien

    Healthy Volunteers
    Descripción

    Healthy Volunteers

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C1708335
    InclusionCriterion_1
    Descripción

    InclusionCriterion_1

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0011849
    ICD10CM
    E08-E13
    ICD9CM
    250
    LNC
    MTHU020781
    MDR
    10012602
    SNOMED CT 2010_0731
    73211009
    IclusionCriterion_2
    Descripción

    IclusionCriterion_2

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    424144002
    LNC
    MTHU010047
    InclusionCriterion_3
    Descripción

    InclusionCriterion_3

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0366781
    LNC
    4548-4
    InclusionCriterion_4
    Descripción

    InclusionCriterion_4

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0011884
    ICD9CM
    362.0
    MDR
    10012689
    SNOMED CT 2010_0731
    4855003
    InclusionCriterion_5
    Descripción

    InclusionCriterion_5

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0271051
    MDR
    10025415
    SNOMED CT 2010_0731
    37231002
    Ausschlusskriterien
    Descripción

    Ausschlusskriterien

    ExclusionCriterion_1
    Descripción

    ExclusionCriterion_1

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0038901
    SNOMED CT 2010_0731
    373353005
    UMLS CUI
    C0743733
    MDR
    10057105
    ExclusionCriterion_2
    Descripción

    ExclusionCriterion_2

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0017601
    CTCAE
    E10392
    ICD10CM
    H40-H42
    ICD9CM
    365
    LNC
    MTHU020819
    MDR
    10018304
    SNOMED CT 2010_0731
    23986001
    ExclusionCriterion_3
    Descripción

    ExclusionCriterion_3

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0007222
    ICD9CM
    429.2
    MDR
    10007649
    SNOMED CT 2010_0731
    49601007
    ExclusionCriterion_4
    Descripción

    ExclusionCriterion_4

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0679637
    ExclusionCriterion_5
    Descripción

    ExclusionCriterion_5

    Tipo de datos

    boolean

    Alias
    UMLS CUI
    C0151746
    MDR
    10038451
    SNOMED CT 2010_0731
    39539005
    UMLS CUI
    C0086565
    MDR
    10019670
    SNOMED CT 2010_0731
    75183008
    UMLS CUI
    C0006826
    ICD10CM
    C00-C96
    ICD9CM
    199
    LNC
    MTHU010328
    MDR
    10028997
    SNOMED CT 2010_0731
    363346000
    UMLS CUI
    C0392920
    MDR
    10061758
    SNOMED CT 2010_0731
    367336001
    UMLS CUI
    C1522449
    MDR
    10037794
    SNOMED CT 2010_0731
    108290001
    Medizinische Konzepte
    Descripción

    Medizinische Konzepte

    Age
    Descripción

    Age

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    424144002
    LNC
    MTHU010047
    Healthy Subject
    Descripción

    Healthy Subject

    Tipo de datos

    string

    Alias
    UMLS CUI
    C1708335
    Diabetes Mellitus
    Descripción

    Diabetes Mellitus

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0011849
    ICD10CM
    E08-E13
    ICD9CM
    250
    LNC
    MTHU020781
    MDR
    10012602
    SNOMED CT 2010_0731
    73211009
    Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
    Descripción

    Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0366781
    LNC
    4548-4
    Diabetic Retinopathy
    Descripción

    Diabetic Retinopathy

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0011884
    ICD9CM
    362.0
    MDR
    10012689
    SNOMED CT 2010_0731
    4855003
    Macular retinal edema
    Descripción

    Macular retinal edema

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0271051
    MDR
    10025415
    SNOMED CT 2010_0731
    37231002
    Ophthalmologic Surgical Procedures
    Descripción

    Ophthalmologic Surgical Procedures

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0038901
    SNOMED CT 2010_0731
    373353005
    Eye laser surgery
    Descripción

    Eye laser surgery

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0743733
    MDR
    10057105
    Glaucoma
    Descripción

    Glaucoma

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0017601
    CTCAE
    E10392
    ICD10CM
    H40-H42
    ICD9CM
    365
    LNC
    MTHU020819
    MDR
    10018304
    SNOMED CT 2010_0731
    23986001
    Cardiovascular Diseases
    Descripción

    Cardiovascular Diseases

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0007222
    ICD9CM
    429.2
    MDR
    10007649
    SNOMED CT 2010_0731
    49601007
    major surgery
    Descripción

    major surgery

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0679637
    Abnormal renal function
    Descripción

    Abnormal renal function

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0151746
    MDR
    10038451
    SNOMED CT 2010_0731
    39539005
    Liver Dysfunction
    Descripción

    Liver Dysfunction

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0086565
    MDR
    10019670
    SNOMED CT 2010_0731
    75183008
    Malignant Neoplasms
    Descripción

    Malignant Neoplasms

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0006826
    ICD10CM
    C00-C96
    ICD9CM
    199
    LNC
    MTHU010328
    MDR
    10028997
    SNOMED CT 2010_0731
    363346000
    Chemotherapy Regimen
    Descripción

    Chemotherapy Regimen

    Tipo de datos

    string

    Alias
    UMLS CUI
    C0392920
    MDR
    10061758
    SNOMED CT 2010_0731
    367336001
    Therapeutic radiology procedure
    Descripción

    Therapeutic radiology procedure

    Tipo de datos

    string

    Alias
    UMLS CUI
    C1522449
    MDR
    10037794
    SNOMED CT 2010_0731
    108290001

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Einschlusskriterien
    Healthy Volunteers
    Item
    boolean
    C1708335 (UMLS CUI)
    InclusionCriterion_1
    Item
    boolean
    C0011849 (UMLS CUI)
    E08-E13 (ICD10CM)
    250 (ICD9CM)
    MTHU020781 (LNC)
    10012602 (MDR)
    73211009 (SNOMED CT 2010_0731)
    IclusionCriterion_2
    Item
    boolean
    C0001779 (UMLS CUI)
    424144002 (SNOMED CT 2010_0731)
    MTHU010047 (LNC)
    InclusionCriterion_3
    Item
    boolean
    C0366781 (UMLS CUI)
    4548-4 (LNC)
    InclusionCriterion_4
    Item
    boolean
    C0011884 (UMLS CUI)
    362.0 (ICD9CM)
    10012689 (MDR)
    4855003 (SNOMED CT 2010_0731)
    InclusionCriterion_5
    Item
    boolean
    C0271051 (UMLS CUI)
    10025415 (MDR)
    37231002 (SNOMED CT 2010_0731)
    Item Group
    Ausschlusskriterien
    ExclusionCriterion_1
    Item
    boolean
    C0038901 (UMLS CUI)
    373353005 (SNOMED CT 2010_0731)
    C0743733 (UMLS CUI)
    10057105 (MDR)
    ExclusionCriterion_2
    Item
    boolean
    C0017601 (UMLS CUI)
    E10392 (CTCAE)
    H40-H42 (ICD10CM)
    365 (ICD9CM)
    MTHU020819 (LNC)
    10018304 (MDR)
    23986001 (SNOMED CT 2010_0731)
    ExclusionCriterion_3
    Item
    boolean
    C0007222 (UMLS CUI)
    429.2 (ICD9CM)
    10007649 (MDR)
    49601007 (SNOMED CT 2010_0731)
    ExclusionCriterion_4
    Item
    boolean
    C0679637 (UMLS CUI)
    ExclusionCriterion_5
    Item
    boolean
    C0151746 (UMLS CUI)
    10038451 (MDR)
    39539005 (SNOMED CT 2010_0731)
    C0086565 (UMLS CUI)
    10019670 (MDR)
    75183008 (SNOMED CT 2010_0731)
    C0006826 (UMLS CUI)
    C00-C96 (ICD10CM)
    199 (ICD9CM)
    MTHU010328 (LNC)
    10028997 (MDR)
    363346000 (SNOMED CT 2010_0731)
    C0392920 (UMLS CUI)
    10061758 (MDR)
    367336001 (SNOMED CT 2010_0731)
    C1522449 (UMLS CUI)
    10037794 (MDR)
    108290001 (SNOMED CT 2010_0731)
    Item Group
    Medizinische Konzepte
    Age
    Item
    string
    C0001779 (UMLS CUI)
    424144002 (SNOMED CT 2010_0731)
    MTHU010047 (LNC)
    Healthy Subject
    Item
    string
    C1708335 (UMLS CUI)
    Diabetes Mellitus
    Item
    string
    C0011849 (UMLS CUI)
    E08-E13 (ICD10CM)
    250 (ICD9CM)
    MTHU020781 (LNC)
    10012602 (MDR)
    73211009 (SNOMED CT 2010_0731)
    Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
    Item
    string
    C0366781 (UMLS CUI)
    4548-4 (LNC)
    Diabetic Retinopathy
    Item
    string
    C0011884 (UMLS CUI)
    362.0 (ICD9CM)
    10012689 (MDR)
    4855003 (SNOMED CT 2010_0731)
    Macular retinal edema
    Item
    string
    C0271051 (UMLS CUI)
    10025415 (MDR)
    37231002 (SNOMED CT 2010_0731)
    Ophthalmologic Surgical Procedures
    Item
    string
    C0038901 (UMLS CUI)
    373353005 (SNOMED CT 2010_0731)
    Eye laser surgery
    Item
    string
    C0743733 (UMLS CUI)
    10057105 (MDR)
    Glaucoma
    Item
    string
    C0017601 (UMLS CUI)
    E10392 (CTCAE)
    H40-H42 (ICD10CM)
    365 (ICD9CM)
    MTHU020819 (LNC)
    10018304 (MDR)
    23986001 (SNOMED CT 2010_0731)
    Cardiovascular Diseases
    Item
    string
    C0007222 (UMLS CUI)
    429.2 (ICD9CM)
    10007649 (MDR)
    49601007 (SNOMED CT 2010_0731)
    major surgery
    Item
    string
    C0679637 (UMLS CUI)
    Abnormal renal function
    Item
    string
    C0151746 (UMLS CUI)
    10038451 (MDR)
    39539005 (SNOMED CT 2010_0731)
    Liver Dysfunction
    Item
    string
    C0086565 (UMLS CUI)
    10019670 (MDR)
    75183008 (SNOMED CT 2010_0731)
    Malignant Neoplasms
    Item
    string
    C0006826 (UMLS CUI)
    C00-C96 (ICD10CM)
    199 (ICD9CM)
    MTHU010328 (LNC)
    10028997 (MDR)
    363346000 (SNOMED CT 2010_0731)
    Chemotherapy Regimen
    Item
    string
    C0392920 (UMLS CUI)
    10061758 (MDR)
    367336001 (SNOMED CT 2010_0731)
    Therapeutic radiology procedure
    Item
    string
    C1522449 (UMLS CUI)
    10037794 (MDR)
    108290001 (SNOMED CT 2010_0731)

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