0 Évaluations

ID

4961

Description

ODM derived from http://clinicaltrials.gov/show/NCT00420212

Lien

http://clinicaltrials.gov/show/NCT00420212

Mots-clés

  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 15/04/2014 15/04/2014 - Julian Varghese
Téléchargé le

15 avril 2014

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility NCT00420212 Relapsing-remitting Multiple Sclerosis

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Description

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter 18 bis 55 Jahre
    Description

    age 18 Years to 55 Years

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
    Description

    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1550543
    HL7 V3 2006_05
    FLFS
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    C0013893
    UMLS CUI 2011AA
    CL414621
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C0034656
    Aged 18 to 55 years old, inclusive, at the time of informed consent.
    Description

    Aged 18 to 55 years old, inclusive, at the time of informed consent.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C0021430
    Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
    Description

    Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0751967
    SNOMED CT 2011_0131
    426373005
    MedDRA 14.1
    10063399
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C0679228
    UMLS CUI 2011AA
    C0026769
    SNOMED CT 2011_0131
    24700007
    MedDRA 14.1
    10028245
    LOINC Version 232
    MTHU020805
    ICD-10-CM Version 2010
    G35
    ICD-9-CM Version 2011
    340
    Must have a baseline EDSS <= 5.0, inclusive.
    Description

    Must have a baseline EDSS <= 5.0, inclusive.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1442488
    UMLS CUI 2011AA
    C0451246
    SNOMED CT 2011_0131
    273554001
    Must have relapsing-remitting disease course.
    Description

    Must have relapsing-remitting disease course.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    UMLS CUI 2011AA
    C0439600
    SNOMED CT 2011_0131
    255319006
    UMLS CUI 2011AA
    C0242656
    SNOMED CT 2011_0131
    246453008
    MedDRA 14.1
    10061818
    Ausschlusskriterien
    Description

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
    Description

    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    CL425201
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C0034656
    Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
    Description

    Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C1290894
    SNOMED CT 2011_0131
    128299006
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    C0205178
    SNOMED CT 2011_0131
    272118002
    UMLS CUI 2011AA
    C0042075
    SNOMED CT 2011_0131
    128606002
    MedDRA 14.1
    10046566
    ICD-10-CM Version 2010
    N39.9
    ICD-9-CM Version 2011
    599.9
    UMLS CUI 2011AA
    C0024115
    SNOMED CT 2011_0131
    19829001
    MedDRA 14.1
    10025082
    ICD-10-CM Version 2010
    J98.4
    UMLS CUI 2011AA
    C0017178
    SNOMED CT 2011_0131
    119292006
    MedDRA 14.1
    10017944
    Pregnant or nursing women.
    Description

    Pregnant or nursing women.

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age 18 Years to 55 Years
    Item
    Alter 18 bis 55 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
    Item
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
    boolean
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1550543 (UMLS CUI 2011AA)
    FLFS (HL7 V3 2006_05)
    C0332282 (UMLS CUI 2011AA)
    255260001 (SNOMED CT 2011_0131)
    C0013893 (UMLS CUI 2011AA)
    CL414621 (UMLS CUI 2011AA)
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    Aged 18 to 55 years old, inclusive, at the time of informed consent.
    Item
    Aged 18 to 55 years old, inclusive, at the time of informed consent.
    boolean
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C0021430 (UMLS CUI 2011AA)
    Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
    Item
    Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
    boolean
    C0750484 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0751967 (UMLS CUI 2011AA)
    426373005 (SNOMED CT 2011_0131)
    10063399 (MedDRA 14.1)
    C0680240 (UMLS CUI 2011AA)
    C0679228 (UMLS CUI 2011AA)
    C0026769 (UMLS CUI 2011AA)
    24700007 (SNOMED CT 2011_0131)
    10028245 (MedDRA 14.1)
    MTHU020805 (LOINC Version 232)
    G35 (ICD-10-CM Version 2010)
    340 (ICD-9-CM Version 2011)
    Must have a baseline EDSS <= 5.0, inclusive.
    Item
    Must have a baseline EDSS <= 5.0, inclusive.
    boolean
    C1442488 (UMLS CUI 2011AA)
    C0451246 (UMLS CUI 2011AA)
    273554001 (SNOMED CT 2011_0131)
    Must have relapsing-remitting disease course.
    Item
    Must have relapsing-remitting disease course.
    boolean
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    C0439600 (UMLS CUI 2011AA)
    255319006 (SNOMED CT 2011_0131)
    C0242656 (UMLS CUI 2011AA)
    246453008 (SNOMED CT 2011_0131)
    10061818 (MedDRA 14.1)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
    Item
    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
    boolean
    C0332282 (UMLS CUI 2011AA)
    255260001 (SNOMED CT 2011_0131)
    CL425201 (UMLS CUI 2011AA)
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C0034656 (UMLS CUI 2011AA)
    Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
    Item
    Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
    boolean
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C1290894 (UMLS CUI 2011AA)
    128299006 (SNOMED CT 2011_0131)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    C0205178 (UMLS CUI 2011AA)
    272118002 (SNOMED CT 2011_0131)
    C0042075 (UMLS CUI 2011AA)
    128606002 (SNOMED CT 2011_0131)
    10046566 (MedDRA 14.1)
    N39.9 (ICD-10-CM Version 2010)
    599.9 (ICD-9-CM Version 2011)
    C0024115 (UMLS CUI 2011AA)
    19829001 (SNOMED CT 2011_0131)
    10025082 (MedDRA 14.1)
    J98.4 (ICD-10-CM Version 2010)
    C0017178 (UMLS CUI 2011AA)
    119292006 (SNOMED CT 2011_0131)
    10017944 (MedDRA 14.1)
    Pregnant or nursing women.
    Item
    Pregnant or nursing women.
    boolean
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)

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