0 Beoordelingen

ID

11993

Beschrijving

A Study of NeuroVax, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02149706 Principal Investigator: Dennis Bourdette, MD F.A.A.N. Oregon Health and Science University

Link

https://clinicaltrials.gov/show/NCT02149706

Trefwoorden

  1. 30-08-15 30-08-15 -
Geüploaded op

30 augustus 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Eligibility Multiple Sclerosis NCT02149706

    Eligibility Multiple Sclerosis NCT02149706

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    Ages Eligible for Study: 18 Years to 70 Years
    Beschrijving

    Ages Eligible for Study: 18 Years to 70 Years

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Genders Eligible for Study: Both
    Beschrijving

    Genders Eligible for Study: Both

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Accepts Healthy Volunteers: No Criteria
    Beschrijving

    Accepts Healthy Volunteers: No Criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1708335 (Healthy Volunteers)
    Subject is between 18 and 70 years of age, inclusive.
    Beschrijving

    Subject is between 18 and 70 years of age, inclusive.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
    Beschrijving

    Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0026769 (Multiple Sclerosis)
    SNOMED
    24700007
    LOINC
    LA14298-6
    Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B).
    Beschrijving

    Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B).

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
    Beschrijving

    Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0856120 (Multiple sclerosis relapse)
    Laboratory values within the following limits:
    Beschrijving

    Laboratory values within the following limits:

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Creatinine 1 . 5 x high normal.
    Beschrijving

    Creatinine 1 . 5 x high normal.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0010294 (creatinine)
    SNOMED
    15373003
    Hemoglobin
    Beschrijving

    Hemoglobin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    Subjects currently prescribed Campath or Lemtrada
    Beschrijving

    Subjects currently prescribed Campath or Lemtrada

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0939276 (Campath)

    Similar models

    Eligibility Multiple Sclerosis NCT02149706

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    age
    Item
    Ages Eligible for Study: 18 Years to 70 Years
    boolean
    C0001779 (UMLS CUI [1])
    gender
    Item
    Genders Eligible for Study: Both
    boolean
    C0079399 (UMLS CUI [1])
    Healthy Volunteers
    Item
    Accepts Healthy Volunteers: No Criteria
    boolean
    C1708335 (UMLS CUI [1])
    age
    Item
    Subject is between 18 and 70 years of age, inclusive.
    boolean
    C0001779 (UMLS CUI [1])
    multiple sclerosis
    Item
    Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
    boolean
    C0026769 (UMLS CUI [1])
    Expanded Disability Status Scale
    Item
    Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B).
    boolean
    C0451246 (UMLS CUI [1])
    Multiple sclerosis relapse
    Item
    Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
    boolean
    C0856120 (UMLS CUI [1])
    laboratory values
    Item
    Laboratory values within the following limits:
    boolean
    C0022885 (UMLS CUI [1])
    creatinine
    Item
    Creatinine 1 . 5 x high normal.
    boolean
    C0010294 (UMLS CUI [1])
    hemoglobin
    Item
    Hemoglobin
    boolean
    C0019046 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    campath
    Item
    Subjects currently prescribed Campath or Lemtrada
    boolean
    C0939276 (UMLS CUI [1])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial