1 Beoordeling
ID

15280

Beschrijving

Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Trefwoorden

Versies (3)
  1. 17-09-15 17-09-15 - Julian Varghese
  2. 22-09-15 22-09-15 - Julian Varghese
  3. 24-05-16 24-05-16 -
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24 mei 2016

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

    Engels

    NON-MS Treatment and symptomatic MS Treatment

    4 Formulieren  
    General Instructions
    Beschrijving

    General Instructions

    Instructions
    Beschrijving

    Please document medications which are taken within 30 days prior to Screening on the Concomitant Medication Form. Please document significant non-drug therapies which are performed after signing the informed consent on the Concomitant Medication Form.

    Datatype

    text

    Medical Examination
    Beschrijving

    Medical Examination

    Medical Examination performed at:
    Beschrijving

    Medical Examination performed at:

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0582103 (Medical Examination)
    SNOMED
    225886003
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Heart rate (in bpm):
    Beschrijving

    HEART RATE

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    bpm
    Systolic blood pressure
    Beschrijving

    Systolic blood pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic
    Beschrijving

    Diastolic blood pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Temperature
    Beschrijving

    Temperature

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    °C
    Body weight
    Beschrijving

    Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Height
    Beschrijving

    Height

    Datatype

    float

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Expanded disability status scale (EDSS)
    Beschrijving

    Expanded disability status scale (EDSS)

    EDSS performed at
    Beschrijving

    EDSS performed at

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Visual testing
    Beschrijving

    Converted FS Score

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0042789 (Vision)
    SNOMED
    281004000
    LOINC
    LP30560-4
    Brianstem testing
    Beschrijving

    Brianstem testing

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0006121 (Brain Stem)
    SNOMED
    15926001
    Pyramidal testing
    Beschrijving

    Pyramidal testing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0228060 (Pyramidal system)
    SNOMED
    24314005
    Cerebellar testing
    Beschrijving

    Cerebellar testing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0742034 (cerebellar function)
    Bowel/Bladder
    Beschrijving

    Bowel/Bladder

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C2707247 (Bladder and bowel)
    LOINC
    LP89773-3
    Cerebral testing
    Beschrijving

    Cerebral testing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0006104 (Brain)
    SNOMED
    12738006
    LOINC
    LP7084-9
    Ambulation Score
    Beschrijving

    Ambulation Score

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    UMLS CUI [1,2]
    C0080331 (Walking (activity))
    SNOMED
    870595007
    LOINC
    LA11834-1
    EDSS step
    Beschrijving

    EDSS score

    Datatype

    float

    Alias
    UMLS CUI [1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    Signature
    Beschrijving

    Signature

    Date
    Beschrijving

    Investigator Signature Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Name/Signature Investigator
    Beschrijving

    Name/Signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Terug naar het begin van de pagina

    Similar models

    NON-MS Treatment and symptomatic MS Treatment

    4 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    General Instructions
    Instructions
    Item
    Instructions
    text
    Item Group
    Medical Examination
    Medical Examination performed at:
    Item
    Medical Examination performed at:
    date
    C0582103 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    HEART RATE
    Item
    Heart rate (in bpm):
    integer
    C0018810 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Item Group
    Expanded disability status scale (EDSS)
    EDSS performed at
    Item
    EDSS performed at
    date
    C0451246 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Visual testing
    integer
    C0451246 (UMLS CUI [1,1])
    C0042789 (UMLS CUI [1,2])
    Visual testing
    Code List
    Visual testing
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 (3)
    CL Item
    3 (4)
    CL Item
    4 (5)
    CL Item
    5 (6)
    CL Item
    6 (7)
    Item
    Brianstem testing
    integer
    C0451246 (UMLS CUI [1,1])
    C0006121 (UMLS CUI [1,2])
    Brianstem testing
    Code List
    Brianstem testing
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 (3)
    CL Item
    3 (4)
    CL Item
    4 (5)
    CL Item
    5 (6)
    Item
    Pyramidal testing
    text
    C0451246 (UMLS CUI [1,1])
    C0228060 (UMLS CUI [1,2])
    Pyramidal testing
    Code List
    Pyramidal testing
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    Item
    Cerebellar testing
    text
    C0451246 (UMLS CUI [1,1])
    C0742034 (UMLS CUI [1,2])
    Cerebellar testing
    Code List
    Cerebellar testing
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    X (X)
    Item
    Bowel/Bladder
    integer
    C0451246 (UMLS CUI [1,1])
    C2707247 (UMLS CUI [1,2])
    Bowel/Bladder
    Code List
    Bowel/Bladder
    CL Item
    Cerebellar testing (1)
    Item
    Cerebral testing
    text
    C0451246 (UMLS CUI [1,1])
    C0006104 (UMLS CUI [1,2])
    Cerebral testing
    Code List
    Cerebral testing
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Item
    Ambulation Score
    text
    C0451246 (UMLS CUI [1,1])
    C0080331 (UMLS CUI [1,2])
    Ambulation Score
    Code List
    Ambulation Score
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    EDSS score
    Item
    EDSS step
    float
    C0451246 (UMLS CUI [1])
    Item Group
    Signature
    Investigator Signature Date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Name/Signature Investigator
    Item
    Name/Signature Investigator
    text
    C2346576 (UMLS CUI [1])
    Terug naar het begin van de pagina 

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