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ID

15546

Beschrijving

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Please document clinically significant findings as Adverse Events. Clinical Significance is defined as any variation in physical findings that has medical relevance and may result in an alteration in medical care. Safety Blood and Urine Examinations: Please document the results for Serum Creatinine, Platelets and TSH on CRF-Pages "Safety Laboratory Assessments". Part: Relapse Evaluation Visit No. X, Please enter Number of Visit below

Link

https://clinicaltrials.gov/ct2/show/NCT02419378

Trefwoorden

  1. 02-06-16 02-06-16 -
Geüploaded op

2 juni 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Relapse Evaluation Visit No. X Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Relapse Evaluation Visit No. X Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Number of Relapse Evaluation Visit
    Beschrijving

    Visit number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1549755 (Visit Number)
    Patient ID (derived)
    Beschrijving

    Patient ID (derived)

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1269815 (Patient identification)
    SNOMED
    372039005
    Vital Signs and Physical Examination: Date
    Beschrijving

    Vital Signs and Physical Examination: Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2826644 (Vital Signs Date)
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

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

    Respiratory Rate

    Datatype

    integer

    Maateenheden
    • /min
    Alias
    UMLS CUI [1]
    C0231832 (Respiratory rate)
    SNOMED
    86290005
    LOINC
    LP20159-7
    /min
    Height
    Beschrijving

    Height

    Datatype

    float

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Systolic blood pressure
    Beschrijving

    Systolic

    Datatype

    integer

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

    Diastolic

    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

    Body weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Physical Examination: General Appearance
    Beschrijving

    Physical Examination: General Appearance

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1148438 (general appearance (physical finding))
    Physical Examination: General Appearance, Text
    Beschrijving

    Physical Examination: General Appearance, Text

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1148438 (general appearance (physical finding))
    Physical Examination: Skin
    Beschrijving

    Physical Examination: Skin

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0437750 (On examination - general skin examination)
    Physical Examination: Skin, Text
    Beschrijving

    Physical Examination: Skin, Text

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0437750 (On examination - general skin examination)
    Physical Examination: HEENT
    Beschrijving

    Physical Examination: HEENT

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3494720 (Review of systems, head, ear, eyes, nose and throat)
    SNOMED
    429031000124106
    Physical Examination: HEENT, Text
    Beschrijving

    Physical Examination: HEENT, Text

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3494720 (Review of systems, head, ear, eyes, nose and throat)
    SNOMED
    429031000124106
    Physical Examination: Lymph Nodes
    Beschrijving

    Lymph Nodes Status

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024204 (lymph nodes)
    SNOMED
    59441001
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Physical Examination: Lymph Nodes, Text
    Beschrijving

    Physical Examination: Lymph Nodes, Text

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0024204 (lymph nodes)
    SNOMED
    59441001
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Physical Examination: Heart
    Beschrijving

    Heart rate, Auscultation of the heart

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0018793 (Heart Auscultation)
    SNOMED
    449263002
    Physical Examination: Heart, Text
    Beschrijving

    Physical Examination: Heart, Text

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0018793 (Heart Auscultation)
    SNOMED
    449263002
    Physical Examination: Lungs
    Beschrijving

    Physical Examination: Lungs

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0024109 (Lung)
    SNOMED
    39607008
    LOINC
    LP7407-2
    Physical Examination: Lungs, Text
    Beschrijving

    Physical Examination: Lungs, Text

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0024109 (Lung)
    SNOMED
    39607008
    LOINC
    LP7407-2
    Physical Examination: Abdomen
    Beschrijving

    Physical Examination: Abdomen

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0000726 (Abdomen)
    SNOMED
    818983003
    LOINC
    LP6990-8
    Physical Examination: Abdomen, Text
    Beschrijving

    Physical Examination: Abdomen, Text

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0000726 (Abdomen)
    SNOMED
    818983003
    LOINC
    LP6990-8
    Physical Examination: Extremeties/Joints
    Beschrijving

    Physical Examination: Extremeties/Joints

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0278454 (All extremities)
    SNOMED
    2592007
    UMLS CUI [1,3]
    C0022417 (Joints)
    SNOMED
    39352004
    Physical Examination: Extremeties/Joints, Text
    Beschrijving

    Physical Examination: Extremeties/Joints, Text

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0022417 (Joints)
    SNOMED
    39352004
    Physical Examination: Mental Status
    Beschrijving

    Physical Examination: Mental Status

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0278060 (Mental state)
    SNOMED
    363871006
    LOINC
    MTHU001424
    Physical Examination: Mental Status, Text
    Beschrijving

    Physical Examination: Mental Status, Text

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0278060 (Mental state)
    SNOMED
    363871006
    LOINC
    MTHU001424
    Vital Signs and Physical Examination: ND
    Beschrijving

    Vital Signs and Physical Examination: ND

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,3]
    C1705848 (Execution)
    LOINC
    LA7554-4

    Similar models

    Relapse Evaluation Visit No. X Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Visit number
    Item
    Number of Relapse Evaluation Visit
    integer
    C1549755 (UMLS CUI [1])
    Patient ID
    Item
    Patient ID (derived)
    text
    C1269815 (UMLS CUI [1])
    Vital Signs date
    Item
    Vital Signs and Physical Examination: Date
    date
    C2826644 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiratory Rate
    Item
    Respiratory Rate
    integer
    C0231832 (UMLS CUI [1])
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Item
    Physical Examination: General Appearance
    text
    C1148438 (UMLS CUI [1,1])
    Code List
    Physical Examination: General Appearance
    CL Item
    yes (1)
    CL Item
    no (0)
    General Appearance
    Item
    Physical Examination: General Appearance, Text
    text
    C1148438 (UMLS CUI [1])
    Item
    Physical Examination: Skin
    text
    C0437750 (UMLS CUI [1])
    Code List
    Physical Examination: Skin
    CL Item
    yes (1)
    CL Item
    no (0)
    Skin examination
    Item
    Physical Examination: Skin, Text
    text
    C0437750 (UMLS CUI [1])
    Item
    Physical Examination: HEENT
    text
    C3494720 (UMLS CUI [1])
    Code List
    Physical Examination: HEENT
    CL Item
    yes (1)
    CL Item
    no (0)
    HEENT Examination
    Item
    Physical Examination: HEENT, Text
    text
    C3494720 (UMLS CUI [1])
    Item
    Physical Examination: Lymph Nodes
    text
    C0024204 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Code List
    Physical Examination: Lymph Nodes
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Lymph Nodes, Text
    Item
    Physical Examination: Lymph Nodes, Text
    text
    C0024204 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Item
    Physical Examination: Heart
    text
    C0018810 (UMLS CUI [1,1])
    C0018793 (UMLS CUI [1,2])
    Code List
    Physical Examination: Heart
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Heart, Text
    Item
    Physical Examination: Heart, Text
    text
    C0018810 (UMLS CUI [1,1])
    C0018793 (UMLS CUI [1,2])
    Item
    Physical Examination: Lungs
    text
    C0031809 (UMLS CUI [1,1])
    C0024109 (UMLS CUI [1,2])
    Code List
    Physical Examination: Lungs
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Lungs, Text
    Item
    Physical Examination: Lungs, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0024109 (UMLS CUI [1,2])
    Item
    Physical Examination: Abdomen
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Code List
    Physical Examination: Abdomen
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Abdomen, Text
    Item
    Physical Examination: Abdomen, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Item
    Physical Examination: Extremeties/Joints
    text
    C0031809 (UMLS CUI [1,1])
    C0278454 (UMLS CUI [1,2])
    C0022417 (UMLS CUI [1,3])
    Code List
    Physical Examination: Extremeties/Joints
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Extremeties/Joints, Text
    Item
    Physical Examination: Extremeties/Joints, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0022417 (UMLS CUI [1,2])
    Item
    Physical Examination: Mental Status
    text
    C0031809 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    Code List
    Physical Examination: Mental Status
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Mental Status, Text
    Item
    Physical Examination: Mental Status, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    Item
    Vital Signs and Physical Examination: ND
    text
    C0518766 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C1705848 (UMLS CUI [1,3])
    Code List
    Vital Signs and Physical Examination: ND
    CL Item
    Not performed (0)

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