0 Evaluaciones

ID

15533

Descripción

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: Month 18

Link

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

Palabras clave

  1. 2/6/16 2/6/16 -
Subido en

2 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0

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    Month 18: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Month 18: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Patient ID (derived)
    Descripción

    Patient ID (derived)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1269815
    Vital Signs and Physical Examination: Date
    Descripción

    Vital Signs and Physical Examination: Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826644
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Respiratory Rate
    Descripción

    Respiratory Rate

    Tipo de datos

    integer

    Unidades de medida
    • /min
    Alias
    UMLS CUI [1]
    C0231832
    /min
    Height
    Descripción

    Height

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Systolic blood pressure
    Descripción

    Systolic

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Descripción

    Diastolic

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0039476
    °C
    Body weight
    Descripción

    Body weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Physical Examination: General Appearance
    Descripción

    Physical Examination: General Appearance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1148438
    Physical Examination: General Appearance, Text
    Descripción

    Physical Examination: General Appearance, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1148438
    Physical Examination: Skin
    Descripción

    Physical Examination: Skin

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0437750
    Physical Examination: Skin, Text
    Descripción

    Physical Examination: Skin, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0437750
    Physical Examination: HEENT
    Descripción

    Physical Examination: HEENT

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3494720
    Physical Examination: HEENT, Text
    Descripción

    Physical Examination: HEENT, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3494720
    Physical Examination: Lymph Nodes
    Descripción

    Lymph Nodes Status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0449438
    Physical Examination: Lymph Nodes, Text
    Descripción

    Physical Examination: Lymph Nodes, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0449438
    Physical Examination: Heart
    Descripción

    Heart rate, Auscultation of the heart

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0018793
    Physical Examination: Heart, Text
    Descripción

    Physical Examination: Heart, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0018793
    Physical Examination: Lungs
    Descripción

    Physical Examination: Lungs

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024109
    Physical Examination: Lungs, Text
    Descripción

    Physical Examination: Lungs, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024109
    Physical Examination: Abdomen
    Descripción

    Physical Examination: Abdomen

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    Physical Examination: Abdomen, Text
    Descripción

    Physical Examination: Abdomen, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    Physical Examination: Extremeties/Joints
    Descripción

    Physical Examination: Extremeties/Joints

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278454
    UMLS CUI [1,3]
    C0022417
    Physical Examination: Extremeties/Joints, Text
    Descripción

    Physical Examination: Extremeties/Joints, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0022417
    Physical Examination: Mental Status
    Descripción

    Physical Examination: Mental Status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278060
    Physical Examination: Mental Status, Text
    Descripción

    Physical Examination: Mental Status, Text

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278060
    Blood Sampling for Eff. Ass.: Date
    Descripción

    Blood Sampling for Eff. Ass.: Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Vital Signs and Physical Examination: ND
    Descripción

    Vital Signs and Physical Examination: ND

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [1,3]
    C1705848
    Physical Examination: Date of Signature
    Descripción

    Physical Examination: Date of Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1519316
    UMLS CUI [1,3]
    C0011008
    Name of Investigator
    Descripción

    Name of Investigator

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892

    Similar models

    Month 18: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Vital Signs
    C0518766 (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])
    Blood Sampling for Eff. Ass.: Date
    Item
    Blood Sampling for Eff. Ass.: Date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (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)
    Physical Examination: Date of Signature
    Item
    Physical Examination: Date of Signature
    text
    C0031809 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Name of Investigator
    Item
    Name of Investigator
    text
    C2826892 (UMLS CUI [1])

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