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ID

15533

Description

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

Keywords

Versions (1)
  1. 6/2/16 6/2/16 -
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June 2, 2016

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Creative Commons BY 4.0
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    Month 18: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    English

    Month 18: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    1 forms  
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Patient ID (derived)
    Description

    Patient ID (derived)

    Data type

    text

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

    Vital Signs and Physical Examination: Date

    Data type

    date

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

    Heart rate

    Data type

    integer

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

    Respiratory Rate

    Data type

    integer

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

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Systolic blood pressure
    Description

    Systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic blood pressure
    Description

    Diastolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    °C
    Body weight
    Description

    Body weight

    Data type

    float

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

    Physical Examination: General Appearance

    Data type

    text

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

    Physical Examination: General Appearance, Text

    Data type

    text

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

    Physical Examination: Skin

    Data type

    text

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

    Physical Examination: Skin, Text

    Data type

    text

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

    Physical Examination: HEENT

    Data type

    text

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

    Physical Examination: HEENT, Text

    Data type

    text

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

    Lymph Nodes Status

    Data type

    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
    Description

    Physical Examination: Lymph Nodes, Text

    Data type

    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
    Description

    Heart rate, Auscultation of the heart

    Data type

    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
    Description

    Physical Examination: Heart, Text

    Data type

    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
    Description

    Physical Examination: Lungs

    Data type

    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
    Description

    Physical Examination: Lungs, Text

    Data type

    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
    Description

    Physical Examination: Abdomen

    Data type

    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
    Description

    Physical Examination: Abdomen, Text

    Data type

    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
    Description

    Physical Examination: Extremeties/Joints

    Data type

    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
    Description

    Physical Examination: Extremeties/Joints, Text

    Data type

    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
    Description

    Physical Examination: Mental Status

    Data type

    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
    Description

    Physical Examination: Mental Status, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0278060 (Mental state)
    SNOMED
    363871006
    LOINC
    MTHU001424
    Blood Sampling for Eff. Ass.: Date
    Description

    Blood Sampling for Eff. Ass.: Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Vital Signs and Physical Examination: ND
    Description

    Vital Signs and Physical Examination: ND

    Data type

    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
    Physical Examination: Date of Signature
    Description

    Physical Examination: Date of Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C1519316 (Signature)
    LOINC
    LP248948-4
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Name of Investigator
    Description

    Name of Investigator

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Back to the top of the page

    Similar models

    Month 18: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Physical Examination: General Appearance
    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])
    Physical Examination: Skin
    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])
    Physical Examination: HEENT
    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])
    Physical Examination: Lymph Nodes
    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])
    Physical Examination: Heart
    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])
    Physical Examination: Lungs
    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])
    Physical Examination: Abdomen
    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])
    Physical Examination: Extremeties/Joints
    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])
    Physical Examination: Mental Status
    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])
    Vital Signs and Physical Examination: ND
    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])
    Back to the top of the page 

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