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ID

33529

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains informations about the subjects diagnostic EEG results. It should be filled out at the screening visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

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  1. 01.12.18 01.12.18 -
  2. 11.12.18 11.12.18 -
  3. 11.12.18 11.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Englisch

    EEG

    1 Formulare  
    1. StudyEvent: ODM
      1. EEG
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Screening number
    Beschreibung

    Subject Screening No.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject no.
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of Assessment
    Beschreibung

    Date of Assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Diagnostic EEG
    Beschreibung

    Diagnostic EEG

    Alias
    UMLS CUI-1
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    EEG Comments
    Beschreibung

    EEG Comments

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    EEG Performed By
    Beschreibung

    Neurophysiologist Staff Initials

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    UMLS CUI [1,2]
    C1550369 (Performed By)
    Clinical Interpretation of EEG
    Beschreibung

    Clinical Interpretation of EEG

    Alias
    UMLS CUI-1
    C4086187 (Clinical Interpretation)
    UMLS CUI-2
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    Is the EEG recording normal?
    Beschreibung

    EEG Recording Normal

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0560017 (EEG normal)
    SNOMED
    164717000
    If No, is the abnormality clinically significant?
    Beschreibung

    EEG Abnormality Clinically Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C2985739 (Clinically Significant Indicator)
    If the EEG recording is abnormal and the abnormality is clinically significant, please comment below and exclude the subject from the trial.
    Beschreibung

    EEG Abnormality Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Conclusion
    Beschreibung

    Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    Neurophysiologist Staff initials
    Beschreibung

    Neurophysiologist Staff initials

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1552089 (Staff Member)
    UMLS CUI [1,2]
    C2986440 (Person Initials)
    UMLS CUI [1,3]
    C0586861 (Clinical neurophysiologist)
    SNOMED
    309348002
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    EEG

    1 Formulare
    1. StudyEvent: ODM
      1. EEG
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Diagnostic EEG
    C0013819 (UMLS CUI-1)
    Actual Time
    Item
    Actual Time
    datetime
    C0040223 (UMLS CUI [1])
    EEG Comments
    Item
    EEG Comments
    text
    C0013819 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    EEG Performed By
    Item
    EEG Performed By
    text
    C0013819 (UMLS CUI [1,1])
    C1550369 (UMLS CUI [1,2])
    Item Group
    Clinical Interpretation of EEG
    C4086187 (UMLS CUI-1)
    C0013819 (UMLS CUI-2)
    EEG Recording Normal
    Item
    Is the EEG recording normal?
    boolean
    C0560017 (UMLS CUI [1])
    EEG Abnormality Clinically Significant
    Item
    If No, is the abnormality clinically significant?
    boolean
    C0013819 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C2985739 (UMLS CUI [1,3])
    EEG Abnormality Comment
    Item
    If the EEG recording is abnormal and the abnormality is clinically significant, please comment below and exclude the subject from the trial.
    text
    C0013819 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    Conclusion
    C1707478 (UMLS CUI-1)
    Neurophysiologist Staff initials
    Item
    Neurophysiologist Staff initials
    text
    C1552089 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    C0586861 (UMLS CUI [1,3])
    Zum Seitenanfang zurückkehren 

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