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ID

29662

Beskrivning

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Physical Examination: Vital Signs, pedal oedema. Time: Treatment Period 1, Day 28, pre-dose.

Länk

https://clinicaltrials.gov/ct2/show/NCT00318630

Nyckelord

Versioner (1)
  1. 2018-04-10 2018-04-10 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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    GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

    Engelsk

    Physical examination - Treatment Period 1, Day 28, Pre-dose

    1 Formulär  
    Vital signs
    Beskrivning

    Vital signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Date
    Beskrivning

    Day Month Year e.g., 01 JAN 03

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Planned relative Time
    Beskrivning

    e.g. 15 min

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Actual Time
    Beskrivning

    Hr : Min (00:00 - 23:59) e.g. 13:02

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Systolic Blood Pressure
    Beskrivning

    Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Systolic e.g. 110

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Diastolic Blood Pressure
    Beskrivning

    Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Diastolic e.g. 80

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Heart rate
    Beskrivning

    e.g., 75

    Datatyp

    text

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Pedal Oedema
    Beskrivning

    Pedal Oedema

    Alias
    UMLS CUI-1
    C0574002 (Edema of foot (finding))
    SNOMED
    102576009
    Date of Assessment
    Beskrivning

    Date of Assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Time of Assessment
    Beskrivning

    Hr : Min (00:00 - 23:59)

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C1516048 (Assessed)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
    Beskrivning

    Note: Use the same ankle throughout the study.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0574002 (Edema of foot (finding))
    SNOMED
    102576009
    UMLS CUI [1,2]
    C0205125 (Deep (qualifier value))
    SNOMED
    795002
    LOINC
    LP18009-8
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    Beskrivning

    Side of assessed ankle

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0574002 (Edema of foot (finding))
    SNOMED
    102576009
    UMLS CUI [1,2]
    C0441987 (Side)
    SNOMED
    182353008
    LOINC
    LP73349-0
    Tillbaka till toppen

    Similar models

    Physical examination - Treatment Period 1, Day 28, Pre-dose

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Planned relative Time
    text
    C0439564 (UMLS CUI [1])
    Planned relative Time
    Code List
    Planned relative Time
    CL Item
    pre-dose (pre-dose)
    CL Item
    unscheduled (unscheduled)
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate
    Item
    Heart rate
    text
    C0018810 (UMLS CUI [1])
    Item Group
    Pedal Oedema
    C0574002 (UMLS CUI-1)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Time of Assessment
    Item
    Time of Assessment
    time
    C1516048 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
    integer
    C0574002 (UMLS CUI [1,1])
    C0205125 (UMLS CUI [1,2])
    Depth of Indentation
    Code List
    Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
    CL Item
    <1 mm (1)
    CL Item
    1-2 mm (2)
    CL Item
    3-5 mm (3)
    CL Item
    6-10 mm (4)
    CL Item
    >10 mm (5)
    Item
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    integer
    C0574002 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Side of assessed ankle
    Code List
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    CL Item
    right ankle (1)
    CL Item
    left ankle (2)
    Tillbaka till toppen 

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