ID

29641

Descripción

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 14, pre-dose.

Link

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

Palabras clave

Versiones (1)
  1. 10/4/18 10/4/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de abril de 2018

DOI

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Licencia

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

    Inglés

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

    1 formularios  
    Vital signs
    Descripción

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Date
    Descripción

    Day Month Year e.g., 01 JAN 03

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
    Planned relative Time
    Descripción

    e.g. 15 min

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0439564
    Actual Time
    Descripción

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

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    Systolic Blood Pressure
    Descripción

    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

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Diastolic Blood Pressure
    Descripción

    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

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate
    Descripción

    e.g., 75

    Tipo de datos

    text

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Pedal Oedema
    Descripción

    Pedal Oedema

    Alias
    UMLS CUI-1
    C0574002
    Date of Assessment
    Descripción

    Date of Assessment

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Time of Assessment
    Descripción

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

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1516048
    UMLS CUI [1,2]
    C0040223
    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.
    Descripción

    Note: Use the same ankle throughout the study.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0574002
    UMLS CUI [1,2]
    C0205125
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    Descripción

    Side of assessed ankle

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0574002
    UMLS CUI [1,2]
    C0441987
    Volver a la parte superior de la página

    Similar models

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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)
    Volver a la parte superior de la página 

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