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ID

29678

Beschreibung

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 Pharmacodynamics. Time: Treatment period 1, Day 29. Sputum Induction.

Link

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

Stichworte

  1. 10.04.18 10.04.18 - Sarah Riepenhausen
  2. 10.04.18 10.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. April 2018

DOI

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Lizenz

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

    Pharmacodynamics - Treatment period 1, Day 29

    Baseline FEV1 Measurement - Sputum Induction post-challenge
    Beschreibung

    Baseline FEV1 Measurement - Sputum Induction post-challenge

    Alias
    UMLS CUI-1
    C1442488
    UMLS CUI-2
    C0429706
    Date of assessment (Sputum induction)
    Beschreibung

    Date of Sputum induction

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C0038056
    Planned relative time
    Beschreibung

    Bronchodilator to be administered 15 minutes prior to post-bronchodilator FEV1 measurement. After 15 minutes rest, measure the post-bronchodilator FEV1 and calculate the post-bronchodilator FEV1 -20% and FEV1 -10%. Time relative to Inhalation.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0429706
    Actual Time of First Reading
    Beschreibung

    Hr : Min 00:00-23:59 Administration time and pre-/post-bronchodilator Measurement

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0429706
    FEV1 Reading 1
    Beschreibung

    No Measurement in Administration period. Bronchodilator to be administered 15 minutes prior to post-bronchodilator FEV1 measurement.

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    FEV1 Reading 2
    Beschreibung

    No Measurement in Administration period.

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    FEV1 Reading 3
    Beschreibung

    No Measurement in Administration period.

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0429706
    L
    Postbronchodilator FEV1 -20%
    Beschreibung

    After 15 minutes rest, measure the post-bronchodilator FEV1 and calculate the post-bronchodilator FEV1 -20%.

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C2599594
    UMLS CUI [1,2]
    C0429706
    L
    Postbronchodilator FEV1 -10%
    Beschreibung

    After 15 minutes rest, measure the post-bronchodilator FEV1 and calculate the post-bronchodilator FEV1 -10%.

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1,1]
    C2599594
    UMLS CUI [1,2]
    C0429706
    L
    Sputum induction post-challenge
    Beschreibung

    Sputum induction post-challenge

    Alias
    UMLS CUI-1
    C2019319
    Planned relative Time
    Beschreibung

    Time relative to Inhalation, e.g., Inhalation Period 1

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0205535
    Actual Time of Inhalation
    Beschreibung

    Hr : Min 00:00 - 23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0001559
    Saline Concentration
    Beschreibung

    Saline Concentration

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1]
    C0036082
    %
    FEV1
    Beschreibung

    FEV1

    Datentyp

    float

    Maßeinheiten
    • L
    Alias
    UMLS CUI [1]
    C0748133
    L
    Was Bronchodilator administered?
    Beschreibung

    Bronchodilator administration

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006280
    UMLS CUI [1,2]
    C1533734
    Dose administered
    Beschreibung

    Dose administered

    Datentyp

    float

    Maßeinheiten
    • µg
    Alias
    UMLS CUI [1,1]
    C0006280
    UMLS CUI [1,2]
    C3174092
    µg
    Sputum post-challenge sample
    Beschreibung

    Sputum post-challenge sample

    Alias
    UMLS CUI-1
    C0038056
    UMLS CUI-2
    C0851347
    Date of assessment
    Beschreibung

    Date of assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Time sample Collected
    Beschreibung

    hr:min 00:00 - 23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0038056
    Time sample processed
    Beschreibung

    hr:min 00:00 - 23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C1709694
    UMLS CUI [1,3]
    C0038056
    Following visual examination / inspection, record below the color, purulence and any signs of blood contamination:
    Beschreibung

    Sputum Sample Quality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0038056
    UMLS CUI [1,2]
    C0332306
    UMLS CUI [2]
    C1880121
    UMLS CUI [3]
    C0241235
    UMLS CUI [4,1]
    C0005767
    UMLS CUI [4,2]
    C2349974
    Sample Weight - Weight of tube
    Beschreibung

    a

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0807984
    UMLS CUI [1,2]
    C0175730
    mg
    Sample Weight - Weight of tube + Sputum
    Beschreibung

    b

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0807984
    UMLS CUI [1,2]
    C0175730
    UMLS CUI [1,3]
    C0038056
    mg
    Sample Weight - Weight of Sputum
    Beschreibung

    b - a = c

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0807984
    UMLS CUI [1,2]
    C0038056
    mg
    Volume of DTT added
    Beschreibung

    4 x c

    Datentyp

    float

    Maßeinheiten
    • µL
    Alias
    UMLS CUI [1,1]
    C0012789
    UMLS CUI [1,2]
    C2700258
    µL
    Volume of PBS Added
    Beschreibung

    4 x c

    Datentyp

    float

    Maßeinheiten
    • µL
    Alias
    UMLS CUI [1,1]
    C2700258
    UMLS CUI [1,2]
    C0036082
    UMLS CUI [1,3]
    C0991865
    µL
    Resuspension Volume
    Beschreibung

    Refer to the Sputum Induction and Processing Reference Manual.

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C2700258
    UMLS CUI [1,2]
    C0439810
    mL
    Sputum hemacytometry post-challenge
    Beschreibung

    Sputum hemacytometry post-challenge

    Alias
    UMLS CUI-1
    C0038056
    UMLS CUI-2
    C0005771
    UMLS CUI-3
    C3856621
    Squares Counted
    Beschreibung

    Squares Counted

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3856621
    Viable Leukocytes
    Beschreibung

    Viable Leukocytes

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0443348
    Dead Leukocytes
    Beschreibung

    Dead Leukocytes

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C1306577
    Total Leukocyte Count
    Beschreibung

    Refer to the Sputum Induction and Processing Reference Manual. Total leukocyte count (cells/mL) = (Average number of viable + dead leukocytes) x trypan blue dilution factor x 10^4.

    Datentyp

    float

    Maßeinheiten
    • cells/mL
    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0439810
    cells/mL
    Total Viable Leukocytes
    Beschreibung

    Total viable leukocyte = (Average number of viable leukocytes) x trypan blue dilution factor x 10^4

    Datentyp

    float

    Maßeinheiten
    • cells/mL
    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0443348
    UMLS CUI [1,3]
    C0439810
    cells/mL
    Percent Viable Leukocytes
    Beschreibung

    % viable leukocytes = (Total viable leukocytes) / (Total leukocytes) x 100.

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0443348
    UMLS CUI [1,3]
    C0439165
    %
    Sputum induction post-challenge summary
    Beschreibung

    Sputum induction post-challenge summary

    Alias
    UMLS CUI-1
    C0242482
    UMLS CUI-2
    C2019319
    Date of assessment
    Beschreibung

    Date of assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Time sample collected
    Beschreibung

    Hr:Min 00:00 - 23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Resuspension volume
    Beschreibung

    Transcribe values from Resuspension segment.

    Datentyp

    float

    Maßeinheiten
    • mL
    Alias
    UMLS CUI [1,1]
    C2700258
    UMLS CUI [1,2]
    C1382107
    mL
    Weight of Sputum
    Beschreibung

    Transcribe values from Resuspension segment.

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0807984
    UMLS CUI [1,2]
    C0038056
    mg
    Total Leukocyte Count
    Beschreibung

    Transcribe values from Resuspension segment.

    Datentyp

    float

    Maßeinheiten
    • cells/mL
    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0439810
    cells/mL
    Number of Cytospin slides prepared
    Beschreibung

    Number of Cytospin slides prepared

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897072
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C4082130
    Number of Cytospin slides stained
    Beschreibung

    Number of Cytospin slides stained

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897072
    UMLS CUI [1,2]
    C0750480
    UMLS CUI [1,3]
    C0038128
    Number of supernatant aliquots saved
    Beschreibung

    Number of supernatant aliquots saved

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C1510844
    UMLS CUI [1,3]
    C1550101
    UMLS CUI [1,4]
    C0003738
    Does any of the sample have under 50 percent viability (hemacytometer) or over 40 percent squamous cells (cytospin slide)?
    Beschreibung

    Viability under 50 percent, over 40 percent squamous cells

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0007634
    UMLS CUI [1,3]
    C0443348
    UMLS CUI [1,4]
    C0439165
    UMLS CUI [2,1]
    C0439165
    UMLS CUI [2,2]
    C2699511
    Date Sputum (supernatant) sample taken
    Beschreibung

    Sample Number: 103

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0038056
    Actual time of sampling
    Beschreibung

    Hr : Min (00:00 - 23:59) Time relative to dosing: post-challenge

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0038056
    Sputum slide results post-challenge
    Beschreibung

    Sputum slide results post-challenge

    Alias
    UMLS CUI-1
    C3897072
    UMLS CUI-2
    C0038056
    UMLS CUI-3
    C1254595
    Date of assessment
    Beschreibung

    Date of assessment

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C3897072
    Number of Reader
    Beschreibung

    Number of Reader

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2986556
    UMLS CUI [2]
    C2986556
    Name of Reader
    Beschreibung

    Name of Reader

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Slide number
    Beschreibung

    Slide number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897072
    UMLS CUI [1,2]
    C0237753
    Absolute count of Eosinophils
    Beschreibung

    Absolute count of Eosinophils

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0200638
    Absolute count of Neutrophils
    Beschreibung

    Absolute count of Neutrophils

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0948762
    Absolute count of Macrophages
    Beschreibung

    Absolute count of Macrophages

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1294065
    Absolute count of Lymphocytes
    Beschreibung

    Absolute count of Lymphocytes

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3544087
    Absolute count of Bronchial epithelial cells
    Beschreibung

    Absolute count of Bronchial epithelial cells

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1273342
    UMLS CUI [1,2]
    C0205039
    Absolute count of squamous cells
    Beschreibung

    Absolute count of squamous cells

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2699511
    Total non-squamous cells
    Beschreibung

    Total non-squamous cells

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0007584
    UMLS CUI [1,2]
    C1545484
    UMLS CUI [1,3]
    C0439810
    Total cells
    Beschreibung

    Total cells

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0007584
    UMLS CUI [1,2]
    C0439810
    Eosinophils: percent of total non squamous cells
    Beschreibung

    Eosinophils: percent of total non squamous cells

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C0200638
    UMLS CUI [1,2]
    C0439165
    %
    Neutrophils: percent of total non squamous cells
    Beschreibung

    Neutrophils: percent of total non squamous cells

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C0948762
    UMLS CUI [1,2]
    C0439165
    %
    Macrophages: percent of total non squamous cells
    Beschreibung

    Macrophages: percent of total non squamous cells

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C1294065
    UMLS CUI [1,2]
    C0439165
    %
    Lymphocytes: percent of total non squamous cells
    Beschreibung

    Lymphocytes: percent of total non squamous cells

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C3544087
    UMLS CUI [1,2]
    C0439165
    %
    Bronchial epithelial cells: percent of total non squamous cells
    Beschreibung

    Bronchial epithelial cells: percent of total non squamous cells

    Datentyp

    float

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1,1]
    C1273342
    UMLS CUI [1,2]
    C0205039
    UMLS CUI [1,3]
    C0439165
    %

    Ähnliche Modelle

    Pharmacodynamics - Treatment period 1, Day 29

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Baseline FEV1 Measurement - Sputum Induction post-challenge
    C1442488 (UMLS CUI-1)
    C0429706 (UMLS CUI-2)
    Date of Sputum induction
    Item
    Date of assessment (Sputum induction)
    date
    C2985720 (UMLS CUI [1,1])
    C0038056 (UMLS CUI [1,2])
    Item
    Planned relative time
    text
    C0439564 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    CL Item
    pre-bronchdilator (pre-bronchdilator)
    CL Item
    administration (no FEV1 meassurement) (administration (no FEV1 meassurement))
    CL Item
    post-bronchodilator (post-bronchodilator)
    Time of First Reading
    Item
    Actual Time of First Reading
    time
    C0040223 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Reading 1
    Item
    FEV1 Reading 1
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Reading 2
    Item
    FEV1 Reading 2
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    FEV1 Reading 3
    Item
    FEV1 Reading 3
    float
    C0456984 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Postbronchodilator FEV1 -20%
    Item
    Postbronchodilator FEV1 -20%
    float
    C2599594 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Postbronchodilator FEV1 -10%
    Item
    Postbronchodilator FEV1 -10%
    float
    C2599594 (UMLS CUI [1,1])
    C0429706 (UMLS CUI [1,2])
    Item Group
    Sputum induction post-challenge
    C2019319 (UMLS CUI-1)
    Item
    Planned relative Time
    text
    C0439564 (UMLS CUI [1,1])
    C0205535 (UMLS CUI [1,2])
    Code List
    Planned relative Time
    CL Item
    Inhalation Period 1 (Inhalation Period 1)
    CL Item
    Inhalation Period 2 (Inhalation Period 2)
    CL Item
    Inhalation Period 3 (Inhalation Period 3)
    CL Item
    Unscheduled (Unscheduled)
    Actual Time of Inhalation
    Item
    Actual Time of Inhalation
    time
    C0040223 (UMLS CUI [1,1])
    C0001559 (UMLS CUI [1,2])
    Saline Concentration
    Item
    Saline Concentration
    float
    C0036082 (UMLS CUI [1])
    FEV1
    Item
    FEV1
    float
    C0748133 (UMLS CUI [1])
    Bronchodilator administration
    Item
    Was Bronchodilator administered?
    boolean
    C0006280 (UMLS CUI [1,1])
    C1533734 (UMLS CUI [1,2])
    Dose administered
    Item
    Dose administered
    float
    C0006280 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Item Group
    Sputum post-challenge sample
    C0038056 (UMLS CUI-1)
    C0851347 (UMLS CUI-2)
    Date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
    Time sample Collected
    Item
    Time sample Collected
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0038056 (UMLS CUI [1,3])
    Time sample processed
    Item
    Time sample processed
    time
    C0040223 (UMLS CUI [1,1])
    C1709694 (UMLS CUI [1,2])
    C0038056 (UMLS CUI [1,3])
    Sputum Sample Quality
    Item
    Following visual examination / inspection, record below the color, purulence and any signs of blood contamination:
    text
    C0038056 (UMLS CUI [1,1])
    C0332306 (UMLS CUI [1,2])
    C1880121 (UMLS CUI [2])
    C0241235 (UMLS CUI [3])
    C0005767 (UMLS CUI [4,1])
    C2349974 (UMLS CUI [4,2])
    Sample Weight - Weight of tube
    Item
    Sample Weight - Weight of tube
    float
    C0807984 (UMLS CUI [1,1])
    C0175730 (UMLS CUI [1,2])
    Sample Weight - Weight of tube + Sputum
    Item
    Sample Weight - Weight of tube + Sputum
    float
    C0807984 (UMLS CUI [1,1])
    C0175730 (UMLS CUI [1,2])
    C0038056 (UMLS CUI [1,3])
    Sample Weight - Weight of Sputum
    Item
    Sample Weight - Weight of Sputum
    float
    C0807984 (UMLS CUI [1,1])
    C0038056 (UMLS CUI [1,2])
    Volume of DTT added
    Item
    Volume of DTT added
    float
    C0012789 (UMLS CUI [1,1])
    C2700258 (UMLS CUI [1,2])
    Volume of PBS Added
    Item
    Volume of PBS Added
    float
    C2700258 (UMLS CUI [1,1])
    C0036082 (UMLS CUI [1,2])
    C0991865 (UMLS CUI [1,3])
    Resuspension Volume
    Item
    Resuspension Volume
    float
    C2700258 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Item Group
    Sputum hemacytometry post-challenge
    C0038056 (UMLS CUI-1)
    C0005771 (UMLS CUI-2)
    C3856621 (UMLS CUI-3)
    Item
    Squares Counted
    text
    C3856621 (UMLS CUI [1])
    Code List
    Squares Counted
    CL Item
    Bottom left 4x4 (Bottom left 4x4)
    CL Item
    Bottom right 4x4 (Bottom right 4x4)
    CL Item
    Top left 4x4 (Top left 4x4)
    CL Item
    Top right 4x4 (Top right 4x4)
    CL Item
    Average (Average)
    Viable Leukocytes
    Item
    Viable Leukocytes
    integer
    C0023508 (UMLS CUI [1,1])
    C0443348 (UMLS CUI [1,2])
    Dead Leukocytes
    Item
    Dead Leukocytes
    integer
    C0023508 (UMLS CUI [1,1])
    C1306577 (UMLS CUI [1,2])
    Total Leukocyte Count
    Item
    Total Leukocyte Count
    float
    C0023508 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Total Viable Leukocytes
    Item
    Total Viable Leukocytes
    float
    C0023508 (UMLS CUI [1,1])
    C0443348 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Percent Viable Leukocytes
    Item
    Percent Viable Leukocytes
    float
    C0023508 (UMLS CUI [1,1])
    C0443348 (UMLS CUI [1,2])
    C0439165 (UMLS CUI [1,3])
    Item Group
    Sputum induction post-challenge summary
    C0242482 (UMLS CUI-1)
    C2019319 (UMLS CUI-2)
    Date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1])
    Time sample collected
    Item
    Time sample collected
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Resuspension volume
    Item
    Resuspension volume
    float
    C2700258 (UMLS CUI [1,1])
    C1382107 (UMLS CUI [1,2])
    Weight of Sputum
    Item
    Weight of Sputum
    float
    C0807984 (UMLS CUI [1,1])
    C0038056 (UMLS CUI [1,2])
    Total Leukocyte Count
    Item
    Total Leukocyte Count
    float
    C0023508 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Number of Cytospin slides prepared
    Item
    Number of Cytospin slides prepared
    integer
    C3897072 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C4082130 (UMLS CUI [1,3])
    Number of Cytospin slides stained
    Item
    Number of Cytospin slides stained
    integer
    C3897072 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    C0038128 (UMLS CUI [1,3])
    Number of supernatant aliquots saved
    Item
    Number of supernatant aliquots saved
    integer
    C0237753 (UMLS CUI [1,1])
    C1510844 (UMLS CUI [1,2])
    C1550101 (UMLS CUI [1,3])
    C0003738 (UMLS CUI [1,4])
    Item
    Does any of the sample have under 50 percent viability (hemacytometer) or over 40 percent squamous cells (cytospin slide)?
    text
    C1274040 (UMLS CUI [1,1])
    C0007634 (UMLS CUI [1,2])
    C0443348 (UMLS CUI [1,3])
    C0439165 (UMLS CUI [1,4])
    C0439165 (UMLS CUI [2,1])
    C2699511 (UMLS CUI [2,2])
    Code List
    Does any of the sample have under 50 percent viability (hemacytometer) or over 40 percent squamous cells (cytospin slide)?
    CL Item
    yes (y)
    CL Item
    no (n)
    Date Sputum (supernatant) sample taken
    Item
    Date Sputum (supernatant) sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0038056 (UMLS CUI [1,2])
    Time of sampling
    Item
    Actual time of sampling
    time
    C0040223 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0038056 (UMLS CUI [1,3])
    Item Group
    Sputum slide results post-challenge
    C3897072 (UMLS CUI-1)
    C0038056 (UMLS CUI-2)
    C1254595 (UMLS CUI-3)
    Date of assessment
    Item
    Date of assessment
    date
    C2985720 (UMLS CUI [1,1])
    C3897072 (UMLS CUI [1,2])
    Item
    Number of Reader
    integer
    C2986556 (UMLS CUI [1])
    C2986556 (UMLS CUI [2])
    Code List
    Number of Reader
    CL Item
    1 (1)
    CL Item
    2 (2)
    Name of Reader
    Item
    Name of Reader
    text
    C2826892 (UMLS CUI [1])
    Item
    Slide number
    integer
    C3897072 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Code List
    Slide number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    Absolute count of Eosinophils
    Item
    Absolute count of Eosinophils
    integer
    C0200638 (UMLS CUI [1])
    Absolute count of Neutrophils
    Item
    Absolute count of Neutrophils
    integer
    C0948762 (UMLS CUI [1])
    Absolute count of Macrophages
    Item
    Absolute count of Macrophages
    integer
    C1294065 (UMLS CUI [1])
    Absolute count of Lymphocytes
    Item
    Absolute count of Lymphocytes
    integer
    C3544087 (UMLS CUI [1])
    Absolute count of Bronchial epithelial cells
    Item
    Absolute count of Bronchial epithelial cells
    integer
    C1273342 (UMLS CUI [1,1])
    C0205039 (UMLS CUI [1,2])
    Absolute count of squamous cells
    Item
    Absolute count of squamous cells
    integer
    C2699511 (UMLS CUI [1])
    Total non-squamous cells
    Item
    Total non-squamous cells
    integer
    C0007584 (UMLS CUI [1,1])
    C1545484 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Total cells
    Item
    Total cells
    integer
    C0007584 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Eosinophils: percent of total non squamous cells
    Item
    Eosinophils: percent of total non squamous cells
    float
    C0200638 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    Neutrophils: percent of total non squamous cells
    Item
    Neutrophils: percent of total non squamous cells
    float
    C0948762 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    Macrophages: percent of total non squamous cells
    Item
    Macrophages: percent of total non squamous cells
    float
    C1294065 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    Lymphocytes: percent of total non squamous cells
    Item
    Lymphocytes: percent of total non squamous cells
    float
    C3544087 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    Bronchial epithelial cells: percent of total non squamous cells
    Item
    Bronchial epithelial cells: percent of total non squamous cells
    float
    C1273342 (UMLS CUI [1,1])
    C0205039 (UMLS CUI [1,2])
    C0439165 (UMLS CUI [1,3])

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