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34727

Beschrijving

Study ID: 115054 Clinical Study ID: 115054 Study Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01323673 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Vehicle / Placebo Trade Name: clobetasol propionate Study Indication: Dermatitis, Chronic

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  1. 25-01-19 25-01-19 -
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GlaxoSmithKline

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25 januari 2019

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Creative Commons BY-NC 3.0
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    Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673

    Engels

    Baseline/ Day 1 - Medical History; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy

    1 Formulieren  
    Medical History
    Beschrijving

    Medical History

    Alias
    UMLS CUI-1
    C0262926
    If there is no medical history to report, place a check in the box
    Beschrijving

    If there is no medical history to report, place a check in the box

    Datatype

    integer

    Disease/ Condition/ Procedure
    Beschrijving

    Use precise medical terminology

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0012634
    UMLS CUI [2]
    C0348080
    UMLS CUI [3]
    C0087111
    Date of Diagnosis/Procedure
    Beschrijving

    Date of Diagnosis/Procedure

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2316983
    UMLS CUI [2]
    C2584899
    Ongoing at Time of Informed Consent?
    Beschrijving

    Ongoing at Time of Informed Consent?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0549178
    UMLS CUI [2]
    C0021430
    Efficacy Assessments- Baseline
    Beschrijving

    Efficacy Assessments- Baseline

    Alias
    UMLS CUI-1
    C1280519
    UMLS CUI-2
    C0220825
    Date of Hand Dermatitis diagnosis
    Beschrijving

    Date of Hand Dermatitis diagnosis

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0744574
    UMLS CUI [1,2]
    C2316983
    Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?
    Beschrijving

    Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3848663
    UMLS CUI [1,2]
    C0013231
    UMLS CUI [1,3]
    C0457083
    Investigator Assessment
    Beschrijving

    Investigator Assessment

    Which hand will be routinely assessed during the study?
    Beschrijving

    Which hand will be routinely assessed during the study?

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C0018563
    UMLS CUI [1,3]
    C0441987
    Investigator Static Global Assessment
    Beschrijving

    Investigator Static Global Assessment

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0450973
    ISGA Assessor Name (First Initial, Last Name)
    Beschrijving

    ISGA Assessor Name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0401804
    UMLS CUI [1,2]
    C0027365
    Subject Assessment
    Beschrijving

    Subject Assessment

    Alias
    UMLS CUI-1
    C0681850
    UMLS CUI-2
    C0220825
    Subject Global Assessment
    Beschrijving

    Subject Global Assessment

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0451514
    Pruritus
    Beschrijving

    Pruritus

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0033774
    Stinging
    Beschrijving

    Stinging

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0677500
    Burning
    Beschrijving

    Burning

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0241057
    Pain
    Beschrijving

    Pain

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0030193
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Systolic BP (mmHg)
    Beschrijving

    Systolic BP (mmHg)

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic BP (mmHg)
    Beschrijving

    Diastolic BP (mmHg)

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse (beats/minute)
    Beschrijving

    Pulse (beats/minute)

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Temperature °C
    Beschrijving

    Temperature °C

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Temperature F
    Beschrijving

    Temperature F

    Datatype

    float

    Maateenheden
    • F
    Alias
    UMLS CUI [1]
    C0005903
    F
    Urine Pregnancy
    Beschrijving

    Urine Pregnancy

    Alias
    UMLS CUI-1
    C0430056
    Urine Pregnancy Test Result
    Beschrijving

    Urine Pregnancy Test Result

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C1274040
    If Not Done or Not Applicable, specify reason:
    Beschrijving

    If Not Done or Not Applicable, specify reason:

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C2826287
    If Other, specify:
    Beschrijving

    If Other, specify:

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826287
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Terug naar het begin van de pagina

    Similar models

    Baseline/ Day 1 - Medical History; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Medical History
    C0262926 (UMLS CUI-1)
    Item
    If there is no medical history to report, place a check in the box
    integer
    If there is no medical history to report, place a check in the box
    Code List
    If there is no medical history to report, place a check in the box
    CL Item
    No medical history to report (1)
    Disease/ Condition/ Procedure
    Item
    Disease/ Condition/ Procedure
    text
    C0012634 (UMLS CUI [1])
    C0348080 (UMLS CUI [2])
    C0087111 (UMLS CUI [3])
    Date of Diagnosis/Procedure
    Item
    Date of Diagnosis/Procedure
    date
    C2316983 (UMLS CUI [1])
    C2584899 (UMLS CUI [2])
    Ongoing at Time of Informed Consent?
    Item
    Ongoing at Time of Informed Consent?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2])
    Item Group
    Efficacy Assessments- Baseline
    C1280519 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Date of Hand Dermatitis diagnosis
    Item
    Date of Hand Dermatitis diagnosis
    date
    C0744574 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?
    Item
    Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?
    boolean
    C3848663 (UMLS CUI [1,1])
    C0013231 (UMLS CUI [1,2])
    C0457083 (UMLS CUI [1,3])
    Item Group
    Investigator Assessment
    Item
    Which hand will be routinely assessed during the study?
    text
    C0220825 (UMLS CUI [1,1])
    C0018563 (UMLS CUI [1,2])
    C0441987 (UMLS CUI [1,3])
    Which hand will be routinely assessed during the study?
    Code List
    Which hand will be routinely assessed during the study?
    CL Item
    Left (L)
    CL Item
    Right (R)
    Item
    Investigator Static Global Assessment
    integer
    C0450973 (UMLS CUI [1])
    Investigator Static Global Assessment
    Code List
    Investigator Static Global Assessment
    CL Item
    Clear - Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting (0)
    CL Item
    Almost Clear - May be trace faint pink erythema, w/ almost no induration/papulation and no oozing/crusting (1)
    CL Item
    Mild - May be faint erythema w/ mild induration/papulation and no oozing/crusting (2)
    CL Item
    Moderate - May be pink-red erythema w/ moderate induration/papulation and some oozing/crusting (3)
    CL Item
    Severe - May be deep or bright red erythema w/ severe induration/papulation and w/ oozing/crusting (4)
    ISGA Assessor Name
    Item
    ISGA Assessor Name (First Initial, Last Name)
    text
    C0401804 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Item Group
    Subject Assessment
    C0681850 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Item
    Subject Global Assessment
    integer
    C0451514 (UMLS CUI [1])
    Subject Global Assessment
    Code List
    Subject Global Assessment
    CL Item
    My skin is clear (0)
    CL Item
    My dermatitis is minimal, maybe a few light pink areas (1)
    CL Item
    My dermatitis is mild, maybe occasional light pink areas (2)
    CL Item
    My dermatitis is moderate, easily noticeable pink-red areas (3)
    CL Item
    My dermatitis is severe, deep or bright red areas which may be warm when touched (4)
    Item
    Pruritus
    integer
    C0033774 (UMLS CUI [1])
    Pruritus
    Code List
    Pruritus
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item
    Stinging
    integer
    C0677500 (UMLS CUI [1])
    Stinging
    Code List
    Stinging
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item
    Burning
    integer
    C0241057 (UMLS CUI [1])
    Burning
    Code List
    Burning
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item
    Pain
    integer
    C0030193 (UMLS CUI [1])
    Pain
    Code List
    Pain
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic BP (mmHg)
    Item
    Systolic BP (mmHg)
    integer
    C0871470 (UMLS CUI [1])
    Diastolic BP (mmHg)
    Item
    Diastolic BP (mmHg)
    integer
    C0428883 (UMLS CUI [1])
    Pulse (beats/minute)
    Item
    Pulse (beats/minute)
    integer
    C0232117 (UMLS CUI [1])
    Temperature °C
    Item
    Temperature °C
    float
    C0005903 (UMLS CUI [1])
    Temperature F
    Item
    Temperature F
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Urine Pregnancy
    C0430056 (UMLS CUI-1)
    Item
    Urine Pregnancy Test Result
    integer
    C0430056 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Urine Pregnancy Test Result
    Code List
    Urine Pregnancy Test Result
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not Done/ Not Applicable (3)
    Item
    If Not Done or Not Applicable, specify reason:
    integer
    C0430056 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    If Not Done or Not Applicable, specify reason:
    Code List
    If Not Done or Not Applicable, specify reason:
    CL Item
    Surgically Sterile (not tubal ligation) (1)
    CL Item
    Post Menopausal (2)
    CL Item
    Pre Menarche (3)
    CL Item
    Other (4)
    If Other, specify:
    Item
    If Other, specify:
    text
    C2826287 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
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