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ID

13817

Beskrivning

This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim

Nyckelord

  1. 2016-03-08 2016-03-08 -
Uppladdad den

8 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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    Visit 5 - Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis

    1. StudyEvent: ODM
      1. Visit 5
    Header module
    Beskrivning

    Header module

    Visit Number
    Beskrivning

    Visit Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1549755 (Visit Number)
    Patient Name
    Beskrivning

    Patient Name

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1299487 (Patient name)
    SNOMED
    371484003
    Center #
    Beskrivning

    Center #

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0009469 (Community Health Centers)
    Date
    Beskrivning

    Date

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Examination
    Beskrivning

    Examination

    Temperature
    Beskrivning

    Temperature

    Datatyp

    integer

    Måttenheter
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Blood pressure
    Beskrivning

    Blood pressure

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • 1/sec
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    1/sec
    Examination of nose
    Beskrivning

    Examination of nose

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0558826 (Examination of nose)
    SNOMED
    274794006
    Change of sinusitis since last visit
    Beskrivning

    Change of sinusitis since last visit

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0037199 (Sinusitis)
    SNOMED
    36971009
    Were Antibiotics administered?
    Beskrivning

    If yes, please specify type of Antibiotics

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    Endoscopy
    Beskrivning

    Endoscopy

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0014245 (Endoscopy (procedure))
    SNOMED
    423827005
    LOINC
    LP6254-9
    Endoscopy findings
    Beskrivning

    Endoscopy findings

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0014245 (Endoscopy (procedure))
    SNOMED
    423827005
    LOINC
    LP6254-9
    UMLS CUI [1,2]
    C0243095 (Finding)
    LOINC
    LA9042-8
    Urine pregnancy test
    Beskrivning

    Urine pregnancy test

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    Medication checked and weighed?
    Beskrivning

    Please state weight

    Datatyp

    integer

    Dairy checked?
    Beskrivning

    Dairy checked?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0376660 (Diary)
    Medication
    Beskrivning

    Medication

    Concomitant drug
    Beskrivning

    Concomitant drug

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    PRN medicine
    Beskrivning

    PRN medicine

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3176065 (PRN medicine:Find:Pt:Medication.current:Ord:PhenX)
    LOINC
    66426-8
    Non-drug therapy
    Beskrivning

    Non-drug therapy

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3661844 (Patient condition appropriate for non-medication therapy)
    SNOMED
    435521000124101
    Adverse event
    Beskrivning

    Adverse event

    Did an adverse event occur?
    Beskrivning

    Did an adverse event occur?

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Is this a serious adverse event ?
    Beskrivning

    Is this a serious adverse event ?

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Adverse event form
    Beskrivning

    Adverse event form

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542

    Similar models

    1. StudyEvent: ODM
      1. Visit 5
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header module
    Visit Number
    Item
    Visit Number
    integer
    C1549755 (UMLS CUI [1])
    Patient Name
    Item
    Patient Name
    integer
    C1299487 (UMLS CUI [1])
    Center #
    Item
    Center #
    integer
    C0009469 (UMLS CUI [1])
    Date
    Item
    Date
    integer
    C0011008 (UMLS CUI [1])
    Item Group
    Examination
    Temperature
    Item
    Temperature
    integer
    C0005903 (UMLS CUI [1])
    Item
    Blood pressure
    integer
    C0005823 (UMLS CUI [1])
    Code List
    Blood pressure
    CL Item
    Systolic (1)
    C0871470 (UMLS CUI-1)
    CL Item
    Diastolic ( 2)
    C0428883 (UMLS CUI-1)
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item
    Examination of nose
    integer
    C0558826 (UMLS CUI [1])
    Code List
    Examination of nose
    CL Item
    Done (1)
    CL Item
    Note done (2)
    CL Item
    Finding (3)
    C0243095 (UMLS CUI-1)
    Change of sinusitis since last visit
    Item
    Change of sinusitis since last visit
    integer
    C0037199 (UMLS CUI [1])
    Were Antibiotics administered?
    Item
    Were Antibiotics administered?
    integer
    C0003232 (UMLS CUI [1])
    Item
    Endoscopy
    integer
    C0014245 (UMLS CUI [1])
    Code List
    Endoscopy
    CL Item
    Done, please state date (1)
    C0802603 (UMLS CUI-1)
    CL Item
    Not done (2)
    C1272696 (UMLS CUI-1)
    CL Item
    Findings (3)
    C0243095 (UMLS CUI-1)
    Item
    Endoscopy findings
    integer
    C0014245 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Code List
    Endoscopy findings
    CL Item
    edema (1)
    C0013604 (UMLS CUI-1)
    CL Item
    flow of secretion (2)
    C0036536 (UMLS CUI-1)
    CL Item
    irritation  (3)
    C1706307 (UMLS CUI-1)
    CL Item
    ulceration (4)
    C0041582 (UMLS CUI-1)
    Item
    Urine pregnancy test
    integer
    C0430056 (UMLS CUI [1])
    Code List
    Urine pregnancy test
    CL Item
    Result (1)
    C2826772 (UMLS CUI-1)
    CL Item
    Not done (2)
    C1272696 (UMLS CUI-1)
    Medication checked and weighed?
    Item
    Medication checked and weighed?
    integer
    Dairy checked?
    Item
    Dairy checked?
    boolean
    C0376660 (UMLS CUI [1])
    Item Group
    Medication
    Item
    Concomitant drug
    integer
    C2347852 (UMLS CUI [1])
    Code List
    Concomitant drug
    CL Item
    Drug name (1)
    C0013227 (UMLS CUI-1)
    CL Item
    Dosage (2)
    C0178602 (UMLS CUI-1)
    CL Item
    Start of medication (3)
    C0451613 (UMLS CUI-1)
    CL Item
    End of medication (4)
    C2826659 (UMLS CUI-1)
    CL Item
    Indication (5)
    C3146298 (UMLS CUI-1)
    Item
    PRN medicine
    integer
    C3176065 (UMLS CUI [1])
    Code List
    PRN medicine
    CL Item
    Drug (1)
    C0013227 (UMLS CUI-1)
    CL Item
    Dosage (2)
    C0178602 (UMLS CUI-1)
    CL Item
    Date (3)
    C0011008 (UMLS CUI-1)
    CL Item
    Indication (4)
    C3146298 (UMLS CUI-1)
    Item
    Non-drug therapy
    integer
    C3661844 (UMLS CUI [1])
    Code List
    Non-drug therapy
    CL Item
    Typ of treatment (1)
    CL Item
    Start (2)
    C0808070 (UMLS CUI-1)
    CL Item
    End (3)
    C0806020 (UMLS CUI-1)
    CL Item
    Indication (4)
    C3146298 (UMLS CUI-1)
    Item Group
    Adverse event
    Did an adverse event occur?
    Item
    Did an adverse event occur?
    integer
    C0877248 (UMLS CUI [1])
    Is this a serious adverse event ?
    Item
    Is this a serious adverse event ?
    integer
    C1519255 (UMLS CUI [1])
    Item
    Adverse event form
    integer
    C0877248 (UMLS CUI [1])
    Code List
    Adverse event form
    CL Item
    Description of adverse event icd (1)
    C1632372 (UMLS CUI-1)
    CL Item
    Date and time of adverse event (2)
    C2826793 (UMLS CUI-1)
    CL Item
    Previously in CRF documted (3)
    CL Item
    Progress (4)
    C1335499 (UMLS CUI-1)
    CL Item
    Related to study drug? (5)
    C0013175 (UMLS CUI-1)

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