0 Evaluaciones

ID

43644

Descripción

A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise; ODM derived from: https://clinicaltrials.gov/show/NCT01435902

Link

https://clinicaltrials.gov/show/NCT01435902

Palabras clave

  1. 15/2/16 15/2/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :


    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Eligibility Asthma NCT01435902

    Eligibility Asthma NCT01435902

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01435902
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    outpatient male or female 12 to 50 years of age
    Descripción

    age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
    Descripción

    Fertility Female or Contraception status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0015895
    UMLS CUI [1,2]
    C0086287
    diagnosis of persistent asthma for at least 6 months
    Descripción

    persistent asthma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3266628
    best pre-bronchodilator fev1 of at least 70%.
    Descripción

    pre-bronchodilator fev1

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3172227
    current use of a low- to moderate-dose inhaled corticosteroid
    Descripción

    corticosteroid Inhales drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0001617
    UMLS CUI [1,2]
    C0556393
    ability to withhold albuterol 6 hours prior to visits.
    Descripción

    albuterol

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001927
    physically able to perform exercise testing on a treadmill when albuterol has been withheld
    Descripción

    Pulmonary exercise test

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1096466
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    intermittent asthma, seasonal asthma, or exercise-induced asthma only
    Descripción

    asthma

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    symptomatic allergic rhinitis and/or thrush
    Descripción

    allergic rhinitis Symptomatic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2607914
    UMLS CUI [1,2]
    C0231220
    abnormal, clinically significant electrocardigraph
    Descripción

    Electrocardiography

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
    Descripción

    respiratory infection; asthma status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0035243
    UMLS CUI [2]
    C1388876
    asthma exacerbation within 12 weeks of first visit
    Descripción

    asthma exacerbation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
    Descripción

    Compliance behavior Limited Comorbidity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
    Descripción

    Study Subject Participation Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    allergy to study drugs or study drug excipients
    Descripción

    hypersensitivity drugs

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013227
    concomitant medications that could interact with study medications or affect the course of asthma
    Descripción

    concomitant medications

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    tobacco use within last year and/or a 10 pack-years history
    Descripción

    smoking status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    inability to comply with requirements of the study
    Descripción

    Compliance behavior

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    affiliation with investigator's site (example: family member)
    Descripción

    relationship Research Personnel

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0439849
    UMLS CUI [1,2]
    C0035173

    Similar models

    Eligibility Asthma NCT01435902

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT01435902
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    outpatient male or female 12 to 50 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Fertility Female or Contraception status
    Item
    females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
    boolean
    C0015895 (UMLS CUI [1,1])
    C0086287 (UMLS CUI [1,2])
    persistent asthma
    Item
    diagnosis of persistent asthma for at least 6 months
    boolean
    C3266628 (UMLS CUI [1])
    pre-bronchodilator fev1
    Item
    best pre-bronchodilator fev1 of at least 70%.
    boolean
    C3172227 (UMLS CUI [1])
    corticosteroid Inhales drugs
    Item
    current use of a low- to moderate-dose inhaled corticosteroid
    boolean
    C0001617 (UMLS CUI [1,1])
    C0556393 (UMLS CUI [1,2])
    albuterol
    Item
    ability to withhold albuterol 6 hours prior to visits.
    boolean
    C0001927 (UMLS CUI [1])
    Pulmonary exercise test
    Item
    physically able to perform exercise testing on a treadmill when albuterol has been withheld
    boolean
    C1096466 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    asthma
    Item
    intermittent asthma, seasonal asthma, or exercise-induced asthma only
    boolean
    C0004096 (UMLS CUI [1])
    allergic rhinitis Symptomatic
    Item
    symptomatic allergic rhinitis and/or thrush
    boolean
    C2607914 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    Electrocardiography
    Item
    abnormal, clinically significant electrocardigraph
    boolean
    C1623258 (UMLS CUI [1])
    respiratory infection; asthma status
    Item
    respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
    boolean
    C0035243 (UMLS CUI [1])
    C1388876 (UMLS CUI [2])
    asthma exacerbation
    Item
    asthma exacerbation within 12 weeks of first visit
    boolean
    C0349790 (UMLS CUI [1])
    Compliance behavior Limited Comorbidity
    Item
    respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    Study Subject Participation Status
    Item
    investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
    boolean
    C2348568 (UMLS CUI [1])
    hypersensitivity drugs
    Item
    allergy to study drugs or study drug excipients
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    concomitant medications
    Item
    concomitant medications that could interact with study medications or affect the course of asthma
    boolean
    C2347852 (UMLS CUI [1])
    smoking status
    Item
    tobacco use within last year and/or a 10 pack-years history
    boolean
    C1519386 (UMLS CUI [1])
    Compliance behavior
    Item
    inability to comply with requirements of the study
    boolean
    C1321605 (UMLS CUI [1])
    relationship Research Personnel
    Item
    affiliation with investigator's site (example: family member)
    boolean
    C0439849 (UMLS CUI [1,1])
    C0035173 (UMLS CUI [1,2])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial