ID

14521

Descrição

Pharmacogenetics of b2-Agonists in Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT00708227

Link

https://clinicaltrials.gov/show/NCT00708227

Palavras-chave

  1. 19/04/2016 19/04/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

19 de abril de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00708227

Eligibility Asthma NCT00708227

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00708227
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diplotype: whites with specific diplotype and african americans with specific diplotypes.
Descrição

diplotype

Tipo de dados

boolean

gender: male or female. women are eligible if they are not pregnant or lactating. females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
Descrição

pregnancy lactation pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0430056
UMLS CUI [5]
C0430567
age: 12 years and older.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
asthma diagnosis: physician diagnosed asthma according to american thoracic society criteria for at least 3 months.
Descrição

asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
asthma therapy: there is no requirement for previous asthma therapy to be included in this study.
Descrição

asthma therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
asthma severity: forced expiratory volume in the first sectond (fev1) must be >= 60% of predicted normal values for age, height, and gender.
Descrição

fev1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0748133
methacholine challenge test provocative concentration (20% fall in fev1) of [<=12]mg/ml.
Descrição

methacholine challenge

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0430567
UMLS CUI [2]
C0748133
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of life-threatening asthma: any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
Descrição

life-threatening asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0020440
UMLS CUI [3]
C0021925
UMLS CUI [4]
C0162297
UMLS CUI [5]
C1843573
asthma instability: hospitalization for asthma within 3 months of visit 1.
Descrição

hospitalization for asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
concurrent respiratory disease: any respiratory disease other than asthma.
Descrição

respiratory disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035204
sensitivities: sensitivities to methacholine, flovent® mdi, ipratropium bromide, albuterol, or advair diskus® that would put the safety of the subject at risk.
Descrição

sensitivities

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0600370
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0720466
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0700580
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0001927
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0939246
respiratory tract infection: any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to visit 1.
Descrição

respiratory tract infection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0003232
expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. these patients can be studied when pollen exposure to which they are sensitive will not occur.
Descrição

exposure to pollen allergen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0323138
UMLS CUI [1,3]
C0020517

Similar models

Eligibility Asthma NCT00708227

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00708227
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
diplotype
Item
diplotype: whites with specific diplotype and african americans with specific diplotypes.
boolean
pregnancy lactation pregnancy test
Item
gender: male or female. women are eligible if they are not pregnant or lactating. females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0430056 (UMLS CUI [4])
C0430567 (UMLS CUI [5])
age
Item
age: 12 years and older.
boolean
C0001779 (UMLS CUI [1])
asthma
Item
asthma diagnosis: physician diagnosed asthma according to american thoracic society criteria for at least 3 months.
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
asthma therapy
Item
asthma therapy: there is no requirement for previous asthma therapy to be included in this study.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
fev1
Item
asthma severity: forced expiratory volume in the first sectond (fev1) must be >= 60% of predicted normal values for age, height, and gender.
boolean
C0748133 (UMLS CUI [1])
methacholine challenge
Item
methacholine challenge test provocative concentration (20% fall in fev1) of [<=12]mg/ml.
boolean
C0430567 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
life-threatening asthma
Item
history of life-threatening asthma: any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0020440 (UMLS CUI [2])
C0021925 (UMLS CUI [3])
C0162297 (UMLS CUI [4])
C1843573 (UMLS CUI [5])
hospitalization for asthma
Item
asthma instability: hospitalization for asthma within 3 months of visit 1.
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
respiratory disease
Item
concurrent respiratory disease: any respiratory disease other than asthma.
boolean
C0035204 (UMLS CUI [1])
sensitivities
Item
sensitivities: sensitivities to methacholine, flovent® mdi, ipratropium bromide, albuterol, or advair diskus® that would put the safety of the subject at risk.
boolean
C0020517 (UMLS CUI [1,1])
C0600370 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0720466 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0700580 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0001927 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0939246 (UMLS CUI [5,2])
respiratory tract infection
Item
respiratory tract infection: any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to visit 1.
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2])
exposure to pollen allergen
Item
expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. these patients can be studied when pollen exposure to which they are sensitive will not occur.
boolean
C0332157 (UMLS CUI [1,1])
C0323138 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])

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