ID

14521

Description

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

Link

https://clinicaltrials.gov/show/NCT00708227

Keywords

Versions (1)
  1. 4/19/16 4/19/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 19, 2016

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00708227

English

Eligibility Asthma NCT00708227

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00708227
Inclusion Criteria
Description

Inclusion Criteria

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

diplotype

Data type

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.
Description

pregnancy lactation pregnancy test

Data type

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.
Description

age

Data type

boolean

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

asthma

Data type

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.
Description

asthma therapy

Data type

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.
Description

fev1

Data type

boolean

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

methacholine challenge

Data type

boolean

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

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.
Description

life-threatening asthma

Data type

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.
Description

hospitalization for asthma

Data type

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.
Description

respiratory disease

Data type

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.
Description

sensitivities

Data type

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.
Description

respiratory tract infection

Data type

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.
Description

exposure to pollen allergen

Data type

boolean

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

Eligibility Asthma NCT00708227

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00708227
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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