ID

14242

Beschrijving

Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131); ODM derived from: https://clinicaltrials.gov/show/NCT00163345

Link

https://clinicaltrials.gov/show/NCT00163345

Trefwoorden

Versies (2)
  1. 04-04-16 04-04-16 -
  2. 05-04-16 05-04-16 -
Geüploaded op

5 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Asthma NCT00163345

Engels

Eligibility Asthma NCT00163345

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163345
Criteria
Beschrijving

Criteria

written informed consent
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
history of bronchial asthma
Beschrijving

asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
fev1 more than or equal to 60% of predicted
Beschrijving

fev1

Datatype

boolean

Alias
UMLS CUI [1]
C0748133
stable asthma
Beschrijving

stable asthma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
patients who are in good health with the exception of asthma
Beschrijving

health status

Datatype

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion criteria
Beschrijving

Exclusion criteria

Alias
UMLS CUI-1
C0680251
concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ics
Beschrijving

comorbidity limiting study protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
Beschrijving

copd or other relevant lung diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0024115
use of ics 4 weeks before entry into the baseline period
Beschrijving

ics

Datatype

boolean

Alias
UMLS CUI [1,1]
C3248292
UMLS CUI [1,2]
C0040223
pregnancy
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
intention to become pregnant during the course of the study
Beschrijving

intention to become pregnant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1283828
breast feeding
Beschrijving

breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
lack of safe contraception
Beschrijving

lack of safe contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
use of other drugs not allowed
Beschrijving

other drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0013227
current smokers and ex-smokers with more than or equal to 10 pack-years
Beschrijving

smoker

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1277691
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Similar models

Eligibility Asthma NCT00163345

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00163345
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
asthma
Item
history of bronchial asthma
boolean
C0004096 (UMLS CUI [1])
fev1
Item
fev1 more than or equal to 60% of predicted
boolean
C0748133 (UMLS CUI [1])
stable asthma
Item
stable asthma
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
health status
Item
patients who are in good health with the exception of asthma
boolean
C0018759 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
comorbidity limiting study protocol
Item
concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ics
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
copd or other relevant lung diseases
Item
copd (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
boolean
C0024117 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
ics
Item
use of ics 4 weeks before entry into the baseline period
boolean
C3248292 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
intention to become pregnant
Item
intention to become pregnant during the course of the study
boolean
C0032961 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
breast feeding
Item
breast feeding
boolean
C0006147 (UMLS CUI [1])
lack of safe contraception
Item
lack of safe contraception
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
other drugs
Item
use of other drugs not allowed
boolean
C0205394 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
smoker
Item
current smokers and ex-smokers with more than or equal to 10 pack-years
boolean
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
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