ID

14483

Description

Predicting the Diagnosis of Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00620334

Lien

https://clinicaltrials.gov/show/NCT00620334

Mots-clés

Versions (1)
  1. 18/04/2016 18/04/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

18 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Eligibility Asthma NCT00620334

Anglais

Eligibility Asthma NCT00620334

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00620334
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-64 years of age at enrollment
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
literacy: the subject must be able to read, comprehend, and record information in english.
Description

literacy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023864
UMLS CUI [1,2]
C0376245
consent: the subject must have the ability to give informed consent.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
type of subject: the subject must be seen in the outpatient setting.
Description

outpatient

Type de données

boolean

Alias
UMLS CUI [1]
C0029921
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
respiratory instability: hospitalization for respiratory disease within the last 6 months during study period and prior to visit 0.
Description

hospitalization for respiratory disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C0040223
respiratory disease: current diagnosis of cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, or any other lower respiratory abnormalities other than asthma.
Description

respiratory disease

Type de données

boolean

Alias
UMLS CUI [1]
C0035204
prior treatment of asthma: treatment for asthma with any medication (except for short acting inhaled bronchodilators) for 12 months or more prior to visit 0
Description

prior treatment of asthma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
drug allergy: any immediate or delayed hypersensitivity reaction to any beta2-agonist or sympathomimetic drug
Description

drug allergy to beta-2-agonist

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1373132
respiratory tract infections: confirmed or suspected infection of the sinus, middle ear, oropharynx, upper respiratory tract, or lower respiratory tract within 28 days prior to testing
Description

respiratory tract infections

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
other concurrent conditions/diseases: any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. the list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: cardiac arrhythmia, congestive heart failure, coronary artery disease, addison's disease, diabetes mellitus, dyspnea by any cause other than asthma, uncontrolled hypertension, hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease, immunologic compromise, current malignancy, current or quiescent tuberculosis.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488
concomitant medications:
Description

concomitant medications

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
1. beta blockers
Description

beta blockers

Type de données

boolean

Alias
UMLS CUI [1]
C0304516
2. systemic corticosteroids
Description

systemic corticosteroids

Type de données

boolean

Alias
UMLS CUI [1]
C4039704
3. angiotensin converting enzyme (ace) inhibitors (note: immunotherapy for the treatment of allergies is allowed, provided that the subject has received a constant dose for 30 days prior to visit 0, and that the same dose will continue throughout the study.)
Description

ACE inhibitors and immunotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0021083
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Similar models

Eligibility Asthma NCT00620334

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00620334
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
18-64 years of age at enrollment
boolean
C0001779 (UMLS CUI [1])
literacy
Item
literacy: the subject must be able to read, comprehend, and record information in english.
boolean
C0023864 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
informed consent
Item
consent: the subject must have the ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
outpatient
Item
type of subject: the subject must be seen in the outpatient setting.
boolean
C0029921 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hospitalization for respiratory disease
Item
respiratory instability: hospitalization for respiratory disease within the last 6 months during study period and prior to visit 0.
boolean
C0035204 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
respiratory disease
Item
respiratory disease: current diagnosis of cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, or any other lower respiratory abnormalities other than asthma.
boolean
C0035204 (UMLS CUI [1])
prior treatment of asthma
Item
prior treatment of asthma: treatment for asthma with any medication (except for short acting inhaled bronchodilators) for 12 months or more prior to visit 0
boolean
C1514463 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
drug allergy to beta-2-agonist
Item
drug allergy: any immediate or delayed hypersensitivity reaction to any beta2-agonist or sympathomimetic drug
boolean
C0020517 (UMLS CUI [1,1])
C1373132 (UMLS CUI [1,2])
respiratory tract infections
Item
respiratory tract infections: confirmed or suspected infection of the sinus, middle ear, oropharynx, upper respiratory tract, or lower respiratory tract within 28 days prior to testing
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
comorbidity
Item
other concurrent conditions/diseases: any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. the list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: cardiac arrhythmia, congestive heart failure, coronary artery disease, addison's disease, diabetes mellitus, dyspnea by any cause other than asthma, uncontrolled hypertension, hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease, immunologic compromise, current malignancy, current or quiescent tuberculosis.
boolean
C0009488 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
concomitant medications
Item
concomitant medications:
boolean
C2347852 (UMLS CUI [1])
beta blockers
Item
1. beta blockers
boolean
C0304516 (UMLS CUI [1])
systemic corticosteroids
Item
2. systemic corticosteroids
boolean
C4039704 (UMLS CUI [1])
ACE inhibitors and immunotherapy
Item
3. angiotensin converting enzyme (ace) inhibitors (note: immunotherapy for the treatment of allergies is allowed, provided that the subject has received a constant dose for 30 days prior to visit 0, and that the same dose will continue throughout the study.)
boolean
C0003015 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
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