Informações:
Falhas:
ID
14503
Descrição
A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00675649
Link
https://clinicaltrials.gov/show/NCT00675649
Palavras-chave
Versões (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 NCT00675649
Eligibility Asthma NCT00675649
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT00675649
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
severe persistent asthma
Item
physician diagnosis of asthma for >= 3 years and a diagnosis of severe, persistent asthma for >= 1 year prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1960048 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C1960048 (UMLS CUI [2])
reversible airway obstruction
Item
reversible airway obstruction
boolean
C0001883 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,2])
inhaled steroids and long-acting beta-2 agonists
Item
continuous treatment with high dose inhaled corticosteroids and long-acting beta2-agonist for at least 3 months prior to screening
boolean
C2065041 (UMLS CUI [1])
C1373132 (UMLS CUI [2])
C1373132 (UMLS CUI [2])
asthma worsening
Item
at least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral)
boolean
C0004096 (UMLS CUI [1,1])
C1457868 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2])
C1457868 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2])
asthma control questionnaire
Item
score of >= 2 points on the asthma control questionnaire (acq) at screening
boolean
C2919686 (UMLS CUI [1])
respiratory disorder
Item
diagnosis of chronic obstructive pulmonary disease (copd), cystic fibrosis, or other significant respiratory disorder
boolean
C0035204 (UMLS CUI [1])
life-threatening asthma requiring intubation
Item
life-threatening asthma attack requiring intubation in the 6-month period prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
steroid prednisone
Item
steroid use at a dose > 20 mg of prednisone at the screening visit
boolean
C0038317 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0032952 (UMLS CUI [2])
malignancy
Item
known malignancy or history of malignancy
boolean
C0006826 (UMLS CUI [1])
previous exposure to anti-tnf therapies
Item
previous exposure to anti-tnf therapies
boolean
C0205156 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0281481 (UMLS CUI [1,3])
C0332157 (UMLS CUI [1,2])
C0281481 (UMLS CUI [1,3])