Informações:
Falhas:
ID
14178
Descrição
Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01976208
Link
https://clinicaltrials.gov/show/NCT01976208
Palavras-chave
Versões (1)
- 03/04/2016 03/04/2016 -
Transferido a
3 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Allergic Asthma NCT01976208
Eligibility Allergic Asthma NCT01976208
- StudyEvent: Eligibility
Similar models
Eligibility Allergic Asthma NCT01976208
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
gender; age
Item
male or female aged 15~65 years
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
informed consent
Item
written informed consent provided
boolean
C0021430 (UMLS CUI [1])
total serum ige
Item
total serum ige >=60iu/ml
boolean
C0797024 (UMLS CUI [1])
allergic asthma
Item
duration of allergic asthma >= 1 year according to gina(2008)
boolean
C0155877 (UMLS CUI [1])
inhaled corticosteroid use; Medication response
Item
poor response to moderate to high dose inhaled corticosteroid (400ug/day~800ug/day) >= 4 weeks
boolean
C0586793 (UMLS CUI [1])
C1319171 (UMLS CUI [2])
C1319171 (UMLS CUI [2])
Contraception status
Item
agreed to be not pregnant, contraception during study and later 6 months.
boolean
C0420837 (UMLS CUI [1])
Exclusion Criteria
Item
patients who met the below criteria were excluded:
boolean
C0680251 (UMLS CUI [1])
smoker
Item
be regular smokers(>10 cigarettes per day and for at least 2 years)
boolean
C1519386 (UMLS CUI [1])
pregnant
Item
patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
boolean
C0032961 (UMLS CUI [1])
copd
Item
copd, according to the guideline of chinese society of respiratory diseases
boolean
C0024117 (UMLS CUI [1])
allergic asthma; Lung diseases
Item
an active lung disease other than allergic asthma
boolean
C0155877 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0024115 (UMLS CUI [2])
significant medical conditions
Item
patients with significant underlying medical conditions
boolean
C3261307 (UMLS CUI [1])
hypersensitivity immunoglobin
Item
allergic to immunoglobin or any formulation ingredient of the product
boolean
C0020517 (UMLS CUI [1,1])
C0021034 (UMLS CUI [1,2])
C0021034 (UMLS CUI [1,2])
diabetes; uncontrolled hypertension; blood pressure
Item
patients with diabetes or uncontrolled hypertension(systolic blood pressure>160mmhg or diastolic blood pressure>95mmhg)
boolean
C0011849 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
C1868885 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
hiv positive; Cancer Patient
Item
hiv positivity or cancer patient
boolean
C0019699 (UMLS CUI [1])
C1516213 (UMLS CUI [2])
C1516213 (UMLS CUI [2])
xolair
Item
prior exposure to xolair
boolean
C1174773 (UMLS CUI [1])