ID

14503

Descripción

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

Palabras clave

Versiones (1)
  1. 19/4/16 19/4/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

19 de abril de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00675649

Inglés

Eligibility Asthma NCT00675649

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00675649
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
physician diagnosis of asthma for >= 3 years and a diagnosis of severe, persistent asthma for >= 1 year prior to screening
Descripción

severe persistent asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1960048
reversible airway obstruction
Descripción

reversible airway obstruction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001883
UMLS CUI [1,2]
C0205343
continuous treatment with high dose inhaled corticosteroids and long-acting beta2-agonist for at least 3 months prior to screening
Descripción

inhaled steroids and long-acting beta-2 agonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C1373132
at least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral)
Descripción

asthma worsening

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457868
UMLS CUI [2]
C0038317
score of >= 2 points on the asthma control questionnaire (acq) at screening
Descripción

asthma control questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2919686
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of chronic obstructive pulmonary disease (copd), cystic fibrosis, or other significant respiratory disorder
Descripción

respiratory disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035204
life-threatening asthma attack requiring intubation in the 6-month period prior to screening
Descripción

life-threatening asthma requiring intubation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0040223
steroid use at a dose > 20 mg of prednisone at the screening visit
Descripción

steroid prednisone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0032952
known malignancy or history of malignancy
Descripción

malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
previous exposure to anti-tnf therapies
Descripción

previous exposure to anti-tnf therapies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0281481
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Similar models

Eligibility Asthma NCT00675649

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00675649
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
reversible airway obstruction
Item
reversible airway obstruction
boolean
C0001883 (UMLS CUI [1,1])
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])
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])
asthma control questionnaire
Item
score of >= 2 points on the asthma control questionnaire (acq) at screening
boolean
C2919686 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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