ID

14463

Description

Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations; ODM derived from: https://clinicaltrials.gov/show/NCT02464995

Link

https://clinicaltrials.gov/show/NCT02464995

Keywords

Versions (1)
  1. 4/16/16 4/16/16 -
Uploaded on

April 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02464995

English

Eligibility Asthma NCT02464995

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02464995
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
asthma which requires treatment with guidelines suggested medications for gina steps 4-5
Description

Asthma Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0087111
four or more bursts of systemic corticosteroids >3 days each in the previous year
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
willingness and ability to give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current smoker and former smoker > 10 pack years total smoking history
Description

Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C2230126
participation in another clinical trial within the prior 4 months
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
omalizumab therapy within the prior 4 months
Description

omalizumab Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C0087111
allergic bronchopulmonary aspergillosis
Description

Aspergillosis, Allergic Bronchopulmonary

Data type

boolean

Alias
UMLS CUI [1]
C0004031
patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (> 60 mg equivalent prednisolone) more than one month in the previous year
Description

Exacerbation of severe persistent asthma | Adrenal Cortex Hormones | prednisolone

Data type

boolean

Alias
UMLS CUI [1]
C3508930
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0032950
post-bronchodilator fev1 of less than 30%
Description

post bronchodilator FEV1

Data type

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0748133
past diagnosis of copd and chronic respiratory insufficiency
Description

Chronic Obstructive Airway Disease | Chronic respiratory insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C1998122
known coagulopathy or platelet dysfunction
Description

Blood Coagulation Disorders | Platelet dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0679429
use of anticoagulants
Description

Use of Anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0003280
use of an internal or external pacemaker or internal cardiac defibrillator
Description

Pacemakers, Cardiac, Implantable | External cardiac pacemaker | Implantation of internal cardiac defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0182148
UMLS CUI [2]
C0810585
UMLS CUI [3]
C1273352
contraindication to perform bronchoscopy
Description

Medical contraindication Bronchoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0006290
contraindication to perform general anesthesia
Description

Medical contraindication General Anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002915
significant cardiovascular disease
Description

Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
current or recent respiratory tract infection resolved less than 4 weeks
Description

Respiratory Tract Infections

Data type

boolean

Alias
UMLS CUI [1]
C0035243
known cancer or cancer history less than 12 months
Description

Malignant Neoplasms | Individual Cancer History

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1512706
pregnancy and nursing mother
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Asthma NCT02464995

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02464995
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-65 years
boolean
C0001779 (UMLS CUI [1])
Asthma Therapeutic procedure
Item
asthma which requires treatment with guidelines suggested medications for gina steps 4-5
boolean
C0004096 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
systemic steroids
Item
four or more bursts of systemic corticosteroids >3 days each in the previous year
boolean
C2825233 (UMLS CUI [1])
Informed Consent
Item
willingness and ability to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history
Item
current smoker and former smoker > 10 pack years total smoking history
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Study Subject Participation Status
Item
participation in another clinical trial within the prior 4 months
boolean
C2348568 (UMLS CUI [1])
omalizumab Therapeutic procedure
Item
omalizumab therapy within the prior 4 months
boolean
C0966225 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Aspergillosis, Allergic Bronchopulmonary
Item
allergic bronchopulmonary aspergillosis
boolean
C0004031 (UMLS CUI [1])
Exacerbation of severe persistent asthma | Adrenal Cortex Hormones | prednisolone
Item
patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (> 60 mg equivalent prednisolone) more than one month in the previous year
boolean
C3508930 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0032950 (UMLS CUI [3])
post bronchodilator FEV1
Item
post-bronchodilator fev1 of less than 30%
boolean
C2599594 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease | Chronic respiratory insufficiency
Item
past diagnosis of copd and chronic respiratory insufficiency
boolean
C0024117 (UMLS CUI [1])
C1998122 (UMLS CUI [2])
Blood Coagulation Disorders | Platelet dysfunction
Item
known coagulopathy or platelet dysfunction
boolean
C0005779 (UMLS CUI [1])
C0679429 (UMLS CUI [2])
Use of Anticoagulants
Item
use of anticoagulants
boolean
C1524063 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
Pacemakers, Cardiac, Implantable | External cardiac pacemaker | Implantation of internal cardiac defibrillator
Item
use of an internal or external pacemaker or internal cardiac defibrillator
boolean
C0182148 (UMLS CUI [1])
C0810585 (UMLS CUI [2])
C1273352 (UMLS CUI [3])
Medical contraindication Bronchoscopy
Item
contraindication to perform bronchoscopy
boolean
C1301624 (UMLS CUI [1,1])
C0006290 (UMLS CUI [1,2])
Medical contraindication General Anesthesia
Item
contraindication to perform general anesthesia
boolean
C1301624 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
Cardiovascular Diseases
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Respiratory Tract Infections
Item
current or recent respiratory tract infection resolved less than 4 weeks
boolean
C0035243 (UMLS CUI [1])
Malignant Neoplasms | Individual Cancer History
Item
known cancer or cancer history less than 12 months
boolean
C0006826 (UMLS CUI [1])
C1512706 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy and nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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