ID

14267

Description

Bronchial Thermoplasty: Mechanism of Action and Defining Asthma Phenotype; ODM derived from: https://clinicaltrials.gov/show/NCT02075151

Link

https://clinicaltrials.gov/show/NCT02075151

Keywords

Versions (2)
  1. 4/6/16 4/6/16 -
  2. 4/6/16 4/6/16 - Julian Varghese
Uploaded on

April 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02075151

English

Eligibility Asthma NCT02075151

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02075151
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females between 21-65 years of age
Description

Age | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
poorly controlled severe persistent asthma (act score < 20) despite high-dose inhaled steroids (>500 mcg fluticasone/day or >800 mcg budesonide/day) in combination with inhaled long-acting beta-2 agonist and/or anticholinergic agent. other drugs include leukotriene modifiers, omalizumab (if used for at least 1 year prior), and oral corticosteroids 10mg/day or less
Description

Severe persistent asthma | Poorly controlled | Asthma control test score | inhaled steroids | fluticasone | Budesonide | Adrenergic beta-2 Receptor Agonists | Anticholinergic Agents | Leukotriene Receptor | agonists | omalizumab | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C1960048
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C2733224
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0082607
UMLS CUI [5]
C0054201
UMLS CUI [6]
C2936789
UMLS CUI [7]
C0242896
UMLS CUI [8,1]
C0206517
UMLS CUI [8,2]
C0243192
UMLS CUI [9]
C0966225
UMLS CUI [10]
C0001617
stopped smoking for > 1 year and <10 pack-years
Description

Stopped smoking | smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0425310
UMLS CUI [2]
C2230126
stable maintenance asthma medications for 4 weeks
Description

Pharmaceutical Preparations | Stable status | Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0004096
pre-bronchodilator fev1 >60 percent predicted
Description

FEV1 | pre bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
males and females <21 and >65 years of age
Description

Age | Out of range | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
presence of pacemaker, internal defibrillator, or other implantable electronic devices
Description

Artificial cardiac pacemaker | Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
patients previously treated with bronchial thermoplasty (bt)
Description

Therapeutic procedure | Bronchial thermoplasty

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3854686
use of immunosuppressant (excluding oral steroids)
Description

Immunosuppressive Agents | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0001617
increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
Description

Risk Assessment | Adverse event | Bronchoscopy | Anesthesia procedures | Pregnancy | Coronary Artery Disease | History of renal failure | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0086930
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0006290
UMLS CUI [3]
C0002903
UMLS CUI [4]
C0032961
UMLS CUI [5]
C1956346
UMLS CUI [6]
C1533077
UMLS CUI [7]
C1868885
inability to cease antiplatelet or anticoagulant therapy prior to procedure
Description

Unable | Stop | Antiplatelet therapy | Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1947925
UMLS CUI [1,3]
C1096021
UMLS CUI [2]
C0150457
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Similar models

Eligibility Asthma NCT02075151

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02075151
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender
Item
males and females between 21-65 years of age
boolean
C0001779 (UMLS CUI [1])
Severe persistent asthma | Poorly controlled | Asthma control test score | inhaled steroids | fluticasone | Budesonide | Adrenergic beta-2 Receptor Agonists | Anticholinergic Agents | Leukotriene Receptor | agonists | omalizumab | Adrenal Cortex Hormones
Item
poorly controlled severe persistent asthma (act score < 20) despite high-dose inhaled steroids (>500 mcg fluticasone/day or >800 mcg budesonide/day) in combination with inhaled long-acting beta-2 agonist and/or anticholinergic agent. other drugs include leukotriene modifiers, omalizumab (if used for at least 1 year prior), and oral corticosteroids 10mg/day or less
boolean
C1960048 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C2733224 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0082607 (UMLS CUI [4])
C0054201 (UMLS CUI [5])
C2936789 (UMLS CUI [6])
C0242896 (UMLS CUI [7])
C0206517 (UMLS CUI [8,1])
C0243192 (UMLS CUI [8,2])
C0966225 (UMLS CUI [9])
C0001617 (UMLS CUI [10])
Stopped smoking | smoking cigarettes: ____ pack-years history
Item
stopped smoking for > 1 year and <10 pack-years
boolean
C0425310 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Pharmaceutical Preparations | Stable status | Asthma
Item
stable maintenance asthma medications for 4 weeks
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2])
FEV1 | pre bronchodilator
Item
pre-bronchodilator fev1 >60 percent predicted
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age | Out of range | Gender
Item
males and females <21 and >65 years of age
boolean
C0001779 (UMLS CUI [1])
Artificial cardiac pacemaker | Implantable defibrillator
Item
presence of pacemaker, internal defibrillator, or other implantable electronic devices
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
Therapeutic procedure | Bronchial thermoplasty
Item
patients previously treated with bronchial thermoplasty (bt)
boolean
C0087111 (UMLS CUI [1,1])
C3854686 (UMLS CUI [1,2])
Immunosuppressive Agents | Adrenal Cortex Hormones
Item
use of immunosuppressant (excluding oral steroids)
boolean
C0021081 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Risk Assessment | Adverse event | Bronchoscopy | Anesthesia procedures | Pregnancy | Coronary Artery Disease | History of renal failure | Uncontrolled hypertension
Item
increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
boolean
C0086930 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0006290 (UMLS CUI [2])
C0002903 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
C1533077 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
Unable | Stop | Antiplatelet therapy | Anticoagulant therapy
Item
inability to cease antiplatelet or anticoagulant therapy prior to procedure
boolean
C1299582 (UMLS CUI [1,1])
C1947925 (UMLS CUI [1,2])
C1096021 (UMLS CUI [1,3])
C0150457 (UMLS CUI [2])
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