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Eligibility Asthma NCT02424552

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02424552
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients, age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a pulmonary specialist documented diagnosis of severe asthma according to the global initiative for asthma and the german asthma network (gan, www.german-asthma-net.de)
Description

Severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581126
treatment with long-acting β2-agonists (laba) and inhaled corticosteroids (ics) at a dose of at least 1000 µg beclomethasone (or equivalent) per day, - chronic oral corticosteroid (ocs) use is allowed stable asthma medication for ≥1 month prior to screening (≥4 months for omalizumab)
Description

Therapeutic procedure Adrenergic beta-2 Receptor Agonists | inhaled steroids | inhaled beclomethasone | Adrenal Cortex Hormones chronic | Stable status Pharmaceutical Preparations Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2936789
UMLS CUI [2]
C2065041
UMLS CUI [3]
C2065042
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0205360
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0004096
asthma control questionnaire (acq-5) score ≥ 1.5
Description

Asthma control questionnaire Score

Data type

boolean

Alias
UMLS CUI [1,1]
C2919686
UMLS CUI [1,2]
C0449820
vitamin d insufficiency as defined by a serum vitamin d concentration of < 30 ng/ml but ≥ 10 ng/ml at screening
Description

Vitamin D Insufficiency Serum vitamin D measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C0231179
UMLS CUI [1,3]
C0428586
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients on vitamin d substitution
Description

Vitamin D Substitution Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C1547587
current smokers or ex-smokers with a smoking history of more than 10 pack-years
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
pregnant or nursing women or women who intend to become pregnant during the study
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
known impaired renal function (gfr < 30 ml/min) and history of physician-diagnosed nephrolithiasis
Description

Renal Insufficiency | Glomerular Filtration Rate | Nephrolithiasis

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0017654
UMLS CUI [3]
C0392525
use of other investigational drugs during the study or within 30 days of screening
Description

Other Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Asthma NCT02424552

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02424552
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients, age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Severe asthma
Item
a pulmonary specialist documented diagnosis of severe asthma according to the global initiative for asthma and the german asthma network (gan, www.german-asthma-net.de)
boolean
C0581126 (UMLS CUI [1])
Therapeutic procedure Adrenergic beta-2 Receptor Agonists | inhaled steroids | inhaled beclomethasone | Adrenal Cortex Hormones chronic | Stable status Pharmaceutical Preparations Asthma
Item
treatment with long-acting β2-agonists (laba) and inhaled corticosteroids (ics) at a dose of at least 1000 µg beclomethasone (or equivalent) per day, - chronic oral corticosteroid (ocs) use is allowed stable asthma medication for ≥1 month prior to screening (≥4 months for omalizumab)
boolean
C0087111 (UMLS CUI [1,1])
C2936789 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C2065042 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0205360 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0004096 (UMLS CUI [5,3])
Asthma control questionnaire Score
Item
asthma control questionnaire (acq-5) score ≥ 1.5
boolean
C2919686 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Vitamin D Insufficiency Serum vitamin D measurement
Item
vitamin d insufficiency as defined by a serum vitamin d concentration of < 30 ng/ml but ≥ 10 ng/ml at screening
boolean
C0042866 (UMLS CUI [1,1])
C0231179 (UMLS CUI [1,2])
C0428586 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Vitamin D Substitution Status
Item
patients on vitamin d substitution
boolean
C0042866 (UMLS CUI [1,1])
C1547587 (UMLS CUI [1,2])
Current Smoker | Former smoker Smoking cigarettes: ____ pack-years history
Item
current smokers or ex-smokers with a smoking history of more than 10 pack-years
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or nursing women or women who intend to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Renal Insufficiency | Glomerular Filtration Rate | Nephrolithiasis
Item
known impaired renal function (gfr < 30 ml/min) and history of physician-diagnosed nephrolithiasis
boolean
C1565489 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
C0392525 (UMLS CUI [3])
Other Investigational New Drugs
Item
use of other investigational drugs during the study or within 30 days of screening
boolean
C0205394 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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