ID

14461

Description

Breath Analysis in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02450461

Link

https://clinicaltrials.gov/show/NCT02450461

Keywords

  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 NCT02450461

Eligibility Asthma NCT02450461

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02450461
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed asthma. diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in fev1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (pc20 methacholine < 4mg/ml) at the time of diagnosis.
Description

Asthma | Chest symptom/complaint | Forced Expiratory Volume in 1 Second Reversibility | Inhaled albuterol preparation | Bronchial Hyperreactivity | Lung function testing normal | Methacholine

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0497258
UMLS CUI [3]
C3830088
UMLS CUI [4]
C0354688
UMLS CUI [5]
C0085129
UMLS CUI [6]
C0438186
UMLS CUI [7]
C0600370
2. age between 18 and 80 years at study entry.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. healthy controls: never-smokers, normal spirometry (baseline fev1 > 85% predicted and fev1/fvc greater than 0.7).
Description

Healthy Control | Never smoked tobacco | Spirometry normal | FEV1 | Forced vital capacity - finding

Data type

boolean

Alias
UMLS CUI [1]
C2986479
UMLS CUI [2]
C0425293
UMLS CUI [3]
C0855776
UMLS CUI [4]
C0748133
UMLS CUI [5]
C1287681
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids)
Description

Exacerbation of asthma | Therapy change | Change in asthma management plan | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C3665894
UMLS CUI [3]
C1272202
UMLS CUI [4]
C0001617
2. any lung disease other than asthma.
Description

Lung diseases | Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004096
3. acute inflammatory disease (e.g. common cold) within the last 4 weeks.
Description

Acute inflammatory disease | Common Cold

Data type

boolean

Alias
UMLS CUI [1]
C1290885
UMLS CUI [2]
C0009443
4. regular intake of oral steroids.
Description

Intake Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0001617
5. active smoking habits / positive history of smoking.
Description

Smoking | Smoking History

Data type

boolean

Alias
UMLS CUI [1]
C0037369
UMLS CUI [2]
C1519384
6. acute or chronic hepatic disease.
Description

Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
7. renal failure or renal replacement therapy.
Description

Kidney Failure | Renal Replacement Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0206074
8. pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Asthma NCT02450461

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02450461
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Chest symptom/complaint | Forced Expiratory Volume in 1 Second Reversibility | Inhaled albuterol preparation | Bronchial Hyperreactivity | Lung function testing normal | Methacholine
Item
1. confirmed asthma. diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in fev1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (pc20 methacholine < 4mg/ml) at the time of diagnosis.
boolean
C0004096 (UMLS CUI [1])
C0497258 (UMLS CUI [2])
C3830088 (UMLS CUI [3])
C0354688 (UMLS CUI [4])
C0085129 (UMLS CUI [5])
C0438186 (UMLS CUI [6])
C0600370 (UMLS CUI [7])
Age
Item
2. age between 18 and 80 years at study entry.
boolean
C0001779 (UMLS CUI [1])
Healthy Control | Never smoked tobacco | Spirometry normal | FEV1 | Forced vital capacity - finding
Item
3. healthy controls: never-smokers, normal spirometry (baseline fev1 > 85% predicted and fev1/fvc greater than 0.7).
boolean
C2986479 (UMLS CUI [1])
C0425293 (UMLS CUI [2])
C0855776 (UMLS CUI [3])
C0748133 (UMLS CUI [4])
C1287681 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Exacerbation of asthma | Therapy change | Change in asthma management plan | Adrenal Cortex Hormones
Item
1. asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids)
boolean
C0349790 (UMLS CUI [1])
C3665894 (UMLS CUI [2])
C1272202 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
Lung diseases | Asthma
Item
2. any lung disease other than asthma.
boolean
C0024115 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Acute inflammatory disease | Common Cold
Item
3. acute inflammatory disease (e.g. common cold) within the last 4 weeks.
boolean
C1290885 (UMLS CUI [1])
C0009443 (UMLS CUI [2])
Intake Adrenal Cortex Hormones
Item
4. regular intake of oral steroids.
boolean
C1512806 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Smoking | Smoking History
Item
5. active smoking habits / positive history of smoking.
boolean
C0037369 (UMLS CUI [1])
C1519384 (UMLS CUI [2])
Liver diseases
Item
6. acute or chronic hepatic disease.
boolean
C0023895 (UMLS CUI [1])
Kidney Failure | Renal Replacement Therapy
Item
7. renal failure or renal replacement therapy.
boolean
C0035078 (UMLS CUI [1])
C0206074 (UMLS CUI [2])
Pregnancy
Item
8. pregnancy.
boolean
C0032961 (UMLS CUI [1])

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