ID

44332

Beskrivning

Leukotriene D4 Bronchial Provocation Test (LTD4-BPT) as an Indicator for the Use of Leukotriene Receptor Antagonist (LTRA); ODM derived from: https://clinicaltrials.gov/show/NCT01414868

Länk

https://clinicaltrials.gov/show/NCT01414868

Nyckelord

Versioner (3)
  1. 2019-10-21 2019-10-21 -
  2. 2019-10-21 2019-10-21 -
  3. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT01414868

Engelsk

Eligibility Bronchial Asthma NCT01414868

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged between 18 and 65，without acute upper respiratory tract infection for the past 2 weeks
Beskrivning

Age | Upper Respiratory Infection Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0041912
UMLS CUI [2,2]
C0332197
had a normal chest radiographic result
Beskrivning

Chest X-ray Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0205307
had a baseline spirometry with the forced expiratory volume in one second (fev1) of not less than 60% predicted
Beskrivning

Percent predicted FEV1 Spirometry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730561
UMLS CUI [1,2]
C0037981
had withheld leukotriene receptor antagonists (ltra) for over 5 days
Beskrivning

Withholding Treatment | Leukotriene Receptor Antagonist

Datatyp

boolean

Alias
UMLS CUI [1]
C0871549
UMLS CUI [2]
C3537183
oral glucocorticosteroid or anti-histamine for 3 days
Beskrivning

Withholding Treatment | Glucocorticoids Oral | Antihistamines Oral

Datatyp

boolean

Alias
UMLS CUI [1]
C0871549
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0019590
UMLS CUI [3,2]
C1527415
oral xanthenes or long-acting bronchodilators for 2 days
Beskrivning

Withholding Treatment | Xanthenes Oral | Bronchodilator Agents Active Long-term

Datatyp

boolean

Alias
UMLS CUI [1]
C0871549
UMLS CUI [2,1]
C0043313
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0006280
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
inhaled corticosteroid or long-acting bronchodilator for a day as well as short-acting bronchodilator for 4 hours prior to the measurement
Beskrivning

Withholding Treatment | Adrenal Cortex Hormones by Inhalation | Bronchodilator Agents Active Long-term | Bronchodilator Agents Active short-term

Datatyp

boolean

Alias
UMLS CUI [1]
C0871549
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205535
UMLS CUI [3,1]
C0006280
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
UMLS CUI [4,1]
C0006280
UMLS CUI [4,2]
C0205177
UMLS CUI [4,3]
C0443303
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects had a fall of no less than 15% in fev1 after repetitive forced respiration or a fall of no less than 20% in fev1 after the inhalation of ethanol diluent control
Beskrivning

C1875022

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4272903
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0035203
UMLS CUI [2,3]
C0441722
UMLS CUI [2,4]
C0205341
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0001962
UMLS CUI [3,4]
C1875022
UMLS CUI [3,5]
C0243148
had a past confirmed history of respiratory disease other than bronchial asthma (copd, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）
Beskrivning

Respiration Disorder | Exception Asthma | Chronic Obstructive Airway Disease | Bronchiectasis | Pulmonary Thromboembolism | Systemic disease Severe | Myocardial Infarction | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004096
UMLS CUI [3]
C0024117
UMLS CUI [4]
C0006267
UMLS CUI [5]
C0524702
UMLS CUI [6,1]
C0442893
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0027051
UMLS CUI [8]
C0006826
had a poor cooperation to the test or limited understandings, were immunocompromised, or had participated other clinical trials for the past 3 months.
Beskrivning

Poor compliance Laboratory Procedures | Comprehension Limited | Immunocompromised patient | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0439801
UMLS CUI [3]
C0085393
UMLS CUI [4]
C2348568
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Similar models

Eligibility Bronchial Asthma NCT01414868

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Upper Respiratory Infection Absent
Item
subjects aged between 18 and 65，without acute upper respiratory tract infection for the past 2 weeks
boolean
C0001779 (UMLS CUI [1])
C0041912 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Chest X-ray Normal
Item
had a normal chest radiographic result
boolean
C0039985 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Percent predicted FEV1 Spirometry
Item
had a baseline spirometry with the forced expiratory volume in one second (fev1) of not less than 60% predicted
boolean
C0730561 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Withholding Treatment | Leukotriene Receptor Antagonist
Item
had withheld leukotriene receptor antagonists (ltra) for over 5 days
boolean
C0871549 (UMLS CUI [1])
C3537183 (UMLS CUI [2])
Withholding Treatment | Glucocorticoids Oral | Antihistamines Oral
Item
oral glucocorticosteroid or anti-histamine for 3 days
boolean
C0871549 (UMLS CUI [1])
C0017710 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0019590 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Withholding Treatment | Xanthenes Oral | Bronchodilator Agents Active Long-term
Item
oral xanthenes or long-acting bronchodilators for 2 days
boolean
C0871549 (UMLS CUI [1])
C0043313 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0006280 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Withholding Treatment | Adrenal Cortex Hormones by Inhalation | Bronchodilator Agents Active Long-term | Bronchodilator Agents Active short-term
Item
inhaled corticosteroid or long-acting bronchodilator for a day as well as short-acting bronchodilator for 4 hours prior to the measurement
boolean
C0871549 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C0006280 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0006280 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
FEV1 decreased Percentage | Status post Respiration Forced Repeated | Status post Inhalation Ethanol Diluent control
Item
subjects had a fall of no less than 15% in fev1 after repetitive forced respiration or a fall of no less than 20% in fev1 after the inhalation of ethanol diluent control
boolean
C4272903 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0035203 (UMLS CUI [2,2])
C0441722 (UMLS CUI [2,3])
C0205341 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0001962 (UMLS CUI [3,3])
C1875022 (UMLS CUI [3,4])
C0243148 (UMLS CUI [3,5])
Respiration Disorder | Exception Asthma | Chronic Obstructive Airway Disease | Bronchiectasis | Pulmonary Thromboembolism | Systemic disease Severe | Myocardial Infarction | Malignant Neoplasms
Item
had a past confirmed history of respiratory disease other than bronchial asthma (copd, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.）
boolean
C0035204 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0024117 (UMLS CUI [3])
C0006267 (UMLS CUI [4])
C0524702 (UMLS CUI [5])
C0442893 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0027051 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
Poor compliance Laboratory Procedures | Comprehension Limited | Immunocompromised patient | Study Subject Participation Status
Item
had a poor cooperation to the test or limited understandings, were immunocompromised, or had participated other clinical trials for the past 3 months.
boolean
C0032646 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0085393 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
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