ID

14514

Beschreibung

Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00213252

Link

https://clinicaltrials.gov/show/NCT00213252

Stichworte

Versionen (1)
  1. 19.04.16 19.04.16 -
Hochgeladen am

19. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma, Bronchial NCT00213252

Englisch

Eligibility Asthma, Bronchial NCT00213252

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 2-17 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of mild to moderate asthma as a second wheezing episode associated with signs of respiratory distress suggesting lower airway obstruction such as tachypnea and/or use of accessory muscles of respiration.
Beschreibung

Mild asthma | Moderate asthma | Wheezing | Respiratory distress | Lower airway obstruction | Tachypnea | Accessory respiratory muscles used

Datentyp

boolean

Alias
UMLS CUI [1]
C0581124
UMLS CUI [2]
C0581125
UMLS CUI [3]
C0043144
UMLS CUI [4]
C0476273
UMLS CUI [5]
C2242492
UMLS CUI [6]
C0231835
UMLS CUI [7]
C0425468
baseline pulmonary index clinical score (appendix b) ≤ 11 out of 15 possible points as well as pram ≤ 8 out of 12 points.
Beschreibung

Respiratory index Score | Respiratory assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0451423
UMLS CUI [1,2]
C0449820
UMLS CUI [2]
C0549075
presenting to the sick kids emergency department
Beschreibung

Hospital emergency department

Datentyp

boolean

Alias
UMLS CUI [1]
C3840745
children capable of fev1 measurement will have fev1 more than 60% of the predicted value
Beschreibung

FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
male or female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
willing and able to provide informed consent (or informed consent by parents)
Beschreibung

Informed Consent | parent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0030551
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no previous history of wheezing or bronchodilator therapy. this population may eventually have diagnoses other than asthma or viral induced wheezing
Beschreibung

Wheezing | Inhaled bronchodilator therapy | Asthma | Viral Wheezing

Datentyp

boolean

Alias
UMLS CUI [1]
C0043144
UMLS CUI [2]
C0578554
UMLS CUI [3]
C0004096
UMLS CUI [4,1]
C0521026
UMLS CUI [4,2]
C0043144
patients who received more than a single dose of oral corticosteroids within 72 hours prior to arrival
Beschreibung

Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
patients receiving more than 500 mcg per day of fluticasone for more than 1 month or more than 250 mcg of fluticasone for more than 7 days prior to arrival
Beschreibung

fluticasone

Datentyp

boolean

Alias
UMLS CUI [1]
C0082607
patients who have had more than 2 previous visits to the asthma clinic at sickkids
Beschreibung

Previous Patient Visit Asthma clinic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1512346
UMLS CUI [1,3]
C3838770
patients who received montelukast within one week of arrival
Beschreibung

montelukast

Datentyp

boolean

Alias
UMLS CUI [1]
C0298130
critically ill patients requiring airway stabilization
Beschreibung

Critical Illness | Airway Stabilization

Datentyp

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2,1]
C0458827
UMLS CUI [2,2]
C1293130
patients with severe asthma, defined as pi 12 to 15 or pram 9 to 12.
Beschreibung

Severe asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0581126
co-existent co-morbidities such as chronic pulmonary disease and cardiac disease requiring pharmacotherapy, neurologic disease and immune disorders.
Beschreibung

Comorbidity | Other chronic pulmonary disease | Heart Diseases Pharmacotherapy | nervous system disorder | Immune System Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0810290
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0013216
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0021053
previous admission to icu for asthma.
Beschreibung

Admission to intensive care unit Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0583239
UMLS CUI [1,2]
C0004096
more than 3 hospitalizations for asthma during the past 12 months.
Beschreibung

Hospitalization Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
contact with varicella within the previous 21 days.
Beschreibung

Contact with or exposure to varicella

Datentyp

boolean

Alias
UMLS CUI [1]
C1455968
insufficient command of the english language
Beschreibung

Comprehension English Language Insufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0231180
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Ähnliche Modelle

Eligibility Asthma, Bronchial NCT00213252

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 2-17 years
boolean
C0001779 (UMLS CUI [1])
Mild asthma | Moderate asthma | Wheezing | Respiratory distress | Lower airway obstruction | Tachypnea | Accessory respiratory muscles used
Item
clinical diagnosis of mild to moderate asthma as a second wheezing episode associated with signs of respiratory distress suggesting lower airway obstruction such as tachypnea and/or use of accessory muscles of respiration.
boolean
C0581124 (UMLS CUI [1])
C0581125 (UMLS CUI [2])
C0043144 (UMLS CUI [3])
C0476273 (UMLS CUI [4])
C2242492 (UMLS CUI [5])
C0231835 (UMLS CUI [6])
C0425468 (UMLS CUI [7])
Respiratory index Score | Respiratory assessment
Item
baseline pulmonary index clinical score (appendix b) ≤ 11 out of 15 possible points as well as pram ≤ 8 out of 12 points.
boolean
C0451423 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0549075 (UMLS CUI [2])
Hospital emergency department
Item
presenting to the sick kids emergency department
boolean
C3840745 (UMLS CUI [1])
FEV1
Item
children capable of fev1 measurement will have fev1 more than 60% of the predicted value
boolean
C0748133 (UMLS CUI [1])
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Informed Consent | parent
Item
willing and able to provide informed consent (or informed consent by parents)
boolean
C0021430 (UMLS CUI [1])
C0030551 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Wheezing | Inhaled bronchodilator therapy | Asthma | Viral Wheezing
Item
no previous history of wheezing or bronchodilator therapy. this population may eventually have diagnoses other than asthma or viral induced wheezing
boolean
C0043144 (UMLS CUI [1])
C0578554 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
C0521026 (UMLS CUI [4,1])
C0043144 (UMLS CUI [4,2])
Adrenal Cortex Hormones
Item
patients who received more than a single dose of oral corticosteroids within 72 hours prior to arrival
boolean
C0001617 (UMLS CUI [1])
fluticasone
Item
patients receiving more than 500 mcg per day of fluticasone for more than 1 month or more than 250 mcg of fluticasone for more than 7 days prior to arrival
boolean
C0082607 (UMLS CUI [1])
Previous Patient Visit Asthma clinic
Item
patients who have had more than 2 previous visits to the asthma clinic at sickkids
boolean
C0205156 (UMLS CUI [1,1])
C1512346 (UMLS CUI [1,2])
C3838770 (UMLS CUI [1,3])
montelukast
Item
patients who received montelukast within one week of arrival
boolean
C0298130 (UMLS CUI [1])
Critical Illness | Airway Stabilization
Item
critically ill patients requiring airway stabilization
boolean
C0010340 (UMLS CUI [1])
C0458827 (UMLS CUI [2,1])
C1293130 (UMLS CUI [2,2])
Severe asthma
Item
patients with severe asthma, defined as pi 12 to 15 or pram 9 to 12.
boolean
C0581126 (UMLS CUI [1])
Comorbidity | Other chronic pulmonary disease | Heart Diseases Pharmacotherapy | nervous system disorder | Immune System Diseases
Item
co-existent co-morbidities such as chronic pulmonary disease and cardiac disease requiring pharmacotherapy, neurologic disease and immune disorders.
boolean
C0009488 (UMLS CUI [1])
C0810290 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
Admission to intensive care unit Asthma
Item
previous admission to icu for asthma.
boolean
C0583239 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Hospitalization Asthma
Item
more than 3 hospitalizations for asthma during the past 12 months.
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Contact with or exposure to varicella
Item
contact with varicella within the previous 21 days.
boolean
C1455968 (UMLS CUI [1])
Comprehension English Language Insufficient
Item
insufficient command of the english language
boolean
C0162340 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
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