ID

31390

Beschreibung

Rapid Onset Action of Salbutamol Versus Formoterol; ODM derived from: https://clinicaltrials.gov/show/NCT00900874

Link

https://clinicaltrials.gov/show/NCT00900874

Stichworte

Versionen (1)
  1. 18.08.18 18.08.18 -
Rechteinhaber

see clinicaltrials.gov

Hochgeladen am

18. August 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT00900874

Englisch

Eligibility Bronchial Asthma NCT00900874

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or pediatric opd
Beschreibung

Child; Age | Gender | Therapeutic procedure; Indication; Exacerbation of asthma; Mild (qualifier value) | Pediatric clinic | Outpatients; Pediatric

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C3146298
UMLS CUI [3,3]
C0349790
UMLS CUI [3,4]
C2945599
UMLS CUI [4]
C3839701
UMLS CUI [5,1]
C0029921
UMLS CUI [5,2]
C1521725
2. mild exacerbation will be defined as:
Beschreibung

Exacerbation of asthma; Mild (qualifier value); Definition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C1704788
children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration
Beschreibung

ID.3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4062507
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0010200
UMLS CUI [3]
C0043144
UMLS CUI [4]
C0013404
no chest indrawing
Beschreibung

Indrawing of ribs during respiration

Datentyp

boolean

Alias
UMLS CUI [1]
C0425469
no difficulty in speech
Beschreibung

Speech impairment

Datentyp

boolean

Alias
UMLS CUI [1]
C0233715
clinical asthma score (or pulmonary index score-annexure 1) between 6-9
Beschreibung

ID.6

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449820
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C2709248
UMLS CUI [2,2]
C0918012
UMLS CUI [2,3]
C0449820
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. children with life threatening asthma detected by presence of any of the following:
Beschreibung

ID.7

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C2826244
severe chest indrawing
Beschreibung

Indrawing of ribs during respiration; Severe (severity modifier)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0425469
UMLS CUI [1,2]
C0205082
cyanosis
Beschreibung

cyanosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0010520
irregular respiration
Beschreibung

Respiration; Irregular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035203
UMLS CUI [1,2]
C0205271
altered sensorium
Beschreibung

Sensation quality; Changing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1455667
UMLS CUI [1,2]
C0392747
2. children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
Beschreibung

Child | Chronic disease of respiratory system; Other | Tuberculosis | Cystic Fibrosis | Acute illness; Other | Current Therapy; Complicated | Disease Response; Asthma; Complicated

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0264220
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0041296
UMLS CUI [4]
C0010674
UMLS CUI [5,1]
C4061114
UMLS CUI [5,2]
C0205394
UMLS CUI [6,1]
C2827774
UMLS CUI [6,2]
C0231242
UMLS CUI [7,1]
C1704632
UMLS CUI [7,2]
C0004096
UMLS CUI [7,3]
C0231242
3. if child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
Beschreibung

Albuterol; Time | Adrenergic beta-Agonists; Long duration | formoterol | salmeterol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001927
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0001644
UMLS CUI [2,2]
C0439591
UMLS CUI [3]
C0060657
UMLS CUI [4]
C0073992
4. child not able to perform spirometry
Beschreibung

Child; Spirometry; Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0037981
UMLS CUI [1,3]
C1299582
5. parents refusing to give consent
Beschreibung

Informed Consent; parent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
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Ähnliche Modelle

Eligibility Bronchial Asthma NCT00900874

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Child; Age | Gender | Therapeutic procedure; Indication; Exacerbation of asthma; Mild (qualifier value) | Pediatric clinic | Outpatients; Pediatric
Item
1. children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or pediatric opd
boolean
C0008059 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0349790 (UMLS CUI [3,3])
C2945599 (UMLS CUI [3,4])
C3839701 (UMLS CUI [4])
C0029921 (UMLS CUI [5,1])
C1521725 (UMLS CUI [5,2])
Exacerbation of asthma; Mild (qualifier value); Definition
Item
2. mild exacerbation will be defined as:
boolean
C0349790 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
ID.3
Item
children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration
boolean
C4062507 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0010200 (UMLS CUI [2])
C0043144 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
Indrawing of ribs during respiration
Item
no chest indrawing
boolean
C0425469 (UMLS CUI [1])
Speech impairment
Item
no difficulty in speech
boolean
C0233715 (UMLS CUI [1])
ID.6
Item
clinical asthma score (or pulmonary index score-annexure 1) between 6-9
boolean
C0004096 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C2709248 (UMLS CUI [2,1])
C0918012 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
1. children with life threatening asthma detected by presence of any of the following:
boolean
C0008059 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
Indrawing of ribs during respiration; Severe (severity modifier)
Item
severe chest indrawing
boolean
C0425469 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
cyanosis
Item
cyanosis
boolean
C0010520 (UMLS CUI [1])
Respiration; Irregular
Item
irregular respiration
boolean
C0035203 (UMLS CUI [1,1])
C0205271 (UMLS CUI [1,2])
Sensation quality; Changing
Item
altered sensorium
boolean
C1455667 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Child | Chronic disease of respiratory system; Other | Tuberculosis | Cystic Fibrosis | Acute illness; Other | Current Therapy; Complicated | Disease Response; Asthma; Complicated
Item
2. children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
boolean
C0008059 (UMLS CUI [1])
C0264220 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0041296 (UMLS CUI [3])
C0010674 (UMLS CUI [4])
C4061114 (UMLS CUI [5,1])
C0205394 (UMLS CUI [5,2])
C2827774 (UMLS CUI [6,1])
C0231242 (UMLS CUI [6,2])
C1704632 (UMLS CUI [7,1])
C0004096 (UMLS CUI [7,2])
C0231242 (UMLS CUI [7,3])
Albuterol; Time | Adrenergic beta-Agonists; Long duration | formoterol | salmeterol
Item
3. if child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
boolean
C0001927 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0001644 (UMLS CUI [2,1])
C0439591 (UMLS CUI [2,2])
C0060657 (UMLS CUI [3])
C0073992 (UMLS CUI [4])
Child; Spirometry; Unable
Item
4. child not able to perform spirometry
boolean
C0008059 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Informed Consent; parent
Item
5. parents refusing to give consent
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
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