ID

38482

Beschreibung

Effects of Montelukast in Asthmatic Children With and Without Food Allergy; ODM derived from: https://clinicaltrials.gov/show/NCT01618929

Link

https://clinicaltrials.gov/show/NCT01618929

Stichworte

Versionen (1)
  1. 21.10.19 21.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Oktober 2019

DOI

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Eligibility Bronchial Asthma NCT01618929

Englisch

Eligibility Bronchial Asthma NCT01618929

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
physician diagnosed asthma (12% reversibility on spirometry test or positive response to provocholine® provocation test).
Beschreibung

Asthma | Spirometry reversibility Percentage | Response Positive Provocholine Provocation Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C1272658
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C1514241
UMLS CUI [3,3]
C0722884
UMLS CUI [3,4]
C0006265
mild to moderate asthmatic children. asthmatic children with pre-budesonide fev1/fvc
Beschreibung

Mild asthma Children | Moderate asthma Children | FEV1/FVC | Status pre- Budesonide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0581124
UMLS CUI [1,2]
C0008059
UMLS CUI [2,1]
C0581125
UMLS CUI [2,2]
C0008059
UMLS CUI [3]
C3815113
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C0054201
≥ 80% will be included.
Beschreibung

ID.3

Datentyp

boolean

at least one food allergy confirmed by specific ige level or skin prick test positivity and a relevant clinical history or open challenge test with food.
Beschreibung

Food Allergy Quantity | Immunoglobulin E measurement | Skin prick test Positive | History of clinical finding | Challenge test Food

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016470
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0202086
UMLS CUI [3,1]
C0430561
UMLS CUI [3,2]
C1514241
UMLS CUI [4]
C2317559
UMLS CUI [5,1]
C1315011
UMLS CUI [5,2]
C0016452
aged between 6-18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
acceptance of involvement in the study and signed informed consent (both patients and one of the parents)
Beschreibung

Informed Consent | Informed Consent Parent

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
who does not sign the informed consent.
Beschreibung

Informed Consent Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
severe asthmatic children
Beschreibung

Severe asthma Children

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0581126
UMLS CUI [1,2]
C0008059
any lung disease except asthma (i.e. cystic fibrosis, bronchiectasia, primary ciliary dyskinesia).
Beschreibung

Lung disease | Exception Asthma | Cystic Fibrosis | Bronchiectasis | Ciliary Motility Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004096
UMLS CUI [3]
C0010674
UMLS CUI [4]
C0006267
UMLS CUI [5]
C0008780
any systemic disease except allergic rhinitis and atopic dermatitis
Beschreibung

Systemic disease | Exception Allergic rhinitis | Exception Atopic Dermatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2607914
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011615
follow-up in intensive care unit or intubation for asthma exacerbation within one year.
Beschreibung

Follow-up Intensive care unit | Intubation Exacerbation of asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0021708
UMLS CUI [2,1]
C0021925
UMLS CUI [2,2]
C0349790
attendance to emergency room or hospital admission within 3 months for asthma exacerbation
Beschreibung

Attendance Emergency Room | Hospital admission Exacerbation of asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2827364
UMLS CUI [1,2]
C4291935
UMLS CUI [2,1]
C0184666
UMLS CUI [2,2]
C0349790
systemic steroid usage within 3 months
Beschreibung

Use of Systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C2825233
upper airway infection within one month.
Beschreibung

Upper Respiratory Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0041912
psychiatric or psychosocial problems
Beschreibung

Psychiatric problem | Psychosocial problem

Datentyp

boolean

Alias
UMLS CUI [1]
C1306597
UMLS CUI [2]
C0740697
poor compliance to asthma treatment protocol
Beschreibung

Poor compliance Asthma Treatment Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040808
any condition contra-indicated for montelukast usage
Beschreibung

Condition Contraindicated Montelukast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0298130
to be aware of the name of the drug either patient or study staff during the study period.
Beschreibung

Awareness Name Investigational New Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004448
UMLS CUI [1,2]
C0027365
UMLS CUI [1,3]
C0013230
worsening of the clinical condition during run-in period.
Beschreibung

Condition Clinical Worsening | Run-in Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0332271
UMLS CUI [2]
C3274438
pregnancy or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Bronchial Asthma NCT01618929

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Spirometry reversibility Percentage | Response Positive Provocholine Provocation Test
Item
physician diagnosed asthma (12% reversibility on spirometry test or positive response to provocholine® provocation test).
boolean
C0004096 (UMLS CUI [1])
C1272658 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1704632 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0722884 (UMLS CUI [3,3])
C0006265 (UMLS CUI [3,4])
Mild asthma Children | Moderate asthma Children | FEV1/FVC | Status pre- Budesonide
Item
mild to moderate asthmatic children. asthmatic children with pre-budesonide fev1/fvc
boolean
C0581124 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0581125 (UMLS CUI [2,1])
C0008059 (UMLS CUI [2,2])
C3815113 (UMLS CUI [3])
C0332152 (UMLS CUI [4,1])
C0054201 (UMLS CUI [4,2])
ID.3
Item
≥ 80% will be included.
boolean
Food Allergy Quantity | Immunoglobulin E measurement | Skin prick test Positive | History of clinical finding | Challenge test Food
Item
at least one food allergy confirmed by specific ige level or skin prick test positivity and a relevant clinical history or open challenge test with food.
boolean
C0016470 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0202086 (UMLS CUI [2])
C0430561 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C2317559 (UMLS CUI [4])
C1315011 (UMLS CUI [5,1])
C0016452 (UMLS CUI [5,2])
Age
Item
aged between 6-18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Parent
Item
acceptance of involvement in the study and signed informed consent (both patients and one of the parents)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Lacking
Item
who does not sign the informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Severe asthma Children
Item
severe asthmatic children
boolean
C0581126 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Lung disease | Exception Asthma | Cystic Fibrosis | Bronchiectasis | Ciliary Motility Disorders
Item
any lung disease except asthma (i.e. cystic fibrosis, bronchiectasia, primary ciliary dyskinesia).
boolean
C0024115 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0010674 (UMLS CUI [3])
C0006267 (UMLS CUI [4])
C0008780 (UMLS CUI [5])
Systemic disease | Exception Allergic rhinitis | Exception Atopic Dermatitis
Item
any systemic disease except allergic rhinitis and atopic dermatitis
boolean
C0442893 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2607914 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011615 (UMLS CUI [3,2])
Follow-up Intensive care unit | Intubation Exacerbation of asthma
Item
follow-up in intensive care unit or intubation for asthma exacerbation within one year.
boolean
C3274571 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2,1])
C0349790 (UMLS CUI [2,2])
Attendance Emergency Room | Hospital admission Exacerbation of asthma
Item
attendance to emergency room or hospital admission within 3 months for asthma exacerbation
boolean
C2827364 (UMLS CUI [1,1])
C4291935 (UMLS CUI [1,2])
C0184666 (UMLS CUI [2,1])
C0349790 (UMLS CUI [2,2])
Use of Systemic steroids
Item
systemic steroid usage within 3 months
boolean
C1524063 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
Upper Respiratory Infection
Item
upper airway infection within one month.
boolean
C0041912 (UMLS CUI [1])
Psychiatric problem | Psychosocial problem
Item
psychiatric or psychosocial problems
boolean
C1306597 (UMLS CUI [1])
C0740697 (UMLS CUI [2])
Poor compliance Asthma Treatment Protocol
Item
poor compliance to asthma treatment protocol
boolean
C0032646 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,3])
Condition Contraindicated Montelukast
Item
any condition contra-indicated for montelukast usage
boolean
C0348080 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0298130 (UMLS CUI [1,3])
Awareness Name Investigational New Drug
Item
to be aware of the name of the drug either patient or study staff during the study period.
boolean
C0004448 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Condition Clinical Worsening | Run-in Period
Item
worsening of the clinical condition during run-in period.
boolean
C0348080 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
C3274438 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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