ID

38482

Descripción

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

Palabras clave

Versiones (1)
  1. 21/10/19 21/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

21 de octubre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Bronchial Asthma NCT01618929

Inglés

Eligibility Bronchial Asthma NCT01618929

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Asthma | Spirometry reversibility Percentage | Response Positive Provocholine Provocation Test

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

ID.3

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Age

Tipo de datos

boolean

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

Informed Consent | Informed Consent Parent

Tipo de datos

boolean

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

Exclusion Criteria

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

Informed Consent Lacking

Tipo de datos

boolean

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

Severe asthma Children

Tipo de datos

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).
Descripción

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

Tipo de datos

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
Descripción

Systemic disease | Exception Allergic rhinitis | Exception Atopic Dermatitis

Tipo de datos

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.
Descripción

Follow-up Intensive care unit | Intubation Exacerbation of asthma

Tipo de datos

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
Descripción

Attendance Emergency Room | Hospital admission Exacerbation of asthma

Tipo de datos

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
Descripción

Use of Systemic steroids

Tipo de datos

boolean

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

Upper Respiratory Infection

Tipo de datos

boolean

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

Psychiatric problem | Psychosocial problem

Tipo de datos

boolean

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

Poor compliance Asthma Treatment Protocol

Tipo de datos

boolean

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

Condition Contraindicated Montelukast

Tipo de datos

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.
Descripción

Awareness Name Investigational New Drug

Tipo de datos

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.
Descripción

Condition Clinical Worsening | Run-in Period

Tipo de datos

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
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Volver a la parte superior de la página

Similar models

Eligibility Bronchial Asthma NCT01618929

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial