ID

14501

Description

Orthomolecular Therapy and Asthma in Children; ODM derived from: https://clinicaltrials.gov/show/NCT00672529

Lien

https://clinicaltrials.gov/show/NCT00672529

Mots-clés

  1. 19/04/2016 19/04/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

19 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00672529

Eligibility Asthma NCT00672529

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00672529
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged 7 to 18 years
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
mild to moderate asthma diagnosed by a respirologist
Description

mild to moderate asthma

Type de données

boolean

Alias
UMLS CUI [1]
C1960046
UMLS CUI [2]
C1960047
use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months
Description

budesonide

Type de données

boolean

Alias
UMLS CUI [1,1]
C0054201
UMLS CUI [1,2]
C0040223
stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. asthma symptoms must be under good control
Description

stable asthma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0349790
baseline forced expiratory volume at 1 second (fev-1) >= 70% of the predicted normal value.
Description

fev1

Type de données

boolean

Alias
UMLS CUI [1]
C0748133
possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (vitamin c > 200mg, vitamin e >50iu, vitamin b12 > 100µg, magnesium > 200mg, selenium > 50µg, omega-3 > 300mg, quercetin > 3mg, vitamin b6 > 75mg will all be considered orthomolecular doses).
Description

orthomolecular therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0029340
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to any component of the orthomolecular therapy or placebo.
Description

hypersensitivity to any component of the orthomolecular therapy or placebo

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0029340
UMLS CUI [1,3]
C0032042
acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Asthma NCT00672529

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00672529
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
male or female aged 7 to 18 years
boolean
C0001779 (UMLS CUI [1])
mild to moderate asthma
Item
mild to moderate asthma diagnosed by a respirologist
boolean
C1960046 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
budesonide
Item
use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months
boolean
C0054201 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
stable asthma
Item
stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. asthma symptoms must be under good control
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2])
fev1
Item
baseline forced expiratory volume at 1 second (fev-1) >= 70% of the predicted normal value.
boolean
C0748133 (UMLS CUI [1])
orthomolecular therapy
Item
possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (vitamin c > 200mg, vitamin e >50iu, vitamin b12 > 100µg, magnesium > 200mg, selenium > 50µg, omega-3 > 300mg, quercetin > 3mg, vitamin b6 > 75mg will all be considered orthomolecular doses).
boolean
C0029340 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity to any component of the orthomolecular therapy or placebo
Item
known hypersensitivity to any component of the orthomolecular therapy or placebo.
boolean
C0020517 (UMLS CUI [1,1])
C0029340 (UMLS CUI [1,2])
C0032042 (UMLS CUI [1,3])
comorbidity
Item
acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.
boolean
C0009488 (UMLS CUI [1])

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