ID

14070

Beschrijving

Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00829179

Link

https://clinicaltrials.gov/show/NCT00829179

Trefwoorden

  1. 24-03-16 24-03-16 -
Geüploaded op

24 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Allergic Asthma NCT00829179

Eligibility Allergic Asthma NCT00829179

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be at least 18 years of age,
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
must have an fev1 of > 70 percent of predicted,
Beschrijving

FEV1

Datatype

boolean

Alias
UMLS CUI [1]
C0748133
must have evidence of bronchial hyperreactivity to methacholine as defined by a methacholine provocation causing a 20% or greater fall in fev1 (pc20) < 8 mg/ml
Beschrijving

Bronchial hyperreactivity | Methacholine | FEV1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085129
UMLS CUI [1,2]
C0600370
UMLS CUI [1,3]
C0748133
use of inhaled steroid is permitted; however, no change in inhaled steroid dosage will be permitted over the duration of study
Beschrijving

Inhaled steroid | Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586793
UMLS CUI [1,2]
C0178602
must have a normal platelet count,
Beschrijving

Platelet count normal

Datatype

boolean

Alias
UMLS CUI [1]
C0427564
must be willing to and competent to sign the consent form
Beschrijving

Informed consent | Competence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0086035
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects that do not have allergic asthma will be excluded.
Beschrijving

Allergic asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0155877
subjects with er visits or upper respiratory infections within the last six weeks will be excluded.
Beschrijving

Emergency room visit | Upper Respiratory Infections

Datatype

boolean

Alias
UMLS CUI [1]
C2114437
UMLS CUI [2]
C0041912
subjects with tobacco use within the past year or > 10 pack year history of tobacco use will be excluded.
Beschrijving

Tobacco use

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
subjects with serum ige levels of less than 30 or greater than 700 iu/ml will be excluded.
Beschrijving

serum IgE measurement

Datatype

boolean

Alias
UMLS CUI [1]
C2229760
subjects that require oral steroid use will be excluded.
Beschrijving

oral steroid

Datatype

boolean

Alias
UMLS CUI [1]
C0574135
subjects who weigh < 30 kg or > 150 kg are excluded, and subjects with baseline ige levels greater than 300 may be excluded, depending on weight
Beschrijving

Body weight | serum IgE measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C2229760
pregnant or nursing females will be excluded.
Beschrijving

Pregnancy | Breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Allergic Asthma NCT00829179

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects must be at least 18 years of age,
boolean
C0001779 (UMLS CUI [1])
FEV1
Item
must have an fev1 of > 70 percent of predicted,
boolean
C0748133 (UMLS CUI [1])
Bronchial hyperreactivity | Methacholine | FEV1
Item
must have evidence of bronchial hyperreactivity to methacholine as defined by a methacholine provocation causing a 20% or greater fall in fev1 (pc20) < 8 mg/ml
boolean
C0085129 (UMLS CUI [1,1])
C0600370 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
Inhaled steroid | Dosage
Item
use of inhaled steroid is permitted; however, no change in inhaled steroid dosage will be permitted over the duration of study
boolean
C0586793 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Platelet count normal
Item
must have a normal platelet count,
boolean
C0427564 (UMLS CUI [1])
Informed consent | Competence
Item
must be willing to and competent to sign the consent form
boolean
C0021430 (UMLS CUI [1,1])
C0086035 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergic asthma
Item
subjects that do not have allergic asthma will be excluded.
boolean
C0155877 (UMLS CUI [1])
Emergency room visit | Upper Respiratory Infections
Item
subjects with er visits or upper respiratory infections within the last six weeks will be excluded.
boolean
C2114437 (UMLS CUI [1])
C0041912 (UMLS CUI [2])
Tobacco use
Item
subjects with tobacco use within the past year or > 10 pack year history of tobacco use will be excluded.
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
serum IgE measurement
Item
subjects with serum ige levels of less than 30 or greater than 700 iu/ml will be excluded.
boolean
C2229760 (UMLS CUI [1])
oral steroid
Item
subjects that require oral steroid use will be excluded.
boolean
C0574135 (UMLS CUI [1])
Body weight | serum IgE measurement
Item
subjects who weigh < 30 kg or > 150 kg are excluded, and subjects with baseline ige levels greater than 300 may be excluded, depending on weight
boolean
C0005910 (UMLS CUI [1,1])
C2229760 (UMLS CUI [1,2])
Pregnancy | Breast feeding
Item
pregnant or nursing females will be excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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