ID

14274

Beschreibung

A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00252135

Link

https://clinicaltrials.gov/show/NCT00252135

Stichworte

Versionen (1)
  1. 07.04.16 07.04.16 -
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CC BY-NC 3.0

Hochgeladen am

7. April 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00252135

Englisch

Eligibility Asthma NCT00252135

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00252135
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
≥12 years of age
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
physician diagnosis of moderate to severe persistent asthma
Beschreibung

moderate to severe persistent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C1960047
UMLS CUI [2]
C1960048
evidence or history of positive skin test or in vitro reactivity to an aeroallergen
Beschreibung

positive skin test or in vitro reactivity to an aeroallergen

Datentyp

boolean

Alias
UMLS CUI [1]
C0037296
UMLS CUI [2]
C0001697
willingness to participate fully for the duration of the study (5 years)
Beschreibung

willingness to participate fully for the duration of the study

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
for patients in the xolair-treated cohort, have received at least one dose of xolair therapy at the time of enrollment
Beschreibung

xolair therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1174773
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication to xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to xolair)
Beschreibung

contraindication to xolair therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1174773
UMLS CUI [1,2]
C1301624
acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
Beschreibung

asthma exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C4039704
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0583237
UMLS CUI [5]
C0019993
acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0019993
use of an experimental drug within 30 days prior to study screening
Beschreibung

experimental drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0040223
diagnosis of cystic fibrosis
Beschreibung

cystic fibrosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0010674
for patients in the non-xolair-treated cohort, any prior treatment with xolair
Beschreibung

prior treatment with xolair

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1174773
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Ähnliche Modelle

Eligibility Asthma NCT00252135

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00252135
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
boolean
C0021430 (UMLS CUI [1])
age
Item
≥12 years of age
boolean
C0001779 (UMLS CUI [1])
moderate to severe persistent asthma
Item
physician diagnosis of moderate to severe persistent asthma
boolean
C1960047 (UMLS CUI [1])
C1960048 (UMLS CUI [2])
positive skin test or in vitro reactivity to an aeroallergen
Item
evidence or history of positive skin test or in vitro reactivity to an aeroallergen
boolean
C0037296 (UMLS CUI [1])
C0001697 (UMLS CUI [2])
willingness to participate fully for the duration of the study
Item
willingness to participate fully for the duration of the study (5 years)
boolean
C1321605 (UMLS CUI [1])
xolair therapy
Item
for patients in the xolair-treated cohort, have received at least one dose of xolair therapy at the time of enrollment
boolean
C1174773 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
contraindication to xolair therapy
Item
contraindication to xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to xolair)
boolean
C1174773 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
asthma exacerbation
Item
acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C4039704 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0583237 (UMLS CUI [4])
C0019993 (UMLS CUI [5])
comorbidity
Item
acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
boolean
C0009488 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
experimental drug
Item
use of an experimental drug within 30 days prior to study screening
boolean
C1514463 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
cystic fibrosis
Item
diagnosis of cystic fibrosis
boolean
C0010674 (UMLS CUI [1])
prior treatment with xolair
Item
for patients in the non-xolair-treated cohort, any prior treatment with xolair
boolean
C1514463 (UMLS CUI [1,1])
C1174773 (UMLS CUI [1,2])
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