ID

14490

Descrição

A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00639691

Link

https://clinicaltrials.gov/show/NCT00639691

Palavras-chave

  1. 18/04/2016 18/04/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

18 de abril de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00639691

Eligibility Asthma NCT00639691

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00639691
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, ≥ 6years of age;
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
who have a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria;
Descrição

allergic asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0040223
severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per canadian asthma consensus report (1999));
Descrição

severe persistent allergic asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1960048
UMLS CUI [1,2]
C0155877
subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;
Descrição

subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
elevated immunoglobin e levels
Descrição

IgE level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2229760
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant systemic disease
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
pregnancy or lactation
Descrição

pregnancy or lactation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
Descrição

lung disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024115
history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
Descrição

anaphylactoid or anaphylactic reaction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0340865
UMLS CUI [2]
C0002792
current treatment with warfarin (coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
Descrição

warfarin immunomodulatory therapy or antiplatelet therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C1963758
UMLS CUI [3]
C1096021

Similar models

Eligibility Asthma NCT00639691

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00639691
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
male or female, ≥ 6years of age;
boolean
C0001779 (UMLS CUI [1])
allergic asthma
Item
who have a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria;
boolean
C0155877 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
severe persistent allergic asthma
Item
severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per canadian asthma consensus report (1999));
boolean
C1960048 (UMLS CUI [1,1])
C0155877 (UMLS CUI [1,2])
subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;
Item
subjects having successfully completed one of the following protocols: cige025a011e3, cige025a2425, cige025aia05;
boolean
C2348568 (UMLS CUI [1])
IgE level
Item
elevated immunoglobin e levels
boolean
C2229760 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
significant systemic disease
boolean
C0009488 (UMLS CUI [1])
pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
lung disease
Item
an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
boolean
C0024115 (UMLS CUI [1])
anaphylactoid or anaphylactic reaction
Item
history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
boolean
C0340865 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
warfarin immunomodulatory therapy or antiplatelet therapy
Item
current treatment with warfarin (coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
boolean
C0043031 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C1096021 (UMLS CUI [3])

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