ID

32358

Description

Correlation Between IgE Parameters and the Response to Omalizumab in Subjects With Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01002976

Link

https://clinicaltrials.gov/show/NCT01002976

Keywords

Versions (1)
  1. 10/27/18 10/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Severe Allergic Asthma NCT01002976

English

Eligibility Severe Allergic Asthma NCT01002976

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who (or as appropriate whose legal guardian) have been informed of the study procedures and medications and have given their written informed consent
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
subjects with severe allergic asthma that based on standard practice have been assigned to omalizumab treatment and fulfill all requirements for such treatment
Description

Allergic asthma Severe | omalizumab | Treatment Requirement Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0966225
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1550543
the requirements include:
Description

Requirement Included

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332257
uncontrolled severe asthma despite maximal and optimal therapy , gina stage iv
Description

Severe asthma Uncontrolled | Therapy Optimal Maximal | Initiative Global Asthma Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0581126
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
UMLS CUI [2,3]
C0205289
UMLS CUI [3,1]
C0424093
UMLS CUI [3,2]
C2348867
UMLS CUI [3,3]
C0004096
UMLS CUI [3,4]
C1306673
reversible airway obstruction ( a change of 12% of fev1 after bronchodilator inhalation)
Description

Airway Obstruction Reversible | Change Percentage FEV1 Post bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0001883
UMLS CUI [1,2]
C0205343
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0849974
UMLS CUI [2,4]
C2599594
non smoking or smoking less then 10 py.
Description

Non-smoker | Tobacco use Smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C2230126
positive skin test or rast test for relevant allergen
Description

Allergen skin test positive | RAST positive

Data type

boolean

Alias
UMLS CUI [1]
C0855854
UMLS CUI [2]
C0855586
ige blood level between 30-700 iu and
Description

Blood immunoglobulin E

Data type

boolean

Alias
UMLS CUI [1]
C0853329
two or more asthma exacerbation needed systemic steroids treatment during the last twelve months or continuing systemic steroid treatment. or
Description

Exacerbation of asthma Quantity | Systemic steroids Required | Systemic steroids Continuing therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C2825233
UMLS CUI [3,2]
C1553904
contraindication to systemic steroid treatment due to side effects, such as osteoporosis and uncontrolled diabetes.
Description

Medical contraindication Systemic steroids | Etiology Side effects | Osteoporosis | Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2825233
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0879626
UMLS CUI [3]
C0029456
UMLS CUI [4]
C0421258
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or nursing mothers
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject who have experienced a severe hypersensitivity reaction to xolair®
Description

Severe allergy Xolair

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C1174773
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Similar models

Eligibility Severe Allergic Asthma NCT01002976

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Legal Guardian
Item
subjects who (or as appropriate whose legal guardian) have been informed of the study procedures and medications and have given their written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Allergic asthma Severe | omalizumab | Treatment Requirement Fulfill
Item
subjects with severe allergic asthma that based on standard practice have been assigned to omalizumab treatment and fulfill all requirements for such treatment
boolean
C0155877 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0966225 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
Requirement Included
Item
the requirements include:
boolean
C1514873 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
Severe asthma Uncontrolled | Therapy Optimal Maximal | Initiative Global Asthma Stage
Item
uncontrolled severe asthma despite maximal and optimal therapy , gina stage iv
boolean
C0581126 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C0205289 (UMLS CUI [2,3])
C0424093 (UMLS CUI [3,1])
C2348867 (UMLS CUI [3,2])
C0004096 (UMLS CUI [3,3])
C1306673 (UMLS CUI [3,4])
Airway Obstruction Reversible | Change Percentage FEV1 Post bronchodilator
Item
reversible airway obstruction ( a change of 12% of fev1 after bronchodilator inhalation)
boolean
C0001883 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0849974 (UMLS CUI [2,3])
C2599594 (UMLS CUI [2,4])
Non-smoker | Tobacco use Smoking cigarettes: ____ pack-years history
Item
non smoking or smoking less then 10 py.
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Allergen skin test positive | RAST positive
Item
positive skin test or rast test for relevant allergen
boolean
C0855854 (UMLS CUI [1])
C0855586 (UMLS CUI [2])
Blood immunoglobulin E
Item
ige blood level between 30-700 iu and
boolean
C0853329 (UMLS CUI [1])
Exacerbation of asthma Quantity | Systemic steroids Required | Systemic steroids Continuing therapy
Item
two or more asthma exacerbation needed systemic steroids treatment during the last twelve months or continuing systemic steroid treatment. or
boolean
C0349790 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3,1])
C1553904 (UMLS CUI [3,2])
Medical contraindication Systemic steroids | Etiology Side effects | Osteoporosis | Diabetic - poor control
Item
contraindication to systemic steroid treatment due to side effects, such as osteoporosis and uncontrolled diabetes.
boolean
C1301624 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0029456 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Severe allergy Xolair
Item
subject who have experienced a severe hypersensitivity reaction to xolair®
boolean
C2945656 (UMLS CUI [1,1])
C1174773 (UMLS CUI [1,2])
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