ID

13986

Description

Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis; ODM derived from: https://clinicaltrials.gov/show/NCT00396409

Link

https://clinicaltrials.gov/show/NCT00396409

Keywords

Versions (1)
  1. 3/21/16 3/21/16 -
Uploaded on

March 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Allergic Asthma NCT00396409

English

Eligibility Allergic Asthma NCT00396409

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0005910
UMLS CUI [1,4]
C2229760
Asthma symptoms are mainly
Description

Allergic asthma

Data type

text

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0440307
UMLS CUI [1,3]
C0440328
UMLS CUI [1,4]
C0861154
patients with a positive rast (>cap2) result for grass pollen (and/or rye pollen) specific ige at screening (visit 1 (v1) or within the previous 12 months.
Description

rast positive

Data type

boolean

Alias
UMLS CUI [1]
C0855586
FEV1
Description

FEV1

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0748133
%
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0006147
any coexisting major illness or organ failure
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0260472
History of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial by the investigator. Relevance in this context refers to any increased risk of hypersensitivity reaction to trial medication. (Specific concerns currently identified with respect to the use of inhaled glutathione in allergic patients per se are not existing)
Description

History of allergies

Data type

boolean

Alias
UMLS CUI [1,1]
C0489531
UMLS CUI [1,2]
C3662483
UMLS CUI [1,3]
C0004034
UMLS CUI [1,4]
C0339808
2. patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
Description

Drug-induced anaphylactoid reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0344178
UMLS CUI [1,2]
C0685898
Hypersensitivity
Description

Allergy

Data type

text

Alias
UMLS CUI [1]
C0020517
Hypersensitivity
Description

Allergy

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013182
UMLS CUI [1,3]
C0038636
UMLS CUI [1,4]
C0019602
UMLS CUI [1,5]
C0032600
UMLS CUI [1,6]
C0966225
UMLS CUI [1,7]
C0003250
UMLS CUI [1,8]
C1328603
UMLS CUI [1,9]
C0021083
Hypersensitivity
Description

Allergy

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0013182
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Similar models

Eligibility Allergic Asthma NCT00396409

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Item
Gender
text
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C2229760 (UMLS CUI [1,4])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Allergic asthma
Item
Asthma symptoms are mainly
text
C0155877 (UMLS CUI [1,1])
C0440307 (UMLS CUI [1,2])
C0440328 (UMLS CUI [1,3])
C0861154 (UMLS CUI [1,4])
rast positive
Item
patients with a positive rast (>cap2) result for grass pollen (and/or rye pollen) specific ige at screening (visit 1 (v1) or within the previous 12 months.
boolean
C0855586 (UMLS CUI [1])
FEV1
Item
FEV1
integer
C0748133 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0006147 (UMLS CUI [1,4])
comorbidity
Item
any coexisting major illness or organ failure
boolean
C0009488 (UMLS CUI [1,1])
C0260472 (UMLS CUI [1,2])
History of allergies
Item
History of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial by the investigator. Relevance in this context refers to any increased risk of hypersensitivity reaction to trial medication. (Specific concerns currently identified with respect to the use of inhaled glutathione in allergic patients per se are not existing)
boolean
C0489531 (UMLS CUI [1,1])
C3662483 (UMLS CUI [1,2])
C0004034 (UMLS CUI [1,3])
C0339808 (UMLS CUI [1,4])
Drug-induced anaphylactoid reaction
Item
2. patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
boolean
C0344178 (UMLS CUI [1,1])
C0685898 (UMLS CUI [1,2])
Allergy
Item
Hypersensitivity
text
C0020517 (UMLS CUI [1])
Allergy
Item
Hypersensitivity
text
C0020517 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
C0038636 (UMLS CUI [1,3])
C0019602 (UMLS CUI [1,4])
C0032600 (UMLS CUI [1,5])
C0966225 (UMLS CUI [1,6])
C0003250 (UMLS CUI [1,7])
C1328603 (UMLS CUI [1,8])
C0021083 (UMLS CUI [1,9])
Allergy
Item
Hypersensitivity
text
C0020517 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,3])
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