ID

27354

Description

Treatment of Bronchial Asthma With Borage and Echium Seed Oils; ODM derived from: https://clinicaltrials.gov/show/NCT00806442

Link

https://clinicaltrials.gov/show/NCT00806442

Keywords

Versions (1)
  1. 11/9/17 11/9/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT00806442

English

Eligibility Bronchial Asthma NCT00806442

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of bronchial asthma
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
male or female 18 years to 65 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
fev1 50 to 90% of predicted, or personal best.
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0849974
improvement in fev1 > 12% after administration of a beta-2 agonist.
Description

Adrenergic beta-2 Receptor Agonists | FEV1 Improvement Percentage

Data type

boolean

Alias
UMLS CUI [1]
C2936789
UMLS CUI [2,1]
C0849974
UMLS CUI [2,2]
C2986411
UMLS CUI [2,3]
C0439165
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
smoking history of > 10 pack years or active smoking within the past year.
Description

smoking cigarettes: ____ pack-years history | Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C2230126
UMLS CUI [2]
C0543414
due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:
Description

Effect Leukotriene biosynthetic process | Therapeutic procedure Asthma | Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1280500
UMLS CUI [1,2]
C1157321
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0004096
UMLS CUI [3]
C0680251
leukotriene modifying drugs,
Description

Pharmaceutical Preparations Leukotrienes Changing

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0023545
UMLS CUI [1,3]
C0392747
theophylline
Description

Theophylline

Data type

boolean

Alias
UMLS CUI [1]
C0039771
oral steroids.
Description

Steroids Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1527415
dietary supplements with fatty acids or other products that may interfere with leukotriene generation.
Description

Dietary Supplements Fatty Acids | Pharmaceutical Preparations Interfere with Leukotriene biosynthetic process

Data type

boolean

Alias
UMLS CUI [1,1]
C0242295
UMLS CUI [1,2]
C0015684
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1157321
treatment within the previous three months with omalizumab (monoclonal antibody directed against ige)
Description

omalizumab

Data type

boolean

Alias
UMLS CUI [1]
C0966225
subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo leukotriene generation because of their effects on leukotriene biosynthesis via inhibition of prostaglandin generation.
Description

Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1]
C0003211
a history of aspirin-sensitive asthma
Description

Asthma aspirin-sensitive

Data type

boolean

Alias
UMLS CUI [1]
C0856716
significant abnormalities in cbc, differential white cell count, renal function, and liver function, or urinalysis.
Description

CBC abnormal | Differential white blood cell count abnormal | Abnormal renal function | Liver Dysfunction | Urine screening abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0742009
UMLS CUI [2]
C0860796
UMLS CUI [3]
C0151746
UMLS CUI [4]
C0086565
UMLS CUI [5]
C0438142
any serious co-morbid medical condition.
Description

Comorbidity Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
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Similar models

Eligibility Bronchial Asthma NCT00806442

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Asthma
Item
diagnosis of bronchial asthma
boolean
C0004096 (UMLS CUI [1])
Age
Item
male or female 18 years to 65 years of age
boolean
C0001779 (UMLS CUI [1])
FEV1
Item
fev1 50 to 90% of predicted, or personal best.
boolean
C0849974 (UMLS CUI [1])
Adrenergic beta-2 Receptor Agonists | FEV1 Improvement Percentage
Item
improvement in fev1 > 12% after administration of a beta-2 agonist.
boolean
C2936789 (UMLS CUI [1])
C0849974 (UMLS CUI [2,1])
C2986411 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
smoking cigarettes: ____ pack-years history | Tobacco use
Item
smoking history of > 10 pack years or active smoking within the past year.
boolean
C2230126 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
Effect Leukotriene biosynthetic process | Therapeutic procedure Asthma | Exclusion Criteria
Item
due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:
boolean
C1280500 (UMLS CUI [1,1])
C1157321 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0680251 (UMLS CUI [3])
Pharmaceutical Preparations Leukotrienes Changing
Item
leukotriene modifying drugs,
boolean
C0013227 (UMLS CUI [1,1])
C0023545 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Theophylline
Item
theophylline
boolean
C0039771 (UMLS CUI [1])
Steroids Oral
Item
oral steroids.
boolean
C0038317 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Dietary Supplements Fatty Acids | Pharmaceutical Preparations Interfere with Leukotriene biosynthetic process
Item
dietary supplements with fatty acids or other products that may interfere with leukotriene generation.
boolean
C0242295 (UMLS CUI [1,1])
C0015684 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1157321 (UMLS CUI [2,3])
omalizumab
Item
treatment within the previous three months with omalizumab (monoclonal antibody directed against ige)
boolean
C0966225 (UMLS CUI [1])
Anti-Inflammatory Agents, Non-Steroidal
Item
subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo leukotriene generation because of their effects on leukotriene biosynthesis via inhibition of prostaglandin generation.
boolean
C0003211 (UMLS CUI [1])
Asthma aspirin-sensitive
Item
a history of aspirin-sensitive asthma
boolean
C0856716 (UMLS CUI [1])
CBC abnormal | Differential white blood cell count abnormal | Abnormal renal function | Liver Dysfunction | Urine screening abnormal
Item
significant abnormalities in cbc, differential white cell count, renal function, and liver function, or urinalysis.
boolean
C0742009 (UMLS CUI [1])
C0860796 (UMLS CUI [2])
C0151746 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
C0438142 (UMLS CUI [5])
Comorbidity Serious
Item
any serious co-morbid medical condition.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
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