ID

37204

Description

Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02061670

Link

https://clinicaltrials.gov/show/NCT02061670

Keywords

Versions (1)
  1. 7/7/19 7/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Seasonal Allergic Rhinitis NCT02061670

English

Eligibility Seasonal Allergic Rhinitis NCT02061670

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, aged 18-65 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
asthma treated by inhaled saba or inhaled saba plus low-medium dose ics in 6 weeks prior to randomisation.
Description

Asthma | Inhalation beta2-Adrenergic Agonist Short-term Active | Inhaled steroids Low dose

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0205535
UMLS CUI [2,2]
C2917450
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0205177
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0445550
a reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
Description

Medical History Consistent with Rhinoconjunctivitis Moderate | Medical History Consistent with Rhinoconjunctivitis Severe | Exposure to Ragweed | Ragweed Seasons Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0861155
UMLS CUI [1,4]
C0205081
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0861155
UMLS CUI [2,4]
C0205082
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0440357
UMLS CUI [4,1]
C0440357
UMLS CUI [4,2]
C0036497
UMLS CUI [4,3]
C1265611
positive skin prick test to ragweed
Description

Skin prick test Positive Ragweed

Data type

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0440357
ragweed-specific immunoglobulin e (ige) ≥ 0.35 ku/l.
Description

Ragweed Specific Immunoglobulin E measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0440357
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0202086
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of life-threatening asthma.
Description

Asthma Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
uncontrolled asthma according to gina
Description

Asthma Uncontrolled | Initiative Global Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0424093
UMLS CUI [2,2]
C2348867
UMLS CUI [2,3]
C0004096
fev1 of < 70 % of predicted, regardless of the cause.
Description

Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0730561
administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
Description

Epinephrine Contraindicated | Coronary heart disease Symptomatic | Coronary heart disease Symptomatic chronic | Hypertension, severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0014563
UMLS CUI [1,2]
C1444657
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0010068
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0205191
UMLS CUI [4]
C4013784
history of severe drug allergy or anaphylactic reaction to food.
Description

Drug Allergy Severe | Food anaphylaxis

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0685898
a history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Description

Disease Significant | Immune System Disease | Lung disease | Cardiovascular Disease | Gastrointestinal Disease | Liver disease | Kidney Disease | Nervous system disorder | Musculoskeletal Disease | Endocrine System Disease | Metabolic Disease | Malignant disease | Mental disorders | Physical impairment Major | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0021053
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0026857
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0025517
UMLS CUI [12]
C0442867
UMLS CUI [13]
C0004936
UMLS CUI [14,1]
C0231171
UMLS CUI [14,2]
C0205164
UMLS CUI [15]
C0038586
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Similar models

Eligibility Seasonal Allergic Rhinitis NCT02061670

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, aged 18-65 years.
boolean
C0001779 (UMLS CUI [1])
Asthma | Inhalation beta2-Adrenergic Agonist Short-term Active | Inhaled steroids Low dose
Item
asthma treated by inhaled saba or inhaled saba plus low-medium dose ics in 6 weeks prior to randomisation.
boolean
C0004096 (UMLS CUI [1])
C0205535 (UMLS CUI [2,1])
C2917450 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0205177 (UMLS CUI [2,4])
C2065041 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
Medical History Consistent with Rhinoconjunctivitis Moderate | Medical History Consistent with Rhinoconjunctivitis Severe | Exposure to Ragweed | Ragweed Seasons Quantity
Item
a reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
boolean
C0262926 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0861155 (UMLS CUI [1,3])
C0205081 (UMLS CUI [1,4])
C0262926 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0861155 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
C0332157 (UMLS CUI [3,1])
C0440357 (UMLS CUI [3,2])
C0440357 (UMLS CUI [4,1])
C0036497 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Skin prick test Positive Ragweed
Item
positive skin prick test to ragweed
boolean
C0430561 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0440357 (UMLS CUI [1,3])
Ragweed Specific Immunoglobulin E measurement
Item
ragweed-specific immunoglobulin e (ige) ≥ 0.35 ku/l.
boolean
C0440357 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0202086 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Asthma Life Threatening
Item
history of life-threatening asthma.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Asthma Uncontrolled | Initiative Global Asthma
Item
uncontrolled asthma according to gina
boolean
C0004096 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0424093 (UMLS CUI [2,1])
C2348867 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
Percent predicted FEV1
Item
fev1 of < 70 % of predicted, regardless of the cause.
boolean
C0730561 (UMLS CUI [1])
Epinephrine Contraindicated | Coronary heart disease Symptomatic | Coronary heart disease Symptomatic chronic | Hypertension, severe
Item
administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
boolean
C0014563 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0010068 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0010068 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C4013784 (UMLS CUI [4])
Drug Allergy Severe | Food anaphylaxis
Item
history of severe drug allergy or anaphylactic reaction to food.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0685898 (UMLS CUI [2])
Disease Significant | Immune System Disease | Lung disease | Cardiovascular Disease | Gastrointestinal Disease | Liver disease | Kidney Disease | Nervous system disorder | Musculoskeletal Disease | Endocrine System Disease | Metabolic Disease | Malignant disease | Mental disorders | Physical impairment Major | Substance Use Disorders
Item
a history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0021053 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0026857 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
C0442867 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0231171 (UMLS CUI [14,1])
C0205164 (UMLS CUI [14,2])
C0038586 (UMLS CUI [15])
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