ID

43657

Description

Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00295737

Link

https://clinicaltrials.gov/show/NCT00295737

Keywords

Versions (2)
  1. 4/23/16 4/23/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Atopy NCT00295737

English

Eligibility Atopy NCT00295737

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Atopy NCT00295737
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
Description

Atopy | Allergic rhinitis | Mild intermittent asthma

Data type

boolean

Alias
UMLS CUI [1]
C0392707
UMLS CUI [2]
C2607914
UMLS CUI [3]
C1960045
age 18-55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
nonsmoker (> 5 years)
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
forced expiratory volume in 1 second (fev1) > 70% of the predicted value
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
a positive skin prick test for grass mix or d. pteronyssinus at or within 12 months prior to the screening visit
Description

Positive Skin prick test Grass seed mixture | Positive Skin prick test Dermatophagoides pteronyssinus

Data type

boolean

Alias
UMLS CUI [1,1]
C1446409
UMLS CUI [1,2]
C0430561
UMLS CUI [1,3]
C0440302
UMLS CUI [2,1]
C1446409
UMLS CUI [2,2]
C0430561
UMLS CUI [2,3]
C1122992
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
females with negative pregnancy test
Description

Female Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infections of the respiratory tract within the last month
Description

Respiratory Tract Infections

Data type

boolean

Alias
UMLS CUI [1]
C0035243
past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
Description

Disease Affecting research results | Cardiovascular Diseases | Malignant Neoplasms | Liver diseases | Kidney Diseases | Hematological Disease | nervous system disorder | Endocrine System Diseases | Lung diseases | Bronchitis, Chronic | Pulmonary Emphysema | Tuberculosis | Bronchiectasis | Cystic Fibrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0018939
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0024115
UMLS CUI [10]
C0008677
UMLS CUI [11]
C0034067
UMLS CUI [12]
C0041296
UMLS CUI [13]
C0006267
UMLS CUI [14]
C0010674
pathological findings in blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
Description

Signs and Symptoms Hematologic Tests | complete blood count with differential | Blood coagulation | Electrolytes | Finding of liver enzyme levels | Body fluid retention Observation parameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0018941
UMLS CUI [2]
C0545131
UMLS CUI [3]
C0005778
UMLS CUI [4]
C0013832
UMLS CUI [5]
C1287351
UMLS CUI [6,1]
C0268000
UMLS CUI [6,2]
C0449381
subject is undergoing allergen desensitization therapy
Description

Allergen Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0162352
permanent medication
Description

Permanent Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205355
systemic or inhaled corticosteroid use within the last month
Description

systemic steroids | inhaled steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C2065041
anti-inflammatory medication within the last month
Description

Anti-Inflammatory Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003209
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
Description

nervous system disorder | Mental disorders | Substance Use Disorders | Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0038586
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0439801
there is a risk of non-compliance with study procedures
Description

Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
participation in a clinical trial 30 days prior to enrolment
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atopy NCT00295737

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Atopy NCT00295737
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atopy | Allergic rhinitis | Mild intermittent asthma
Item
physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
boolean
C0392707 (UMLS CUI [1])
C2607914 (UMLS CUI [2])
C1960045 (UMLS CUI [3])
Age
Item
age 18-55 years
boolean
C0001779 (UMLS CUI [1])
Non-smoker
Item
nonsmoker (> 5 years)
boolean
C0337672 (UMLS CUI [1])
FEV1
Item
forced expiratory volume in 1 second (fev1) > 70% of the predicted value
boolean
C0748133 (UMLS CUI [1])
Positive Skin prick test Grass seed mixture | Positive Skin prick test Dermatophagoides pteronyssinus
Item
a positive skin prick test for grass mix or d. pteronyssinus at or within 12 months prior to the screening visit
boolean
C1446409 (UMLS CUI [1,1])
C0430561 (UMLS CUI [1,2])
C0440302 (UMLS CUI [1,3])
C1446409 (UMLS CUI [2,1])
C0430561 (UMLS CUI [2,2])
C1122992 (UMLS CUI [2,3])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Female Pregnancy test negative
Item
females with negative pregnancy test
boolean
C0086287 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Respiratory Tract Infections
Item
infections of the respiratory tract within the last month
boolean
C0035243 (UMLS CUI [1])
Disease Affecting research results | Cardiovascular Diseases | Malignant Neoplasms | Liver diseases | Kidney Diseases | Hematological Disease | nervous system disorder | Endocrine System Diseases | Lung diseases | Bronchitis, Chronic | Pulmonary Emphysema | Tuberculosis | Bronchiectasis | Cystic Fibrosis
Item
past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0024115 (UMLS CUI [9])
C0008677 (UMLS CUI [10])
C0034067 (UMLS CUI [11])
C0041296 (UMLS CUI [12])
C0006267 (UMLS CUI [13])
C0010674 (UMLS CUI [14])
Signs and Symptoms Hematologic Tests | complete blood count with differential | Blood coagulation | Electrolytes | Finding of liver enzyme levels | Body fluid retention Observation parameter
Item
pathological findings in blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
boolean
C0037088 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0545131 (UMLS CUI [2])
C0005778 (UMLS CUI [3])
C0013832 (UMLS CUI [4])
C1287351 (UMLS CUI [5])
C0268000 (UMLS CUI [6,1])
C0449381 (UMLS CUI [6,2])
Allergen Immunotherapy
Item
subject is undergoing allergen desensitization therapy
boolean
C0162352 (UMLS CUI [1])
Permanent Pharmaceutical Preparations
Item
permanent medication
boolean
C0013227 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
systemic steroids | inhaled steroids
Item
systemic or inhaled corticosteroid use within the last month
boolean
C2825233 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
Anti-Inflammatory Agents
Item
anti-inflammatory medication within the last month
boolean
C0003209 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
nervous system disorder | Mental disorders | Substance Use Disorders | Compliance behavior Limited
Item
neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
Compliance behavior Limited
Item
there is a risk of non-compliance with study procedures
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in a clinical trial 30 days prior to enrolment
boolean
C2348568 (UMLS CUI [1])
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