ID

14605

Descrição

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

Palavras-chave

Versões (2)
  1. 23/04/2016 23/04/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

23 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Atopy NCT00295737

    Inglês

    Eligibility Atopy NCT00295737

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility Atopy NCT00295737
    Inclusion Criteria
    Descrição

    Inclusion Criteria

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

    Atopy | Allergic rhinitis | Mild intermittent asthma

    Tipo de dados

    boolean

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

    Age

    Tipo de dados

    boolean

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

    Non-smoker

    Tipo de dados

    boolean

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

    FEV1

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    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
    Descrição

    Informed Consent

    Tipo de dados

    boolean

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

    Female Pregnancy test negative

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0015780
    UMLS CUI [1,2]
    C0427780
    Exclusion Criteria
    Descrição

    Exclusion Criteria

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

    Respiratory Tract Infections

    Tipo de dados

    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).
    Descrição

    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

    Tipo de dados

    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)
    Descrição

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

    Tipo de dados

    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
    Descrição

    Allergen Immunotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0162352
    permanent medication
    Descrição

    Permanent Pharmaceutical Preparations

    Tipo de dados

    boolean

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

    systemic steroids | inhaled steroids

    Tipo de dados

    boolean

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

    Anti-Inflammatory Agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003209
    pregnancy
    Descrição

    Pregnancy

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    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
    Descrição

    Compliance behavior Limited

    Tipo de dados

    boolean

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

    Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Atopy NCT00295737

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility Atopy NCT00295737
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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
    C0015780 (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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