0 Avaliações

ID

14422

Descrição

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling); ODM derived from: https://clinicaltrials.gov/show/NCT02327897

Link

https://clinicaltrials.gov/show/NCT02327897

Palavras-chave

  1. 14/04/2016 14/04/2016 -
Transferido a

14 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Asthma NCT02327897

    Eligibility Asthma NCT02327897

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02327897
    Criteria
    Descrição

    Criteria

    participants must meet all of the following criteria for enrollment:
    Descrição

    Study Subject Participation Status | Inclusion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C1512693
    1. male or female, 18 to 60 years of age
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. must have clinical evidence of moderate-severe atopic asthma:
    Descrição

    Moderate persistent allergic asthma | Severe persistent allergic asthma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4039651
    UMLS CUI [2]
    C4041248
    self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) for at least one year, and
    Descrição

    Asthma Symptoms | Wheezing | Chest tightness | Dyspnea | Nocturnal cough

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C1457887
    UMLS CUI [2]
    C0043144
    UMLS CUI [3]
    C0232292
    UMLS CUI [4]
    C0013404
    UMLS CUI [5]
    C0231912
    a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (pc20 fev1) < 16 mg/ml for participants on inhaled corticosteroids and < 8 mg/ml for participants not on inhaled corticosteroids] or postbronchodilator fev1 with at least 12% or 200 ml increase in fev1 or forced volume vital capacity (fvc) on bronchodilator challenge, and
    Descrição

    Pulmonary methacholine challenge test Positive | FEV1 | inhaled steroids | FEV1 post bronchodilator | Forced vital capacity - finding | Bronchodilator Agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1096470
    UMLS CUI [1,2]
    C1446409
    UMLS CUI [2]
    C0748133
    UMLS CUI [3]
    C2065041
    UMLS CUI [4,1]
    C0748133
    UMLS CUI [4,2]
    C2599594
    UMLS CUI [5]
    C1287681
    UMLS CUI [6]
    C0006280
    no other diagnosis that could explain symptoms.
    Descrição

    Other Diagnosis | Symptoms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C1457887
    3. able to travel to the niehs cru, in research triangle park, north carolina, for required study visits
    Descrição

    Ability travel | Clinic / Center - Research North Carolina

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C0040802
    UMLS CUI [2,1]
    C1552456
    UMLS CUI [2,2]
    C0028407
    4. able to present a valid government issued form of identification for entry to the niehs campus
    Descrição

    Human Identification Card (document) | Government

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0242954
    UMLS CUI [1,2]
    C3275277
    UMLS CUI [2]
    C0018104
    5. able to receive asthma treatment medication(s) via mail
    Descrição

    Therapeutic procedure Asthma | Pharmaceutical Preparations Mail

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0004096
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0024492
    6. willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol
    Descrição

    Compliance behavior | Medication regimen | Diet | Life Style

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    UMLS CUI [2]
    C0237125
    UMLS CUI [3]
    C0012155
    UMLS CUI [4]
    C0023676
    7. access to a vacuum cleaner with a detachable hose component
    Descrição

    Access Vacuum Cleaners

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0444454
    UMLS CUI [1,2]
    C0392308
    bronchoscopy sub-study inclusion criterion
    Descrição

    Bronchoscopy | Inclusion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006290
    UMLS CUI [2]
    C1512693
    in addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy sub-study.
    Descrição

    Ability Fasting 6 Hours

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0085732
    UMLS CUI [1,2]
    C0015663
    UMLS CUI [1,3]
    C1292428
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:
    Descrição

    Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    1. women who are pregnant or lactating at the time of screening (this exclusion is in place because certain enrollment procedures, may pose an undue risk on the unborn fetus; women may rescreen at a later date once no longer pregnant or breastfeeding; women who are pregnant or lactating at the time of the baseline visit and are scheduled to complete the methacholine challenge will be withdrawn due to the potential risk to the fetus; women who become pregnant after completing the baseline visit will not be excluded from further participation but will also not be eligible for participation in the bronchoscopy sub-study)
    Descrição

    Pregnancy | Breast Feeding | Methacholine challenge | Withdrawn | Study Subject Participation Status | Bronchoscopy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0430567
    UMLS CUI [4]
    C0424092
    UMLS CUI [5]
    C2348568
    UMLS CUI [6]
    C0006290
    2. current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/ml at screening), or a history of smoking greater than 5 pack years. smoking encompasses all inhaled products, including e-cigarettes.
    Descrição

    Current Smoker | Second hand smoke exposure | Urine cotinine measurement | smoking cigarettes: ____ pack-years history | Electronic Cigarettes

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3241966
    UMLS CUI [2]
    C1545750
    UMLS CUI [3]
    C1278256
    UMLS CUI [4]
    C2230126
    UMLS CUI [5]
    C3849993
    3. pico smokealyzer value of > 11ppm
    Descrição

    Carbon monoxide analyzer Measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0179602
    UMLS CUI [1,2]
    C0242485
    4. history of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (cf), emphysema, non-cf bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension
    Descrição

    Comorbidity | Chronic Obstructive Airway Disease | Cystic Fibrosis | Pulmonary Emphysema | Bronchiectasis | Pulmonary Fibrosis | Sarcoidosis | Angina, Unstable | Pulmonary Hypertension

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0024117
    UMLS CUI [3]
    C0010674
    UMLS CUI [4]
    C0034067
    UMLS CUI [5]
    C0006267
    UMLS CUI [6]
    C0034069
    UMLS CUI [7]
    C0036202
    UMLS CUI [8]
    C0002965
    UMLS CUI [9]
    C0020542
    5. allergy or history of adverse reactions to methacholine
    Descrição

    Hypersensitivity Methacholine | Adverse reactions Methacholine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0600370
    UMLS CUI [2,1]
    C0559546
    UMLS CUI [2,2]
    C0600370
    6. any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures
    Descrição

    Disease Study Subject Participation Status Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801
    7. comorbid diseases that affect global health or survival- such as dvt, pulmonary embolism, class iii - iv congestive heart failure, or a malignancy under treatment
    Descrição

    Comorbidity Affecting Global Health | Comorbidity Affecting Continuance of life | Deep Vein Thrombosis | Pulmonary Embolism | Congestive heart failure New York Heart Association class III/IV | Malignant Neoplasms Therapeutic procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C1456573
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0038952
    UMLS CUI [3]
    C0149871
    UMLS CUI [4]
    C0034065
    UMLS CUI [5,1]
    C0018802
    UMLS CUI [5,2]
    C0278962
    UMLS CUI [6,1]
    C0006826
    UMLS CUI [6,2]
    C0087111
    bronchoscopy sub-study exclusion criteria
    Descrição

    Bronchoscopy Study Exclusion Criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006290
    UMLS CUI [1,2]
    C2603343
    UMLS CUI [1,3]
    C0680251
    in addition to the above exclusion criteria, participants meeting any of the following criteria will not be eligible for enrollment into the bronchoscopy sub-study:
    Descrição

    Study Subject Participation Status Bronchoscopy Study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0006290
    UMLS CUI [1,3]
    C2603343
    1. pregnant, as indicated by urine pregnancy test
    Descrição

    Pregnancy Urine pregnancy test

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0430056
    2. any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy
    Descrição

    Disease Study Subject Participation Status Limited | Bronchoscopy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [2]
    C0006290
    3. bleeding disorders
    Descrição

    Blood Coagulation Disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    4. facial deformity, major facial surgery
    Descrição

    facial deformity | facial surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1385263
    UMLS CUI [2]
    C2224535
    5. asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit
    Descrição

    Exacerbation of asthma | Respiratory Tract Infections

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0349790
    UMLS CUI [2]
    C0035243
    6. severe persistent asthma, defined as by ats-ers criteria.
    Descrição

    Severe persistent asthma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1960048
    7. allergy or history of adverse reactions to lidocaine
    Descrição

    Hypersensitivity Lidocaine | Adverse reactions Lidocaine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0023660
    UMLS CUI [2,1]
    C0559546
    UMLS CUI [2,2]
    C0023660
    8. temperature > 37.6 (infinite)c; blood pressure < 90/50 mm hg or > 160/100 mm hg; pulse rate < 50 or > 100 beats/minute
    Descrição

    Temperature | Blood Pressure | Pulse Rate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0039476
    UMLS CUI [2]
    C0005823
    UMLS CUI [3]
    C0232117
    9. body weight < 50 kg (< 110 lbs)
    Descrição

    Body Weight

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005910
    10. the following abnormal lab values (values obtained during clinical assessment):
    Descrição

    Laboratory test result abnormal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    platelet count < 150,000 per l
    Descrição

    Platelet Count measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    white blood cells count < 3000 per l
    Descrição

    White Blood Cell Count procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    absolute neutrophil count < 1000 per l
    Descrição

    Absolute neutrophil count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    hematocrit < 35% for both female and male
    Descrição

    Hematocrit procedure | Gender

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018935
    UMLS CUI [2]
    C0079399
    prothrombin time (pt) / abnormal international normalized ratio (inr) and partial prothromboplastin time (ptt) based on reference laboratory established reference ranges
    Descrição

    Prothrombin time assay INR - international normal ratio abnormal | Partial thromboplastin time finding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C0580417
    UMLS CUI [2]
    C1531697
    serum creatinine > 1.4 mg/dl
    Descrição

    Creatinine measurement, serum (procedure)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    participants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.
    Descrição

    Bronchial Spasm | Bronchoscopy day

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006266
    UMLS CUI [2,1]
    C0006290
    UMLS CUI [2,2]
    C0439228

    Similar models

    Eligibility Asthma NCT02327897

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02327897
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Study Subject Participation Status | Inclusion
    Item
    participants must meet all of the following criteria for enrollment:
    boolean
    C2348568 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    Age
    Item
    1. male or female, 18 to 60 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Moderate persistent allergic asthma | Severe persistent allergic asthma
    Item
    2. must have clinical evidence of moderate-severe atopic asthma:
    boolean
    C4039651 (UMLS CUI [1])
    C4041248 (UMLS CUI [2])
    Asthma Symptoms | Wheezing | Chest tightness | Dyspnea | Nocturnal cough
    Item
    self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) for at least one year, and
    boolean
    C0004096 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    C0043144 (UMLS CUI [2])
    C0232292 (UMLS CUI [3])
    C0013404 (UMLS CUI [4])
    C0231912 (UMLS CUI [5])
    Pulmonary methacholine challenge test Positive | FEV1 | inhaled steroids | FEV1 post bronchodilator | Forced vital capacity - finding | Bronchodilator Agents
    Item
    a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (pc20 fev1) < 16 mg/ml for participants on inhaled corticosteroids and < 8 mg/ml for participants not on inhaled corticosteroids] or postbronchodilator fev1 with at least 12% or 200 ml increase in fev1 or forced volume vital capacity (fvc) on bronchodilator challenge, and
    boolean
    C1096470 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    C0748133 (UMLS CUI [2])
    C2065041 (UMLS CUI [3])
    C0748133 (UMLS CUI [4,1])
    C2599594 (UMLS CUI [4,2])
    C1287681 (UMLS CUI [5])
    C0006280 (UMLS CUI [6])
    Other Diagnosis | Symptoms
    Item
    no other diagnosis that could explain symptoms.
    boolean
    C0011900 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [2])
    Ability travel | Clinic / Center - Research North Carolina
    Item
    3. able to travel to the niehs cru, in research triangle park, north carolina, for required study visits
    boolean
    C0085732 (UMLS CUI [1,1])
    C0040802 (UMLS CUI [1,2])
    C1552456 (UMLS CUI [2,1])
    C0028407 (UMLS CUI [2,2])
    Human Identification Card (document) | Government
    Item
    4. able to present a valid government issued form of identification for entry to the niehs campus
    boolean
    C0242954 (UMLS CUI [1,1])
    C3275277 (UMLS CUI [1,2])
    C0018104 (UMLS CUI [2])
    Therapeutic procedure Asthma | Pharmaceutical Preparations Mail
    Item
    5. able to receive asthma treatment medication(s) via mail
    boolean
    C0087111 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C0024492 (UMLS CUI [2,2])
    Compliance behavior | Medication regimen | Diet | Life Style
    Item
    6. willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol
    boolean
    C1321605 (UMLS CUI [1])
    C0237125 (UMLS CUI [2])
    C0012155 (UMLS CUI [3])
    C0023676 (UMLS CUI [4])
    Access Vacuum Cleaners
    Item
    7. access to a vacuum cleaner with a detachable hose component
    boolean
    C0444454 (UMLS CUI [1,1])
    C0392308 (UMLS CUI [1,2])
    Bronchoscopy | Inclusion
    Item
    bronchoscopy sub-study inclusion criterion
    boolean
    C0006290 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    Ability Fasting 6 Hours
    Item
    in addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy sub-study.
    boolean
    C0085732 (UMLS CUI [1,1])
    C0015663 (UMLS CUI [1,2])
    C1292428 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    Exclusion Criteria
    Item
    participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:
    boolean
    C0680251 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Methacholine challenge | Withdrawn | Study Subject Participation Status | Bronchoscopy
    Item
    1. women who are pregnant or lactating at the time of screening (this exclusion is in place because certain enrollment procedures, may pose an undue risk on the unborn fetus; women may rescreen at a later date once no longer pregnant or breastfeeding; women who are pregnant or lactating at the time of the baseline visit and are scheduled to complete the methacholine challenge will be withdrawn due to the potential risk to the fetus; women who become pregnant after completing the baseline visit will not be excluded from further participation but will also not be eligible for participation in the bronchoscopy sub-study)
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0430567 (UMLS CUI [3])
    C0424092 (UMLS CUI [4])
    C2348568 (UMLS CUI [5])
    C0006290 (UMLS CUI [6])
    Current Smoker | Second hand smoke exposure | Urine cotinine measurement | smoking cigarettes: ____ pack-years history | Electronic Cigarettes
    Item
    2. current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/ml at screening), or a history of smoking greater than 5 pack years. smoking encompasses all inhaled products, including e-cigarettes.
    boolean
    C3241966 (UMLS CUI [1])
    C1545750 (UMLS CUI [2])
    C1278256 (UMLS CUI [3])
    C2230126 (UMLS CUI [4])
    C3849993 (UMLS CUI [5])
    Carbon monoxide analyzer Measurement
    Item
    3. pico smokealyzer value of > 11ppm
    boolean
    C0179602 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Comorbidity | Chronic Obstructive Airway Disease | Cystic Fibrosis | Pulmonary Emphysema | Bronchiectasis | Pulmonary Fibrosis | Sarcoidosis | Angina, Unstable | Pulmonary Hypertension
    Item
    4. history of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (cf), emphysema, non-cf bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension
    boolean
    C0009488 (UMLS CUI [1])
    C0024117 (UMLS CUI [2])
    C0010674 (UMLS CUI [3])
    C0034067 (UMLS CUI [4])
    C0006267 (UMLS CUI [5])
    C0034069 (UMLS CUI [6])
    C0036202 (UMLS CUI [7])
    C0002965 (UMLS CUI [8])
    C0020542 (UMLS CUI [9])
    Hypersensitivity Methacholine | Adverse reactions Methacholine
    Item
    5. allergy or history of adverse reactions to methacholine
    boolean
    C0020517 (UMLS CUI [1,1])
    C0600370 (UMLS CUI [1,2])
    C0559546 (UMLS CUI [2,1])
    C0600370 (UMLS CUI [2,2])
    Disease Study Subject Participation Status Limited
    Item
    6. any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures
    boolean
    C0012634 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    Comorbidity Affecting Global Health | Comorbidity Affecting Continuance of life | Deep Vein Thrombosis | Pulmonary Embolism | Congestive heart failure New York Heart Association class III/IV | Malignant Neoplasms Therapeutic procedure
    Item
    7. comorbid diseases that affect global health or survival- such as dvt, pulmonary embolism, class iii - iv congestive heart failure, or a malignancy under treatment
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C1456573 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0038952 (UMLS CUI [2,3])
    C0149871 (UMLS CUI [3])
    C0034065 (UMLS CUI [4])
    C0018802 (UMLS CUI [5,1])
    C0278962 (UMLS CUI [5,2])
    C0006826 (UMLS CUI [6,1])
    C0087111 (UMLS CUI [6,2])
    Bronchoscopy Study Exclusion Criteria
    Item
    bronchoscopy sub-study exclusion criteria
    boolean
    C0006290 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [1,3])
    Study Subject Participation Status Bronchoscopy Study
    Item
    in addition to the above exclusion criteria, participants meeting any of the following criteria will not be eligible for enrollment into the bronchoscopy sub-study:
    boolean
    C2348568 (UMLS CUI [1,1])
    C0006290 (UMLS CUI [1,2])
    C2603343 (UMLS CUI [1,3])
    Pregnancy Urine pregnancy test
    Item
    1. pregnant, as indicated by urine pregnancy test
    boolean
    C0032961 (UMLS CUI [1,1])
    C0430056 (UMLS CUI [1,2])
    Disease Study Subject Participation Status Limited | Bronchoscopy
    Item
    2. any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy
    boolean
    C0012634 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C0006290 (UMLS CUI [2])
    Blood Coagulation Disorders
    Item
    3. bleeding disorders
    boolean
    C0005779 (UMLS CUI [1])
    facial deformity | facial surgery
    Item
    4. facial deformity, major facial surgery
    boolean
    C1385263 (UMLS CUI [1])
    C2224535 (UMLS CUI [2])
    Exacerbation of asthma | Respiratory Tract Infections
    Item
    5. asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit
    boolean
    C0349790 (UMLS CUI [1])
    C0035243 (UMLS CUI [2])
    Severe persistent asthma
    Item
    6. severe persistent asthma, defined as by ats-ers criteria.
    boolean
    C1960048 (UMLS CUI [1])
    Hypersensitivity Lidocaine | Adverse reactions Lidocaine
    Item
    7. allergy or history of adverse reactions to lidocaine
    boolean
    C0020517 (UMLS CUI [1,1])
    C0023660 (UMLS CUI [1,2])
    C0559546 (UMLS CUI [2,1])
    C0023660 (UMLS CUI [2,2])
    Temperature | Blood Pressure | Pulse Rate
    Item
    8. temperature > 37.6 (infinite)c; blood pressure < 90/50 mm hg or > 160/100 mm hg; pulse rate < 50 or > 100 beats/minute
    boolean
    C0039476 (UMLS CUI [1])
    C0005823 (UMLS CUI [2])
    C0232117 (UMLS CUI [3])
    Body Weight
    Item
    9. body weight < 50 kg (< 110 lbs)
    boolean
    C0005910 (UMLS CUI [1])
    Laboratory test result abnormal
    Item
    10. the following abnormal lab values (values obtained during clinical assessment):
    boolean
    C0438215 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelet count < 150,000 per l
    boolean
    C0032181 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    white blood cells count < 3000 per l
    boolean
    C0023508 (UMLS CUI [1])
    Absolute neutrophil count
    Item
    absolute neutrophil count < 1000 per l
    boolean
    C0948762 (UMLS CUI [1])
    Hematocrit procedure | Gender
    Item
    hematocrit < 35% for both female and male
    boolean
    C0018935 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    Prothrombin time assay INR - international normal ratio abnormal | Partial thromboplastin time finding
    Item
    prothrombin time (pt) / abnormal international normalized ratio (inr) and partial prothromboplastin time (ptt) based on reference laboratory established reference ranges
    boolean
    C0033707 (UMLS CUI [1,1])
    C0580417 (UMLS CUI [1,2])
    C1531697 (UMLS CUI [2])
    Creatinine measurement, serum (procedure)
    Item
    serum creatinine > 1.4 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Bronchial Spasm | Bronchoscopy day
    Item
    participants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.
    boolean
    C0006266 (UMLS CUI [1])
    C0006290 (UMLS CUI [2,1])
    C0439228 (UMLS CUI [2,2])

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