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ID

43973

Description

In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics; ODM derived from: https://clinicaltrials.gov/show/NCT00836368

Link

https://clinicaltrials.gov/show/NCT00836368

Keywords

Versions (2)
  1. 4/3/16 4/3/16 -
  2. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY 4.0
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    Eligibility Allergic NCT00836368

    English

    Eligibility Allergic NCT00836368

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Allergic NCT00836368
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. specific allergy to house dust mite farinae confirmed by positive immediate skin test response.
    Description

    house dust mite allergy; skin test response finding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0339808
    UMLS CUI [2]
    C0312646
    2. oxygen saturation of > 94 % at baseline 3. blood pressure within the following parameters (systolic between 140 - 90, diastolic between 90-60 mm hg) 4. moderate or severe persistent asthma according to nhlbi definitions including history of one of the following:
    Description

    oxygen saturation; blood pressure; persistent asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0523807
    UMLS CUI [2]
    C0005823
    UMLS CUI [3]
    C3266628
    1. episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity
    Description

    episodic wheezing; shortness of breath

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2203183
    UMLS CUI [2]
    C0013404
    2. asthma symptoms occurring at night or during sleep at least 1 time per week
    Description

    Asthma night-time symptoms; Asthma daytime symptoms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1273489
    UMLS CUI [2]
    C1276804
    3. measured fev1 or fvc is <80% of predicted or
    Description

    fev1; Forced Vital Capacity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3815113
    UMLS CUI [2]
    C3714541
    4. physician diagnosed moderate or severe persistent asthma which is currently treated or controlled with maintenance medication including moderate or high dose inhaled corticosteroid, or any dose of inhaled corticosteroid and a long-acting inhaled b2-agonist
    Description

    inhaled corticosteroid; Adrenergic beta-2 Receptor Agonists

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2065041
    UMLS CUI [2]
    C2936789
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. any chronic medical condition considered by the pi as a contraindication to receiving gamma-t, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
    Description

    medical contraindication; cardiovascular disease; diabetes; chronic renal disease; Thyroid Diseases; coagulation defects

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1301624
    UMLS CUI [2]
    C0007222
    UMLS CUI [3]
    C0011847
    UMLS CUI [4]
    C1561643
    UMLS CUI [5]
    C0040128
    UMLS CUI [6]
    C0005779
    2. use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) which have been used for at least one month are allowed. patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study.
    Description

    inhaled steroids; leukotriene inhibitors; Therapeutic regimen Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2065041
    UMLS CUI [2]
    C0595726
    UMLS CUI [3,1]
    C1276413
    UMLS CUI [3,2]
    C0004096
    3. non-steroidal anti-inflammatory drugs (nsaids) or aspirin (asa) use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study.
    Description

    non-steroidal anti-inflammatory drugs; aspirin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003211
    UMLS CUI [2]
    C0004057
    5. diagnosis of anemia or abnormal blood counts at screening. abnormal pt or ptt values at screening (pt that is prolonged more than 1-2 sec and ptt prolonged more than 3-5 sec of normal. the normal values used will be those defined by mclendon lab.)
    Description

    anemia; blood counts; ptt

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002871
    UMLS CUI [2]
    C0005771
    UMLS CUI [3]
    C0030605
    6. pregnancy or nursing a baby. as this is a phase i study, the potential risk to a fetus cannot be justified.
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    4. use of anticoagulants including warfarin, heparin, or clopidogrel.
    Description

    anticoagulants warfarin heparin clopidogrel

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003280
    UMLS CUI [1,2]
    C0043031
    UMLS CUI [1,3]
    C0019134
    UMLS CUI [1,4]
    C0070166
    7. children will not be included in this study as the potential risk to a growing child cannot be justified.
    Description

    Study Subject children

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C0008059
    8. adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
    Description

    age; concomitant disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0243087
    9. known vagal response to venipuncture
    Description

    venipuncture; vagal response

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0600406
    UMLS CUI [2]
    C1710621
    10. use of any tobacco product within the past 6 months
    Description

    tobacco use

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    11. hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90.
    Description

    hypertension; blood pressure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2]
    C0005823
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    Similar models

    Eligibility Allergic NCT00836368

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Allergic NCT00836368
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    house dust mite allergy; skin test response finding
    Item
    1. specific allergy to house dust mite farinae confirmed by positive immediate skin test response.
    boolean
    C0339808 (UMLS CUI [1])
    C0312646 (UMLS CUI [2])
    oxygen saturation; blood pressure; persistent asthma
    Item
    2. oxygen saturation of > 94 % at baseline 3. blood pressure within the following parameters (systolic between 140 - 90, diastolic between 90-60 mm hg) 4. moderate or severe persistent asthma according to nhlbi definitions including history of one of the following:
    boolean
    C0523807 (UMLS CUI [1])
    C0005823 (UMLS CUI [2])
    C3266628 (UMLS CUI [3])
    episodic wheezing; shortness of breath
    Item
    1. episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity
    boolean
    C2203183 (UMLS CUI [1])
    C0013404 (UMLS CUI [2])
    Asthma night-time symptoms; Asthma daytime symptoms
    Item
    2. asthma symptoms occurring at night or during sleep at least 1 time per week
    boolean
    C1273489 (UMLS CUI [1])
    C1276804 (UMLS CUI [2])
    fev1; Forced Vital Capacity
    Item
    3. measured fev1 or fvc is <80% of predicted or
    boolean
    C3815113 (UMLS CUI [1])
    C3714541 (UMLS CUI [2])
    inhaled corticosteroid; Adrenergic beta-2 Receptor Agonists
    Item
    4. physician diagnosed moderate or severe persistent asthma which is currently treated or controlled with maintenance medication including moderate or high dose inhaled corticosteroid, or any dose of inhaled corticosteroid and a long-acting inhaled b2-agonist
    boolean
    C2065041 (UMLS CUI [1])
    C2936789 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    medical contraindication; cardiovascular disease; diabetes; chronic renal disease; Thyroid Diseases; coagulation defects
    Item
    1. any chronic medical condition considered by the pi as a contraindication to receiving gamma-t, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
    boolean
    C1301624 (UMLS CUI [1])
    C0007222 (UMLS CUI [2])
    C0011847 (UMLS CUI [3])
    C1561643 (UMLS CUI [4])
    C0040128 (UMLS CUI [5])
    C0005779 (UMLS CUI [6])
    inhaled steroids; leukotriene inhibitors; Therapeutic regimen Asthma
    Item
    2. use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) which have been used for at least one month are allowed. patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study.
    boolean
    C2065041 (UMLS CUI [1])
    C0595726 (UMLS CUI [2])
    C1276413 (UMLS CUI [3,1])
    C0004096 (UMLS CUI [3,2])
    non-steroidal anti-inflammatory drugs; aspirin
    Item
    3. non-steroidal anti-inflammatory drugs (nsaids) or aspirin (asa) use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study.
    boolean
    C0003211 (UMLS CUI [1])
    C0004057 (UMLS CUI [2])
    anemia; blood counts; ptt
    Item
    5. diagnosis of anemia or abnormal blood counts at screening. abnormal pt or ptt values at screening (pt that is prolonged more than 1-2 sec and ptt prolonged more than 3-5 sec of normal. the normal values used will be those defined by mclendon lab.)
    boolean
    C0002871 (UMLS CUI [1])
    C0005771 (UMLS CUI [2])
    C0030605 (UMLS CUI [3])
    pregnancy
    Item
    6. pregnancy or nursing a baby. as this is a phase i study, the potential risk to a fetus cannot be justified.
    boolean
    C0032961 (UMLS CUI [1])
    anticoagulants warfarin heparin clopidogrel
    Item
    4. use of anticoagulants including warfarin, heparin, or clopidogrel.
    boolean
    C0003280 (UMLS CUI [1,1])
    C0043031 (UMLS CUI [1,2])
    C0019134 (UMLS CUI [1,3])
    C0070166 (UMLS CUI [1,4])
    Study Subject children
    Item
    7. children will not be included in this study as the potential risk to a growing child cannot be justified.
    boolean
    C0681850 (UMLS CUI [1,1])
    C0008059 (UMLS CUI [1,2])
    age; concomitant disease
    Item
    8. adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
    boolean
    C0001779 (UMLS CUI [1])
    C0243087 (UMLS CUI [2])
    venipuncture; vagal response
    Item
    9. known vagal response to venipuncture
    boolean
    C0600406 (UMLS CUI [1])
    C1710621 (UMLS CUI [2])
    tobacco use
    Item
    10. use of any tobacco product within the past 6 months
    boolean
    C0543414 (UMLS CUI [1])
    hypertension; blood pressure
    Item
    11. hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90.
    boolean
    C0020538 (UMLS CUI [1])
    C0005823 (UMLS CUI [2])
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