ID

43973

Beschreibung

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

Stichworte

Versionen (2)
  1. 03.04.16 03.04.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Allergic NCT00836368

Englisch

Eligibility Allergic NCT00836368

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Allergic NCT00836368
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

house dust mite allergy; skin test response finding

Datentyp

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:
Beschreibung

oxygen saturation; blood pressure; persistent asthma

Datentyp

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
Beschreibung

episodic wheezing; shortness of breath

Datentyp

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
Beschreibung

Asthma night-time symptoms; Asthma daytime symptoms

Datentyp

boolean

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

fev1; Forced Vital Capacity

Datentyp

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
Beschreibung

inhaled corticosteroid; Adrenergic beta-2 Receptor Agonists

Datentyp

boolean

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

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.
Beschreibung

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

Datentyp

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.
Beschreibung

inhaled steroids; leukotriene inhibitors; Therapeutic regimen Asthma

Datentyp

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.
Beschreibung

non-steroidal anti-inflammatory drugs; aspirin

Datentyp

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.)
Beschreibung

anemia; blood counts; ptt

Datentyp

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.
Beschreibung

pregnancy

Datentyp

boolean

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

anticoagulants warfarin heparin clopidogrel

Datentyp

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.
Beschreibung

Study Subject children

Datentyp

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.
Beschreibung

age; concomitant disease

Datentyp

boolean

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

venipuncture; vagal response

Datentyp

boolean

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

tobacco use

Datentyp

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.
Beschreibung

hypertension; blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005823
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Ähnliche Modelle

Eligibility Allergic NCT00836368

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Allergic NCT00836368
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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