Information:
Fel:
ID
14296
Beskrivning
Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00380354
Länk
https://clinicaltrials.gov/show/NCT00380354
Nyckelord
Versioner (1)
- 2016-04-07 2016-04-07 -
Rättsinnehavare
CC BY-NC 3.0
Uppladdad den
7 april 2016
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Eligibility Asthma NCT00380354
Eligibility Asthma NCT00380354
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT00380354
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
bronchial asthma
Item
documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
boolean
C0004096 (UMLS CUI [1])
C0001644 (UMLS CUI [2])
C0001644 (UMLS CUI [2])
pre-bronchodilator fev1
Item
pre-bronchodilator fev1 >75% of predicted at screening.
boolean
C3172227 (UMLS CUI [1])
non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
allergic reaction
Item
demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
boolean
C1527304 (UMLS CUI [1])
asthmatic response
Item
have asthmatic response
boolean
written informed consent
Item
able and willing to give written informed consent to take part in the study.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
available to complete all study measurements.
boolean
C1321605 (UMLS CUI [1])
cardiovascular disease
Item
history of cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
urine protein levels
Item
clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
boolean
C0262923 (UMLS CUI [1])
hayfever
Item
history of hayfever
boolean
C0018621 (UMLS CUI [1])
hepatitis b or c
Item
the subject has tested positive for hepatitis c antibody or hepatitis b surface antigen.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019196 (UMLS CUI [2])
hiv
Item
the subject has tested positive for hiv antibodies.
boolean
C0019682 (UMLS CUI [1])
positive drugs of abuse test
Item
the subject has positive drugs of abuse test.
boolean
C0038586 (UMLS CUI [1])
body weight
Item
subjects weighing less than 50kg are to be excluded from participating in the study.
boolean
C0005910 (UMLS CUI [1])
participated in a study with a new molecular entity
Item
the subject has participated in a study with a new molecular entity during the previous 3 months.
boolean
C2348568 (UMLS CUI [1])
methacholine or allergen challenge tests
Item
history of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
boolean
C0430567 (UMLS CUI [1,1])
C1704410 (UMLS CUI [1,2])
C0449891 (UMLS CUI [2,1])
C1704410 (UMLS CUI [2,2])
C1704410 (UMLS CUI [1,2])
C0449891 (UMLS CUI [2,1])
C1704410 (UMLS CUI [2,2])
non-compliance
Item
there is a risk of non-compliance with study medication or study procedures.
boolean
C1321605 (UMLS CUI [1])
blood donation
Item
history of blood donation (450 ml) within 2 months of starting the clinical study.
boolean
C0005794 (UMLS CUI [1])
alcohol consumption
Item
the subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. one unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
boolean
C0001948 (UMLS CUI [1])