ID

14765

Beschrijving

Randomized Controlled Trial of Silymarin in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01049178

Link

https://clinicaltrials.gov/show/NCT01049178

Trefwoorden

  1. 21-04-16 21-04-16 -
  2. 27-04-16 27-04-16 - Julian Varghese
Geüploaded op

27 april 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Atopic Asthma NCT01049178

Eligibility Atopic Asthma NCT01049178

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria male or female subject with confirmed asthma, and
Beschrijving

Asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
asthma control test (act) score of 15-20, and
Beschrijving

Asthma control test score

Datatype

boolean

Alias
UMLS CUI [1]
C2733224
documented atopy by prick skin testing (most study participants will likely have participated in one of the investigators prior observational studies and will have had skin testing, if not, this will be performed at an in-person screening visit), and
Beschrijving

Atopy | Skin prick test

Datatype

boolean

Alias
UMLS CUI [1]
C0392707
UMLS CUI [2]
C0430561
for women: not pregnant, as determined by a negative urinary pregnancy test at the initial visit(visit 1), and at the start of the cross-over period (visit 4), and using birth control
Beschrijving

Pregnant | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergies to plants in the asteraceae family (thistles, daisies, artichokes, kiwi)
Beschrijving

Hypersensitivity Asteraceae | Cirsium | Bellis | Cynara scolymus | Actinidia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0446228
UMLS CUI [2]
C1009560
UMLS CUI [3]
C1009534
UMLS CUI [4]
C1021820
UMLS CUI [5]
C0949891
non-asthmatic, or inadequate documentation which includes lack of signs and symptoms of asthma, or lack of prior confirmatory testing
Beschrijving

Not Asthma | No signs/symptoms Asthma | No confirmation of Asthma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518422
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C3846032
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C0521092
UMLS CUI [3,2]
C0004096
pregnant
Beschrijving

Patient currently pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
age < 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
non-english speaking
Beschrijving

English speaking

Datatype

boolean

Alias
UMLS CUI [1]
C0376245
current smoker (current, or within last year)
Beschrijving

Current Smoker

Datatype

boolean

Alias
UMLS CUI [1]
C3241966
chronic obstructive pulmonary disease(copd)
Beschrijving

Chronic Obstructive Airway Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
unable to swallow capsules
Beschrijving

Swallowing problem capsule

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392678
UMLS CUI [1,2]
C0006935
unable to obtain informed consent
Beschrijving

Unable Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
unable to comply with avoidance of honey and propolis containing foods (which interfere with the silybin assays for measurement of plasma concentrations)
Beschrijving

Compliance behavior Limited | silybin | plasma concentration Measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0600334
UMLS CUI [3,1]
C0683150
UMLS CUI [3,2]
C0242485

Similar models

Eligibility Atopic Asthma NCT01049178

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Asthma
Item
inclusion criteria male or female subject with confirmed asthma, and
boolean
C0004096 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Asthma control test score
Item
asthma control test (act) score of 15-20, and
boolean
C2733224 (UMLS CUI [1])
Atopy | Skin prick test
Item
documented atopy by prick skin testing (most study participants will likely have participated in one of the investigators prior observational studies and will have had skin testing, if not, this will be performed at an in-person screening visit), and
boolean
C0392707 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
Pregnant | Contraceptive methods
Item
for women: not pregnant, as determined by a negative urinary pregnancy test at the initial visit(visit 1), and at the start of the cross-over period (visit 4), and using birth control
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Asteraceae | Cirsium | Bellis | Cynara scolymus | Actinidia
Item
known allergies to plants in the asteraceae family (thistles, daisies, artichokes, kiwi)
boolean
C0020517 (UMLS CUI [1,1])
C0446228 (UMLS CUI [1,2])
C1009560 (UMLS CUI [2])
C1009534 (UMLS CUI [3])
C1021820 (UMLS CUI [4])
C0949891 (UMLS CUI [5])
Not Asthma | No signs/symptoms Asthma | No confirmation of Asthma
Item
non-asthmatic, or inadequate documentation which includes lack of signs and symptoms of asthma, or lack of prior confirmatory testing
boolean
C1518422 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3846032 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0521092 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
Patient currently pregnant
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
English speaking
Item
non-english speaking
boolean
C0376245 (UMLS CUI [1])
Current Smoker
Item
current smoker (current, or within last year)
boolean
C3241966 (UMLS CUI [1])
Chronic Obstructive Airway Disease
Item
chronic obstructive pulmonary disease(copd)
boolean
C0024117 (UMLS CUI [1])
Swallowing problem capsule
Item
unable to swallow capsules
boolean
C0392678 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Unable Informed Consent
Item
unable to obtain informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Limited | silybin | plasma concentration Measurement
Item
unable to comply with avoidance of honey and propolis containing foods (which interfere with the silybin assays for measurement of plasma concentrations)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0600334 (UMLS CUI [2])
C0683150 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])

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