ID

14543

Description

Modification of Asthma With Soy Isoflavone; ODM derived from: https://clinicaltrials.gov/show/NCT00741208

Link

https://clinicaltrials.gov/show/NCT00741208

Keywords

Versions (1)
  1. 4/20/16 4/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 20, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Asthma NCT00741208

English

Eligibility Asthma NCT00741208

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00741208
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older;
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
physician diagnosed asthma;
Description

asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
positive methacholine bronchoprovocation test (20% fall in fev1 at less than 8 mg/ml) with the past 3 years;
Description

positive methacholine bronchoprovocation test

Data type

boolean

Alias
UMLS CUI [1]
C0430567
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0040223
smoking status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pulmonary function fev1< 70% predicted pre-bronchodilator;
Description

pre-bronchodilator fev1

Data type

boolean

Alias
UMLS CUI [1]
C3172227
other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of copd, emphysema, or chronic bronchitis;
Description

comorbidity limiting study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0034067
UMLS CUI [4]
C0008677
medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months or use of an investigational treatment within the previous 30 days;
Description

soy isoflavone or oral steroids or investigational treatment

Data type

boolean

Alias
UMLS CUI [1]
C0677666
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0442027
UMLS CUI [3]
C0949266
UMLS CUI [4]
C0040223
drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
Description

known adverse reaction to genistein, other phytoestrogens, or soy products

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0061202
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0071011
UMLS CUI [3]
C2136331
females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
Description

childbearing potential: pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
non-adherence: inability or unwillingness to provide informed consent or inability to swallow study medication or inability to perform baseline measurements or completion of fewer than 5 of the 7 days of screening period diary entry or inability to be contacted by telephone;
Description

compliance behavior and informed consent

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0021430
other exclusions: recent asthma exacerbation (within 6 weeks) or recent upper respiratory tract infection (within 2 weeks) or change in diet over the past 1 month or expected change in diet (for example a weight loss diet) during the 6 week study period.
Description

asthma exacerbation or upper respiratory tract infection or change in diet

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0041912
UMLS CUI [3]
C3671772
UMLS CUI [4]
C0040223
Back to the top of the page

Similar models

Eligibility Asthma NCT00741208

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00741208
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
18 years of age or older;
boolean
C0001779 (UMLS CUI [1])
asthma
Item
physician diagnosed asthma;
boolean
C0004096 (UMLS CUI [1])
positive methacholine bronchoprovocation test
Item
positive methacholine bronchoprovocation test (20% fall in fev1 at less than 8 mg/ml) with the past 3 years;
boolean
C0430567 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
smoking history
Item
smoking status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
pre-bronchodilator fev1
Item
pulmonary function fev1< 70% predicted pre-bronchodilator;
boolean
C3172227 (UMLS CUI [1])
comorbidity limiting study participation
Item
other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of copd, emphysema, or chronic bronchitis;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0024117 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
C0008677 (UMLS CUI [4])
soy isoflavone or oral steroids or investigational treatment
Item
medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months or use of an investigational treatment within the previous 30 days;
boolean
C0677666 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0442027 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
known adverse reaction to genistein, other phytoestrogens, or soy products
Item
drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
boolean
C0020517 (UMLS CUI [1,1])
C0061202 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071011 (UMLS CUI [2,2])
C2136331 (UMLS CUI [3])
childbearing potential: pregnancy or lactation
Item
females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
compliance behavior and informed consent
Item
non-adherence: inability or unwillingness to provide informed consent or inability to swallow study medication or inability to perform baseline measurements or completion of fewer than 5 of the 7 days of screening period diary entry or inability to be contacted by telephone;
boolean
C1321605 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
asthma exacerbation or upper respiratory tract infection or change in diet
Item
other exclusions: recent asthma exacerbation (within 6 weeks) or recent upper respiratory tract infection (within 2 weeks) or change in diet over the past 1 month or expected change in diet (for example a weight loss diet) during the 6 week study period.
boolean
C0349790 (UMLS CUI [1])
C0041912 (UMLS CUI [2])
C3671772 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial