ID

14543

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00741208

Palavras-chave

Versões (1)
  1. 20/04/2016 20/04/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

20 de abril de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00741208

Inglês

Eligibility Asthma NCT00741208

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00741208
Inclusion Criteria
Descrição

Inclusion Criteria

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

age

Tipo de dados

boolean

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

asthma

Tipo de dados

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;
Descrição

positive methacholine bronchoprovocation test

Tipo de dados

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.
Descrição

smoking history

Tipo de dados

boolean

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

Exclusion Criteria

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

pre-bronchodilator fev1

Tipo de dados

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;
Descrição

comorbidity limiting study participation

Tipo de dados

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;
Descrição

soy isoflavone or oral steroids or investigational treatment

Tipo de dados

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;
Descrição

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

Tipo de dados

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;
Descrição

childbearing potential: pregnancy or lactation

Tipo de dados

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;
Descrição

compliance behavior and informed consent

Tipo de dados

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.
Descrição

asthma exacerbation or upper respiratory tract infection or change in diet

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0041912
UMLS CUI [3]
C3671772
UMLS CUI [4]
C0040223
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Similar models

Eligibility Asthma NCT00741208

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00741208
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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