ID

14359

Descrição

SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII); ODM derived from: https://clinicaltrials.gov/show/NCT00455923

Link

https://clinicaltrials.gov/show/NCT00455923

Palavras-chave

  1. 12/04/2016 12/04/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

12 de abril de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Asthma NCT00455923

Eligibility Asthma NCT00455923

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00455923
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing to give informed consent.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
males or females aged 18-70.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and complete dairy cards.
Descrição

able to understand and complete dairy cards

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 >80% predicted 4. pc20 <8mg/ml
Descrição

mild persistent asthma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960046
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1714620
UMLS CUI [4,1]
C1276804
UMLS CUI [4,2]
C0436350
UMLS CUI [5,1]
C2957235
UMLS CUI [5,2]
C0436350
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
change to regular asthma medication in 4-weeks prior to visit 1.
Descrição

asthma medication change

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0580105
UMLS CUI [1,4]
C0040223
use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
Descrição

corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0040223
lower respiratory tract within 4 weeks of visit 1
Descrição

lower respiratory tract infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149725
received investigational study drug within 4 weeks of visit
Descrição

investigational drug

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
smoking history of >10 pack years of more.
Descrição

smoking history

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
serious uncontrolled disease.
Descrição

serious uncontrolled disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
medical conditions or medications known to affect the assessments or endpoints.
Descrição

comorbidity limiting study protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
evidence of alcohol or drug abuse.
Descrição

alcohol or drug abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
known pregnancy or planned pregnancy.
Descrição

pregnancy or planned pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1283828
known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
Descrição

hypersensitivity to inhaled corticosteroids, beta-agonists or lactose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2065041
UMLS CUI [1,3]
C0001644
UMLS CUI [1,4]
C0022949
previous enrollment in the study
Descrição

previous enrollment in the study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Asthma NCT00455923

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00455923
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
age
Item
males or females aged 18-70.
boolean
C0001779 (UMLS CUI [1])
able to understand and complete dairy cards
Item
able to understand and complete dairy cards.
boolean
C1321605 (UMLS CUI [1])
mild persistent asthma
Item
mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 >80% predicted 4. pc20 <8mg/ml
boolean
C1960046 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1714620 (UMLS CUI [3])
C1276804 (UMLS CUI [4,1])
C0436350 (UMLS CUI [4,2])
C2957235 (UMLS CUI [5,1])
C0436350 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
asthma medication change
Item
change to regular asthma medication in 4-weeks prior to visit 1.
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
corticosteroids
Item
use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
boolean
C0001617 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
lower respiratory tract infection
Item
lower respiratory tract within 4 weeks of visit 1
boolean
C0149725 (UMLS CUI [1])
investigational drug
Item
received investigational study drug within 4 weeks of visit
boolean
C0013230 (UMLS CUI [1])
smoking history
Item
smoking history of >10 pack years of more.
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
serious uncontrolled disease
Item
serious uncontrolled disease.
boolean
C0009488 (UMLS CUI [1])
comorbidity limiting study protocol
Item
medical conditions or medications known to affect the assessments or endpoints.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
alcohol or drug abuse
Item
evidence of alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
pregnancy or planned pregnancy
Item
known pregnancy or planned pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
hypersensitivity to inhaled corticosteroids, beta-agonists or lactose
Item
known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
boolean
C0020517 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0001644 (UMLS CUI [1,3])
C0022949 (UMLS CUI [1,4])
previous enrollment in the study
Item
previous enrollment in the study
boolean
C2348568 (UMLS CUI [1])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

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