ID

14373

Descrição

Causes, Characteristics and Mechanisms of Infective Exacerbations in Subjects With Asthma and Chronic Obstructive Pulmonary Disease (COPD); ODM derived from: https://clinicaltrials.gov/show/NCT00512954

Link

https://clinicaltrials.gov/show/NCT00512954

Palavras-chave

Versões (1)
  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.

Voltar para os comentários do modelo
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 NCT00512954

Inglês

Eligibility Asthma NCT00512954

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00512954
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 - 80 years.
Descrição

age postmenopausal state contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0700589
2. any severity of exacerbation of obstructive airway disease attending the outpatient clinic.
Descrição

exacerbation of obstructive airway disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600260
UMLS CUI [1,2]
C0235874
3. history of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy.
Descrição

3. history of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235874
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0003232
UMLS CUI [4]
C0006280
UMLS CUI [5]
C0586793
4. signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits.
Descrição

written informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. if the exacerbation is severe enough to warrant hospitalization.
Descrição

exacerbation hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235874
UMLS CUI [2]
C0019993
2. active malignancy.
Descrição

active malignancy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0006826
3. significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits.
Descrição

significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
4. recent (within the past 2 months) or planned (within the study period) lung surgery.
Descrição

lung surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038903
5. psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic.
Descrição

psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
6. pregnant or nursing females, as this could affect the compliance during the trial.
Descrição

pregnancy or lactation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study.
Descrição

any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Voltar ao início da página

Similar models

Eligibility Asthma NCT00512954

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00512954
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
age postmenopausal state contraception
Item
1. male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 - 80 years.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
exacerbation of obstructive airway disease
Item
2. any severity of exacerbation of obstructive airway disease attending the outpatient clinic.
boolean
C0600260 (UMLS CUI [1,1])
C0235874 (UMLS CUI [1,2])
3. history of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy
Item
3. history of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy.
boolean
C0235874 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
C0006280 (UMLS CUI [4])
C0586793 (UMLS CUI [5])
written informed consent
Item
4. signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exacerbation hospitalization
Item
1. if the exacerbation is severe enough to warrant hospitalization.
boolean
C0235874 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
active malignancy
Item
2. active malignancy.
boolean
C0205177 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance
Item
3. significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
lung surgery
Item
4. recent (within the past 2 months) or planned (within the study period) lung surgery.
boolean
C0038903 (UMLS CUI [1])
psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic
Item
5. psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy or lactation
Item
6. pregnant or nursing females, as this could affect the compliance during the trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study
Item
7. any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Voltar ao início da página 

Contacto

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

Campos marcados com * são obrigatórios.

Ajuda

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