ID

14299

Descrição

To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02195284

Link

https://clinicaltrials.gov/show/NCT02195284

Palavras-chave

Versões (1)
  1. 08/04/2016 08/04/2016 -
Transferido a

8 de abril de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
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 NCT02195284

Inglês

Eligibility Asthma NCT02195284

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02195284
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent: subject must give their signed and dated written informed consent to participate; subject understands and is willing, able, and likely to comply with study procedures and restrictions; subject must be able to read, comprehend, and record information in dutch and/or english
Descrição

Informed Consent | Compliance behavior | Able to read Comprehension Able to write English Language | Dutch Language

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C0584993
UMLS CUI [3,4]
C0376245
UMLS CUI [4,1]
C0586740
UMLS CUI [4,2]
C0162340
UMLS CUI [4,3]
C0584993
UMLS CUI [4,4]
C0376241
age: >=18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
gender: male or female subjects.
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
asthma diagnosis: a diagnosis of asthma as defined by the national institutes of health. comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
Descrição

Asthma | Comorbidity | Rheumatoid Arthritis | Musculoskeletal Diseases | Visual Impairment | Depressive disorder | Anxiety | Inhaler

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0026857
UMLS CUI [5]
C3665347
UMLS CUI [6]
C0011581
UMLS CUI [7]
C0003467
UMLS CUI [8]
C0021461
asthma treatment: all subjects should be currently receiving treatment for asthma.
Descrição

Therapeutic procedure Asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
must be naive to using ellipta inhaler and at least one other inhaler device.
Descrição

Inhaler | Inhaler aid device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021461
UMLS CUI [2]
C0461716
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic obstructive pulmonary disease (copd): subjects with a current diagnosis of copd only.
Descrição

Chronic Obstructive Airway Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024117
contraindications: a history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
Descrição

Medical contraindication | Lactose Intolerance | Hypersensitivity Magnesium stearate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C0022951
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0126791
subjects who are currently participating in another randomised pharmacological interventional trial.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
Descrição

Unable to read | Compliance behavior Limited

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0586741
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
Voltar ao início da página

Similar models

Eligibility Asthma NCT02195284

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02195284
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Compliance behavior | Able to read Comprehension Able to write English Language | Dutch Language
Item
informed consent: subject must give their signed and dated written informed consent to participate; subject understands and is willing, able, and likely to comply with study procedures and restrictions; subject must be able to read, comprehend, and record information in dutch and/or english
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0586740 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C0584993 (UMLS CUI [3,3])
C0376245 (UMLS CUI [3,4])
C0586740 (UMLS CUI [4,1])
C0162340 (UMLS CUI [4,2])
C0584993 (UMLS CUI [4,3])
C0376241 (UMLS CUI [4,4])
Age
Item
age: >=18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender
Item
gender: male or female subjects.
boolean
C0079399 (UMLS CUI [1])
Asthma | Comorbidity | Rheumatoid Arthritis | Musculoskeletal Diseases | Visual Impairment | Depressive disorder | Anxiety | Inhaler
Item
asthma diagnosis: a diagnosis of asthma as defined by the national institutes of health. comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
boolean
C0004096 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0026857 (UMLS CUI [4])
C3665347 (UMLS CUI [5])
C0011581 (UMLS CUI [6])
C0003467 (UMLS CUI [7])
C0021461 (UMLS CUI [8])
Therapeutic procedure Asthma
Item
asthma treatment: all subjects should be currently receiving treatment for asthma.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Inhaler | Inhaler aid device
Item
must be naive to using ellipta inhaler and at least one other inhaler device.
boolean
C0021461 (UMLS CUI [1])
C0461716 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease
Item
chronic obstructive pulmonary disease (copd): subjects with a current diagnosis of copd only.
boolean
C0024117 (UMLS CUI [1])
Medical contraindication | Lactose Intolerance | Hypersensitivity Magnesium stearate
Item
contraindications: a history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
boolean
C1301624 (UMLS CUI [1])
C0022951 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0126791 (UMLS CUI [3,2])
Study Subject Participation Status
Item
subjects who are currently participating in another randomised pharmacological interventional trial.
boolean
C2348568 (UMLS CUI [1])
Unable to read | Compliance behavior Limited
Item
inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
boolean
C0586741 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
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