ID

14151

Descrição

Longitudinal Assessment of Adults With Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01976767

Link

https://clinicaltrials.gov/show/NCT01976767

Palavras-chave

Versões (1)
  1. 01/04/2016 01/04/2016 -
Transferido a

1 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Asthma NCT01976767

Inglês

Eligibility Asthma NCT01976767

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01976767
Criteria
Descrição

Criteria

1. able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. informed consent must be obtained prior to undertaking any study procedures.
Descrição

Informed consent | Compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [2]
C1321605
2. male or female subject aged 18 years or older at screening.
Descrição

Age | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
3. able to complete the study and all measurements.
Descrição

Compliance behavior | Ability

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0085732
4. able to read, comprehend, and write at a sufficient level to complete study related materials.
Descrição

Able to read | Comprehension | Able to write | Compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0586740
UMLS CUI [2]
C0162340
UMLS CUI [3]
C0584993
UMLS CUI [4]
C1321605
5. subjects will be allowed to enrol in other studies while taking part on this study. however, permission from the scientific board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
general exclusion criteria:
Descrição

Exclusion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2828389
1. as a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the subject due to the study or the influence this may have on the study results.
Descrição

Study Subject Participation Status | Medically unfit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3841806
UMLS CUI [3]
C0031809
2. the subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
Descrição

recreational drug use | Other allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1318616
UMLS CUI [2]
C2886714
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2348568
3. subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. if a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0086839
UMLS CUI [4]
C0420983
4. the subject has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. any u-biopred assessments should be deferred until 3 months after the first dose or invasive procedure. permission from the scientific board must be obtained to enroll or allow the continued participation of a subject enrolled in another study.
Descrição

Study Subject Participation Status | invasive medical procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0199173
5. those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
Descrição

Patient Non-Compliance | Risk Assessment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0376405
UMLS CUI [1,2]
C0086930
6. the subject has a recent history of incapacitating psychiatric disorders
Descrição

Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
7. history or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).
Descrição

Upper Respiratory Infections | Lower respiratory tract infection | Common Cold

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
UMLS CUI [3]
C0009443
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Similar models

Eligibility Asthma NCT01976767

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01976767
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Informed consent | Compliance behavior
Item
1. able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. informed consent must be obtained prior to undertaking any study procedures.
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2])
Age | Gender
Item
2. male or female subject aged 18 years or older at screening.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Compliance behavior | Ability
Item
3. able to complete the study and all measurements.
boolean
C1321605 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Able to read | Comprehension | Able to write | Compliance behavior
Item
4. able to read, comprehend, and write at a sufficient level to complete study related materials.
boolean
C0586740 (UMLS CUI [1])
C0162340 (UMLS CUI [2])
C0584993 (UMLS CUI [3])
C1321605 (UMLS CUI [4])
Study Subject Participation Status
Item
5. subjects will be allowed to enrol in other studies while taking part on this study. however, permission from the scientific board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.
boolean
C2348568 (UMLS CUI [1])
Exclusion
Item
general exclusion criteria:
boolean
C2828389 (UMLS CUI [1])
Study Subject Participation Status | Medically unfit
Item
1. as a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the subject due to the study or the influence this may have on the study results.
boolean
C2348568 (UMLS CUI [1])
C3841806 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
recreational drug use | Other allergy
Item
2. the subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
boolean
C1318616 (UMLS CUI [1])
C2886714 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
3. subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. if a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0086839 (UMLS CUI [3])
C0420983 (UMLS CUI [4])
Study Subject Participation Status | invasive medical procedure
Item
4. the subject has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. any u-biopred assessments should be deferred until 3 months after the first dose or invasive procedure. permission from the scientific board must be obtained to enroll or allow the continued participation of a subject enrolled in another study.
boolean
C2348568 (UMLS CUI [1])
C0199173 (UMLS CUI [2])
Patient Non-Compliance | Risk Assessment
Item
5. those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
boolean
C0376405 (UMLS CUI [1,1])
C0086930 (UMLS CUI [1,2])
Mental disorders
Item
6. the subject has a recent history of incapacitating psychiatric disorders
boolean
C0004936 (UMLS CUI [1])
Upper Respiratory Infections | Lower respiratory tract infection | Common Cold
Item
7. history or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
C0009443 (UMLS CUI [3])
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