ID

14373

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00512954

Nyckelord

Versioner (1)
  1. 2016-04-12 2016-04-12 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

12 april 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00512954

Engelsk

Eligibility Asthma NCT00512954

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00512954
Inclusion Criteria
Beskrivning

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.
Beskrivning

age postmenopausal state contraception

Datatyp

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.
Beskrivning

exacerbation of obstructive airway disease

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

exacerbation hospitalization

Datatyp

boolean

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

active malignancy

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

lung surgery

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

pregnancy or lactation

Datatyp

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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Asthma NCT00512954

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00512954
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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