ID

26238

Descrição

Selenium Supplementation in Chronic Obstructive Pulmonary Disease (COPD) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00186706

Link

https://clinicaltrials.gov/show/NCT00186706

Palavras-chave

Versões (1)
  1. 13/10/2017 13/10/2017 -
Titular dos direitos

see clinicaltrials.gov

Transferido a

13 de outubro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Obstructive Pulmonary Disease NCT00186706

Inglês

Eligibility Chronic Obstructive Pulmonary Disease NCT00186706

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged 40 years or older (no upper limit).
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. established respirologist-diagnosed mild or moderate copd, according to the canadian thoracic society (cts) lung function guidelines.(33) for a diagnosis of mild copd, patients must have fev1 60% to 79% predicted and fev1 / fvc < 0.7. for a diagnosis of moderate copd, patients must have fev1 40% to 59% predicted and fev1 / fvc < 0.7.
Descrição

Mild or moderate copd and spirometry

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0730604
UMLS CUI [1,2]
C0037981
UMLS CUI [2,1]
C0730605
UMLS CUI [2,2]
C0037981
3. current or former smokers with > 20 pack-year smoking history.
Descrição

Smoking History

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519384
4. ability to provide informed consent.
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
5. women subjects must be post-menopausal.
Descrição

Female subjects must be post-menopausal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206159
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current or recent (within 4 weeks) acute exacerbation of chronic bronchitis
Descrição

Acute exaverbation of chronic bronchitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0856695
2. current daily use of mineral or vitamin + mineral supplements or other natural health products that provide a daily dose of selenium that is greater than 100 µg
Descrição

Current daily use of Supplements that provide a daily dose of selenium that is greater than 100 µg

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0724359
UMLS CUI [1,2]
C0036581
UMLS CUI [2,1]
C1566558
UMLS CUI [2,2]
C0036581
3. current daily use of >5000 u of vitamin a, >1000 mg of vitamin c, or >800 u vitamin e
Descrição

Current daily use of vitamins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3661611
UMLS CUI [2]
C3661608
UMLS CUI [3]
C3661607
4. known significant co-morbidity such as renal (creatinine > 150 mol/l) or hepatic disease (ast or alt >3 times normal). measurement of these will be a requirement of the study. creatinine and alanine aminotransferase (alt) will be measured at the beginning and at the end of the study.
Descrição

Comorbidity due to kidney or liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0022658
UMLS CUI [1,3]
C0201975
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0023895
UMLS CUI [2,3]
C0428321
5. known or suspected active cancer other than non-melanoma skin cancer.
Descrição

Known or susspected active caner

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1882062
UMLS CUI [2,2]
C0332147
6. other concurrent major respiratory diagnosis other than copd/asthma.
Descrição

Other concurrent polmunary diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024115
7. plan to start statin drugs during the 12 weeks of study drug (may enroll if statins started >1 month before current study enrollment or deferred until study completion).
Descrição

Concomitant medication with Hydroxymethylglutaryl-CoA Reductase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0360714
8. consumption of brazil nuts.
Descrição

Consumption of brazil nuts

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0440287
UMLS CUI [1,2]
C0013470
9. individuals who have homocystinuria
Descrição

Comorbidity due to homocystinuria

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0019880
10. on niacin at a daily dose of 500 mg or higher for hyperlipidemia.
Descrição

Concomitant medication with niacin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0027996
11. if you have allergies to products that contain dicalcium phosphate, talc sugarloaf, stearic acid, or silica.
Descrição

Allergies to products

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0795598
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039267
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038229
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0037098
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Similar models

Eligibility Chronic Obstructive Pulmonary Disease NCT00186706

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. aged 40 years or older (no upper limit).
boolean
C0001779 (UMLS CUI [1])
Mild or moderate copd and spirometry
Item
2. established respirologist-diagnosed mild or moderate copd, according to the canadian thoracic society (cts) lung function guidelines.(33) for a diagnosis of mild copd, patients must have fev1 60% to 79% predicted and fev1 / fvc < 0.7. for a diagnosis of moderate copd, patients must have fev1 40% to 59% predicted and fev1 / fvc < 0.7.
boolean
C0730604 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
C0730605 (UMLS CUI [2,1])
C0037981 (UMLS CUI [2,2])
Smoking History
Item
3. current or former smokers with > 20 pack-year smoking history.
boolean
C1519384 (UMLS CUI [1])
Informed consent
Item
4. ability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Female subjects must be post-menopausal
Item
5. women subjects must be post-menopausal.
boolean
C0206159 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute exaverbation of chronic bronchitis
Item
1. current or recent (within 4 weeks) acute exacerbation of chronic bronchitis
boolean
C0856695 (UMLS CUI [1])
Current daily use of Supplements that provide a daily dose of selenium that is greater than 100 µg
Item
2. current daily use of mineral or vitamin + mineral supplements or other natural health products that provide a daily dose of selenium that is greater than 100 µg
boolean
C0724359 (UMLS CUI [1,1])
C0036581 (UMLS CUI [1,2])
C1566558 (UMLS CUI [2,1])
C0036581 (UMLS CUI [2,2])
Current daily use of vitamins
Item
3. current daily use of >5000 u of vitamin a, >1000 mg of vitamin c, or >800 u vitamin e
boolean
C3661611 (UMLS CUI [1])
C3661608 (UMLS CUI [2])
C3661607 (UMLS CUI [3])
Comorbidity due to kidney or liver disease
Item
4. known significant co-morbidity such as renal (creatinine > 150 mol/l) or hepatic disease (ast or alt >3 times normal). measurement of these will be a requirement of the study. creatinine and alanine aminotransferase (alt) will be measured at the beginning and at the end of the study.
boolean
C0009488 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0023895 (UMLS CUI [2,2])
C0428321 (UMLS CUI [2,3])
Known or susspected active caner
Item
5. known or suspected active cancer other than non-melanoma skin cancer.
boolean
C1882062 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1882062 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
Other concurrent polmunary diseases
Item
6. other concurrent major respiratory diagnosis other than copd/asthma.
boolean
C0009488 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
Concomitant medication with Hydroxymethylglutaryl-CoA Reductase Inhibitors
Item
7. plan to start statin drugs during the 12 weeks of study drug (may enroll if statins started >1 month before current study enrollment or deferred until study completion).
boolean
C2826666 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Consumption of brazil nuts
Item
8. consumption of brazil nuts.
boolean
C0440287 (UMLS CUI [1,1])
C0013470 (UMLS CUI [1,2])
Comorbidity due to homocystinuria
Item
9. individuals who have homocystinuria
boolean
C0009488 (UMLS CUI [1,1])
C0019880 (UMLS CUI [1,2])
Concomitant medication with niacin
Item
10. on niacin at a daily dose of 500 mg or higher for hyperlipidemia.
boolean
C2826666 (UMLS CUI [1,1])
C0027996 (UMLS CUI [1,2])
Allergies to products
Item
11. if you have allergies to products that contain dicalcium phosphate, talc sugarloaf, stearic acid, or silica.
boolean
C0020517 (UMLS CUI [1,1])
C0795598 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039267 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0038229 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0037098 (UMLS CUI [4,2])
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