ID

26238

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00186706

Nyckelord

Versioner (1)
  1. 2017-10-13 2017-10-13 -
Rättsinnehavare

see clinicaltrials.gov

Uppladdad den

13 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Obstructive Pulmonary Disease NCT00186706

Engelsk

Eligibility Chronic Obstructive Pulmonary Disease NCT00186706

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

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.
Beskrivning

Mild or moderate copd and spirometry

Datatyp

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.
Beskrivning

Smoking History

Datatyp

boolean

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

Informed consent

Datatyp

boolean

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

Female subjects must be post-menopausal

Datatyp

boolean

Alias
UMLS CUI [1]
C0206159
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Acute exaverbation of chronic bronchitis

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Current daily use of vitamins

Datatyp

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.
Beskrivning

Comorbidity due to kidney or liver disease

Datatyp

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.
Beskrivning

Known or susspected active caner

Datatyp

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.
Beskrivning

Other concurrent polmunary diseases

Datatyp

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).
Beskrivning

Concomitant medication with Hydroxymethylglutaryl-CoA Reductase Inhibitors

Datatyp

boolean

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

Consumption of brazil nuts

Datatyp

boolean

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

Comorbidity due to homocystinuria

Datatyp

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.
Beskrivning

Concomitant medication with niacin

Datatyp

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.
Beskrivning

Allergies to products

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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