ID

21143

Beschrijving

Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00299169

Link

https://clinicaltrials.gov/show/NCT00299169

Trefwoorden

  1. 11-04-17 11-04-17 -
Geüploaded op

11 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes NCT00299169

Eligibility Diabetes NCT00299169

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00299169
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
established diagnosis of type 1 or 2 diabetes
Beschrijving

Diagnosis of Diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0011849
age 18-80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
indication for a statin by the 2003 canadian diabetes association (cda) clinical practice guidelines
Beschrijving

Indication for a statin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C3146298
willingness to re-try a statin despite previous apparent intolerance
Beschrijving

Re-try statin therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0205341
provision of signed informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (ck, ast, alt >three times upper limit of normal), pregnancy or lactation
Beschrijving

Contraindication to statin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0360714
impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min)
Beschrijving

Creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
presence of a condition such as malignancy for which the one-year prognosis is poor
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
inability of the patient to comply with the rigorous conditions of the trial
Beschrijving

Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
any other condition deemed to render the study harmful to the participant
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488

Similar models

Eligibility Diabetes NCT00299169

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00299169
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis of Diabetes mellitus
Item
established diagnosis of type 1 or 2 diabetes
boolean
C0011900 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Age
Item
age 18-80 years
boolean
C0001779 (UMLS CUI [1])
Indication for a statin
Item
indication for a statin by the 2003 canadian diabetes association (cda) clinical practice guidelines
boolean
C0360714 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Re-try statin therapy
Item
willingness to re-try a statin despite previous apparent intolerance
boolean
C0360714 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Informed consent
Item
provision of signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contraindication to statin
Item
contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (ck, ast, alt >three times upper limit of normal), pregnancy or lactation
boolean
C0522473 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Creatinine clearance
Item
impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min)
boolean
C0373595 (UMLS CUI [1])
Life Expectancy
Item
presence of a condition such as malignancy for which the one-year prognosis is poor
boolean
C0023671 (UMLS CUI [1])
Compliance
Item
inability of the patient to comply with the rigorous conditions of the trial
boolean
C1321605 (UMLS CUI [1])
Comorbidity
Item
any other condition deemed to render the study harmful to the participant
boolean
C0009488 (UMLS CUI [1])

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