ID

20015

Beskrivning

The Canadian Prevention of Renal and Cardiovascular Endpoints Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00231803

Länk

https://clinicaltrials.gov/show/NCT00231803

Nyckelord

Versioner (1)
  1. 2017-02-03 2017-02-03 -
Uppladdad den

3 februari 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Chronic Kidney Disease NCT00231803

Engelsk

Eligibility Chronic Kidney Disease NCT00231803

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
stratum 1 (expected about 50% of trial subjects): diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and ckd as documented by calculated (cockroft-gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; or
Beskrivning

Diabetes Mellitus | Plasma glucose result Range Diabetic | Hypoglycemic Agents | Chronic Kidney Diseases | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0455280
UMLS CUI [2,2]
C1514721
UMLS CUI [2,3]
C0241863
UMLS CUI [3]
C0020616
UMLS CUI [4]
C1561643
UMLS CUI [5]
C2711451
UMLS CUI [6]
C0201976
stratum 2 (expected about 20% of trial subjects): non-diabetic with ckd as defined for stratum 1 and proteinuria of > 1g/l by dipstick in random urine at screening; or
Beskrivning

Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Urine dipstick test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241863
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1561643
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0201976
UMLS CUI [5,1]
C0033687
UMLS CUI [5,2]
C0430370
stratum 3 (expected about 30% of trial subjects): non-diabetic with ckd as defined for stratum 1, but without proteinuria as for stratum 2 at screening
Beskrivning

Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241863
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1561643
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0201976
UMLS CUI [5,1]
C0033687
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
unwilling to provide informed consent
Beskrivning

Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
likely to die of any known existing disease within 6 months
Beskrivning

Cessation of life Probably | Death caused by Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0750492
UMLS CUI [2,1]
C0011065
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0012634
recently unstable/advanced cardiovascular disease (mi or acute coronary syndrome, hospitalized heart failure, tia or stroke, leg amputation or gangrene in past 6 months)
Beskrivning

Cardiovascular Disease Unstable | Cardiovascular Disease Advanced | Myocardial Infarction | Acute Coronary Syndrome | Hospitalization Due to Heart failure | Transient Ischemic Attack | Cerebrovascular accident | Amputation of lower limb | Gangrene

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0948089
UMLS CUI [5,1]
C0019993
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0018801
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0337308
UMLS CUI [9]
C0017086
currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
Beskrivning

cancer treatment | Skin carcinoma Localized

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C0392752
progressive kidney disease currently treated by immunotherapy
Beskrivning

Immunotherapy RENAL DISEASE PROGRESSIVE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0748293
currently receiving dialysis or likely to do so within 6 months
Beskrivning

Dialysis procedure | Dialysis procedure Probably

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0750492
current organ transplant recipient (or planned within 6 months)
Beskrivning

Transplanted organ Recipient | Transplanted organ Recipient Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524930
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0524930
UMLS CUI [2,2]
C1709854
UMLS CUI [2,3]
C1301732
currently receiving ongoing care for ckd, or cardiovascular disease, in a multiple intervention, disease management program.
Beskrivning

Medical care Chronic Kidney Disease | Medical care Cardiovascular Disease | Intervention multiple | Disease management program

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0496675
UMLS CUI [1,2]
C1561643
UMLS CUI [2,1]
C0496675
UMLS CUI [2,2]
C0007222
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0439064
UMLS CUI [4]
C1303150
currently enrolled in another interventional trial
Beskrivning

Study Subject Participation Status | Enrollment Interventional Study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C3274035
residing in a location not amenable to follow up for the trial
Beskrivning

Living place Amenable Clinical Study Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0337646
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C3274571
Tillbaka till toppen

Similar models

Eligibility Chronic Kidney Disease NCT00231803

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus | Plasma glucose result Range Diabetic | Hypoglycemic Agents | Chronic Kidney Diseases | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum
Item
stratum 1 (expected about 50% of trial subjects): diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and ckd as documented by calculated (cockroft-gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; or
boolean
C0011849 (UMLS CUI [1])
C0455280 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C0241863 (UMLS CUI [2,3])
C0020616 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
C2711451 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Urine dipstick test
Item
stratum 2 (expected about 20% of trial subjects): non-diabetic with ckd as defined for stratum 1 and proteinuria of > 1g/l by dipstick in random urine at screening; or
boolean
C0241863 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1561643 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0033687 (UMLS CUI [5,1])
C0430370 (UMLS CUI [5,2])
Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Absent
Item
stratum 3 (expected about 30% of trial subjects): non-diabetic with ckd as defined for stratum 1, but without proteinuria as for stratum 2 at screening
boolean
C0241863 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1561643 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0033687 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unwilling
Item
unwilling to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Cessation of life Probably | Death caused by Disease
Item
likely to die of any known existing disease within 6 months
boolean
C0011065 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C0011065 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Cardiovascular Disease Unstable | Cardiovascular Disease Advanced | Myocardial Infarction | Acute Coronary Syndrome | Hospitalization Due to Heart failure | Transient Ischemic Attack | Cerebrovascular accident | Amputation of lower limb | Gangrene
Item
recently unstable/advanced cardiovascular disease (mi or acute coronary syndrome, hospitalized heart failure, tia or stroke, leg amputation or gangrene in past 6 months)
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
C0019993 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0018801 (UMLS CUI [5,3])
C0007787 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0337308 (UMLS CUI [8])
C0017086 (UMLS CUI [9])
cancer treatment | Skin carcinoma Localized
Item
currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
boolean
C0920425 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
Immunotherapy RENAL DISEASE PROGRESSIVE
Item
progressive kidney disease currently treated by immunotherapy
boolean
C0021083 (UMLS CUI [1,1])
C0748293 (UMLS CUI [1,2])
Dialysis procedure | Dialysis procedure Probably
Item
currently receiving dialysis or likely to do so within 6 months
boolean
C0011946 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
Transplanted organ Recipient | Transplanted organ Recipient Planned
Item
current organ transplant recipient (or planned within 6 months)
boolean
C0524930 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0524930 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Medical care Chronic Kidney Disease | Medical care Cardiovascular Disease | Intervention multiple | Disease management program
Item
currently receiving ongoing care for ckd, or cardiovascular disease, in a multiple intervention, disease management program.
boolean
C0496675 (UMLS CUI [1,1])
C1561643 (UMLS CUI [1,2])
C0496675 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0184661 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])
C1303150 (UMLS CUI [4])
Study Subject Participation Status | Enrollment Interventional Study
Item
currently enrolled in another interventional trial
boolean
C2348568 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C3274035 (UMLS CUI [2,2])
Living place Amenable Clinical Study Follow-up
Item
residing in a location not amenable to follow up for the trial
boolean
C0337646 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial