ID

36224

Description

Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium for the Calculation of GFR and Validity Compared to the Renal Clearance of Inulin; ODM derived from: https://clinicaltrials.gov/show/NCT02300376

Link

https://clinicaltrials.gov/show/NCT02300376

Keywords

Versions (1)
  1. 4/23/19 4/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT02300376

English

Eligibility Kidney Disease NCT02300376

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for v1:
Description

Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
for transplanted patients : patients from 18 to 80 years, after estimation of their renal function by mdrds formulas (mdrd = modification of diet in renal disease) , regardless their nephropathy, regardless the age of the transplantation, with a normal state body hydratation, with a social insurance and who have given their prior consent.
Description

Patients Transplanted | Age | Kidney Function Test MDRD formula | Independent of Kidney Disease | Independent of Time Interval Transplantation | Body Hydration status Normal | Social insurance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0040732
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0022662
UMLS CUI [3,2]
C3839656
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0022658
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0872291
UMLS CUI [5,3]
C0040732
UMLS CUI [6,1]
C0460148
UMLS CUI [6,2]
C1321013
UMLS CUI [6,3]
C0205307
UMLS CUI [7]
C0037435
UMLS CUI [8]
C0021430
for other patients : patients from 18 to 80 years, after estimation of their renal function by mdrds formulas, who need a reliable assess of their renal function, with a normal state body hydratation, with a social insurance and who have given their prior consent.
Description

Patients Other | Age | Kidney Function Test MDRD formula | Requirement Renal function Assessment | Body Hydration status Normal | Social insurance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0022662
UMLS CUI [3,2]
C3839656
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0232804
UMLS CUI [4,3]
C1516048
UMLS CUI [5,1]
C0460148
UMLS CUI [5,2]
C1321013
UMLS CUI [5,3]
C0205307
UMLS CUI [6]
C0037435
UMLS CUI [7]
C0021430
inclusion criteria for v2: transplanted patients who have participated to v1, with stable clinical conditions, with a stable gfr (less than 30% variation of creatinine clearance by mdrds formulas) and who have given their prior consent.
Description

Patients Transplanted | Clinical status Stable | Glomerular Filtration Rate Stable | Creatinine clearance measurement MDRD formula | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0040732
UMLS CUI [2,1]
C0449440
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0017654
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0373595
UMLS CUI [4,2]
C3839656
UMLS CUI [5]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to calcium edetate de sodium
Description

Hypersensitivity Edetate calcium disodium

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006692
inulin or excipients
Description

Insulin | Insulin Excipient

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0015237
lead or other heavy metal intoxication
Description

Lead intoxication | Toxic effect of heavy metal

Data type

boolean

Alias
UMLS CUI [1]
C0023176
UMLS CUI [2]
C0274869
volume expansion or dehydration
Description

Body Fluid Volume Expanded | Dehydration

Data type

boolean

Alias
UMLS CUI [1,1]
C0005889
UMLS CUI [1,2]
C0449971
UMLS CUI [1,3]
C0205229
UMLS CUI [2]
C0011175
acute renal disease
Description

Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
bladder voiding affections
Description

Difficulty in urination

Data type

boolean

Alias
UMLS CUI [1]
C0241705
coagulation disorders
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
poor venous capital
Description

Capacity Venous Poor

Data type

boolean

Alias
UMLS CUI [1,1]
C1516240
UMLS CUI [1,2]
C0348013
UMLS CUI [1,3]
C0542537
people in guardianship
Description

Patients Guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
patients already involved in an other research
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
women in child bearing age without any method of contraception
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Kidney Disease NCT02300376

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria
Item
inclusion criteria for v1:
boolean
C1512693 (UMLS CUI [1])
Patients Transplanted | Age | Kidney Function Test MDRD formula | Independent of Kidney Disease | Independent of Time Interval Transplantation | Body Hydration status Normal | Social insurance | Informed Consent
Item
for transplanted patients : patients from 18 to 80 years, after estimation of their renal function by mdrds formulas (mdrd = modification of diet in renal disease) , regardless their nephropathy, regardless the age of the transplantation, with a normal state body hydratation, with a social insurance and who have given their prior consent.
boolean
C0030705 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0022662 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
C0332291 (UMLS CUI [4,1])
C0022658 (UMLS CUI [4,2])
C0332291 (UMLS CUI [5,1])
C0872291 (UMLS CUI [5,2])
C0040732 (UMLS CUI [5,3])
C0460148 (UMLS CUI [6,1])
C1321013 (UMLS CUI [6,2])
C0205307 (UMLS CUI [6,3])
C0037435 (UMLS CUI [7])
C0021430 (UMLS CUI [8])
Patients Other | Age | Kidney Function Test MDRD formula | Requirement Renal function Assessment | Body Hydration status Normal | Social insurance | Informed Consent
Item
for other patients : patients from 18 to 80 years, after estimation of their renal function by mdrds formulas, who need a reliable assess of their renal function, with a normal state body hydratation, with a social insurance and who have given their prior consent.
boolean
C0030705 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0022662 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0232804 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C0460148 (UMLS CUI [5,1])
C1321013 (UMLS CUI [5,2])
C0205307 (UMLS CUI [5,3])
C0037435 (UMLS CUI [6])
C0021430 (UMLS CUI [7])
Patients Transplanted | Clinical status Stable | Glomerular Filtration Rate Stable | Creatinine clearance measurement MDRD formula | Informed Consent
Item
inclusion criteria for v2: transplanted patients who have participated to v1, with stable clinical conditions, with a stable gfr (less than 30% variation of creatinine clearance by mdrds formulas) and who have given their prior consent.
boolean
C0030705 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0449440 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0373595 (UMLS CUI [4,1])
C3839656 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Edetate calcium disodium
Item
hypersensitivity to calcium edetate de sodium
boolean
C0020517 (UMLS CUI [1,1])
C0006692 (UMLS CUI [1,2])
Insulin | Insulin Excipient
Item
inulin or excipients
boolean
C0021641 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
Lead intoxication | Toxic effect of heavy metal
Item
lead or other heavy metal intoxication
boolean
C0023176 (UMLS CUI [1])
C0274869 (UMLS CUI [2])
Body Fluid Volume Expanded | Dehydration
Item
volume expansion or dehydration
boolean
C0005889 (UMLS CUI [1,1])
C0449971 (UMLS CUI [1,2])
C0205229 (UMLS CUI [1,3])
C0011175 (UMLS CUI [2])
Kidney Disease
Item
acute renal disease
boolean
C0022658 (UMLS CUI [1])
Difficulty in urination
Item
bladder voiding affections
boolean
C0241705 (UMLS CUI [1])
Blood Coagulation Disorders
Item
coagulation disorders
boolean
C0005779 (UMLS CUI [1])
Capacity Venous Poor
Item
poor venous capital
boolean
C1516240 (UMLS CUI [1,1])
C0348013 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
Patients Guardianship
Item
people in guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients already involved in an other research
boolean
C2348568 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent
Item
women in child bearing age without any method of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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