ID

28012

Beskrivning

Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate; ODM derived from: https://clinicaltrials.gov/show/NCT00962000

Länk

https://clinicaltrials.gov/show/NCT00962000

Nyckelord

Versioner (1)
  1. 2017-12-10 2017-12-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 december 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00962000

Engelsk

Eligibility Chronic Kidney Disease NCT00962000

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (esrd) three times a week for at least three months with a stable treatment prescription
Beskrivning

Adult | Age | Chronic haemodialysis Frequency End stage renal disease | Prescription of therapeutic regimen Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1740835
UMLS CUI [3,2]
C0439603
UMLS CUI [3,3]
C0022661
UMLS CUI [4,1]
C0199249
UMLS CUI [4,2]
C0205360
subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
Beskrivning

Hospitalization Absent Kidney Disease | Hospitalization Absent Complication of dialysis | Exception Construction of vascular access

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0022658
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0274416
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0398220
subject with an av fistula or graft capable of routinely delivering a blood flow rate of 400 ml/min
Beskrivning

Arteriovenous fistula | Graft Capability Blood Flow Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0003855
UMLS CUI [2,1]
C0332835
UMLS CUI [2,2]
C2698977
UMLS CUI [2,3]
C1999075
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject who is non-compliant with dialysis prescription
Beskrivning

Compliance behavior Lacking Dialysis Prescription

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0011946
UMLS CUI [1,4]
C0033080
subject whose hemodialysis schedule is not three times a week
Beskrivning

Hemodialysis Frequency Schedule

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0439603
UMLS CUI [1,3]
C0086960
subject using a catheter for blood access
Beskrivning

Catheter Use of Vascular access

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085590
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0750138
subject who is not anticoagulated with heparin during hemodialysis
Beskrivning

Heparin Lacking During Hemodialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0019004
subject with a current malignancy involving sites other than skin
Beskrivning

Malignant Neoplasms Involving Site | Exception Skin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1123023
subject with a history of drug or alcohol abuse within the last six months
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant
Beskrivning

Study Subject Unable Completion of clinical trial | Comorbidity | Life Expectancy | Kidney Transplantation Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C2732579
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0023671
UMLS CUI [4,1]
C0022671
UMLS CUI [4,2]
C0205539
subject who is pregnant
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
subject who is considered incompetent to give an informed consent
Beskrivning

Informed Consent incompetent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231190
subject with a positive test for hepatitis b surface antigen within the past 30 days (testing for hepatitis b surface antigen is not required for subjects who have tested positive for hepatitis b antibody within the past year and any such patients will not be subject to this exclusion criterion)
Beskrivning

Hepatitis B surface antigen positive | Exception Hepatitis B antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0860013
subject with known hiv infection (if this is not known, no hiv testing will be performed
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Chronic Kidney Disease NCT00962000

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Chronic haemodialysis Frequency End stage renal disease | Prescription of therapeutic regimen Stable
Item
adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (esrd) three times a week for at least three months with a stable treatment prescription
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1740835 (UMLS CUI [3,1])
C0439603 (UMLS CUI [3,2])
C0022661 (UMLS CUI [3,3])
C0199249 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Hospitalization Absent Kidney Disease | Hospitalization Absent Complication of dialysis | Exception Construction of vascular access
Item
subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
boolean
C0019993 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0022658 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0274416 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0398220 (UMLS CUI [3,2])
Arteriovenous fistula | Graft Capability Blood Flow Rate
Item
subject with an av fistula or graft capable of routinely delivering a blood flow rate of 400 ml/min
boolean
C0003855 (UMLS CUI [1])
C0332835 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C1999075 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Lacking Dialysis Prescription
Item
subject who is non-compliant with dialysis prescription
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0033080 (UMLS CUI [1,4])
Hemodialysis Frequency Schedule
Item
subject whose hemodialysis schedule is not three times a week
boolean
C0019004 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0086960 (UMLS CUI [1,3])
Catheter Use of Vascular access
Item
subject using a catheter for blood access
boolean
C0085590 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0750138 (UMLS CUI [1,3])
Heparin Lacking During Hemodialysis
Item
subject who is not anticoagulated with heparin during hemodialysis
boolean
C0019134 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0019004 (UMLS CUI [1,4])
Malignant Neoplasms Involving Site | Exception Skin
Item
subject with a current malignancy involving sites other than skin
boolean
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
Substance Use Disorders
Item
subject with a history of drug or alcohol abuse within the last six months
boolean
C0038586 (UMLS CUI [1])
Study Subject Unable Completion of clinical trial | Comorbidity | Life Expectancy | Kidney Transplantation Scheduled
Item
subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant
boolean
C0681850 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
C0022671 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
Pregnancy
Item
subject who is pregnant
boolean
C0032961 (UMLS CUI [1])
Informed Consent incompetent
Item
subject who is considered incompetent to give an informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0231190 (UMLS CUI [1,2])
Hepatitis B surface antigen positive | Exception Hepatitis B antibody positive
Item
subject with a positive test for hepatitis b surface antigen within the past 30 days (testing for hepatitis b surface antigen is not required for subjects who have tested positive for hepatitis b antibody within the past year and any such patients will not be subject to this exclusion criterion)
boolean
C0149709 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0860013 (UMLS CUI [2,2])
HIV Infection
Item
subject with known hiv infection (if this is not known, no hiv testing will be performed
boolean
C0019693 (UMLS CUI [1])
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