ID

40708

Beskrivning

Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD); ODM derived from: https://clinicaltrials.gov/show/NCT01111266

Länk

https://clinicaltrials.gov/show/NCT01111266

Nyckelord

Versioner (1)
  1. 2020-05-01 2020-05-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT01111266

Engelsk

Eligibility Kidney Disease NCT01111266

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent obtained from patient or parents/ guardian.
Beskrivning

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
subject age >= 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
effective blood flow 350 ml/min and dialysate flow of 500 ml/min
Beskrivning

Blood flow measurement | Dialysate Flow mL/min

Datatyp

boolean

Alias
UMLS CUI [1]
C0005776
UMLS CUI [2,1]
C0011947
UMLS CUI [2,2]
C0806140
UMLS CUI [2,3]
C0439445
on hemodialysis for a minimum of 3 months
Beskrivning

Hemodialysis Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0449238
use of cimino- or gore-tex shunts
Beskrivning

Cimino shunt | GORE-TEX Shunt

Datatyp

boolean

Alias
UMLS CUI [1]
C1142577
UMLS CUI [2,1]
C0018088
UMLS CUI [2,2]
C0542331
routine dialysis-treatment for 240 min
Beskrivning

Routine Dialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205547
UMLS CUI [1,2]
C0011946
documented dialysis adequacy parameter that has been stable for past 3 months
Beskrivning

Dialysis Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0205360
plan to dialyze at participating hemodialysis centre for at least 3-months duration.
Beskrivning

Dialysis Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C1301732
free from any currently known unusual clotting or access problems
Beskrivning

Free of Clotting Unusual | Free of Access Problem

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0005779
UMLS CUI [1,3]
C2700116
UMLS CUI [2,1]
C0332296
UMLS CUI [2,2]
C0444454
UMLS CUI [2,3]
C0033213
hepatitis b surface antigen (hbsag) negative, documented within the past 90 days or hepatitis b surface antibody (anti-hbs) positive.
Beskrivning

Hepatitis B surface antigen negative | Hepatitis B surface antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0919711
UMLS CUI [2]
C0149708
anti hepatitis c virus (anti-hcv) negative, documented within the past 90 days
Beskrivning

Hepatitis C antibody negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0853904
anti human immunodeficiency virus (anti hiv) negative, documented within the past 90 days
Beskrivning

HIV antibody negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1142096
hematocrit (hct) between 25 and 40% or haemoglobin (hb) not less than 8 g/dl, as documented 14 days prior to the first treatment
Beskrivning

Hematocrit level | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0518015
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are unable to tolerate an effective blood flow of 350 ml/min
Beskrivning

Intolerance Blood flow mL/min

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0232338
UMLS CUI [1,3]
C0439445
patients using catheter for dialysis
Beskrivning

Dialysis catheter

Datatyp

boolean

Alias
UMLS CUI [1]
C0179747
pregnant or nursing woman. women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: iud; condom with spermicidal gel; diaphragm; sponge; cervical cap)
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Hormonal contraception | Contraceptive implant | Contraceptive patch | Contraceptives, Oral, Hormonal | Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C2985296
UMLS CUI [4]
C1657106
UMLS CUI [5]
C2985284
UMLS CUI [6]
C0009907
UMLS CUI [7,1]
C0004764
UMLS CUI [7,2]
C0205173
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0221829
UMLS CUI [10]
C0087145
UMLS CUI [11]
C0042241
UMLS CUI [12]
C0183461
UMLS CUI [13]
C0493327
previous plan for extended absences from the participating hemodialysis centre
Beskrivning

Absence Hemodialysis Center

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0019004
UMLS CUI [1,3]
C1552416
expected to be transplanted (living related donor) within the maximum of 3 months for the study period
Beskrivning

Transplantation Expected | Living related donor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C1517001
UMLS CUI [2]
C3494891
any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
Beskrivning

Medical condition Interferes with Therapeutic procedure | Medical condition Interferes with Assessment | Medical condition Excludes Completion of clinical trial | Disability Interferes with Therapeutic procedure | Disability Interferes with Assessment | Disability Excludes Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C0231170
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0087111
UMLS CUI [5,1]
C0231170
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1516048
UMLS CUI [6,1]
C0231170
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C2732579
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Similar models

Eligibility Kidney Disease NCT01111266

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
written informed consent obtained from patient or parents/ guardian.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Age
Item
subject age >= 18
boolean
C0001779 (UMLS CUI [1])
Blood flow measurement | Dialysate Flow mL/min
Item
effective blood flow 350 ml/min and dialysate flow of 500 ml/min
boolean
C0005776 (UMLS CUI [1])
C0011947 (UMLS CUI [2,1])
C0806140 (UMLS CUI [2,2])
C0439445 (UMLS CUI [2,3])
Hemodialysis Duration
Item
on hemodialysis for a minimum of 3 months
boolean
C0019004 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Cimino shunt | GORE-TEX Shunt
Item
use of cimino- or gore-tex shunts
boolean
C1142577 (UMLS CUI [1])
C0018088 (UMLS CUI [2,1])
C0542331 (UMLS CUI [2,2])
Routine Dialysis
Item
routine dialysis-treatment for 240 min
boolean
C0205547 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
Dialysis Stable
Item
documented dialysis adequacy parameter that has been stable for past 3 months
boolean
C0011946 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Dialysis Planned
Item
plan to dialyze at participating hemodialysis centre for at least 3-months duration.
boolean
C0011946 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Free of Clotting Unusual | Free of Access Problem
Item
free from any currently known unusual clotting or access problems
boolean
C0332296 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
C2700116 (UMLS CUI [1,3])
C0332296 (UMLS CUI [2,1])
C0444454 (UMLS CUI [2,2])
C0033213 (UMLS CUI [2,3])
Hepatitis B surface antigen negative | Hepatitis B surface antibody positive
Item
hepatitis b surface antigen (hbsag) negative, documented within the past 90 days or hepatitis b surface antibody (anti-hbs) positive.
boolean
C0919711 (UMLS CUI [1])
C0149708 (UMLS CUI [2])
Hepatitis C antibody negative
Item
anti hepatitis c virus (anti-hcv) negative, documented within the past 90 days
boolean
C0853904 (UMLS CUI [1])
HIV antibody negative
Item
anti human immunodeficiency virus (anti hiv) negative, documented within the past 90 days
boolean
C1142096 (UMLS CUI [1])
Hematocrit level | Hemoglobin measurement
Item
hematocrit (hct) between 25 and 40% or haemoglobin (hb) not less than 8 g/dl, as documented 14 days prior to the first treatment
boolean
C0518014 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Intolerance Blood flow mL/min
Item
patients who are unable to tolerate an effective blood flow of 350 ml/min
boolean
C0231199 (UMLS CUI [1,1])
C0232338 (UMLS CUI [1,2])
C0439445 (UMLS CUI [1,3])
Dialysis catheter
Item
patients using catheter for dialysis
boolean
C0179747 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Hormonal contraception | Contraceptive implant | Contraceptive patch | Contraceptives, Oral, Hormonal | Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE
Item
pregnant or nursing woman. women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: iud; condom with spermicidal gel; diaphragm; sponge; cervical cap)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
C1657106 (UMLS CUI [4])
C2985284 (UMLS CUI [5])
C0009907 (UMLS CUI [6])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0087145 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0183461 (UMLS CUI [12])
C0493327 (UMLS CUI [13])
Absence Hemodialysis Center
Item
previous plan for extended absences from the participating hemodialysis centre
boolean
C0332197 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
C1552416 (UMLS CUI [1,3])
Transplantation Expected | Living related donor
Item
expected to be transplanted (living related donor) within the maximum of 3 months for the study period
boolean
C0040732 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C3494891 (UMLS CUI [2])
Medical condition Interferes with Therapeutic procedure | Medical condition Interferes with Assessment | Medical condition Excludes Completion of clinical trial | Disability Interferes with Therapeutic procedure | Disability Interferes with Assessment | Disability Excludes Completion of clinical trial
Item
any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0231170 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0231170 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1516048 (UMLS CUI [5,3])
C0231170 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
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