ID

29318

Beskrivning

Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT00825318

Länk

https://clinicaltrials.gov/show/NCT00825318

Nyckelord

Versioner (1)
  1. 2018-03-18 2018-03-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility End-stage Renal Disease NCT00825318

Engelsk

Eligibility End-stage Renal Disease NCT00825318

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than or equal to 18 years and less than or equal to 80 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
stable three treatments per week dialysis schedule for at least three months prior to beginning the study
Beskrivning

Schedule Dialysis Frequency Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030703
UMLS CUI [1,2]
C0011946
UMLS CUI [1,3]
C0439603
UMLS CUI [1,4]
C0449238
residual renal clearance <1.5ml/min per 35l of urea volume
Beskrivning

Residual Urea Clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0523964
pre-dialysis serum sodium levels of greater than 136 meq/l
Beskrivning

Serum sodium level Pre-dialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0587356
UMLS CUI [1,2]
C1264634
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
Beskrivning

Hemodialysis Compliance behavior Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0332268
unable to verbally communicate in english or spanish
Beskrivning

Lacking Able to communicate English Language | Lacking Able to communicate Spanish Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2364293
UMLS CUI [2,3]
C0037750
current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
Beskrivning

Patient need for Hemodialysis Frequency | Etiology Comorbidity | Ultrafiltration Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0019004
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0009488
UMLS CUI [3,1]
C0041612
UMLS CUI [3,2]
C1265611
currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
Beskrivning

Hemodialysis Daily | Hemodialysis nocturnal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0332173
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0240526
expected geographic unavailability at dialysis center during any phase of the trial
Beskrivning

Patient unavailable Geographic Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C1517526
UMLS CUI [1,3]
C1517001
less than 3 months since the patient returned after acute rejection resulting in allograft failure
Beskrivning

Rejection Resulting in Allograft Failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018129
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0040739
UMLS CUI [1,4]
C0231174
currently in acute care or chronic care hospital
Beskrivning

Hospital care | Hospital care chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0259945
UMLS CUI [2,1]
C0259945
UMLS CUI [2,2]
C0205191
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
current involvement in any non-observational trial
Beskrivning

Study Subject Participation Status | Clinical Trial Without Observation

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0302523
unable or unwilling to follow the study protocol for any reason (including mental incompetence)
Beskrivning

Protocol Compliance Unable | Protocol Compliance Unwilling | Mental Incompetence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
UMLS CUI [3]
C0086455
unable or unwilling to provide informed consent or sign irb-approved consent form
Beskrivning

Informed Consent Unable | Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
pace maker, implantable pump, artificial joint
Beskrivning

Artificial cardiac pacemaker | Infusion Pumps, Implantable | Artificial joint

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0021438
UMLS CUI [3]
C0481488
amputation of a limb
Beskrivning

Amputation of limb

Datatyp

boolean

Alias
UMLS CUI [1]
C0002689
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Similar models

Eligibility End-stage Renal Disease NCT00825318

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater than or equal to 18 years and less than or equal to 80 years
boolean
C0001779 (UMLS CUI [1])
Schedule Dialysis Frequency Duration
Item
stable three treatments per week dialysis schedule for at least three months prior to beginning the study
boolean
C0030703 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Residual Urea Clearance
Item
residual renal clearance <1.5ml/min per 35l of urea volume
boolean
C0523964 (UMLS CUI [1])
Serum sodium level Pre-dialysis
Item
pre-dialysis serum sodium levels of greater than 136 meq/l
boolean
C0587356 (UMLS CUI [1,1])
C1264634 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hemodialysis Compliance behavior Lacking
Item
non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
boolean
C0019004 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Lacking Able to communicate English Language | Lacking Able to communicate Spanish Language
Item
unable to verbally communicate in english or spanish
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2364293 (UMLS CUI [2,2])
C0037750 (UMLS CUI [2,3])
Patient need for Hemodialysis Frequency | Etiology Comorbidity | Ultrafiltration Quantity
Item
current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
boolean
C0686904 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0041612 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Hemodialysis Daily | Hemodialysis nocturnal
Item
currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
boolean
C0019004 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2,1])
C0240526 (UMLS CUI [2,2])
Patient unavailable Geographic Expected
Item
expected geographic unavailability at dialysis center during any phase of the trial
boolean
C1301818 (UMLS CUI [1,1])
C1517526 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Rejection Resulting in Allograft Failure
Item
less than 3 months since the patient returned after acute rejection resulting in allograft failure
boolean
C0018129 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0040739 (UMLS CUI [1,3])
C0231174 (UMLS CUI [1,4])
Hospital care | Hospital care chronic
Item
currently in acute care or chronic care hospital
boolean
C0259945 (UMLS CUI [1])
C0259945 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Without Observation
Item
current involvement in any non-observational trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0302523 (UMLS CUI [2,3])
Protocol Compliance Unable | Protocol Compliance Unwilling | Mental Incompetence
Item
unable or unwilling to follow the study protocol for any reason (including mental incompetence)
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0086455 (UMLS CUI [3])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to provide informed consent or sign irb-approved consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Artificial cardiac pacemaker | Infusion Pumps, Implantable | Artificial joint
Item
pace maker, implantable pump, artificial joint
boolean
C0030163 (UMLS CUI [1])
C0021438 (UMLS CUI [2])
C0481488 (UMLS CUI [3])
Amputation of limb
Item
amputation of a limb
boolean
C0002689 (UMLS CUI [1])
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