ID

29289

Beskrivning

Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration; ODM derived from: https://clinicaltrials.gov/show/NCT00976846

Länk

https://clinicaltrials.gov/show/NCT00976846

Nyckelord

Versioner (1)
  1. 2018-03-15 2018-03-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility End Stage Kidney Disease NCT00976846

Engelsk

Eligibility End Stage Kidney Disease NCT00976846

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have signed an informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients between 18 and 75 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients who have been treated with hemodialysis for more than three months.
Beskrivning

Hemodialysis Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0449238
patients who are treated three times a week for 4-5 hours.
Beskrivning

Therapeutic procedure Frequency Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439603
UMLS CUI [1,3]
C0449238
patients who are usually treated with high-flux dialyzers.
Beskrivning

Dialyzers, High-Flux

Datatyp

boolean

Alias
UMLS CUI [1]
C3688647
patients who are on a stable anticoagulation and erythropoetin regimen.
Beskrivning

Anticoagulation Therapy Stable | Erythropoietin Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0014822
UMLS CUI [2,2]
C0205360
patients whose hematocrit is over 28 %.
Beskrivning

Hematocrit level

Datatyp

boolean

Alias
UMLS CUI [1]
C0518014
patients having no vascular access related problems.
Beskrivning

Vascular access Problem Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750138
UMLS CUI [1,2]
C0033213
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients not meeting the inclusion criteria.
Beskrivning

Inclusion criteria Mismatch

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1881865
patients who are in a poor nutritional status as judged by the investigator.
Beskrivning

Nutritional status Poor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392209
UMLS CUI [1,2]
C0542537
patients in a gravid state.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
patients with an unstable clinical condition (e.g. cardiac or vascular instability).
Beskrivning

Medical condition Unstable | Instability cardiac | Instability Vascular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1444783
UMLS CUI [2,2]
C0018787
UMLS CUI [3,1]
C1444783
UMLS CUI [3,2]
C1801960
patients whose life expectancy is less than 12 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patients with a positive anamnesis for the first use syndrome.
Beskrivning

Anamnesis Positive First use syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025084
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1707736
patients with known coagulation problems.
Beskrivning

Blood Coagulation Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
patients who receive hemodialysis via a single dialysis needle or central venous catheter.
Beskrivning

Hemodialysis Needle Single | Hemodialysis Central venous catheter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0027551
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C1145640
patients participating in another study that may interfere with the outcome of the present study.
Beskrivning

Study Subject Participation Status Interferes with Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
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Similar models

Eligibility End Stage Kidney Disease NCT00976846

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients who have signed an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
patients between 18 and 75 years.
boolean
C0001779 (UMLS CUI [1])
Hemodialysis Duration
Item
patients who have been treated with hemodialysis for more than three months.
boolean
C0019004 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Therapeutic procedure Frequency Duration
Item
patients who are treated three times a week for 4-5 hours.
boolean
C0087111 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Dialyzers, High-Flux
Item
patients who are usually treated with high-flux dialyzers.
boolean
C3688647 (UMLS CUI [1])
Anticoagulation Therapy Stable | Erythropoietin Stable
Item
patients who are on a stable anticoagulation and erythropoetin regimen.
boolean
C0003281 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0014822 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Hematocrit level
Item
patients whose hematocrit is over 28 %.
boolean
C0518014 (UMLS CUI [1])
Vascular access Problem Absent
Item
patients having no vascular access related problems.
boolean
C0750138 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Mismatch
Item
patients not meeting the inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
Nutritional status Poor
Item
patients who are in a poor nutritional status as judged by the investigator.
boolean
C0392209 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
Pregnancy
Item
patients in a gravid state.
boolean
C0032961 (UMLS CUI [1])
Medical condition Unstable | Instability cardiac | Instability Vascular
Item
patients with an unstable clinical condition (e.g. cardiac or vascular instability).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1444783 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C1444783 (UMLS CUI [3,1])
C1801960 (UMLS CUI [3,2])
Life Expectancy
Item
patients whose life expectancy is less than 12 months.
boolean
C0023671 (UMLS CUI [1])
Anamnesis Positive First use syndrome
Item
patients with a positive anamnesis for the first use syndrome.
boolean
C0025084 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1707736 (UMLS CUI [1,3])
Blood Coagulation Disorders
Item
patients with known coagulation problems.
boolean
C0005779 (UMLS CUI [1])
Hemodialysis Needle Single | Hemodialysis Central venous catheter
Item
patients who receive hemodialysis via a single dialysis needle or central venous catheter.
boolean
C0019004 (UMLS CUI [1,1])
C0027551 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0019004 (UMLS CUI [2,1])
C1145640 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results
Item
patients participating in another study that may interfere with the outcome of the present study.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Tillbaka till toppen 

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