ID

35854

Beschrijving

The EvAluation of TaBlo In-CLinic and In-HOme; ODM derived from: https://clinicaltrials.gov/show/NCT02460263

Link

https://clinicaltrials.gov/show/NCT02460263

Trefwoorden

Versies (1)
  1. 28-03-19 28-03-19 -
Houder van rechten

See clinicaltrials.gov

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28 maart 2019

DOI

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Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT02460263

Engels

Eligibility End Stage Renal Disease NCT02460263

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has end stage renal disease (esrd) adequately treated by maintenance dialysis achieving a kt/v ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
Beschrijving

Kidney Failure, Chronic | Maintenance Dialysis Kt/V | Study Subject Stable status

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C0429662
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0205360
subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
Beschrijving

Vascular access Functioning Well Stable | Blood flow measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750138
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C0205170
UMLS CUI [1,4]
C0205360
UMLS CUI [2]
C0005776
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy less than 12 months from first study procedure.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
subject has had a recent major cardiovascular adverse event within the last 3 months.
Beschrijving

Adverse event Cardiovascular Major

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3887460
UMLS CUI [1,3]
C0205164
subject has new york class iii or iv congestive heart failure, or ejection fraction less than 30%.
Beschrijving

Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0232174
subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
Beschrijving

Fluid overload Due to Refractory ascites | Refractory ascites Secondary to Liver Cirrhosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0546817
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3532188
UMLS CUI [2,1]
C3532188
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0023890
subject has uncontrolled blood pressure.
Beschrijving

Blood Pressure Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
subject is intolerant to heparin.
Beschrijving

Intolerance to Heparin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0019134
subject is seroreactive for hepatitis b surface antigen.
Beschrijving

Hepatitis B Surface Antigens Seropositive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0521143
subject has an active, life-threatening, rheumatologic disease.
Beschrijving

Rheumatism Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035435
UMLS CUI [1,2]
C2826244
subject has a history of adverse reactions to dialyzer membrane material.
Beschrijving

Adverse reactions Dialyzer Membrane Materials

Datatype

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0180409
UMLS CUI [1,3]
C1706182
UMLS CUI [1,4]
C0520510
subject is expected to receive an organ transplant during the course of the study.
Beschrijving

Organ Transplantation Expected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C1517001
subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
Beschrijving

Malignant Neoplasms Life Threatening | Therapeutic procedure Preventing Completion Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C2348563
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Similar models

Eligibility End Stage Renal Disease NCT02460263

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Kidney Failure, Chronic | Maintenance Dialysis Kt/V | Study Subject Stable status
Item
subject has end stage renal disease (esrd) adequately treated by maintenance dialysis achieving a kt/v ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
boolean
C0022661 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C0429662 (UMLS CUI [2,3])
C0681850 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Vascular access Functioning Well Stable | Blood flow measurement
Item
subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
boolean
C0750138 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0205170 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0005776 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
life expectancy less than 12 months from first study procedure.
boolean
C0023671 (UMLS CUI [1])
Adverse event Cardiovascular Major
Item
subject has had a recent major cardiovascular adverse event within the last 3 months.
boolean
C0877248 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction
Item
subject has new york class iii or iv congestive heart failure, or ejection fraction less than 30%.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
Fluid overload Due to Refractory ascites | Refractory ascites Secondary to Liver Cirrhosis
Item
subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
boolean
C0546817 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3532188 (UMLS CUI [1,3])
C3532188 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0023890 (UMLS CUI [2,3])
Blood Pressure Uncontrolled
Item
subject has uncontrolled blood pressure.
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Intolerance to Heparin
Item
subject is intolerant to heparin.
boolean
C1744706 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
Hepatitis B Surface Antigens Seropositive
Item
subject is seroreactive for hepatitis b surface antigen.
boolean
C0019168 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
Rheumatism Life Threatening
Item
subject has an active, life-threatening, rheumatologic disease.
boolean
C0035435 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Adverse reactions Dialyzer Membrane Materials
Item
subject has a history of adverse reactions to dialyzer membrane material.
boolean
C0559546 (UMLS CUI [1,1])
C0180409 (UMLS CUI [1,2])
C1706182 (UMLS CUI [1,3])
C0520510 (UMLS CUI [1,4])
Organ Transplantation Expected
Item
subject is expected to receive an organ transplant during the course of the study.
boolean
C0029216 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Malignant Neoplasms Life Threatening | Therapeutic procedure Preventing Completion Study Protocol
Item
subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
boolean
C0006826 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
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