ID

35854

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02460263

Nyckelord

  1. 2019-03-28 2019-03-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 mars 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility End Stage Renal Disease NCT02460263

Eligibility End Stage Renal Disease NCT02460263

Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Vascular access Functioning Well Stable | Blood flow measurement

Datatyp

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
Beskrivning

Exclusion Criteria

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

Life Expectancy

Datatyp

boolean

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

Adverse event Cardiovascular Major

Datatyp

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%.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Blood Pressure Uncontrolled

Datatyp

boolean

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

Intolerance to Heparin

Datatyp

boolean

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

Hepatitis B Surface Antigens Seropositive

Datatyp

boolean

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

Rheumatism Life Threatening

Datatyp

boolean

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

Adverse reactions Dialyzer Membrane Materials

Datatyp

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.
Beskrivning

Organ Transplantation Expected

Datatyp

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.
Beskrivning

Malignant Neoplasms Life Threatening | Therapeutic procedure Preventing Completion Study Protocol

Datatyp

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

Similar models

Eligibility End Stage Renal Disease NCT02460263

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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