ID

40123

Descrição

Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound; ODM derived from: https://clinicaltrials.gov/show/NCT01704170

Link

https://clinicaltrials.gov/show/NCT01704170

Palavras-chave

Versões (1)
  1. 12/03/2020 12/03/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de março de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT01704170

Inglês

Eligibility Hypertension NCT01704170

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is at least 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject has systolic blood pressure of 160 mmhg in average or greater.
Descrição

Average systolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1282151
subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
Descrição

Refractory hypertension Stable | Antihypertensive Agents Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0860493
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
subject has two functioning kidneys, defined as egfr ≥ 45 ml/min.
Descrição

Both kidneys functioning | Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0227665
UMLS CUI [1,2]
C0542341
UMLS CUI [2]
C3811844
subject has at least one renal artery on each side which is greater than 4mm.
Descrição

Renal artery Diameter Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has hydronephrosis as seen on mra or ultrasound.
Descrição

Hydronephrosis MRA | Hydronephrosis Ultrasonography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020295
UMLS CUI [1,2]
C0243032
UMLS CUI [2,1]
C0020295
UMLS CUI [2,2]
C0041618
subject has renal stenosis greater than 50% based on baseline mra.
Descrição

Renal Artery Stenosis Percentage MRA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0243032
subject has a renal stent or other implant in the region.
Descrição

STENT, RENAL | Implant Region of kidney

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1262325
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C1276227
subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
Descrição

Kidney Calculi Symptomatic | Kidney Calculi Size | Kidney Calculi Interfere with Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0022650
UMLS CUI [2,2]
C0456389
UMLS CUI [3,1]
C0022650
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0087111
subject has a history of abdominal surgery within the past six months.
Descrição

Operation on abdominal region

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0198482
subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
Descrição

Heterogeneity Kidney Interferes with Treatment | Renal cyst Large | Kidney Neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019409
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C3887499
UMLS CUI [2,2]
C0549177
UMLS CUI [3]
C0022665
subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
Descrição

Pyelonephritis | History of Pyelonephritis Interferes with Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034186
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0034186
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0087111
subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
Descrição

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
subject has hemodynamically significant valvular heart disease.
Descrição

Heart valve disease Hemodynamics Significance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with mri.
Descrição

Implantable defibrillator | Pacemaker | Neurostimulator | Medical Device Inconsistent MRI

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0810633
UMLS CUI [3]
C0582124
UMLS CUI [4,1]
C0025080
UMLS CUI [4,2]
C0442809
UMLS CUI [4,3]
C0024485
subject has a body weight > 150 kilograms.
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
subject has a target treatment depth > 14 cm.
Descrição

Target Treatment Depth

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205125
subject is pregnant, nursing or intends to become pregnant during the trial period.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
subject is currently enrolled in other potentially confounding research.
Descrição

Study Subject Participation Status | Research study Interferes with Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0681814
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Descrição

Patient condition Excludes Participation Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0008976
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Similar models

Eligibility Hypertension NCT01704170

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Average systolic blood pressure
Item
subject has systolic blood pressure of 160 mmhg in average or greater.
boolean
C1282151 (UMLS CUI [1])
Refractory hypertension Stable | Antihypertensive Agents Quantity
Item
subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
boolean
C0860493 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Both kidneys functioning | Estimated Glomerular Filtration Rate
Item
subject has two functioning kidneys, defined as egfr ≥ 45 ml/min.
boolean
C0227665 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Renal artery Diameter Quantity
Item
subject has at least one renal artery on each side which is greater than 4mm.
boolean
C0035065 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hydronephrosis MRA | Hydronephrosis Ultrasonography
Item
subject has hydronephrosis as seen on mra or ultrasound.
boolean
C0020295 (UMLS CUI [1,1])
C0243032 (UMLS CUI [1,2])
C0020295 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Renal Artery Stenosis Percentage MRA
Item
subject has renal stenosis greater than 50% based on baseline mra.
boolean
C0035067 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0243032 (UMLS CUI [1,3])
STENT, RENAL | Implant Region of kidney
Item
subject has a renal stent or other implant in the region.
boolean
C1262325 (UMLS CUI [1])
C0021102 (UMLS CUI [2,1])
C1276227 (UMLS CUI [2,2])
Kidney Calculi Symptomatic | Kidney Calculi Size | Kidney Calculi Interfere with Treatment
Item
subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
boolean
C0022650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0022650 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0022650 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Operation on abdominal region
Item
subject has a history of abdominal surgery within the past six months.
boolean
C0198482 (UMLS CUI [1])
Heterogeneity Kidney Interferes with Treatment | Renal cyst Large | Kidney Neoplasm
Item
subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
boolean
C0019409 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3887499 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0022665 (UMLS CUI [3])
Pyelonephritis | History of Pyelonephritis Interferes with Treatment
Item
subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
boolean
C0034186 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0034186 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Heart valve disease Hemodynamics Significance
Item
subject has hemodynamically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Implantable defibrillator | Pacemaker | Neurostimulator | Medical Device Inconsistent MRI
Item
subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with mri.
boolean
C0162589 (UMLS CUI [1])
C0810633 (UMLS CUI [2])
C0582124 (UMLS CUI [3])
C0025080 (UMLS CUI [4,1])
C0442809 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Body Weight
Item
subject has a body weight > 150 kilograms.
boolean
C0005910 (UMLS CUI [1])
Target Treatment Depth
Item
subject has a target treatment depth > 14 cm.
boolean
C1521840 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subject is pregnant, nursing or intends to become pregnant during the trial period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status | Research study Interferes with Clinical Trial
Item
subject is currently enrolled in other potentially confounding research.
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Patient condition Excludes Participation Clinical Trial
Item
subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
boolean
C0683521 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
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