ID

22334

Beskrivning

Effects of Deep Brain Stimulation for the Treatment of Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00358189

Länk

https://clinicaltrials.gov/show/NCT00358189

Nyckelord

Versioner (1)
  1. 2017-05-30 2017-05-30 -
Uppladdad den

30 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson NCT00358189

Engelsk

Eligibility Parkinson NCT00358189

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Parkinson NCT00358189
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
a) patients must have had the deep brain stimulator implanted for at least six months prior to enrollment.
Beskrivning

Deep brain stimulator implant

Datatyp

boolean

Alias
UMLS CUI [1]
C4069029
hoehn and yahr stage iii or worse when off stimulation and medication
Beskrivning

Hoehn and Yahr Stage | Stimulation Off | Pharmaceutical Preparations Off

Datatyp

boolean

Alias
UMLS CUI [1]
C3639483
UMLS CUI [2,1]
C1292856
UMLS CUI [2,2]
C1518543
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1518543
intractable, disabling motor fluctuations, dyskinesias or freezing episodes
Beskrivning

Motor fluctuations Disabling Intractable | Dyskinetic syndrome | Freezing Episode of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C4061999
UMLS CUI [1,3]
C0205269
UMLS CUI [2]
C0013384
UMLS CUI [3,1]
C3639445
UMLS CUI [3,2]
C0332189
age between 30-75 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
normal cognition
Beskrivning

Normal Cognition

Datatyp

boolean

Alias
UMLS CUI [1]
C2712133
demonstrated good response to levodopa. in order to exclude patients with parkinson's plus (i.e. progressive supranuclear palsy, multiple system atrophy, striato-nigral degeneration, etc) all patients included in this study must have demonstrated a good response to levodopa, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based on updrs motor examination subscore following the administration of levodopa during their screening neurological exam.
Beskrivning

Levodopa | Good therapeutic response | Atypical Parkinson Disease | Progressive supranuclear palsy | Multiple System Atrophy | Striatonigral Degeneration | Neurologic Examination UPDRS - Motor Examination Sub-total

Datatyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0184785
UMLS CUI [3]
C1868596
UMLS CUI [4]
C0038868
UMLS CUI [5]
C0393571
UMLS CUI [6]
C0270733
UMLS CUI [7,1]
C0027853
UMLS CUI [7,2]
C3827704
unsatisfactory clinical response to maximal medical management a stable and optimal medical regimen of antiparkinsonian drug therapy for at least three months prior to or after surgery
Beskrivning

Antiparkinson Agents Stable Optimal | Clinical Response Unsatisfactory

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C2698651
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C0439856
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
Beskrivning

Disease Risk Increased Postoperative Complications | Disease Risk Complication Preoperative | Heart Diseases | Lung diseases | Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0442805
UMLS CUI [1,4]
C0032787
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0009566
UMLS CUI [2,4]
C0445204
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0024115
UMLS CUI [5]
C1868885
evidence of secondary or atypical parkinsonism as suggested by:
Beskrivning

Secondary Parkinson Disease Evidence of | Atypical Parkinson Disease Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030569
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1868596
UMLS CUI [2,2]
C0332120
history of cva's, exposure to toxins, neuroleptics or encephalitis
Beskrivning

Cerebrovascular accident | Toxin Exposure to | Antipsychotic Agents | Encephalitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0040549
UMLS CUI [2,2]
C0332157
UMLS CUI [3]
C0040615
UMLS CUI [4]
C0014038
neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy or significant orthostatic hypertension
Beskrivning

Neurologic Signs Involvement Upper motor neuron | Neurologic Signs Involvement Cerebellum | Supranuclear gaze palsy | Orthostatic hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0751378
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0524458
UMLS CUI [2,1]
C0751378
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0007765
UMLS CUI [3]
C1720037
UMLS CUI [4]
C0544618
dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain
Beskrivning

Dementia Evidence of | Neuropsychologic impairment Quantity | Neuropsychologic impairment Additional | Borderline Neuropsychologic impairment Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1854569
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1854569
UMLS CUI [3,2]
C1524062
UMLS CUI [4,1]
C0870217
UMLS CUI [4,2]
C1854569
UMLS CUI [4,3]
C1524062
use of dbs for psychiatric disorder (obsessive compulsive or depression)
Beskrivning

Deep Brain Stimulation Mental disorders | Obsessive-Compulsive Disorder | Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0394162
UMLS CUI [1,2]
C0004936
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0011581
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Similar models

Eligibility Parkinson NCT00358189

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Parkinson NCT00358189
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Deep brain stimulator implant
Item
a) patients must have had the deep brain stimulator implanted for at least six months prior to enrollment.
boolean
C4069029 (UMLS CUI [1])
Hoehn and Yahr Stage | Stimulation Off | Pharmaceutical Preparations Off
Item
hoehn and yahr stage iii or worse when off stimulation and medication
boolean
C3639483 (UMLS CUI [1])
C1292856 (UMLS CUI [2,1])
C1518543 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1518543 (UMLS CUI [3,2])
Motor fluctuations Disabling Intractable | Dyskinetic syndrome | Freezing Episode of
Item
intractable, disabling motor fluctuations, dyskinesias or freezing episodes
boolean
C1868976 (UMLS CUI [1,1])
C4061999 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0013384 (UMLS CUI [2])
C3639445 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
Age
Item
age between 30-75 years
boolean
C0001779 (UMLS CUI [1])
Normal Cognition
Item
normal cognition
boolean
C2712133 (UMLS CUI [1])
Levodopa | Good therapeutic response | Atypical Parkinson Disease | Progressive supranuclear palsy | Multiple System Atrophy | Striatonigral Degeneration | Neurologic Examination UPDRS - Motor Examination Sub-total
Item
demonstrated good response to levodopa. in order to exclude patients with parkinson's plus (i.e. progressive supranuclear palsy, multiple system atrophy, striato-nigral degeneration, etc) all patients included in this study must have demonstrated a good response to levodopa, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based on updrs motor examination subscore following the administration of levodopa during their screening neurological exam.
boolean
C0023570 (UMLS CUI [1])
C0184785 (UMLS CUI [2])
C1868596 (UMLS CUI [3])
C0038868 (UMLS CUI [4])
C0393571 (UMLS CUI [5])
C0270733 (UMLS CUI [6])
C0027853 (UMLS CUI [7,1])
C3827704 (UMLS CUI [7,2])
Antiparkinson Agents Stable Optimal | Clinical Response Unsatisfactory
Item
unsatisfactory clinical response to maximal medical management a stable and optimal medical regimen of antiparkinsonian drug therapy for at least three months prior to or after surgery
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
C4055223 (UMLS CUI [2,1])
C0439856 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Disease Risk Increased Postoperative Complications | Disease Risk Complication Preoperative | Heart Diseases | Lung diseases | Uncontrolled hypertension
Item
clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
boolean
C0012634 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0032787 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0009566 (UMLS CUI [2,3])
C0445204 (UMLS CUI [2,4])
C0018799 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
Secondary Parkinson Disease Evidence of | Atypical Parkinson Disease Evidence of
Item
evidence of secondary or atypical parkinsonism as suggested by:
boolean
C0030569 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1868596 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Cerebrovascular accident | Toxin Exposure to | Antipsychotic Agents | Encephalitis
Item
history of cva's, exposure to toxins, neuroleptics or encephalitis
boolean
C0038454 (UMLS CUI [1])
C0040549 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0040615 (UMLS CUI [3])
C0014038 (UMLS CUI [4])
Neurologic Signs Involvement Upper motor neuron | Neurologic Signs Involvement Cerebellum | Supranuclear gaze palsy | Orthostatic hypertension
Item
neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy or significant orthostatic hypertension
boolean
C0751378 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0524458 (UMLS CUI [1,3])
C0751378 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0007765 (UMLS CUI [2,3])
C1720037 (UMLS CUI [3])
C0544618 (UMLS CUI [4])
Dementia Evidence of | Neuropsychologic impairment Quantity | Neuropsychologic impairment Additional | Borderline Neuropsychologic impairment Additional
Item
dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain
boolean
C0497327 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1854569 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1854569 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0870217 (UMLS CUI [4,1])
C1854569 (UMLS CUI [4,2])
C1524062 (UMLS CUI [4,3])
Deep Brain Stimulation Mental disorders | Obsessive-Compulsive Disorder | Depressive disorder
Item
use of dbs for psychiatric disorder (obsessive compulsive or depression)
boolean
C0394162 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0028768 (UMLS CUI [2])
C0011581 (UMLS CUI [3])
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