ID

31447

Beskrivning

Effects of Deep Brain Stimulation in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00855621

Länk

https://clinicaltrials.gov/show/NCT00855621

Nyckelord

Versioner (1)
  1. 2018-08-22 2018-08-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00855621

Engelsk

Eligibility Parkinson's Disease NCT00855621

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of parkinson's disease
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
symptoms ≥ 5 years
Beskrivning

Symptoms Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0449238
severity of parkinson's disease ≥ 20 points in updrs motor scale (scale 0-108) in off medication state
Beskrivning

Parkinson Disease Unified Parkinson's Disease Rating Scale Motor | Status Pharmaceutical Preparations Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3639721
UMLS CUI [1,3]
C0234130
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0332197
marked fluctuations of motor symptoms and/or troublesome dyskinesias and/or severe tremor and/or intolerable side-effects of dopaminergic drugs
Beskrivning

Fluctuations Marked Motor symptoms | Dyskinesia | Tremor Severe | Adverse effects Dopamine Agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231239
UMLS CUI [1,2]
C1706089
UMLS CUI [1,3]
C0426980
UMLS CUI [2]
C0013384
UMLS CUI [3,1]
C0040822
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0178601
failure of medical treatment to sufficiently control symptoms
Beskrivning

Pharmacotherapy Symptom control failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1274136
UMLS CUI [1,3]
C0231175
l-dopa responsive symptoms with ≥30% reduction in updrs motor score in drug on state compared to off state or severe l-dopa unresponsive tremor
Beskrivning

Symptoms Levodopa-responsive Unified Parkinson's Disease Rating Scale Motor | Status Pharmaceutical Preparations Present | Tremor Severe Unresponsive to Levodopa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1853846
UMLS CUI [1,3]
C3639721
UMLS CUI [1,4]
C0234130
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0150312
UMLS CUI [3,1]
C0040822
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0205269
UMLS CUI [3,4]
C0023570
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous surgery for parkinson's disease
Beskrivning

Operative Surgical Procedures Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
marked axial motor symptoms unresponsive to treatment with l-dopa
Beskrivning

Motor symptoms Axial Marked | Unresponsive to Levodopa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0426980
UMLS CUI [1,2]
C0205131
UMLS CUI [1,3]
C1706089
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0023570
dementia (mattis dementia rating scale < 130).
Beskrivning

Dementia Clinical dementia rating scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451074
patient suffering from untreated moderate or major depression or anxiety disorder
Beskrivning

Moderate depression untreated | Major Depressive Disorder untreated | Anxiety Disorders untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0588007
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0003469
UMLS CUI [3,2]
C0332155
presence of other psychiatric disorder preventing necessary co-operation
Beskrivning

Mental disorders Preventing Cooperation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0392337
brain mri showing marked atrophy or white matter changes
Beskrivning

Atrophy Marked MRI brain | White matter changes MRI brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0333641
UMLS CUI [1,2]
C1706089
UMLS CUI [1,3]
C0412675
UMLS CUI [2,1]
C1833300
UMLS CUI [2,2]
C0412675
increased risk of bleeding
Beskrivning

Bleeding risk Increased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3251812
UMLS CUI [1,2]
C0205217
presence of medical illness with short life expectancy
Beskrivning

Illness | Life Expectancy Short

Datatyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C1806781
other surgical contra-indications
Beskrivning

Medical contraindication Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0543467
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Similar models

Eligibility Parkinson's Disease NCT00855621

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
diagnosis of parkinson's disease
boolean
C0030567 (UMLS CUI [1])
Symptoms Duration
Item
symptoms ≥ 5 years
boolean
C1457887 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Parkinson Disease Unified Parkinson's Disease Rating Scale Motor | Status Pharmaceutical Preparations Absent
Item
severity of parkinson's disease ≥ 20 points in updrs motor scale (scale 0-108) in off medication state
boolean
C0030567 (UMLS CUI [1,1])
C3639721 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,3])
C0449438 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Fluctuations Marked Motor symptoms | Dyskinesia | Tremor Severe | Adverse effects Dopamine Agonists
Item
marked fluctuations of motor symptoms and/or troublesome dyskinesias and/or severe tremor and/or intolerable side-effects of dopaminergic drugs
boolean
C0231239 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
C0426980 (UMLS CUI [1,3])
C0013384 (UMLS CUI [2])
C0040822 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0879626 (UMLS CUI [4,1])
C0178601 (UMLS CUI [4,2])
Pharmacotherapy Symptom control failed
Item
failure of medical treatment to sufficiently control symptoms
boolean
C0013216 (UMLS CUI [1,1])
C1274136 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Symptoms Levodopa-responsive Unified Parkinson's Disease Rating Scale Motor | Status Pharmaceutical Preparations Present | Tremor Severe Unresponsive to Levodopa
Item
l-dopa responsive symptoms with ≥30% reduction in updrs motor score in drug on state compared to off state or severe l-dopa unresponsive tremor
boolean
C1457887 (UMLS CUI [1,1])
C1853846 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
C0234130 (UMLS CUI [1,4])
C0449438 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0040822 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
C0023570 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedures Parkinson Disease
Item
previous surgery for parkinson's disease
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Motor symptoms Axial Marked | Unresponsive to Levodopa
Item
marked axial motor symptoms unresponsive to treatment with l-dopa
boolean
C0426980 (UMLS CUI [1,1])
C0205131 (UMLS CUI [1,2])
C1706089 (UMLS CUI [1,3])
C0205269 (UMLS CUI [2,1])
C0023570 (UMLS CUI [2,2])
Dementia Clinical dementia rating scale
Item
dementia (mattis dementia rating scale < 130).
boolean
C0497327 (UMLS CUI [1,1])
C0451074 (UMLS CUI [1,2])
Moderate depression untreated | Major Depressive Disorder untreated | Anxiety Disorders untreated
Item
patient suffering from untreated moderate or major depression or anxiety disorder
boolean
C0588007 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1269683 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0003469 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Mental disorders Preventing Cooperation
Item
presence of other psychiatric disorder preventing necessary co-operation
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0392337 (UMLS CUI [1,3])
Atrophy Marked MRI brain | White matter changes MRI brain
Item
brain mri showing marked atrophy or white matter changes
boolean
C0333641 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
C0412675 (UMLS CUI [1,3])
C1833300 (UMLS CUI [2,1])
C0412675 (UMLS CUI [2,2])
Bleeding risk Increased
Item
increased risk of bleeding
boolean
C3251812 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Illness | Life Expectancy Short
Item
presence of medical illness with short life expectancy
boolean
C0221423 (UMLS CUI [1])
C0023671 (UMLS CUI [2,1])
C1806781 (UMLS CUI [2,2])
Medical contraindication Operative Surgical Procedures
Item
other surgical contra-indications
boolean
C1301624 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
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