Information:
Fel:
ID
14616
Beskrivning
Deep Brain Stimulation for Parkinson's Disease Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00053625
Länk
https://clinicaltrials.gov/show/NCT00053625
Nyckelord
Versioner (1)
- 2016-04-24 2016-04-24 -
Uppladdad den
24 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00053625
Eligibility Parkinson's Disease NCT00053625
- StudyEvent: Eligibility
Similar models
Eligibility Parkinson's Disease NCT00053625
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Parkinson's disease: Specifiation
Item
clinical diagnosis of idiopathic parkinson's disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to levodopa therapy.
boolean
C0030567 (UMLS CUI [1])
C0234130 (UMLS CUI [2])
C0683154 (UMLS CUI [3,1])
C0023570 (UMLS CUI [3,2])
C0234130 (UMLS CUI [2])
C0683154 (UMLS CUI [3,1])
C0023570 (UMLS CUI [3,2])
Hoehn & yahr
Item
hoehn & yahr staging iii or worse "off " medication periods.
boolean
C0451215 (UMLS CUI [1])
Motor function
Item
intractable, disabling motor fluctuations, dyskinesias, or freezing episodes.
boolean
C0234130 (UMLS CUI [1])
Disease response
Item
unsatisfactory clinical response to maximal medical management or previous surgical treatment.
boolean
C1704632 (UMLS CUI [1])
Stable on parkinson's medications
Item
stable on parkinson's medications for at least 30 days with total l-dopa equivalence varying no more than +/- twenty percent during the 30 day period.
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,2])
Informed consent limited by comorbidity
Item
absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Exclusion criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Comorbidity interferes with operative complication
Item
clinically significant medical history that increases pre- / post operative complications (cardiac or pulmonary disease, uncontrolled hypertension, diabetes…).
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0274311 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0274311 (UMLS CUI [1,3])
Secondary or atypical parkinsonism
Item
secondary or atypical parkinsonism as suggested by: i. history of stroke, encephalitis, exposure to toxins or neuroleptics. ii. neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. mri scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen.
boolean
C0030569 (UMLS CUI [1])
C1868596 (UMLS CUI [2])
C1868596 (UMLS CUI [2])
Dementia rating scale and dsm-iv for dementia
Item
dementia as indicated by a mattis dementia rating scale (drs) less than 116 or dsm-iv criterion for dementia.
boolean
C0451074 (UMLS CUI [1])
C0220952 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C0220952 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
Anxiety, depressive, or psychotic disorder
Item
clinically significant psychiatric disorder meeting structured clinical interview for the dsm-iv criteria for an active anxiety, depressive, or psychotic disorder.
boolean
C0003467 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0011581 (UMLS CUI [2])
C0033975 (UMLS CUI [3])