ID

14616

Description

Deep Brain Stimulation for Parkinson's Disease Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00053625

Link

https://clinicaltrials.gov/show/NCT00053625

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Parkinson's Disease NCT00053625

English

Eligibility Parkinson's Disease NCT00053625

1 forms  
Criteria
Description

Criteria

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.
Description

Parkinson's disease: Specifiation

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0234130
UMLS CUI [3,1]
C0683154
UMLS CUI [3,2]
C0023570
hoehn & yahr staging iii or worse "off " medication periods.
Description

Hoehn & yahr

Data type

boolean

Alias
UMLS CUI [1]
C0451215
intractable, disabling motor fluctuations, dyskinesias, or freezing episodes.
Description

Motor function

Data type

boolean

Alias
UMLS CUI [1]
C0234130
unsatisfactory clinical response to maximal medical management or previous surgical treatment.
Description

Disease response

Data type

boolean

Alias
UMLS CUI [1]
C1704632
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.
Description

Stable on parkinson's medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
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.
Description

Informed consent limited by comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
exclusion:
Description

Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
clinically significant medical history that increases pre- / post operative complications (cardiac or pulmonary disease, uncontrolled hypertension, diabetes…).
Description

Comorbidity interferes with operative complication

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0274311
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.
Description

Secondary or atypical parkinsonism

Data type

boolean

Alias
UMLS CUI [1]
C0030569
UMLS CUI [2]
C1868596
dementia as indicated by a mattis dementia rating scale (drs) less than 116 or dsm-iv criterion for dementia.
Description

Dementia rating scale and dsm-iv for dementia

Data type

boolean

Alias
UMLS CUI [1]
C0451074
UMLS CUI [2,1]
C0220952
UMLS CUI [2,2]
C0497327
clinically significant psychiatric disorder meeting structured clinical interview for the dsm-iv criteria for an active anxiety, depressive, or psychotic disorder.
Description

Anxiety, depressive, or psychotic disorder

Data type

boolean

Alias
UMLS CUI [1]
C0003467
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0033975
Back to the top of the page

Similar models

Eligibility Parkinson's Disease NCT00053625

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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])
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])
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])
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])
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])
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])
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial