ID

15795

Beschrijving

Parkinson's KinetiGraph as Tool for DBS Eligibility Assessment; ODM derived from: https://clinicaltrials.gov/show/NCT02509325

Link

https://clinicaltrials.gov/show/NCT02509325

Trefwoorden

Versies (1)
  1. 13-06-16 13-06-16 -
Geüploaded op

13 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02509325

Engels

Eligibility Parkinson's Disease NCT02509325

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients are diagnosed with pd.
Beschrijving

Parkinson Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
patients are presented to the clinical sites to evaluate dbs candidacy or optimize their pd treatment eventually with dbs therapy.
Beschrijving

Evaluation Indication of Deep Brain Stimulation | Therapeutic procedure Parkinson Disease Associated with Deep Brain Stimulation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0394162
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0030567
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0394162
patients are at least 18 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients are able to provide written data release consent as required by ec institutions or local law and regulations.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients have restricted movement, e.g. bed bound.
Beschrijving

Movement Restricted | Bed-ridden

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026649
UMLS CUI [1,2]
C0443288
UMLS CUI [2]
C0425251
patients operate heavy machinery for prolonged periods.
Beschrijving

Patients operate heavy machinery | Period Prolonged

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3242339
UMLS CUI [1,3]
C0681590
UMLS CUI [2,1]
C1948053
UMLS CUI [2,2]
C0439590
patients have serious medical conditions that compromise safety or interfere with mobility in addition to pd (e.g. arthritis and rheumatisms).
Beschrijving

medical condition Affecting patient safety | medical condition Interferes with Mobility | Parkinson Disease | Arthritis | Rheumatism

Datatype

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0425245
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0003864
UMLS CUI [5]
C0035435
patients have been already screened by stimulus or earlystimulus questionnaires
Beschrijving

Screening | Stimulus Questionnaire

Datatype

boolean

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0234402
UMLS CUI [2,2]
C0034394
patients present no response to levodopa medication or have atypical parkinsonism.
Beschrijving

Treatment response determination, no response Levodopa | Parkinsonism Atypical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184782
UMLS CUI [1,2]
C0023570
UMLS CUI [2,1]
C0242422
UMLS CUI [2,2]
C0205182
patients have major medical or psychiatric illness other than stable, treated depression or anxiety that may jeopardize the patient's ability to give informed consent, follow study requirements, or that may confound the patient's diagnosis or assessments.
Beschrijving

Comorbidity Informed Consent Limited | Comorbidity Compliance behavior Limited | Comorbidity Interferes with Evaluation of diagnostic study results

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1299715
patients have major neurological diagnoses other than pd.
Beschrijving

nervous system disorder Major | Parkinson Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0030567
patients are not capable of following the required clinical instructions
Beschrijving

Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Parkinson's Disease NCT02509325

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
patients are diagnosed with pd.
boolean
C0030567 (UMLS CUI [1])
Evaluation Indication of Deep Brain Stimulation | Therapeutic procedure Parkinson Disease Associated with Deep Brain Stimulation
Item
patients are presented to the clinical sites to evaluate dbs candidacy or optimize their pd treatment eventually with dbs therapy.
boolean
C0220825 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0394162 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0394162 (UMLS CUI [2,4])
Age
Item
patients are at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
patients are able to provide written data release consent as required by ec institutions or local law and regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Movement Restricted | Bed-ridden
Item
patients have restricted movement, e.g. bed bound.
boolean
C0026649 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0425251 (UMLS CUI [2])
Patients operate heavy machinery | Period Prolonged
Item
patients operate heavy machinery for prolonged periods.
boolean
C0030705 (UMLS CUI [1,1])
C3242339 (UMLS CUI [1,2])
C0681590 (UMLS CUI [1,3])
C1948053 (UMLS CUI [2,1])
C0439590 (UMLS CUI [2,2])
medical condition Affecting patient safety | medical condition Interferes with Mobility | Parkinson Disease | Arthritis | Rheumatism
Item
patients have serious medical conditions that compromise safety or interfere with mobility in addition to pd (e.g. arthritis and rheumatisms).
boolean
C1699700 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C1699700 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0425245 (UMLS CUI [2,3])
C0030567 (UMLS CUI [3])
C0003864 (UMLS CUI [4])
C0035435 (UMLS CUI [5])
Screening | Stimulus Questionnaire
Item
patients have been already screened by stimulus or earlystimulus questionnaires
boolean
C0220908 (UMLS CUI [1])
C0234402 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
Treatment response determination, no response Levodopa | Parkinsonism Atypical
Item
patients present no response to levodopa medication or have atypical parkinsonism.
boolean
C0184782 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0242422 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
Comorbidity Informed Consent Limited | Comorbidity Compliance behavior Limited | Comorbidity Interferes with Evaluation of diagnostic study results
Item
patients have major medical or psychiatric illness other than stable, treated depression or anxiety that may jeopardize the patient's ability to give informed consent, follow study requirements, or that may confound the patient's diagnosis or assessments.
boolean
C0009488 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1299715 (UMLS CUI [3,3])
nervous system disorder Major | Parkinson Disease
Item
patients have major neurological diagnoses other than pd.
boolean
C0027765 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0030567 (UMLS CUI [2])
Compliance behavior Limited
Item
patients are not capable of following the required clinical instructions
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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