ID

18770

Beskrivning

Studying Automatic Movements in Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00063661

Länk

https://clinicaltrials.gov/show/NCT00063661

Nyckelord

Versioner (1)
  1. 2016-11-19 2016-11-19 -
Uppladdad den

19 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00063661

Engelsk

Eligibility Parkinson Disease NCT00063661

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
thirty patients with pd will be included in the study.
Beskrivning

Parkinson Disease | Patients Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1265611
the diagnosis of pd is based on medical history, physical and neurological examinations, response to levodopa or dopaminergic drugs, and laboratory tests and mri scans to exclude other diseases.
Beskrivning

Parkinson Disease | Medical History | Physical Examination | Neurologic Examination | Levodopa Response | Dopaminergic Agents Response | Laboratory Procedures | MRI Scans

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0027853
UMLS CUI [5,1]
C0023570
UMLS CUI [5,2]
C1704632
UMLS CUI [6,1]
C0013036
UMLS CUI [6,2]
C1704632
UMLS CUI [7]
C0022885
UMLS CUI [8]
C0917711
patients will be assessed with the unified parkinson's disease rating scale (updrs) and mini-mental state exam (mmse). only patients with mild to moderate motor disability (udrs less than or equal to 40) and without cognitive impairment (mmt score greater than or equal to 25) will be investigated.
Beskrivning

Unified Parkinson's Disease Rating Scale Questionnaire | Mini-mental state examination | Disability motor Mild | Disability motor Moderate | Impaired cognition

Datatyp

boolean

Alias
UMLS CUI [1]
C3639721
UMLS CUI [2]
C0451306
UMLS CUI [3,1]
C0231170
UMLS CUI [3,2]
C1513492
UMLS CUI [3,3]
C2945599
UMLS CUI [4,1]
C0231170
UMLS CUI [4,2]
C1513492
UMLS CUI [4,3]
C0205081
UMLS CUI [5]
C0338656
patients will be studied only after their medication has been withdrawn for at least 12 hours.
Beskrivning

Pharmaceutical Preparations Withdrawn

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2349954
all subjects participating in the study should have a valid clinical center medical record number.
Beskrivning

Study Subject Medical record number Valid Clinic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1301894
UMLS CUI [1,3]
C2349099
UMLS CUI [1,4]
C0442592
the fmri experiment will follow the standard operating procedures of the hmcs neuroimaging group.
Beskrivning

fMRI experiment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0681814
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with psychiatric disorders or severe motor disabilities will be excluded.
Beskrivning

Mental disorders | Disability motor Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C1513492
UMLS CUI [2,3]
C0205082
subjects with pacemakers, cardiac or neural defibrillators, intracranial aneurysm clips, intraorbital metallic structures, insulin pumps, cochlear implants, and other metallic objects will not be scanned.
Beskrivning

Artificial cardiac pacemaker | Cardiac defibrillator | Defibrillators neural | Aneurysm clip | Metallic foreign body orbital | Insulin pump | Cochlear Implants | Metallic Object

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C1391956
UMLS CUI [3,1]
C0180307
UMLS CUI [3,2]
C3714606
UMLS CUI [4]
C0179977
UMLS CUI [5,1]
C1720389
UMLS CUI [5,2]
C1183518
UMLS CUI [6]
C1140609
UMLS CUI [7]
C0009199
UMLS CUI [8]
C2826620
women who are pregnant are excluded from mri because the safety of the fetus in the presence of high magnetic fields is not established. therefore, all women of childbearing potential will have a pregnancy test performed, which must be negative, before proceeding.
Beskrivning

Pregnancy Excluded Magnetic Resonance Imaging | Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
subjects under age 18 will be excluded.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Parkinson Disease NCT00063661

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Patients Quantity
Item
thirty patients with pd will be included in the study.
boolean
C0030567 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Parkinson Disease | Medical History | Physical Examination | Neurologic Examination | Levodopa Response | Dopaminergic Agents Response | Laboratory Procedures | MRI Scans
Item
the diagnosis of pd is based on medical history, physical and neurological examinations, response to levodopa or dopaminergic drugs, and laboratory tests and mri scans to exclude other diseases.
boolean
C0030567 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0027853 (UMLS CUI [4])
C0023570 (UMLS CUI [5,1])
C1704632 (UMLS CUI [5,2])
C0013036 (UMLS CUI [6,1])
C1704632 (UMLS CUI [6,2])
C0022885 (UMLS CUI [7])
C0917711 (UMLS CUI [8])
Unified Parkinson's Disease Rating Scale Questionnaire | Mini-mental state examination | Disability motor Mild | Disability motor Moderate | Impaired cognition
Item
patients will be assessed with the unified parkinson's disease rating scale (updrs) and mini-mental state exam (mmse). only patients with mild to moderate motor disability (udrs less than or equal to 40) and without cognitive impairment (mmt score greater than or equal to 25) will be investigated.
boolean
C3639721 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
C0231170 (UMLS CUI [3,1])
C1513492 (UMLS CUI [3,2])
C2945599 (UMLS CUI [3,3])
C0231170 (UMLS CUI [4,1])
C1513492 (UMLS CUI [4,2])
C0205081 (UMLS CUI [4,3])
C0338656 (UMLS CUI [5])
Pharmaceutical Preparations Withdrawn
Item
patients will be studied only after their medication has been withdrawn for at least 12 hours.
boolean
C0013227 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Study Subject Medical record number Valid Clinic
Item
all subjects participating in the study should have a valid clinical center medical record number.
boolean
C0681850 (UMLS CUI [1,1])
C1301894 (UMLS CUI [1,2])
C2349099 (UMLS CUI [1,3])
C0442592 (UMLS CUI [1,4])
fMRI experiment
Item
the fmri experiment will follow the standard operating procedures of the hmcs neuroimaging group.
boolean
C0376335 (UMLS CUI [1,1])
C0681814 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Disability motor Severe
Item
subjects with psychiatric disorders or severe motor disabilities will be excluded.
boolean
C0004936 (UMLS CUI [1])
C0231170 (UMLS CUI [2,1])
C1513492 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Artificial cardiac pacemaker | Cardiac defibrillator | Defibrillators neural | Aneurysm clip | Metallic foreign body orbital | Insulin pump | Cochlear Implants | Metallic Object
Item
subjects with pacemakers, cardiac or neural defibrillators, intracranial aneurysm clips, intraorbital metallic structures, insulin pumps, cochlear implants, and other metallic objects will not be scanned.
boolean
C0030163 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
C0180307 (UMLS CUI [3,1])
C3714606 (UMLS CUI [3,2])
C0179977 (UMLS CUI [4])
C1720389 (UMLS CUI [5,1])
C1183518 (UMLS CUI [5,2])
C1140609 (UMLS CUI [6])
C0009199 (UMLS CUI [7])
C2826620 (UMLS CUI [8])
Pregnancy Excluded Magnetic Resonance Imaging | Childbearing Potential Pregnancy test negative
Item
women who are pregnant are excluded from mri because the safety of the fetus in the presence of high magnetic fields is not established. therefore, all women of childbearing potential will have a pregnancy test performed, which must be negative, before proceeding.
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Age
Item
subjects under age 18 will be excluded.
boolean
C0001779 (UMLS CUI [1])
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