Eligibility Parkinson Disease NCT00753519

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StudyEvent: Eligibility
1. Eligibility Parkinson Disease NCT00753519

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

Item Group

Age | Parkinson Disease Levodopa-responsive

Item

men and women aged 40 to 80 years with dopa-responsive pd

boolean

C0001779 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C1853846 (UMLS CUI [2,2])

Hoehn and Yahr grades

Item

hoehn and yahr grade of 2 to 4 while off

boolean

C0451215 (UMLS CUI [1])

Therapeutic procedure Including Levodopa

Item

must be on a regimen including levodopa.

boolean

C0087111 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])

Levodopa | Dopamine Agonists | Dopamine Equivalent | Total Dose U/day

Item

total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day

boolean

C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
C0013030 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C2986497 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])

Difficulty walking | Freezing of gait Time Distance

Item

problems with walking, including freezing gait time for a 10-meter distance greater than six seconds or more

boolean

C0311394 (UMLS CUI [1])
C0860515 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0012751 (UMLS CUI [2,3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Mental disorder | Dementia

Item

any active psychiatric disease or evidence of dementia

boolean

C0004936 (UMLS CUI [1])
C0497327 (UMLS CUI [2])

Seizures | Epilepsy

Item

history of seizures and epilepsy

boolean

C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])

Tricyclic Antidepressive Agents | Antipsychotic Agents | Pharmaceutical Preparations Lowered convulsive threshold | Exception Antiparkinson Agents | Exception SSRI

Item

concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for ssri

boolean

C0003290 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0234976 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0003405 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0360105 (UMLS CUI [5,2])

Pallidotomy | Electrodes, Implanted | Deep brain stimulator

Item

pallidotomy, implanted electrodes and generator for deep brain stimulation

boolean

C0195893 (UMLS CUI [1])
C0013814 (UMLS CUI [2])
C4069029 (UMLS CUI [3])

Pregnancy

Item

pregnancy

boolean

C0032961 (UMLS CUI [1])

Item

surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tep.

boolean

C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0182537 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
C0018768 (UMLS CUI [4,1])
C0021102 (UMLS CUI [4,2])
C0182313 (UMLS CUI [5])
C3693688 (UMLS CUI [6,1])
C2951888 (UMLS CUI [6,2])
C3693688 (UMLS CUI [7,1])
C0015392 (UMLS CUI [7,2])

Study Subject Participation Status At risk | Tendency to fall | Fatigue Excessive | Frailty General | Apprehensiveness Excessive

Item

study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.

boolean

C2348568 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2830327 (UMLS CUI [2])
C0015672 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0424594 (UMLS CUI [4,1])
C0205246 (UMLS CUI [4,2])
C0233485 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])

Dementia Mini-mental state examination | Mental impairment | Informed Consent Unable

Item

dementia as assessed by the folstein's mini-mental test examination (mmse less than or equal to 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying updrs will evaluate patient's mental capacity using conventional clinical interview)

boolean

C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0683322 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])

Lacking Able to walk Meter Quantity

Item

unable to walk a 10-meter distance.

boolean

C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C0475209 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])

Falls Daily UPDRS | History of fall | Injuries | Absence of postural response | Impairment of balance UPDRS

Item

more than occasional falls, i.e. daily falls (corresponding to a score greater than or equal to 3 and more in updrs item 13), history of fall(s) with significant injuries, absence of postural response in the on condition and/or spontaneous loss of balance in the off condition (corresponding to a score of greater than or equal to 2 and greater than or equal to 3 in on/off condition, respectively, in updrs item 30)

boolean

C0000921 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
C1561668 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C4036289 (UMLS CUI [4])
C0241981 (UMLS CUI [5,1])
C3639721 (UMLS CUI [5,2])

Childbearing Potential Urine pregnancy test | Childbearing Potential Contraceptive methods

Item

pregnancy is unusual in patients with pd, grade 2-4. urine sample for the pregnancy test will be obtained in patients of childbearing potential prior to the itbs start, at the day of the initial interview and signing the consent form. women of childbearing potential will be asked to take appropriate measures to prevent a pregnancy during the study.

boolean

C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])

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Eligibility Parkinson Disease NCT00753519