Eligibility Idiopathic Parkinson's Disease NCT02352363

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StudyEvent: Eligibility
1. Eligibility Idiopathic Parkinson's Disease NCT02352363

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed Consent

Item

has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.

boolean

C0021430 (UMLS CUI [1])

Contraceptive methods | Female of child bearing age | serum human chorionic gonadotropin (hCG) measurement

Item

women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.

boolean

C0700589 (UMLS CUI [1])
C1960468 (UMLS CUI [2])
C2208823 (UMLS CUI [3])

PARKINSON IDIOPATHIC

Item

patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.

boolean

C0747270 (UMLS CUI [1])

severity; staging; stage; state

Item

patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.

boolean

C3639483 (UMLS CUI [1])

Motor fluctuations

Item

patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.

boolean

C1868976 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Dyskinetic syndrome; Severities

Item

patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.

boolean

C0013384 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])

pregnant or lactating females

Item

pregnant or lactating females or females wishing to become pregnant.

boolean

C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])

Levodopa; Contraindication | melanoma | Angle Closure Glaucoma

Item

patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.

boolean

C0023570 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0025202 (UMLS CUI [2])
C0017605 (UMLS CUI [3])

Surgery specialty; Parkinson Disease

Item

patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).

boolean

C0038894 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])

Psychotic symptom | Suicide ideation

Item

patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).

boolean

C0871189 (UMLS CUI [1])
C1821181 (UMLS CUI [2])

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Eligibility Idiopathic Parkinson's Disease NCT02352363