Informed Consent | Patient authorization
Item
must give written informed consent and any authorizations required by local law.
boolean
C0021430 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0680281 (UMLS CUI [2,2])
Parkinson Disease Disease length | Absence Cause Other Parkinsonism | Signs Main Quantity | Bradykinesia | Resting Tremor | Muscle Rigidity | Postural instability
Item
must carry a diagnosis of idiopathic parkinson's disease(pd), without any other known or suspected cause of parkinsonism, according to the uk parkinson's disease society brain bank clinical diagnostic criteria. initial diagnosis of pd must have been made within the 5 years prior to screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0242422 (UMLS CUI [2,4])
C0311392 (UMLS CUI [3,1])
C1542147 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0233565 (UMLS CUI [4])
C0234379 (UMLS CUI [5])
C0026837 (UMLS CUI [6])
C1843921 (UMLS CUI [7])
Modified Hoehn and Yahr Staging
Item
must be modified hoehn & yahr stage 1 to 2.5 (inclusive).
boolean
C3639878 (UMLS CUI [1])
UPDRS Motor Score
Item
must have a baseline updrs (part iii) motor score of at least 10.
boolean
C3639721 (UMLS CUI [1,1])
C0682711 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Anticholinergic Agents Dose Stable | MAO-B Inhibitor Dose Stable | Other Antiparkinson Agents Absent
Item
subjects may be receiving an anticholinergic agent and/or mao-b inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other pd medication.
boolean
C0242896 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C2917433 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1579414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Mini-mental state examination
Item
a mini mental state examination (mmse) score <26.
boolean
C0451306 (UMLS CUI [1])
Feature Clinical Consistent with Atypical Parkinson Disease
Item
history or clinical features consistent with an atypical parkinsonian syndrome.
boolean
C2348519 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1868596 (UMLS CUI [1,4])
CNS disorder | Exception Parkinson Disease
Item
any significant non-pd central nervous system disorder.
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Axis I diagnosis
Item
any significant axis i psychiatric disease as defined by the diagnostic and statistical manual of mental disorders.
boolean
C0270287 (UMLS CUI [1])
Cognition Disorders | Neuropsychiatric syndrome
Item
history of cognitive or neuropsychiatric conditions.
boolean
C0009241 (UMLS CUI [1])
C3203509 (UMLS CUI [2])
Operative Surgical Procedures Parkinson Disease
Item
history of surgical intervention for pd.
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Motor Complication Levodopa Induced | Complication Levodopa Induced
Item
history of l-dopa-induced motor or non-motor complication.
boolean
C0682711 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0205263 (UMLS CUI [1,4])
C0009566 (UMLS CUI [2,1])
C0023570 (UMLS CUI [2,2])
C0205263 (UMLS CUI [2,3])
Malignant Neoplasms
Item
history of malignancy.
boolean
C0006826 (UMLS CUI [1])
Allergic Reaction Severe Pharmaceutical Preparations | Anaphylaxis Severe Pharmaceutical Preparations
Item
history of severe allergic or anaphylactic reactions to any drug.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Renal dysfunction
Item
clinically significant renal dysfunction.
boolean
C3279454 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c >7.0%.
boolean
C0474680 (UMLS CUI [1])
Electrocardiography Clinical Significance
Item
clinically significant baseline ecg.
boolean
C1623258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Hypotension, Orthostatic
Item
orthostatic hypotension.
boolean
C0020651 (UMLS CUI [1])
Carbidopa / Levodopa | Benserazide / Levodopa
Item
treatment with l-dopa/carbidopa or l-dopa/benserazide for more than 6 cumulative months at anytime since subject's initial pd diagnosis.
boolean
C0353697 (UMLS CUI [1])
C0358787 (UMLS CUI [2])