Parkinson Disease | Parkinsonism, Juvenile
Item
1. male or female patients with diagnosis of pd including juvenile parkinsonism, in whom the onset began at the age of forty or younger.
boolean
C0030567 (UMLS CUI [1])
C0752105 (UMLS CUI [2])
Modified Hoehn and Yahr Scale score
Item
2. patients with a modified hoehn and yahr scale of ii to iv at "on" time.
boolean
C4274318 (UMLS CUI [1])
Levodopa Dose Stable | Levodopa Associated with DOPA Decarboxylase Inhibitors
Item
3. patients who have received an individual dosage of l-dopa (either standard l-dopa or l-dopa with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (visit 2).
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0598272 (UMLS CUI [2,3])
Levodopa | Problem Therapeutic
Item
4. patients who exhibit any therapeutically problematic issues or status based on l-dopa therapy:
boolean
C0023570 (UMLS CUI [1])
C0033213 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
Wearing off effect
Item
wearing-off phenomena
boolean
C1504539 (UMLS CUI [1])
Optic Neuritis Absent | Optic Neuritis Delayed
Item
no on /delayed on
boolean
C0029134 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0029134 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
Dystonia
Item
dystonia at off time
boolean
C0013421 (UMLS CUI [1])
On - off phenomenon
Item
on-off phenomena
boolean
C0852903 (UMLS CUI [1])
Freezing phenomenon
Item
freezing phenomena at off time
boolean
C1262022 (UMLS CUI [1])
Levodopa Dose Suboptimal | Etiology Adverse effects | Dyskinetic syndrome
Item
the sub-optimal dose of l-dopa had been administered due to side effects (such as dyskinesia), or therapeutical strategy
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0013384 (UMLS CUI [3])
Parkinsonian Disorders Atypical Drug-induced | Parkinsonian Disorders Atypical Due to Metabolic Diseases | Parkinsonian Disorders Atypical Due to Encephalitis | Parkinsonian Disorders Atypical Due to Degenerative disorder
Item
1. atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
boolean
C0242422 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
C0458082 (UMLS CUI [1,3])
C0242422 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0025517 (UMLS CUI [2,4])
C0242422 (UMLS CUI [3,1])
C0205182 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0014038 (UMLS CUI [3,4])
C0242422 (UMLS CUI [4,1])
C0205182 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C1285162 (UMLS CUI [4,4])
Dementia Mini-mental state examination
Item
2. dementia, as defined by a mini-mental state examination (mmse) score <24 at screening visit.
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Mental disorders Preventing Compliance behavior | Mental disorders Preventing Completion of clinical trial | Mental disorders Study Subject Participation Status At risk
Item
3. any psychiatric disorder according to dsm-iv criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
Psychotic Disorders | Exception Drug-induced hallucinations
Item
4. history of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
boolean
C0033975 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1456732 (UMLS CUI [2,2])
Electrocardiogram abnormal
Item
5. clinically significant ecg abnormalities at screening visit, according to investigator's judgement.
boolean
C0522055 (UMLS CUI [1])
Hypotension | Hypotension orthostatic symptomatic | Postural dizziness | Decreased systolic arterial pressure | Decreased diastolic arterial pressure | Lying systolic blood pressure Post Rest | Lying diastolic blood pressure Post Rest
Item
6. clinically significant hypotension or symptomatic orthostatic hypotension (i.e., clinical symptoms of orthostatic hypotension such as dizziness postural etc associated with a decline >=20 mmhg in systolic blood pressure and a decline >=10 mmhg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
boolean
C0020649 (UMLS CUI [1])
C0740482 (UMLS CUI [2])
C0234987 (UMLS CUI [3])
C0277885 (UMLS CUI [4])
C0277890 (UMLS CUI [5])
C1319895 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C0035253 (UMLS CUI [6,3])
C1319896 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C0035253 (UMLS CUI [7,3])
Disease At risk Patient | Disease Preventing Compliance behavior | Disease Preventing Completion of clinical trial
Item
7. any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Pregnancy Serum pregnancy test | Breast Feeding
Item
8. pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0430064 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Gender Sexually active | Childbearing Potential Contraceptive methods Absent
Item
9. sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased
Item
10. serum levels of ast, alt, alkaline phosphatases or bilirubin >2 upper limits of normal .
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
C0859062 (UMLS CUI [4])
Creatinine clearance measurement
Item
11. patients with a creatinine clearance <50 ml/min
boolean
C0373595 (UMLS CUI [1])
Complication | Signs Malignant Neoplasms
Item
12. patients with a complication or signs of malignant tumours or those within 5 years after the treatment.
boolean
C0009566 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])