Gender | Parkinson Disease | Resting Tremor | Bradykinesia | Muscle Rigidity
Item
1. male or female patient with idiopathic parkinsons disease (pd) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0234379 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
Parkinson Disease Disease length
Item
2. parkinsons disease diagnosed within 5 years.
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
3. patients 30 years of age or older at the time of diagnosis.
boolean
C0001779 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
4. modified hoehn and yahr stage of 1 to 3.
boolean
C3639878 (UMLS CUI [1])
Additional Therapy Parkinsonian symptoms | Introduction Therapeutic procedure Parkinsonian symptoms
Item
5. patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, v1) according to the investigators judgement.
boolean
C1706712 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
C0579004 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0242422 (UMLS CUI [2,3])
Parkinsonian Disorders Atypical Due to Pharmaceutical Preparations | Metoclopramide | Flunarizine | Metabolic Diseases | Hepatolenticular Degeneration | Encephalitis | Degenerative disorder | Progressive supranuclear palsy
Item
1. atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
boolean
C0242422 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0025853 (UMLS CUI [2])
C0016295 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
C0019202 (UMLS CUI [5])
C0014038 (UMLS CUI [6])
C1285162 (UMLS CUI [7])
C0038868 (UMLS CUI [8])
Dementia Mini-mental state examination
Item
2. dementia, as defined by a mini-mental state exam score < 24 at screening visit
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Mental disorders
Item
3. any psychiatric disorder according to diagnostic and statistical manual of mental disorders 4th (dsm-iv)
boolean
C0004936 (UMLS CUI [1])
Psychotic Disorders
Item
4. history of psychosis
boolean
C0033975 (UMLS CUI [1])
ECG abnormality
Item
5. clinically significant electrocardiogram (ecg) abnormalities at screening visit
boolean
C0522055 (UMLS CUI [1])
Hypotension
Item
6. clinically significant hypotension
boolean
C0020649 (UMLS CUI [1])
Melanoma | Prior Therapy Melanoma
Item
7. malignant melanoma or history of previously treated malignant melanoma
boolean
C0025202 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0025202 (UMLS CUI [2,2])
Disease At risk Patient | Disease Preventing Compliance | Disease Preventing Completion of clinical trial
Item
8. any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
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
Item
9. pregnancy
boolean
C0032961 (UMLS CUI [1])
Gender Sexually active Contraceptive methods Lacking | Childbearing Potential Contraceptive methods Lacking
Item
10. sexually active female of childbearing potential not using a medically approved method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin
Item
11. serum levels of aspartate aminotransferase (ast) , alanine aminotransferase (alt), alkaline phosphatases or bilirubin > 2 upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151849 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Creatinine clearance measurement
Item
12. patients with a creatinine clearance < 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Dopamine Agonists | Pramipexole | Levodopa
Item
13. any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or l-dopa within 8 weeks prior to baseline visit.
boolean
C0178601 (UMLS CUI [1])
C0074710 (UMLS CUI [2])
C0023570 (UMLS CUI [3])
Levodopa Exposure to | Duration Cumulative Total
Item
14. total cumulative duration of prior exposure to levodopa of more than 3 months.
boolean
C0023570 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2,1])
C1511559 (UMLS CUI [2,2])
C0439810 (UMLS CUI [2,3])
Dopamine Antagonists | Dopamine Antagonists Formulation Intramuscular
Item
15. any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
boolean
C0242702 (UMLS CUI [1])
C0242702 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0442117 (UMLS CUI [2,3])
Methylphenidate | Cinnarizine | Amphetamines
Item
16. any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
boolean
C0025810 (UMLS CUI [1])
C0008803 (UMLS CUI [2])
C0002667 (UMLS CUI [3])
Flunarizine
Item
17. flunarizine within 3 months prior to baseline visit
boolean
C0016295 (UMLS CUI [1])
Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient
Item
18. known hypersensitivity to pramipexole or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0074710 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0074710 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Substance Use Disorders
Item
19. drug abuse (including alcohol), according to investigators judgement, within 2 years prior to screening.
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
20. participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])