Gender
Item
1. gender: male or female
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. age: 30 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. body mass index (bmi): 18 - 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Parkinson Disease Hoehn and Yahr grades
Item
4. diagnosed with idiopathic parkinson's disease, with hoehn and yahr (h&y) of i-iii
boolean
C0030567 (UMLS CUI [1,1])
C0451215 (UMLS CUI [1,2])
Patients Levodopa Responsive | Carbidopa / Levodopa Dose Stable
Item
5. levodopa-responsive patients treated with a stable dose of levodopa/carbidopa
boolean
C0030705 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0205342 (UMLS CUI [1,3])
C0353697 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
12 lead ECG Normal | 12 lead ECG Abnormality Hazard Free of
Item
6. electrocardiogram recording (12 leads) normal or with abnormalities which are not hazardous to the patient according to the opinion of the investigator.
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0598697 (UMLS CUI [2,3])
C0332296 (UMLS CUI [2,4])
Serum Beta-HCG Test Negative | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Intrauterine Devices | Contraception, Barrier | Contraceptives, Oral | Barrier Contraception Double | Postmenopausal state | Female Sterilization
Item
7. negative beta-hcg test and not lactating (females). women who are of childbearing potential must be using acceptable methods of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical research study. accepted forms of contraception are: i.e. intrauterine device and a barrier method, combined oral contraceptives and a barrier method, or double-barrier method throughout the study. female volunteers who are post-menopausal or surgically sterile may be enrolled
boolean
C1255526 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0232970 (UMLS CUI [8])
C0015787 (UMLS CUI [9])
Dosage Diary Completion | Levodopa Dose | Investigational New Drugs Dose | Informed Consent
Item
8. ability to maintain an accurate and complete dosing diary, with the help of a caregiver, recording doses of levodopa and study medication taken at home all parameters will be determined within three weeks prior to first dosing. subjects must have given written informed consent before any study-related activities are carried out
boolean
C0178602 (UMLS CUI [1,1])
C0376660 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4])
Criteria Mismatch
Item
to be eligible for inclusion in this study the subjects must not meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])
Pharmaceutical Preparations Causing Dopamine Release | Reserpine | Pharmaceutical Preparations Affecting Levodopa Metabolism | Catechol O-Methyltransferase Inhibitors | Exception Aromatic Amino Acid Decarboxylation Inhibitor | Medical contraindication Monoamine Oxidase Type B Inhibitor | Medical contraindication Carbidopa / Levodopa | Selective Serotonin Reuptake Inhibitors allowed | SNRIs allowed
Item
1. co-administration of other drugs causing dopamine release (e.g. reserpine) or affecting levodopa metabolism (e.g comt inhibitors except aadc inhibitors) or any other medication clinically contraindicated with mao b inhibitors or with levodopa/carbidopa note: use of selective serotonin reuptake inhibitors [ssri] and selective noradrenalin reuptake inhibitors [snri] will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0013030 (UMLS CUI [1,3])
C1283071 (UMLS CUI [1,4])
C0035179 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0023570 (UMLS CUI [3,3])
C0025519 (UMLS CUI [3,4])
C2917201 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C2917347 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C2917433 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0353697 (UMLS CUI [7,2])
C0360105 (UMLS CUI [8,1])
C0683607 (UMLS CUI [8,2])
C1579361 (UMLS CUI [9,1])
C0683607 (UMLS CUI [9,2])
Monoamine Oxidase Inhibitors | Selegiline | Rasagiline
Item
2. co-administration of other mao inhibitors (e.g. selegiline, rasagiline)
boolean
C0026457 (UMLS CUI [1])
C0036579 (UMLS CUI [2])
C0525678 (UMLS CUI [3])
Parkinson Disease Late stage | Dose Peak Severely disabling | Dyskinesia Biphasic | Fluctuation Symptoms
Item
3. the patient is in a late stage of parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms
boolean
C0030567 (UMLS CUI [1,1])
C0683337 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0444505 (UMLS CUI [2,2])
C4035398 (UMLS CUI [2,3])
C0013384 (UMLS CUI [3,1])
C0205184 (UMLS CUI [3,2])
C0231239 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
Indication Parkinsonian Disorders | Exception Idiopathic Parkinson Disease
Item
4. any indication of forms of parkinsonism, other than idiopathic parkinson's disease.
boolean
C3146298 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Pharmaceutical Preparations Causing Drug metabolising enzyme decreased | Pharmaceutical Preparations Causing Drug metabolising enzyme increased | Barbiturates | ST. JOHN'S WORT EXTRACT
Item
5. treatment with any agent known to inhibit or induce drug-metabolizing enzymes (e.g., barbiturates, st john's wort etc.) within 4 weeks prior study treatment
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C3203677 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C3203676 (UMLS CUI [2,3])
C0004745 (UMLS CUI [3])
C0813171 (UMLS CUI [4])
Oral iron agent
Item
6. concomitant oral iron treatment
boolean
C1298638 (UMLS CUI [1])
Hypersensitivity MAO-B Inhibitors | Medical contraindication MAO-B Inhibitors | Levodopa allergy | Medical contraindication Levodopa
Item
7. history of hypersensitivity or contraindications to mao-b inhibitors or levodopa
boolean
C0020517 (UMLS CUI [1,1])
C4020574 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C4020574 (UMLS CUI [2,2])
C0570730 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0023570 (UMLS CUI [4,2])
Hypersensitivity | Drug Allergy
Item
8. clinically relevant allergies (especially hypersensitivity toward any medicinal drugs)
boolean
C0020517 (UMLS CUI [1])
C0013182 (UMLS CUI [2])
Hepatic impairment
Item
9. significant hepatic impairment
boolean
C0948807 (UMLS CUI [1])
Renal Insufficiency
Item
10. significant renal impairment
boolean
C1565489 (UMLS CUI [1])
Gastrointestinal Diseases Influence Gastrointestinal Absorption | Gastrointestinal Surgical Procedure Influence Gastrointestinal Absorption | Gastrointestinal Diseases Influence Gastrointestinal Motility | Gastrointestinal Surgical Procedure Influence Gastrointestinal Motility
Item
11. diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility
boolean
C0017178 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C3714657 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C3714657 (UMLS CUI [2,3])
C0017178 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])
C0524722 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0017184 (UMLS CUI [4,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
12. diagnosis of human immunodeficiency virus (hiv), or acute hepatitis b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Disease Study Subject Participation Status Excluded | Cardiovascular Diseases | Lung diseases | Angle Closure Glaucoma | Endocrine System Diseases | Hyperthyroidism | Pheochromocytoma
Item
13. clinically relevant disease which in the investigator's opinion would exclude the subject from the study, such as significant cardiovascular and lung diseases, narrow-angle glaucoma or endocrinological diseases such as hyperthyroidism or pheochromocytoma
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0017605 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0020550 (UMLS CUI [6])
C0031511 (UMLS CUI [7])
Neoplastic disease | Neoplastic disease Remission
Item
14. a neoplastic disorder, which is either currently active or has been in remission for less than one year.
boolean
C1882062 (UMLS CUI [1])
C1882062 (UMLS CUI [2,1])
C0544452 (UMLS CUI [2,2])
Mental disorders | Schizophrenia | Depression, psychotic
Item
15. active psychiatric disease (e.g, schizophrenia, psychotic depression)
boolean
C0004936 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0743072 (UMLS CUI [3])
Melanoma Undiagnosed | Neoplasm Undiagnosed | Skin lesion Melanoma Suspicious
Item
16. history of melanoma or current cancer disease and undiagnosed, but melanoma suspicious skin lesion
boolean
C0025202 (UMLS CUI [1,1])
C1408353 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1408353 (UMLS CUI [2,2])
C0037284 (UMLS CUI [3,1])
C0025202 (UMLS CUI [3,2])
C0750493 (UMLS CUI [3,3])
Signs Dementia Interfere with Protocol Compliance
Item
17. signs for dementia which could interfere with the compliance to the study as judged by the investigator
boolean
C0311392 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Disorder of eye Medical History | Albino | Family history Retinal Disease Hereditary | Reduced visual acuity Progressive | Reduced visual acuity Severe | Retinitis Pigmentosa | Retinal pigmentation Due to Cause Any | Retinal Diseases | Inflammatory abnormality of the eye | Uveitis | Diabetic Retinopathy
Item
18. ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
boolean
C0015397 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0001916 (UMLS CUI [2])
C0241889 (UMLS CUI [3,1])
C0035309 (UMLS CUI [3,2])
C0439660 (UMLS CUI [3,3])
C0234632 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0234632 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0035334 (UMLS CUI [6])
C0151892 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0015127 (UMLS CUI [7,3])
C1552551 (UMLS CUI [7,4])
C0035309 (UMLS CUI [8])
C4020969 (UMLS CUI [9])
C0042164 (UMLS CUI [10])
C0011884 (UMLS CUI [11])
Caffeine consumption Quantity | Consumption Tea Quantity | Tobacco use Cigarettes per day
Item
19. consumption of important quantities of coffee or tea corresponding to more than 600 mg caffeine/day, or tobacco smoking (more than 10 cigarettes per day)
boolean
C0948365 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0009830 (UMLS CUI [2,1])
C0039400 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0543414 (UMLS CUI [3,1])
C3694146 (UMLS CUI [3,2])
Diet Abnormal | Vegan diet | Increased protein diet
Item
20. diet considerably deviating from normal nutritional patterns (e.g. vegan; diets with very high protein content [atkins])
boolean
C0012155 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0344353 (UMLS CUI [2])
C0425403 (UMLS CUI [3])
Study Subject Participation Status
Item
21. participation in another clinical study within 30 days prior to the planned first drug administration
boolean
C2348568 (UMLS CUI [1])
Substance Use Disorders
Item
22. alcohol and drug abuse (during the past three years)
boolean
C0038586 (UMLS CUI [1])
Blood Transfusion | Transfusion Plasma derivative
Item
23. transfusion of blood or plasma derivatives within 3 month prior to the planned first drug administration
boolean
C0005841 (UMLS CUI [1])
C1879316 (UMLS CUI [2,1])
C2964352 (UMLS CUI [2,2])
Blood Donation
Item
24. blood donation within 90 days before the start of the clinical study
boolean
C0005794 (UMLS CUI [1])
Signs and Symptoms Suggestive of Transmissible spongiform encephalopathy | Family member Transmissible spongiform encephalopathy
Item
25. signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
boolean
C0037088 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C3700367 (UMLS CUI [1,3])
C0086282 (UMLS CUI [2,1])
C3700367 (UMLS CUI [2,2])