ID

30056

Descrição

A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics; ODM derived from: https://clinicaltrials.gov/show/NCT01026428

Link

https://clinicaltrials.gov/show/NCT01026428

Palavras-chave

Versões (1)
  1. 07/05/2018 07/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de maio de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01026428

Inglês

Eligibility Idiopathic Parkinson's Disease NCT01026428

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. gender: male or female
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
2. age: 30 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. body mass index (bmi): 18 - 32 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
4. diagnosed with idiopathic parkinson's disease, with hoehn and yahr (h&y) of i-iii
Descrição

Parkinson Disease Hoehn and Yahr grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0451215
5. levodopa-responsive patients treated with a stable dose of levodopa/carbidopa
Descrição

Patients Levodopa Responsive | Carbidopa / Levodopa Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C0205342
UMLS CUI [2,1]
C0353697
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
6. electrocardiogram recording (12 leads) normal or with abnormalities which are not hazardous to the patient according to the opinion of the investigator.
Descrição

12 lead ECG Normal | 12 lead ECG Abnormality Hazard Free of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0598697
UMLS CUI [2,4]
C0332296
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
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1255526
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0009905
UMLS CUI [7,1]
C0004764
UMLS CUI [7,2]
C0205173
UMLS CUI [8]
C0232970
UMLS CUI [9]
C0015787
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
Descrição

Dosage Diary Completion | Levodopa Dose | Investigational New Drugs Dose | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0376660
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0178602
UMLS CUI [4]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
to be eligible for inclusion in this study the subjects must not meet any of the following criteria:
Descrição

Criteria Mismatch

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1881865
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.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0013030
UMLS CUI [1,4]
C1283071
UMLS CUI [2]
C0035179
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0023570
UMLS CUI [3,4]
C0025519
UMLS CUI [4]
C2917201
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2917347
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C2917433
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0353697
UMLS CUI [8,1]
C0360105
UMLS CUI [8,2]
C0683607
UMLS CUI [9,1]
C1579361
UMLS CUI [9,2]
C0683607
2. co-administration of other mao inhibitors (e.g. selegiline, rasagiline)
Descrição

Monoamine Oxidase Inhibitors | Selegiline | Rasagiline

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0036579
UMLS CUI [3]
C0525678
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
Descrição

Parkinson Disease Late stage | Dose Peak Severely disabling | Dyskinesia Biphasic | Fluctuation Symptoms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0683337
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0444505
UMLS CUI [2,3]
C4035398
UMLS CUI [3,1]
C0013384
UMLS CUI [3,2]
C0205184
UMLS CUI [4,1]
C0231239
UMLS CUI [4,2]
C1457887
4. any indication of forms of parkinsonism, other than idiopathic parkinson's disease.
Descrição

Indication Parkinsonian Disorders | Exception Idiopathic Parkinson Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0242422
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
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
Descrição

Pharmaceutical Preparations Causing Drug metabolising enzyme decreased | Pharmaceutical Preparations Causing Drug metabolising enzyme increased | Barbiturates | ST. JOHN'S WORT EXTRACT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C3203677
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C3203676
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0813171
6. concomitant oral iron treatment
Descrição

Oral iron agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298638
7. history of hypersensitivity or contraindications to mao-b inhibitors or levodopa
Descrição

Hypersensitivity MAO-B Inhibitors | Medical contraindication MAO-B Inhibitors | Levodopa allergy | Medical contraindication Levodopa

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4020574
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C4020574
UMLS CUI [3]
C0570730
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0023570
8. clinically relevant allergies (especially hypersensitivity toward any medicinal drugs)
Descrição

Hypersensitivity | Drug Allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0013182
9. significant hepatic impairment
Descrição

Hepatic impairment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948807
10. significant renal impairment
Descrição

Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
11. diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility
Descrição

Gastrointestinal Diseases Influence Gastrointestinal Absorption | Gastrointestinal Surgical Procedure Influence Gastrointestinal Absorption | Gastrointestinal Diseases Influence Gastrointestinal Motility | Gastrointestinal Surgical Procedure Influence Gastrointestinal Motility

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C3714657
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C3714657
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0017184
UMLS CUI [4,1]
C0524722
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0017184
12. diagnosis of human immunodeficiency virus (hiv), or acute hepatitis b or c
Descrição

HIV Infection | Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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
Descrição

Disease Study Subject Participation Status Excluded | Cardiovascular Diseases | Lung diseases | Angle Closure Glaucoma | Endocrine System Diseases | Hyperthyroidism | Pheochromocytoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0017605
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0020550
UMLS CUI [7]
C0031511
14. a neoplastic disorder, which is either currently active or has been in remission for less than one year.
Descrição

Neoplastic disease | Neoplastic disease Remission

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1882062
UMLS CUI [2,2]
C0544452
15. active psychiatric disease (e.g, schizophrenia, psychotic depression)
Descrição

Mental disorders | Schizophrenia | Depression, psychotic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0743072
16. history of melanoma or current cancer disease and undiagnosed, but melanoma suspicious skin lesion
Descrição

Melanoma Undiagnosed | Neoplasm Undiagnosed | Skin lesion Melanoma Suspicious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025202
UMLS CUI [1,2]
C1408353
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1408353
UMLS CUI [3,1]
C0037284
UMLS CUI [3,2]
C0025202
UMLS CUI [3,3]
C0750493
17. signs for dementia which could interfere with the compliance to the study as judged by the investigator
Descrição

Signs Dementia Interfere with Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0497327
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
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.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0001916
UMLS CUI [3,1]
C0241889
UMLS CUI [3,2]
C0035309
UMLS CUI [3,3]
C0439660
UMLS CUI [4,1]
C0234632
UMLS CUI [4,2]
C0205329
UMLS CUI [5,1]
C0234632
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0035334
UMLS CUI [7,1]
C0151892
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0015127
UMLS CUI [7,4]
C1552551
UMLS CUI [8]
C0035309
UMLS CUI [9]
C4020969
UMLS CUI [10]
C0042164
UMLS CUI [11]
C0011884
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)
Descrição

Caffeine consumption Quantity | Consumption Tea Quantity | Tobacco use Cigarettes per day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0948365
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0039400
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0543414
UMLS CUI [3,2]
C3694146
20. diet considerably deviating from normal nutritional patterns (e.g. vegan; diets with very high protein content [atkins])
Descrição

Diet Abnormal | Vegan diet | Increased protein diet

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0344353
UMLS CUI [3]
C0425403
21. participation in another clinical study within 30 days prior to the planned first drug administration
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
22. alcohol and drug abuse (during the past three years)
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
23. transfusion of blood or plasma derivatives within 3 month prior to the planned first drug administration
Descrição

Blood Transfusion | Transfusion Plasma derivative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005841
UMLS CUI [2,1]
C1879316
UMLS CUI [2,2]
C2964352
24. blood donation within 90 days before the start of the clinical study
Descrição

Blood Donation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005794
25. signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Descrição

Signs and Symptoms Suggestive of Transmissible spongiform encephalopathy | Family member Transmissible spongiform encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C3700367
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C3700367
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT01026428

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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