Parkinson Disease
Item
pd as defined by united kingdom pd society brain bank criteria12
boolean
C0030567 (UMLS CUI [1])
Sialorrhea Moderate MDS-UPDRS | Sialorrhea Severe MDS-UPDRS
Item
moderate-to-severe sialorrhea defined by a score in the item 2.2 of the mds-updrs greater than 2.
boolean
C0037036 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3639714 (UMLS CUI [1,3])
C0037036 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3639714 (UMLS CUI [2,3])
Parkinsonian Disorders idiopathic | Progressive supranuclear palsy | Corticobasal degeneration | Multiple System Atrophy
Item
1. other idiopathic parkinsonian syndromes, e.g., progressive supranuclear palsy, cortico-basal syndrome, or multiple system atrophy
boolean
C0242422 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0038868 (UMLS CUI [2])
C0393570 (UMLS CUI [3])
C0393571 (UMLS CUI [4])
Parkinsonian Disorders Secondary | Parkinsonism due to drug | Parkinsonian Disorders Traumatic | Parkinson Disease, Postencephalitic | Parkinson Disease, Secondary Vascular
Item
2. secondary parkinsonian syndromes (drug-induced, traumatic, encephalitic or vascular)
boolean
C0242422 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0270729 (UMLS CUI [2])
C0242422 (UMLS CUI [3,1])
C0332663 (UMLS CUI [3,2])
C0030568 (UMLS CUI [4])
C0751414 (UMLS CUI [5])
Antiparkinson Agents Change
Item
3. change in antiparkinsonian medication one month prior to enrolment
boolean
C0003405 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Glycopyrrolate | Hypersensitivity Glycopyrrolate
Item
4. prior use of glycopyrrolate with or without known hypersensitivity will be considered an exclusion criterion, as it increases the risk of unblinding due to prior knowledge of potential side effects or therapeutic benefit
boolean
C0017970 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0017970 (UMLS CUI [2,2])
Anticholinergic Agents Dose Change | Pharmaceutical Preparations Dose Change | Pharmaceutical Preparations Affecting Saliva production | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Clozapine | quetiapine | Hypnotics | Pharmaceutical Preparations Dose Stable
Item
5. change in the dose one month prior to enrolment of other anticholinergic agents or other drugs potentially affecting saliva production, such as tricyclic antidepressants, mao-a inhibitors, neuroleptics (including clozapine and quetiapine more frequently used in pd) or hypnotics. these mediation will remain in a constant dose throughout the trial;
boolean
C0242896 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1821986 (UMLS CUI [3,3])
C0003290 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C0009079 (UMLS CUI [7])
C0123091 (UMLS CUI [8])
C0020591 (UMLS CUI [9])
C0013227 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0205360 (UMLS CUI [10,3])
Potassium Chloride Oral Product
Item
6. concomitant use of solid oral dosage forms of potassium chloride;
boolean
C3214855 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Absent | Gender Contraceptive methods Absent | Sexual Abstinence | Intrauterine Devices | Vaginal contraceptive diaphragm | Spermatocidal Agents | Condoms | Contraceptives, Oral
Item
7. pregnancy, breastfeeding, and premenopausal females or males not using adequate contraception; medically acceptable birth control methods for this study include: (1) abstinence (no sexual intercourse); (2) intrauterine device (iud); (3) diaphragm with spermicide; (4) condom with spermicide; and (5) oral contraceptives (birth control pills) + condom/diaphragm with spermicide.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0037862 (UMLS CUI [8])
C0677582 (UMLS CUI [9])
C0009905 (UMLS CUI [10])
Constipation, moderate to severe | Therapy Optimal | MDS-UPDRS
Item
8. moderate-to-severe constipation in spite of optimal treatment (mds-updrs, item 1.11>2);
boolean
C3550392 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C3639714 (UMLS CUI [3])
Condition Excludes Anticholinergic Agents | Inflammatory Bowel Diseases | Symptoms Suggestive of Inflammatory Bowel Diseases | Glaucoma | Myasthenia Gravis | Prostatic Hypertrophy | URINARY OBSTRUCTIVE SYMPTOMS
Item
9. conditions that preclude anticholinergic therapy, e.g., documented history or symptoms suggestive of inflammatory bowel disease, glaucoma, myasthenia gravis, prostatic hypertrophy or obstructive urinary symptoms;
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0242896 (UMLS CUI [1,3])
C0021390 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0021390 (UMLS CUI [3,3])
C0017601 (UMLS CUI [4])
C0026896 (UMLS CUI [5])
C1739363 (UMLS CUI [6])
C0749941 (UMLS CUI [7])
Exacerbation Due to Glycopyrrolate | Congestive heart failure | Symptoms Suggestive of Congestive heart failure | Coronary heart disease | Gastroesophageal reflux disease | Hyperthyroidism
Item
10. conditions that can be exacerbated by anticholinergic effects of glycopyrrolate, e.g., documented history or symptoms suggestive of congestive heart failure, coronary heart disease, gastro-esophageal reflux disease or hyperthyroidism;
boolean
C4086268 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0017970 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0018802 (UMLS CUI [3,3])
C0010068 (UMLS CUI [4])
C0017168 (UMLS CUI [5])
C0020550 (UMLS CUI [6])
Hypertensive disease Uncontrolled | Systolic Pressure | Diastolic blood pressure | Use of Electronic sphygmomanometer
Item
11. uncontrolled arterial hypertension (tas>140 mmhg or tad>90 mmhg, using an electronic sphygmomanometer and standardized procedure16);
boolean
C0020538 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C1524063 (UMLS CUI [4,1])
C0183429 (UMLS CUI [4,2])
Tachyarrhythmia | RR Interval Single Measurement
Item
12. tachyarrhythmia (interval rr <0.6 sec.);
boolean
C0080203 (UMLS CUI [1])
C3897782 (UMLS CUI [2])
Thyroid stimulating hormone measurement
Item
13. tsh<0.4 miu/l;
boolean
C0202230 (UMLS CUI [1])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
14. liver dysfunction (ast, alt, alp >2xupper normal limit);
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal dysfunction | Creatinine clearance measurement | Glycopyrrolate Renal clearance predominant
Item
15. renal dysfunction (creatinine clearance <50 ml/min), as glycopyrrolate has predominant renal clearance;
boolean
C3279454 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0017970 (UMLS CUI [3,1])
C0232813 (UMLS CUI [3,2])
C1542147 (UMLS CUI [3,3])
Informed Consent Unable | Informed Consent Guardian Unable | Informed Consent Patient Representative Unable | Informed Consent Unwilling | Informed Consent Guardian Unwilling | Informed Consent Patient Representative Unwilling
Item
16. inability or unwillingness of subject or legal guardian/representative to give written informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0021430 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5,1])
C1274041 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
C0021430 (UMLS CUI [6,1])
C0030701 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Study Subject Participation Status | Clinical Trial
Item
17. participation in another investigational study at the time of recruitment or during the prior month.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])