Parkinson Disease | Parkinsonism Etiology unknown
Item
1. male or female diagnosed with idiopathic pd, without any known cause for parkinsonism.
boolean
C0030567 (UMLS CUI [1])
C0242422 (UMLS CUI [2,1])
C0743626 (UMLS CUI [2,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | NuvaRing Vaginal Product | Oral contraception | Injectable contraception | Ttransdermal patch | Contraceptive implant | Contraception, Barrier
Item
2. if female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as nova ring, oral, injected, transdermal patch, implanted, or barrier). the subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3233268 (UMLS CUI [3])
C0029151 (UMLS CUI [4])
C1262153 (UMLS CUI [5])
C2135981 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Age
Item
3. at least 30 years old at the time of diagnosis of pd.
boolean
C0001779 (UMLS CUI [1])
Mini-mental state examination
Item
4. mini mental state examination (mmse) ≥ 26 at screening visit.
boolean
C0451306 (UMLS CUI [1])
Levodopa-responsive | Carbidopa / Levodopa Dose Stable | Carbidopa / Levodopa Oral Product | Carbidopa / Levodopa Controlled release
Item
5. a responder to ld and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release cd ld for at least 1 month.
boolean
C1853846 (UMLS CUI [1])
C0353697 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C3210219 (UMLS CUI [3])
C0353697 (UMLS CUI [4,1])
C0868939 (UMLS CUI [4,2])
Fluctuation On - off phenomenon
Item
6. must have predictable fluctuations between "on" and "off" states.
boolean
C0231239 (UMLS CUI [1,1])
C0852903 (UMLS CUI [1,2])
Hoehn and Yahr Stage
Item
7. hoehn and yahr stage i-iv when "on".
boolean
C3639483 (UMLS CUI [1])
Informed Consent
Item
8. able to provide informed consent and willing to sign health insurance portability and accountability act (hipaa) authorization.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance | Availability of Blood specimen
Item
9. able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.
boolean
C0525058 (UMLS CUI [1])
C0470187 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
1. pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atypical Parkinsonism
Item
2. diagnosed with atypical parkinsonism.
boolean
C4302185 (UMLS CUI [1])
Medical History Suggestive of Diagnosis Other | Physical findings Suggestive of Diagnosis Other | Laboratory Results Suggestive of Diagnosis Other | Exception Parkinson Disease
Item
3. history, physical findings or laboratory results suggesting a diagnosis other than pd.
boolean
C0262926 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0311392 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0011900 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C1254595 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0011900 (UMLS CUI [3,3])
C0205394 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0030567 (UMLS CUI [4,2])
Hypersensitivity Carbidopa / Levodopa | Unresponsive to Carbidopa / Levodopa
Item
4. allergic or nonresponsive to previous cd-ld therapy.
boolean
C0020517 (UMLS CUI [1,1])
C0353697 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0353697 (UMLS CUI [2,2])
Medical condition compromises Patient safety | Hepatic impairment | Renal Insufficiency | Peptic Ulcer
Item
5. any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the investigator's opinion, may jeopardize the subject's safety.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0948807 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
Exposure to Investigational New Drugs
Item
6. exposure to any investigational agent within 30 days prior to visit 1.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Blood Donation | Plasma Donation
Item
7. donated blood or plasma within 28 days.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
Neurosurgical Procedures Functional Parkinson Disease | Ablation | Deep Brain Stimulation
Item
20. had prior functional neurosurgical treatment for pd (ablation or deep brain stimulation).
boolean
C0524850 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0547070 (UMLS CUI [2])
C0394162 (UMLS CUI [3])