Eligibility Parkinson's Disease NCT00070941

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StudyEvent: Eligibility
1. Eligibility Parkinson's Disease NCT00070941

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Parkinson Disease Signs | Resting Tremor | Rigidity | Bradykinesia | Postural reflex impairment

Item

idiopathic parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment

boolean

C0030567 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
C0234379 (UMLS CUI [2])
C0026837 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C1868839 (UMLS CUI [5])

Antiparkinson Agents Stable | Pharmaceutical Preparations unchanged

Item

stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry

boolean

C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])

Antidepressive Agents | Antipsychotic Agents

Item

no antidepressant or antipsychotic medications within 30 days prior to study entry

boolean

C0003289 (UMLS CUI [1])
C0040615 (UMLS CUI [2])

Pharmacotherapy | Psychotherapy | Behavior Therapy | Study Subject Participation Status

Item

agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial

boolean

C0013216 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
C0004933 (UMLS CUI [3])
C2348568 (UMLS CUI [4])

Contraceptive methods Acceptable

Item

acceptable methods of contraception

boolean

C0700589 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])

Able to read Instructions written English Language | Instructions Oral English Language Compliance Ability

Item

ability to read and/or follow written and oral instructions presented in english

boolean

C0586740 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1576874 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C1442085 (UMLS CUI [2,1])
C0442027 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C3714738 (UMLS CUI [2,4])
C0085732 (UMLS CUI [2,5])

Cognitive status Sufficient Informed Consent Related | Mini-mental state examination

Item

sufficient cognitive ability (baseline mini-mental status > 24) to provide informed consent

boolean

C0945985 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0451306 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Item

history of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials

boolean

C0018799 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0042373 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0449913 (UMLS CUI [9,1])
C1704258 (UMLS CUI [9,2])
C2347946 (UMLS CUI [9,3])
C0205210 (UMLS CUI [9,4])

Laboratory test result abnormal

Item

certain abnormal laboratory values

boolean

C0438215 (UMLS CUI [1])

Pregnancy | Breast Feeding

Item

pregnant or breastfeeding

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Investigational New Drugs

Item

use of an investigational drug within 3 months of study entry

boolean

C0013230 (UMLS CUI [1])

ST. JOHN'S WORT EXTRACT | Natural Products Mood Enhancement

Item

use of st. john's wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry

boolean

C0813171 (UMLS CUI [1])
C1566558 (UMLS CUI [2,1])
C0026516 (UMLS CUI [2,2])
C2349975 (UMLS CUI [2,3])

Selegiline | Monoamine Oxidase Inhibitors

Item

selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry

boolean

C0036579 (UMLS CUI [1])
C0026457 (UMLS CUI [2])

Item

regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed

boolean

C0040616 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C2054158 (UMLS CUI [2,1])
C0205353 (UMLS CUI [2,2])
C0027415 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0521114 (UMLS CUI [3,3])
C0039468 (UMLS CUI [4])
C0025219 (UMLS CUI [5])
C0078839 (UMLS CUI [6])

Psychotherapy Initiation

Item

psychotherapy initiated in the 6 months prior to study entry

boolean

C0033968 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])

Bipolar Disorder | Hypomania | Mania | Schizophrenia | Psychotic Disorders

Item

history of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder

boolean

C0005586 (UMLS CUI [1])
C0241934 (UMLS CUI [2])
C0338831 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C0033975 (UMLS CUI [5])

Suicide attempt Serious | Suicidal tendency Serious | Potential Suicidal Serious

Item

serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential

boolean

C0038663 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0235196 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3245505 (UMLS CUI [3,1])
C0438696 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])

Dopamine Antagonists | Metoclopramide | Haloperidol

Item

use of dopamine receptor antagonist (metoclopramide, haloperidol)

boolean

C0242702 (UMLS CUI [1])
C0025853 (UMLS CUI [2])
C0018546 (UMLS CUI [3])

Item

secondary parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases

boolean

C0242422 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0242702 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C0014038 (UMLS CUI [5])
C1285162 (UMLS CUI [6])

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Eligibility Parkinson's Disease NCT00070941