Informações:
Falhas:
ID
15597
Descrição
Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00200525
Link
https://clinicaltrials.gov/show/NCT00200525
Palavras-chave
Versões (1)
- 04/06/2016 04/06/2016 -
Transferido a
4 de junho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00200525
Eligibility Parkinson Disease NCT00200525
- StudyEvent: Eligibility
Similar models
Eligibility Parkinson Disease NCT00200525
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
adults of any age ≥ 18
boolean
C0001779 (UMLS CUI [1])
pregnancy or lactating
Item
men and non-pregnant, non-lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
negative pregnancy test
Item
women of childbearing potential had a negative serum (beta hcg) pre-study pregnancy test prior to randomization
boolean
C0427780 (UMLS CUI [1])
contraception
Item
women of childbearing potential used an acceptable form of contraception
boolean
C0700589 (UMLS CUI [1])
idiopathic parkinsons disease
Item
patients with a clinical diagnosis of idiopathic parkinson's disease, i.e., not induced by drugs or caused by other diseases;
boolean
C0030567 (UMLS CUI [1])
hoehn and yahr scale
Item
patients classified as stage (ii-iv) of the hoehn and yahr scale for staging the severity of parkinson's disease
boolean
C0451215 (UMLS CUI [1])
oral therapy regimen for parkinson
Item
the patient must have been on an optimally maximized oral therapy regimen. optimized oral anti-parkinson medications must have included levodopa/carbidopa inhibitors, in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
boolean
C0030567 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
apomorphine subcutaneous injections
Item
patients must have been receiving apomorphine subcutaneous injections for rescue therapy for off events for at least three months
boolean
C0003596 (UMLS CUI [1])
minimum apomorphine baseline-dosing
Item
the minimum apomorphine baseline-dosing requirement was an average of at least 2 doses per day over the week prior to enrollment.
boolean
C0003596 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
protocol apo401
Item
patients participating in protocol apo401, an open-label study primarily designed to collect safety data, were eligible for participation in this trial without termination of participation in apo401
boolean
C2348568 (UMLS CUI [1])
psychoses or dementia
Item
patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of anti-parkinson medications. (patients with hallucinations or other central adverse reactions associated solely with anti-parkinson medications were not excluded.)
boolean
C0033975 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0497327 (UMLS CUI [2])
drug or alcohol dependency
Item
patients with a history of drug or alcohol dependency within one year prior to study enrollment
boolean
C0038586 (UMLS CUI [1])
comorbidity
Item
patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the three months before the start of the study.
boolean
C0009488 (UMLS CUI [1])
allergy to morphine or its derivatives
Item
patinets with a history of true allergy to morphine or its derivatives (including apomorphine), sulfur, sulfur containing medications, sulfites, sulfates, tigan(r)(trimethobenzamide).
boolean
C0020517 (UMLS CUI [1,1])
C0026549 (UMLS CUI [1,2])
C0026549 (UMLS CUI [1,2])
participation in another study
Item
patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 30 days before study entry. patients with participation in mylan-sponsored study apo202 were excluded from participation in this study.
boolean
C2348568 (UMLS CUI [1])
apomorphine regimen
Item
patients whose apomorphine regimen was characterized by administration methods other than intermittent subcutaneous injection.
boolean
C0003596 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
informed consent limited
Item
patients who could not or would not sign an informed consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])