ID

13303

Beschreibung

Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00006077

Link

https://clinicaltrials.gov/show/NCT00006077

Stichworte

Versionen (1)
  1. 01.02.16 01.02.16 -
Hochgeladen am

1. Februar 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00006077

Englisch

Eligibility Parkinson's Disease NCT00006077

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and females are eligible for this study.
Beschreibung

gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
ages 18-75.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
women must be at least one year post-menopausal or using an adequate contraceptive method for at least one month prior to and during participation in the study.
Beschreibung

menopause, contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0025320
UMLS CUI [2]
C0700589
all will carry the diagnosis of idiopathic parkinson's disease based on the presence of a characteristic clinical history and neurologic findings.
Beschreibung

idiopathic parkinson

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0332240
all will have relatively advanced disease with levodopa-associated motor response complications, including wearing-off fluctuations and peak-dose dyskinesias.
Beschreibung

disease stage

Datentyp

boolean

Alias
UMLS CUI [1]
C0699749
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
any clinically significant laboratory abnormalities including liver enzyme elevations more than twice the upper limit of normal, or neutropenia (wbc less than 4000).
Beschreibung

laboratory test

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
patients with diphasic or end-of dose dyskinesias or disabling dystonia.
Beschreibung

dyskinesia, dystonia

Datentyp

boolean

Alias
UMLS CUI [1]
C0013384
UMLS CUI [2]
C0013421
patients who are unable to be treated with levodopa/carbidopa alone or a single, relatively short-acting dopamine agonist.
Beschreibung

dopa, dopa agonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0178601
UMLS CUI [2]
C0023570
patients with any form of parkinsonism other than idiopathic pd or with a diagnosis of dementia or major psychiatric disorder. individuals with mild to moderate depression will be sought for this study, unless their depressive disorder currently requires regular medical therapy.
Beschreibung

secondary parkinson, dementia, mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0030569
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0004936
patients who are on unacceptable prior/concomitant medications.
Beschreibung

medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
pregnant women
Beschreibung

pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
those who are not practicing effective birth control.
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
patients with prior bilateral neurosurgical intervention for the treatment of parkinsonian symptoms, i.e. deep brain stimulation, pallidotomy, fetal tissue transplantation as well as patients at risk for symptomatic hypotension, cardiac arrhythmia, and/or myocardial ischemia secondary to intravenous levodopa challenge or ns2330 therapy.
Beschreibung

neurosurgery, risk factors

Datentyp

boolean

Alias
UMLS CUI [1]
C0524850
UMLS CUI [2]
C0035648
patients who have taken an investigational drug within the last two months prior to randomization.
Beschreibung

study subject participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
previous participation in any ns 2330 study.
Beschreibung

study subject participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT00006077

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
gender
Item
male and females are eligible for this study.
boolean
C0079399 (UMLS CUI [1])
age
Item
ages 18-75.
boolean
C0001779 (UMLS CUI [1])
menopause, contraception
Item
women must be at least one year post-menopausal or using an adequate contraceptive method for at least one month prior to and during participation in the study.
boolean
C0025320 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
idiopathic parkinson
Item
all will carry the diagnosis of idiopathic parkinson's disease based on the presence of a characteristic clinical history and neurologic findings.
boolean
C0030567 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
disease stage
Item
all will have relatively advanced disease with levodopa-associated motor response complications, including wearing-off fluctuations and peak-dose dyskinesias.
boolean
C0699749 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.
boolean
C0009488 (UMLS CUI [1])
laboratory test
Item
any clinically significant laboratory abnormalities including liver enzyme elevations more than twice the upper limit of normal, or neutropenia (wbc less than 4000).
boolean
C0022885 (UMLS CUI [1])
dyskinesia, dystonia
Item
patients with diphasic or end-of dose dyskinesias or disabling dystonia.
boolean
C0013384 (UMLS CUI [1])
C0013421 (UMLS CUI [2])
dopa, dopa agonists
Item
patients who are unable to be treated with levodopa/carbidopa alone or a single, relatively short-acting dopamine agonist.
boolean
C0178601 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
secondary parkinson, dementia, mental disorders
Item
patients with any form of parkinsonism other than idiopathic pd or with a diagnosis of dementia or major psychiatric disorder. individuals with mild to moderate depression will be sought for this study, unless their depressive disorder currently requires regular medical therapy.
boolean
C0030569 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
medication
Item
patients who are on unacceptable prior/concomitant medications.
boolean
C0013227 (UMLS CUI [1])
pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
contraception
Item
those who are not practicing effective birth control.
boolean
C0700589 (UMLS CUI [1])
neurosurgery, risk factors
Item
patients with prior bilateral neurosurgical intervention for the treatment of parkinsonian symptoms, i.e. deep brain stimulation, pallidotomy, fetal tissue transplantation as well as patients at risk for symptomatic hypotension, cardiac arrhythmia, and/or myocardial ischemia secondary to intravenous levodopa challenge or ns2330 therapy.
boolean
C0524850 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
study subject participation status
Item
patients who have taken an investigational drug within the last two months prior to randomization.
boolean
C2348568 (UMLS CUI [1])
study subject participation status
Item
previous participation in any ns 2330 study.
boolean
C2348568 (UMLS CUI [1])
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