ID

40368

Description

Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy; ODM derived from: https://clinicaltrials.gov/show/NCT01782222

Link

https://clinicaltrials.gov/show/NCT01782222

Keywords

  1. 4/14/20 4/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 14, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Idiopathic Parkinson's Disease NCT01782222

Eligibility Idiopathic Parkinson's Disease NCT01782222

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with early or advanced idiopathic parkinson's disease
Description

Parkinson Disease Early | Parkinson Disease Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1279919
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0205179
patients with advanced idiopathic parkinson's disease: intake of levodopa on a stable dose of at least 200 mg/day
Description

Parkinson Disease Advanced | Levodopa Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
unsatisfactory control of parkinson's disease motor symptoms under current treatment
Description

Control Unsatisfactory Parkinson Disease | Motor symptoms Treating

Data type

boolean

Alias
UMLS CUI [1,1]
C2587213
UMLS CUI [1,2]
C0439856
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C0426980
UMLS CUI [2,2]
C1522326
patients experiencing apathy associated with parkinson's disease
Description

Apathy Associated with Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0085632
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0030567
hoehn and yahr stage score of i to iv
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
mini-mental state examination score ≥ 25
Description

Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
if an antidepressant drug is taken, the dose must be stable
Description

Antidepressive Agents Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
therapy with a dopamine agonist
Description

Dopamine Agonists

Data type

boolean

Alias
UMLS CUI [1]
C0178601
discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy
Description

Dopamine Agonists Discontinued | Etiology Lack of Efficacy

Data type

boolean

Alias
UMLS CUI [1,1]
C0178601
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0235828
any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation
Description

Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | Medical condition Impairing Study Subject Participation Status | Mental condition Impairing Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C2348568
patient has received neuroleptics, dopamine releasing substances, dopamine modulating substances, alpha-methyldopa, metoclopramide, mao-a inhibitors, budipine, or tolcapone
Description

Antipsychotic Agents | Substance Releasing Dopamine | Substance Modulating Dopamine | Methyldopa | Metoclopramide | Monoamine Oxidase Inhibitors | budipine | tolcapone

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0439861
UMLS CUI [2,2]
C1283071
UMLS CUI [2,3]
C0013030
UMLS CUI [3,1]
C0439861
UMLS CUI [3,2]
C0443264
UMLS CUI [3,3]
C0013030
UMLS CUI [4]
C0025741
UMLS CUI [5]
C0025853
UMLS CUI [6]
C0026457
UMLS CUI [7]
C0054202
UMLS CUI [8]
C0246330
electroconvulsive therapy
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
patient has a
Description

Patient has

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
current/anticipated psychotherapy or behavior therapy
Description

Psychotherapy | Behavior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
UMLS CUI [2]
C0004933
history of deep brain stimulation
Description

Deep Brain Stimulation

Data type

boolean

Alias
UMLS CUI [1]
C0394162
history of suicide attempt or has suicidal ideation
Description

History of suicide attempt | Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0455507
UMLS CUI [2]
C0424000
impulse control disorder
Description

Impulse control disorder

Data type

boolean

Alias
UMLS CUI [1]
C0868740
severe depression
Description

Severe depression

Data type

boolean

Alias
UMLS CUI [1]
C0588008

Similar models

Eligibility Idiopathic Parkinson's Disease NCT01782222

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Early | Parkinson Disease Advanced
Item
patients with early or advanced idiopathic parkinson's disease
boolean
C0030567 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0030567 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Parkinson Disease Advanced | Levodopa Dose Stable U/day
Item
patients with advanced idiopathic parkinson's disease: intake of levodopa on a stable dose of at least 200 mg/day
boolean
C0030567 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0023570 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Control Unsatisfactory Parkinson Disease | Motor symptoms Treating
Item
unsatisfactory control of parkinson's disease motor symptoms under current treatment
boolean
C2587213 (UMLS CUI [1,1])
C0439856 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0426980 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Apathy Associated with Parkinson Disease
Item
patients experiencing apathy associated with parkinson's disease
boolean
C0085632 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Hoehn and Yahr Stage
Item
hoehn and yahr stage score of i to iv
boolean
C3639483 (UMLS CUI [1])
Mini-mental state examination
Item
mini-mental state examination score ≥ 25
boolean
C0451306 (UMLS CUI [1])
Antidepressive Agents Dose Stable
Item
if an antidepressant drug is taken, the dose must be stable
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Dopamine Agonists
Item
therapy with a dopamine agonist
boolean
C0178601 (UMLS CUI [1])
Dopamine Agonists Discontinued | Etiology Lack of Efficacy
Item
discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy
boolean
C0178601 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | Medical condition Impairing Study Subject Participation Status | Mental condition Impairing Study Subject Participation Status
Item
any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Antipsychotic Agents | Substance Releasing Dopamine | Substance Modulating Dopamine | Methyldopa | Metoclopramide | Monoamine Oxidase Inhibitors | budipine | tolcapone
Item
patient has received neuroleptics, dopamine releasing substances, dopamine modulating substances, alpha-methyldopa, metoclopramide, mao-a inhibitors, budipine, or tolcapone
boolean
C0040615 (UMLS CUI [1])
C0439861 (UMLS CUI [2,1])
C1283071 (UMLS CUI [2,2])
C0013030 (UMLS CUI [2,3])
C0439861 (UMLS CUI [3,1])
C0443264 (UMLS CUI [3,2])
C0013030 (UMLS CUI [3,3])
C0025741 (UMLS CUI [4])
C0025853 (UMLS CUI [5])
C0026457 (UMLS CUI [6])
C0054202 (UMLS CUI [7])
C0246330 (UMLS CUI [8])
Electroconvulsive Therapy
Item
electroconvulsive therapy
boolean
C0013806 (UMLS CUI [1])
Patient has
Item
patient has a
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Psychotherapy | Behavior Therapy
Item
current/anticipated psychotherapy or behavior therapy
boolean
C0033968 (UMLS CUI [1])
C0004933 (UMLS CUI [2])
Deep Brain Stimulation
Item
history of deep brain stimulation
boolean
C0394162 (UMLS CUI [1])
History of suicide attempt | Feeling suicidal
Item
history of suicide attempt or has suicidal ideation
boolean
C0455507 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
Impulse control disorder
Item
impulse control disorder
boolean
C0868740 (UMLS CUI [1])
Severe depression
Item
severe depression
boolean
C0588008 (UMLS CUI [1])

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