ID

40368

Descripción

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

Palabras clave

Versiones (1)
  1. 14/4/20 14/4/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de abril de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01782222

Inglés

Eligibility Idiopathic Parkinson's Disease NCT01782222

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Parkinson Disease Early | Parkinson Disease Advanced

Tipo de datos

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
Descripción

Parkinson Disease Advanced | Levodopa Dose Stable U/day

Tipo de datos

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
Descripción

Control Unsatisfactory Parkinson Disease | Motor symptoms Treating

Tipo de datos

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
Descripción

Apathy Associated with Parkinson Disease

Tipo de datos

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
Descripción

Hoehn and Yahr Stage

Tipo de datos

boolean

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

Mini-mental state examination

Tipo de datos

boolean

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

Antidepressive Agents Dose Stable

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
therapy with a dopamine agonist
Descripción

Dopamine Agonists

Tipo de datos

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
Descripción

Dopamine Agonists Discontinued | Etiology Lack of Efficacy

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Electroconvulsive Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013806
patient has a
Descripción

Patient has

Tipo de datos

boolean

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

Psychotherapy | Behavior Therapy

Tipo de datos

boolean

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

Deep Brain Stimulation

Tipo de datos

boolean

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

History of suicide attempt | Feeling suicidal

Tipo de datos

boolean

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

Impulse control disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0868740
severe depression
Descripción

Severe depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0588008
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT01782222

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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