ID

18782

Descrição

Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00228150

Link

https://clinicaltrials.gov/show/NCT00228150

Palavras-chave

Versões (1)
  1. 20/11/2016 20/11/2016 -
Transferido a

20 de novembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00228150

Inglês

Eligibility Parkinson Disease NCT00228150

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients.
Descrição

Gender | Outpatients

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0029921
age >=35 years at screening.·
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of parkinson's syndrome, on at least two of the three key parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
Descrição

Parkinson Disease Symptoms Quantity | Resting Tremor | Bradykinesia | Rigidity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0234379
UMLS CUI [3]
C0233565
UMLS CUI [4]
C0026837
duration of the disease of less than 3 years since diagnosis·
Descrição

disease length

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0872146
modified hoehn and yahr stage <= 2.5.
Descrição

UPDRS - Modified Hoehn and Yahr Staging

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3639878
untreated patients.
Descrição

Patients untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
generally healthy and ambulatory.
Descrição

General health good | Ambulatory

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2]
C0439841
patient has given his informed written consent and is capable of following study procedures.
Descrição

Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any indication of forms of parkinsonism other than pd.
Descrição

Indication Parkinsonian Disorders | Parkinson Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0242422
UMLS CUI [2]
C0030567
severe resting tremor.
Descrição

Resting Tremor Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0234379
UMLS CUI [1,2]
C0205082
presence of either dyskinesia, fluctuations, or loss of postural reflexes·
Descrição

Dyskinetic syndrome | Motor fluctuations | Postural reflex Loss

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013384
UMLS CUI [2]
C1868976
UMLS CUI [3,1]
C0234154
UMLS CUI [3,2]
C1517945
treatment with l-dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (comt ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
Descrição

Levodopa | Dopamine Agonists | Amantadine | Anticholinergic Agents | Catechol-O-methyltransferase inhibitor | Selegiline | Dopamine Antagonists | catecholamine inhibitor | Dopamine Agonists Indirect | Methyldopa

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
UMLS CUI [3]
C0002403
UMLS CUI [4]
C0242896
UMLS CUI [5]
C0595267
UMLS CUI [6]
C0036579
UMLS CUI [7]
C0242702
UMLS CUI [8]
C0596280
UMLS CUI [9,1]
C0178601
UMLS CUI [9,2]
C0439852
UMLS CUI [10]
C0025741
electroconvulsive therapy (ect).
Descrição

Electroconvulsive Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013806
use of cyp3a4 strong, and moderate inducers or inhibitors.
Descrição

CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inhibitors Moderate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3850041
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C3850053
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3850053
UMLS CUI [4,2]
C0205081
participation in another clinical trial with an investigational drug within two months prior to randomization.
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
dementia, uncontrolled depression, psychotic disorder.
Descrição

Dementia | Depressive disorder Uncontrolled | Psychotic Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0033975
history of substance-related disorders including alcohol or other substance use disorders.
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
females of child bearing potential.
Descrição

Childbearing Potential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
evidence (detected by history, physical examination and/or laboratory/ecg tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.
Descrição

Disease Clinical Significance Interferes with Study Subject Participation Status | Disease Unstable Interferes with Study Subject Participation Status | Medical History | Physical Examination | Laboratory Tests | ECG finding | Disease Unstable Interferes with Investigational New Drug absorption | Disease Unstable Interferes with Investigational New Drug metabolism | Disease Unstable Interferes with Investigational New Drug excretion | Disease Unstable Interferes with Investigational New Drug Evaluation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0031809
UMLS CUI [5]
C0022885
UMLS CUI [6]
C0438154
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0443343
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C0013230
UMLS CUI [7,5]
C0678745
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0443343
UMLS CUI [8,3]
C0521102
UMLS CUI [8,4]
C0013230
UMLS CUI [8,5]
C0025520
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0443343
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C0013230
UMLS CUI [9,5]
C0683141
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0443343
UMLS CUI [10,3]
C0521102
UMLS CUI [10,4]
C0013230
UMLS CUI [10,5]
C1261322
alterations of laboratory tests or ecg findings of potential clinical significance.
Descrição

Laboratory Tests Alteration | ECG finding Clinical Significance potential

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1515926
UMLS CUI [2,1]
C0438154
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C3245505
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Similar models

Eligibility Parkinson Disease NCT00228150

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Outpatients
Item
male or female outpatients.
boolean
C0079399 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Age
Item
age >=35 years at screening.·
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease Symptoms Quantity | Resting Tremor | Bradykinesia | Rigidity
Item
diagnosis of parkinson's syndrome, on at least two of the three key parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
boolean
C0030567 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0234379 (UMLS CUI [2])
C0233565 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
disease length
Item
duration of the disease of less than 3 years since diagnosis·
boolean
C0872146 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
modified hoehn and yahr stage <= 2.5.
boolean
C3639878 (UMLS CUI [1])
Patients untreated
Item
untreated patients.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
General health good | Ambulatory
Item
generally healthy and ambulatory.
boolean
C1277245 (UMLS CUI [1])
C0439841 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
patient has given his informed written consent and is capable of following study procedures.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Indication Parkinsonian Disorders | Parkinson Disease
Item
any indication of forms of parkinsonism other than pd.
boolean
C3146298 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
C0030567 (UMLS CUI [2])
Resting Tremor Severe
Item
severe resting tremor.
boolean
C0234379 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Dyskinetic syndrome | Motor fluctuations | Postural reflex Loss
Item
presence of either dyskinesia, fluctuations, or loss of postural reflexes·
boolean
C0013384 (UMLS CUI [1])
C1868976 (UMLS CUI [2])
C0234154 (UMLS CUI [3,1])
C1517945 (UMLS CUI [3,2])
Levodopa | Dopamine Agonists | Amantadine | Anticholinergic Agents | Catechol-O-methyltransferase inhibitor | Selegiline | Dopamine Antagonists | catecholamine inhibitor | Dopamine Agonists Indirect | Methyldopa
Item
treatment with l-dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (comt ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
C0002403 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
C0595267 (UMLS CUI [5])
C0036579 (UMLS CUI [6])
C0242702 (UMLS CUI [7])
C0596280 (UMLS CUI [8])
C0178601 (UMLS CUI [9,1])
C0439852 (UMLS CUI [9,2])
C0025741 (UMLS CUI [10])
Electroconvulsive Therapy
Item
electroconvulsive therapy (ect).
boolean
C0013806 (UMLS CUI [1])
CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inhibitors Moderate
Item
use of cyp3a4 strong, and moderate inducers or inhibitors.
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3850053 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3850053 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another clinical trial with an investigational drug within two months prior to randomization.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Dementia | Depressive disorder Uncontrolled | Psychotic Disorder
Item
dementia, uncontrolled depression, psychotic disorder.
boolean
C0497327 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3])
Substance Use Disorders
Item
history of substance-related disorders including alcohol or other substance use disorders.
boolean
C0038586 (UMLS CUI [1])
Childbearing Potential
Item
females of child bearing potential.
boolean
C3831118 (UMLS CUI [1])
Disease Clinical Significance Interferes with Study Subject Participation Status | Disease Unstable Interferes with Study Subject Participation Status | Medical History | Physical Examination | Laboratory Tests | ECG finding | Disease Unstable Interferes with Investigational New Drug absorption | Disease Unstable Interferes with Investigational New Drug metabolism | Disease Unstable Interferes with Investigational New Drug excretion | Disease Unstable Interferes with Investigational New Drug Evaluation
Item
evidence (detected by history, physical examination and/or laboratory/ecg tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0022885 (UMLS CUI [5])
C0438154 (UMLS CUI [6])
C0012634 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C0678745 (UMLS CUI [7,5])
C0012634 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0025520 (UMLS CUI [8,5])
C0012634 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0013230 (UMLS CUI [9,4])
C0683141 (UMLS CUI [9,5])
C0012634 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0521102 (UMLS CUI [10,3])
C0013230 (UMLS CUI [10,4])
C1261322 (UMLS CUI [10,5])
Laboratory Tests Alteration | ECG finding Clinical Significance potential
Item
alterations of laboratory tests or ecg findings of potential clinical significance.
boolean
C0022885 (UMLS CUI [1,1])
C1515926 (UMLS CUI [1,2])
C0438154 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C3245505 (UMLS CUI [2,3])
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