ID

36780

Descripción

Inhibiting COMT in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02070887

Link

https://clinicaltrials.gov/show/NCT02070887

Palabras clave

Versiones (1)
  1. 7/6/19 7/6/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de junio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02070887

Inglés

Eligibility Parkinson's Disease NCT02070887

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 60 - 75 years,
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
caucasian ethnicity,
Descripción

Caucasians

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043157
diagnosed pd by uk brain bank criteria,
Descripción

Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030567
hoehn & yahr scale 2 - 3,
Descripción

Hoehn and Yahr Scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4274667
fertile females have to use contraception
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
group 1: medication with stalevo® (l-dopa/ddi + entacapone)
Descripción

Stalevo | Levodopa | DOPA Decarboxylase Inhibitors | entacapone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1434452
UMLS CUI [2]
C0023570
UMLS CUI [3]
C0598272
UMLS CUI [4]
C0165921
group 2: medication with madopar® or sinemet® (l-dopa/ddi)
Descripción

Madopar | Sinemet | Levodopa | DOPA Decarboxylase Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0065502
UMLS CUI [2]
C0074559
UMLS CUI [3]
C0023570
UMLS CUI [4]
C0598272
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
methotrexate therapy during the last 12 months,
Descripción

Methotrexate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025677
treatment with tolcapone
Descripción

tolcapone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0246330
vitamin b6, b12 and/or folic acid supplementation during last 6 months,
Descripción

Vitamin B6 supplementation | Vitamin B12 supplementation | Folic acid supplementation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4524021
UMLS CUI [2]
C4524262
UMLS CUI [3]
C0556110
pregnancy,
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
intention to become pregnant during the course of the study,
Descripción

Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032992
breast feeding,
Descripción

Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
other clinically relevant concomitant disease states by discretion of the investigator
Descripción

Comorbidity Relevant Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
known or suspected non-compliance, drug or alcohol abuse,
Descripción

Compliance behavior Lacking | Compliance behavior Lacking Suspected | Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0750491
UMLS CUI [3]
C0038586
inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
Descripción

Protocol Compliance Unable | Etiology Language problems | Etiology Mental disorders | Etiology Dementia | Etiology Confusion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1405458
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0004936
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0497327
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0009676
participation in another study with investigational drug within the 30 days preceding and during the present study,
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
enrolment of the investigator, his/her family members, employees and other dependent persons.
Descripción

Enrollment Investigator | Enrollment Family member | Enrollment Employee | Enrollment Persons dependent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0086282
UMLS CUI [3,1]
C1516879
UMLS CUI [3,2]
C0599987
UMLS CUI [4,1]
C1516879
UMLS CUI [4,2]
C0027361
UMLS CUI [4,3]
C3244310
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Similar models

Eligibility Parkinson's Disease NCT02070887

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 60 - 75 years,
boolean
C0001779 (UMLS CUI [1])
Caucasians
Item
caucasian ethnicity,
boolean
C0043157 (UMLS CUI [1])
Parkinson Disease
Item
diagnosed pd by uk brain bank criteria,
boolean
C0030567 (UMLS CUI [1])
Hoehn and Yahr Scale
Item
hoehn & yahr scale 2 - 3,
boolean
C4274667 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
fertile females have to use contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Stalevo | Levodopa | DOPA Decarboxylase Inhibitors | entacapone
Item
group 1: medication with stalevo® (l-dopa/ddi + entacapone)
boolean
C1434452 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
C0598272 (UMLS CUI [3])
C0165921 (UMLS CUI [4])
Madopar | Sinemet | Levodopa | DOPA Decarboxylase Inhibitors
Item
group 2: medication with madopar® or sinemet® (l-dopa/ddi)
boolean
C0065502 (UMLS CUI [1])
C0074559 (UMLS CUI [2])
C0023570 (UMLS CUI [3])
C0598272 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Methotrexate
Item
methotrexate therapy during the last 12 months,
boolean
C0025677 (UMLS CUI [1])
tolcapone
Item
treatment with tolcapone
boolean
C0246330 (UMLS CUI [1])
Vitamin B6 supplementation | Vitamin B12 supplementation | Folic acid supplementation
Item
vitamin b6, b12 and/or folic acid supplementation during last 6 months,
boolean
C4524021 (UMLS CUI [1])
C4524262 (UMLS CUI [2])
C0556110 (UMLS CUI [3])
Pregnancy
Item
pregnancy,
boolean
C0032961 (UMLS CUI [1])
Pregnancy, Planned
Item
intention to become pregnant during the course of the study,
boolean
C0032992 (UMLS CUI [1])
Breast Feeding
Item
breast feeding,
boolean
C0006147 (UMLS CUI [1])
Comorbidity Relevant Clinical
Item
other clinically relevant concomitant disease states by discretion of the investigator
boolean
C0009488 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Compliance behavior Lacking | Compliance behavior Lacking Suspected | Substance Use Disorders
Item
known or suspected non-compliance, drug or alcohol abuse,
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3])
Protocol Compliance Unable | Etiology Language problems | Etiology Mental disorders | Etiology Dementia | Etiology Confusion
Item
inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1405458 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0004936 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0497327 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0009676 (UMLS CUI [5,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another study with investigational drug within the 30 days preceding and during the present study,
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Enrollment Investigator | Enrollment Family member | Enrollment Employee | Enrollment Persons dependent
Item
enrolment of the investigator, his/her family members, employees and other dependent persons.
boolean
C1516879 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C0086282 (UMLS CUI [2,2])
C1516879 (UMLS CUI [3,1])
C0599987 (UMLS CUI [3,2])
C1516879 (UMLS CUI [4,1])
C0027361 (UMLS CUI [4,2])
C3244310 (UMLS CUI [4,3])
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