ID

17237

Beskrivning

A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00517842

Länk

https://clinicaltrials.gov/show/NCT00517842

Nyckelord

Versioner (1)
  1. 2016-09-01 2016-09-01 -
Uppladdad den

1 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00517842

Engelsk

Eligibility Parkinson Disease NCT00517842

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
a subject will be eligible for study participation if he/she meets all the following criteria:
Beskrivning

Inclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1512693
1. age of at least 30 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of symptomatic, idiopathic parkinson' disease using the united kingdom parkinson's disease society brain bank diagnostic criteria (appendix 3 in the protocol)
Beskrivning

diagnosis of symptomatic, idiopathic parkinson disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
3. stage 1-4 on the modified hoehn and yahr scale (appendix 4 in the protocol)
Beskrivning

Modified hoehn and yahr scale

Datatyp

boolean

Alias
UMLS CUI [1]
C3639878
4. possesses three of the four cardinal signs of parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism
Beskrivning

Rigidity, bradykinesia, resting tremor, postural instability

Datatyp

boolean

Alias
UMLS CUI [1]
C0026837
UMLS CUI [2]
C0233565
UMLS CUI [3]
C0234379
UMLS CUI [4]
C1843921
5. if receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry
Beskrivning

Good response to levodopa or other symptomatic treatments

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1704632
6. voluntarily signs and dates an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), prior to any study-specific procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject will be excluded from the study if he/she meets any of the following criteria:
Beskrivning

Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
1. presence of atypical parkinsonian syndromes
Beskrivning

Atypical parkinsonian syndromes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0205182
2. dementia as defined by the mini-mental state examination score (appendix 5 in the protocol) of 22 or less
Beskrivning

mini-mental state examination score

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
3. serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
Beskrivning

Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C1882062
4. used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry
Beskrivning

Centrally active therapies

Datatyp

boolean

Alias
UMLS CUI [1]
C0007680
5. used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-a inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry
Beskrivning

Methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-a inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0025810
UMLS CUI [2]
C0008803
UMLS CUI [3]
C0035179
UMLS CUI [4]
C0002658
UMLS CUI [5]
C0026457
6. has history of receiving any neuroleptics
Beskrivning

Neuroleptics

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
7. used alpha-methyldopa or flunarizine within 6 months of study entry
Beskrivning

alpha-methyldopa or flunarizine

Datatyp

boolean

Alias
UMLS CUI [1]
C0025741
UMLS CUI [2]
C0016295
8. females who are pregnant or breastfeeding.
Beskrivning

pregnant or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (visit 1).
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
10. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening of this study (visit 1).
Beskrivning

traditional chinese medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025124
UMLS CUI [1,2]
C0013227
11. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Beskrivning

Protocol compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
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Similar models

Eligibility Parkinson Disease NCT00517842

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion Criteria
Item
a subject will be eligible for study participation if he/she meets all the following criteria:
boolean
C1512693 (UMLS CUI [1])
Age
Item
1. age of at least 30 years
boolean
C0001779 (UMLS CUI [1])
diagnosis of symptomatic, idiopathic parkinson disease
Item
2. diagnosis of symptomatic, idiopathic parkinson' disease using the united kingdom parkinson's disease society brain bank diagnostic criteria (appendix 3 in the protocol)
boolean
C0030567 (UMLS CUI [1])
Modified hoehn and yahr scale
Item
3. stage 1-4 on the modified hoehn and yahr scale (appendix 4 in the protocol)
boolean
C3639878 (UMLS CUI [1])
Rigidity, bradykinesia, resting tremor, postural instability
Item
4. possesses three of the four cardinal signs of parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism
boolean
C0026837 (UMLS CUI [1])
C0233565 (UMLS CUI [2])
C0234379 (UMLS CUI [3])
C1843921 (UMLS CUI [4])
Good response to levodopa or other symptomatic treatments
Item
5. if receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry
boolean
C0023570 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
Informed Consent
Item
6. voluntarily signs and dates an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), prior to any study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
a subject will be excluded from the study if he/she meets any of the following criteria:
boolean
C0680251 (UMLS CUI [1])
Atypical parkinsonian syndromes
Item
1. presence of atypical parkinsonian syndromes
boolean
C0242422 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
mini-mental state examination score
Item
2. dementia as defined by the mini-mental state examination score (appendix 5 in the protocol) of 22 or less
boolean
C0451306 (UMLS CUI [1])
Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
Item
3. serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease
boolean
C0009488 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C1882062 (UMLS CUI [5])
Centrally active therapies
Item
4. used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry
boolean
C0007680 (UMLS CUI [1])
Methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-a inhibitors
Item
5. used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-a inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry
boolean
C0025810 (UMLS CUI [1])
C0008803 (UMLS CUI [2])
C0035179 (UMLS CUI [3])
C0002658 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
Neuroleptics
Item
6. has history of receiving any neuroleptics
boolean
C0040615 (UMLS CUI [1])
alpha-methyldopa or flunarizine
Item
7. used alpha-methyldopa or flunarizine within 6 months of study entry
boolean
C0025741 (UMLS CUI [1])
C0016295 (UMLS CUI [2])
pregnant or breastfeeding
Item
8. females who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
9. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (visit 1).
boolean
C2348568 (UMLS CUI [1])
traditional chinese medication
Item
10. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening of this study (visit 1).
boolean
C0025124 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Protocol compliance
Item
11. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
boolean
C0525058 (UMLS CUI [1])
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