ID

25634

Beschrijving

A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Study part: Neurological examination

Trefwoorden

Versies (3)
  1. 06-08-17 06-08-17 -
  2. 12-08-17 12-08-17 -
  3. 07-09-17 07-09-17 -
Geüploaded op

7 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Neurological examination GSK study Dyskinesia in Parkinson's disease NCT00363727

Engels

Neurological examination GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren  
General information
Beschrijving

General information

Protocol identifier
Beschrijving

Protocol identifier

Datatype

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Beschrijving

Visit Description

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Neurological examination
Beschrijving

Neurological examination

Mental status
Beschrijving

Mental status

Datatype

integer

Alias
UMLS CUI [1]
C0278060
Mental Status: comments
Beschrijving

Mental status comments

Datatype

text

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C0947611
Gait
Beschrijving

Gait

Datatype

integer

Alias
UMLS CUI [1]
C0016928
Gait: comments
Beschrijving

Gait comments

Datatype

text

Alias
UMLS CUI [1,1]
C0016928
UMLS CUI [1,2]
C0947611
Balance
Beschrijving

Balance

Datatype

integer

Alias
UMLS CUI [1]
C0560184
Balance: comments
Beschrijving

Balance comments

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0560184
Coordination
Beschrijving

Coordination

Datatype

integer

Alias
UMLS CUI [1]
C0242414
Coordination: comments
Beschrijving

Coordination comments

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0242414
Cranial nerves
Beschrijving

Cranial nerves

Datatype

integer

Alias
UMLS CUI [1]
C0010268
Cranial nerves: comments
Beschrijving

Cranial nerves comments

Datatype

text

Alias
UMLS CUI [1,1]
C0010268
UMLS CUI [1,2]
C0947611
Motor
Beschrijving

Motor

Datatype

integer

Alias
UMLS CUI [1]
C0026606
Motor: comments
Beschrijving

Motor comments

Datatype

text

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0947611
Reflexes
Beschrijving

Reflexes

Datatype

integer

Alias
UMLS CUI [1]
C0436145
Reflexes: comments
Beschrijving

Reflexes comments

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0436145
Sensory
Beschrijving

Sensory

Datatype

integer

Alias
UMLS CUI [1]
C0445254
Sensory: comments
Beschrijving

Sensory comments

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0445254
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
Beschrijving

If No, the subject is not eligible to participate in the study

Datatype

boolean

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Similar models

Neurological examination GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information
Protocol identifier
Item
Protocol identifier
integer
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Description
Item
Visit Description
integer
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Neurological examination
Item
Mental status
integer
C0278060 (UMLS CUI [1])
Mental status
Code List
Mental status
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Mental status comments
Item
Mental Status: comments
text
C0278060 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Gait
integer
C0016928 (UMLS CUI [1])
Gait
Code List
Gait
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Gait comments
Item
Gait: comments
text
C0016928 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Balance
integer
C0560184 (UMLS CUI [1])
Balance
Code List
Balance
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Balance comments
Item
Balance: comments
text
C0947611 (UMLS CUI [1,1])
C0560184 (UMLS CUI [1,2])
Item
Coordination
integer
C0242414 (UMLS CUI [1])
Coordination
Code List
Coordination
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Coordination comments
Item
Coordination: comments
text
C0947611 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
Item
Cranial nerves
integer
C0010268 (UMLS CUI [1])
Cranial nerves
Code List
Cranial nerves
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Cranial nerves comments
Item
Cranial nerves: comments
text
C0010268 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Motor
integer
C0026606 (UMLS CUI [1])
Motor
Code List
Motor
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Motor comments
Item
Motor: comments
text
C0026606 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Reflexes
integer
C0436145 (UMLS CUI [1])
Reflexes
Code List
Reflexes
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Reflexes comments
Item
Reflexes: comments
text
C0947611 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
Item
Sensory
integer
C0445254 (UMLS CUI [1])
Sensory
Code List
Sensory
CL Item
Normal (0)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (1)
C0205161 (UMLS CUI-1)
(Comment:en)
Sensory comments
Item
Sensory: comments
text
C0947611 (UMLS CUI [1,1])
C0445254 (UMLS CUI [1,2])
Neurological examination Parkinson's disease consistency
Item
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
boolean
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