ID

25634

Description

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

Mots-clés

Versions (3)
  1. 06/08/2017 06/08/2017 -
  2. 12/08/2017 12/08/2017 -
  3. 07/09/2017 07/09/2017 -
Téléchargé le

7 septembre 2017

DOI

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Licence

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

Anglais

Neurological examination GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulaires  
General information
Description

General information

Protocol identifier
Description

Protocol identifier

Type de données

integer

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Description
Description

Visit Description

Type de données

integer

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

Neurological examination

Mental status
Description

Mental status

Type de données

integer

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

Mental status comments

Type de données

text

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

Gait

Type de données

integer

Alias
UMLS CUI [1]
C0016928
Gait: comments
Description

Gait comments

Type de données

text

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

Balance

Type de données

integer

Alias
UMLS CUI [1]
C0560184
Balance: comments
Description

Balance comments

Type de données

text

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

Coordination

Type de données

integer

Alias
UMLS CUI [1]
C0242414
Coordination: comments
Description

Coordination comments

Type de données

text

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

Cranial nerves

Type de données

integer

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

Cranial nerves comments

Type de données

text

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

Motor

Type de données

integer

Alias
UMLS CUI [1]
C0026606
Motor: comments
Description

Motor comments

Type de données

text

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

Reflexes

Type de données

integer

Alias
UMLS CUI [1]
C0436145
Reflexes: comments
Description

Reflexes comments

Type de données

text

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

Sensory

Type de données

integer

Alias
UMLS CUI [1]
C0445254
Sensory: comments
Description

Sensory comments

Type de données

text

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

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

Type de données

boolean

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Similar models

Neurological examination GSK study Dyskinesia in Parkinson's disease NCT00363727

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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