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ID
21023
Beschrijving
A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease. Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: AVA100193, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00334568?term=NCT00334568&rank=1
Link
https://clinicaltrials.gov/ct2/show/NCT00334568?term=NCT00334568&rank=1
Trefwoorden
Versies (1)
- 03-04-17 03-04-17 -
Geüploaded op
3 april 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Screening Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193
Screening Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193
Similar models
Screening Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Investigator Instructions
C0008961 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
C1442085 (UMLS CUI-2)
Subject registry
Item
Telephone the Interactive Voice Response System (IVRS) to register the subject.
text
C0034975 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
Arabic/North Africa (1)
CL Item
Black (2)
CL Item
East & South East Asian (3)
CL Item
Japanese (4)
CL Item
South Asian (5)
CL Item
White/Caucasian (6)
CL Item
Other (7)
Item Group
Alzheimer´s disease diagnosis and course
C0002395 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0750729 (UMLS CUI-3)
C0011900 (UMLS CUI-2)
C0750729 (UMLS CUI-3)
Date of first symptoms
Item
Date of first symptoms
date
C2316983 (UMLS CUI [1,1])
C0449990 (UMLS CUI [1,2])
C0449990 (UMLS CUI [1,2])
Date of diagnosis
Item
Date of diagnosis of probable AD
date
C2316983 (UMLS CUI [1])
Worsening
Item
Has there been a significant worsening in the past 6 months?
boolean
C0012634 (UMLS CUI [1,1])
C1442792 (UMLS CUI [1,2])
C1442792 (UMLS CUI [1,2])
CL Item
Yes (Parent/sibling/child) (1)
CL Item
No (Parent/sibling/child) (2)
CL Item
Unknown (Parent/sibling/child) (3)
CL Item
Yes (Other relative) (4)
CL Item
No (Other relative) (5)
CL Item
Unknown (Other relative) (6)
Body Height
Item
Body
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure. (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.) Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.)
float
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart rate (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.) Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0018810 (UMLS CUI [1])
Years of education
Item
How many full years of education did the subject complete? (include primary to post-university education)
float
C0013658 (UMLS CUI [1])
Neurological findings
Item
Perform a Neurological Examination on the subject, including assessment of gait, balance, coordination, cranial nerves and motor and sensory systems. Note: If any abnormalities are found as a result of the neurological examination, these must be recorded on the Medical Conditions page.
text
C0437208 (UMLS CUI [1])
physical examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the neurological examination, these must be recorded on the Medical Conditions page.
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0018793 (UMLS CUI [2])
C2230255 (UMLS CUI [3])
C0243095 (UMLS CUI [1,2])
C0018793 (UMLS CUI [2])
C2230255 (UMLS CUI [3])
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Check the appropriate box below to indicate which ankle was assessed at this visit.
integer
C0003086 (UMLS CUI [1])
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item
What is the subject´s history of tobacco use (includes all tobacco products)?
integer
C0543414 (UMLS CUI [1])
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Last Smoked
Item
When did the subject last smoke?
date
C3172719 (UMLS CUI [1])
Number of cigarettes
Item
Number of cigarettes smoked per day?
float
C1608325 (UMLS CUI [1])
Smoking
Item
Number of years during which the subject has smoked?
float
C1277691 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
Item Group
Prior and Concomitant Medications
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-2)
C2826257 (UMLS CUI-2)
Concomitant Medication
Item
Were any concomitant medications taken by the subject within 60 days prior to the study? If yes, record each medication on a separate line using Trade Names where possible.
boolean
C2347852 (UMLS CUI [1])
Item Group
Prior And Concomitant Medications
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-3)
C2826257 (UMLS CUI-3)
Drug name
Item
Drug name (e.g. Aspirin)
text
C0013227 (UMLS CUI [1])
total daily dose
Item
Total Daily Dose (e.g. 400)
float
C2348070 (UMLS CUI [1])
Units
Item
Units (e.g. mg)
text
C1519795 (UMLS CUI [1])
Route
Item
Route (e.g. PO)
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication (e.g. Headache)
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start Date (e.g. 31 May 02)
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date (e.g. 31 May 02)
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Item Group
Central Laboratory (Fasting Samples)
C1880016 (UMLS CUI-1)
Date sample taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Assess eligibility (exclusion criterion 4) and record abnormalities within the medical conditions item) (3)
Depression score
Item
Depression score Note: A score of 0-7 is required for a subject to be eligible for this study.
float
C3539657 (UMLS CUI [1])
MMSE Score
Item
MMSE Score Note: A score of 16-26 is required for a subject to be eligible for this study.
float
C2225229 (UMLS CUI [1])
Ejection fraction
Item
Ejection fraction Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
float
C0232174 (UMLS CUI [1])