ID
25793
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.
Trefwoorden
Versies (2)
- 20-09-17 20-09-17 -
- 20-09-21 20-09-21 -
Houder van rechten
Glaxo Smith Klyne
Geüploaded op
20 september 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Screening Visit
Screening Visit
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Subject Identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Centre or investigator number
Datatype
integer
Alias
- UMLS CUI [1]
- C2826689
Beschrijving
Visit Date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Alzheimers disease diagnosis and course
Alias
- UMLS CUI-1
- C0002395
- UMLS CUI-2
- C0011900
- UMLS CUI-3
- C0449259
Beschrijving
Date of first symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Date of diagnosis of probable AD
Datatype
date
Alias
- UMLS CUI [1,1]
- C0332148
- UMLS CUI [1,2]
- C0011008
Beschrijving
Significant worsening
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332271
Beschrijving
family history of AD
Datatype
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0002395
Beschrijving
First degree relative
Datatype
text
Alias
- UMLS CUI [1]
- C1517194
Beschrijving
Other relative
Datatype
text
Alias
- UMLS CUI [1]
- C3174795
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Height
Datatype
integer
Alias
- UMLS CUI [1]
- C0489786
Beschrijving
Weight
Datatype
integer
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood pressure
Datatype
integer
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure
Datatype
integer
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Education History
Alias
- UMLS CUI-1
- C0013622
Beschrijving
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Gait assessment
Datatype
text
Alias
- UMLS CUI [1]
- C2459822
Beschrijving
Balance assessment
Datatype
text
Alias
- UMLS CUI [1]
- C0560184
Beschrijving
Coordination
Datatype
text
Alias
- UMLS CUI [1]
- C0242414
Beschrijving
Cranial nerves
Datatype
text
Alias
- UMLS CUI [1]
- C0010268
Beschrijving
Motor system
Datatype
text
Alias
- UMLS CUI [1]
- C0026606
Beschrijving
Sensory system
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Pedal Edema
Alias
- UMLS CUI-1
- C0013604
Beschrijving
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschrijving
Pedal edema
Datatype
integer
Alias
- UMLS CUI [1]
- C0574002
Beschrijving
Tobacco use
Alias
- UMLS CUI-1
- C0038586
- UMLS CUI-2
- C0543414
Beschrijving
includes all tobacco products
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0841002
Beschrijving
Former smoker
Datatype
date
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C4288952
Beschrijving
If current or former smoker, answer the following questions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Beschrijving
If current or former smoker, answer the following questions
Datatype
integer
Maateenheden
- yrs
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Beschrijving
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschrijving
Medical condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0009488
Beschrijving
CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3176928
Beschrijving
Concomitant Medication
Beschrijving
Medication Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Total Daily Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Beschrijving
Route of administration
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
i.e "Headache"
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Day Month Year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Day Month Year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Screening summary
Alias
- UMLS CUI-1
- C1710032
- UMLS CUI-2
- C0242482
Beschrijving
Collection date fasting samples
Datatype
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C2348510
Beschrijving
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Date of 12 lead ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Beschrijving
ECG result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschrijving
ECG result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschrijving
Note: A score of 0-7 is required for a subject to be eligible for this study
Datatype
integer
Alias
- UMLS CUI [1]
- C3539657
Beschrijving
Note: A score of 16-26 is required for a subject to be eligible for this study
Datatype
integer
Alias
- UMLS CUI [1]
- C0451306
Beschrijving
Eligibility Assessment
Datatype
text
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Alzheimer's Disease Assessment Scale
Datatype
text
Alias
- UMLS CUI [1]
- C0450989
Beschrijving
Investigator instruction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442085
Beschrijving
Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C2243117
- UMLS CUI [1,2]
- C2700377
Beschrijving
Eligibility Assessment
Datatype
text
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Inclusion criteria
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-2
- C1512693
Beschrijving
Eligibility
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
(Subjects with a clinical diagnosis of possible Alzheimer's disease are not eligible).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0002395
Beschrijving
mild to moderate Alzheimer's disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0451306
Beschrijving
Age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Concomitant medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Post-menopausal or if of childbearing potential use effective contraceptive method
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232970
- UMLS CUI [2,1]
- C3831118
- UMLS CUI [2,2]
- C0700589
Beschrijving
CT or MRI scan shows no evidence of tumor or structural abnormality or degenerative disease other than Alzheimers disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0006118
- UMLS CUI [1,2]
- C0332197
- UMLS CUI [2,1]
- C4021085
- UMLS CUI [2,2]
- C0332197
- UMLS CUI [3,1]
- C0524851
- UMLS CUI [3,2]
- C0205394
- UMLS CUI [3,3]
- C0332197
Beschrijving
Neurological exam without focal changes
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0239622
- UMLS CUI [1,3]
- C0332197
Beschrijving
Compliance behavior
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Caregiver
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085537
Beschrijving
Caregiver informed consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0085537
- UMLS CUI [1,2]
- C0021430
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Diabetes mellitus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschrijving
Fasting plasma glucose measurement and Hemoglobin measurement
Datatype
boolean
Alias
- UMLS CUI [1]
- C0583513
- UMLS CUI [2]
- C0518015
Beschrijving
congestive heart failure New York Heart Association criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Beschrijving
Ejection fraction measurement, ECG abnormalities
Datatype
boolean
Alias
- UMLS CUI [1]
- C2020641
- UMLS CUI [2]
- C1832603
Beschrijving
Medical history of cardiovascular event,significant arrhythmia or major intervention
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1320716
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0003811
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0018821
Beschrijving
vascular dementia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011269
Beschrijving
history or evidence of CNS disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0455508
Beschrijving
(score on Hospital Anxiety and Depression Scale (HADS) depression questions >7) (See Protocol Appendix 11)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Beschrijving
peripheral edema
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085649
Beschrijving
Hypertensive disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0020538
Beschrijving
Anemia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002871
Beschrijving
Renal dysfunction
Datatype
boolean
Alias
- UMLS CUI [1]
- C3279454
Beschrijving
Liver diseases
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023895
Beschrijving
Fasting triglyceride measurement
Datatype
boolean
Alias
- UMLS CUI [1]
- C0582824
Beschrijving
Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0202252
- UMLS CUI [2,1]
- C0022885
- UMLS CUI [2,2]
- C0919842
- UMLS CUI [3,1]
- C0022885
- UMLS CUI [3,2]
- C0202230
Beschrijving
Eligibility Determination, other relevant conditions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C0036464
Beschrijving
Blood Donation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005794
Beschrijving
Substance use disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
Compliance behavior limited
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Beschrijving
Family member of research personnel
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C0086282
Beschrijving
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date of completion
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Similar models
Screening Visit
- StudyEvent: ODM
C0011900 (UMLS CUI-2)
C0449259 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C0841002 (UMLS CUI [1,2])
C4288952 (UMLS CUI [1,2])
C1519386 (UMLS CUI [1,2])
C1519386 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
C3176928 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2348510 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,2])
C2700377 (UMLS CUI [1,2])
C1512693 (UMLS CUI-2)
C0002395 (UMLS CUI [1,2])
C0451306 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [1,2])
C4021085 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0524851 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0239622 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C1275491 (UMLS CUI [1,2])
C1832603 (UMLS CUI [2])
C1320716 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0018821 (UMLS CUI [3,2])
C0004936 (UMLS CUI [1,2])
C0202252 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0919842 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C0202230 (UMLS CUI [3,2])
C0036464 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
C0086282 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])