ID
21524
Beschrijving
Documentation Part: Screening An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline
Link
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Trefwoorden
Versies (2)
- 25-04-17 25-04-17 -
- 20-09-21 20-09-21 -
Geüploaded op
25 april 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of birth
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnicity
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Geographic Ancestry
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Child-bearing Potential (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C1960468
Beschrijving
Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Local Laboratory Result Data
Alias
- UMLS CUI-1
- C1254595
Beschrijving
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0009488
Beschrijving
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Current
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0012634
Beschrijving
Past
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1444637
- UMLS CUI [1,2]
- C0012634
Beschrijving
Urine Drug Screen
Alias
- UMLS CUI-1
- C0202274
Beschrijving
Date and time of sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschrijving
Amphetamines
Datatype
text
Alias
- UMLS CUI [1]
- C0002667
Beschrijving
Barbiturates
Datatype
text
Alias
- UMLS CUI [1]
- C0004745
Beschrijving
Cannabis
Datatype
text
Alias
- UMLS CUI [1]
- C0936079
Beschrijving
Cocaine
Datatype
text
Alias
- UMLS CUI [1]
- C0009170
Beschrijving
Morphine and derivatives
Datatype
text
Alias
- UMLS CUI [1]
- C0279996
Beschrijving
Alcohol Test
Alias
- UMLS CUI-1
- C0868676
Beschrijving
Serology - HIV/Hepatitis Screen
Alias
- UMLS CUI-1
- C0459958
- UMLS CUI-2
- C1445958
Beschrijving
Date sample taken
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0459958
- UMLS CUI [1,2]
- C1445958
- UMLS CUI [1,3]
- C1302413
Beschrijving
HIV antibody
Datatype
text
Alias
- UMLS CUI [1]
- C0019683
Beschrijving
Hepatitis B surface antigen
Datatype
text
Alias
- UMLS CUI [1]
- C0019168
Beschrijving
Hepatitis C antibody
Datatype
text
Alias
- UMLS CUI [1]
- C0281863
Beschrijving
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Date of Assessment
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0031809
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Hair and skin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Lymph nodes
Datatype
text
Alias
- UMLS CUI [1]
- C0024204
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Eyes
Datatype
text
Alias
- UMLS CUI [1]
- C0200149
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Ears, Nose and Throat
Datatype
text
Alias
- UMLS CUI [1]
- C0278350
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Breasts
Datatype
text
Alias
- UMLS CUI [1]
- C0199850
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Respiratory
Datatype
text
Alias
- UMLS CUI [1]
- C0599324
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Cardiovascular
Datatype
text
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Abdomen
Datatype
text
Alias
- UMLS CUI [1]
- C0562238
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Urogenital
Datatype
text
Alias
- UMLS CUI [1]
- C1828035
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Pelvic
Datatype
text
Alias
- UMLS CUI [1]
- C0200045
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Rectal
Datatype
text
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Musculoskeletal
Datatype
text
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Neurological
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
Mental Status
Datatype
text
Alias
- UMLS CUI [1]
- C0278060
Beschrijving
[different findings should be separated by either a (;) or a (/)]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschrijving
History of tobacco use
Alias
- UMLS CUI-1
- C0841002
Beschrijving
What is the subject's history of tobacco use?
Datatype
text
Alias
- UMLS CUI [1]
- C0841002
Beschrijving
If former smoker: When did the subject last smoke/use tobacco?
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
If current or former smoker, answer the following question: Number of cigarettes smoked per day?
Datatype
integer
Maateenheden
- cigarettes per day
Alias
- UMLS CUI [1]
- C3694146
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body Mass Index
Datatype
float
Maateenheden
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschrijving
Planned Relative Time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschrijving
Actual time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Subject position
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Start date of ECG
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013798
Beschrijving
Planned Relative Time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
Beschrijving
Start Time of ECG
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013798
Beschrijving
Ventricular Rate
Datatype
integer
Maateenheden
- Beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschrijving
QTC interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Result of the ECG
Datatype
text
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0199556
Beschrijving
Sinus bradycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 40-50 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 30-39 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate < 30 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus pause
Datatype
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschrijving
Sinus tachycardia (heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschrijving
Ectopic supraventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschrijving
Ectopic supraventricular rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschrijving
Wandering atrial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschrijving
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0221158
Beschrijving
Supraventricular tachycardia (heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039240
Beschrijving
Atrial flutter
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschrijving
Atrial Fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
Junctional rhythm (heart rate ≤100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional tachycardia (heart rate > 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschrijving
Ectopic ventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschrijving
Ventricular couplets
Datatype
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschrijving
Bigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschrijving
Trigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschrijving
Electrical alternans
Datatype
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschrijving
R on T phenomenon
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschrijving
Ventricular Fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschrijving
Idioventricular rhythm (heart rate < 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschrijving
Sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschrijving
Non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschrijving
Wide QRS Tachycardia (diagnosis unknown)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschrijving
Ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschrijving
Monomorphic ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschrijving
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344432
Beschrijving
Artificial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschrijving
Other abnormal rhythm
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1533266
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
Beschrijving
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C2216025
- UMLS CUI-4
- C0429098
Beschrijving
Left atrial abnormality (P mitrale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschrijving
Right atrial abnormality (P pulmonale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschrijving
Right ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschrijving
Intraatrial conduction delay
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschrijving
Increased voltage consistent with left ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112650
Beschrijving
Other morphology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C2216025
- UMLS CUI [1,3]
- C0429098
Beschrijving
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0232217
Beschrijving
First degree AV block (PR interval > 200 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschrijving
Short PR interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschrijving
Second degree AV block (Mobitz type 1)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschrijving
Second degree AV block (Mobitz type 2)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschrijving
2:1 AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschrijving
Third degree AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschrijving
Left axis deviation (QRS axis more negative than -30°)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschrijving
Right axis deviation (QRS axis more positive than +110°)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschrijving
Incomplete right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschrijving
Incomplete left bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschrijving
Right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschrijving
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschrijving
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschrijving
Left Bundle Branch Block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschrijving
Bifascicular block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschrijving
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschrijving
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Beschrijving
Prolonged QT interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschrijving
QT/QTc prolongation ≥ 500 msec
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschrijving
AV dissociation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
Other conduction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0027051
Beschrijving
Myocardial infarction, old
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschrijving
Myocardial infarction, anterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschrijving
Myocardial infarction, lateral
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschrijving
Myocardial infarction, posterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschrijving
Myocardial infarction, inferior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschrijving
Myocardial infarction, septal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschrijving
Myocardial infarction, Non-Q wave
Datatype
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschrijving
Other myocardial infarction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0948857
Beschrijving
Non-specific ST-T changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschrijving
J point elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschrijving
ST elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschrijving
ST elevation-pericarditis
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschrijving
ST depression
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschrijving
ST segment abnormality, not specified
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschrijving
U waves abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschrijving
T wave inversion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschrijving
T wave peaked
Datatype
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschrijving
T waves flat
Datatype
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschrijving
T waves biphasic
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschrijving
Notched T-waves
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschrijving
Low QRS voltage
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschrijving
T-wave flattening/inversion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beschrijving
T wave abnormality, not specified
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschrijving
Other depolarisation/repolarisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: Other Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0205394
Beschrijving
Local laboratory result data (haematology)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0474523
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Has the subject fasted?
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Haemoglobin (Hb)
Datatype
float
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Haematocrit
Datatype
float
Alias
- UMLS CUI [1]
- C0018935
Beschrijving
Mean cell haemoglobin (MCH)
Datatype
float
Alias
- UMLS CUI [1]
- C0369183
Beschrijving
Mean cell haemoglobin concentration (MCHC)
Datatype
float
Alias
- UMLS CUI [1]
- C0474535
Beschrijving
Red blood cell count (RBC)
Datatype
float
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
White blood cell count (WBC)
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Platelets
Datatype
float
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
Lymphocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0024264
Beschrijving
Neutrophils
Datatype
float
Alias
- UMLS CUI [1]
- C0948762
Beschrijving
Monocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0026473
Beschrijving
Basophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Eosinophils
Datatype
float
Alias
- UMLS CUI [1]
- C0362902
Beschrijving
Units for differential
Datatype
text
Alias
- UMLS CUI [1,1]
- C1820731
- UMLS CUI [1,2]
- C1519795
Beschrijving
Local laboratory result data - (clinical chemistry)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0525044
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Has the subject fasted?
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Sodium
Datatype
float
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Potassium
Datatype
float
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Urea
Datatype
float
Alias
- UMLS CUI [1]
- C0523961
Beschrijving
Creatinine
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Total Protein
Datatype
float
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
Albumin
Datatype
float
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Total Bilirubin
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Aspartate aminotransferase (AST)
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Alanine aminotransferase (ALT)
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Alkaline phosphatase (AP)
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Gamma glutamyl transferase (GGT)
Datatype
float
Alias
- UMLS CUI [1]
- C0202035
Beschrijving
Calcium
Datatype
float
Alias
- UMLS CUI [1]
- C0201925
Beschrijving
Phosphate
Datatype
float
Alias
- UMLS CUI [1]
- C0523826
Beschrijving
Cholesterol
Datatype
float
Alias
- UMLS CUI [1]
- C1445957
Beschrijving
Triglycerides
Datatype
float
Alias
- UMLS CUI [1]
- C0202236
Beschrijving
Glucose
Datatype
float
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
Creatine phosphokinase
Datatype
float
Alias
- UMLS CUI [1]
- C0201973
Beschrijving
Chloride
Datatype
float
Alias
- UMLS CUI [1]
- C0201952
Beschrijving
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [1,4]
- C0200345
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Urinalysis (Dipstick) Test: pH
Datatype
integer
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
Urinalysis (Dipstick) Test: Protein
Datatype
float
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
Urinalysis (Dipstick) Test: Glucose
Datatype
float
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Urinalysis (Dipstick) Test: Bilirubin
Datatype
float
Alias
- UMLS CUI [1]
- C0042040
Beschrijving
Urinalysis (Dipstick) Test: Blood
Datatype
float
Alias
- UMLS CUI [1]
- C0202514
Beschrijving
Urinalysis (Dipstick) Test: Specific Gravity
Datatype
float
Alias
- UMLS CUI [1]
- C0430383
Beschrijving
Was sedimentary microscopy performed?
Datatype
text
Alias
- UMLS CUI [1]
- C2700128
Beschrijving
Urinalysis (Microscopy) Test: White blood cells
Datatype
integer
Alias
- UMLS CUI [1]
- C0919738
Beschrijving
Urinalysis (Microscopy) Test: Red blood cells
Datatype
integer
Alias
- UMLS CUI [1]
- C0221752
Beschrijving
Urinalysis (Microscopy) Test: Hyaline casts
Datatype
integer
Alias
- UMLS CUI [1]
- C1254537
Beschrijving
Urinalysis (Microscopy) Test: Granular casts
Datatype
integer
Alias
- UMLS CUI [1]
- C2697521
Beschrijving
Urinalysis (Microscopy) Test: Cellular casts
Datatype
integer
Alias
- UMLS CUI [1]
- C2699157
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Male or female patients aged between 30 and 85 years of age inclusive at screening.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2]
- C0005910
Beschrijving
Diagnosis of idiopathic Parkinson's Disease graded according to modified Hoehn & Yahr Stage I-III (Appendix 4 of protocol).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0451215
Beschrijving
Patients must have provided written informed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle Branch Block).
Datatype
boolean
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Childbearing potential
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0032961
- UMLS CUI [1,3]
- C0700589
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Clinical abnormality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0747585
- UMLS CUI [1,2]
- C0035648
Beschrijving
Comorbidity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0009488
Beschrijving
clinically significant abnormal laboratory value, ECG, or physical examination findings
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438215
- UMLS CUI [2]
- C0522055
- UMLS CUI [3]
- C0747585
Beschrijving
Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody at screening.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0281863
- UMLS CUI [1,2]
- C0149709
- UMLS CUI [1,3]
- C0920548
Beschrijving
Positive alcohol test result and / or urine test for undeclared drugs at screening.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0948726
- UMLS CUI [1,2]
- C0743300
Beschrijving
history of moderate to severe dizziness, syncope, or orthostatic hypotension
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012833
- UMLS CUI [1,2]
- C0039070
- UMLS CUI [1,3]
- C0020651
Beschrijving
Significant sleep disorder or Epworth Sleep Score (Appendix 5) ≥9 at screening.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0851578
- UMLS CUI [1,2]
- C2129304
Beschrijving
Patients with a lying/sitting diastolic blood pressure ≥110mmHg or ≤50mmHg or a systolic blood pressure ≥180mmHg or ≤90mmHg at the Screening or Baseline Visit.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0428883
Beschrijving
Concomtant medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013036
- UMLS CUI [1,2]
- C2347852
Beschrijving
Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin, fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior to study enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent for at least one month prior to enrolment and throughout the treatment phase of the study.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0282402
- UMLS CUI [1,2]
- C0207509
Beschrijving
Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0453996
Beschrijving
Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3163616
- UMLS CUI [1,2]
- C0005794
Beschrijving
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0244821
Beschrijving
Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschrijving
Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug. Patients who have taken OTC medication may still be entered in the study, if in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013231
Beschrijving
drug dependence or abuse of alcohol
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1510472
- UMLS CUI [1,2]
- C0085762
Beschrijving
Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
- UMLS CUI [2]
- C0422727
- UMLS CUI [3]
- C2347852
Beschrijving
Women who are pregnant or breast-feeding.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschrijving
Patients with prior or current major psychosis (eg schizophrenia or psychotic depression). Eg scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033975
Beschrijving
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Similar models
Screening Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
C0220908 (UMLS CUI [1,2])
C0015895 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C2122182 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0868676 (UMLS CUI [1,2])
C1445958 (UMLS CUI-2)
C1445958 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0013798 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C2216025 (UMLS CUI-3)
C0429098 (UMLS CUI-4)
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,2])
C0429098 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0232217 (UMLS CUI-3)
C0043202 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1704258 (UMLS CUI-2)
C0027051 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0948857 (UMLS CUI-2)
C0429059 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0474523 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0525044 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
C0022877 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2])
C0451215 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2])
C0747585 (UMLS CUI [3])
C0149709 (UMLS CUI [1,2])
C0920548 (UMLS CUI [1,3])
C0743300 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,3])
C2129304 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0207509 (UMLS CUI [1,2])
C0005794 (UMLS CUI [1,2])
C0244821 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
C0085762 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2])
C2347852 (UMLS CUI [3])
C0006147 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])