ID
43527
Beschreibung
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
Stichworte
Versionen (2)
- 25.04.17 25.04.17 -
- 20.09.21 20.09.21 -
Hochgeladen am
20. September 2021
DOI
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Lizenz
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
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnicity
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Geographic Ancestry
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Child-bearing Potential (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C1960468
Beschreibung
Pregnancy Test (Complete for Female Subjects of Child-bearing Potential Only)
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Local Laboratory Result Data
Alias
- UMLS CUI-1
- C1254595
Beschreibung
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0009488
Beschreibung
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Current
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0012634
Beschreibung
Past
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1444637
- UMLS CUI [1,2]
- C0012634
Beschreibung
Urine Drug Screen
Alias
- UMLS CUI-1
- C0202274
Beschreibung
Date and time of sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschreibung
Amphetamines
Datentyp
text
Alias
- UMLS CUI [1]
- C0002667
Beschreibung
Barbiturates
Datentyp
text
Alias
- UMLS CUI [1]
- C0004745
Beschreibung
Cannabis
Datentyp
text
Alias
- UMLS CUI [1]
- C0936079
Beschreibung
Cocaine
Datentyp
text
Alias
- UMLS CUI [1]
- C0009170
Beschreibung
Morphine and derivatives
Datentyp
text
Alias
- UMLS CUI [1]
- C0279996
Beschreibung
Alcohol Test
Alias
- UMLS CUI-1
- C0868676
Beschreibung
Serology - HIV/Hepatitis Screen
Alias
- UMLS CUI-1
- C0459958
- UMLS CUI-2
- C1445958
Beschreibung
Date sample taken
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0459958
- UMLS CUI [1,2]
- C1445958
- UMLS CUI [1,3]
- C1302413
Beschreibung
HIV antibody
Datentyp
text
Alias
- UMLS CUI [1]
- C0019683
Beschreibung
Hepatitis B surface antigen
Datentyp
text
Alias
- UMLS CUI [1]
- C0019168
Beschreibung
Hepatitis C antibody
Datentyp
text
Alias
- UMLS CUI [1]
- C0281863
Beschreibung
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Date of Assessment
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0031809
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Hair and skin
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Lymph nodes
Datentyp
text
Alias
- UMLS CUI [1]
- C0024204
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Eyes
Datentyp
text
Alias
- UMLS CUI [1]
- C0200149
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Ears, Nose and Throat
Datentyp
text
Alias
- UMLS CUI [1]
- C0278350
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Breasts
Datentyp
text
Alias
- UMLS CUI [1]
- C0199850
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Respiratory
Datentyp
text
Alias
- UMLS CUI [1]
- C0436121
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Cardiovascular
Datentyp
text
Alias
- UMLS CUI [1]
- C3854344
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Abdomen
Datentyp
text
Alias
- UMLS CUI [1]
- C0562238
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Urogenital
Datentyp
text
Alias
- UMLS CUI [1]
- C1828035
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Pelvic
Datentyp
text
Alias
- UMLS CUI [1]
- C0200045
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Rectal
Datentyp
text
Alias
- UMLS CUI [1]
- C0199900
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Musculoskeletal
Datentyp
text
Alias
- UMLS CUI [1]
- C0475091
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Neurological
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
Mental Status
Datentyp
text
Alias
- UMLS CUI [1]
- C0278060
Beschreibung
[different findings should be separated by either a (;) or a (/)]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0678257
Beschreibung
History of tobacco use
Alias
- UMLS CUI-1
- C0841002
Beschreibung
What is the subject's history of tobacco use?
Datentyp
text
Alias
- UMLS CUI [1]
- C0841002
Beschreibung
If former smoker: When did the subject last smoke/use tobacco?
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
If current or former smoker, answer the following question: Number of cigarettes smoked per day?
Datentyp
integer
Maßeinheiten
- cigarettes per day
Alias
- UMLS CUI [1]
- C3694146
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body Mass Index
Datentyp
float
Maßeinheiten
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Date
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschreibung
Planned Relative Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschreibung
Actual time
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beschreibung
Systolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Subject position
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Start date of ECG
Datentyp
date
Maßeinheiten
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013798
Beschreibung
Planned Relative Time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0439564
Beschreibung
Start Time of ECG
Datentyp
time
Maßeinheiten
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013798
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- Beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschreibung
QTC interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Result of the ECG
Datentyp
text
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschreibung
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0199556
Beschreibung
Sinus bradycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate 40-50 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate 30-39 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate < 30 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Sinus tachycardia (heart rate >100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschreibung
Ectopic supraventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
Ectopic supraventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschreibung
Wandering atrial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschreibung
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0221158
Beschreibung
Supraventricular tachycardia (heart rate >100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039240
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial Fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Junctional rhythm (heart rate ≤100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional tachycardia (heart rate > 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschreibung
Ectopic ventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
Ventricular couplets
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschreibung
Bigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschreibung
Trigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschreibung
Electrical alternans
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschreibung
R on T phenomenon
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschreibung
Ventricular Fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschreibung
Idioventricular rhythm (heart rate < 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschreibung
Sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
Non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
Wide QRS Tachycardia (diagnosis unknown)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschreibung
Ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschreibung
Monomorphic ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschreibung
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344432
Beschreibung
Artificial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
Other abnormal rhythm
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1533266
- UMLS CUI [1,2]
- C0205394
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
Beschreibung
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
Beschreibung
Left atrial abnormality (P mitrale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschreibung
Right atrial abnormality (P pulmonale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschreibung
Right ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschreibung
Intraatrial conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschreibung
Increased voltage consistent with left ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112650
Beschreibung
Other morphology
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C2216025
- UMLS CUI [1,3]
- C0429098
Beschreibung
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0232217
Beschreibung
First degree AV block (PR interval > 200 msec)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschreibung
Short PR interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschreibung
Second degree AV block (Mobitz type 1)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschreibung
Second degree AV block (Mobitz type 2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschreibung
2:1 AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschreibung
Third degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
Left axis deviation (QRS axis more negative than -30°)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
Right axis deviation (QRS axis more positive than +110°)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
Incomplete right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
Incomplete left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschreibung
Right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschreibung
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschreibung
Left Bundle Branch Block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
Bifascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschreibung
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschreibung
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Beschreibung
Prolonged QT interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschreibung
QT/QTc prolongation ≥ 500 msec
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschreibung
AV dissociation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
Other conduction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [1,4]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0027051
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
Myocardial infarction, anterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschreibung
Myocardial infarction, lateral
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschreibung
Myocardial infarction, posterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschreibung
Myocardial infarction, inferior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschreibung
Myocardial infarction, septal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschreibung
Myocardial infarction, Non-Q wave
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
Other myocardial infarction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0027051
- UMLS CUI [1,4]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0948857
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
J point elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
ST elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
ST elevation-pericarditis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschreibung
ST depression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
ST segment abnormality, not specified
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschreibung
U waves abnormal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschreibung
T wave inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschreibung
T wave peaked
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschreibung
T waves flat
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschreibung
T waves biphasic
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
Notched T-waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschreibung
Low QRS voltage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
T-wave flattening/inversion
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beschreibung
T wave abnormality, not specified
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschreibung
Other depolarisation/repolarisation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: Other Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0205394
Beschreibung
Local laboratory result data (haematology)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0474523
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschreibung
Laboratory name
Datentyp
text
Alias
- UMLS CUI [1]
- C1882331
Beschreibung
Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschreibung
Has the subject fasted?
Datentyp
text
Alias
- UMLS CUI [1]
- C0015663
Beschreibung
Haemoglobin (Hb)
Datentyp
float
Alias
- UMLS CUI [1]
- C0518015
Beschreibung
Haematocrit
Datentyp
float
Alias
- UMLS CUI [1]
- C0018935
Beschreibung
Mean cell haemoglobin (MCH)
Datentyp
float
Alias
- UMLS CUI [1]
- C0369183
Beschreibung
Mean cell haemoglobin concentration (MCHC)
Datentyp
float
Alias
- UMLS CUI [1]
- C0474535
Beschreibung
Red blood cell count (RBC)
Datentyp
float
Alias
- UMLS CUI [1]
- C0014772
Beschreibung
White blood cell count (WBC)
Datentyp
float
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Platelets
Datentyp
float
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
Lymphocytes
Datentyp
float
Alias
- UMLS CUI [1]
- C0024264
Beschreibung
Neutrophils
Datentyp
float
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
Monocytes
Datentyp
float
Alias
- UMLS CUI [1]
- C0026473
Beschreibung
Basophils
Datentyp
float
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
Eosinophils
Datentyp
float
Alias
- UMLS CUI [1]
- C0362902
Beschreibung
Units for differential
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1820731
- UMLS CUI [1,2]
- C1519795
Beschreibung
Local laboratory result data - (clinical chemistry)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0525044
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschreibung
Laboratory name
Datentyp
text
Alias
- UMLS CUI [1]
- C1882331
Beschreibung
Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschreibung
Has the subject fasted?
Datentyp
text
Alias
- UMLS CUI [1]
- C0015663
Beschreibung
Sodium
Datentyp
float
Alias
- UMLS CUI [1]
- C0337443
Beschreibung
Potassium
Datentyp
float
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
Urea
Datentyp
float
Alias
- UMLS CUI [1]
- C0523961
Beschreibung
Creatinine
Datentyp
float
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Total Protein
Datentyp
float
Alias
- UMLS CUI [1]
- C0555903
Beschreibung
Albumin
Datentyp
float
Alias
- UMLS CUI [1]
- C0201838
Beschreibung
Total Bilirubin
Datentyp
float
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
Aspartate aminotransferase (AST)
Datentyp
float
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
Alanine aminotransferase (ALT)
Datentyp
float
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
Alkaline phosphatase (AP)
Datentyp
float
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
Gamma glutamyl transferase (GGT)
Datentyp
float
Alias
- UMLS CUI [1]
- C0202035
Beschreibung
Calcium
Datentyp
float
Alias
- UMLS CUI [1]
- C0201925
Beschreibung
Phosphate
Datentyp
float
Alias
- UMLS CUI [1]
- C0523826
Beschreibung
Cholesterol
Datentyp
float
Alias
- UMLS CUI [1]
- C1445957
Beschreibung
Triglycerides
Datentyp
float
Alias
- UMLS CUI [1]
- C0202236
Beschreibung
Glucose
Datentyp
float
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
Creatine phosphokinase
Datentyp
float
Alias
- UMLS CUI [1]
- C0201973
Beschreibung
Chloride
Datentyp
float
Alias
- UMLS CUI [1]
- C0201952
Beschreibung
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [1,4]
- C0200345
Beschreibung
Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschreibung
Urinalysis (Dipstick) Test: pH
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042044
Beschreibung
Urinalysis (Dipstick) Test: Protein
Datentyp
float
Alias
- UMLS CUI [1]
- C0262923
Beschreibung
Urinalysis (Dipstick) Test: Glucose
Datentyp
float
Alias
- UMLS CUI [1]
- C0004076
Beschreibung
Urinalysis (Dipstick) Test: Bilirubin
Datentyp
float
Alias
- UMLS CUI [1]
- C0042040
Beschreibung
Urinalysis (Dipstick) Test: Blood
Datentyp
float
Alias
- UMLS CUI [1]
- C0202514
Beschreibung
Urinalysis (Dipstick) Test: Specific Gravity
Datentyp
float
Alias
- UMLS CUI [1]
- C0430383
Beschreibung
Was sedimentary microscopy performed?
Datentyp
text
Alias
- UMLS CUI [1]
- C2700128
Beschreibung
Urinalysis (Microscopy) Test: White blood cells
Datentyp
integer
Alias
- UMLS CUI [1]
- C0919738
Beschreibung
Urinalysis (Microscopy) Test: Red blood cells
Datentyp
integer
Alias
- UMLS CUI [1]
- C0221752
Beschreibung
Urinalysis (Microscopy) Test: Hyaline casts
Datentyp
integer
Alias
- UMLS CUI [1]
- C1254537
Beschreibung
Urinalysis (Microscopy) Test: Granular casts
Datentyp
integer
Alias
- UMLS CUI [1]
- C2697521
Beschreibung
Urinalysis (Microscopy) Test: Cellular casts
Datentyp
integer
Alias
- UMLS CUI [1]
- C2699157
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Male or female patients aged between 30 and 85 years of age inclusive at screening.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2]
- C0005910
Beschreibung
Diagnosis of idiopathic Parkinson's Disease graded according to modified Hoehn & Yahr Stage I-III (Appendix 4 of protocol).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0451215
Beschreibung
Patients must have provided written informed consent prior to performing any Screening assessments, including any washout of concomitant medications in preparation for this study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle Branch Block).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Childbearing potential
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0032961
- UMLS CUI [1,3]
- C0700589
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Clinical abnormality
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0747585
- UMLS CUI [1,2]
- C0035648
Beschreibung
Comorbidity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0009488
Beschreibung
clinically significant abnormal laboratory value, ECG, or physical examination findings
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438215
- UMLS CUI [2]
- C0522055
- UMLS CUI [3]
- C0747585
Beschreibung
Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody at screening.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0281863
- UMLS CUI [1,2]
- C0149709
- UMLS CUI [1,3]
- C0920548
Beschreibung
Positive alcohol test result and / or urine test for undeclared drugs at screening.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0948726
- UMLS CUI [1,2]
- C0743300
Beschreibung
history of moderate to severe dizziness, syncope, or orthostatic hypotension
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012833
- UMLS CUI [1,2]
- C0039070
- UMLS CUI [1,3]
- C0020651
Beschreibung
Significant sleep disorder or Epworth Sleep Score (Appendix 5) ≥9 at screening.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0851578
- UMLS CUI [1,2]
- C2129304
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0428883
Beschreibung
Concomtant medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013036
- UMLS CUI [1,2]
- C2347852
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0282402
- UMLS CUI [1,2]
- C0207509
Beschreibung
Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0453996
Beschreibung
Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3163616
- UMLS CUI [1,2]
- C0005794
Beschreibung
Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0559546
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0244821
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013231
Beschreibung
drug dependence or abuse of alcohol
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1510472
- UMLS CUI [1,2]
- C0085762
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
- UMLS CUI [2]
- C0422727
- UMLS CUI [3]
- C2347852
Beschreibung
Women who are pregnant or breast-feeding.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschreibung
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].
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033975
Beschreibung
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Ähnliche Modelle
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])