ID

30544

Beschreibung

This ODM file contains the Holter Abnormalities Form. To be filled for each Holter with abnormalities during the study. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Stichworte

Versionen (1)
  1. 13.06.18 13.06.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. Juni 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

Englisch

Holter Abnormalities

1 Formulare  
  1. StudyEvent: ODM
    1. Holter Abnormalities
Holter Abnormalities Administrative Data
Beschreibung

Holter Abnormalities Administrative Data

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0522055
UMLS CUI-3
C1320722
Start Date of Holter
Beschreibung

Start Date of Holter

Datentyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Beschreibung

Start Time of Holter

Datentyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop Date of Holter
Beschreibung

Stop Date of Holter

Datentyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop Time of Holter
Beschreibung

Stop Time of Holter

Datentyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Holter ECG Abnormalities
Beschreibung

Holter ECG Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0522055
Sinus bradycardia (50-59 beats/min)
Beschreibung

A01

Datentyp

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia (40-49 beats/min)
Beschreibung

A02

Datentyp

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia (30-39 beats/min)
Beschreibung

A03

Datentyp

boolean

Alias
UMLS CUI [1]
C0085610
Sinus bradycardia (<30 beats/min)
Beschreibung

A04

Datentyp

boolean

Alias
UMLS CUI [1]
C0085610
Sinus pause
Beschreibung

A05

Datentyp

boolean

Alias
UMLS CUI [1]
C1955864
Sinus tachycardia (>100 beats/min)
Beschreibung

A06

Datentyp

boolean

Alias
UMLS CUI [1]
C0039239
Ectopic supraventricular beats
Beschreibung

A07

Datentyp

boolean

Alias
UMLS CUI [1]
C0033036
Ectopic supraventricular rhythm
Beschreibung

A08

Datentyp

boolean

Alias
UMLS CUI [1]
C2348376
Wandering atrial pacemaker
Beschreibung

A09

Datentyp

boolean

Alias
UMLS CUI [1]
C1321523
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate> 100 beats/min)
Beschreibung

A10

Datentyp

boolean

Alias
UMLS CUI [1]
C0221158
Non-sustained supra ventricular tachycardia(> 100 beats/min, 3-30 beats)
Beschreibung

A11

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0750194
Sustained supraventricular tachycardia(> 100 beats/min, >30 beats)
Beschreibung

A12

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039240
UMLS CUI [1,2]
C0443318
Atrial flutter
Beschreibung

A13

Datentyp

boolean

Alias
UMLS CUI [1]
C0004239
Atrial fibrillation
Beschreibung

A14

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
Beschreibung

A15

Datentyp

boolean

Alias
UMLS CUI [1]
C0232208
Junctional tachycardia (> I 00 beats/min)
Beschreibung

A16

Datentyp

boolean

Alias
UMLS CUI [1]
C0039235
Ventricular premature depolarisation
Beschreibung

A17

Datentyp

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular couplets
Beschreibung

A18

Datentyp

boolean

Alias
UMLS CUI [1]
C0429001
Bigeminy
Beschreibung

A19

Datentyp

boolean

Alias
UMLS CUI [1]
C0262662
Trigeminy
Beschreibung

A20

Datentyp

boolean

Alias
UMLS CUI [1]
C0428999
Electrical alternans
Beschreibung

A21

Datentyp

boolean

Alias
UMLS CUI [1]
C1142551
R on T phenomenon
Beschreibung

A22

Datentyp

boolean

Alias
UMLS CUI [1]
C0877658
Ventricular fibrillation
Beschreibung

A23

Datentyp

boolean

Alias
UMLS CUI [1]
C0042510
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
Beschreibung

A24

Datentyp

boolean

Alias
UMLS CUI [1]
C0700363
Non-sustained ventricular tachycardia (> I 00 beats/min, 3-30 beats)
Beschreibung

A25

Datentyp

boolean

Alias
UMLS CUI [1]
C0750194
Sustained ventricular tachycardia (>100 beats/min, >30 beats)
Beschreibung

A26

Datentyp

boolean

Alias
UMLS CUI [1]
C0750197
Wide QRS tachycardia (diagnosis unknown)
Beschreibung

A27

Datentyp

boolean

Alias
UMLS CUI [1]
C0344429
Monomorphic non-sustained ventricular tachycardia (> I 00 beats/min, 3-30 beats)
Beschreibung

A28

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344431
UMLS CUI [1,2]
C0750194
Monomorphic sustained ventricular tachycardia (> I 00 beats/min,>30 beats)
Beschreibung

A29

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344431
UMLS CUI [1,2]
C0750197
Polymorphic non-sustained ventricular tachycardia(> 100 beats/min, 3-30 beats)
Beschreibung

A30

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344432
UMLS CUI [1,2]
C0750194
Polymorphic sustained ventricular tachycardia(> 1OO beats/min, >30 beats)
Beschreibung

A31

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344432
UMLS CUI [1,2]
C0750197
Torsade de Pointes (TdP)
Beschreibung

A32

Datentyp

boolean

Alias
UMLS CUI [1]
C0040479
Pacemaker
Beschreibung

A33

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
First degree AV block (PR interval >200msec)
Beschreibung

A34

Datentyp

boolean

Alias
UMLS CUI [1]
C0085614
Short PR Interval
Beschreibung

A35

Datentyp

boolean

Alias
UMLS CUI [1]
C0520878
Second degree AV block (Mobitz type I)
Beschreibung

A36

Datentyp

boolean

Alias
UMLS CUI [1]
C0264907
Second degree AV block (Mobitz type 2)
Beschreibung

A37

Datentyp

boolean

Alias
UMLS CUI [1]
C0155700
2:1 AV block
Beschreibung

A38

Datentyp

boolean

Alias
UMLS CUI [1]
C2346542
Third degree AV block
Beschreibung

A39

Datentyp

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation (QRS axis more negative than -30 degrees)
Beschreibung

A40

Datentyp

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation (QRS axis more positive than + 110 degrees)
Beschreibung

A41

Datentyp

boolean

Alias
UMLS CUI [1]
C0232296
Incomplete right bundle branch block
Beschreibung

A42

Datentyp

boolean

Alias
UMLS CUI [1]
C0262525
Incomplete left bundle branch block
Beschreibung

A43

Datentyp

boolean

Alias
UMLS CUI [1]
C0281878
Right bundle branch block
Beschreibung

A44

Datentyp

boolean

Alias
UMLS CUI [1]
C0085615
Left anterior hemiblock
Beschreibung

A45

Datentyp

boolean

Alias
UMLS CUI [1]
C0264912
Left posterior hemiblock
Beschreibung

A46

Datentyp

boolean

Alias
UMLS CUI [1]
C0264913
Left bundle branch block
Beschreibung

A47

Datentyp

boolean

Alias
UMLS CUI [1]
C0023211
Bifascicular block
Beschreibung

A48

Datentyp

boolean

Alias
UMLS CUI [1]
C0264914
Non-specific intraventricular conduction delay (QRS >= 120 msec)
Beschreibung

A49

Datentyp

boolean

Alias
UMLS CUI [1]
C3697597
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine)
Beschreibung

A50

Datentyp

boolean

Alias
UMLS CUI [1]
C1963785
QTc prolongation >=500 msec
Beschreibung

A51

Datentyp

boolean

Alias
UMLS CUI [1]
C1969409
AV dissociation
Beschreibung

A52

Datentyp

boolean

Alias
UMLS CUI [1]
C0004331
Myocardial infarction, old
Beschreibung

A53

Datentyp

boolean

Alias
UMLS CUI [1]
C0155668
Myocardial infarction, non Q-wave
Beschreibung

A54

Datentyp

boolean

Alias
UMLS CUI [1]
C0542269
Non-specific ST-T changes
Beschreibung

A55

Datentyp

boolean

Alias
UMLS CUI [1]
C1112720
J point devation
Beschreibung

A56

Datentyp

boolean

Alias
UMLS CUI [1]
C2346597
ST elevation
Beschreibung

A57

Datentyp

boolean

Alias
UMLS CUI [1]
C0520886
ST depression
Beschreibung

A58

Datentyp

boolean

Alias
UMLS CUI [1]
C0520887
ST segment abnormality
Beschreibung

A59

Datentyp

boolean

Alias
UMLS CUI [1]
C2348120
U waves
Beschreibung

A60

Datentyp

boolean

Alias
UMLS CUI [1]
C0232333
T wave inversion
Beschreibung

A61

Datentyp

boolean

Alias
UMLS CUI [1]
C0520888
T wave peaked
Beschreibung

A62

Datentyp

boolean

Alias
UMLS CUI [1]
C0239242
T waves biphasic
Beschreibung

A63

Datentyp

boolean

Alias
UMLS CUI [1]
C2348639
T waves flat
Beschreibung

A64

Datentyp

boolean

Alias
UMLS CUI [1]
C2215959
Notched T-waves
Beschreibung

A65

Datentyp

boolean

Alias
UMLS CUI [1]
C2347367
Low QRS voltage
Beschreibung

A66

Datentyp

boolean

Alias
UMLS CUI [1]
C2349945
T wave abnomality
Beschreibung

A67

Datentyp

boolean

Alias
UMLS CUI [1]
C0438167
If Other morphology, please specify
Beschreibung

A95

Datentyp

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0013801
If Other abnormal rhythm, please specify
Beschreibung

A94

Datentyp

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0013801
If Other conduction, please specify
Beschreibung

A96

Datentyp

text

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0013801
If Other myocardial infarction, please specify
Beschreibung

A97

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0013801
If Other depolarisation/repolarisation, please specify
Beschreibung

A98

Datentyp

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0013801
If Other abnormality/Cardiologist comments, please specify
Beschreibung

A99

Datentyp

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0013801
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Ähnliche Modelle

Holter Abnormalities

1 Formulare
  1. StudyEvent: ODM
    1. Holter Abnormalities
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Holter Abnormalities Administrative Data
C0013801 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date of Holter
Item
Stop Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time of Holter
Item
Stop Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Holter ECG Abnormalities
C0013801 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
Sinus bradycardia (50-59 beats/min)
Item
Sinus bradycardia (50-59 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (40-49 beats/min)
Item
Sinus bradycardia (40-49 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (30-39 beats/min)
Item
Sinus bradycardia (30-39 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (<30 beats/min)
Item
Sinus bradycardia (<30 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia (>100 beats/min)
Item
Sinus tachycardia (>100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia
Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate> 100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Non-sustained supra ventricular tachycardia
Item
Non-sustained supra ventricular tachycardia(> 100 beats/min, 3-30 beats)
boolean
C0039240 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
Sustained supraventricular tachycardia
Item
Sustained supraventricular tachycardia(> 100 beats/min, >30 beats)
boolean
C0039240 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia
Item
Junctional tachycardia (> I 00 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ventricular premature depolarisation
Item
Ventricular premature depolarisation
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm
Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
boolean
C0700363 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia (> I 00 beats/min, 3-30 beats)
boolean
C0750194 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats)
boolean
C0750197 (UMLS CUI [1])
Wide QRS tachycardia
Item
Wide QRS tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Monomorphic non-sustained ventricular tachycardia
Item
Monomorphic non-sustained ventricular tachycardia (> I 00 beats/min, 3-30 beats)
boolean
C0344431 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
Monomorphic sustained ventricular tachycardia
Item
Monomorphic sustained ventricular tachycardia (> I 00 beats/min,>30 beats)
boolean
C0344431 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
Polymorphic non-sustained ventricular tachycardia
Item
Polymorphic non-sustained ventricular tachycardia(> 100 beats/min, 3-30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750194 (UMLS CUI [1,2])
Polymorphic sustained ventricular tachycardia
Item
Polymorphic sustained ventricular tachycardia(> 1OO beats/min, >30 beats)
boolean
C0344432 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
Torsade de Pointes (TdP)
Item
Torsade de Pointes (TdP)
boolean
C0040479 (UMLS CUI [1])
Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1])
First degree AV block
Item
First degree AV block (PR interval >200msec)
boolean
C0085614 (UMLS CUI [1])
Short PR Interval
Item
Short PR Interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type I)
Item
Second degree AV block (Mobitz type I)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2:1 AV block
Item
2:1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation
Item
Left axis deviation (QRS axis more negative than -30 degrees)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation (QRS axis more positive than + 110 degrees)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock
Item
Left anterior hemiblock
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock
Item
Left posterior hemiblock
boolean
C0264913 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay
Item
Non-specific intraventricular conduction delay (QRS >= 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway
Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine)
boolean
C1963785 (UMLS CUI [1])
QTc prolongation >=500 msec
Item
QTc prolongation >=500 msec
boolean
C1969409 (UMLS CUI [1])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, non Q-wave
Item
Myocardial infarction, non Q-wave
boolean
C0542269 (UMLS CUI [1])
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point devation
Item
J point devation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
ST segment abnormality
Item
ST segment abnormality
boolean
C2348120 (UMLS CUI [1])
U waves
Item
U waves
boolean
C0232333 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T wave abnomality
Item
T wave abnomality
boolean
C0438167 (UMLS CUI [1])
morphology
Item
If Other morphology, please specify
text
C0332437 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
abnormal rhythm
Item
If Other abnormal rhythm, please specify
text
C0232187 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
conduction
Item
If Other conduction, please specify
text
C0232219 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
myocardial infarction
Item
If Other myocardial infarction, please specify
text
C0027051 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
depolarisation/repolarisation
Item
If Other depolarisation/repolarisation, please specify
text
C0948857 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Other abnormality Holter ECG
Item
If Other abnormality/Cardiologist comments, please specify
text
C0522055 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
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