ID

37510

Beschreibung

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Stichworte

  1. 26.06.19 26.06.19 -
  2. 27.06.19 27.06.19 -
  3. 04.08.19 04.08.19 -
  4. 17.09.21 17.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

Day -1 - 12-Lead ECG; Summary Holter; Summary Holter Abnormalities; Vital Signs; Electronically Transferred Lab Data; Urinalysis; PET; Functional MRI Scan; MRI Scan; Randomisation Number

Date of Visit
Beschreibung

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
12-Lead ECG - Hart rate
Beschreibung

12-Lead ECG - Hart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
PR Intreval
Beschreibung

PR Intreval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Beschreibung

Method of QTc Calculation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Summary Holter
Beschreibung

Summary Holter

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Start Date and Time of Holter
Beschreibung

Start Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Beschreibung

Stop Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Interpretation of Holter
Beschreibung

Interpretation of Holter

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Holter monitoring method
Beschreibung

Holter monitoring method

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
Summary Holter Abnormalities
Beschreibung

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0522055
UMLS CUI-3
C0242482
Start Date and Time of Holter
Beschreibung

Start Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Beschreibung

Stop Date and Time of Holter

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Holter Abnormalities
Beschreibung

Check all that apply

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
Other abnormal rhythm
Beschreibung

Other abnormal rhythm

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0199556
UMLS CUI [1,3]
C0205161
Other morphology
Beschreibung

Other morphology

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332437
Other conduction
Beschreibung

Other conduction

Datentyp

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
Other myocardial infarction
Beschreibung

Other myocardial infarction

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0027051
Other depolarisation/repolarisation
Beschreibung

Other depolarisation/repolarisation

Datentyp

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
Other abnormality/ Cardiologist comments
Beschreibung

Other abnormality/ Cardiologist comments

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1832603
UMLS CUI [2]
C0947611
Vital Signs - Pre-Baseline Scan
Beschreibung

Vital Signs - Pre-Baseline Scan

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1442488
UMLS CUI-3
C0332152
Vital Signs - Actual date/time
Beschreibung

Vital Signs - Actual date/time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood pressure
Beschreibung

Systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Beschreibung

Diastolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Beschreibung

Temperature

Datentyp

text

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital signs - Heart rate
Beschreibung

Vital signs - Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Electronically Transerred Lab Data
Beschreibung

Electronically Transerred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date and time sample taken
Beschreibung

Haematology Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sample not taken
Beschreibung

Haematology sample not taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Beschreibung

Clinical Chemistry Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sample not taken
Beschreibung

Clinical Chemistry sample not taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Serum Prolactin Date and time sample taken
Beschreibung

Serum Prolactin Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Serum Prolactin sample not taken
Beschreibung

Serum Prolactin sample not taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1272696
TSH Date and time sample taken
Beschreibung

TSH Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
TSH sample not taken
Beschreibung

TSH sample not taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Testosterone Date and time sample taken
Beschreibung

Testosterone Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Testosterone sample not taken
Beschreibung

Testosterone sample not taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis - Dipstick Details
Beschreibung

Urinalysis - Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Urinalysis Date and time sample taken
Beschreibung

Urinalysis Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Sample not taken
Beschreibung

Urinalysis Sample not taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Dipstick - pH
Beschreibung

Urinalysis Dipstick - pH

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
Urinalysis Dipstick - pH Numeric Result
Beschreibung

Urinalysis Dipstick - pHN umeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - pH Character Result
Beschreibung

Urinalysis Dipstick - pH Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - Specific Gravity
Beschreibung

Urinalysis Dipstick - Specific Gravity

Datentyp

integer

Alias
UMLS CUI [1]
C0430383
Urinalysis Dipstick - Specific Gravitiy Numeric Result
Beschreibung

Urinalysis Dipstick - Specific Gravitiy Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430383
UMLS CUI [1,2]
C2347373
Urinalysis Dipstick - Specific Gravitiy Character Result
Beschreibung

Urinalysis Dipstick - Specific Gravitiy Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430383
UMLS CUI [1,2]
C2350015
Urinalysis Dipstick - Protein
Beschreibung

Urinalysis Dipstick - Protein

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0262923
Urinalysis Dipstick - Protein Numeric Result
Beschreibung

Urinalysis Dipstick - Protein Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0262923
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - Protein Character Result
Beschreibung

Urinalysis Dipstick - Protein Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0262923
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - Glucose
Beschreibung

Urinalysis Dipstick - Glucose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0004076
Urinalysis Dipstick - Glucose Numeric Result
Beschreibung

Urinalysis Dipstick - Glucose Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0004076
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - Glucose Character Result
Beschreibung

Urinalysis Dipstick - Glucose Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0004076
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - Ketones
Beschreibung

Urinalysis Dipstick - Ketones

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1991100
Urinalysis Dipstick - Ketones Numeric Result
Beschreibung

Urinalysis Dipstick - Ketones Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1991100
UMLS CUI [1,3]
C0332307
Urinalysis Dipstick - Ketones Character Result
Beschreibung

Urinalysis Dipstick - Ketones Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1991100
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - RBC
Beschreibung

Urinalysis Dipstick - RBC

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0014772
Urinalysis Dipstick - RBC Numeric Result
Beschreibung

Urinalysis Dipstick - RBC Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - RBC Character Result
Beschreibung

Urinalysis Dipstick - RBC Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - WBC
Beschreibung

Urinalysis Dipstick - WBC

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0023508
Urinalysis Dipstick - WBC Numeric Result
Beschreibung

Urinalysis Dipstick - WBC Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - WBC Character Result
Beschreibung

Urinalysis Dipstick - WBC Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2350015
Result of dipstick
Beschreibung

Result of dipstick

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
If positive urine dipstick result, was sedimentary microscopy performed?
Beschreibung

If yes, provide details on the MICROSCOPY form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
UMLS CUI [2,1]
C0430397
UMLS CUI [2,2]
C2700128
Urinalysis - Microscopy Details
Beschreibung

Urinalysis - Microscopy Details

Alias
UMLS CUI-1
C0430397
Urinalysis Microscopy - Date and time sample taken
Beschreibung

Urinalysis Microscopy - Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0200345
Urinalysis Microscopy - White blood cells
Beschreibung

Urinalysis Microscopy - White blood cells

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
Urinalysis Microscopy - White blood cells Numeric Result
Beschreibung

Urinalysis Microscopy - White blood cells Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - White blood cells Character Result
Beschreibung

Urinalysis Microscopy - White blood cells Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Red blood cells
Beschreibung

Urinalysis Microscopy - Red blood cells

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
Urinalysis Microscopy - Red blood cells Numeric Result
Beschreibung

Urinalysis Microscopy - Red blood cells Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Red blood cells Character Result
Beschreibung

Urinalysis Microscopy - Red blood cells Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Hyaline casts
Beschreibung

Urinalysis Microscopy - Hyaline casts

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
Urinalysis Microscopy - Hyaline casts Numeric Result
Beschreibung

Urinalysis Microscopy - Hyaline casts Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Hyaline casts Character Result
Beschreibung

Urinalysis Microscopy - Hyaline casts Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Granular casts
Beschreibung

Urinalysis Microscopy - Granular casts

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
Urinalysis Microscopy - Granular casts Numeric Result
Beschreibung

Urinalysis Microscopy - Granular casts Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Granular casts Character Result
Beschreibung

Urinalysis Microscopy - Granular casts Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Cellular casts
Beschreibung

Urinalysis Microscopy - Cellular casts

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
Urinalysis Microscopy - Cellular casts Numeric Result
Beschreibung

Urinalysis Microscopy - Cellular casts Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Cellular casts Character Result
Beschreibung

Urinalysis Microscopy - Cellular casts Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
UMLS CUI [1,3]
C2350015
PET - Scan Baseline
Beschreibung

PET - Scan Baseline

Alias
UMLS CUI-1
C0032743
UMLS CUI-2
C1442488
Date of PET Scan
Beschreibung

Date of PET Scan

Datentyp

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0011008
PET Examination Number
Beschreibung

PET Examination Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
Radiochemical purity at release
Beschreibung

Radiochemical purity at release

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0599914
UMLS CUI [1,2]
C0678739
UMLS CUI [1,3]
C1963578
UMLS CUI [1,4]
C0032743
%
Radiochemical purity time at release
Beschreibung

Radiochemical purity time at release

Datentyp

time

Alias
UMLS CUI [1,1]
C0599914
UMLS CUI [1,2]
C0678739
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1963578
UMLS CUI [1,5]
C0032743
Mass of tracer administered
Beschreibung

Mass of tracer administered

Datentyp

float

Maßeinheiten
  • ug
Alias
UMLS CUI [1,1]
C1522485
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0032743
ug
Volume to be administered (inc diluent)
Beschreibung

Volume to be administered (inc diluent)

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1,1]
C0449468
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0032743
mL
Bolus activity injected
Beschreibung

Bolus activity injected

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1,1]
C2986768
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Bolus injection Start time
Beschreibung

Bolus injection Start time

Datentyp

time

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1301880
UMLS CUI [1,3]
C0032743
Duration of bolus injection
Beschreibung

Duration of bolus injection

Datentyp

durationDatetime

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0032743
Constant infusion activity concentration (at start of infusion)
Beschreibung

Constant infusion activity concentration (at start of infusion)

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Constant infusion start time
Beschreibung

Constant infusion start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [1,3]
C0032743
Constant infusion stop time
Beschreibung

Constant infusion stop time

Datentyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1522314
UMLS CUI [1,3]
C0032743
Volume of constant infusion administered
Beschreibung

Volume of constant infusion administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C0032743
mL
Functional MRI Scan
Beschreibung

Functional MRI Scan

Alias
UMLS CUI-1
C0376335
Has an fMRI scan been carried out?
Beschreibung

Has an fMRI scan been carried out?

Datentyp

boolean

Alias
UMLS CUI [1]
C0376335
If fMRI has been carried out, enter date of fMRI Scan
Beschreibung

If fMRI has been carried out, enter date of fMRI Scan

Datentyp

date

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0011008
fMRI Examination Number
Beschreibung

fMRI Examination Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
fMRI Scan start time
Beschreibung

fMRI Scan start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C1301880
fMRI Scan end time
Beschreibung

fMRI Scan end time

Datentyp

time

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C1522314
Describe any abnormal situation which ocurred during the fMRI scan.
Beschreibung

Leave blank if scan was without incident (e.g., ‘subject moved’, subject was coughing‘)

Datentyp

text

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2745955
MRI Scan
Beschreibung

MRI Scan

Alias
UMLS CUI-1
C0024485
Has an MRI scan been carried out?
Beschreibung

Has an MRI scan been carried out?

Datentyp

boolean

Alias
UMLS CUI [1]
C0024485
If MRI has been carried out, enter date of MRI Scan
Beschreibung

If MRI has been carried out, enter date of MRI Scan

Datentyp

date

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0011008
MRI Examination Number
Beschreibung

MRI Examination Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
MRI Scan start time
Beschreibung

MRI Scan start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1301880
MRI Scan end time
Beschreibung

MRI Scan end time

Datentyp

time

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1522314
Describe any abnormal situation which ocurred during the MRI scan.
Beschreibung

Leave blank if scan was without incident (e.g., subject moved’, subject was coughing)

Datentyp

text

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2745955
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beschreibung

Was the subject able to be randomised?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
If Sucject was randomised, provide Randomisation number
Beschreibung

If Sucject was randomised, provide Randomisation number

Datentyp

integer

Date of randomisation
Beschreibung

Date of randomisation

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008

Ähnliche Modelle

Day -1 - 12-Lead ECG; Summary Holter; Summary Holter Abnormalities; Vital Signs; Electronically Transferred Lab Data; Urinalysis; PET; Functional MRI Scan; MRI Scan; Randomisation Number

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
12-Lead ECG - Hart rate
Item
12-Lead ECG - Hart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Intreval
Item
PR Intreval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the Holter abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (4)
CL Item
Unable to evaluate (8)
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 Lead 180Hz (2)
CL Item
3 Lead 180Hz (3)
CL Item
5 Lead 512Hz (5)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0242482 (UMLS CUI-3)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Holter Abnormalities
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
Code List
Holter Abnormalities
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Atrial fibrillation (A14)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Trigeminy (A20)
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (A24)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
First degree AV block (PR interval >200msec) (A34)
CL Item
Short PR Interval (A35)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
complete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial infarction, old (A53)
CL Item
Myocardial infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A66)
CL Item
ST depression (A67)
CL Item
ST segment abnormality (A68)
CL Item
U waves (A69)
CL Item
T wave inversion (A70)
CL Item
T wave peaked (A71)
CL Item
T waves biphasic (A72)
CL Item
T waves flat (A73)
CL Item
Notched T-waves (A74)
CL Item
Low QRS voltage (A75)
CL Item
T wave abnormality (A76)
Other abnormal rhythm
Item
Other abnormal rhythm
text
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Other morphology
Item
Other morphology
text
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
Other conduction
Item
Other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other myocardial infarction
Item
Other myocardial infarction
text
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C0205394 (UMLS CUI [1,1])
C1832603 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Item Group
Vital Signs - Pre-Baseline Scan
C0518766 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
text
C0005903 (UMLS CUI [1])
Vital signs - Heart rate
Item
Vital signs - Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Item Group
Electronically Transerred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sample not taken
CL Item
Not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Clinical Chemistry sample not taken
CL Item
Not done (1)
Serum Prolactin Date and time sample taken
Item
Serum Prolactin Date and time sample taken
datetime
C0373706 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Serum Prolactin sample not taken
integer
C0373706 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Serum Prolactin sample not taken
CL Item
Not done (1)
TSH Date and time sample taken
Item
TSH Date and time sample taken
datetime
C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
TSH sample not taken
integer
C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
TSH sample not taken
CL Item
Not done (1)
Testosterone Date and time sample taken
Item
Testosterone Date and time sample taken
datetime
C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Testosterone sample not taken
integer
C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Testosterone sample not taken
CL Item
Not done (1)
Item Group
Urinalysis - Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis Sample not taken
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis Sample not taken
CL Item
Not Done (1)
Item
Urinalysis Dipstick - pH
integer
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - pH
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - pHN umeric Result
Item
Urinalysis Dipstick - pH Numeric Result
float
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - pH Character Result
Item
Urinalysis Dipstick - pH Character Result
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Specific Gravity
integer
C0430383 (UMLS CUI [1])
Code List
Urinalysis Dipstick - Specific Gravity
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Specific Gravitiy Numeric Result
Item
Urinalysis Dipstick - Specific Gravitiy Numeric Result
float
C0430383 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Urinalysis Dipstick - Specific Gravitiy Character Result
Item
Urinalysis Dipstick - Specific Gravitiy Character Result
text
C0430383 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Urinalysis Dipstick - Protein
integer
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - Protein
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Protein Numeric Result
Item
Urinalysis Dipstick - Protein Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - Protein Character Result
Item
Urinalysis Dipstick - Protein Character Result
text
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Glucose
integer
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - Glucose
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Glucose Numeric Result
Item
Urinalysis Dipstick - Glucose Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - Glucose Character Result
Item
Urinalysis Dipstick - Glucose Character Result
text
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Ketones
integer
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - Ketones
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Ketones Numeric Result
Item
Urinalysis Dipstick - Ketones Numeric Result
float
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Urinalysis Dipstick - Ketones Character Result
Item
Urinalysis Dipstick - Ketones Character Result
text
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - RBC
integer
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - RBC
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - RBC Numeric Result
Item
Urinalysis Dipstick - RBC Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - RBC Character Result
Item
Urinalysis Dipstick - RBC Character Result
text
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - WBC
integer
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Code List
Urinalysis Dipstick - WBC
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - WBC Numeric Result
Item
Urinalysis Dipstick - WBC Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - WBC Character Result
Item
Urinalysis Dipstick - WBC Character Result
text
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of dipstick
CL Item
No result  (NR)
CL Item
Negative  (NEG)
CL Item
Positive (POS)
If positive urine dipstick result, was sedimentary microscopy performed?
Item
If positive urine dipstick result, was sedimentary microscopy performed?
boolean
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0430397 (UMLS CUI [2,1])
C2700128 (UMLS CUI [2,2])
Item Group
Urinalysis - Microscopy Details
C0430397 (UMLS CUI-1)
Urinalysis Microscopy - Date and time sample taken
Item
Urinalysis Microscopy - Date and time sample taken
datetime
C0430397 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Item
Urinalysis Microscopy - White blood cells
integer
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - White blood cells
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - White blood cells Numeric Result
Item
Urinalysis Microscopy - White blood cells Numeric Result
float
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - White blood cells Character Result
Item
Urinalysis Microscopy - White blood cells Character Result
text
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Red blood cells
integer
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Red blood cells
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Red blood cells Numeric Result
Item
Urinalysis Microscopy - Red blood cells Numeric Result
float
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Red blood cells Character Result
Item
Urinalysis Microscopy - Red blood cells Character Result
text
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Hyaline casts
integer
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Hyaline casts
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Hyaline casts Numeric Result
Item
Urinalysis Microscopy - Hyaline casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Hyaline casts Character Result
Item
Urinalysis Microscopy - Hyaline casts Character Result
text
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Granular casts
integer
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Granular casts
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Granular casts Numeric Result
Item
Urinalysis Microscopy - Granular casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Granular casts Character Result
Item
Urinalysis Microscopy - Granular casts Character Result
text
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Cellular casts
integer
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
Code List
Urinalysis Microscopy - Cellular casts
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Cellular casts Numeric Result
Item
Urinalysis Microscopy - Cellular casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Cellular casts Character Result
Item
Urinalysis Microscopy - Cellular casts Character Result
text
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item Group
PET - Scan Baseline
C0032743 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Date of PET Scan
Item
Date of PET Scan
date
C0032743 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
PET Examination Number
Item
PET Examination Number
integer
C0032743 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Radiochemical purity at release
Item
Radiochemical purity at release
integer
C0599914 (UMLS CUI [1,1])
C0678739 (UMLS CUI [1,2])
C1963578 (UMLS CUI [1,3])
C0032743 (UMLS CUI [1,4])
Radiochemical purity time at release
Item
Radiochemical purity time at release
time
C0599914 (UMLS CUI [1,1])
C0678739 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1963578 (UMLS CUI [1,4])
C0032743 (UMLS CUI [1,5])
Mass of tracer administered
Item
Mass of tracer administered
float
C1522485 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Volume to be administered (inc diluent)
Item
Volume to be administered (inc diluent)
float
C0449468 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Bolus activity injected
Item
Bolus activity injected
float
C2986768 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Bolus injection Start time
Item
Bolus injection Start time
time
C1511237 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Duration of bolus injection
Item
Duration of bolus injection
durationDatetime
C1511237 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Constant infusion activity concentration (at start of infusion)
Item
Constant infusion activity concentration (at start of infusion)
float
C0574032 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Constant infusion start time
Item
Constant infusion start time
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Constant infusion stop time
Item
Constant infusion stop time
time
C0574032 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Volume of constant infusion administered
Item
Volume of constant infusion administered
float
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Item Group
Functional MRI Scan
C0376335 (UMLS CUI-1)
Has an fMRI scan been carried out?
Item
Has an fMRI scan been carried out?
boolean
C0376335 (UMLS CUI [1])
If fMRI has been carried out, enter date of fMRI Scan
Item
If fMRI has been carried out, enter date of fMRI Scan
date
C0376335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
fMRI Examination Number
Item
fMRI Examination Number
integer
C0376335 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
fMRI Scan start time
Item
fMRI Scan start time
time
C0376335 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
fMRI Scan end time
Item
fMRI Scan end time
time
C0376335 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Describe any abnormal situation which ocurred during the fMRI scan.
Item
Describe any abnormal situation which ocurred during the fMRI scan.
text
C0376335 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
MRI Scan
C0024485 (UMLS CUI-1)
Has an MRI scan been carried out?
Item
Has an MRI scan been carried out?
boolean
C0024485 (UMLS CUI [1])
If MRI has been carried out, enter date of MRI Scan
Item
If MRI has been carried out, enter date of MRI Scan
date
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
MRI Examination Number
Item
MRI Examination Number
integer
C0024485 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
MRI Scan start time
Item
MRI Scan start time
time
C0024485 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
MRI Scan end time
Item
MRI Scan end time
time
C0024485 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Describe any abnormal situation which ocurred during the MRI scan.
Item
Describe any abnormal situation which ocurred during the MRI scan.
text
C0024485 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
If Sucject was randomised, provide Randomisation number
Item
If Sucject was randomised, provide Randomisation number
integer
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

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