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Información:
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ID
36947
Descripción
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
Palabras clave
Versiones (2)
- 23/6/19 23/6/19 -
- 4/8/19 4/8/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de junio de 2019
DOI
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Licencia
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 (NCT 00814957)
Screen - Inform Screening; Inform Enrolment; Date of visit; Demography; Vitals Signs
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Screen - Inform Screening; Inform Enrolment; Date of visit; Demography; Vitals Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Subject initials
Item
Subject initials
integer
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Date bf birth
Item
Date bf birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Vital Signs - Measurement 1 Semi-Supine
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C2826644 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
C2826762 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Blood pressure - semi supine
Item
Systolic Blood pressure - semi supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart rate - semi supine
Item
Heart rate - semi supine
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Respiration rate semi supine
Item
Respiration rate semi supine
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 1 Standing
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Vital signs - actual time
Item
Vital signs - actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure - standing
Item
Systolic Blood Pressure - standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure - standing
Item
Diastolic Blood Pressure - standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Heart rate - standing
Item
Heart rate - standing
integer
C2029905 (UMLS CUI [1])
Item Group
Vital Signs - Measurement 2 Semi-Supine
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood pressure semi supine
Item
Systolic Blood pressure semi supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure semi supine
Item
Diastolic Blood Pressure semi supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart rate semi-supine
Item
Heart rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Respiration rate semi supine
Item
Respiration rate semi supine
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 2 Standing
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Vital signs - actual time
Item
Vital signs - actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure - standing
Item
Systolic Blood Pressure - standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure - standing
Item
Diastolic Blood Pressure - standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Heart rate - standing
Item
Heart rate - standing
integer
C2029905 (UMLS CUI [1])
Item Group
Vital Signs - Measurement 3 Semi-Supine
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood pressure semi supine
Item
Systolic Blood pressure semi supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure semi supine
Item
Diastolic Blood Pressure semi supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Heart rate semi-supine
Item
Heart rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Respiration rate semi supine
Item
Respiration rate semi supine
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Item Group
Vital Signs - Measurement 3 Standing
C0518766 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
C0242485 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
Vital signs - actual time
Item
Vital signs - actual time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure - standing
Item
Systolic Blood Pressure - standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Diastolic Blood Pressure - standing
Item
Diastolic Blood Pressure - standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
Heart rate - standing
Item
Heart rate - standing
integer
C2029905 (UMLS CUI [1])