ID

40422

Beschrijving

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Trefwoorden

Versies (1)
  1. 19/04/20 19/04/20 -
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GlaxoSmithKline

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19 aprile 2020

DOI

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Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

Engels

Neurological Exam; Ptosis & Nystagmus Assessment; Sensory Stimulus VAS Session

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study
Beschrijving

Study

Datatype

text

Alias
UMLS CUI [1]
C2603343
Subject
Beschrijving

Subject

Datatype

text

Alias
UMLS CUI [1]
C0681850
Collected by
Beschrijving

Collected by

Datatype

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Beschrijving

Study Phase

Datatype

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Beschrijving

Session

Datatype

text

Alias
UMLS CUI [1]
C1883017
Neurological Exam
Beschrijving

Neurological Exam

Alias
UMLS CUI-1
C0027853
Neurological Exam - Physical Date
Beschrijving

Neurological Exam - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0011008
Neurological Exam - Time
Beschrijving

Neurological Exam - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0040223
Neurological Exam - Day
Beschrijving

Neurological Exam - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0439228
Neurological Exam - Hour
Beschrijving

Neurological Exam - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0439227
h
Neurological Exam - Min
Beschrijving

Neurological Exam - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0439232
min
Was a neurological exam required?
Beschrijving

Was a neurological exam required?

Datatype

boolean

Alias
UMLS CUI [1]
C0027853
Ptosis & Nystagmus Assessment
Beschrijving

Ptosis & Nystagmus Assessment

Alias
UMLS CUI-1
C0028738
UMLS CUI-2
C1516048
UMLS CUI-4
C0033377
UMLS CUI-5
C1516048
Ptosis & Nystagmus Assessment - Physical Date
Beschrijving

Ptosis & Nystagmus Assessment - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0011008
Ptosis & Nystagmus Assessment - Time
Beschrijving

Ptosis & Nystagmus Assessment - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0040223
Ptosis & Nystagmus Assessment - Day
Beschrijving

Ptosis & Nystagmus Assessment - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0439228
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0439228
Ptosis & Nystagmus Assessment - Hour
Beschrijving

Ptosis & Nystagmus Assessment - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0439227
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0439227
h
Ptosis & Nystagmus Assessment - Min
Beschrijving

Ptosis & Nystagmus Assessment - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0439232
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0439232
min
Ptosis Test Normal?
Beschrijving

Ptosis Test Normal?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033377
UMLS CUI [1,2]
C1096215
Nystagmus Test Normal?
Beschrijving

Nystagmus Test Normal?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1096215
Sensory Stimulus VAS Session 1
Beschrijving

Sensory Stimulus VAS Session 1

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 1 - Physical Date
Beschrijving

Sensory Stimulus VAS Session 1 - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0011008
Sensory Stimulus VAS Session 1 - Time
Beschrijving

Sensory Stimulus VAS Session 1 - Time

Datatype

time

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0040223
Sensory Stimulus VAS Session 1 - Day
Beschrijving

Sensory Stimulus VAS Session 1 - Day

Datatype

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439228
Sensory Stimulus VAS Session 1 - Hour
Beschrijving

Sensory Stimulus VAS Session 1 - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439227
h
Sensory Stimulus VAS Session 1 - Min
Beschrijving

Sensory Stimulus VAS Session 1 - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439232
min
Sensory Stimulus VAS Session 1
Beschrijving

Sensory Stimulus VAS Session 1

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 1 Prompt
Beschrijving

Sensory Stimulus VAS Session 1 Prompt

Datatype

integer

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1602245
Sensory Stimulus VAS Session 1 - Assessment Details
Beschrijving

Sensory Stimulus VAS Session 1 - Assessment Details

Datatype

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1522508
UMLS CUI [1,4]
C0220825
Sensory Stimulus VAS Session 2
Beschrijving

Sensory Stimulus VAS Session 2

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 2 - Physical Date
Beschrijving

Sensory Stimulus VAS Session 2 - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0011008
Sensory Stimulus VAS Session 2 - Time
Beschrijving

Sensory Stimulus VAS Session 2 - Time

Datatype

time

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0040223
Sensory Stimulus VAS Session 2 - Day
Beschrijving

Sensory Stimulus VAS Session 2 - Day

Datatype

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439228
Sensory Stimulus VAS Session 2 - Hour
Beschrijving

Sensory Stimulus VAS Session 2 - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439227
h
Sensory Stimulus VAS Session 2 - Min
Beschrijving

Sensory Stimulus VAS Session 2 - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439232
min
Sensory Stimulus VAS Session 2
Beschrijving

Sensory Stimulus VAS Session 2

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 2 Prompt
Beschrijving

Sensory Stimulus VAS Session 2 Prompt

Datatype

integer

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1602245
Sensory Stimulus VAS Session 2 - Assessment Details
Beschrijving

Sensory Stimulus VAS Session 2 - Assessment Details

Datatype

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1522508
UMLS CUI [1,4]
C0220825
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Similar models

Neurological Exam; Ptosis & Nystagmus Assessment; Sensory Stimulus VAS Session

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
Neurological Exam
C0027853 (UMLS CUI-1)
Neurological Exam - Physical Date
Item
Neurological Exam - Physical Date
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Neurological Exam - Time
Item
Neurological Exam - Time
time
C0027853 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Neurological Exam - Day
Item
Neurological Exam - Day
text
C0027853 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Neurological Exam - Hour
Item
Neurological Exam - Hour
integer
C0027853 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Neurological Exam - Min
Item
Neurological Exam - Min
integer
C0027853 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Was a neurological exam required?
Item
Was a neurological exam required?
boolean
C0027853 (UMLS CUI [1])
Item Group
Ptosis & Nystagmus Assessment
C0028738 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0033377 (UMLS CUI-4)
C1516048 (UMLS CUI-5)
Ptosis & Nystagmus Assessment - Physical Date
Item
Ptosis & Nystagmus Assessment - Physical Date
date
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Time
Item
Ptosis & Nystagmus Assessment - Time
time
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Day
Item
Ptosis & Nystagmus Assessment - Day
text
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0439228 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Hour
Item
Ptosis & Nystagmus Assessment - Hour
integer
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0439227 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Min
Item
Ptosis & Nystagmus Assessment - Min
integer
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0439232 (UMLS CUI [2,3])
Ptosis Test Normal?
Item
Ptosis Test Normal?
boolean
C0033377 (UMLS CUI [1,1])
C1096215 (UMLS CUI [1,2])
Nystagmus Test Normal?
Item
Nystagmus Test Normal?
boolean
C0028738 (UMLS CUI [1,1])
C1096215 (UMLS CUI [1,2])
Item Group
Sensory Stimulus VAS Session 1
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Sensory Stimulus VAS Session 1 - Physical Date
Item
Sensory Stimulus VAS Session 1 - Physical Date
date
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Time
Item
Sensory Stimulus VAS Session 1 - Time
time
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Day
Item
Sensory Stimulus VAS Session 1 - Day
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Hour
Item
Sensory Stimulus VAS Session 1 - Hour
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Min
Item
Sensory Stimulus VAS Session 1 - Min
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item Group
Sensory Stimulus VAS Session 1
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Item
Sensory Stimulus VAS Session 1 Prompt
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1602245 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 Prompt
Code List
Sensory Stimulus VAS Session 1 Prompt
CL Item
Syringe 1 sweetness (1)
CL Item
Syringe 1 creaminess (2)
CL Item
Syringe 1 fat content (3)
CL Item
Syringe 2 sweetness (4)
CL Item
Syringe 2 creaminess (5)
CL Item
Syringe 2 fat content (6)
CL Item
Syringe 3 sweetness (7)
CL Item
Syringe 3 creaminess (8)
CL Item
Syringe 3 fat content (9)
CL Item
Syringe 4 sweetness (10)
CL Item
Syringe 4 creaminess (11)
CL Item
Syringe 4 fat content (12)
CL Item
Syringe 5 sweetness (13)
CL Item
Syringe 5 creaminess (14)
CL Item
Syringe 5 fat content (15)
CL Item
Syringe 6 sweetness (16)
CL Item
Syringe 6 creaminess (17)
CL Item
Syringe 6 fat content (18)
CL Item
Syringe 7 sweetness (19)
CL Item
Syringe 7 creaminess (20)
CL Item
Syringe 7 fat content (21)
CL Item
Syringe 8 sweetness (22)
CL Item
Syringe 8 creaminess (23)
CL Item
Syringe 8 fat content (24)
CL Item
Syringe 9 sweetness (25)
CL Item
Syringe 9 creaminess (26)
CL Item
Syringe 9 fat content (27)
CL Item
Syringe 10 sweetness (28)
CL Item
Syringe 10 creaminess (29)
CL Item
Syringe 10 fat content (30)
CL Item
Syringe 11 sweetness (31)
CL Item
Syringe 11 creaminess (32)
CL Item
Syringe 11 fat content (33)
CL Item
Syringe 12 sweetness (34)
CL Item
Syringe 12 creaminess (35)
CL Item
Syringe 12 fat content (36)
CL Item
Syringe 13 sweetness (37)
CL Item
Syringe 13 creaminess (38)
CL Item
Syringe 13 fat content (39)
CL Item
Syringe 14 sweetness (40)
CL Item
Syringe 14 creaminess (41)
CL Item
Syringe 14 fat content (42)
CL Item
Syringe 15 sweetness (43)
CL Item
Syringe 15 creaminess (44)
CL Item
Syringe 15 fat content (45)
CL Item
Syringe 16 sweetness (46)
CL Item
Syringe 16 creaminess (47)
CL Item
Syringe 16 fat content (48)
CL Item
Syringe 17 sweetness (49)
CL Item
Syringe 17 creaminess (50)
CL Item
Syringe 17 fat content (51)
CL Item
Syringe 18 sweetness (52)
CL Item
Syringe 18 creaminess (53)
CL Item
Syringe 18 fat content (54)
CL Item
Syringe 19 sweetness (55)
CL Item
Syringe 19 creaminess (56)
CL Item
Syringe 19 fat content (57)
CL Item
Syringe 20 sweetness (58)
CL Item
Syringe 20 creaminess (59)
CL Item
Syringe 20 fat content (60)
Sensory Stimulus VAS Session 1 - Assessment Details
Item
Sensory Stimulus VAS Session 1 - Assessment Details
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
Item Group
Sensory Stimulus VAS Session 2
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Sensory Stimulus VAS Session 2 - Physical Date
Item
Sensory Stimulus VAS Session 2 - Physical Date
date
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Time
Item
Sensory Stimulus VAS Session 2 - Time
time
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Day
Item
Sensory Stimulus VAS Session 2 - Day
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Hour
Item
Sensory Stimulus VAS Session 2 - Hour
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Min
Item
Sensory Stimulus VAS Session 2 - Min
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item Group
Sensory Stimulus VAS Session 2
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Item
Sensory Stimulus VAS Session 2 Prompt
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1602245 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 Prompt
Code List
Sensory Stimulus VAS Session 2 Prompt
CL Item
Syringe 1 sweetness (1)
CL Item
Syringe 1 creaminess (2)
CL Item
Syringe 1 fat content (3)
CL Item
Syringe 2 sweetness (4)
CL Item
Syringe 2 creaminess (5)
CL Item
Syringe 2 fat content (6)
CL Item
Syringe 3 sweetness (7)
CL Item
Syringe 3 creaminess (8)
CL Item
Syringe 3 fat content (9)
CL Item
Syringe 4 sweetness (10)
CL Item
Syringe 4 creaminess (11)
CL Item
Syringe 4 fat content (12)
CL Item
Syringe 5 sweetness (13)
CL Item
Syringe 5 creaminess (14)
CL Item
Syringe 5 fat content (15)
CL Item
Syringe 6 sweetness (16)
CL Item
Syringe 6 creaminess (17)
CL Item
Syringe 6 fat content (18)
CL Item
Syringe 7 sweetness (19)
CL Item
Syringe 7 creaminess (20)
CL Item
Syringe 7 fat content (21)
CL Item
Syringe 8 sweetness (22)
CL Item
Syringe 8 creaminess (23)
CL Item
Syringe 8 fat content (24)
CL Item
Syringe 9 sweetness (25)
CL Item
Syringe 9 creaminess (26)
CL Item
Syringe 9 fat content (27)
CL Item
Syringe 10 sweetness (28)
CL Item
Syringe 10 creaminess (29)
CL Item
Syringe 10 fat content (30)
CL Item
Syringe 11 sweetness (31)
CL Item
Syringe 11 creaminess (32)
CL Item
Syringe 11 fat content (33)
CL Item
Syringe 12 sweetness (34)
CL Item
Syringe 12 creaminess (35)
CL Item
Syringe 12 fat content (36)
CL Item
Syringe 13 sweetness (37)
CL Item
Syringe 13 creaminess (38)
CL Item
Syringe 13 fat content (39)
CL Item
Syringe 14 sweetness (40)
CL Item
Syringe 14 creaminess (41)
CL Item
Syringe 14 fat content (42)
CL Item
Syringe 15 sweetness (43)
CL Item
Syringe 15 creaminess (44)
CL Item
Syringe 15 fat content (45)
CL Item
Syringe 16 sweetness (46)
CL Item
Syringe 16 creaminess (47)
CL Item
Syringe 16 fat content (48)
CL Item
Syringe 17 sweetness (49)
CL Item
Syringe 17 creaminess (50)
CL Item
Syringe 17 fat content (51)
CL Item
Syringe 18 sweetness (52)
CL Item
Syringe 18 creaminess (53)
CL Item
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Sensory Stimulus VAS Session 2 - Assessment Details
Item
Sensory Stimulus VAS Session 2 - Assessment Details
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
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