ID

29671

Beskrivning

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Physical Examination: Vital Signs, pedal oedema. Time: Treatment Period 1, Day 29.

Länk

https://clinicaltrials.gov/ct2/show/NCT00318630

Nyckelord

Versioner (1)
  1. 2018-04-10 2018-04-10 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Engelsk

Physical examination - Treatment Period 1, Day 29

1 Formulär  
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Date
Beskrivning

Day Month Year e.g., 01 JAN 03

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Planned relative Time
Beskrivning

e.g. 15 min

Datatyp

text

Alias
UMLS CUI [1]
C0439564
Actual Time
Beskrivning

Hr : Min (00:00 - 23:59) e.g. 13:02

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beskrivning

Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Systolic e.g. 110

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood Pressure
Beskrivning

Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Diastolic e.g. 80

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Beskrivning

e.g., 75

Datatyp

text

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pedal Oedema
Beskrivning

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Time of Assessment
Beskrivning

Hr : Min (00:00 - 23:59)

Datatyp

time

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0040223
Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
Beskrivning

Note: Use the same ankle throughout the study.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Mark the appropriate box below to indicate which ankle was assessed at this visit.
Beskrivning

Side of assessed ankle

Datatyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
Tillbaka till toppen

Similar models

Physical examination - Treatment Period 1, Day 29

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned relative Time
text
C0439564 (UMLS CUI [1])
Planned relative Time
Code List
Planned relative Time
CL Item
unscheduled (unscheduled)
(Comment:en)
CL Item
pre-challenge (pre-challenge)
(Comment:en)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
text
C0018810 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Time of Assessment
Item
Time of Assessment
time
C1516048 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Depth of Indentation
Code List
Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
CL Item
<1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
>10 mm (5)
Item
Mark the appropriate box below to indicate which ankle was assessed at this visit.
integer
C0574002 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Side of assessed ankle
Code List
Mark the appropriate box below to indicate which ankle was assessed at this visit.
CL Item
right ankle (1)
CL Item
left ankle (2)
Tillbaka till toppen 

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