ID

29680

Descripción

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 2, Day 1, pre-dose.

Link

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

Palabras clave

Versiones (1)
  1. 11/4/18 11/4/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Physical examination - Treatment Period 2, Day 1, Pre-dose

1 formularios  
Vital signs
Descripción

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Date
Descripción

Day Month Year e.g., 01 JAN 03

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Planned relative Time
Descripción

e.g. 15 min

Tipo de datos

text

Alias
UMLS CUI [1]
C0439564
Actual Time
Descripción

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

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

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

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood Pressure
Descripción

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

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Descripción

e.g., 75

Tipo de datos

text

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pedal Oedema
Descripción

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Date of Assessment
Descripción

Date of Assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Time of Assessment
Descripción

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

Tipo de datos

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.
Descripción

Note: Use the same ankle throughout the study.

Tipo de datos

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.
Descripción

Side of assessed ankle

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
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Similar models

Physical examination - Treatment Period 2, Day 1, Pre-dose

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
pre-dose (pre-dose)
CL Item
unscheduled (unscheduled)
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)
Volver a la parte superior de la página 

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