ID

29639

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 Follow-Up Part 1: Physical Examination, Vital Signs and Pedal Oedema as well as Pulmonary Function Test.

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

För en begäran logga in.

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

Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
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

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0518766
Planned Relative Time
Beskrivning

Planned Relative Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0518766
Actual Time of Vital Signs
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic blood pressure
Beskrivning

The subject should be in the supine position for at least 5 minutes before and during the recording.

Datatyp

integer

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

The subject should be in the supine position for at least 5 minutes before and during the recording.

Datatyp

integer

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

The subject should be in the supine position for at least 5 minutes before and during the recording.

Datatyp

integer

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 [1,1]
C2985720
UMLS CUI [1,2]
C0574002
Time of Assessment
Beskrivning

Hr:Min 00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0574002
Pick one.
Beskrivning

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. Note: Use the same ankle throughout the study.

Datatyp

integer

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

Side Ankle

Datatyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
Physical examination
Beskrivning

Physical examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Hair and skin
Beskrivning

Indicate current physical findings by ticking the appropriate box below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: if abnormal, describe concisely
Beskrivning

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Datatyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
UMLS CUI [1,3]
C1704258
Lymph nodes
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1]
C0024204
Lymph nodes: if abnormal, describe concisely
Beskrivning

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Datatyp

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1704258
Eyes
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
Eyes: if abnormal, describe concisely
Beskrivning

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Datatyp

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C1704258
Ears, nose and throat
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1]
C0278350
Ears, nose and throat: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C0278350
UMLS CUI [1,2]
C1704258
Breasts
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1]
C0199850
Breasts: if abnormal, describe concisely:
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0006141
Respiratory
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1]
C0231832
Respiratory: if abnormal, describe concisely
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
Cardiovascular
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1]
C3854344
Cardiovascular: if abnormal, describe concisely
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C0205161
Abdomen
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datatyp

text

Alias
UMLS CUI [1]
C0562238
Abdomen: if abnormal, describe concisely
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0000726
Urogenital
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1]
C1828035
Urogenital: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C1828035
UMLS CUI [1,2]
C0205161
Pelvic
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Pelvic: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0205161
Rectal
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1]
C0199900
Rectal: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C0199900
UMLS CUI [1,2]
C0205161
Musculoskeletal
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C0475091
UMLS CUI [1,2]
C0205161
Neurological
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1]
C0027853
Neurological: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027853
Mental Status
Beskrivning

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datatyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Mental Status: if abnormal, describe concisely.
Beskrivning

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datatyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
Pulmonary function tests / FEV 1
Beskrivning

Pulmonary function tests / FEV 1

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0429706
Date of FEV1
Beskrivning

Date of FEV1

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
Planned Relative Time
Beskrivning

Time relative to dosing

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0748133
Pulmonary Function Time
Beskrivning

Pulmonary Function Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
FEV1 Reading 1
Beskrivning

FEV1 Reading 1

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 2
Beskrivning

FEV1 Reading 2

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
FEV1 Reading 3
Beskrivning

FEV1 Reading 3

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Tillbaka till toppen

Similar models

Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Follow-Up (Follow-Up)
CL Item
Unscheduled (Unscheduled)
Actual Time
Item
Actual Time of Vital Signs
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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
integer
C0018810 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C0574002 (UMLS CUI [1,2])
Time of Assessment
Item
Time of Assessment
time
C0011008 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0574002 (UMLS CUI [1,3])
Item
Pick one.
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Depth of Indentation
Code List
Pick one.
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
Pick 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 Ankle
Code List
Pick the appropriate box below to indicate which ankle was assessed at this visit:
CL Item
right ankle (1)
CL Item
left ankle (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Hair and skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormal Hair and skin
Item
Hair and Skin: if abnormal, describe concisely
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Lymph nodes
Code List
Lymph nodes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Lymph nodes
Item
Lymph nodes: if abnormal, describe concisely
text
C0024204 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Eyes
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Eyes
Code List
Eyes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal eyes
Item
Eyes: if abnormal, describe concisely
text
C0015392 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Ears, nose and throat
text
C0278350 (UMLS CUI [1])
Ears, nose and throat
Code List
Ears, nose and throat
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Ears, nose and throat
Item
Ears, nose and throat: if abnormal, describe concisely.
text
C0278350 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Breasts
text
C0199850 (UMLS CUI [1])
Ears, nose and throat
Code List
Breasts
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Breasts
Item
Breasts: if abnormal, describe concisely:
text
C1704258 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Item
Respiratory
text
C0231832 (UMLS CUI [1])
Ears, nose and throat
Code List
Respiratory
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Respiratory: if abnormal, describe concisely
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Ears, nose and throat
Code List
Respiratory: if abnormal, describe concisely
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Cardiovascular
text
C3854344 (UMLS CUI [1])
Ears, nose and throat
Code List
Cardiovascular
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Cardiovascular: if abnormal, describe concisely
text
C3854344 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Cardiovascular: if abnormal, describe concisely
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Abdomen
text
C0562238 (UMLS CUI [1])
Ears, nose and throat
Code List
Abdomen
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Abdomen: if abnormal, describe concisely
text
C1704258 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Abdomen: if abnormal, describe concisely
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Ears, nose and throat
Code List
Urogenital
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal urogenital
Item
Urogenital: if abnormal, describe concisely.
text
C1828035 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Pelvic
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Pelvic
Item
Pelvic: if abnormal, describe concisely.
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
Rectal
text
C0199900 (UMLS CUI [1])
Ears, nose and throat
Code List
Rectal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Rectal
Item
Rectal: if abnormal, describe concisely.
text
C0199900 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Ears, nose and throat
Code List
Musculoskeletal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Musculoskeletal
Item
Musculoskeletal: if abnormal, describe concisely.
text
C0475091 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Neurological
text
C0027853 (UMLS CUI [1])
Ears, nose and throat
Code List
Neurological
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal neurological
Item
Neurological: if abnormal, describe concisely.
text
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Mental Status
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Mental Status
Item
Mental Status: if abnormal, describe concisely.
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Item Group
Pulmonary function tests / FEV 1
C0024119 (UMLS CUI-1)
C0429706 (UMLS CUI-2)
Date of FEV1
Item
Date of FEV1
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Unscheduled (Unscheduled)
CL Item
Follow-Up (Follow-Up)
Pulmonary Function Time
Item
Pulmonary Function Time
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
FEV1 Reading 1
Item
FEV1 Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading 2
Item
FEV1 Reading 2
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
FEV1 Reading 3
Item
FEV1 Reading 3
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Tillbaka till toppen 

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