ID

29518

Description

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 Screening Part 1 - Administrative Data and beta-agonist usage.

Link

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

Keywords

Versions (2)
  1. 4/5/18 4/5/18 - Sarah Riepenhausen
  2. 4/5/18 4/5/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 5, 2018

DOI

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License

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

English

Screening Part 1 - Administrative Data and beta-agonist usage

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Description

Volunteer Identifier

Data type

text

Alias
UMLS CUI [1]
C1300638
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Short-Acting Beta-Agonist Therapy
Description

Short-Acting Beta-Agonist Therapy

Alias
UMLS CUI-1
C2936789
UMLS CUI-2
C1806781
Has the subject abstained from short-acting beta-agonist therapy for at least 8 hours?
Description

No short-acting beta-agonist therapy for >= 8 hours

Data type

text

Alias
UMLS CUI [1,1]
C2936789
UMLS CUI [1,2]
C1806781
UMLS CUI [1,3]
C0457083
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race.

Data type

text

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0086409
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0086528
Race: African American / African Heritage
Description

(1 1) A person having origins in any of the black racial groups of Africa

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
Race: American Indian or Alaskan Native
Description

(1 2) A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Race: Asian - Central / South Asian Heritage
Description

(1 3) A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

Data type

boolean

Alias
UMLS CUI [1,1]
C0238696
UMLS CUI [1,2]
C1519427
Race: Asian - East Asian Heritage
Description

(1 4) A person having origins in China, Korea

Data type

boolean

Alias
UMLS CUI [1,1]
C0078988
UMLS CUI [1,2]
C0152035
UMLS CUI [2,1]
C0078988
UMLS CUI [2,2]
C1556095
Race: Asian - Japanese Heritage
Description

(1 5) A person having origins in Japan

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Race: Asian - South East Asia Heritage
Description

(1 6) A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Race: Native Hawaiian or other Pacific Islander
Description

(1 7) A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan

Data type

boolean

Alias
UMLS CUI [1]
C1513907
Race: White - Arabic / North African Heritage
Description

(1 8) A person having origins in any of the original peoples of Middle East or North Africa

Data type

text

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C0026068
Race White - White/Caucasian European Heritage
Description

(1 9) A person having origins in any of the original peoples of Europe

Data type

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Screening Part 1 - Administrative Data and beta-agonist usage

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Short-Acting Beta-Agonist Therapy
C2936789 (UMLS CUI-1)
C1806781 (UMLS CUI-2)
Item
Has the subject abstained from short-acting beta-agonist therapy for at least 8 hours?
text
C2936789 (UMLS CUI [1,1])
C1806781 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,3])
No short-acting beta-agonist therapy for >= 8 hours
Code List
Has the subject abstained from short-acting beta-agonist therapy for at least 8 hours?
CL Item
yes (Y)
CL Item
no (N)
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
text
C0015031 (UMLS CUI [1,1])
C0086409 (UMLS CUI [1,2])
C0015031 (UMLS CUI [2,1])
C0086528 (UMLS CUI [2,2])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Race: African American / African Heritage
Item
Race: African American / African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Race: American Indian or Alaskan Native
Item
Race: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Race: Asian - Central / South Asian Heritage
Item
Race: Asian - Central / South Asian Heritage
boolean
C0238696 (UMLS CUI [1,1])
C1519427 (UMLS CUI [1,2])
Race: Asian - East Asian Heritage
Item
Race: Asian - East Asian Heritage
boolean
C0078988 (UMLS CUI [1,1])
C0152035 (UMLS CUI [1,2])
C0078988 (UMLS CUI [2,1])
C1556095 (UMLS CUI [2,2])
Race: Asian - Japanese Heritage
Item
Race: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Race: Asian - South East Asia Heritage
Item
Race: Asian - South East Asia Heritage
boolean
C0238697 (UMLS CUI [1])
Race: Native Hawaiian or other Pacific Islander
Item
Race: Native Hawaiian or other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Race: White - Arabic / North African Heritage
Item
Race: White - Arabic / North African Heritage
text
C0238604 (UMLS CUI [1])
C0026068 (UMLS CUI [2])
Race White - White/Caucasian European Heritage
Item
Race White - White/Caucasian European Heritage
boolean
C0043157 (UMLS CUI [1])
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