ID

29518

Descrição

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

Palavras-chave

Versões (2)
  1. 05/04/2018 05/04/2018 - Sarah Riepenhausen
  2. 05/04/2018 05/04/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

5 de abril de 2018

DOI

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Licença

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

Inglês

Screening Part 1 - Administrative Data and beta-agonist usage

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Descrição

Volunteer Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C1300638
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrição

Centre Number

Tipo de dados

text

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

Visit date

Tipo de dados

date

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

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?
Descrição

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

Tipo de dados

text

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

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrição

Gender

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

(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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

(1 5) A person having origins in Japan

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

(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

Tipo de dados

boolean

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

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

Tipo de dados

text

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

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Screening Part 1 - Administrative Data and beta-agonist usage

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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