ID

14485

Description

Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics; ODM derived from: https://clinicaltrials.gov/show/NCT00634036

Link

https://clinicaltrials.gov/show/NCT00634036

Keywords

Versions (1)
  1. 4/18/16 4/18/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 18, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Asthma NCT00634036

English

Eligibility Asthma NCT00634036

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00634036
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
asthma diagnosed by a physician at least 1 year prior to study enrollment
Description

asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
poorly-controlled asthma at study enrollment
Description

poorly controlled asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C3853134
non smokers (stopped smoking at least 1 year ago) and limited life-time history of smoking
Description

non-smokers and smoking history

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C1519384
body mass index 30-60
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
responds to methacholine challenge test with pc20 of <16 mg/ml
Description

methacholine challenge

Data type

boolean

Alias
UMLS CUI [1]
C0430567
on a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry
Description

inhaled corticosteroid

Data type

boolean

Alias
UMLS CUI [1]
C0586793
fev1 >60% predicted
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
able to obtain weekly weights at home
Description

weighing compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1305866
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
systemic steroids within the past 4 weeks
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0040223
lung pathology other than asthma
Description

lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0024115
other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction <50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), aids, renal failure with serum creatinine >3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
b-type natriuretic peptide (bnp) >400 pg/ml
Description

bnp

Data type

boolean

Alias
UMLS CUI [1]
C1095989
pregnant or lactating
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
currently taking a beta blocker, a cyp2c8 inhibitor or inducer such as gemfibrozil or rifampin, a tzd (thiazolidinedione), or allergic to tzd
Description

beta blocker cyp2c8 inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0001645
UMLS CUI [2,1]
C1382144
UMLS CUI [2,2]
C1999216
UMLS CUI [2,3]
C3898767
UMLS CUI [3]
C1257987
taking antioxidants or nutritional supplements (stable dose of calcium, vitamin d, or multivitamin is ok)
Description

antioxidant or nutritional supplements

Data type

boolean

Alias
UMLS CUI [1]
C0003402
UMLS CUI [2]
C0242295
illicit drug use within the past year
Description

illicit drug use

Data type

boolean

Alias
UMLS CUI [1]
C2239127
current/active upper respiratory infection (if active uri, wait until asymptomatic for 1 week to enroll)
Description

upper respiratory infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
asthma exacerbation within the past 4 weeks (includes er, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0583237
UMLS CUI [3]
C0019993
undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months will be allowed to participate)
Description

sleep apnea

Data type

boolean

Alias
UMLS CUI [1]
C0037315
clinically significant abnormalities present on screening 12-lead electrocardiogram
Description

12-lead ecg

Data type

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
Description

childbearing potential and contraception

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Back to the top of the page

Similar models

Eligibility Asthma NCT00634036

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00634036
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
asthma
Item
asthma diagnosed by a physician at least 1 year prior to study enrollment
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
poorly controlled asthma
Item
poorly-controlled asthma at study enrollment
boolean
C0004096 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
non-smokers and smoking history
Item
non smokers (stopped smoking at least 1 year ago) and limited life-time history of smoking
boolean
C0337672 (UMLS CUI [1])
C1519384 (UMLS CUI [2])
body mass index
Item
body mass index 30-60
boolean
C1305855 (UMLS CUI [1])
methacholine challenge
Item
responds to methacholine challenge test with pc20 of <16 mg/ml
boolean
C0430567 (UMLS CUI [1])
inhaled corticosteroid
Item
on a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry
boolean
C0586793 (UMLS CUI [1])
fev1
Item
fev1 >60% predicted
boolean
C0748133 (UMLS CUI [1])
weighing compliance
Item
able to obtain weekly weights at home
boolean
C1321605 (UMLS CUI [1,1])
C1305866 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
systemic steroids
Item
systemic steroids within the past 4 weeks
boolean
C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
lung diseases
Item
lung pathology other than asthma
boolean
C0024115 (UMLS CUI [1])
comorbidity
Item
other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction <50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), aids, renal failure with serum creatinine >3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
boolean
C0009488 (UMLS CUI [1])
bnp
Item
b-type natriuretic peptide (bnp) >400 pg/ml
boolean
C1095989 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
beta blocker cyp2c8 inhibitor
Item
currently taking a beta blocker, a cyp2c8 inhibitor or inducer such as gemfibrozil or rifampin, a tzd (thiazolidinedione), or allergic to tzd
boolean
C0001645 (UMLS CUI [1])
C1382144 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C3898767 (UMLS CUI [2,3])
C1257987 (UMLS CUI [3])
antioxidant or nutritional supplements
Item
taking antioxidants or nutritional supplements (stable dose of calcium, vitamin d, or multivitamin is ok)
boolean
C0003402 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
illicit drug use
Item
illicit drug use within the past year
boolean
C2239127 (UMLS CUI [1])
upper respiratory infection
Item
current/active upper respiratory infection (if active uri, wait until asymptomatic for 1 week to enroll)
boolean
C0041912 (UMLS CUI [1])
asthma exacerbation
Item
asthma exacerbation within the past 4 weeks (includes er, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0583237 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
sleep apnea
Item
undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months will be allowed to participate)
boolean
C0037315 (UMLS CUI [1])
12-lead ecg
Item
clinically significant abnormalities present on screening 12-lead electrocardiogram
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
childbearing potential and contraception
Item
women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial