ID

14485

Descripción

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

Palabras clave

Versiones (1)
  1. 18/4/16 18/4/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

18 de abril de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00634036

Inglés

Eligibility Asthma NCT00634036

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00634036
Inclusion Criteria
Descripción

Inclusion Criteria

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

asthma

Tipo de datos

boolean

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

poorly controlled asthma

Tipo de datos

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
Descripción

non-smokers and smoking history

Tipo de datos

boolean

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

body mass index

Tipo de datos

boolean

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

methacholine challenge

Tipo de datos

boolean

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

inhaled corticosteroid

Tipo de datos

boolean

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

fev1

Tipo de datos

boolean

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

weighing compliance

Tipo de datos

boolean

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

Exclusion Criteria

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

systemic steroids

Tipo de datos

boolean

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

lung diseases

Tipo de datos

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
Descripción

comorbidity

Tipo de datos

boolean

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

bnp

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1095989
pregnant or lactating
Descripción

pregnant or lactating

Tipo de datos

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
Descripción

beta blocker cyp2c8 inhibitor

Tipo de datos

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)
Descripción

antioxidant or nutritional supplements

Tipo de datos

boolean

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

illicit drug use

Tipo de datos

boolean

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

upper respiratory infection

Tipo de datos

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)
Descripción

asthma exacerbation

Tipo de datos

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)
Descripción

sleep apnea

Tipo de datos

boolean

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

12-lead ecg

Tipo de datos

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
Descripción

childbearing potential and contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
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Similar models

Eligibility Asthma NCT00634036

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00634036
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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