ID

14423

Description

Safety Study of Chinese Herbal Therapy to Treat Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00601263

Link

https://clinicaltrials.gov/show/NCT00601263

Keywords

Versions (1)
  1. 4/14/16 4/14/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 14, 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 NCT00601263

English

Eligibility Asthma NCT00601263

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00601263
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ages 18-40 and otherwise in good health as determined by medical history and physical examination
Description

age and health status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018759
history of asthma documented by a physician
Description

history of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or rast testing
Description

allergy to two or more common environmental allergens as evidenced by positive prick skin or rast testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1548334
UMLS CUI [2]
C0430561
the subject agrees to participate in the study
Description

agrees to participate in the study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
Description

childbearing potential contraception

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute illness (such as cold, flu, etc.) within one week before the administration of study drug
Description

acute illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)
Description

comorbidity limiting study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
abnormal hepatic function
Description

hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
abnormal bone marrow function
Description

bone marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0005953
abnormal renal function
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
clinically significant abnormal electrocardiogram
Description

electrocardiogram

Data type

boolean

Alias
UMLS CUI [1]
C0013798
current uncontrolled moderate to severe asthma with fev1 <80% predicted
Description

moderate to severe asthma

Data type

boolean

Alias
UMLS CUI [1]
C0581125
UMLS CUI [2]
C0581126
UMLS CUI [3]
C0748133
participation in another experimental study within 30 days of this study
Description

participation in another experimental study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
history of alcohol or drug abuse (by self report)
Description

history of alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
pregnant or lactating female subjects. females of childbearing potential will need a negative serum pregnancy test to be considered for this study
Description

pregnancy or lactation childbearing potential pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0032976
current smokers
Description

current smoker

Data type

boolean

Alias
UMLS CUI [1]
C3241966
Back to the top of the page

Similar models

Eligibility Asthma NCT00601263

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00601263
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age and health status
Item
male and female subjects ages 18-40 and otherwise in good health as determined by medical history and physical examination
boolean
C0001779 (UMLS CUI [1])
C0018759 (UMLS CUI [2])
history of asthma
Item
history of asthma documented by a physician
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
allergy to two or more common environmental allergens as evidenced by positive prick skin or rast testing
Item
documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or rast testing
boolean
C0020517 (UMLS CUI [1,1])
C1548334 (UMLS CUI [1,2])
C0430561 (UMLS CUI [2])
agrees to participate in the study
Item
the subject agrees to participate in the study
boolean
C2348568 (UMLS CUI [1])
childbearing potential contraception
Item
females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
acute illness
Item
acute illness (such as cold, flu, etc.) within one week before the administration of study drug
boolean
C0009488 (UMLS CUI [1])
comorbidity limiting study participation
Item
any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hepatic function
Item
abnormal hepatic function
boolean
C0232741 (UMLS CUI [1])
bone marrow function
Item
abnormal bone marrow function
boolean
C0005953 (UMLS CUI [1])
renal function
Item
abnormal renal function
boolean
C0232804 (UMLS CUI [1])
electrocardiogram
Item
clinically significant abnormal electrocardiogram
boolean
C0013798 (UMLS CUI [1])
moderate to severe asthma
Item
current uncontrolled moderate to severe asthma with fev1 <80% predicted
boolean
C0581125 (UMLS CUI [1])
C0581126 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
participation in another experimental study
Item
participation in another experimental study within 30 days of this study
boolean
C2348568 (UMLS CUI [1])
history of alcohol or drug abuse
Item
history of alcohol or drug abuse (by self report)
boolean
C0038586 (UMLS CUI [1])
pregnancy or lactation childbearing potential pregnancy test
Item
pregnant or lactating female subjects. females of childbearing potential will need a negative serum pregnancy test to be considered for this study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
current smoker
Item
current smokers
boolean
C3241966 (UMLS CUI [1])
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