Informationen:
Fehler:
ID
14492
Beschreibung
A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands; ODM derived from: https://clinicaltrials.gov/show/NCT00657774
Link
https://clinicaltrials.gov/show/NCT00657774
Stichworte
Versionen (1)
- 18.04.16 18.04.16 -
Rechteinhaber
CC BY-NC 3.0
Hochgeladen am
18. April 2016
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility Asthma NCT00657774
Eligibility Asthma NCT00657774
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Asthma NCT00657774
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
age
Item
age 18-65 at the screening visit;
boolean
C0001779 (UMLS CUI [1])
history of asthma
Item
history of asthma for at least 6 months prior to screening visit
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
short acting beta agonist
Item
well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to screening visit
boolean
C0001927 (UMLS CUI [1])
pregnancy or lactation
Item
female subjects that are not pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
healthy
Item
otherwise healthy as determined by the investigator.
boolean
C1708335 (UMLS CUI [1])
life-threatening asthma
Item
life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the screening visit;
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
pulmonary disease
Item
significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
boolean
C0024115 (UMLS CUI [1])
steroid
Item
use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
boolean
C0038317 (UMLS CUI [1])
respiratory tract infection comorbidity
Item
an upper or lower respiratory tract infection within the last 4 weeks pior to screening visit or acute illness or infection within 6 weeks prior to dosing
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
comorbidity limiting study protocol
Item
any significant disease or major disorder that may jeopardize subject safety
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
smoking history
Item
history of tabacco use within 6 months prior to dosing and/or smoking history > 10 pack-years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1277691 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
hormone replacement therapy hormonal contraception
Item
female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months
boolean
C0282402 (UMLS CUI [1])
C2985296 (UMLS CUI [2])
C2985296 (UMLS CUI [2])
criteria
Item
additional inclusion and exclusion criteria will evaluated by the investigator.
boolean
C0242801 (UMLS CUI [1])