ID

43603

Descripción

A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00658749

Link

https://clinicaltrials.gov/show/NCT00658749

Palabras clave

Versiones (2)
  1. 18/4/16 18/4/16 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Asthma NCT00658749

Inglés

Eligibility Asthma NCT00658749

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00658749
Criteria
Descripción

Criteria

good general health (with or without allergic rhinitis and/or controlled asthma)
Descripción

good health

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
non-smoker for at least 2 years
Descripción

non-smoker

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0337672
UMLS CUI [1,2]
C0040223
normal lung function (dlco)
Descripción

dlco

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516251
able to provide informed consent and to understand and comply with the requirements of the study
Descripción

informed consent and to understand and comply with the requirements of the study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
exclusion criteria*:
Descripción

exclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
clinically significant medical history or condition which precludes participation
Descripción

comorbidity limiting study protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
clinically significant ecg abnormality
Descripción

ecg abnormality

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
clinically significant vs or pe abnormality
Descripción

vs or pe abnormality

Tipo de datos

boolean

clinically significant screening lab abnormality
Descripción

abnormal laboratory value

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
abnormal lung function (fev1 <80% predicted)
Descripción

fev1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748133
respiratory infection within 14 days of randomization
Descripción

respiratory infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
hbv, hcv, or hiv
Descripción

hbv or hcv or hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019682
breastfeeding or pregnant female
Descripción

pregnancy or lactation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of alcohol abuse or illicit drug use within past 24 months
Descripción

history of alcohol abuse or illicit drug use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
use of any tobacco or nicotine-containing product within past 6 months
Descripción

smoking history

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
UMLS CUI [1,3]
C0040223
use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
Descripción

herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1504473
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0304227
use of any investigational drug within past 30 days
Descripción

investigational drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0040223
use of any investigational monoclonal antibody or recombinant protein within past 90 days
Descripción

monoclonal antibody or recombinant protein

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0034861
UMLS CUI [2,2]
C0013230
donation of plasma within past 7 days
Descripción

donation of plasma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0005794
donation or loss of whole blood within past 56 days
Descripción

blood donation or loss of blood

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C3163616
UMLS CUI [3]
C0040223
simplified list of i/e criteria; unabridged list available upon request.
Descripción

criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242801
Volver a la parte superior de la página

Similar models

Eligibility Asthma NCT00658749

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00658749
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
good health
Item
good general health (with or without allergic rhinitis and/or controlled asthma)
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
non-smoker
Item
non-smoker for at least 2 years
boolean
C0337672 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
dlco
Item
normal lung function (dlco)
boolean
C1516251 (UMLS CUI [1])
informed consent and to understand and comply with the requirements of the study
Item
able to provide informed consent and to understand and comply with the requirements of the study
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
exclusion criteria
Item
exclusion criteria*:
boolean
C0680251 (UMLS CUI [1])
comorbidity limiting study protocol
Item
clinically significant medical history or condition which precludes participation
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
ecg abnormality
Item
clinically significant ecg abnormality
boolean
C0522055 (UMLS CUI [1])
vs or pe abnormality
Item
clinically significant vs or pe abnormality
boolean
abnormal laboratory value
Item
clinically significant screening lab abnormality
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
fev1
Item
abnormal lung function (fev1 <80% predicted)
boolean
C0748133 (UMLS CUI [1])
respiratory infection
Item
respiratory infection within 14 days of randomization
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
hbv or hcv or hiv
Item
hbv, hcv, or hiv
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
pregnancy or lactation
Item
breastfeeding or pregnant female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
history of alcohol abuse or illicit drug use
Item
history of alcohol abuse or illicit drug use within past 24 months
boolean
C0038586 (UMLS CUI [1])
smoking history
Item
use of any tobacco or nicotine-containing product within past 6 months
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
Item
use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
boolean
C1504473 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0304227 (UMLS CUI [3])
investigational drug
Item
use of any investigational drug within past 30 days
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
monoclonal antibody or recombinant protein
Item
use of any investigational monoclonal antibody or recombinant protein within past 90 days
boolean
C0003250 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0034861 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
donation of plasma
Item
donation of plasma within past 7 days
boolean
C0032105 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
blood donation or loss of blood
Item
donation or loss of whole blood within past 56 days
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
criteria
Item
simplified list of i/e criteria; unabridged list available upon request.
boolean
C0242801 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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