ID

14178

Beskrivning

Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01976208

Länk

https://clinicaltrials.gov/show/NCT01976208

Nyckelord

  1. 2016-04-03 2016-04-03 -
Uppladdad den

3 april 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Allergic Asthma NCT01976208

Eligibility Allergic Asthma NCT01976208

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged 15~65 years
Beskrivning

gender; age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
written informed consent provided
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
total serum ige >=60iu/ml
Beskrivning

total serum ige

Datatyp

boolean

Alias
UMLS CUI [1]
C0797024
duration of allergic asthma >= 1 year according to gina(2008)
Beskrivning

allergic asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0155877
poor response to moderate to high dose inhaled corticosteroid (400ug/day~800ug/day) >= 4 weeks
Beskrivning

inhaled corticosteroid use; Medication response

Datatyp

boolean

Alias
UMLS CUI [1]
C0586793
UMLS CUI [2]
C1319171
agreed to be not pregnant, contraception during study and later 6 months.
Beskrivning

Contraception status

Datatyp

boolean

Alias
UMLS CUI [1]
C0420837
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who met the below criteria were excluded:
Beskrivning

Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
be regular smokers(>10 cigarettes per day and for at least 2 years)
Beskrivning

smoker

Datatyp

boolean

Alias
UMLS CUI [1]
C1519386
patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
Beskrivning

pregnant

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
copd, according to the guideline of chinese society of respiratory diseases
Beskrivning

copd

Datatyp

boolean

Alias
UMLS CUI [1]
C0024117
an active lung disease other than allergic asthma
Beskrivning

allergic asthma; Lung diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0155877
UMLS CUI [2]
C0024115
patients with significant underlying medical conditions
Beskrivning

significant medical conditions

Datatyp

boolean

Alias
UMLS CUI [1]
C3261307
allergic to immunoglobin or any formulation ingredient of the product
Beskrivning

hypersensitivity immunoglobin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021034
patients with diabetes or uncontrolled hypertension(systolic blood pressure>160mmhg or diastolic blood pressure>95mmhg)
Beskrivning

diabetes; uncontrolled hypertension; blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0005823
hiv positivity or cancer patient
Beskrivning

hiv positive; Cancer Patient

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1516213
prior exposure to xolair
Beskrivning

xolair

Datatyp

boolean

Alias
UMLS CUI [1]
C1174773

Similar models

Eligibility Allergic Asthma NCT01976208

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
gender; age
Item
male or female aged 15~65 years
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
informed consent
Item
written informed consent provided
boolean
C0021430 (UMLS CUI [1])
total serum ige
Item
total serum ige >=60iu/ml
boolean
C0797024 (UMLS CUI [1])
allergic asthma
Item
duration of allergic asthma >= 1 year according to gina(2008)
boolean
C0155877 (UMLS CUI [1])
inhaled corticosteroid use; Medication response
Item
poor response to moderate to high dose inhaled corticosteroid (400ug/day~800ug/day) >= 4 weeks
boolean
C0586793 (UMLS CUI [1])
C1319171 (UMLS CUI [2])
Contraception status
Item
agreed to be not pregnant, contraception during study and later 6 months.
boolean
C0420837 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
patients who met the below criteria were excluded:
boolean
C0680251 (UMLS CUI [1])
smoker
Item
be regular smokers(>10 cigarettes per day and for at least 2 years)
boolean
C1519386 (UMLS CUI [1])
pregnant
Item
patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
boolean
C0032961 (UMLS CUI [1])
copd
Item
copd, according to the guideline of chinese society of respiratory diseases
boolean
C0024117 (UMLS CUI [1])
allergic asthma; Lung diseases
Item
an active lung disease other than allergic asthma
boolean
C0155877 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
significant medical conditions
Item
patients with significant underlying medical conditions
boolean
C3261307 (UMLS CUI [1])
hypersensitivity immunoglobin
Item
allergic to immunoglobin or any formulation ingredient of the product
boolean
C0020517 (UMLS CUI [1,1])
C0021034 (UMLS CUI [1,2])
diabetes; uncontrolled hypertension; blood pressure
Item
patients with diabetes or uncontrolled hypertension(systolic blood pressure>160mmhg or diastolic blood pressure>95mmhg)
boolean
C0011849 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
hiv positive; Cancer Patient
Item
hiv positivity or cancer patient
boolean
C0019699 (UMLS CUI [1])
C1516213 (UMLS CUI [2])
xolair
Item
prior exposure to xolair
boolean
C1174773 (UMLS CUI [1])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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