ID

12046

Beschreibung

"SEVERE ASTHMA" in the COMMUNITY; ODM derived from: https://clinicaltrials.gov/show/NCT01961258

Link

https://clinicaltrials.gov/show/NCT01961258

Stichworte

Versionen (1)
  1. 04.09.15 04.09.15 - Julian Varghese
Hochgeladen am

4. September 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Severe Asthma NCT01961258

Englisch

Eligibility Severe Asthma NCT01961258

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

age 20-70 years old
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
a computerized diagnosis-title of "bronchial asthma", at any stage of severity.
Beschreibung

diagnosis; severity; stage; asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0439793
UMLS CUI [3]
C1300072
UMLS CUI [4]
C0004096
a subgroup of the above asthmatic patients will be considered as having "severe asthma" according to the ats workshop consensus definition of severe/refractory asthma, based on the level of prescribed medication criteria 2000:
Beschreibung

medication; severe; asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0205082
UMLS CUI [3]
C0004096
an obligatory criteria of at least 12 month inhaler-therapy prescription of a combination of high dose corticosteroid +laba (at least 12 inhalers of symbicort 160/4.5 mcg or at least 10 inhalers of seretide 500 mcg, a year)
Beschreibung

corticosteroid; prescription; combination; inhalers; therapy; dose; high; year; mcg

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C1521941
UMLS CUI [3]
C0205195
UMLS CUI [4]
C0021461
UMLS CUI [5]
C0087111
UMLS CUI [6]
C3174092
UMLS CUI [7]
C0205250
UMLS CUI [8,1]
C1521801
UMLS CUI [8,2]
C0439234
UMLS CUI [8,3]
C0392920
UMLS CUI [8,4]
C0332152
UMLS CUI [8,5]
C0011008
UMLS CUI [8,6]
C0001552
UMLS CUI [9]
C0439211
plus at least one of the following criteria:
Beschreibung

at least one of the following criteria:

Datentyp

boolean

Alias
UMLS CUI [1,1]
CL414621
UMLS CUI [1,2]
C0439091
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0205447
prescription of saba, either ventolin or bricalin inhalers at least once a quarter of a year or at least 4 inhalers in 12 months or at least one prescription a month of inhalation-solution of ventolin or bricalin a month.
Beschreibung

prescription; inhalers; year; one

Datentyp

boolean

Alias
UMLS CUI [1]
C1521941
UMLS CUI [2]
C0021461
UMLS CUI [3,1]
C1521801
UMLS CUI [3,2]
C0439234
UMLS CUI [3,3]
C0392920
UMLS CUI [3,4]
C0332152
UMLS CUI [3,5]
C0011008
UMLS CUI [3,6]
C0001552
UMLS CUI [4]
C0205447
prescription of an oral or im corticosteroid, at least twice in the last 12 months.
Beschreibung

corticosteroid; prescription; last; oral

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C1521941
UMLS CUI [3,1]
C2986440
UMLS CUI [3,2]
C1517741
UMLS CUI [4]
C0442027
the fulfilment of the above mentioned criteria indicates that these asthmatic patients are not conrolled, according to the gina definition of controlled asthma.
Beschreibung

controlled; asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C2826678
UMLS CUI [2]
C0004096
asthmatics that potentially have "difficult to treat severe asthma" due to co-morbidities or potential triggering factors will be sub-grouped according to these criteria (criteria for potential exclusion of having "treatment resistant severe asthma"):
Beschreibung

co-morbidities; treatment; severe; asthma; due to

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0205082
UMLS CUI [4]
C0004096
UMLS CUI [5,1]
C1512900
UMLS CUI [5,2]
C0332307
having computerized title-diagnosis of copd, congestive heart failure, smoking, bronchiectasis, interstitial lung disease.
Beschreibung

heart failure; bronchiectasis; diagnosis; disease; smoking; lung; copd

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0006267
UMLS CUI [3]
C0011900
UMLS CUI [4,1]
C1527021
UMLS CUI [4,2]
C0678257
UMLS CUI [4,3]
C0012634
UMLS CUI [5]
C1519384
UMLS CUI [6]
C0024109
UMLS CUI [7,1]
C1512699
UMLS CUI [7,2]
C0262926
UMLS CUI [7,3]
C0024117
prescription of an oral or topical (ocular) beta-blockers.
Beschreibung

beta-blockers; prescription; topical; oral

Datentyp

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2]
C1521941
UMLS CUI [3]
C0332237
UMLS CUI [4]
C0442027
Exclusion Criteria
Beschreibung

Exclusion Criteria

age <20 or >70 years old.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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Ähnliche Modelle

Eligibility Severe Asthma NCT01961258

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
age
Item
age 20-70 years old
boolean
C0001779 (UMLS CUI [1])
diagnosis; severity; stage; asthma
Item
a computerized diagnosis-title of "bronchial asthma", at any stage of severity.
boolean
C0011900 (UMLS CUI [1])
C0439793 (UMLS CUI [2])
C1300072 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
medication; severe; asthma
Item
a subgroup of the above asthmatic patients will be considered as having "severe asthma" according to the ats workshop consensus definition of severe/refractory asthma, based on the level of prescribed medication criteria 2000:
boolean
C0013227 (UMLS CUI [1])
C0205082 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
corticosteroid; prescription; combination; inhalers; therapy; dose; high; year; mcg
Item
an obligatory criteria of at least 12 month inhaler-therapy prescription of a combination of high dose corticosteroid +laba (at least 12 inhalers of symbicort 160/4.5 mcg or at least 10 inhalers of seretide 500 mcg, a year)
boolean
C0001617 (UMLS CUI [1])
C1521941 (UMLS CUI [2])
C0205195 (UMLS CUI [3])
C0021461 (UMLS CUI [4])
C0087111 (UMLS CUI [5])
C3174092 (UMLS CUI [6])
C0205250 (UMLS CUI [7])
C1521801 (UMLS CUI [8,1])
C0439234 (UMLS CUI [8,2])
C0392920 (UMLS CUI [8,3])
C0332152 (UMLS CUI [8,4])
C0011008 (UMLS CUI [8,5])
C0001552 (UMLS CUI [8,6])
C0439211 (UMLS CUI [9])
at least one of the following criteria:
Item
plus at least one of the following criteria:
boolean
CL414621 (UMLS CUI [1,1])
C0439091 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0205447 (UMLS CUI [1,4])
prescription; inhalers; year; one
Item
prescription of saba, either ventolin or bricalin inhalers at least once a quarter of a year or at least 4 inhalers in 12 months or at least one prescription a month of inhalation-solution of ventolin or bricalin a month.
boolean
C1521941 (UMLS CUI [1])
C0021461 (UMLS CUI [2])
C1521801 (UMLS CUI [3,1])
C0439234 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0011008 (UMLS CUI [3,5])
C0001552 (UMLS CUI [3,6])
C0205447 (UMLS CUI [4])
corticosteroid; prescription; last; oral
Item
prescription of an oral or im corticosteroid, at least twice in the last 12 months.
boolean
C0001617 (UMLS CUI [1])
C1521941 (UMLS CUI [2])
C2986440 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0442027 (UMLS CUI [4])
controlled; asthma
Item
the fulfilment of the above mentioned criteria indicates that these asthmatic patients are not conrolled, according to the gina definition of controlled asthma.
boolean
C2826678 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
co-morbidities; treatment; severe; asthma; due to
Item
asthmatics that potentially have "difficult to treat severe asthma" due to co-morbidities or potential triggering factors will be sub-grouped according to these criteria (criteria for potential exclusion of having "treatment resistant severe asthma"):
boolean
C0009488 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0205082 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C1512900 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
heart failure; bronchiectasis; diagnosis; disease; smoking; lung; copd
Item
having computerized title-diagnosis of copd, congestive heart failure, smoking, bronchiectasis, interstitial lung disease.
boolean
C0018801 (UMLS CUI [1])
C0006267 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
C1527021 (UMLS CUI [4,1])
C0678257 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C1519384 (UMLS CUI [5])
C0024109 (UMLS CUI [6])
C1512699 (UMLS CUI [7,1])
C0262926 (UMLS CUI [7,2])
C0024117 (UMLS CUI [7,3])
beta-blockers; prescription; topical; oral
Item
prescription of an oral or topical (ocular) beta-blockers.
boolean
C0304516 (UMLS CUI [1])
C1521941 (UMLS CUI [2])
C0332237 (UMLS CUI [3])
C0442027 (UMLS CUI [4])
age
Item
age <20 or >70 years old.
boolean
C0001779 (UMLS CUI [1])
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