ID

14335

Beschreibung

Environmental Control as Add-on Therapy in Childhood Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02251379

Link

https://clinicaltrials.gov/show/NCT02251379

Stichworte

Versionen (1)
  1. 11.04.16 11.04.16 -
Hochgeladen am

11. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT02251379

Englisch

Eligibility Asthma NCT02251379

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02251379
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma symptoms for at least 1 year
Beschreibung

Asthma | Asthma Symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C1457887
meet criteria for current persistent asthma defined as either:
Beschreibung

Persistent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C3266628
1. on a long-term controller medication for asthma, or
Beschreibung

Long-term drug therapy Control substance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0420257
UMLS CUI [1,2]
C1550141
2. meet naepp guideline requirements for persistent disease:(46)
Beschreibung

Persistent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C3266628
asthma symptoms 3 or more days per week over the past 2 weeks or
Beschreibung

Asthma Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
nocturnal asthma symptoms at least 3 times in the past month
Beschreibung

Asthma night-time symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C1273489
have evidence of uncontrolled disease as defined by at least one of the following:
Beschreibung

Uncontrolled Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0004096
1. one asthma-related unscheduled visit to an emergency department (ed), clinic or urgent care facility in the previous 12 mo
Beschreibung

Asthma | Emergency department patient visit | Clinic Visits | Urgent Care Clinic/Center Visit

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0586082
UMLS CUI [3]
C0008952
UMLS CUI [4,1]
C1551285
UMLS CUI [4,2]
C0545082
2. one asthma-related overnight hospitalization in the previous 12 mo
Beschreibung

Asthma | Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0019993
3. one or more bursts of oral corticosteroids in the previous 12 mo
Beschreibung

Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
reside within a geographic area of the study site so that home visits are feasible.
Beschreibung

Home visit Possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0332149
have no plans to move within the upcoming 6 months
Beschreibung

Relocation of home | Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C2699029
UMLS CUI [2]
C1301732
have insurance to cover prescription medications.
Beschreibung

Prescription benefits coverage

Datentyp

boolean

Alias
UMLS CUI [1]
C2114292
have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust mites or have a positive cat, dog, mouse, german cockroach, or d. farinae-specific ige test, as quantified using the immunocap system (≥0.35 ku/l)
Beschreibung

Skin prick test Positive | Welts | Felis catus | Canis familiaris | House mice | Dictyoptera | Blattella germanica | Pyroglyphidae | Dermatophagoides farinae | ige test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C1446409
UMLS CUI [2]
C0221232
UMLS CUI [3]
C0007450
UMLS CUI [4]
C0012984
UMLS CUI [5]
C0025914
UMLS CUI [6]
C0009208
UMLS CUI [7]
C0322502
UMLS CUI [8]
C0998367
UMLS CUI [9]
C0323677
UMLS CUI [10]
C0851103
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
lung disease, other than asthma, that requires daily medication
Beschreibung

Lung diseases | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004096
cardiovascular disease that requires daily medication, excluding hypertension
Beschreibung

Cardiovascular Diseases | Hypertensive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0020538
taking a beta-blocker
Beschreibung

Adrenergic beta-Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0001645
allergy to dairy
Beschreibung

Allergy to dairy product

Datentyp

boolean

Alias
UMLS CUI [1]
C1960715
on xolair < 5 months
Beschreibung

Use of Xolair

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1174773
on immunotherapy and has not reached maintenance dose
Beschreibung

Immunotherapy | Maintenance dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C3714445
sleeping in another home 4 or more nights/week
Beschreibung

Other Home environment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0442519
active smoker defined as a positive urine screen for high levels of urine cotinine
Beschreibung

Smoker | Urine screening Positive | Urine cotinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0337664
UMLS CUI [2,1]
C0595946
UMLS CUI [2,2]
C1446409
UMLS CUI [3]
C1278256
unable to access areas of home necessary to conduct extermination
Beschreibung

Unable Access Home environment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0444454
UMLS CUI [1,3]
C0442519
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Ähnliche Modelle

Eligibility Asthma NCT02251379

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02251379
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Asthma Symptoms
Item
have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma symptoms for at least 1 year
boolean
C0004096 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Persistent asthma
Item
meet criteria for current persistent asthma defined as either:
boolean
C3266628 (UMLS CUI [1])
Long-term drug therapy Control substance
Item
1. on a long-term controller medication for asthma, or
boolean
C0420257 (UMLS CUI [1,1])
C1550141 (UMLS CUI [1,2])
Persistent asthma
Item
2. meet naepp guideline requirements for persistent disease:(46)
boolean
C3266628 (UMLS CUI [1])
Asthma Symptoms
Item
asthma symptoms 3 or more days per week over the past 2 weeks or
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Asthma night-time symptoms
Item
nocturnal asthma symptoms at least 3 times in the past month
boolean
C1273489 (UMLS CUI [1])
Uncontrolled Asthma
Item
have evidence of uncontrolled disease as defined by at least one of the following:
boolean
C0205318 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Asthma | Emergency department patient visit | Clinic Visits | Urgent Care Clinic/Center Visit
Item
1. one asthma-related unscheduled visit to an emergency department (ed), clinic or urgent care facility in the previous 12 mo
boolean
C0004096 (UMLS CUI [1])
C0586082 (UMLS CUI [2])
C0008952 (UMLS CUI [3])
C1551285 (UMLS CUI [4,1])
C0545082 (UMLS CUI [4,2])
Asthma | Hospitalization
Item
2. one asthma-related overnight hospitalization in the previous 12 mo
boolean
C0004096 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
Adrenal Cortex Hormones
Item
3. one or more bursts of oral corticosteroids in the previous 12 mo
boolean
C0001617 (UMLS CUI [1])
Home visit Possible
Item
reside within a geographic area of the study site so that home visits are feasible.
boolean
C0020043 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Relocation of home | Planned
Item
have no plans to move within the upcoming 6 months
boolean
C2699029 (UMLS CUI [1])
C1301732 (UMLS CUI [2])
Prescription benefits coverage
Item
have insurance to cover prescription medications.
boolean
C2114292 (UMLS CUI [1])
Skin prick test Positive | Welts | Felis catus | Canis familiaris | House mice | Dictyoptera | Blattella germanica | Pyroglyphidae | Dermatophagoides farinae | ige test
Item
have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust mites or have a positive cat, dog, mouse, german cockroach, or d. farinae-specific ige test, as quantified using the immunocap system (≥0.35 ku/l)
boolean
C0430561 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0221232 (UMLS CUI [2])
C0007450 (UMLS CUI [3])
C0012984 (UMLS CUI [4])
C0025914 (UMLS CUI [5])
C0009208 (UMLS CUI [6])
C0322502 (UMLS CUI [7])
C0998367 (UMLS CUI [8])
C0323677 (UMLS CUI [9])
C0851103 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Lung diseases | Asthma
Item
lung disease, other than asthma, that requires daily medication
boolean
C0024115 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Cardiovascular Diseases | Hypertensive disease
Item
cardiovascular disease that requires daily medication, excluding hypertension
boolean
C0007222 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
Adrenergic beta-Antagonists
Item
taking a beta-blocker
boolean
C0001645 (UMLS CUI [1])
Allergy to dairy product
Item
allergy to dairy
boolean
C1960715 (UMLS CUI [1])
Use of Xolair
Item
on xolair < 5 months
boolean
C1524063 (UMLS CUI [1,1])
C1174773 (UMLS CUI [1,2])
Immunotherapy | Maintenance dose
Item
on immunotherapy and has not reached maintenance dose
boolean
C0021083 (UMLS CUI [1])
C3714445 (UMLS CUI [2])
Other Home environment
Item
sleeping in another home 4 or more nights/week
boolean
C0205394 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
Smoker | Urine screening Positive | Urine cotinine measurement
Item
active smoker defined as a positive urine screen for high levels of urine cotinine
boolean
C0337664 (UMLS CUI [1])
C0595946 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C1278256 (UMLS CUI [3])
Unable Access Home environment
Item
unable to access areas of home necessary to conduct extermination
boolean
C1299582 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
C0442519 (UMLS CUI [1,3])
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