ID

33228

Beschreibung

Allergy Immunotherapy for the Reduction of Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01028560

Link

https://clinicaltrials.gov/show/NCT01028560

Stichworte

Versionen (1)
  1. 03.12.18 03.12.18 -
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See clinicaltrials.gov

Hochgeladen am

3. Dezember 2018

DOI

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Eligibility Wheezing NCT01028560

Englisch

Eligibility Wheezing NCT01028560

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Wheezing NCT01028560
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
Beschreibung

Children | Age | Wheezing Episode Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0043144
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
positive skin tests or specific ige antibody titers to at least one of common airborne allergens: dust mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
Beschreibung

Skin test positive Airborne allergen | IgE antibody Titer Airborne allergen | Dust mite | Cat | Cockroach | Mouse | Dog | Pollen | Allergy testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0542213
UMLS CUI [1,2]
C0596057
UMLS CUI [2,1]
C1292069
UMLS CUI [2,2]
C0475208
UMLS CUI [2,3]
C0596057
UMLS CUI [3]
C0998367
UMLS CUI [4]
C0007450
UMLS CUI [5]
C0009208
UMLS CUI [6]
C0025914
UMLS CUI [7]
C0012984
UMLS CUI [8]
C0032385
UMLS CUI [9]
C0199747
the child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions or 2 of the following minor conditions:
Beschreibung

High risk of Persistent asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C3266628
major criteria: history of atopic dermatitis and/or parental history of asthma.
Beschreibung

Dermatitis, Atopic | Asthma parental

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0030551
minor criteria: md-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.
Beschreibung

Allergic rhinitis | Wheezing Independent of Common Cold | Eosinophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C2607914
UMLS CUI [2,1]
C0043144
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0009443
UMLS CUI [3]
C0200638
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant asd, vsd or heart murmur).
Beschreibung

Systemic disease Severe | Exception Hypersensitivity | Exception Asthma | Seizures | Major Congenital Anomaly | Physical developmental delay | Intellectual delay | Cerebral Palsy | Thoracic Surgical Procedures | Tuberculosis | Primary immune deficiency disorder | Secondary immune deficiency disorder | Heart Disease | Exception Atrial Septal Defect | Exception Hemodynamically insignificant ventricular septal defect | Exception Heart murmur

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0004096
UMLS CUI [4]
C0036572
UMLS CUI [5]
C4288779
UMLS CUI [6]
C0848141
UMLS CUI [7]
C1839029
UMLS CUI [8]
C0007789
UMLS CUI [9]
C0524832
UMLS CUI [10]
C0041296
UMLS CUI [11]
C0398686
UMLS CUI [12]
C0398795
UMLS CUI [13]
C0018799
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0018817
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C4546215
UMLS CUI [16,1]
C1705847
UMLS CUI [16,2]
C0018808
the child was born following 35 or less weeks of gestation.
Beschreibung

Childbirth Weeks of gestation Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1148523
UMLS CUI [1,2]
C1135241
UMLS CUI [1,3]
C1265611
parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
Beschreibung

Oxygen Received Neonatal period | Requirement Mechanical ventilation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030054
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0935562
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0199470
the child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
Beschreibung

Failure to Thrive

Datentyp

boolean

Alias
UMLS CUI [1]
C0015544
the child has chronic lung disease of prematurity (cldp), cystic fibrosis or any other chronic lung disease.
Beschreibung

Chronic lung disease of prematurity | Cystic Fibrosis | Chronic lung disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0006287
UMLS CUI [2]
C0010674
UMLS CUI [3]
C0746102
the child ever received immunotherapy.
Beschreibung

Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
the child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
Beschreibung

Gammaglobulin Intravenous | Immunosuppressive Agents Intravenous | Exception Adrenal Cortex Hormones Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3702062
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C0004096
history of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
Beschreibung

Life threatening acute exacerbation of asthma Requirement Intubation | Life threatening acute exacerbation of asthma Requirement Mechanical ventilation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4543404
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021925
UMLS CUI [2,1]
C4543404
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0199470
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Ähnliche Modelle

Eligibility Wheezing NCT01028560

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Wheezing NCT01028560
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Children | Age | Wheezing Episode Quantity
Item
children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0043144 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Skin test positive Airborne allergen | IgE antibody Titer Airborne allergen | Dust mite | Cat | Cockroach | Mouse | Dog | Pollen | Allergy testing
Item
positive skin tests or specific ige antibody titers to at least one of common airborne allergens: dust mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
boolean
C0542213 (UMLS CUI [1,1])
C0596057 (UMLS CUI [1,2])
C1292069 (UMLS CUI [2,1])
C0475208 (UMLS CUI [2,2])
C0596057 (UMLS CUI [2,3])
C0998367 (UMLS CUI [3])
C0007450 (UMLS CUI [4])
C0009208 (UMLS CUI [5])
C0025914 (UMLS CUI [6])
C0012984 (UMLS CUI [7])
C0032385 (UMLS CUI [8])
C0199747 (UMLS CUI [9])
High risk of Persistent asthma
Item
the child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions or 2 of the following minor conditions:
boolean
C0332167 (UMLS CUI [1,1])
C3266628 (UMLS CUI [1,2])
Dermatitis, Atopic | Asthma parental
Item
major criteria: history of atopic dermatitis and/or parental history of asthma.
boolean
C0011615 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
Allergic rhinitis | Wheezing Independent of Common Cold | Eosinophil count
Item
minor criteria: md-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.
boolean
C2607914 (UMLS CUI [1])
C0043144 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0009443 (UMLS CUI [2,3])
C0200638 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Systemic disease Severe | Exception Hypersensitivity | Exception Asthma | Seizures | Major Congenital Anomaly | Physical developmental delay | Intellectual delay | Cerebral Palsy | Thoracic Surgical Procedures | Tuberculosis | Primary immune deficiency disorder | Secondary immune deficiency disorder | Heart Disease | Exception Atrial Septal Defect | Exception Hemodynamically insignificant ventricular septal defect | Exception Heart murmur
Item
the child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant asd, vsd or heart murmur).
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0036572 (UMLS CUI [4])
C4288779 (UMLS CUI [5])
C0848141 (UMLS CUI [6])
C1839029 (UMLS CUI [7])
C0007789 (UMLS CUI [8])
C0524832 (UMLS CUI [9])
C0041296 (UMLS CUI [10])
C0398686 (UMLS CUI [11])
C0398795 (UMLS CUI [12])
C0018799 (UMLS CUI [13])
C1705847 (UMLS CUI [14,1])
C0018817 (UMLS CUI [14,2])
C1705847 (UMLS CUI [15,1])
C4546215 (UMLS CUI [15,2])
C1705847 (UMLS CUI [16,1])
C0018808 (UMLS CUI [16,2])
Childbirth Weeks of gestation Quantity
Item
the child was born following 35 or less weeks of gestation.
boolean
C1148523 (UMLS CUI [1,1])
C1135241 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Oxygen Received Neonatal period | Requirement Mechanical ventilation
Item
parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
boolean
C0030054 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0935562 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0199470 (UMLS CUI [2,2])
Failure to Thrive
Item
the child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
boolean
C0015544 (UMLS CUI [1])
Chronic lung disease of prematurity | Cystic Fibrosis | Chronic lung disease
Item
the child has chronic lung disease of prematurity (cldp), cystic fibrosis or any other chronic lung disease.
boolean
C0006287 (UMLS CUI [1])
C0010674 (UMLS CUI [2])
C0746102 (UMLS CUI [3])
Immunotherapy
Item
the child ever received immunotherapy.
boolean
C0021083 (UMLS CUI [1])
Gammaglobulin Intravenous | Immunosuppressive Agents Intravenous | Exception Adrenal Cortex Hormones Asthma
Item
the child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
boolean
C3702062 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0004096 (UMLS CUI [3,3])
Life threatening acute exacerbation of asthma Requirement Intubation | Life threatening acute exacerbation of asthma Requirement Mechanical ventilation
Item
history of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
boolean
C4543404 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021925 (UMLS CUI [1,3])
C4543404 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0199470 (UMLS CUI [2,3])
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