ID

43594

Beskrivning

Study of Acid Reflux Therapy for Children With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00604851

Länk

https://clinicaltrials.gov/show/NCT00604851

Nyckelord

Versioner (2)
  1. 2016-04-18 2016-04-18 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00604851

Engelsk

Eligibility Asthma NCT00604851

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00604851
Criteria
Beskrivning

Criteria

6-16 years
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
asthma: physician diagnosed asthma, mathacholine pc20<16 mg/ml, treatment with a stable dose of daily inhaled corticosteroid equivalent to 200 micrograms/day of fluticasone or greater for 8 weeks or longer
Beskrivning

asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0040223
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0430567
poor asthma control: use of beta-agonist for asthma symptoms twice/week or more, nocturnal awakening with asthma symptoms more than once per week, 2 or more emergency department, unscheduled physician visit, prednisone course, or hospitalizations for asthma in the past 12 months, score of 1.5 or greater on the juniper scale of recent asthma control
Beskrivning

poor asthma control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2700379
UMLS CUI [1,3]
C2587213
UMLS CUI [2]
C4039704
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0583237
UMLS CUI [4]
C0019993
absence of gerd symptoms: no symptoms clearly attributed to ger at the time of enrollment.
Beskrivning

gerd symptom

Datatyp

boolean

Alias
UMLS CUI [1]
C2367776
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
surgery: previous anti-reflux or peptic ulcer surgery, previous tracheo-esophageal fistula repair
Beskrivning

prior surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0744961
UMLS CUI [2]
C0399651
UMLS CUI [3]
C0749751
UMLS CUI [4]
C0472916
pulmonary function:fev1 <60% predicted normal as measured immediately before methacholine bronchoprovocation. methacholine bronchoprovocation limited to participants with an fev1 >70% of predicted in accordance with fda indication
Beskrivning

fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0430567
other major chronic illnesses: any major chronic illness including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders or other conditions that would interfere with participation in the study.
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
medication use: anti-reflux medication (proton pump inhibitors, h2 blockers, bethanecol, metaclopromide) within 1 month; theophylline preparations, azoles, anti-coagulants, insulin, digitalis, any investigative drug within 2 months.
Beskrivning

medication use

Datatyp

boolean

Alias
UMLS CUI [1]
C0746470
UMLS CUI [2]
C0358591
UMLS CUI [3]
C0019593
UMLS CUI [4]
C0053526
UMLS CUI [5]
C0025853
UMLS CUI [6]
C0039771
UMLS CUI [7]
C0004504
UMLS CUI [8]
C0003280
UMLS CUI [9]
C0021641
UMLS CUI [10]
C0304520
UMLS CUI [11]
C0013230
drug allergy: previous adverse effects from lansoprazole, other proton pump inhibitors or methacholine challenge.
Beskrivning

drug allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0050940
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0358591
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0430567
non-adherence: inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent. inability to swallow study medication. inability to perform baseline measurements. less than 80% completion of screening period diaries. inability to contact by telephone. intention to move out of the areqa within 6 months. no pregnancy.
Beskrivning

non-adherence

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0021430
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Similar models

Eligibility Asthma NCT00604851

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00604851
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
age
Item
6-16 years
boolean
C0001779 (UMLS CUI [1])
asthma
Item
asthma: physician diagnosed asthma, mathacholine pc20<16 mg/ml, treatment with a stable dose of daily inhaled corticosteroid equivalent to 200 micrograms/day of fluticasone or greater for 8 weeks or longer
boolean
C0004096 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0430567 (UMLS CUI [4])
poor asthma control
Item
poor asthma control: use of beta-agonist for asthma symptoms twice/week or more, nocturnal awakening with asthma symptoms more than once per week, 2 or more emergency department, unscheduled physician visit, prednisone course, or hospitalizations for asthma in the past 12 months, score of 1.5 or greater on the juniper scale of recent asthma control
boolean
C0004096 (UMLS CUI [1,1])
C2700379 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,3])
C4039704 (UMLS CUI [2])
C2065041 (UMLS CUI [3,1])
C0583237 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4])
gerd symptom
Item
absence of gerd symptoms: no symptoms clearly attributed to ger at the time of enrollment.
boolean
C2367776 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior surgery
Item
surgery: previous anti-reflux or peptic ulcer surgery, previous tracheo-esophageal fistula repair
boolean
C0744961 (UMLS CUI [1])
C0399651 (UMLS CUI [2])
C0749751 (UMLS CUI [3])
C0472916 (UMLS CUI [4])
fev1
Item
pulmonary function:fev1 <60% predicted normal as measured immediately before methacholine bronchoprovocation. methacholine bronchoprovocation limited to participants with an fev1 >70% of predicted in accordance with fda indication
boolean
C0748133 (UMLS CUI [1])
C0430567 (UMLS CUI [2])
comorbidity
Item
other major chronic illnesses: any major chronic illness including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders or other conditions that would interfere with participation in the study.
boolean
C0009488 (UMLS CUI [1])
medication use
Item
medication use: anti-reflux medication (proton pump inhibitors, h2 blockers, bethanecol, metaclopromide) within 1 month; theophylline preparations, azoles, anti-coagulants, insulin, digitalis, any investigative drug within 2 months.
boolean
C0746470 (UMLS CUI [1])
C0358591 (UMLS CUI [2])
C0019593 (UMLS CUI [3])
C0053526 (UMLS CUI [4])
C0025853 (UMLS CUI [5])
C0039771 (UMLS CUI [6])
C0004504 (UMLS CUI [7])
C0003280 (UMLS CUI [8])
C0021641 (UMLS CUI [9])
C0304520 (UMLS CUI [10])
C0013230 (UMLS CUI [11])
drug allergy
Item
drug allergy: previous adverse effects from lansoprazole, other proton pump inhibitors or methacholine challenge.
boolean
C0020517 (UMLS CUI [1,1])
C0050940 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0358591 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0430567 (UMLS CUI [3,2])
non-adherence
Item
non-adherence: inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent. inability to swallow study medication. inability to perform baseline measurements. less than 80% completion of screening period diaries. inability to contact by telephone. intention to move out of the areqa within 6 months. no pregnancy.
boolean
C1321605 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
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