ID

44663

Beskrivning

Alendronate to Prevent Loss of Bronchoprotection in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02230332

Länk

https://clinicaltrials.gov/show/NCT02230332

Nyckelord

Versioner (2)
  1. 2016-04-10 2016-04-10 -
  2. 2021-09-27 2021-09-27 -
Uppladdad den

27 september 2021

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.

Tillbaka till modellkommentarer
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 Asthma NCT02230332

Engelsk

Eligibility Asthma NCT02230332

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02230332
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical history consistent with moderate asthma for >1 year
Beskrivning

Moderate persistent asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C1960047
asthma is controlled with ics, with an fp dose ≤ 1000mcg/day and >100mcg/day (or equivalent)
Beskrivning

Asthma | inhaled steroids | Fluticasone propionate

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0117996
able to perform reproducible spirometry according to ats criteria
Beskrivning

Ability Spirometry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0037981
baseline fev1 ≥ 50% of predicted and ≥1l.
Beskrivning

FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
if fev1 <80%, a minimum 12% increase in fev1 post-bronchodilator or a mch pc20 ≤ 8 mg/ml
Beskrivning

FEV1 post bronchodilator | Methacholine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
UMLS CUI [2]
C0600370
if fev1 ≥80%, a mch pc20 ≤ 8 mg/ml
Beskrivning

FEV1 | Methacholine

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0600370
salmeterol protected mch ≤ 16 mg/ml
Beskrivning

salmeterol | Methacholine

Datatyp

boolean

Alias
UMLS CUI [1]
C0073992
UMLS CUI [2]
C0600370
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled asthma, as suggested by an act score <18 while on high-dose ics (fp daily dose >500mcg or equivalent)
Beskrivning

Asthma Uncontrolled | Asthma control test score | inhaled steroids | Fluticasone propionate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C2733224
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0117996
non-ics controller medication or laba use within 4 weeks of study entry.
Beskrivning

inhaled steroids | Adrenergic beta-2 Receptor Agonists

Datatyp

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2936789
contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study
Beskrivning

contraindications Diphosphonates | intolerance to substance Diphosphonates | Ulcer of esophagus | Hematemesis | Gastroesophageal reflux disease Uncontrolled | Oral drug preparation | Aseptic necrosis of bone of jaw | Tooth Extraction | Root Canal Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079164
UMLS CUI [1,2]
C0012544
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0012544
UMLS CUI [3]
C0151970
UMLS CUI [4]
C0018926
UMLS CUI [5,1]
C0017168
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0304289
UMLS CUI [7]
C2711248
UMLS CUI [8]
C0040440
UMLS CUI [9]
C0035849
calculated gfr of less than 35 ml/min
Beskrivning

Glomerular Filtration Rate Calculated (procedure)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017654
UMLS CUI [1,2]
C0444686
history of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or > 10 pack-years total if ≥ 18 years of age
Beskrivning

Smoking History | Cigarette | Cigars | smoking pipe | Marihuana | smoking cigarettes: ____ pack-years history | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C0677453
UMLS CUI [3]
C0678446
UMLS CUI [4]
C0240766
UMLS CUI [5]
C0024808
UMLS CUI [6]
C2230126
UMLS CUI [7]
C0001779
systemic corticosteroid treatment for any condition within 4 weeks of enrollment at visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years
Beskrivning

Exacerbation of asthma | Therapeutic procedure systemic steroids | Exacerbation of asthma Life Threatening | Intubation | Mechanical ventilation | Hypoxic convulsions

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2825233
UMLS CUI [3,1]
C0349790
UMLS CUI [3,2]
C2826244
UMLS CUI [4]
C0021925
UMLS CUI [5]
C0199470
UMLS CUI [6]
C1843573
history of a respiratory tract infection within 4 weeks of visit 1
Beskrivning

Respiratory Tract Infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0035243
receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment
Beskrivning

hypersensitivity desensitization Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178702
UMLS CUI [1,2]
C0549178
Tillbaka till toppen

Similar models

Eligibility Asthma NCT02230332

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02230332
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Moderate persistent asthma
Item
clinical history consistent with moderate asthma for >1 year
boolean
C1960047 (UMLS CUI [1])
Asthma | inhaled steroids | Fluticasone propionate
Item
asthma is controlled with ics, with an fp dose ≤ 1000mcg/day and >100mcg/day (or equivalent)
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
Ability Spirometry
Item
able to perform reproducible spirometry according to ats criteria
boolean
C0085732 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
FEV1
Item
baseline fev1 ≥ 50% of predicted and ≥1l.
boolean
C0748133 (UMLS CUI [1])
FEV1 post bronchodilator | Methacholine
Item
if fev1 <80%, a minimum 12% increase in fev1 post-bronchodilator or a mch pc20 ≤ 8 mg/ml
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C0600370 (UMLS CUI [2])
FEV1 | Methacholine
Item
if fev1 ≥80%, a mch pc20 ≤ 8 mg/ml
boolean
C0748133 (UMLS CUI [1])
C0600370 (UMLS CUI [2])
salmeterol | Methacholine
Item
salmeterol protected mch ≤ 16 mg/ml
boolean
C0073992 (UMLS CUI [1])
C0600370 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Asthma Uncontrolled | Asthma control test score | inhaled steroids | Fluticasone propionate
Item
uncontrolled asthma, as suggested by an act score <18 while on high-dose ics (fp daily dose >500mcg or equivalent)
boolean
C0004096 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2733224 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0117996 (UMLS CUI [4])
inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
non-ics controller medication or laba use within 4 weeks of study entry.
boolean
C2065041 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
contraindications Diphosphonates | intolerance to substance Diphosphonates | Ulcer of esophagus | Hematemesis | Gastroesophageal reflux disease Uncontrolled | Oral drug preparation | Aseptic necrosis of bone of jaw | Tooth Extraction | Root Canal Therapy
Item
contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study
boolean
C0079164 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
C0151970 (UMLS CUI [3])
C0018926 (UMLS CUI [4])
C0017168 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0304289 (UMLS CUI [6])
C2711248 (UMLS CUI [7])
C0040440 (UMLS CUI [8])
C0035849 (UMLS CUI [9])
Glomerular Filtration Rate Calculated (procedure)
Item
calculated gfr of less than 35 ml/min
boolean
C0017654 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Smoking History | Cigarette | Cigars | smoking pipe | Marihuana | smoking cigarettes: ____ pack-years history | Age
Item
history of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or > 10 pack-years total if ≥ 18 years of age
boolean
C1519384 (UMLS CUI [1])
C0677453 (UMLS CUI [2])
C0678446 (UMLS CUI [3])
C0240766 (UMLS CUI [4])
C0024808 (UMLS CUI [5])
C2230126 (UMLS CUI [6])
C0001779 (UMLS CUI [7])
Exacerbation of asthma | Therapeutic procedure systemic steroids | Exacerbation of asthma Life Threatening | Intubation | Mechanical ventilation | Hypoxic convulsions
Item
systemic corticosteroid treatment for any condition within 4 weeks of enrollment at visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years
boolean
C0349790 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2825233 (UMLS CUI [2,2])
C0349790 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0021925 (UMLS CUI [4])
C0199470 (UMLS CUI [5])
C1843573 (UMLS CUI [6])
Respiratory Tract Infections
Item
history of a respiratory tract infection within 4 weeks of visit 1
boolean
C0035243 (UMLS CUI [1])
hypersensitivity desensitization Continuous
Item
receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment
boolean
C0178702 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

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

Fält markerade med * är obligatoriska.

Hjälp

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