ID

14342

Beschrijving

Hyperpolarized Magnetic Resonance Imaging in Asthma Pre- and Post-Bronchial Thermoplasty; ODM derived from: https://clinicaltrials.gov/show/NCT02263794

Link

https://clinicaltrials.gov/show/NCT02263794

Trefwoorden

Versies (1)
  1. 11-04-16 11-04-16 -
Geüploaded op

11 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Asthma NCT02263794

Engels

Eligibility Asthma NCT02263794

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02263794
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
Beschrijving

Study Subject Participation Status | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0021430
male and female aged 18-60 years of age with a clinical diagnosis of asthma, as per:
Beschrijving

Asthma | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0001779
beta-agonist reversibility of fev1>12%, or
Beschrijving

Adrenergic beta-Agonists Reversibility FEV1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001644
UMLS CUI [1,2]
C0449261
UMLS CUI [1,3]
C0748133
methacholine fev1 pc20 ≤ 8 mg/ml if not receiving ics or ≤ 16mg/ml if receiving an ics.
Beschrijving

Methacholine FEV1 | inhaled steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600370
UMLS CUI [1,2]
C0748133
UMLS CUI [2]
C2065041
subject has asthma and is taking regular maintenance medication for the past 12 months that includes:
Beschrijving

Asthma | Maintenance Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0013227
inhaled corticosteroid (ics)
Beschrijving

inhaled steroids

Datatype

boolean

Alias
UMLS CUI [1]
C2065041
long-acting beta agonist (laba)
Beschrijving

Adrenergic beta-Agonists

Datatype

boolean

Alias
UMLS CUI [1]
C0001644
other asthma medication such as leukotriene modifier, or anti-ige, are acceptable
Beschrijving

Leukotriene Antagonists | Anti-Immunoglobulin E antibody

Datatype

boolean

Alias
UMLS CUI [1]
C0595726
UMLS CUI [2]
C0051978
fev1 > 50%pred pre-bronchodilator
Beschrijving

FEV1 pre bronchodilator

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
subject assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
Beschrijving

Bronchial thermoplasty | Therapeutic procedure Asthma

Datatype

boolean

Alias
UMLS CUI [1]
C3854686
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0004096
subject is a non-smoker for 1 year or greater (if former smoker less than 10 pack years total smoking history).
Beschrijving

Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history

Datatype

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C2230126
subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have fev1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
Beschrijving

Ability Pulmonary function tests | Spirometry | FEV1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C0037981
UMLS CUI [3]
C0748133
subject is judged to be in otherwise stable health on the basis of medical history
Beschrijving

Other personal health Stable status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0683314
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
Beschrijving

Disease Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
subject is unable to perform spirometry or plethysmography maneuvers
Beschrijving

Unable Spirometry | Unable Plethysmography

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0037981
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C0032221
subject is pregnant
Beschrijving

Patient currently pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
recent (within 4 weeks of bl visit 1) or current asthma exacerbation and/or respiratory tract infection
Beschrijving

Exacerbation of asthma | Respiratory Tract Infections

Datatype

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0035243
subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.) (at the discretion of the mri technologist/3t manager)
Beschrijving

Implants | Artificial cardiac pacemaker | Neurostimulator | Biogenic Stimulators | Insulin pump | Aneurysm clip | Bioprosthesis device | Limb Prosthesis | Foreign Bodies | Shunt Device | Staple, Surgical | Surgical Clips | Metallic suture

Datatype

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0582124
UMLS CUI [4]
C0524729
UMLS CUI [5]
C1140609
UMLS CUI [6]
C0179977
UMLS CUI [7]
C0005557
UMLS CUI [8]
C0347948
UMLS CUI [9]
C0016542
UMLS CUI [10]
C0542331
UMLS CUI [11]
C0524724
UMLS CUI [12]
C0038917
UMLS CUI [13]
C1961548
in the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the mri, such as severe claustrophobia.
Beschrijving

Disease Preventing Magnetic Resonance Imaging | Severe Claustrophobia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0205082
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Similar models

Eligibility Asthma NCT02263794

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02263794
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Informed Consent
Item
subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
boolean
C2348568 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Asthma | Age
Item
male and female aged 18-60 years of age with a clinical diagnosis of asthma, as per:
boolean
C0004096 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adrenergic beta-Agonists Reversibility FEV1
Item
beta-agonist reversibility of fev1>12%, or
boolean
C0001644 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
Methacholine FEV1 | inhaled steroids
Item
methacholine fev1 pc20 ≤ 8 mg/ml if not receiving ics or ≤ 16mg/ml if receiving an ics.
boolean
C0600370 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
Asthma | Maintenance Pharmaceutical Preparations
Item
subject has asthma and is taking regular maintenance medication for the past 12 months that includes:
boolean
C0004096 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
inhaled steroids
Item
inhaled corticosteroid (ics)
boolean
C2065041 (UMLS CUI [1])
Adrenergic beta-Agonists
Item
long-acting beta agonist (laba)
boolean
C0001644 (UMLS CUI [1])
Leukotriene Antagonists | Anti-Immunoglobulin E antibody
Item
other asthma medication such as leukotriene modifier, or anti-ige, are acceptable
boolean
C0595726 (UMLS CUI [1])
C0051978 (UMLS CUI [2])
FEV1 pre bronchodilator
Item
fev1 > 50%pred pre-bronchodilator
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
Bronchial thermoplasty | Therapeutic procedure Asthma
Item
subject assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
boolean
C3854686 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Non-smoker | Former smoker Smoking cigarettes: ____ pack-years history
Item
subject is a non-smoker for 1 year or greater (if former smoker less than 10 pack years total smoking history).
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C2230126 (UMLS CUI [2,2])
Ability Pulmonary function tests | Spirometry | FEV1
Item
subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have fev1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
boolean
C0085732 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0037981 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
Other personal health Stable status
Item
subject is judged to be in otherwise stable health on the basis of medical history
boolean
C0205394 (UMLS CUI [1,1])
C0683314 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Disease Study Subject Participation Status Limited
Item
subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Unable Spirometry | Unable Plethysmography
Item
subject is unable to perform spirometry or plethysmography maneuvers
boolean
C1299582 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C0032221 (UMLS CUI [2,2])
Patient currently pregnant
Item
subject is pregnant
boolean
C0549206 (UMLS CUI [1])
Exacerbation of asthma | Respiratory Tract Infections
Item
recent (within 4 weeks of bl visit 1) or current asthma exacerbation and/or respiratory tract infection
boolean
C0349790 (UMLS CUI [1])
C0035243 (UMLS CUI [2])
Implants | Artificial cardiac pacemaker | Neurostimulator | Biogenic Stimulators | Insulin pump | Aneurysm clip | Bioprosthesis device | Limb Prosthesis | Foreign Bodies | Shunt Device | Staple, Surgical | Surgical Clips | Metallic suture
Item
subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.) (at the discretion of the mri technologist/3t manager)
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0582124 (UMLS CUI [3])
C0524729 (UMLS CUI [4])
C1140609 (UMLS CUI [5])
C0179977 (UMLS CUI [6])
C0005557 (UMLS CUI [7])
C0347948 (UMLS CUI [8])
C0016542 (UMLS CUI [9])
C0542331 (UMLS CUI [10])
C0524724 (UMLS CUI [11])
C0038917 (UMLS CUI [12])
C1961548 (UMLS CUI [13])
Disease Preventing Magnetic Resonance Imaging | Severe Claustrophobia
Item
in the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the mri, such as severe claustrophobia.
boolean
C0012634 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
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