ID

14426

Description

Structure and Function MRI of Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02351141

Link

https://clinicaltrials.gov/show/NCT02351141

Keywords

Versions (1)
  1. 4/14/16 4/14/16 -
Uploaded on

April 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02351141

English

Eligibility Asthma NCT02351141

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02351141
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects male and female aged 18-60 with a clinical diagnosis of asthma
Description

Asthma | Age

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0001779
smoking history ≤ 1 pack/year
Description

smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C2230126
subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
Description

Informed Consent | Study Subject Participation Status | Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2348568
UMLS CUI [3]
C1321605
subject is judged to be in otherwise stable health on the basis of medical history
Description

Medical History | Health Stable status

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2,1]
C0018684
UMLS CUI [2,2]
C0205360
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.)
Description

Ability Pulmonary function tests | Spirometry | FEV1

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0024119
UMLS CUI [2]
C0037981
UMLS CUI [3]
C0748133
fev1 >60% predicted
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient 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
Description

Disease Study Subject Participation Status Limited | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0021430
patient is unable to perform spirometry or plethysmography maneuvers
Description

Unable Spirometry | Unable Plethysmography

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0037981
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C0032221
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)
Description

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 | Implant, Middle Ear

Data type

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
UMLS CUI [14]
C0086454
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.
Description

Disease Preventing Magnetic Resonance Imaging | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C0008909
patient is pregnant
Description

Patient currently pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0549206
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Similar models

Eligibility Asthma NCT02351141

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02351141
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Age
Item
subjects male and female aged 18-60 with a clinical diagnosis of asthma
boolean
C0004096 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
smoking cigarettes: ____ pack-years history
Item
smoking history ≤ 1 pack/year
boolean
C2230126 (UMLS CUI [1])
Informed Consent | Study Subject Participation Status | Compliance behavior
Item
subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
boolean
C0021430 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
Medical History | Health Stable status
Item
subject is judged to be in otherwise stable health on the basis of medical history
boolean
C0262926 (UMLS CUI [1])
C0018684 (UMLS CUI [2,1])
C0205360 (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])
FEV1
Item
fev1 >60% predicted
boolean
C0748133 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Study Subject Participation Status Limited | Informed Consent
Item
patient 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])
C0021430 (UMLS CUI [2])
Unable Spirometry | Unable Plethysmography
Item
patient 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])
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 | Implant, Middle Ear
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])
C0086454 (UMLS CUI [14])
Disease Preventing Magnetic Resonance Imaging | 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])
Patient currently pregnant
Item
patient is pregnant
boolean
C0549206 (UMLS CUI [1])
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