ID

14088

Beschrijving

Observational Assessment of Baseline Asthma Control in African-American Children; ODM derived from: https://clinicaltrials.gov/show/NCT01891630

Link

https://clinicaltrials.gov/show/NCT01891630

Trefwoorden

Versies (1)
  1. 29-03-16 29-03-16 -
Geüploaded op

29 maart 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Asthma NCT01891630

Engels

Eligibility Asthma NCT01891630

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01891630
Criteria
Beschrijving

Criteria

1. self-identified as african-american
Beschrijving

Human identification | African American

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242954
UMLS CUI [1,2]
C0085756
2. ages 12-17 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. live within convenient driving distance of the unc rex clinic in raleigh, nc.
Beschrijving

Living place | Clinic | North Carolina

Datatype

boolean

Alias
UMLS CUI [1,1]
C0337646
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0028407
4. physician-diagnosis of moderate-to-severe persistent asthma
Beschrijving

Moderate persistent asthma | Severe persistent asthma

Datatype

boolean

Alias
UMLS CUI [1]
C1960047
UMLS CUI [2]
C1960048
5. current treatment with appropriate therapy for moderate-to-severe persistent asthma symptoms as per the nhlbi guidelines including: daily controller medication use for asthma requiring at least a medium-dose inhaled corticosteroids (ics) or a low dose ics + long-acting beta2 agonist (laba) combination. subjects may use daily or every other day oral corticosteroids for control of asthma symptoms
Beschrijving

Current Therapy | Inhaled steroids | Adrenergic beta-2 Receptor Agonists | Oral steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C2827774
UMLS CUI [1,2]
C1960047
UMLS CUI [1,3]
C1960048
UMLS CUI [1,4]
C0586793
UMLS CUI [2,1]
C2936789
UMLS CUI [2,2]
C0419839
inclusion criteria for well-controlled asthmatics (from nhlbi guidelines):
Beschrijving

Persistent asthma, well controlled

Datatype

boolean

Alias
UMLS CUI [1]
C3661869
1. nighttime awakening with asthma symptoms ≤ 2x/month over the past 6 months
Beschrijving

Asthma night-time symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C1273489
2. use of short-acting beta2 agonist for symptom control ≤ 2 days /week over the past 6 months
Beschrijving

Adrenergic beta-2 Receptor Agonists | Use of

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936789
UMLS CUI [1,2]
C1524063
3. asthma control test score >19. the asthma control test is a standardized clinical tool to assess asthma control over the previous 4 week period (attached).
Beschrijving

Asthma control test score

Datatype

boolean

Alias
UMLS CUI [1]
C2733224
4. baseline fev1(pre-albuterol) > 80 percent of that predicted for gender, ethnicity, age and height (nhanes iii predicted set)
Beschrijving

FEV1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0001927
UMLS CUI [1,3]
C2825743
UMLS CUI [1,4]
C0079399
UMLS CUI [1,5]
C0015031
UMLS CUI [1,6]
C0001779
UMLS CUI [1,7]
C0005890
inclusion criteria for poorly-controlled asthmatics (from nhlbi guidelines):
Beschrijving

Asthmatics | Poorly controlled

Datatype

boolean

Alias
UMLS CUI [1,1]
C3816164
UMLS CUI [1,2]
C3853134
1. nighttime awakening with asthma symptoms > 2x/month over the past 6 months
Beschrijving

Asthma night-time symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C1273489
2. use of short-acting beta2 agonist for symptom control > 2 days /week over the past 6 months
Beschrijving

Adrenergic beta-2 Receptor Agonists | Use of

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936789
UMLS CUI [1,2]
C1524063
3. asthma control test score <19. the asthma control test is a standardized clinical tool to assess asthma control over the previous 4 week period (attached).
Beschrijving

Asthma control test score

Datatype

boolean

Alias
UMLS CUI [1]
C2733224
4. baseline fev1 (pre-albuterol) < 80 percent of that predicted for gender, ethnicity, age and height (nhanes iii predicted set)
Beschrijving

FEV1 | Albuterol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0001927
UMLS CUI [1,3]
C2825743
UMLS CUI [1,4]
C0079399
UMLS CUI [1,5]
C0015031
UMLS CUI [1,6]
C0001779
UMLS CUI [1,7]
C0005890
exclusion criteria for all subjects:
Beschrijving

Exclusion

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
1. children younger than age 12 and older than 17
Beschrijving

Children | Age | Out of range

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C3845292
2. children unable to perform spirometry
Beschrijving

Children | Unable | Spirometry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0037981
3. medical history or underlying health problems that may preclude participation in the protocol per the study physician (including but not limited to cystic fibrosis, chronic bronchitis, recurrent pneumonia, immunodeficiency, hematologic disorders)
Beschrijving

Study Subject Participation Status | Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0010674
UMLS CUI [2]
C0008677
UMLS CUI [3]
C0694550
UMLS CUI [4]
C0021051
UMLS CUI [5]
C0018939
4. history of bleeding disorder or anemia
Beschrijving

Bleeding Risk | Anemia

Datatype

boolean

Alias
UMLS CUI [1]
C3251812
UMLS CUI [2]
C0002871
5. subjects and families unwilling to travel to the clinic for the required 6 visits
Beschrijving

Study subject | Unwilling | travel | Clinic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0015576
UMLS CUI [1,3]
C0558080
UMLS CUI [1,4]
C0040802
UMLS CUI [1,5]
C0442592
6. unwilling or unable to refrain from the following medications for the week prior to the study as well as the week of the study including fish oil; anti-inflammatory agents such as ibuprofen (advil, motrin), naproxen (aleve) or aspirin as needed**. acetaminophen (tylenol) is allowed.**if the child requires anti-inflammatory medications for a fever or joint/muscle pain, in the week prior to the study visit, all subsequent visits may be rescheduled.
Beschrijving

Unwilling | Unable | Drug dose omission

Datatype

boolean

Alias
UMLS CUI [1]
C0558080
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C1535996
UMLS CUI [2,3]
C0016157
UMLS CUI [3]
C0003209
UMLS CUI [4]
C0020740
UMLS CUI [5]
C0593507
UMLS CUI [6]
C0699203
UMLS CUI [7]
C0027396
UMLS CUI [8]
C0718343
UMLS CUI [9]
C0004057
UMLS CUI [10]
C0000970
UMLS CUI [11]
C0699142
7. other uncontrolled health problems
Beschrijving

Disease | Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
8. non-english speaking subjects
Beschrijving

Study Subject | Non-English speaking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1546417
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Similar models

Eligibility Asthma NCT01891630

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01891630
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Human identification | African American
Item
1. self-identified as african-american
boolean
C0242954 (UMLS CUI [1,1])
C0085756 (UMLS CUI [1,2])
Age
Item
2. ages 12-17 years
boolean
C0001779 (UMLS CUI [1])
Living place | Clinic | North Carolina
Item
3. live within convenient driving distance of the unc rex clinic in raleigh, nc.
boolean
C0337646 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0028407 (UMLS CUI [1,3])
Moderate persistent asthma | Severe persistent asthma
Item
4. physician-diagnosis of moderate-to-severe persistent asthma
boolean
C1960047 (UMLS CUI [1])
C1960048 (UMLS CUI [2])
Current Therapy | Inhaled steroids | Adrenergic beta-2 Receptor Agonists | Oral steroids
Item
5. current treatment with appropriate therapy for moderate-to-severe persistent asthma symptoms as per the nhlbi guidelines including: daily controller medication use for asthma requiring at least a medium-dose inhaled corticosteroids (ics) or a low dose ics + long-acting beta2 agonist (laba) combination. subjects may use daily or every other day oral corticosteroids for control of asthma symptoms
boolean
C2827774 (UMLS CUI [1,1])
C1960047 (UMLS CUI [1,2])
C1960048 (UMLS CUI [1,3])
C0586793 (UMLS CUI [1,4])
C2936789 (UMLS CUI [2,1])
C0419839 (UMLS CUI [2,2])
Persistent asthma, well controlled
Item
inclusion criteria for well-controlled asthmatics (from nhlbi guidelines):
boolean
C3661869 (UMLS CUI [1])
Asthma night-time symptoms
Item
1. nighttime awakening with asthma symptoms ≤ 2x/month over the past 6 months
boolean
C1273489 (UMLS CUI [1])
Adrenergic beta-2 Receptor Agonists | Use of
Item
2. use of short-acting beta2 agonist for symptom control ≤ 2 days /week over the past 6 months
boolean
C2936789 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Asthma control test score
Item
3. asthma control test score >19. the asthma control test is a standardized clinical tool to assess asthma control over the previous 4 week period (attached).
boolean
C2733224 (UMLS CUI [1])
FEV1
Item
4. baseline fev1(pre-albuterol) > 80 percent of that predicted for gender, ethnicity, age and height (nhanes iii predicted set)
boolean
C0748133 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])
C2825743 (UMLS CUI [1,3])
C0079399 (UMLS CUI [1,4])
C0015031 (UMLS CUI [1,5])
C0001779 (UMLS CUI [1,6])
C0005890 (UMLS CUI [1,7])
Asthmatics | Poorly controlled
Item
inclusion criteria for poorly-controlled asthmatics (from nhlbi guidelines):
boolean
C3816164 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Asthma night-time symptoms
Item
1. nighttime awakening with asthma symptoms > 2x/month over the past 6 months
boolean
C1273489 (UMLS CUI [1])
Adrenergic beta-2 Receptor Agonists | Use of
Item
2. use of short-acting beta2 agonist for symptom control > 2 days /week over the past 6 months
boolean
C2936789 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Asthma control test score
Item
3. asthma control test score <19. the asthma control test is a standardized clinical tool to assess asthma control over the previous 4 week period (attached).
boolean
C2733224 (UMLS CUI [1])
FEV1 | Albuterol
Item
4. baseline fev1 (pre-albuterol) < 80 percent of that predicted for gender, ethnicity, age and height (nhanes iii predicted set)
boolean
C0748133 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])
C2825743 (UMLS CUI [1,3])
C0079399 (UMLS CUI [1,4])
C0015031 (UMLS CUI [1,5])
C0001779 (UMLS CUI [1,6])
C0005890 (UMLS CUI [1,7])
Exclusion
Item
exclusion criteria for all subjects:
boolean
C2828389 (UMLS CUI [1])
Children | Age | Out of range
Item
1. children younger than age 12 and older than 17
boolean
C0008059 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C3845292 (UMLS CUI [1,3])
Children | Unable | Spirometry
Item
2. children unable to perform spirometry
boolean
C0008059 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
Study Subject Participation Status | Limited
Item
3. medical history or underlying health problems that may preclude participation in the protocol per the study physician (including but not limited to cystic fibrosis, chronic bronchitis, recurrent pneumonia, immunodeficiency, hematologic disorders)
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C0008677 (UMLS CUI [2])
C0694550 (UMLS CUI [3])
C0021051 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
Bleeding Risk | Anemia
Item
4. history of bleeding disorder or anemia
boolean
C3251812 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
Study subject | Unwilling | travel | Clinic
Item
5. subjects and families unwilling to travel to the clinic for the required 6 visits
boolean
C0681850 (UMLS CUI [1,1])
C0015576 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0040802 (UMLS CUI [1,4])
C0442592 (UMLS CUI [1,5])
Unwilling | Unable | Drug dose omission
Item
6. unwilling or unable to refrain from the following medications for the week prior to the study as well as the week of the study including fish oil; anti-inflammatory agents such as ibuprofen (advil, motrin), naproxen (aleve) or aspirin as needed**. acetaminophen (tylenol) is allowed.**if the child requires anti-inflammatory medications for a fever or joint/muscle pain, in the week prior to the study visit, all subsequent visits may be rescheduled.
boolean
C0558080 (UMLS CUI [1])
C1299582 (UMLS CUI [2,1])
C1535996 (UMLS CUI [2,2])
C0016157 (UMLS CUI [2,3])
C0003209 (UMLS CUI [3])
C0020740 (UMLS CUI [4])
C0593507 (UMLS CUI [5])
C0699203 (UMLS CUI [6])
C0027396 (UMLS CUI [7])
C0718343 (UMLS CUI [8])
C0004057 (UMLS CUI [9])
C0000970 (UMLS CUI [10])
C0699142 (UMLS CUI [11])
Disease | Uncontrolled
Item
7. other uncontrolled health problems
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Study Subject | Non-English speaking
Item
8. non-english speaking subjects
boolean
C0681850 (UMLS CUI [1,1])
C1546417 (UMLS CUI [1,2])
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