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])