Informed Consent | Assent
Item
1. informed consent and assent signed and dated before participation.
boolean
C0021430 (UMLS CUI [1,1])
C1879749 (UMLS CUI [1,2])
Age | Gender | Racial group | Ethnic group
Item
2. male or female, ages 8 through 17 at baseline; all races and ethnicities
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0034510 (UMLS CUI [3])
C0015031 (UMLS CUI [4])
Asthma | inhaled steroids
Item
3. asthma and currently taking a prescribed daily inhaled steroid asthma medication
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
Able to speak | English Language | parent
Item
4. english-speaking with at least one english-speaking parent
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0030551 (UMLS CUI [2])
Vitamin D Deficiency
Item
5. vitamin d deficiency (<20 ng/ml)
boolean
C0042870 (UMLS CUI [1])
Compliance behavior | Clinic Visits | Asthma
Item
6. compliant with attending at least 2/4 of their last asthma-related scheduled clinic visits
boolean
C1321605 (UMLS CUI [1])
C0008952 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned | Sexually active | Contraceptive methods
Item
1. if female, pregnant, planning to become pregnant, and/or sexually active and not using reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0241028 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Informed Consent | Limited | Mental Retardation
Item
2. unable to provide informed consent (mental retardation, etc)
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0025362 (UMLS CUI [2])
Substance Dependence
Item
3. current substance dependence (within the past 2 months)
boolean
C0038580 (UMLS CUI [1])
Metabolic Bone Disorder | Rickets
Item
4. known metabolic bone disease, including rickets
boolean
C0005944 (UMLS CUI [1])
C0035579 (UMLS CUI [2])
Malabsorption Syndrome | Crohn Disease | Ulcerative Colitis | Celiac Disease
Item
5. known malabsorption disease: crohn's, ulcerative colitis, celiac sprue
boolean
C0024523 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0007570 (UMLS CUI [4])
Body mass index
Item
6. bmi>40
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure | Vitamin D
Item
7. has begun new treatment with vitamin d (>600 iu/day) within the past month
boolean
C0087111 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
Therapeutic procedure | Prednisone | Adrenal Cortex Hormones | Intravenous steroid injection
Item
8. treatment with prednisone or other oral or iv steroid within the past 4 weeks
boolean
C0087111 (UMLS CUI [1,1])
C0032952 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
C0563322 (UMLS CUI [3])
Taking medication | Mineral Oil | Thiazide Diuretics
Item
9. taking mineral oil or thiazide diuretics on a daily basis
boolean
C1290952 (UMLS CUI [1,1])
C0026156 (UMLS CUI [1,2])
C0012802 (UMLS CUI [2])
Liver diseases | Kidney Diseases | Endocrine System Diseases | nervous system disorder | Communicable Diseases | Autoimmune Diseases | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Hematological Disease | Metabolic Diseases
Item
10. acute or chronic liver, renal, endocrine, neurologic, infectious, autoimmune, cardiac, pulmonary, gastrointestinal, hematologic, metabolic disorder or any other disorder, per study physician judgment.
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0017178 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
Noncompliance with therapeutic regimen | Severe
Item
11. severe treatment noncompliance documented in medical record or by managing provider report.
boolean
C0184543 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Contraceptive methods | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Intrauterine Devices | Sexual Abstinence | Vasectomy | condom use
Item
our definition of a highly effective method of birth control is consistent with ich guidance for industry m3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals (april 1997) when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine devices (iuds), sexual abstinence, or a vasectomized partner. subjects will also be reminded to use condoms to prevent sexually transmitted diseases and as a second method toward birth control.
boolean
C0700589 (UMLS CUI [1])
C1657106 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0042387 (UMLS CUI [7])
C0679782 (UMLS CUI [8])