Age | Informed Consent parent | Informed Consent Supervisor | Protocol Compliance
Item
1. patients between 10 and 14, patients parents or supervisors must have given their informed consent before commencing the procedures specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0403172 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4])
Peak flow meter Use of Ability | Ability to perform spirometry | Able to swallow capsules
Item
2. patients able to use peak flow meters, to perform spirometry and to swallow capsules.
boolean
C0180915 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C4038887 (UMLS CUI [2])
C2712086 (UMLS CUI [3,1])
C0006935 (UMLS CUI [3,2])
Age
Item
3. patient aged between 4 and 14 years, males or females.
boolean
C0001779 (UMLS CUI [1])
Outpatients
Item
4. out patients.
boolean
C0029921 (UMLS CUI [1])
Asthma Established Disease length
Item
5. patients with an established (i.e. at least 6 months) clinical history of asthma.
boolean
C0004096 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Asthma Remission Long-term Absent
Item
6. absence of long-term remissions of asthma (lasting more than 1 month)
boolean
C0004096 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Asthma Poorly controlled Causes multiple
Item
7. poorly controlled asthma, due to various reasons.
boolean
C0004096 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0439064 (UMLS CUI [1,4])
Cardiovascular Diseases | Kidney Diseases | nervous system disorder | Mental disorders | Liver diseases | Immune System Diseases | Endocrine System Diseases | Communicable Disease | Disease Clinical Significance | Dysfunction Clinical Significance | Disease Patient Risk | Disease Affecting research results | Disease Affecting Study Subject Participation Status
Item
1. history or presence of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. a clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0021053 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0012634 (UMLS CUI [9,1])
C2826293 (UMLS CUI [9,2])
C3887504 (UMLS CUI [10,1])
C2826293 (UMLS CUI [10,2])
C0012634 (UMLS CUI [11,1])
C0030705 (UMLS CUI [11,2])
C0035647 (UMLS CUI [11,3])
C0012634 (UMLS CUI [12,1])
C0392760 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C0012634 (UMLS CUI [13,1])
C0392760 (UMLS CUI [13,2])
C2348568 (UMLS CUI [13,3])
Tuberculosis Indication Therapeutic procedure
Item
2. patients with active tuberculosis with indication for treatment.
boolean
C0041296 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Hematology finding abnormal Clinical Significance | Blood chemistry abnormal Clinical Significance | Urine screening abnormal Clinical Significance
Item
3. patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis or if the abnormal defines a disease listed as an exclusion criterion.
boolean
C0475182 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0438142 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs | side effects Investigational New Drugs | intolerance to Investigational New Drugs
Item
4. patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0001688 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Monoamine Oxidase Inhibitors | Tricyclic Antidepressive Agents | Antiepileptic Agents | Narcotics
Item
5. patients currently using mao inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
boolean
C0026457 (UMLS CUI [1])
C0003290 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
C0027415 (UMLS CUI [4])
Age | parent Unlikely | Supervisor Unlikely | Protocol Compliance Unable | Protocol Compliance Unwilling
Item
6. patients between 10 and 14, parents or supervisor of patients unlikely, unable or unwilling to comply with the requirements of the protocol.
boolean
C0001779 (UMLS CUI [1])
C0030551 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0403172 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C0525058 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])