ID

19722

Description

Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00366067

Link

https://clinicaltrials.gov/show/NCT00366067

Keywords

Versions (1)
  1. 1/23/17 1/23/17 -
Uploaded on

January 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT00366067

English

Eligibility Bronchial Asthma NCT00366067

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

Age | Informed Consent parent | Informed Consent Supervisor | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0403172
UMLS CUI [4]
C0525058
2. patients able to use peak flow meters, to perform spirometry and to swallow capsules.
Description

Peak flow meter Use of Ability | Ability to perform spirometry | Able to swallow capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C0180915
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C4038887
UMLS CUI [3,1]
C2712086
UMLS CUI [3,2]
C0006935
3. patient aged between 4 and 14 years, males or females.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. out patients.
Description

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
5. patients with an established (i.e. at least 6 months) clinical history of asthma.
Description

Asthma Established Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0443211
UMLS CUI [1,3]
C0872146
6. absence of long-term remissions of asthma (lasting more than 1 month)
Description

Asthma Remission Long-term Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0544452
UMLS CUI [1,3]
C0443252
UMLS CUI [1,4]
C0332197
7. poorly controlled asthma, due to various reasons.
Description

Asthma Poorly controlled Causes multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C3853134
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0439064
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0021053
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0009450
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C2826293
UMLS CUI [10,1]
C3887504
UMLS CUI [10,2]
C2826293
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0030705
UMLS CUI [11,3]
C0035647
UMLS CUI [12,1]
C0012634
UMLS CUI [12,2]
C0392760
UMLS CUI [12,3]
C0683954
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0392760
UMLS CUI [13,3]
C2348568
2. patients with active tuberculosis with indication for treatment.
Description

Tuberculosis Indication Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0087111
3. patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis or if the abnormal defines a disease listed as an exclusion criterion.
Description

Hematology finding abnormal Clinical Significance | Blood chemistry abnormal Clinical Significance | Urine screening abnormal Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0475182
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0438258
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0438142
UMLS CUI [3,2]
C2826293
4. patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
Description

Hypersensitivity Investigational New Drugs | side effects Investigational New Drugs | intolerance to Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0001688
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0013230
5. patients currently using mao inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
Description

Monoamine Oxidase Inhibitors | Tricyclic Antidepressive Agents | Antiepileptic Agents | Narcotics

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0003290
UMLS CUI [3]
C0003299
UMLS CUI [4]
C0027415
6. patients between 10 and 14, parents or supervisor of patients unlikely, unable or unwilling to comply with the requirements of the protocol.
Description

Age | parent Unlikely | Supervisor Unlikely | Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C0750558
UMLS CUI [3,1]
C0403172
UMLS CUI [3,2]
C0750558
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C1299582
UMLS CUI [5,1]
C0525058
UMLS CUI [5,2]
C0558080
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Similar models

Eligibility Bronchial Asthma NCT00366067

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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