ID

41020

Descripción

Novel Gentic Variations Contributing to Asthma Susceptability in Saudi Arabia; ODM derived from: https://clinicaltrials.gov/show/NCT01216215

Link

https://clinicaltrials.gov/show/NCT01216215

Palabras clave

Versiones (1)
  1. 13/6/20 13/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Collection of Clinical Data That Will be Used in This Study and Will Form a Data Bank for Asthma in Saudi Arabia NCT01216215

Inglés

Eligibility Collection of Clinical Data That Will be Used in This Study and Will Form a Data Bank for Asthma in Saudi Arabia NCT01216215

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects with documented clinical history of asthma for a period of at least 6 months prior to study entry (and a minimum of one clinic follow-up visit since initial diagnosis)
Descripción

Asthma Disease length | Follow-up visit Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1265611
2. willing to provide written informed consent and in the judgment of the investigator, individuals who are able to understand the informed consent process.
Descripción

Informed Consent | Comprehension Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0021430
3. subjects with documented clinical history (in preceding 12 months) of airway reversibility of at least 12% based on forced expiratory volume (fev1), measured pre and post inhalation of a β-2 agonist (2 puffs of albuterol using a measured dose inhaler with spacer) or
Descripción

Airway Reversibility Percentage | FEV1 | Status pre- Adrenergic beta-2 Receptor Agonist Inhalation | Status post Adrenergic beta-2 Receptor Agonist Inhalation | Albuterol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0458827
UMLS CUI [1,2]
C0449261
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C0849974
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C2936789
UMLS CUI [3,3]
C0205535
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C2936789
UMLS CUI [4,3]
C0205535
UMLS CUI [5]
C0001927
4. individuals demonstrating airway 12% reversibility during recruitment testing and asthmatic symptoms, but with no prior history of asthma and not on an asthma treatment plan, can be recruited as affected individuals if in the opinion of the investigator the individuals are truly asthmatic and have no confounding factors that could explain the reversibility and symptoms.
Descripción

Airway Reversibility Percentage | Recruitment Testing | Symptoms Asthmatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0458827
UMLS CUI [1,2]
C0449261
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0242800
UMLS CUI [2,2]
C0039593
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0004096
7. individuals with strong history of asthma but with waning, or no current symptoms may be included in the study if their asthma was well controlled using an asthma medication. principal investigator must verify or know the clinical history of an individual before accepting him as an asthmatic individual.
Descripción

History of asthma | Symptoms Absent | Asthma well controlled | Pharmaceutical Preparations Asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0455544
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C4296063
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0004096
8. individuals with positive history of asthma but no asthma medication usage and with family history of asthma should be considered for inclusion as cases in the study only if other family members are being recruited.
Descripción

History of asthma | Absence Pharmaceutical Preparations Asthma | Family history of asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0455544
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0004096
UMLS CUI [3]
C1261327
9. able to perform spirometry/fev1 correctly (only for those above 7years).
Descripción

Ability Perform Spirometry | Ability Perform FEV1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0037981
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0884358
UMLS CUI [2,3]
C0849974
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age < 3 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. smoking for 20 years, 1 pack/day or more.
Descripción

Tobacco use | Smoking cigarettes: ____ pack-years history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
3. congestive heart failure.
Descripción

Congestive heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
4. copd.
Descripción

Chronic Obstructive Airway Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024117
5. chronic lung disease other than asthma and copd.
Descripción

Chronic lung disease | Exception Asthma | Exception Chronic Obstructive Airway Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0746102
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024117
6. bronchiectasis.
Descripción

Bronchiectasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006267
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Similar models

Eligibility Collection of Clinical Data That Will be Used in This Study and Will Form a Data Bank for Asthma in Saudi Arabia NCT01216215

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Asthma Disease length | Follow-up visit Quantity
Item
1. subjects with documented clinical history of asthma for a period of at least 6 months prior to study entry (and a minimum of one clinic follow-up visit since initial diagnosis)
boolean
C0004096 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Informed Consent | Comprehension Informed Consent
Item
2. willing to provide written informed consent and in the judgment of the investigator, individuals who are able to understand the informed consent process.
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Airway Reversibility Percentage | FEV1 | Status pre- Adrenergic beta-2 Receptor Agonist Inhalation | Status post Adrenergic beta-2 Receptor Agonist Inhalation | Albuterol
Item
3. subjects with documented clinical history (in preceding 12 months) of airway reversibility of at least 12% based on forced expiratory volume (fev1), measured pre and post inhalation of a β-2 agonist (2 puffs of albuterol using a measured dose inhaler with spacer) or
boolean
C0458827 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0849974 (UMLS CUI [2])
C0332152 (UMLS CUI [3,1])
C2936789 (UMLS CUI [3,2])
C0205535 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C2936789 (UMLS CUI [4,2])
C0205535 (UMLS CUI [4,3])
C0001927 (UMLS CUI [5])
Airway Reversibility Percentage | Recruitment Testing | Symptoms Asthmatic
Item
4. individuals demonstrating airway 12% reversibility during recruitment testing and asthmatic symptoms, but with no prior history of asthma and not on an asthma treatment plan, can be recruited as affected individuals if in the opinion of the investigator the individuals are truly asthmatic and have no confounding factors that could explain the reversibility and symptoms.
boolean
C0458827 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0242800 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
History of asthma | Symptoms Absent | Asthma well controlled | Pharmaceutical Preparations Asthma
Item
7. individuals with strong history of asthma but with waning, or no current symptoms may be included in the study if their asthma was well controlled using an asthma medication. principal investigator must verify or know the clinical history of an individual before accepting him as an asthmatic individual.
boolean
C0455544 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C4296063 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0004096 (UMLS CUI [4,2])
History of asthma | Absence Pharmaceutical Preparations Asthma | Family history of asthma
Item
8. individuals with positive history of asthma but no asthma medication usage and with family history of asthma should be considered for inclusion as cases in the study only if other family members are being recruited.
boolean
C0455544 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
C1261327 (UMLS CUI [3])
Ability Perform Spirometry | Ability Perform FEV1
Item
9. able to perform spirometry/fev1 correctly (only for those above 7years).
boolean
C0085732 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C0884358 (UMLS CUI [2,2])
C0849974 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age < 3 years
boolean
C0001779 (UMLS CUI [1])
Tobacco use | Smoking cigarettes: ____ pack-years history
Item
2. smoking for 20 years, 1 pack/day or more.
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Congestive heart failure
Item
3. congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Chronic Obstructive Airway Disease
Item
4. copd.
boolean
C0024117 (UMLS CUI [1])
Chronic lung disease | Exception Asthma | Exception Chronic Obstructive Airway Disease
Item
5. chronic lung disease other than asthma and copd.
boolean
C0746102 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0024117 (UMLS CUI [3,2])
Bronchiectasis
Item
6. bronchiectasis.
boolean
C0006267 (UMLS CUI [1])
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