ID

40511

Descripción

Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01434082

Link

https://clinicaltrials.gov/show/NCT01434082

Palabras clave

Versiones (1)
  1. 29/4/20 29/4/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de abril de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT01434082

Inglés

Eligibility Juvenile Idiopathic Arthritis NCT01434082

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
children
Descripción

Children

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008059
children with and without arthritis, 6 thru 11 years old, able to speak english
Descripción

Arthritis | Arthritis Absent | Age | Able to speak English Language

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2,1]
C0003864
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0564215
UMLS CUI [4,2]
C0376245
children with jia not recently hospitalized for severe jia.
Descripción

Juvenile arthritis | Hospitalization Absent Juvenile arthritis Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3495559
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C3495559
UMLS CUI [2,4]
C0205082
parents
Descripción

Parents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030551
subject's parents or legal guardian are > 18 years of age and able to read and speak english.
Descripción

Parents | Legal Guardian | Age | Able to read English Language | Able to speak English Language

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030551
UMLS CUI [2]
C0023226
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0586740
UMLS CUI [4,2]
C0376245
UMLS CUI [5,1]
C0564215
UMLS CUI [5,2]
C0376245
subject's parent or legal guardian has provided written informed consent prior to screening for this study.
Descripción

Informed Consent Parent | Informed Consent Legal Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
children
Descripción

Children

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008059
a child with a history of/current diagnosis of a psychiatric condition meeting dsm-iv-tr (e.g. depression, bipolar disorder) that would interfere with ability to comply with protocol requirements, or give informed consent, or be expected to have disordered sleep.
Descripción

Mental disorder Interferes with Protocol Compliance | Mental disorder Interferes with Informed Consent | Mental disorder Sleep Disorder Expected | Depressive disorder | Bipolar Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0851578
UMLS CUI [3,3]
C1517001
UMLS CUI [4]
C0011581
UMLS CUI [5]
C0005586
a child with acute illness such as a cold or the flu that would interfere with sleep and neurobehavioral testing.
Descripción

Acute illness Interferes with Sleep testing | Acute illness Interferes with Neurobehavioral test | Cold | Influenza

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162701
UMLS CUI [2,1]
C4061114
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0599858
UMLS CUI [3]
C0009443
UMLS CUI [4]
C0021400
a chronic condition such as cancer, diabetes, or asthma which would, in the investigator's opinion, compromise the subject's ability to comply with the study requirements and interfere with ability to comply with protocol requirements.
Descripción

Chronic condition compromises Protocol Compliance | Chronic condition Interferes with Protocol Compliance | Malignant Neoplasms | Diabetes Mellitus | Asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4315615
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C4315615
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0004096
children admitted to the hospital for severe jia within the last 2 months.
Descripción

Hospital admission Juvenile arthritis Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C3495559
UMLS CUI [1,3]
C0205082
children with a bmi >95th percentile (defined as obesity by cdc) will be excluded because of potential impact of obesity on sdb.
Descripción

Body mass index percentile | Obesity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2227318
UMLS CUI [2]
C0028754
parents
Descripción

Parents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030551
a parent or legal guardian with a chronic condition that would compromise the parent's ability to comply with protocol requirements.
Descripción

Parent | Legal Guardian | Chronic condition compromises Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030551
UMLS CUI [2]
C0023226
UMLS CUI [3,1]
C4315615
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
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Similar models

Eligibility Juvenile Idiopathic Arthritis NCT01434082

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Children
Item
children
boolean
C0008059 (UMLS CUI [1])
Arthritis | Arthritis Absent | Age | Able to speak English Language
Item
children with and without arthritis, 6 thru 11 years old, able to speak english
boolean
C0003864 (UMLS CUI [1])
C0003864 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0564215 (UMLS CUI [4,1])
C0376245 (UMLS CUI [4,2])
Juvenile arthritis | Hospitalization Absent Juvenile arthritis Severe
Item
children with jia not recently hospitalized for severe jia.
boolean
C3495559 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3495559 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Parents
Item
parents
boolean
C0030551 (UMLS CUI [1])
Parents | Legal Guardian | Age | Able to read English Language | Able to speak English Language
Item
subject's parents or legal guardian are > 18 years of age and able to read and speak english.
boolean
C0030551 (UMLS CUI [1])
C0023226 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0586740 (UMLS CUI [4,1])
C0376245 (UMLS CUI [4,2])
C0564215 (UMLS CUI [5,1])
C0376245 (UMLS CUI [5,2])
Informed Consent Parent | Informed Consent Legal Guardian
Item
subject's parent or legal guardian has provided written informed consent prior to screening for this study.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Children
Item
children
boolean
C0008059 (UMLS CUI [1])
Mental disorder Interferes with Protocol Compliance | Mental disorder Interferes with Informed Consent | Mental disorder Sleep Disorder Expected | Depressive disorder | Bipolar Disorder
Item
a child with a history of/current diagnosis of a psychiatric condition meeting dsm-iv-tr (e.g. depression, bipolar disorder) that would interfere with ability to comply with protocol requirements, or give informed consent, or be expected to have disordered sleep.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0851578 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
C0011581 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
Acute illness Interferes with Sleep testing | Acute illness Interferes with Neurobehavioral test | Cold | Influenza
Item
a child with acute illness such as a cold or the flu that would interfere with sleep and neurobehavioral testing.
boolean
C4061114 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162701 (UMLS CUI [1,3])
C4061114 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0599858 (UMLS CUI [2,3])
C0009443 (UMLS CUI [3])
C0021400 (UMLS CUI [4])
Chronic condition compromises Protocol Compliance | Chronic condition Interferes with Protocol Compliance | Malignant Neoplasms | Diabetes Mellitus | Asthma
Item
a chronic condition such as cancer, diabetes, or asthma which would, in the investigator's opinion, compromise the subject's ability to comply with the study requirements and interfere with ability to comply with protocol requirements.
boolean
C4315615 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C4315615 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0004096 (UMLS CUI [5])
Hospital admission Juvenile arthritis Severe
Item
children admitted to the hospital for severe jia within the last 2 months.
boolean
C0184666 (UMLS CUI [1,1])
C3495559 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Body mass index percentile | Obesity
Item
children with a bmi >95th percentile (defined as obesity by cdc) will be excluded because of potential impact of obesity on sdb.
boolean
C2227318 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
Parents
Item
parents
boolean
C0030551 (UMLS CUI [1])
Parent | Legal Guardian | Chronic condition compromises Protocol Compliance
Item
a parent or legal guardian with a chronic condition that would compromise the parent's ability to comply with protocol requirements.
boolean
C0030551 (UMLS CUI [1])
C0023226 (UMLS CUI [2])
C4315615 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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