ID

14164

Beskrivning

Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze; ODM derived from: https://clinicaltrials.gov/show/NCT01982162

Länk

https://clinicaltrials.gov/show/NCT01982162

Nyckelord

Versioner (1)
  1. 2016-04-02 2016-04-02 -
Uppladdad den

2 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Asthma NCT01982162

Engelsk

Eligibility Asthma NCT01982162

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01982162
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. informed consent must be obtained prior to undertaking any study procedures.
Beskrivning

Informed consent | parent | Study Subject Participation Status | Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1321605
2. assent should be obtained from all children in the study where appropriate.
Beskrivning

Assent | Child

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1879749
UMLS CUI [1,2]
C0008059
3. male or female subject aged between 1 - 17 years inclusive at screening.
Beskrivning

Age | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
4. the parent / guardian, or where appropriate the child must be able to read, comprehend, and write at a sufficient level to complete study related materials.
Beskrivning

Parent | Able to read | Comprehension | Able to write | Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C0584993
UMLS CUI [1,5]
C1321605
5. subjects will be allowed to enrol in other studies while taking part on this study. however, permission from the scientific board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. as a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
Beskrivning

Child | Medically unfit | Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C3841806
UMLS CUI [2]
C0031809
2. the subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
Beskrivning

Drug Allergy | Other allergy | Medical contraindication | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C2886714
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2348568
3. subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. if a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
Beskrivning

Pregnancy | Breast Feeding | Postpartum Period | Breastfeeding stopped

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0086839
UMLS CUI [4]
C0420983
4. the child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. any u-biopred assessments should be deferred until 3 months after the first dose or invasive procedure. permission from the scientific board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Medical Procedure (invasive)

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C1548804
5. those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
Beskrivning

Compliance behavior | Risk Assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0086930
6. prematurity ≤35 weeks gestation
Beskrivning

Gestational Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0017504
7. the child had changed asthma medication within 4 weeks of the screening assessment(except those using the symbicort maintenance and reliever therapy (smart) regime)(assessment should be deferred)
Beskrivning

Asthma | Change of medication | Child | Symbicort | Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0580105
UMLS CUI [1,3]
C0008059
UMLS CUI [2,1]
C1121854
UMLS CUI [2,2]
C0087111
8. history or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
Beskrivning

Upper Respiratory Infections | Lower respiratory tract infection | Common Cold

Datatyp

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
UMLS CUI [3]
C0009443
9. the child has had a severe exacerbation (requiring er attendance or hospital admission and/or a course of high dose ocs for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
Beskrivning

Exacerbation of asthma | Severe | Child | Emergency room admission | Hospital admission | Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0008059
UMLS CUI [2]
C0583237
UMLS CUI [3]
C0184666
UMLS CUI [4]
C0001617
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Similar models

Eligibility Asthma NCT01982162

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01982162
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent | parent | Study Subject Participation Status | Compliance behavior
Item
1. parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. informed consent must be obtained prior to undertaking any study procedures.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
Assent | Child
Item
2. assent should be obtained from all children in the study where appropriate.
boolean
C1879749 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Age | Gender
Item
3. male or female subject aged between 1 - 17 years inclusive at screening.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Parent | Able to read | Comprehension | Able to write | Compliance behavior
Item
4. the parent / guardian, or where appropriate the child must be able to read, comprehend, and write at a sufficient level to complete study related materials.
boolean
C0030551 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0584993 (UMLS CUI [1,4])
C1321605 (UMLS CUI [1,5])
Study Subject Participation Status
Item
5. subjects will be allowed to enrol in other studies while taking part on this study. however, permission from the scientific board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Child | Medically unfit | Physical Examination
Item
1. as a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
boolean
C0008059 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
Drug Allergy | Other allergy | Medical contraindication | Study Subject Participation Status
Item
2. the subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
boolean
C0013182 (UMLS CUI [1])
C2886714 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Postpartum Period | Breastfeeding stopped
Item
3. subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. if a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0086839 (UMLS CUI [3])
C0420983 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Medical Procedure (invasive)
Item
4. the child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. any u-biopred assessments should be deferred until 3 months after the first dose or invasive procedure. permission from the scientific board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1548804 (UMLS CUI [3])
Compliance behavior | Risk Assessment
Item
5. those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
boolean
C1321605 (UMLS CUI [1,1])
C0086930 (UMLS CUI [1,2])
Gestational Age
Item
6. prematurity ≤35 weeks gestation
boolean
C0017504 (UMLS CUI [1])
Asthma | Change of medication | Child | Symbicort | Therapeutic procedure
Item
7. the child had changed asthma medication within 4 weeks of the screening assessment(except those using the symbicort maintenance and reliever therapy (smart) regime)(assessment should be deferred)
boolean
C0004096 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
C1121854 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Upper Respiratory Infections | Lower respiratory tract infection | Common Cold
Item
8. history or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
C0009443 (UMLS CUI [3])
Exacerbation of asthma | Severe | Child | Emergency room admission | Hospital admission | Adrenal Cortex Hormones
Item
9. the child has had a severe exacerbation (requiring er attendance or hospital admission and/or a course of high dose ocs for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
boolean
C0349790 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
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