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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026271
Receipt No. R000030170
Scientific Title Heart rate monitoring during oral food challenge
Date of disclosure of the study information 2017/08/01
Last modified on 2017/02/23

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Basic information
Public title Heart rate monitoring during oral food challenge
Acronym Heart rate monitoring during oral food challenge
Scientific Title Heart rate monitoring during oral food challenge
Scientific Title:Acronym Heart rate monitoring during oral food challenge
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the usefulness of heart rate monitoring during oral food challenge for performing the test without severe adverse event
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate change rate from baseline heart rate value.
Key secondary outcomes heart rate differences.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria The person who was able to conduct an examination calmly
Key exclusion criteria The person who was not able to conduct an examination calmly
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhito Iikura
Organization Jikei university hospital
Division name pediatrics
Zip code
Address Tokyo Jikei University Hospital
TEL 0334331111
Email k.i.96002@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kastuhito Iikura
Organization Jikei university hospital
Division name Pediatrics
Zip code
Address 3-19-18 Nishishinbashi
TEL 0334331111
Homepage URL
Email k.i.96002@gmail.com

Sponsor
Institute Jikei university hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Heart rate data of 50 subjects were analyzed
by off-line. The differences of heart rate value among groups were analyzed.

Management information
Registered date
2017 Year 02 Month 23 Day
Last modified on
2017 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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