UMIN-CTR Clinical Trial

Basic information
Public title	Sampling of vomitus for making artificial vomitus
Acronym	Sampling of vomitus
Scientific Title	Sampling of vomitus for making artificial vomitus
Scientific Title:Acronym	Sampling of vomitus
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Sampling of vomitus
Basic objectives2	Others
Basic objectives -Others	Sampling
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	none
Key secondary outcomes	none

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The person who vomited in Tokyo Heart Center
Key exclusion criteria	Infectious diseases such as the infectious enteritis
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Kobayashi
Organization	Tokyo Heart Center
Division name	pharmacy
Zip code	141-0001
Address	5-4-12 Kita-Shinagawa, Shinagawa-ku, Tokyo
TEL	03-5789-8115
Email	pkobayashi@tokyoheart.or.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Kobayashi
Organization	Tokyo Heart Center
Division name	pharmacy
Zip code	141-0001
Address	5-4-12 Kita-Shinagawa, Shinagawa-ku, Tokyo
TEL	03-5789-8115
Homepage URL
Email	pkobayashi@tokyoheart.or.jp

Sponsor
Institute	Tokyo Heart Center
Institute
Department

Funding Source
Organization	Tokyo Heart Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

Other related organizations
Co-sponsor	Tokyo University of Science Faculty of Pharmaceutical Sciences
Name of secondary funder(s)	Tokyo University of Science Faculty of Pharmaceutical Sciences

IRB Contact (For public release)
Organization	Tokyo Heart Center
Address	5-4-12 Kita-Shinagawa, Shinagawa-ku, Tokyo
Tel	03-5789-8115
Email	cposhima@j-gcpl.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	0082CR
Org. issuing International ID_1	Tokyo Heart Center Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団 冠心会 大崎病院東京ハートセンター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 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	20
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	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 06 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Sampling Target person: The person who vomited in Tokyo Heart Center and showed an oral agreement

Management information
Registered date	2018 Year 03 Month 01 Day
Last modified on	2019 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036016