UMIN-CTR Clinical Trial

Basic information
Public title	Attribution of non-ClinicalTrials.gov registries among World Health Organization International Clinical Trials Registry Platform-registered trials from 2014 to 2018: a meta-epidemiological study
Acronym	Attribution of non-ClinicalTrials.gov registries from 2014 to 2018
Scientific Title	Attribution of non-ClinicalTrials.gov registries among World Health Organization International Clinical Trials Registry Platform-registered trials from 2014 to 2018: a meta-epidemiological study
Scientific Title:Acronym	Attribution of non-ClinicalTrials.gov registries from 2014 to 2018
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

Condition
Condition	registered trials on World Health Organization International Clinical Trials Registry Platform (ICTRP)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will report the attribution of non-ClinicalTrials.gov registries among ICTRP-registered trials from 2014 to 2018.
Basic objectives2	Others
Basic objectives -Others	We will compare characteristics of registered clinical trials on ClinicalTrials.gov and on other registries among ICTRP from 2014 to 2018 and investigate distribution of primary registries about trials of top five countries in order of the quantity of registered trials among ICTRP.
Trial characteristics_1	Others
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The total attribution of non-ClinicalTrials.gov registries among ICTRP-registered trials in each year from 2014 to 2018.
Key secondary outcomes	1. The attribution of each non-ClinicalTrials.gov registry among ICTRP-registered trials in each year from 2014 to 2018. 2. Recruitment status, target sample size, study type, study design, countries, prospective registration (Yes, No), funding (Yes, No), and study phase of the trials on ClinicalTrials.gov and on other registries from 2014 to 2018. 3. Distribution of primary registries about trials of top five countries in order of the quantity of registered trials among ICTRP

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	All clinical trials registered on ICTRP from 1 January 2014 to 31 December 2018.
Key exclusion criteria	Observational studies, using <study type> in the data set.
Target sample size	0

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Banno
Organization	Seichiryo Hospital
Division name	Department of Psychiatry
Zip code
Address	4-16-27, Tsurumai, Showa-ku, Nagoya City, Aichi Prefecture, 466-0064 Japan
TEL	+81-52-741-1231
Email	delerium.rurutia2018@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Masahiro Banno
Organization	Seichiryo Hospital
Division name	Department of Psychiatry
Zip code
Address	4-16-27, Tsurumai, Showa-ku, Nagoya City, Aichi Prefecture, 466-0064 Japan
TEL	+81-52-741-1231
Homepage URL
Email	delerium.rurutia2018@gmail.com

Sponsor
Institute	Department of Psychiatry, Seichiryo Hospital
Institute
Department

Funding Source
Organization	1. Department of Respiratory Medicine , Hyogo Prefectural Amagasaki General Medical Center 2. Nagoya University Academy of Psyc hiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2018 Year 10 Month 09 Day

Related information
URL releasing protocol	https://doi.org/10.7287/peerj.preprints.27298v2
Publication of results	Published

Result
URL related to results and publications	https://www.jclinepi.com/article/S0895-4356(19)30557-8/pdf
Number of participants that the trial has enrolled	0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 09 Month 12 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 09 Day
Date of IRB	2018 Year 10 Month 30 Day
Anticipated trial start date	2019 Year 03 Month 12 Day
Last follow-up date	2019 Year 06 Month 09 Day
Date of closure to data entry	2019 Year 06 Month 09 Day
Date trial data considered complete	2019 Year 06 Month 09 Day
Date analysis concluded	2019 Year 06 Month 09 Day

Other
Other related information	The total attribution of non-ClinicalTrials.gov registries among ICTRP-registered trials in each year from 2014 to 2018. Date of IRB is dummy data because this study did not need ethics approval.

Management information
Registered date	2018 Year 10 Month 07 Day
Last modified on	2019 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039230