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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011723
Receipt No. R000013708
Scientific Title Effects of hypothermia and hyperthermia on the release of cytokines from immune cells
Date of disclosure of the study information 2013/09/12
Last modified on 2013/09/12

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Basic information
Public title Effects of hypothermia and hyperthermia on the release of cytokines from immune cells
Acronym Effects of hypothermia and hyperthermia on the release of cytokines from immune cells
Scientific Title Effects of hypothermia and hyperthermia on the release of cytokines from immune cells
Scientific Title:Acronym Effects of hypothermia and hyperthermia on the release of cytokines from immune cells
Region
Japan

Condition
Condition Healty Volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To know the effects of hypothermia and hyperthermia on the release of cytokines from immune cells
Basic objectives2 Others
Basic objectives -Others Kinetics of cytokine production
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Levels of cytokines production
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteer
Key exclusion criteria Subjects with a history of thyroid disease, renal disease, liver disease, diabetes, recent fracture, or pregnant women
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro MATSUI
Organization Yamaguchi University Graduate school of Medicine
Division name Laboratory sciences
Zip code
Address 1-1-1, Minami-kogushi, Ube
TEL 0836-22-2865
Email giants@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro MATSUI
Organization Yamaguchi University Graduate school of Medicine
Division name Laboratory sciences
Zip code
Address 1-1-1, Minami-kogushi, Ube
TEL 0836-22-2865
Homepage URL
Email giants@yamaguchi-u.ac.jp

Sponsor
Institute Tomohiro MATSUI
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization the Ministry of Education, Culture, Sports, Science, and Technology of Japan, Grant-in-Aid
Organization
Division
Category of Funding Organization
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
2013 Year 09 Month 12 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Random sampling

Management information
Registered date
2013 Year 09 Month 12 Day
Last modified on
2013 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013708


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