UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023400
Receipt number R000026959
Scientific Title Study for clinical application of biogas analysis
Date of disclosure of the study information 2016/07/29
Last modified on 2019/08/01 09:37:53

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Basic information

Public title

Study for clinical application of biogas analysis

Acronym

Biogas anaysis study

Scientific Title

Study for clinical application of biogas analysis

Scientific Title:Acronym

Biogas anaysis study

Region

Japan


Condition

Condition

Cardiovascular disease

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate clinical usefulness of biogas analysis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between biogas results and clinical data

Key secondary outcomes



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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Cardiovascular disease

Key exclusion criteria

Dementia

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuchika Takeishi

Organization

Fukushima Medical University

Division name

Department of Cardiovascular Medicine

Zip code


Address

1, Hikarigaoka, Fukushima, Fukushima

TEL

024-547-1190

Email

takeishi@fmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuro Yokokawa

Organization

Fukushima Medical University

Division name

Department of Cardiovascular Medicine

Zip code


Address

1, Hikarigaoka, Fukushima, Fukushima

TEL

024-547-1190

Homepage URL


Email

yokotetu@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Grants-in-aid for Scientific Research, Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 07 Month 29 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

Completed

Date of protocol fixation

2016 Year 07 Month 29 Day

Date of IRB

2016 Year 07 Month 29 Day

Anticipated trial start date

2016 Year 07 Month 29 Day

Last follow-up date

2019 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study for patients with cardiovascular disease in Fukushima medical university hospital


Management information

Registered date

2016 Year 07 Month 29 Day

Last modified on

2019 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026959


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name