臨床研究等提出・公開システム

Scientific Title	Between Oxygenation in the Body and Functional Prognosis in Patients with Amyotrophic Lateral Sclerosis.
Public Title	Between Oxygenation in the Body and Functional Prognosis in Patients with Amyotrophic Lateral Sclerosis.

Contact for Scientific Queries	Name	Ogita Mihoko
	Affiliation	Shiga University of Medical Science
	Address	Seta Tsukinowa-cho, Otsu, Shiga, Japan
	Telephone	+81-77-548-2390
	E-mail	tan3434@belle.shiga-med.ac.jp
Contact for Public Queries	Name	Ogita Mihoko
	Affiliation	Shiga University of Medical Science
	Address	Seta Tsukinowa-cho, Otsu, Shiga, Japan
	Telephone	+81-77-548-2390
	E-mail	tan3434@belle.shiga-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2023
Actual date of first enrollment		May. 23, 2023
Target sample size		60
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with a diagnosis of ALS who are 20 years old or older The most recent ALSFRS-R score in the hospital is 21points or higher Expected hospitalization period is 5days or more
	Exclusion Criteria	The most recent ALSFRS-R score in the hospital is less than 21points
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Amyotrophic Lateral Sclerosis
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D000690
Intervention(s) Code
Primary Outcome(s)		ALSFRS-R score after 6 months
Secondary Outcome(s)		Life prognosis after 2 years

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology, Grants-in-Aid for Scientific Research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Shiga University of Medical Science Ethics Review office
Address	Seta Tsukinowa-cho, Otsu, Shiga, Japan, Shiga
Telephone	+81-77-548-3576
E-Mail	hqrec@belle.shiga-med.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none