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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016996
Receipt No. R000019333
Scientific Title A single institution study based on olfaction about an association with various kinds of end-stage symptoms for developing a novel technique of improving quality of life at the end of life
Date of disclosure of the study information 2015/04/01
Last modified on 2017/10/01

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Basic information
Public title A single institution study based on olfaction about an association with various kinds of end-stage symptoms for developing a novel technique of improving quality of life at the end of life
Acronym A single institution study about the association with olfaction and various kinds of end-stage symptoms
Scientific Title A single institution study based on olfaction about an association with various kinds of end-stage symptoms for developing a novel technique of improving quality of life at the end of life
Scientific Title:Acronym A single institution study about the association with olfaction and various kinds of end-stage symptoms
Region
Japan

Condition
Condition Dysosmia, Cacogeusia, Depression, Anxiety
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 First, this study aims to determine the association with olfactory and various kinds of symptoms. Second, this study try to identify the offending drug of dysosmia.
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Associations with olfactory and end-stage symptoms
Key secondary outcomes Associations with olfactory and drugs

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Test of olfactory, Test of taste, Assessment of depression and anxiety
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 Hospitalized patients in Ashiya Municipal Hospital who can assess olfactory, taste, depression and anxiety.
Key exclusion criteria Bedridden or heavily demented patients who can not assess olfactory, taste, depression and anxiety.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakajima Shinichiro, Okamoto Yoshiaki, Niki Kazuyuki
Organization Ashiya Municipal Hospital,
Osaka University
Division name Department of Palliative Care, Graduate School of Pharmaceutical Sciences, Department of Pharmacy
Zip code
Address Hyogo, Ashiya, Asahigaokacho 39-1, Osaka, Suita, Yamadaoka1-6
TEL 06-6879-8250
Email k-niki@phs.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Niki Kazuyuki
Organization Osaka University, Ashiya Municipal Hospital
Division name Graduate School of Pharmaceutical Sciences, Department of Pharmacy
Zip code
Address Osaka, Suita, Yamadaoka1-6
TEL 06-6879-8250
Homepage URL
Email k-niki@phs.osaka-u.ac.jp

Sponsor
Institute Ashiya Municipal Hospital, Osaka University, Graduate School of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Osaka-Yakugyo-Club
Organization
Division
Category of Funding Organization Other
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 市立芦屋病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 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
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
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 31 Day
Last modified on
2017 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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