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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024658
Receipt No. R000028366
Scientific Title Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/31

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Basic information
Public title Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Acronym Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Scientific Title Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Scientific Title:Acronym Nursing research on pain associated with subcutaneous Treprostinil Therapy in patients with pulmonary arterial hypertension
Region
Japan

Condition
Condition pulmonary arterial hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the problems of nursing care in pain management to the Cardiology definitive Treprostinil continuous subcutaneous administration patient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes

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 Patients who had done Treprostinil continuous subcutaneous administration from October 2015 until June 2016.
Key exclusion criteria Not set for the case study.
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chie Myouchin
Organization hospital
Division name West 9 floor
Zip code
Address 1-1 Seryoutyou Aoba-ku Sedai-shi Miyagi-ken 8574-980
TEL 022-717-7786
Email dbfhw551@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Myouchin
Organization Tohoku University
Division name West 9 Floor
Zip code
Address 1-1 Seryoutyou Aoba-ku Sedai-shi Miyagi-ken 8574-980
TEL 022-7171-7786
Homepage URL
Email dbfhw551@yahoo.co.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In the west 9 floor ward researchers belong, to target the two patients who started the Trepurostinil continuous subcutaneous administration to pulmonary hypertension. Symptoms from the October 2015 first case of the subject was admitted to the second example in June 2016 by the subject was discharged of, about the contents of the implementation nursing intervention, information collected from nursing records and medical records. Lack of information to supplement with your recorder. Further, based on the data obtained from nursing records and medical records, summarized in chronological nursing interventions

Management information
Registered date
2016 Year 10 Month 31 Day
Last modified on
2016 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028366

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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