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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048499 |
Receipt No. | R000055270 |
Scientific Title | The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/28 |
Basic information | ||
Public title | The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial | |
Acronym | The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial | |
Scientific Title | The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial | |
Scientific Title:Acronym | The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial | |
Region |
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Condition | ||||
Condition | cardiopulmonary diseases | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We developed the clinical decision support system of machine learning model to assist cardiopulmonary auscultation. We hypothesized the system improve the correct answer rate of auscultation. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Total rate of correct answer |
Key secondary outcomes | Correct answer rate for each sound
Self-confidence in the answer |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | The participant of intervention group auscultate the previous recorded sounds with clinical decision support system from machine learning model. They completed the types of sounds they recognized and the self-confidence in a structured questionnaire. | |
Interventions/Control_2 | The participant of control group auscultate the previous recorded sounds. They completed the types of sounds they recognized and the self-confidence in a structured questionnaire. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | We recruit junior resident doctors and general internal medicine doctors from Dokkyo Medical University Hospital. | |||
Key exclusion criteria | We exclude the doctors with hearing loss, and the doctors who was unsuitable to participate this study. | |||
Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Dokkyo Medical University | ||||||
Division name | Department of Diagnostic and Generalist Medicine | ||||||
Zip code | 321-0293 | ||||||
Address | 880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi | ||||||
TEL | 0282861111 | ||||||
hirosawa@dokkyomed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Dokkyo Medical University | ||||||
Division name | Department of Diagnostic and Generalist Medicine | ||||||
Zip code | 321-0293 | ||||||
Address | 880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi | ||||||
TEL | 0282861111 | ||||||
Homepage URL | |||||||
hirosawa@dokkyomed.ac.jp |
Sponsor | |
Institute | Dokkyo Medical University |
Institute | |
Department |
Funding Source | |
Organization | Dokkyo Medical University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | The Ethics Committee of Dokkyo Medical University |
Address | 880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi |
Tel | 0282861111 |
r-kenkyu@dokkyomed.ac.jp |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055270 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |