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INFORMED CONSENT | Informed consent was obtained from all individual participants included in the study. | PMC10315327 | ||
TRIAL REGISTRATION | Iranian Registry of Clinical Trial (registered prospectively: IRCT20191112045424N1; available at: | PMC10315327 | ||
ACKNOWLEDGMENTS | We are tankful to all study participants. We would like to thank the Clinical Research Development Unit, Imam Reza Hospital, Mashhad University of Medical Sciences, for their assistance in this manuscript. | PMC10315327 | ||
DATA AVAILABILITY STATEMENT | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10315327 | ||
REFERENCES | PMC10315327 | |||
Objective | NONALCOHOLIC FATTY LIVER DISEASE, TYPE 2 DIABETES | Academic Editor: Ferdinando Carlo Sasso The aim of study was to evaluate the effect and safety of pioglitazone-metformin combined treatment in the newly diagnosed type 2 diabetes patients with nonalcoholic fatty liver disease. | PMC10250100 | |
Methods | nonalcoholic fatty liver disease | NONALCOHOLIC FATTY LIVER DISEASE, TYPE 2 DIABETES | A total of 120 newly diagnosed type 2 diabetes patients with nonalcoholic fatty liver disease from 8 centers were randomly divided into the control group (metformin hydrochloride) and the test group (pioglitazone hydrochloride and metformin hydrochloride). | PMC10250100 |
Results | fatty liver | FATTY LIVER | Compared to the control group, after treatment, the proportion of people with mild and moderate fatty liver increased, and the proportion of people with severe fatty liver decreased, and this change was more obvious in the population with moderate and severe fatty liver. The level of | PMC10250100 |
Conclusion | diabetic | ADVERSE EVENTS, NONALCOHOLIC FATTY LIVER DISEASE | Combined treatment with pioglitazone-metformin can effectively reduce liver fat content and gamma-GT level in newly diagnosed diabetic patients with nonalcoholic fatty liver disease, and adverse events do not increase compared with the control group, showing good safety and tolerance. This trial is registered with Cli... | PMC10250100 |
1. Introduction | NAFLD, fatty liver, weight gain, hypoglycemic, type 2 diabetes, diabetes | ADVERSE EVENTS, FATTY LIVER, CHRONIC DISEASES, INSULIN RESISTANCE, TYPE 2 DIABETES, DIABETES | As one of the most common chronic diseases, the prevalence rate of diabetes in China has skyrocketed, and the estimated prevalence of diabetes in Chinese adults is 11.6%, with type 2 diabetes predominating [Clinically, NAFLD is currently treated with multiple drugs, one of which is insulin sensitizer. Many literature r... | PMC10250100 |
2. Materials and Methods | PMC10250100 | |||
2.1. Study Design and Participants | This study was a randomized, double-blind, double-simulation, and positive drug control multicenter clinical trial (ClinicalTrials.gov registration number: Inclusion criteria are as follows: according to WHO criteria, age 18-70 years old, BMI between 21 and 35 kg/m | PMC10250100 | ||
2.2. Randomization and Masking | LIVER | Through a computer-generated centralized management program, all participants were randomized by a stratified computed randomization procedure to account for age, sex, and BMI to test group or control group at a ratio of 1 : 1 and were masked to the treatment assignment. The test group received pioglitazone-metformin c... | PMC10250100 | |
2.3. Procedures | thirst, gastrointestinal tolerance, overdose, hypoglycemia, weight loss | HYPOGLYCEMIA, CONCOMITANT DISEASE | In order to improve gastrointestinal tolerance, all patients in the group received a weekly dose titration. The initial dose of the test group was once a day, 500 mg metformin and 15 mg pioglitazone (both from Hangzhou Zhongmei Huadong Pharma Ceutical Co., Ltd.) were taken before breakfast or dinner, and after 1 week o... | PMC10250100 |
2.4. Quantitative Ultrasound for Liver Steatosis | In our study, we mainly used controlled attenuation parameter (CAP) for liver fat quantification, which is best studied and clinically available technique for liver fat quantification, with the first clinical studies dating back to 2010 [ | PMC10250100 | ||
2.5. Outcomes | fasting blood glucose, hypoglycemic, postprandial blood glucose | EVENTS, SECONDARY, INSULIN RESISTANCE | The primary end points are liver fat content (ultrasonic quantitative determination of liver fat content), ALT, AST, gamma-GT levels, and insulin resistance index. The secondary endpoints are HbA1c, intravenous fasting blood glucose, 2 h postprandial blood glucose, total cholesterol, triglyceride, HDL cholesterol, LDL ... | PMC10250100 |
2.6. Statistical Analysis | The statistical analysis was performed using SAS (9.1.3) statistical analysis software. The | PMC10250100 | ||
3. Results | PMC10250100 | |||
3.1. Baseline Characteristics | NAFLD | TYPE 2 DIABETES | This study enrolled a total of 120 type 2 diabetes patients with NAFLD from 8 hospitals in Shaanxi Province. As shown in the Consolidated Standards of Reporting Trials (CONSORT) diagram in | PMC10250100 |
3.2. Primary Endpoint Measurement | After 24 weeks of treatment, 8 (13%) of the 60 patients in the test group had substantial improvement in degree of liver fat content, and the degree of liver fat content decreased from moderate and severe grade to mild grade. In contrast, 4 of 60 patients (6%) in the metformin group saw their liver fat content drop fro... | PMC10250100 | ||
3.3. Secondary Endpoint Measurement | After 24 weeks of treatment, the HbA1c level of the pioglitazone-metformin combined treatment group and the metformin treatment group decreased significantly (pioglitazone-metformin combined treatment: 1.78% (95% CI: 1.53-2.04) and metformin treatment: 1.71% (95% CI: 1.46-1.96)), but there was no significant difference... | PMC10250100 | ||
3.4. Safety Evaluation | In this study, the compliance of pioglitazone-metformin combined treatment group was 95.79%, and that of the metformin group was 95.10%. As shown in | PMC10250100 | ||
4. Discussion | NAFLD, occult blood, diarrhea, fatty liver, adverse cardiovascular events, angina pectoris, liver cirrhosis, ALD, NAFL, hypoglycemic, metabolic stress liver injury, hypertension | ADVERSE REACTIONS, ALCOHOLIC LIVER DISEASE, HYPERTENSION, ADVERSE EVENTS, NONALCOHOLIC STEATOHEPATITIS (NASH), DISEASE, NONALCOHOLIC FATTY LIVER, FATTY LIVER, LIVER CIRRHOSIS, INSULIN RESISTANCE, HEPATOCELLULAR CARCINOMA, NONALCOHOLIC FATTY LIVER DISEASE, ALD, TYPE 2 DIABETES | Nonalcoholic fatty liver disease is a metabolic stress liver injury closely related to insulin resistance and genetic susceptibility. Except that the patient has no history of excessive drinking, its pathological changes are similar to alcoholic liver disease (ALD). The disease spectrum includes nonalcoholic fatty live... | PMC10250100 |
5. Limitation | NAFLD | Although our research is a randomized, double-blinded, double-simulated multicenter study, but our research still has some limitations. First of all, our study did not incorporate the gold standard of liver biopsy into our main results because of the expected early stages of NAFLD in these patients and the short durati... | PMC10250100 | |
6. Conclusion | NAFLD, fatty liver | FATTY LIVER, TYPE 2 DIABETES | In conclusion, the results of this study showed that in the observation period of 24 weeks, in newly diagnosed type 2 diabetes patients with NAFLD, the pioglitazone-metformin combined treatment can effectively reduce liver fat content, especially in patients with moderate to severe fatty liver and | PMC10250100 |
Acknowledgments | We thank all the participants, investigators, and trial-site staff who were involved in the conduct of the study. We also thank Hangzhou Zhongmei Huadong Pharma Ceutical Co., Ltd. for providing free experimental drugs and placebos. This study was funded by the Xijing Hospital. | PMC10250100 | ||
Data Availability | The original contributions presented in the study are included in the article. Further inquiries can be directed to the corresponding author. | PMC10250100 | ||
Ethical Approval | The research protocol was approved by the Ethics Committee of Xijing Hospital of Air Force Medical University (ClinicalTrials.gov registration number: | PMC10250100 | ||
Consent | Written informed consent was obtained from all the participants after a full explanation of the study. | PMC10250100 | ||
Disclosure | This trial represents independent academic research funded by Xijing Hospital. The trial drug and placebo were provided free of charge by Hangzhou Zhongmei Huadong Pharma Ceutical Co., Ltd., which did not participate in the design of the experiment, collection, analysis, and interpretation of data, report writing, and ... | PMC10250100 | ||
Conflicts of Interest | All authors participating in this study reported no conflicts of interest. | PMC10250100 | ||
Authors' Contributions | ±, fatty liver | ADVERSE EVENTS, FATTY LIVER | F.J.F and J.Q.H participated in the conception and design of this research, explained the data, and critically revised the manuscript. All authors have read and approved the final version. All authors participated in data collection, collation, and manuscript writing. All authors are guarantors of this work and are res... | PMC10250100 |
Supplementary Information | lymphopenia | LYMPHOPENIA, MYOCARDIAL INFARCTION (MI) | Myocardial infarction (MI) accelerates immune ageing characterised by lymphopenia, expansion of terminally differentiated CD8The online version contains supplementary material available at 10.1007/s11357-023-00794-6. | PMC10122201 |
Keywords | PMC10122201 | |||
Introduction | death | MYOCARDIAL INFARCTION (MI), ACUTE CORONARY SYNDROME, PROLIFERATION, INFLAMMATION, VIRAL INFECTION, EVENTS | Despite modern advances in therapy, myocardial infarction (MI) still carries a substantial risk of death or recurrent cardiovascular events [Immunosenescence is mainly linked to thymic involution and changes in cellular immunity as a response to pathogens, such as recurrent viral infections, throughout life [Lymphocyte... | PMC10122201 |
Methods | PMC10122201 | |||
Trial design and oversight | coronary heart disease | CORONARY HEART DISEASE | The TACTIC trial was a single-centre, randomized, double-blind, parallel-group, placebo-controlled phase IIa pilot trial comparing TA-65 with placebo in 90 participants with coronary heart disease who were diagnosed with myocardial infarction in the 6 months prior to enrolment. A total of 90 patients were randomized to... | PMC10122201 |
Trial population | comorbidity, substance addiction, obstructive coronary artery disease, malignancy, NSTEMI, epicardial vessel stenosis, arrhythmias, immunological dysfunction, hepatitis | ACUTE MYOCARDIAL INFARCTION, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, BLOOD, EVENT, DISEASE, CARDIOGENIC SHOCK, ARRHYTHMIAS, HEPATITIS, INSULIN-DEPENDENT DIABETES MELLITUS | Patients were eligible for the trial if they a) were aged 65 years or over with an index presentation of an acute myocardial infarction (either STEMI or NSTEMI) within the previous 6 months, b) had successfully completed revascularisation or were being managed medically following myocardial infarction, c) had evidence ... | PMC10122201 |
Randomization and blinding | NSTEMI | Randomisation was performed using a minimisation scheme to ensure patients randomised to each group were comparable at baseline. The minimisation scheme accounted for gender (male or female), type of MI (STEMI or NSTEMI) and proportion of terminally differentiated effector memory CD8 | PMC10122201 | |
Outcome measures | The primary outcome measure was the proportion of CD8 | PMC10122201 | ||
Flow-cytometric assays | Two different assays were used for flow cytometric analysis of leucocytes. All measurements were performed on fresh blood within 4 h of collection. There was no significant amount of non-viable cells (< 1%) with this approach. The TruCount assay (containing CD45, CD3, CD4, CD8, CD19, CD16, CD56 fluorochrome-labelled mo... | PMC10122201 | ||
Telomerase activity | LYSED | Nuclear telomerase activity in peripheral blood mononuclear cells (PBMCs) was measured using the Telomerase Repeated Activation Protocol (TRAP) – quantitative polymerase chain reaction (qPCR) assay. Within 24 h of collection, whole blood was centrifuged to isolate PBMCs, which were cryopreserved at − 80 C. The cells we... | PMC10122201 | |
Oxidative stress | OXIDATIVE STRESS | Oxidative stress was measured using the TBARS colorimetric assay. This assay is described in detail in the | PMC10122201 | |
Endothelial function | hyperaemia | HYPERAEMIA, PAT | Endothelial function was evaluated using the EndoPAT device (Itamar Medical Ltd, Caesarea, Israel). This non-invasive operator-independent system consists of finger probes that measures peripheral arterial tone (PAT) for 5 min at rest and during reactive hyperaemia induced by 5-min forearm cuff occlusion. The reactive ... | PMC10122201 |
Echocardiography | Transthoracic echocardiography (TTE) was performed at baseline and 12 months to evaluate left ventricular function including global longitudinal strain ( | PMC10122201 | ||
Adverse events | ADVERSE REACTIONS, ADVERSE EVENT, EVENT, ADVERSE EVENTS | Adverse events (AEs), adverse reactions (ARs), serious adverse events (SAEs), and serious adverse reactions (SARs) were assessed by a medical practitioner for severity and causality. The severity of each was classified as follows: grade 1—minor event not requiring medical intervention, grade 2—an event which is symptom... | PMC10122201 | |
Statistical analysis | Continuous variables were reported by number, mean ± SD, median (IQR) or minimum and maximum, whereas number and percentages summarised categorical variables. The proportion of CD8 | PMC10122201 | ||
Results | PMC10122201 | |||
Trial progress | All patients were recruited at The James Cook University Hospital, Middlesbrough, UK, between 21Consolidated Standards of Reporting Trials (CONSORT) diagram of patient enrolment. The diagram shows the number of patients who met the inclusion or exclusion criteria and their distribution among the two study groups. TA-65... | PMC10122201 | ||
Effect on telomerase activity and oxidative stress | Nuclear telomerase activity did not change significantly between baseline and 12 months in either group. The estimated change after 12 months in telomerase activity was + 22.9 (95% CI − 91.8–136.0) in the placebo group, and + 18.5 (95% CI: − 89.4–125.9) in the TA-65 group (Table | PMC10122201 | ||
Effect on endothelial function and cardiac function | There were no significant treatment effects of TA-65 on reactive hyperaemic index after 6 or 12 months compared to baseline (Table | PMC10122201 | ||
Discussion | MYOCARDIAL INFARCTION | In this novel clinical trial investigating TA-65 versus placebo in patients aged 65 years and over following myocardial infarction, we established four main results: there was no significant change in senescence-like CD8 | PMC10122201 | |
Reversal of lymphopenia under TA-65 | lymphopenia, NSTEMI | LYMPHOPENIA | We demonstrated that TA-65 led to a reversal of relative lymphopenia. This was notable in NSTEMI but not STEMI patients. In STEMI, baseline lymphocytes are elevated between 24 and 72 h post reperfusion [ | PMC10122201 |
Mitochondrial dysfunction in T cells as a driver of senescence and inflammageing | mitochondrial dysfunction | MITOCHONDRIAL DYSFUNCTION | Senescence can be driven directly by mitochondrial dysfunction [ | PMC10122201 |
Mitochondrial telomerase activation as a potential mechanism of TA-65 | Although there is no direct evidence to suggest that mitochondrial Tert protects against senescence induction, global TERT activation inhibits senescence [ | PMC10122201 | ||
Inflammation as a residual risk post ACS | hypercholesterolemia, myocardial infarction, TA-65, impaired innate immunity, inflammation, infections, sepsis, platelet aggregation, coronary artery disease | HYPERCHOLESTEROLEMIA, MYOCARDIAL INFARCTION, ADVERSE EVENTS, INFLAMMATION, INFECTIONS, EVENTS, SEPSIS, CORONARY ARTERY DISEASE | Secondary prevention in patients who have undergone revascularisation after myocardial infarction aims to reduce their residual risk, predominantly by targeting hypercholesterolemia (with cholesterol-lowering agents) and platelet aggregation (with antiplatelet therapy). Recently, inflammation, as quantified by hsCRP, h... | PMC10122201 |
Limitations | Our trial did not have an age matched healthy control. It is not clear whether TA-65 preserves lymphocyte count for the age group or accelerates its return to normal after MI. While a reduction in hsCRP is demonstrated, measurement of systemic cytokine levels is needed to elucidate the impact of TA-65 on SASP. We used ... | PMC10122201 | ||
Conclusion | myocardial infarction, TA-65 | MYOCARDIAL INFARCTION | Our pilot trial suggests that activation of telomerase could be a promising new drug target for patients following MI. Given the significant findings in lymphocyte increase, the trend in hsCRP reduction, as well as the extremely favourable safety profile, we propose as a next step a larger phase II clinical trial with ... | PMC10122201 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 11827 KB) | PMC10122201 | ||
Acknowledgements | HEART | The trial was funded by TA-Sciences Inc (New York, US) as an investigator-led grant to I.S.BK is supported by a British Heart Foundation personal chair (CH//13/2/30154). K. Stellos is supported by grants from the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme (... | PMC10122201 | |
Data availability | Data are available upon request and following approval by the trial steering committee. | PMC10122201 | ||
Declarations | PMC10122201 | |||
Conflict of interest | The authors declare no competing interests. | PMC10122201 | ||
References | PMC10122201 | |||
Background | mental illness | Some children of parents with mental illness need support. This study aimed to develop and test the effectiveness of an e-learning program for training elementary schoolteachers to support children of parents with mental illness. | PMC10024023 | |
Methods | mental illness | The program, which included a 30-min video-based e-learning program, aimed to help schoolteachers gain basic knowledge about mental illness and children of parents with mental illness, recognize children in need of support, and gain confidence in supporting them. A school-based cluster randomized controlled trial was c... | PMC10024023 | |
Results | Baseline responses were collected from 87 participants in the intervention group and 84 in the control group. The total score of the Sense of Coping Difficulty subscale at T3 was significantly lower in the intervention group than in the control group ( | PMC10024023 | ||
Conclusions | mental illness | The program was effective for schoolteachers in supporting children of parents with mental illness. | PMC10024023 | |
Trial registration | UMIN000045483; 14/09/2021. | PMC10024023 | ||
Keywords | PMC10024023 | |||
Background | mental illness | Mental illness is an important public health issue affecting many people, with one in five Japanese individuals reportedly being affected during their lifetime [In Japan, it has only been about 15 years since the existence of children raised by parents with mental illness became known to society [Even if the children t... | PMC10024023 | |
Methods | PMC10024023 | |||
Design | A school-based cluster randomized controlled trial (RCT) was conducted to test the effectiveness of the program. Contamination of the information provided across groups within the same school may have occurred. Therefore, the RCTs of schoolteachers could use schools as clusters [The program, which was offered online on... | PMC10024023 | ||
Study participants | Requests for research participation were sent to 322 public elementary schools in three Japanese prefectures. Only schools that were willing to cooperate were included in the study.A maximum of 10 schoolteachers participated from each school. The inclusion criterion was full-time schoolteachers, and the exclusion crite... | PMC10024023 | ||
Program development | mental illness | DISORDERS | The program was called the WATASHI-KOKO (“We are here” in Japanese) PROGRAM. It involved a 30-min video-based e-learning program for elementary schoolteachers, which was designed to help them support children of parents with mental illness. It aimed to help schoolteachers gain basic knowledge about mental illness and c... | PMC10024023 |
Outcome measures | The outcomes were measured at the individual level. The questionnaire was developed by multidisciplinary experts who were research members of this project. The pre-test was conducted among 18 elementary schoolteachers. After watching the video of the program, they were asked to answer the questionnaire and also asked t... | PMC10024023 | ||
Confidence in supporting children | The Sense of Coping Difficulty subscale was used to assess confidence in supporting children (Purpose 3 of the program). The Sense of Coping Difficulty/Possibility Scale refers to analogous concepts of self-efficacy, which is the expectation that professionals can deal with difficult situations [ | PMC10024023 | ||
Actual behaviors and attitude | Three self-developed questions were used at T1 and T3 in order to assess the effects of program Purposes 2 and 3 on behaviors and attitudes. The program introduced the life situations of children in need of support and highlighted certain signs to look out for when identifying such children. The first question asked sc... | PMC10024023 | ||
Knowledge | mental illness | Knowledge questions, with responses that could be correct or incorrect, were administered to the schoolteachers; they were developed in order to assess program Purpose 1 (gaining basic knowledge about mental illness and children of parents with mental illness). The five items related to parental mental illness were lif... | PMC10024023 | |
Program goals achievement | mental illness, illness | The degree to which the participants had achieved the eight items representing the program goals was measured using a seven-point scale ranging from “not at all” (1 point) to “very well” (7 points). The following goals were set as an assessment for achieving program Purpose 1: 1) be able to describe the impact of paren... | PMC10024023 | |
Process and feasibility evaluation measures | The process and feasibility evaluation measures were as follows: program satisfaction (very satisfied, somewhat satisfied, not very satisfied, not satisfied at all); whether the participants would recommend the program to other schoolteachers (would recommend, would not recommend); length of the program (long, just rig... | PMC10024023 | ||
Basic characteristics | mental illness | The basic characteristics included age, gender, years of experience, job title, experience in special needs teaching, experience of supporting parents with mental illness, experience of supporting students with mental illness, experience of learning about mental illness, and the history of someone close, who has, or is... | PMC10024023 | |
Randomization and blinding | mental illness | BLIND | When school-based applications were received by the research office, a random number table was prepared by a person who was unrelated to the implementation process, and independent allocations were made to either the intervention or control group in the order of arrival of the applications. After the school application... | PMC10024023 |
Analyses | As the primary population, the full analysis set (FAS), excluding the scores of those who did not respond to T1 from all randomized participants, was used in all analyses, except process and feasibility evaluation. The per-protocol set (PPS), which excluded participants who did not respond on time, those who did not co... | PMC10024023 | ||
Ethical procedures | ADVERSE EVENTS | This study was approved by the Ethics Committee for the Intervention Study of Osaka University Hospital (approval no. 21144; 5/10/2021). Written informed consent was obtained from all the participants. This study was conducted in accordance with the principles of the Declaration of Helsinki. This project has been regis... | PMC10024023 | |
Results | PMC10024023 | |||
Study participants | infection | MAY, INFECTION | This study was conducted between October 2021 and May 2022. The flow of study participants is shown in Fig. Flow of study participantsEighty-six participants in the intervention group and 82 in the control group completed T3. Of the 86 participants in the intervention group, 73 became PPS, excluding 8, who responded af... | PMC10024023 |
Process and feasibility evaluations | In the intervention group, 83 of 86 participants were "very satisfied" or "somewhat satisfied" with the program, and three were "not very satisfied." Regarding whether they would recommend the program to other schoolteachers, 85 were "willing to recommend" and 1 was "unwilling to recommend.” The length of the program w... | PMC10024023 | ||
Discussion | PMC10024023 | |||
Study participants | mental illness, illness | The intervention and control groups had approximately the same number of clusters and schoolteachers, with no significant baseline differences. The mean age of the study participants was 43.6 years (intervention group) and 41.1 years (control group), similar to the mean age of public elementary schoolteachers in Japan,... | PMC10024023 | |
Effectiveness of the program | mental illness | The program was effective in reducing schoolteachers’ difficulty in supporting children of parents with mental illness. The effect sizes were as large as –0.90 (FAS) and –0.86 (PPS). Goal attainment was also effective for over one month. Few studies on mental health interventions for schoolteachers have been conducted ... | PMC10024023 | |
Program feasibility and adaptation to practice | Although Japanese schoolteachers are very busy, 168 of the 171 baseline participants remained in the study until the end. This may have been due to the short duration of the program (30 min) and the easy participation in the e-learning format, which was not restricted to any location and allowed them to choose their ow... | PMC10024023 | ||
Study limitations | This study had several limitations. First, the program assessed the understanding and behaviors of individual schoolteachers but not the organizational response of the school as a whole. There were opinions that in order to identify and support children, not only the efforts of individual schoolteachers, but also the w... | PMC10024023 | ||
Conclusion | mental illness | We developed a 30-min video-based e-learning program to help elementary schoolteachers support children of parents with mental illness and evaluated its effectiveness using a school-based cluster randomized controlled trial. It was observed that it was significantly effective, over one month, in reducing difficulties i... | PMC10024023 | |
Acknowledgements | mental illness | We thank all elementary schoolteachers who contributed to our research. I would like to thank the core group members of the self-help group for adult children of parents with mental illness, “KODOMO-PEER.” We also thank Prof. Yoshie Hamashima (Osaka Dental University) and Ms. Natsumi Asada (Taanto Life) for their advic... | PMC10024023 | |
Authors’ contributions | RS | Design of the study: MK, AM; development of the program: MK, AK, TS, YE, AM, SS, HK, SI, KY; development of question items: MK, YE, SS, AM; coordination with research fields: AM, KY, MK; quantitative analysis: RS; qualitative analysis: MK, KK; data management: MK, KK, HK; manuscript preparation: MK. All the authors hav... | PMC10024023 | |
Funding | This study was supported by JSPS KAKENHI (grant numbers JP 19H03960 and 20K10788). | PMC10024023 | ||
Availability of data and materials | The materials for this program are openly available ( | PMC10024023 | ||
Declarations | PMC10024023 | |||
Ethics approval and consent to participate | ADVERSE EVENTS | This study was approved by the Ethics Committee for the Intervention Study of Osaka University Hospital (approval no. 21144; 5/10/2021). Written informed consent was obtained from all the participants. This study was conducted in accordance with the principles of the Declaration of Helsinki. This project has been regis... | PMC10024023 |
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