ABSTRACT
Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
ABSTRACT
Objectives: To assess humoral and cellular immune responses and safety profiles after two doses of different mRNA vaccine against SARS-CoV- 2;BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) in patients with rheumatic musculoskeletal disease (RMD). Method(s): We enrolled consecutive, previously uninfected RMD patients with inflammatory rheumatic diseases receiving mRNA vaccine including BNT162b2 and mRNA-1273. Healthy participants all receiving BNT162b2 were recruited as control. Blood samples were obtained 3weeks after second dose of vaccines. We measured titres of neutralizing antibodies against SARS-CoV- 2 with chemiluminescent enzyme immunoassay to evaluate humoral responses and assessed T-cell immunity responses with interferon releasing assay against SARS-CoV- 2 in a part of the patients. Adverse reaction symptoms were obtained from participants through questionnaire. Result(s): A total of 1040 RMD patients and healthy 621 control participants were enrolled. Among RMD patients with immunosuppressants, 704 were received BNT162b2 and 156 were received mRNA-1273. Neutralizing antibody titres 3 weeks after vaccination and positive seroconversion rates were significantly higher in healthy participants with BNT162b2 and RMD patients with mRNA-1273 compared with RMD patients with BNT162b2;neutralizing antibody titre, 23.9 +/- 14.2 IU/mL vs 29.4 +/- 33.9 IU/mL vs 10.8 +/- 16.5 IU/mL, p < 0.001;seroconversion rates, 99.5% vs 99.4% vs 80.2%, p < 0.001, respectively, We identified that age, glucocorticoid (prednisolone dose > 7.5mg/day), and use of immunosuppressants including methotrexate, mycophenolate and rituximab, are associated with attenuation of humoral responses in patients with BNT162b2. T cell reaction against SARS-CoV- 2 were also higher in patients with RMD vaccinated with mRNA-1273 than those with BNT162b2 (Interferon gamma levels for antigen 1, 3.2 +/- 6.5 IU/mL vs 0.6 +/- 1.3 IU/mL, p = 0.002;for antigen 2, 3.2 +/- 6.3 IU/mL vs 1.0 +/- 2.1 IU/mL, p = 0.021, respectively). Regarding adverse reaction of mRNA vaccine, the proportion of systemic adverse reactions including fever and general fatigue are significantly higher in healthy controls and RMD patients with mRNA-1273 than those with BNT162b2;fever, 46.2% vs 56.7% vs 14.3%, p < 0.001;general fatigue, 62.6% vs 73.0% vs 38.5%, p < 0.001, respectively, while the frequency of background RMD flare after vaccination were not significantly different between mRNA-1273 and BNT162b2 (5.2% [n = 8] vs. 3.7% [n = 26], p = 0.41) Conclusion(s): We demonstrated higher humoral, cellular immunogenicity of the SARS-CoV- 2 mRNA-1273 (Moderna) compared with the BNT162b2 (Pfizer-BioNTech) in RMD patients. Although reactogenicity including systemic adverse reaction including fever and fatigue were observed mRNA1273 vaccinated patients, proportion of RMD relapse were similar between the patients with mRNA-1273 and BNT162b2.
ABSTRACT
Recently, tourism contents concerning a slope way has attracted lots of attention. A severe slope way has significant risk for tourists to abort their plan because of avoiding to be tired. However, its solution is not fully developed. In Post-Covid (Coronavirus disease)-19 environment, support for tourism in an actual field could become imperative again. Therefore, the present paper develops and evaluates a system to reduce the above-mentioned negative factor of a slope way. Concretely, we propose the following three menus in our system: 1) a menu to show some useful or helpful spots existing along a severe slope way, 2) a menu to show how much useful for diet trial based on the gap of two elevations such as the highest and lowest points, and 3) a communication menu to helpful character emerging along a severe slope way. We develop these three menus and provide tourists with positive factors derived from walking a slope way. It also brings some novel values of a severe slope way walking. We have evaluated our pilot system by the following two method: (1) evaluation experiment with some subjects, and (2) interviews to tourism professionals. Both of their results shows that our system would be useful in order to encourage nervous tourists towards a severe slope way. © 2022 IEEE.
ABSTRACT
The COVID-19 pandemic caused by a virus called RARS-CoV-2 spread worldwide. As the result, the number of people who are lack exercise has increased. In addition, there are few systems to evaluate exercise movements and facilitate physical exercise at home. In this study, we developed a boxing glove type sensation device an acceleration sensor was installed in a boxing glove to evaluate the power of a punch, and the device has the function of glitz to the punches by producing sound, vibration, and light according to the type and power of the punching motion. An evaluation experiment was conducted to confirm that this device could induce exercise and promote health by having fun. A comparison was made between a normal boxing glove and the boxing glove type sensation device. As the results, we could confirm that, the number of strong punches with high acceleration and the total number of punches increased in the sensation device. In addition, the heart rate after exercise increased significantly compared to before and after exercise. The results also showed an increase in mood elevation and positive emotions. © 2022 IEEE.