Impact of the Clinical Trials Act on Noncommercial Clinical Research in Japan: An Interrupted Time-series Analysis

Background: The number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry. Methods: An interrupted time-series design was used in the analysis, which was conducted from April 2015 to March 2019. We collected data for studies registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network. Results: In total, 35, 811 studies were registered; of these, 16, 455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new studies after CTA enforcement decreased significantly by 15.0 (95% confidence interval [CI], −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) studies from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical studies, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors. Conclusions: The number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety

Path Loss Prediction Model for a Sloped Area in Microcell Based on Scale Model and Real Environment Measurements

The forests in Japan occupy 70% of the country, and there are many mountains and hills in Japan. As cities and residential areas have expanded the living space for people has spread to such hilly or sloped areas. Mobile communication systems are already a vital infrastructure to daily life, so covering these sloped areas is important in terms of service provisioning. It is necessary to predict propagation losses over the sloped areas for radio link design.The 1st IEEE Asia Pacific Conference on Wireless and Mobile 2014 (APWiMob 2014), Aug. 28-30, 2014, Grand Inna Kuta Hotel, Bali, Indonesi

Monitoring of muscle mass in critically ill patients : comparison of ultrasound and two bioelectrical impedance analysis devices

Background: Skeletal muscle atrophy commonly occurs in critically ill patients, and decreased muscle mass is associated with worse clinical outcomes. Muscle mass can be assessed using various tools, including ultrasound and bioelectrical impedance analysis (BIA). However, the effectiveness of muscle mass monitoring is unclear in critically ill patients. This study was conducted to compare ultrasound and BIA for the monitoring of muscle mass in critically ill patients. Methods: We recruited adult patients who were expected to undergo mechanical ventilation for > 48 h and to remain in the intensive care unit (ICU) for > 5 days. On days 1, 3, 5, 7, and 10, muscle mass was evaluated using an ultrasound and two BIA devices (Bioscan: Malton International, England; Physion: Nippon Shooter, Japan). The influence of fluid balance was also evaluated between each measurement day. Results: We analyzed 93 images in 21 patients. The age of the patients was 69 (interquartile range, IQR, 59–74) years, with 16 men and 5 women. The length of ICU stay was 11 days (IQR, 9–25 days). The muscle mass, monitored by ultrasound, decreased progressively by 9.2% (95% confidence interval (CI), 5.9–12.5%), 12.7% (95% CI, 9.3–16.1%), 18.2% (95% CI, 14.7–21.6%), and 21.8% (95% CI, 17.9–25.7%) on days 3, 5, 7, and 10 (p < 0.01), respectively, with no influence of fluid balance (r = 0.04, p = 0.74). The muscle mass did not decrease significantly in both the BIA devices (Bioscan, p = 0.14; Physion, p = 0.60), and an influence of fluid balance was observed (Bioscan, r = 0.37, p < 0.01; Physion, r = 0.51, p < 0.01). The muscle mass assessment at one point between ultrasound and BIA was moderately correlated (Bioscan, r = 0.51, p < 0.01; Physion, r = 0.37, p < 0.01), but the change of muscle mass in the same patient did not correlate between these two devices (Bioscan, r = − 0.05, p = 0.69; Physion, r = 0.23, p = 0.07). Conclusions: Ultrasound is suitable for sequential monitoring of muscle atrophy in critically ill patients. Monitoring by BIA should be carefully interpreted owing to the influence of fluid change

First mesopause temperature measurements using sodium lidar observations in the Antarctic region

The mesopause temperature structure was observed using a sodium temperature lidar system at Syowa Station (69°00\u27 S, 39°35\u27 E), beginning in February 2000. The laser transmitter was newly developed and included two injection-seeded Nd: YAG lasers. Regular observations were performed using the two-frequency technique as demonstrated by C.Y. She et al. (Geophys. Res. Lett., 17, 929, 1990), with a spatial resolution of about 1 km and a temporal resolution of 6 min. The temperature structures of the 85km to 105km region of the upper atmosphere were measured by Na D_2 Doppler profile-fitting as well as the two-frequency technique. Temperatures derived from the two techniques agreed well and were consistent with the MSIS 90 model temperature structure. Night-time temperature variations over a 15-hour period were measured in May 2000. A large temperature fluctuation with an interval of about 4 hours, and an amplitude of 60 K (probably caused by gravity waves) was observed. From the average night temperature profile, the mesopause was determined to be located at 102km, and have a temperature of 180K. These values are similar to winter values observed in the northern hemisphere

Excellent mechanical and corrosion properties of austenitic stainless steel with a unique crystallographic lamellar microstructure via selective laser melting

We first developed a unique “crystallographic lamellar microstructure” (CLM), in which two differently oriented grains appear alternately, in a 316L stainless steel specimen via selective laser melting technology. The CLM was composed of major 〈011〉 grains and minor 〈001〉 grains aligned along the build direction, which stemmed from vertical and approximately ±45° inclined columnar cells formed in the central and side parts of melt-pools, respectively. The development of CLM was found to largely improve the material properties via the strengthening of the product, simultaneously showing superior corrosion resistance to commercially obtained specimens.Sun S., Ishimoto T., Hagihara K., et al. Excellent mechanical and corrosion properties of austenitic stainless steel with a unique crystallographic lamellar microstructure via selective laser melting. Scripta Materialia, 159, 89. https://doi.org/10.1016/j.scriptamat.2018.09.017

Urinary titin as a biomarker for muscle atrophy

Objective: Although skeletal muscle atrophy is common in critically ill patients, biomarkers associated with muscle atrophy have not been identified reliably. Titin is a spring-like protein found in muscles and has become a measurable biomarker for muscle breakdown. We hypothesized that urinary titin is useful for monitoring muscle atrophy in critically ill patients. Therefore, we investigated urinary titin level and its association with muscle atrophy in critically ill patients. Design: Two-center, prospective observational study Setting: Mixed medical/surgical intensive care unit (ICU) in Japan Patients: Nonsurgical adult patients who were expected to remain in ICU for >5 days Interventions: None Methods: Urine samples were collected on days 1, 2, 3, 5, and 7 of ICU admission. To assess muscle atrophy, rectus femoris cross-sectional area and diaphragm thickness were measured with ultrasound on days 1, 3, 5, and 7. Secondary outcomes included its relationship with ICU-acquired weakness (ICU-AW), ICU Mobility Scale (IMS), and ICU mortality. Measurements and Main Results: Fifty-six patients and 232 urinary titin measurements were included. Urinary titin (normal range: 1–3 pmol/mg Cr) was 27.9 (16.8–59.6), 47.6 (23.5–82.4), 46.6 (24.4–97.6), 38.4 (23.6–83.0), and 49.3 (27.4–92.6) pmol/mg Cr on days 1, 2, 3, 5, and 7, respectively. Cumulative urinary titin level was significantly associated with rectus femoris muscle atrophy on days 3–7 (p < 0.03), although urinary titin level was not associated with change in diaphragm thickness (p = 0.31–0.45). Furthermore, cumulative urinary titin level was associated with incidence of ICU-AW (p = 0.01) and ICU mortality (p = 0.02) but not with IMS (p = 0.18). Conclusions: In nonsurgical critically ill patients, urinary titin level increased 10–30 times compared with the normal level. The increased urinary titin level was associated with lower limb muscle atrophy, incidence of ICU-AW, and ICU mortality

Flexible Multifunctional Sensors for Wearable and Robotic Applications

This review provides an overview of the current state-of-the-art of the emerging field of flexible multifunctional sensors for wearable and robotic applications. In these application sectors, there is a demand for high sensitivity, accuracy, reproducibility, mechanical flexibility, and low cost. The ability to empower robots and future electronic skin (e-skin) with high resolution, high sensitivity, and rapid response sensing capabilities is of interest to a broad range of applications including wearable healthcare devices, biomedical prosthesis, and human–machine interacting robots such as service robots for the elderly and electronic skin to provide a range of diagnostic and monitoring capabilities. A range of sensory mechanisms is examined including piezoelectric, pyroelectric, piezoresistive, and there is particular emphasis on hybrid sensors that provide multifunctional sensing capability. As an alternative to the physical sensors described above, optical sensors have the potential to be used as a robot or e-skin; this includes sensory color changes using photonic crystals, liquid crystals, and mechanochromic effects. Potential future areas of research are discussed and the challenge for these exciting materials is to enhance their integration into wearables and robotic applications.</p

Cool core disturbed: Observational evidence for coexistence of sub-sonic sloshing gas and stripped shock-heated gas around the core of RX J1347.5-1145

RXJ1347.5-1145 (z = 0.451) is one of the most luminous X-ray galaxy clusters, which hosts a prominent cool core and exhibits a signature of a major merger. We present the first direct observational evidence for sub-sonic nature of sloshing motion of the cool core. We find that a residual X-ray image from the Chandra X-ray Observatory after removing the global emission shows a clear dipolar pattern characteristic of gas sloshing, whereas we find no significant residual in the Sunyaev-Zel'dovich effect (SZE) image from the Atacama Large Millimeter/submillimeter Array (ALMA). We estimate the equation of state of perturbations in the gas from the X-ray and SZE residual images. The inferred velocity is 420 +310 -420 km s-1, which is much lower than the adiabatic sound speed of the intracluster medium in the core. We thus conclude that the perturbation is nearly isobaric, and gas sloshing motion is consistent with being in pressure equilibrium. Next, we report evidence for gas stripping of an infalling subcluster, which likely shock-heats gas to high temperature well in excess of 20 keV. Using mass distribution inferred from strong lensing images of the Hubble Space Telescope (HST), we find that the mass peak is located away from the peak position of stripped gas with statistical significance of > 5{\sigma}. Unlike for the gas sloshing, the velocity inferred from the equation of state of the excess hot gas is comparable to the adiabatic sound speed expected for the 20 keV intracluster medium. All of the results support that the southeast substructure is created by a merger. On the other hand, the positional offset between the mass and the gas limits the self-interaction cross section of dark matter to be less than 3.7 h-1 cm2 g-1 (95% CL).Comment: 18 pages, 10 figures, accepted for publication in Ap