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Hitomi Ejiri,1 Hiroyuki Uchida,2 Kenji Tsuchiya,3 Kazuhiko Fujiwara,4 Senichiro Kikuchi,1,5 Kazuki Hirao1,5 1Department of Occupational Therapy, Faculty of Medicine, Gunma University, Maebashi, Japan; 2Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan; 3Department of Rehabilitation, Faculty of Health Sciences, Nagano University of Health and Medicine, Nagano, Japan; 4Department of Rehabilitation Sciences, Faculty of Rehabilitation Sciences, Nishikyushu University, Kanzaki, Japan; 5Graduate School of Health Sciences, Gunma University, Maebashi, JapanCorrespondence: Kazuki Hirao, Graduate School of Health Sciences, Gunma University, 3-39-22 Showa, Maebashi, Gunma, 371-8514, Japan, Tel +81-27-220-8952, Fax +81-27-220-8952, Email kazuki.hirao@gunma-u.ac.jpBackground: Preventive interventions for subthreshold depression (StD) are essential to reduce the incidence of major depressive disorder. Our smartphone application presenting positive word stimulation in video (ie, Subliminal Priming with Supraliminal Reward Stimulation, SPSRS) was suggested to improve depressive symptoms in people with StD, although it is unclear whether it can immediately improve depressed mood. This pilot randomized controlled trial (RCT) aimed to investigate the preliminary efficacy of SPSRS application intervention on depressive mood in people with StD.Methods: Thirty-two participants with StD were randomly assigned to the experimental (n = 16) or control group (n = 16). The experimental group received SPSRS application intervention (10-minute video with positive word stimulation) and the control group received YouTube application intervention (10-minute video without positive word stimulation). Both groups used identical iPhones managed by the research team. The primary outcome was the change from baseline in depression-dejection on the Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short) after the intervention.Results: No participants dropped out of the study. The experimental group showed a small improvement in depression-dejection on the POMS 2-A Short score (adjusted Hedges’s g = − 0.32) compared to the control group. Post-hoc power analyses estimated a sample size of 56 per group (112 total) to evaluate depression-dejection on the POMS 2-A Short in a future full-scale RCT.Conclusion: SPSRS application intervention may be effective in immediately improving depressive mood in people with StD. A future full-scale RCT based on a formally calculated sample size should be conducted to replicate these findings.Keywords: depressed mood, subthreshold depression, mobile application

Hiroyuki Uchida,1 Chiaki Kuroiwa,2 Sae Ohki,3 Kana Takahashi,4 Kenji Tsuchiya,5 Senichiro Kikuchi,2,3 Kazuki Hirao2,3 1Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan; 2Graduate School of Health Sciences, Gunma University, Maebashi, Japan; 3Department of Occupational Therapy, Faculty of Medicine, Gunma University, Maebashi, Japan; 4Department of Rehabilitation, Okayama Kounan Hospital, Okayama, Japan; 5Department of Rehabilitation, Faculty of Health Sciences, Nagano University of Health and Medicine, Nagano, JapanCorrespondence: Kazuki Hirao, Graduate School of Health Sciences, Gunma University, 3-39-22 Showa, Maebashi, Gunma, 371-8514, Japan, Tel/Fax +81-27-220-8952, Email kazuki.hirao@gunma-u.ac.jpBackground: Psychological distress is prevalent worldwide and can lead to the development of mental conditions such as major depression and anxiety disorders. It is essential to assess the severity of patient-reported outcomes to provide effective treatment for psychological distress. The Kessler Psychological Distress Scale (K6) is one of the most widely used psychological distress scales. However, the smallest detectable change (SDC) of the K6 score has not been elucidated. Therefore, the current study aimed to determine the SDC of the K6 score in a Japanese adult population.Methods: Participants aged 20– 59 years who are native Japanese speakers were recruited from the panel list of a web research firm. The K6 score was assessed at baseline (T1) and at 2-week follow-up (T2). SDCs were calculated at the individual (SDCind) and group (SDCgroup) levels. Intraclass correlation coefficient agreement (ICCagreement) was calculated to assess test–retest reliability and Cronbach’s alpha to evaluate internal consistency.Results: A total of 3254 (1627 [50%] female) responded at T1 and T2. The mean (standard deviation) K6 scores were 5.71 (5.84) at T1 and 5.65 (5.83) at T2. The SDCind and SDCgroup of the K6 score were 8.47 (35.31%) and 0.15 (0.63%), respectively. The ICCagreement was 0.73, and the Cronbach’s alpha was 0.94.Conclusion: Our study provided evidence on the reliability and interpretation of the K6 score. Calculating the SDC of the K6 score can help identify the significance of changes in psychological distress over time and can determine the efficacy of interventions for psychological distress.Keywords: psychological distress, reliability, measurement error, mental health

Hitomi Ejiri,1 Hiroyuki Uchida,2 Kenji Tsuchiya,1,3 Kazuhiko Fujiwara,4 Senichiro Kikuchi,1,3 Kazuki Hirao1,3 1School of Health Sciences, Faculty of Medicine, Gunma University, Maebashi, Japan; 2Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan; 3Graduate School of Health Sciences, Gunma University, Maebashi, Japan; 4Department of Rehabilitation Sciences, Faculty of Rehabilitation Sciences, Nishikyusyu University, Kanzaki, JapanCorrespondence: Kazuki HiraoGraduate School of Health Sciences, Gunma University, 3-39-22 Showa, Maebashi, Gunma, 371-8514, JapanTel/Fax +81-27-220-8952Email kazuki.hirao@gunma-u.ac.jpBackground: Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study presents a protocol for investigating the immediate effects of the SPSRS application intervention on depressed mood in people with StD.Methods: The study is designed as an open-label, parallel-group, and pilot randomized controlled trial (RCT). Thirty-two people who meet the criteria for StD (Beck Depression Inventory-II score of 10 points or more and fails to meet the diagnostic criteria for MDD) will be recruited and studied. It compares the immediate effects of the SPSRS application intervention (with positive word stimulus in a 10-minute video; n = 16) and YouTube application intervention (without positive word stimulus in 10-minute video; n = 16). The primary outcome is the change in the score for the Profile of Mood States 2nd Edition-Adult Short after 10 minutes of intervention. The secondary outcome is the change in the State–Trait Anxiety Inventory State after 10 min of intervention.Discussion: The pilot RCT is the first to evaluate the immediate effects of the SPSRS application intervention on depressed mood in people with StD. The results are expected to provide a preliminary outcome of the immediate effect of the SPSRS application on the depressed mood of people with StD and aid in planning a full-scale trial.Trial Registration: ClinicalTrials.gov; Identifier: NCT03864484.Keywords: depression, subthreshold depression, depressed mood, mobile application, smartphone

Koki Tsuchiya,1 Koji Ishikawa,1 Soji Tani,1 Yusuke Oshita,2 Takuma Kuroda,1 Ryo Yamamura,1 Haruka Emori,1 Hiroshi Maruyama,1 Akira Matsuoka,1 Yoshifumi Kudo,1 Toshiyuki Shirahata,1 Tomoaki Toyone,1 Takashi Nagai,1 Katsunori Inagaki11Department of Orthopaedic Surgery, Showa University School of Medicine, Tokyo 142-8666, Japan; 2Department of Orthopaedic Surgery, Yamanashi Red Cross Hospital, Yamanashi, JapanAbstract: Discontinuation of denosumab during osteoporosis treatment leads to rapid loss of bone mineral density and induces a bone turnover rebound effect. Previous studies have reported analysis based on dual-energy X-ray absorptiometry scanning (DXA). Here, we report the first case involving analysis of three-dimensional bone mineral density and bone strength, measured by quantitative computed tomography (QCT) after discontinuation of denosumab. An 82-year-old woman who discontinued denosumab because of patient’s wish was administered the fifth dose after a gap of 14 months. Her bone mineral density evaluated by DXA and QCT, bone strength, and bone turnover marker levels showed significant rebound phenomenon. The levels of the cortical parameters of the hip were also decreased indicating an increased risk of femoral fractures after denosumab interruption. Our case highlights the increased risk of fractures after discontinuation of denosumab. Therefore, denosumab must be used judiciously without interruption in the dosage schedule.Keywords: lumbar spine, femoral neck, bone turnover markers, cortical bone, biomechanical analysis

Koji Ishikawa,1–3 Takashi Nagai,1 Koki Tsuchiya,1 Yusuke Oshita,3 Takuma Kuroda,1 Hiroshi Ito,1 Soji Tani,1 Yusuke Dodo,1 Tomoaki Toyone,1 Katsunori Inagaki1 1Department of Orthopaedic Surgery, Showa University School of Medicine, Tokyo, Japan; 2Department of Orthopaedic and Spine Surgery, Sanraku Hospital, Tokyo, Japan; 3Department of Orthopaedic Surgery, Yamanashi Red Cross Hospital, Yamanashi, Japan Abstract: Denosumab is a fully human monoclonal antibody against the receptor activator of nuclear factor-κB ligand (RANKL) that is used for the treatment of osteoporosis. Denosumab-induced hypocalcemia is a rare but important adverse event, which is usually asymptomatic in patients with osteoporosis. It is also known that hypocalcemia is common in patients with bone metastases and severe renal impairment. Here we report a case of symptomatic hypocalcemia following administration of 60 mg of denosumab in a patient with high bone turnover and no renal impairment (estimated glomerular filtration rate [eGFR], 71 mL/min), despite prophylactic oral vitamin D administration. This report supports our observation that there is a risk of protracted and marked denosumab-induced hypocalcemia in patients with high bone turnover, irrespective of their degree of renal impairment. Keywords: denosumab, symptomatic hypocalcemia, high bone turnover, no renal impairment

Shunji Suzuki,1,2 Norio Hanafusa,3 Kenji Kubota,1 Ken Tsuchiya,3 Kosaku Nitta2 1Department of Nephrology, Kawaguchi Saiseikai Hospital, Kawaguchi, Japan; 2Department of Medicine, Kidney Center, Tokyo Women’s Medical University, Tokyo, Japan; 3Department of Blood Purification, Kidney Center, Tokyo Women’s Medical University, Tokyo, Japan Background: Fluid overload in chronic kidney disease (CKD) is generally controlled by diuretics, with potentially harmful effects on renal function. The efficacy of tolvaptan, a vasopressin V2-receptor antagonist and aquaretic, has not been evaluated for fluid control in CKD with reduced renal function.Methods: Each patient from a group of 24 CKD patients on tolvaptan 15 mg/d plus conventional diuretics (T group) was matched by age and sex with a patient from a group of 24 CKD patients on conventional nonaquaretic diuretics alone not associated to tolvaptan other than tolvaptan (C group). Changes in renal function were compared between the groups for 1 year.Results: There were no significant differences in blood pressure, hemoglobin levels, cardiac function, urine specific gravity, and urinary sodium concentration between the 2 groups at the beginning of the follow-up period and 1 year after. The estimated glomerular filtration rate (eGFR) by the formula developed by Japanese Society of Nephrology (in mL/min/1.73 m2) decreased: C group (from 28.3±13.6 to 23.0±12.3, p=0.09), T group (from 22.7±12.4 to 19.4±12.2, p=0.18), but both did not reach significance. A 50% reduction in eGFR was observed in 4 patients in the C group and 1 in the T group (p

Kenji Tsuchiya,1 Shinichi Mitsui,1 Ryuji Fukuyama,2 Noriki Yamaya,3 Takaaki Fujita,4 Kaori Shimoda,1 Fusae Tozato1 1Department of Rehabilitation Sciences, Gunma University Graduate School of Health Sciences, Gunma, 2Department of Rehabilitation, Gunma Seishi Ryougoen, Gunma, 3Department of Health Sciences, Gunma University School of Medicine, Gunma, 4Department of Rehabilitation, Faculty of Health Sciences, Tohoku Fukushi University, Miyagi, Japan Purpose: Although acute bouts of exercise reportedly have beneficial effects on executive function, inactive people may find it difficult to start exercising. In this study, we focused on housework activities (HAs) that generate a sense of accomplishment and require a mild intensity of physical activity. We examined the impact of an acute bout of HA on executive function and oxygenated hemoglobin (oxy-Hb) flow to related cortical regions. Materials and methods: Twenty-five participants (age, 18–21 years; mean, 19.88±0.60 years; six males and 19 females) underwent two experiments, ie, HA and control experiments, which were conducted on different days. Participants vacuumed a dirty floor in the HA experiment and mimicked the same motion with an unplugged vacuum cleaner on a clean floor in the control experiment.Results: Heart rate recorded during the experiments showed no significant difference in the intensity of physical activity between control and HA groups. A questionnaire revealed a sense of accomplishment after completing the HA experiment. Participants performed the Stroop color–word task (SCWT) pre- and post-experiments; cortical hemodynamic changes were simultaneously monitored using functional near-infrared spectroscopy. Variation in Stroop interference scores for SCWT total response between pre- and post-experiments was significantly higher in the HA group than in the control group, and that for SCWT correct response showed a similar trend. Variation in the Stroop interference score for oxy-Hb flow to the right ventrolateral prefrontal cortex (R-VLPFC) showed the same trend.Conclusion: Thus, HAs may have a greater beneficial effect on executive function than other physical activities through the activation of PFC, including R-VLPFC. Keywords: cognitive function, near-infrared spectroscopy, cleaning, stroop interference, positive emotion, prefrontal cortex

Koh Takeuchi,1 Atsushi Hirota,2 Sachito Minegishi,1 Jotaro Kobayashi,1 Keiji Tsuchiya3 1Division of Cardiovascular Surgery, 2Department of Neonatology, 3Department of Pediatrics, Japanese Red Cross Medical Center, Shibuya, Tokyo, Japan Abstract: Pharmacological and/or surgical closure of a hemodynamically significant patent ductus arteriosus (PDA) in the very premature infant has been the standard of care over the past few decades. However, the rationale for closure of PDA has recently been challenged. In this article, three ways of approaching the closure of PDA including pharmacological treatment, catheter intervention, and surgical intervention, are reviewed in detail. In addition, the different treatment strategies applied in clinical care are evaluated with a focus on the discussion of the available evidence of PDA treatment in the literature. Keywords: patent ductus arteriosus, premature infant, treatment option

Keiko Tsuchiya1, Norihisa Nitta1, Akinaga Sonoda1, Ayumi Nitta-Seko1, Shinichi Ohta1, Masashi Takahashi1, Kiyoshi Murata1, Kenichi Mukaisho2, Masashi Shiomi3, Yasuhiko Tabata4, Satoshi Nohara51Department of Radiology, 2Department of Pathology, Shiga University of Medical Science, Otsu, Shiga, 3Institute for Experimental Animals, Kobe University School of Medicine, Kobe, Hyogo, 4Department of Biomaterials, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, 5Nagoya Research Laboratory, Meito Sangyo, Kiyosu, Aichi, JapanAbstract: Magnetic resonance imaging (MRI) can detect atherosclerotic lesions containing accumulations of ultrasmall superparamagnetic iron oxides (USPIO). Positing that improved USPIO with a higher affinity for atherosclerotic plaques would yield better plaque images, we performed MRI and histologic studies to compare the uptake of dextran- and mannan–dextran-coated USPIO (D-USPIO and DM-USPIO, respectively) by the atherosclerotic walls of rabbits. We intravenously injected atherosclerotic rabbits with DM-USPIO (n = 5) or D-USPIO (n = 5). Two rabbits were the controls. The doses delivered were 0.08 (dose 1) (n = 1), 0.4 (dose 2) (n = 1), or 0.8 (dose 3) (n = 3) mmol iron/Kg. The dose 3 rabbits underwent in vivo contrast-enhanced magnetic resonance angiography (MRA) before and 5 days after USPIO administration. Afterwards, all animals were euthanized, the aortae were removed and subjected to in vitro MRI study. The signal-to-noise ratio (SNR) of the aortic wall in the same region of interest (ROI) was calculated in both in vivo and in vitro studies. Histological assessment through measurement of iron-positive regions in Prussian blue-stained specimens showed that iron-positive regions were significantly larger in rabbits injected with DM- rather than D-USPIO (P < 0.05) for all doses. In vivo MRA showed that the SNR-reducing effect of DM- was greater than that of D-USPIO (P < 0.05). With in vitro MRI scans, SNR was significantly lower in rabbits treated with dose 2 of DM-USPIO compared with D-USPIO treatment (P < 0.05), and it tended to be lower at dose 3 (P < 0.1). In conclusion, we suggest that DM-USPIO is superior to D-USPIO for the study of atherosclerotic lesions in rabbits.Keywords: atherosclerosis, magnetic resonance imaging, contrast media, plaque, mannan–dextran-coated USPIO

Keiko Tsuchiya1, Norihisa Nitta1, Akinaga Sonoda1, Ayumi Nitta-Seko1, Shinichi Ohta1, Hideji Otani1, Masashi Takahashi1, Kiyoshi Murata1, Katsutoshi Murase2, Satoshi Nohara2, Kenichi Mukaisho31Department of Radiology, Shiga University of Medical Science, Otsu, Shiga, 2The Nagoya Research Laboratory, Meito Sangyo Co, Ltd, Kiyosu, Aichi, 3Department of Pathology, Shiga University of Medical Science, Otsu, Shiga, JapanAbstract: The biodynamics of ultrasmall and small superparamagnetic iron oxide (USPIO and SPIO, respectively) particles that were injected intraperitoneally into 36 C57BL/6 mice were investigated chronologically. Their distribution was studied histologically at six time points by measuring iron-positive areas (µm2) in organ sections stained with Prussian blue. The uptake of the differently sized particles was also compared by cultured murine macrophages (J774.1). Iron-positive areas in the liver were significantly larger in the mice injected with USPIO than those injected with SPIO at the first three time points (P < 0.05). The amount of USPIO in the lung parenchyma around the airway was larger than that of SPIO at four time points (P < 0.05); distribution to the lymph nodes was not significantly different. The amount of iron was significantly larger in SPIO- than USPIO-treated cultured cells (P < 0.05). In conclusion, it is suggested that intra peritoneally injected USPIO particles could be used more quickly than SPIO to make Kupffer images of the liver and that both agents could help get lymph node images of similar quality.Keywords: USPIO, SPIO, contrast agent, biodistribution, histology

With reducing the size and weight of electric devices, high-tensile, light and fine copper wire is demanded. So the production technique of a copper wire plated on a super fiber resin (Vectran film) was researched for improving the adhesion strength between the copper and the resin. In this study, we used the Cu2+ or Pd2+ complex prepared with a chemically adsorbed monolayer (CAM) to improve the adhesion strength between the copper plated layer and the Vectran film. As the result of scotch tape test, it was observed that the adhesion strength between the copper plated layer and Vectran film was improved by the Cu2+ or Pd2+ complex CAM.