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Abstract In December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued and implemented the guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance. This guideline recommends the use of a tiered approach to assess clinically meaningful driving impairment. It is noted that adverse events cannot be solely explained by pharmacokinetics, as the onset and duration of these events vary. Among these adverse events, those affecting alertness, such as drowsiness caused by psychotropic drugs on driving performance, are more frequently observed during initial treatment stages and dose escalation. Hence, when evaluating the effects of psychotropic drugs on driving performance, it becomes crucial to assess the persistence of clinically meaningful impairment. Therefore, the MHLW guideline, developed by the authors, emphasizes the need to assess the temporal profile of adverse events affecting driving in all clinical trials. Additionally, the guideline states that when conducting driving studies, the timing of multiple dosing should consider not only the pharmacokinetics of the investigational drug but also its tolerance.

Abstract The association between daily breakfast habits during pregnancy and offspring neurodevelopment remains unknown. We evaluated the association between breakfast habits during pregnancy and offspring neurodevelopment. Data of 72,260 women with singleton deliveries at and after 37 weeks of gestation enrolled during 2011–2014 in the Japan Environment and Children’s Study were analysed. Offspring neurodevelopmental delays at 3 years of age were evaluated using the Ages and Stages Questionnaire, Third Edition (ASQ-3). Participants were stratified by tertiles of maternal daily energy intake (DEI) (Groups 1, 2, and 3:

Abstract We evaluated the association between gestational age at threatened preterm birth (TPTB) diagnosis and preterm birth (PTB) incidence using a nationwide birth cohort. Data of 94,236 women with singleton deliveries from the Japan Environment and Children’s Study (enrolled between 2011 and 2014) were analysed. Participants were divided based on parity and gestational age at TPTB diagnosis (22–24, 25–27, 28–30, 31–33, and 34–36 weeks). Multivariable logistic regression models were used to calculate the odds ratios (ORs) for PTB before 37 and 34 weeks in women from all groups, using participants without TPTB as the reference. The adjusted ORs for PTB before 37 weeks were the highest in the latest gestational age group in nulliparous and multiparous women without previous PTB, while those before 34 weeks were the highest in the earliest and latest gestational age group in multiparous women without previous PTB and in the earliest gestational age group in multiparous women with previous PTB. The association between gestational age at TPTB diagnosis and PTB incidence varies based on maternal parity and PTB before 37 or 34 weeks. Further studies with detailed clinical data and a unified TPTB diagnosis protocol are necessary to clarify this association.

Abstract In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies. Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.

Objectives To evaluate the association between urinary 8-hydroxy-2′-deoxyguanosine (U8-OHdG) level—a marker of oxidative stress—and the incidence of preterm births (PTBs).Design Prospective cohort study.Setting The Japan Environment and Children’s Study (JECS).Participants Data from 92 715 women with singleton pregnancies at and after 22 weeks of gestation who were enrolled in the JECS, a nationwide birth cohort study, between 2011 and 2014 were analysed. U8-OHdG levels were assessed once in the second/third trimester using liquid chromatography–tandem mass spectrometry. Participants were categorised into the following three or five groups: low (

Abstract This study evaluated the association between labour duration (LD) and incidence of low neonatal Apgar scores and foetal acidosis. Data of 37,682 women with full-term singleton spontaneous vaginal deliveries from the Japan Environment and Children’s Study were analysed. Women were classified according to the median LD as nulliparous (

Abstract Background In reproductive medicine, vitamin D (VitD) is of particular interest because its deficiency has been linked to various infertility issues. Thus, preconception care, including appropriate VitD supplementation, is essential, especially in women using assisted reproductive technology (ART). Despite the therapeutic benefits of VitD, adverse events due to a high daily intake may influence obstetric outcomes. However, the effects of either low or high preconception VitD intake on obstetric outcomes, including the outcomes in women who used ART, remain unclear. Therefore, the aim of this study was to examine the association between pre-pregnancy daily VitD intake and obstetric outcomes in Japanese women, including those who conceived through ART. Methods Data were obtained from the Japan Environment and Children’s study database comprising 92,571 women recruited between January 2011 and March 2014 in Japan. Participants were categorized into five quintiles according to pre-pregnancy VitD intake (Q1 and Q5 had the lowest and highest VitD intake, respectively) and stratified according to the use of ART. Multiple logistic regression was performed to identify the effects of pre-pregnancy VitD intake on preterm birth (PTB), low-birth weight infant (LBW), and small for gestational age (SGA). Results Using Q3 (middle VitD intake) as a reference, our analysis revealed that Q5 (highest VitD intake) showed an increased risk of LBW

Abstract Background While breastfeeding provides benefits for infants and the mother, many women either do not breastfeed or terminate breastfeeding earlier than recommended. The aim of this analysis was to identify factors associated with early discontinuation of breastfeeding in Japanese women. Methods This study used data from medical records of women delivering a singleton live birth between March 2017 and August 2019 in Iwase General Hospital, Fukushima Prefecture, Japan to assess cessation of breastfeeding by the 1-month postpartum appointment. Demographic (age at birth, and employment status), medical (parity, and physical and mental condition of the mother; and infant medical factors, such as sex, Apgar score, and jaundice, among other), and family factors (husband/partner, family members living at the same house, among others) in 734 women who had initiated breastfeeding during their delivery hospital stay were examined, and multiple logistic regression was used to determine significant predictors of early cessation of exclusive breastfeeding. Results Bivariate analysis revealed that women who were primipara, unmarried, exposed to secondhand smoke, and employed; those who smoked before pregnancy; and those who had asthma were more likely to discontinue exclusive breastfeeding than other women. Infant factors associated with discontinuation were lower birthweight, earlier gestational age, neonatal intensive care unit admission, treatment for jaundice, or lower weight gain. Multivariable analysis revealed that primiparity, passive smoking before pregnancy, maternal employment, and neonatal jaundice therapy were associated with discontinuation of breastfeeding. Conclusions In particular, women whose partners smoked before pregnancy may need to be targeted for additional support for breastfeeding.

Abstract Background The association of maternal preconception dysmenorrhea, especially primary dysmenorrhea, with obstetric complications has not been clearly described. Therefore, we evaluated the association of preconception dysmenorrhea with obstetric complications while accounting for the presence of pelvic pathologies. Methods We analyzed the data of women with singleton live births at and after 22 weeks of gestation enrolled in the Japan Environment and Children’s Study, a nationwide birth cohort study, between 2011 and 2014. Participants with psychological disorders were excluded. Preconception dysmenorrhea, identified in the medical record transcripts, was categorized into mild dysmenorrhea (MD) and severe dysmenorrhea (SD). Furthermore, excluding those who had pelvic pathologies via self-reported questionnaires (endometriosis, adenomyosis, and uterine myomas) with MD and SD, preconception dysmenorrhea was categorized into mild primary dysmenorrhea (MPD) and severe primary dysmenorrhea (SPD), respectively. Using multiple logistic regression, adjusted odds ratios (aORs) for obstetric complications, including preterm birth (PTB) before 37 weeks and 34 weeks, small-for-gestational-age infants, preterm premature rupture of membrane, and hypertensive disorders of pregnancy, were calculated (considering confounders) in women with (1) MD or SD and (2) MPD or SPD. Women without preconception dysmenorrhea were used as a reference. Results A total of 80,242 participants were analyzed. In women with SD, the aOR for PTB before 37 weeks was 1.38 (95% confidence interval [CI] 1.10, 1.72). In women with SPD, the aOR for PTB before 37 weeks was 1.32 (95% CI 1.02, 1.71). There was no association between women with MD or MPD and obstetric complications. Conclusions SD and SPD are significantly associated with an increased incidence of PTB before 37 weeks. Care providers should provide proper counseling regarding the association between preconception dysmenorrhea and obstetric complications. Optimal management of pregnant women with preconception dysmenorrhea to reduce the incidence of PTB should be elucidated in further studies, with detailed clinical data of pelvic pathologies.

Previous evidence indicated that interventions with combined neuromuscular electrical stimulation (NMES) and voluntary muscle contractions could have superior effects on corticospinal excitability when the produced total force is larger than each single intervention. However, it is unclear whether the superior effects exist when the produced force is matched between the interventions. Ten able-bodied individuals performed three intervention sessions on separate days: (i) NMES-tibialis anterior (TA) stimulation; (ii) NMES+VOL-TA stimulation combined with voluntary ankle dorsiflexion; (iii) VOL-voluntary ankle dorsiflexion. Each intervention was exerted at the same total output of 20% of maximal force and applied intermittently (5 s ON / 19 s OFF) for 16 min. Motor evoked potentials (MEP) of the right TA and soleus muscles and maximum motor response (Mmax) of the common peroneal nerve were assessed: before, during, and for 30 min after each intervention. Additionally, the ankle dorsiflexion force-matching task was evaluated before and after each intervention. Consequently, the TA MEP/Mmax during NMES+VOL and VOL sessions were significantly facilitated immediately after the interventions started until the interventions were over. Compared to NMES, larger facilitation was observed during NMES+VOL and VOL sessions, but no difference was found between them. Motor control was not affected by any interventions. Although superior combined effects were not shown compared to voluntary contractions alone, low-level voluntary contractions combined with NMES resulted in facilitated corticospinal excitability compared to NMES alone. This suggests that the voluntary drive could improve the effects of NMES even during low-level contractions, even if motor control is not affected.

Abstract Aims/Introduction To examine adverse outcomes in women with early‐diagnosed gestational diabetes mellitus using data from a large birth cohort study in Japan. Materials and Methods This study analyzed data from singleton pregnancies in the Japan Environment and Children’s Study including births during 2011–2014. Mothers with an HbA1c level ≥6.5% in the first trimester, a history of diabetes mellitus, or steroid use during pregnancy were excluded. The participants were divided into three groups: control (without gestational diabetes mellitus), early‐diagnosed gestational diabetes mellitus (diagnosed before gestational week 24), and late‐diagnosed gestational diabetes mellitus (diagnosed after gestational week 24). Multiple logistic regression analysis was performed to calculate the risk of early‐diagnosed and late‐diagnosed gestational diabetes mellitus for adverse obstetrics outcomes. Results In total, 100,376 eligible participants were included in this study. The number of individuals in control cases, early‐diagnosed gestational diabetes mellitus cases, and late‐diagnosed gestational diabetes mellitus cases was 98,090 (97.7%), 751 (0.7%), and 1,535 (1.5%), respectively. When control cases were used as reference, multiple logistic regression analysis revealed that early‐diagnosed gestational diabetes mellitus increased the risk of hypertensive disorders of pregnancy (adjusted odds ratio: 2.08, 95% confidence interval: 1.51–2.86), early‐onset hypertensive disorders of pregnancy (adjusted odds ratio: 1.91, 95% confidence interval: 1.01–3.65), and late‐onset hypertensive disorders of pregnancy (adjusted odds ratio: 1.92, 95% confidence interval: 1.29–2.86). Conclusion Early‐diagnosed gestational diabetes mellitus is associated with serious obstetric complications. Our findings indicate the necessity of further investigations to validate the benefit of early screening for gestational diabetes mellitus in pregnant women.

Summary: Radium is refocused from the viewpoint of an environmental pollutant and cancer therapy using alpha particles, where it mainly exists as a hydrated ion. We investigated the radium hydration structure and the dynamics of water molecules by extended X-ray absorption fine structure (EXAFS) spectroscopy and ab initio molecular dynamics (AIMD) simulation. The EXAFS experiment showed that the coordination number and average distance between radium ion and the oxygen atoms in the first hydration shell are 9.2 ± 1.9 and 2.87 ± 0.06 Å, respectively. They are consistent with those obtained from the AIMD simulations, 8.4 and 2.88 Å. The AIMD simulations also revealed that the water molecules in the first hydration shell of radium are less structured and more mobile than those of barium, which is an analogous element of radium. Our results indicate that radium can be more labile than barium in terms of interactions with water.

Abstract Background Polycystic ovary syndrome (PCOS) causes anovulation and is associated with a reduced clinical pregnancy rate. Metformin, which is widely used for treating PCOS, can lead to successful pregnancy by restoring the ovulation cycle and possibly improving endometrial abnormality during the implantation period. However, the mechanism by which metformin improves endometrial abnormality remains unknown. Women with PCOS have an aberrant expression of steroid hormone receptors and homeobox A10 (HOXA10), which is essential for embryo implantation in the endometrium. Methods In this study, we examined whether metformin affects androgen receptor (AR) and HOXA10 expression in PCOS endometrium in vivo and in human endometrial cell lines in vitro. Expression of AR and HOXA10 was evaluated by immunohistochemistry, fluorescent immunocytochemistry, and western blot analysis. Results AR expression was localized in both epithelial and stromal cells; however, HOXA10 expression was limited to only stromal cells in this study. In women with PCOS, 3 months after metformin treatment, the expression of AR was reduced in epithelial and stromal cells in comparison to their levels before treatment. In contrast, HOXA10 expression in the stromal cells with metformin treatment increased in comparison to its level before treatment. Further, we showed that metformin counteracted the testosterone-induced AR expression in both Ishikawa cells and human endometrial stromal cells (HESCs); whereas, metformin partly restored the testosterone-reduced HOXA10 expression in HESCs in vitro. Conclusions Our results suggest that metformin may have a direct effect on the abnormal endometrial environment of androgen excess in women with PCOS. Trial registration The study was approved by the Ethical Committee of Fukushima Medical University (approval no. 504, approval date. July 6, 2006), and written informed consent was obtained from all patients. https://www.fmu.ac.jp/univ/sangaku/rinri.html

Abstract Background The adequate maternal sleep duration required for favorable obstetric outcomes is unknown. We evaluated the association between maternal sleep duration and low birth weight infants, small for gestational age infants, and macrosomia. Methods Participants enrolled in the Japan Environment and Children’s Study, a nationwide birth cohort study, with singleton pregnancies after 22 weeks, who gave birth between 2011 and 2014 were enrolled and categorized into five groups according to maternal sleep duration during pregnancy: 4000 g), with women with maternal sleep duration of 6.0–7.9 h as the reference, using a multiple logistic regression model. Results In total, 82,171 participants were analyzed. The adjusted odds ratios (95% confidence intervals) for low birth weight infants in women with maternal sleep duration of 9.0–9.9 h and 10.0–12.0 h and for small for gestational age infants in women with maternal sleep duration of 9.0–9.9 h were 0.90 (0.83–0.99), 0.86 (0.76–0.99), and 0.91 (0.82–0.99), respectively, before adjusting for excessive gestational weight gain. No significant association was observed between maternal sleep duration and these outcomes after adjusting for excessive gestational weight gain. Among women with appropriate gestational weight gain, the adjusted odds ratios (95% confidence intervals) for low birth weight infants and for small for gestational age infants with sleep duration of 9.0–9.9 h were 0.88 (0.80–0.97) and 0.87 (0.78–0.97), respectively. Conclusions Maternal sleep duration of 9.0–9.9 h was significantly associated with the decreased incidence of low birth weight infants and small for gestational age infants in pregnant women with appropriate gestational weight gain, compared with that of 6.0–7.9 h. Care providers should provide proper counseling regarding the association between maternal sleep duration and neonatal birth weight and suggest comprehensive maternal lifestyle modifications to prevent low birth weight and small for gestational age infants.

Abstract High serum immunoglobulin E (IgE) levels are associated with cardiovascular events. We aimed to evaluate the association between total IgE levels during the first trimester of pregnancy and pregnancy-induced hypertension (PIH) development in a large Japanese cohort. We analysed data pertaining to singleton primipara pregnancies recorded in the Japan Environment and Children’s Study involving births from 2011 to 2014. Serum IgE levels were determined using the immunonephelometric technique. High serum IgE was defined as level ≥ 170 IU/ml. Hypertensive disorders in pregnancy (HDP) were categorized into early onset (Eo) PIH (developed

Abstract Background Intrauterine inflammation affects short- and long-term neonatal outcomes. Histological chorioamnionitis and funisitis are acute inflammatory responses in the fetal membranes and umbilical cord, respectively. Although labor dystocia includes a potential risk of intrauterine inflammation, the risk of histological chorioamnionitis and funisitis of labor dystocia has not been evaluated yet. This study aimed to examine the association between labor dystocia and risk of histological chorioamnionitis and funisitis. Methods In this retrospective cohort study, the cases who underwent histopathological examinations of the placenta and umbilical cord at Fukushima Medical University Hospital, Japan, between 2015 and 2020, were included. From the dataset, the pathological findings of the patients with labor dystocia and spontaneous preterm birth were reviewed. Based on the location of leukocytes, the inflammation in the placenta (histological chorioamnionitis) and umbilical cord (funisitis) was staged as 0–3. Multiple logistic regression analysis was performed to evaluate the risk of histological chorioamnionitis, histological chorioamnionitis stage ≥2, funisitis, and funisitis stage ≥2. Result Of 317 women who met the study criteria, 83 and 144 women had labor dystocia and spontaneous preterm birth, respectively, and 90 women were included as controls. Labor dystocia was a risk factor for histological chorioamnionitis (adjusted odds ratio, 6.3; 95% confidential interval, 1.9–20.5), histological chorioamnionitis stage ≥2 (adjusted odds ratio, 6.0; 95% confidence interval, 1.7–21.8), funisitis (adjusted odds ratio, 15.4; 95% confidence interval, 2.3–101.3), and funisitis stage ≥2 (adjusted odds ratio, 18.5; 95% confidence interval, 2.5–134.0). Spontaneous preterm birth was also a risk factor for histological chorioamnionitis (adjusted odds ratio, 3.7; 95% confidence interval, 1.7–7.8), histological chorioamnionitis stage ≥2 (adjusted odds ratio, 3.0; 95% confidence interval, 1.2–7.9), and funisitis (adjusted odds ratio, 6.6; 95% confidence interval, 1.4–30.6). However, the adjusted odds ratio was smaller in spontaneous preterm births than in labor dystocia. Conclusion Labor dystocia is a risk factor for severe histological chorioamnionitis and funisitis. Further studies are required to evaluate the effects of histological chorioamnionitis and funisitis on long-term neonatal outcomes.

Abstract A high maternal body mass index (BMI) is associated with increased risks of asphyxia-related neonatal morbidity. We evaluated the association between maternal pre-pregnancy BMI and foetal acidosis while accounting for the mode of delivery. Participants from the Japan Environment and Children’s Study with singleton pregnancies after 22 weeks of gestation who gave birth during 2011–2014 were included. The participants (n = 71,799) were categorised into five groups according to the pre-pregnancy BMI: G1 (BMI

Abstract Transdermal nitric oxide donor may be a relatively safe treatment strategy for fetal growth restriction and oligohydramnios due to placental insufficiency.

Abstract Inappropriate gestational weight gain (GWG), either above or below the recommended values, has been associated with an increased risk of adverse obstetric outcomes. To evaluate the risks of GWG for foetal acidosis according to pre-pregnancy body mass index (BMI) and mode of delivery, we analysed women with singleton pregnancies between 2011 and 2014 in the Japan Environment and Children’s Study. Participants (n = 71,799) were categorised according to pre-pregnancy BMI. GWG was categorised into insufficient, appropriate, or excessive. Foetal acidosis was defined as umbilical artery pH (UmA-pH)

Abstract Background Determining the appropriate preconception care to reduce the occurrence of hypertensive disorder of pregnancy (HDP) remains a challenge in modern obstetrics. This study aimed to examine the association between pre-pregnancy calcium (Ca) intake and HDP in normotensive primiparas. Methods We used data from the Japan Environment Children’s study (JECS), which is the largest birth cohort study. A total of 33,894 normotensive Japanese primiparas were recruited for JECS between January 2011 and March 2014. Participants were categorized into five groups according to pre-pregnancy Ca intake quintiles (Q1 and Q5 were the lowest and highest Ca intake groups, respectively) to compare their basic background and obstetrics outcome. Multiple logistic regressions were performed to identify the effect of pre-pregnancy Ca intake on HDP, early onset HDP, and late-onset HDP, using Ca intake thresholds of 500, 550, 650, 700, 1000, 1500, and 1500 mg. Results We found significant differences in maternal background among the Ca intake groups; in particular, there were more participants with low socioeconomic status, indicated by low education level and low household income, and smokers in the lowest Ca intake group. Multiple logistic regression did not show any significant difference with regard to HDP, early onset HDP, and late-onset HDP in each Ca intake threshold. Conclusions Despite considerable recommendations concerning Ca intake for women of reproductive age, the present study indicates that pre-pregnancy Ca intake was not associated with an increased risk of new-onset hypertension among primiparas during pregnancy. Further studies examining the effect of other pre-pregnancy dietary factors on obstetric outcomes should be considered in the formulation of earlier preventive strategies for primiparas.

This study aimed to investigate the impact of Chlamydia trachomatis (CT) infection on pregnancy outcome in pregnant Japanese women. We utilized the data from a nationwide birth cohort study, the Japan Environment and Children's Study (JECS), for this study. We enrolled 26,385 individuals who could refer to data on pregnancy outcomes and confounding factors, with data on CT. Binominal logistic regression models were used to determine whether pregnant women with CT positivity were at more risk of experiencing adverse pregnancy outcomes, preterm birth (PTB), preterm prelabor rupture of membrane (pPROM), low birth weight (LBW) infants, small for gestational age (SGA) births, or hypertensive disorders of pregnancy (HDP). After adjusting for maternal age, parity, marital status, smoking status, and education status, there were no significantly increased risks of PTB, pPROM, LBW infants, SGA, and HDP in the odds ratios. No significant increase in the risk of adverse pregnancy outcomes was observed in any of the subgroup analyses, which were limited to the pregnancy women in Fukushima prefecture, where CT screening could be confirmed at 28-30 weeks of gestation. We believe that the results of this study will make a significant contribution to the future of medical care for pregnant women in Japan. Our findings are important for medical practitioners to contribute to the future medical treatment of Japanese pregnant women, and also to contribute to pre-conception care for Japanese society as a whole, including pregnant women.

Background. Mechanically ventilated critically ill patients need the opportunity to communicate their physical and psychosocial concerns to nurses. However, these patients face the unique problem of lacking even the opportunity to communicate. Aims. The study aimed to describe the characteristics of communication opportunities for critically ill mechanically ventilated patients. Methods. The study was designed as a video-based descriptive observational study. Participants included seven mechanically ventilated critically ill patients at the intensive care unit, coronary care unit, or high care unit who were conscious and seven registered nurses (seven pairs). Videos were recorded continuously from 8 am to 4 pm, and the footage was then descriptively analyzed. Data collection took place between July 2019 and June 2020. Results. The total recording time was 668.0 minutes. Of these 668.0 minutes, nurses stayed in the Conversation Area of the Patient for 279.6 minutes, and of these 279.6 minutes, two-way face-to-face communication between nurse and patient occurred for 78.0 minutes. Of these 78.0 minutes, communications were started by nurses for 47.2 minutes (174 scenes) and by patients for 24.2 minutes (36 scenes). The patient-started two-way communication scenes included 37 instances of Patient-Intentional-Action that triggered the start of communication. Actions using the upper limbs were observed in 20 instances and represented the most frequently used body part. The head/face, lower limbs, or trunk were also used in some of the actions. Gestures were the most commonly used action type (14 instances). Other types included lip movement, grimace, leg flex/extension, and cough. Conclusions. We found that nurses tended to start communication more frequently than patients did and that patients demonstrated Patient-Intentional-Action with a variety of actions using various body parts. Communication opportunities for patients were created when nurses took the initiative to start communication or when they noticed and responded to the Patient-Intentional-Action. Our findings demonstrate that nurses need to recognize and always respond to Patient-Intentional-Action and to take the initiative in communicating rather than waiting for the patient to do so.

Functional electrical stimulation therapy (FEST) can improve motor function after neurological injuries. However, little is known about cortical changes after FEST and weather it can improve motor function after traumatic brain injury (TBI). Our study examined cortical changes and motor improvements in one male participant with chronic TBI suffering from mild motor impairment affecting the right upper-limb during 3-months of FEST and during 3-months follow-up. In total, 36 sessions of FEST were applied to enable upper-limb grasping and reaching movements. Short-term assessments carried out using transcranial magnetic stimulation (TMS) showed reduced cortical silent period (CSP), indicating cortical and/or subcortical inhibition after each intervention. At the same time, no changes in motor evoked potentials (MEPs) were observed. Long-term assessments showed increased MEP corticospinal excitability after 12-weeks of FEST, which seemed to remain during both follow-ups, while no changes in CSP were observed. Similarly, long-term assessments using TMS mapping showed larger hand MEP area in the primary motor cortex (M1) after 12-weeks of FEST as well as during both follow-ups. Corroborating TMS results, functional magnetic resonance imaging (fMRI) data showed M1 activations increased during hand grip and finger pinch tasks after 12-weeks of FEST, while gradual reduction of activity compared to after the intervention was seen during follow-ups. Widespread changes were seen not only in the M1, but also sensory, parietal rostroventral, supplementary motor, and premotor areas in both contralateral and ipsilateral hemispheres, especially during the finger pinch task. Drawing test performance showed improvements after the intervention and during follow-ups. Our findings suggest that task-specific and repetitive FEST can effectively increase cortical activations by integrating voluntary motor commands and sensorimotor network through functional electrical stimulation (FES). Overall, our results demonstrated cortical re-organization in an individual with chronic TBI after FEST.

Abstract This is the fourth reported case of central diabetes insipidus with oligohydramnios. Central diabetes insipidus does not adversely affect pregnancy; it can present with oligohydramnios, which can be improved by treating central diabetes insipidus.

Abstract Background Placenta accreta spectrum (PAS) is a life-threating complication in the field of obstetrics. Sometimes we face with unexpected PAS cases which is potentially higher maternal mortality and morbidity compared with expected cases. The present study was conducted to examine the prevalence of PAS and to elucidate its risk factors using a large Japanese birth cohort study. Methods We reviewed the results of a nationwide prospective birth cohort study in Japan, and identified 90,554 participants treated from 2011 to 2014 in 15 regional centers. Multiple regression models were created to identify the risk factors for PAS. These data were obtained from self-reported questionnaires or patient medical records. Results This analysis consisted of 202 cases of PAS (18 with placenta previa and 184 without placenta previa) and 90,352 cases without PAS. The multiple logistic regression analysis showed that placenta previa (adjusted odds ratio [aOR]: 12.86, 95% confidence interval [CI] 7.70–21.45, P

ObjectivePlacental abruption is a significant obstetric complication that affects both maternal and neonatal mortality and morbidity. The present study examined the effect of maternal age on the incidence of placental abruption.MethodsWe used data of singleton pregnancies from the Japan Environment and Children's Study, which was a prospective birth cohort study conducted between January 2011 and March 2014 across 15 regional centers in Japan. A multiple regression model was used to identify whether maternal age (ResultsA total of 94,410 Japanese women (93,994 without placental abruption and 416 with placental abruption) were recruited. Herein, 764, 8421, 25915, 33517, and 25793 women were aged ConclusionsIn the Japanese general population, besides advanced maternal age, teenage pregnancy was associated with placental abruption. Recently, the mean maternal age has been changing in Japan. Therefore, it is important for obstetric care providers to provide proper counseling to young women based on up-to-date evidence.

Introduction: Pyoderma gangrenosum and myelodysplastic syndrome in pregnant women are both very rare, but can coexist. Here, we present a case of pyoderma gangrenosum in a cesarean section wound in a woman with myelodysplastic syndrome. Case: A 34-year-old woman presented with thrombocytopenia and macrocytic anemia during pregnancy. The pregnancy was uneventful until 36 weeks of gestation, when premature rupture of membranes occurred and a cesarean section was performed for breech presentation. She presented four days later with redness and blisters at the wound site. Surgical site infection was diagnosed but did not improve with antibiotics, and multiple wound cultures were negative. Skin biopsy indicated pyoderma gangrenosum, and the redness and blisters responded to oral prednisolone. Post-partum bone marrow aspiration showed myelodysplastic syndrome. As the patient demonstrated no symptoms such as abnormal bleeding, no additional treatment was started, and she went on to receive regular follow-up for myelodysplastic disorder. Discussion: This case shows the need for further assessment of hematological disorders diagnosed in pregnancy in women with pyoderma gangrenosum post-partum.

Introduction: Prader-Willi syndrome (PWS) is a complex neurodevelopmental genetic disorder. No definitive clinical signs of antenatal PWS have been identified. Case: A healthy, nulliparous, 29-year-old woman demonstrated polyhydramnios at 27 weeks of gestation. Cardiotocography (CTG) showed an absence of foetal heart rate (FHR) acceleration and moderate FHR variability. Daily CTG demonstrated an absence of FHR acceleration. A male newborn was delivered by caesarean section, weighing 2492 g, which is appropriate for gestational age; the Apgar scores at 1 and 5 min were 6 and 6, respectively, and the umbilical artery pH was 7.295. The newborn exhibited marked hypotonia, lack of sucking, and cryptorchidism. FISH analysis performed due to severe hypotonia showed 46, XY. Ish del (15) (q11. 2q 11.2), which led to the diagnosis of PWS. Discussion: Polyhydramnios and abnormal FHR patterns may be associated with feeding difficulty and hypotonia. These signs may be an indication for antenatal molecular genetic testing to diagnose PWS.

Systemic lupus erythematosus, simply known as lupus, is associated with adverse obstetric outcomes. This study evaluated the incidence of preterm births (before 37 and 34 weeks), low birthweight infants (

Introduction: Ritodrine hydrochloride is still widely used as a tocolytic agent in Japan, but it can cause maternal pulmonary edema, which may paradoxically induce preterm birth. Here we present a case of severe pulmonary edema due to

This study was designed to determine the effects of a food thickener and deglutition aid jelly for oral administration, jelly wafer, on the pharmacokinetics of levofloxacin orally disintegrating tablets. With an increase in immersion time, the disintegration time of levofloxacin orally disintegrating tablets immersed in food thickener was prolonged, whereas that of the tablets immersed in jelly wafer was shortened. The dissolution behavior of non-immersed levofloxacin orally disintegrating tablets was not similar to that of tablets immersed in food thickener, but was similar to that of tablets immersed in jelly wafer. The time to reach the maximum systemic levofloxacin concentration was the same for non-immersed orally disintegrating tablets and tablets immersed in food thickener and jelly wafer. Moreover, there was no significant difference in the maximum concentration after administration between non-immersed orally disintegrating tablets and tablets immersed in food thickener or jelly wafer. These findings suggest that drugs with a high bioavailability, such as levofloxacin, enter the systemic circulation even when administered with a food thickener or jelly wafer.

Introduction: Pyoderma gangrenosum (PG) in pregnant women is rare and resembles surgical site infection (SSI). Here we present two cases of PG after caesarean section. Case 1: A 29-year-old woman, who had a history of recurrent wound dehiscence after surgery, exhibited wound ulceration and exudate 6 days after caesarean section. Antibiotics were ineffective and multiple wound cultures were negative. Skin biopsy indicated PG and oral steroid administration resulted in wound improvement. Case 2: A 27-year-old woman, who had a history of PG, exhibited wound ulceration and exudate 5 days after caesarean section. The lesion developed despite antibiotic administration, and multiple wound cultures were negative. Skin biopsy indicated PG and the wound improved after oral steroid administration. Discussion: Definitive diagnosis of PG is essential because its treatment differs from that of SSI. PG after caesarean section can be misdiagnosed as SSI, even when there is a history of wound dehiscence or PG. Keywords: Pyoderma gangrenosum, Caesarean section

Selenium (Se) acts as a cofactor of antioxidant enzymes. Preconception care may reduce the risk of gestational diabetes mellitus (GDM). We examined the association between preconception Se intake and the risk of GDM in Japanese women. Using the Japan Environment and Children’s Study database, we identified 92,764 Japanese women recruited between January 2011 and March 2014. Participants were categorized into five groups according to preconception Se intake quintiles (Q1 and Q5 were the lowest and highest Se intake groups, respectively). GDM was categorized as early-onset (Eo-GDM) or late-onset (Lo-GDM) diagnosed before or after 24 weeks, respectively. Multiple logistic regressions were performed to identify the effect of preconception Se intake on GDM, Eo-GDM, and Lo-GDM. Using Q3 (the middle Se intake group) as the reference, a multiple logistic regression analysis showed that the highest (Q5) Se intake group demonstrated increased risks of GDM (adjusted odds ratio (aOR): 1.15, 95% confidence interval (CI): 1.01–1.30) and the lowest (Q1) Se intake group had increased risks of Lo-GDM (aOR: 1.19, 95% CI: 1.01–1.41). Thus, both high and low preconception Se intakes increase risks of glucose intolerance during pregnancy. This finding may indicate new recommendations for preconception Se intake to prevent GDM.

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Background: Clostridium butyricum is a butyrate-producing beneficial bacterium and is generally recognized as a significant indicator of appropriate gut microbial metabolism in human health. Objective: The synergistic effects of commercially available prebiotic partially hydrolyzed guar gum (PHGG) dietary fiber as a carbon source on a butyrate-producing bacterial strain were evaluated during in-vitro fermentation with Clostridium butyricum bacterial strain in a basal medium. Additionally, their prebiotic activities were compared to those of other dietary fibers. Methods: The examined functional dietary fiber substrates (PHGG, LMW-PHGG, indigestible dextrin, and inulin) demonstrated selective prebiotic effects on pH variation of a basal medium, leading to enhanced bacterial growth and butyrate production with Clostridium butyricum bacterial strains during in-vitro fermentation. Results: Prebiotic PHGG supplementation had the highest fermentability among dietary fibers, resulting in greater bacterial growth (OD660: 1.93 ± 0.01) of the Clostridium butyricum strain and enhanced butyrate generation (4.52 ± 2.09 mM) after cultivation in a basal medium. A significant difference in promoting bacterial growth (p ≤ 0.05), pH reduction (p < 0.05), and butyrate production (p < 0.05) compared to indigestible dextrin and inulin was observed. Mannose demonstrated the strongest butyrogenic effect and improved fermentability on the Clostridium butyricum, among the studied prebiotic monosaccharides (galactose, glucose, and starch). The order of bacterial growth and butyrate synthesis was mannose > galactose > glucose > starch. The PHGG with a relatively lower molecular weight (LMW-PHGG) exhibited the improved bacterial growth of Clostridium butyricum and demonstrated the highest butyrate production after cultivation in a basal medium. A similar trend was observed when Clostridium butyricum was cultivated in-vitro using PHGG-supplemented artificial intestinal fluid containing MRS-agar medium. Conclusion: These findings suggest that the symbiotic combination of prebiotic PHGG and probiotic Clostridium butyricum could have major industrial applications as a therapeutic adjuvant for improved gastrointestinal health. [ABSTRACT FROM AUTHOR]

Background: Hesperidin, a flavonoid glycoside, is widely found in the peels and rinds of citrus fruits, offering various physiological benefits. However, its effectiveness is hindered by challenges related to insolubility and low bioavailability. To overcome these obstacles, we developed the hesperetin-7-glucoside -β-cyclodextrin inclusion complex (HCD). This complex demonstrates superior solubility and bioavailability compared to hesperidin. In a previous study where participants consumed 300 mg/day of HCD for 12 weeks, there was a notable improvement in endothelial dysfunction. Importantly, no significant adverse clinical events were reported during this period. Objective: To evaluate the safety of the excessive intake of HCD in healthy Japanese subjects. Methods: Fourteen healthy male and female volunteers (with a mean age of 39.1±9.1) participated in this excessive HCD intake clinical trial. Subjects took 1500 mg/day HCD, which was five times the dosage of 300 mg/day HCD, for 4 consecutive weeks. Physical examination, blood tests, and urin tests were performed during this period. Results: Results demonstrated no significant differences at 2, and 4 weeks compared to the baseline at 0 weeks with 1500 mg HCD (equivalent to 195 mg HPTG) supplementation in healthy subjects. Conclusions: It has been demonstrated that there are no safety concerns when consuming 1500 mg of HCD daily, continuously for 4 weeks. [ABSTRACT FROM AUTHOR]

The incidence of Acinetobacter infections has increased in recent years. Acinetobacter infections are resistant to most antibiotics and can be found in hospitalized patients. Pregnancies complicated by severe sepsis or septic shock are associated with a higher rate of preterm labor and delivery, fetal infection, and operative delivery. This case report describes septic shock due to Acinetobacter lwoffii infection in the 31st week of gestation. A 47-year-old woman, with a gestation of 31 weeks and one day, presented with a fever, and signs of bacterial infection on laboratory tests. Although the patient was started on tazobactam/piperacillin, she went into septic shock, and was transferred to our hospital. Cesarean section was performed at a gestation of 31 weeks and 4 days because of severe maternal pneumonia and non-reassuring fetal status. A. lwoffii was detected in blood cultures collected at the previous hospital, and susceptibility to piperacillin and meropenem to A. lwoffii was confirmed. The pneumonia responded to antibiotic treatment and there were no findings of infection in the neonate. Maternal sepsis is an infrequent but important complication, causing significant maternal and fetal morbidity and fetal and neonatal mortality; therefore, early antibiotic therapy is required to improve the clinical outcome. [ABSTRACT FROM AUTHOR]