Gross anatomical features of the insular cortex in affective disorders.

Introduction: The number of insular gyri is elevated in patients with schizophrenia. Thus, it has potential as a marker of early neurodevelopmental abnormalities. However, currently it remains unclear whether patients with other neuropsychiatric disorders, such as affective disorders, also have this gross brain anatomical feature.

Treatment patterns and satisfaction in patients with type 2 diabetes newly initiating oral monotherapy with antidiabetic drugs in Japan: results from the prospective Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND).

Introduction: To present longitudinal data from the Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND) in Japan.

Research Design And Methods: In this multicenter, prospective, observational cohort study, patients with type 2 diabetes mellitus (T2DM) newly initiated on monotherapy were followed up for 2 years. Primary outcomes included changes in treatment pattern over time, target hemoglobin A1c (HbA1c) attainment and treatment satisfaction per Oral Hypoglycaemic Agent Questionnaire (OHA-Q).

Impact of Systolic Blood Pressure Time in Target Range on Adverse Events in Patients With Nonvalvular Atrial Fibrillation (from the J-RHYTHM Registry).

Although time in target range (TTR) of systolic blood pressure (BP), an index of consistency of BP control, is reportedly associated with major cardiovascular outcomes, the impact of BP-TTR on adverse events in patients with nonvalvular atrial fibrillation (NVAF) has not been thoroughly investigated. Thus, we performed a post hoc analysis to clarify it in patients with NVAF using data of the J-RHYTHM registry. Of 7,406 outpatients with NVAF, 7,226 (age, 70 ± 10 years; men, 71%), in whom BP was measured 4 times or more (15 ± 5 times) during the 2-year follow-up period or until occurrence of an event, constituted the study group.

Longitudinal Changes in Brain Gyrification in Schizophrenia Spectrum Disorders.

Previous magnetic resonance imaging (MRI) studies reported increased brain gyrification in schizophrenia and schizotypal disorder, a prototypic disorder within the schizophrenia spectrum. This may reflect deviations in early neurodevelopment; however, it currently remains unclear whether the gyrification pattern longitudinally changes over the course of the schizophrenia spectrum. The present MRI study using FreeSurfer compared longitudinal changes (mean inter-scan interval of 2.

An autopsy case of pure nigropathy with TUBA4A nonsense mutation.

We showed the results of pathological and genetic investigation for an autopsy case who was evaluated as longstanding Parkinson's disease (PD) in alive. Neuropathological investigation showed "pure nigropathy" without Lewy and tau pathology, and genetic analyses using next-generation sequencing detected novel TUBA4A nonsence mutation. Subsequent physiological study added to strength the hypothesis that the variant is pathogenic one.

Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan.

Introduction: To investigate factors affecting glycemic control, oral antidiabetic drug (OAD) treatment distribution and self-care activities among patients with type 2 diabetes mellitus (T2DM) who newly initiate OAD monotherapy in a real-world setting in Japan.

Research Design And Methods: A Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND) is an ongoing, prospective, observational cohort study with follow-up at 6, 12, 18 and 24 months. Primary objectives include OAD treatment patterns (cross-sectional and longitudinal) among diabetes specialists versus non-specialists; adherence to diabetes self-care activities; quality of life; treatment satisfaction among patients and target attainment rates of parameters, including glycated hemoglobin.

Pineal Gland Volume in Major Depressive and Bipolar Disorders.

Abnormal melatonin secretion has been demonstrated in patients with affective disorders such as major depressive disorder (MDD) and bipolar disorder (BD). However, magnetic resonance imaging (MRI) studies that previously investigated the volume of the pineal gland, which regulates circadian rhythms by secreting melatonin, in these patients reported inconsistent findings. The present study employed MRI to examine pineal gland volumes and pineal cyst prevalence in 56 MDD patients (29 currently depressed and 27 remitted patients), 26 BD patients, and matched controls (33 for MDD and 24 for BD).

Thalamic and striato-pallidal volumes in schizophrenia patients and individuals at risk for psychosis: A multi-atlas segmentation study.

Despite previous neuroimaging studies demonstrating morphological abnormalities of the thalamus and other subcortical structures in patients with schizophrenia, the potential role of the thalamus and its subdivisions in the pathophysiology of this illness remains elusive. It is also unclear whether similar changes of these structures occur in individuals at high risk for psychosis. In this study, magnetic resonance imaging was employed with the Multiple Automatically Generated Templates (MAGeT) brain segmentation algorithm to determine volumes of the thalamic subdivisions, the striatum (caudate, putamen, and nucleus accumbens), and the globus pallidus in 62 patients with schizophrenia, 38 individuals with an at-risk mental state (ARMS) [4 of whom (10.

Major cardiovascular and bleeding events with long-term use of aspirin in patients with prior cardiovascular diseases: 1-year follow-up results from the Management of Aspirin-induced Gastrointestinal Complications (MAGIC) study.

Aspirin should be used for the prevention of cardiovascular (CV) events by the risk-benefit balance. This study was conducted to clarify CV and bleeding events in Japanese aspirin users with a history of CV diseases. This study was a prospective, nationwide, multicenter cooperative registry of Japanese patients with CV diseases at risk of thromboembolism who were taking aspirin (75-325 mg) for at least 1 year.

Quality of Systematic Reviews of the Foods with Function Claims in Japan: Comparative Before- and After-Evaluation of Verification Reports by the Consumer Affairs Agency.

In Japan, a new type of foods with health claims, called Foods with Function Claims (FFC), was introduced in April 2015 in order to make more products available that are clearly labeled with certain health functions. Regarding substantiating product effectiveness, scientific evidence for the proposed function claims must be explained by systematic reviews (SRs), but the quality of SRs was not clear. The objectives of this review were to assess the quality of SRs based on the FFC registered on the Consumer Affairs Agency (CAA) website in Japan, and to determine whether the CAA's verification report in 2016 was associated with improvement in the quality of SRs.

Evaluation of Risk Factors for Major Amputation in Patients With Diabetes and Peripheral Artery Disease Receiving Antiplatelet Therapy - Post Hoc Analysis of a Prospective Observational Multicenter Cohort Study (SEASON).

Background: Guidelines for peripheral arterial disease (PAD) recommend long-term antiplatelet therapy in symptomatic patients to reduce cardiovascular morbidity and mortality risk. Although diabetes is a known risk factor for PAD, PAD has been undertreated in these patients. This study aimed to evaluate risk factors for major amputation in patients with diabetes undergoing antiplatelet therapy for PAD.

Evaluation of Risk Factors for Limb-Specific Peripheral Vascular Events in Patients With Peripheral Artery Disease: A Post Hoc Analysis of the SEASON Prospective Observational Study.

Surveillance of cardiovascular Events in Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON) is a 2-year, prospective, real-world, registry study conducted in Japan from 2009 to 2013. This post hoc analysis evaluated risk factors for limb ischemia in patients with peripheral arterial disease (PAD) and ankle-brachial index (ABI) <0.90.

A case of suspected MPO-ANCA-related hypertrophic pachymeningitis with atypical presentation.

A 66-year-old man presented to our emergency department with acute consciousness disorder, headache, and fever. Initial laboratory data indicated a high level of inflammatory reaction. Enhanced magnetic resonance imaging revealed a thickening of the right cranial dura mater on T1-weighted images.

Preeclampsia mediates the association between shorter height and increased risk of preterm delivery.

Background: Maternal short stature has been observed to increase the risk of preterm birth; however, the aetiology behind this phenomenon is unknown. We investigated whether preeclampsia, an obstetric complication that often leads to preterm delivery and is reported to have an inverse association with women's height, mediates this association.

Methods: We studied 218 412 women with no underlying diseases before pregnancy, who delivered singletons from 2005 to 2011 and were included in the Japan Society of Obstetrics and Gynecology perinatal database, which is a national multi-centre-based delivery database among tertiary hospitals.

Two-Year Follow-Up of Vascular Events in Peripheral Arterial Disease Treated With Antiplatelet Agents: A Prospective Observational Multicenter Cohort Study (SEASON).

The present analysis was intended to evaluate the real-world management of peripheral arterial disease (PAD) in Asia, and to explore cardiovascular events in patients with PAD undergoing antiplatelet therapy over 2 years of follow-up. The Surveillance of cardiovascular Events in Antiplatelet-treated arteriosclerosis Obliterans patients in JapaN (SEASON) registry is a prospective observational multicenter study of cardiovascular events in antiplatelet-treated patients with PAD in Japan. The SEASON registry included 11,375 patients who were scheduled to receive treatment for PAD.

Quality of systematic reviews of the Foods with Function Claims registered at the Consumer Affairs Agency Web site in Japan: a prospective systematic review.

The objective of this review was to assess the quality of systematic reviews (SRs) based on the Foods with Function Claims (FFC) registered at the Consumer Affairs Agency (CAA) Web site in Japan by AMSTAR checklist. Study design was a prospective SR of SRs based on the FFC registered at the CAA Web site in Japan. We searched the database from 1 April 2015 (starting date) through 27 October 2015 on the CAA Web site.

Bixalomer in Hyperphosphatemic Patients With Chronic Kidney Disease Not on Dialysis: Phase 3 Randomized Trial.

Currently, calcium- or metal-containing phosphate binders are available to treat hyperphosphatemia in predialysis patients with chronic kidney disease. Bixalomer, a non-calcium, metal-free phosphate binder, has not been studied in these patients. We evaluated the efficacy and safety of bixalomer versus placebo for treatment of hyperphosphatemia in Japanese predialysis patients with chronic kidney disease.

Tocilizumab in systemic juvenile idiopathic arthritis in a real-world clinical setting: results from 1 year of postmarketing surveillance follow-up of 417 patients in Japan.

Objectives: To evaluate the safety and effectiveness of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA) in real-world clinical settings in Japan.

Methods: Paediatric patients with sJIA initiating TCZ between April 2008 and February 2012 and those previously enrolled in clinical trials who initiated TCZ before April 2008 were enrolled in a Japanese registry surveillance programme. Safety and effectiveness parameters were collected for 52 weeks.

The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression.

Objectives: To evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTX-naive, early rheumatoid arthritis (RA) with poor prognostic factors, compared with MTX alone.

Methods: MTX-naive, early RA patients with ≤12 months persistent disease, high anti-cyclic citrullinated peptide, and either rheumatoid factor positive and/or presence of bone erosions were enrolled in this multicentre, double-blind, randomised placebo (PBO)-controlled study. Patients were randomised 1:1 to CZP+MTX or PBO+MTX for 52 weeks.

Japanese Patients' and Physicians' Preferences for Anticoagulant Use in Atrial Fibrillation: Results from a Discrete-choice Experiment.

Anticoagulants are recommended for stroke prevention in patients with atrial fibrillation (AF), but are associated with an increased risk of bleeding; therefore, physicians face benefit-risk tradeoffs when prescribing anticoagulants to AF patients. Although the unmet medical need for safer anticoagulants has been well-documented, there is limited information about the importance that patients and physicians place on cardiovascular events. The aim of this study was to quantify patients' and physicians' willingness to accept tradeoffs between the benefits and risks of anticoagulants in order to 1) document the potential differences between patients' and physicians' perceptions of benefits and risks and 2) support physicians' clinical decision making.