Evaluating the effectiveness of lateral postural management for breech presentation: study protocol for a randomized controlled trial (BRLT study).

Background: Breech presentation is observed in 3-4% at term of pregnancy and is one of the leading causes of cesarean section. There is no established treatment for breech presentation before 36 weeks. A retrospective cohort study was conducted to demonstrate that the lateral position is effective for breech presentation.

Hysteroscopic resection of retained products of conception combined with uterine artery balloon occlusion: A novel case report.

Retained products of conception can cause massive bleeding that can be prevented by uterine artery embolization before resection; however, uterine artery balloon occlusion is less invasive. While scattered reports of its use for postpartum hemorrhage exist, no indications have been described. We report a case of hysteroscopic resection of retained products of conception using uterine artery balloon occlusion instead of uterine artery embolization.

Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases: Further subset analysis from the whole INBUILD trial.

Background: A previous subgroup analysis of data from the INBUILD trial showed that nintedanib reduced the annual rate of decline in forced vital capacity (FVC) in Japanese patients with progressive fibrosing interstitial lung diseases (PF-ILDs). The safety profile of nintedanib over 52 weeks in Japanese patients was similar to that of the overall population.

Methods: Using data from 108 Japanese patients with PF-ILDs who had received at least 1 dose of study medication in the INBUILD trial, we evaluated the effect of nintedanib on disease progression and assessed the safety profile over the whole trial period (i.

Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial.

Background: The efficacy of nintedanib in progressive fibrosing interstitial lung diseases (ILDs) was demonstrated in the randomised, double-blind, placebo-controlled INBUILD trial. This subgroup analysis evaluated the efficacy and safety of nintedanib in the Japanese population.

Methods: Patients with progressive fibrosing ILDs (evaluated by physicians within 24 months of screening) were randomised (1:1) to twice-daily 150-mg nintedanib or placebo; treatment continued until the last patient completed 52 weeks.

Current monitoring and treatment of progressive fibrosing interstitial lung disease: a survey of physicians in Japan, the United States, and the European Union.

Objective: To understand assumptions about and approaches to interstitial lung disease (ILD), including those of the progressive phenotype (progressive fibrosing ILD), this multinational survey assessed physicians' attitudes toward, knowledge of, and management strategies for progressive fibrosing ILD.

Methods: This internet-based survey of physicians was conducted between November 2018 and February 2019. Practical management strategies for progressive fibrosing ILD, and current approaches to the assessment and treatment of ILD, were compared between countries/regions (Japan vs.

Study Design of VESUTO: Efficacy of Tiotropium/Olodaterol on Lung Hyperinflation, Exercise Capacity, and Physical Activity in Japanese Patients with Chronic Obstructive Pulmonary Disease.

Introduction: The superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD.

Methods: A protocol is developed for the VESUTO study that investigates the efficacy of tiotropium/olodaterol fixed-dose combination (FDC) compared with tiotropium alone on inspiratory capacity (IC, volume from functional residual capacity to total lung capacity), exercise capacity, and daily physical activity in Japanese patients with COPD.

Long-term safety and efficacy of combined tiotropium and olodaterol in Japanese patients with chronic obstructive pulmonary disease.

Background: The efficacy and safety of once-daily tiotropium+olodaterol (T+O) (2.5/5µg or 5/5µg) for treating chronic obstructive pulmonary disease (COPD) have been demonstrated in the large, multinational, randomized, Phase III studies TONADO 1 and 2, which included 413 Japanese patients (~80 in each group). This study was conducted to supplement the TONADO study data to assess long-term safety in ≥100 Japanese patients treated for 1 year in compliance with International Conference on Harmonisation guidelines.

The efficacy and safety of combined tiotropium and olodaterol via the Respimat(®) inhaler in patients with COPD: results from the Japanese sub-population of the Tonado(®) studies.

Background: The efficacy and safety of once-daily tiotropium + olodaterol (T+O) maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonado(®) 1 (NCT01431274) and 2 (NCT01431287) studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD.

Methods: In this Tonado(®) subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants.

Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease.

Background: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.

Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).

Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat Soft Mist inhaler.

An autopsy case of a decomposed body with keyhole gunshot wound and secondary skull fractures.

The decomposed body of a 53 or 57-year-old male was found with a gun in a locked car parked in a coin-operated parking lot. During autopsy, the entrance wound in the frontal bone showed a characteristic keyhole defect with internal and external beveling. There was no exit wound.

Effects of a program to prevent social isolation on loneliness, depression, and subjective well-being of older adults: a randomized trial among older migrants in Japan.

Social isolation among the elderly is a concern in developed countries. Using a randomized trial, this study examined the effect of a social isolation prevention program on loneliness, depression, and subjective well-being of the elderly in Japan. Among the elderly people who relocated to suburban Tokyo, 63 who responded to a pre-test were randomized and assessed 1 and 6 months after the program.