Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals.

Introduction: In clinical research, ethical review is required prior to conducting the research. A surgical procedure is a complex intervention with properties that make it more difficult to evaluate rigorously and monitor than drug treatments. This study aimed to clarify the current status and issues in the ethical review and monitoring of surgical research.

Characteristics of Asian 4 countries on cancer clinical trials registered in the International Clinical Trials Registry Platform between 2005 and 2018.

Background: The characteristics and comparison of countries regarding clinical trials for cancer were unknown. The World Health Organization-International Clinical Trials Registry Platform (WHO-ICTRP) are providing data from various countries and releases them generally in a downloadable format. We aimed to examine and descriptively identify the number of cancer clinical trials registered in the world and the fundamental characteristics in Asian 4 countries of China, India, Japan and South Korea, focusing on study characteristics, e.

Supervision of new surgical procedures in Japan: Current practice and supervision issues at university hospitals in Japan.

Background: Sometimes the development of new surgical procedures takes place during patient treatment in clinical practice but can result in undesirable outcomes and social concerns. This study aims to reveal how university hospitals in Japan supervise the implementation of new surgical procedures and what difficulties they confront.

Methods: Self-administered questionnaire surveys were conducted, targeting all university-affiliated hospitals in Japan.

Optimization of therapeutic strategy for p16-positive oropharyngeal squamous cell carcinoma: Multi-institutional observational study based on the national Head and Neck Cancer Registry of Japan.

Background: Although the American Joint Committee on Cancer TNM classification has been amended to include human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC) as an independent entity, to the authors' knowledge the optimized de-escalating treatment modality has not been established to date.

Methods: The authors conducted a retrospective, nationwide, observational study in patients with HPV-related OPSCC who were treated from 2011 to 2014 in Japan to determine the best treatment modality.

Results: A total of 688 patients who were newly diagnosed with HPV-related OPSCC who were treated with curative intent at 35 institutions and had coherent clinical information and follow-up data available were included in the current study.

Effect of Neoadjuvant Nab-Paclitaxel plus Gemcitabine Therapy on Overall Survival in Patients with Borderline Resectable Pancreatic Cancer: A Prospective Multicenter Phase II Trial (NAC-GA Trial).

We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version).

Evaluation of the Validity of a Novel CKD Assessment Checklist Used in the Frontier of Renal Outcome Modifications in Japan Study.

Objective: This study aimed to assess the validity of a novel chronic kidney disease (CKD) evaluation checklist method used in the Frontier of Renal Outcome Modifications in Japan study.

Methods: Nineteen patients with CKD were recruited, and each patient was assessed by 2 dietitians using the checklist and provided with lifestyle modification instructions based on their assessment. We evaluated the concordance between dietitians, and we assessed the accuracy of the protein and salt intake estimates made by dietitians who only had access to patients' food diaries and verbal reports through comparison with assessments made by an independent dietitian who additionally had access to patients' meal photographs and urine collections.

The Speckle Tracking Imaging for the Assessment of Cardiac Resynchronization Therapy (START) study.

Background: We sought to identify the feasibility of speckle tracking echocardiography (STE) to predict cardiac resynchronization therapy (CRT) responders in a prospective multicenter study. METHODS AND RESULTS: Patients who were newly implanted with a CRT device were enrolled. Time (T) from QRS to maximum peak radial and circumferential strain (CS) in 6 segments on the left ventricular (LV) short-axis plane, and to the maximum peak of longitudinal strain in 18 segments on 3 apical LV planes was measured (Tmax).

Arsenic exposure affects plasma insulin-like growth factor 1 (IGF-1) in children in rural Bangladesh.

Background: Exposure to inorganic arsenic (As) through drinking water during pregnancy is associated with lower birth size and child growth. The aim of the study was to assess the effects of As exposure on child growth parameters to evaluate causal associations.

Methodology/findings: Children born in a longitudinal mother-child cohort in rural Bangladesh were studied at 4.

Association between calcium in cord blood and newborn size in Bangladesh.

Ca status in the uterus during pregnancy has been suggested to affect fetal growth and size at birth. In Bangladesh, low Ca levels in pregnant women and low birth weight in infants are common. The present study explored the association between Ca levels in cord blood and newborn size at birth (birth weight and birth length) in Bangladesh.

Measurement of health-related quality of life in patients with chronic kidney disease in Japan with EuroQol (EQ-5D).

Background: Chronic kidney disease (CKD) is a health-related quality-of-life (HRQOL) deteriorating disease which is not only a public health but also a socioeconomic problem. Interest in developing cost-effective interventions to control CKD has increased. The aim of this study was to measure HRQOL in terms of quality-adjustment weights for cost-effectiveness analysis using EQ-5D in patients with CKD.

Beneficial effects of a new 20-hydroxyeicosatetraenoic acid synthesis inhibitor, TS-011 [N-(3-chloro-4-morpholin-4-yl) phenyl-N'-hydroxyimido formamide], on hemorrhagic and ischemic stroke.

The present study characterized the effects of TS-011 [N-(3-chloro-4-morpholin-4-yl) phenyl-N'-hydroxyimido formamide], a new selective inhibitor of the synthesis of 20-hydroxyeicosatetraenoic acid (20-HETE), on the metabolism of arachidonic acid by human and rat renal microsomes and the inhibitory effects of this compound on hepatic cytochrome P450 enzymes involved in drug metabolism. The effects of TS-011 on the fall in cerebral blood flow following subarachnoid hemorrhage (SAH) and in reducing infarct size in ischemic stroke models were also examined since 20-HETE may contribute to the development of cerebral vasospasm. TS-011 inhibited the synthesis of 20-HETE by human renal microsomes and recombinant CYP4A11 and 4F2, 4F3A, and 4F3B enzymes with IC50 values around 10 to 50 nM.

Increased excretion of urinary 20-HETE in rats with cyclosporine-induced nephrotoxicity.

The present study examined the contribution of 20-hydroxy-5,8,11,14-eicosatetraenoic acid (20-HETE) in cyclosporine A (CsA)-induced renal nephrotoxicity. Treatment of rats with CsA (50 mg/kg) for 9 days induced renal damage as indicated by marked increase in urine flow (from 9.0 +/- 0.