Can switching to abatacept therapy in patients with rheumatoid arthritis on background methotrexate reverse TNF-inhibitor-induced antinuclear autoantibody/double-stranded DNA autoantibody conversion? An analysis of the AMPLE and ATTEST trials.

Objectives: To explore antinuclear autoantibody (ANA) and anti-double-stranded DNA (anti-dsDNA) autoantibody development during abatacept and tumour necrosis factor inhibitor (TNFi) treatment, and effects of switching from TNFi to abatacept in ANA/anti-dsDNA autoantibody-positive patients.

Methods: This was a post hoc analysis of biologic-naïve patients with active RA in ATTEST and AMPLE. In AMPLE, patients received subcutaneous abatacept or adalimumab (2 years).

Development of a self-efficacy questionnaire, 'Insulin Therapy Self-efficacy Scale (ITSS)', for insulin users in Japanese: The Self-Efficacy-Q study.

Aims/introduction: Although patient self-efficacy is known to affect adherence to therapy, no available tool measures self-efficacy of insulin therapy administration while addressing the entire therapeutic process and management. In light of this, we developed the 'Insulin Therapy Self-efficacy Scale (ITSS).'

Materials And Methods: Development of the ITSS involved three phases: (i) item generation and creation of a questionnaire draft; (ii) testing and correcting the items through interviews with patients; and (iii) a multicenter, single-arm study to validate the questionnaire.

Phase II feasibility study of preoperative concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil and elective lymph node irradiation for clinical stage II/III esophageal squamous cell carcinoma.

Background: Preoperative chemoradiotherapy (CRT) is a standard treatment for stage II/III esophageal cancer. Preoperative chemotherapy is also considered a standard treatment for stage II/III esophageal squamous cell carcinoma (ESCC) in patients who undergo radical lymph node dissection. We conducted a feasibility study of preoperative CRT with cisplatin plus 5-fluorouracil (CF) and elective lymph node irradiation followed by esophagectomy with radical lymph node dissection in patients with stage II/III ESCC.

Modern management for brain metastasis patients using stereotactic radiosurgery: literature review and the authors' gamma knife treatment experiences.

Historically, whole brain radiotherapy was administered to most patients with brain metastases. However, over the past three decades, stereotactic radiosurgery (SRS), targeted at individual cranial lesions, has been accepted widely. In this study, based on the authors' experiences along with published data, recent trends in SRS for brain metastases are discussed.

Optimization of combination therapy for chronic myeloid leukemia with dosing constraints.

In this work, we demonstrate a mathematical technique for optimizing combination regimens with constraints. We apply the technique to a mathematical model for treatment of patients with chronic myeloid leukemia. The in-host model includes leukemic cell and immune system dynamics during treatment with tyrosine kinase inhibitors and immunomodulatory compounds.

Effectiveness of a cognitive behavioural therapy-based anxiety prevention programme at an elementary school in Japan: a quasi-experimental study.

Background: The efficacy of cognitive behavioural therapy (CBT) for anxiety related problems in children is empirically supported. In addition, universal anxiety prevention programmes based on CBT have been demonstrated in recent years. The purpose of this study was to verify the effectiveness of a CBT based original programme 'Journey of the Brave,' aiming to prevent anxiety disorders and anxiety-related problems for Japanese children aged 10-12 years old.

Medical costs attributable to overweight and obesity in Japanese individuals.

Objective: We aimed to reveal the association between body mass index (BMI) and medical costs in the current Japanese population, and to estimate the population attributable fraction (PAF) of medical costs due to overweight and obesity.

Methods: A generalized linear mixed model with log link function and gamma distribution was used to evaluate the association between BMI and medical costs in 34,537 beneficiaries of the National Health Insurance aged 40-69 years in Chiba City. Medical cost data were obtained from insurance claims submitted between April 2012 and March 2016.

Imaging peritoneal metastasis of gastric cancer with F-fluorothymidine positron emission tomography/computed tomography: a proof-of-concept study.

Objective: Peritoneal metastasis (PM) is the most frequent form of metastasis in gastric cancer (GC). The sensitivity of detecting PM by pre-operative imaging modalities is low. Utility of positron emission tomography (PET) with F-fluodeoxyglucose (FDG) for GC is limited, because diffuse-type tumors are not FDG-avid.

The effects of xanthine oxidase inhibitor in patients with chronic heart failure complicated with hyperuricemia: a prospective randomized controlled clinical trial of topiroxostat vs allopurinol-study protocol.

Background: Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia.

Identifying improvable employment-related factors in schizophrenia patients.

Although many studies report various factors related to future employment of schizophrenia patients, few identify the treatable or improvable ones. The responses to the first year of treatment and daily antipsychotic drug doses may be the treatable and improvable factors. We surveyed 235 schizophrenia outpatients in three facilities, of whom 129 and 106 were employed and unemployed, respectively.

Intravenous nicorandil versus adenosine for fractional flow reserve measurement: a crossover, randomized study.

Nicorandil has vasodilatory effects on both the epicardial coronary arteries and the coronary microvasculature, thereby increasing coronary blood flow. The objective of the present study was to investigate the effectiveness of intravenous (IV) nicorandil infusion for fractional flow reserve (FFR) measurement. In this crossover randomized study, 49 patients underwent FFR measurement with a consecutive randomized order of patient-blind infusions of continuous IV adenosine administration and a single bolus IV administration of nicorandil.

Bronchoscopic assessment of bronchial anastomosis by visualizing local circulation status-index of hemoglobin (IHb) imaging.

Background: Healing of airway anastomosis is largely affected by local circulation. Index of hemoglobin (IHb) imaging is a color enhancement technique that clarifies local circulation in the gastrointestinal endoscopic field. In this study, we investigated the relationship between bronchoscopic assessment of bronchial anastomosis using IHb mode and occurrence of anastomosis-related complications.

Prevalence and Analysis of Medical Device-Related Pressure Injuries: Results from the International Pressure Ulcer Prevalence Survey.

Objective: To examine the prevalence and characteristics of medical device-related pressure injuries (MDR PIs) in a large, generalizable database.

Methods: This study is a retrospective analysis of the 2016 International Pressure Ulcer Prevalence data. Data were limited to US and Canadian facilities.

Is ganglionated plexus ablation effective for treating atrial fibrillation?

Purpose: Very few studies have investigated the efficacy of ganglionated plexus ablation during the conventional maze procedure. In this study, we sought to evaluate its additive effect in reducing recurrent atrial fibrillation after concomitant maze surgery.

Methods: A retrospective study was conducted of 79 patients who underwent Cox maze IV concomitantly with open-heart surgery with (GP group) or without (Maze group) ganglionated plexus mapping.

Hepatitis B virus reactivation in patients with rheumatoid arthritis: Analysis of the National Database of Japan.

This study aimed to determine the incidence and risk factors for hepatitis B virus (HBV) reactivation in patients with rheumatoid arthritis (RA) undergoing immunosuppressive therapy. The National Database of Japan, in which insurance claim data have been comprehensively accumulated, was utilized. The subjects were 76 641 RA patients who were plausibly initiated on immunosuppressive therapy from April 2013 to March 2014.

Evaluating cardiac risk: exposure response analysis in early clinical drug development.

The assessment of a drug's cardiac liability has undergone considerable metamorphosis by regulators since International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use E14 guideline was introduced in 2005. Drug developers now have a choice in how proarrhythmia risk can be evaluated; the options include a dedicated thorough QT (TQT) study or exposure response (ER) modeling of intensive electrocardiogram (ECG) captured in early clinical development. The alternative approach of ER modeling was incorporated into a guidance document in 2015 as a primary analysis tool which could be utilized in early phase dose escalation studies as an option to perform a dedicated TQT trial.

Development of new method to enrich human iPSC-derived renal progenitors using cell surface markers.

Cell therapy using renal progenitors differentiated from human embryonic stem cells (hESCs) or induced pluripotent stem cells (hiPSCs) has the potential to significantly reduce the number of patients receiving dialysis therapy. However, the differentiation cultures may contain undifferentiated or undesired cell types that cause unwanted side effects, such as neoplastic formation, when transplanted into a body. Moreover, the hESCs/iPSCs are often genetically modified in order to isolate the derived renal progenitors, hampering clinical applications.

Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial.

Background: Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein C5, in patients with severe Guillain-Barré syndrome.

A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.

Purpose: Pegfilgrastim is a long-acting granulocyte colony-stimulating factor indicated for prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy by promoting neutrophil recovery.

Methods: This phase 1, randomized, double-blind, three-way crossover trial in healthy volunteers evaluated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of the proposed biosimilar, comparing MYL-1401H, reference pegfilgrastim (Neulasta, Amgen Inc, Thousand Oaks, CA, USA) sourced from the European Union, and reference pegfilgrastim sourced from the USA. Primary PK end points were peak plasma concentration of pegfilgrastim (C) and area under the plasma concentration-time curve from the time of dosing to infinity (AUC).

Circulating autoantibodies against neuroblastoma suppressor of tumorigenicity 1 (NBL1): A potential biomarker for coronary artery disease in patients with obstructive sleep apnea.

Objective: Although severe obstructive sleep apnea (OSA) is an important risk factor for atherosclerosis-related diseases including coronary artery disease (CAD), there is no reliable biomarker of CAD risks in patients with OSA. This study aimed to test our hypothesis that circulating autoantibodies against neuroblastoma suppressor of tumorigenicity 1 (NBL1-Abs) are associated with the prevalence of CAD in patients with OSA.

Methods: Eighty-two adults diagnosed with OSA by polysomnography, 96 patients with a diagnosis of acute coronary syndrome (ACS) and 64 healthy volunteers (HVs) were consecutively enrolled.

A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.

Introduction: Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods: In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.

Type of second primary malignancy after achieving complete response by definitive chemoradiation therapy in patients with esophageal squamous cell carcinoma.

Background: While the standard treatment for stage II-III (non-T4) esophageal squamous cell carcinoma (ESCC) is neoadjuvant therapy followed by esophagectomy, definitive chemoradiation therapy (dCRT) is an option to treat ESCC patients who reject or may not tolerate surgical treatment. Second primary malignancy (SPM) is a problem for long-term survivors after achieving complete response (CR) by dCRT.

Methods: The source of the subjects in this study was the patients with stage II/III (excluding T4 disease) ESCC (UICC6th) who underwent dCRT from 2000 to 2011 at the National Cancer Center Hospital, Japan.

The antibody response in the bovine mammary gland is influenced by the adjuvant and the site of subcutaneous vaccination.

Intramammary infections in cattle resulting in mastitis have detrimental effects on cows' well-being, lifespan and milk production. In the host defense against S. aureus mastitis antibodies are thought to play an important role.

Impact of Arterial Stiffness on WatchPAT Variables in Patients With Obstructive Sleep Apnea.

Study Objectives: The WatchPAT is a wrist-worn portable device that creates integration data regarding peripheral arterial tone (PAT), oxyhemoglobin saturation, heart rate, and actigraphy to diagnose or screen for obstructive sleep apnea (OSA). Previous studies have demonstrated the efficacy and validity of respiratory variables measured by the WatchPAT compared to those using polysomnography (PSG). However, the effects of arterial stiffness or atherosclerosis on WatchPAT parameters remain to be elucidated.

Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.

The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin versus dual therapy with dapagliflozin or saxagliptin plus metformin was compared in a post-hoc analysis of 3 randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/d plus saxagliptin 5 mg/d. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/d or dapagliflozin 10 mg/d received dapagliflozin 10 mg/d or saxagliptin 5 mg/d, respectively, as add-on therapy.