Drug review process advancement and required manufacturer and contract research oraganization responses.

The United States Senate passed the "FDA Modernization Act 2.0." on September 29, 2022.

Estimating dim light melatonin onset time in children using delta changes in melatonin.

Unlabelled: We aimed to establish a method for estimating dim light melatonin onset (DLMO) using mathematical slopes calculated from melatonin concentrations at three sampling points before and after sleep in children. The saliva of 30 children (mean age ± SD: 10.2 ± 1.

Anatase and rutile titanium oxide nanoparticles induce acute kidney injury by coadministration with paraquat, cisplatin or 5-aminosalicylic acid.

Nanoparticles are used in a variety of fields; for example, titanium oxide nanoparticles are used in paints, food additives, cosmetics, and sunscreen materials. Although the use of titanium oxide nanoparticles is regulated, their safety has not been established. Furthermore, the interaction between titanium oxide nanoparticles and various chemical substances and pharmaceuticals is unknown.

Reduction in short interval intracortical inhibition from the early stage reflects the pathophysiology in amyotrophic lateral sclerosis: A meta-analysis study.

Background And Purpose: Cortical hyperexcitability has been identified as a diagnostic and pathogenic biomarker of amyotrophic lateral sclerosis (ALS). Cortical excitability is assessed by transcranial magnetic stimulation (TMS), a non-invasive neurophysiological technique. The TMS biomarkers exhibiting highest sensitivity for cortical hyperexcitability in ALS remain to be elucidated.

Overcoming antibody-resistant SARS-CoV-2 variants with bispecific antibodies constructed using non-neutralizing antibodies.

A current challenge is the emergence of SARS-CoV-2 variants, such as BQ.1.1 and XBB.

Distinguishing two distinct types of salivary extracellular vesicles: a potential tool for understanding their pathophysiological roles.

Extracellular vesicles (EVs), which are found in almost all cells and human body fluids, are currently being studied as a source of pathophysiological information. Previously, we demonstrated that at least two types of EVs can be isolated from human whole saliva (WS) using enzymatic activity of dipeptidyl peptidase IV (DPP IV) as a marker for differentiating the EV subsets. In the present study, EV fractions, termed EV-I 20 k-ppt and EV-II 100 k-ppt, were prepared by a combination of size-exclusion chromatography of improved condition and sequential centrifugation.

Effects of Overweight on Risk of Thyroid Nodules in Children and Adolescents: The Fukushima Health Management Survey.

Context: Examining how overweight/obesity impacts thyroid nodule development in children and adolescents by sex and age can speculate on the mechanism.

Objective: We examined whether overweight in children and adolescents are associated with thyroid nodule development by sex and age.

Design: Approximately 300,000 participants who underwent thyroid ultrasonography in the Fukushima Health Management Survey after a nuclear accident were enrolled.

Capillary electrophoresis using triple layer modified capillary facilitating salivary ion analyses: Application to search for potential stress markers induced by cold pressure test.

In this study, we introduce a novel approach for the analysis of salivary ions using capillary electrophoresis (CE) with a triple-layer coated capillary. The capillary is sequentially coated with cationic silylating reagents, poly(vinylsulfonate), and polybrene to form a custom designed surface that effectively inhibits adsorption of protein matrix on the capillary inner wall and allows for reproducible ion analysis. For the CE with capacitively coupled contactless conductivity detection, we used suitable background electrolytes (BGEs) for salivary ion analysis.

Effects of small community walking intervention on physical activity, well-being, and social capital among older patients with cardiovascular disease in the maintenance phase: a randomized controlled trial.

[Purpose] Older patients with cardiovascular disease should increase their physical activity and prioritize positive psychological and social approaches in the maintenance phase of their cardiac rehabilitation. This study aimed to clarify the effect of small community walking on physical activity, well-being, and social capital in older patients with cardiovascular disease in the maintenance phase. [Participants and Methods] We conducted a multicenter study in Kumamoto, Japan.

Impact of Prefracture Cognitive Impairment and Postoperative Delirium on Recovery after Hip Fracture Surgery.

Objectives: This study aimed to examine the impact of prefracture cognitive impairment (CI) severity and postoperative delirium on recovery after hip fracture surgery in older patients.

Design: Prospective study with a 1-year follow-up.

Setting And Participants: We included 355 patients aged ≥80 years from 2 acute hospitals in Japan.

Comparison by ultrasound shear wave elastography of toe flexor muscle contraction during MTP flexion exercise and short-foot exercise.

Background: The intrinsic foot muscles play an important role in medial longitudinal arch support, as well as several extrinsic foot muscles. While various strength training methods specific to intrinsic foot muscles have been conducted, these exercises are associated with certain concerns regarding their effectiveness and difficulty. We developed a new exercise for the intrinsic muscles (MTP flexion exercise).

Association of Head-Neck Rotation With History of Pitching-Related Elbow Pain in Youth Baseball Players.

Background: Prevention of pitching-related elbow pain in youth baseball players is important. Overhead pitching involves a whole-body motion, including head-neck rotation. A limited range of motion of head-neck rotation may cause inefficient pitching motion; however, this association is unclear.

Development of an on-site therapeutic drug monitoring method using a portable spectrometer.

We report on the development of an on-site therapeutic drug monitoring (TDM) method for vancomycin (VCM) utilizing a portable spectrometer and commercially available immunoturbidimetric assay reagents designed for automated clinical chemistry analyzers. The method enables the quantification of VCM in plasma samples within 10 min, with a good correlation between the measured values and the theoretical values (r = 0.995).

Socioeconomic status and incident depressive symptoms among older adults: A 3-year longitudinal study from the Japan Gerontological Evaluation Study.

Objectives: The association between socioeconomic status (SES) and the onset of depressive symptoms has attracted considerable attention. However, few studies have simultaneously examined the association of multiple SES indicators, including "assets," with the onset of depressive symptoms. Therefore, this study examined the association of four SES indicators in old age ('years of education' 'equivalent income,' 'equivalent assets,' and 'the longest-held job') with new-onset depressive symptoms in a large Japanese dataset.

Topical Skin Application of Small-Molecule Antiplatelet Agent against Pressure Injury in Rat Models.

Due to prolonged forced positioning, the incidence of intraoperative pressure injuries is high. This study aimed to explore the impact of small-molecule antiplatelet drugs on pressure injuries by locally applying them before an injury occurs. In the first part of this study, water-soluble tracers with different molecular weights were applied to normal and early-stage pressure-injured skin.

Nucleotide alterations in the HLA-C class I gene can cause aberrant splicing and marked changes in RNA levels in a polymorphic context-dependent manner.

Polymorphisms of HLA genes, which play a crucial role in presenting peptides with diverse sequences in their peptide-binding pockets, are also thought to affect HLA gene expression, as many studies have reported associations between HLA gene polymorphisms and their expression levels. In this study, we devised an ectopic expression assay for the HLA class I genes in the context of the entire gene, and used the assay to show that the and polymorphic differences observed in association studies indeed cause different levels of RNA expression. Subsequently, we investigated the null allele, which was previously noted for its reduced expression, attributed to an alternate exon 3 3' splice site generated by G/A polymorphism at position 781 within the exon 3.

Post-Disaster Community Transition of Psychiatric Inpatients: Lessons from the Fukushima Nuclear Accident.

This study sought to explore factors related to community transition after the mandatory evacuation of psychiatric inpatients to other hospitals owing to the Fukushima Daiichi Nuclear Power Plant accident. A retrospective cohort design was adopted and 391 psychiatric patients were examined. Univariate and multivariate analyses were conducted to confirm the association between the achievement or non-achievement of discharge to community living and their backgrounds (age, gender, evacuation destination, psychiatric diagnoses, and physical complications).

Clinical effectiveness of trigger point acupuncture on chronic neck and shoulder pain (katakori) with work productivity loss in office workers: a randomized clinical trial.

Objectives: To evaluate whether trigger point acupuncture (TrPA) is beneficial for office workers who have reduced job performance (presenteeism) due to chronic neck and shoulder pain (katakori).

Methods: A 4-week single-center randomized controlled trial was conducted on 20 eligible female office workers with chronic neck and shoulder pain of at least 3-month duration. The control group implemented only workplace-recommended presenteeism measures, whereas the intervention group received TrPA up to 4 times per month in addition to the presenteeism measures recommended by each workplace.

Factors Related to Job Continuance of Nurses Who Migrated to Japan: A Cross-Sectional Study.

Japan has accepted nurses from Indonesia, the Philippines, and Vietnam under the Economic Partnership Agreement, but nearly half of them have already left the workforce. This study aimed to clarify the factors related to the job continuance of nurses who migrated to Japan under the Economic Partnership Agreement. Our goal was to explore factors specific to migrant nurses and to contribute to the development of support measures for them.

Mouse transient receptor potential melastatin 2 (TRPM2) isoform 7 attenuates full-length mouse TRPM2 activity through reductions in its expression by targeting it to ER-associated degradation.

Transient receptor potential melastatin 2 (TRPM2) assembles into tetramers to function as an oxidative stress-sensitive Ca channel at the surface membrane. Limited information is currently available on the 10 protein isoforms of mouse TRPM2 (mTRPM2) identified. This study investigated whether these isoforms function as Ca channels and examined their effects on full-length mTRPM2 activity using the HEK 293 cell exogenous expression system.

Guidance for assessment of the inflammation etiologic criterion for the GLIM diagnosis of malnutrition: A modified Delphi approach.

Background & Aims: The Global Leadership Initiative on Malnutrition (GLIM) approach to malnutrition diagnosis is based on assessment of three phenotypic (weight loss, low body mass index, and reduced skeletal muscle mass) and two etiologic (reduced food intake/assimilation and disease burden/inflammation) criteria, with diagnosis confirmed by fulfillment of any combination of at least one phenotypic and at least one etiologic criterion. The original GLIM description provided limited guidance regarding assessment of inflammation and this has been a factor impeding further implementation of the GLIM criteria. We now seek to provide practical guidance for assessment of inflammation in support of the etiologic criterion for inflammation.

Relationships between flexion strength and dexterity of the toes and physical performance.

Background: Toe function is characterised by the strength and dexterity of toe motion. However, previous studies have mostly focused on the importance of toe strength.

Objective: This study aimed to investigate the relationships between flexion strength and dexterity of the toes and physical performance.