Safety of iGlarLixi in Japanese People with Type 2 Diabetes: A Post-marketing Database Study.

Introduction: In this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide).

Methods: In this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed.

Suggested Improvements to the Current East African Community Medicines Regulatory Harmonization Joint Review Process and a Proposed New Review Model for this Initiative.

Background: In 2012, the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative was established to improve access to safe, effective, and high-quality medical products to patients in the East African region. The East African Community (EAC) Partner States, the Republic of Burundi, Democratic Republic of Congo, Republic of Rwanda, United Republic of Tanzania, Republic of Kenya, Republic of South Sudan, and the Republic of Uganda, have a population of 290 million inhabitants. The timely access to medical products for this population was to be achieved through harmonisation of regulatory requirements, joint assessments, joint inspections of manufacturing sites, and the strengthening of regulatory systems.

Performance and Safety of the Medical Device Ialuxid Gel in the Treatment of Mild-Moderate Acne Vulgaris: An Open-Label, Noncomparative Multicentre Interventional Clinical Trial.

Background: Medical literature shows there is no ideal treatment for acne, but topical therapies like benzoyl peroxide, retinoids, and antibiotics have proven to improve mild-moderate cases. Replacing benzoyl peroxide (potentially irritating) with hydrogen peroxide has already been suggested in the medical literature.

Aims: We investigated a medical device, a proprietary combination of hyaluronic acid, hydrogen peroxide, and glycine in mild-moderate acne vulgaris.

Heard But Not Seen-Swedish Opera Choristers' Thoughts on Occupational Environment and Vocal Health, an Explorative Qualitative Study.

Objective: Professional operatic singing is vocally demanding, making the maintenance of professional vocal health a paramount concern for the opera chorister. Occupational environment has been shown to affect vocal health for other vocally dependent professions. Hence, the objective of the current study was to explore what occupational environment factors affect the professional vocal health of Swedish opera choristers.

Tinnitus and Its Comorbidities: A Comprehensive Analysis of Their Relationships.

This study aimed to explore the demographic and clinical features of tinnitus individuals and analyse its correlation with associated comorbidities. The study population comprised 147 participants (66 men, 81 women; median age: 52 years) who experienced persistent tinnitus. Comprehensive assessments were carried out, including audiological examinations, scoring using the Tinnitus Handicap Inventory, and thorough medical evaluations.

Pilot Study of Bone Turnover Biomarkers, Diet, and Exercise in Elite Female Ballet Dancers.

Elite ballet is one of the most demanding physical activities for the skeleton, making dancers susceptible to bone stress injuries. This pilot study compared bone remodeling in professional female ballet dancers from the Royal Ballet Company with controls from Imperial College London. The study included dancers (n = 5, median age 29 ± 16 years) and controls (n = 6, median age 24 ± 8.

Cognitive effects of ocrelizumab vs interferon β-1a in relapsing multiple sclerosis: A post hoc analysis of the OPERA I/II trials.

Background: Cognitive impairment is a well-recognized symptom of multiple sclerosis (MS) that can manifest early in the disease course. Deficits in cognitive function can have a major impact on daily life. However, cognitive decline is often under-examined in clinical trials and clinical practice due to lack of adequate data.

Long-Term Treatment With Ocrelizumab in Patients With Early-Stage Relapsing MS: Nine-Year Data From the OPERA Studies Open-Label Extension.

Background And Objectives: Patients with multiple sclerosis (MS) may demonstrate better disease control when treatment is initiated on high-efficacy disease-modifying therapies (DMTs) from onset. This subgroup analysis assessed the long-term efficacy and safety profile of the high-efficacy DMT ocrelizumab (OCR) as first-line therapy for early-stage relapsing MS (RMS).

Methods: Post hoc exploratory analyses of efficacy and safety were performed in a subgroup of treatment-naive patients with RMS who received ≥1 dose of OCR in the multicenter OPERA I/II (NCT01247324/NCT01412333) studies.

"Minimal-Advice" on Salt Intake: Results of a Multicentre Pilot Randomised Controlled Trial on Hypertensive Patients.

Introduction: A strong and well-known association exists between salt consumption, potassium intake, and cardiovascular diseases. MINISAL-SIIA results showed high salt and low potassium consumption in Italian hypertensive patients. In addition, a recent Italian survey showed that the degree of knowledge and behaviour about salt was directly interrelated, suggesting a key role of the educational approach.

The role of Chinese folk ritual music in biodiversity conservation: an ethnobiological perspective from the Lingnan region.

Background: Traditional ecological knowledge embedded in cultural practices is vital for biodiversity conservation but is increasingly under threat from modernization and globalization. This study investigates the role of Chinese folk ritual music in promoting biodiversity conservation, with a focus on Cantonese Opera and agricultural rituals in the Lingnan region of southern China.

Methods: We employed literature review, qualitative fieldwork, and ethnographic analysis, including interviews with local musicians and community members, to investigate how Cantonese Opera and agricultural rituals contribute to ecological sustainability by integrating cultural narratives with environmental stewardship.

Sucrose-preferring gut microbes prevent host obesity by producing exopolysaccharides.

Commensal bacteria affect host health by producing various metabolites from dietary carbohydrates via bacterial glycometabolism; however, the underlying mechanism of action remains unclear. Here, we identified Streptococcus salivarius as a unique anti-obesity commensal bacterium. We found that S.

Establishing minimal clinically important difference of modified dynamic gait index in people with subacute stroke.

Background: People with stroke (PwST) often have significant balance limitations, making it crucial to focus rehabilitation on improving mobility and reducing the risk of falls. The Modified Dynamic Gait Index (MDGI) is recommended for measuring balance in various neurological conditions, but a minimal clinically important difference (MCID) score specific to PwST is missing.

Objectives: To calculate the MCID of the MDGI in PwST during the subacute phase.

[Influence of non-opiate analgesia on postoperative pain intensity and patient satisfaction].

Objective: To compare the results of postoperative opiate and non-opiate analgesia.

Material And Methods: The study was carried out as a part of the OPERAS global trial. Analysis was conducted in accordance with the STROBE reporting guidelines for observational studies.

DNA methylation patterns of circadian and ultradian genes are altered in the peripheral blood of patients with hidradenitis suppurativa.

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that affects hair follicles in areas with apocrine sweat glands, such as the underarms, groin, and buttocks. The pathogenesis of HS is not fully understood, but considering the key role played by the biological clock in the control of immune/inflammatory processes the derangement of circadian and ultradian pathways could be hypothesized.

Methods: We analyzed genome-wide DNA methylation patterns in peripheral blood from 24 HS cases and 24 controls using the Infinium HumanMethylation450 BeadChip array (Illumina), followed by bioinformatics and statistical analyses.

Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized Trial.

Introduction: A slower adoption rate of fixed dose combinations (FDC) in diabetes management is partly due to insufficient data. This study evaluates the safety and efficacy of an FDC of dapagliflozin + sitagliptin + metformin hydrochloride extended release (XR), compared to a dual FDC of sitagliptin + metformin hydrochloride XR among patients with type 2 diabetes mellitus (T2DM) with poor glycemic control when treated with metformin monotherapy.

Methods: A total of 274 patients with T2DM were randomized (1:1) to either arm X, receiving FDC of dapagliflozin (10 mg) + sitagliptin (100 mg) + metformin hydrochloride XR (1000 mg) (Dapa + Sita + Met) tablets, or arm Y, receiving sitagliptin phosphate (100 mg) + metformin hydrochloride XR (1000 mg) (Sita + Met) tablets, and treated for 16 weeks.

Longitudinal Assessment of Age-Related Macular Degeneration Using Ultrawidefield Imaging: The Optos Peripheral Retina Follow-up Study.

Purpose: With the widespread availability of Ultrawidefield (UWF) imaging, peripheral retinal abnormalities in age-related macular degeneration (AMD) have garnered attention. However, longitudinal studies of AMD peripheral findings are limited. This study aimed to characterize and quantify these features over 5 years.

Machine learning predicts pulmonary Long Covid sequelae using clinical data.

Long COVID is a multi-systemic disease characterized by the persistence or occurrence of many symptoms that in many cases affect the pulmonary system. These, in turn, may deteriorate the patient's quality of life making it easier to develop severe complications. Being able to predict this syndrome is therefore important as this enables early treatment.

Real-World Study of US Adults with Paroxysmal Nocturnal Hemoglobinuria Treated with Pegcetacoplan.

: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening disease characterized by complement-mediated hemolysis. OPERA is the first US longitudinal real-world study on C3 inhibitor therapy, known as pegcetacoplan. : OPERA enrolled US patients with PNH, age ≥18, who were prescribed pegcetacoplan, and data were collected from routine care.

A phase III randomised trial on the addition of a contact X-ray brachytherapy boost to standard neoadjuvant chemo-radiotherapy for organ preservation in early rectal adenocarcinoma: 5 year results of the OPERA trial.

Background: The OPERA trial has shown that a contact X-ray brachytherapy 50 kV (CXB) boost with neoadjuvant chemoradiotherapy (NCRT) can increase organ preservation (OP) rate for early rectal adenocarcinoma (ADK) of low-mid rectum. We report the results after 5 years of follow-up.

Patients And Methods: OPERA was a multicentre, phase III trial that included operable patients (pts), with cT2-cT3b low-mid rectal ADK, tumours <5 cm, cN0 or cN1 <8 mm.

The minimally clinically important difference in the 2-minute walk test for people in the subacute phase after a stroke.

Background: The 2-Minute Walk Test (2MWT) is a simple and reliable test used by clinicians to assess gait function in people with stroke (pwST). No studies established the minimal clinically important difference (MCID) of the 2MWT.

Objective: To determine the MCID of the 2MWT in subacute pwST using data from a longitudinal cohort study.

Monte Carlo modeling of the origin of contaminant electrons on a 0.5T bi-planar Linac-MR.

Introduction: In the last decade, hybrid linear accelerator magnetic resonance imaging (Linac-MR) devices have evolved into FDA-cleared clinical tools, facilitating magnetic resonance guided radiotherapy (MRgRT). The addition of a magnetic field to radiation therapy has previously demonstrated dosimetric and electron effects regardless of magnetic field orientation.

Purpose: This study uses Monte Carlo simulations to investigate the importance and efficacy of the magnetic field design in mitigating surface dose enhancement in the Aurora-RT, focusing specifically on contaminant electrons, their origin, and energy spectrum.

Virologically suppressed switch to Dolutegravir/Lamivudine 2-Drug regimen versus switch to commonly prescribed 3-Drug regimens in the United States.

Background: Two-drug regimens (2DRs) have been introduced in recent years to potentially reduce antiretroviral therapy (ART) toxicities and drug-drug interactions while demonstrating comparable efficacy to three-drug regimens (3DRs) for people with HIV (PWH). The objective of this study was to compare the real-world effectiveness and durability of a single-tablet 2DR of dolutegravir/lamivudine (DTG/3TC) with that of commonly prescribed 3DRs in ART-experienced, virologically suppressed PWH during the first 24 months of DTG/3TC availability in the United States.

Methods: Virologically suppressed (viral load [VL] < 200 copies/mL) adult PWH initiating DTG/3TC 2DR, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), or a DTG-based 3DR between 01MAY2019 and 31OCT2020 were identified in the OPERA cohort and followed through 30APR2021.