Pharmacokinetic, Pharmacokinetic/Pharmacodynamic, and Safety Investigations of Cefiderocol in Chinese Healthy Subjects.

Introduction: We aim to evaluate the safety and pharmacokinetic (PK) properties of cefiderocol in Chinese participants, following single and subsequent multiple administrations of 2 g q8h with 3-h intravenous infusion, and to predict its efficacy for the treatment of Gram-negative bacilli (GNB) infection based on PK/pharmacodynamic (PD) analysis.

Methods: This was an open-label, single-center, single- and multiple-dose phase I study, conducted from September 2022 to October 2022, with 12 eligible healthy Chinese adults (6 men and 6 women). The PK profiles were described by noncompartmental analysis and a two-compartment model using WinNonlin (v.

Classification of coastal wetlands in the Liaohe Delta with multi-source and multi-feature integration.

Coastal wetlands, situated at the interface of land and sea, are the most productive ecosystems on the planet, boasting the richest biodiversity and the highest value in ecological services. The primary goal of this study is to analyze the spatial distribution of land use within the Liaohe Delta wetlands and to introduce a wetland classification system that integrates multiple sources and features, utilizing Google Earth Engine (GEE) for the Liaohe Delta wetlands. Firstly, the Sentinel 2 data were downloaded by median synthesis on GEE, after which random sample points were selected on QGIS, and secondly, the multi-source feature set was created by integrating data from Sentinel 1, Sentinel 2, and a Digital Elevation Model (DEM), utilizing the Recursive Feature Elimination (RFE) algorithm within a Random Forest (RF) framework to optimize feature selection.

Waterbird community response to wetland and climate changes in the Liaohe River Estuary wetlands, China.

The Liaohe River Estuary (LRE) wetland is a critical stopover on the East Asian-Australasian Flyway (EAAF), vital to coastal ecological balance and biodiversity. However, the drivers of changes in waterbird diversity remain unclear. This study utilised random forests to produce reliable time-series wetland mapping from 2010 to 2023.

Population pharmacokinetics and pharmacodynamics of HFB30132A, a monoclonal antibody against SARS-CoV-2, in healthy Chinese and US subjects.

Development of neutralizing monoclonal antibodies (nAbs) is a strategy for treatment of infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of HFB30132A, a fully human nAb targeting the SARS-CoV-2 spike protein receptor binding domain in healthy subjects. A randomized, double-blind, placebo-controlled phase I trial was performed in healthy Chinese and US subjects.

The effects of a facilitator-enabled online multicomponent iSupport for dementia programme: A multicentre randomised controlled trial.

Background: Multicomponent interventions with carers of people with dementia demonstrate positive effects on the health and quality of life for carers and care recipients. The World Health Organization's iSupport for Dementia is an evidence-based online psychoeducation programme for carers. However, the programme was mainly implemented as a self-learning tool which might have limited its positive effects on carers and care recipients.

Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypes.

Obstructive hypertrophic cardiomyopathy (oHCM) is a subtype of HCM characterized by left ventricular outflow tract obstruction resulting from cardiac muscle hypertrophy and anatomic alterations in the mitral valve and apparatus. Mavacamten, a cardiac myosin inhibitor metabolized primarily by CYP2C19 in the liver, is the first and only targeted medication approved for the treatment of symptomatic New York Heart Association (NYHA) class II-III oHCM. Previous pharmacokinetic (PK) results of mavacamten in healthy Caucasian, Japanese, and Asian participants demonstrated that mavacamten exposure was affected by CYP2C19 metabolism status.

Impacts of a herring gull colony on runoff water quality from an urban green roof.

Green infrastructure (GI) strategies, including green roofs, have become a common, decentralized, nature-based strategy for reducing urban runoff and restoring ecosystem services to the urban environment. In this study, we examined the water quality of incident rainfall and runoff from a green roof installed on top of the Jacob K. Javits Convention Center in New York City.

Laparoscopic ileocecal-sparing vs traditional right hemicolectomy for cancer of the hepatic flexure or proximal transverse colon: a dual-center propensity score-matched study.

Background: Traditional right hemicolectomy (TRH) is the standard treatment for patients with nonmetastatic right colon cancer. However, the ileocecum, a vital organ with mechanical and immune functions, is removed in these patients regardless of the tumor location. This study aimed to evaluate the technical and oncological safety of laparoscopic ileocecal-sparing right hemicolectomy (LISH).

Barriers and facilitators to dementia care in long-term care facilities: protocol for a qualitative systematic review and meta-synthesis.

Introduction: Long-term care needs for people with dementia are predicted to increase due to increased life expectancy and dementia diagnoses. Most published meta- syntheses of dementia care focus on hospitals or home settings. When focusing on long-term care facilities, most reviews about dementia care only focus on a single outcome, such as feeding, behavioural symptoms management, palliative care and others, which is limited.

Safety and pharmacokinetics of IBI112, an IL-23 monoclonal antibody, in Chinese healthy volunteers: a first-in-human phase 1 study.

Background: Interleukin (IL) 23p19 monoclonal antibodies were efficacious and safe in the treatment of psoriasis. A first-in-human (FIH) study was conducted to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of IBI112, a novel IL-23p19 monoclonal antibody.

Methods: In this FIH, randomized, double-blind, placebo-controlled, single-ascending-dose study, a subcutaneous (SC, 5-600 mg) or intravenous (IV, 100 and 600 mg) or placebo was administered to eligible healthy subjects.

Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study.

The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) still protracts worldwide. HFB30132A is an anti- SARS-CoV-2 monoclonal antibody purposely engineered for an extended half-life with neutralizing activity against majority of the virus variants identified so far. The aim of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of HFB30132A in healthy Chinese subjects.

LZM008, a proposed tocilizumab biosimilar: Pharmacokinetics, safety, and immunogenicity profiles compared with ACTEMRA in Chinese healthy male subjects.

This study aimed to investigate the pharmacokinetics, safety, and immunogenicity of recombinant humanized anti-human IL-6R monoclonal antibody injection, LZM008, and evaluate the pharmacokinetic similarity between LZM008 and tocilizumab (ACTEMRA) in Chinese healthy male subjects. In this randomized, double-blinded, paralleled, two-center Phase I clinical trial, 96 subjects were randomized with a 1:1 ratio to receive 4 mg/kg intravenous dose of LZM008 or ACTEMRA and evaluated for 28 days. The pharmacokinetic bioequivalence was assessed by the maximum serum concentration (C), the area under the serum concentration-time curve (AUC) from time 0 to the last detectable drug concentration (AUC), and AUC.

A Randomized Phase III Study of Anlotinib Versus Bevacizumab in Combination With CAPEOX as First-Line Therapy for Wild-Type Metastatic Colorectal Cancer: A Clinical Trial Protocol.

Chemotherapy combined with antivascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor monoclonal antibodies is the most promising approach to prolong survival and improve the quality of life of patients with unresectable metastatic colorectal cancer (mCRC). Anlotinib is an oral antiangiogenic tyrosine kinase inhibitor that targets VEGF receptors 1/2/3, fibroblast growth factor receptors 1-4, and platelet-derived growth factor receptors a/β. Since anlotinib combined with oxaliplatin and capecitabine (CAPEOX) as a first-line treatment was previously shown to be effective and safe for patients with wild-type (WT) mCRC, we designed this randomized, open-label, parallel-group, non-inferiority, phase III study to evaluate the efficacy and safety of anlotinib plus CAPEOX versus bevacizumab plus CAPEOX in patients with WT mCRC.

Plasma-generated reactive water mist for disinfection of N95 respirators laden with MS2 and T4 bacteriophage viruses.

Due to the shortage of personal protective equipment (PPE) during the COVID-19 pandemic, the interest and demand for sterilization devices to reuse PPE has increased. For reuse of face masks, they must be effectively decontaminated of potential infectious agents without compromising its filtration ability during sterilization. In this study, we utilized an atmospheric pressure pulsed dielectric barrier discharge (DBD), combined with nebulized liquid microdroplets to generate plasma-activated mist (PAM).

Seroprevalence of influenza viruses in Shandong, Northern China during the COVID-19 pandemic.

Nonpharmaceutical interventions (NPIs) have been commonly deployed to prevent and control the spread of the coronavirus disease 2019 (COVID-19), resulting in a worldwide decline in influenza prevalence. However, the influenza risk in China warrants cautious assessment. We conducted a cross-sectional, seroepidemiological study in Shandong Province, Northern China in mid-2021.

The Effectiveness of Multi-Component Interventions on the Positive and Negative Aspects of Well-Being among Informal Caregivers of People with Dementia: A Systematic Review and Meta-Analysis.

The present review aims to examine whether multi-component interventions for informal caregivers of people with dementia are effective on positive and negative aspects of caregiver well-being. Eleven databases were searched from inception to 8 March 2021. Only randomized controlled trials reporting the effectiveness of multi-component intervention on positive and negative aspects of caregiver well-being were eligible.

Phase II study of anlotinib in combination with oxaliplatin and capecitabine for patients with RAS/BRAF wild-type metastatic colorectal adenocarcinoma as the first-line therapy.

Background: Anlotinib, an oral small molecule tyrosine kinase inhibitor targeting VEGFR 1/2/3, FGFR 1-4, PDGFR a/β, and c-kit, had demonstrated prolonged progression-free survival (PFS) in refractory metastatic colorectal cancer (mCRC). This multicenter, single-arm, phase II, exploratory study was conducted to evaluate the efficacy and safety of anlotinib combined with capecitabine and oxaliplatin as first-line treatment for unresectable RAS/BRAF wild-type mCRC.

Methods: Patients aged 18-75 with RAS/BRAF wild-type unresectable mCRC, without prior systemic treatment, and ECOG performance status ≤1 were enrolled.

OLA1 promotes colorectal cancer tumorigenesis by activation of HIF1α/CA9 axis.

Background: Obg-like ATPase 1 (OLA1) is a highly conserved GTPase, which was over expressed in a variety of malignant tumors, but its role in colorectal cancer (CRC) was poorly studied.

Patients And Methods: Three public CRC gene databases were applied for OLA1 mRNA expression detection. The clinical data of 111 CRC patients were retrospectively collected from the Second Affiliated Hospital of Zhejiang University (SAHZU) for OLA1 protein expression and Kaplan-Meier Survival analysis.

Long-term risk of colorectal cancer after removal of adenomas during screening colonoscopies in a large community-based population in China.

Patients with conventional adenoma removal are recommended to undergo colonoscopy surveillance to prevent colorectal cancer (CRC). However, evidence supporting the guidelines of colonoscopy surveillance is limited, especially among the Chinese population. We investigated the association between colonoscopy adenoma findings and CRC risk among individuals aged 40 to 74 years who underwent baseline colonoscopy from 2007 to 2016 in Jiashan and Haining, Zhejiang, China; 34 382 participants were categorized into advanced adenoma, nonadvanced adenoma and no adenoma based on adenoma findings.

Efficacy of rigosertib, a small molecular RAS signaling disrupter for the treatment of -mutant colorectal cancer.

Objective: Mutant KRAS, the principal isoform of RAS, plays a pivotal role in the oncogenesis of colorectal cancer by constitutively activating the RAF/MEK/ERK and PI3K/AKT pathways. Effective targeted therapies are urgently needed. We investigated whether rigosertib, a benzyl styryl sulfone RAS signaling disruptor, could selectively kill -mutant colorectal cancer cells.

Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread rapidly worldwide. This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab (CB6, JS016, LY3832479, or LY-CoV016), in healthy adults. This paper describes a randomized, double-blind, placebo-controlled, phase 1 study.

Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Oral Doses of Tegoprazan in Healthy Chinese Subjects.

Background And Objectives: Tegoprazan is one of the potassium-competitive acid blockers (P-CABs). It exhibits its anti-secretory effects by competitively and reversibly blocking the availability of K of the H, K-ATPase. This study was designed to investigate the safety and pharmacokinetics of tegoprazan in healthy Chinese subjects.

Prevalence and Associated Factors of Fecal Incontinence and Double Incontinence among Rural Elderly in North China.

Fecal and double incontinence are known to be more prevalent among the rural elderly. Yet, there have been few studies on their epidemic condition among Chinese rural elders. This study estimated the prevalence and correlates of fecal and double incontinence in rural elderly aged 65 years and over in North China.