Emergency randomized controlled

OBJECTIVE: The aim of this study was to demonstrate whether lasofoxifene improves vaginal signs/symptoms of genitourinary syndrome of menopause. METHODS: Two identical, phase 3 trials randomized postmenopausal women with moderate to severe vaginal symptoms to oral lasofoxifene 0.25 or 0.5 mg/d, or placebo, for 12 week. Changes from baseline to week 12 in most bothersome symptom, vaginal pH, and percentages of vaginal parabasal and superficial cells were evaluated...

This study aimed to evaluate the pharmacokinetics (PKs), safety, and immunogenicity of the biosimilar HEC14028 compared to reference Trulicity® (dulaglutide) in healthy male Chinese subjects. This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period. A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0...

BACKGROUND: Growing evidence suggests that cognitive dysfunction significantly impacts patients' quality of life. Intermittent theta burst stimulation (iTBS) has emerged as a potential intervention for cognitive dysfunction. However, consensus on the iTBS protocol for cognitive impairment is lacking. METHODS: We conducted searches in the Cochrane Central Register of Controlled Trials, EMBASE, PubMed, Chinese National Knowledge Infrastructure, Wanfang Database and the Chongqing VIP Chinese Science and Technology Periodical Database from their inception to January 2024...

Amblyopia is a neurodevelopmental disorder of the visual system that impairs the vision of millions of children worldwide. Amblyopia is best treated within the sensitive period of visual development when a child is up to seven years of age. Currently, the gold standard for early treatment of childhood amblyopia is patching, with new treatments emerging in recent years. We aim to evaluate the effectiveness of these newly developed treatments for amblyopia in children aged seven years and younger while comparing them to the current industry standard of patching...

BACKGROUND: Older people require extra attention due to their reduced ability to prepare for disasters, as they adequately possess distinct needs. These groups necessitate uncomplicated, readily consumable, and palatable food options that fulfill their micronutrient needs. The objective of this research was to assess the effects of a snack bar enriched with api-api mangrove ( Avicennia marina ) and sword bean ( Canavalia ensiformis ) on the body weight and Body Mass Index (BMI) of older people individuals afflicted by a landslide event...

This was a double-blind, randomized, phase 2 study of adults (18-64 years) with DSM-5 diagnosis of major depressive disorder (MDD), with moderate-to-severe episode severity (Montgomery-Åsberg Depression Rating Scale [MADRS] ≥25) despite an adequate course with ongoing antidepressant for ≥6 weeks to ≤12 months. Following a double-blind placebo lead-in period (up to 3 weeks), participants were randomized to receive once daily aticaprant 10 mg or continue placebo, added to their ongoing treatment, for 6 weeks...

BACKGROUND: Immersive virtual reality (IVR) as a research platform to study human behaviors is an emerging field and may be useful for studying self-care management, especially in the gap between formal healthcare recommendations and day-to-day living. Self-care activities, such as grocery shopping, can be challenging for people with chronic illness. We developed an IVR environment that simulates a real-life grocery store and conducted a usability study to demonstrate the safety and acceptability of IVR as an experimental environment...

BACKGROUND OBJECTIVES: Insect growth regulators (IGRs) are biological hormone analogue or mimics used as pesticides to inhibit the growth of larva during their molting and skin shedding. This study aimed to test the effect of IGRs on the eggs hatching and post-hatching inhibition of Aedes mosquitoes and understanding its effect in the mosquito breeding habitats for reduction in adult emergence. METHODS: Experiments on the evaluation of three insect growth regulators (IGRs) for the control of different stages of Aedes aegypti was carried out during 2020-21...

ARISE (Aneurysm/AVM/cSDH Roundtable Discussion With Industry and Stroke Experts) organized a one-and-a-half day meeting and workshop and brought together representatives from academia, industry, and government to discuss the most promising approaches to improve outcomes for patients with chronic subdural hematoma (cSDH). The emerging role of middle meningeal artery embolization in clinical practice and the design of current and potential future trials were the primary focuses of discussion. Existing evidence for imaging, indications, agents, and techniques was reviewed, and areas of priority for study and key questions surrounding the development of new and existing treatments for cSDH were identified...

RATIONALE: Early identification of children with poorly controlled asthma is imperative for optimizing treatment strategies. The analysis of exhaled volatile organic compounds (VOCs) is an emerging approach to identify prognostic and diagnostic biomarkers in pediatric asthma. OBJECTIVES: To assess the accuracy of gas chromatography-mass spectrometry based exhaled metabolite analysis to differentiate between controlled and uncontrolled pediatric asthma. METHODS: This study encompassed a discovery (SysPharmPediA) and validation phase (U-BIOPRED, PANDA)...

EVER206 (also known as SPR206) is a novel polymyxin analog that has shown in vitro potency and in vivo efficacy against multidrug-resistant (MDR) Gram-negative pathogens. This randomized, double-blinded, placebo-controlled, Phase I study evaluated the safety, tolerability, and pharmacokinetics of EVER206 in healthy Chinese subjects. After single administration of 50-300 mg EVER206, the Cmax ranged from 3.94 to 25.82 mg/L, and the AUC0-inf ranged from 12.42 to 101.67 h·mg/L. The plasma exposure displayed a linear relationship with the dose administered...

BACKGROUND: Pediatric femoral fractures are common in emergency rooms, with treatment options varying by age. This study compares elastic stable intramedullary nailing (ESIN) and plate fixation for diaphyseal femoral fractures in children aged 5-10. MATERIAL AND METHODS: Conducted at Al-Kindi Teaching Hospital, Baghdad, from December 2017 to December 2019, this prospective study included 32 children with closed transverse diaphyseal femoral fractures. Patients were divided into two groups: 16 treated with ESIN (Group 1) and 16 with plate fixation (Group 2)...

The global adoption of remote thyroidectomy is increasing, with the transoral endoscopic thyroidectomy vestibular approach (TOETVA) and transareolar approach (TAA) emerging as predominant methods. However, existing meta-analyses comparing these approaches to operative surgeries and short-term postoperative complications have significant limitations. To address this gap, our meta-analysis provides a comprehensive comparison between the TOETVA and TAA, focusing on operation time, intraoperative blood loss, postoperative drainage, and hospital stay duration...

Traumatic brain injury (TBI) confers significant morbidity and mortality, and is a pathology often encountered by trauma surgeons. Several recent trials have evaluated management protocols of patients with severe TBI. The Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II trial (BOOST-II) evaluated efficacy and feasibility of brain oxygen measurement in severe TBI. BOOST phase 3 trial (BOOST-3) and two ongoing trials look to measure functional outcomes in this population. Furthermore, middle meningeal artery embolization has now become standard therapy for adult patients with chronic subdural hematoma (SDH) and has increasing popularity in those with recurrent SDH as an alternative to surgical intervention...

OBJECTIVE: To investigate the application of personal health record (PHR) and chronic disease management platform established on the basis of patient portal system (PPS) in managing older adults with coronary heart disease and to examine the effect on patients' self-care ability, coping mode, and quality of life. METHODS: A total of 532 elderly patients with coronary heart disease were included in the study. All the participants enrolled were admitted to a tertiary-care hospital between January 2019 and June 2021...

INTRODUCTION: Gastric cancer (GC) is the third largest cause of cancer-related death worldwide, with major geographic disparities in incidence and outcomes. Sociodemographic indicators, food habits, and genetic predispositions all add to the load. Despite advances in systemic treatments, peritoneal metastasis remains a concern, with intraperitoneal chemotherapy (IPC) emerging as a promising treatment option. METHODS: A prospective cohort research was done, with 30 GC patients receiving cytoreductive surgery (CRS) followed by lobaplatin-based intraoperative chemotherapy...

While rapid development and roll out of COVID-19 vaccines is necessary in a pandemic, the process limits the ability of clinical trials to assess longer-term vaccine efficacy. We leveraged COVID-19 surveillance data in the U.S. to evaluate vaccine efficacy in U.S. Government-funded COVID-19 vaccine efficacy trials with a three-step estimation process. First, we used a compartmental epidemiological model informed by county-level surveillance data, a "population model", to estimate SARS-CoV-2 incidence among the unvaccinated...

We investigated efficacy and safety of mavorixafor, an oral CXCR4 antagonist for participants with Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) syndrome, a rare immunodeficiency caused by CXCR4 gain-of-function variants. This randomized (1:1), double-blind, placebo-controlled, phase 3 trial enrolled participants aged ≥12 years with WHIM syndrome and absolute neutrophil count (ANC) ≤400/μL. Participants received once-daily mavorixafor or placebo for 52 weeks. Primary endpoint was time (hours) above ANC threshold ≥500/μL (TATANC; over 24 hours)...

BACKGROUND: People with severe mental illness, such as schizophrenia-spectrum disorder and bipolar disorder, face poorer health outcomes from multiple chronic illnesses. Physical multimorbidity, the coexistence of two or more chronic physical conditions, and psychiatric multimorbidity, the coexistence of three or more psychiatric disorders, are both emerging concepts useful in conceptualising disease burden. However, the prevalence of physical and psychiatric multimorbidity in this cohort is unknown...

INTRODUCTION: Intraoperative iatrogenic MCL injuries during primary TKA are rare complications that lack a gold standard management protocol. This review aims to provide insight into various treatment modalities and evidence-based guidance for improved patient outcomes. METHODS: A comprehensive search across five databases identified relevant randomized control trials and retrospective cohort studies with reported outcomes. A total of 17 studies were included, and variables such as patient demographics, injury type, management, and Knee Society Scores (KSS) were assessed...