Unused medicine take-back programmes: a systematic review.

Background: Improper disposal of unused medicine can impact the environment causing significant healthcare and financial burdens. While the medicine take-back programme is an effective management strategy, its effectiveness differs across countries. This study aimed to systematically review the take-back programmes in various countries and to identify areas needing improvement for programme enhancement.

Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.

Introduction: Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI.

Objective, Design, And Patients: To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities.

Prevalence of Comorbid Factors in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Randomized Trial of an Oral Microbiota-Based Therapeutic.

Background: Although comorbidities are risk factors for recurrent Clostridioides difficile infection (rCDI), many clinical trials exclude patients with medical conditions such as malignancy or immunosuppression. In a phase 3, double-blind, placebo-controlled, randomized trial (ECOSPOR III), fecal microbiota spores, live (VOWST, Seres Therapeutics; hereafter "VOS," formerly SER-109), an oral microbiota therapeutic, significantly reduced the risk of rCDI at week 8. We evaluated the efficacy of VOS compared with placebo in patients with comorbidities and other risk factors for rCDI.

Risk assessment of eighteen elements leaching from ceramic tableware in China.

Ceramic products are among the most frequently used food contact materials. Health risks associated with ceramic tableware usually arise from the migration of heavy metals. In this study, 767 pieces of ceramic tableware of different shapes and types were collected across China, and the migration levels of 18 elements were determined using inductively coupled plasma mass spectrometry.

Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial.

Importance: A safe and effective treatment for recurrent Clostridioides difficile infection (CDI) is urgently needed. Antibiotics kill toxin-producing bacteria but do not repair the disrupted microbiome, which promotes spore germination and infection recurrence.

Objectives: To evaluate the safety and rate of CDI recurrence after administration of investigational microbiome therapeutic SER-109 through 24 weeks.

SER-109: An Oral Investigational Microbiome Therapeutic for Patients with Recurrent Infection (rCDI).

Clostridioides difficile infection (CDI) is classified as an urgent health threat by the Centers for Disease Control and Prevention (CDC), and affects nearly 500,000 Americans annually. Approximately 20−25% of patients with a primary infection experience a recurrence, and the risk of recurrence increases with subsequent episodes to greater than 40%. The leading risk factor for CDI is broad-spectrum antibiotics, which leads to a loss of microbial diversity and impaired colonization resistance.

SER-109, an Oral Microbiome Therapy for Recurrent Infection.

Background: Current therapies for recurrent infection do not address the disrupted microbiome, which supports spore germination into toxin-producing bacteria. SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of recurrent infection.

Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial in which patients who had had three or more episodes of infection (inclusive of the qualifying acute episode) received SER-109 or placebo (four capsules daily for 3 days) after standard-of-care antibiotic treatment.

Resident Supervision and Patient Care: A Comparative Time Study in a Community-Academic Versus a Community Emergency Department.

Objective: The objective was to compare attending emergency physician (EP) time spent on direct and indirect patient care activities in emergency departments (EDs) with and without emergency medicine (EM) residents.

Methods: We performed an observational, time-motion study on 25 EPs who worked in a community-academic ED and a nonacademic community ED. Two observations of each EP were performed at each site.

A Multicenter Collaboration for Simulation-Based Assessment of ACGME Milestones in Emergency Medicine.

In 2014, the six allopathic emergency medicine (EM) residency programs in Chicago established an annual, citywide, simulation-based assessment of all postgraduate year 2 EM residents. The cases and corresponding assessment tools were designed by the simulation directors from each of the participating sites. All assessment tools include critical actions that map directly to numerous EM milestones in 11 different subcompetencies.

Clinical application of a novel developed pressure bladder indicator in lumbar epidural puncture.

Study Objective: A novel pressure bladder indicator was developed, and this study aimed to evaluate the clinical application of the pressure bladder indicator by measuring the epidural space pressure and bladder working pressure on patients undergoing lumbar epidural puncture.

Design: Randomized, prospective, double-blinded study

Patients: 130 patients

Setting: The Second Hospital of Shandong University

Interventions: In this study, 60 patients undergoing surgical procedures under lumbar epidural anesthesia were enrolled to detect epidural pressure, and other 70 patients who were undergoing lumbar epidural anesthesia or combined spinal-epidural anesthesia were enrolled to evaluate the pressure bladder indicator.

Measurements: After successful breakthrough of ligamentum flavum by traditional methods, a pressure transducer was connected to an epidural needle tail and a monitor to measure the epidural pressure at L1-L5 in 60 patients.

Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial.

Background: IL-23 is associated with plaque psoriasis susceptibility and pathogenesis. BI 655066 is a fully human IgG1 mAb specific for the IL-23 p19 subunit.

Objective: This first-in-human proof-of-concept study evaluated the clinical and biological effects of BI 655066 in patients with moderate-to-severe plaque psoriasis.

Systems-based practice: Summary of the 2010 Council of Emergency Medicine Residency Directors Academic Assembly Consensus Workgroup--teaching and evaluating the difficult-to-teach competencies.

Objectives: The development of robust Accreditation Council for Graduate Medical Education (ACGME) systems-based practice (SBP) training and validated evaluation tools has been generally challenging for emergency medicine (EM) residency programs. The purpose of this paper is to report the results of a consensus workgroup session of the 2010 Council of Emergency Medicine Residency Directors (CORD) Academic Assembly with the following objectives: 1) to discuss current and preferred local and regional methods for teaching and assessing SBP and 2) to develop consensus within the CORD community using the modified Delphi method with respect to EM-specific SBP domains and link these domains to specific SBP educational and evaluative methods.

Methods: Consensus was developed using a modified Delphi method.

Induction of TRPV1 desensitization by a biased receptor agonist.

Selective suppression of hyperactive sensory neurons is an attractive strategy for managing pathological pain. Blocking Na(+) channels to eliminate action potentials and desensitizing transduction channels can both reduce sensory neuron excitability. The novel synthetic vanilloid ligand cap-ET preserves agonist activation of intracellular Ca(2+) signals and large organic cation transport but loses effective electric current induction.