Protocol for Cancloz: multicentre randomised, placebo-controlled, double-blind, parallel-group adaptive trial of cannabidiol for clozapine-resistant schizophrenia.

Background: Although clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia (TRS), only 40% of people with TRS respond, and there is limited evidence for augmentation agents. Cannabidiol (CBD) reduces positive symptoms in individuals with schizophrenia, but no trials have specifically examined its efficacy in those with clozapine-resistant schizophrenia.

Aims: To examine the clinical efficacy of CBD augmentation in people with clozapine-resistant schizophrenia.

Associations of the Gut Microbiome With Treatment Resistance in Schizophrenia.

Importance: There is growing interest in the role of gut microbiome composition in schizophrenia. However, lifestyle factors are often neglected, and few studies have investigated microbiome composition in treatment-resistant schizophrenia.

Objective: To explore associations between the gut microbiome and schizophrenia diagnosis, treatment resistance, clozapine response, and treatment-related adverse effects while adjusting for demographic and lifestyle factors.

Reversal learning in those with early psychosis features contingency-dependent changes in loss response and learning.

Introduction: People with psychotic disorders commonly feature broad decision-making impairments that impact their functional outcomes. Specific associative/reinforcement learning problems have been demonstrated in persistent psychosis. But these phenotypes may differ in early psychosis, suggesting that aspects of cognition decline over time.

Comprehensive Geriatric Assessment for younger outpatients with severe mental illness: protocol for a feasibility study.

Introduction: Individuals with severe mental illness are at risk of becoming prematurely frail. There is a critical unmet need for an intervention that reduces the risk of frailty and minimises the associated negative outcomes in this population. This study aims to provide novel evidence on the feasibility, acceptability and preliminary effectiveness of Comprehensive Geriatric Assessment (CGA) to improve health outcomes among people with co-occurring frailty and severe mental illness.

Suitability of a Low-Cost Wearable Sensor to Assess Turning in Healthy Adults.

Background: Turning is a complex measure of gait that accounts for over 50% of daily steps. Traditionally, turning has been measured in a research grade laboratory setting, however, there is demand for a low-cost and portable solution to measure turning using wearable technology. This study aimed to determine the suitability of a low-cost inertial sensor-based device (AX6, Axivity) to assess turning, by simultaneously capturing and comparing to a turn algorithm output from a previously validated reference inertial sensor-based device (Opal), in healthy young adults.

Impairments in goal-directed action and reversal learning in a proportion of individuals with psychosis.

Cognitive impairment in psychosis is one of the strongest predictors of functional decline. Problems with decision-making processes, such as goal-directed action and reversal learning, can reflect cortico-striatal dysfunction. The heterogenous symptoms and neurobiology observed in those with psychosis suggests that specific cognitive phenotypes may reflect differing causative mechanisms.

Development of the Sepsis-Associated Adverse Outcomes in Pregnancy Score.

Objective: This study aimed to develop and evaluate a scoring system-called the Sepsis-Associated Adverse Outcomes in Pregnancy (SAAP) Score-to identify individuals with maternal infection that have composite maternal adverse outcomes (CMAO).

Study Design: Using the International Classification of Disease codes, we identified pregnant and postpartum (up to 6 weeks after birth) individuals admitted at our center with a primary diagnosis of infection. The primary outcome was CMAO which included any of the following: maternal intensive care unit admission, surgical intervention, vasopressor use, acute respiratory distress syndrome, pulmonary edema, mechanical ventilation, high-flow nasal cannula, disseminated intravascular coagulation, dialysis, organ failure, venous thromboembolism, or maternal death.

Clinical findings predictive of maternal adverse outcomes with pyelonephritis.

Background: Pyelonephritis, a leading cause of infection during pregnancy, is associated with increased maternal adverse outcomes. Therefore, early recognition and intervention of pyelonephritis are important. Early recognition of pyelonephritis has historically been dependent on fever and costovertebral angle tenderness.

Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia.

Background: Schizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative holds potential to be an effective, accessible treatment for schizophrenia, though the optimal dosing and mechanism of action of the compound requires further investigation.

CoMET: a randomised controlled trial of co-commencement of metformin versus placebo as an adjunctive treatment to attenuate weight gain in patients with schizophrenia newly commenced on clozapine.

Background: There is limited evidence on interventions to minimise weight gain at clozapine commencement. We compared the effect of adjunctive metformin placebo at clozapine initiation.

Methods: People with schizophrenia commencing on clozapine were randomised to either metformin or placebo for 24 weeks.

The Effect of Adjunctive Mangosteen Pericarp on Cognition in People With Schizophrenia: Secondary Analysis of a Randomized Controlled Trial.

Cognitive impairment is prevalent and often highly burdensome in people with schizophrenia. The aim of this study was to investigate if mangosteen ( Linn.) pericarp extract may be an effective intervention to improve cognitive performance in this population.

Cannabidiol for at risk for psychosis youth: A randomized controlled trial.

Background: No biological treatment has been firmly established for the at-risk stage of psychotic disorder. In this study we aim to test if subthreshold psychotic symptoms can be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa. The question has taken on increased importance in the wake of evidence questioning both the need and efficacy of specific pharmacological interventions in the ultra-high risk (UHR) for psychosis group.

Analysis of the use of a mobile simulation unit using the principles of a managed educational network.

Introduction: One of the challenges of delivering safe, reliable, quality health care is ensuring the workforce have access to the right training at the right time wherever they are practising. Like other high reliability fields, healthcare education has recognised the important role of simulation based education in embedding a culture of readiness for practice. Managed clinical networks (MCNs) have a proven track record in enhancing services for patients.

Adjunctive Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d'appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d'efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo.

Objectives: Linn. ("mangosteen") pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia.

Effect of Sodium Benzoate vs Placebo Among Individuals With Early Psychosis: A Randomized Clinical Trial.

Importance: There is evidence that sodium benzoate (BZ) may be an effective adjunctive treatment for schizophrenia. The clinical efficacy of BZ has been investigated in chronic schizophrenia; however, the efficacy of this agent has not been studied in individuals with early psychosis.

Objective: To examine the clinical efficacy of the adjunctive use of BZ for symptoms in people with early psychosis.

Randomized controlled trial of social cognition and interaction training compared to befriending group.

Background: Deficits in social cognition are common in people with schizophrenia and are associated with impaired functioning. Finding effective interventions to address these deficits is a priority. Social Cognition Interaction Training (SCIT) is a psychosocial intervention that has demonstrated acceptability and feasibility in various health care settings.

Effects of Sterilization Techniques on Bioactivity of Polymethyl Methacrylate Antibiotic Beads Containing Vancomycin and Tobramycin.

Objectives: Prefabrication and storage of antibiotic beads may decrease surgical time and allow for use in other settings. This study investigated the effects of sterilization technique and storage time on the bioactivity of antibiotic polymethyl methacrylate (PMMA) beads.

Methods: Uniform beads of PMMA containing 1 g each of tobramycin and vancomycin were sterilized using autoclave, ethylene oxide (ETO), or ultraviolet (UV) light.

Students' Perceptions on a Business Plan Assignment for an Ambulatory Care Pharmacy Elective.

To evaluate a business-centered assignment implemented in a pharmacy elective course at two different institutions and analyze student perceptions of the delivery platforms used and the value and utility of the assignment. The ambulatory care electives at Butler University and Samford University introduce students to the expanding role of the ambulatory care pharmacist, emphasizing business plan development for new ambulatory care pharmacy services. As part of the elective, students are asked to work in groups to complete a business plan for a new ambulatory care service of their choosing.

Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis.

Background: CADENCE-BZ is a multi-centre, parallel-group, double-blind randomized controlled trial designed to examine the clinical efficacy and safety of an accessible food preservative, sodium benzoate, as an add-on treatment for patients with early psychosis. The original study protocol was published in 2017. Here, we describe the updated protocol along with the Statistical Analysis Plan (SAP) for the CADENCE-BZ trial prior to study completion.

Protocol and Rationale: A 24-week Double-blind, Randomized, Placebo Controlled Trial of the Efficacy of Adjunctive Linn. (Mangosteen) Pericarp for Schizophrenia.

Objective: : Linn., commonly known as mangosteen, is a tropical fruit with a thick pericarp rind containing bioactive compounds that may be beneficial as an adjunctive treatment for schizophrenia. The biological underpinnings of schizophrenia are believed to involve altered neurotransmission, inflammation, redox systems, mitochondrial dysfunction, and neurogenesis.

CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine.

Introduction: Clozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.

Methods And Analysis: A 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement.

Lumbar Spine Trabecular Bone Score (TBS) Reflects Diminished Bone Quality in Patients With Diabetes Mellitus and Oral Glucocorticoid Therapy.

Trabecular bone score (TBS) is a texture parameter that measures the grayscale variation within dual-energy X-ray absorptiometry (DXA) images, and has been shown to significantly correlate with the 3-dimensional bone microarchitecture. The objective of this study was to determine whether TBS is a better clinical tool than traditionally used bone mineral density (BMD) to detect the skeletal deterioration seen in patients with diabetes (DM), patients undergoing oral glucocorticoid (GC) therapy, and patients who are both diabetic and taking steroids (GC + DM). We performed retrospective, cross-sectional study using DXA images of patients who visited UTHealth Department of Internal Medicine DXA clinic in Houston, TX, from May 30, 2014 to May 30, 2016.

The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial.

Background: Psychotic disorders affect up to 3% of the population and are often chronic and disabling. Innovation in the pharmacological treatment of psychosis has remained stagnant in recent decades. In order to improve outcomes for those with psychotic disorders, we present a protocol for the trial of a common food preservative, sodium benzoate, as an adjunctive treatment in early psychosis.

Novel virus dynamics in an Emiliania huxleyi bloom.

Diel studies of an Emiliania huxleyi bloom within a mesocosm revealed a highly dynamic associated viral community, changing on small times scales of hours.